Page last updated: 2024-11-04

prednisone

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Description

Prednisone: A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

prednisone : A synthetic glucocorticoid drug that is particularly effective as an immunosuppressant, and affects virtually all of the immune system. Prednisone is a prodrug that is converted by the liver into prednisolone (a beta-hydroxy group instead of the oxo group at position 11), which is the active drug and also a steroid. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID5865
CHEMBL ID635
CHEBI ID8382
SCHEMBL ID3288
MeSH IDM0017465

Synonyms (275)

Synonym
MLS002207083
MLS002154191
BRD-K85883481-001-04-2
pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy-
(8s,9s,10r,13s,14s,17r)-17-hydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-6,7,8,9,12,14,15,16-octahydrocyclopenta[a]phenanthrene-3,11-dione
17,21-dihydroxypregna-1,4-diene-3,11,20-trione
MEGXM0_000443
ACON0_000082
in-sone
metacortandracin
u 6020
diadreson
ancortone
pregna-1,11,20-trione, 17,21-dihydroxy-
.delta.sone
delta e
nsc 10023
encortone
delta-dome
.delta.-cortisone
zenadrid
enkorton
sk-prednisone
ultracortene
deltacortone
zenadrid [veterinary]
cortan
nsc-10023
wojtab
prednison
deltra
dacortin
decortin
supercortil
wln: l e5 b666 cv ov ahttt&j a1 e1 fv1q fq
dekortin
.delta.-cortelan
1,21-diol-3,11,20-trione
cotone
bicortone
paracort
1,2-dehydrocortisone
servisone
decortisyl
di-adreson
deltacortisone
delta-cortelan
cortidelt
.delta. e
meticorten
encorton
dehydrocortisone
nci-c04897
mls002638114 ,
delta e.
ultracorten
lisacort
.delta.1-cortisone
decortancyl
nsc10023
1-dehydrocortisone
hostacortin
deltison
.delta.-e
prednilonga
pregna-1,11,20-trione, 17,21-hydroxy-
precort
prednicen-m
rectodelt
deltisone
.delta.(sup1)-cortisone
juvason
deltasone
.delta.1-dehydrocortisone
.delta.-cortone
colisone
orasone
prednizon
PRESTWICK_405
cas-53-03-2
PRESTWICK2_000077
BPBIO1_000323
BSPBIO_000293
PRESTWICK3_000077
ACON1_000297
MLS001335908
CHEBI:8382 ,
prednisona
MLS001335907
prednisonum
NCGC00090766-01
meticorten (veterinary)
dacorten
ai3-52939
prednitone
dellacort a
delta(sup 1)-cortisone
pregna-1,4-diene-3,11,20-trione monohydrate, 17,21-dihydroxy-
nurison
pronison
prednisonum [inn-latin]
origen prednisone
parmenison
prednovister
novoprednisone
presone
prednisona [inn-spanish]
sone
prednicort
delta-1-dehydrocortisone
prednicorm
nizon
sterapred
prednisone intensol
cartancyl
adasone
incocortyl
einecs 200-160-3
deltacortene
delta(sup 1)-dehydrocortisone
econosone
deltisona
fiasone
predeltin
panasol
hsdb 3168
zenadrid (veterinary)
lodotra
delta-cortisone
apo-prednisone
nisona
pehacort
1,4-pregnadiene-17-alpha,21-diol-3,11,20-trione
dellacort
ccris 2646
winpred
panafcort
me-korti
delta-1-cortisone
prednidib
liquid pred
delta cortelan
prednicot
retrocortine
53-03-2
fernisone
C07370
prednisone
1-cortisone
prednisone, >=98%
DB00635
1,4-pregnadiene-17alpha,21-diol-3,11,20-trione
NCI60_000008
PRESTWICK1_000077
SPBIO_002214
PRESTWICK0_000077
MLS001304073
smr000718760
NCGC00090766-03
NCGC00090766-02
smr001227202
MLS001061265
HMS2090J13
AC-11112
3en3hg4wsw
CHEMBL635
prednisone anhydrous
prednisone tablets
p1276 ,
HMS1568O15
LMST02030180
AKOS005267096
NCGC00090766-05
NCGC00090766-04
HMS3259I09
HMS2095O15
AKOS007930684
(1r,3as,3bs,9ar,9bs,11as)-1-hydroxy-1-(2-hydroxyacetyl)-9a,11a-dimethyl-1h,2h,3h,3ah,3bh,4h,5h,7h,9ah,9bh,10h,11h,11ah-cyclopenta[a]phenanthrene-7,10-dione
EN300-52605
HMS3039K07
NCGC00259113-01
NCGC00254096-01
tox21_201564
tox21_300196
deltadehydrocortisone
MLS002548880
dtxcid701185
dtxsid4021185 ,
tox21_111014
HMS2231I24
pred
vb0r961hzt ,
lodtra
unii-vb0r961hzt
prednisone [usp:inn:ban]
rayos
prednisone [iarc]
prednisone [mi]
prednisone [usp-rs]
prednisone [green book]
prednisone [hsdb]
prednisolone impurity b [ep impurity]
prednisone [mart.]
prednisone [usp monograph]
prednisone [orange book]
prednisone [ep monograph]
prednisone tablets [usp-rs]
prednisone [who-dd]
prednisone [vandf]
prednisone [inn]
S1622
gtpl7096
XOFYZVNMUHMLCC-ZPOLXVRWSA-N
CCG-220077
HY-B0214
NC00475
SCHEMBL3288
NCGC00090766-07
tox21_111014_1
17alpha,21-dihydroxypregna-1,4-diene-3,11,20-trione
prednisone for peak identification, european pharmacopoeia (ep) reference standard
mfcd00003608
prednisone, tested according to ph.eur.
prednisone, pharmaceutical secondary standard; traceable to usp, pheur and bp
sr-01000837536
SR-01000837536-3
(8s,9s,10r,13s,14s,17r)-17-hydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-7,8,9,10,12,13,14,15,16,17-decahydro-3h-cyclopenta[a]phenanthrene-3,11(6h)-dione
prednisone, united states pharmacopeia (usp) reference standard
prednisone, pharmaceutical secondary standard; certified reference material
prednisone, european pharmacopoeia (ep) reference standard
HMS3712O15
prednisone, british pharmacopoeia (bp) reference standard
delta1-cortisone
delta1-dehydrocortisone
delta(sup1)-cortisone
prednisone (adasone)
prednisone(adasone)
(8s,10r,13s,17r)-17-hydroxy-17-(2-hydroxy-acetyl)-10,13-dimethyl-7,8,9,10,12,13,14,15,16,17-decahydro-6h-cyclopenta[a]phenanthrene-3,11-dione
?1-dehydrocortisone; dehydrocortisone; prednisolone ep impurity b; 17,21-dihydroxypregna-1,4-diene-3,11,20-trione; 1,2-dehydrocortisone; 1,4-pregnadiene-17?,21-diol-3,11,20-trione
AS-11685
BCP09049
Q424972
BRD-K85883481-001-08-3
BRD-K85883481-001-25-7
HMS3884C04
bdbm50550126
Z756390288
promifen
precortal
prednisone (mart.)
prednisone (ep monograph)
panasol-s
prednisonum (latin)
prednisone tablets (usp-rs)
delta 1-cortisone
1, 2-dehydrocortisone
predicorten
prednisonum (inn-latin)
nci-co4897
meprosona-f
keteocort
deltra prenovis
prednisone (usp:inn:ban)
delta(1)-cortisone
h02ab07
prednisone (usp monograph)
prednisolone impurity b (ep impurity)
perrigo prednisone
prednisona (inn-spanish)
prednisone (usp-rs)
ofisolona
prednisone (iarc)
predicor
1,2-dehydrocortisone delta (1)-cortisone
a07ea03

Research Excerpts

Overview

Prednisone (PRED) is a synthetic glucocorticoid (GC) widely used in immune-mediated diseases for its immunosuppressive and anti-inflammatory properties. Prednisone is an old and very valuable drug in clinical use for over 60 years by now.

ExcerptReferenceRelevance
"Prednisone (PRED) is a synthetic glucocorticoid (GC) widely used in immune-mediated diseases for its immunosuppressive and anti-inflammatory properties. "( Integrative Analysis of Gut Microbiota and Fecal Metabolites in Rats after Prednisone Treatment.
Feng, D; Huang, WY; Kang, Y; Law, HK; Wu, Y; Zhang, J; Zhu, GH, 2021
)
2.29
"Prednisone is a corticosteroid-derived drug which is widely used for its role in immunosuppression and treatment of lung disorders. "( Prednisone stimulates white adipocyte browning via β3-AR/p38 MAPK/ERK signaling pathway.
Mukherjee, S; Yun, JW, 2022
)
3.61
"Prednisone is a mainstay of treatment for patients with focal segmental glomerulosclerosis (FSGS), a disease characterized by reduced podocyte number and glomerulosclerosis. "( Podocyte repopulation by renal progenitor cells following glucocorticoids treatment in experimental FSGS.
Krofft, RD; Liu, ZH; Naito, S; Pippin, JW; Shankland, SJ; Zhang, J, 2013
)
1.83
"Prednisone is a well-established treatment option in rheumatoid arthritis. "( Modified-release prednisone: in patients with rheumatoid arthritis.
Henness, S; Yang, LP, 2013
)
2.17
"Prednisone is an old and very valuable drug in clinical use for over 60 years by now. "( The current relevance and use of prednisone in rheumatoid arthritis.
Baerwald, C; Krasselt, M, 2014
)
2.13
"Prednisone (PDN) is a well-known steroid clinically used in the treatment of hearing loss."( Prednisone inhibits the IL-1β-induced expression of COX-2 in HEI-OC1 murine auditory cells through the inhibition of ERK-1/2, JNK-1 and AP-1 activity.
Hong, H; Jang, BC, 2014
)
2.57
"Prednisone is a widely used anti-inflammatory for a variety of conditions. "( Palatability of a novel oral formulation of prednisone in healthy young adults.
Bai, S; Dormer, N; Kearns, GL; Meyer, A; Neville, KA; Pierce, CD; Shoults, C, 2017
)
2.16
"Prednisone therapy is a safe and effective adjunctive treatment for epilepsy."( Prednisone therapy in pediatric epilepsy.
Sinclair, DB, 2003
)
2.48
"Prednisone is an alternative form of treatment for ELS, although the mechanism for its action is unclear."( Eaton-Lambert myasthenic syndrome: long-term treatment of three patients with prednisone.
Rothner, AD; Streib, EW, 1981
)
1.21
"Prednisone is an active drug in the treatment of multiple myeloma. "( Efficacy of prednisone in refractory multiple myeloma and measurement of glucocorticoid receptors. A Southwest Oncology Group study.
Beckford, J; Bonnet, JD; Chilton, D; Gupta, V; Pierce, HI; Salmon, SE; Stock-Novack, D; Thompson, EB, 1994
)
2.11
"Prednisone is a major factor of bone loss after kidney transplantation. "( Changes in bone mineral density over 18 months following kidney transplantation: the respective roles of prednisone and parathyroid hormone.
Casez, JP; Horber, FF; Jaeger, P; Lippuner, K; Montandon, A, 2002
)
1.97
"Prednisone seems to be an important component of the MOPP combination in the management of stage IV Hodgkin's disease."( Value of prednisone in combination chemotherapy of stage IV Hodgkin's disease. Report from the British National Lymphoma Investigation.
, 1975
)
1.39
"Prednisone is a widely used medication in dermatology, particularly in pemphigus patients. "( Estimation of prednisone intake in pemphigus vulgaris patients with the use of simple laboratory methods.
Feuerman, EJ; Kaufman, H; Maayan, R; Segal, R, 1987
)
2.08
"Prednisone is a glucocorticoid that must be converted in vivo to prednisolone for pharmacologic activity. "( Effects of cimetidine and ranitidine on the conversion of prednisone to prednisolone.
Eshelman, FN; Ferguson, RK; Rocci, ML; Sirgo, MA; Vlasses, PH, 1985
)
1.96

Effects

Prednisone acetate (PA) has many adverse side effects despite the fact that oral administration of PA is widely administrated in the clinic. Oral prednisone has been the mainstay of therapy since its release for clinical use in 1948.

ExcerptReferenceRelevance
"Prednisone acetate (PA) has many adverse side effects despite the fact that oral administration of PA is widely administrated in the clinic. "( Intragastric administration of prednisone acetate induced impairment of hippocampal long-term potentiation.
Ding, X; Wang, Y; Xiang, S; Zhang, J; Zhang, M, 2023
)
2.64
"Oral prednisone has been the mainstay of therapy in JDM, and prednisone was reduced faster in patients diagnosed after 1997 when there was also an increase in other medications. "( Medications received by patients with juvenile dermatomyositis.
Bayat, N; Huber, AM; Kishi, T; Mamyrova, G; Miller, FW; Rider, LG; Targoff, IN; Ward, MM; Warren-Hicks, WJ; Wu, L, 2018
)
0.99
"Prednisone response has been confirmed to be still great prognostic value and PPR children patients have poor outcomes generally. "( [Prognostic Value of Prednisone Response in CCLG-ALL 2008].
An, WB; Chang, LX; Liu, TF; Ren, YY; Wan, Y; Zhang, JL; Zhu, XF; Zou, Y, 2015
)
2.18
"DR prednisone has been approved in 16 European countries as well as Australia and Israel."( A fresh look at glucocorticoids how to use an old ally more effectively.
Buttgereit, F, 2012
)
0.89
"Prednisone has been demonstrated to have a beneficial effect on muscle strength and function in boys with Duchenne dystrophy and should be offered (at a dose of 0.75 mg/kg/day) as treatment. "( Practice parameter: corticosteroid treatment of Duchenne dystrophy: report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society.
Ashwal, S; Baumbach, L; Connolly, A; Florence, J; Mathews, K; McDonald, C; Moxley, RT; Pandya, S; Sussman, M; Wade, C, 2005
)
1.77
"Prednisone has been the mainstay of therapy since its release for clinical use in 1948."( Current perspectives on the treatment of idiopathic pulmonary fibrosis.
Collard, HR; King, TE; Walter, N, 2006
)
1.06
"Prednisone has been used in this setting; however, limited data is available for this monotherapy in the asymptomatic HRPC population."( Prednisone monotherapy in asymptomatic hormone refractory prostate cancer.
Chi, KN; Heng, DY, 2006
)
2.5
"Thus prednisone liquid has comparable bioavailability to the tablet, with an earlier peak plasma prednisolone concentration and significantly higher plasma prednisolone concentrations within the first hour of administration."( Bioavailability assessment of a liquid prednisone preparation.
Flesher, KA; Georgitis, JW; Szefler, SJ, 1982
)
0.99
"Prednisone has been shown to decrease IFN-alpha-related toxicity without reducing the response rate."( Interferon-alpha, 5-FU and prednisone in metastatic renal cell carcinoma: a phase II study.
Fosså, SD; Haarstad, H; Jacobsen, AB; Risberg, T; Schjølseth, SA, 1994
)
1.31
"Prednisone therapy has improved hematologic function in some patients, but has not resulted in a reduction in bone mass."( Osteopetrosis. The pharmaco-physiologic basis of therapy.
Key, LL; Ries, WL, 1993
)
1.01
"Prednisone has been shown to improve strength in Duchenne dystrophy. "( Duchenne dystrophy: randomized, controlled trial of prednisone (18 months) and azathioprine (12 months)
Brooke, MH; Cwik, VA; Fenichel, GM; Griggs, RC; Mendell, JR; Miller, JP; Moxley, RT; Pandya, S; Pestronk, A; Robison, J, 1993
)
1.98
"Prednisone tapering has become more common in the management of transplant recipients. "( Quality of life outcomes associated with variable posttransplant prednisone dosing regimens.
Gaber, AO; Hathaway, DK; Milstead, J; Wicks, MN; Winsett, RP, 1996
)
1.97
"Prednisone has been commonly considered the mainstay of immunosuppressive therapy after liver transplantation. "( Immunosuppression without prednisone after liver transplantion is safe and associated with normal early graft function: preliminary results of a randomized study.
Angelico, M; Anselmo, A; Baiocchi, L; Casciani, CU; Negrini, S; Orlando, G; Palmieri, G; Pisani, F; Tisone, G; Vennarecci, G, 1998
)
2.04
"Prednisone has to be continued over a large period of time creating adverse effects in elderly people unless minimal doses are used."( [Polymyalgia rheumatica and temporal arteritis. Observations on prognosis and treatment].
Auquier, L; Paolaggi, JB, 1990
)
1

Actions

Prednisone alone or a lower dose of prednisone in combination with azathioprine induces remission and enhances survival in autoimmune hepatitis. Prednisone therapy might enhance earlier recovery but does not improve the long-term prognosis of VN.

ExcerptReferenceRelevance
"The prednisone-mediated increase in α7 integrin was associated with increased laminin-α2 in prednisone-treated dystrophin-deficient muscle."( Levels of α7 integrin and laminin-α2 are increased following prednisone treatment in the mdx mouse and GRMD dog models of Duchenne muscular dystrophy.
Burkin, DJ; Kornegay, JN; Sarathy, A; Wuebbles, RD, 2013
)
1.11
"A prednisone increase led to remission in 35 patients (80%)."( Outcomes of nonsevere relapses in antineutrophil cytoplasmic antibody-associated vasculitis treated with glucocorticoids.
Brunetta, P; Ding, L; Fervenza, FC; Hoffman, GS; Iklé, D; Kallenberg, CG; Langford, CA; Lim, N; Merkel, PA; Miloslavsky, EM; Monach, PA; Seo, P; Specks, U; Spiera, R; St Clair, EW; Stone, JH; Tchao, NK; Villareal, M, 2015
)
0.98
"Prednisone might inhibit lymphoproliferation and valganciclovir might prevent complications related to HHV-6 reactivation."( Treatment of DIHS/DRESS syndrome with combined N-acetylcysteine, prednisone and valganciclovir--a hypothesis.
Mian, P; Moling, O; Pagani, E; Piccin, A; Rimenti, G; Rossi, P; Tappeiner, L; Vedovelli, C, 2012
)
1.34
"Prednisone alone or a lower dose of prednisone in combination with azathioprine induces remission and enhances survival in autoimmune hepatitis. "( Emerging treatments for autoimmune hepatitis.
Czaja, AJ, 2002
)
1.76
"Prednisone therapy might enhance earlier recovery but does not improve the long-term prognosis of VN. "( Prednisone treatment for vestibular neuritis.
Braverman, I; Golz, A; Issa, A; Shupak, A, 2008
)
3.23
"Prednisone levels were lower than prednisolone levels."( Pharmacokinetics of prednisone and its metabolite prednisolone in children with nephrotic syndrome during the active phase and in remission.
Barberis, L; Frigo, GM; Gatti, G; Martini, A; Notarangelo, LD; Perucca, E, 1984
)
1.31
"Prednisone was shown to cause a small but significant improvement over no treatment in scored neurological disability, some measures of computer-assisted sensory detection threshold, graded muscle strength, and some attributes of nerve conduction."( Prednisone improves chronic inflammatory demyelinating polyradiculoneuropathy more than no treatment.
Bartleson, JD; Daube, JR; Dinapoli, RP; Dyck, PJ; Low, PA; Mokri, B; O'Brien, PC; Oviatt, KF; Swift, T; Windebank, AJ, 1982
)
2.43
"Prednisone dosage was lower in diabetics with EOD at 6 months, but did not differ among the three groups at 12 months."( Heart transplantation in patients with diabetic end-organ damage before transplantation.
Aleksic, I; Blanche, C; Czer, LS; Dalichau, H; Freimark, D; Nessim, S; Nusser, P; Takkenberg, JJ; Trento, A, 1996
)
1.02
"Prednisone did not produce an immediate change in gastric secretion--there being a latent period lasting 1 to 2 days before marked changes were observed."( Effects of prednisone on gastric secretion and development of stomach lesions in swine.
Grummer, RH; Hoekstra, WG; Kowalczyk, T; Will, JA; Zamora, CS, 1975
)
1.37
"Prednisone may also suppress cartilage breakdown by either acting at the level of the synthesis or by acting on the release/action of the stimulating factors."( Role of synovial membrane inflammation in cartilage matrix breakdown in the Pond-Nuki dog model of osteoarthritis.
Ghandur-Mnaymneh, L; Howell, DS; Martel-Pelletier, J; Pelletier, JP; Woessner, JF, 1985
)
0.99

Treatment

Prednisone or vitamin E treatment reduced urinary protein from 14 days to 28 days after ADR injection. Prednisone treatment, even at moderate doses, increases the risk, whilst antimalarials have a protective effect.

ExcerptReferenceRelevance
"The prednisone treatment group was given progesterone (20 ∼ 40 mg daily injection) + prednisone (5 mg/d) for four weeks."( Clinical Research into Treating Unexplained Recurrent Spontaneous Abortion during Early Pregnancy with the Qing Yi Tiao Mian Formula.
Du, L; Jiang, GJ; Pan, DC; Shen, MJ,
)
0.61
"Prednisone treatment was significantly associated with a higher risk of adverse events (24.2% vs."( Budesonide as first-line treatment in patients with autoimmune hepatitis seems inferior to standard predniso(lo)ne administration.
Álvarez-Navascúes, C; Arencibía, A; Barreira-Díaz, A; Conde, I; Crespo, J; Del Barrio, M; Díaz-González, Á; El Hajra, I; Escudé, L; Estévez, P; Fernández, A; Ferre-Aracil, C; García-Retortillo, M; Gómez, E; Gómez, J; Hernández-Guerra, M; Horta, D; Londoño, MC; López, C; Mateos, B; Molina, E; Morillas, RM; Pérez-Medrano, I; Riveiro-Barciela, M; Salcedo, M; Sapena, V; Soria, A; Zamora, J, 2023
)
1.63
"Both prednisone treatment and targeting Pebp1 pathway are promising strategies to alleviate inflammation and necroptosis that occurred in AAV gene therapy or related diseases."( AAV induces hepatic necroptosis and carcinoma in diabetic and obese mice dependent on Pebp1 pathway.
Cheng, Y; Dong, J; Feng, N; Gao, P; Han, Y; He, Z; Huang, R; Lai, H; Yang, Y; Yu, H; Zhai, Q; Zhang, Y; Zhang, Z; Zhong, W, 2023
)
1.37
"Oral prednisone treatment does not appear to significantly reduce the incidence of AVB requiring acute PPM implantation after TAVI."( Effect of acute CORticosteroids on conduction defects after Transcatheter Aortic Valve Implantation: the CORTAVI study.
Barillà, F; Barone, L; Belli, M; Di Luozzo, M; Marchei, M; Muscoli, S; Prandi, FR; Romeo, F; Sergi, D; Uccello, G, 2023
)
1.42
"Prednisone treatment (3 mg/kg from 8 weeks of age) relieved the decrease of NAA but further increased the accumulation of pyruvate in the frontal cortex, additionally affected eight enriched pathways in the hypothalamus, and led to significant imbalances between the excitation and inhibition in both the frontal cortex and hypothalamus."( Analysis of brain metabolites by gas chromatography-mass spectrometry reveals the risk-benefit concerns of prednisone in MRL/lpr lupus mice.
Li, S; Lu, F; Lu, H; Wang, S; Wen, C; Wu, D; Xie, M; Xie, Z; Xu, ZH; Zhou, J, 2020
)
1.49
"Prednisone pre-treatment was associated with a numerically higher rate of recurrence and colchicine treatment with a numerically lower rate, but the differences were non-significant."( Do Colchicine and Prednisone Affect the Rate of Recurrence of Post-Pericardiotomy Syndrome.
Aravot, D; Freidkin, L; Iakobishvili, Z; Kornowski, R; Landes, U; Mager, A; Schamroth Pravda, N, 2020
)
1.61
"Prednisone treatment duration at diagnosis was also significantly reduced (13.1 versus 5.8 days, p = 0.004)."( Using a standardised protocol was effective in reducing hospitalisation and treatment use in children with newly diagnosed immune thrombocytopenia.
Chartrand, C; Di Liddo, L; Labrosse, R; Nguyen, UP; Pastore, Y; Vincent, M, 2017
)
1.18
"Oral prednisone treatment resulted in complete clinical remission."( [Sarcoid-like granulomatosis associated with eosinophilic fasciitis].
Bagot, M; Battistella, M; Bouaziz, JD; Guibal, F; Hefez, L; Leonard-Louis, S; Sallé de Chou, C; Vignon-Pennamen, MD; Zuelgaray, E, 2018
)
0.94
"Prednisone treatment for 30 and 90 days improved articular structure and decelerated the degeneration of the femur in CIA rats, but did not improve BMD and bone biomechanics."( Effect of prednisone treatment for 30 and 90 days on bone metabolism in collagen-induced arthritis (CIA) rats.
Chen, W; Cui, L; Lu, J; Lv, X; Min, Y; Wu, X; Xu, B; Zhang, X; Zou, L, 2018
)
1.6
"Prednisone treatment modified circulatory NET levels and was associated with beneficial outcome.CAP is accompanied by pronounced NET formation."( Markers of neutrophil extracellular traps predict adverse outcome in community-acquired pneumonia: secondary analysis of a randomised controlled trial.
Baumgartner, C; Blum, CA; Christ-Crain, M; Ebrahimi, F; Giaglis, S; Hahn, S; Hasler, P; Kutz, A; Mueller, B; Schuetz, P; van Breda, SV, 2018
)
1.2
"Prednisone treatment during the first 4 weeks after the initiation of ART for HIV infection resulted in a lower incidence of tuberculosis-associated IRIS than placebo, without evidence of an increased risk of severe infections or cancers. "( Prednisone for the Prevention of Paradoxical Tuberculosis-Associated IRIS.
Blumenthal, L; Buyze, J; Colebunders, R; Jackson, A; Lynen, L; Maartens, G; Meintjes, G; Nair, A; Ravinetto, R; Schutz, C; Stek, C; Thienemann, F; van Loen, H; Wilkinson, RJ, 2018
)
3.37
"Prednisone-treated patients had higher levels of depressive symptoms and subjective and objective cognitive deficits than those not taking prednisone."( A comparison of clinician-rated neuropsychological and self-rated cognitive assessments in patients with asthma and rheumatologic disorders.
Brown, ES; Frol, AB; Getahun, Y; Khan, DA; Pacheco, M; Vasquez, A,
)
0.85
"Prednisone-treated patients did not develop new treatment-related clinical problems."( Long-term clinical follow-up of the multicentre, randomized study to test immunosuppressive therapy with oral prednisone for the prevention of restenosis after percutaneous coronary interventions: Cortisone plus BMS or DES veRsus BMS alone to EliminAte Re
Boccuzzi, G; De Luca, G; Ferrero, V; Ghini, AS; Marino, P; Pesarini, G; Presbitero, P; Ribichini, F; Rognoni, A; Tomai, F; Vassanelli, C; Zivelonghi, C, 2013
)
1.32
"All prednisone-treated patients had normal plasma creatinine (PCr) after 1 month of treatment (median 59.1 [45-85] μmol/l) whereas only 50 % of patients in the non-treatment group had normal creatinine (median 81.0 [42-123] μmol/l) at the same time point (p = 0.025). "( Prednisone in the treatment of tubulointerstitial nephritis in children.
Ala-Houhala, M; Arikoski, P; Jahnukainen, T; Nuutinen, M; Rönnholm, K; Saarela, V; Ylinen, E, 2013
)
2.39
"A prednisone-treated systemic flare occurred during the first trimester without later complication."( Adult-onset Still's disease and pregnancy: about ten cases and review of the literature.
Broussolle, C; Durieu, I; Gerfaud-Valentin, M; Hot, A; Huissoud, C; Seve, P, 2014
)
0.96
"Prednisone treatment is often used as the first-line treatment and studies suggest response to treatment in 50-66% of cases."( Common variable immunodeficiency-associated granulomatous and interstitial lung disease.
Kayser, G; Prasse, A; Warnatz, K, 2013
)
1.11
"Prednisone treatment promoted nephrin expression in the kidney (P<0.05)."( [Effects of prednisone on renal FAK and Pyk2 expressions in rats with adriamycin- induced nephritis].
Chen, X; Lin, X; Liu, C; Wang, J; Wu, X; Zheng, J, 2014
)
1.5
"Prednisone treatment for 7 days in patients with community-acquired pneumonia admitted to hospital shortens time to clinical stability without an increase in complications. "( Adjunct prednisone therapy for patients with community-acquired pneumonia: a multicentre, double-blind, randomised, placebo-controlled trial.
Arici, B; Baumgartner, C; Bingisser, R; Blum, CA; Briel, M; Burki, D; Christ-Crain, M; Drozdov, D; Duplain, H; Elsaesser, H; Mueller, B; Nigro, N; Refardt, J; Rodondi, N; Schuetz, P; Suter-Widmer, I; Tarr, P; Thomann, R; Ullmer, E; Urwyler, SA; Winzeler, B; Wirz, S; Zimmerli, W, 2015
)
2.29
"The prednisone-treated group showed an adjusted mean 6.4-point (95% CI, 1.9-10.9; P = .006) greater improvement in ODI scores at 3 weeks than the placebo group and a mean 7.4-point (95% CI, 2.2-12.5; P = .005) greater improvement at 52 weeks."( Oral steroids for acute radiculopathy due to a herniated lumbar disk: a randomized clinical trial.
Ackerson, L; Avins, AL; Carragee, E; Carver, R; Firtch, W; Goldberg, H; Hamilton, L; Maratukulam, A; Pressman, A; Smith, W; Tyburski, M; Won, LA, 2015
)
0.9
"Prednisone treatment dose-dependently attenuated the lupus symptoms in MRL/lpr mice with decreased proteinuria levels, prolonged survival times, decreased serum anti-nuclear antibody levels, and reduced spleen and thymus indices. "( Prednisone treatment inhibits the differentiation of B lymphocytes into plasma cells in MRL/MpSlac-lpr mice.
Deng, XM; Sun, XJ; Wang, QT; Wei, W; Yan, SX, 2015
)
3.3
"Prednisone treatment restricts B lymphocyte differentiation into plasma cells in MRL/lpr mice, which may be correlated with the inhibition of IL-21 production and the restoration of the balance between Blimp-1 and Bcl-6."( Prednisone treatment inhibits the differentiation of B lymphocytes into plasma cells in MRL/MpSlac-lpr mice.
Deng, XM; Sun, XJ; Wang, QT; Wei, W; Yan, SX, 2015
)
3.3
"Prednisone-treated dogs were more likely to develop polyuria, polydipsia, and polyphagia than were cyclosporine-treated dogs."( Comparison of the efficacy of prednisone and cyclosporine for treatment of dogs with primary immune-mediated polyarthritis.
Herrera, MA; Kass, PH; Rhoades, AC; Sykes, JE; Vernau, W, 2016
)
1.44
"Prednisone treatment significantly increased serum cystatin C concentration from 1.24 +/- 0.40 mg/L at baseline to 1.61 +/- 0.80 mg/L at the end of study (p < 0.05). "( Corticosteroids Significantly Increase Serum Cystatin C Concentration without Affecting Renal Function in Symptomatic Heart Failure.
Ge, N; Liu, C; Zhai, JL; Zhao, Q; Zhen, Y, 2016
)
1.88
"Prednisone treatment did not significantly modify the function and expression of MDR1 in T and NK cells of ITP patients."( Multidrug resistance-1 in T lymphocytes and natural killer cells of adults with idiopathic thrombocytopenic purpura: effect of prednisone treatment.
Crespo-Solís, E; Graue, G; López-Karpovitch, X; Piedras, J, 2008
)
1.27
"Prednisone or vitamin E treatment reduced urinary protein from 14 days to 28 days after ADR injection. "( [Relationship between glomerular nephrin expression and oxidative stress reaction in rats with adriamycin-induced nephrosis].
Lu, L; Zhu, Y, 2009
)
1.8
"Prednisone treatment, even at moderate doses, increases the risk, whilst antimalarials have a protective effect."( Predictors of major infections in systemic lupus erythematosus.
Aguirre, C; Egurbide, MV; Martinez-Berriotxoa, A; Olivares, N; Ruiz-Arruza, I; Ruiz-Irastorza, G, 2009
)
1.07
"In prednisone-treated dogs, serum chloride and corrected chloride concentrations were significantly lower on days 7, 14, 21, and 28 and serum bicarbonate concentrations were significantly higher on days 14, 21, and 28, compared with baseline values."( Effect of glucocorticoid administration on serum aldosterone concentration in clinically normal dogs.
Behrend, EN; Corrigan, AM; Kemppainen, RJ; Martin, LG, 2010
)
0.87
"Prednisone treatment in mdx mice resulted in decreased CTSB activity and increased grip strength in forelimbs and hindlimbs."( Non-invasive optical imaging of muscle pathology in mdx mice using cathepsin caged near-infrared imaging.
Baudy, AR; Hoffman, EP; Johnston, HK; Jordan, S; Kesari, A; Nagaraju, K; Sali, A, 2011
)
1.09
"Prednisone treatment delays the progressive course of Duchenne muscular dystrophy. "( Normal height and weight in a series of ambulant Duchenne muscular dystrophy patients using the 10 day on/10 day off prednisone regimen.
de Groot, IJ; Hendriks, JC; Noordam, C; Sie, LT; ten Dam, K; van Alfen, N, 2012
)
2.03
"MR prednisone plus DMARD treatment produced higher response rates for ACR20 (48% vs 29%, p<0.001) and ACR50 (22% vs 10%, p<0.006) and a greater median relative reduction from baseline in morning stiffness (55% vs 35%, p<0.002) at week 12 than placebo plus DMARD treatment. "( Low-dose prednisone chronotherapy for rheumatoid arthritis: a randomised clinical trial (CAPRA-2).
Alten, RE; Boers, M; Buttgereit, F; Kirwan, J; Mehta, D; Romer, U; Saag, KG; Supronik, J; Szechinski, J; Szombati, I; Witte, S, 2013
)
1.43
"Prednisone treatment significantly normalized the intensities of peaks 9069 and 15005 (which correspond to cortexin-1 and interleukin-17A, respectively, according to Swiss Prot database) by increasing the expression of 9069 but reducing expression of 15005."( Proteomic analysis indicates altered expression of plasma proteins in a rat nephropathy model.
Ai, S; Chen, R; Lin, Q; Zheng, J, 2013
)
1.11
"Prednisone treatment induced a decrease in Bcl-2 and Bcl-xl levels in 17 and 16 of the 28 patients, respectively, while Bax protein increased in 14 of the 21 patients."( Determination of the in vivo effects of prednisone on Bcl-2 family protein expression in childhood acute lymphoblastic leukemia.
Addeo, R; Casale, F; Crisci, S; D'Angelo, V; Di Tullio, MT; Indolfi, P; Morgera, C; Poggi, V, 2003
)
1.31
"The prednisone treatment group had a marked increase in the median CD4 cell count in the first 2 weeks, which stabilized at a level similar to that in the nonprednisone treatment group."( Randomized, controlled study of the effects of a short course of prednisone on the incidence of rash associated with nevirapine in patients infected with HIV-1.
Cahn, P; Casssetti, LI; Gigliotti, M; Hall, DB; Losso, M; McDonough, M; Montaner, JS; Robinson, PA; Wruck, J; Zala, C, 2003
)
1.04
"Prednisone treatment with hemodialysis improved the situation."( Renal failure in a patient with autosomal dominant polycystic kidney disease and coexisting dermato-polymyositis: first report in the literature.
Atik, E; Bahceci, F; Karincaoglu, Y; Sari, R; Sarikaya, M; Sevinc, A, 2004
)
1.04
"Prednisone treatment is used to prolong ambulation in patients with Duchenne muscular dystrophy (DMD). "( Intermittent prednisone therapy in Duchenne muscular dystrophy: a randomized controlled trial.
Beenakker, EA; Brouwer, OF; Fock, JM; Koopman, HM; Maurits, NM; Van der Hoeven, JH; Van Tol, MJ, 2005
)
2.14
"Prednisone-treated patients manifested a significant reduction in tinnitus."( Oral administration of prednisone to control refractory vertigo in Ménière's disease: a pilot study.
Cornejo-Suarez, A; Gonzalez-Perez, O; Morales-Luckie, E; Zaragoza-Contreras, MA, 2005
)
1.36
"Prednisone treatment may lead to a shortened course of chorea (4.0 weeks in prednisone-treated [n = 32] vs 9.0 weeks in untreated [n = 14]; P < .0001)."( Rheumatic chorea: relationship to systemic manifestations and response to corticosteroids.
Bale, JF; Firth, SD; Tani, LY; Thompson, JA; Veasy, LG; Walker, AR, 2007
)
1.06
"Prednisone treatment 1) did not affect leucine Ra or leucine oxidation; 2) increased plasma glutamine Ra, mostly owing to enhanced glutamine de novo synthesis (medians +/- interquartiles, 412 +/- 61 vs."( Corticosteroids increase glutamine utilization in human splanchnic bed.
Altomare, A; Darmaun, D; Haymond, M; Mauras, N; Sager, B; Thibault, R; Welch, S, 2008
)
1.07
"Prednisone treatment tended to accelerate the conversion, but not significantly."( Conversion of micronodular cirrhosis into macronodular cirrhosis.
Christensen, E; Fauerholdt, L; Juhl, E; Poulsen, H; Schlichting, P; Tygstrup, N,
)
0.85
"Prednisone treatment also resulted in significantly more thyroid cytoplasmic colloid droplets per follicular cell (3.19 vs 0.57 in treated and control dogs)."( Effect of prednisone on thyroid gland morphology and plasma thyroxine and triiodothyronine concentrations in the dog.
Kemppainen, RJ; Lorenz, MD; Munnell, JF; Thompson, FN; Woltz, HH, 1983
)
1.39
"Prednisone treatment appears to have improved the survival, but it is probable that treatment with prednisone alone may be less effective than a regimen in which it is combined with cyclophosphamide or nitrogen mustard."( Evaluation of treatment in lupus nephritis: effects of prednisone.
Dosekun, AK; Pollak, VE, 1982
)
1.23
"The prednisone-treated groups had a reduction in serum IgG concentrations (1 mg/kg vs placebo, p < 0.007; 2 mg/kg vs placebo, p < 0.003)."( A multicenter study of alternate-day prednisone therapy in patients with cystic fibrosis. Cystic Fibrosis Foundation Prednisone Trial Group.
Eigen, H; FitzSimmons, S; Rosenstein, BJ; Schidlow, DV, 1995
)
1.05
"Prednisone treatment was not associated with any significant change in the concentrations of albumin or mucin-like glycoprotein."( Analysis of induced sputum to examine the effects of prednisone on airway inflammation in asthmatic subjects.
Boushey, HA; Claman, DM; Fahy, JV; Liu, J; Wong, H, 1994
)
1.26
"Prednisone treatment resulted in symptom resolution and lesion regression."( Endoscopic findings in arytenoid sarcoidosis.
Bisetti, A; Guidi, L; Mariotta, S; Valeri, B, 1994
)
1.01
"Prednisone-treated dogs were hyperglycemic during treatment but returned to normoglycemia after steroid withdrawal."( Acceleration of chronic failure of intrahepatic canine islet autografts by a short course of prednisone.
Carroll, PB; Demetris, J; Fontes, P; Ricordi, C; Rilo, HL; Zeng, YJ, 1994
)
1.23
"Prednisone-treated dogs lost 13.2% of their initial bone mass by 48 wk."( Salmon calcitonin reduces vertebral bone loss in glucocorticoid-treated beagles.
Jackson, TW; Lyles, KW; Nesbitt, T; Quarles, LD, 1993
)
1.01
"Prednisone treatment during the first month on the drug prevented the interferon-gamma-secreting cell surge."( Interferon-gamma-secreting cells in multiple sclerosis patients treated with interferon beta-1b.
Arnason, BG; Dayal, AS; Jensen, MA; Lledo, A, 1995
)
1.01
"Prednisone-treated men with preoperative antisperm antibodies showed improved fertilization rates (40% vs."( Indications for corticosteroids prior to epididymal sperm retrieval.
Goldstein, M; Palermo, GD; Rosenwaks, Z; Schlegel, PN; Shin, D,
)
0.85
"Prednisone-treated dogs had significant (P < 0.05) decreases in all SIg levels, all lymphocyte subpopulations and erythrocyte numbers, and had an increase in neutrophil counts."( The effects of prednisone and azathioprine on circulating immunoglobulin levels and lymphocyte subpopulations in normal dogs.
Kaushik, A; Kruth, SA; Rinkardt, NE, 1999
)
1.38
"CyA-prednisone treatment caused a marked shift in the carbohydrate disposal from a meal, enhancing the hepatic glucose uptake and decreasing peripheral glucose disposal."( Disposition of a mixed meal by conscious dogs after seven days of treatment with cyclosporine A and prednisone.
Cherrington, AD; Goldstein, RE; Lacy, DB; Moore, MC; Palmer, B,
)
0.91
"Prednisone-treated patients had a significant increase in HCV RNA from baseline during steroid treatment (400 +/- 60% increase vs."( Prednisone withdrawal followed by interferon alpha for treatment of chronic hepatitis C infection: results of a randomized controlled trial.
Anguiano, A; Bylund, DL; McHutchison, JG; Mondala, T; Pockros, PJ; Ponnudurai, R; Wilkes, LB, 2001
)
2.47
"Prednisone treatment significantly reduced the level of TGF-beta1 and HYP in diaphragm from mdx mice to values similar to control mice, but resulted in a higher level of the HP cross-link compared with untreated mdx mice."( Impact of prednisone on TGF-beta1 and collagen in diaphragm muscle from mdx mice.
Gosselin, LE; Granchelli, JA; Hartel, JV; Hudecki, MS; Pollina, CM, 2001
)
1.43
"Prednisone treatment inhibited the appearance of mRNA, protein, or both for T(H)2 cytokines (IL-4 and IL-5), as well as for IL-2 and transforming growth factor alpha, but did not inhibit increases of immunoreactive GM-CSF in bronchoalveolar lavage fluid."( Effects of prednisone on the cellular responses and release of cytokines and mediators after segmental allergen challenge of asthmatic subjects.
Bochner, BS; Breslin, L; Freidhoff, LR; Hubbard, WC; Lichtenstein, LM; Liu, MC; Proud, D; Schleimer, RP; Schroeder, JT; Stealey, BA; Xiao, H, 2001
)
1.42
"Prednisone treatment started within the first week of the disease can restore better function to the paralyzed face than is achieved without such therapy, and facial nerve decompression has been unnecessary."( The true nature of Bell's palsy: analysis of 1,000 consecutive patients.
Adour, KK; Byl, FM; Hilsinger, RL; Kahn, ZM; Sheldon, MI, 1978
)
0.98
"Prednisone treatment for infertility and subsequent pregnancy maintenance in humans resulted in a significant decrease in the birth weight of full-term infants and a marked increase in the percentage of newborn infants weighing 2500 grams or less, that is, "light for dates" in comparison to control offspring. "( Prenatal exposure to prednisone in humans and animals retards intrauterine growth.
Gandelman, R; Karow, WG; Reinisch, JM; Simon, NG, 1978
)
2.02
"Prednisone treatment of patients with chronic active hepatitis inhibited both spontaneous and concanavalin A-stimulated lymphocyte cytotoxicity to human Chang liver cells."( Lymphocyte cytotoxicity to autologous liver cells in chronic active hepatitis.
Isselbacher, KJ; Wands, KR, 1975
)
0.98
"The prednisone treated patients showed significantly lower values of all sex hormones with respect to deflazacort treated patients."( Sex hormones and bone metabolism in postmenopausal rheumatoid arthritis treated with two different glucocorticoids.
Caporali, R; Caprotti, M; Caprotti, P; Montecucco, C; Notario, A, 1992
)
0.76
"Prednisone pretreatment did not seem to improve the efficacy of interferon therapy."( [Treatment of chronic hepatitis B with interferon alpha (Wellferon) with and without previous corticosteroid therapy -- results of a multicenter, double blind study].
Cianciara, J; Gładysz, A; Juszczyk, J; Laskus, T; Loch, T; Mach, G; Machaj, A; Simon, K, 1992
)
1
"Prednisone treatment appeared to reduce the patient's antibody titers to normal levels."( Management and monitoring of cancer-associated retinopathy.
Keltner, JL; Roth, AM; Thirkill, CE; Tyler, NK, 1992
)
1
"Prednisone treatment did not significantly alter the cardiovascular responses."( Interaction between corticosteroid and beta-agonist drugs. Biochemical and cardiovascular effects in normal subjects.
Flannery, EM; Herbison, GP; Taylor, DR; Wilkins, GT, 1992
)
1
"Prednisone treatment led to 10 of 41 (24%) patients improving, while secondary therapy with ATG led to four of 21 (19%) improving."( Acute graft-versus-host disease following unrelated donor marrow transplantation: failure of conventional therapy.
Blazar, BR; Filipovich, AH; Kersey, JH; McGlave, PB; Miller, WJ; Ramsay, NK; Roy, J; Weisdorf, DJ, 1992
)
1
"The prednisone-treated group had a mean reduction in adrenocortical function (mean +/- SEM change in stimulated plasma cortisol of -19.8 +/- 1.77 micrograms/dl) that was significant (p less than 0.0001) compared with that of the placebo-treated group."( A comparative study of the effects of intranasal triamcinolone acetonide aerosol (ITAA) and prednisone on adrenocortical function.
Dockhorn, R; Ellis, E; Feiss, G; Mansfield, L; Morris, R; Rom, D; Smith, JA; Tobey, RE, 1992
)
0.98
"Prednisone treatment resulted in diminished bone formation rates (15 +/- 3.4 vs."( Prednisone-induced osteopenia in beagles: variable effects mediated by differential suppression of bone formation.
Quarles, LD, 1992
)
2.45
"Prednisone pretreatment did not alter the immediate skin erythema or release of histamine but ablated the late secondary erythema and rise in histamine."( Prednisone inhibits the appearance of inflammatory mediators and the influx of eosinophils and basophils associated with the cutaneous late-phase response to allergen.
Charlesworth, EN; Kagey-Sobotka, A; Lichtenstein, LM; Norman, PS; Schleimer, RP, 1991
)
2.45
"Prednisone treatment did not influence the prevalence of revertants."( Dystrophin expression and somatic reversion in prednisone-treated and untreated Duchenne dystrophy. CIDD Study Group.
Bulman, DE; Burghes, AH; Burrow, KL; Coovert, DD; Kissel, JT; Klein, CJ; Mendell, JR; Rammohan, KW, 1991
)
1.26
"Prednisone pretreatment does not seem to have any additional benefit to using interferon alone in these patients, while the effect in patients with elevated aminotransferase levels remains to be proven."( Alpha-interferon treatment in Chinese patients with chronic hepatitis B.
Fung, YL; Lai, CL; Lau, JY; Leung, EK; Lok, AS; Wong, LS; Wu, PC, 1990
)
1
"Prednisone treatment causes protein wasting and adds additional risks to a patient, whereas human growth hormone (hGH) treatment causes positive nitrogen balance. "( Human growth hormone prevents the protein catabolic side effects of prednisone in humans.
Haymond, MW; Horber, FF, 1990
)
1.96
"Prednisone is the first treatment we employ."( Cluster headaches.
Ryan, RE, 1989
)
1
"Prednisone treatment at dose levels frequently effective in polymyositis failed to prevent disease progression in those patients observed for 2 or more years."( Inclusion body myositis. Observations in 40 patients.
Engel, AG; Litchy, WJ; Lotz, BP; Nishino, H; Stevens, JC, 1989
)
1
"Prednisone treatment led to a decrease in the concentration of serum testosterone in seven of nine patients where it was not initially suppressed below 2 nmol/L, and caused a decrease in serum levels of androstenedione and dehydroepiandrosterone sulfate in more than 50% of patients."( Treatment of metastatic prostatic cancer with low-dose prednisone: evaluation of pain and quality of life as pragmatic indices of response.
Gospodarowicz, M; Meakin, W; Panzarella, T; Rider, W; Stewart, L; Tannock, I, 1989
)
1.25
"Oral prednisone pretreatment significantly reduced the mean of each subject's peak late-phase concentration of both MBP (30.7 +/- 5.8 ng/ml versus 13.3 +/- 4.3 ng/ml; p = 0.005) and EDN (885 +/- 659 ng/ml versus 71 +/- 41 ng/ml; p less than 0.05)."( Major basic protein and eosinophil-derived neurotoxin concentrations in nasal-lavage fluid after antigen challenge: effect of systemic corticosteroids and relationship to eosinophil influx.
Bascom, R; Dunnette, S; Gleich, GJ; Lichtenstein, LM; Naclerio, RM; Pipkorn, U; Proud, D, 1989
)
0.73
"The prednisone-treated group required 9 admissions to hospital for CF-related pulmonary disease compared with 35 for the placebo group."( Alternate-day prednisone reduces morbidity and improves pulmonary function in cystic fibrosis.
Auerbach, HS; Colten, HR; Kirkpatrick, JA; Williams, M, 1985
)
1.11
"Prednisone treatment can sometimes reverse this condition when combined with parenteral nutrition."( [Acute manifestations in Crohn disease and ulcerative colitis. Conservative treatment of acute situations].
Goebell, H, 1988
)
1
"Prednisone remains the treatment of choice and, in many cases, its use can be intermittent."( Allergic bronchopulmonary aspergillosis and fungoses.
Greenberger, PA, 1988
)
1
"The prednisone-treated group had higher mean plasma levels of triglyceride [2.06 +/- 1.3 (+/- SD) vs."( Elevated apolipoprotein-B levels in corticosteroid-treated patients with systemic lupus erythematosus.
Ettinger, WH; Hazzard, WR, 1988
)
0.76
"prednisone treatment of chronic aggressive hepatitis and/or nonalcoholic cirrhosis, 20 were HBsAg positive on entry."( Immunosuppressive treatment of HBsAg-positive chronic liver disease: significance of HBeAg.
Aldershvile, J; Schlichting, P; Tage-Jensen, U,
)
0.85
"The treatment of prednisone plus HCQ may improve implantation rate, biochemical pregnancy rate, and clinical pregnancy rate, and reduce pregnancy loss rate in frozen embryo transfer outcomes for ANA-positive women."( Combined treatment of prednisone and hydroxychloroquine may improve outcomes of frozen embryo transfer in antinuclear antibody-positive patients undergoing IVF/ICSI treatment.
Cheng, K; Deng, W; Gao, R; Meng, C; Qin, L; Zeng, X, 2021
)
1.26
"Treatment with prednisone 10 mg/day was maintained."( [Diagnostic difficulties of IgG4-related disease - a case report].
Gładyś, A; Lenczewska, K; Leśniak, K; Niemczyk, S; Żelek, K, 2022
)
1.06
"Treatment with prednisone plus levothyroxine may present a novel approach in these patients."( Combined prednisone and levothyroxine improve treatment of severe thrombocytopenia in hepatitis B with compensatory cirrhosis accompanied by subclinical and overt hypothyroidism.
Feng, R; Fu, H; Huang, X; Jiang, H; Jiang, Q; Liu, H; Liu, K; Lu, J; Niu, T; Wang, H; Wang, J; Wang, X; Xie, Y; Xu, L; Xue, J; Zhang, X, 2018
)
1.24
"Treatment with prednisone, azathioprine, and ursodeoxycholic acid led to a good response."( Type 2 autoimmune hepatitis overlapping with primary sclerosing cholangitis in a 10-year-old boy.
Bahri, I; Boudawara, T; Gargouri, L; Maalej, B; Mahfoudh, A; Majdoub, I; Mnif, H; Mnif, L; Safi, F; Tahri, N; Turki, F, 2013
)
0.73
"Treatment with prednisone significantly reduced the frequency of CD4(+)CXCR5(+) and CD4(+)CXCR5(+)PD-1(+) TFH cells and the levels of serum IL-21, but increased IL-4 and IL-10 in those patients."( A higher frequency of CD4⁺CXCR5⁺ T follicular helper cells in patients with newly diagnosed IgA nephropathy.
Jiang, Y; Shi, X; Wang, Y; Zhang, L; Zou, H,
)
0.47
"Treatment with prednisone, methotrexate, and acyclovir induced the complete remission of mucosal and joint symptoms, which then relapsed after interruption of antiviral therapy or immunosuppressive therapy."( Pemphigus vulgaris in a patient with arthritis and uveitis: successful treatment with immunosuppressive therapy and acyclovir.
Bottoni, U; Carlesimo, M; Cordiali, P; Di Carlo, A; Di Napoli, A; Laganà, B; Muscianese, M; Pimpinelli, F; Pranteda, G,
)
0.47
"Treatment with prednisone or/and immunosuppressive drugs significantly reduced the frequency of CD4(+)CXCR5(+), CD4(+)CXCR5(+)PD-1(+) TFH cells and serum IL-21 level, but increased IL-4 and IL-10 levels in the patients."( Frequency of CD4+CXCR5+ TFH cells in patients with hepatitis b virus-associated membranous nephropathy.
Ayana, DA; Jiang, Y; Liu, Y; Qu, Z; Zhao, P, 2014
)
0.74
"post-treatment with prednisone); and evaluating parameters before and after prednisone use, including values for sputum eosinophils, sputum eosinophil cationic protein (ECP), and sputum IL-5-with or without values for post-bronchodilator FEV1-with corresponding 95% CIs or with sufficient data for calculation."( Effects of prednisone on eosinophilic bronchitis in asthma: a systematic review and meta-analysis.
Maurici, R; Pizzichini, E; Pizzichini, MM; Sakae, TM; Trevisol, DJ, 2014
)
1.11
"Treatment with prednisone alone was associated with more frequent relapses (odds ratio [OR] 2.90), while large vessel involvement (OR 6.14) and cerebral infarcts at the time of diagnosis (OR 3.32) were associated with a poor response to treatment."( Adult primary central nervous system vasculitis treatment and course: analysis of one hundred sixty-three patients.
Brown, RD; Christianson, TJ; Giannini, C; Hunder, GG; Huston, J; Miller, DV; Salvarani, C, 2015
)
0.76
"The treatment with prednisone resulted in a rapid resolution of clinical symptoms."( Polymyalgia rheumatica in a patient with splenic marginal zone lymphoma - a case report.
Gawroński, K; Kisiel, B; Rzepecki, P; Tłustochowicz, W, 2015
)
0.74
"A treatment with prednisone was introduced, and the patient's condition significantly improved."( [Neuralgic amyotrophy--a case report].
Banach, M; Miller, M, 2015
)
0.75
"Treatment with prednisone was associated with greater weight gain (β = 0.072 kg/m(2) , 95% CI 0.042, 0.10; P < 0.001)."( Changes in Body Mass Related to the Initiation of Disease-Modifying Therapies in Rheumatoid Arthritis.
Baker, JF; Cannella, A; Cannon, GW; Caplan, L; Davis, L; Ibrahim, S; Jorgenson, E; Michaud, K; Mikuls, TR; Sauer, BC; Teng, CC, 2016
)
0.77
"Treatment with prednisone 60 mg daily resulted in significant improvement by the next day."( Neutrophilic dermatosis of the dorsal hands in an elderly man.
Brandt, JC; Gonzalez, A; Perbtani, Y; Steffes, W; Vaziri, S, 2016
)
0.77
"Treatment with prednisone resulted in decreased CD86 expression in marrow (P=0.02) and PB (P=0.04) monocytes."( Increased donor CD86+CD14+ cells in the bone marrow and peripheral blood of patients with chronic graft-versus-host disease.
Arpinati, M; Baccarani, M; Chirumbolo, G; Marzocchi, G; Rondelli, D, 2008
)
0.69
"Cats treated with prednisone had a significantly longer survival time than those receiving other treatments."( Feline gastrointestinal eosinophilic sclerosing fibroplasia.
Craig, LE; Flatland, B; Hardam, EE; Hertzke, DM; Moore, RR; Rohrbach, BW, 2009
)
0.68
"The treatment with prednisone (1 mg/kg) brought the rapid improvement of muscle weakness and CPK value as well as mouth dryness and cholestatic liver dysfunction like in primary biliary cirrhosis."( [A case of chronic graft-versus-host disease presenting with polymyositis].
Inoue, M; Kitazono, T; Maeda, A; Okazaki, T; Ozaki, S; Shibata, T, 2009
)
0.67
"Dogs treated with prednisone experience statistically significant increases in blood lactate concentrations, which can result in type B hyperlactatemia. "( Effects of prednisone on blood lactate concentrations in healthy dogs.
Boysen, SR; Bozzetti, M; Dunn, M; Pang, DS; Rose, L,
)
0.86
"Treatment with prednisone and methotrexate resulted in complete remission of symptoms."( Dermatomyositis with inclusion body myositis pathology.
Iverson, D; Layzer, R; Lee, HS; Margeta, M, 2009
)
0.69
"Treatment with prednisone successfully resolved the lesions in this patient."( A case of linear immunoglobulin A bullous dermatosis in a patient exposed to sun and an analgesic.
Caldarola, G; Cozzani, E; Parodi, A; Pellicano, R, 2009
)
0.69
"Treatment with prednisone and cyclosporine was initiated based on a presumptive diagnosis of granulomatous meningoencephalitis."( Detection of Neospora caninum tachyzoites in cerebrospinal fluid of a dog following prednisone and cyclosporine therapy.
Galgut, BI; Grondin, TM; Harkin, KR; Janardhan, KS; Wight-Carter, MT, 2010
)
0.92
"Treatment with prednisone and azathioprine resulted in a dramatically improved outcome."( De novo autoimmune hepatitis with centrilobular necrosis following liver transplantation for primary biliary cirrhosis: a case report.
Wang, B; Wang, T; Zhang, Y, 2010
)
0.7
"Upon treatment with prednisone, the pain quickly decreased and 3 months later the inflammatory changes visible on MRI were clearly reduced."( [Low back pain and MRI-abnormalities: atypical polymyalgia rheumatica].
Bravenboer, B; de Rijk, MC; Pijpers, R; Wlazlo, N, 2011
)
0.68
"Treatment with prednisone and azathioprine, plus, in three children, cyclosporine, resulted in complete remission in eight, partial remission in six, and failure in two."( Giant cell hepatitis with autoimmune hemolytic anemia in early childhood: long-term outcome in 16 children.
Bernard, O; Choulot, JJ; Fabre, M; Gori, L; Jacquemin, E; Maggiore, G; Pacifico, L; Resti, M; Sciveres, M, 2011
)
0.71
"Treatment with prednisone and ursodeoxycholic acid led to a good response."( Overlap syndrome of autoimmune hepatitis and primary biliary cirrhosis triggered by fluvastatin.
Murashima, N; Nakayama, S, 2011
)
0.71
"Treatment with prednisone and chlorambucil was initiated, and the dog had a good response."( Waldenström's macroglobulinemia in a dog with a bleeding diathesis.
Fournel-Fleury, C; Jaillardon, L, 2011
)
0.71
"Treatment with prednisone resulted in normal values after only 3 days."( Asymptomatic macrothrombocytopenia in a young pure-bred beagle dog: a case report.
Abel, SJ; Bodié, K; Desmond, DJ; Fagerland, JA; Gagne, GD; Sramek, MK, 2011
)
0.71
"Treatment with prednisone 10 mg daily, colchicine 0.6 mg twice daily, and pentoxifylline 400 mg three times daily resulted in significant improvement in this case of idiopathic neutrophilic dermatosis of the hands."( A rare case of idiopathic neutrophilic dermatosis of the hands.
Cook, E; Epstein, R; Miller, R, 2011
)
0.71
"Treatment with prednisone is initiated with a clinical and laboratory improvement in the patient's condition."( [Kikuchi-Fujimoto disease].
Alianak, M; Corral, M; Fainberg, A; Huergo, I; Staffieri, F, 2012
)
0.72
"Treatment with prednisone and gamma interferon normalised the thickness of the gastric wall and gastric outlet function."( [Gastric outlet obstruction in chronic granulomatous disease].
Born, M; Hassan, C; Willinek, WA, 2002
)
0.65
"Treatment of prednisone is more beneficial to reversion of atrial fibrillation into sinus rhythm among patients with HARGD."( [Treatment of hyperthyroid atrial fibrillation associated with Graves disease by prednisone].
Li, M; Qiu, M; Wei, H, 2002
)
0.91
"Treatment with prednisone induced clinical improvement and normalization of the laboratory data."( Pfeifer-Weber-Christian's panniculitis in an obese patient with antinuclear antibody-positive leukocytoclastic vasculitis.
De Capite, C; Foccillo, G; Giunta, R; Lucivero, G; Mordente, S,
)
0.47
"Treatment with prednisone and/or cyclophosphamide controlled mucocutaneous and nail manifestations in all cases."( Nail manifestations in pemphigus vulgaris.
Cahali, JB; Kakuda, EY; Maruta, CW; Santi, CG,
)
0.47
"Treatment with prednisone resulted in a significant decrease in the L/M ratio."( The mechanisms of prednisone inhibition of inflammation in Crohn's disease involve changes in intestinal permeability, mucosal TNFalpha production and nuclear factor kappa B expression.
Bitton, A; Thomson, AB; Waschke, KA; Wild, GE, 2003
)
0.99
"Treatment with prednisone (50 mg/day) and blood transfusion was started before delivery."( Pregnancy complicated with pure red cell aplasia: a case report.
Kawarabayashi, T; Makino, Y; Nagano, M; Tamura, K, 2003
)
0.66
"Treatment with prednisone and hydroxychloroquine led to complete control of the cutaneous and muscular involvement, which was maintained during prednisone tapering."( Inflammatory myopathy in a patient with cutaneous findings of pityriasis rubra pilaris: a case of Wong's dermatomyositis.
Bellosta, M; Bogliolo, L; Caporali, R; Cavagna, L; Montecucco, C, 2004
)
0.66
"Treatment with prednisone did not influence the levels of IL-8."( Decreased levels of myeloperoxidase in induced sputum of patients with COPD after treatment with oral glucocorticoids.
Barczyk, A; Pierzchala, W; Sozañska, E; Trzaska, M, 2004
)
0.66
"The treatment with prednisone at the dose of 40 mg/d during 6 weeks was introduced, and the dose was decreased gradually to 10 mg/d within 6 months."( [Outcome of immunosuppressive treatment of a patient with renal failure due to retroperitoneal fibrosis].
Kurzawska-Firlej, D; Oko, A; Piernik, T; Suchanek-Krawiec, A, 2004
)
0.64
"Treatment with prednisone alone as first line, then combined prednisone with cyclophosphamide if NR to prednisone seemed equally effective when compared with using combined prednisone and cyclophosphamide initially."( Acquired factor VIII inhibitors in non-haemophilic patients: clinical experience of 15 cases.
Huang, YW; Philipp, C; Saidi, P, 2004
)
0.66
"Treatment with prednisone is preferable, followed by immunosuppressive therapy or tamoxifen in case of resistance to steroids."( [Fatigue, loss of appetite and anuria due to retroperitoneal fibrosis].
de Beus, E; Rensma, PL, 2007
)
0.68
"Oral treatment with prednisone has demonstrated efficacy in reducing restenosis after percutaneous coronary interventions (PCI). "( Neutropenia in patients treated with thienopyridines and high-dose oral prednisone after percutaneous coronary interventions.
Brunelleschi, S; Feola, M; Ferrero, V; Ribichini, F; Rognoni, A; Vacca, G; Vassanelli, C, 2007
)
0.9
"Treatment with prednisone showed good response in a majority of both adults and childhood PRCA."( Thirty-nine cases of pure red cell aplasia: a single center experience from India.
Mahapatra, M; Pati, HP; Saxena, R; Srinivas, U, 2007
)
0.68
"Treatment with prednisone and azathioprine may lead to a rapid improvement in aminotransferase levels."( Development of autoimmune hepatitis in primary biliary cirrhosis.
Gossard, AA; Lindor, KD, 2007
)
0.68
"Treatment with prednisone with gradual tapering yielded a good response."( Chronic idiopathic granulomatous mastitis.
Ablin, J; Ben-David, D; Gutman, M; Katz, U; Langevitz, P; Molad, Y; Paran, D, 2007
)
0.68
"Treatment with prednisone 40 mg led to complete improvement of his pulmonary disease."( Pulmonary sarcoidosis associated with etanercept therapy.
Farah, RE; Shay, MD, 2007
)
0.68
"Treatment with prednisone and cyclophosphamide failed to induce remission."( Plasmapheresis-immunoadsorption for treatment of systemic lupus erythematosus in a dog.
Gordon, BR; Hurvitz, AI; Matus, RE; Saal, S; Scott, RC, 1983
)
0.61
"Pretreatment with prednisone plus diphenhydramine or prednisone and diphenhydramine plus ephedrine decreased the reaction rate to 9.0% and 3.1%, respectively, during 657 procedures in 563 patients."( Two pretreatment regimens for high-risk patients receiving radiographic contrast media.
Greenberger, PA; Patterson, R; Radin, RC, 1984
)
0.59
"Pretreatment with prednisone and diphenhydramine has been demonstrated to reduce this reaction rate to 9% in 465 procedures."( Contrast media reactions.
Greenberger, PA, 1984
)
0.59
"Treatment with prednisone resulted in a dramatic improvement in both symptoms and respiratory values."( Sarcoidosis. Reversal of respiratory failure 21 years after onset of disease.
Hunt, KK; Matthews, JI, 1984
)
0.61
"Treatment with prednisone corrected hypoventilation, improved symptoms, increased lung volumes, returned respiratory muscle strength to normal range, but did not change the degree of lung stiffness."( Reversible hypercapnic respiratory insufficiency in scleroderma caused by respiratory muscle weakness.
Chausow, AM; Kane, T; Levinson, D; Szidon, JP, 1984
)
0.61
"Treatment with prednisone and azathioprine resulted in the disappearance of vetetating lesions and in healing, with postinflammatory hyperpigmentation."( Pyodermite végétante of Hallopeau. Immunofluorescence studies performed in an early disease stage.
Faber, WR; Neumann, HA, 1980
)
0.6
"Treatment with prednisone administered on alternate days was accompanied by decreasing proteinuria and increasing serum levels of albumin in all the patients."( Membranous nephropathy: high-dose alternate-day therapy with prednisone.
Biava, CG; Hopper, J; Tu, WH, 1981
)
0.84
"Treatment with prednisone, immunosuppressants, and aspirin was unsuccessful."( Bilateral acute retinal necrosis.
Price, FW; Schlaegel, TF, 1980
)
0.6
"Pigs treated with prednisone had hemorrhages in the proper gastric (fundic) gland area of the stomach."( Effect of prednisone on gastric blood flow in swine.
Frandle, KA; Reddy, VK; Samson, MD; Zamora, CS, 1980
)
0.99
"Treatment by prednisone made it possible to maintain the percentages of binding to the three tracers for two weeks at the levels reached after the fourth plasma exchange."( Reduction of anti-thyroid hormone autoantibodies through plasma exchange and corticosteroid therapy.
Attali, JR; Perret, G; Sebaoun, J; Valensi, P, 1994
)
0.64
"Treatment with prednisone as soon as a significant rise in anti-dsDNA occurs prevents relapse in most cases, without increasing the cumulative dose of prednisdone given."( Prevention of relapses in systemic lupus erythematosus.
Bootsma, H; de Boer, G; Derksen, R; Gmelig-Meyling, F; Hermans, J; Kallenberg, C; Kater, L; Limburg, P; Spronk, P; Wolters-Dicke, H, 1995
)
0.63
"Treatment with prednisone and cyclophosphamide produced total remission after a follow-up of 22 months."( [Idiopathic granulomatous angiitis of the central nervous system].
Alonso de Leciñana, M; Arpa, J; Barreiro, P; Gutiérrez Molina, M; Morales, C; Palomo, F, 1994
)
0.63
"Treatment with prednisone was found to induce disturbances of the lipid metabolism at the level of total cholesterol and of triglycerides."( Lipid peroxidation in autoimmune systemic vasculitides. Effect of corticoid treatment on lipid peroxidation. Antioxidant protection with vitamin E.
Serban, MG; Tănăseanu, S,
)
0.47
"The treatment with prednisone did not change the level of peroxides neither the activity of the antioxidant enzymes studied."( Lipid peroxidation and the activity of some antioxidant enzymes in patients with systemic vasculitides treated with corticoids.
Niţă, V; Serban, MG; Tănăseanu, S,
)
0.45
"Treatment with prednisone (2 mg/kg daily for 8 weeks) and vincristine (1 mg/m2 once weekly for 4 weeks) brought about partial remission of the angioimmunoblastic lymphadenopathy with normalization of the clinical and laboratory findings, the splenohepatomegaly regressed, and there was only a small amount of ascites."( [Reversible myelofibrosis in angioimmunoblastic lymphadenopathy].
Mayet, WJ; Meyer zum Büschenfelde, KH; Orth, T; Störkel, S; Treichel, U, 1994
)
0.63
"Treatment with prednisone and azathioprine did not give any improvement of the neurological symptoms."( Hemiparkinsonism in a patient with primary Sjögren's syndrome. A case report and a review of the literature.
Koudstaal, PJ; van de Merwe, JP; Visser, LH, 1993
)
0.63
"Treatment with prednisone resulted in relief of lumbar and flank pain a well as in prevention of further digestive tract hemorrhage."( [Retroperitoneal fibrosis and portal hypertension].
Bernasconi, S; Pedrinis, E; Realini, S; Reiner, M, 1993
)
0.63
"Treatment with prednisone and cyclophosphamide was started with a good clinical response, stabilization of renal insufficiency and disappearance of P-ANCA (MPO)."( Microscopic polyangiitis. A systemic vasculitis with a positive P-ANCA.
Bernis, C; Daudén, E; Fraga, J; Peñas, PF; Porras, JI; Sarriá, C, 1996
)
0.63
"Treatment with prednisone rather than placebo resulted in a more rapid improvement in arterial PO2 (PaO2) (1.12 mm Hg/d versus -0.03 mm Hg/day; p = 0.002), alveolar-arterial oxygen gradient (A-aDO2) (-1.16 mm Hg/d versus -0.03 mm Hg/day; p = 0.04), FEV1 (0.05 L/d versus 0.00 L/d; p = 0.006), and peak expiratory flow (PEF) (0.15 L/s/d versus 0.04 L/s/d; p = 0.009)."( Controlled trial of oral prednisone in outpatients with acute COPD exacerbation.
Carvalho, P; Charan, NB; Crowley, JJ; Nielson, CP; Thompson, WH, 1996
)
0.94
"Treatment with prednisone (2 mg/kg/day) resulted in regression of her dyspnoea with a decrease of systolic pulmonary artery pressure to 65 mmHg, and of the arterio-capillary gradient to 15 mmHg; the lupus serology became negative with a clinical follow-up of 37 months."( [Precapillary pulmonary arterial hypertension disclosing systemic lupus erythematosus].
Babuty, D; Cosnay, P; Fauchier, JP; Fauchier, L; Goupille, P; Marchal, C; Valat, JP, 1996
)
0.63
"Treatment with prednisone, a 3-week tapering dose (60, 40, 20 mg), cleared the dermatitis."( Wrist dermatitis: contact allergy to neoprene in a keyboard wrist rest.
Elston, DM; Johnson, RC, 1997
)
0.64
"Treatment with prednisone resulted in normalization of calcium levels in all patients."( Idiopathic calcitriol-induced hypercalcemia. A new disease entity?
Evron, E; Goland, S; Schattner, A; Sthoeger, ZM; von der Walde, J, 1997
)
0.64
"Treatment with prednisone (40 mg/day) and PTU resulted in a prompt normalization of T3."( [Treatment of amiodarone-induced hyperthyroidism: corticosteroids or potassium perchlorate? What value do interleukin-6 levels have?].
Konfino, O; Martin-Du Pan, R; Zimmermann, M, 1997
)
0.64
"Treatment with prednisone and isotonic saline (0.9% NaCl) solution led to prompt clinical response."( Adrenal insufficiency in a neonatal foal.
Couëtil, LL; Hoffman, AM, 1998
)
0.64
"Treatment with prednisone and vitamin E resulted in complete resolution of the nephrotic syndrome and slow improvement of the yellow nails, respectively."( Yellow nails and minimal change nephrotic syndrome.
Fernández-Llaca, H; Val-Bernal, JF; Yáñez, S, 1999
)
0.64
"Treatment with prednisone of 0.5 to 2 mg/kg/day should be considered in all patients and continued for six months before declaring the patient resistant to therapy."( Management of focal segmental glomerulosclerosis: evidence-based recommendations.
Burgess, E, 1999
)
0.64
"Treatment with prednisone suppressed median sputum eosinophilia (from 16.3 to 0%, p<0.001), decreased sputum ECP (from 7,480 to 700 microg x L(-1), p = 0.01), but did not improve neutrophil numbers, fibrinogen or IL-5."( Prednisone-dependent asthma: inflammatory indices in induced sputum.
Clelland, L; Dolovich, J; Efthimiadis, A; Hargreave, FE; Pavord, I; Pizzichini, E; Pizzichini, MM, 1999
)
2.09
"Treatment with prednisone, furosemide and theophylline was started, which led to a gradual improvement in 2 weeks and a persistent remission after 9 months."( Chronic systemic capillary leak syndrome. Report of a case and review of the literature.
Airaghi, L; Miadonna, A; Montori, D; Santambrogio, L; Tedeschi, A, 2000
)
0.65
"A treatment of prednisone was started together with methotrexate."( [Takayasu's arteritis--case report and review of the literature].
Gerster, JC; Schurch, MA, 2000
)
0.65
"Treatment with prednisone resulted in complete resolution of hypercalcemia in 4 cats."( Idiopathic hypercalcemia in cats.
Center, SA; Chew, DJ; DiBartola, SP; Midkiff, AM; Randolph, JF,
)
0.47
"Treatment with prednisone was successful."( [Pulmonary sarcoidosis diagnosed in 2 cases suspected to be neoplasms].
Bernard, J; Burakowska, B; Langfort, R; Wiatr, E, 2000
)
0.65
"Treatment with prednisone improved clinical symptoms and MRI findings concomitant with reduction of RF titer."( Rheumatoid factor positive hypertrophic cranial pachymeningitis in association with hypopituitarism and multiple cranial nerve palsies.
Abe, K; Hayashi, T; Manabe, Y; Narai, H; Sakai, K; Warita, H, 2001
)
0.65
"Treatment with prednisone, laser or plastic surgery operation are all effective to body surface hemangioma and proper treatment method should be selected according to different period and different type of hemangioma to improve the therapeutic effectiveness."( [Treatment methods of body surface hemangioma].
Chen, JM; Huang, HB; Liang, J, 2002
)
0.67
"Treatment with prednisone, carnitine, vitamins and food containing carnitine rich is very effective."( [Studies of the clinicopathological changes of eight patients with lipid storage myopathy].
Wang, C; Xu, X; Yin, J, 2001
)
0.65
"Treatment with prednisone or gamma rays inhibits partially and delays the appearance of arthritis in LEW, acting essentially on ConA-stimulable subpopulation."( [Lymphocyte subpopulations in adjuvant arthritis of rats. Effects of corticoids and gamma irradiation].
Delbarre, F; Kahan, A; Le Gô, A; Piatier, D, 1978
)
0.6
"Treatment with prednisone resulted in clinical improvement but no change in muscle histology."( Hereditary carnitine deficiency of muscle.
Dimauro, S; Griggs, RC; Markesbery, W; VanDyke, DH, 1975
)
0.59
"Treatment with prednisone improved the condition, and the CT abnormality disappeared."( Computed tomography changes in neurosarcoidosis clearing with steroid treatment.
Brooks, J; Fowler, HL; Strickland, MC; Vulpe, M; Williams, JP, 1979
)
0.6
"Treatment with prednisone, cyclophosphamide, and plasmapheresis was associated with rapid disappearance of the serum anti-GMB antibody and temporary stabilization of renal function."( Treatment of Goodpasture's syndrome with immunosuppression and plasmapheresis.
Finch, RA; McGowan, E; Rutsky, EA; Wilson, CB, 1979
)
0.6
"On treatment with prednisone, the patient's strength and reading skill improved, symptoms resolved, and muscle enzymes returned to normal."( Reversible alexia, mitochondrial myopathy, and lactic acidemia.
Skoglund, RR, 1979
)
0.58
"Treatment with prednisone followed by beclomethasone resulted in a marked improvement in her condition."( Idiopathic bronchial stenosis in a young woman.
Hooper, RG; Matthews, JI, 1978
)
0.6
"Treatment with prednisone was associated with improvement in the clinical disease and the histologic picture on repeat biopsy."( Renal failure as a presenting sign of diffuse sarcoidosis in an adolescent girl.
Ruley, EJ; Shin, ML; Turner, MC, 1977
)
0.6
"Treatment with prednisone produced impressive amelioration of the pericarditis with no recurrence of the lupus erythematosis syndrome during a prolonged period of observation following cessation of corticosteroid therapy."( Pericardial tamponade. A presenting manifestation of procainamide-induced lupus erythematosus.
Ghose, MK, 1975
)
0.59
"Treatment with prednisone was followed by an improvement in bleeding time, although in vitro platelet function deteriorated."( Prednisone-induced hemostasis in a platelet function abnormality.
Hathaway, WE; Hutter, JJ, 1975
)
2.04
"Treatment with prednisone and penicillin over a three-month period resulted in return of good cochlear function in one ear."( Hearing loss of acquired syphilis: diagnosis confirmed by incudectomy.
Nadol, JB, 1975
)
0.59
"Treatment with prednisone and sulfasalazine was continued. "( Dietary supplementation with fish oil in ulcerative colitis.
Beeken, W; Burakoff, R; Cort, D; DeSchryver-Kecskemeti, K; Gramlich, TL; Rodgers, J; Stenson, WF, 1992
)
0.64
"Treatment with prednisone and aspirin appears to be efficacious, safe, and economic in the prevention of pregnancy loss and fetal growth retardation in patients with aCL."( Prevention of anticardiolipin antibody-related pregnancy losses with prednisone and aspirin.
Angel, J; Espinoza, LR; Hubble, CL; Jara, LJ; Martínez-Osuna, P; O'Brien, W; Saway, S; Seleznick, MJ; Silveira, LH, 1992
)
0.87
"Treatment with prednisone and plasma exchange resulted in some improvement."( Case-of-the-month: perineuritis presenting as mononeuritis multiplex.
Albers, JW; Sima, AA; Simmons, Z, 1992
)
0.62
"Boys treated with prednisone had stronger average muscle strength scores, than did boys treated with placebo as early as 10 days after starting therapy."( Prednisone in Duchenne dystrophy. A randomized, controlled trial defining the time course and dose response. Clinical Investigation of Duchenne Dystrophy Group.
Brooke, MH; Fenichel, GM; Griggs, RC; Mendell, JR; Miller, JP; Moxley, RT; Pestronk, A, 1991
)
2.05
"Treatment with prednisone or 5-aminosalicylic acid reduced TXB2 levels in the chronic stage of the inflammatory disease and improved the morphological damage as assessed macroscopically and histologically."( Participation of thromboxane and other eicosanoid synthesis in the course of experimental inflammatory colitis.
Guarner, F; Malagelada, JR; Rodriguez, R; Salas, A; Vilaseca, J, 1990
)
0.62
"Treatment with prednisone was accompanied by resolution of hypoglycemic episodes and disappearance of the antireceptor antibodies."( Hypoglycemia due to antiinsulin receptor antibodies in systemic lupus erythematosus.
Boden, G; Lopatin, M; Varga, J, 1990
)
0.62
"Treatment with prednisone again resulted in resolution of all symptoms and normalization of radiographic and hepatic function abnormalities."( Pulmonary fibrosis after bone marrow transplantation responsive to treatment with prednisone and cyclosporine.
Abbondanzo, SL; Cottler-Fox, M; Deeg, HJ; Raschko, JW; Spitzer, TR; Torrisi, JR, 1989
)
0.84
"Treatment with prednisone alone results in fewer infections and better survival than prednisone and azathioprine in standard-risk chronic GVHD."( Prednisone and azathioprine compared with prednisone and placebo for treatment of chronic graft-v-host disease: prognostic influence of prolonged thrombocytopenia after allogeneic marrow transplantation.
Appelbaum, FR; Dahlberg, S; Deeg, HJ; Doney, KC; Flournoy, N; Sanders, JE; Storb, R; Sullivan, KM; Weiden, P; Witherspoon, RP, 1988
)
2.06
"Treatment with prednisone resulted in almost complete recovery of renal function."( Renal failure due to granulomatous interstitial nephritis after pulmonary sarcoidosis.
Jie, K; Lobatto, S; Valentijn, RM; van Dorp, WT; Weening, JJ, 1987
)
0.61
"Treatment with prednisone and cyclophosphamide did not improve the hearing loss."( Sensorineural hearing loss in lupus erythematosus.
Caldarelli, DD; Corey, JP; Rejowski, JE, 1986
)
0.61
"Treatment with prednisone (3 X 30 mg daily) led to complete cure of the hemiparesis within 6 weeks."( Cerebral vasculitis as presenting symptom of systemic lupus erythematosus.
Hogenhuis, LA; Sanders, EA, 1986
)
0.61
"Treatment with prednisone and azathioprine improved the liver condition in 16 of the 18 patients given treatment."( Liver disease associated with anti-liver-kidney microsome antibody in children.
Alagille, D; Alvarez, F; Bernard, O; Hadchouel, M; Hadchouel, P; Homberg, JC; Maggiore, G; Odièvre, M, 1986
)
0.61
"Treatment with prednisone and vincristine led to a rise in the platelet count to 100,000/mm3 after two months with no change in the splenomegaly."( Autoimmune thrombocytopenia in sarcoidosis.
Greenberg, BR; Lawrence, HJ, 1985
)
0.61

Toxicity

Low-dose prednisone for OMG has an acceptable side-effect profile. Tripterygium glycosides enhances the effect of thiamazole andprednisone in the treatment of hyperthyroidism.

ExcerptReferenceRelevance
" In DCA-saline pretreated rats the LD50 of isoproterenol was determined to be 14."( Potentiation of isoproterenol cardiotoxicity by corticoids.
Green, M; Guideri, G; Lehr, D, 1978
)
0.26
" This case suggests that disseminated intravascular coagulation, and its rare association with hepatotoxicity, is a potentially fatal side effect of aspirin therapy."( Aspirin hepatotoxicity and disseminated intravascular coagulation.
Bennett, RM; Sbarbaro, JA, 1977
)
0.26
" Vindesine was more toxic than Vincristine."( A study of toxicity and comparative therapeutic efficacy of vindesine-prednisone vs. vincristine-prednisone in children with acute lymphoblastic leukemia in relapse. A Pediatric Oncology Group study.
Beardsley, GP; Buchanan, G; Hvizdale, E; Krischer, J; Link, M; Maybee, D; Mehta, P; Nitschke, R; Ragab, A; Vats, T, 1992
)
0.52
" Clinicians should not fear using high dose ACTH/corticosteroids to treat severe Crohn's disease with an abdominal mass, if indicated, as it is both safe and effective whether an abscess cavity is present or not."( The safety of corticosteroid therapy in Crohn's disease with an abdominal mass.
Adler, DJ; Felder, JB; Korelitz, BI, 1991
)
0.28
" The publication of cases of overdoses may provide useful information on the causes of the mistakes, on drug-induced toxic effects, and on salvage therapy."( Overdose of vinblastine in a child with Langerhans' cell histiocytosis: toxicity and salvage therapy.
Conter, V; Corbetta, A; D'Angelo, P; Fraschini, D; Jankovic, M; Masera, G; Pacheco, C; Rabbone, ML,
)
0.13
"5 mg/kg daily from the first postoperative day is a safe practice after heart-lung transplantation."( The safety of low-dose prednisone before and immediately after heart-lung transplantation.
Ahmad, D; Kostuk, WJ; McKenzie, FN; Menkis, AH; Novick, RJ; Pflugfelder, PW; Reid, KR, 1991
)
0.59
"Pulmonary toxicity is a well recognised side effect of anticancer agents particularly bleomycin, cyclophosphamide, methotrexate, and busulphan."( Pulmonary toxicity following MOPP chemotherapy.
Byrne, MJ; Cohney, SJ; Millward, MJ; Ryan, GF, 1990
)
0.28
" From June 1988 to December 1989, 27 previously untreated patients with early-staged Hodgkin's disease with adverse features for disease-free survival received combined-modality therapy."( NOVP: a novel chemotherapeutic regimen with minimal toxicity for treatment of Hodgkin's disease.
Cabanillas, F; Hagemeister, FB; Liang, JC; McLaughlin, P; Meistrich, ML; Redman, JR; Rodríguez, MA; Romaguera, JE; Swan, F; Velásquez, WS, 1990
)
0.28
" There were three fatal toxic events, two due to viral infection and one to a second malignant tumor (NHL)."( Hodgkin's disease in children: treatment with MOPP and low-dose, extended field irradiation without laparotomy. Late results and toxicity.
Berry, M; Blanchette, V; Chan, H; Doherty, M; Doyle, J; Freedman, M; Greenberg, M; Jenkin, D; Panzarella, T; Saunders, F, 1990
)
0.28
" Home nebulizer therapy for children with asthma appears safe and reduces the need for hospital care and short courses of prednisone therapy."( The efficacy and safety of home nebulizer therapy for children with asthma.
Akhter, J; Gaspar, M; Zimo, DA, 1989
)
0.48
"Eighty-five corticosteroid dependent patients with respiratory diseases requiring alternate day prednisone were studied for certain adverse effects that have been reported to be associated with corticosteroid therapy."( Prevalence of adverse effects in corticosteroid dependent asthmatics.
Aksamit, T; Fitzsimons, R; Grammer, LC; Halwig, JM; Patterson, R,
)
0.35
"The morbidity and mortality due to short-term adverse effects of antileukemic chemotherapy were studied in a follow-up of 100 children with ALL on a conventional regimen."( Toxicity of conventional ALL chemotherapy: incidence of short-term adverse effects in 100 children.
Saarinen, UM, 1987
)
0.27
" That preuremic transplantation is safe and efficacious in patients with immanent end-stage renal disease has not been established."( Renal transplantation done safely without prior chronic dialysis therapy.
Ascher, NL; Fryd, D; Migliori, RJ; Najarian, JS; Payne, WD; Simmons, RL; Sutherland, DE, 1987
)
0.27
" In the 101 patients prospectively studied, the benefits from prednisone treatment far outweighed the adverse side effects, which occurred in 61 patients."( Adverse side effects associated with prednisone in the treatment of patients with oral inflammatory ulcerative diseases.
Lozada, F; Migliorati, C; Silverman, S, 1984
)
0.78
" In terms of reproductive and developmental toxicity, cyclosporine produces some adverse effects in both experimental animals and humans."( International Commission for Protection Against Environmental Mutagens and Carcinogens. Cyclosporine A: review of genotoxicity and potential for adverse human reproductive and developmental effects. Report of a Working Group on the genotoxicity of cyclosp
Mattison, DR; Olshan, AF; Zwanenburg, TS, 1994
)
0.29
" Adverse events occurred frequently (80."( A prospective study of the long-term efficacy and toxicity of low-dose methotrexate in rheumatoid arthritis.
Carotti, M; Cervini, C; Salaffi, F; Sartini, A,
)
0.13
"During a one month followup period, adverse reactions occurred with equal frequency among patients with RA and healthy controls."( Immunization of patients with rheumatoid arthritis against influenza: a study of vaccine safety and immunogenicity.
Chalmers, A; Patterson, C; Scheifele, D; Shuckett, R; Teufel, A; Weber, J; Williams, D, 1994
)
0.29
" For CS, charts were abstracted from the date of prednisone start for predefined adverse events (AEs)."( Low dose long-term corticosteroid therapy in rheumatoid arthritis: an analysis of serious adverse events.
Brasington, R; Burmeister, LF; Caldwell, JR; Furst, DE; Koehnke, R; Kohler, JA; Saag, KG; Zimmerman, B, 1994
)
0.54
"Although disease severity is an important confounding factor, low dose long-term prednisone use equal to or greater than 5 mg/d is correlated with the development of specific adverse events in a dose-dependent fashion."( Low dose long-term corticosteroid therapy in rheumatoid arthritis: an analysis of serious adverse events.
Brasington, R; Burmeister, LF; Caldwell, JR; Furst, DE; Koehnke, R; Kohler, JA; Saag, KG; Zimmerman, B, 1994
)
0.51
"In equally favorable cases, RP without diversion is not as safe as RP with diversion, especially in patients taking > or = 20 mg of prednisone/day."( Omission of temporary diversion in restorative proctocolectomy--is it safe?
Fabre, JM; Fazio, VW; Lavery, IC; Milsom, JW; Oakley, JR; Tjandra, JJ, 1993
)
0.49
"Cardiotoxicity is a well recognized side effect of anthracyclines (doxorubicin and epirubicin) or antracenadiones (mitoxantrone) at cumulative or high doses."( Late cardiac toxicity of doxorubicin, epirubicin, and mitoxantrone therapy for Hodgkin's disease in adults.
Arévila, N; Avilés, A; Díaz Maqueo, JC; García, R; Gómez, T; Nambo, MJ, 1993
)
0.29
" Gastrointestinal morbidity was less in the cohort treated without Ara-C; however, infectious morbidity persisted at unacceptable levels and this program was terminated as too toxic to administer."( Severe toxicity limits intensification of induction therapy for acute lymphoblastic leukemia.
Berman, E; Gaynor, J; Gee, T; Kempin, S; Kritz, A; Little, C; Scheinberg, D; Sogoloff, H; Telford, P; Weiss, M, 1993
)
0.29
"The authors reviewed the clinical records of 602 patients with ocular inflammatory disease treated with immunosuppressive drug therapy and/or systemic corticosteroids for adverse systemic effects while undergoing therapy."( Systemic drug toxicity trends in immunosuppressive therapy of immune and inflammatory ocular disease.
Akova, YA; Christen, WG; Foster, CS; Messmer, E; Rodriguez, A; Tamesis, RR, 1996
)
0.29
"Immunosuppressive drug treatment was more likely to result in discontinuation of therapy because of toxic side effects than was corticosteroid treatment."( Systemic drug toxicity trends in immunosuppressive therapy of immune and inflammatory ocular disease.
Akova, YA; Christen, WG; Foster, CS; Messmer, E; Rodriguez, A; Tamesis, RR, 1996
)
0.29
"These findings suggest that when properly administered and monitored for adverse effects, most immunosuppressive agents used in the current study have similar risk profiles with relatively few serious therapeutic mishaps and largely reversible side effects."( Systemic drug toxicity trends in immunosuppressive therapy of immune and inflammatory ocular disease.
Akova, YA; Christen, WG; Foster, CS; Messmer, E; Rodriguez, A; Tamesis, RR, 1996
)
0.29
" the primary side effect of sirolimus was a reversible decrease in platelet (PLT) and white blood cell (WBC) counts."( The side effect profile of sirolimus: a phase I study in quiescent cyclosporine-prednisone-treated renal transplant patients.
Jordan, S; Kahan, BD; Murgia, MG, 1996
)
0.52
"5 mg/d within 1 year, was effective and less toxic in this patient population, than the two higher dose regimens."( Efficacy and adverse effects of different corticosteroid dose regimens in temporal arteritis: a retrospective study.
Nesher, G; Rubinow, A; Sonnenblick, M,
)
0.13
" Data were collected at each treatment cycle via a 75-item self-report questionnaire, with severity of each side effect graded on a 5-point scale."( Side effects of CHOP in the treatment of non-hodgkin's lymphoma.
North, C; Sitzia, J; Stanley, J; Winterberg, N, 1997
)
0.3
" These data, though preliminary, indicate that early immunosuppression without the use of prednisone is safe and tends to be associated with improved liver and renal functions compared to conventional triple therapy."( Immunosuppression without prednisone after liver transplantion is safe and associated with normal early graft function: preliminary results of a randomized study.
Angelico, M; Anselmo, A; Baiocchi, L; Casciani, CU; Negrini, S; Orlando, G; Palmieri, G; Pisani, F; Tisone, G; Vennarecci, G, 1998
)
0.82
" Toxicity information for IFN had been collected using patient-completed diaries so the actual duration of each adverse event could be determined."( Quality-adjusted time without symptoms or toxicity analysis of interferon maintenance in multiple myeloma.
Browman, G; Cole, B; James, K; Johnston, D; Li, T; Pater, J; Sugano, D; Zee, B, 1998
)
0.3
" The aim of this study was to assess whether conversion from Sandimmune to Neoral provides safe and effective oral immunosuppression in stable liver transplant recipients."( An open-label study of the safety and tolerability of converting stable liver transplant recipients to neoral.
Dahlke, LM; Krom, RA; Pasha, TM; Porayko, MK; Wiesner, RH, 1998
)
0.3
" Medical files were reviewed for adverse side effects: fever, pancreatitis, infections, gastrointestinal intolerance, aminotransferase level increase, leukopenia, and thrombocytopenia."( Safety of azathioprine and 6-mercaptopurine in pediatric patients with inflammatory bowel disease.
Kirschner, BS, 1998
)
0.3
"AZA or 6-MP was tolerated in 51 of 95 patients (54%) without adverse reaction; 27 of 95 (28%) experienced side effects that responded to dose reduction (23 patients) or spontaneously (4 patients), most commonly increased aminotransferase level (13."( Safety of azathioprine and 6-mercaptopurine in pediatric patients with inflammatory bowel disease.
Kirschner, BS, 1998
)
0.3
" The incidences of premature withdrawal from the study due to adverse events in the three groups were 4 of 51 (7."( A randomized double-blind, multicenter plasma concentration controlled study of the safety and efficacy of oral mycophenolate mofetil for the prevention of acute rejection after kidney transplantation.
de Fijter, JW; Hale, MD; Hené, RJ; Hilbrands, LB; Navarro, MT; Nicholls, AJ; Squifflet, JP; van Gelder, T; Vanrenterghem, Y; Verpooten, GA; Weimar, W, 1999
)
0.3
"MPA Cpredose and MPA AUC are significantly related to the incidence of biopsy-proven rejection after kidney transplantation, whereas MMF dose is significantly related to the occurrence of adverse events."( A randomized double-blind, multicenter plasma concentration controlled study of the safety and efficacy of oral mycophenolate mofetil for the prevention of acute rejection after kidney transplantation.
de Fijter, JW; Hale, MD; Hené, RJ; Hilbrands, LB; Navarro, MT; Nicholls, AJ; Squifflet, JP; van Gelder, T; Vanrenterghem, Y; Verpooten, GA; Weimar, W, 1999
)
0.3
" Many of these adverse side effects can be greatly reduced or prevented with close monitoring of patients."( Ocular toxicity of systemic medications: a case series.
To, TQ; Townsend, JC, 2000
)
0.31
" Clinical cases illustrating possible adverse ocular side effects are presented, which include INH-induced optic neuropathy, phenothiazine-induced retinopathy, steroid-induced glaucoma, and vortex epitheliopathy secondary to amiodarone."( Ocular toxicity of systemic medications: a case series.
To, TQ; Townsend, JC, 2000
)
0.31
" No toxic deaths have occurred."( Etoposide, mitoxantrone and prednisone: a salvage regimen with low toxicity for refractory or relapsed non-Hodgkin's lymphoma.
Budel, L; Doorduijn, JK; Löwenberg, B; Sonneveld, P; Spruit, P; van Der Holt, B; van't Veer, M, 2000
)
0.6
" Despite increased hematotoxicity, moderate dose escalation is safe for the majority of the patients with G-CSF assistance and standard supportive treatment."( Acute hematologic toxicity and practicability of dose-intensified BEACOPP chemotherapy for advanced stage Hodgkin's disease. German Hodgkin's Lymphoma Study Group (GHSG).
Diehl, V; Engel, C; Loeffler, M; Schmitz, S; Tesch, H, 2000
)
0.31
" Clinical response, remission, corticosteroid tapering, and adverse event data were collected."( Efficacy and safety of repeated infliximab infusions for Crohn's disease: 1-year clinical experience.
Cohen, RD, 2001
)
0.31
" The distribution of adverse prognostic factors was comparable in the two-induction arm."( Daunorubicin continuous infusion induces more toxicity than bolus infusion in acute lymphoblastic leukemia induction regimen: a randomized study.
Bernard, M; Casassus, P; Delain, M; Desablens, B; Guilhot, F; Hunault-Berger, M; Ifrah, N; Jouet, JP; Milpied, N; Sadoun, A, 2001
)
0.31
" The long-term effectiveness and side-effect profiles of pulse immunosuppressive regimens warrant further study."( Combination therapy with pulse cyclophosphamide plus pulse methylprednisolone improves long-term renal outcome without adding toxicity in patients with lupus nephritis.
Austin, HA; Balow, JE; Boumpas, DT; Collins, L; Crane, M; Danning, CL; Gourley, MF; Illei, GG; Klippel, JH; Kuroiwa, T; Steinberg, AD; Vaughan, EM; Yarboro, CH, 2001
)
0.31
"Rates of treatment failure (defined as need for supplemental immunosuppressive therapy or doubling of serum creatinine concentration, or death) and adverse events."( Combination therapy with pulse cyclophosphamide plus pulse methylprednisolone improves long-term renal outcome without adding toxicity in patients with lupus nephritis.
Austin, HA; Balow, JE; Boumpas, DT; Collins, L; Crane, M; Danning, CL; Gourley, MF; Illei, GG; Klippel, JH; Kuroiwa, T; Steinberg, AD; Vaughan, EM; Yarboro, CH, 2001
)
0.31
" Combination therapy and cyclophosphamide therapy alone did not differ statistically in terms of effectiveness or adverse events."( Combination therapy with pulse cyclophosphamide plus pulse methylprednisolone improves long-term renal outcome without adding toxicity in patients with lupus nephritis.
Austin, HA; Balow, JE; Boumpas, DT; Collins, L; Crane, M; Danning, CL; Gourley, MF; Illei, GG; Klippel, JH; Kuroiwa, T; Steinberg, AD; Vaughan, EM; Yarboro, CH, 2001
)
0.31
" The combination of pulse cyclophosphamide and methylprednisolone appears to provide additional benefit over pulse cyclophosphamide alone and does not confer additional risk for adverse events."( Combination therapy with pulse cyclophosphamide plus pulse methylprednisolone improves long-term renal outcome without adding toxicity in patients with lupus nephritis.
Austin, HA; Balow, JE; Boumpas, DT; Collins, L; Crane, M; Danning, CL; Gourley, MF; Illei, GG; Klippel, JH; Kuroiwa, T; Steinberg, AD; Vaughan, EM; Yarboro, CH, 2001
)
0.31
"Sputum induction is a safe and effective technique to study airway inflammation in stable asthma."( Safety of sputum induction with isotonic saline in adults with acute severe asthma.
Gibson, PG; Hensley, MJ; Simpson, JL; Wark, PA, 2001
)
0.31
" Adverse effects were documented every 3 months."( Low-dose prednisone therapy for patients with early active rheumatoid arthritis: clinical efficacy, disease-modifying properties, and side effects: a randomized, double-blind, placebo-controlled clinical trial.
Bijlsma, JW; Jacobs, JW; Siewertsz Van Reesema, DR; van Everdingen, AA, 2002
)
0.73
" No clinically relevant adverse effects were observed, except for a higher incidence of osteoporotic fractures in the prednisone group."( Low-dose prednisone therapy for patients with early active rheumatoid arthritis: clinical efficacy, disease-modifying properties, and side effects: a randomized, double-blind, placebo-controlled clinical trial.
Bijlsma, JW; Jacobs, JW; Siewertsz Van Reesema, DR; van Everdingen, AA, 2002
)
0.94
"Data from 185 patients were retrospectively evaluated for adverse events, duration of exposure (person-days), and the mean atorvastatin dose exposure."( Safety and efficacy of atorvastatin in heart transplant recipients.
Aaronson, KD; Baliga, RR; Cody, RJ; Dyke, DB; Koelling, TM; Lake, KD; Pagani, FD; Patel, DN, 2002
)
0.31
"Data from 185 patients were retrospectively evaluated for adverse events, duration of exposure (person-days), and the mean atorvastatin dose exposure."( Safety and efficacy of atorvastatin in heart transplant recipients.
Aaronson, KD; Baliga, RR; Cody, RJ; Dyke, DB; Koelling, TM; Lake, KD; Pagani, FD; Patel, DN, 2002
)
0.31
"Atorvastatin, when used at moderate doses and with close biochemical and clinical monitoring, appears to be safe and is effective in aggressively lowering LDL in heart transplant recipients when treatment with other statins has failed to achieve LDL goals."( Safety and efficacy of atorvastatin in heart transplant recipients.
Aaronson, KD; Baliga, RR; Cody, RJ; Dyke, DB; Koelling, TM; Lake, KD; Pagani, FD; Patel, DN, 2002
)
0.31
"In this study we aimed to discuss whether the gonadal suppression is effective or not in preventing the gonadal toxic effects of some chemotherapeutics."( The effects of GnRH analogues and antiandrogenes in preventing the gonadotoxic effects of COPP chemotherapy.
Akay, AF; Bircan, MK; Deniz, M; Göçmen, M; Nergiz, Y; Sahin, H, 2001
)
0.31
"As a conclusion we think that gonadal suppression applied during chemotherapy regimen could decrease the testicular toxic effects of chemotherapeutic but more clinical investigations needed for routine application."( The effects of GnRH analogues and antiandrogenes in preventing the gonadotoxic effects of COPP chemotherapy.
Akay, AF; Bircan, MK; Deniz, M; Göçmen, M; Nergiz, Y; Sahin, H, 2001
)
0.31
" All the chemicals have been tested to evaluate their toxic effects on freshwater organisms from different trophic levels."( Identification of phototransformation products of prednisone by sunlight: toxicity of the drug and its derivatives on aquatic organisms.
DellaGreca, M; Fiorentino, A; Iesce, MR; Isidori, M; Nardelli, A; Previtera, L; Temussi, F, 2003
)
0.57
" Although arthroplasty is safe in the general population, its safety in liver transplant recipients is unclear."( The safety and outcome of joint replacement surgery in liver transplant recipients.
Cohen, SM; Levitsky, J; Te, HS, 2003
)
0.32
"CHOP-14 with the addition of rhG-CSF is safe and practicable in a large multicentre setting in patients aged 18-75 years."( Practicability and acute haematological toxicity of 2- and 3-weekly CHOP and CHOEP chemotherapy for aggressive non-Hodgkin's lymphoma: results from the NHL-B trial of the German High-Grade Non-Hodgkin's Lymphoma Study Group (DSHNHL).
Bittner, S; Kloess, M; Loeffler, M; Pfreundschuh, M; Reiser, M; Rudolph, C; Schmalenberg, H; Schmits, R; Truemper, L; Wunderlich, A, 2003
)
0.32
" After completion of study drug administration, the patients were monitored until day 56 by serial laboratory tests, clinical examinations, and recording of adverse events."( Pharmacodynamics, pharmacokinetics, and safety of multiple doses of FTY720 in stable renal transplant patients: a multicenter, randomized, placebo-controlled, phase I study.
Chodoff, L; Ferguson, RM; Gonwa, TA; Kahan, BD; Karlix, JL; Leichtman, AB; Mulgaonkar, S; Schmouder, RL; Skerjanec, A, 2003
)
0.32
" Compared with placebo-treated patients, FTY720 subjects did not show a major increase in adverse events or a change in renal function."( Pharmacodynamics, pharmacokinetics, and safety of multiple doses of FTY720 in stable renal transplant patients: a multicenter, randomized, placebo-controlled, phase I study.
Chodoff, L; Ferguson, RM; Gonwa, TA; Kahan, BD; Karlix, JL; Leichtman, AB; Mulgaonkar, S; Schmouder, RL; Skerjanec, A, 2003
)
0.32
" The safety of pegfilgrastim in this patient population was determined by reports of adverse events."( Fixed-dose pegfilgrastim is safe and allows neutrophil recovery in patients with non-Hodgkin's lymphoma.
Case, D; George, S; Hackett, J; Liang, BC; Meza, LA; Neumann, TA; Shogan, JE; Yang, BB; Yunus, F, 2003
)
0.32
"A retrospective cohort analysis of clinical data regarding adverse events of azathioprine in Crohn's disease."( Side effects of azathioprine in patients with Crohn's disease.
de Jong, DJ; Goullet, M; Naber, TH, 2004
)
0.32
"In 15 of the 50 patients azathioprine was preliminary discontinued due to adverse events and in 11 of these patients (22%) adverse events were probably related to azathioprine."( Side effects of azathioprine in patients with Crohn's disease.
de Jong, DJ; Goullet, M; Naber, TH, 2004
)
0.32
"Twenty-two per cent of patients discontinued azathioprine prematurely probably as a result of related adverse events."( Side effects of azathioprine in patients with Crohn's disease.
de Jong, DJ; Goullet, M; Naber, TH, 2004
)
0.32
" Following an uncomplicated pregnancy, a healthy child was born at full term and careful haematological and immunological monitoring has revealed no adverse effects resulting from exposure to rituximab."( Safety of rituximab therapy during the first trimester of pregnancy: a case history.
Elinder, G; Kimby, E; Sverrisdottir, A, 2004
)
0.32
" Hyperlipidemia was the only adverse event more frequent among SRL patients (49% vs."( An open-label randomized trial of the safety and efficacy of sirolimus vs. azathioprine in living related renal allograft recipients receiving cyclosporine and prednisone combination.
Alfieri, F; Felipe, CR; Franco, M; Garcia, R; Hanzawa, NM; Machado, PG; Medina-Pestana, JO; Park, SI; Silva, HT, 2004
)
0.52
"Corticosteroid therapy after renal transplantation is associated with many adverse effects."( Randomized prospective trial of early steroid withdrawal compared with low-dose steroids in renal transplant recipients using serial protocol biopsies to assess efficacy and safety.
Applegate, M; Dagher, F; Dayton, M; Guzowski, H; Kohli, R; Laftavi, MR; Leca, N; O'Keefe, J; Pankewycz, O; Pierce, D; Rubino, A; Stefanick, B; Stephan, R, 2005
)
0.33
" Graft function, incidence of acute rejection (AR), findings of protocol graft biopsy and adverse effects were compared."( Quadruple immunosuppression with basiliximab, tacrolimus, mycophenolate mofetil and prednisone is safe and effective for renal transplantation.
Fukuzawa, N; Harada, H; Hirano, T; Iwami, D; Miura, M; Ogawa, Y; Satoh, H; Seki, T; Taniguchi, A; Togashi, M, 2005
)
0.55
" This regimen is safe and effective for application during the early period after renal transplantation."( Quadruple immunosuppression with basiliximab, tacrolimus, mycophenolate mofetil and prednisone is safe and effective for renal transplantation.
Fukuzawa, N; Harada, H; Hirano, T; Iwami, D; Miura, M; Ogawa, Y; Satoh, H; Seki, T; Taniguchi, A; Togashi, M, 2005
)
0.55
" The purpose of this study was to explore the association between these polymorphisms and the occurrence of azathioprine adverse effects in 112 renal transplant recipients undergoing triple immunosuppressive therapy including azathioprine, cyclosporine, and prednisone."( The impact of thiopurine s-methyltransferase polymorphism on azathioprine-induced myelotoxicity in renal transplant recipients.
Domański, L; Droździk, M; Dziewanowski, K; Gawrońska-Szklarz, B; Kurzawski, M, 2005
)
0.51
"Influenza vaccination in SLE patients with quiescent disease is safe but is less effective than in controls."( Safety and efficacy of influenza vaccination in systemic lupus erythematosus patients with quiescent disease.
Benne, CA; Bijl, M; De Vries, JJ; Holvast, A; Horst, G; Huckriede, A; Kallenberg, CG; Wilschut, J, 2006
)
0.33
"5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects."( Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004
)
0.32
"Immunosuppression without steroids is safe and reduces infection and metabolic complications."( Immunosuppression without steroids in liver transplantation is safe and reduces infection and metabolic complications: results from a prospective multicenter randomized study.
Baliellas, C; Castellote, J; Fabregat, J; Figueras, J; Garcia-Gil, A; Gonzalez-Pinto, I; Lladó, L; Memba, R; Rafecas, A; Ramos, E; Serrano, T; Torras, J; Xiol, X, 2006
)
0.33
" Severe adverse events occurred on 12 occasions (4% of cycles), involving 11 patients (22% of total); the most frequent severe adverse event was interstitial pneumonia which occurred in seven patients (14% of total)."( Dose-dense R-CHOP-14 supported by pegfilgrastim in patients with diffuse large B-cell lymphoma: a phase II study of feasibility and toxicity.
Brusamolino, E; Fava, S; Gargantini, L; Lazzarino, M; Montalbetti, L; Morra, E; Pagnucco, G; Pascutto, C; Pinotti, G; Rigacci, L; Rusconi, C; Uziel, L, 2006
)
0.33
" Adverse events were higher in everolimus-treated patients especially at the 4-mg/day dose, but there was no difference in the incidence of thrombocytopenia or leukopenia between all groups and renal function as determined by serum creatinine, and creatinine clearance remained stable to 36 months in everolimus-treated patients."( Safety, tolerability, and efficacy of everolimus in de novo liver transplant recipients: 12- and 36-month results.
Abecassis, M; Calmus, Y; Fischer, L; Freeman, R; Klempnauer, J; Langnas, A; Levy, G; Mayer, D; Nashan, B; Neuhaus, P; Punch, J; Roberts, J; Rogiers, X; Samuel, D; Schmidli, H; Sloof, M; Tuttle-Newhall, E, 2006
)
0.33
" The main outcome measures were average time to clinical remission, average time to immunologic remission (non-detectable circulating pemphigus vulgaris antibodies), proportion of patients who remained free of clinical relapse within 5 years after discontinuation of therapy, time from treatment discontinuation until first relapse, and incidence of adverse effects."( Efficacy and safety of cyclophosphamide, azathioprine, and cyclosporine (ciclosporin) as adjuvant drugs in pemphigus vulgaris.
Blaszczyk, M; Cwikla, J; Kolacinska-Strasz, Z; Labecka, H; Natorska, U; Olszewska, M; Sulej, J, 2007
)
0.34
"More than 50 years after the introduction of corticosteroids, few studies have focused on corticosteroid-induced adverse events after long-term systemic therapy."( Corticosteroid-induced clinical adverse events: frequency, risk factors and patient's opinion.
Cabane, J; Fardet, L; Flahault, A; Généreau, T; Kettaneh, A; Lebbé, C; Tiev, KP; Tolédano, C, 2007
)
0.34
"To assess the frequency, risk factors and patient's opinion regarding clinical adverse events occurring early during prednisone therapy."( Corticosteroid-induced clinical adverse events: frequency, risk factors and patient's opinion.
Cabane, J; Fardet, L; Flahault, A; Généreau, T; Kettaneh, A; Lebbé, C; Tiev, KP; Tolédano, C, 2007
)
0.55
" The main clinical adverse events attributable to corticosteroids were assessed after 3 months of therapy, by comparison with baseline status."( Corticosteroid-induced clinical adverse events: frequency, risk factors and patient's opinion.
Cabane, J; Fardet, L; Flahault, A; Généreau, T; Kettaneh, A; Lebbé, C; Tiev, KP; Tolédano, C, 2007
)
0.34
" Lipodystrophy was the most frequent adverse event [63."( Corticosteroid-induced clinical adverse events: frequency, risk factors and patient's opinion.
Cabane, J; Fardet, L; Flahault, A; Généreau, T; Kettaneh, A; Lebbé, C; Tiev, KP; Tolédano, C, 2007
)
0.34
"Lipodystrophy and neuropsychiatric disorders are common adverse events of long-term prednisone therapy and are particularly distressing for the patients concerned."( Corticosteroid-induced clinical adverse events: frequency, risk factors and patient's opinion.
Cabane, J; Fardet, L; Flahault, A; Généreau, T; Kettaneh, A; Lebbé, C; Tiev, KP; Tolédano, C, 2007
)
0.56
"The dose-dense CHOP-14 regimen is efficient and safe in elderly patients with diffuse large B-cell lymphoma (DLBCL)."( Feasibility, efficacy and safety of CHOP-14 in elderly patients with very high-risk diffuse large B-cell lymphoma.
de Nully Brown, P; Hansen, M; Jurlander, J; Tholstrup, D, 2007
)
0.34
" The main adverse events were neutropenia (48% of cycles) and infections (10% of cycles), which were fatal in seven patients."( Safety and efficacy of cyclophosphamide, adriamycin, vincristine, prednisone and rituximab in patients with human immunodeficiency virus-associated diffuse large B-cell lymphoma: results of a phase II trial.
Abella, E; García, M; Gardella, S; González-Barca, E; López, A; López-Guillermo, A; Miralles, P; Morgades, M; Oriol, A; Ribera, JM, 2008
)
0.58
" Thirteen stopped infliximab because of loss of efficacy (n = 4), remission (n = 6) or non-compliance, chest tightness or side effect (1 each)."( Infliximab efficacy and safety against refractory systemic necrotising vasculitides: long-term follow-up of 15 patients.
Cohen, P; Guaydier-Souquières, G; Guillevin, L; Hayem, G; Job-Deslandre, C; Josselin, L; Liferman, F; Mahr, A; Pagnoux, C; Pourrat, J, 2008
)
0.35
"These observations highlight infliximab as a potentially useful and safe salvage treatment for patients with refractory SNV."( Infliximab efficacy and safety against refractory systemic necrotising vasculitides: long-term follow-up of 15 patients.
Cohen, P; Guaydier-Souquières, G; Guillevin, L; Hayem, G; Job-Deslandre, C; Josselin, L; Liferman, F; Mahr, A; Pagnoux, C; Pourrat, J, 2008
)
0.35
" Infliximab infusion can be complicated by clinically heterogeneous adverse reactions, potentially interfering with the course of treatment."( Safety and tolerability of infliximab therapy: suggestions and criticisms based on wide clinical experience.
Maggi, E; Matucci, A; Palandri, F; Parronchi, P; Romagnani, S; Rossi, O; Vultaggio, A,
)
0.13
" The major adverse events in combination group were infusion-related responses which could be well tolerated in patients, and hematological toxicities which were similar to those in CHOP group."( [Comparison between efficacy and safety of rituximab plus CHOP regimen and CHOP regimen for treatment of newly diagnosed patients with diffuse large B-cell lymphoma].
Li, JY; Lu, H; Qian, SX; Qiu, HX; Sheng, RL; Wu, HX; Xu, W; Zhang, ZH, 2008
)
0.35
"IFN-alpha2a is efficient and safe for the long-term management of severe uveitis associated with Behçet disease."( Long-term efficacy and safety of low-dose interferon alpha2a therapy in severe uveitis associated with Behçet disease.
Bodaghi, B; Cassoux, N; Fardeau, C; Gendron, G; Gueudry, J; Lehoang, P; Piette, JC; Terrada, C; Wechsler, B, 2008
)
0.35
" Most adverse events were transient and did not require change in therapy."( The effectiveness and safety of mycophenolate mofetil in lupus nephritis.
Ballou, S; Elyan, M, 2009
)
0.35
"To report the adverse effects associated with prolonged high-dose prednisone for the treatment of autoimmune inner ear disease (AIED)."( Safety of high-dose corticosteroids for the treatment of autoimmune inner ear disease.
Alexander, TH; Brookhouser, PE; Derebery, JM; Espeland, MA; Gantz, BJ; Gulya, AJ; Hammerschlag, PE; Hannley, M; Harris, JP; Hughes, GB; Moscicki, R; Nelson, RA; Niparko, JK; Rauch, SD; Telian, SA; Weisman, MH, 2009
)
0.59
" The present study suggests that with appropriate patient selection, monitoring, and patient education, high-dose corticosteroids are a safe and effective treatment of AIED."( Safety of high-dose corticosteroids for the treatment of autoimmune inner ear disease.
Alexander, TH; Brookhouser, PE; Derebery, JM; Espeland, MA; Gantz, BJ; Gulya, AJ; Hammerschlag, PE; Hannley, M; Harris, JP; Hughes, GB; Moscicki, R; Nelson, RA; Niparko, JK; Rauch, SD; Telian, SA; Weisman, MH, 2009
)
0.35
"We sought to determine whether treatment with steroids, immunosuppressives (ISs), and anti-tumor necrosis factor (TNF) agents is associated with an increased risk of adverse events in patients with Crohn's disease (CD)."( Adverse events associated with common therapy regimens for moderate-to-severe Crohn's disease.
Arrighi, HM; Hass, S; Marehbian, J; Sandborn, WJ; Tian, H, 2009
)
0.35
" Follow-up adverse events in patients with CD and controls were compared across different treatment categories and are presented as hazard ratios (HRs) and 95% confidence intervals (CIs)."( Adverse events associated with common therapy regimens for moderate-to-severe Crohn's disease.
Arrighi, HM; Hass, S; Marehbian, J; Sandborn, WJ; Tian, H, 2009
)
0.35
" Most treatment-emergent adverse events (TEAEs) occurred in the 10-mg/kg intetumumab group."( A phase 1, multicenter, open-label study of the safety of two dose levels of a human monoclonal antibody to human α(v) integrins, intetumumab, in combination with docetaxel and prednisone in patients with castrate-resistant metastatic prostate cancer.
Chu, FM; Dreicer, R; Foster, B; Fracasso, PM; Lang, Z; Picus, J, 2011
)
0.56
"Intetumumab was generally safe and well tolerated in combination with docetaxel, with a higher incidence of TEAEs in the 10 mg/kg dose cohort."( A phase 1, multicenter, open-label study of the safety of two dose levels of a human monoclonal antibody to human α(v) integrins, intetumumab, in combination with docetaxel and prednisone in patients with castrate-resistant metastatic prostate cancer.
Chu, FM; Dreicer, R; Foster, B; Fracasso, PM; Lang, Z; Picus, J, 2011
)
0.56
"The severe pulmonary adverse events tended to occur more frequently with R-CHOP (18."( Severe pulmonary adverse effects in lymphoma patients treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen plus rituximab.
Bang, SM; Kang, YA; Kim, JH; Lee, CT; Lee, JH; Lee, JS; Lee, KW; Lim, KH; Yoon, HI, 2010
)
0.57
" Thalidomide, in combination with MP, is associated with adverse events (AEs) including peripheral neuropathy and venous thromboembolism."( Consensus guidelines for the optimal management of adverse events in newly diagnosed, transplant-ineligible patients receiving melphalan and prednisone in combination with thalidomide (MPT) for the treatment of multiple myeloma.
Bladé, J; Davies, F; Delforge, M; Facon, T; Garcia Sanz, R; Kropff, M; Leal da Costa, F; Moreau, P; Morgan, G; Palumbo, A; Schey, S, 2010
)
0.56
" No patient developed vaccine-associated serious adverse events or disease flares."( The effect of anti-TNF treatment on the immunogenicity and safety of the 7-valent conjugate pneumococcal vaccine in children with juvenile idiopathic arthritis.
Farmaki, E; Kanakoudi-Tsakalidou, F; Pratsidou-Gertsi, P; Spoulou, V; Theodoridou, M; Trachana, M; Tritsoni, M, 2010
)
0.36
" Secondary end-points were the rate of control of chronic cough at each step of therapy, the duration of treatment required, changes in cough symptom score, health-related quality of life and possible adverse effects."( Efficacy and safety of modified sequential three-step empirical therapy for chronic cough.
Li, X; Liang, S; Liu, B; Lü, H; Qiu, Z; Wang, L; Wang, Y; Wei, W; Yu, L, 2010
)
0.36
" An understanding of structure-activity relationships (SARs) of chemicals can make a significant contribution to the identification of potential toxic effects early in the drug development process and aid in avoiding such problems."( Developing structure-activity relationships for the prediction of hepatotoxicity.
Fisk, L; Greene, N; Naven, RT; Note, RR; Patel, ML; Pelletier, DJ, 2010
)
0.36
" Nonhematologic grade 3/4 adverse events were reported in 35% of once-weekly patients and 51% of twice-weekly patients (P = ."( Efficacy and safety of once-weekly bortezomib in multiple myeloma patients.
Benevolo, G; Boccadoro, M; Bringhen, S; Callea, V; Cangialosi, C; Cavalli, M; Cavo, M; De Rosa, L; Evangelista, A; Falcone, AP; Gaidano, G; Gentili, S; Genuardi, M; Grasso, M; Guglielmelli, T; Larocca, A; Levi, A; Liberati, AM; Musto, P; Nozzoli, C; Palumbo, A; Patriarca, F; Ria, R; Rizzo, V; Rossi, D, 2010
)
0.36
" Neutropenia (48%) was the most frequent grade 3 to 4 adverse event (AE); no grade 3 to 4 cardiac AEs were observed."( Activity and safety of dose-adjusted infusional cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy with rituximab in very elderly patients with poor-prognostic untreated diffuse large B-cell non-Hodgkin lymphoma.
Ardizzoni, A; Boggiani, D; Franciosi, V; Musolino, A; Panebianco, M; Salvagni, S; Vasini, G, 2011
)
0.59
"DA-POCH-R was an active and safe combination therapy for patients aged ≥70 years with poor-prognostic untreated DLBCL."( Activity and safety of dose-adjusted infusional cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy with rituximab in very elderly patients with poor-prognostic untreated diffuse large B-cell non-Hodgkin lymphoma.
Ardizzoni, A; Boggiani, D; Franciosi, V; Musolino, A; Panebianco, M; Salvagni, S; Vasini, G, 2011
)
0.59
"The majority of patients with Hodgkin's disease can be cured by combination of polychemotherapy and radiotherapy (RT) that can produce late toxic pulmonary and cardiac effects which often remain at a subclinical level."( Cardiopulmonary toxicity of different chemoradiotherapy combined regimens for Hodgkin's disease.
Bonfante, V; Busia, A; Laffranchi, A; Villani, F; Viviani, S, 2010
)
0.36
"These data confirm that the combination of mediastinal RT with the more commonly used polychemotherapy regimens produce late toxic effects."( Cardiopulmonary toxicity of different chemoradiotherapy combined regimens for Hodgkin's disease.
Bonfante, V; Busia, A; Laffranchi, A; Villani, F; Viviani, S, 2010
)
0.36
"The aim of the study is to characterize the pharmacokinetics and the gastrointestinal side effect profiles of enteric-coated mycophenolate sodium (EC-MPS) in de novo kidney transplant patients of Hispanic ethnicity."( The pharmacokinetics of enteric-coated mycophenolate sodium and its gastrointestinal side effects in de novo renal transplant recipients of Hispanic ethnicity.
Hutchinson, I; Min, DI; Qazi, Y; Shah, T; Tellez-Corrales, E; Wang, J; Wilson, J; Yang, JW, 2011
)
0.37
" In conclusion, low-dose rATG induction therapy is safe and effective in patients older than 65."( Low-dose thymoglobulin use in elderly renal transplant recipients is safe and effective induction therapy.
Alnimri, M; Kohli, R; Laftavi, MR; Pankewycz, O; Patel, S; Said, M; Soliman, MR, 2011
)
0.37
" Though lack of difference may be attributed to the small sample size, suboptimal supportive care for intensive treatment would increase risk of toxic deaths."( Outcome and haemato-toxicity of two chemotherapy regimens for childhood non-Hodgkin's lymphoma in a Kenyan hospital.
Macharia, WM, 2009
)
0.35
" Febrile neutropenia was rare (4%) and there were no toxic deaths."( Lenalidomide can be safely combined with R-CHOP (R2CHOP) in the initial chemotherapy for aggressive B-cell lymphomas: phase I study.
Ansell, SM; Habermann, TM; Inwards, DJ; Johnston, PB; Klebig, RR; LaPlant, B; Macon, WR; Micallef, IN; Nowakowski, GS; Porrata, LF; Reeder, CB; Rivera, CE; Witzig, TE, 2011
)
0.37
" In both arms, greater rates of severe hematologic adverse events were associated with RI (eGFR < 50 mL/min), however, therapy discontinuation rates were unaffected."( Safety and efficacy of bortezomib-melphalan-prednisone-thalidomide followed by bortezomib-thalidomide maintenance (VMPT-VT) versus bortezomib-melphalan-prednisone (VMP) in untreated multiple myeloma patients with renal impairment.
Baldini, L; Benevolo, G; Boccadoro, M; Bringhen, S; Cascavilla, N; Cavo, M; Di Raimondo, F; Gentile, M; Grasso, M; Guglielmelli, T; Majolino, I; Marasca, R; Mazzone, C; Montefusco, V; Morabito, F; Musolino, C; Musto, P; Nozzoli, C; Offidani, M; Palumbo, A; Patriarca, F; Petrucci, MT; Ria, R; Rossi, D; Vincelli, I, 2011
)
0.63
" This case illustrates a unique side effect of INH that caused exudative EPEs and drug-induced lupus with positive anti-dsDNA."( Isoniazid (INH)-induced eosinophilic exudative pleural effusion and lupus erythematosus. A clinical reminder of drug side effects.
Dahal, K; Khattri, S; Kushawaha, A; Lee, M; Mobarakai, N, 2011
)
0.37
"MTX treatment is safe and beneficial as a steroid-sparing agent in PV."( Methotrexate is an effective and safe adjuvant therapy for pemphigus vulgaris.
Barzilai, A; Baum, S; Greenberger, S; Lyakhovitsky, A; Samuelov, L; Solomon, M; Trau, H,
)
0.13
"In the largest adult case series in Burkitt-PTLD to date, sequential immunochemotherapy with rituximab followed by standard CHOP or R-CHOP was a both safe and effective treatment."( Burkitt post-transplantation lymphoma in adult solid organ transplant recipients: sequential immunochemotherapy with rituximab (R) followed by cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or R-CHOP is safe and effective in an analysis
Anagnostopoulos, I; Atta, J; Gärtner, B; Lehmkuhl, H; Lenze, D; Neuhaus, R; Oertel, S; Planker, M; Reinke, P; Riess, H; Trappe, RU; Zimmermann, H, 2012
)
0.57
"Treatment with chronic corticosteroids has been associated with frequent significant adverse effects."( Safety of prednisone for ocular myasthenia gravis.
Bruce, BB; Kupersmith, MJ, 2012
)
0.78
"Low-dose prednisone for OMG has an acceptable side-effect profile and causes few serious complications (2-year risk, ∼1%)."( Safety of prednisone for ocular myasthenia gravis.
Bruce, BB; Kupersmith, MJ, 2012
)
1.2
"Pregabalin is one of the first-line treatments for painful diabetic peripheral neuropathy in many countries, and we have administered it to relieve the neurotoxicity associated with adverse effects of VCR in a DLBCL patient treated with the R-CHOP regimen."( [A case of neurotoxicity reduced with pregabalin in R-CHOP chemotherapy for diffuse large B-cell lymphoma].
Hosokawa, A; Ito, T; Kiba, T; Kido, M; Kimura, A; Kozawa, K; Nakashima, T; Niimi, H; Ogawa, Y; Okada, Y; Okikawa, Y; Saito, A; Shintani, H; Taniguchi, T; Taniyama, K, 2012
)
0.38
" A causality assessment of the adverse reaction identified the antibiotic as the most probable cause of the observation."( A case of severe toxicity during coadministration of vincristine and piperacillin: are drug transporters involved in vincristine hypersensitivity and drug-drug interactions?
Andres, CR; Benz-de Bretagne, I; Gendrot, C; Jonville-Bera, AP; Jourdain, A; Le Guellec, C; Tarfaoui, N, 2012
)
0.38
" The adverse events in R-CHOP group were similar with that in CHOP group."( [Evaluation of the impact of R-CHOP chemotherapy on efficacy, safety and prognosis in newly diagnosed diffuse large B-cell lymphoma patients and its prognostic impact: a multicenter retrospective study with long term follow-up].
Cao, JN; Chen, FY; Cheng, YF; Cheng, ZX; Li, F; Li, JM; Wang, C; Wang, JM; Wei, Z; Zou, SH, 2012
)
0.38
"R-CHOP is a safe and effective regimen for management of newly diagnosed DLBCL, with a better remission rate, PFS and OS."( [Evaluation of the impact of R-CHOP chemotherapy on efficacy, safety and prognosis in newly diagnosed diffuse large B-cell lymphoma patients and its prognostic impact: a multicenter retrospective study with long term follow-up].
Cao, JN; Chen, FY; Cheng, YF; Cheng, ZX; Li, F; Li, JM; Wang, C; Wang, JM; Wei, Z; Zou, SH, 2012
)
0.38
"To clarify whether increase of body weight in patients with early rheumatoid arthritis (RA) upon administration of prednisone is a side effect of prednisone or a result of better control of disease activity, we examined the association of prednisone and disease activity with a subsequent change in body mass index (BMI)."( Increase of body mass index in a tight controlled methotrexate-based strategy with prednisone in early rheumatoid arthritis: side effect of the prednisone or better control of disease activity?
Bakker, MF; Bijlsma, JW; Bossema, ER; Ehrlich, JC; Geenen, R; Jacobs, JW; Jurgens, MS; Lafeber, FP; van Albada-Kuipers, IA; Welsing, PM, 2013
)
0.82
" Secondary endpoints include AIRs during the 24 h following their second infusion and any adverse events experienced during the 26-week study; efficacy measures were also followed as secondary endpoints."( A safety analysis of oral prednisone as a pretreatment for rituximab in rheumatoid arthritis.
Carter, JD; McNeil, A; Ricca, LR; Sebba, AI; Valeriano-Marcet, J; Vasey, FB; Zarabadi, SA, 2012
)
0.68
" Only 1 patient experienced a grade 4 adverse event due to a nonsymptomatic pulmonary embolism."( Safety and efficacy of maintenance therapy with a nonspecific cytochrome P17 inhibitor (CYP17i) after response/stabilization to docetaxel in metastatic castration-resistant prostate cancer.
Arévalo, E; Carranza, OE; Castañón, E; Castillo, A; Collado-Gómez, V; Fusco, JP; Gil-Aldea, I; Gil-Bazo, I; López, I; Zudaire, ME, 2013
)
0.39
" The most common grade 2-3 hematologic adverse event was neutropenia, which was observed in 47 patients (56 %)."( Safety and efficacy of metronomic non-pegylated liposomal encapsulated doxorubicin in heavily pretreated advanced breast cancer patients.
Ciruelos, E; Cortés-Funes, H; Dorta, M; Ghanem, I; Manneh, R; Manso, L; Mendiola, C; Sepúlveda, J; Valdiviezo, N; Vega, E, 2013
)
0.39
"NPLD-based metronomic regimen was effective and safe in pretreated advanced breast cancer patients."( Safety and efficacy of metronomic non-pegylated liposomal encapsulated doxorubicin in heavily pretreated advanced breast cancer patients.
Ciruelos, E; Cortés-Funes, H; Dorta, M; Ghanem, I; Manneh, R; Manso, L; Mendiola, C; Sepúlveda, J; Valdiviezo, N; Vega, E, 2013
)
0.39
" The two most frequent treatment-related adverse events (AEs) were fatigue and nausea."( A multicenter phase II trial to determine the safety and efficacy of combination therapy with denileukin diftitox and cyclophosphamide, doxorubicin, vincristine and prednisone in untreated peripheral T-cell lymphoma: the CONCEPT study.
Advani, R; Bolejack, V; Foss, FM; Goy, A; Jacobsen, E; Komrokji, R; Pendergrass, K; Sjak-Shie, N; Smith, MR, 2013
)
0.59
" No adverse events were recorded."( Rituximab is an efficient and safe treatment in adults with steroid-dependent minimal change disease.
Audard, V; Bouachi, K; Dahan, KY; Deschênes, G; Lang, P; Mojaat, R; Munyentwali, H; Plaisier, EM; Remy, P; Ronco, PM, 2013
)
0.39
"Elderly kidney transplant recipients receiving rabbit antithymocyte globulin did not experience different short-term graft survival, graft function or rates of infection, malignancy or hematologic adverse reactions than did nonelderly patients; they experienced fewer episodes of delayed graft function, but had lower 3-year patient survival."( Evaluating safety and efficacy of rabbit antithymocyte globulin induction in elderly kidney transplant recipients.
Campos, S; Dinh, DB; Feyssa, EL; Jawa, P; Khanmoradi, K; Knorr, JP; Ortiz, JA; Parsikia, A; Zaki, RF, 2013
)
0.39
" Two toxic deaths were observed."( High response rate and acceptable toxicity of a combination of rituximab, vinorelbine, ifosfamide, mitoxantrone and prednisone for the treatment of diffuse large B-cell lymphoma in first relapse: results of the R-NIMP GOELAMS study.
Alexis, M; Arakelyan, N; Banos, A; Cartron, G; Courby, S; Damotte, D; Dreyfus, F; Fontan, J; Gressin, R; Gyan, E; Lamy, T; Laribi, K; Le Gouill, S; Maisonneuve, H; Quittet, P; Schmidt-Tanguy, A; Sénécal, D; Solal-Céligny, P; Tournilhac, O, 2013
)
0.6
" Severe adverse events occurred in only the control group (14."( Efficacy and safety of traditional chinese medicine (Shenqi particle) for patients with idiopathic membranous nephropathy: a multicenter randomized controlled clinical trial.
Chen, N; Chen, X; Chen, Y; Deng, W; Deng, Y; Ni, Z; Shi, W; Yuan, F; Zhan, Y; Zhong, Y, 2013
)
0.39
" Grade 3-4 hematologic adverse events were: neutropenia in 28% of the courses, thrombocytopenia in 9%, and anemia in 3%."( Lenalidomide plus cyclophosphamide, doxorubicin, vincristine, prednisone and rituximab is safe and effective in untreated, elderly patients with diffuse large B-cell lymphoma: a phase I study by the Fondazione Italiana Linfomi.
Baldi, I; Bottelli, C; Carella, AM; Castellino, A; Chiappella, A; Ciccone, G; De Masi, P; Gaidano, G; Ladetto, M; Liberati, AM; Orsucci, L; Palumbo, A; Pavone, V; Perticone, S; Rossi, G; Rossini, B; Salvi, F; Tucci, A; Vitolo, U; Zanni, M, 2013
)
0.63
" No serious adverse events were observed."( Leflunomide plus oral prednisone in treatment of idiopathic membranous nephropathy: a retrospective clinical study of efficacy and safety.
Lu, W; Xie, L; Xue, W; Yang, S; Yin, A, 2013
)
0.7
" No grade 3-4 adverse events were observed."( Safety of Abiraterone Acetate in Castration-resistant Prostate Cancer Patients With Concomitant Cardiovascular Risk Factors.
de Braud, F; Grassi, P; Procopio, G; Salvioni, R; Testa, I; Torri, V; Valdagni, R; Verzoni, E, 2015
)
0.42
"AA appears to be safe and well tolerated even in patients with cardiovascular comorbidities or with increased risk factors for cardiovascular diseases."( Safety of Abiraterone Acetate in Castration-resistant Prostate Cancer Patients With Concomitant Cardiovascular Risk Factors.
de Braud, F; Grassi, P; Procopio, G; Salvioni, R; Testa, I; Torri, V; Valdagni, R; Verzoni, E, 2015
)
0.42
"Our study confirmed the weight of cardiac toxic effect of CHOP ± R regimen."( Incidence and risk-factors of CHOP/R-CHOP-related cardiotoxicity in patients with aggressive non-Hodgkin's lymphoma.
Brion, A; Cahn, JY; Daguindau, E; Deconinck, E; Limat, S; Nerich, V; Perrin, S; Woronoff-Lemsi, MC, 2014
)
0.4
" Fifty-three patients withdrew after cycle 1; 10 for grade 3 or 4 IRRs and one for a grade 3 adverse event."( Phase III safety study of rituximab administered as a 90-minute infusion in patients with previously untreated diffuse large B-cell and follicular lymphoma.
Brewster, M; Chai, A; Dakhil, S; Gregory, SA; Hermann, R; Hurst, D; Monte, M; Richards, P; Schreeder, MT; Windsor, KS, 2014
)
0.4
" Number of cabazitaxel cycles, dose reductions for any cause, dose delays possibly related to cabazitaxel adverse events, and tolerability were similar in the three age groups."( Safety of cabazitaxel in senior adults with metastatic castration-resistant prostate cancer: results of the European compassionate-use programme.
Bracarda, S; Climent, MA; Fossa, S; Heidenreich, A; Hitier, S; Mason, M; Ozen, H; Papandreou, C; Sengelov, L; Van Oort, I, 2014
)
0.4
" All patients were evaluated for the occurrence of adverse drug reactions associated with prednisone at week 12."( [The short-term efficacy and safety of methotrexate plus low dose prednisone in patients with rheumatoid arthritis].
He, YJ; Liu, SY; Yang, L; Zhang, L; Zhang, X, 2013
)
0.85
" No serious adverse event was observed during the study."( [The short-term efficacy and safety of methotrexate plus low dose prednisone in patients with rheumatoid arthritis].
He, YJ; Liu, SY; Yang, L; Zhang, L; Zhang, X, 2013
)
0.63
" Adverse events were summarised descriptively."( Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302).
Beer, TM; Carles, J; de Bono, JS; de Souza, P; Efstathiou, E; Fizazi, K; Flaig, TW; Fradet, Y; Griffin, TW; Hainsworth, JD; Higano, CS; Kheoh, T; Logothetis, CJ; Mainwaring, P; Molina, A; Mulders, PF; North, S; Park, YC; Rathkopf, DE; Ryan, CJ; Saad, F; Scher, HI; Shore, ND; Small, EJ; Smith, MR; Taplin, ME; Todd, MB; Van Poppel, H; Yu, EY; Yu, MK, 2014
)
0.4
"In recent decades, numerous methods have been developed for data mining of large drug safety databases, such as Food and Drug Administration's (FDA's) Adverse Event Reporting System, where data matrices are formed by drugs such as columns and adverse events as rows."( Zero-inflated Poisson model based likelihood ratio test for drug safety signal detection.
Huang, L; Tiwari, R; Zalkikar, J; Zheng, D, 2017
)
0.46
"We conducted a phase III study to test the hypothesis that initial therapy with "lower dose" prednisone is effective and safe for patients with newly diagnosed acute graft-versus-host disease."( Effectiveness and safety of lower dose prednisone for initial treatment of acute graft-versus-host disease: a randomized controlled trial.
Boeckh, M; Carpenter, PA; Flowers, ME; Furlong, T; Green, ML; Martin, PJ; McDonald, GB; Mielcarek, M; Storb, R; Storer, BE, 2015
)
0.91
"Addition of abiraterone to LHRHa with radiation is safe and achieves effective prostatic androgen suppression."( External beam radiation therapy and abiraterone in men with localized prostate cancer: safety and effect on tissue androgens.
Cho, E; Dalkin, BL; Konodi, MA; Kurland, BF; Liao, JJ; Marck, BT; Matsumoto, AM; Montgomery, RB; Mostaghel, EA; Russell, KJ, 2015
)
0.42
" Five adverse events induced therapy termination: 2 myocardial infarctions, 2 pneumonias, and 1 reduced condition."( Nonpegylated Liposomal Doxorubicin as a Component of R-CHOP Is an Effective and Safe Alternative to Conventional Doxorubicin in the Treatment of Patients With Diffuse Large B-Cell Lymphoma and Preexisting Cardiac Diseases.
Aurich, M; Ho, AD; Rohlfing, S; Schöning, T; Witzens-Harig, M, 2015
)
0.42
" Adverse effects were more frequent among HD recipients (MD=43%, HD=66%, p=0."( Effectiveness and safety of medium-dose prednisone in giant cell arteritis: a retrospective cohort study of 103 patients.
Les, I; Martínez-Berriotxoa, A; Pijoán, JI; Rodríguez-Álvarez, R; Ruiz-Irastorza, G,
)
0.4
"MD prednisone regimen may be an effective and safe alternative to HD prednisone regimen in GCA."( Effectiveness and safety of medium-dose prednisone in giant cell arteritis: a retrospective cohort study of 103 patients.
Les, I; Martínez-Berriotxoa, A; Pijoán, JI; Rodríguez-Álvarez, R; Ruiz-Irastorza, G,
)
1.02
" Specific adverse events with abiraterone-prednisone were similar between the age subgroups."( Efficacy and Safety of Abiraterone Acetate in Elderly (75 Years or Older) Chemotherapy Naïve Patients with Metastatic Castration Resistant Prostate Cancer.
Carles, J; Griffin, TW; Kheoh, T; Li, J; Molina, A; Mulders, PF; Rathkopf, DE; Ryan, CJ; Smith, MR; Van Poppel, H, 2015
)
0.68
"Twice daily budesonide transnasal nebulization is an effective and safe treatment as evidenced by significant improvements in nasal symptoms and reduction in polyp size, coupled with an absence of hypothalamic-pituitary-adrenal axis suppression, which is safer than the systemic corticosteroids."( [The efficacy and safety of budesonide inhalation suspension via transnasal nebulization compared with oral corticosteroids in chronic rhinosinusitis with nasal polyps].
Lou, H; Wang, C; Zhang, L, 2015
)
0.42
"Both groups were followed for 24 months after transplantation for immunosuppressive regimen-associated and time-dependent occurrences of adverse events (AEs) and serious adverse events (SAEs)."( Time-Dependent and Immunosuppressive Drug-Associated Adverse Event Profiles in De Novo Kidney Transplant Recipients Converted from Tacrolimus to Sirolimus Regimens.
Felipe, CR; Felix, MJ; Osmar Medina-Pestana, J; Tedesco-Silva, H, 2016
)
0.43
"Exploring the relationships among adverse events is important because those that arise from a common mechanism are amenable to a common intervention, which can improve symptom management, quality of life, and treatment adherence."( Identifying Severe Adverse Event Clusters Using the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Hershman, DL; Lee, SM; Lim, EA; Moinpour, CM; Unger, J; Zhong, X, 2016
)
0.43
"The CTCAE data from a randomized clinical trial conducted by SWOG that compared docetaxel plus estramustine versus mitoxantrone plus predinsone in patients with advanced prostate cancer were used to identify severe adverse event clusters."( Identifying Severe Adverse Event Clusters Using the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Hershman, DL; Lee, SM; Lim, EA; Moinpour, CM; Unger, J; Zhong, X, 2016
)
0.43
"A total of 109 adverse event types were captured using the CTCAE."( Identifying Severe Adverse Event Clusters Using the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Hershman, DL; Lee, SM; Lim, EA; Moinpour, CM; Unger, J; Zhong, X, 2016
)
0.43
"Several severe adverse event clusters were identified in patients with advanced prostate cancer."( Identifying Severe Adverse Event Clusters Using the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Hershman, DL; Lee, SM; Lim, EA; Moinpour, CM; Unger, J; Zhong, X, 2016
)
0.43
" The therapeutic efficacy of patients in 2 groups was analyzed according to the peripheral hemogram indexes, symptom and sign disappeared time as well as adverse reaction incidence."( [Clinical Efficacy and Safety of Rituximab Combined with Fludarabine and Cyclophosphamide for Treatment of Chronic Lymphocytic Leukemia].
Han, HJ; Lu, YW; Xia, RX, 2016
)
0.43
"application of rituximab combined with fludarabine and cyclophosphamide in the treatment of CLL shows the higher curative effect, can effectively improve the symptoms and reduce the incidence of adverse reactions."( [Clinical Efficacy and Safety of Rituximab Combined with Fludarabine and Cyclophosphamide for Treatment of Chronic Lymphocytic Leukemia].
Han, HJ; Lu, YW; Xia, RX, 2016
)
0.43
" Conversion to MPS was associated with a higher incidence of adverse events."( Efficacy and Safety of Elective Conversion From Sotrastaurin (STN) to Tacrolimus (TAC) or Mycophenolate (MPS) in Stable Kidney Transplant Recipients.
Aguiar, W; Campos, E; Cristelli, M; Felipe, C; Ferreira, A; Franco, M; Gerbase de Lima, M; Hannun, P; Medina-Pestana, J; Sandes-Freitas, T; Tedesco-Silva, H, 2016
)
0.43
"To investigate whether long-term use of low-dose P with or without AA leads to corticosteroid-associated adverse events (CA-AEs) in mCRPC patients."( Low Incidence of Corticosteroid-associated Adverse Events on Long-term Exposure to Low-dose Prednisone Given with Abiraterone Acetate to Patients with Metastatic Castration-resistant Prostate Cancer.
Charnas, R; Chi, KN; de Bono, JS; De Porre, P; Fizazi, K; Gomella, LG; Londhe, A; McGowan, T; Miller, K; Montgomery, B; Pelhivanov, N; Rathkopf, DE; Ryan, CJ; Scher, HI; Shore, ND; Todd, MB, 2016
)
0.65
"We assessed adverse events in patients with metastatic castration-resistant prostate cancer during long-term treatment with a low dose of a corticosteroid."( Low Incidence of Corticosteroid-associated Adverse Events on Long-term Exposure to Low-dose Prednisone Given with Abiraterone Acetate to Patients with Metastatic Castration-resistant Prostate Cancer.
Charnas, R; Chi, KN; de Bono, JS; De Porre, P; Fizazi, K; Gomella, LG; Londhe, A; McGowan, T; Miller, K; Montgomery, B; Pelhivanov, N; Rathkopf, DE; Ryan, CJ; Scher, HI; Shore, ND; Todd, MB, 2016
)
0.65
" Incidence of acute rejection, renal graft survival and SRL-related adverse effects of the immunosuppressive regimen were also observed."( [Effectiveness and safety of conversion therapy with the combination of sirolimus with low dose cyclosporine in renal transplantation recipients: a five-year clinical observation].
Chen, G; Ding, T; Lin, ZB; Wang, XX; Zhu, L, 2016
)
0.43
"The combination therapy of SRL and low dose of CsA is overall a safe and effective maintenance immunosuppressive regimen, but it is important to initiate at an appropriate stage."( [Effectiveness and safety of conversion therapy with the combination of sirolimus with low dose cyclosporine in renal transplantation recipients: a five-year clinical observation].
Chen, G; Ding, T; Lin, ZB; Wang, XX; Zhu, L, 2016
)
0.43
" These patients were followed up for 18 months, and the total effective rate, the survival rate and the adverse reaction rate were compared between these two groups."( [Clinical Efficiency and Safety of the First-line CHOP Regimen Containing PLD Applied to Treat Aged Patients with Advanced DLBCL].
Li, ZH; Wang, Y; Xing, MT; Zhan, XR; Zhang, YP, 2016
)
0.43
" The most common grade 3-4 adverse events were haematological; the most common of these was grade 4 neutropenia in 18 (75%) of 24 patients."( Everolimus combined with R-CHOP-21 for new, untreated, diffuse large B-cell lymphoma (NCCTG 1085 [Alliance]): safety and efficacy results of a phase 1 and feasibility trial.
Ansell, SM; Colgan, JP; Habermann, TM; Inwards, DJ; Johnston, PB; LaPlant, B; McPhail, E; Micallef, IN; Nowakowski, GS; Witzig, TE, 2016
)
0.43
"Glucocorticoids (GCs), such as prednisone, are the standard of care for several inflammatory and immunologically mediated diseases, but their chronic systemic administration is severely limited by serious adverse effects that are both dose and time dependent."( Safety and pharmacodynamic dose response of short-term prednisone in healthy adult subjects: a dose ranging, randomized, placebo-controlled, crossover study.
Daniel, S; Fleishaker, DL; Mukherjee, A; Whaley, FS; Zeiher, BG, 2016
)
0.97
" The incidence of adverse effects with prednisone was not dose related, and nervous system disorders, mainly headache, were the most frequently reported adverse effects."( Safety and pharmacodynamic dose response of short-term prednisone in healthy adult subjects: a dose ranging, randomized, placebo-controlled, crossover study.
Daniel, S; Fleishaker, DL; Mukherjee, A; Whaley, FS; Zeiher, BG, 2016
)
0.95
" The overall incidence of adverse events was similar between the two treatment groups (p > ."( Efficacy and safety of triple therapy with aprepitant, ondansetron, and prednisone for preventing nausea and vomiting induced by R-CEOP or CEOP chemotherapy regimen for non-Hodgkin lymphoma: a phase 2 open-label, randomized comparative trial.
Song, Z; Wang, H; Yang, F; Zhang, H; Zhang, M; Zhao, K, 2017
)
0.69
" The most frequent adverse events in all 3 active treatment arms were Cushingoid appearance, erythema, hirsutism, increased weight, headache, and nasopharyngitis."( Efficacy and safety of deflazacort vs prednisone and placebo for Duchenne muscular dystrophy.
Cwik, V; Dubow, JS; Fehlings, DL; Florence, JM; Greenberg, CR; Griggs, RC; King, W; Kissel, JT; Mendell, JR; Meyer, JM; Miller, JP; Moxley, RT; Pandya, S; Pestronk, A; Vanasse, M, 2016
)
0.71
" Clinical outcomes of induction and maintenance therapy with infliximab, predictors of response, and adverse events were evaluated."( Efficacy and Safety of Infliximab Therapy and Predictors of Response in Korean Patients with Crohn's Disease: A Nationwide, Multicenter Study.
Cha, JM; Chang, SK; Cho, YK; Choi, CH; Han, DS; Im, JP; Jang, BI; Jeen, YT; Jeon, SR; Jeon, TJ; Jung, SA; Kim, ES; Kim, HJ; Kim, HS; Kim, JH; Kim, JS; Kim, JW; Kim, N; Kim, TO; Kim, WH; Kim, YH; Kim, YS; Koo, JS; Lee, BI; Lee, CK; Lee, KM; Lee, SY; Park, DI; Park, SJ; Park, YS; Shin, SJ; Song, HJ; Song, ID; Yang, SK; Ye, BD, 2016
)
0.43
"3%) experienced adverse events related to infliximab."( Efficacy and Safety of Infliximab Therapy and Predictors of Response in Korean Patients with Crohn's Disease: A Nationwide, Multicenter Study.
Cha, JM; Chang, SK; Cho, YK; Choi, CH; Han, DS; Im, JP; Jang, BI; Jeen, YT; Jeon, SR; Jeon, TJ; Jung, SA; Kim, ES; Kim, HJ; Kim, HS; Kim, JH; Kim, JS; Kim, JW; Kim, N; Kim, TO; Kim, WH; Kim, YH; Kim, YS; Koo, JS; Lee, BI; Lee, CK; Lee, KM; Lee, SY; Park, DI; Park, SJ; Park, YS; Shin, SJ; Song, HJ; Song, ID; Yang, SK; Ye, BD, 2016
)
0.43
" However, clinicians must be aware of the risk of rare yet critical adverse events."( Efficacy and Safety of Infliximab Therapy and Predictors of Response in Korean Patients with Crohn's Disease: A Nationwide, Multicenter Study.
Cha, JM; Chang, SK; Cho, YK; Choi, CH; Han, DS; Im, JP; Jang, BI; Jeen, YT; Jeon, SR; Jeon, TJ; Jung, SA; Kim, ES; Kim, HJ; Kim, HS; Kim, JH; Kim, JS; Kim, JW; Kim, N; Kim, TO; Kim, WH; Kim, YH; Kim, YS; Koo, JS; Lee, BI; Lee, CK; Lee, KM; Lee, SY; Park, DI; Park, SJ; Park, YS; Shin, SJ; Song, HJ; Song, ID; Yang, SK; Ye, BD, 2016
)
0.43
" All patients experienced at least one adverse event during induction, most commonly infusion-related reactions (58%), the majority of which were grade 1/2."( Safety and efficacy of obinutuzumab with CHOP or bendamustine in previously untreated follicular lymphoma.
Díaz, MG; Dreyling, M; Dyer, MJ; Grigg, A; Knapp, A; Lei, G; Marlton, P; Rule, S; Wassner-Fritsch, E, 2017
)
0.46
" Adverse events [AEs] in pre-specified categories and serious AEs were recorded at least every 6 months of the 5-year observation period."( Five-year Safety Data From ENCORE, a European Observational Safety Registry for Adults With Crohn's Disease Treated With Infliximab [Remicade®] or Conventional Therapy.
Boice, J; Colombel, JF; Cornillie, F; D'Haens, G; Ghosh, S; Hommes, DW; Huang, Z; Huyck, S; Lindgren, S; Panes, J; Prantera, C; Reinisch, W, 2017
)
0.46
" An effective and safe alternative induction regimen is needed."( Efficacy and safety of rituximab in comparison with common induction therapies in pediatric active lupus nephritis.
Babu, BG; Basu, B; Roy, B, 2017
)
0.46
" In comparison with few minor adverse events in the other two cohorts, several serious adverse events occurred in the CYC group."( Efficacy and safety of rituximab in comparison with common induction therapies in pediatric active lupus nephritis.
Babu, BG; Basu, B; Roy, B, 2017
)
0.46
" However, among patients with DLBCL toxic effects due to therapy treatment are still very frequent, as well as inter-individual differences in the outcomes of patients even having similar stage, histological grade and histopathological type of the tumor."( How gene polymorphisms can influence clinical response and toxicity following R-CHOP therapy in patients with diffuse large B cell lymphoma.
Allegra, A; Cimino, F; Falduto, A; Gangemi, S; Musolino, C; Saija, A; Speciale, A, 2017
)
0.46
" The common adverse events (AEs) were in line with the well-known toxicity profiles associated with VMP."( A prospective, open-label, multicenter, observational study to evaluate the efficacy and safety of bortezomib-melphalan-prednisone as initial treatment for autologous stem cell transplantation-ineligible patients with multiple myeloma.
Bae, SB; Bae, SH; Cho, DY; Choi, CW; Do, YR; Hyun, MS; Jeong, SH; Jo, DY; Joo, YD; Kim, BS; Kim, H; Kim, HG; Kim, HJ; Kim, JA; Kim, JS; Kim, K; Kim, KH; Kim, MK; Kim, SH; Kim, SJ; Kim, SY; Kim, YS; Kwak, JY; Lee, HS; Lee, JH; Lee, JJ; Lee, JO; Lee, MH; Lee, SM; Lee, WS; Lim, SN; Min, CK; Moon, JH; Mun, YC; Nam, SH; Park, JS; Park, KW; Park, MR; Park, SK; Shin, HJ; Song, MK; Yi, HG; Yoon, SS, 2017
)
0.66
" Adverse events or laboratory abnormalities requiring TCZ dose modification were reported for 66 (13."( Patterns of tocilizumab use, effectiveness and safety in patients with rheumatoid arthritis: core data results from a set of multinational observational studies.
Bernasconi, C; Caporali, R; Casado, G; Czirják, L; Haraoui, B; Reiss, W; Taylor, A,
)
0.13
" The main adverse effects in TAC treatment were glucose intolerance, diabetes and abnormal aminotransferase."( The efficacy and safety of tacrolimus monotherapy in adult-onset nephrotic syndrome caused by idiopathic membranous nephropathy.
Chen, J; Li, H; Li, X; Liang, Q; Qu, F; Xie, X, 2017
)
0.46
" Haemocytopenia was the predominant adverse effect, and acute toxicity was moderate, tolerable and well managed in both arms."( The efficacy and safety of gemcitabine, cisplatin, prednisone, thalidomide versus CHOP in patients with newly diagnosed peripheral T-cell lymphoma with analysis of biomarkers.
Chang, Y; Duan, W; Fu, X; Li, L; Li, X; Li, Z; Nan, F; Sun, Z; Wang, X; Wu, J; Yan, J; Young, KH; Zhang, L; Zhang, M; Zhang, X, 2017
)
0.71
" The clinical efficacy, PFS (progression-free survival), OS and the adverse reactions in the 2 groups were compared."( [Clinical Efficacy and Safety of CMOD Regimen as the First Treatment for Aged New-diagnosed Patients with Peripheral T-cell Lymphoma].
Cui, N; Gao, L; Liu, XL, 2017
)
0.46
" The adverse reactions in 2 groups were as follows: myelosuppression, mucositis, gastrointestinal reactions, fever, liver dysfunction, neurotoxicity, and alopecia etc."( [Clinical Efficacy and Safety of CMOD Regimen as the First Treatment for Aged New-diagnosed Patients with Peripheral T-cell Lymphoma].
Cui, N; Gao, L; Liu, XL, 2017
)
0.46
"Chronic use of corticosteroids for the treatment of uveitis has been linked with drug-associated toxicity and adverse events (AEs)."( Corticosteroid-Related Adverse Events Systematically Increase with Corticosteroid Dose in Noninfectious Intermediate, Posterior, or Panuveitis: Post Hoc Analyses from the VISUAL-1 and VISUAL-2 Trials.
Bao, Y; Betts, KA; Camez, A; Joshi, A; Mittal, M; Suhler, EB; Tari, S; Thorne, JE, 2017
)
0.46
"This trial shows that MR prednisone appears to be a safe and effective treatment for GCA with a similar outcome profile to standard IR prednisolone."( A 26-week feasibility study comparing the efficacy and safety of modified-release prednisone with immediate-release prednisolone in newly diagnosed cases of giant cell arteritis.
Achilleos, K; Dasgupta, B; Gayford, D; Mackerness, C; Mapplebeck, S; Maw, WW; Merinopoulos, D; Raine, C; Schofield, P; Stapleton, PP, 2018
)
1.01
"A 23-item questionnaire (SIDECORT: side effect of corticosteroids) was constructed to assess the perception of these benefits and side effects in a systematic manner."( Development of a New Self-Reporting Instrument Measuring Benefits and Side Effects of Corticosteroids in Duchenne Muscular Dystrophy: Report from a Pilot Study.
Biggar, WD; Hendriksen, JGM; Hendriksen, RGF; Lionarons, JM; McAdam, LC; Vles, JSH,
)
0.13
" Using factor analyses on the side effect items as reported by parents, two underlying factors were found, with the first factor describing cognitive, behavioural and emotional functioning, and the second factor describing physical functioning."( Development of a New Self-Reporting Instrument Measuring Benefits and Side Effects of Corticosteroids in Duchenne Muscular Dystrophy: Report from a Pilot Study.
Biggar, WD; Hendriksen, JGM; Hendriksen, RGF; Lionarons, JM; McAdam, LC; Vles, JSH,
)
0.13
" The most common treatment-emergent adverse events were fatigue (32%), decreased appetite (25%), asthenia (18%), back pain (17%), and arthralgia (16%)."( Antitumour Activity and Safety of Enzalutamide in Patients with Metastatic Castration-resistant Prostate Cancer Previously Treated with Abiraterone Acetate Plus Prednisone for ≥24 weeks in Europe.
Baron, B; Chowdhury, S; de Bono, JS; Elliott, T; Feyerabend, S; Fizazi, K; Grande, E; Hirmand, M; Melhem-Bertrandt, A; Werbrouck, P, 2018
)
0.68
"Due to enhanced T-cell activity, immune checkpoint inhibitors cause immune-related adverse effects."( Corticosteroids for the management of immune-related adverse events in patients receiving checkpoint inhibitors.
Grauer, DW; Henry, DW; Rockey, ML; Williams, KJ, 2019
)
0.51
" The primary objective was to evaluate corticosteroid use for immune-related adverse effects, including starting dose, taper strategy, total duration, and resumption of immunotherapy."( Corticosteroids for the management of immune-related adverse events in patients receiving checkpoint inhibitors.
Grauer, DW; Henry, DW; Rockey, ML; Williams, KJ, 2019
)
0.51
"One hundred and three patients met inclusion criteria and experienced 123 immune-related adverse effects."( Corticosteroids for the management of immune-related adverse events in patients receiving checkpoint inhibitors.
Grauer, DW; Henry, DW; Rockey, ML; Williams, KJ, 2019
)
0.51
"Utilization of steroids for immune-related adverse effect at our institution is highly variable."( Corticosteroids for the management of immune-related adverse events in patients receiving checkpoint inhibitors.
Grauer, DW; Henry, DW; Rockey, ML; Williams, KJ, 2019
)
0.51
" Adverse events included neutropenia (92/76%), thrombocytopenia (70/10%) and leukopenia (65/50%)."( Efficacy and safety of frontline rituximab, cyclophosphamide, doxorubicin and prednisone plus bortezomib (VR-CAP) or vincristine (R-CHOP) in a subset of newly diagnosed mantle cell lymphoma patients medically eligible for transplantation in the randomized
Belch, A; Bosly, A; Bunworasate, U; Cavalli, F; Dascalescu, A; Drach, J; Farber, C; Huang, H; Masliak, Z; Novak, J; Pei, L; Robak, T; Rooney, B; Samoilova, O; van de Velde, H; Vilchevskaya, K; Zaucha, J, 2018
)
0.71
" Despite differences in total belimumab exposure (24 weeks in the placebo-to-belimumab group versus 76 weeks in the belimumab group), the proportions of patients experiencing more than one adverse event (AE) or a serious AE in the open-label phase were similar between groups (placebo-to-belimumab: 51."( A 6-month open-label extension study of the safety and efficacy of subcutaneous belimumab in patients with systemic lupus erythematosus.
Bass, D; Doria, A; Fox, NL; Gordon, D; Groark, J; Hammer, A; Kleoudis, C; Roth, D; Scheinberg, M; Schwarting, A; Stohl, W, 2018
)
0.48
" We analyzed the main outcomes, including the overall survival (OS), progression-free survival (PFS), prostate-specific antigen (PSA) response, tumor response and severe adverse events (AEs)."( The efficacy and safety comparison of docetaxel, cabazitaxel, estramustine, and mitoxantrone for castration-resistant prostate cancer: A network meta-analysis.
Huang, C; Song, P; Wang, Y, 2018
)
0.48
" Outcomes were number of responders to treatment, remission rate of treatment responders, overall probability of 5-year remission, and the occurrence of adverse events."( Corticosteroids in chronic inflammatory demyelinating polyneuropathy : A retrospective, multicentre study, comparing efficacy and safety of daily prednisolone, pulsed dexamethasone, and pulsed intravenous methylprednisolone.
Basta, I; Doneddu, PE; Eftimov, F; Gallia, F; Nikolic, A; Nobile-Orazio, E; Peric, S; van Lieverloo, GGA; van Schaik, IN; Verhamme, C; Wieske, L, 2018
)
0.48
" Adverse events leading to a change in treatment occurred in ten patients (8%)."( Corticosteroids in chronic inflammatory demyelinating polyneuropathy : A retrospective, multicentre study, comparing efficacy and safety of daily prednisolone, pulsed dexamethasone, and pulsed intravenous methylprednisolone.
Basta, I; Doneddu, PE; Eftimov, F; Gallia, F; Nikolic, A; Nobile-Orazio, E; Peric, S; van Lieverloo, GGA; van Schaik, IN; Verhamme, C; Wieske, L, 2018
)
0.48
" Compared with conventional chemotherapy, immunotherapy is associated with a unique set of immune reactions known collectively as immune-related adverse events (irAEs)."( A Case of Nivolumab-Induced Bullous Pemphigoid: Review of Dermatologic Toxicity Associated with Programmed Cell Death Protein-1/Programmed Death Ligand-1 Inhibitors and Recommendations for Diagnosis and Management.
Geskin, L; Lopez, AT, 2018
)
0.48
"PD-1/PD-L1 inhibitor-induced bullous pemphigoid (BP) is a rare but potentially serious dermatologic toxicity associated with checkpoint inhibitorsIn patients with pruritus or rash that is refractory to topical steroids, physicians should have a greater index of suspicion for higher-grade cutaneous immune-related adverse events."( A Case of Nivolumab-Induced Bullous Pemphigoid: Review of Dermatologic Toxicity Associated with Programmed Cell Death Protein-1/Programmed Death Ligand-1 Inhibitors and Recommendations for Diagnosis and Management.
Geskin, L; Lopez, AT, 2018
)
0.48
" The adverse drug effects of tacrolimus were monitored."( Efficacy and safety of tacrolimus in Osserman grade III and Osserman grade IV Myasthenia Gravis.
Cao, M; Fang, XJ; Jiang, QL; Liang, Y; Liu, XM; She, SF; Wang, SS; Zhao, LN, 2018
)
0.48
" Nineteen patients in the tacrolimus group had adverse drug reactions, but no severe adverse effects appeared."( Efficacy and safety of tacrolimus in Osserman grade III and Osserman grade IV Myasthenia Gravis.
Cao, M; Fang, XJ; Jiang, QL; Liang, Y; Liu, XM; She, SF; Wang, SS; Zhao, LN, 2018
)
0.48
"Our study suggested that tacrolimus could be an effective and safe treatment for Osserman grade III and Osserman grade IV MG patients."( Efficacy and safety of tacrolimus in Osserman grade III and Osserman grade IV Myasthenia Gravis.
Cao, M; Fang, XJ; Jiang, QL; Liang, Y; Liu, XM; She, SF; Wang, SS; Zhao, LN, 2018
)
0.48
" We hypothesized that sirolimus administration within the first postoperative month in selected lung transplant recipients is safe and may be associated with favorable short-term and long-term outcomes due to its anti-proliferative properties and minimal adverse side effects."( Early Sirolimus-Based Immunosuppression is Safe for Lung Transplantation Patients: Retrospective, Single Arm, Exploratory Study.
Karolak, W; Ochman, M; Wojarski, J; Żegleń, S, 2018
)
0.48
" The major adverse effects were bone marrow suppression, reduction of fibrinogen level, liver dysfunction, and digestive tract toxicities."( PEG-L-CHOP treatment is safe and effective in adult extranodal NK/T-cell lymphoma with a low rate of clinical hypersensitivity.
Deng, L; Gao, Y; Ke, X; Lin, N; Liu, W; Ping, L; Ren, H; Song, Y; Su, L; Tu, M; Wang, X; Xie, Y; Ying, Z; Zhang, C; Zhang, W; Zheng, W; Zhu, J, 2018
)
0.48
"PEG-L-CHOP chemotherapy in combination radiotherapy is safe and durably effective treatment for adult extranodal NK/T-cell lymphoma with fewer allergic reactions."( PEG-L-CHOP treatment is safe and effective in adult extranodal NK/T-cell lymphoma with a low rate of clinical hypersensitivity.
Deng, L; Gao, Y; Ke, X; Lin, N; Liu, W; Ping, L; Ren, H; Song, Y; Su, L; Tu, M; Wang, X; Xie, Y; Ying, Z; Zhang, C; Zhang, W; Zheng, W; Zhu, J, 2018
)
0.48
" The most frequently reported adverse events (>20% in either group) in the Japanese subgroup were hypertension, nasopharyngitis, weight increased, hypokalemia, hot flush, back pain, hyperglycemia, ALT and AST elevation."( Efficacy and safety of abiraterone acetate plus prednisone in Japanese patients with newly diagnosed, metastatic hormone-naïve prostate cancer: a subgroup analysis of LATITUDE, a randomized, double-blind, placebo-controlled, Phase 3 study.
Enjo, K; Fizazi, K; Fukasawa, S; Kawaguchi, K; Matsubara, N; Noguchi, H; Suzuki, H; Todd, M; Tran, N, 2018
)
0.74
"Advances in anti-lymphoma therapy prolong overall survival, making late adverse effects, like doxorubicin-related cardiotoxicity, an even more important clinical issue."( Primary Cardioprotection Reduces Mortality in Lymphoma Patients with Increased Risk of Anthracycline Cardiotoxicity, Treated by R-CHOP Regimen.
Długosz-Danecka, M; Gruszka, AM; Jaroszyński, A; Jurczak, W; Krawczyk, K; Ogórka, T; Olszanecka, A; Skotnicki, AB; Sobociński, M; Szmit, S, 2018
)
0.48
" The most frequently reported grade 3 or 4 adverse event in both the AA + prednisone and prednisone-alone groups was elevated alanine aminotransferase level in 5 of 43 patients (11."( Abiraterone acetate for chemotherapy-naive metastatic castration-resistant prostate cancer: a single-centre prospective study of efficacy, safety, and prognostic factors.
Chi, C; Dong, B; Fan, L; Gong, Y; Huang, Y; Pan, J; Sha, J; Shangguan, X; Wang, Y; Xue, W; Zhou, L, 2018
)
0.71
" Nevertheless, glucocorticoid administration, in long-term especially, is also seen critically because of its potential adverse conditions."( New concepts to reduce glucocorticoid toxicity.
Alten, R; Mischkewitz, M, 2019
)
0.51
"Myalgia and arthralgia immune-related adverse events (irAEs) in patients treated with checkpoint inhibitors (CPIs) present a clinical challenge."( Myalgia and Arthralgia Immune-related Adverse Events (irAEs) in Patients With Genitourinary Malignancies Treated With Immune Checkpoint Inhibitors.
Allman, KD; Calabrese, C; Calabrese, LH; Garcia, JA; Grivas, P; Kirchner, E; Kontzias, A; Martin, A; Ornstein, MC; Profusek, P; Rini, BI; Wood, LS, 2019
)
0.51
" ICIs initate antitumor immunity; however, these agents are associated with immune-related adverse events (irAEs) that may affect a variety of organs."( Diagnosis and Management of Immune Checkpoint Inhibitor-Associated Renal Toxicity: Illustrative Case and Review.
Reynolds, KL; Seethapathy, H; Sise, ME, 2019
)
0.51
" Information evaluated included patient signalment, feline immunodeficiency virus/feline leukemia virus status, anatomic location(s) of lymphoma, prior protocols (type and number), MOPP doses, MOPP response, remission duration, hematologic and biochemical parameters, and owner-reported adverse effects."( Efficacy and toxicity of mustargen, vincristine, procarbazine and prednisone (MOPP) for the treatment of relapsed or resistant lymphoma in cats.
Brown, DC; Krick, EL; MaloneyHuss, MA; Mauldin, GE; Veluvolu, SM, 2020
)
0.8
" The most common adverse effects were neutropenia and gastrointestinal upset, which were reported in 18."( Efficacy and toxicity of mustargen, vincristine, procarbazine and prednisone (MOPP) for the treatment of relapsed or resistant lymphoma in cats.
Brown, DC; Krick, EL; MaloneyHuss, MA; Mauldin, GE; Veluvolu, SM, 2020
)
0.8
"MOPP is a safe protocol for the treatment of relapsed or refractory feline lymphoma, with a promising overall response rate and median remission time."( Efficacy and toxicity of mustargen, vincristine, procarbazine and prednisone (MOPP) for the treatment of relapsed or resistant lymphoma in cats.
Brown, DC; Krick, EL; MaloneyHuss, MA; Mauldin, GE; Veluvolu, SM, 2020
)
0.8
" Remission rate, relapse rate, and adverse events in the two groups were assessed."( Efficacy and safety of tacrolimus-based treatment for nephrotic idiopathic membranous nephropathy in young adults: A retrospective study.
Bai, DF; Fang, W; Hu, Z; Ji, CF; Wang, L; Yuan, JZ; Zhang, J; Zhang, XJ, 2019
)
0.51
"There are limited data on treatment patterns, adverse events (AEs), and economic burden in younger, commercially insured patients treated for mantle cell lymphoma (MCL)."( Treatment patterns, adverse events, healthcare resource use and costs among commercially insured patients with mantle cell lymphoma in the United States.
Burudpakdee, C; Kabadi, SM; Near, A; Wada, K, 2019
)
0.51
" The administration of intratympanic infliximab is an effective and safe technique."( Intratympanic infliximab is a safe and effective rescue therapy for refractory immune-mediated hearing loss.
García-Fernández, A; Mata-Castro, N; Sanz-López, L; Varillas-Delgado, D, 2020
)
0.56
" This subpopulation analysis assessed the impact of lenalidomide maintenance and treatment-emergent adverse events (TEAEs) on health-related quality of life (HRQOL)."( Lenalidomide maintenance for diffuse large B-cell lymphoma patients responding to R-CHOP: quality of life, dosing, and safety results from the randomised controlled REMARC study.
Abraham, J; Bouabdallah, R; Bron, D; Caballero, D; Casadebaig, ML; Casasnovas, RO; Catalano, J; Cohen, AM; Coiffier, B; Costello, R; da Silva, MG; Daguindau, N; Deeren, D; Eisenmann, JC; Fitoussi, O; Fruchart, C; Gaulard, P; Gonzalez, H; Greil, R; Grosicki, S; Howlett, S; Le Du, K; Lionne-Huyghe, P; Morschhauser, F; Mounier, N; Nicolas-Virezelier, E; Obéric, L; Perrot, A; Pica, GM; Roulin, L; Snauwaert, S; Takeshita, K; Thieblemont, C; Tilly, H; Tricot, S; Trotman, J; van Eygen, K, 2020
)
0.56
" Clinical manifestation, IgG4-RD responder index (IgG-RD RI), serological indexes, gland ultrasound findings, and adverse drug effect were recorded."( Efficacy and safety of iguratimod on patients with relapsed or refractory IgG4-related disease.
Bian, W; Chen, D; Chen, J; Fu, J; Li, Y; Li, Z; Liu, Y; Sun, X; Zhang, W; Zhang, Y; Zhao, X, 2020
)
0.56
" Rituximab (R) was added 10 days later without incident, and the patient completed six cycles of the R-CHOP therapy without adverse events."( Safe administration of rituximab for follicular lymphoma after obinutuzumab infusion-related reaction.
Hara, T; Ikeda, Y; Matsumoto, R; Murayama, M; Ohno, A; Sobajima, T; Sugiyama, Y; Suzuki, R; Tsurumi, H; Yamada, R; Yamagishi, Y; Yamakawa, K, 2020
)
0.56
" The most important reported side effect was weight gain, associated with increased appetite among prednisone users (as monotherapy as well as in combination with other drugs)."( Ranking Self-reported Gastrointestinal Side Effects of Pharmacotherapy in Sarcoidosis.
Bast, A; de Jong, SMG; Drent, M; Ebner, NM; Elfferich, MDP; Jessurun, NT; Lewis, EDO; Proesmans, VLJ, 2020
)
0.77
" The strongest association between a reported side effect and drug use was that of weight gain associated with increased appetite among prednisone users."( Ranking Self-reported Gastrointestinal Side Effects of Pharmacotherapy in Sarcoidosis.
Bast, A; de Jong, SMG; Drent, M; Ebner, NM; Elfferich, MDP; Jessurun, NT; Lewis, EDO; Proesmans, VLJ, 2020
)
0.76
" (iii) Evaluation of the relative risk (RR) and risk difference of serious toxicity defined as adverse events (AEs) with grade ≥ 3 specific AEs."( Systemic Treatment for Metastatic Hormone Sensitive Prostate Cancer: A Comprehensive Meta-Analysis Evaluating Efficacy and Safety in Specific Sub-Groups of Patients.
Ardizzoni, A; Battelli, N; Conti, A; Di Nunno, V; Massari, F; Mollica, V; Montironi, R; Santoni, M, 2020
)
0.56
" We hypothesised that ex vivo expanded lymphokine-activated killer (LAK) cells administered to FL-remission patients are safe and improve anti-CD20 efficacy."( Maintenance therapy with ex vivo expanded lymphokine-activated killer cells and rituximab in patients with follicular lymphoma is safe and may delay disease progression.
Andrade-Campos, M; Bandrés, E; Feliu, J; García-Muñoz, R; Giraldo, P; Grande, C; Inogés, S; López-Díaz de Cerio, A; Martínez-Calle, N; Núñez-Córdoba, JM; Olave, MT; Panizo, Á; Panizo, C; Pena, E; Rodríguez-Calvillo, M, 2020
)
0.56
"Patients treated for non-Hodgkin lymphoma are at risk of cardiovascular adverse events, with the risk of heart failure being particularly high."( Cardiovascular adverse events in patients with non-Hodgkin lymphoma treated with first-line cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or CHOP with rituximab (R-CHOP): a systematic review and meta-analysis.
Asselbergs, FW; Bosman, LP; Cramer, MJ; Doevendans, PA; Kamphuis, JAM; Linschoten, M; Teske, AJ; van Rhenen, A, 2020
)
0.76
" Studies reporting on cardiovascular adverse events and treatment-related cardiovascular mortality were included."( Cardiovascular adverse events in patients with non-Hodgkin lymphoma treated with first-line cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or CHOP with rituximab (R-CHOP): a systematic review and meta-analysis.
Asselbergs, FW; Bosman, LP; Cramer, MJ; Doevendans, PA; Kamphuis, JAM; Linschoten, M; Teske, AJ; van Rhenen, A, 2020
)
0.76
" Grade 3/4 adverse events were reported in 24 (68."( Efficacy and safety of abiraterone acetate plus prednisone in Japanese patients with newly diagnosed, metastatic hormone-naive prostate cancer: final subgroup analysis of LATITUDE, a randomized, double-blind, placebo-controlled, phase 3 study.
Fizazi, K; Fukasawa, S; Hashine, K; Kitani, S; Matsubara, N; Mundle, S; Ohtake, N; Shibayama, K; Shin, T; Suzuki, H; Tran, N, 2020
)
0.81
" RTX-related adverse events were mostly mild (most infusion-related reactions) in nature and serious adverse events were rare."( Efficacy and safety of rituximab in the treatment of membranous nephropathy: A systematic review and meta-analysis.
Gong, S; Li, J; Lu, W; Luo, H; Wang, Y, 2020
)
0.56
"RTX proved to be efficient, well-tolerated and a safe drug in the treatment of membranous nephropathy."( Efficacy and safety of rituximab in the treatment of membranous nephropathy: A systematic review and meta-analysis.
Gong, S; Li, J; Lu, W; Luo, H; Wang, Y, 2020
)
0.56
" No increase in mineralocorticoid excess-related adverse events was observed."( Pharmacokinetics, Safety, and Antitumor Effect of Apalutamide with Abiraterone Acetate plus Prednisone in Metastatic Castration-Resistant Prostate Cancer: Phase Ib Study.
Abrams, C; Attard, G; Chi, KN; Chien, C; de Jonge, MJA; de Wit, R; Friedlander, TW; Hellemans, P; Jiao, JJ; Posadas, EM; Saad, F; Yu, MK, 2020
)
0.78
"In this single-center, prospective, randomized study, adverse events (AEs), serious AEs (SAEs), viral infections, laboratory abnormalities, dose reductions, and temporary or permanent discontinuation of the immunosuppressant were compared among patients receiving r-ATG/EVR (n = 85), BAS/EVR (n = 102), and BAS/MPS (n = 101)."( Immunosuppressive Drug-Associated Adverse Event Profiles in De Novo Kidney Transplant Recipients Receiving Everolimus and Reduced Tacrolimus Doses.
Felipe, CR; Medina Pestana, JO; Miranda, TA; Santos, RHN; Tedesco-Silva Junior, H, 2020
)
0.56
" Physician-reported incidences of adverse events (AEs) for Cushingoid appearance, hirsutism, weight gain, and behavior change were less for vamorolone than published incidences for prednisone and deflazacort."( Efficacy and safety of vamorolone in Duchenne muscular dystrophy: An 18-month interim analysis of a non-randomized open-label extension study.
Arrieta, A; Castro, D; Clemens, PR; Conklin, LS; Damsker, JM; Dang, UJ; Finkel, RS; Gordish-Dressman, H; Guglieri, M; Hagerty, L; Hoffman, EP; Jaros, M; Kerchner, L; Kuntz, NL; Mah, JK; McDonald, CM; Mengle-Gaw, LJ; Morgenroth, LP; Nevo, Y; Ryan, MM; Schwartz, BD; Shale, P; Shimony, M; Smith, EC; Tulinius, M; Webster, R, 2020
)
0.75
"This study indicates that Tripterygium glycosides enhances the effect of thiamazole and prednisone in the treatment of hyperthyroidism and without increasing the risk of adverse events."( Efficacy and safety of tripterygium glycosides in the treatment of hyperthyroidism: A systemic review and meta-analysis.
Gao, J; He, C; Jia, S; Xie, C, 2020
)
0.78
" Other adverse reactions such as fever, debilitation, and alopecia were also observed."( Efficacy and safety of docetaxel and prednisolone chemotherapy in very elderly men with metastatic castration-resistant prostate cancer (mCRPC) in real world: a single institute experience.
Hu, YC; Jiang, JH; Ma, L; Ma, Q; Wang, KY; Zhang, LL, 2021
)
0.62
" We hypothesized that outpatient administration of DA-EPOCH at a comprehensive cancer center is both safe and cost-effective."( Safety and financial analysis of outpatient dose-adjusted EPOCH for B-cell lymphoma at a tertiary comprehensive cancer center.
Kubal, TE; Li, W; McCarthy, KT; Richter, KA; Tobon, KA, 2021
)
0.62
" Additional safety endpoints included hospitalizations between cycles, infectious complications, extravasations, drug spills, pump-malfunctions, and drug-related adverse events."( Safety and financial analysis of outpatient dose-adjusted EPOCH for B-cell lymphoma at a tertiary comprehensive cancer center.
Kubal, TE; Li, W; McCarthy, KT; Richter, KA; Tobon, KA, 2021
)
0.62
"Routine outpatient administration of DA-EPOCH is both safe and feasible with a positive annual impact on margin of $1,444,548 at a comprehensive cancer center."( Safety and financial analysis of outpatient dose-adjusted EPOCH for B-cell lymphoma at a tertiary comprehensive cancer center.
Kubal, TE; Li, W; McCarthy, KT; Richter, KA; Tobon, KA, 2021
)
0.62
" Two serious adverse events occurred, both in the placebo group (inguinal hernia and severe deterioration of cluster headache)."( Safety and efficacy of prednisone versus placebo in short-term prevention of episodic cluster headache: a multicentre, double-blind, randomised controlled trial.
Böger, A; Diener, HC; Freilinger, T; Gaul, C; Holle, D; Jansen, JP; Jürgens, TP; Katsarava, Z; Kaube, H; Kleinschnitz, C; Kraya, T; Nägel, S; Obermann, M; Ose, C; Scherag, A; Sonuc, N; Storch, P; Straube, A, 2021
)
0.93
"Limited published real-world data describe adverse events (AEs) among patients treated for mantle-cell lymphoma (MCL)."( Adverse Events and Economic Burden Among Patients Receiving Systemic Treatment for Mantle Cell Lymphoma: A Real-World Retrospective Cohort Study.
Byfield, SD; Kabadi, SM; LE, L; Olufade, T, 2021
)
0.62
" Oral corticosteroid dose, adverse events, exacerbations, symptom control, disease activity, blood markers, and lung function were evaluated before, during, and after 7 monthly reslizumab treatments."( Efficacy and safety of reslizumab in the treatment of eosinophilic granulomatosis with polyangiitis.
Denson, JL; Dollin, YT; Dunn, RM; Guntur, VP; Manka, LA; Strand, MJ; Wechsler, ME, 2021
)
0.62
" One had a severe adverse event, requiring removal from the study."( Efficacy and safety of reslizumab in the treatment of eosinophilic granulomatosis with polyangiitis.
Denson, JL; Dollin, YT; Dunn, RM; Guntur, VP; Manka, LA; Strand, MJ; Wechsler, ME, 2021
)
0.62
"Yielding similar results to other anti-interleukin 5 biologic medications, reslizumab is generally a safe and effective treatment for EGPA that warrants further study."( Efficacy and safety of reslizumab in the treatment of eosinophilic granulomatosis with polyangiitis.
Denson, JL; Dollin, YT; Dunn, RM; Guntur, VP; Manka, LA; Strand, MJ; Wechsler, ME, 2021
)
0.62
"2%) had grade 3/4 treatment-emergent adverse events, the most common being thrombocytopenia (26."( Niraparib with androgen receptor-axis-targeted therapy in patients with metastatic castration-resistant prostate cancer: safety and pharmacokinetic results from a phase 1b study (BEDIVERE).
Bradic, B; Chi, KN; De Meulder, M; Espina, BM; Francis, P; Graff, JN; Hayreh, V; Hazra, A; Lattouf, JB; Mamidi, RNVS; Posadas, EM; Rezazadeh Kalebasty, A; Saad, F; Shore, ND; Yu, A; Zhu, E, 2021
)
0.62
"To describe the frequency and severity of parent-reported medication side effects (SEs) in children with juvenile idiopathic arthritis (JIA) relative to physician-reported actionable adverse events (AEs), and to assess their impact on health-related quality of life (HRQoL)."( Parent-Reported Medication Side Effects and Their Impact on Health-Related Quality of Life in Children With Juvenile Idiopathic Arthritis.
Batthish, M; Berard, RA; Bruns, A; Cabral, DA; Chédeville, G; Duffy, CM; Gerhold, K; Gerschman, T; Guzman, J; McGuire, K; Proulx-Gauthier, JP; Rumsey, DG; Schmeling, H; Shiff, NJ; Soon, G; Tucker, LB, 2022
)
0.72
" Baseline characteristics, safety (treatment-emergent adverse events, treatment-emergent severe adverse events), and efficacy [progression-free survival (PFS) and overall survival (OS)] were analyzed."( Real-World Safety and Efficacy Outcomes with Abiraterone Acetate Plus Prednisone or Prednisolone as the First- or Second-Line Treatment for Metastatic Castration-Resistant Prostate Cancer: Data from the Prostate Cancer Registry.
Birtle, A; Bjartell, A; Chowdhury, S; Costa, L; Feyerabend, S; Gomez-Veiga, F; Kalinka, E; Kramer, G; Lefresne, F; Lukac, M; Lumen, N; Maroto, P; Matveev, V; Paiss, T; Spaëth, D; Wapenaar, R, 2021
)
0.86
" There were no unexpected adverse events in any patient subgroup."( Real-World Safety and Efficacy Outcomes with Abiraterone Acetate Plus Prednisone or Prednisolone as the First- or Second-Line Treatment for Metastatic Castration-Resistant Prostate Cancer: Data from the Prostate Cancer Registry.
Birtle, A; Bjartell, A; Chowdhury, S; Costa, L; Feyerabend, S; Gomez-Veiga, F; Kalinka, E; Kramer, G; Lefresne, F; Lukac, M; Lumen, N; Maroto, P; Matveev, V; Paiss, T; Spaëth, D; Wapenaar, R, 2021
)
0.86
"Dexamethasone is the glucocorticoid of choice in many human inflammatory and immune-mediated conditions, given its reported effectiveness and limited side effect profile."( Dexamethasone Can Be Safely and Effectively Used for Treatment of Masticatory Muscle Myositis in Dogs.
Cherubini, GB; Foreman, M, 2021
)
0.62
"Most data on overall survival (OS) and adverse events (AEs) in patients with mantle cell lymphoma (MCL) are from controlled trials; therefore, in this population-based study, we retrospectively assessed treatment patterns, OS, and AEs in MCL patients initiating systemic treatment during 2013-2015 using the United States Medicare claims database."( Real-world evidence on survival, adverse events, and health care burden in Medicare patients with mantle cell lymphoma.
Davis, K; Du, XL; Goyal, RK; Jain, P; Kabadi, SM; Kaye, JA; Le, H; Nagar, SP; Wang, M, 2021
)
0.62
" The most common adverse events during induction were anemia (91%), febrile neutropenia (64%; grade 4 in 46%), thrombocytopenia (39%), and mucositis (21%)."( Safety and Efficacy of Replacing Vindesine with Vincristine in R-ACVBP Regimen for the Treatment of Large B Cell Lymphomas.
Abou Dalle, I; Al Chami, F; Bazarbachi, A; Charafeddine, M; El Cheikh, J; El Darsa, H; El Sayed, R; Ibrahim, A; Kort, J, 2021
)
0.62
"The replacement of vindesine with vincristine in mR-ACVBP seems feasible, with manageable adverse events and excellent 2-year progression-free survival."( Safety and Efficacy of Replacing Vindesine with Vincristine in R-ACVBP Regimen for the Treatment of Large B Cell Lymphomas.
Abou Dalle, I; Al Chami, F; Bazarbachi, A; Charafeddine, M; El Cheikh, J; El Darsa, H; El Sayed, R; Ibrahim, A; Kort, J, 2021
)
0.62
" Grade ≥3 treatment-emergent adverse events (TEAEs) occurred in 58% versus 49% of older patients receiving cabazitaxel versus abiraterone/enzalutamide and 48% versus 42% of younger patients."( Efficacy and Safety of Cabazitaxel Versus Abiraterone or Enzalutamide in Older Patients with Metastatic Castration-resistant Prostate Cancer in the CARD Study.
Bamias, A; Carles, J; Castellano, D; de Bono, J; de Wit, R; Eymard, JC; Feyerabend, S; Fizazi, K; Geffriaud-Ricouard, C; Helissey, C; Iacovelli, R; Kramer, G; Melichar, B; Ozatilgan, A; Poole, EM; Sternberg, CN; Sverrisdóttir, Á; Theodore, C; Tombal, B; Wülfing, C, 2021
)
0.62
" Serious adverse events (SAEs) were similar between older and younger patients (21."( Retrospective analysis of safety and outcomes of rituximab for myasthenia gravis in patients ≥65 years old.
Amato, AA; David, WS; Doughty, CT; Guidon, AC; Suh, J, 2021
)
0.62
" The results showed that SCR is safe and feasible in terms of a high compliance rate and stable nutritional status."( Safety, Feasibility, and Effects of Short-Term Calorie Reduction during Induction Chemotherapy in Patients with Diffuse Large B-Cell Lymphoma: A Pilot Study.
Huang, TC; Lee, CY; Lin, JM; Tang, CC; Tien, FM; Yeh, YC, 2021
)
0.62
" We evaluated adverse side effects (ASEs) of corticosteroid treatment in patients with gMG."( Adverse Side Effects Associated with Corticosteroid Therapy: A Study in 39 Patients with Generalized Myasthenia Gravis.
Govindarajan, R; Johnson, S; Katyal, N; Narula, N, 2021
)
0.62
" The primary endpoint was objective response rates (ORR), and secondary endpoints were duration of response and incidence of adverse events (AEs)."( The Short-Term Efficacy and Safety of Brentuximab Vedotin Plus Cyclophosphamide, Epirubicin and Prednisone in Untreated PTCL: A Real-World, Retrospective Study.
Bai, O; Feng, X; Guo, Q; Guo, W; Li, J; Qu, L; Wang, Y; Yan, X; Young, KH; Zhao, Y, 2022
)
0.94
" Adverse events (AEs), including incidence and severity of febrile neutropenia (26% patients in the BV-CEP group and 30% in the CHOEP group), were similar between groups."( The Short-Term Efficacy and Safety of Brentuximab Vedotin Plus Cyclophosphamide, Epirubicin and Prednisone in Untreated PTCL: A Real-World, Retrospective Study.
Bai, O; Feng, X; Guo, Q; Guo, W; Li, J; Qu, L; Wang, Y; Yan, X; Young, KH; Zhao, Y, 2022
)
0.94
" The frequency of severe adverse events from the two regimens was similar."( Efficacy and safety comparison between R-CHOP and modified NHL-BFM-90 regimens in children and adolescents with diffuse large B-cell lymphoma.
Cai, R; Guan, J; Huang, H; Huang, J; Lu, S; Que, Y; Sun, F; Sun, X; Wang, J; Xia, Z; Zhang, Y; Zhen, Z; Zhu, J; Zhu, X, 2022
)
0.72
"In this single center, open label pilot study, once-weekly prednisone was safe and well tolerated."( An Open Label Exploratory Clinical Trial Evaluating Safety and Tolerability of Once-Weekly Prednisone in Becker and Limb-Girdle Muscular Dystrophy.
Ajroud-Driss, S; Casey, P; Joslin, BC; McNally, EM; Zelikovich, AS, 2022
)
1.19
" Treatment-emergent adverse events related to DCVAC/PCa or placebo occurred in 69 of 749 (9."( Efficacy and Safety of Autologous Dendritic Cell-Based Immunotherapy, Docetaxel, and Prednisone vs Placebo in Patients With Metastatic Castration-Resistant Prostate Cancer: The VIABLE Phase 3 Randomized Clinical Trial.
Bahl, A; Bartunkova, J; Beer, TM; Cheung, E; Csöszi, T; Feyerabend, S; Filipovic, Z; Fricke, H; Gerritsen, W; Goncalves, F; Hajek, J; Hussain, A; Hussain, S; Kadlecova, P; Khoo, V; Korolkiewicz, RP; Kukielka-Budny, B; Oudard, S; Prokhorov, A; Samal, V; Scheiner, T; Sousa, N; Spisek, R; Stenzl, A; Vogelzang, NJ; Wiechno, P, 2022
)
0.95
" This study aimed to evaluate the response and the adverse events of treatment with imatinib mesylate (IM) compared to conventional therapy using vinblastine and prednisolone (VP) in canine cutaneous MCTs."( Imatinib Mesylate for the Treatment of Canine Mast Cell Tumors: Assessment of the Response and Adverse Events in Comparison with the Conventional Therapy with Vinblastine and Prednisone.
Alexandre, PA; Brandão, PE; Casagrande, TAC; Dagli, MLZ; de Queiroz, GF; Fukumasu, H; Macedo, TR; Matera, JM; Melo, SR; Pinto, ACBCF, 2022
)
0.91
"To generate initial data on the frequency and effect of symptomatic adverse events (AEs) associated with rheumatoid arthritis (RA) drug therapy from the patient perspective."( Frequency of Symptomatic Adverse Events in Rheumatoid Arthritis: An Exploratory Online Survey.
Bartlett, SJ; Bykerk, V; Hazlewood, GS; Hull, PM; Mujaab, K; Proulx, L; Richards, D; Schieir, O; Tugwell, P; Wells, G, 2022
)
0.72
"We conducted an exploratory online survey asking patients with RA to indicate whether they currently or had ever experienced the 80 different symptomatic AEs included in the Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)."( Frequency of Symptomatic Adverse Events in Rheumatoid Arthritis: An Exploratory Online Survey.
Bartlett, SJ; Bykerk, V; Hazlewood, GS; Hull, PM; Mujaab, K; Proulx, L; Richards, D; Schieir, O; Tugwell, P; Wells, G, 2022
)
0.72
" Many of the strongest associations between current symptomatic AEs and medication use aligned with known side effect profiles."( Frequency of Symptomatic Adverse Events in Rheumatoid Arthritis: An Exploratory Online Survey.
Bartlett, SJ; Bykerk, V; Hazlewood, GS; Hull, PM; Mujaab, K; Proulx, L; Richards, D; Schieir, O; Tugwell, P; Wells, G, 2022
)
0.72
" Adverse events occurred in 78."( Efficacy and safety of mavrilimumab in giant cell arteritis: a phase 2, randomised, double-blind, placebo-controlled trial.
Blockmans, D; Brouwer, E; Cid, MC; Dagna, L; Dasgupta, B; Hellmich, B; Molloy, E; Paolini, JF; Pupim, L; Salvarani, C; Samant, M; Trapnell, BC; Unizony, SH; Warrington, KJ; Wicks, I; Zhou, T, 2022
)
0.72
"7%) patients had adverse events (AEs), and 96/424 (22."( Phase 3, long-term, open-label extension period of safety and efficacy of belimumab in patients with systemic lupus erythematosus in China, for up to 6 years.
Bass, D; Chu, M; Curtis, P; DeRose, K; Gu, J; Kurrasch, R; Li, X; Li, Y; Lowe, J; Meizlik, P; Roth, DA; Su, Y; Wang, G; Wang, M; Zhang, F; Zheng, J, 2022
)
0.72
"Pituitary immune-related adverse events induced by programmed cell death protein 1 inhibitors in advanced lung cancer patients: A report of 3 cases SUMMARY Programmed cell death protein 1 (PD-1) and its ligand 1 (PD-L1) have been widely used in lung cancer treatment, but their immune-related adverse events (irAEs) require intensive attention."( [Pituitary immune-related adverse events induced by programmed cell death protein 1 inhibitors in advanced lung cancer patients: A report of 3 cases].
Cao, BS; Gu, YC; Liu, Y; Xie, C, 2022
)
0.72
" This retrospective study shows that CARMEN is a safe and active regimen both in HIV-negative and -positive patients with MYC-rearranged lymphomas."( Safety and efficacy of a dose-dense short-term therapy in patients with MYC-translocated aggressive lymphoma.
Allione, B; Angelillo, P; Cattaneo, C; Erbella, F; Facchetti, F; Ferreri, AJM; Flospergher, E; Foppoli, M; Lleshi, A; Pagani, C; Pecciarini, L; Ponzoni, M; Re, A; Rossi, G; Sassone, M; Spina, M; Steffanoni, S; Verga, L, 2022
)
0.72
"Corticosteroidal anti-inflammatory drugs are widely prescribed but long-term use shows adverse effects that detract from patient quality of life."( Efficacy and Safety of Vamorolone vs Placebo and Prednisone Among Boys With Duchenne Muscular Dystrophy: A Randomized Clinical Trial.
Ahmet, A; Baranello, G; Castro, D; Childs, AM; Clemens, PR; Damsker, JM; Dang, UJ; de Groot, IJM; De Waele, L; Deconinck, N; Finkel, RS; Goemans, N; Guglieri, M; Haberlova, J; Harper, AD; Hoffman, EP; Horrocks, I; James, MK; Jaros, M; Katsalouli, M; Kuntz, NL; Mah, JK; McDonald, CM; McMillan, HJ; Mengle-Gaw, LJ; Monduy, M; Nascimento-Osorio, A; Nevo, Y; Niks, EH; Perlman, SJ; Rao, VK; Ryan, MM; Sbrocchi, AM; Schwartz, BD; Selby, KA; Shale, P; Shieh, PB; Smith, EC; Spinty, S; Straub, V; Tulinius, M; van den Anker, J; Vilchez-Padilla, JJ; Ward, LM; Webster, R; Yang, ML, 2022
)
0.98
"In this pivotal randomized clinical trial, vamorolone was shown to be effective and safe in the treatment of boys with DMD over a 24-week treatment period."( Efficacy and Safety of Vamorolone vs Placebo and Prednisone Among Boys With Duchenne Muscular Dystrophy: A Randomized Clinical Trial.
Ahmet, A; Baranello, G; Castro, D; Childs, AM; Clemens, PR; Damsker, JM; Dang, UJ; de Groot, IJM; De Waele, L; Deconinck, N; Finkel, RS; Goemans, N; Guglieri, M; Haberlova, J; Harper, AD; Hoffman, EP; Horrocks, I; James, MK; Jaros, M; Katsalouli, M; Kuntz, NL; Mah, JK; McDonald, CM; McMillan, HJ; Mengle-Gaw, LJ; Monduy, M; Nascimento-Osorio, A; Nevo, Y; Niks, EH; Perlman, SJ; Rao, VK; Ryan, MM; Sbrocchi, AM; Schwartz, BD; Selby, KA; Shale, P; Shieh, PB; Smith, EC; Spinty, S; Straub, V; Tulinius, M; van den Anker, J; Vilchez-Padilla, JJ; Ward, LM; Webster, R; Yang, ML, 2022
)
0.98
" Data about the immunogenicity and adverse effects of the vaccine on patients with systemic autoimmune rheumatic diseases (SARDs) is emerging."( Immunogenicity and safety of the mRNA-based BNT162b2 vaccine in systemic autoimmune rheumatic diseases patients.
Gepstein, R; Halperin, T; Kimhi, O; Kivity, S; Levy, Y; Naser, R; Parikh, R; Pri-Paz Basson, Y; Tartakover Matalon, S; Tayer-Shifman, OE; Ziv, A; Ziv-Baran, T, 2022
)
0.72
" An adverse effects questionnaire was given to the participants upon their first visit to the clinic after their BNT162b2 vaccination."( Immunogenicity and safety of the mRNA-based BNT162b2 vaccine in systemic autoimmune rheumatic diseases patients.
Gepstein, R; Halperin, T; Kimhi, O; Kivity, S; Levy, Y; Naser, R; Parikh, R; Pri-Paz Basson, Y; Tartakover Matalon, S; Tayer-Shifman, OE; Ziv, A; Ziv-Baran, T, 2022
)
0.72
" No fever was observed following the BNT162b2 vaccine in seronegative patients, and the frequency of musculoskeletal adverse effects upon the second dose of the BNT162b2 vaccine was significantly higher in seropositive compared to seronegative patients and in the control group compared to the SARDs patients (p = 0."( Immunogenicity and safety of the mRNA-based BNT162b2 vaccine in systemic autoimmune rheumatic diseases patients.
Gepstein, R; Halperin, T; Kimhi, O; Kivity, S; Levy, Y; Naser, R; Parikh, R; Pri-Paz Basson, Y; Tartakover Matalon, S; Tayer-Shifman, OE; Ziv, A; Ziv-Baran, T, 2022
)
0.72
" Adverse effects of the vaccine including fever and musculoskeletal symptoms might be a signal for the acquisition of immunity in those patients."( Immunogenicity and safety of the mRNA-based BNT162b2 vaccine in systemic autoimmune rheumatic diseases patients.
Gepstein, R; Halperin, T; Kimhi, O; Kivity, S; Levy, Y; Naser, R; Parikh, R; Pri-Paz Basson, Y; Tartakover Matalon, S; Tayer-Shifman, OE; Ziv, A; Ziv-Baran, T, 2022
)
0.72
" • There is a correlation between immunogenicity and adverse effects of the vaccine."( Immunogenicity and safety of the mRNA-based BNT162b2 vaccine in systemic autoimmune rheumatic diseases patients.
Gepstein, R; Halperin, T; Kimhi, O; Kivity, S; Levy, Y; Naser, R; Parikh, R; Pri-Paz Basson, Y; Tartakover Matalon, S; Tayer-Shifman, OE; Ziv, A; Ziv-Baran, T, 2022
)
0.72
" The two groups did not differ in severe adverse events."( Efficacy and safety of methylprednisolone pulse followed by oral prednisone vs. oral prednisone alone in sarcoidosis tubulointerstitial nephritis: a randomized, open-label, controlled clinical trial.
Audard, V; Boffa, JJ; Cez, A; Daugas, E; Delahousse, M; Guerrot, D; Hanrotel, C; Krastinova, E; Mahevas, M; Pillebout, E; Rousseau, A; Valeyre, D; Verhelst, D, 2023
)
1.15
" All treated patients experienced ≥1 adverse event (AE; 32 patients [76."( Safety and efficacy of atezolizumab with rituximab and CHOP in previously untreated diffuse large B-cell lymphoma.
Burke, JM; Cheson, BD; Diefenbach, CS; Ferrari, S; Hahn, UH; Hawkes, EA; Khan, C; Lossos, IS; Musuraca, G; Nielsen, TG; Raval, A; Sellam, G; Sharman, JP; Shivhare, M; Tani, M; Vitolo, U; Younes, A; Yuen, S, 2023
)
0.91
" Overall, safety risks increased with increasing dose and/or duration, but evidence on which dose is safe was conflicting."( Efficacy, duration of use and safety of glucocorticoids: a systematic literature review informing the 2022 update of the EULAR recommendations for the management of rheumatoid arthritis.
Aletaha, D; Bergstra, SA; Caporali, R; de Souza, S; Edwards, CJ; Hyrich, KL; Kerschbaumer, A; Landewé, RBM; Pope, JE; Schoones, JW; Sepriano, A; Smolen, JS; Stamm, TA; Takeuchi, T; van der Heijde, D; Verschueren, P; Winthrop, KL, 2023
)
0.91
" No moderate/severe adverse events attributable to the vaccine were observed."( Anti-SARS-CoV-2 inactivated vaccine in patients with ANCA-associated vasculitis: Immunogenicity, safety, antibody decay and the booster dose.
Aikawa, NE; Barbas, CV; Bonfa, E; Caparbo, VF; Dagostin, MA; Fusco, SRG; Kupa, LVK; Martins, CCMF; Martins, VAO; Medeiros-Ribeiro, AC; Pasoto, SG; Pereira, RMR; Saad, CGS; Sales, LP; Shinjo, SK; Silva, CA; Yuki, EFN, 2023
)
0.91
" Here we characterise the safety of these agents in subpopulations and assess manageability of key adverse events (AEs)."( Safety Profile of Ipatasertib Plus Abiraterone vs Placebo Plus Abiraterone in Metastatic Castration-resistant Prostate Cancer.
Bracarda, S; Chen, G; Chi, KN; de Bono, J; Garcia, J; Harris, A; Hinton, H; Massard, C; Matsubara, N; Olmos, D; Sandhu, S; Sane, R; Schenkel, F; Sternberg, CN; Sweeney, C, 2023
)
0.91
" The primary outcome investigated was adverse events (AEs)."( Safety and efficacy associated with long-term low-dose glucocorticoids in rheumatoid arthritis: a systematic review and meta-analysis.
Boers, M; Boyadzhieva, Z; Buttgereit, F; Christensen, R; Da Silva, JAP; Dejaco, C; Hartman, L; Kirwan, J; Nielsen, SM; Palmowski, A; Pankow, A; Schneider, A; Wassenberg, S, 2023
)
0.91
"Hematologic toxicity (HT) is a joint adverse event after CAR-T cells infusion."( Low-dose administration of prednisone has a good effect on the treatment of prolonged hematologic toxicity post-CD19 CAR-T cell therapy.
Bai, X; Guo, R; Li, Q; Lu, W; Lyu, H; Meng, J; Pu, Y; Wang, J; Xiao, X; Yuan, T; Zhang, M; Zhao, M, 2023
)
1.21
"First-line AZA plus prednisone realizes a better hematological response and relapse-free duration with acceptable adverse events compared to prednisone alone in ANA-positive ITP patients."( Efficacy and safety of azathioprine plus prednisone versus prednisone alone as first-line treatment for antinuclear antibody-positive immune thrombocytopenia: a retrospective cohort study.
Chen, X; Dong, Z; Ma, L; Su, J; Wang, Q; Xiao, P; Xu, M, 2023
)
1.5
"No studies have examined the association between the Geriatric Nutritional Risk Index (GNRI) at the initiation of chemotherapy for malignant lymphoma and the occurrence of adverse events."( Influence of Geriatric Nutritional Risk Index on Occurrence of Adverse Events and Duration of Treatment in Patients With Lymphoma Receiving R-CHOP Therapy.
Kikuchi, K; Sato, H; Sawada, M; Souma, T; Takeda, G; Watanabe, T,
)
0.13
"To evaluate the incidence, diagnosis and treatment of immune-related adverse events (e-irAE) of checkpoint inhibition (ICI) in metastatic urothelial carcinoma (mUC) and metastatic renal cell carcinoma (mRCC)."( Endocrine immune-related adverse events in patients with metastatic renal and urothelial cancer treated with immune checkpoint-inhibitors.
Burger, M; Büttner, R; Oppolzer, IA; Riester, J; Schnabel, MJ, 2023
)
0.91
"A course of tacrolimus of more than one year was effective and well-tolerated in young children with MG, and tacrolimus improved MG symptoms and reduced the dose and adverse events of oral prednisone."( Long-term efficacy and safety of tacrolimus in young children with myasthenia gravis.
Li, W; Zhang, L; Zhang, M; Zhang, Y; Zhou, S, 2023
)
1.1
"ICIs can cause rheumatic adverse events, resulting in decreased quality of life that may require immunesuppressive treatment."( [Rheumatic adverse events due to immune checkpoint inhibitors].
Heslinga, SC; Labots, M; Lems, WF; Tsang-A-Sjoe, MWP; van Binsbergen, WH; van der Laken, J, 2023
)
0.91

Pharmacokinetics

Twenty-eight days of SJW treatment resulted in no significant alterations in the pharmacokinetic parameters for prednisone or prednisolone. The aim of the present study was to assess the safety and pharmacodynamic interactions between EBR and GZR.

ExcerptReferenceRelevance
" With increasing dose there is prolongation of the plasma half-life and increase in the volume of distribution and plasma clearance of prednisolone."( Dose dependent pharmacokinetics of prednisolone.
Downie, WW; Leatham, PA; Lowe, JR; Pickup, ME; Rhind, VM; Wright, V, 1977
)
0.26
" However, the in vitro dissolution rates were not predictive of the overall bioavailability of the prednisone tablets tested in terms of peak concentration and area under the serum concentration-time curve."( Bioavailability and pharmacokinetics of prednisone in humans.
Desante, KA; Disanto, AR, 1975
)
0.74
" Blood and urine samples were collected, and the pharmacokinetic parameters of prednisone and prednisolone were determined in each treatment period."( Effect of the anti-inflammatory agent tenidap on the pharmacokinetics and pharmacodynamics of prednisolone.
Blum, R; Garg, V; Jusko, WJ; Wilner, KD, 1992
)
0.51
" The prednisolone pharmacokinetic parameters derived demonstrated an increased total clearance (by 60%), an increased volume of distribution (by 46%), a lower peak concentration (by 35%), and no difference in elimination half-life in patients with CF compared with those with asthma."( Altered prednisolone pharmacokinetics in patients with cystic fibrosis.
Accurso, FJ; Dove, AM; Hill, MR; Jusko, WJ; Larsen, GL; Szefler, SJ, 1992
)
0.28
" Eleven blood samples were collected over 24 h for the pharmacokinetic studies on day 1 (first day of treatment) and on day Y (after the clinical evaluation)."( Pharmacokinetics of prednisone and prednisolone in bullous pemphigoid patients.
Chosidow, O; Diquet, B; Etienne, SD; Herson, S; Puech, AJ; Vandermeersch, V; Vu-Thi-My-Le, C, 1991
)
0.6
" Thirdly, due to the short half-life of prednisolone no steady-state is achieved, and therefore area under the concentration-time curve needed to be determined in all studies."( Clinical pharmacokinetics of prednisone and prednisolone.
Frey, BM; Frey, FJ, 1990
)
0.57
" All the pharmacokinetic parameters, including the conversion of prednisone to prednisolone were similar to the data already published in children with INS."( Pharmacokinetics of prednisolone in children with the nephrotic syndrome.
Alvinerie, M; Barthe, P; Bouissou, F; Houin, G; Rostin, M, 1990
)
0.52
" These findings suggest a decreased systemic availability of prednisolone after prednisolone sodium metasulfobenzoate (Solupred) administration and show, from a strictly pharmacokinetic point of view, that equimolar doses of prednisone and prednisolone sodium metasulfobenzoate are not equivalent therapies."( [Pharmacokinetic parameters of prednisone and prednisolone in healthy volunteers].
Chosidow, O; Diquet, B; Etienne, SD; Godeau, P; Herson, S; Vandermeersch, V; Vu-Thi-My-Le, C, 1990
)
0.75
" The same parasitic burden provoked only a slight decrease in the elimination half-life of methylprednisolone alcohol when its hemisuccinate ester was administered."( Comparative incidence of experimental fascioliasis on corticosteroid pharmacokinetics in sheep.
Alvinerie, M; Galtier, P; Houin, G; Toutain, PL; Tufenkji, AE, 1989
)
0.28
" For total prednisolone, the mean elimination half-life was relatively short (1."( Pharmacokinetics of prednisolone in children with acute lymphoblastic leukaemia.
Blackburn, M; Choonara, I; Lewis, I; Rayner, P; Wheeldon, J, 1989
)
0.28
" The results of the three experiments support the use of a non-linear reversible metabolism model to describe the pharmacokinetic relationship between prednisone and prednisolone."( The non-linear pharmacokinetics of prednisone and prednisolone. III. Experiments using the rabbit as an animal model.
Ferry, JJ; Wagner, JG,
)
0.61
"In order to assess the impact of demographic factors on serum levels of cyclosporine (CsA) estimated by radioimmunoassay (RIA) in renal allograft recipients, 493 pharmacokinetic studies were performed in 212 patients."( Demographic factors affecting the pharmacokinetics of cyclosporine estimated by radioimmunoassay.
Flechner, SM; Kahan, BD; Kramer, WG; Lorber, MI; Van Buren, CT; Wideman, C, 1986
)
0.27
"Three simple linear and three simple non-linear pharmacokinetic models are presented which incorporate the reversible metabolism that occurs between prednisone and prednisolone."( The non-linear pharmacokinetics of prednisone and prednisolone. I. Theoretical.
Ferry, JJ; Wagner, JG,
)
0.61
" Half-life values were similar on both occasions."( Pharmacokinetics of prednisone and its metabolite prednisolone in children with nephrotic syndrome during the active phase and in remission.
Barberis, L; Frigo, GM; Gatti, G; Martini, A; Notarangelo, LD; Perucca, E, 1984
)
0.59
"Clinical and pharmacokinetic observations suggest that azathioprine may diminish the plasma level of prednisolone."( A single dose of azathioprine does not affect the pharmacokinetics of prednisolone following oral prednisone.
Frey, BM; Frey, FJ; Guentert, T; Lozada, F, 1981
)
0.48
"The simplest three pharmacokinetic models which apply in cases of reversible metabolism are described."( Reversible metabolism and pharmacokinetics: application to prednisone-prednisolone.
Albert, KS; DiSanto, AR; Gillespie, WR; Wagner, JG, 1981
)
0.51
" Changes in prednisone half-life were insignificant, but increases in the half-life of its metabolite were dose-dependent."( Dose dependent pharmacokinetics of prednisone and prednisolone in man.
Jusko, WJ; Rose, JQ; Yurchak, AM, 1981
)
0.92
"Standard pharmacokinetic measures were performed in 35 patients beginning MTX therapy and 15 patients who had received the drug for a mean of 81 months."( Examination of pharmacokinetic variables in a cohort of patients with rheumatoid arthritis beginning therapy with methotrexate compared with a cohort receiving the drug for a mean of 81 months.
Hamilton, RA; Kremer, JM; Petrillo, GF, 1995
)
0.29
"No significant differences in area under the serum concentration versus time curve (AUC), maximal methotrexate concentration following dosing (Cmax), time to Cmax (Tmax), bioavailability (F), urinary MTX, renal clearance of MTX or creatinine clearance were observed between the 2 cohorts."( Examination of pharmacokinetic variables in a cohort of patients with rheumatoid arthritis beginning therapy with methotrexate compared with a cohort receiving the drug for a mean of 81 months.
Hamilton, RA; Kremer, JM; Petrillo, GF, 1995
)
0.29
" The mean values of half-life and apparent volume of distribution at steady-state in each group were similar."( Effects of acute and chronic inflammation on the pharmacokinetics of prednisolone in rats.
Garg, V; Hon, YY; Jusko, WJ, 1994
)
0.29
"The pharmacokinetics and the pharmacodynamic profile of subcutaneously administered recombinant human non-glycosylated interleukin-3 (rhIL-3) was studied in lymphoma patients after standard CHOP chemotherapy."( Pharmacokinetic and pharmacodynamic studies of subcutaneously administered recombinant human interleukin-3 following chemotherapy for non-Hodgkin's lymphoma.
Hovgaard, DJ; Mortensen, BT; Nissen, NI, 1995
)
0.29
" Eighteen volunteers entered the study; pharmacokinetic data were evaluable for 15 participants."( Lack of pharmacokinetic interaction after administration of lansoprazole or omeprazole with prednisone.
Cavanaugh, JH; Karol, MD, 1996
)
0.51
" Peak concentration was significantly higher with liquid prednisolone (mean +/- SD 430."( A pharmacokinetic comparison of two oral liquid glucocorticoid formulations.
Kamada, AK; LaVallee, NM; Scott, MB; Selner, JC; Szefler, SJ; Wiener, MB,
)
0.13
"In this 2-week, ascending dose study, the pharmacokinetic activity of sirolimus was examined in 40 stable renal transplant patients treated with cyclosporine and prednisone."( Pharmacokinetics of sirolimus in stable renal transplant patients after multiple oral dose administration.
Kahan, BD; Zimmerman, JJ, 1997
)
0.49
"We prospectively assessed the pharmacokinetics of methotrexate, mercaptopurine, and erythrocyte thioguanine nucleotide levels in a homogenous population of children with lower risk acute lymphoblastic leukemia and correlated pharmacokinetic parameters with disease outcome."( Pharmacokinetics and pharmacodynamics of oral methotrexate and mercaptopurine in children with lower risk acute lymphoblastic leukemia: a joint children's cancer group and pediatric oncology branch study.
Ames, MM; Balis, FM; Bleyer, WA; Ge, J; Gilchrist, GS; Holcenberg, JS; Murphy, RF; Poplack, DG; Sather, HN; Tubergen, DG; Waskerwitz, MJ; Zimm, S, 1998
)
0.3
"The pharmacokinetic and adrenal interactions of recombinant human interleukin-10 and prednisolone were examined in this open-label, randomized, four-way crossover study in 12 healthy adult male volunteers."( Pharmacokinetic and adrenal interactions of IL-10 and prednisone in healthy volunteers.
Blum, RA; Chakraborty, A; Cutler, DL; Jusko, WJ; Mis, SM, 1999
)
0.55
" This study also describes the application of the ELISA method to a pharmacokinetic study in a homogeneous group of patients with follicular lymphoma who received 4 weekly doses of MAb at the standard dose of 375 mg/m2 as consolidation of chemotherapy."( Rituximab (IDEC-C2B8): validation of a sensitive enzyme-linked immunoassay applied to a clinical pharmacokinetic study.
Arcaini, L; Astori, C; Avanzini, MA; Iacona, I; Lazzarino, M; Lunghi, F; Morra, E; Orlandi, E; Regazzi, MB; Rupolo, M; Zagonel, V, 2000
)
0.31
" The aim of this study was to compare the mycophenolic acid (MPA) pharmacokinetic profile and its pharmacodynamic effect on patients receiving either standard (2 g) or low (1."( Pharmacokinetics and pharmacodynamics of mycophenolic acid in stable renal transplant recipients treated with low doses of mycophenolate mofetil.
Brunet, M; Carrillo, M; Corbella, J; Martorell, J; Millán, O; Oppenheimer, F; Rojo, I; Vilardell, J, 2000
)
0.31
" Pharmacokinetic parameters of prednisolone as assessed by Cmax, t 1/2, AUC, or serum protein binding were not affected by prasterone."( Effects of oral prasterone (dehydroepiandrosterone) on single-dose pharmacokinetics of oral prednisone and cortisol suppression in normal women.
Blum, RA; Jusko, WJ; Meno-Tetang, GM; Schwartz, KE, 2001
)
0.53
"Although renal allograft outcome correlates more closely with area under the concentration time curve (AUC) for cyclosporin (CsA) compared with the 12-h trough level (C0), few studies have prospectively evaluated pharmacokinetic monitoring in kidney transplantation."( Can a pharmacokinetic approach to immunosuppression eliminate ethnic disparities in renal allograft outcome?
Browne, BJ; Emovon, OE; Op't Holt, C, 2002
)
0.31
" This paper describes the outcome of 32 A-A recipients of de novo renal allograft who received CsA-based triple immunotherapy according to individual pharmacokinetic profiles."( Effect of cyclosporin pharmacokinetics on renal allograft outcome in African-Americans.
Browne, BJ; Emovon, OE; Holt, CO; Howell, D; King, JA; Singleton, B, 2003
)
0.32
" Pharmacokinetic measurements revealed that FTY720 displayed linear relations of doses and concentrations over a wide range, but had no effect on CsA exposure."( Pharmacodynamics, pharmacokinetics, and safety of multiple doses of FTY720 in stable renal transplant patients: a multicenter, randomized, placebo-controlled, phase I study.
Chodoff, L; Ferguson, RM; Gonwa, TA; Kahan, BD; Karlix, JL; Leichtman, AB; Mulgaonkar, S; Schmouder, RL; Skerjanec, A, 2003
)
0.32
" The coadministration of daclizumab did not result in a pharmacokinetic interaction with MPA, the active metabolite of MMF."( Pharmacokinetics of daclizumab and mycophenolate mofetil with cyclosporine and steroids in renal transplantation.
Bumgardner, G; Gaston, RS; Kirkman, RL; Light, S; Nieforth, K; Patel, IH; Pescovitz, MD; Vincenti, F, 2003
)
0.32
" A comparison is also presented between several methods based on animal pharmacokinetic data, using the same set of proprietary compounds, and it lends further support for the use of this method, as opposed to methods that require the gathering of pharmacokinetic data in laboratory animals."( Prediction of human volume of distribution values for neutral and basic drugs. 2. Extended data set and leave-class-out statistics.
Gao, F; Lombardo, F; Obach, RS; Shalaeva, MY, 2004
)
0.32
"To characterize the pharmacokinetic behavior of oral cyclosporin (CsA) in renal transplant patient, based on through blood concentration (C0) value, and to develop and to evaluate a Bayesian method for the individualized adjustment of CsA daily dose (DD)."( [Cyclosporin pharmacokinetic modeling in renal transplant patients].
Jiménez Torres, NV; Pallardó Mateu, L; Pérez Ruixo, JJ; Porta Oltra, B,
)
0.13
" Group A (N=48) was used to characterize CsA pharmacokinetic behavior and Group B (N=19) to evaluate Bayesian predictive performance for the model developed."( [Cyclosporin pharmacokinetic modeling in renal transplant patients].
Jiménez Torres, NV; Pallardó Mateu, L; Pérez Ruixo, JJ; Porta Oltra, B,
)
0.13
" In the final model, the Dmax parameter is affected by plasmatic urea values and shows a half-life stabilization time of 90."( [Cyclosporin pharmacokinetic modeling in renal transplant patients].
Jiménez Torres, NV; Pallardó Mateu, L; Pérez Ruixo, JJ; Porta Oltra, B,
)
0.13
"The characterization of the pharmacokinetic behavior of CsA requires us to consider parameters such as Dmax and Km as non lineal functions of time, while the first order autoregressive terms DD and C0 must also be incorporated into the model."( [Cyclosporin pharmacokinetic modeling in renal transplant patients].
Jiménez Torres, NV; Pallardó Mateu, L; Pérez Ruixo, JJ; Porta Oltra, B,
)
0.13
" We compared three groups of children according to the growth kinetics during the study year (catch-up, stable, or decline) for clinical and pharmacokinetic parameters."( Glucocorticoid pharmacokinetics and growth retardation in children with renal transplants.
Bresson, JL; Broyer, M; Chavatte, C; Gimenez, F; Guest, G; Hankard, R; Le Bihan, C; Loirat, C; Maisin, A; Mogenet, A; Niaudet, P; Proust, V; Singlas, E, 2004
)
0.32
"Complete pharmacokinetics and pharmacodynamic analysis was determined in 19 patients during 38 cycles of chemotherapy: 19 cycles with CHOP and 19 CHOP + HAART in a crossover-designed study."( Effect of highly active antiretroviral therapy (HAART) on pharmacokinetics and pharmacodynamics of doxorubicin in patients with HIV-associated non-Hodgkin's lymphoma.
Boiocchi, M; Cattarossi, G; Corona, G; Di Gennaro, G; Tirelli, U; Toffoli, G; Vaccher, E, 2004
)
0.32
" Therefore, pharmacodynamic interactions between HAART and DOX should be considered."( Effect of highly active antiretroviral therapy (HAART) on pharmacokinetics and pharmacodynamics of doxorubicin in patients with HIV-associated non-Hodgkin's lymphoma.
Boiocchi, M; Cattarossi, G; Corona, G; Di Gennaro, G; Tirelli, U; Toffoli, G; Vaccher, E, 2004
)
0.32
"Human pharmacokinetic parameters are often predicted prior to clinical study from in vivo preclinical pharmacokinetic data."( Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
Jolivette, LJ; Ward, KW, 2005
)
0.33
" The purpose of this study was to detect interpatient pharmacokinetic variability of tacrolimus and to assess the predictability of individual tacrolimus concentrations at various times for the area under the curve (AUC) seeking to find the best sampling time for an abbreviated AUC to predict the total body exposure of tacrolimus after the first oral dose in Chinese renal transplantation recipients."( Clinical pharmacokinetics of tacrolimus after the first oral administration in combination with mycophenolate mofetil and prednisone in Chinese renal transplant recipients.
Chen, LZ; Chen, YH; Dai, YP; Fei, JG; Li, J; Qiu, J; Zheng, KL, 2005
)
0.54
"5, and 3 hours as an abbreviated AUC were as good as a full pharmacokinetic study (r = ."( Clinical pharmacokinetics of tacrolimus after the first oral administration in combination with mycophenolate mofetil and prednisone in Chinese renal transplant recipients.
Chen, LZ; Chen, YH; Dai, YP; Fei, JG; Li, J; Qiu, J; Zheng, KL, 2005
)
0.54
" Therefore, we tested the pharmacokinetic profile of microemulsion CsA as a superior approach to guide clinical immunosuppression after de novo simultaneous pancreas-kidney transplantations."( Pharmacokinetic profiling of cyclosporine microemulsion during the first 3 weeks after simultaneous pancreas-kidney transplantation.
Drewelow, B; Gock, M; Klar, E; Kundt, G; Schareck, W; Wacke, R, 2006
)
0.33
" Based on literature datasets, a linear two-compartment pharmacokinetic model was developed to adequately describe the reversible metabolism between free prednisone and prednisolone."( A pharmacokinetic/pharmacodynamic approach to predict total prednisolone concentrations in human plasma.
Derendorf, H; Winkler, J; Xu, J, 2007
)
0.54
"Three plasma samples and a 24-hour urine collection for day 1 of the first three cycles of chemotherapy were analysed in 30 patients, and the pharmacokinetic parameters of the respective drugs were estimated by population pharmacokinetic methods (nonlinear mixed-effects model [NONMEM] software)."( Population pharmacokinetics of the BEACOPP polychemotherapy regimen in Hodgkin's lymphoma and its effect on myelotoxicity.
Busse, D; Diehl, V; Engert, A; Fuhr, U; Hempel, G; Jaehde, U; Jetter, A; Josting, A; Kasel, D; Klimm, B; Merkel, U; Reif, S; Rietbrock, S; Schwab, M; Wilde, S, 2007
)
0.34
"The pharmacokinetic parameters and respective covariates were similar to the published data."( Population pharmacokinetics of the BEACOPP polychemotherapy regimen in Hodgkin's lymphoma and its effect on myelotoxicity.
Busse, D; Diehl, V; Engert, A; Fuhr, U; Hempel, G; Jaehde, U; Jetter, A; Josting, A; Kasel, D; Klimm, B; Merkel, U; Reif, S; Rietbrock, S; Schwab, M; Wilde, S, 2007
)
0.34
" Antibiotic peak concentration in blood decreased by 55%, doxorubicin circulated several times longer, and the area under the concentration-time curve increased 5 times if compared with standard doxorubicin administration."( Doxorubicin pharmacokinetics in lymphoma patients treated with doxorubicin-loaded eythrocytes.
Ataullakhanov, FI; Galkina, NM; Kulikova, EV; Medvedev, PV; Pivnik, AV; Skorokhod, O; Vitvitsky, VM; Zybunova, EE, 2007
)
0.34
"Twenty-eight days of SJW treatment resulted in no significant alterations in the pharmacokinetic parameters for prednisone or prednisolone."( Lack of pharmacokinetic interaction between St. John's wort and prednisone.
Bell, EC; Chan, HM; Lin, YJ; Ravis, WR, 2007
)
0.79
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
"This study was conducted to evaluate time-dependent pharmacokinetic changes and drug interactions over the first 6 months after transplantation in kidney transplant recipients receiving tacrolimus (TAC), prednisone (PRED) and mycophenolate mofetil (MMF) or sirolimus (SRL)."( Tacrolimus pharmacokinetic drug interactions: effect of prednisone, mycophenolic acid or sirolimus.
Casarini, DE; Felipe, CR; Fernandes, FB; Garcia, R; Medina-Pestana, JO; Park, SI; Pinheiro-Machado, PG; Tedesco-Silva, H, 2009
)
0.79
" Mycophenolic acid area under the time concentration curve from 0 to 12 hours and apparent mycophenolic acid plasma clearance (CL/f) were measured for each patient."( Influence of renal graft function on mycophenolic acid pharmacokinetics during the early period after kidney transplant.
Abtahi, B; Mohammadpur, AH; Naghibi, M; Nazemian, F, 2008
)
0.35
"Mycophenolic acid area under the time-concentration curve (0-12 h), mycophenolic acid area under the time-concentration curve (6-10 h), first peak concentration (Cmax1), and secondary peak concentration (Cmax2) were higher in the impaired group, while mycophenolic acid plasma clearance was higher in the control group (P < ."( Influence of renal graft function on mycophenolic acid pharmacokinetics during the early period after kidney transplant.
Abtahi, B; Mohammadpur, AH; Naghibi, M; Nazemian, F, 2008
)
0.35
" We carried out a pilot pharmacokinetic study in 10 patients with B-cell non-Hodgkin lymphoma treated with rituximab associated with chemotherapy on a three-weekly basis."( Pharmacokinetics of rituximab associated with CHOP chemotherapy in B-cell non-Hodgkin lymphoma.
Blasco, H; Chatelut, E; Congy-Jolivet, N; de Bretagne, IB; Le Guellec, C, 2009
)
0.35
"To determine the pharmacokinetic (PK) profile of manganese (Mn) after a 2-hour intravenous infusion of mangafodipir at 5 micromol/kg body weight and to correlate Mn concentrations with oxidative stress, early decrease in serum total bilirubin concentration, and prothrombin time (PT) in chronic alcoholic patients with acute alcoholic hepatitis."( Pharmacokinetic-pharmacodynamic modeling of manganese after a single intravenous infusion of mangafodipir in patients with acute alcoholic hepatitis.
Batteux, F; Debray, M; Hirt, D; Laurent, A; Pavlovic, S; Poupon, J; Richardet, JP; Sogni, P; Treluyer, JM; Urien, S; Weill, B, 2009
)
0.35
" The elimination half-life at steady state of rituximab in all patients was estimated to be 19."( Pharmacokinetics of rituximab in patients with CD20 positive B-cell malignancies.
Aarden, L; Baars, JW; Beijnen, JH; Huitema, AD; Tran, L, 2010
)
0.36
" The pharmacokinetic comparability of Prolastin-C to Prolastin was assessed in subjects with AAT deficiency."( Pharmacokinetic comparability of Prolastin®-C to Prolastin® in alpha₁-antitrypsin deficiency: a randomized study.
Brantly, ML; Campos, MA; Chapman, KR; Kueppers, F; Sandhaus, RA; Stocks, JM; Strange, C; Turino, G; Wang-Smith, L, 2010
)
0.36
" Pharmacokinetic plasma samples were drawn over 7 days following last dose in the first treatment period and over 10 days following the last dose in the second period."( Pharmacokinetic comparability of Prolastin®-C to Prolastin® in alpha₁-antitrypsin deficiency: a randomized study.
Brantly, ML; Campos, MA; Chapman, KR; Kueppers, F; Sandhaus, RA; Stocks, JM; Strange, C; Turino, G; Wang-Smith, L, 2010
)
0.36
"09, demonstrating pharmacokinetic equivalence between the 2 products."( Pharmacokinetic comparability of Prolastin®-C to Prolastin® in alpha₁-antitrypsin deficiency: a randomized study.
Brantly, ML; Campos, MA; Chapman, KR; Kueppers, F; Sandhaus, RA; Stocks, JM; Strange, C; Turino, G; Wang-Smith, L, 2010
)
0.36
"Prolastin-C demonstrated pharmacokinetic equivalence and a comparable safety profile to Prolastin."( Pharmacokinetic comparability of Prolastin®-C to Prolastin® in alpha₁-antitrypsin deficiency: a randomized study.
Brantly, ML; Campos, MA; Chapman, KR; Kueppers, F; Sandhaus, RA; Stocks, JM; Strange, C; Turino, G; Wang-Smith, L, 2010
)
0.36
" At 3 days, there was a strong correlation between AUC0-24 and Cmin both for tacrolimus QD (r=."( Pharmacokinetics of once- versus twice-daily tacrolimus formulations in kidney transplant patients receiving expanded criteria deceased donor organs: a single-center, randomized study.
Burgos, D; Cabello, M; Díez de los Rios, MJ; García, P; García-Sáiz, M; González-Molina, M; Gutiérrez, C; Hernández, D; López, V; Sola, E, 2010
)
0.36
"The pharmacokinetic study of EC-MPS was conducted in 11 de novo kidney transplant patients of Hispanic ethnicity."( The pharmacokinetics of enteric-coated mycophenolate sodium and its gastrointestinal side effects in de novo renal transplant recipients of Hispanic ethnicity.
Hutchinson, I; Min, DI; Qazi, Y; Shah, T; Tellez-Corrales, E; Wang, J; Wilson, J; Yang, JW, 2011
)
0.37
" The mean daily dose of EC-MPS at the time of the pharmacokinetic study was 1408 ± 108 mg."( The pharmacokinetics of enteric-coated mycophenolate sodium and its gastrointestinal side effects in de novo renal transplant recipients of Hispanic ethnicity.
Hutchinson, I; Min, DI; Qazi, Y; Shah, T; Tellez-Corrales, E; Wang, J; Wilson, J; Yang, JW, 2011
)
0.37
" The MPA exposure expressed by the AUC appears to be higher in Hispanic patients than those reported in other ethnic groups, which may be the result of various factors such as difference of the uridine diphosphate glucuronosyltransferase enzyme genotypes, but gastrointestinal side effects were acceptable and the Cmax or AUC of MPAG showed correlations with gastrointestinal symptoms."( The pharmacokinetics of enteric-coated mycophenolate sodium and its gastrointestinal side effects in de novo renal transplant recipients of Hispanic ethnicity.
Hutchinson, I; Min, DI; Qazi, Y; Shah, T; Tellez-Corrales, E; Wang, J; Wilson, J; Yang, JW, 2011
)
0.37
"To investigate the pharmacodynamic and pharmacokinetic parameters of pegylated liposomal doxorubicin (PLD) combined with cyclophosphamide, vincristine, and prednisolone in patients with peripheral T-cell lymphomas (PTCL)."( Pharmacodynamic and pharmacokinetic study of pegylated liposomal doxorubicin combination (CCOP) chemotherapy in patients with peripheral T-cell lymphomas.
Fan, Y; Fang, L; Huang, ZY; Lin, NM; Luo, LH; Wu, FQ; Yu, HF, 2011
)
0.37
" The pharmacokinetics (PKs) software was used to estimate the pharmacokinetic parameters of PLD."( Pharmacodynamic and pharmacokinetic study of pegylated liposomal doxorubicin combination (CCOP) chemotherapy in patients with peripheral T-cell lymphomas.
Fan, Y; Fang, L; Huang, ZY; Lin, NM; Luo, LH; Wu, FQ; Yu, HF, 2011
)
0.37
" The pharmacokinetic parameters AUC(0-∞), CL, t(1/2), and V(d) were 910."( Pharmacodynamic and pharmacokinetic study of pegylated liposomal doxorubicin combination (CCOP) chemotherapy in patients with peripheral T-cell lymphomas.
Fan, Y; Fang, L; Huang, ZY; Lin, NM; Luo, LH; Wu, FQ; Yu, HF, 2011
)
0.37
" The results of the pharmacokinetic parameters showed that PLD had long retention time in blood circulation."( Pharmacodynamic and pharmacokinetic study of pegylated liposomal doxorubicin combination (CCOP) chemotherapy in patients with peripheral T-cell lymphomas.
Fan, Y; Fang, L; Huang, ZY; Lin, NM; Luo, LH; Wu, FQ; Yu, HF, 2011
)
0.37
"The purpose of this study was to characterize the pharmacokinetic (PK) properties of prednisolone, the metabolite of the prodrug prednisone, in cSLE patients and explore the relationship between PK properties and cSLE disease activity."( Pharmacokinetics of prednisolone at steady state in young patients with systemic lupus erythematosus on prednisone therapy: an open-label, single-dose study.
Brunner, HI; Rieder, MJ; Sagcal-Gironella, AC; Sherwin, CM; Tirona, RG; Vinks, AA, 2011
)
0.79
" Population pharmacokinetic modeling was performed with nonlinear mixed-effect modeling software (NONMEM VI)."( The role of sex and weight on rituximab clearance and serum elimination half-life in elderly patients with DLBCL.
Held, G; Lengfelder, E; Metzner, B; Müller, C; Murawski, N; Nickenig, C; Peter, N; Pfreundschuh, M; Poeschel, V; Reiser, M; Rixecker, T; Wenger, M; Wiesen, MH; Zeynalova, S; Zwick, C, 2012
)
0.38
" Neutropenia in cycle 1 may be a pharmacodynamic marker for docetaxel, which may enable tailored dosing in metastatic castration-resistant prostate cancer (mCRPC)."( Neutropenia as a potential pharmacodynamic marker for docetaxel-based chemotherapy in men with metastatic castration-resistant prostate cancer.
Berry, WR; Galsky, MD; Leopold, L; Pond, GR; Sonpavde, G; Wood, BA, 2012
)
0.38
"For patients with mCRPC who received docetaxel, ≥grade 3 neutropenia on day 8 was prognostic for improved OS, which suggests its utility as a pharmacodynamic marker, in this hypothesis-generating analysis."( Neutropenia as a potential pharmacodynamic marker for docetaxel-based chemotherapy in men with metastatic castration-resistant prostate cancer.
Berry, WR; Galsky, MD; Leopold, L; Pond, GR; Sonpavde, G; Wood, BA, 2012
)
0.38
" Altered organ function, changing biochemistry and use of a number of concomitant medicines in transplantation appear to lead to pharmacokinetic differences in transplant recipients compared with other patient groups."( Clinical pharmacokinetics and pharmacodynamics of prednisolone and prednisone in solid organ transplantation.
Barraclough, KA; Bergmann, TK; Lee, KJ; Staatz, CE, 2012
)
0.62
" There was no substantial difference in pharmacokinetic parameters of the formulations apart from the programmed delay in release of glucocorticoid from the modified-release tablets (C(max) 97%, AUC(0-∞) 101%, 90% confidence intervals within the requisite range for bioequivalence)."( Pharmacokinetics of modified-release prednisone tablets in healthy subjects and patients with rheumatoid arthritis.
Clarke, L; Derendorf, H; Kirwan, JR; Ruebsamen, K; Schaeffler, A, 2013
)
0.66
" The aims of this study were to evaluate the correlation between free serum and salivary PLN levels and to quantify this relationship within a population pharmacokinetic model."( Monitoring prednisolone and prednisone in saliva: a population pharmacokinetic approach in healthy volunteers.
Ackermans, MT; Freijer, J; Guan, Z; Kist-van Holthe, JE; Nauta, J; Ruiter, AF; Teeninga, N; van Gelder, T, 2013
)
0.68
" Population pharmacokinetic analysis was performed with nonlinear mixed effect modeling using NONMEM."( Monitoring prednisolone and prednisone in saliva: a population pharmacokinetic approach in healthy volunteers.
Ackermans, MT; Freijer, J; Guan, Z; Kist-van Holthe, JE; Nauta, J; Ruiter, AF; Teeninga, N; van Gelder, T, 2013
)
0.68
"This study is the first to describe the relationship between salivary and (free) serum PLN using a population pharmacokinetic model."( Monitoring prednisolone and prednisone in saliva: a population pharmacokinetic approach in healthy volunteers.
Ackermans, MT; Freijer, J; Guan, Z; Kist-van Holthe, JE; Nauta, J; Ruiter, AF; Teeninga, N; van Gelder, T, 2013
)
0.68
" Pharmacokinetic parameters were determined using noncompartmental methods and geometric least-square mean ratios, and 90% confidence intervals were generated."( Effect of prednisone on the pharmacokinetics of the integrase inhibitor dolutegravir.
Borland, J; Chen, S; Peppercorn, AF; Piscitelli, S; Savina, P; Song, IH, 2013
)
0.79
"Cyclosporine exhibits pharmacokinetic and pharmacodynamic variability in renal transplant recipients (RTR) attributed to P-glycoprotein (P-gp), an ABCB1 efflux transporter that influences bioavailability and intracellular distribution."( Sex differences in cyclosporine pharmacokinetics and ABCB1 gene expression in mononuclear blood cells in African American and Caucasian renal transplant recipients.
Brazeau, D; Danison, R; DiFrancesco, R; Dole, K; Gillis, K; Gundroo, A; Leca, N; Tornatore, KM; Venuto, RC; Wilding, G; Zack, J, 2013
)
0.39
" Our objective was to evaluate the influence of the sources of infliximab pharmacokinetic variability in RA."( Relationship between inflammation and infliximab pharmacokinetics in rheumatoid arthritis.
Corondan, A; Devauchelle-Pensec, V; Ducourau, E; Goupille, P; Le Goff, B; Mulleman, D; Paintaud, G; Perdriger, A; Solau-Gervais, E; Ternant, D; Watier, H, 2014
)
0.4
" Infliximab concentrations were described using a two-compartment population pharmacokinetic model."( Relationship between inflammation and infliximab pharmacokinetics in rheumatoid arthritis.
Corondan, A; Devauchelle-Pensec, V; Ducourau, E; Goupille, P; Le Goff, B; Mulleman, D; Paintaud, G; Perdriger, A; Solau-Gervais, E; Ternant, D; Watier, H, 2014
)
0.4
" Pharmacokinetic parameters of prednisone or its pharmacologically active metabolite, prednisolone, are not well characterized in transplant recipients."( Pharmacokinetics of total and unbound prednisone and prednisolone in stable kidney transplant recipients with diabetes mellitus.
Akhlaghi, F; Gohh, RY; Ionita, IA; Ogasawara, K, 2014
)
0.96
" This review summarizes its efficacy and toxicity, and focuses on the pharmacokinetic features of vincristine that affect clinical outcomes."( Pharmacokinetic evaluation of vincristine for the treatment of lymphoid malignancies.
Said, R; Tsimberidou, AM, 2014
)
0.4
" A physiologically-based pharmacokinetic (PBPK) model was also built."( Prednisone has no effect on the pharmacokinetics of CYP3A4 metabolized drugs - midazolam and odanacatib.
Ballard, J; Evers, R; Gibson, CR; Hreniuk, D; Kassahun, K; Liu, C; Mahon, C; Marcantonio, EE; Mehta, A; Morris, D; Mostoller, K; Palamanda, J; Stoch, SA; Tang, C; Wagner, JA; Zajic, S, 2014
)
1.85
" Population pharmacokinetic parameters were estimated by the NLME software."( [SLCO1B1c. 521T>C gene polymorphisms are associated with high-dose methotrexate pharmacokinetics and clinical outcome of pediatric acute lymphoblastic leukemia].
Chen, Y; Gao, P; He, X; Li, J; Niu, C; Wang, C; Wang, Y; Zhang, H, 2014
)
0.4
" Pharmacokinetic sampling was performed at pre-dose, post-infusion, 24, 48 h, 7 and 21 days."( Population pharmacokinetics of Reditux™, a biosimilar Rituximab, in diffuse large B-cell lymphoma.
Gota, V; Karanam, A; Menon, H; Nair, R; Rath, S; Sengar, M; Subramanian, P; Tembhare, P; Yadav, A, 2016
)
0.43
"The pharmacokinetic profile and B-cell response to Reditux™ are comparable with those reported for MabThera™."( Population pharmacokinetics of Reditux™, a biosimilar Rituximab, in diffuse large B-cell lymphoma.
Gota, V; Karanam, A; Menon, H; Nair, R; Rath, S; Sengar, M; Subramanian, P; Tembhare, P; Yadav, A, 2016
)
0.43
" This study was conducted to characterize the safety and pharmacodynamic (PD) dose-response of a 7-day course of oral prednisone on biomarkers of GC receptor agonism."( Safety and pharmacodynamic dose response of short-term prednisone in healthy adult subjects: a dose ranging, randomized, placebo-controlled, crossover study.
Daniel, S; Fleishaker, DL; Mukherjee, A; Whaley, FS; Zeiher, BG, 2016
)
0.89
" In addition, Cmax was associated with a progression-free survival advantage."( Bortezomib pharmacokinetics in tumor response and peripheral neuropathy in multiple myeloma patients receiving bortezomib-containing therapy.
Choi, K; Han, S; Hong, T; Lee, J; Lee, SE; Min, CK; Park, GJ; Yim, DS, 2017
)
0.46
" The aim of the present study was to assess the safety and pharmacokinetic interactions between EBR and GZR and single doses of cyclosporine, tacrolimus, mycophenolate mofetil (MMF), and prednisone."( Pharmacokinetic Interactions Between Elbasvir/Grazoprevir and Immunosuppressant Drugs in Healthy Volunteers.
Butterton, JR; Caro, L; Fandozzi, CM; Feng, HP; Guo, Z; Iwamoto, M; Panebianco, D; Talaty, J; Wolford, D; Yeh, WW, 2018
)
0.67
" Prednisone and its metabolite, prednisolone, steady-state noncompartmental pharmacokinetic parameters were estimated."( Prednisone Pharmacokinetics During Pregnancy and Lactation.
Ahmed, MS; Bennett, B; Caritis, SN; Clark, S; Easterling, TR; Hays, K; Hebert, MF; Honaker, MT; Kantrowitz-Gordon, I; Ryu, RJ; Shen, DD; Thummel, KE; Umans, JG; Venkataramanan, R, 2018
)
2.83
" To take advantage of the predictive power of machine learning and the explanatory power of pharmacokinetics, we propose a latent variable mixture model for learning clusters of pharmacokinetic models demonstrated on a clinical data set investigating 11β-hydroxysteroid dehydrogenase enzymes (11β-HSD) activity in healthy adults."( Learning pharmacokinetic models for in vivo glucocorticoid activation.
Arlt, W; Bunte, K; Chappell, MJ; Hassan-Smith, ZK; Smith, DJ; Tiňo, P; Tomlinson, JW, 2018
)
0.48
" Pharmacokinetic evaluation was performed at two consecutive visits at least 4 weeks apart."( Inter- and intra-patient variability in pharmacokinetics of abiraterone acetate in metastatic prostate cancer.
Arasaratnam, M; Bhatnagar, A; Crumbaker, M; Gurney, H; McKay, MJ; Molloy, MP, 2019
)
0.51
" Serial blood samples for pharmacokinetic analysis were collected on C1D7 and C2D8."( Pharmacokinetics, Safety, and Antitumor Effect of Apalutamide with Abiraterone Acetate plus Prednisone in Metastatic Castration-Resistant Prostate Cancer: Phase Ib Study.
Abrams, C; Attard, G; Chi, KN; Chien, C; de Jonge, MJA; de Wit, R; Friedlander, TW; Hellemans, P; Jiao, JJ; Posadas, EM; Saad, F; Yu, MK, 2020
)
0.78
" No clinically significant pharmacokinetic interaction was observed between abiraterone and apalutamide; however, apalutamide decreased exposure to prednisone."( Pharmacokinetics, Safety, and Antitumor Effect of Apalutamide with Abiraterone Acetate plus Prednisone in Metastatic Castration-Resistant Prostate Cancer: Phase Ib Study.
Abrams, C; Attard, G; Chi, KN; Chien, C; de Jonge, MJA; de Wit, R; Friedlander, TW; Hellemans, P; Jiao, JJ; Posadas, EM; Saad, F; Yu, MK, 2020
)
0.98
"Mycophenolic acid (MPA) is an effective oral immunosuppressive drug used to treat lupus nephritis (LN), which exhibits large pharmacokinetic variability."( Population pharmacokinetics of mycophenolic acid in Mexican patients with lupus nephritis.
Abud-Mendoza, C; Martínez-Martínez, MU; Medellín-Garibay, SE; Milán-Segovia, RDC; Reséndiz-Galván, JE; Romano-Aguilar, M; Romano-Moreno, S, 2020
)
0.56
"This is the first MPA population pharmacokinetic model to have found that co-administration of prednisone results in a considerable increase on clearance."( Population pharmacokinetics of mycophenolic acid in Mexican patients with lupus nephritis.
Abud-Mendoza, C; Martínez-Martínez, MU; Medellín-Garibay, SE; Milán-Segovia, RDC; Reséndiz-Galván, JE; Romano-Aguilar, M; Romano-Moreno, S, 2020
)
0.78
"A human mechanistic physiology-based pharmacokinetic (PBPK) model of vincristine following intravenous dosing was developed to predict potential DDI interactions with combination therapy."( Mechanistic physiology-based pharmacokinetic modeling to elucidate vincristine-induced peripheral neuropathy following treatment with novel kinase inhibitors.
Chen, B; Fretland, AJ; McGinnity, DF; Pilla Reddy, V; Sharma, S; Vishwanathan, K; Ware, JA; Xu, Y; Zhou, D, 2021
)
0.62
" The physiologically based pharmacokinetic (PBPK) modeling is a well-established method that permits extrapolation from adult to juvenile populations."( Application of a physiologically based pharmacokinetic model in predicting captopril disposition in children with chronic kidney disease.
Ahmad, T; Alqahtani, F; Alqahtani, NS; Alshammari, FA; Imran, I; Khalid, S; Masood, I; Rasool, MF; Saeed, H, 2023
)
0.91

Compound-Compound Interactions

Prednisone in combination with an antibiotic can effectively relieve pain and voiding symptoms, improve QOL and reduce WBC in the EPS of CNP patients, and therefore well deserves to be recommended in clinical application.

ExcerptReferenceRelevance
"The patients were randomly assigned to a regimen of cyclophosphamide, vincristine, prednisone, and doxorubicin or to this regimen combined with recombinant interferon alfa."( Interferon alfa combined with cytotoxic chemotherapy for patients with non-Hodgkin's lymphoma.
Andersen, JW; Bhide, V; Borden, EC; Hawkins, MJ; O'Connell, MJ; Oken, MM; Smalley, RV, 1992
)
0.51
" All other disease stages will require a different strategy that should consist of radiotherapy combined with short-term effective regimens, such as ABVD (doxorubicin, bleomycin, vinblastine and decarbazine) or VBM (vinblastine, bleomycin and methotrexate) to reduce the incidence of MOPP-associated gonadal dysfunction and leukaemogenesis."( Early stage Hodgkin's disease: ten-year results of a non-randomised study with radiotherapy alone or combined with MOPP.
Banfi, A; Bonadonna, G; Bonfante, V; Devizzi, L; Santoro, A; Tesoro Tess, JD; Valagussa, P; Viviani, S; Zanini, M; Zucali, R, 1992
)
0.28
" A randomized double-blind study evaluated a polyethylene glycol (PEG) conjugate L-asparaginase combined with chemotherapy (vincristine, cyclophosphamide, doxorubicin, and prednisone)."( Evaluation of L-asparaginase: polyethylene glycol conjugate versus native L-asparaginase combined with chemotherapy. A randomized double-blind study in canine lymphoma.
Fox, LE; Kurzman, ID; Loar, AS; MacEwen, EG; Rosenthal, RC,
)
0.33
" Therapy should be given with a great deal of caution in patients with decompensated liver disease, as one may precipitate the untimely demise of the patient even though viral replication is decreased."( Alpha-interferon combined with immunomodulation in the treatment of chronic hepatitis B.
Peters, M, 1991
)
0.28
" We have characterized PCN or macrolides induced cytochromes P-450 by their specific ability to interact with macrolide derivatives and, using the cytochrome P-450 spectral binding assays, we have shown that some compounds, implicated in drug interaction with macrolides, interact preferentially with the same cytochromes."( Specific drug binding to rat liver cytochrome P-450 isozymes induced by pregnenolone-16 alpha-carbonitrile and macrolide antibiotics. Implications for drug interactions.
Delaforge, M; Sartori, E, 1990
)
0.28
"Five responses (lung metastases, three; lymph node metastases, two) were observed in 23 patients with metastatic renal cell carcinoma who received recombinant interferon-alpha-2A (IFN) 18 X 10(6) U in three intramuscular doses each week combined with oral prednisone (10 to 20 mg daily)."( Recombinant interferon-alpha combined with prednisone in metastatic renal cell carcinoma. Reduced toxicity without reduction of the response rate--a phase II study.
Fosså, SD; Gunderson, R; Moe, B, 1990
)
0.72
" It is noteworthy that in all subsets, ABVD (Adriamycin + bleomycin + vinblastine + dacarbazine), either combined with irradiation or alternated with MOPP (mechlorethamine + vincristine + procarbazine + prednisone), yielded superior results compared with MOPP with or without irradiation."( Prognosis of bulky Hodgkin's disease treated with chemotherapy alone or combined with radiotherapy.
Bonadonna, G; Santoro, A; Valagussa, P, 1985
)
0.46
" There was little evidence that either form of treatment was superior in prolonging survival, for in one study the patients treated with a drug combination lived significantly longer than those treated with MP, while in another the reverse was true, and there was no difference in the survival of the two groups in the remaining 11 studies."( Melphalan/prednisone versus drug combinations for plasma cell myeloma.
Bergsagel, DE, 1989
)
0.68
"Primary brain lymphomas are usually treated with surgery in combination with radiotherapy, whereas only a few cases have been treated with chemotherapy."( Primary brain malignant non-Hodgkin lymphoma: report of a case treated with chemotherapy in combination with radiotherapy.
Büchi, G; Ferrari, G; Geda, C; Grosso, E; Termine, G, 1986
)
0.27
"From 1976 to 1981, 335 patients with untreated Hodgkin's disease, clinical stages I, II, and IIIA, have been treated by MOPP (nitrogen mustard, vincristine, procarbazine, prednisone) chemotherapy, three to six cycles according to the prognostic factors, combined with radiotherapy."( Extended versus involved fields irradiation combined with MOPP chemotherapy in early clinical stages of Hodgkin's disease.
Audebert, A; Bernadou, A; Diebold, J; Eghbali, H; Hoerni, B; Krulik, M; Merle-Béral, H; Parlier, Y; Rojouan, J; Zittoun, R, 1985
)
0.46
"One hundred recipients of first cadaveric kidney transplants were treated with three different immunosuppressive regimens: (1) conventional immunosuppression, (2) CsA alone, and (3) low-dose CsA in combination with low-dose prednisone, with rapid adjustment to give CsA whole blood trough levels of 300 to 800 ng/mL."( Cyclosporine alone or in combination with prednisone in cadaveric renal transplantation.
Brünisholz, M; Brunner, F; Follat, F; Harder, F; Landmann, J; Loertscher, R; Mihatsch, M; Thiel, G; Wenk, M, 1984
)
0.72
"One hundred and seventy-nine previously treated children with acute lymphoblastic leukemia in relapse considered not "resistant" to vincristine (VCR) were randomly allocated to receive reinduction therapy with either vindesine (VND) or VCR, in combination with prednisone and L-asparaginase."( Comparison of the therapeutic response of patients with childhood acute lymphoblastic leukemia in relapse to vindesine versus vincristine in combination with prednisone and L-asparaginase: a phase III trial.
Anderson, J; Chard, R; Chilcote, R; Hammond, D; Krivit, W; Pyesmany, A,
)
0.51
"20 patients with myasthenia gravis (MG), refractory to anticholinesterase and steroid therapy, underwent plasma exchange therapy combined with immunosuppressive drugs and lymphocytapheresis."( Plasma exchange combined with cytotoxic drugs and lymphocytapheresis for myasthenia gravis.
Cornelio, F; Forlani, G; Garelli, S; Pelucchetti, D; Valbonesi, M; Zerbi, D, 1982
)
0.26
"In a twelve-month period, 56 consecutive patients with acute leukemia, aged 15-50, were treated by administration of a 10-day continuous infusion of Ara-C in combination with adriamycin, oncovin and prednisone (10 day ADOAP)."( Adriamycin combined with 10-day Ara-C, vincristine, and prednisone (10-day ADOAP) in the treatment of adult acute leukemia patients under fifty years of age. A Southwest Oncology Group Study.
Amare, M; Morrison, FS; Oishi, N; Pendleton, O; Saiki, JH; Schreiter, SL; Stuckey, WJ; Vial, R, 1982
)
0.7
"In an 18-month period, 340 consecutive adult patients with acute leukemia were treated using a 7-day continuous infusion of Ara-C in combination with rubidazone, vincristine and prednisone (ROAP)."( Rubidazone in combination with Ara-C, vincristine and prednisone (ROAP) in the treatment of adult acute leukemia. A Southwest Oncology Group Study.
Amare, M; Balcerzak, S; Benjamin, R; Costanzi, JJ; Hussein, K; Morrison, FS; Pendleton, OJ; Ryan, DH, 1982
)
0.71
"The clinical efficacy of COP-BLAM chemotherapy combined with human recombinant granulocyte colony-stimulating factor (G-CSF) was evaluated in 104 previously untreated patients with non-Hodgkin's lymphoma (NHL)."( COP-BLAM regimen combined with granulocyte colony-stimulating factor and high-grade non-Hodgkin's lymphoma.
Niitsu, N; Umeda, M, 1995
)
0.29
" This pilot study examines the effect of donor bone marrow (DBM) infusion and antithymocyte serum (ATS) in combination with immunosuppressive drug therapy in prolonging renal allograft survival in dogs."( Renal allograft survival in outbred mongrel dogs using rabbit anti-dog thymocyte serum in combination with immunosuppressive drug therapy with or without donor bone marrow.
Atilola, M; Binnington, AG; Holmberg, DL; Johnston, K; Mathews, KA; Maxie, G; Miller, CM; Smith, G,
)
0.13
"18 patients with acute promyelocytic leukemia (APL) were treated with HATP (Harringtonine, Adriamycin, Thioguanine, Prednisone) chemotherapy combined with chinese traditional medications."( [HATP chemotherapy combined with Chinese traditional medications in treating acute promyelocytic leukemia].
Guo, AX; Huang, SL; Wang, QE, 1993
)
0.5
"Three hundred thirty-five previously untreated patients with multiple myeloma in clinical stages II and III entered a randomized trial comparing intermittent oral melphalan and prednisone (MP) therapy (n = 171) with MP in combination with natural (leukocyte-derived) alpha-interferon (MP/IFN) (n = 164)."( Natural interferon-alpha in combination with melphalan/prednisone versus melphalan/prednisone in the treatment of multiple myeloma stages II and III: a randomized study from the Myeloma Group of Central Sweden.
Björeman, M; Björkholm, M; Brenning, G; Carlson, K; Celsing, F; Gahrton, G; Grimfors, G; Gyllenhammar, H; Hast, R; Osterborg, A, 1993
)
0.73
"We evaluated the efficacy and adverse effects of biweekly COP-BLAM (cyclophosphamide, vincristine, prednisone, bleomycin, doxorubicin and procarbazine) therapy combined with granulocyte colony-stimulating factor (G-CSF) for treating non-Hodgkin's lymphoma (NHL)."( Biweekly COP-BLAM (cyclophosphamide, vincristine, prednisone, bleomycin, doxorubicin and procarbazine) regimen combined with granulocyte colony stimulating factor (G-CSF) for intermediate-grade non-Hodgkin's lymphoma.
Niitsu, N; Umeda, M, 1996
)
0.76
"To determine response rate and remission as well as survival times for dogs with multicentric lymphoma treated first with doxorubicin alone or in combination with asparaginase and then with cyclophosphamide, vincristine sulfate, and prednisone (CVP) and to identify prevalence of toxicoses associated with this protocol and factors associated with prognosis."( Doxorubicin alone or in combination with asparaginase, followed by cyclophosphamide, vincristine, and prednisone for treatment of multicentric lymphoma in dogs: 121 cases (1987-1995).
Getzy, DM; Mallinckrodt, CH; Ogilvie, GK; Valerius, KD, 1997
)
0.7
"For dogs with multicentric lymphoma, treatment with doxorubicin alone or in combination with asparaginase and then with CVP resulted in an acceptable response rate and low prevalence of toxicoses."( Doxorubicin alone or in combination with asparaginase, followed by cyclophosphamide, vincristine, and prednisone for treatment of multicentric lymphoma in dogs: 121 cases (1987-1995).
Getzy, DM; Mallinckrodt, CH; Ogilvie, GK; Valerius, KD, 1997
)
0.51
" In conclusion, intensive therapy using high-dose CSA combined with VP16 and prednisone might be a therapeutic option for patients with otherwise refractory LCH."( Treatment of relapsed Langerhans cell histiocytosis by cyclosporin A combined with etoposide and prednisone.
Göbel, U; Janssen, G; Körholz, D,
)
0.58
"Mycophenolate mofetil (MMF) combined with conventional cyclosporine and steroids doses efficiently prevents acute rejection in kidney transplants."( Incidence of leukopenia and cytomegalovirus disease in kidney transplants treated with mycophenolate mofetil combined with low cyclosporine and steroid doses.
Andrés, A; Cruzado, JM; Fulladosa, X; Gil-Vernet, S; Grinyó, JM; Morales, JM; Moreso, F; Pérez, JL; Serón, D, 1998
)
0.3
"One hundred and sixty seven patients with non-Hodgkin's lymphoma were randomly divided into two groups, the treatment group, which consisted of 112 cases using Chinese herbs combined with chemotherapy and 55 cases of control group were treated by chemotherapy only."( [Clinical observation on 112 cases with non-Hodgkin's lymphoma treated by Chinese herbs combined with chemotherapy].
Guo, XM; Li, JX; Yang, XF, 1997
)
0.3
" These showed that Chinese herbs combined with chemotherapy was a safe and effective method for treating NHL and deserve to be recommended."( [Clinical observation on 112 cases with non-Hodgkin's lymphoma treated by Chinese herbs combined with chemotherapy].
Guo, XM; Li, JX; Yang, XF, 1997
)
0.3
"IVIg combined with prednisone for a 3-month period was not effective in IBM."( A controlled study of intravenous immunoglobulin combined with prednisone in the treatment of IBM.
Cupler, E; Dalakas, MC; Fujii, M; Koffman, B; Sivakumar, K; Spector, S, 2001
)
0.88
"Thirty-three patients with previously untreated advanced aggressive B-cell NHL received six infusions of Rituxan (375 mg/m2 per dose) on day 1 of each cycle in combination with six doses of CHOP chemotherapy given on day 3 of each cycle."( Phase II study of rituximab in combination with chop chemotherapy in patients with previously untreated, aggressive non-Hodgkin's lymphoma.
Czuczman, M; Fisher, RI; Gilman, P; Grillo-Lopez, A; Grossbard, ML; Kunkel, LA; Link, BK; Lowe, A; Vose, JM, 2001
)
0.31
"This is the first report to demonstrate the safety and efficacy of the Rituxan chimeric anti-CD20 antibody in combination with standard-dose CHOP in the treatment of aggressive B-cell lymphoma."( Phase II study of rituximab in combination with chop chemotherapy in patients with previously untreated, aggressive non-Hodgkin's lymphoma.
Czuczman, M; Fisher, RI; Gilman, P; Grillo-Lopez, A; Grossbard, ML; Kunkel, LA; Link, BK; Lowe, A; Vose, JM, 2001
)
0.31
"Patients who were PCR-positive for B-cell leukemia-lymphoma 2 (bcl-2) gene rearrangement [t(14;18)] were evaluated for responses to rituximab alone or combined with CHOP."( Clearing of cells bearing the bcl-2 [t(14;18)] translocation from blood and marrow of patients treated with rituximab alone or in combination with CHOP chemotherapy.
Alkuzweny, B; Czuczman, MS; Gordon, L; Grillo-López, AJ; LoBuglio, AF; Maloney, D; McLaughlin, P; Rosenberg, J; Saleh, M; White, CA, 2001
)
0.31
"Rituximab, alone or combined with CHOP, eradicated bcl-2 positive cells from PB and BM in over half of the patients treated and was associated with a high overall clinical response rate."( Clearing of cells bearing the bcl-2 [t(14;18)] translocation from blood and marrow of patients treated with rituximab alone or in combination with CHOP chemotherapy.
Alkuzweny, B; Czuczman, MS; Gordon, L; Grillo-López, AJ; LoBuglio, AF; Maloney, D; McLaughlin, P; Rosenberg, J; Saleh, M; White, CA, 2001
)
0.31
" In addition, the effects on viral load, CD4 counts, and opportunistic infections were examined with the use of combination chemotherapy combined with HAART."( Chemotherapy for human immunodeficiency virus-associated non-Hodgkin's lymphoma in combination with highly active antiretroviral therapy.
Ambinder, R; Flexner, C; Grochow, L; Hamzeh, F; Harrington, W; Herndier, B; Kaplan, L; Lee, J; Levine, A; Ratner, L; Redden, D; Scadden, D; Straus, D; Tan, B; Tang, S, 2001
)
0.31
" The first 40 patients entered onto the study received reduced doses of cyclophosphamide and doxorubicin, combined with vincristine and prednisone (modified CHOP [mCHOP]), whereas the subsequent 25 patients entered onto the study received full doses of CHOP combined with granulocyte colony-stimulating factor (G-CSF)."( Chemotherapy for human immunodeficiency virus-associated non-Hodgkin's lymphoma in combination with highly active antiretroviral therapy.
Ambinder, R; Flexner, C; Grochow, L; Hamzeh, F; Harrington, W; Herndier, B; Kaplan, L; Lee, J; Levine, A; Ratner, L; Redden, D; Scadden, D; Straus, D; Tan, B; Tang, S, 2001
)
0.51
"The complete response rates were 30% and 48% among patients who received mCHOP and full-dose CHOP combined with HAART, respectively."( Chemotherapy for human immunodeficiency virus-associated non-Hodgkin's lymphoma in combination with highly active antiretroviral therapy.
Ambinder, R; Flexner, C; Grochow, L; Hamzeh, F; Harrington, W; Herndier, B; Kaplan, L; Lee, J; Levine, A; Ratner, L; Redden, D; Scadden, D; Straus, D; Tan, B; Tang, S, 2001
)
0.31
"To investigate the effects of Tiaojining recipe (TJNR) combined with corticosterone (CS) in treating infantile primary nephrotic syndrome (IPNS)."( [Clinical observation of tiaojining recipe in combination with corticosterone in infantile primary nephrotic syndrome].
Li, R; Peng, Z; Wei, Y, 2000
)
0.31
"Sixty inpatients with IPNS were divided into two groups, which consisted of 30 cases as the treated group treated by TJNR combined with CS and 30 cases of the control group were treated by CS alone for 8 weeks."( [Clinical observation of tiaojining recipe in combination with corticosterone in infantile primary nephrotic syndrome].
Li, R; Peng, Z; Wei, Y, 2000
)
0.31
"Alternating COPP/ABVD and rapid alternating COPP/ABV/IMEP in combination with extended-field radiotherapy are equally effective in intermediate-stage Hodgkin's lymphoma and produce excellent long-term treatment results."( Rapidly alternating COPP/ABV/IMEP is not superior to conventional alternating COPP/ABVD in combination with extended-field radiotherapy in intermediate-stage Hodgkin's lymphoma: final results of the German Hodgkin's Lymphoma Study Group Trial HD5.
Anselmo, AP; Brosteanu, O; Diehl, V; Doelken, G; Duehmke, E; Engert, A; Franklin, J; Georgii, A; Greil, R; Hasenclever, D; Herrmann, R; Josting, A; Kirchner, H; Koch, P; Koch, T; Lathan, B; Loeffler, M; Munker, R; Paulus, U; Pfistner, B; Pfreundschuh, M; Rueffer, U; Schalk, KP; Sieber, M; Tesch, H; Wolf, J, 2002
)
0.31
"Low-dose cyclosporin(CsA) therapy combined with prednisolone was performed in 10 adult patients with frequently relapsing minimal change nephrotic syndrome(MCNS)."( [Low-dose cyclosporin therapy combined with prednisolone for relapsing minimal change nephrotic syndrome in adults].
Honda, K; Itabashi, M; Koike, M; Nihei, H; Nitta, K; Suzuki, K; Tsukada, M; Uchida, K; Yumura, W, 2002
)
0.31
" We report the case of a 49 year-old female with advanced mantle cell lymphoma (MCL), who successfully underwent auto-peripheral blood stem cell transplant (auto-PBSCT) in combination with in vivo purging of tumor cells using rituximab."( [A patient with mantle cell lymphoma who successfully underwent auto-PBSCT in combination with in vivo purging of tumor cells using rituximab].
Hino, N; Ishibashi, K; Kanaji, N; Uno, H, 2002
)
0.31
"To explore the clinical effect of recombinant roasted licorice decoction (RRLD) combined with low-dose glucocorticoids (GC) in treating idiopathic thrombocytopenic purpura (ITP)."( [Clinical study on effect of recombinant roasted licorice decoction combined with low-dose glucocorticoids in treating idiopathic thrombocytopenic purpura].
Hu, J; Liu, YQ; Luo, YG, 2001
)
0.31
"To explore the clinical effect of Tripterygiitotorum (T II) combined with prednisone in treating patients with myasthenia gravis (MG) and the changes of immune function after treatment."( [Clinical effect of Tripterygiitotorum combined with prednisone and its effect on serum IL-6 level in treating patients with myasthenia gravis].
Li, ZX; Tan, H; Xiong, XJ, 2002
)
0.8
" However, the optimal dose of granulocyte colony-stimulating factor (G-CSF) for PBSC mobilization in combination with chemotherapy for autograft remains unknown."( A dose-finding study of glycosylated G-CSF (Lenograstim) combined with CHOP therapy for stem cell mobilization in patients with non-Hodgkin's lymphoma.
Chou, T; Kasai, M; Kawano, F; Kiyama, Y; Masaki, Y; Mitsuya, H; Morishima, Y; Ogura, M; Ohnishi, K; Sasaki, T; Takeyama, K; Tobinai, K; Yokozawa, T, 2003
)
0.32
"To find the optimal dose of glycosylated G-CSF (lenograstim) for PBSC mobilization in combination with chemotherapy for aggressive non-Hodgkin's lymphoma (NHL), we conducted a dose-finding study on 43 newly diagnosed patients who had unfavorable prognostic factors."( A dose-finding study of glycosylated G-CSF (Lenograstim) combined with CHOP therapy for stem cell mobilization in patients with non-Hodgkin's lymphoma.
Chou, T; Kasai, M; Kawano, F; Kiyama, Y; Masaki, Y; Mitsuya, H; Morishima, Y; Ogura, M; Ohnishi, K; Sasaki, T; Takeyama, K; Tobinai, K; Yokozawa, T, 2003
)
0.32
"Liposomal doxorubicin at doses of 40, 50, 60, and 80 mg/m(2) was given with fixed doses of cyclophosphamide, vincristine, and prednisone every 21 days."( Liposome-encapsulated doxorubicin in combination with standard agents (cyclophosphamide, vincristine, prednisone) in patients with newly diagnosed AIDS-related non-Hodgkin's lymphoma: results of therapy and correlates of response.
Boswell, WD; Espina, B; Levine, AM; Lieberman, RD; Nathwani, BN; Sherrod, A; Tulpule, A; Welles, L, 2004
)
0.74
"Liposomal doxorubicin in combination with cyclophosphamide, vincristine, and prednisone is active in AIDS-NHL, with complete remissions achieved in 75% independent of HIV viral control or tissue MDR-1 expression."( Liposome-encapsulated doxorubicin in combination with standard agents (cyclophosphamide, vincristine, prednisone) in patients with newly diagnosed AIDS-related non-Hodgkin's lymphoma: results of therapy and correlates of response.
Boswell, WD; Espina, B; Levine, AM; Lieberman, RD; Nathwani, BN; Sherrod, A; Tulpule, A; Welles, L, 2004
)
0.77
"Records of 75 patients with aggressive B-NHL,received infusions of 375 mg/m(2) of rituximab combined with or without chemotherapy in our center,have been retrospectively analyzed."( [Clinical analysis of rituximab combined with chemotherapy in treating aggressive B-cell non-Hodgkin's lymphoma].
Guan, ZZ; He, YJ; Huang, HQ; Jiang, WQ; Lin, TY; Sun, XF; Xia, ZJ; Zhang, HY; Zhang, L, 2004
)
0.32
"Docetaxel, a taxane previously approved for the treatment of breast cancer and non-small cell lung cancer, was approved by the United States Food and Drug Administration on May 19, 2004 for use in combination with prednisone for the treatment of metastatic androgen-independent (hormone-refractory) prostate cancer."( Approval summary: Docetaxel in combination with prednisone for the treatment of androgen-independent hormone-refractory prostate cancer.
Abraham, S; Dagher, R; Li, N; Pazdur, R; Rahman, A; Sridhara, R, 2004
)
0.77
" Diagnosis was based on the very typical ocular feature combined with a positive blood or vitreous culture."( [Endogenous Candida endophthalmitis combined with severe general diseases].
Stoffelns, BM, 2005
)
0.33
" When given with prednisone, docetaxel was also shown to reduce pain and serum prostate specific antigen levels and improve quality of life compared with mitoxantrone/prednisone."( Which drug combination for hormone-refractory prostate cancer?
Doggrell, SA, 2005
)
0.67
"The present study aimed to determine the long-term safety and efficacy of chimeric anti-CD 20 antibody rituxan (rituximab, Biogen IDEC, San Diego, CA, USA; Genentech, South San Francisco, CA, USA) in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) chemotherapy in previously untreated patients with aggressive non-Hodgkin's lymphoma (NHL)."( Long-term update of a phase II study of rituximab in combination with CHOP chemotherapy in patients with previously untreated, aggressive non-Hodgkin's lymphoma.
Czuczman, M; Fisher, RI; Grillo-Lopez, A; Grossbard, ML; Link, BK; Vose, JM, 2005
)
0.51
"Data on tacrolimus pharmacokinetics in combination with mycophenolate mofetil and prednisone are scarce in Chinese renal transplantation recipients."( Clinical pharmacokinetics of tacrolimus after the first oral administration in combination with mycophenolate mofetil and prednisone in Chinese renal transplant recipients.
Chen, LZ; Chen, YH; Dai, YP; Fei, JG; Li, J; Qiu, J; Zheng, KL, 2005
)
0.76
"Tacrolimus AUC12 show remarkable interindividual variations after the first oral dose in combination with mycophenolate mofetil and prednisone in Chinese renal transplant recipients."( Clinical pharmacokinetics of tacrolimus after the first oral administration in combination with mycophenolate mofetil and prednisone in Chinese renal transplant recipients.
Chen, LZ; Chen, YH; Dai, YP; Fei, JG; Li, J; Qiu, J; Zheng, KL, 2005
)
0.74
" The treatment group (n=22) were treated with acupoint-injection of Chinese medicine combined with prednisone, and the control group (n=19) with prednisone."( [Observation on clinical therapeutic effect of acupoint-injection therapy combined with prednisone on nephrotic syndrome and effect on immunologic function].
Cao, Y; Zhang, YM, 2005
)
0.77
"Acupoint-injection of Chinese medicine combined with prednisone can significantly increase therapeutic effect on nephrotic syndrome and strengthen immunologic function."( [Observation on clinical therapeutic effect of acupoint-injection therapy combined with prednisone on nephrotic syndrome and effect on immunologic function].
Cao, Y; Zhang, YM, 2005
)
0.8
" In this study, the antitumor activity of A in combination with ADR (AHOP) was investigated in comparison with the standard CHOP regimen."( NSC 290205-based therapy in murine pancreatic adenocarcinoma PAN02 in combination with adriamycin (ADR).
Andreadis, C; Boutis, A; Lialiaris, TS; Mouratidou, D; Papageorgiou, A,
)
0.13
"It is very likely that the D-lactamic steroid (androstan) alkylator forA, containing the amide group -NH-CO-, combined with ADR which intercalates between DNA base-pairs, is the explanation for the higher activity of AHOP as compared to CHOP."( NSC 290205-based therapy in murine pancreatic adenocarcinoma PAN02 in combination with adriamycin (ADR).
Andreadis, C; Boutis, A; Lialiaris, TS; Mouratidou, D; Papageorgiou, A,
)
0.13
" It is possible that lamivudine combined with chemotherapy may have had a therapeutic effect on ATL in this case."( [Development of acute type, CD 8 positive adult T-cell leukemia in a carrier of hepatitis B virus--possible therapeutic effect of lamivudine combined with chemotherapy].
Hasegawa, H; Miyagi, T; Nagasaki, A; Nakachi, S; Shinzato, O; Taira, N; Takasu, N; Tomoyose, T, 2006
)
0.33
" We conclude that both sirolimus monotherapy and sirolimus in combination with prednisone and/or MMF are efficacious and safe in liver transplant recipients."( Sirolimus monotherapy versus sirolimus in combination with steroids and/or MMF for immunosuppression after liver transplantation.
Maheshwari, A; Thuluvath, PJ; Torbenson, MS, 2006
)
0.56
"To study the effect of Shenbing Mistura (SM) combined with glucocorticoid on recurrent nephrotic syndrome (RNS) in children and levels of interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) in blood and urine."( [Clinical effect of shenbing mistura combined with glucocorticoid on recurrent nephrotic syndrome in children and levels of interleukin-6 and tumor necrosis factor-alpha in blood and urine].
Dang, XQ; Hu, GH; Wang, JH, 2006
)
0.33
"SM combined with glucocorticoid could significantly reduce the recurrence rate and elevate the clinical effect in children with RNS, it could also lower the levels of IL-6 and TNF-alpha in patients' blood and urine."( [Clinical effect of shenbing mistura combined with glucocorticoid on recurrent nephrotic syndrome in children and levels of interleukin-6 and tumor necrosis factor-alpha in blood and urine].
Dang, XQ; Hu, GH; Wang, JH, 2006
)
0.33
"A systematic review was undertaken and an economic model constructed to evaluate the clinical effectiveness and cost-effectiveness of docetaxel (Taxotere, Sanofi-Aventis) in combination with prednisone/prednisolone for the treatment of metastatic hormone-refractory prostate cancer (mHRPC)."( A systematic review and economic model of the clinical effectiveness and cost-effectiveness of docetaxel in combination with prednisone or prednisolone for the treatment of hormone-refractory metastatic prostate cancer.
Birtle, A; Collins, R; Fenwick, E; Light, K; Norman, G; Palmer, S; Perard, R; Riemsma, R; Trowman, R, 2007
)
0.74
"To observe the curative effect of Qingjin Runfei Decoction (QRD) combined with hormone and antibiotic in treating radiation pneumonia (RP)."( [Clinical observation on treatment of radiation pneumonia by Qingjin Runfei Decoction combined with hormone and antibiotic].
Ma, SL; Yue, JH; Zhang, T, 2007
)
0.34
"The objective of this study is to evaluate the long-term efficacy and safety of rituximab combined with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in Chinese patients with newly diagnosed diffuse large B cell lymphoma (DLBCL)."( Rituximab in combination with CHOP chemotherapy for the treatment of diffuse large B cell lymphoma in Chinese patients.
Chen, QS; Chen, Y; Li, JM; Qian, Y; Shen, Y; Shen, ZX; Wang, L; Xia, ZG; You, JH; Zeng, XY, 2007
)
0.54
"Sixty-one patients with PMR were randomly assigned to two groups, the 32 patients in the treatment group treated with YHD two doses per day combined with prednisone and the 29 patients in the control group treated with prednisone alone."( [Clinical observation on effect of modified Yanghe Decoction combined with glycocorticoid for treatment of polymyalgia rheumatica].
Fu, HZ, 2007
)
0.54
"EA warming therapy combined with western medicine has a significant therapeutic effect on myasthenia gravis."( [Electroacupuncture warming therapy combined with western medicine for treatment of myasthenia gravis and effect on IL-4 level in the patients].
Cui, X; Feng, J; Wang, SH, 2007
)
0.34
"To evaluate the preliminary efficacy, safety, and impact on quality of life (QoL) of high-dose calcitriol (DN-101) combined with mitoxantrone and glucocorticoids in androgen-independent prostate cancer (AIPC)."( A phase II study of high-dose calcitriol combined with mitoxantrone and prednisone for androgen-independent prostate cancer.
Beer, TM; Chan, JS; Dehaze, DR; Garzotto, M; Pinski, JK; Quinn, DI; Ryan, CW; Sokoloff, M, 2008
)
0.58
"To evaluate the efficacy and safety of corticoid in combination with an antibiotic in the treatment of chronic nonbacterial prostatitis (CNP)."( [Corticoid combined with an antibiotic for chronic nonbacterial prostatitis].
Hou, Y; Lü, C; Wu, ZP; Xiao, N; Yang, MG; Zhao, XK, 2009
)
0.35
"Prednisone in combination with an antibiotic can effectively relieve pain and voiding symptoms, improve QOL and reduce WBC in the EPS of CNP patients, and therefore well deserves to be recommended in clinical application."( [Corticoid combined with an antibiotic for chronic nonbacterial prostatitis].
Hou, Y; Lü, C; Wu, ZP; Xiao, N; Yang, MG; Zhao, XK, 2009
)
1.8
" The treated group was administered with GTC and prednisone, while the control group with prednisone alone."( [Clinical observation on treatment of 10 patients with chronic inflammatory demyelinating polyneuropathy by gullong tongluo capsule combined with prednisone].
Chen, JL; Hu, JY; Zhang, ZH, 2009
)
0.81
"The curative effect of GTC combined with prednisone in treating CIDP was better than that of prednisone alone."( [Clinical observation on treatment of 10 patients with chronic inflammatory demyelinating polyneuropathy by gullong tongluo capsule combined with prednisone].
Chen, JL; Hu, JY; Zhang, ZH, 2009
)
0.82
"Third-generation regimens (MACOP-B [methotrexate/leucovorin (LV)/doxorubicin/cyclophosphamide/vincristine/ prednisone/bleomycin] or VACOP-B [etoposide/LV/doxorubicin/cyclophosphamide/vincristine/prednisone/bleomycin]) in combination with local radiation therapy seem to improve lymphoma-free survival of primary mediastinal large B-cell lymphoma (PMLBCL)."( Rituximab combined with MACOP-B or VACOP-B and radiation therapy in primary mediastinal large B-cell lymphoma: a retrospective study.
Broccoli, A; Brusamolino, E; Cabras, MG; Chiappella, A; Finolezzi, E; Martelli, M; Rossi, A; Salvi, F; Stefoni, V; Zinzani, PL, 2009
)
0.57
"To retrospectively analyze and compare the treatment efficiency of CHOP-based regimens with or without high-dose consolidation treatment combined with hematopoietic stem cell transplantation (HDT-HSCT) in the patients with lymphoblastic lymphoma (LBL)."( [Comparison of the efficiency of CHOP-based regimen with or without high dose consolidation treatment combined with hematopoietic stem cell transplantation in 63 lymphoblastic lymphoma patients].
Dong, M; Feng, FY; Han, XH; He, XH; Liu, P; Qin, Y; Shi, YK; Sun, Y; Wang, JW; Yang, JL; Yang, S; Zhang, CG; Zhou, LQ; Zhou, SY, 2009
)
0.35
"To investigate the feasibility and efficacy of rituximab combined with high-dose chemotherapy supported by autologous peripheral blood stem cell transplantation (ASCT) in patients with aggressive B-cell non-Hodgkin lymphoma (NHL)."( [A prospective multicenter study of rituximab combined with high-dose chemotherapy and autologous peripheral blood stem cell transplantation for aggressive B-cell lymphoma].
Cen, XN; Chen, H; Han, MZ; Han, XH; He, XH; Huang, H; Huang, HQ; Jiang, WQ; Liu, P; Ma, J; Ren, HY; Shen, XM; Shi, YK; Wang, C; Wang, JM; Yang, S; Zhou, SY; Zhu, J, 2009
)
0.35
"We evaluated the safety and efficacy of intetumumab in combination with docetaxel in patients with castrate-resistant metastatic prostate cancer."( A phase 1, multicenter, open-label study of the safety of two dose levels of a human monoclonal antibody to human α(v) integrins, intetumumab, in combination with docetaxel and prednisone in patients with castrate-resistant metastatic prostate cancer.
Chu, FM; Dreicer, R; Foster, B; Fracasso, PM; Lang, Z; Picus, J, 2011
)
0.56
"Intetumumab was generally safe and well tolerated in combination with docetaxel, with a higher incidence of TEAEs in the 10 mg/kg dose cohort."( A phase 1, multicenter, open-label study of the safety of two dose levels of a human monoclonal antibody to human α(v) integrins, intetumumab, in combination with docetaxel and prednisone in patients with castrate-resistant metastatic prostate cancer.
Chu, FM; Dreicer, R; Foster, B; Fracasso, PM; Lang, Z; Picus, J, 2011
)
0.56
" The results of five phase III trials assessing thalidomide in combination with melphalan and prednisone (MPT) have demonstrated significantly improved response rates compared with melphalan and prednisone (MP) alone."( Consensus guidelines for the optimal management of adverse events in newly diagnosed, transplant-ineligible patients receiving melphalan and prednisone in combination with thalidomide (MPT) for the treatment of multiple myeloma.
Bladé, J; Davies, F; Delforge, M; Facon, T; Garcia Sanz, R; Kropff, M; Leal da Costa, F; Moreau, P; Morgan, G; Palumbo, A; Schey, S, 2010
)
0.78
"CHOP-like regimen combined with rituximab is a standard chemotherapy for diffuse large B-cell lymphoma (DLBCL)."( Importance of maintaining the relative dose intensity of CHOP-like regimens combined with rituximab in patients with diffuse large B-cell lymphoma.
Dan, K; Gomi, S; Hirakawa, T; Inokuchi, K; Yamaguchi, H; Yokose, N, 2010
)
0.36
"To observe the effects of ginsenosides combined with prednisone in SLE patients."( [Efficacy of ginsenosides combined with prednisone in patients with systemic lupus erythematosus: a prospective, randomized, double-blind, placebo-controlled trial].
Cai, Q; Feng, YL; Guan, JL; Ling, CQ; Xu, MJ; Xu, X; You, YL; Zhang, LL, 2010
)
0.88
"Prednisone combined with ginsenosides can increase the clinical effective rate and improve the clinical symptoms of SLE patients."( [Efficacy of ginsenosides combined with prednisone in patients with systemic lupus erythematosus: a prospective, randomized, double-blind, placebo-controlled trial].
Cai, Q; Feng, YL; Guan, JL; Ling, CQ; Xu, MJ; Xu, X; You, YL; Zhang, LL, 2010
)
2.07
"The prognosis and management of acute exacerbations of hepatitis-B in patients with lymphoma after chemotherapy in combination with rituximab remain unclear."( Prognostic analysis of acute exacerbations of hepatitis-B after chemotherapy in combination with rituximab in 19 patients with lymphoma.
Chen, ZH; Dong, M; Li, X; Lin, Q; Ma, XK; Wei, L; Wen, JY; Wu, XY, 2010
)
0.36
"This randomized trial was performed to investigate the efficacy of low-dose rituximab in combination with glucocorticoids for treatment of patients with immune thrombocytopenia (ITP)."( Low-dose rituximab combined with short-term glucocorticoids up-regulates Treg cell levels in patients with immune thrombocytopenia.
Cao, J; He, X; Li, Z; Lu, G; Mou, W; Pan, X; Xu, K, 2011
)
0.37
" All patients received rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for varying durations."( Rituximab in combination with multiagent chemotherapy for pediatric follicular lymphoma.
Dogan, A; Galardy, PJ; Khan, SP; Kumar, R; Rodriguez, V, 2011
)
0.59
"To investigate the therapeutic effects and mechanisms of using artemisinin (Art) combined with glucocorticoid (GC) to treat lupus nephritis (LN) mice."( Effect of artemisinin combined with glucocorticoid on the expressions of glucocorticoid receptor α mRNA, glucocorticoid receptor β mRNA and P300/CBP protein in lupus nephritis mice.
An, P; Qiao, CL; Shi, XM; Sun, WS; Wang, Z; Wu, XL; Zhang, WG, 2011
)
0.37
"As rituximab combined with CHOP improves complete remission and overall survival in diffuse large B-cell lymphoma, intensified chemotherapy followed by autologous stem-cell transplantation has also been advocated for high-risk patients."( Survival impact of rituximab combined with ACVBP and upfront consolidation autotransplantation in high-risk diffuse large B-cell lymphoma for GELA.
Anglaret, B; Belhadj, K; Brechignac, S; Casasnovas, O; Ferme, C; Feugier, P; Fitoussi, O; Gabarre, J; Ghesquieres, H; Gisselbrecht, C; Haioun, C; Herbrecht, R; Janvier, M; Morschhauser, F; Mounier, N; Parrens, M; Salles, G; Tilly, H; Van Den Neste, E; Ysebaert, L, 2011
)
0.37
" We conducted a phase I trial to establish the maximum tolerated dose of lenalidomide that could be combined with R-CHOP (rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone)."( Lenalidomide can be safely combined with R-CHOP (R2CHOP) in the initial chemotherapy for aggressive B-cell lymphomas: phase I study.
Ansell, SM; Habermann, TM; Inwards, DJ; Johnston, PB; Klebig, RR; LaPlant, B; Macon, WR; Micallef, IN; Nowakowski, GS; Porrata, LF; Reeder, CB; Rivera, CE; Witzig, TE, 2011
)
0.56
"This study was purposed to investigate the changes of serum immunoglobulin (Ig) level during treatment of diffuse large B cell lymphoma by using rituximab (RTX) combined with CHOP."( [Change of serum immunoglobulin level in patients with diffuse large B cell lymphoma after rituximab combined with chemotherapy].
Gao, CJ; Huang, WR; Li, HH; Wang, QS; Wang, SH; Yu, L; Zhao, Y, 2011
)
0.37
"This phase 1/2 study assessed sunitinib combined with docetaxel (Taxotere) and prednisone in chemotherapy-naive metastatic, castration-resistant prostate cancer (mCRPC) patients."( Sunitinib in combination with docetaxel and prednisone in chemotherapy-naive patients with metastatic, castration-resistant prostate cancer: a phase 1/2 clinical trial.
Chen, I; Chow Maneval, E; George, DJ; Harmon, CS; Hutson, TE; Kozloff, M; Liu, G; Logothetis, CJ; Mathew, P; Shore, ND; Wang, SL; Wilding, G; Zurita, AJ, 2012
)
0.87
"To study the treatment effects of cultured Cordyceps sinensis combined with glucocorticosteroid on experimental pulmonary fibrosis in rats induced by bleomycin."( [Effectiveness of cultured Cordyceps sinensis combined with glucocorticosteroid on pulmonary fibrosis induced by bleomycin in rats].
Gu, Y; Li, S; Liao, D; Lin, Y; Liu, R; Xu, H, 2011
)
0.37
" sinensis combined with prednisone group."( [Effectiveness of cultured Cordyceps sinensis combined with glucocorticosteroid on pulmonary fibrosis induced by bleomycin in rats].
Gu, Y; Li, S; Liao, D; Lin, Y; Liu, R; Xu, H, 2011
)
0.68
"AT-101 (A), a small molecule oral inhibitor of the Bcl-2 family, has activity alone and in combination with docetaxel (Taxotere) and prednisone (DP) in metastatic castration-resistant prostate cancer (mCRPC)."( Randomized phase II trial of docetaxel plus prednisone in combination with placebo or AT-101, an oral small molecule Bcl-2 family antagonist, as first-line therapy for metastatic castration-resistant prostate cancer.
Berry, WR; Brookes, M; Burke, JM; Caton, JR; Fleming, MT; Galsky, MD; Holmlund, JT; Hutson, TE; Karlov, P; Leopold, L; Matveev, V; Sonpavde, G; Wood, BA, 2012
)
0.84
"AT-101 was tolerable but did not extend OS when combined with DP in mCRPC; a potential benefit was observed in high-risk patients."( Randomized phase II trial of docetaxel plus prednisone in combination with placebo or AT-101, an oral small molecule Bcl-2 family antagonist, as first-line therapy for metastatic castration-resistant prostate cancer.
Berry, WR; Brookes, M; Burke, JM; Caton, JR; Fleming, MT; Galsky, MD; Holmlund, JT; Hutson, TE; Karlov, P; Leopold, L; Matveev, V; Sonpavde, G; Wood, BA, 2012
)
0.64
" In preclinical and clinical studies, panobinostat showed good anti-myeloma activity in combination with several agents."( Phase II study of melphalan, thalidomide and prednisone combined with oral panobinostat in patients with relapsed/refractory multiple myeloma.
Alesiani, F; Ballanti, S; Boccadoro, M; Caraffa, P; Catarini, M; Cavallo, F; Corvatta, L; Gentili, S; Leoni, P; Liberati, AM; Offidani, M; Palumbo, A; Polloni, C; Pulini, S, 2012
)
0.64
"An international, Phase II trial was conducted to assess two doses of ofatumumab, a human CD20 monoclonal antibody, combined with cyclophosphamide (750 mg/m(2) ), doxorubicin (50 mg/m(2) ), prednisone (100 mg days 3-7) and vincristine (1·4 mg/m(2) ) (O-CHOP), as frontline treatment for follicular lymphoma (FL)."( Chemoimmunotherapy with ofatumumab in combination with CHOP in previously untreated follicular lymphoma.
Czuczman, MS; Gadeberg, OV; Goldstein, N; Gupta, I; Hess, G; Jewell, RC; Lin, TS; Lisby, S; Pedersen, LM; Strange, C; Viardot, A; Windfeld, K, 2012
)
0.57
"Bortezomib has demonstrated efficacy in patients with relapsed B-cell non-Hodgkin lymphoma (NHL) both alone and in combination with other agents; however, limited data exist regarding its toxicity in combination with common frontline therapies for indolent NHL."( A phase 1 dose escalation study of bortezomib combined with rituximab, cyclophosphamide, doxorubicin, modified vincristine, and prednisone for untreated follicular lymphoma and other low-grade B-cell lymphomas.
Bumpers, K; Flowers, CR; Heffner, LT; Hutchison-Rzepka, A; Kaufman, JL; Khoury, HJ; King, N; Lechowicz, MJ; Lewis, C; Lonial, S; Shenoy, PJ; Sinha, R; Tighiouart, M, 2012
)
0.58
"Bortezomib combined with modified R-CHOP produced high response rates without substantial increases in toxicity."( A phase 1 dose escalation study of bortezomib combined with rituximab, cyclophosphamide, doxorubicin, modified vincristine, and prednisone for untreated follicular lymphoma and other low-grade B-cell lymphomas.
Bumpers, K; Flowers, CR; Heffner, LT; Hutchison-Rzepka, A; Kaufman, JL; Khoury, HJ; King, N; Lechowicz, MJ; Lewis, C; Lonial, S; Shenoy, PJ; Sinha, R; Tighiouart, M, 2012
)
0.58
"The authors present the report of an ankylosing spondylitis combined with angioimmunoblastic T cell lymphoma after the anti-tumour necrosis factor treatment."( Ankylosing spondylitis combined with angioimmunoblastic T cell lymphoma.
Xu, L, 2011
)
0.37
"We performed a dose-escalation study to investigate the safety of sorafenib in combination with docetaxel and prednisone in chemo-naïve patients with metastatic castration-resistant prostate cancer (mCRPC)."( Phase I study of sorafenib in combination with docetaxel and prednisone in chemo-naïve patients with metastatic castration-resistant prostate cancer.
Canon, JL; Clausse, M; D'Hondt, L; Duck, L; Kerger, J; Machiels, JP; Mardjuadi, F; Medioni, J; Moxhon, A; Musuamba, F; Oudard, S, 2012
)
0.83
"Three-weekly docetaxel and prednisone could be combined with sorafenib at 400 mg BID on days 1-21 without reaching MTD."( Phase I study of sorafenib in combination with docetaxel and prednisone in chemo-naïve patients with metastatic castration-resistant prostate cancer.
Canon, JL; Clausse, M; D'Hondt, L; Duck, L; Kerger, J; Machiels, JP; Mardjuadi, F; Medioni, J; Moxhon, A; Musuamba, F; Oudard, S, 2012
)
0.92
"We performed a phase II study to evaluate the efficacy of bortezomib in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) as first-line treatment for patients with stage III/IV peripheral T-cell lymphomas (PTCLs) based on our phase I study results."( Bortezomib in combination with CHOP as first-line treatment for patients with stage III/IV peripheral T-cell lymphomas: a multicentre, single-arm, phase 2 trial.
Do, IG; Huh, J; Kang, HJ; Kim, HJ; Kim, HK; Kim, JS; Kim, SJ; Kim, WS; Ko, YH; Lee, J; Lee, SS; Min, SK; Park, SK; Ryoo, BY; Suh, C; Yang, WI; Yoon, DH, 2012
)
0.58
"To study the effectiveness of mycophenolate mofetil (MMF) as first-line therapy combined with systemic corticosteroids in acute uveitis associated with Vogt-Koyanagi-Harada (VKH) disease."( The outcomes of mycophenolate mofetil therapy combined with systemic corticosteroids in acute uveitis associated with Vogt-Koyanagi-Harada disease.
Abu El-Asrar, AM; Al-Mezaine, HS; Al-Muammar, AM; Hemachandran, S; Kangave, D, 2012
)
0.38
" Here, safety of LDE as carmustine carrier (50 mg m(-2) , intravenous) combined with vincristine and prednisone for the treatment of dogs with lymphoma was tested and compared with commercial carmustine with vincristine and prednisone."( Pilot clinical study of carmustine associated with a lipid nanoemulsion in combination with vincristine and prednisone for the treatment of canine lymphoma.
Barboza, R; Coelho, BM; Guerra, JL; Lucas, SR; Maranhão, RC; Pozzi, DH, 2015
)
0.85
"To research the effects of Qingyang Toujie Mixture (QTM) in combination with prednisone tablet on the balance of Th1 and Th2 (Th1/Th2) of systemic lupus erythematosus (SLE) patients of yin deficiency syndrome (YDS)."( [Effects of qingyang toujie mixture in combination with prednisone tablet on Th1/Th2 cytokines in patients suffering from systemic lupus erythematosus].
Chen, YH; Duan, HY; He, YP; Huang, GH; Linag, XF; Liu, Y; Wen, XM; Xu, QY; Zeng, ZL; Zhong, JX, 2013
)
0.87
"QTM in combination with prednisone tablet was effective to improve the balance of Th1/Th2 cytokines, and alleviate the toxic and adverse reactions of hormone or immune inhibitors."( [Effects of qingyang toujie mixture in combination with prednisone tablet on Th1/Th2 cytokines in patients suffering from systemic lupus erythematosus].
Chen, YH; Duan, HY; He, YP; Huang, GH; Linag, XF; Liu, Y; Wen, XM; Xu, QY; Zeng, ZL; Zhong, JX, 2013
)
0.94
"Aflibercept in combination with docetaxel and prednisone given as first-line chemotherapy for men with metastatic castrate-resistant prostate cancer resulted in no improvement in overall survival and added toxicity compared with placebo."( Aflibercept versus placebo in combination with docetaxel and prednisone for treatment of men with metastatic castration-resistant prostate cancer (VENICE): a phase 3, double-blind randomised trial.
Arén, O; Bavbek, S; Birtle, A; Elliott, T; Fizazi, K; Fléchon, A; Gil, T; Gravis, G; Hatteville, L; Ivanov, S; Karlsson, CT; Karyakin, O; Magherini, E; Matveev, V; Orlandi, F; Petrylak, D; Rosenthal, M; Skoneczna, I; Tannock, IF; Tombal, B; Viana, L, 2013
)
0.89
") in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC)."( Abiraterone acetate in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer: U.S. Food and Drug Administration drug approval summary.
Aziz, R; Ghosh, D; Ibrahim, A; Justice, R; Kluetz, PG; Maher, VE; Mehrotra, N; Ning, YM; Palmby, T; Pazdur, R; Pfuma, E; Sridhara, R; Tang, S; Tilley, A; Zhang, L; Zirkelbach, JF, 2013
)
0.97
" In this study we assessed cytotoxicity of ONC in combination with currently used anticancer drugs on a human diffuse large B-cell lymphoma (DLBCL)-derived cell line (Toledo)."( In vitro cytotoxicity of ranpirnase (onconase) in combination with components of R-CHOP regimen against diffuse large B cell lymphoma (DLBCL) cell line.
Bogusz, J; Cebula-Obrzut, B; Darzynkiewicz, Z; Majchrzak, A; Mędra, A; Robak, T; Smolewski, P; Witkowska, M; Zwolińska, M, 2013
)
0.39
"GLS combined with cTnT may provide a reliable and non-invasive method to predict cardiac dysfunction in patients receiving anthracycline-based chemotherapy."( Two-dimensional speckle tracking echocardiography combined with high-sensitive cardiac troponin T in early detection and prediction of cardiotoxicity during epirubicine-based chemotherapy.
Chen, H; Cheng, L; Kang, Y; Li, L; Pan, C; Shu, X; Sun, M; Xu, X, 2014
)
0.4
" In the present protocol, bortezomib was combined with bendamustine and prednisone, in order to assess the efficacy and safety of this combination therapy in patients with newly diagnosed/untreated MM."( Bendamustine and prednisone in combination with bortezomib (BPV) in the treatment of patients with newly diagnosed/untreated multiple myeloma.
Andrea, M; Becker, C; Behre, G; Bourgeois, M; Edelmann, T; Gutsche, K; Hammerschmidt, D; Hennig, E; Heyn, S; Hoffmann, FA; Holzvogt, B; Kaiser, T; Krahl, R; Kreibich, U; Lindner, T; Niederwieser, D; Plötze, M; Pönisch, W; Reifenrath, K; Remane, Y; Schliwa, T; Schwarz, M; Schwarzer, A; Vucinic, V; Winkelmann, C; Zehrfeld, T, 2014
)
0.97
"The aim of the present study was to evaluate the efficacy of cyclosporine A (CsA) combined with medium/low dose prednisone in the treatment of progressive immunoglobulin A nephropathy (IgAN)."( Cyclosporine A combined with medium/low dose prednisone in progressive IgA nephropathy.
Guan, GJ; Liu, ZC; Luo, Q; Lv, XA; Xu, L, 2014
)
0.87
" We demonstrated that lenalidomide can be safely combined with R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone); this new combination is known as R2CHOP."( Lenalidomide combined with R-CHOP overcomes negative prognostic impact of non-germinal center B-cell phenotype in newly diagnosed diffuse large B-Cell lymphoma: a phase II study.
Ansell, SM; Foran, JM; Gascoyne, RD; Habermann, TM; Inwards, DJ; Johnston, PB; LaPlant, B; Macon, WR; Micallef, IN; Nelson, GD; Nowakowski, GS; Porrata, LF; Reeder, CB; Rivera, CE; Thompson, CA; Witzig, TE, 2015
)
0.62
"Low-dose THAL together with PRED appeared to be effective in the treatment of PMF-associated anemia, and the response duration would prolong significantly if combined with DANA."( [Comparison of low-dose thalidomide and prednisone combined with or without danazol for the treatment of primary myelofibrosis-associated anemia].
Fang, L; Hu, N; Li, B; Pan, L; Qin, T; Qu, S; Xiao, Z; Xu, J; Xu, Z; Zhang, H; Zhang, Y, 2014
)
0.67
" We aimed to explore the effectiveness and safety of low-dose prednisone or cyclosporine A (CsA) combined with nucleoside analog (NA) in patients with severe thrombocytopenia associated with HBV-related LC."( Immunosuppressive treatment combined with nucleoside analog is superior to nucleoside analog only in the treatment of severe thrombocytopenia in patients with cirrhosis associated with hepatitis B in China: A multicenter, observational study.
Feng, R; Fu, HX; Hu, JD; Huang, XJ; Jiang, H; Jiang, M; Jiang, Q; Liu, H; Ma, H; Niu, T; Wang, H; Wang, JW; Wang, X; Wang, Z; Wei, L; Xie, YD; Xu, LP; Zhang, XH; Zhu, XL, 2015
)
0.66
"The CHOP-OR study is a prospective phase II study to evaluate the safety, feasibility and activity of a CHOP chemotherapy in combination with ofatumumab in induction and subsequent maintenance for patients with newly diagnosed RS."( Single arm NCRI phase II study of CHOP in combination with Ofatumumab in induction and maintenance for patients with newly diagnosed Richter's syndrome.
Boyle, L; Clifford, R; Dutton, SJ; Eyre, TA; Francis, A; Roberts, C; Schuh, A, 2015
)
0.42
" Ofatumumab in combination with prednisone is safe and a phase II examination of efficacy is ongoing."( Ofatumumab in combination with glucocorticoids for primary therapy of chronic graft-versus-host disease: phase I trial results.
Alsina, M; Anasetti, C; Ayala, E; Betts, BC; Fernandez, HF; Field, T; Kharfan-Dabaja, MA; Kim, J; Locke, FL; Mishra, A; Nishihori, T; Ochoa-Bayona, L; Perez, L; Pidala, J; Riches, M, 2015
)
0.7
"We conducted an open-label, single-arm Phase I/II clinical trial in metastatic CRPC (mCRPC) patients eligible for docetaxel combined with treatment with autologous mature dendritic cells (DCs) pulsed with killed LNCaP prostate cancer cells (DCVAC/PCa)."( Phase I/II clinical trial of dendritic-cell based immunotherapy (DCVAC/PCa) combined with chemotherapy in patients with metastatic, castration-resistant prostate cancer.
Babjuk, M; Bartunkova, J; Becht, E; Bilkova, P; Fucikova, J; Gasova, Z; Horvath, R; Hromadkova, H; Jarolim, L; Kayserova, J; Kubackova, K; Lastovicka, J; Podrazil, M; Rozkova, D; Sochorova, K; Spisek, R; Vavrova, K; Vrabcova, P, 2015
)
0.42
"To investigate the efficacy and safety of Rituximab combined with second line regimen for treatment of relapsed and refractory Hodgkin lymphoma."( [Rituximab combined with second line regimens for treatment of seven relapsed and refractory Hodgkin lymphoma patients].
Li, H; Liu, H; Qiu, L; Xiong, W; Yi, S; Zou, D, 2015
)
0.42
"Seven patients with relapsed and refractory Hodgkin lymphoma were treated with Rituximab combined with second line regimen."( [Rituximab combined with second line regimens for treatment of seven relapsed and refractory Hodgkin lymphoma patients].
Li, H; Liu, H; Qiu, L; Xiong, W; Yi, S; Zou, D, 2015
)
0.42
"These results indicate that the Rituximab combined with second line regimen is an effective therapy for relapsed and refractory Hodgkin lymphoma."( [Rituximab combined with second line regimens for treatment of seven relapsed and refractory Hodgkin lymphoma patients].
Li, H; Liu, H; Qiu, L; Xiong, W; Yi, S; Zou, D, 2015
)
0.42
" This study aimed to assess the efficacy and toxicity of dose-adjusted CHOP alone or in combination with rituximab (R-CHOP) by examining the stem cell mobilization in NHL patients."( Autologous peripheral blood stem cell mobilization following dose-adjusted cyclophosphamide, doxorubicin, vincristine, and prednisolone chemotherapy alone or in combination with rituximab in treating high-risk non-Hodgkin's lymphoma.
Gui, L; Han, X; He, X; Liu, P; Qin, Y; Shi, Y; Yang, J; Yang, S; Yao, J; Zhang, C; Zhang, S; Zhao, L; Zhou, P; Zhou, S, 2015
)
0.42
"To evaluate the efficacy and safety of methotrexate (MTX) used alone or combined with low- to moderate-dose oral corticosteroids (OC) for treating severe AA (totalis, universalis and severe multifocal)."( Efficacy and Safety of Methotrexate Combined with Low- to Moderate-Dose Corticosteroids for Severe Alopecia Areata.
Anuset, D; Bernard, P; Perceau, G; Reguiai, Z, 2016
)
0.43
"MTX combined with low- to moderate-dose OC may be an efficient and well-tolerated treatment for severe AA."( Efficacy and Safety of Methotrexate Combined with Low- to Moderate-Dose Corticosteroids for Severe Alopecia Areata.
Anuset, D; Bernard, P; Perceau, G; Reguiai, Z, 2016
)
0.43
" These patients may benefit from rituximab combined with intensive chemotherapy."( [Curative effect analysis of rituximab combined with intensive chemotherapy for follicular lymphoma patients with bone marrow involvement].
Li, H; Li, Z; Liu, H; Liu, W; Lü, R; Qiu, L; Xiong, W; Yi, S; Zou, D, 2015
)
0.42
" We conducted a phase 1b trial to determine the maximum tolerated dose (MTD) of lenalidomide in combination with R-ESHAP (rituximab, etoposide, cisplatin, cytarabine, methylprednisolone) (LR-ESHAP) in patients with relapsed or refractory DLBCL."( Lenalidomide in combination with R-ESHAP in patients with relapsed or refractory diffuse large B-cell lymphoma: a phase 1b study from GELTAMO group.
Caballero, D; Canales, M; Dlouhy, I; González-Barca, E; López-Guillermo, A; Martín, A; Montes-Moreno, S; Ocio, EM; Redondo, AM; Salar, A, 2016
)
0.43
"To compare the therapeutic effects of prednisone combined with mycophenolate mofetil (MMF) versus cyclosporin A (CsA) in children with steroid-resistant nephrotic syndrome (SRNS)."( [Comparison of therapeutic effects of prednisone combined with mycophenolate mofetil versus cyclosporin A in children with steroid-resistant nephrotic syndrome].
Ding, YF; Duan, CR; Li, ZH; Lin, Z; Wu, TH; Xun, M; Yin, Y; Zhang, L; Zhang, Y, 2016
)
0.98
"The clinical data of 164 SRNS children who were treated with prednisone combined with MMF or CsA between January 2004 and December 2013 were collected, and the clinical effect of prednisone combined with MMF (MMF group, 112 children) or CsA (CsA group, 52 children) was analyzed retrospectively."( [Comparison of therapeutic effects of prednisone combined with mycophenolate mofetil versus cyclosporin A in children with steroid-resistant nephrotic syndrome].
Ding, YF; Duan, CR; Li, ZH; Lin, Z; Wu, TH; Xun, M; Yin, Y; Zhang, L; Zhang, Y, 2016
)
0.95
"Prednisone combined with MMF or CsA is effective and safe for the treatment of SRNS in children, and within 3 months of treatment, CsA has a better effect than MMF."( [Comparison of therapeutic effects of prednisone combined with mycophenolate mofetil versus cyclosporin A in children with steroid-resistant nephrotic syndrome].
Ding, YF; Duan, CR; Li, ZH; Lin, Z; Wu, TH; Xun, M; Yin, Y; Zhang, L; Zhang, Y, 2016
)
2.15
"To explore the clinical efficacy and safety of rituximab combined with fludarabine and cyclophosphamide for the treatment of the chronic lymphocytic leukemia (CLL)."( [Clinical Efficacy and Safety of Rituximab Combined with Fludarabine and Cyclophosphamide for Treatment of Chronic Lymphocytic Leukemia].
Han, HJ; Lu, YW; Xia, RX, 2016
)
0.43
" The patients in control group were treated with CHOP chemotherapy, the patients in observation group were treated with rituximab combined with fludarabine, cyclophosphamide treatment."( [Clinical Efficacy and Safety of Rituximab Combined with Fludarabine and Cyclophosphamide for Treatment of Chronic Lymphocytic Leukemia].
Han, HJ; Lu, YW; Xia, RX, 2016
)
0.43
"application of rituximab combined with fludarabine and cyclophosphamide in the treatment of CLL shows the higher curative effect, can effectively improve the symptoms and reduce the incidence of adverse reactions."( [Clinical Efficacy and Safety of Rituximab Combined with Fludarabine and Cyclophosphamide for Treatment of Chronic Lymphocytic Leukemia].
Han, HJ; Lu, YW; Xia, RX, 2016
)
0.43
"To investigate the clinical efficacy and safety between CHOPE regimen alone and it combined with thalidomide for relapsed and refractory non-Hodgkin's lymphoma."( [Clinical Efficacy Comparison between CHOPE Regimen alone and It Combined with Thalidomide for Relapsed and Refractory Non-Hodgkin's Lymphoma].
Yang, YZ, 2016
)
0.43
"Compared with CHOPE regimen alone, CHOPE regimen combined with thalidomide for relapsed and refractory non-Hodgkin's lymphoma can efficiently delay the disease progression, reduce tumor burden level, enhance the long-term survival rate, morever did not increase the risk of toxic side effects."( [Clinical Efficacy Comparison between CHOPE Regimen alone and It Combined with Thalidomide for Relapsed and Refractory Non-Hodgkin's Lymphoma].
Yang, YZ, 2016
)
0.43
"Low-dose P given with or without AA is associated with low overall incidence of CA-AEs."( Low Incidence of Corticosteroid-associated Adverse Events on Long-term Exposure to Low-dose Prednisone Given with Abiraterone Acetate to Patients with Metastatic Castration-resistant Prostate Cancer.
Charnas, R; Chi, KN; de Bono, JS; De Porre, P; Fizazi, K; Gomella, LG; Londhe, A; McGowan, T; Miller, K; Montgomery, B; Pelhivanov, N; Rathkopf, DE; Ryan, CJ; Scher, HI; Shore, ND; Todd, MB, 2016
)
0.65
"To evaluate the safety, preliminary efficacy, and pharmacokinetics of inotuzumab ozogamicin, an anti-CD22 antibody conjugated to calicheamicin, in combination with the immunochemotherapeutic regimen, rituximab, cyclophosphamide, vincristine, and prednisone (R-CVP), in patients with relapsed/refractory CD22+ B-cell non-Hodgkin lymphoma (NHL)."( Phase I Study of Inotuzumab Ozogamicin Combined with R-CVP for Relapsed/Refractory CD22+ B-cell Non-Hodgkin Lymphoma.
Ananthakrishnan, R; Boni, J; Crump, M; Davies, A; Hatake, K; Ishibashi, T; MacDonald, D; Ogura, M; Paccagnella, ML; Tobinai, K; Vandendries, E, 2016
)
0.62
"To evaluate the efficacy and adverse effects of low dose thalidomide (TD) combined with modified VCMP (vincristine+cyclophosphamide+melphalan+prednisone) (TD+mVCMP) and VAD (vincristine+doxorubicin+dexamethsone) (TD+VAD) regimens for treating aged patients with MM."( [Efficacy Comparison of Low dose Thalidomide Combined with Modified VCMP and VAD regimens for Treatment of Aged MM Patients].
Liu, HB; Wang, W, 2016
)
0.64
"Low dose TD combined with modified VCMP regimen for treatment of newly diagnosed aged patients with MM is safe and effective, which may be used as the first line treatment regimen for population in aged MM patients."( [Efficacy Comparison of Low dose Thalidomide Combined with Modified VCMP and VAD regimens for Treatment of Aged MM Patients].
Liu, HB; Wang, W, 2016
)
0.43
" The primary endpoint of the phase 1 portion of this study was to establish the maximum tolerated dose of everolimus that could be combined with R-CHOP-21."( Everolimus combined with R-CHOP-21 for new, untreated, diffuse large B-cell lymphoma (NCCTG 1085 [Alliance]): safety and efficacy results of a phase 1 and feasibility trial.
Ansell, SM; Colgan, JP; Habermann, TM; Inwards, DJ; Johnston, PB; LaPlant, B; McPhail, E; Micallef, IN; Nowakowski, GS; Witzig, TE, 2016
)
0.43
"The mTORC1 inhibitor everolimus given for 14 days in combination with R-CHOP-21 for patients with DLBCL is safe."( Everolimus combined with R-CHOP-21 for new, untreated, diffuse large B-cell lymphoma (NCCTG 1085 [Alliance]): safety and efficacy results of a phase 1 and feasibility trial.
Ansell, SM; Colgan, JP; Habermann, TM; Inwards, DJ; Johnston, PB; LaPlant, B; McPhail, E; Micallef, IN; Nowakowski, GS; Witzig, TE, 2016
)
0.43
" Bortezomib is the first product to be approved for the treatment of patients with previously untreated MCL, for whom haematopoietic stem cell transplantation is unsuitable, and is used in combination with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (VR-CAP)."( Cost-effectiveness analysis of bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (VR-CAP) in patients with previously untreated mantle cell lymphoma.
Gairy, K; Lee, D; Seshagiri, D; Thilakarathne, P; van Keep, M, 2016
)
0.82
"To evaluate the effectiveness and safety of mycophenolate mofetil (MMF) as first-line therapy combined with systemic corticosteroids in initial-onset acute uveitis associated with Vogt-Koyanagi-Harada (VKH) disease."( Mycophenolate mofetil combined with systemic corticosteroids prevents progression to chronic recurrent inflammation and development of 'sunset glow fundus' in initial-onset acute uveitis associated with Vogt-Koyanagi-Harada disease.
Abu El-Asrar, AM; Al-Muammar, A; Dosari, M; Gikandi, PW; Hemachandran, S, 2017
)
0.46
"Use of MMF as first-line therapy combined with systemic corticosteroids in patients with initial-onset acute VKH disease prevents progression to chronic recurrent granulomatous inflammation and development of 'sunset glow fundus'."( Mycophenolate mofetil combined with systemic corticosteroids prevents progression to chronic recurrent inflammation and development of 'sunset glow fundus' in initial-onset acute uveitis associated with Vogt-Koyanagi-Harada disease.
Abu El-Asrar, AM; Al-Muammar, A; Dosari, M; Gikandi, PW; Hemachandran, S, 2017
)
0.46
" We have previously shown in a retrospective analysis that lenalidomide combined with continuous low-dose cyclophosphamide and prednisone (REP) had remarkable activity in heavily pretreated, lenalidomide-refractory MM patients."( Phase 1/2 study of lenalidomide combined with low-dose cyclophosphamide and prednisone in lenalidomide-refractory multiple myeloma.
Beeker, A; Bloem, AC; Bos, GMJ; Broijl, A; Faber, LM; Franssen, LE; Klein, SK; Koene, HR; Levin, MD; Lokhorst, HM; Mutis, T; Nijhof, IS; Oostvogels, R; Raymakers, R; Sonneveld, P; van de Donk, NWCJ; van der Spek, E; van Kessel, B; van Spronsen, DJ; van Velzen, J; Westerweel, PE; Ypma, PF; Zweegman, S, 2016
)
0.87
"We treated 4 with a diagnosis of diffuse large B cell lymphoma involving the gastrointestinal tract with rituximab combined with adjusted dose EPOCH (R-DA-EPOCH) scheme based on a comprehensive analysis of the onset process, clinical and pathological features, and prognosis of the patients, and evaluated their treatment response."( [Rituximab combined with EPOCH regimen for treatment of diffuse large B cell lymphoma of the gastrointestinal tract: analysis of 4 cases].
Guo, YX; Hu, RH; Hui, WH; Su, L; Sun, WL; Wan, SG; Zhao, H, 2016
)
0.43
" In both animal models the anti-lymphoma activity of selinexor is enhanced through combination with DEX or EVER."( Anti-tumor activity of selective inhibitor of nuclear export (SINE) compounds, is enhanced in non-Hodgkin lymphoma through combination with mTOR inhibitor and dexamethasone.
Aboukameel, A; Azmi, AS; Baloglu, E; Bhutani, D; Carlson, R; Elloul, S; Kauffman, M; Mohammad, RM; Muqbil, I; Senapedis, W; Shacham, S; Zonder, J, 2016
)
0.43
"The aim of this study was to evaluate the clinical efficacy of Aidi injection combined with CHOP chemotherapy regimen in the treatment of malignant lymphoma."( Aidi injection combined with CHOP chemotherapy regimen in the treatment of malignant lymphoma: A meta-analysis based on randomized controlled trials.
Fang, B; Jiang, J; Jiang, Y; Jin, W; Lan, Y; Liu, M; Liu, Y; Ma, G; Qu, Z; Wang, X; Zeng, Y, 2016
)
0.43
" All the clinical studies related to Aidi injection combined with CHOP chemotherapy regimen in the treatment of malignant lymphoma were screened and reviewed."( Aidi injection combined with CHOP chemotherapy regimen in the treatment of malignant lymphoma: A meta-analysis based on randomized controlled trials.
Fang, B; Jiang, J; Jiang, Y; Jin, W; Lan, Y; Liu, M; Liu, Y; Ma, G; Qu, Z; Wang, X; Zeng, Y, 2016
)
0.43
" The pooled results showed that Aidi injection combined with CHOP chemotherapy regimen can significantly improve the ORR (odds ratio [OR] =1."( Aidi injection combined with CHOP chemotherapy regimen in the treatment of malignant lymphoma: A meta-analysis based on randomized controlled trials.
Fang, B; Jiang, J; Jiang, Y; Jin, W; Lan, Y; Liu, M; Liu, Y; Ma, G; Qu, Z; Wang, X; Zeng, Y, 2016
)
0.43
"With the present evidence, Aidi injection combined with CHOP chemotherapy regimen can improve the treatment response and quality of life and decrease the risk of developing severe leukopenia or thrombocytopenia."( Aidi injection combined with CHOP chemotherapy regimen in the treatment of malignant lymphoma: A meta-analysis based on randomized controlled trials.
Fang, B; Jiang, J; Jiang, Y; Jin, W; Lan, Y; Liu, M; Liu, Y; Ma, G; Qu, Z; Wang, X; Zeng, Y, 2016
)
0.43
"LEF combined with prednisone has a certain efficacy on the RNS and displays few adverse reactions."( Efficacy of leflunomide combined with prednisone in the treatment of refractory nephrotic syndrome.
Chen, W; Liu, L; Liu, Y; Qu, X; Zhang, Y, 2016
)
1.04
" The aim of this study was to investigate the efficacy and safety of bortezomib combined with glucocorticoids in refractory lupus patients."( The short-term efficacy of bortezomib combined with glucocorticoids for the treatment of refractory lupus nephritis.
Hou, J; Hu, W; Huang, L; Huang, X; Liu, Z; Zhang, H; Zhou, M, 2017
)
0.46
"This was a phase I/II trial to determine the safety and efficacy of alisertib when given in combination with abiraterone plus prednisone (AP)."( A Phase I/II Study of the Investigational Drug Alisertib in Combination With Abiraterone and Prednisone for Patients With Metastatic Castration-Resistant Prostate Cancer Progressing on Abiraterone.
Cristofanilli, M; Hoffman-Censits, JH; Kelly, WK; Kennedy, B; Kilpatrick, D; Leiby, B; Lewis, N; Lin, J; Mu, Z; Patel, SA; Sama, AR; Yang, H; Ye, Z, 2016
)
0.86
"A tolerable dose of alisertib in combination with AP in mCRPC was not established in this study."( A Phase I/II Study of the Investigational Drug Alisertib in Combination With Abiraterone and Prednisone for Patients With Metastatic Castration-Resistant Prostate Cancer Progressing on Abiraterone.
Cristofanilli, M; Hoffman-Censits, JH; Kelly, WK; Kennedy, B; Kilpatrick, D; Leiby, B; Lewis, N; Lin, J; Mu, Z; Patel, SA; Sama, AR; Yang, H; Ye, Z, 2016
)
0.65
" The aim of the SYNERGY trial was to investigate the effect of custirsen in combination with docetaxel and prednisone on overall survival in patients with metastatic castration-resistant prostate cancer."( Custirsen in combination with docetaxel and prednisone for patients with metastatic castration-resistant prostate cancer (SYNERGY trial): a phase 3, multicentre, open-label, randomised trial.
Bergman, AM; Blumenstein, B; Chi, KN; de Bono, JS; Ferrero, JM; Feyerabend, S; Gleave, M; Gravis, G; Higano, CS; Jacobs, C; Merseburger, AS; Mukherjee, SD; Reeves, J; Saad, F; Stenzl, A; Zalewski, P, 2017
)
0.93
" Drug-drug interactions (DDIs) may occur in prostate cancer patients due to inhibition by abiraterone of liver cytochrome P450 (CYP)-dependent enzymes CYP2C8 and 2D6, which are involved in the metabolism of approximately 25% of all drugs, and induction by enzalutamide of CYP3A4, 2C9 and 2C19, which metabolize up to 50% of medications."( The role of drug-drug interactions in prostate cancer treatment: Focus on abiraterone acetate/prednisone and enzalutamide.
Bracarda, S; Crucitta, S; Danesi, R; De Souza, P; Del Re, M; Derosa, L; Fogli, S; Massari, F; Santini, D, 2017
)
0.67
"We evaluated the efficacy and safety of tacrolimus (TAC) combined with corticosteroids in treating patients with idiopathic membranous nephropathy (IMN)."( Therapy of tacrolimus combined with corticosteroids in idiopathic membranous nephropathy.
Cui, W; Dong, W; Guan, S; Li, Q; Li, W; Liu, M; Lu, X; Luo, M; Luo, P; Miao, L; Min, X; Wang, Y, 2017
)
0.46
" The authors used appropriate linear regression univariate models and created 5 different multivariate models to examine individual drug-drug interactions (DDIs)."( A Retrospective Study on Mycophenolic Acid Drug Interactions: Effect of Prednisone, Sirolimus, and Tacrolimus With MPA.
Alvarez-Elías, AC; Filler, G; Singh, RN; Todorova, EK; Yoo, EC, 2017
)
0.69
" We aimed to assess whether custirsen in combination with cabazitaxel and prednisone increases overall survival in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel."( Custirsen (OGX-011) combined with cabazitaxel and prednisone versus cabazitaxel and prednisone alone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel (AFFINITY): a randomised, open-label, international, ph
Alekseev, B; Beer, TM; Blumenstein, B; Chi, KN; Fizazi, K; Fléchon, A; Gravis, G; Hotte, SJ; Jacobs, CA; Joly, F; Malik, Z; Matveev, V; Saad, F; Stewart, PS, 2017
)
0.94
"To investigate the effectiveness, visual outcome, and prognostic factors of Vogt-Koyanagi-Harada (VKH) disease treatment with a reduced dose of corticosteroids combined with immunosuppressive agents."( Novel treatment regimen of Vogt-Koyanagi-Harada disease with a reduced dose of corticosteroids combined with immunosuppressive agents.
Du, L; Kijlstra, A; Liang, L; Qi, J; Wang, C; Wu, L; Yang, P; Ye, Z; Zhou, Q, 2018
)
0.48
" Reduced doses of corticosteroids combined with immunosuppressive agents were used for 1-1."( Novel treatment regimen of Vogt-Koyanagi-Harada disease with a reduced dose of corticosteroids combined with immunosuppressive agents.
Du, L; Kijlstra, A; Liang, L; Qi, J; Wang, C; Wu, L; Yang, P; Ye, Z; Zhou, Q, 2018
)
0.48
"A reduced dose of corticosteroids combined with immunosuppressive agents effectively controlled the intraocular inflammation and improved visual acuity in most Chinese VKH patients."( Novel treatment regimen of Vogt-Koyanagi-Harada disease with a reduced dose of corticosteroids combined with immunosuppressive agents.
Du, L; Kijlstra, A; Liang, L; Qi, J; Wang, C; Wu, L; Yang, P; Ye, Z; Zhou, Q, 2018
)
0.48
"This study aimed to evaluate the efficacy and safety of rituximab combined with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for treating patients with diffuse large B-cell lymphoma (DLBCL)."( Efficacy of rituximab combined with CHOP for treating patients with diffuse large B-cell lymphoma.
Ding, SS; Guo, L; Hu, X; Li, S; Liang, X; Wen, SJ; Yang, SE; Zeng, M, 2017
)
0.66
" S0806 was a single arm phase I/II trial of vorinostat given at 400 mg po daily on days 1-9 (subsequently amended to days 1-5 due to toxicity), combined with R-CHOP given on day 3 of a 21-day cycle for 8 cycles, with primary phase II endpoint of 2-year progression free survival (PFS)."( A phase I/II trial of vorinostat (SAHA) in combination with rituximab-CHOP in patients with newly diagnosed advanced stage diffuse large B-cell lymphoma (DLBCL): SWOG S0806.
Bane, CL; Barr, PM; Fisher, RI; Friedberg, JW; LeBlanc, M; Li, H; Persky, DO; Popplewell, LL; Rimsza, LM; Smith, SM; Von Gehr, A, 2018
)
0.48
" Case reports and small reviews have evaluated the addition of agents directed against plasma cell disorders in combination with traditional lymphoma-directed regimens."( Bortezomib in combination with dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) induces long-term survival in patients with plasmablastic lymphoma: a retrospective analysis.
Dittus, C; Ellsworth, S; Grover, N; Park, SI; Tan, X, 2018
)
0.72
"A pharmacotherapy combined with early HBO resulted in full recovery of hearing."( Successful treatment of sudden sensorineural hearing loss by means of pharmacotherapy combined with early hyperbaric oxygen therapy: Case report.
Olex-Zarychta, D, 2017
)
0.46
" Previous data indicated that treatment with prednisone in combination with antibiotics results in significant acceleration of the healing phase."( Corticosteroid Therapy in Combination with Antibiotics for Erysipelas.
Barzilai, A; Baum, S; Elphasy, H; Solomon, M; Trau, H, 2018
)
0.74
"To investigate the effectiveness of corticosteroids combined with antibiotics for the treatment of erysipelas."( Corticosteroid Therapy in Combination with Antibiotics for Erysipelas.
Barzilai, A; Baum, S; Elphasy, H; Solomon, M; Trau, H, 2018
)
0.48
"We prospectively enrolled 215 newly diagnosed patients with IgG4-RD, who were initially treated with glucocorticoid (GC) alone or in combination with immunosuppressive agents (IM), and had at least 6 months of follow up."( Failure of remission induction by glucocorticoids alone or in combination with immunosuppressive agents in IgG4-related disease: a prospective study of 215 patients.
Fei, Y; Feng, R; Lai, Y; Peng, L; Wang, L; Wang, M; Zeng, X; Zhang, F; Zhang, P; Zhang, W; Zhang, X; Zhao, Y, 2018
)
0.48
" To investigate the clinical efficacy of glucocorticoids in combination with ursodesoxycholic acid in the treatment of glucocorticoids in combination with ursodesoxycholic acid, one hundred and twenty patients with AH who were admitted to the hospital from February 2014 and February 2016 were selected and randomly divided into an observation group and a control group using random number table."( Glucocorticoids in combination with ursodesoxycholic acid in the treatment of autoimmune hepatitis.
Li, WY; Wang, YC; Yang, XS,
)
0.13
"Lenalidomide in combination with R-CHOP had an acceptable safety profile and showed anti-cancer activity in patients with previously untreated high burden follicular lymphoma."( Lenalidomide in combination with R-CHOP (R2-CHOP) as first-line treatment of patients with high tumour burden follicular lymphoma: a single-arm, open-label, phase 2 study.
Becker, S; Bouabdallah, R; Cabeçadas, J; Casasnovas, O; Feugier, P; Gabarre, J; Gouill, SL; Haioun, C; Jardin, F; Lamy, T; Molina, TJ; Morschhauser, F; Mounier, N; Salles, G; Tilly, H; Tournilhac, O, 2018
)
0.48
"To assess the efficacy and safety of tacrolimus in combination with corticosteroids in patients with immune-mediated necrotising myopathy."( Tacrolimus combined with corticosteroids effectively improved the outcome of a cohort of patients with immune-mediated necrotising myopathy.
Bu, B; Feng, F; Ji, S; Li, Y; Wang, Q,
)
0.13
"The medical records of 20 hospitalised patients with immune-mediated necrotising myopathy (IMNM) who had received tacrolimus combined with oral prednisone from January 2014 to August 2017 were retrospectively reviewed."( Tacrolimus combined with corticosteroids effectively improved the outcome of a cohort of patients with immune-mediated necrotising myopathy.
Bu, B; Feng, F; Ji, S; Li, Y; Wang, Q,
)
0.33
" This review will cover the current use of abiraterone acetate in combination with prednisone for the treatment of castration-resistant prostate cancer."( Abiraterone acetate to treat metastatic castration-resistant prostate cancer in combination with prednisone.
Duarte, C; Jimeno, A; Kessler, ER, 2019
)
0.96
"The primary purpose of this study was to identify the most common drug-drug interactions (DDI'S) in patients prescribed medications upon discharge from the emergency department."( Descriptive study of drug-drug interactions attributed to prescriptions written upon discharge from the emergency department.
Bridgeman, PJ; Jawaro, T; Mele, J; Wei, G, 2019
)
0.51
" The primary endpoint is the identification and characterization of drug-drug interactions caused by discharge prescriptions written by the treating physician."( Descriptive study of drug-drug interactions attributed to prescriptions written upon discharge from the emergency department.
Bridgeman, PJ; Jawaro, T; Mele, J; Wei, G, 2019
)
0.51
" Here, we explore the therapeutic potential and possible mechanisms of SAA in combination with low-dose prednisone in adriamycin (ADR)-induced minimal change disease (MCD) rat model and mouse podocyte injury cell model."( Therapeutic and antiproteinuric effects of salvianolic acid A in combined with low-dose prednisone in minimal change disease rats: Involvement of PPARγ/Angptl4 and Nrf2/HO-1 pathways.
Fan, H; Fu, F; Gao, Z; Ji, K; Kong, L; Li, X; Liu, K; Liu, Y; Qi, D; Wang, X; Xie, H; Yu, C; Yue, G; Zhu, H, 2019
)
0.95
" We observed the efficacy and safety of tocilizumab combined with methotrexate (MTX) in the treatment of refractory AOSD, and to explore the possibility of reducing the dosage of tocilizumab after disease control."( Refractory adult-onset Still disease treated by tocilizumab combined with methotrexate: A STROBE-compliant article.
Guo, SH; Shen, HL; Wang, CY; Wang, LP, 2019
)
0.51
" We report the pharmacokinetics (PK) and drug-drug interaction (DDI) for pola."( Pharmacokinetics of polatuzumab vedotin in combination with R/G-CHP in patients with B-cell non-Hodgkin lymphoma.
Agarwal, P; Dere, RC; Girish, S; Jin, JY; Lee, C; Li, C; Li, X; Lu, D; Lu, T; Miles, D; Shemesh, CS, 2020
)
0.56
" Pola was evaluated as a potential victim and perpetrator of a PK drug-drug interaction with R/G-CHP."( Pharmacokinetics of polatuzumab vedotin in combination with R/G-CHP in patients with B-cell non-Hodgkin lymphoma.
Agarwal, P; Dere, RC; Girish, S; Jin, JY; Lee, C; Li, C; Li, X; Lu, D; Lu, T; Miles, D; Shemesh, CS, 2020
)
0.56
"We conducted a phase I/II multicenter trial using 6 cycles of brentuximab vedotin (BV) in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for treatment of patients with CD30-positive (+) B-cell lymphomas."( Brentuximab vedotin in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone as frontline treatment for patients with CD30-positive B-cell lymphomas.
Bair, SM; Ballard, H; Barta, SK; Bogusz, AM; Chong, E; Dwivedy Nasta, S; Filicko-O'Hara, J; Gaballa, S; Gerson, J; Hung, SS; Khan, N; King, C; Landsburg, DJ; Lim, M; Maity, A; Mitnick, S; Nagle, SJ; Nakamura, H; Nejati, R; Plastaras, JP; Ruella, M; Schuster, SJ; Steidl, C; Strelec, L; Svoboda, J; Waite, TS; Youngman, M, 2021
)
1.04
" Abiraterone acetate in combination with prednisone was the first approved hormone therapy demonstrating survival benefit, and represents, to date, an alternative, or a second-line treatment after taxane-based chemotherapy, in addition to androgen-deprivation therapy, in hormone sensitive, and metastatic castration-resistant prostate cancer."( Abiraterone acetate in combination with prednisone in the treatment of prostate cancer: safety and efficacy.
Manceau, C; Mourey, L; Ploussard, G; Pouessel, D, 2020
)
1.09
" High-dose chemotherapy regimens such as DA-EPOCH should be administered to young patients in combination with rituximab."( Chidamide combined with ibrutinib improved the prognosis of primary bone marrow diffuse large B cell lymphoma.
Chen, Z; Li, Y; Tian, C, 2020
)
0.56
" In a monocentric cohort of 68 SMLZ patients, we showed that rituximab in monotherapy or in combination with bendamustine, compared with rituximab associated with the polychemotherapy cycle cyclophosphamide, hydroxydaunorubicin, vincristine and prednisolone (CHOP), resulted in a higher 5-year progression-free survival (91."( Rituximab Monotherapy or in Combination with Bendamustine Is Not Inferior to Rituximab-CHOP Regimen in the Treatment of Patients with Splenic Marginal Zone Lymphoma in the Real Life.
Cabras, MG; Caocci, G; Dessì, D; La Nasa, G; Mantovani, D; Moi, G; Mulas, O, 2021
)
0.62
" We conducted a phase II study to investigate the efficacy and safety of dose-adjusted (DA)- EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab) combined with high-dose methotrexate (HD-MTX) in newly diagnosed patients with CD5+ DLBCL."( DA-EPOCH-R combined with high-dose methotrexate in patients with newly diagnosed stage II-IV CD5-positive diffuse large B-cell lymphoma: a single-arm, open-label, phase II study.
Asano, N; Igarashi, T; Izutsu, K; Katayama, N; Kato, K; Kinoshita, T; Miyawaki, K; Miyazaki, K; Nishikawa, M; Nishikori, M; Nishimura, Y; Ohata, K; Ohshima, K; Okamoto, M; Sakai, R; Sunami, K; Suzumiya, J; Takahashi, N; Tamaru, S; Yamada, T; Yamaguchi, M; Yamamoto, G; Yano, H; Yoshida, I, 2020
)
0.77
" This study was designed to explore the effect of dexamethasone and gamma globulin combined with prednisone in the treatment of pediatric HSPN."( Effects of dexamethasone and gamma globulin combined with prednisone on the therapeutic effect and immune function of Henoch-Schonlein purpura nephritis in children.
Chen, L; Liu, X; Ma, K; Wang, X; Yin, L, 2021
)
1.08
"According to the treatment plan, 60 children treated with dexamethasone and gamma globulin were included in the control group, and the rest 55 children treated with dexamethasone and gamma globulin combined with prednisone were selected as the research group."( Effects of dexamethasone and gamma globulin combined with prednisone on the therapeutic effect and immune function of Henoch-Schonlein purpura nephritis in children.
Chen, L; Liu, X; Ma, K; Wang, X; Yin, L, 2021
)
1.05
"Dexamethasone and gamma globulin combined with prednisone can improve the immune function of children with HSPN and promote the recovery of renal function."( Effects of dexamethasone and gamma globulin combined with prednisone on the therapeutic effect and immune function of Henoch-Schonlein purpura nephritis in children.
Chen, L; Liu, X; Ma, K; Wang, X; Yin, L, 2021
)
1.12
"To analyze the efficacy of rituximab combined with CHOP/EPOCH regimen for treatment of diffuse large B-cell lymphoma(DLBCL) patients, and to explore the high risk factors of refractory and relapsed patients."( [Analysis of Relevant Factors of Refractory and Relapse DLBCL Treated by Rituximab Combined with CHOP/EPOCH Regimen].
Chen, BA; Gao, C; Gu, Y; Wu, X; Zhang, J, 2020
)
0.56
" The remission rate of DLBCL patients treated by rituximab combined with CHOP/EPOCH was analyzed, and survival analysis was conducted to explore the risk factors influencing refractory recurrence."( [Analysis of Relevant Factors of Refractory and Relapse DLBCL Treated by Rituximab Combined with CHOP/EPOCH Regimen].
Chen, BA; Gao, C; Gu, Y; Wu, X; Zhang, J, 2020
)
0.56
"The remission rate of DLBCL patients treated by rituximab combined with CHOP/EPOCH regimen is high, but about one third of the patients still show refractory and relapsed."( [Analysis of Relevant Factors of Refractory and Relapse DLBCL Treated by Rituximab Combined with CHOP/EPOCH Regimen].
Chen, BA; Gao, C; Gu, Y; Wu, X; Zhang, J, 2020
)
0.56
" Although the safety profile and efficacy of RW-CHOP was comparable with R-CHOP and its tolerability was acceptable, weekly rituximab in combination with CHOP during the early treatment period did not improve PFS in untreated patients with DLBCL."( A randomized phase 2/3 study of R-CHOP vs CHOP combined with dose-dense rituximab for DLBCL: the JCOG0601 trial.
Ando, K; Dobashi, N; Fukuhara, N; Hotta, T; Iida, S; Imaizumi, Y; Ishizawa, K; Kinoshita, T; Kuroda, J; Maruyama, D; Masaki, Y; Miyazaki, K; Mizutani, T; Murayama, T; Nagai, H; Nosaka, K; Ogawa, G; Ogura, M; Ohmachi, K; Suehiro, Y; Takamatsu, Y; Tobinai, K; Tokunaga, T; Tsukamoto, N; Tsukasaki, K; Uchida, T; Utsumi, T; Yakushijin, Y; Yamamoto, K; Yamauchi, N; Yoshida, I; Yoshida, S; Yoshino, T, 2021
)
0.62
" We evaluated bone scan lesion area (BSLA), a quantitative imaging assessment of response in patients with mCRPC receiving radium-223 alone or in combination with androgen receptor pathway inhibitors (abiraterone/prednisone or enzalutamide)."( A randomized phase IIa study of quantified bone scan response in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with radium-223 dichloride alone or in combination with abiraterone acetate/prednisone or enzalutamide.
Albany, C; Dawson, NA; Higano, CS; Mehlhaff, BA; Nordquist, LT; Patel, KR; Petrylak, DP; Quinn, DI; Sartor, O; Siegel, J; Trandafir, L; Vaishampayan, UN; Wagner, VJ, 2021
)
0.99
"Technetium-99m imaging BSLA may offer objective, quantifiable assessment of isotope uptake changes, and potentially treatment response, in patients with mCRPC and bone metastases treated with radium-223 alone or in combination with abiraterone/prednisone or enzalutamide."( A randomized phase IIa study of quantified bone scan response in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with radium-223 dichloride alone or in combination with abiraterone acetate/prednisone or enzalutamide.
Albany, C; Dawson, NA; Higano, CS; Mehlhaff, BA; Nordquist, LT; Patel, KR; Petrylak, DP; Quinn, DI; Sartor, O; Siegel, J; Trandafir, L; Vaishampayan, UN; Wagner, VJ, 2021
)
0.99
"This study evaluated the clinical efficacy of leflunomide combined with low-dose prednisone (0."( Clinical evaluation of efficacy of leflunomide combined with low-dose prednisone for treatment of myasthenia gravis.
Chen, J; Huang, X; Liu, W; Lu, Y; Ou, C; Qiu, L; Ran, H; Yang, W, 2023
)
1.37
"Many clinical trials have assessed the effect and safety of monoclonal antibodies (MAbs) in combination with proteasome inhibitors or immunomodulators plus dexamethasone/prednisone for the treatment of multiple myeloma (MM)."( Comparison of monoclonal antibodies targeting CD38, SLAMF7 and PD-1/PD-L1 in combination with Bortezomib/Immunomodulators plus dexamethasone/prednisone for the treatment of multiple myeloma: an indirect-comparison Meta-analysis of randomised controlled tr
Deng, J; Gong, Y; Liu, X; Wu, X; Ye, W; Zheng, X, 2021
)
1.02
" In conclusion, MAbs targeting CD38 are the best, followed by those targeting SLAMF7; MAbs targeting PD-1/PD-L1 are the worst when in combination with bortezomib/immunomodulators plus dexamethasone/prednisone for the treatment of MM."( Comparison of monoclonal antibodies targeting CD38, SLAMF7 and PD-1/PD-L1 in combination with Bortezomib/Immunomodulators plus dexamethasone/prednisone for the treatment of multiple myeloma: an indirect-comparison Meta-analysis of randomised controlled tr
Deng, J; Gong, Y; Liu, X; Wu, X; Ye, W; Zheng, X, 2021
)
1.01
" We present population pharmacokinetics (PopPK) and exposure-response (ER) analyses for venetoclax (a selective BCL-2 inhibitor) administered with rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with relapsed/refractory (R/R) and previously untreated (1L) non-Hodgkin lymphoma (NHL) from the phase 1b/2 CAVALLI study, to confirm dose selection for future studies."( Population Pharmacokinetics and Exposure-Response Analyses for Venetoclax in Combination with R-CHOP in Relapsed/Refractory and Previously Untreated Patients with Diffuse Large B Cell Lymphoma.
Bazeos, A; Ding, H; Gibiansky, L; Huang, W; Humphrey, K; Li, C; Miles, D; Rajwanshi, R; Salem, AH; Samineni, D; Sinha, A; Zhang, R, 2022
)
0.91
"Analyses included 216 patients with R/R or 1L NHL treated for eight 21-day cycles with 400-800 mg venetoclax (cycle 1: days 4-10; cycles 2-8: days 1-10) in combination with R for eight cycles and CHOP for 6-8 cycles."( Population Pharmacokinetics and Exposure-Response Analyses for Venetoclax in Combination with R-CHOP in Relapsed/Refractory and Previously Untreated Patients with Diffuse Large B Cell Lymphoma.
Bazeos, A; Ding, H; Gibiansky, L; Huang, W; Humphrey, K; Li, C; Miles, D; Rajwanshi, R; Salem, AH; Samineni, D; Sinha, A; Zhang, R, 2022
)
0.72
"The PopPK and ER analyses, in addition to the positive benefit-risk observed in the clinical data, support the selection of 800 mg venetoclax given with R-CHOP for future studies in BCL-2-immunohistochemistry-positive patients with 1L DLBCL."( Population Pharmacokinetics and Exposure-Response Analyses for Venetoclax in Combination with R-CHOP in Relapsed/Refractory and Previously Untreated Patients with Diffuse Large B Cell Lymphoma.
Bazeos, A; Ding, H; Gibiansky, L; Huang, W; Humphrey, K; Li, C; Miles, D; Rajwanshi, R; Salem, AH; Samineni, D; Sinha, A; Zhang, R, 2022
)
0.72
" The experimental group took oral cyclosporine A and prednisone tablets, while the control group received oral cyclosporine A combined with shock therapy."( Clinical nephrotoxicity induced by cyclosporin A combined with hormone therapy for nephrotic syndrome.
Huang, Y; Li, G; Liu, X; Song, Q; Wang, C; Wang, R; Xun, Z, 2021
)
0.87
"Ribociclib, a CDK4/6 inhibitor, demonstrates preclinical antitumor activity in combination with taxanes."( A Phase Ib/II Study of the CDK4/6 Inhibitor Ribociclib in Combination with Docetaxel plus Prednisone in Metastatic Castration-Resistant Prostate Cancer.
Aggarwal, R; Carneiro, BA; de Kouchkovsky, I; Fong, L; Friedlander, T; Lewis, C; Paris, PL; Phone, A; Rao, A; Ryan, CJ; Small, EJ; Szmulewitz, RZ; Zhang, L, 2022
)
0.94
"Rituximab (R) or obinutuzumab (G) combined with CHOP chemotherapy are used in previously untreated follicular lymphoma (FL)."( Comparative analysis of rituximab or obinutuzumab combined with CHOP in first-line treatment of follicular lymphoma.
Boulanger, C; Claustre, G; Durot, E; Etienne-Selloum, N; Fornecker, LM; Graff, V; Maloisel, F; Slimano, F, 2023
)
0.91
"This study retrospectively explored the effectiveness of electroacupuncture (EA) combined with Qianzhengsan decoction (QZSD) for the treatment of peripheral facial paralysis (PFP)."( Electroacupuncture combined with Qianzhengsan decoction for the treatment of peripheral facial paralysis: A retrospective study.
Chen, WQ; Li, Q, 2022
)
0.72
"To investigate the efficacy of cyclophosphamide combined with prednisone in membranous nephropathy (MN) patients with different cytochrome P450 (CYP) 2B6 gene polymorphisms and explore the factors influencing the efficacy."( The Efficacy of Cyclophosphamide Combined with Prednisone in Membranous Nephropathy Patients with Different Cytochrome P450 2B6 Gene Polymorphisms and Analysis of Factors Influencing the Efficacy.
Liu, H; Lv, Y; Zhang, M, 2022
)
1.22
"Cyclophosphamide combined with prednisone was effective in treating MN with different CYP2B6 gene polymorphisms."( The Efficacy of Cyclophosphamide Combined with Prednisone in Membranous Nephropathy Patients with Different Cytochrome P450 2B6 Gene Polymorphisms and Analysis of Factors Influencing the Efficacy.
Liu, H; Lv, Y; Zhang, M, 2022
)
1.26
"To review the drug-drug interactions between tacrolimus and lopinavir/ritonavir in 23 patients who received solid organ transplant during the first wave of COVID-19 and to determine the efficacy as well as safety of prednisone monotherapy."( Drug-drug interactions of ritonavir-boosted SARS-CoV-2 protease inhibitors in solid organ transplant recipients: experience from the initial use of lopinavir-ritonavir.
Ambrosioni, J; Arranz, N; Bodro, M; Brunet, M; Castel, MÁ; Cofan, F; Crespo, G; Diekmann, F; Farrero, M; Forner, A; Gonzalez-García, R; LLigoña, A; Marcos, MÁ; Miró, JM; Moreno, A; Rodríguez-García, M; Roma, JR; Ruiz, P; Soy, D; Tuset, M, 2023
)
1.1
"This is a retrospective, single-center PSM study evaluating the efficacy and safety of chidamide combined with the CHOEP (C-CHOEP) regimen versus the single CHOEP regimen in patients with untreated peripheral T cell lymphomas (PTCL)."( Long-time follow-up of patients with untreated peripheral T cell lymphoma following chidamide combined with cyclophosphamide, epirubicin, vindesine, prednisone, and etoposide therapy: a single-center propensity score-matching study.
Wang, W; Wei, C; Zhang, W; Zhang, Y; Zhao, D; Zhou, D, 2023
)
1.11
" Aim: This study aimed to perform a retrospective analysis for analyzing the efficacy of treatment with oral steroids combined with postauricular steroid injection in patients with delaying effective treatment."( Effects of Oral Steroids Combined with Postauricular Steroid Injection on Patients with Sudden Sensorineural Hearing Loss with Delaying Intervention: A Retrospective Analysis.
Fei, B; Liu, ZB; Lv, LY; Zhu, WY, 2023
)
0.91
"Oral steroids combined with postauricular steroid injection should be employed for treatment of SSNHL patients with delaying effective treatment over three weeks."( Effects of Oral Steroids Combined with Postauricular Steroid Injection on Patients with Sudden Sensorineural Hearing Loss with Delaying Intervention: A Retrospective Analysis.
Fei, B; Liu, ZB; Lv, LY; Zhu, WY, 2023
)
0.91

Bioavailability

Oral dexamethason can be considered as a non-cytotoxic biomaterial with high potential to improve the mesalamine and prednisone bioavailability by sustaining the drug release and enhancing drug permeability.

ExcerptReferenceRelevance
" Prednisone is effectively absorbed and converted to its active therapeutic derivative, prednisolone, in healthy volunteers and in patients with liver disease; the bioavailability of oral prednisone approximates 100% of an intravenous dose and is comparable after administration of either prednisone or prednisolone."( Corticosteroid pharmacokinetics in liver disease.
Go, VL; Uribe, M,
)
1.04
" In patients, variability was similarly wide after both preparations, but overall bioavailability after both prednisone and prednisolone was similar to that found in controls, although three patients showed subnormal values after both preparations, possibly as a result of impaired intestinal absorption."( Prednisone or prednisolone for the treatment of chronic active hepatitis? A comparison of plasma availability.
Chakraborty, J; Davis, M; English, J; Ideo, G; Marks, V; Tempini, S; Williams, R, 1978
)
1.91
" Factors that affect bioavailability among drugs of the same type (especially oral drugs) include not only disintegration and absorption rates but also the amount of food taken before or with the dose, interactions with other drugs, the physical state of the patient, and the "first-pass effect" upon drug with high liver clearance."( Drug bioavailability studies.
Wagner, JG, 1977
)
0.26
"A three-way crossover bioavailability study was performed using nine adult male volunteers with three different commercial prednisone tablets."( In vitro and in vivo availability of commercial prednisone tablets.
Albert, KS; Blair, DC; Sakmar, E; Sullivan, TJ; Wagner, JG, 1975
)
0.72
"In a clinical study involving 22 normal adult volunteers, the bioavailability and pharmacokinetics of prednisone tablets with varying dissolution rates were evaluated."( Bioavailability and pharmacokinetics of prednisone in humans.
Desante, KA; Disanto, AR, 1975
)
0.74
"This presentation has attempted to provide a brief view of the importance of bioavailability and bioequivalence to those physicians who use corticosteroids."( Corticosteroids and bioavailability.
Stubbs, SS, 1975
)
0.25
" A considerable inter-patient variation in bioavailability after a standard dose of prednisolone (20 mg) was noted."( Measurement of plasma prednisolone in man.
May, CS; Paterson, JW; Ssendagire, R; Wilson, CG, 1975
)
0.25
"Several reports document an inverse correlation between bioavailability of maintenance chemotherapeutic agents and the likelihood of relapse in childhood."( Relapse in acute lymphoblastic leukemia as a function of white blood cell and absolute neutrophil counts during maintenance chemotherapy.
Blatt, J; Gula, MJ; Lucas, K,
)
0.13
" Bioavailability averaged 88."( Altered prednisolone pharmacokinetics in patients with cystic fibrosis.
Accurso, FJ; Dove, AM; Hill, MR; Jusko, WJ; Larsen, GL; Szefler, SJ, 1992
)
0.28
"A randomized, four-way cross-over study was conducted in eight healthy male volunteers to determine the relative and absolute bioavailability of prednisone (PN) and prednisolone (PL)."( Relative and absolute bioavailability of prednisone and prednisolone after separate oral and intravenous doses.
Bekersky, I; Colburn, WA; Ferry, JJ; Heath, EC; Horvath, AM; Ryan, CF, 1988
)
0.74
"The relative bioavailability of single oral doses of prednisone with and without sucralfate administration was determined in 12 healthy male volunteers."( Lack of effect of sucralfate on prednisone bioavailability.
Amend, WJ; Birnbaum, J; Gambertoglio, JG; Lizak, P; Romac, DR; Yong, CL, 1987
)
0.81
" The bioavailability of prednisone in these patients exhibited a low intersubject variability, while the metabolic clearance rate of total and of unbound prednisolone varied considerably from patient to patient."( Prednisolone clearance: a possible determinant for glucocorticoid efficacy in patients with oral vesiculo-erosive diseases.
Benet, LZ; Frey, FJ; Lozada, F, 1983
)
0.57
" The bioavailability of prednisone, the interconversion of prednisone into prednisolone, the total and unbound prednisolone clearances, the prednisolone binding capacity of albumin and transcortin, and the affinity of albumin for prednisolone were not different when the 14 patients without cushingoid side effects were compared with the 13 cushingoid patients."( Endogenous and exogenous glucocorticoids in cushingoid patients.
Amend, WJ; Benet, LZ; Frey, BM; Frey, FJ; Lozada, F, 1982
)
0.57
"The pharmacokinetics and bioavailability of prednisolone after doses of oral prednisone and intravenous prednisolone were determined in seven patients receiving corticosteroids for treatment of inflammatory bowel disease in active disease and remission."( Effect of inflammatory bowel disease on absorption and disposition of prednisolone.
George, DE; Jusko, WJ; Lebenthal, E; Milsap, RL; Murray, KA; Szefler, SJ, 1983
)
0.49
" Since the absorption rate is not clinically relevant in patients on long-term glycoside therapy, our results indicate that digitoxin is preferable to digoxin in such patients."( Cytostatic drugs are without significant effect on digitoxin plasma level and renal excretion.
Kuhlmann, J; Rietbrock, N; Wilke, J, 1982
)
0.26
"Limited information is available on the pharmacokinetics and bioavailability of prednisone and prednisolone in patients with different disease states."( Pharmacokinetics and bioavailability of prednisone and prednisolone in healthy volunteers and patients: a review.
Amend, WJ; Benet, LZ; Gambertoglio, JG, 1980
)
0.76
"Prednisone and prednisolone are drugs with the potential for therapeutic inequivalence due to bioavailability problems."( Prednisone and prednisolone bioavailability in renal transplant patients.
Amend, WJ; Birnbaum, JL; Feduska, NJ; Frey, FJ; Gambertoglio, JG; Holford, NH; Lizak, PS; Salvatierra, O; Vincenti, F, 1982
)
3.15
"To assess the relative bioavailability of a recently developed liquid prednisone preparation, prednisolone pharmacokinetics were evaluated after the administration of three separate steroid preparations."( Bioavailability assessment of a liquid prednisone preparation.
Flesher, KA; Georgitis, JW; Szefler, SJ, 1982
)
0.77
" Distribution, elimination and other bioavailability parameters were calculated from the obtained data."( [Pharmacokinetics of prednisolone in adrenal insufficiency ].
Benker, G; Hackenberg, K; Reinwein, D; von Papen, C, 1982
)
0.26
"The pharmacokinetics and bioavailability of prednisolone and prednisone after doses of 60 mg/m2 oral prednisone and 50 mg/m2 intravenous prednisolone were determined in six children receiving corticosteroids for treatment of nephrotic syndrome during active disease and in remission."( Effect on nephrotic syndrome on absorption and disposition of prednisolone in children.
Appiani, AC; Assael, BM; Edefonti, A; Jusko, WJ; Rocci, ML, 1982
)
0.51
" Renal graft impairment together with decreased IGF bioavailability may, in addition to the presumed direct effects of PDN on cartilage, contribute to the growth retardation after RTx."( Levels of growth hormone, insulin-like growth factor-I (IGF-I) and -II, IGF-binding protein-1 and -3, and cortisol in prednisone-treated children with growth retardation after renal transplantation.
Blum, WF; de Muinck Keizer-Schrama, SM; Drop, SL; Hokken-Koelega, AC; Stijnen, T, 1993
)
0.49
"No significant differences in area under the serum concentration versus time curve (AUC), maximal methotrexate concentration following dosing (Cmax), time to Cmax (Tmax), bioavailability (F), urinary MTX, renal clearance of MTX or creatinine clearance were observed between the 2 cohorts."( Examination of pharmacokinetic variables in a cohort of patients with rheumatoid arthritis beginning therapy with methotrexate compared with a cohort receiving the drug for a mean of 81 months.
Hamilton, RA; Kremer, JM; Petrillo, GF, 1995
)
0.29
"The pharmacokinetics of prednisone and prednisolone was examined in 12 healthy male subjects to assess the bioavailability and the parameters of reversible metabolism between the two steroids."( Bioavailability and reversible metabolism of prednisone and prednisolone in man.
Garg, V; Jusko, WJ, 1994
)
0.86
"), the bioavailability (0."( Metabolism of prednisone in kidney transplanted patients with necrosis of the femoral head.
Egfjord, M; Lausten, GS; Olgaard, K, 1993
)
0.65
" The bioavailability of both IGF-I and IGF-II is regulated by specific IGF-binding proteins (IGFBPs)."( Serum levels of insulin-like growth factor-I, -II and insulin-like growth factor binding proteins -2 and -3 in children with acute lymphoblastic leukaemia.
Aumann, V; Blum, WF; Kluba, U; Mittler, U; Mohnike, KL; Vorwerk, P, 1996
)
0.29
" This study suggests that variable oral bioavailability of CsA represents a biopharmaceutical risk factor for the occurrence of chronic rejection."( Variable oral absorption of cyclosporine. A biopharmaceutical risk factor for chronic renal allograft rejection.
Kahan, BD; Katz, SM; Rutzky, LP; Schoenberg, L; Urbauer, DL; Van Buren, CT; Welsh, M, 1996
)
0.29
"01), and the relative bioavailability of the prednisolone liquid using prednisone liquid as the reference standard was 116 +/- 14%."( A pharmacokinetic comparison of two oral liquid glucocorticoid formulations.
Kamada, AK; LaVallee, NM; Scott, MB; Selner, JC; Szefler, SJ; Wiener, MB,
)
0.36
"Fluticasone propionate is a glucocorticoid with negligible oral bioavailability and very low intranasal bioavailability that is used as an intranasal spray for the treatment of rhinitis."( Effect of fluticasone propionate aqueous nasal spray versus oral prednisone on the hypothalamic-pituitary-adrenal axis.
Dockhorn, RJ; Field, EA; Findlay, SR; Korenblat, PE; Kral, KM; Vargas, R, 1998
)
0.54
" No correlation was found between the degree of gastrointestinal damage and the presumed bioavailability of co-trimoxazole as estimated from serum levels of trimethoprim and sulphamethoxazole."( Gastrointestinal damage induced by cytostatic treatment does not affect the bioavailability of co-trimoxazole.
Höglund, P; Johnsson, A; Ljungberg, B; Nilsson-Ehle, I; Nyhlén, A,
)
0.13
"Prednisone and methylprednisolone are well absorbed orally and have lower treatment costs than IV methylprednisolone, but concern that low-dose corticosteroid may cause increased disease activity and that high oral doses may cause gastric ulceration inhibits use of oral therapy for MS attacks."( Gastric tolerance of high-dose pulse oral prednisone in multiple sclerosis.
Enns, R; Hilsden, RJ; Meddings, JB; Metz, LM; Sabuda, D, 1999
)
2.01
"The quantitative structure-bioavailability relationship of 232 structurally diverse drugs was studied to evaluate the feasibility of constructing a predictive model for the human oral bioavailability of prospective new medicinal agents."( QSAR model for drug human oral bioavailability.
Topliss, JG; Yoshida, F, 2000
)
0.31
"Oral budesonide in adult studies is a potent corticosteroid with decreased systemic bioavailability and an improved adverse effect profile in comparison with prednisone."( Benign intracranial hypertension associated with budesonide treatment in children with Crohn's disease.
Ballin, A; Bujanover, Y; Hager, H; Lerman-Sagie, T; Levine, A; Watemberg, N, 2001
)
0.51
"To quantify the influence of a high-fat meal on the oral bioavailability of the immunosuppressant everolimus in a single-dose study in healthy subjects and to confirm the results in a small food-effect screening assessment in patients with renal transplants who were receiving multiple-dose everolimus."( Effect of food on everolimus absorption: quantification in healthy subjects and a confirmatory screening in patients with renal transplants.
Budde, K; Figueiredo, J; Golor, G; Hartmann, S; Kovarik, JM; Lison, A; Neumayer, HH; Rordorf, C, 2002
)
0.31
" The results of these studies indicate that prednisone has poor efficacy for the treatment of heaves because it is poorly absorbed and the active metabolite prednisolone is rarely produced."( Prednisone per os is likely to have limited efficacy in horses.
Kollias-Baker, C; Peroni, DL; Robinson, NE; Stanley, S, 2002
)
2.02
"As a part of a steroid-sparing clinical trial, we studied the effect of steroids on MPA bioavailability in 26 kidney transplant recipients."( Glucocorticoids interfere with mycophenolate mofetil bioavailability in kidney transplantation.
Cattaneo, D; Gaspari, F; Gotti, E; Perico, N; Remuzzi, G, 2002
)
0.31
" Bioavailability of cyclosporin (CsA) has been implicated as a possible contributing factor."( Effect of cyclosporin pharmacokinetics on renal allograft outcome in African-Americans.
Browne, BJ; Emovon, OE; Holt, CO; Howell, D; King, JA; Singleton, B, 2003
)
0.32
" Interaction between copper and other stressors operating only in the field probably balance the higher bioavailability in spiked soil."( Effect of a copper gradient on plant community structure.
Attrill, MJ; Axelsen, JA; Jensen, J; Pedersen, MB; Strandberg, B, 2006
)
0.33
" Human oral bioavailability is an important pharmacokinetic property, which is directly related to the amount of drug available in the systemic circulation to exert pharmacological and therapeutic effects."( Hologram QSAR model for the prediction of human oral bioavailability.
Andricopulo, AD; Moda, TL; Montanari, CA, 2007
)
0.34
"In the setting of a controlled clinical study, the co-administration of GFJ with FK506 increased the bioavailability of FK506."( Co-administration of grapefruit juice increases bioavailability of tacrolimus in liver transplant patients: a prospective study.
Liu, C; Liu, XM; Lv, Y; Ma, F; Shang, YF; Wang, B; Wu, Z; Yu, L; Zhang, XF; Zhang, XG, 2009
)
0.35
"Sunitinib is an orally bioavailable small molecule that inhibits multiple receptor tyrosine kinases."( Successful desensitization protocol for hypersensitivity reaction caused by sunitinib in a patient with a gastrointestinal stromal tumor.
Atrash, F; Bar-Sela, G; Hadad, S; Haim, N; Kedem, E; Pollack, S; Shahar, E, 2010
)
0.36
"Defibrotide is a novel orally bioavailable polydisperse oligonucleotide with anti-thrombotic and anti-adhesive effects."( Melphalan, prednisone, thalidomide and defibrotide in relapsed/refractory multiple myeloma: results of a multicenter phase I/II trial.
Anderson, K; Benevolo, G; Boccadoro, M; Bringhen, S; Cavallo, F; Gaidano, G; Gay, F; Genuardi, M; Iacobelli, M; Kotwica, K; Larocca, A; Magarotto, V; Masini, L; Mitsiades, C; Palumbo, A; Richardson, P; Rossi, D; Rus, C, 2010
)
0.75
"Oral bioavailability (F) is a product of fraction absorbed (Fa), fraction escaping gut-wall elimination (Fg), and fraction escaping hepatic elimination (Fh)."( Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
Chang, G; El-Kattan, A; Miller, HR; Obach, RS; Rotter, C; Steyn, SJ; Troutman, MD; Varma, MV, 2010
)
0.36
" Hepatic biotransformation of 1α,25(OH)(2)D(3) by cytochrome P450 (P450) enzymes could be an important determinant of bioavailability in serum and tissues."( Cytochrome P450 3A-mediated microsomal biotransformation of 1α,25-dihydroxyvitamin D3 in mouse and human liver: drug-related induction and inhibition of catabolism.
Adomat, H; Deb, S; Guns, ES; Pandey, M, 2012
)
0.38
" Administration after a full or light meal did not affect pharmacokinetic characteristics, but bioavailability was reduced under fasted conditions."( Pharmacokinetics of modified-release prednisone tablets in healthy subjects and patients with rheumatoid arthritis.
Clarke, L; Derendorf, H; Kirwan, JR; Ruebsamen, K; Schaeffler, A, 2013
)
0.66
" Findings suggest low comparative bioavailability of oral prednisone compared to prednisolone in cats and consideration of lean body mass or ideal body weight for dosing practices."( Influence of body condition on plasma prednisolone and prednisone concentrations in clinically healthy cats after single oral dose administration.
Center, SA; Randolph, JF; Rishniw, M; Simpson, KW; Warner, KL, 2013
)
0.88
"Cyclosporine exhibits pharmacokinetic and pharmacodynamic variability in renal transplant recipients (RTR) attributed to P-glycoprotein (P-gp), an ABCB1 efflux transporter that influences bioavailability and intracellular distribution."( Sex differences in cyclosporine pharmacokinetics and ABCB1 gene expression in mononuclear blood cells in African American and Caucasian renal transplant recipients.
Brazeau, D; Danison, R; DiFrancesco, R; Dole, K; Gillis, K; Gundroo, A; Leca, N; Tornatore, KM; Venuto, RC; Wilding, G; Zack, J, 2013
)
0.39
" Our results demonstrate that DSMs can be considered as a non-cytotoxic biomaterial with high potential to improve the mesalamine and prednisone bioavailability by sustaining the drug release and enhancing drug permeability."( Diatom silica microparticles for sustained release and permeation enhancement following oral delivery of prednisone and mesalamine.
da Silva, TH; Hirvonen, JT; Mäkilä, EM; Reis, RL; Salonen, JJ; Santos, HA; Shahbazi, MA; Zhang, H, 2013
)
0.81
"Oral dexamethasone demonstrates bioavailability similar to that of oral prednisone but has a longer half-life."( A Randomized Controlled Noninferiority Trial of Single Dose of Oral Dexamethasone Versus 5 Days of Oral Prednisone in Acute Adult Asthma.
Alter, HJ; Lam, J; Liu, B; Rehrer, MW; Rodriguez, M, 2016
)
0.88
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51
" Primary DLBCL of the central nervous system (CNS) (primary central nervous system lymphoma [PCNSL]) is an exception because of the low CNS bioavailability of related drugs."( Improving the antitumor activity of R-CHOP with NGR-hTNF in primary CNS lymphoma: final results of a phase 2 trial.
Angelillo, P; Anzalone, N; Bordignon, C; Calimeri, T; Cattaneo, D; Ciceri, F; Citterio, G; Conte, GM; Corti, A; Curnis, F; De Lorenzo, D; Fallanca, F; Ferreri, AJM; Foppoli, M; Guggiari, E; Lopedote, P; Nonis, A; Politi, LS; Ponzoni, M; Rrapaj, E; Sassone, M; Scarano, E; Steffanoni, S; Tarantino, V, 2020
)
0.56
" Predictably, the excretion trend of the analytes of interest were generally comparable with those obtained after oral administration, even if the excretion profile showed a broad interindividual variability, with the absorption rate and the systemic bioavailability after rectal administration being strongly influenced by the type of formulations (suppository or rectal cream, in our case) as well as the physiological conditions of the absorption area."( Urinary excretion profile of prednisolone and prednisone after rectal administration: Significance in antidoping analysis.
Botrè, F; Colamonici, C; Comunità, F; Curcio, D; de la Torre, X; Iannella, L; Mazzarino, M, 2022
)
0.98

Dosage Studied

The mean daily dosage of prednisone (or its equivalent) was 8. The acyclovir dosage was 2400 mg (800 mg three times a da.

ExcerptRelevanceReference
" The common liquid dosage preservatives methylparaben, propylparaben, and sodium benzoate do not interfere with quantitative prednisolone, prednisone, and hydrocortisone determinations."( High-pressure liquid chromatographic evaluation of aqueous vehicles for preparation of prednisolone and prednisone liquid dosage forms.
Gupta, VD, 1979
)
0.68
" Because of rapid progression of the amyloidosis and further infections, cytotoxic drug therapy was stopped, corticosteroid dosage was decreased, and supplementary immunoglobulin therapy was instituted."( Amyloidosis associated with dermatomyositis and features of multiple myeloma. The progression of amyloidosis associated with corticosteroid and cytotoxic drug therapy.
Dawkins, RL; Zilko, PJ, 1975
)
0.25
" The analysis of the maintaining therapy in 22 patients affected with an acute myelocytic leukemia and living for more than 6 months revealed that the interval therapy with a high dosage of cytostatic combinations in the sense of the COAP scheme is preferable compared with the daily administration of 6-mercaptopurin, in addition methotrexate twice a week."( [Problems in maintenance therapy in acute myeloid leukemias in adults].
Gürtler, R; Raderecht, C, 1975
)
0.25
" The development of interstitial pneumopathy after this low bleomycin dosage may have been favored by a previous thorax irradiation 22 years earler for round cell sarcoma."( [Interstial pneumopathy after low dose bleomycin therapy].
Frey, F; Marone, C; Zimmermann, A, 1977
)
0.26
" The frequency of infection was significantly lower among the patients on the PEPA program, and dosage escalation of the chemotherapeutic agents was accomplished more often among these patients."( Protected environment-prophylactic antibiotic program for malignant lymphoma. Randomized trial during chemotherapy to induce remission.
Bodey, GP; Cabanillas, F; Freireich, EJ; Rodriguez, V, 1979
)
0.26
" The test regimen differed from the standard prednisone relapse regimen used by the International Study of Kidney Disease in Children in that the total dosage was about double, and the duration of daily therapy (8 weeks vs."( Nephrotic syndrome in children: a randomized trial comparing two prednisone regimens in steroid-responsive patients who relapse early. Report of the international study of kidney disease in children.
, 1979
)
0.76
" In fact, when the optimum dosage of 75 (mumol/kg)/day x 5 was used, the administration of ara-C alone was followed by an increased life span (ILS) of 45%."( Nucleoside conjugates as potential antitumor agents. 2. Synthesis and biological activity of 1-(beta-D-arabinofuranosyl)cytosine conjugates of prednisolone and prednisone.
Hong, CI; Nechaev, A; West, CR, 1979
)
0.46
" It is concluded that allopurinol should be used only in select patients, and the dosage should be modified if renal disease exists."( Severe hypersensitivity reactions to allopurinol.
Lang, PG, 1979
)
0.26
" At the end of 2 years, the seven patients still taking prednisone were on maintenance dosage of this drug."( Alternate-day prednisone: preliminary report of a double-blind controlled study.
Daube, JR; Duane, DD; Howard, FM; Lambert, EH, 1976
)
0.86
" A longitudinal study of serum ACE activity was found to be an effective way of judging the therapeutic efficacy of various steroid dosage levels."( The specificity and nature of serum-angiotensin-converting enzyme (serum ACE) elevations in sarcoidosis.
Lieberman, J, 1976
)
0.26
" Dosage is initially high (60--100 mg daily, secondarily on alternate days), and should be reduced very slowly, once a definite improvement is achieved."( [Long term administration of oral prednisone or prednisolone in treatment of myasthenia gravis. Report of five cases (author's transl)].
Contamin, F; Ecoffet, M; Mignot, B; Offenstadt, G; Singer, B,
)
0.41
"A 63-year-old man, with a Waldenström's disease discovered by cryoglobulinemia (ischemic lesions of fingers) was quickly aggravating (hyperviscosity syndrome) under treatment by chlorambucil in a dosage of 8 mg daily."( [Polychimiotherapy and Waldenström's macroglobulinemia (author's transl)].
Barrier, J; Bouret, O; Grolleau, JY; Ozanne, P; Renault, JJ,
)
0.13
" 46% complete and 12% partial remissions were obtained in 37 patients treated with cytosine arabinoside and 6-thioguanine doubling the dosage of the above mentioned regimen followed by 3 cycles of TRAP (and COAP)."( [Induction and maintenance treatment of acute myelogenous leukemia in adults by sequential use of combination chemotherapy (author's transl)].
Fülle, HH, 1977
)
0.26
" CA and CYT were each given in the dosage of 120 mg/m2 intravenously, daily in 3 divided doses, for 4 days."( Improved survival in young children with acute granulocytic leukemia treated with combination therapy using cyclophosphamide, oncovin, cytosine arabinoside, and prednisone.
Madanat, FF; Sullivan, MP, 1979
)
0.46
" The amount of improvement correlated linearly with beclomethasone dosage over the range 200 to 1,600 microng/day."( A graded dose assessment of the efficacy of beclomethasone dipropionate aerosol for severe chronic asthma.
Baksh, L; Chuang, L; Errington, N; Haines, DS; Jennings, B; Lefcoe, NM; Toogood, JH, 1977
)
0.26
" The duration of hemodialysis, the age of the patients, and daily dosage of prednisone did not seem to influence the development of cataracts."( Ocular complications after renal transplantation.
Gombos, GM; Kountz, SL; Pfefferman, R, 1977
)
0.49
" Dose-response curves using six concentrations of PHA and five concentrations of cells over 0-5 days revealed a decrease in [(3)H]TdR by stimulated lymphocytes from some SLE patients."( Phytohemagglutinin response in systemic lupus erythematosus. Reconstitution experiments using highly purified lymphocyte subpopulations and monocytes.
Utsinger, PD; Yount, WJ, 1977
)
0.26
" No significant correlations were found between the lipid levels and daily prednisone dosage or with the duration of the period following transplantation."( Abnormal serum lipid patterns in primary renal allograft recipients.
Azen, SP; Blankenhorn, DH; Boothe, S; Chatterjee, SN; Chin, HP; Massry, SG, 1977
)
0.49
" Limited weight bearing and reduction in the dosage of prednisone failed to prevent the progressive destruction of five femoral heads in three patients."( Aseptic necrosis after renal transplantation in children.
Ettenger, RB; Fine, RN; Isaacson, AS; Malekzadeh, MH; Pennisi, AJ; Stanley, P; Uittenbogaart, CH, 1978
)
0.51
" Present knowledge of mechanisms of action and dose-response relationships is complete, and it is difficult to prescribe therapy which will achieve a predictable therapeutic effect without inhibiting growth."( Growth and glucocorticoids in children with kidney disease.
Chesney, R; McEnery, P; Moel, D; Pennisi, A; Potter, D; Talwalkar, YB; Travis, LB; Wolff, E, 1978
)
0.26
" A therapeutic program, which included high dose corticosteroids initially, the combinations of azathioprine with corticosteroids chronically, and the rapid reduction in corticosteroid dosage to an alternate day schedule, appears to contribute to improved survivorship."( Longterm survival of lupus nephritis patients treated with azathioprine and prednisone.
Barnett, EV; Dornfeld, L; Lee, DB; Liebling, MR, 1978
)
0.49
" Haemodialysis was started, cytotoxic drugs were stopped, and steroid dosage was reduced."( Haemodialysis and transplantation in Wegener's granulomatosis.
Alexandre, GP; Pirson, Y; van Ypersele de Strihou, C; Vandenbroucke, JM, 1979
)
0.26
" Dosage in such patients should be reduced in accordance with serum albumin concentration."( Corticosteroid pharmacokinetics in liver disease.
Go, VL; Uribe, M,
)
0.13
" Our results suggest that high dosage of prednisone decreases the renal blood flow and this adverse effect has to be considered in the therapy."( Effect of high-dose prednisone on renal hemodynamics of normal and transplanted dog kidneys.
Althaus, P; Horpácsy, G; May, G; Mebel, M; Schuldt, HH, 1979
)
0.85
" Group III (n = 4) dogs were not operated upon and received all drugs in full dosage in order to test any direct toxic effect on normal kidneys."( Cimetidine for kidney transplantation: experimental observations.
Toledo-Pereyra, LH; Zammit, M, 1979
)
0.26
" Our data suggest that for optimal graft and patient survival the dosage of steroids should be less than 150 mg/day of methylprednisolone on days 1-3, less than 50 mg/day of prednisone on days 4-21, less than 30 mg/day on days 22-30, and less than 20 mg/day between one mo and one yr."( Steroid treatment for routine immunosuppression in cadaver renal transplantation. A survey of hospitals.
Gonzalez, FM; Kodlin, D; Kumar, P; Leech, SH,
)
0.32
" steroid was required, but the steroid dosage requirement then rebounded in the 2 weeks after the end of the prescribed treatment period."( Antithymocyte globulin (ATGAM) in renal allograft recipients. Multicenter trials using a 14-dose regimen.
Brodie, JA; Morrell, RM; Rafi, M; Schultz, JR; Wechter, WJ, 1979
)
0.26
" The lesion regressed over a four-month period with high dosage corticosteroid therapy, but he developed optic atrophy and visual acuity of no light perception."( Ocular sarcoidosis occurring as a unilateral optic disk vascular lesion.
Noble, KG, 1979
)
0.26
" In four occasions, excessive dosage of vitamine D impaired the evolution of a previous nephropathy."( [Hypervitaminosis D. Review of fifteen cases].
Callís, L; Castelló, F; Nieto, JL; Vilaplana, E, 1979
)
0.26
"A novel computerized automated system is described which conforms to the basic requirements set forth in the compendia for testing the dissolution characteristics of solid dosage forms."( ADS-12: an automated programmable 12-tablet dissolution testing system.
Bendrot, H; Cioffi, FJ; Martynovych, S, 1979
)
0.26
"A case is described of severe systemic lupus erythematosus, uncontrolled with moderate dosage of corticosteroid and cyclophosphamide, which responded quickly after 3 courses of plasmapheresis."( Plasmapheresis combined with corticosteroids and cyclophosphamide in uncontrolled active systemic lupus erythematosus.
Dequeker, J; Schildermans, F; Van de Putte, I,
)
0.13
"The stability of liquid dosage forms of ethacrynic acid (1 mg/ml), indomethacin (2 mg/ml), methyldopate hydrochloride (25 mg/ml), prednisone (0."( Stability of pediatric liquid dosage forms of ethacrynic acid, indomethacin, methyldopate hydrochloride, prednisone and spironolactone.
Das Gupta, V; Ghanekar, AG; Gibbs, CW, 1978
)
0.68
"Twenty-three children with idiopathic, relapsing minimal lesion nephrotic syndrome were divided according to their pattern of response to prednisone: (1) steroid dependent, if the relapse occurred while the dosage of prednisone was being decreased; and (2) frequent relapser, if the relapse occurred at variable periods of time (one week to two months) after discontinuing prednisone therapy."( Pattern of response to prednisone in idiopathic, minimal lesion nephrotic syndrome as a criterion in selecting patients for cyclophosphamide therapy.
Fennell, RS; Garin, EH; Pryor, ND; Richard, GA, 1978
)
0.77
" The dosage of corticosteroids ingested during the initial period of therapy in patients with AN was tabulated and compared with that of 25 SLE control patients."( Aseptic necrosis of bone in systemic lupus erythematosus. Relationship to corticosteroid therapy.
Abeles, M; Rothfield, NF; Urman, JD, 1978
)
0.26
"The utilization of ternary sugar solid dispersion systems and the incorporation of these systems into tablet dosage forms were investigated."( Dissolution rates of hydrocortisone and prednisone utilizing sugar solid dispersion systems in tablet form.
Allen, LV; Levinson, RS; Martono, DD, 1978
)
0.53
" There appeared to be some correlation between dosage and degree of apparent atrophy."( Steroids and apparent cerebral atrophy on computed tomography scans.
Bentson, J; Reza, M; Wilson, G; Winter, J, 1978
)
0.26
"The average prednisone dosage of 54 corticosteroid-dependent asthmatics was computed for one year prior to initiation of beclomethasone dipropionate."( Long-term effects of beclomethasone dipropionate on prednisone dosage in the corticosteroid-dependent asthmatic.
Bacal, E; Patterson, R, 1978
)
0.89
" Following intensive round-the-clock therapy with theophylline (the dosage of which maintained serum levels of theophylline between 10 microgram/ml and 20 microgram/ml) and therapy with prednisone (20 mg twice daily for three weeks or more), there were improvements in spirometric and body plethysmographic measurements."( Irreversibility of obstructive changes in severe asthma in childhood.
Bell, TD; Buck, VM; Chai, H; Cooley, RL; Leung, PK; Loren, ML, 1978
)
0.45
" Serial MEVs were not only useful for prognosis, but also helpful in regulating the dosage of prednisone."( Prognostic value of minimal excitability of facial nerve in Bell's palsy.
Challenor, Y; Devi, S; Duarte, N; Lovelace, RE, 1978
)
0.48
" Thereafter, this therapy may need to be continued, often at an extremely low dosage level, sometimes intermittently, for many years before the hemoglobin value maintains itself without medication."( Congenital hypoplastic anemia.
Alter, BP; Diamond, LK; Wang, WC, 1976
)
0.26
"A renal transplant service is described in which the pharmacist attends daily rounds, monitors drug dosage and conducts a medication instruction program aimed at improving patient compliance."( Pharmacist involvement as a member of a renal transplant team.
Mitchell, JF, 1976
)
0.26
" in the same dosage in combination with heparin 5000 U/day."( Treatment of acute allograft rejection with high doses of corticosteroids.
Alarcon-Zurita, A; Ladefoged, J, 1976
)
0.26
" Serum cholesterol and triglyceride levels could both be related to the dosage of prednisone these patients received."( Hyperlipidemia following renal transplantation.
Alfrey, AC; Ibels, LS; Subryan, V; Weil, R, 1976
)
0.48
" Allergic nasal symptoms were disabling in many patients when the oral dosage of corticosteroids was tapered."( Beclomethasone dipropionate aerosol in the treatment of steroid-dependent asthma. A 12-week double-blind study comparing beclomethasone dipropionate and a vehicle aerosol.
Harvey, LL; Kass, I; Nair, SV, 1976
)
0.26
" Serious complications and mortality could be related to high dosage of steroids and severe leukopenia."( Influence of rejection on graft survival after renal transplantation.
Black, HR; Finkelstein, FO; Lytton, B; Schiff, M, 1976
)
0.26
" Serious complications and mortality could be related to high dosage of steroids and severe leukopenia."( Influence of rejection on graft survival after renal transplantation.
Black, HR; Finkelstein, FO; Lytton, B; Schiff, M, 1975
)
0.25
" Depression of RES phagocytosis could be related to total steroid dosage in the previous year and to the patients liability to bacterial infections."( Altered reticuloendothelial function in long-term renal allograft recipients.
Drivas, G; Pulman, L; Uldall, PR; Wardle, N, 1976
)
0.26
" As a consequence, shorter dosing intervals of these drugs seems to be advisable, rather than a reduction in the total daily dose."( Drug protein binding and the nephrotic syndrome.
Azarnoff, DL; Gugler, R, 1976
)
0.26
" Mortality and morbidity closely correlated with the corticosteroid dosage used to attain control."( Pemphigus: a 20-year review of 107 patients treated with corticosteroids.
Nelson, CT; Rosenberg, FR; Sanders, S, 1976
)
0.26
" Collaborators were supplied with 4 composites of tablets of different dosage levels, 2 containing prednisolone and 2 containing prednisone."( Collaborative study of a semiautomated method for the analysis of prednisolone and prednisone tablets.
Brower, JF, 1977
)
0.69
" Tolerable dosage levels of both regimens have been defined for future clincial trials."( Pilot study of two adriamycin-based regimens in patients with advanced malignant lymphomas.
Kiely, JM; O'Connell, MJ; Silverstein, MN; White, WL,
)
0.13
" tcoherin has proven efficacious by three criteria: As a result of coherin treatment those patients receiving steroids could either eliminate them or reduce the dosage to safe levels."( Long-term results in the treatment of regional ileitis with coherin.
Goodman, I; Hiatt, RB, 1977
)
0.26
"Twenty-three steroid-dependent severely asthmatic patients, ranging in age from 20 to 67 years, tolerated reduction in their oral dosage of steroids during a one-year trial of triamcinolone acetonide aerosol."( A one-year trial of triamcinolone acetonide aerosol in severe steroid-dependent asthma.
Chmelik, F; doPico, G; Kriz, RJ; Reed, CE, 1977
)
0.26
" The corticosteroid dosage was proportional to each patient's weight."( Reversibility of corticosteroid-associated cataracts in children with the nephrotic syndrome.
Forman, AR; Loreto, JA; Tina, LU, 1977
)
0.26
"Analysis of the response to corticosteroid therapy in a personal series of 8 consecutive cases of dermatomyositis in childhood shows that there are advantages in a moderate dosage, short-term treatment schedule, with gradual tapering of the dosage as soon as there is clinical improvement without waiting for full remission, and in trying to stop steroid therapy within six months rather than following the more prolonged regimen currently still in vogue."( Treatment of dermatomyositis in childhood.
Dubowitz, V, 1976
)
0.26
"A patient with idiopathic thrombocytopenia purpura who was treated with high dosage corticosteroids for ten years, developed 18 separate lesions of avascular necrosis in 12 different bones."( Steroid induced avascular necrosis of bones in eighteen sites: a case report.
Milgram, JW; Riley, LH, 1976
)
0.26
" The effect of treatment was to allow a reduction in corticosteroid dosage and a sustained remission of disease activity in patients."( Rheumatoid arthritis treated with chlorambucil: a five-year follow-up.
Thorpe, P, 1976
)
0.26
" Ovarian over-stimulation was directly related to the dosage of clomiphene, and the increased levels of 17 alpha-hydroxyprogesterone thus produced persisted into the seventh week of pregnancy."( Corpus luteum function during pregnancies of previously infertile women.
Gentry, WC; Karow, WG, 1976
)
0.26
" Prednisone at a dosage of approximately 1 mg/kg daily by the oral route produced significant reduction of this phenomenon only when commenced 2 weeks before inoculation."( The peritoneal reaction to starch and its modification by prednisone.
Cade, D; Ellis, H, 1976
)
1.41
" She was treated with high dosage corticosteroids and incurred severe side effects, including bone marrow depression, renal magnesium stones, osteoporosis, depression of affect, convulsions with cerebral damage and adrenal suppression."( Unwanted corticosteroid effects in childhood bone marrow failure, renal failure and brain damage: case report.
Gillies, AH; Shellshear, ID, 1975
)
0.25
" Although azathioprine does not confer dramatic benefit upon patients with chronic ulcerative colitis who require steroids, it does permit reduction of steroid dosage without apparent worsening of the disease."( A controlled trial of azathioprine in the management of chronic ulcerative colitis.
Binder, HJ; Kirsner, JB; Levin, B; Rosenberg, JL; Wall, AJ, 1975
)
0.25
" The mean reduction in steriod dosage in the azathioprine group at the end of the trial (-15."( A controlled trial of azathioprine in Crohn's disease.
Kirsner, JB; Levin, B; Rosenberg, JL; Wall, AJ, 1975
)
0.25
" The dosage of prednisone during the first posttransplant year corrected for patient weight showed a significant correlation with the development of PSC during the first posttransplant year."( Posterior subcapsular cataracts: posttransplantation in children.
Fine, RN; Malekzadeh, MH; Mickey, MR; Offner, G; Pennisi, AF; Wilson, WA, 1975
)
0.61
"001--and with a variety of other measurements of bronchial dynamics and lung volumes, suggesting that the total eosinophil count reflects asthmatic activity and is useful for regulating steroid dosage and for early detection of exacerbations."( Total eosinophil counts in the management of bronchial asthma.
Horn, BR; Robin, ED; Theodore, J; Van Kessel, A, 1975
)
0.25
" Functional psychosis was usually preciptated by corticsoteroid therapy and respond to a reduction in steroid dosage and administration of psychotropic drugs."( Central nervous system disease in systemic lupus erythematosus. Therapy and prognosis.
Klempner, MS; Lipsky, BA; Lockshin, MD; Sergent, JS, 1975
)
0.25
" Prednisone in high dosage was associated in this series with 9 deaths and in 6 patients, with renal failure or an extra-renal complication."( [Lupus nephropathy. Treatment with the indomethacin-hydroxychloroquine combination and comparison with corticoids].
Conte, JJ; Fournie, GJ; Mignon-Conte, MA, 1975
)
1.16
" Dosage adjustments were often necessary during the initial phases of therapy."( A controlled study in the use of combined drug therapy for metastatic breast cancer.
Alberto, P; Brunner, KW; Martz, G; Obrecht, P; Senn, HJ; Sonntag, RW, 1975
)
0.25
" Methodology and dosage schemes are discussed."( Towards curative treatment of advanced Hodgkin's disease.
Falkson, G; Falkson, HC, 1975
)
0.25
" Addition of pg quantities of [3H]-prednisolone following oral dosage with prednisone or prednisolone."( Measurement of plasma prednisolone in man.
May, CS; Paterson, JW; Ssendagire, R; Wilson, CG, 1975
)
0.48
" Radical excision of the tumor, if possible, and the remaining thymus, high dosage alternate day prednisone, and radiation therapy, if indicated, seem the treatments of choice."( Myasthenia gravis and invasive thymoma: a 20-year experience.
Brown, WJ; Goldman, AJ; Herrmann, C; Keesey, JC; Mulder, DG, 1975
)
0.47
" A dose of 10-15 mg per day may be considered marginal for the development of cataract; dosage has no basic effect on the development of glaucoma."( [Ophthalmic complications in general corticoid therapy].
Cepilová, Z; Krchnavá, B; Porubská, M; Slámová, J, 1991
)
0.28
" Initial dosage was 500 mg, and the dose was escalated provided the total white blood cell count remained > 3,000 cells per cubic millimeter."( Use of intermittent, intravenous cyclophosphamide for idiopathic pulmonary fibrosis.
Baughman, RP; Lower, EE, 1992
)
0.28
" This was associated with a significant fall in the average prednisone dosage from 32 +/- 13."( Use of intermittent, intravenous cyclophosphamide for idiopathic pulmonary fibrosis.
Baughman, RP; Lower, EE, 1992
)
0.53
"Intermittent, intravenous cyclophosphamide therapy was associated with improved pulmonary function and reduced corticosteroid dosage in patients with idiopathic pulmonary fibrosis who survived at least six months after institution of therapy."( Use of intermittent, intravenous cyclophosphamide for idiopathic pulmonary fibrosis.
Baughman, RP; Lower, EE, 1992
)
0.28
" coli L-asparaginase (L-ase) in the induction phase at a dosage of 6000 U/m2/day x 7 d starting on d 15, as well as vincristine, prednisone, daunorubicin and cyclophosphamide, the last-named by random 1:1."( Incidence of thrombotic complications in adult patients with acute lymphoblastic leukaemia receiving L-asparaginase during induction therapy: a retrospective study. The GIMEMA Group.
Annino, L; Defazio, D; Gugliotta, L; Leone, G; Mandelli, F; Mattioli-Belmonte, M; Mazzucconi, MG; Tura, S, 1992
)
0.49
" Patients received prednisone, at a dosage of 40 mg/d, for 4 weeks."( Prevention of anticardiolipin antibody-related pregnancy losses with prednisone and aspirin.
Angel, J; Espinoza, LR; Hubble, CL; Jara, LJ; Martínez-Osuna, P; O'Brien, W; Saway, S; Seleznick, MJ; Silveira, LH, 1992
)
0.85
" In 11 of the 12, the prednisone dosage could eventually be tapered to < or = 5 mg/day."( Methotrexate treatment of recalcitrant childhood dermatomyositis.
DeNardo, BA; Miller, LC; Schaller, JG; Sisson, BA; Tucker, LB, 1992
)
0.6
" Both disease remission and a reduction in corticosteroid dosage were obtained in four patients."( Treatment of idiopathic inflammatory myopathies with cyclophosphamide pulses: clinical experience and a review of the literature.
De Vita, S; Fossaluzza, V, 1992
)
0.28
" Also this result differs from what most authors have observed: they maintain that Horton's arteritis has become rather resistant to the cortisone therapy and required high dosage for a very long time."( [Horton's bitemporal arteritis. A case report].
Carmenini, G; Di Maio, F; Martusciello, S; Meloni, F; Nicoletti, M; Scioli, A, 1992
)
0.28
" Three months previously (having symptoms of polymyalgia rheumatica) she had started treatment with a low dosage of prednison."( [Temporal arteritis without histological changes].
Bomholt, C; Dietrichson, O; Prause, JU, 1992
)
0.28
" In protocol ALL VIII/87 the only modification was the reduction of the MTX dosage from 5 g/m2 to 1 g/m2 with an infusion time of 24 hours (leucovorin rescue 15 mg/m2 after 48 and 54 hours)."( [Experiences with modified BFM protocols in the treatment of children with acute lymphoblastic leukemia (ALL) in East Germany 1981-1991].
Domula, M; Dörffel, W; Eggers, G; Exadaktylos, P; Hermann, J; Hilgenfeld, E; Kotte, W; Malke, H; Reimann, M; Zintl, F,
)
0.13
" Larger numbers of patients will be needed to ascertain whether specific guidelines for dosage modifications can be made on the basis of serial WBC."( Relapse in acute lymphoblastic leukemia as a function of white blood cell and absolute neutrophil counts during maintenance chemotherapy.
Blatt, J; Gula, MJ; Lucas, K,
)
0.13
" After each period, dose-response curves were measured on 4 study days with doubling doses of salbutamol, ipratropium, a combination of salbutamol and ipratropium, and placebo until a plateau in FEV1 was reached."( Separate and combined effects of corticosteroids and bronchodilators on airflow obstruction and airway hyperresponsiveness in asthma.
Alting-Hebing, D; Breederveld, N; Koëter, GH; Postma, DS; van der Mark, TW; Wempe, JB, 1992
)
0.28
" Long-term use of alternate-day prednisone in high dosage appears to be the most efficacious regimen in both controlled and uncontrolled studies."( Idiopathic membranoproliferative glomerulonephritis in childhood.
West, CD, 1992
)
0.57
" Works carried out by the Canadian research worker Toogood have addressed the question of the equivalent clinical dosing potency of inhaled and oral steroids."( [Oral and inhaled corticoid therapy. Rivals or partners?].
Lacronique, J, 1992
)
0.28
" Prednisone was used in 17 cases, high dosage of methylprednisolone in 8 (in one case twice), azathioprine in 11 and cyclophosphamide in 10."( Immunosuppressive treatment for juvenile myasthenia gravis.
Badurska, B; Ryniewicz, B; Strugalska, H, 1992
)
1.19
" The results of this study indicate that 6 weeks of treatment with 220 micrograms/day or 440 micrograms/day of ITAA has no effect on adrenocortical function, but prednisone, at a dosage of 10 mg/day for 6 weeks, produces partial adrenocortical suppression."( A comparative study of the effects of intranasal triamcinolone acetonide aerosol (ITAA) and prednisone on adrenocortical function.
Dockhorn, R; Ellis, E; Feiss, G; Mansfield, L; Morris, R; Rom, D; Smith, JA; Tobey, RE, 1992
)
0.7
" The latency period between the steroid therapy and the occurrence of AON ranged from 12 to 60 months; steroid therapy lasted for 12 to 16 days with a total dosage equivalent to 2370-7180 mg prednisolone."( [Craniocerebral trauma and aseptic osteonecrosis. Steroid-induced sequelae after therapy of brain edema].
Griss, P; Pfeiffer, M, 1992
)
0.28
" In those treated for two months or longer, the mean total serum IgE level fell from 2,462 U/ml (CI, 752 to 4,202 U/ml) to 502 U/ml (CI, 123 to 880 U/ml) during each course, and the mean daily steroid dosage was decreased to a mean of 24 mg/day (CI, 11 to 37 mg/day)."( Adjunctive therapy of allergic bronchopulmonary aspergillosis with itraconazole.
Denning, DW; Lewiston, NJ; Stevens, DA; Van Wye, JE, 1991
)
0.28
"Two hundred dogs with pituitary dependent hyperadrenocorticism (PDH) were treated with mitotane at an initial daily dosage of 21 to 69 mg/kg (mean = 45."( Mitotane (o,p'-DDD) treatment of 200 dogs with pituitary-dependent hyperadrenocorticism.
Kintzer, PP; Peterson, ME,
)
0.13
" In a multivariate analysis where both disease-related and treatment-related factors were taken into account drug dosage remained a significant prognostic factor."( Treatment of Hodgkin's disease with MOPP chemotherapy: effect of dose and schedule modification on treatment outcome.
Bezwoda, MA; Bezwoda, WR; Dansey, R, 1990
)
0.28
" The results failed to show that prednisone at this dosage and frequency was of any benefit either in the short-term clinical response or in the long-term follow-up with regard to later requirement of valvular surgery (using the 5% level of significance)."( A double-blind placebo-controlled trial of prednisone in active rheumatic carditis.
Haffejee, IE; Moosa, A, 1990
)
0.82
" EPVP II is given every 21 days with increased dosage and increased intensity of epirubicin."( Novel combination of epirubicin, bleomycin, vinblastine and prednisone (EBVP II) before radical radiotherapy in localized stages (I-IIIA) of Hodgkin's disease. Early results in 100 consecutive patients. Pierre-et-Marie-Curie Group.
Blanc, CM; David, B; Eghbali, H; Hoerni, B; Orgerie, MB; Rojouan, J; Zittoun, R, 1991
)
0.52
"5 micrograms/kg/day, sc), which significantly shortened the duration of neutropenia and decreased the number of days with episodes of fever when compared with those not given rhG-CSF, consequently facilitating the treatment without prolonging the dosing intervals."( [The COP-BLAM III therapy of non-Hodgkin's lymphoma].
Arai, N; Hara, A; Shirai, T; Umeda, M, 1991
)
0.28
" Postoperatively, all received daily doses of cyclosporine (15 mg/kg) and azathioprine (1 mg/kg) and were subdivided into three steroid dosage groups."( Normal bronchial healing without bronchial wrapping in canine lung transplantation.
Auteri, JS; Jeevanandam, V; Kirby, TJ; Marboe, CC; Sanchez, JA; Smith, CR, 1992
)
0.28
" Twelve patients remained in the study at the 84-month visit; the mean weekly dosage of MTX was 10."( Long-term prospective study of methotrexate in the treatment of rheumatoid arthritis. 84-month update.
Coblyn, JS; Falchuk, KR; Fraser, PA; Holdsworth, DE; Maier, AL; Weinblatt, ME; Weissman, BN, 1992
)
0.28
" The progressive reduction of corticosteroid dosage led rapidly to a distinct improvement, but not to a remission, of symptoms."( Steroid myopathy: clinical and immunohistochemical study of a case.
Camporeale, FS; Carandente, M; Cioffi, M; Gentile, A; Marolda, M; Orsini, AV; Palma, V, 1991
)
0.28
" In a separate group of ten patients whose previous reactions to RCM were life threatening (shock), pretreatment was accompanied by a provocative dosing regimen."( Comparison of three pretreatment protocols to prevent anaphylactoid reactions to radiocontrast media.
Lieberman, PL; Marshall, GD, 1991
)
0.28
" Our results suggest that CsA at normal dosage has no clinically important effect on beta-cell function."( Cyclosporine's effect on insulin secretion in patients with kidney transplants.
Casamitjana, R; Esmatjes, E; Ferrer, JP; Oppenhaimer, F; Ricart, MJ; Vilardell, J, 1991
)
0.28
" 15% of previously untreated myeloma patients achieve a clinical response to IFN alpha alone with a possible dose-response relationship."( Treatment of multiple myeloma with interferon alpha: the Scandinavian experience.
Björeman, M; Björkholm, M; Brenning, G; Gahrton, G; Grimfors, G; Gyllenhammar, H; Hast, R; Juliusson, G; Mellstedt, H; Osterborg, A, 1991
)
0.28
" We also found that neither patient assessment of severity of symptoms nor corticosteroid dosage correlate with objective spirometric measurements."( Variability of pulmonary function tests in stable corticosteroid dependent asthma patients.
Garb, KS; Kinney, JL; Klaustermeyer, WB; Santiago, SM,
)
0.13
" Pulmonary function was assessed and dosage of prednisone and BDP (or P) were adjusted every 15 days according to a clinical score."( High-dose beclomethasone: oral steroid-sparing effect in severe asthmatic patients.
Georges, D; Henry-Amar, M; Lacronique, J; Marsac, J; Renon, D, 1991
)
0.54
" Newly diagnosed patients with ITP received the usual prednisone therapy, 1 mg/kg/day, for 3 weeks, after which period the dosage was tapered off."( Effect of high-dose dexamethasone in prednisone-resistant autoimmune thrombocytopenic purpura (ITP).
Dubbeld, P; Hillen, HF; van der Heul, C, 1991
)
0.8
" The long-term administration of small dosage of corticosteroid is effective in treating this disease in its active stage."( Clinical studies in 500 patients with aortoarteritis.
Fan, DJ; Liu, LS; Zheng, DY, 1990
)
0.28
" A decrease in or cessation of cyclosporine dosage frequently is used in an attempt to minimize nephrotoxicity."( Highly sensitized patients with delayed graft function: a management protocol.
Hakala, TR; Hickey, DP; Hrebinko, R; Jordan, ML; Lopatin, WB; O'Donovan, R; Vivas, CA, 1991
)
0.28
" In addition to the excellent graft survival obtained through 4 years, lower prednisone and CyA dosage levels are achieved with significantly decreased infection rates during the posttransplant period."( Improved results with combined donor-specific transfusion (DST) and sequential therapy protocol.
Amend, W; Garovoy, M; Husing, R; McVicar, J; Melzer, J; Rabkin, J; Salvatierra, O; Tomlanovich, S; Vincenti, F, 1991
)
0.51
" Higher dosage of prednisolone or prednisone more than 120 mg/day has never been used."( Treatment of pemphigus.
Ophaswongse, S; Piamphongsant, T, 1991
)
0.56
" Fifty-six patients received an oral dosage of 50 mg/kg of aminocaproic acid every 4 hours for 5 days, up to a maximum of 30 g daily, and 56 patients received an oral dosage of 40 mg of prednisone daily (adjusted for weight) in two divided doses."( Aminocaproic acid versus prednisone for the treatment of traumatic hyphema. A randomized clinical trial.
Farber, MD; Fiscella, R; Goldberg, MF, 1991
)
0.78
" To compare alternate-day and daily dosing of prednisone with respect to benefits and adverse side effects, the placebo group was started on alternate-day prednisone therapy, and the treatment group regimens were changed to equivalent doses of alternate-day prednisone without breaking the double-blind nature."( A comparison of daily and alternate-day prednisone therapy in the treatment of Duchenne muscular dystrophy.
Brooke, MH; Fenichel, GM; Griggs, RC; King, W; Mendell, JR; Miller, JP; Moxley, RT; Pestronk, A; Robison, J; Signore, L, 1991
)
0.81
" We conclude that prednisone in moderate dosage has no significant effect on respiratory muscle function in humans, at least in the short term."( Corticosteroid therapy and respiratory muscle function in humans.
Gallagher, CG; Vasquez, A; Wang, YM; Zintel, T, 1991
)
0.62
" After the surgical excision of the mediastinal mass (January, 1989) until now, Behcet's syndrome is in complete remission with a low dosage of prednisone."( Unicentric Castleman's lymphadenopathy presenting with Behçet's syndrome: a case report.
Ambrosetti, A; Bambara, LM; Biasi, D; Frigo, A; Givanni, S; Lunardi, C; Pacor, ML; Peroli, P; Urbani, G,
)
0.33
" Maintenance with the same drugs in a modified dosage schedule continued for approximately 2 years."( Multiagent chemotherapy in relapsed acute lymphoblastic leukemia in children.
Belasco, JB; Luery, N; Scher, C, 1990
)
0.28
" After increasing the dosage of prednisone, she recovered almost completely from this episode."( [Cerebral disseminated lupus erythematosus; brain-racking for patient and physician].
de Glas-Vos, JW; Prins, JM, 1990
)
0.56
" Long-term follow-up studies did not disclose any recurrence of the pituitary granulomatous process nor objective evidence of underlying disease even after steroid dosage has been tapered."( Pituitary granuloma and pyoderma gangrenosum.
Chanson, P; Derome, PJ; Guillausseau, PJ; Kujas, M; Lubetzki, J; Timsit, J; Violante, A; Warnet, A, 1990
)
0.28
" We concluded that SCE analysis did not reveal any evidence suggesting that the dosage of CY used in this study had induced a permanent genetic damage."( Cyclophosphamide-induced sister chromatid exchanges in patients with nephrotic syndrome.
Bogdanović, R; Cvorić, A; Guć-Sśekić, M; Pilić, G, 1990
)
0.28
" Prednisone was administered according to the following dosage schedules: 1) long-term daily, 2) standard intermittent, 3) standard alternate-day, and 4) short-term daily."( Comparison of different regimens of prednisone therapy in frequently relapsing nephrotic syndrome.
Müller-Wiefel, DE; Schärer, K; Wingen, AM, 1990
)
1.46
" ALG dosage modifications were made in order to maintain peripheral CD3+ cells between 10 and 20%."( Antilymphoblast globulin, cyclosporine, and steroids in cadaveric renal transplantation.
Alsina, J; Andres, E; Castelao, AM; Diaz, C; Gil-Vernet, S; Griño, JM; Mestre, M; Sabate, I; Sabater, R; Seron, D, 1990
)
0.28
" Concerning other patients with TA and with PMR a starting dose of 10 to 30 mg depending on the clinical picture then a follow up dosage of 10 and even less, is suggested."( [Polymyalgia rheumatica and temporal arteritis. Observations on prognosis and treatment].
Auquier, L; Paolaggi, JB, 1990
)
0.28
" Therefore, the patients were given prednisone at an initial dosage of 50-100 mg which was subsequently reduced."( [Persisting alveolitis after Legionella pneumonia].
Hürter, T; Lorenz, J; Rumpelt, HJ; Schlegel, J, 1990
)
0.55
" The mean dosage of azathioprin and prednisone in patients with SLE did not significantly differ from the non-SLE group."( [Reactivation of the alpha 1-fetoprotein synthesis in systemic lupus erythematosus].
Knopf, B; Schulze, M; Wollina, U, 1985
)
0.54
" In addition, increasing the dosage of epirubicin did not result in an increase in the haematologic toxicity or percent of CR."( Comparison of CHOP-B vs CEOP-B in 'poor prognosis' non-Hodgkin's lymphomas. A randomized trial.
Brandi, M; Calabrese, P; De Lena, M; Lorusso, V; Maiello, E; Marzullo, F; Mazzei, A; Romito, S, 1989
)
0.28
" Prednisone dosage decreased from 21."( Methotrexate induces clinical and histologic remission in patients with refractory inflammatory bowel disease.
Ball, TJ; Botoman, VA; Gelfand, MD; Kozarek, RA; Patterson, DJ; Wilske, KR, 1989
)
1.19
" Regulation of dosage has to be individualized, and when one reaches the lower dose such as 5 to 10 mg per day, the drug may have to be tapered more slowly, or even maintained at that level for a period of time to prevent further recurrence of symptoms."( Cluster headaches.
Ryan, RE, 1989
)
0.28
" Such a reduction in the TH/S ratio and in the number of circulating suppressor cells was not found in esophagitis due to either HSV or Candida and was unrelated to the serum cyclosporine level or prednisone dosage prescribed."( T-cell populations in liver and renal transplant recipients with infectious esophagitis.
Alexander, J; Brouillette, DE; Chien, MC; Gavaler, J; Tarter, RE; Van Thiel, DH; Yoo, YK, 1989
)
0.47
" The predictive value of mechlorethamine dosage with regard to OS was retained in an analysis restricted to the patients receiving greater than or equal to six cycles of chemotherapy."( Dose intensity of MOPP chemotherapy and survival in Hodgkin's disease.
de Meijer, AJ; Dekker, AW; Haanen, C; van Rijswijk, RE; Verbeek, J, 1989
)
0.28
" Repeated hemoptysis in September 1988 prompted us to add cyclosporine A in a dosage providing whole blood levels of 250-350 ng/ml."( [Rare vascular complications of Behçet's disease (so-called angiobehçet)].
Salvetti, M; Stricker, H, 1989
)
0.28
" It seems possible, however, that high initial dosing of CsA might trigger this complication in the early posttransplant period when other predisposing factors are present."( Allograft renal vascular thrombosis--lack of increase with cyclosporine immunosuppression.
Canafax, DM; Chavers, B; Fryd, DS; Gruber, SA; Matas, A; Najarian, JS; Payne, WD; Simmons, RL, 1989
)
0.28
" These data indicated that hypertension develops in almost all patients after heart transplantation despite the lower dosage of cyclosporine used with the triple-drug immunosuppressive therapy and the absence of significant renal impairment with this regimen, and probably it is not the result of activation of the sympathetic nervous system."( Arterial hypertension in heart transplant recipients treated with triple-drug immunosuppressive therapy.
Antolick, A; Olivari, MT; Ring, WS,
)
0.13
" The first era (1974-1980) consisted of the prophylactic administration of prednisone, Imuran (AZA), and Minnesota antilymphocyte globulin (MAG) with high prednisone dosage used to treat rejection."( Prednisone when used as treatment for rejection correlates with poor outcome.
Bond, O; Callender, CO; Dunston, GM; Flores, J; Gear, JC; John, D; Thompson, C; Toussaint, RM; Walters, CS; Yeager, C, 1989
)
1.95
" Four attempts at reducing this dosage to 1 mg every other day brought about the recurrence of a few bullae and of cutaneous fragility."( [Value of colchicine in treating acquired epidermolysis bullosa].
Berbis, P; Privat, Y, 1989
)
0.28
" The drugs proved equally effective, provided a sufficient dosage was administered."( Bioequivalent doses of budesonide and prednisone in moderate and severe asthma.
Baskerville, J; Jennings, B; Johansson, SA; Lefcoe, NM; Toogood, JH, 1989
)
0.55
" All of the patients had received preliminary treatment with oral NAC in a dosage of 1,200 mg daily (Mucomyst Retard) or a placebo for 22 weeks in a double-blind design."( [Steroid response after long-term treatment with oral N-acetylcysteine in patients with chronic obstructive bronchitis].
Balsløv, S; Brorson-Riis, L; Evald, T; Hansen, M; Hansen, NC; Maltbaek, N; Thorshauge, H, 1989
)
0.28
" Gradual steroid dosage tapering resulted in prompt clinical improvement and marked increases in respiratory muscle strength, maximal inspiratory pressure increasing by 33 percent in one patient and by 70 percent in the other."( Corticosteroid-induced myopathy and the respiratory muscles. Report of two cases.
Decramer, M; Janssens, S, 1989
)
0.28
" The CVPP schedule gave: (1) a constant drug dosage for each patient independent of body surface or weight; and (2) a total drug dosage dependent on haematological tolerance, since the treatment was given for 21 days or until the leukocyte count dropped to 2 x 10(9) l-1."( Influence of dose intensity and density on therapeutic and toxic effects in Hodgkin's disease.
Bonichon, F; Chauvergne, J; de Mascarel, I; Eghbali, H; Hoerni, B; Lagarde, P, 1989
)
0.28
" Childhood dermatomyositis is almost uniformly responsive to steroid treatment; there is a good chance of remission with minimal risk of secondary complications with an initial low dosage of prednisone (1 mg/kg/day)."( [Dermatomyositis in children].
Dumas, R, 1989
)
0.47
" Twenty-five of 39 patients had normal complement levels within six months (Group 1), and immunosuppressive therapy was tapered but continuously readjusted to the lowest dosage that preserved normal CH50 and maintained clinical remission."( Effect of long-term normalization of serum complement levels on the course of lupus nephritis.
Bank, N; Barland, P; Glicklich, D; Grayzel, AI; Laitman, RS; Sablay, LB, 1989
)
0.28
" Our failure to demonstrate the differences in stage II patients may be due to the narrow range of dose intensity in this study or to a difference in the dose-response curves depending on the stage of disease."( Analysis of dose intensity in doxorubicin-containing adjuvant chemotherapy in stage II and III breast carcinoma.
Ang, PT; Buzdar, AU; Hortobagyi, GN; Kau, S; Smith, TL, 1989
)
0.28
" In a prospective randomized multicenter trial, 123 patients undergoing acute rejection of cadaveric renal transplants were treated either with OKT3 daily for a mean of 14 days, with concomitant lowering of the dosage of other immunosuppressive drugs (63 patients), or with conventional high-dose steroids (60 patients)."( A randomized clinical trial of OKT3 monoclonal antibody for acute rejection of cadaveric renal transplants.
, 1985
)
0.27
" Bedtime dosing may prevent nocturnal shortness of breath."( Pharmacologic approaches to obstructive airway disease.
Beck, BW, 1985
)
0.27
" We administered systemic cyclosporine but could not obtain a favorable effect without a concomitant low dosage of prednisone."( Multicentric reticulohistiocytosis in a child with sclerosing lesion of the leg. Immunohistopathologic studies and therapeutic trial with systemic cyclosporine.
Aiba, S; Iizawa, O; Kuramoto, Y; Makino, Y; Tagami, H, 1989
)
0.49
" The low dosage utilized (8 mg/kg instead of the usual 14-17 mg/kg) avoided virtually all the extrarenal side-effects of cyclosporin A, but not its nephrotoxicity."( [Prospective study of a triple immunosuppressive combination in renal transplantation: cyclosporin A-corticoids-azathioprine].
Bellamy, J; Benoit, G; Charpentier, B; Fries, D; Hammouche, M; Kechrid, C; Moulin, B; Neyrat, N; Rieu, P, 1985
)
0.27
" Nineteen patients had ocular manifestations of giant cell arteritis always from the onset, except for a fall in visual acuity; 26 relapses were observed in 18 patients, either during reduction of steroid dosage (21 cases) or after withdrawal (5 cases)."( [Prognosis of treated temporal arteritis. Retrospective study of 87 cases].
Alcalay, M; Becq-Giraudon, B; Boissonnot, L; Bontoux, D; Gil, R; Gouet, D; Le Berre, D; Lefevre, JP; Maréchaud, R; Risse, JF, 1986
)
0.27
" The second group of six patients received DFC initially followed by the PDN dosing regimen."( Effects of a new heterocyclic glucocorticoid, deflazacort (DFC), on the functions of lymphocytes from patients with rheumatoid arthritis (RA).
Imbimbo, B; Indiveri, F; Piccardo, C; Piovano, P; Scudeletti, M, 1987
)
0.27
" The mean initial steroid dosage was 87 mg prednisone equivalent per day."( [Therapy of pemphigus. Critical remarks based on 44 clinical cases].
Smolle, J, 1985
)
0.53
" The data demonstrate that ATG has a deleterious influence on the incidence and severity of CMV infection in renal transplant patients, even when the dosage of other immunosuppressive drugs is decreased during ATG therapy."( Effect of treatment with cyclosporine versus azathioprine on incidence and severity of cytomegalovirus infection posttransplantation.
Andiman, W; Bia, MJ; Flye, W; Gaudio, K; Kliger, A; Siegel, N; Smith, D, 1985
)
0.27
" One may hope that this dosage of mechlorethamine will not be gonadotoxic."( [Value of chlormethine in children with corticoid-dependent or partially corticoid-sensitive nephrosis, in steroid poisoning].
Loirat, C; Macher, MA; Maisin, A; Mathieu, H; Pillion, G,
)
0.13
" The first patient suffered from ulcerative colitis and developed Guillain-Barré syndrome when the steroid dosage was being tapered."( Appearance of Guillain-Barré syndrome in patients during corticosteroid treatment.
Abramsky, O; Steiner, I; Wirguin, I, 1986
)
0.27
" All patients received CyA in increasing dosage (3 mg/kg to 6-10 mg/kg) postoperatively according to renal function, obtaining a trough high-pressure liquid chromatographic whole-blood target level of 200 to 400 ng/ml at the end of the first week."( Incidence and severity of acute cardiac allograft rejection with two different low-dose cyclosporine maintenance protocols.
Kober, I; Laczkovics, A; Laufer, G; Schreiner, W; Wollenek, G; Wolner, E, 1988
)
0.27
" The ability of intensive dosing with the glucocorticoid steroid methylprednisolone to beneficially affect post-traumatic ischemia and to promote chronic neurologic recovery in spinal cord injured animals has been correlated not with its glucocorticoid activity, but rather with the ability to inhibit post-traumatic spinal lipid peroxidation."( New pharmacological treatment of acute spinal cord trauma.
Braughler, JM; Hall, ED; McCall, JM, 1988
)
0.27
" However, measurement of IgE may be helpful in CEP, as it has been in allergic bronchopulmonary aspergillosis, to guide the dosage and duration of corticosteroid therapy."( Chronic eosinophilic pneumonia (Carrington's) with increased serum IgE levels. A distinct subset?
Gonzalez, EB; Hayes, D; Weedn, VW, 1988
)
0.27
" The subsequent radiotherapy was limited to the initially involved fields, the dosage of 35, 30 or 25 Gy depending on the extent of chemotherapy."( [Significance of procarbazine in the chemotherapy of Hodgkin's disease--a report of the Cooperative Therapy Study DAL-HD-85].
Bökkerink, JP; Brämswig, J; Heinecke, H; Hörnig, I; Ludwig, R; Niethammer, D; Reiter, A; Schellong, G; Steinhoff, A; von Lengerke, HJ,
)
0.13
" The corticosteroid dosage and the serum testosterone level were inversely related (r = -0."( Reduction of serum testosterone levels during chronic glucocorticoid therapy.
Chipps, BE; MacAdams, MR; White, RH, 1986
)
0.27
" Our study suggests that HPN and bowel rest is a useful therapeutic approach to selected patients with active Crohn's disease, which permits a reduction in corticosteroid dosage and partial healing of mucosal lesions in most."( Endoscopic, radiographic, and clinical response to prolonged bowel rest and home parenteral nutrition in Crohn's disease.
Kushner, RF; Shapir, J; Sitrin, MD,
)
0.13
" Group II received prednisone at a comparable dosage and ciclosporin."( Ciclosporin and prednisone v. prednisone in treatment of Graves' ophthalmopathy: a controlled, randomized and prospective study.
Beyer, J; Dennebaum, R; Kahaly, G; Krause, U; Meuer, S; Muller, W; Schrezenmeir, J; Schweikert, B, 1986
)
0.95
" Increasing the Cs dosage induced a remission again."( A patient with a spontaneous factor VIII:C autoantibody: successful treatment with cyclosporine.
Freen, M; Hart, HC; Kerckhaert, JA; Kraaijenhagen, RJ; van de Wiel, A; Verdel, G, 1988
)
0.27
" To clarify this apparent disparity and to determine if glucocorticoid stimulation can augment GH release in man after direct pituitary stimulation with GHRH, we administered 1 microgram/kg GHRH dosage to seven normal men before and after a 4-day course of prednisone (20 mg, orally, three times daily)."( Inhibition by prednisone of growth hormone (GH) response to GH-releasing hormone in normal men.
Culler, FL; Jones, KL; Kaufmann, S; Wehrenberg, WB, 1988
)
0.82
" We retrospectively examined the relationship between serum creatine kinase (CK), muscle strength and the dosage and method of administration of prednisone in 30 patients with PM-DM observed monthly for a minimum of one year."( Relationship between serum creatine kinase level and corticosteroid therapy in polymyositis-dermatomyositis.
Medsger, TA; Oddis, CV, 1988
)
0.48
" This quantity appears minimal and supplemental dosing of prednisone or modification of administration time would seem to be unnecessary."( [Removal of prednisone and prednisolone during plasma exchange].
Assogba, U; Baumelou, A; Durande, JP; Lenoir, G; Pecquinot, MA; Raymond, F; Rottembourg, J, 1988
)
0.9
" In patients who received cyclosporine, the dosage was adjusted to achieve trough whole blood concentrations of 100 to 250 ng/ml measured by liquid chromatography."( Cyclosporine nephrotoxicity is minimized by adjusting dosage on the basis of drug concentration in blood.
Anderson, CF; Moyer, TP; Post, GR; Sterioff, S, 1988
)
0.27
"To test our previous observation that methotrexate reduces corticosteroid requirements of patients with severe asthma, we studied 14 patients with corticosteroid-dependent bronchial asthma in a 24-week randomized double-blind crossover trial comparing a low dosage of methotrexate (15 mg per week) with placebo."( Methotrexate in the treatment of corticosteroid-dependent asthma. A double-blind crossover study.
Andrade, WP; Bailey, GA; Blumenstein, BA; Mullarkey, MF; Olason, I; Wetzel, CE, 1988
)
0.27
" Chemotherapy consisted of two cycles of CF (cyclophosphamide at a dosage of 100 mg/m2 orally on days 1-14+5-fluorouracil at 600 mg/m2 iv on days 1 and 8) during concurrent radiotherapy, followed by six cycles of CMFP (same CF dosages+methotrexate at 40 mg/m2 iv on days 1 and 8+prednisone at 40 mg/m2 orally on days 1-14)."( Integration of full-dose adjuvant chemotherapy with definitive radiotherapy for primary breast cancer: four-year update.
Fowble, BL; Fox, KR; Glick, JH; Glover, DJ; Goodman, RL; Haller, DG; Hurwitz, S; Mackie, JA; Rosato, EF; Weiler, C, 1988
)
0.45
" Anticholinesterase medication (nine patients) and corticosteroid dosage (six patients) had been kept constant for a 2-month period."( Effects of repeated doses of intravenous immunoglobulin in myasthenia gravis.
Arsura, EL; Bick, A; Brunner, NG; Grob, D, 1988
)
0.27
" Since then, a multitude of different combinations and variations in drug dosage and timing have been used."( Adjuvant chemotherapy for breast cancer: 20 years experience using CVFMP chemotherapy.
Cooper, RG, 1988
)
0.27
" In four patients, including two of the patients in whom rapid test dosing of a sulfonamide had been unsuccessful, treatment of the sulfa reaction with corticosteroids and antihistamines permitted continued sulfa administration."( The management of patients with sulfonamide allergy.
Boxer, MB; Dykewicz, MS; Greenberger, PA; Kelly, JF; Patterson, R,
)
0.13
" In patients without clinical remission immunosuppressive drugs were prescribed in different schedule; the greater percentage of pharmacological remissions with less adverse effects was obtained with administration of prednisone 50-75 mg/die initially, than gradually reduced to smaller dosage in alternate day, associated to azathioprine."( Myasthenia gravis treatment: twelve years experience on 110 patients.
Jann, S; Premoselli, S; Scarlato, G; Valli, G, 1987
)
0.46
" Careful tailoring of dosage is important to avoid adrenal atrophy and signs of adrenocortical hypofunction."( Corticosteroids for rheumatic disease. 1. Physiology, pharmacology, and therapeutic strategies.
Jamieson, T, 1986
)
0.27
" It consisted of hydrocortisone (mean dosage 26 mg/m2) or prednisone (8."( Compensatory maturational deceleration of growth or "catch-down growth" in patients with congenital adrenal hyperplasia after delayed initiation of therapy.
Hunziker, U; Largo, R; Prader, A; Zachmann, M, 1986
)
0.52
" Neither the presence of diabetes mellitus nor the CsA dosing frequency affected the measured pharmacokinetic parameters."( Demographic factors affecting the pharmacokinetics of cyclosporine estimated by radioimmunoassay.
Flechner, SM; Kahan, BD; Kramer, WG; Lorber, MI; Van Buren, CT; Wideman, C, 1986
)
0.27
"Severe cases of pemphigus vulgaris should be treated with prednisone in high dosage (180-360 mg daily)."( [Therapy of pemphigus and pemphigoid].
Schaumburg-Lever, G, 1986
)
0.52
"We report a young woman with systemic lupus erythematosus complicated by pseudotumor cerebri which resolved with high dosage corticosteroid therapy."( Dural sinus thrombosis: a mechanism for pseudotumor cerebri in systemic lupus erythematosus.
Goodwin, JA; Levinson, DJ; Parnass, SM; Patel, DV; Reinhard, JD, 1987
)
0.27
" Basic treatment depends on systemic corticotherapy at a dosage of 30-80 mg of prednisone throughout several months."( [Laryngeal manifestations of sarcoidosis].
Bertrand, B; Frederickx, Y; Pigeolet, Y; Remacle, M, 1986
)
0.5
" Patients received a mean dosage of 12."( The safety and efficacy of the use of methotrexate in long-term therapy for rheumatoid arthritis.
Kremer, JM; Lee, JK, 1986
)
0.27
" The use of these two drugs in combination does not result in an interaction requiring dosage regimen alteration."( Lack of effect of sucralfate on prednisone bioavailability.
Amend, WJ; Birnbaum, J; Gambertoglio, JG; Lizak, P; Romac, DR; Yong, CL, 1987
)
0.56
" Danazol was given at a daily dosage of 600 mg for 4 months."( Therapeutic effect of danazol on metrorrhagia in patients with idiopathic thrombocytopenic purpura (ITP).
Ambríz, R; Avilés, A; Chávez, G; Guillén, C; Morales, M; Pizzuto, J, 1986
)
0.27
" Demonstration of systemic signs, bioptically confirmed bone-marrow infiltration and suboptimal cytostatic dosage correlated significantly with a lower full-remission rate."( [Chemotherapy of advanced lymphogranulomatosis. Results of MOPP/COPP treatment at the West German Tumor Center, Essen].
Becher, R; Höffken, K; Ippisch, A; Pfeiffer, R; Schmidt, CG; Seeber, S, 1985
)
0.27
" We are uncertain about the pharmacologic basis of these results but suggest that the increased dosage and more frequent administration of VP-16, relative to that of VM-26, was sufficient to overcome apparent resistance to the latter compound."( Etoposide (VP-16) with prednisone and vincristine for the treatment of refractory acute lymphoblastic leukemia.
Abromowitch, M; Bowman, WP; Ochs, J; Rivera, G, 1985
)
0.58
" All but one of the patients subsequently received steroid therapy, the dosage of which varied."( Dense deposit disease in children: prognostic value of clinical and pathologic indicators. The Southwest Pediatric Nephrology Study Group.
, 1985
)
0.27
" The admission and survival data of 488 patients with cirrhosis who participated in a controlled clinical trial of prednisone in a dosage of 10-15 mg daily (251 patients) versus placebo (237 patients) and who were observed for up to 12 yr were analyzed using Cox's multiple regression model."( A therapeutic index that predicts the individual effects of prednisone in patients with cirrhosis.
Andersen, PK; Christensen, E; Fauerholdt, L; Juhl, E; Poulsen, H; Schlichting, P; Tygstrup, N, 1985
)
0.72
" Initial prednisone dosage ranged from 20 mg every other day to 2 mg/kg/day (maximum 60 mg), with subsequent modifications based on improvement."( Prednisone therapy of membranoproliferative glomerulonephritis in children.
Guggenheim, SJ; Lum, GM; Sedman, A; Warady, BA, 1985
)
2.13
" Thereafter, the steroid dosage was reduced to 0-10 mg every other day and the measurements were repeated between the 12th and 24th month."( The pathophysiology and response to steroid therapy in sarcoidosis.
Ploysongsang, Y; Roberts, RD, 1986
)
0.27
" The minor alterations in prednisolone kinetics during concomitant cimetidine dosing are not likely to induce clinically significant alterations in steroid effect."( Effects of cimetidine and ranitidine on the conversion of prednisone to prednisolone.
Eshelman, FN; Ferguson, RK; Rocci, ML; Sirgo, MA; Vlasses, PH, 1985
)
0.51
" Seventy-five patients were given a course of prednisone in an initial dosage of 60mg/24hr, tapering over the following 8-16 weeks."( Adult-onset nephrotic syndrome with minimal changes: response to corticosteroids and cyclophosphamide.
Cameron, JS; Hicks, J; Nolasco, F; Ogg, CS; Williams, DG, 1985
)
0.53
", CAF (CPA + ADM + 5-FU), and AC (ADM + CPA) are well known, but the dosage and administration schedule differ somewhat with the researcher."( [Chemotherapy for recurrent breast carcinoma].
Taguchi, T, 1985
)
0.27
" Seventy-five patients received corticosteroids, with a mean prednisone dosage of 22."( Polymyalgia rheumatica. Duration of therapy and long-term outcome.
Ayoub, WT; Franklin, CM; Torretti, D, 1985
)
0.51
"In an 18-month period seven children who were treated for a variety of neurological and non-neurological diseases, and in whom the corticosteroid or corticotrophin dosage was reduced, developed a syndrome indistinguishable from "benign intracranial hypertension."( Benign intracranial hypertension following corticosteroid withdrawal in childhood.
Neville, BG; Wilson, J, 1970
)
0.25
"The rate of recovery of adrenocortical function seems mainly to be determined by the dosage of corticosteroids during the initial stages of treatment rather than by the nature of the disease."( Recovery of adrenocortical function during long-term treatment with corticosteroids.
Der Kinderen, PJ; Schwarz, F; Thijssen, JH; Van Ditmars, MJ; Westerhof, L, 1972
)
0.25
"The requirement for insulin decreased in both patients during the period of renal insufficiency and increased following transplantation; this seemed to be related to the large dose of steroids given because now that a maintenance level of steroids has been established, both patients require the same dosage of insulin as they did before the onset of renal insufficiency."( Treatment of renal failure from diabetic nephropathy with cadaveric homograft.
Beaudry, C; Laplate, L, 1973
)
0.25
" Treatment with increased dosage of prednisone was associated with a rapid reversion to normal of the migration index and improvement in renal function."( Changes in leucocyte migration after renal transplantation.
Bewick, M; Dominguez, JA; Eddleston, AL; Evans, DB; Smith, MG; Williams, R, 1969
)
0.52
" In patients whose renal function was stable at the time of initiation of MPG therapy, prednisone dosage could be lowered to an average of 37% of the previous dose and the patient's Cushingoid appearance or aseptic necrosis of the hips either did not progress or improved."( Allograft prolongation with synthetic progestins.
Gikas, PW; Haines, RF; Niederhuber, JE; Turcotte, JG, 1971
)
0.47
" Corticosteroid administration was continued concurrently with azathioprine, but the dosage could be reduced and in one case they were withdrawn."( Treatment of ulcerative colitis with azathioprine.
Gilon, E; Theodor, E; Waks, U, 1968
)
0.25
" The importance of dosage schedule for remission maintenance chemotherapy is stressed."( The management of acute leukemia.
Freireich, EJ, 1967
)
0.25
" Dose-response studies indicate that bradykinin is more potent than serotonin or histamine in respect of wealing."( Responses of skin blood vessels to bradykinin, histamine and 5-hydroxytryptamine.
Greaves, M; Shuster, S, 1967
)
0.25
" The side effects of antihistamines are minor, and the dosage of corticosteroid used and length of time it is given are small enough to avoid major side effects."( Chronic urticaria. Possible causes, suggested treatment alternatives.
Kaplan, AP, 1983
)
0.27
" Preliminary results seem to indicate, that the dosage used may be reduced slowly and therapy finally stopped after 3-4 years of treatment in most patients."( [Therapy of chronic hepatitis (author's transl)].
Arnold, W; Meyer zum Büschenfelde, KH, 1981
)
0.26
" From 1976 to 1979 patients with Stage IV disease were treated wither with MOPP or with MOPP plus bleomycin at low dosage (B-MOPP); the incidence of complete remission was not significantly different in the two groups of patients (52 vs."( Combination chemotherapy for stage IV Hodgkin's disease (Report no 14).
Goldman, JM, 1981
)
0.26
" Dosage is 1 mg/kg/day."( [Idiopathic thrombocytopenic purpura (ITP) in childhood (author's transl)].
Schaison, G; Tobelem, G,
)
0.13
" Nephrotoxicity, hepatotoxicity and other side-effects of cyclosporin A could usually be dealt with by dosage adjustments, making feasible the chronic use of this agent."( Cyclosporin A and steroid therapy in sixty-six cadaver kidney recipients.
Fernandez-Bueno, C; Iwatsuki, S; Klintmalm, GB; MacHugh, N; Porter, KA; Schroter, GP; Starzl, TE; Weil, R, 1981
)
0.26
" Reduction of prednisone led to deterioration in all 3 patients; strength was regained when the higher dosage of prednisone was resumed."( Eaton-Lambert myasthenic syndrome: long-term treatment of three patients with prednisone.
Rothner, AD; Streib, EW, 1981
)
0.85
" After tapering the steroid dosage retinal perivasculitis developed associated with a small but significant elevation of the serum angiotensin-converting enzyme level."( Angiotensin-converting enzyme in sarcoid perivasculitis.
Tang, RA; Unger, KM; Willis, DA, 1983
)
0.27
" Forty out of 45 patients suffered one or more rejection episodes which were treated by raising the dosage of prednisone."( Ratios of T lymphocyte subpopulations predict survival of cadaveric renal allografts in adult patients on low dose corticosteroid therapy.
Baldwin, WM; Oljans, PJ; Ploem, JS; Tanke, HJ; Van Es, A; Vanes, LA, 1983
)
0.48
" Flare-ups of autoimmune ear disease are best managed by increasing steroid dosage or adding cytotoxic medications."( Practical versus theoretical management of autoimmune inner ear disease.
Barna, BP; Calabrese, LH; Hughes, GB; Kinney, SE, 1984
)
0.27
" It seems reasonable to formulate a specific goal of treatment, and then fit dosage to the individual needs and tolerances of the patient rather than to a conventionalized "safe" limit, based on averaged data from different and perhaps quite dissimilar subjects."( Personal observations on the use of inhaled corticosteroid drugs for chronic asthma.
Baskerville, J; Jennings, B; Lefcoe, NM; Toogood, JH, 1984
)
0.27
" In conclusion, (1) the rapid reduction in the CsA dosage is beneficial and has no drawbacks, and (2) our guidelines for withdrawing prednisone (timing of withdrawal, rate of reduction in dosage) still need further refinement."( Cyclosporine alone or in combination with prednisone in cadaveric renal transplantation.
Brünisholz, M; Brunner, F; Follat, F; Harder, F; Landmann, J; Loertscher, R; Mihatsch, M; Thiel, G; Wenk, M, 1984
)
0.74
" He did not improve until the prednisone dosage was increased to 4 mg per kg per day."( Cicatricial pemphigoid in a 6-year-old child: report of a case and review of the literature.
Esterly, NB; Gerson, CR; Greenwald, MJ; Rosenbaum, MM, 1984
)
0.56
" There were no differences in dosage of these two agents between patients who remain alive in CR and those who relapsed and died."( Simultaneous low-dose radiation and low-dose chemotherapy in the treatment of advanced Hodgkin's disease.
Gomez, GA; Han, T; Henderson, ES; Ozer, H; Panahon, AM; Stutzman, L, 1984
)
0.27
" Supplemental dosing of prednisone following plasma exchange appears unnecessary."( Removal of prednisone and prednisolone by plasma exchange.
Henry, DH; Stigelman, WH; Talbert, RL; Townsend, RJ,
)
0.83
"Obesity is accompanied by altered secretion and disposition of sex and glucocorticoid hormones, including cortisol, and also confounds parameter normalization and drug dosage selection relative to body weight."( Prednisolone disposition in obese men.
Jusko, WJ; Milsap, RL; Plaisance, KI, 1984
)
0.27
" The data showed no statistical difference in any of the pharmacokinetic parameters among tableted products, subjects, or dosing periods in the study."( In vitro and in vivo bioequivalence of commercial prednisone tablets.
Brown, WJ; Francisco, GE; Honigberg, IL; Kotzan, JA; Pelsor, FR; Schary, WL; Shah, VP; Stewart, JT,
)
0.38
" There was no correlation between drug dosage and length of survival, whereas the disappearance of blast cells from the peripheral blood appeared to be directly correlated with a longer survival."( Characterization and treatment of the non-lymphoblastic crisis of chronic myelogenous leukemia.
Annino, L; Mandelli, F; Mariani, G; Solinas, S, 1983
)
0.27
" The adverse effects, which could be minimized by reducing the dosage in most instances, were primarily related to treatment that persisted for more than two weeks."( Adverse side effects associated with prednisone in the treatment of patients with oral inflammatory ulcerative diseases.
Lozada, F; Migliorati, C; Silverman, S, 1984
)
0.54
" These findings lend support to other data which indicate a useful role for MTX in the induction chemotherapy of advanced high-grade NHL, though the optimum dosage and drug sequence have yet to be determined."( A pilot study of cyclical chemotherapy with high-dose methotrexate and CHOP (MTX-CHOP) in poor-prognosis non-Hodgkin's lymphoma (NHL).
Barnard, DL; Cartwright, SC; Child, JA; Lauder, I; Simmons, AV; Stone, J; Thorogood, J, 1983
)
0.27
"A dose-response analysis of the results of MOPP chemotherapy in 132 patients with Hodgkin's disease was carried out."( A dose and time response analysis of the treatment of Hodgkin's disease with MOPP chemotherapy.
Carde, P; MacKintosh, FR; Rosenberg, SA, 1983
)
0.27
" However, the disease progressed despite relatively high dose steroid therapy, complications of which contraindicated increasing the dosage and even necessitated rapid withdrawal of steroids."( [Role of dapsone in the treatment of Horton's disease and polymyalgia rheumatica].
Celton, H; Doury, P; Eulry, F; Fabresse, FX; Larroque, P; Pattin, S, 1984
)
0.27
" In two patients the corticosteroid dosage could be tapered."( Cutaneous lesions of dermatomyositis are improved by hydroxychloroquine.
Bickers, DR; Callen, JP; Hanno, R; Hawkins, C; Voorhees, JJ; Woo, TY, 1984
)
0.27
" The latter group, therefore, does not profit from cytotoxic drugs in the dosage used."( The treatment of minimal change nephrotic syndrome (lipoid nephrosis): cooperative studies of the Arbeitsgemeinschaft für Pädiatrische Nephrologie (APN).
Brodehl, J; Ehrich, JH; Krohn, HP,
)
0.13
"Eighty percent of 26 steroid-dependent, chronically asthmatic adults eliminated oral steroid dosage after 12 weeks of treatment with triamcinolone acetonide aerosol (800 micrograms/day)."( Long-term triamcinolone acetonide aerosol treatment in adult patients with chronic bronchial asthma.
Golub, JR, 1980
)
0.26
" Treatment was continued until reductions in corticosteroid dosage no longer resulted in clinical evidence of GCA."( Duration of corticosteroid therapy in giant cell arteritis.
Fernandez-Herlihy, L,
)
0.13
" The intermediate form shows a transient steroid-induced complete remission giving place to widely fluctuating platelet counts above and below 100,000 microliters once the steroid dosage is reduced to maintenance levels."( Childhood idiopathic thrombocytopenic purpura in Egypt and the neighboring Arab countries: a regional form with three different patterns of clinical expression.
Adnan, M; Afifi, AM; Guindi, MM, 1981
)
0.26
"A short course of prednisone suspension given in a decreasing dosage schedule for up to ten days was often effective (68%) in resolving mucoid otitis media with effusion (OME, middle ear effusion)."( Otitis media with effusion: results of treatment with a short course of oral prednisone or intranasal beclomethasone aerosol.
Schwartz, RH,
)
0.69
" A comparison of drug dosage in the group receiving TPN and the group receiving standard nutrition is a measure of drug tolerance in these patients."( A prospective randomized study of adjuvant parenteral nutrition in the treatment of diffuse lymphoma: effect on drug tolerance.
Brennan, MF; Fisher, RI; Popp, MB; Simon, RM, 1981
)
0.26
" The neurological toxicity was little and led to reduction of the dosage in only two adults with preexisting neuropathy."( A phase II study of vindesine in patients with hematological malignancies.
Bosly, A; Cornu, G; Delannoy, A; Ferránt, A; Hulhoven, R; Michaux, JL; Sokal, G, 1980
)
0.26
" The administration of pharmacological doses of glucocorticoids increased the dosage of 1,25(OH)2D3 needed to maintain a normal serum calcium level 7- to 10-fold in 2 patients whose renal grafts failed to function, but there was no decrease in sensitivity to 1,25(OH)2D3 in 1 patient whose renal graft functioned normally."( Interactions between treatment with 1,25(OH)2D3 and glucocorticoids in uremic patients after kidney transplantation.
Coburn, JW; Siemsen, AW; Sugihara, JG; Wong, EG, 1980
)
0.26
" Life-table analysis of two dosage schedules of chlorambucil at four years showed that 91 per cent of patients on low doses and 80 per cent of those on high doses were still in remission."( Long-term evaluation of chlorambucil plus prednisone in the idiopathic nephrotic syndrome of childhood.
Grupe, WE; Ingelfinger, JR; Makker, SP; Williams, SA, 1980
)
0.53
" During such outbreaks the use of flunisolide not only delayed the need for more prednisone but also reduced the dosage needed."( Episodic asthma as a bronchial provocation test.
Izu, AE; Leech, SH; Rolston, BS, 1980
)
0.49
" Toxicity was acceptable with minor adjustments in dosage and timing of the myelosuppressive agents."( A new therapy schedule for pediatric non-Hodgkin lymphoma toxicity with preliminary results.
Anderson, J; Chilcote, R; Coccia, P; Exelby, P; Hammond, D; Jenkin, RD; Kushner, J; Leikin, S; Meadows, AT; Siegel, S; Wilson, JF, 1980
)
0.26
" The major defect was depressed granulocyte adherence early postoperatively and at the time of rejection crises, when prednisone dosage was maximal."( Granulocyte function in recipients of renal transplant from live related donors and from cadavers.
Barker, CF; Golshan, N; MacGregor, RR, 1980
)
0.47
" The findings suggest that the development of steroid diabetes can serve as a warning signal for excessive dosage of corticosteroids, and help to identify patients that are particularly sensitive to immunosuppressive therapy with large doses of steroids."( Steroid diabetes--a sign of overtreatment with steroids in the renal graft recipient?
Groth, CG; Gunnarsson, R; Lundgren, G; Magnusson, G; Ost, L, 1980
)
0.26
" A reduction of more than 50% in corticosteroid dosage applied within three months after transplantation seems to be possible, with a sharp decrease of morbidity rate."( Less aggressive rejection therapy and low-dose corticosteroids leading to satisfactory cadaveric kidney graft survival and low morbidity rate.
de Graeff, J; Kalff, MW; Koolen, MI; van den Broek, PH; van Es, A; van Hooff, JP, 1980
)
0.26
" The TDD patients were begun on half the dosage of steroids, and at 30 days were receiving approximately two-thirds the dose that the non-TDD patients received."( Renal transplantation after thoracic duct drainage.
Bell, JD; Fish, JC; Flye, MW; Remmers, A; Sarles, HE; Townsend, CM, 1981
)
0.26
" Reduction of the steroid dosage was followed by regression of the tumor."( Kaposi's sarcoma complicating corticosteroid therapy for temporal arteritis.
Fam, AG; Leung, F; Osoba, D, 1981
)
0.26
"On the basis of 15-years' experience with the allogeneic transplantation of the kidney, the authors present recommendations, concerning the dosage of azathioprine and prednisone (methylprednisolone) during the schematic immunosuppression."( Schematic and controlled immunosupression after renal allotransplantation.
Jirka, J; Kaslík, J; Kaslíková, J; Kocandrle, V, 1981
)
0.46
" The COPP patients received 84% of the calculated ideal doses of cyclophosphamide and 78% of the ideal dosage of procarbazine."( Nodular mixed lymphoma: results of a randomized trial failing to confirm prolonged disease-free survival with COPP chemotherapy.
Barnes, JM; Bennett, JM; Berard, CW; Ezdinli, EZ; Glick, JH; Orlow, EL, 1981
)
0.26
" Of the 34 children shows relapses had tended to occur after the prednisone dosage had been reduced or immediately after the drug was discontinued (the steroid-dependent group), 22 also had early relapses after cytotoxic-drug treatment."( Effect of cytotoxic drugs in frequently relapsing nephrotic syndrome with and without steroid dependence.
, 1982
)
0.5
" Total prednisone dosage was identical during the 6-mo study periods and only dose spacing differed."( Comparison of daily and alternate-day prednisone during chronic maintenance therapy: a controlled crossover study.
Curtis, JJ; Galla, JH; Luke, RG; Saykaly, RJ; Woodford, SY, 1981
)
0.99
" All patients were given a 50 IU intravenous test dose followed in 30 min by the full dosage (10,000 IU/m2), if no reaction occurred to the test dose."( Anaphylactoid reactions to Escherichia coli and Erwinia asparaginase in children with leukemia and lymphoma.
Barker, LF; Crom, WR; Dahl, GV; Denison, M; Evans, WE; Mauer, AM; Murphy, SB; Rivera, G; Tsiatis, A, 1982
)
0.26
" Early convalescence was highly variable, often necessitating adjustments of cyclosporin A and steroid dosage to accommodate the possibilities of rejection or cyclosporin A nephrotoxicity, or both, simultaneously."( Variable convalescence and therapy after cadaveric renal transplantation under cyclosporin A and steroids.
Hakala, TR; Iwatsuki, S; Rosenthal, JT; Shaw, BW; Starzl, TE, 1982
)
0.26
" The efficacy of corticosteroids, immunosuppressive and cytotoxic agents remains uncertain due to variable drug and dosage schedules, lack of comparable patient populations, and retrospective nature of previous reports."( Lymphomatoid granulomatosis. Clinicopathologic study of four cases and literature review.
Lynch, JP; Patton, WF, 1982
)
0.26
" Proper dosage and sufficient length of treatment are absolutely essential for such successful outcome."( The treatment of subglottic hemangiomas of infants with prednisone.
Grunebaum, M; Sadan, N; Sadé, J, 1982
)
0.51
" Marrow from Patient 1 yielded linear increases in numbers of colonies in erythropoietin dose-response studies, and the magnitude of response was much greater while on prednisone compared to pretreatment."( Diamond-Blackfan syndrome. I. Erythropoiesis in prednisone responsive and resistant disease.
Chan, HS; Freedman, MH; Saunders, EF, 1982
)
0.71
"The influence of various dosing regimens on the response of asthmatic patients to aerosol steroid was investigated."( Influence of dosing frequency and schedule on the response of chronic asthmatics to the aerosol steroid, budesonide.
Baskerville, JC; Jennings, B; Johansson, SA; Lefcoe, NM; Toogood, JH, 1982
)
0.26
" Prednisone in a dosage of 100 mg daily successfully interrupted the neutrophil cycling and prevented infection."( Acquired cyclic neutropenia: successful treatment with prednisone.
Rodgers, GM; Shuman, MA, 1982
)
1.42
" The phenomenon was dose related and markedly diminished in two patients as the dosage of corticosteroid was decreased, despite the fact that the alternate-day regimen was continued."( Relationship between alternate-day corticosteroid therapy and behavioral abnormalities.
Fauci, AS; Sack, DS; Sharfstein, SS, 1982
)
0.26
"Frentizole, an immunosuppressive phenylurea agent, used in a dosage of 4 mg/kg per day, was found to produce quick elevation of platelet counts in three thrombocytopenic patients."( Frentizole therapy of thrombocytopenia in systemic lupus erythematosus and refractory idiopathic thrombocytopenic purpura.
Colgan, JP; Ferguson, RH; O'Duffy, JD; Phyliky, RL, 1980
)
0.26
" Suppression of cortisol and estrogens was greater after dexamethasone (Dx) than after a glucocorticoid-equivalent dosage of prednisone (Pd)."( Loss of diurnal rhythm in plasma estrone, estradiol, and estriol in women treated with synthetic glucocorticoids at 34 to 35 weeks' gestation.
Challis, J; Patrick, J; Richardson, B; Tevaarwerk, G, 1981
)
0.47
" Eighteen patients were in early stage (I or II) and 11 of them were also submitted to involved field radiotherapy (60Co), immediately before (stage I) or during (stage II) the chemotherapy, with a mean dosage of 4,500 rad."( Combination chemotherapy with cyclophosphamide, adriamycin, vincristine and prednisone (CHOP) for non-Hodgkin's lymphomas with unfavorable histology: preliminary results.
Abate, G; Bruni, GS; Comella, G; Comella, P; Pergola, M; Zarrilli, D, 1980
)
0.49
" Gradual reduction in prednisone dosage to 5 mg daily has coincided with a period of clinical resolution and modest improvement in lymphocyte reactivity."( Idiopathic pyoderma gangrenosum and impaired lymphocyte function: failure of azathioprine and corticosteroid therapy.
Breathnach, SM; Valdimarsson, H; Wells, GC, 1981
)
0.58
" While earlier results suggested that adjuvant chemotherapy is especially effective in premenopausal women, newer studies and analyses indicate that appropriate dosage and consistent administration of chemotherapy are of decisive importance."( [Results of, and indications for adjuvant chemotherapy in breast cancer].
Brunner, KW; Goldhirsch, A; Joss, R; Sonntag, RW; Tschopp, L, 1981
)
0.26
" Based on the course in our patients and the cases presented in previous reports, a suggested program of treatment for immunoblastic lymphadenopathy includes administration of moderate doses of steroids initially, with a subsequent increase to a higher dosage if desired improvement does not occur."( The lung in immunoblastic lymphadenopathy.
Banks, PM; Bradley, SL; Dines, DE; Hill, RW, 1981
)
0.26
" Three cases of vitamin D poisoning are described, in each of which the indication for treating the patients was reasonable but the dosage was not adapted as it should have been."( [Vitamin D intoxication].
Courvoisier, B; Jung, A, 1980
)
0.26
" Approximately half the patients were being treated with an alternate day regime of prednisone, receiving high dosage one day and low the next."( Psychiatric effects of alternate day steroid therapy.
Cordess, C; Drachman, D; Folstein, M, 1981
)
0.49
" Although the degree of leukocytosis was related to the dosage administered, it did appear sooner with higher doses."( Prednisone-induced leukocytosis. Influence of dosage, method and duration of administration on the degree of leukocytosis.
Gallant, LA; Gurewich, Y; Pinkhas, J; Shoenfeld, Y, 1981
)
1.71
" dosage range."( Dose dependent pharmacokinetics of prednisone and prednisolone in man.
Jusko, WJ; Rose, JQ; Yurchak, AM, 1981
)
0.54
" Nevertheless, persistent use of steroids in high dosage resulted in normalization of both CSF and brain scan abnormalities."( Temporal arteritis: cerebrospinal fluid and brain scan abnormalities (case report).
Gordon, EP; Gordon, M, 1980
)
0.26
" Maintenance steroid dosage at the time of study ranged from 20 to 50 mg on alternate days, averaging 31 +/- 8 mg."( Long-term corticosteroid effect on lymphocyte and polymorphonuclear cell function in asthmatics.
Chiang, JL; Harris, K; McGillen, JJ; Patterson, R; Phair, JP; Riesing, KS; Roberts, M, 1980
)
0.26
" A general discussion is presented on the role of the peristaltic apparatus in selecting a suitable dosage form at the developmental stage."( Peristaltic dissolution apparatus: prediction of relative in vivo performance of prednisone tablets in humans.
Legore, AA; Picotte, P; Simmons, DL, 1980
)
0.49
" After initial negative radiologic investigations, his corticosteroid dosage was tapered, and the recurrence of his symptoms and signs prompted repeat computed tomographic scans."( Medulloblastoma causing a corticosteroid-responsive optic neuropathy.
Hirst, LW; Kumar, AJ; Miller, NR; Udvarhelyi, GB, 1980
)
0.26
" To establish an optimal dosage schedule, 15 healthy male volunteers entered a two-phased study to determine (1) the single dose of prednisone required to produce maximal suppression of histamine and basophil levels and (2) the effects of repeated prednisone doses."( Dose-response studies of the suppression of whole blood histamine and basophil counts by prednisone.
Kay, DR; Mathews, KP; Muilenberg, ML; Pan, PM; Saavedra-Delgado, AM, 1980
)
0.69
" The first drug used, in 20 patients, was methysergide maleate in a dosage of 3--6 mg daily over a four weeks period."( [Cluster headache: clinical and therapeutic aspects in 26 cases].
Sanvito, WL; Tilbery, CP, 1980
)
0.26
" The recognition of high NAG enzymuria permits to reduce dosage or discontinue treatment with potentially nephrotoxic drug prior to irreversible renal insufficiency as shown in the case of a patient with psoriatic arthritis treated with simultaneously administered cyclosporin and diclofenac."( N-acetyl-beta-D-glucosaminidase enzymuria as an indicator in monitoring the therapy of some rheumatic diseases with potentially nephrotoxic drugs.
Szechiński, J; Wiland, P, 1994
)
0.29
" No (inverse) correlation between serum osteocalcin and the daily dosage of prednisone was found."( Vertebral fractures in patients with rheumatoid arthritis treated with corticosteroids.
Bijlsma, JW; Jacobs, JW; Jahangier, ZN; Lems, WF,
)
0.36
" There was no increase in concurrent immunosuppressives dosage after the conversion."( Alternate-day prednisone in the maintenance immunosuppressive therapy after orthotopic liver transplantation.
Kaplan, MM; Pedrosa, MC; Rohrer, RM, 1995
)
0.65
" Their dosage of oral prednisone was adjusted weekly according to predetermined criteria."( Fluticasone propionate reduces oral prednisone use while it improves asthma control and quality of life.
Boltansky, H; Busse, WW; Chervinsky, P; de Boisblanc, BP; Kellerman, D; Noonan, M; Pearlman, D; Pinnas, J; Repsher, L; Weisberg, SC, 1995
)
0.88
" It is clear that new dosing arrangements need to be created and studied."( Corticosteroids in the treatment of rheumatologic diseases.
Weisman, MH, 1995
)
0.29
" Corticosteroid treatment (prednisone at the starting dosage of 30 mg/day) produced the healing of the disease in 5 months."( [Scleroderma induced by chemical agents. Description of a case and review of the literature].
Bambara, LM; Biasi, D; Caramaschi, P; Carletto, A; Pacor, ML; Spinaci, E, 1995
)
0.59
" When the glucocorticoid dosage was reduced or the drug discontinued, the nephrotic syndrome recurred."( [T-cell lymphoma under immunosuppressive treatment in minimal change glomerulopathy with nephrotic syndrome].
Schollmeyer, P; Späth, M, 1995
)
0.29
"These data suggest that long-term renal function in cyclosporine-treated kidney transplant patients is primarily influenced by the occurrence of early and late rejection episodes rather than by the dosage or duration of cyclosporine therapy."( Long-term renal function in cyclosporine-treated renal allograft recipients.
Hodge, E; Novick, AC; Streem, S; Tanabe, K, 1995
)
0.29
"Prednisone dosage was successfully tapered to 10 to 20 mg/d without worsening symptoms in 10 (38%) of the 26 patients studied."( Therapeutic considerations in patients with refractory neurosarcoidosis.
Agbogu, BN; Sewell, C; Stern, BJ; Yang, G, 1995
)
1.73
"No significant differences in area under the serum concentration versus time curve (AUC), maximal methotrexate concentration following dosing (Cmax), time to Cmax (Tmax), bioavailability (F), urinary MTX, renal clearance of MTX or creatinine clearance were observed between the 2 cohorts."( Examination of pharmacokinetic variables in a cohort of patients with rheumatoid arthritis beginning therapy with methotrexate compared with a cohort receiving the drug for a mean of 81 months.
Hamilton, RA; Kremer, JM; Petrillo, GF, 1995
)
0.29
" The present study was designed to evaluate the ability of specific inspiratory muscle training (SIMT) to prevent the effects of a therapeutic dosage of corticosteroids on inspiratory muscle function in patients receiving the drug for diseases other than pulmonary, with no underlying respiratory or muscular disease."( Inspiratory muscle training during treatment with corticosteroids in humans.
Azgad, Y; Weiner, M; Weiner, P, 1995
)
0.29
"Iatrogenic osteoporosis is a very common secondary osteoporosis is found in patients treated with large dosage of glucocorticosteroid of long duration."( [Iatrogenic osteoporsis: six case reports].
Wang, JZ; Zheng, LM, 1994
)
0.29
"An inverse relationship between the ophthalmodynamometric retinal venous collapse pressure and systemic prednisone dosage was observed."( Ophthalmodynamometry and corticosteroids in central retinal vein occlusion.
Beaumont, PE; Kang, HK, 1994
)
0.5
"A total of 121 patients with fewer than 50 x 10(9) platelets per liter received an initial treatment with prednisone (PDN) at a dosage of 1 mg/kg of body weight for 1 month."( Long-term observation of 208 adults with chronic idiopathic thrombocytopenic purpura.
Adomo, G; Amadori, S; Cecconi, M; Masi, M; Oliva, F; Perrotti, AP; Sciarra, A; Scimò, MT; Stasi, R; Stipa, E, 1995
)
0.5
" The lung cancer (without lymph node metastases) was resected, and the temporal arteritis treated with prednisone in the standard dosage regimen."( Simultaneous clinical manifestations of malignancy and giant cell temporal arteritis in a young woman.
Lie, JT, 1995
)
0.51
" The introduction of cyclosporine has allowed us to reduce the dosage of oral steroids and to accept DM patients (pts) for HTx."( Mid-term results of heart transplantation in diabetic patients.
Bianco, R; Boffa, GM; Caforio, AL; Casarotto, D; Casula, R; Gambino, A; Grassi, G; Livi, U; Milano, A; Thiene, G, 1994
)
0.29
" GCS dosage was increased in 2 patients: 1 with recurrent serositis, 1 with persistent vasculitis."( A 2 year, open ended trial of methotrexate in systemic lupus erythematosus.
Abeles, M; Wilson, K, 1994
)
0.29
" Trough levels of 400-600 ng/dl (measured by radioimmunoassay) were achieved, at which point oral cyclosporine was given and oral dosage was adjusted to similar levels."( Cyclosporine as an alternative to surgery in children with inflammatory bowel disease.
Benkov, KJ; Janowitz, HD; LeLeiko, NS; Rosh, JR; Schwersenz, AH, 1994
)
0.29
" The efficacy was assessed on the daily dosage of prednisone and was also evaluated using the FEV1 (VEMS) (the variations expressed were a percentage of the variation from the predicted value)."( [Methotrexate in the treatment of asthma. Open trial in 10 corticoid-dependent patients with severe asthma].
Becquart, LA; Guéné-Ribassin, C; Lassalle, P; Tonnel, AB; Wallaert, B, 1994
)
0.54
" Prednisone dosage was also significantly less when comparing the time before methotrexate therapy to immediately after completion of methotrexate therapy (0."( Methotrexate therapy in pediatric heart transplantation as treatment of recurrent mild to moderate acute cellular rejection.
Bullock, EA; Hawkins, JA; McGough, EC; Olsen, SL; Orsmond, GS; Renlund, DG; Shaddy, RE; Tani, LY; Taylor, DO,
)
1.04
"Patients with active RA diagnosed at age > or = 60 were randomized to receive prednisone (15 mg/day for 1 month, with the dosage tapered as low as possible thereafter) (n = 28) or chloroquine (n = 28)."( Prednisone treatment of elderly-onset rheumatoid arthritis. Disease activity and bone mass in comparison with chloroquine treatment.
Breedveld, FC; Dijkmans, BA; Han, KH; Papapoulos, S; Pauwels, EK; Valkema, R; van Schaardenburg, D; Zwinderman, AH, 1995
)
1.96
"Data from published research were extracted and evaluated according to study design, sample size, dosing regimen, outcome measures, and treatment efficacy and safety."( Treatment of infantile spasms.
Casto, DT; Haines, ST, 1994
)
0.29
" However, the form of drug used, dosing regimen, and route of administration are highly variable."( The use of corticosteroids in croup: a survey.
Connors, K; Gavula, D; Terndrup, T, 1994
)
0.29
" When rifampin-prednisone treatment must be used in giant cell arteritis, we propose increasing the prednisone dosage to 2 mg/kg per day."( Rifampin-induced nonresponsiveness of giant cell arteritis to prednisone treatment.
Becq-Giraudon, B; Bouquet, S; Carrie, F; Delon, A; Roblot, F; Roblot, P, 1994
)
0.88
" Steady state dosage between 1/2 and 3 tablets per day was individually adjusted according to the severity of the clinical symptoms."( Long-term therapy with the new glucocorticosteroid deflazacort in rheumatoid arthritis. Double-blind controlled randomized 12-months study against prednisone.
Eberhardt, R; Gross, W; Krüger, K; Reiter, W; Zwingers, T, 1994
)
0.49
" Comparison of the dose-response relationships for humans and rats indicates that, under conditions of no depletion of O6-alkylguanine-DNA alkyltransferase (AGT), O6-meG accumulates in blood leukocyte DNA of humans at a rate which is only approximately 2-fold lower than in rats, implying that, to the extent to which O6-meG contributes to the genotoxic activity of procarbazine, human susceptibility to it is likely to be comparable to that of the rat."( Comparative dosimetry of O6-methylguanine in humans and rodents treated with procarbazine.
Boussiotis, VA; Kyrtopoulos, SA; Pangalis, GA; Souliotis, VL; Valavanis, C, 1994
)
0.29
" Until day 14, all recipients received cytomegalovirus hyperimmunoglobulin at a dosage of 2 ml/kg/day."( Monitoring of cytomegalovirus disease after heart transplantation: persistence of anti-cytomegalovirus IgM antibodies.
Auer, T; Halwachs-Baumann, G; Iberer, F; Müller, H; Petutschnigg, B; Pleisnitzer, A; Rödl, S; Tscheliessnigg, K; Wasler, A; Wilders-Truschnig, M,
)
0.13
" The patient has been free of lesions with a maintenance dosage of 10 mg of prednisone every other day."( Pemphigus vulgaris in adolescence. A case presentation and review of the literature.
Gorsky, M; Raviv, E; Raviv, M, 1994
)
0.52
" At the time of entry, the subjects' mean dosage of prednisone was 23."( Comparison of oral pulse methotrexate with placebo in the treatment of severe glucocorticosteroid-dependent asthma.
Diaz, JD; Ledford, DK; Lockey, RF; Seleznick, MJ; Stewart, GE; Trudeau, WL, 1994
)
0.54
" We describe 3 such patients, and our experience in tapering their steroid dosage with the use of dapsone or methotrexate."( Steroid-sparing medications in temporal arteritis--report of three cases and review of 174 reported patients.
Nesher, G; Sonnenblick, M, 1994
)
0.29
" This was associated with delivery of 100% of the planned dosage of vincristine, prednisone, and daunorubicin at induction."( Poor outcome of intensive chemotherapy for adult acute lymphoblastic leukemia: a possible dose effect.
Chan, LC; Chan, TK; Chiu, EK; Kwong, YL; Liang, R; Lie, A; Todd, D, 1994
)
0.51
" The latter were successfully treated with oral vancomycine, but in the last relapse an increased dosage of prednisone was required, too."( [Clostridium difficile in early childhood ulcerative pancolitis].
Hoppen, T; Keller, KM; Rister, M; Stolte, M, 1993
)
0.5
" Kaplan Meier survival curves for the development of the first AE showed a dose-response relationship between prednisone and AE occurrence, independent of rheumatoid nodules."( Low dose long-term corticosteroid therapy in rheumatoid arthritis: an analysis of serious adverse events.
Brasington, R; Burmeister, LF; Caldwell, JR; Furst, DE; Koehnke, R; Kohler, JA; Saag, KG; Zimmerman, B, 1994
)
0.5
" Increased growth is a major benefit of decreased steroid dosing in these children."( Monotherapy with cyclosporine for chronic immunosuppression in pediatric liver transplant recipients.
Billmire, DF; Dunn, SP; Falkenstein, K; Lawrence, JP; Meyers, R; Vinocur, CD; Weintraub, WH, 1994
)
0.29
" If disease activity allows, a reduction in prednisone dosage may reduce the risk of bacterial superinfection during zoster episodes."( Herpes zoster infections in systemic lupus erythematosus: risk factors and outcome.
Kahl, LE, 1994
)
0.55
" Further investigation and formal studies of the dose-response relationships and kinetics of steroid administration may lead to improvement in the management of acute GVHD."( Prednisone therapy for acute graft-versus-host disease: short- versus long-term treatment. A prospective randomized trial.
Blazar, BL; Filipovich, AH; Hings, IM; Kersey, JH; McGlave, PB; Miller, WJ; Ramsay, NK; Weisdorf, DJ, 1993
)
1.73
" The close correlation of plasma IL-6 concentrations with clinical symptoms suggests a direct contribution of this cytokine to the disease manifestations and presents the possibility that monitoring IL-6 levels would be useful in making decisions on adjustment of corticosteroid dosage in individual patients."( Correlation of interleukin-6 production and disease activity in polymyalgia rheumatica and giant cell arteritis.
Fulbright, JW; Goronzy, JJ; Hunder, GG; Roche, NE; Wagner, AD; Weyand, CM, 1993
)
0.29
" After randomization, 123 patients also received interferon alfa-2b at a dosage of 5 million units three times weekly for 18 months."( Recombinant interferon alfa-2b combined with a regimen containing doxorubicin in patients with advanced follicular lymphoma. Groupe d'Etude des Lymphomes de l'Adulte.
Bosly, A; Brice, P; Brousse, N; Haioun, C; Lepage, E; Leporrier, M; Parlier, Y; Peuchmaur, M; Reyes, F; Solal-Celigny, P, 1993
)
0.29
" The authors believe that increasing dosage of the immunosuppressants is an effective method for the management of chronic renal rejection and the earlier the treatment is given the better the results would be."( Treatment of chronic allograft rejection.
Fan, Y; Jin, WH; Wang, XH; Xie, T; Xu, D, 1993
)
0.29
" In 27 other patients, the prednisone dosage has been tapered to 5 mg/day or less with the aim of discontinuing the drug."( Prednisone withdrawal in HLA identical and one haplotype-matched live-related donor and cadaver renal transplant recipients.
Alexander, JW; First, MR; Hariharan, S; Schroeder, TJ; Weiskittel, P, 1993
)
2.03
" Dosage began at 60 mg/m2 for 3 month, was reduced to 30 mg/m2 by 1 year and 15 mg/m2 by 2 years."( Treatment of IgA nephropathy in children: efficacy of alternate-day oral prednisone.
Benfield, MR; Herrera, GA; Kelly, DR; Kohaut, EC; Waldo, FB; Wyatt, RJ, 1993
)
0.52
" Gradual steroid dosage tapering resulted in marked improvement in both strength and endurance; the inspiratory muscle strength rose significantly to 112."( The effect of corticosteroids on inspiratory muscle performance in humans.
Azgad, Y; Weiner, M; Weiner, P, 1993
)
0.29
" Three children who were treated with adrenocorticotropic hormone dosage larger than recommended died."( Risk of infection during adrenocorticotropic hormone treatment in infants with infantile spasms.
Alpert, G; Garty, BZ; Kivity, S; Rachmel, A; Shamir, R, 1993
)
0.29
" The onset of symptoms may occur after only some weeks or after up to several years with no dose-response relationship."( Interstitial lung disease--an underdiagnosed side effect of chlorambucil?
Huhn, D; Kingreen, D; Mohr, M; Rühl, H, 1993
)
0.29
" All drugs but mafosfamide, tested in place of cyclophosphamide, were used at concentrations corresponding to the in vivo dosage employed in the CEOP regimen."( In vitro chemosensitivity of chronic lymphocytic leukemia B-cells to multidrug regimen (CEOP) compounds using the MTT colorimetric assay.
Brugiatelli, M; Callea, V; Messina, G; Morabito, F; Nobile, F; Oliva, B; Ramirez, F,
)
0.13
" ALG treatment should usually be limited to 14 days, but azathioprine dosage can safely be increased after ALG discontinuation."( Bone marrow function during quadruple immunosuppressive therapy after renal transplantation.
Heaf, J, 1993
)
0.29
" Of the 13 case patients whose dosage was recorded, 7 received less than the equivalent of 2 mg/kg per day of prednisone."( Severe varicella associated with steroid use.
Bresee, JS; Dowell, SF, 1993
)
0.5
" Prednisone was administered at immunosuppressive dosage (1 mg."( Effects of a short prednisone regime at clinical onset of type 1 diabetes.
Casamitjana, R; Fernandez, J; Goday, A; Gomis, R; Pujol-Borrell, R; Rios, M; Vilardell, E, 1993
)
1.52
" Primary measures of efficacy were quantified strength testing, antihuman acetylcholine receptor antibody titer, and dosage of corticosteroid medication."( A clinical therapeutic trial of cyclosporine in myasthenia gravis.
Hall, K; Phillips, JT; Rollins, JA; Tindall, RS; Wells, L, 1993
)
0.29
"To complete research in this type of coagulation and cancer, a multicentric randomized clinical trial was performed, including 303 patients with small cell lung cancer (SCLC), treated by the addition of aspirin at 1 g/day (a dosage at which aspirin is considered to be a platelet aggregation inhibitor) to combined chemotherapy."( No effect of an antiaggregant treatment with aspirin in small cell lung cancer treated with CCAVP16 chemotherapy. Results from a randomized clinical trial of 303 patients. The "Petites Cellules" Group.
Chastang, C; Fabre, C; Lebeau, B; Massin, F; Muir, JF; Vincent, J, 1993
)
0.29
"Prednisone was given orally to 12 dogs daily for 35 days at an anti-inflammatory dosage (1."( Effects of oral administration of anti-inflammatory doses of prednisone on thyroid hormone response to thyrotropin-releasing hormone and thyrotropin in clinically normal dogs.
Ferguson, DC; Hoenig, M; Moore, GE, 1993
)
1.97
"Forty-one heart transplant patients with 43 episodes of asymptomatic moderate cardiac rejection were randomized to receive 3 days of 1,000 mg of intravenous Solu-Medrol (20 episodes) or prednisone as a bolus dose of 100 mg orally for 3 days, tapering to the previous maintenance dosage over 14 days (23 episodes)."( Is intravenous glucocorticoid therapy better than an oral regimen for asymptomatic cardiac rejection? A randomized trial.
Brownfield, E; Drinkwater, DC; Kawata, N; Kobashigawa, JA; Laks, H; Moriguchi, JD; Stevenson, LW, 1993
)
0.48
"Inhaled steroid therapy is being emphasized in the treatment of asthma but requires patient adherence to regular dosing regimens and skilled inhalation techniques for treatment to be effective."( Disappearance of eosinophils from bronchoalveolar lavage fluid after patient education and high-dose inhaled corticosteroids: a case report.
Fahy, J; Geaghan, S; Golden, J; Janson-Bjerklie, S,
)
0.13
" After treatment with Chai-Ling-Tang, relapse was markedly improved, time for negative conversion of proteinuria shortened, prednisone dosage significantly reduced, and side effects eased."( Therapeutic effect of chai-ling-tang (sairei-to) on the steroid-dependent nephrotic syndrome in children.
Liu, XY, 1995
)
0.5
" The CSA-associated toxicity may be reduced by initiating therapy at very low initial doses, with incremental dosage escalation to the desired target range."( Low-dose cyclosporin A therapy in treating chronic, noninfectious uveitis.
Foster, CS; Rodriguez, A; Vitale, AT, 1996
)
0.29
"Twenty eligible patients with NHL and chronic lymphatic leukemia (CLL), resistant to or relapsed after previous protocols of polychemotherapy were treated with oral etoposide at a dosage of 50 mg/m2/day for 21 days in a 28-day cycle."( Severe myelotoxicity of oral etoposide in heavily pretreated patients with non-Hodgkin's lymphoma or chronic lymphatic leukemia.
Bairey, O; Blickstein, D; Hadar, H; Lahav, M; Prokocimer, M; Shaklai, M; Shaklai, S; Sulkes, J, 1996
)
0.29
" All patients needed course shortening and dosage reduction."( Severe myelotoxicity of oral etoposide in heavily pretreated patients with non-Hodgkin's lymphoma or chronic lymphatic leukemia.
Bairey, O; Blickstein, D; Hadar, H; Lahav, M; Prokocimer, M; Shaklai, M; Shaklai, S; Sulkes, J, 1996
)
0.29
" However, unlike many of the side effects of corticosteroid treatment, the side effects of immunosuppressive therapy were reversible with reduction in dosage or discontinuation of the drug."( Systemic drug toxicity trends in immunosuppressive therapy of immune and inflammatory ocular disease.
Akova, YA; Christen, WG; Foster, CS; Messmer, E; Rodriguez, A; Tamesis, RR, 1996
)
0.29
" For patients receiving acyclovir, the dosage was 2,000 mg (400 mg 5 times daily) for 10 days."( Bell's palsy treatment with acyclovir and prednisone compared with prednisone alone: a double-blind, randomized, controlled trial.
Adour, KK; Byl, FM; Hitchcock, T; Quesenberry, CP; Ruboyianes, JM; Trent, CS; Von Doersten, PG, 1996
)
0.56
" rhGM-CSF was administered at a dosage of 5 micrograms/kg for 10 days or until neutrophils were > 1/nl following chemotherapy."( Recombinant human granulocyte-macrophage colony-stimulating factor after combined chemotherapy in high-grade non-Hodgkin's lymphoma--a randomised pilot study.
Bergmann, L; Hoelzer, D; Karakas, T; Knuth, A; Lautenschläger, G; Mitrou, PS, 1995
)
0.29
" The corticosteroid dosage was gradually tapered."( Predominant tubulointerstitial lupus nephritis.
Madias, NE; Singh, AK; Ucci, A, 1996
)
0.29
" The most significant factor responsible for these metabolic complications was the total dosage of prednisone and cyclosporine."( Metabolic problems in recipients of liver transplants.
Filo, RS; Hughes, D; Jindal, RM; Leapman, SB; Lumeng, L; Milgrom, ML; Pescovitz, MD; Sidner, RA, 1996
)
0.51
" For lymphoma, CHOP chemotherapy dosage costs are approximately half of those for CDE infusion related to the specific drug regimen and drug dosage used."( Comparison of costs for infusion versus bolus chemotherapy administration: analysis of five standard chemotherapy regimens in three common tumors--Part one. Model projections for cost based on charges.
Anderson, NR; Lokich, JJ; Moore, CL, 1996
)
0.29
" The principle cost differences between bolus and infusional schedules relate to drug dosage and the toxicity profile."( Comparison of costs for infusion versus bolus chemotherapy administration: analysis of five standard chemotherapy regimens in three common tumors--Part one. Model projections for cost based on charges.
Anderson, NR; Lokich, JJ; Moore, CL, 1996
)
0.29
" Six years after the start of corticosteroid therapy for her annoying skin lesion, we started to treat her with high-dose intravenous immunoglobulin (IVIG) infusion therapy because of the difficulty of reducing the dosage of oral prednisone, that had secondarily induced adverse effects."( Successful treatment of a therapy-resistant severely pruritic skin eruption of malignancy-associated dermatomyositis with high-dose intravenous immunoglobulin.
Kikuchi-Numagami, K; Sato, M; Tagami, H, 1996
)
0.48
" Once the patient's liver function normalized, prednisone dosage was reduced by 5 mg weekly."( Dapsone hypersensitivity syndrome.
Prussick, R; Shear, NH, 1996
)
0.55
"Changes in beta 2-adrenoceptor function by chronic dosing of beta 2-mimetics and the possible influence of a single dose of prednisone have been studied as changes over time in the concentration-effect relationship of the beta 2-adrenoceptor agonist terbutaline."( Pharmacodynamic modelling of the drug-induced downregulation of a beta 2-adrenoceptor mediated response and lack of restoration of receptor function after a single high dose of prednisone.
Braat, MC; Jonkers, RE; Koopmans, RP; van Boxtel, CJ, 1995
)
0.69
" This modest dosage was found to give an excellent result in three patients and a poor result in one whose treatment was started at a much later stage of the disease than in the others."( Oral prednisone in the treatment of acne agminata.
Aiba, S; Tagami, H; Uesugi, Y; Usuba, M, 1996
)
0.81
" GC mini pulses are effective on early clinical and biological parameters of inflammation and requires a lower cumulative daily dosage than conventional oral GC treatment."( 6-methylprednisolone 'mini-pulses': a new modality of glucocorticoid treatment in systemic onset juvenile chronic arthritis.
Borrone, C; Buoncompagni, A; Gattorno, M; Picco, P; Pistoia, V, 1996
)
0.29
" Prednisone therapy was continued until the patient was discharged on hospital day 5, at which time the dosage was tapered."( Reversal of erythema multiforme major with cyclophosphamide and prednisone.
Cole, GW; Eastham, JH; Gómez, MF; Segal, JL, 1996
)
1.44
" The most common postoperative dosage (used by 62 percent) was 100 mg of hydrocortisone phosphate intravenously every eight hours, which was tapered to 50 mg intravenously every 8 to 12 hours."( Perioperative steroid use in colorectal patients. Results of a survey.
Beck, DE; Opelka, FG, 1996
)
0.29
" Methotrexate was given weekly for 8 weeks beginning at the conclusion of OKT3 therapy (postoperative days 8 to 16), and dosed according to white blood cell count."( Methotrexate for rejection prophylaxis after heart transplantation.
Ensley, RD; Olsen, SL; Renlund, DG; Taylor, DO,
)
0.13
" carinii pneumonia reported to date in methotrexate-treated rheumatoid arthritis patients demonstrated a number of characteristics: the rheumatoid arthritis was of recent onset in some cases (a few months in one patient); lymphopenia was present in two thirds of cases; one-third of patients were not receiving corticosteroid therapy; the dosage and duration of methotrexate therapy varied widely, from 5 to 30 mg per week and two to 48 months; and four patients died."( Pneumocystis carinii pneumonia in rheumatoid arthritis patients treated with methotrexate. A report of two cases.
Cortet, B; Delcambre, B; Duquesnoy, B; Flipo, RM; Lafitte, JJ; Roux, N; Tonnel, AB, 1996
)
0.29
" MP dosage based on BMI may be a reasonable alternative to a fixed-dose regimen with the advantage of limiting steroid exposure and the consequent side-effects."( Treatment of renal allograft acute rejection with methylprednisolone: effect of fixed dose versus dose per body mass index.
Carson, RW; Douzdjian, V; Fisch, JC; Gugliuzza, KK; Rice, JC, 1996
)
0.29
"In the patients who were receiving DHEA, the SLEDAI score, patient's and physician's overall assessment of disease activity, and concurrent prednisone dosage decreased, while in the patients taking placebo, small increases were seen."( Dehydroepiandrosterone in systemic lupus erythematosus. Results of a double-blind, placebo-controlled, randomized clinical trial.
Engleman, EG; McGuire, JL; van Vollenhoven, RF, 1995
)
0.49
" The results suggest that (i) DFC and PRED in equal anti-inflammatory dosage are similarly or equally efficient in slowing down the decline of muscle strength in DMD; (ii) benefits outweigh the side effects."( Deflazacort vs. prednisone in Duchenne muscular dystrophy: trends of an ongoing study.
Reitter, B, 1995
)
0.64
" Two patients developed exacerbation of hepatitis when the dosage of prednisolone was reduced after they had ten weeks of high dose prednisolone."( Exacerbation of hepatitis in hepatitis B carriers following chemotherapy for haematological malignancies.
Chong, R; Goh, YT; Lee, LH; Ng, HS; Tan, P; Wong, GC, 1996
)
0.29
" The mean daily dosage of prednisone was 10."( Calcific degeneration of bioprosthetic aortic valves in patients receiving steroid therapy.
Eishi, K; Ishibashi-Ueda, H; Kobayashi, J; Kosakai, Y; Nakano, K; Sasako, Y; Yutani, C, 1996
)
0.59
" Prednisone dosage was lower in diabetics with EOD at 6 months, but did not differ among the three groups at 12 months."( Heart transplantation in patients with diabetic end-organ damage before transplantation.
Aleksic, I; Blanche, C; Czer, LS; Dalichau, H; Freimark, D; Nessim, S; Nusser, P; Takkenberg, JJ; Trento, A, 1996
)
1.2
" A second daily dosage of 50 mg of prednisone was successful in 21 days."( Cranial polyneuropathy--Ramsay Hunt's syndrome: case report and discussion.
Geunes, PM; Schuman, NJ; Turner, JE, 1997
)
0.57
"The better pregnancy outcome associated with lower prednisone dosage is probably related to the fact that the patients selected to receive the low-dose regimen have had a longer and less complicated post-transplantation course."( Prednisone dosage and pregnancy outcome in renal allograft recipients.
Bar, J; Boner, G; Fisch, B; Gelerenter, I; Hod, M; Wittenberg, C, 1997
)
1.99
" One exception might be CBCC patients who were younger (median age 56 years) and who were usually in good general condition so that they might qualify for high dosage chemotherapy and stem cell support."( Outcome of patients with low-grade B cell non-Hodgkin lymphoma and initial bone marrow involvement: data of a single institution.
Heinz, R; Hopfinger, G; Tüchler, H, 1997
)
0.3
"002) inhibited by dexamethasone (10 mol/L), reflecting a shift of the dose-response curve."( Steroid-resistant asthma immunologic characteristics.
Luo, W; Sun, Y, 1996
)
0.29
"From each article, the following was abstracted: reference citation; type of control; whether study incorporated a run-in period in which the baseline level of prednisone was reduced to the lowest possible dose; dosage and length of methotrexate therapy; baseline dosage; and type of steroid."( Low-dose methotrexate spares steroid usage in steroid-dependent asthmatic patients: a meta-analysis.
Marin, MG, 1997
)
0.49
" The greatest effect was evident in patients in whom an effort was made to reduce baseline steroid dosage and in whom methotrexate was used for 24 weeks."( Low-dose methotrexate spares steroid usage in steroid-dependent asthmatic patients: a meta-analysis.
Marin, MG, 1997
)
0.3
"Daily dosage of oral CSA was 3 to 5 mg/kg and mean duration of treatment was 37 months (range, 22-48 months)."( Systemic cyclosporine A in severe atopic keratoconjunctivitis.
Hannouche, D; Hoang-Xuan, T; Prisant, O; Robin, H, 1997
)
0.3
" In summary, G-CSF (filgrastim) will facilitate the shortening of the dosage interval between cycles of CHOP chemotherapy due to accelerated hematological recovery."( A phase I trial to assess the value of recombinant human granulocyte colony stimulating factor (R-MeTHuG-CSF, filgrastim) in accelerating the dose rate of chemotherapy for intermediate and high-grade non-Hodgkin's lymphoma (NHL). The Central Lymphoma Grou
Bailey, NP; Barnard, D; Child, JA; Cullen, MH; Earl, H; Fletcher, J; Smith, GM; Woodruffe, CM, 1996
)
0.29
" Three patients were treated with intravenous acyclovir with concomitant reduction of steroid dosage and recovered completely."( Management of varicella infection during the course of inflammatory bowel disease.
Balasubramanian, S; Giannadaki, E; Greenstein, AJ; Manousos, ON; Mouzas, IA; Sachar, DB, 1997
)
0.3
" If varicella infection occurs, prompt diagnosis and treatment with acyclovir and concomitant reduction in immunosuppressive therapy (reduction in steroid dosage and discontinuation of azathioprine) should be initiated immediately to limit viremia and avoid fatal complications."( Management of varicella infection during the course of inflammatory bowel disease.
Balasubramanian, S; Giannadaki, E; Greenstein, AJ; Manousos, ON; Mouzas, IA; Sachar, DB, 1997
)
0.3
" Prognostic factors other than age should be taken into account, particularly when doses and dosing intervals are determined."( Prognostic factors in elderly patients with non-Hodgkin's lymphoma treated with cyclophosphamide, vincristine, prednisone, bleomycin, Adriamycin, procarbazine (COP-BLAM) therapy.
Niitsu, N, 1997
)
0.51
" All of them achieved acceptable platelet counts within the first 4 weeks of danazol therapy that allowed the prednisone dosage to be tapered."( Successful therapy with danazol in refractory autoimmune thrombocytopenia associated with rheumatic diseases.
Blanco, R; González-Gay, MA; Martinez-Taboada, VM; Rodriguez-Valverde, V; Sanchez-Andrade, A, 1997
)
0.51
" In case of failure of this treatment, a high dose of prednisone (1 mg/kg) could be tried or a lower dosage (40 mg/day) could be used in cases with high IL-6 levels (type II)."( [Treatment of amiodarone-induced hyperthyroidism: corticosteroids or potassium perchlorate? What value do interleukin-6 levels have?].
Konfino, O; Martin-Du Pan, R; Zimmermann, M, 1997
)
0.55
" Registered variables included demographic data, disease characteristics, prednisone dosage and duration, comorbidities, and clinical outcomes."( Clinical outcome of 149 patients with polymyalgia rheumatica and giant cell arteritis.
Bahlas, S; Davis, P; Ramos-Remus, C, 1998
)
0.53
" Furthermore, no patients had evidence of adrenal suppression from either dosing regimen."( A pilot study of steroid therapy after emergency department treatment of acute asthma: is a taper needed?
Cydulka, RK; Emerman, CL,
)
0.13
"The efficacy and safety of regular-strength beclomethasone dipropionate MDI prescribed within its recommended dosing range of 2 to 5 puffs three to four times daily has been well established in more than 25 years of worldwide use."( A systemic bioactivity comparison of double-strength and regular-strength beclomethasone dipropionate MDI formulations.
Affrime, MB; Brannan, MD; Herron, JM; Reidenberg, P, 1998
)
0.3
"Beclomethasone dipropionate, administered either via a double-strength (84 microg/puff) or regular-strength (42 microg/puff) inhaler dosed at 840 microg/day showed no evidence of hypothalamic-pituitary-adrenocortical axis suppression in adults with moderate asthma."( A systemic bioactivity comparison of double-strength and regular-strength beclomethasone dipropionate MDI formulations.
Affrime, MB; Brannan, MD; Herron, JM; Reidenberg, P, 1998
)
0.3
" These results suggest that increasing DNM dosage in induction is one of the possible approaches to improve the outcome of adult ALL by decreasing the relapse occurrence."( Estimated 6-year event-free survival of 55% in 60 consecutive adult acute lymphoblastic leukemia patients treated with an intensive phase II protocol based on high induction dose of daunorubicin.
April, F; Meneghini, V; Perona, G; Pizzolo, G; Ricetti, MM; Solero, P; Tecchio, C; Todeschini, G; Veneri, D; Zanotti, R, 1998
)
0.3
" The acyclovir dosage was 2400 mg (800 mg three times a day) for 10 days, and prednisone was given as a single daily dose of 1 mg/kg of body weight for 10 days and tapered to 0 over the next 6 days."( Idiopathic facial paralysis: a randomized, prospective, and controlled study using single-dose prednisone versus acyclovir three times daily.
De Diego, JI; De Sarriá, MJ; Gavilán, J; Madero, R; Prim, MP, 1998
)
0.75
"5-3 times the upper limit of normal received prednisone for a total of six weeks prior to interferon starting at 60 mg daily with reduction in dosage by 20 mg every two weeks with a two-week period between finishing prednisone and starting interferon-alpha2b."( Interferon-alpha2b therapy is efficacious in Asian-Americans with chronic hepatitis B infection: a prospective controlled trial.
Hann, HW; Maddrey, WC; Martin, P; Muñoz, SJ; Rubin, R; Westerberg, S, 1998
)
0.56
" IFNalpha was withdrawn because of toxicity in 10% of the patients, and a dosage reduction or temporary suspension was required in 28%."( Doxorubicin-containing regimen with or without interferon alfa-2b for advanced follicular lymphomas: final analysis of survival and toxicity in the Groupe d'Etude des Lymphomes Folliculaires 86 Trial.
Bouabdallah, R; Brice, P; Brousse, N; Coiffier, B; Doyen, C; Gabarre, J; Haïoun, C; Lepage, E; Pignon, B; Rossi, JF; Solal-Céligny, P; Tendler, CL; Tertian, G, 1998
)
0.3
" The IFN dosage was 5 x 10(6) U three times weekly for 18 months."( Quality-of-life-adjusted survival analysis of interferon alfa-2b treatment for advanced follicular lymphoma: an aid to clinical decision making.
Cole, BF; Gelber, RD; Gisselbrecht, C; Goldhirsch, A; Lepage, E; Reyes, F; Sebban, C; Solal-Céligny, P; Sugano, D; Tendler, C, 1998
)
0.3
" This new product has been well received due to convenient dosing and relatively few side effects."( Churg-Strauss syndrome associated with zafirlukast.
Allen, JN; Knoell, DL; Lucas, J, 1998
)
0.3
" On the basis of comparisons with other data sets, we hypothesize a dose-response relationship between glucocorticoid dose and PSA decline."( Effect of prednisone on prostate-specific antigen in patients with hormone-refractory prostate cancer.
Figg, WD; Li, A; Moore, A; Sartor, O; Weinberger, M, 1998
)
0.7
" After conversion, the Neoral dosage was adjusted on the basis of trough levels measured at weeks 1, 2, 3, 4, 6, 8, and 12."( An open-label study of the safety and tolerability of converting stable liver transplant recipients to neoral.
Dahlke, LM; Krom, RA; Pasha, TM; Porayko, MK; Wiesner, RH, 1998
)
0.3
" These medications were continued during the episode and subsequently afterwards, with adjustment to the prednisone dosage only."( Hypersensitivity syndrome reaction to oral terbinafine.
Gupta, AK; Porges, AJ, 1998
)
0.51
"The results of this study do not suggest the use of TXT at this dosage and schedule in advanced soft tissue sarcoma."( [Phase II study of docetaxel in patients with advanced stage soft tissue sarcoma].
Amodio, A; Carpano, S; Foggi, P; Gionfra, T; Lopez, M; Manfredi, C; Paoletti, G; Rinaldi, M,
)
0.13
" The initial dosage was 200 mg a day, which was increased to 400 mg a day after 4 months."( Disfiguring cutaneous manifestation of sarcoidosis treated with thalidomide: a case report.
Koblenzer, PS; Lee, JB, 1998
)
0.3
" Further follow-up is required to assess the effect of dosage and the effect on survival and late toxicities."( BEACOPP, a new dose-escalated and accelerated regimen, is at least as effective as COPP/ABVD in patients with advanced-stage Hodgkin's lymphoma: interim report from a trial of the German Hodgkin's Lymphoma Study Group.
Bischoff, H; Diehl, V; Duehmke, E; Engert, A; Franklin, J; Georgii, A; Glunz, A; Haedicke, C; Hasenclever, D; Hermann, R; Holmer, L; Krause, S; Lathan, B; Loeffler, M; Paulus, U; Pfreundschuh, M; Rueffer, JU; Sextro, M; Sieber, M; Stappert-Jahn, U; Tesch, H; von Kalle, K; Winnerlein-Trump, E; Wolf, J; Wulf, G, 1998
)
0.3
" Oral steroid dosing requirements and acute episodes of ABPA for days with vs days without itraconazole were compared."( Allergic bronchopulmonary aspergillosis in cystic fibrosis: role of atopy and response to itraconazole.
Esrig, S; Moss, RB; Nepomuceno, IB, 1999
)
0.3
" Dosing with interleukin-10 produced strong inhibition of ex vivo cytokine production for the 24-hour postdosing period, whereas prednisolone, the active form of prednisone, was partly inhibitory for only 3 hours."( Pharmacoimmunodynamic interactions of interleukin-10 and prednisone in healthy volunteers.
Blum, RA; Chakraborty, A; Cutler, DL; Jusko, WJ, 1999
)
0.74
"Both plasma and urine cortisol suppression showed a dose-response for the daily doses of budesonide."( A cortisol suppression dose-response comparison of budesonide in controlled ileal release capsules with prednisolone.
Edsbäcker, S; Larsson, P; Nilsson, M, 1999
)
0.3
" Corticosteroid dosing involves six phases: (1) initial high doses to control inflammation; (2) tapering to a maintenance dose that will continue to suppress the inflammation but lessen the risk of corticosteroid toxic reactions; (3) continuing to receive the maintenance dose until a decision to taper off corticosteroids is made; (4) tapering off corticosteroid therapy; (5) observation for relapse; and (6) treatment if relapse occurs."( An approach to the treatment of pulmonary sarcoidosis with corticosteroids: the six phases of treatment.
Judson, MA, 1999
)
0.3
" The average number of days before reduction of the prednisone dosage could begin was 16."( Pemphigus vulgaris: benefits of tetracycline as adjuvant therapy in a series of thirteen patients.
Calebotta, A; Carvalho, M; Castillo, R; González, F; Sáenz, AM, 1999
)
0.55
"Oral methotrexate, at an initial dosage of 5 mg/wk, was given to 11 consecutive patients older than 70 years of age who were not responding to potent topical steroids."( Low-dose oral pulse methotrexate as monotherapy in elderly patients with bullous pemphigoid.
Albertioni, F; Heilborn, JD; Peterson, C; Ståhle-Bäckdahl, M; Stephansson, E; Vassilaki, I, 1999
)
0.3
" Neither dosage nor glucocorticoid employed were modified during the study."( An open comparison of the diabetogenic effect of deflazacort and prednisone at a dosage ratio of 1.5 mg:1 mg.
Blanch Sancho, JJ; Carmona Martín, M; Navarro López, V; Puras Tellaeche, A; Sáez Barcelona, JA, 1999
)
0.54
" A nonnephrotoxic and powerful immunosuppressant such as mycophenolate mofetil (MMF) could allow a reduction of cyclosporine dosage or its withdrawal and an improvement in renal function in these patients."( Conversion of liver transplant recipients on cyclosporine with renal impairment to mycophenolate mofetil.
Alvárez-Cienfuegos, J; Girala, M; Gómez-Manero, N; Herrero, JI; Pardo, F; Prieto, J; Quiroga, J; Sangro, B, 1999
)
0.3
" There is no apparent reason to change the dosing regimen of prophylactic co-trimoxazole when there is clinical evidence of damage to the gastrointestinal mucosa induced by chemotherapy."( Gastrointestinal damage induced by cytostatic treatment does not affect the bioavailability of co-trimoxazole.
Höglund, P; Johnsson, A; Ljungberg, B; Nilsson-Ehle, I; Nyhlén, A,
)
0.13
" They were seen monthly and prednisone dosage was tapered following a pre-determined schedule."( Methotrexate is steroid sparing in acute sarcoidosis: results of a double blind, randomized trial.
Baughman, RP; Lower, EE; Winget, DB, 2000
)
0.6
" All patients went into remission with a lower daily dosage of oral prednisone at 3 and 6 months postplasmapheresis."( Plasmapheresis as a steroid saving procedure in bullous pemphigoid.
Egan, CA; Meadows, KP; Zone, JJ, 2000
)
0.54
", the dosing interval-corrected area under the concentration-time curves, and >/=36% for the trough concentration (C(0))."( Low intraindividual variability of cyclosporin A exposure reduces chronic rejection incidence and health care costs.
Beusterien, KM; Dicesare, J; Kahan, BD; Katz, SM; Mosheim, MB; Schoenberg, LP; Urbauer, DL; VAN Buren, CT; Welsh, M; Wood, MR, 2000
)
0.31
" Because previous pharmacokinetic studies showed a correlation between Rituximab serum levels and tumor response, the ELISA method used in this study, which allows a precise control of serum concentrations, could be useful for predicting the final response to the MAb and for selecting patients able to benefit from higher dosage or repeated drug administration."( Rituximab (IDEC-C2B8): validation of a sensitive enzyme-linked immunoassay applied to a clinical pharmacokinetic study.
Arcaini, L; Astori, C; Avanzini, MA; Iacona, I; Lazzarino, M; Lunghi, F; Morra, E; Orlandi, E; Regazzi, MB; Rupolo, M; Zagonel, V, 2000
)
0.31
"Sixteen textbooks and chemotherapy reference books reviewed quoted only one prednisone dosage as part of the standard CHOP regimen; the prednisone dosages quoted as standard varied between publications."( The prednisone dosage in the CHOP chemotherapy regimen for non-Hodgkin's lymphomas (NHL): is there a standard?
Colon-Otero, G; Moreno, A; Solberg, LA, 2000
)
1.09
" The mobilization kinetics of circulating progenitor cells in patients with aggressive NHL is dependent on the dosage and schedule of CHOP."( Randomized comparison of mobilization kinetics of circulating CD34+ cells between biweekly CHOP and dose-escalated CHOP with the prophylactic use of lenograstim (glycosylated rHuG-CSF) in aggressive non-Hodgkin's lymphoma. The lenograstim/Lymphoma Study G
Chou, T; Ikeda, S; Itoh, K; Kasai, M; Mizorogi, F; Morishima, Y; Ogura, M; Ohno, T; Ohtsu, T; Sai, T; Sasaki, Y; Taniwaki, M; Tobinai, K; Uike, N; Yoshida, K, 2000
)
0.31
"9 mg/m2/week (90% of ideal CHOP dosing for both drugs)."( Granulocyte-colony stimulating factor (G-CSF) may improve disease outcome in elderly patients with diffuse large cell lymphoma (DLCL) treated with CHOP chemotherapy.
Bertino, J; Donnelly, GB; Glassman, J; Long, C; Moskowitz, CH; O'Brien, JP; Portlock, CS; Straus, DJ; Torres, P; Zelenetz, AD, 2000
)
0.31
" It is suggested that cyclosporine, together with the decrease of prednisone dosage but independent of renal function, PTH, and vitamin D status, contributes to a transient stimulation of bone remodeling at six months, which counterbalances the deleterious effect of prednisone on bone formation and BMD."( Cyclosporine bone remodeling effect prevents steroid osteopenia after kidney transplantation.
Achard, JM; Brazier, M; El Esper, I; Ezaitouni, F; Fardellone, P; Fournier, A; Hottelart, C; Ivan, C; Mazouz, H; Petit, J; Pruna, A; Westeel, FP, 2000
)
0.54
" Prednisone dosage adjustments were based on a defined schedule determined by the change in a subject's disease activity score, and steroid administration was discontinued as remission was achieved."( A multicenter trial of 6-mercaptopurine and prednisone in children with newly diagnosed Crohn's disease.
Daum, F; Grancher, K; Kohn, N; Lesser, M; Markowitz, J, 2000
)
1.48
" Remission, pharmacological remission, and marked improvement with reduction in drug dosage were considered good results."( Clinical characteristics and prognosis of myasthenia gravis in older people.
Batocchi, AP; Di Schino, C; Evoli, A; Minisci, C; Tonali, P, 2000
)
0.31
" In severe ophthalmopathy steroids are effective in more than 60% of patients [1, 3], but to be effective high dosage is necessary [1, 4-6]."( [Treatment of Grave's ophthalmopathy with high doses of corticosteroids].
Cirić, J; Drezgić, M; Gligorović, M; Nesović, M; Pepenezić, Z; Randjelović, G; Stojanović, M; Trbojević, B; Zarković, M,
)
0.13
" In the multiple regression test, a linear coincidence was observed between apo A1, apo B and prednisone cumulative dosage after the 1st month, TG and cyclosporine in the 6th month and LDL and cyclosporine in the 12th month after transplantation."( Does immunosuppressive regimen influence the lipid disturbances in kidney recipients?
Kisielnicka, E; Kortas, B; Lysiak-Szydłowska, W; Rutkowski, B; Wróblewska, M; Zdrojewski, Z,
)
0.35
" Plasma concentrations were near the lower limit of quantitation (50 pg/mL) at the MF DPI 400-microg qd dosage and approximately 250 pg/mL at the 1,200-microg qd dosage."( Mometasone furoate has minimal effects on the hypothalamic-pituitary-adrenal axis when delivered at high doses.
Affrime, MB; Flannery, BE; Herron, JM; Kosoglou, T; Thonoor, CM, 2000
)
0.31
"The MF 800-microg bid dosage (1,600 microg/d), which is twice the highest projected clinical dosage, represents the lower limit for consistently detectable systemic effects of MF."( Mometasone furoate has minimal effects on the hypothalamic-pituitary-adrenal axis when delivered at high doses.
Affrime, MB; Flannery, BE; Herron, JM; Kosoglou, T; Thonoor, CM, 2000
)
0.31
"Interferon seems to be an effective drug in the treatment of cryoglobulinaemic glomerulonephritis, but dosage and length of treatment still need to be addressed by large multicentre studies."( Interferon versus steroids in patients with hepatitis C virus-associated cryoglobulinaemic glomerulonephritis.
Baracetti, S; Campanacci, L; Carniello, S; Crovatto, M; Faccini, L; Faelli, A; Mazzaro, C; Mazzi, G; Nascimben, F; Panarello, G; Pozzato, G; Zorat, F, 2000
)
0.31
" They had been receiving oral prednisone treatment for a median of 30 months (range 6-74); mean daily dosage during the six-month study period was 12."( Management of glucocorticoid-induced osteoporosis in male veterans.
Binkley, NC; Carnes, ML; Elliott, ME; Farrah, RM; Gudmundsson, A, 2000
)
0.6
" All four patients obtained no clinical benefit from the treatment; moreover, inflammation indices worsened and the prednisone dosage was increased during the trial, in spite of a significant fall in CD4+ T cells."( Unsuccessful treatment with fludarabine in four cases of refractory rheumatoid arthritis.
Bambara, LM; Biasi, D; Caramaschi, P; Carletto, A, 2000
)
0.52
" Despite this, the pharmacokinetics of prednisolone have never been fully characterized in these patients, and consequently dosing remains empirical."( Simultaneous determination of plasma prednisolone, prednisone, and cortisol levels by high-performance liquid chromatography.
Akhlaghi, F; Holt, DW; Lee, T; Majid, O; Trull, A, 2001
)
0.56
" The regimen of glucocorticoid therapy was oral prednisone, starting with 160 mg daily followed by reducing the dosage by 20 mg every three days until 40 mg per day was attained and then tapering the dosage at 70 mg every other day until stoppage of the drug."( [Treatment of acute optic neuritis with high dose of prednisone].
Ai, F; Hu, T; Jiang, R; Liu, Q; Zhang, M, 1998
)
0.81
"Reasonable therapeutic dosage regimen for pemphigus are analyzed to find the factors related to prognosis."( [A clinical analysis of 64 cases of pemphigus].
He, Z; Wang, B; Yu, B, 1998
)
0.3
"We recommend a moderate to high dosage of corticosteroids be the first choice to control pemphigus."( [A clinical analysis of 64 cases of pemphigus].
He, Z; Wang, B; Yu, B, 1998
)
0.3
" When prednisone dosage was tapered from 10 mg/d to 10 mg every other day, clinically significant improvements were seen in weight, systolic and diastolic blood pressure, blood pressure medications, glycosylated hemoglobin level, and diabetic medications."( Lack of long-term benefits of steroid withdrawal in renal transplant recipients.
Landsberg, D; Nussbaumer, G; Sivaraman, P, 2001
)
0.79
" The clinical remission in the CsA-treated group confirmed the therapeutic effectiveness of this therapy in antihistaminic unresponsive CIU and, at dosage used, side effects were rare, mild and reversible."( Cyclosporin A in patients affected by chronic idiopathic urticaria: a therapeutic alternative.
Cavallo, E; D'Oronzio, L; Dambra, PP; Ferrannini, A; Loria, MP; Nettis, E; Pannofino, A; Tursi, A, 2001
)
0.31
" A frequent problem is relapse of disease when corticosteroid dosage is tapered off."( Successful treatment of bronchiolitis obliterans organizing pneumonia with low-dose methotrexate in a patient with Hodgkin's disease.
Breitbart, A; Egerer, G; Goldschmidt, H; Ho, AD; Möller, P; Spaeth, A; Witzens, M, 2001
)
0.31
" In order to obtain a corticosteroid-sparing effect, new studies are necessary to evaluate a reduced initial dosage of corticosteroids."( [Horton's disease in elderly patients aged over 75: clinical course, complications of corticotherapy. Comparative study of 164 patients. Towards a reduced initial dose].
Barrier, JH; Chevalet, P; de Wazières, B; Duhamel, E; el Kouri, D; Glémarec, J; Hamidou, M; Jégo, P; Maugars, Y; Planchon, B; Rodat, O, 2001
)
0.31
" This suggested that, although the adult 12-hour dosing interval was appropriate for pediatric patients, they would require reduced dosing based on body size compared with adults."( Safety and efficacy of TOR inhibitors in pediatric renal transplant recipients.
Ettenger, RB; Grimm, EM, 2001
)
0.31
"Clinical studies comparing the potency of inhaled corticosteroids require steep dose-response slopes (b) and minimal response variability (s), as statistical power is inversely related to the s/b ratio."( Asthma stability after oral prednisone: a clinical model for comparing inhaled steroid potency.
Ahrens, RC; Donnell, D; Han, SH; Lux, CR; Teresi, ME; Vanden Burgt, JA, 2001
)
0.6
" Because of that, there was no need to increase dosage nor to switch systemic immunosuppressors."( [Transeptal steroids in necrotizing scleritis].
Folch Ramos, J; Sainz De La Maza Serra, M, 2001
)
0.31
"This study sought to determine effects of multiple dosing of prasterone (DHEA, dehydroepiandrosterone) on the pharmacokinetics of prednisolone and endogenous cortisol secretion."( Effects of oral prasterone (dehydroepiandrosterone) on single-dose pharmacokinetics of oral prednisone and cortisol suppression in normal women.
Blum, RA; Jusko, WJ; Meno-Tetang, GM; Schwartz, KE, 2001
)
0.53
" Steroid dosage significantly predicted aggressive, but not anxious/depressed, behavior."( Daily reports and pooled time series analysis: pediatric psychology applications.
Lande, MB; Moore, KJ; Soliday, E,
)
0.13
" The following objective parameters were used to assess the clinical outcome pre- and post-IVIg therapy: number of side effects, frequencies of recurrences and relapses, duration and total dosage of prednisone therapy, and the quality of life."( Intravenous immunoglobulin therapy in patients with multiple mucosal involvement in mucous membrane pemphigoid.
Bhol, KC; Razzaque Ahmed, A; Sami, N, 2002
)
0.5
" Despite prompt initiation of antimycotic therapy the outcome was fatal; dosage of conventional and liposomal amphotericin B was limited due to treatment-related toxicities."( A novel type of metastatically spreading subcutaneous aspergillosis without epidermal lesions following allogeneic stem cell transplantation.
Bethe, U; Cornely, OA; Pels, H; Ritzkowsky, A; Seibold, M; Soehngen, D; Toepelt, K, 2001
)
0.31
" Retarded FH was associated with higher average prednisone dosage and better FH was associated with good graft function."( The contribution of renal transplantation to final adult height: a report of the North American Pediatric Renal Transplant Cooperative Study (NAPRTCS).
Fine, RN; Ho, M; Tejani, A, 2001
)
0.57
" Corticosteroid treatment led to long-lasting renal and hematologic remission, maintained by a small dosage of prednisone."( Glomerular involvement in myelodysplastic syndromes.
Bogdanović, R; Bunjevacki, G; Kuzmanović, M; Marković-Lipkovski, J; Mićić, D; Nikolić, V; Ognjanović, M; Stajić, N; Stanković, I, 2001
)
0.52
" The dosage of prednisone could be tapered smoothly among the steroid dependent patients."( [Mycophenolate mofetil in the treatment of primary nephrotic syndrome].
Chen, X; Chen, Y; Liu, Y; Liu, Z; Lu, F; Wang, H; Zhang, Y; Zhao, M, 2001
)
0.66
"8 months), total used dosage of steroids (G1= 20, G2= 28, G3= 16 grams) and time of drug use (G1= 20, G2= 26, G3= 14."( [A comparative study of therapeutic complications in Systemic Lupus Erythematosus and in idiopathic glomerulopathy].
Almeida, DB; Balbi, AL; Barbosa, RA; Lima, MC,
)
0.13
" These patients (n = 13) were treated again with GH at the same dosage (0."( Linear growth in children suffering from juvenile idiopathic arthritis requiring steroid therapy: natural history and effects of growth hormone treatment on linear growth.
Czernichow, P; Lucidarme, N; Prieur, AM; Ruiz, JC; Simon, D, 2001
)
0.31
" On two occasions, a pharmacokinetic profile was obtained over the dosing interval after drug administration under fasting conditions and after a high-fat meal in a randomized sequence."( Effect of food on everolimus absorption: quantification in healthy subjects and a confirmatory screening in patients with renal transplants.
Budde, K; Figueiredo, J; Golor, G; Hartmann, S; Kovarik, JM; Lison, A; Neumayer, HH; Rordorf, C, 2002
)
0.31
" Infliximab was administered at the dosage of 3 mg/Kg at the weeks 0, 2 and 6 and then every 8 weeks."( [Infliximab in aggressive and refractory rheumatoid arthritis. A pilot study].
Bambara, LM; Biasi, D; Canestrini, S; Caramaschi, P; Carletto, A; Scambi, C; Scarperi, A, 2002
)
0.31
"Randomised trials comparing different routes of administration and dosage schemes of corticosteroid or adrenocorticotrophic hormone therapy versus a control group where no therapy considered effective for this condition was administered, unless it was also given in a similar way to the experimental group."( Corticosteroids for Bell's palsy (idiopathic facial paralysis).
Alvarez, G; Alvarez, MI; Ferreira, J; Salinas, RA, 2002
)
0.31
"Leflunomide seems to possess substantial immune suppressive potency in renal and liver transplant recipients and may be safely dosed for more than 300 days."( Experiences with leflunomide in solid organ transplantation.
Brady, L; Chong, A; Huang, W; Jensik, S; Kottayil, A; Longstreth, J; Millis, M; Mital, D; Williams, JW, 2002
)
0.31
" The dosage of prednisone used was reduced by routine in both groups but Chinese herbal treatment was added to the treated group in the period of prednisone reduction."( [Assessment on application of Chinese herbs in process of corticosterone reduction in nephrotic syndrome].
Guo, M; Xiao, Q; Zhao, X, 2000
)
0.66
" Alternative dosing regimens based on pharmacokinetic simulation and limited clinical trials are being investigated."( A multicenter, open-label, comparative trial of two daclizumab dosing strategies vs. no antibody induction in combination with tacrolimus, mycophenolate mofetil, and steroids for the prevention of acute rejection in simultaneous kidney-pancreas transplant
Alloway, RR; Hodge, E; Lo, A; Stratta, RJ, 2002
)
0.31
" The mean daily prednisone dosage in the treated patients with sarcoidosis was 20 mg and the mean duration of prednisone therapy was 6 months."( Corticosteroid therapy increases HDL-cholesterol concentrations in patients with active sarcoidosis and hypoalphalipoproteinemia.
Argimón, JM; Hurtado, I; Mañá, J; Pintó, X; Pujol, R; Salazar, A, 2002
)
0.66
"Adding oral prednisone or in vitro organ irradiation to an immunosuppressive regimen for laryngeal transplantation may allow cyclosporine dosage to be decreased without compromising organ rejection rates."( Effects of adding steroids, in vitro irradiation, or both to cyclosporine immunosuppression in the murine laryngeal transplantation model.
Dan, O; Haug, M; Lorenz, RR; Strome, M, 2002
)
0.69
" Secondly, an extended release low dosage tablet was followed for 7 h resulting in a linear dissolution profile."( Multiple fiber-optic dual-beam UV/Vis system with application to dissolution testing.
Cauchi, M; Johansson, J; Sundgren, M, 2002
)
0.31
"The mean starting dosage of MMF was (1."( Mycophenolate mofetil treatment for diffuse proliferative lupus nephritis: a multicenter clinical trial in China.
Li, L; Lin, S; Wang, H, 2002
)
0.31
"The following information was documented in each of the 15 patients before and after the initiation of IVIg therapy: total dosage and total duration of prednisone therapy and number of relapses."( Corticosteroid-sparing effect of intravenous immunoglobulin therapy in patients with pemphigus vulgaris.
Ahmed, AR; Qureshi, A; Ruocco, E; Sami, N, 2002
)
0.51
" Thus the goal was first to reduce tumour burden using the CHOP regimen as induction treatment followed by consolidation with rituximab administered on a standard 4 wk schedule at a dosage of 375 mg m-2 body surface area."( Rituximab (anti-CD20 monoclonal antibody) as consolidation of first-line CHOP chemotherapy in patients with follicular lymphoma: a phase II study.
Brezinschek, R; Höfler, G; Jäeger, G; Linkesch, W; Neumeister, P; Quehenberger, F; Sill, H, 2002
)
0.31
" These patients (n = 13) were treated again with GH at the same dosage (0."( Treatment of growth failure in juvenile chronic arthritis.
Czernichow, P; Lucidarme, N; Prieur, AM; Ruiz, JC; Simon, D, 2002
)
0.31
" We used a different dosing regimen of prednisone to determine if benefit to boys with Duchenne muscular dystrophy might be maintained with fewer side effects."( High dose weekly oral prednisone improves strength in boys with Duchenne muscular dystrophy.
Connolly, AM; Florence, J; Renna, R; Schierbecker, J, 2002
)
0.9
" Prednisone therapy in a daily dosage of 1 mg/kg induced a marked improvement."( Idiopathic retroperitoneal fibrosis and ankylosing spondylitis. A new case report.
Abbar, M; Abouzahir, A; Archane, MI; Bezza, A; El Maghraoui, A; Ghadouane, M; Ghafir, D; Ohayon, V; Tabache, F, 2002
)
1.22
" During delayed intensification, all patients received a dexamethasone dosage of 10 mg/m(2)/d for 21 days, with taper."( Dexamethasone versus prednisone and daily oral versus weekly intravenous mercaptopurine for patients with standard-risk acute lymphoblastic leukemia: a report from the Children's Cancer Group.
Bostrom, BC; Erdmann, GR; Gaynon, PS; Gold, S; Heerema, NA; Hutchinson, RJ; Johnston, K; La, MK; Provisor, AJ; Sather, HN; Sensel, MR; Trigg, ME, 2003
)
0.64
"Forty-three patients were divided semi-randomly into the treated group (n = 21) and the control group (n = 22), the former was treated with RRLD plus low-dose GC, and the latter was treated mainly with normal dosage of GC."( [Clinical study on effect of recombinant roasted licorice decoction combined with low-dose glucocorticoids in treating idiopathic thrombocytopenic purpura].
Hu, J; Liu, YQ; Luo, YG, 2001
)
0.31
" Corticosteroid treatment led to long-lasting renal and haematologic remission, maintained by a small dosage of prednisone."( [Corticoid-sensitive nephrotic syndrome in children with myelodysplastic syndromes].
Bogdanović, R; Bunjevacki, G; Kuzmanović, M; Marković-Lipkovski, J; Mićić, D; Nikolić, V; Ognjanović, M; Stajić, N; Stanković, I,
)
0.34
" Unless contraindicated, patients with diplopia were recommended for therapy with prednisone, up to 40 to 60 mg/d, with the dosage tapered for 5 to 6 weeks."( Development of generalized disease at 2 years in patients with ocular myasthenia gravis.
Homel, P; Kupersmith, MJ; Latkany, R, 2003
)
0.54
" Until optimal dosing strategies and a more complete adverse effect profile are established, combination therapy should be utilized cautiously in these patients."( Early experience with sirolimus in lung transplant recipients with chronic allograft rejection.
Cahill, BC; Crompton, JA; Karwande, SV; O'Rourke, MK; Parker, ST; Somerville, KT; Stringham, JC, 2003
)
0.32
" All patients responded with complete remission of symptomatology and had a prednisone dosage reduction until 70%."( Plasmapheresis therapy in pemphigus vulgaris and bullous pemphigoid.
Da Ponte, C; De Roia, D; Guerra, R; Mazzi, G; Orazi, BM; Raineri, A; Santarossa, L; Zanolli, FA, 2003
)
0.55
" Prednisone dosage was reduced from a mean of 19."( Immunomodulators and "on demand" therapy with infliximab in Crohn's disease: clinical experience with 400 infusions.
France, R; Kinney, T; Kozarek, R; Patterson, D; Rawlins, M, 2003
)
1.23
" The daily dosage of prednisolone and beclomethasone was progressively decreased while the gain in nasal comfort was being preserved."( Corticosteroid treatment in nasal polyposis with a three-year follow-up period.
Avan, P; Bonfils, P; Halimi, P; Norès, JM, 2003
)
0.32
" There was also no difference in the survival between radiotherapy dosage 50 Gy."( [Clinical analysis of 75 patients with nasopharyngeal non-Hodgkin's lymphoma].
Guan, ZZ; He, YJ; Huang, HQ; Jiang, WQ; Li, YH; Lin, TY; Xia, ZJ; Xu, RH, 2003
)
0.32
" Whether additional local radiotherapy is necessary,and the optimal radiation dosage warrant prospective randomized trial."( [Clinical analysis of 75 patients with nasopharyngeal non-Hodgkin's lymphoma].
Guan, ZZ; He, YJ; Huang, HQ; Jiang, WQ; Li, YH; Lin, TY; Xia, ZJ; Xu, RH, 2003
)
0.32
"This paper proposes the use of neural networks for individualizing the dosage of cyclosporine A (CyA) in patients who have undergone kidney transplantation."( Prediction of cyclosporine dosage in patients after kidney transplantation using neural networks.
Camps-Valls, G; Jiménez-Torres, NV; Martín-Guerrero, JD; Pérez-Ruixo, JJ; Porta-Oltra, B; Serrano-López, AJ; Soria-Olivas, E, 2003
)
0.32
" Dosing of these agents was concentration-controlled and open-labeled."( Bicêtre hospital experience with sirolimus-based therapy in human renal transplantation: the Sirolimus European Renal Transplant Study.
Bäckman, L; Brattström, C; Calne, R; Campistol, JM; Charpentier, B; Claesson, K; Durand, D; Groth, CG; Kreis, H; Lang, P; Morales, JM; Touraine, JL; Wramner, L, 2003
)
0.32
"Mycophenolate mofetil (MMF) has proven to be a very effective drug for the prevention of acute rejection following renal transplantation when dosed as prescribed at 2 or 3 g/d."( The impact of mycophenolate mofetil dosing patterns on clinical outcome after renal transplantation.
Akin, B; Bumgardner, GL; Elkhammas, EA; Ferguson, RM; Henry, ML; Pelletier, RP; Rajab, A, 2003
)
0.32
" Nevirapine was administered at the lead-in dosage of 200 mg once daily."( Randomized, controlled study of the effects of a short course of prednisone on the incidence of rash associated with nevirapine in patients infected with HIV-1.
Cahn, P; Casssetti, LI; Gigliotti, M; Hall, DB; Losso, M; McDonough, M; Montaner, JS; Robinson, PA; Wruck, J; Zala, C, 2003
)
0.56
" Psychosis was unpredictable by the routes and dosage of corticosteroid used."( Factors predictive of corticosteroid psychosis in patients with systemic lupus erythematosus.
Chau, SY; Mok, CC, 2003
)
0.32
" The phototests were performed on large skin areas of the forearm or trunk; the first dose was twice the minimal erythema dose and the dosage was increased according to the individual reactions of the patients at the test sites."( Photosensitivity in patients with lupus erythematosus: a clinical and photobiological study of 100 patients using a prolonged phototest protocol.
Bruijnzeel-Koomen, CA; Kazzaz, GA; Sanders, CJ; Sigurdsson, V; Toonstra, J; Van Weelden, H, 2003
)
0.32
"Thirty patients with active Crohn's disease were treated with a 10 week course of prednisone using a tapering dosing regimen."( The mechanisms of prednisone inhibition of inflammation in Crohn's disease involve changes in intestinal permeability, mucosal TNFalpha production and nuclear factor kappa B expression.
Bitton, A; Thomson, AB; Waschke, KA; Wild, GE, 2003
)
0.88
" In addition, before the modification, patients with Stage IV disease received a cumulative dose of 15,600 mg/m(2) of cyclophosphamide for 3 years; after 1980, these patients received the same dosage as the other patients (i."( Lymphoblastic lymphoma of childhood and the LSA2-L2 protocol: the 30-year experience at Memorial-Sloan-Kettering Cancer Center.
Filippa, DA; Mora, J; Qin, J; Wollner, N, 2003
)
0.32
" Inflammation was stabilized, and steroid dosage could be significantly reduced."( Nonnecrotizing herpetic retinopathies masquerading as severe posterior uveitis.
Bodaghi, B; Cassoux, N; Fardeau, C; LeHoang, P; Rozenberg, F, 2003
)
0.32
" The size of dosage and individual susceptibility appeared to be important factors in the development of digestive disturbances from steroids."( Effectiveness of antacids in reducing digestive disturbances in patients treated with prednisone and prednisolone.
BOLAND, EW, 1958
)
0.46
"All patients were treated with GCs and responded rapidly (median initial dosage 60 mg prednisone/day)."( Glucocorticoid therapy in giant cell arteritis: duration and adverse outcomes.
Gabriel, SE; Hunder, GG; O'Fallon, WM; Orces, C; Proven, A, 2003
)
0.54
"GCs are therapeutically effective in GCA and the prednisone dosage was reduced to physiologic levels in three-fourths of the patients within 1 year."( Glucocorticoid therapy in giant cell arteritis: duration and adverse outcomes.
Gabriel, SE; Hunder, GG; O'Fallon, WM; Orces, C; Proven, A, 2003
)
0.57
" Patients with carotid abnormalities were significantly older, had higher blood pressure and total serum cholesterol levels, and had taken a higher prednisone cumulative dosage than those without any lesions."( Risk factors for subclinical atherosclerosis in a prospective cohort of patients with systemic lupus erythematosus.
Corbanese, S; Doria, A; Favaretto, E; Gambari, PF; Ghirardello, A; Gilburd, B; Iaccarino, L; Patnaik, M; Pauletto, P; Peter, JB; Puato, M; Sherer, Y; Shoenfeld, Y; Todesco, S; Wu, R; Zampieri, S, 2003
)
0.52
" Ligustrazine with the dosage of 80 mg twice a day was given to 25 patients in the treatment group by intravenous perfusion besides the medicine used in the control group."( [Effect of ligustrazine on proliferative glomerulonephritis].
Tang, X, 2003
)
0.32
"In the Swedish National Care Programme for Hodgkin's lymphoma (HL) a less intensive chemotherapy regimen with individualized dosing (LVPP/OEPA) was introduced in 1989."( Patients above sixty years of age with Hodgkin's lymphoma treated with a new strategy.
Enblad, G; Glimelius, B; Gustavsson, A; Sundström, C, 2002
)
0.31
" Beginning from the second LDL-A course, a dosage of 1 mg/kg/d of prednisone was administered for 6 weeks, then tapered."( A combined low-density lipoprotein apheresis and prednisone therapy for steroid-resistant primary focal segmental glomerulosclerosis in children.
Akioka, Y; Chikamoto, H; Fukazawa, A; Hattori, M; Ito, K; Kawaguchi, H; Khono, M; Matsunaga, A; Miyakawa, S; Nakakura, H; Ogino, D, 2003
)
0.81
" Satisfactory compliance was defined as taking compliance or correct dosing > 80%, while unsatisfactory compliance was defined as taking compliance or correct dosing < or = 80%."( The compliance-questionnaire-rheumatology compared with electronic medication event monitoring: a validation study.
de Klerk, E; Landewé, R; van der Linden, S; van der Tempel, H; van der Heijde, D, 2003
)
0.32
" CsA was given at a starting dosage of 5 mg x kg(-1) x d(-1) for 3 months, with a 1 mg x kg(-1) x d(-1) reduction every month and then maintained at a dosage of 2 mg x kg(-1) x d(-1)."( Cyclosporine A in treatment of membranous lupus nephropathy.
Chen, H; Hu, W; Li, L; Li, S; Liu, Z; Shen, S; Yao, X, 2003
)
0.32
" Since a significant gain of therapeutic effects could not be observed as thalidomide dosage was escalated, the optimal dose of thalidomide remains to be determined."( Low dose thalidomide in patients with relapsed or refractory multiple myeloma.
Ackermann, J; Dimou, G; Drach, J; Gisslinger, H; Kees, M; Lechner, K; Sillaber, C, 2003
)
0.32
" Levels of mycophenolic acid (MPA), its glucuronide metabolite, and daclizumab were measured after dosing on days 28 and 56."( Pharmacokinetics of daclizumab and mycophenolate mofetil with cyclosporine and steroids in renal transplantation.
Bumgardner, G; Gaston, RS; Kirkman, RL; Light, S; Nieforth, K; Patel, IH; Pescovitz, MD; Vincenti, F, 2003
)
0.32
" In case of steroid responsiveness, the risk is the relapse when the steroid dosage is tapered or stopped and the complications related to the treatment which is given to maintain remission."( [Lipoid nephrosis in childhood].
Niaudet, P, 2003
)
0.32
" The patients received PTX at the initiating dosage until complete clinical cure."( [Pentoxifylline in the treatment of erythema nodosum leprosum: results of an open study].
Achirafi, A; de Carsalade, GY; Flageul, B, 2003
)
0.32
" The SRL was dosed to achieve defined target whole blood 12-h trough levels."( Short sirolimus half-life in pediatric renal transplant recipients on a calcineurin inhibitor-free protocol.
Baluarte, J; Brayman, KL; Harmon, WE; Meyers, KE; Palmer, JA; Salmanullah, M; Schachter, AD; Spaneas, LD, 2004
)
0.32
" This observation suggests a strategy of individualized dosing adapted to hematotoxicity."( Low acute hematological toxicity during chemotherapy predicts reduced disease control in advanced Hodgkin's disease.
Brosteanu, O; Diehl, V; Hasenclever, D; Loeffler, M, 2004
)
0.32
" These patients had a lower cumulative prednisolon dosage and a stable clinical course."( [Bone metabolism in 53 children and adolescents with chronic inflammatory bowel disease].
Borte, G; Deutscher, J; Gelbrich, G; Kiess, W; Kratzsch, J; Scheer, K,
)
0.13
" Cumulative steroid dosage early after OLT is shown to be important, presumably by decreasing bone formation rates."( Immunosuppressive and postoperative effects of orthotopic liver transplantation on bone metabolism.
Clarke, BL; Guichelaar, MM; Hay, JE; Malinchoc, M; Sibonga, J, 2004
)
0.32
" Cox multivariate analysis included: donor age, sex, and weight; recipient sex, age, pre-HT diagnosis, hypertension, diabetes and hyperlipidemia post-HT; number of treated rejections and RS; and immunosuppressive dosage at 3, 6, and 12 months."( Immune and nonimmune predictors of cardiac allograft vasculopathy onset and severity: multivariate risk factor analysis and role of immunosuppression.
Angelini, A; Caforio, AL; Feltrin, G; Fortina, AB; Gambino, A; Gerosa, G; Iliceto, S; Piaserico, S; Ramondo, A; Thiene, G; Tona, F; Valente, M, 2004
)
0.32
" If patients were receiving cytotoxic agents, the dosage was not increased."( Anti-tumor necrosis factor therapy in patients with difficult to treat Takayasu arteritis.
Brasington, RD; Hoffman, GS; Lenschow, DJ; Liang, P; Merkel, PA, 2004
)
0.32
" In 9 of the 14 responders, an increase in the anti-TNF dosage was required to sustain remission."( Anti-tumor necrosis factor therapy in patients with difficult to treat Takayasu arteritis.
Brasington, RD; Hoffman, GS; Lenschow, DJ; Liang, P; Merkel, PA, 2004
)
0.32
"Prednisone dosage (25 mg/d) was tapered to 0 mg/d within 24 weeks and was adjusted if flare-ups occurred."( Prednisone plus methotrexate for polymyalgia rheumatica: a randomized, double-blind, placebo-controlled trial.
Caporali, R; Cimmino, MA; Ferraccioli, G; Gerli, R; Klersy, C; Montecucco, C; Salvarani, C, 2004
)
3.21
"Follow-up was short, and a high dose of folinic acid and a relatively high starting dosage of prednisone were used."( Prednisone plus methotrexate for polymyalgia rheumatica: a randomized, double-blind, placebo-controlled trial.
Caporali, R; Cimmino, MA; Ferraccioli, G; Gerli, R; Klersy, C; Montecucco, C; Salvarani, C, 2004
)
1.99
"Randomised trials comparing different routes of administration and dosage schemes of corticosteroid or adrenocorticotrophic hormone therapy versus a control group where no therapy considered effective for this condition was administered, unless it was also given in a similar way to the experimental group."( Corticosteroids for Bell's palsy (idiopathic facial paralysis).
Alvarez, G; Ferreira, J; Salinas, RA, 2004
)
0.32
" Anicteric survival with the native liver was statistically compared between groups categorized by steroid dosage using Kaplan-Meier analysis."( Postoperative corticosteroid therapy for bile drainage in biliary atresia--a nationwide survey.
Hashimoto, T; Iwanaka, T; Kato, T; Muraji, T; Nio, M; Ohhama, Y; Ohi, R; Ohnuma, N; Takamatsu, H, 2004
)
0.32
" Only the 200 mg of thalidomide arm of this trial met our definition of a tolerable maintenance therapy, defined as no dose reductions or discontinuation due to toxicity in at least 65% of patients for a minimum of 6 months, thus establishing a dosing schedule for phase III trials."( Results of a multicenter randomized phase II trial of thalidomide and prednisone maintenance therapy for multiple myeloma after autologous stem cell transplant.
Belch, AR; Chen, CI; Ding, K; Howson-Jan, K; Kovacs, MJ; Meyer, RM; Roy, J; Sadura, A; Shepherd, L; Shustik, C; Stewart, AK; White, D, 2004
)
0.56
" Future studies should focus on alternative dosing schedules with more aggressive use of adjuvant therapies, including GFs."( Applicability, tolerability and efficacy of preemptive antiviral therapy in hepatitis C-infected patients undergoing liver transplantation.
Ascher, NA; Bollinger, K; Khalili, M; Roberts, JP; Shergill, AK; Straley, S; Terrault, NA, 2005
)
0.33
" Two class I trials examined the effect of lower dosage of prednisone (0."( Practice parameter: corticosteroid treatment of Duchenne dystrophy: report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society.
Ashwal, S; Baumbach, L; Connolly, A; Florence, J; Mathews, K; McDonald, C; Moxley, RT; Pandya, S; Sussman, M; Wade, C, 2005
)
0.57
" The severity of rejection events, as well as the CyA and prednisone dosing regimens used during rejection, were assessed using a comprehensive chart analysis."( Paradoxical cyclosporine A requirements in pediatric renal transplants receiving high-dose steroids.
Acott, PD; Crocker, JF; Goralski, KB; Hardy, KW; McLellan, H; Renton, KW, 2005
)
0.57
" Particularly in patients aged over 80 years, to avoid side effects it is essential to adjust dosage and route of administration of chemotherapy."( [Malignant lymphoma, multiple myeloma and myeloproliferative diseases in the elderly].
Umeda, M, 2004
)
0.32
" Our findings revealed a dose-response relationship between 8-iso-PGF2alpha concentrations and the dosage of prednisone."( 8-Isoprostaglandin F2 alpha: a potential index of lipid peroxidation in systemic lupus erythematosus.
Abou-Raya, A; el-Hallous, D; Fayed, H, 2004
)
0.54
"Although our prednisone dosing data could not be used as an accurate predictor of onset or joint distribution, there was a tendency for correlation between the average daily dosing and the ARCO score."( Inflammatory bowel disease related osteonecrosis: report of a large series with a review of the literature.
Klingenstein, G; Kornbluth, A; Levy, RN; Present, DH; Shah, AK, 2005
)
0.7
" The dosage or drugs chosen for salvage therapy are limited by doxorubicin-induced cardiomyopathy."( Phase I/II study of the rituximab-EPOCT regimen in combination with granulocyte colony-stimulating factor in patients with relapsed or refractory follicular lymphoma including evaluation of its cardiotoxicity using B-type natriuretic peptide and troponin
Hayama, M; Higashihara, M; Kajiwara, K; Khori, M; Niitsu, N; Tamaru, J, 2005
)
0.33
" Seven patients received indinavir at a dosage of 800 mg three times daily and three patients received nelfinavir at a dosage of 750 mg three times daily."( Pharmacokinetic interaction between chemotherapy for non-Hodgkin's lymphoma and protease inhibitors in HIV-1-infected patients.
Bassetti, D; Bassetti, M; Cinelli, R; Cruciani, M; Di Gennaro, G; Gatti, G; Tirelli, U; Vaccher, E, 2005
)
0.33
"There is a paucity of data examining the efficacy of valganciclovir (VGC) for cytomegalovirus (CMV) prophylaxis in kidney transplant patients, particularly with regard to utilization of a risk-stratified dosing regimen."( Cytomegalovirus prophylaxis with valganciclovir in African-American renal allograft recipients based on donor/recipient serostatus.
Alangaden, GJ; Chandrasekar, P; El-Amm, JM; Garnick, J; Granger, DK; Gruber, SA; Haririan, A; Morawski, K; Sillix, DH; West, MS, 2005
)
0.33
" Adding anti-TNF therapy (24%) or another DMARD (10%), increasing the methotrexate dosage (24%), and substituting leflunomide for methotrexate were the main recommended treatments."( Practices for managing a flare of long-standing rheumatoid arthritis: survey among French rheumatologists.
Bergé, C; Boissier, MC; Daurès, JP; Maravic, M,
)
0.13
" Although the symptoms worsened when the prednisone dosage was gradually reduced, her growth retardation and increased weight decided us to stop prednisone treatment."( [Allergic bronchopulmonary aspergillosis in asthma and cystic fibrosis].
Dompeling, E; Hendriks, JJ; Jöbsis, Q; van Hoorn, JH, 2005
)
0.59
" In this multicenter study, THP (pirarubicin)-COP (cyclophosphamide, vincristine, and prednisolone) was compared to two thirds dosage of full CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) regimen with regard to both adverse events and efficacy."( Long-term results of a multicenter randomized, comparative trial of modified CHOP versus THP-COP versus THP-COPE regimens in elderly patients with non-Hodgkin's lymphoma.
Harada, M; Hotta, T; Kitamura, K; Masaoka, T; Masuda, M; Matsuda, T; Miura, AB; Miyazaki, T; Mizoguchi, H; Mori, M; Niho, Y; Saito, H; Shibata, A; Takaku, F, 2005
)
0.33
" Dosage was split with 18 mg given at breakfast and 18 mg zinc with supper."( Treatment of acute lymphocytic leukemia using zinc adjuvant with chemotherapy and radiation--a case history and hypothesis.
Eby, GA, 2005
)
0.33
" All patients were initiated with equivalent azathioprine dosage (50 mg qd)."( Increased rates of early adverse reaction to azathioprine in patients with Crohn's disease compared to autoimmune hepatitis: a tertiary referral center experience.
Bajaj, JS; Binion, DG; Emmons, J; Franco, J; Knox, JF; Levy, M; Podoll, J; Saeian, K; Varma, RR, 2005
)
0.33
"Modifications in the timing and dosage of immunosuppression can ameliorate the morbidity and mortality that has prevented widespread use of intestinal transplantation (ITx) in children."( Intestinal transplantation under tacrolimus monotherapy after perioperative lymphoid depletion with rabbit anti-thymocyte globulin (thymoglobulin).
Abu-Elmagd, K; Bond, GJ; Macedo, C; Mazariegos, GV; Murase, N; Peters, J; Reyes, J; Sindhi, R; Starzl, TE, 2005
)
0.33
" Gender, ALL-immunophenotype, steroid-type or ASP dosing schedule did not alter the risk but older age and HR-disease were factors predisposing to TE associated with DFCI-ALL protocols."( Thromboembolism in children with acute lymphoblastic leukaemia treated on Dana-Farber Cancer Institute protocols: effect of age and risk stratification of disease.
Athale, UH; Barr, RD; Chan, AK; Crowther, M; Siciliano, SA, 2005
)
0.33
" After week 2, prednisone and MMF were both tapered by 20% of the initial dosage per week."( Donor leukocytes combine with immunosuppressive drug therapy to prolong limb allograft survival.
Bishop, GA; Fujioka, H; Kanatani, T; Kurosaka, M; Lanzetta, M; Matsumoto, T; McCaughan, GW; Owen, E, 2005
)
0.68
" The combination of IFN-alpha and hydroxyurea is very useful and allows dosage reduction of IFN-alpha and better control of hypereosinophilia than with either agent alone."( Interferon treatment for hypereosinophilic syndromes and systemic mastocytosis.
Butterfield, JH, 2005
)
0.33
" The employment of methotrexate attained decrease in the dosage of steroids temporarily."( [Treatment with nebulized lidocaine in steroid-dependent asthma].
de Paz Arranz, S; Fernández Parra, B; Herrera Mozo, I; Pérez Pimiento, A; Rodríguez Mosquera, M; Santaolalla Montoya, M,
)
0.13
" She had received several bouts of steroids and had been in clinical remission for 12 weeks under a dosage of 40 mg/d prednisone."( [Recurrent aseptic osteonecrosis in Crohn's disease - extraintestinal manifestation or steroid related complication?].
Dienes, HP; Kruis, W; Lanyi, B, 2005
)
0.54
" Since single daily dosing of cyclosporine is rarely used, the objective of this investigation was to evaluate the efficacy of a single daily dose versus twice daily dosing of cyclosporine in renal transplant recipients."( Single daily dose administration of cyclosporine in renal transplant recipients: a preliminary report.
Al-Mousawi, M; Al-Mozairai, I; Halim, MA; Hamid, MH; Johny, KV; Nair, MP; Nampoory, MR; Said, T, 2005
)
0.33
"MDOL can obviously improve the effect of hormonotherapy in SLE, it has advantages in reducing the dosage used and antagonizing the adverse reactions of glucocorticoid."( [Intervention of maiwei dihuang oral liquid on hormonotherapy in treating active systemic lupus erythematosus].
Xu, DH; Yang, XY, 2005
)
0.33
" The mean starting dosage of MTX in the study group was 15 mg/m(2)/week."( The effectiveness of treating juvenile dermatomyositis with methotrexate and aggressively tapered corticosteroids.
Cameron, B; Campbell-Webster, N; Feldman, BM; Laxer, RM; Ota, S; Parker, S; Ramanan, AV; Schneider, R; Silverman, ED; Spiegel, L; Tran, D; Tyrrell, PN, 2005
)
0.33
" Prednisone at a dosage of 1 mg/kg twice a day decreased the platelet count within 45 days of its initiation."( Reactive thrombocytosis: an early manifestation of Takayasu arteritis.
Colón, E; Goñi, M; Peredo, R; Ríos-Solá, G; Vilá, S, 2005
)
1.24
" The immunosuppression scheme and dosage of drugs used in pregnant women are vital to both the normal course of pregnancy and delivery of a healthy child."( [Immunosuppressive drug therapy during pregnancy after kidney transplantation].
Gryboś, M; Kazimierczak, I; Kazimierczak, K; Klinger, M; Weyde, W; Zmonarski, S, 2005
)
0.33
"4g of aciclovir tablets 3 times per day for 5 days and 50 mg of prednisone daily for 5 days, and the patients in P group were treated with 50 mg of prednisone daily for 5 days, and then the dosage of prednisone was reduced by 20 mg per two days for the next 10 days."( [Outcome of treatment 46 patients with Bell's palsy with aciclovir and prednisone].
Chen, WL; Huang, ZQ; Yang, ZH, 2005
)
0.8
"The groups were comparable at baseline in age, gender, daily dosage of prednisone, BMD at the spine and the hip and markers of bone turnover, while the number of patients with prevalent vertebral deformities was slightly higher in the alendronate-treated patients (54% versus 39%, not significant)."( Positive effect of alendronate on bone mineral density and markers of bone turnover in patients with rheumatoid arthritis on chronic treatment with low-dose prednisone: a randomized, double-blind, placebo-controlled trial.
Bijlsma, JW; Dijkmans, BA; Geusens, P; Lems, WF; Lips, P; Lodder, MC; Schrameijer, N; van de Ven, CM, 2006
)
0.76
" However, the most appropriate dosage regimen remains controversial, as the corticosteroid regimens used in these trials differed greatly, and no studies have directly compared medium-, high-, and low-dose regimens."( Is there an optimal corticosteroid regimen for the management of an acute exacerbation of chronic obstructive pulmonary disease?
Hemstreet, BA; Vondracek, SF, 2006
)
0.33
" Comparison of lipid levels at different prednisone dosages and disease activity levels revealed that changes in triglyceride levels were mainly associated with changes in disease activity, changes in both total cholesterol and LDL cholesterol levels were associated with changes in the prednisone dosage and not disease activity, and low levels of HDL cholesterol were associated with active SLE, whereas the prednisone dosage was associated with increased levels of HDL cholesterol."( The complex nature of the interaction between disease activity and therapy on the lipid profile in patients with pediatric systemic lupus erythematosus.
Adeli, K; Beyenne, J; Feldman, B; Sarkissian, T; Silverman, E, 2006
)
0.6
" There was no dose-response relationship for doses 30 Gy or higher, even for larger tumors."( Prognostic factors in solitary plasmacytoma of the bone: a multicenter Rare Cancer Network study.
Belkacémi, Y; Bolla, M; Castelain, B; Knobel, D; Landmann, C; Oner, FD; Ozsahin, M; Poortmans, P; Tsang, RW; Zouhair, A, 2006
)
0.33
" In this case, once the dosage of oral prednisone was increased and methotrexate was added to the therapeutic scheme, inflammation was controlled within 1 month."( Combination of azathioprine and corticosteroids in the treatment of serpiginous choroiditis.
Burnier, MN; Deschênes, J; Ozdal, PC; Vianna, RN, 2006
)
0.6
" Unfortunately, high dosage prednisone can be used for only a month, because of steroid toxicity."( An informative case of Graves' disease with implications for schizophrenia.
Adams, DD; Knight, JG; Manning, P; Smith, G,
)
0.43
"Temporal arteritis (TA) may offer major complications, whilst high dosage of prednisone may result in serious side effects."( Relationship between histological subtypes and clinical characteristics at presentation and outcome in biopsy-proven temporal arteritis. Identification of a relatively benign subgroup.
Haanen, HC; Seldenrijk, CA; ter Borg, EJ, 2007
)
0.57
" The accentuated neutropenia may be related to the specific chemotherapy regimen or drug, eg, cyclophosphamate since same day Pf was safe with regimens in which a non alkylating agent (taxane, gemcitabine, navelbine, cisplatin) was used with a weekly chemotherapy dosing schema and did not generate accentuated neutropenia."( Same day Pegfilgrastim and CHOP chemotherapy for non-Hodgkin lymphoma.
Lokich, JJ, 2006
)
0.33
" All errors were due to incorrect dosing or failure to administer an indicated medication."( Oral outpatient chemotherapy medication errors in children with acute lymphoblastic leukemia.
Geyer, LJ; Hawkins, DS; Taylor, JA; Winter, L, 2006
)
0.33
" Questions remain concerning the optimal dosage and schedule of rituximab for DLBCL, as well as the optimal chemotherapy regimen partner for rituximab."( Rituximab for the treatment of diffuse large B-cell lymphomas.
Held, G; Pfreundschuh, M; Pöschel, V, 2006
)
0.33
" MTX was given at an initial weekly dosage of 15 mg (n = 3), 20 mg (n = 9), or 25 mg (n = 10)."( The use of methotrexate alone or in combination with low doses of oral corticosteroids in the treatment of alopecia totalis or universalis.
Joly, P, 2006
)
0.33
" A control group included 16 RA patients only with stable therapy (some dosage of prednisone and MTX)."( [Are there any positive effects of TNF-alpha blockers on bone metabolism?].
Cutolo, M; Paolino, S; Seriolo, B; Sulli, A,
)
0.36
"The purpose of this study was to examine the relationship between the specific types of medication, length of use, frequency of use, and dosing time of day on the dental caries of children diagnosed with asthma."( A cross-sectional study of medication-related factors and caries experience in asthmatic children.
Chen, JW; Donovan, K; Lee, JY; Milano, M,
)
0.13
" PL-doxorubicin 30 mg/m2, was given in combination with standard dosage of prednisone, vincristine, cyclophosphamide, rituximab (according to CHOP-R regimen) every 21 days for six courses."( CHOP-rituximab with pegylated liposomal doxorubicin for the treatment of elderly patients with diffuse large B-cell lymphoma.
Battista, M; Battista, R; Cabras, MG; Fabbri, A; Fanin, R; Gallamini, A; Lenoci, M; Molinari, AL; Tomadini, V; Zaccaria, A; Zaja, F, 2006
)
0.56
" A high daily dosage of prednisone relative to body weight was found to be neither a predictor of exacerbation nor a predictor of early improvement in bivariate correlation analysis."( Clinical predictors of steroid-induced exacerbation in myasthenia gravis.
Bae, JS; Go, SM; Kim, BJ, 2006
)
0.64
" Patients who remained clinically stable but showed serologic evidence of an SLE flare (elevation of both the anti-dsDNA level by 25% and the C3a level by 50% over the previous 1-2 monthly visits) were randomized to receive either prednisone or placebo therapy at a dosage of 30 mg/day for 2 weeks, 20 mg/day for 1 week, and 10 mg/day for 1 week."( The effect of moderate-dose corticosteroids in preventing severe flares in patients with serologically active, but clinically stable, systemic lupus erythematosus: findings of a prospective, randomized, double-blind, placebo-controlled trial.
Abramson, SB; Belmont, HM; Buyon, JP; Diamond, B; Haines, K; Ilie, V; Kim, M; Mackay, M; Marder, G; Rosenthal, P; Tseng, CE, 2006
)
0.52
" Severe flares resulted in an increase in the prednisone dosage to >40 mg/day and/or the addition of an immunosuppressive agent."( The effect of moderate-dose corticosteroids in preventing severe flares in patients with serologically active, but clinically stable, systemic lupus erythematosus: findings of a prospective, randomized, double-blind, placebo-controlled trial.
Abramson, SB; Belmont, HM; Buyon, JP; Diamond, B; Haines, K; Ilie, V; Kim, M; Mackay, M; Marder, G; Rosenthal, P; Tseng, CE, 2006
)
0.59
" After a few dosage increases, ending with a weekly warfarin dose of 21 mg, the patient's INR values remained in the therapeutic range."( Effects of prednisone on the International Normalized Ratio.
Chock, A; Faulkner, MA; Skrabal, MZ; Stading, JA, 2006
)
0.72
" We also examined how glucocorticoid dosage affected osteoporosis management in adjusted models."( Osteoporosis management in patients with rheumatoid arthritis: Evidence for improvement.
Bukowski, JF; Cabral, D; Coblyn, JS; Katz, JN; Patrick, AR; Solomon, DH, 2006
)
0.33
" While the mechanism is unclear, treatment of steroid psychosis involves dosage reduction or discontinuation of prednisone."( Steroid-induced psychosis in an adolescent: treatment and prophylaxis with risperidone.
Bilge, I; Hergüner, S; Tüzün, DU; Yavuz Yilmaz, A,
)
0.34
"Clinical management of warfarin therapy is complex, and dosing algorithms do not include genetic factors or interactions with other drugs for warfarin dose determinations."( Oral anticoagulation with warfarin is significantly influenced by steroids and CYP2C9 polymorphisms in children with cancer.
Bergan, S; Holmstrøm, H; Ruud, E; Wesenberg, F, 2008
)
0.35
" Prednisone was reduced in dosage or discontinued in 17 dogs."( Procarbazine as adjunctive therapy for treatment of dogs with presumptive antemortem diagnosis of granulomatous meningoencephalomyelitis: 21 cases (1998-2004).
Barone, G; Coates, JR; Dewey, CW; Holloway-Azene, NM; Sessions, JK; Vitale, CL,
)
1.04
"The results show that the individual pharmacokinetics of BEACOPP drugs are an important link between dosage and toxicity."( Population pharmacokinetics of the BEACOPP polychemotherapy regimen in Hodgkin's lymphoma and its effect on myelotoxicity.
Busse, D; Diehl, V; Engert, A; Fuhr, U; Hempel, G; Jaehde, U; Jetter, A; Josting, A; Kasel, D; Klimm, B; Merkel, U; Reif, S; Rietbrock, S; Schwab, M; Wilde, S, 2007
)
0.34
"Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing prednisone are reviewed."( Biowaiver monographs for immediate release solid oral dosage forms: prednisone.
Barends, DM; Derendorf, H; Dressman, JB; Junginger, HE; Krämer, J; Midha, KK; Shah, VP; Stavchansky, S; Vogt, M, 2007
)
0.77
"Aim of the study was to assess the clinical and angiographic efficacy of oral treatment with prednisone at immunosuppressive dosage after percutaneous coronary interventions (PCI) in patients with bifurcation lesions treated with elective bare metal stent (BMS) implantation in the main-branch (MB) and provisional stenting in the side-branch (SB)."( Percutaneous treatment of coronary bifurcations: lesion preparation before provisional bare metal stenting and subsequent immunosuppression with oral prednisone. The IMPRESS-Y study.
Brunelleschi, S; Ferrero, V; Marino, P; Ribichini, F; Rognoni, A; Vassanelli, C, 2007
)
0.76
"In our retrospective study we considered the mean daily dosage of steroids received by 25 patients after intestinal/multivisceral transplantation (minimal follow-up was six months)."( Steroids in intestinal transplantation.
Cescon, M; D'Errico, A; Dazzi, A; Di Simone, M; Ercolani, G; Faenza, S; Grazi, GL; Lauro, A; Lazzarotto, T; Pinna, AD; Pironi, L; Vivarelli, M; Zanfi, C,
)
0.13
"This study assessed clinical and angiographic efficacies of oral treatment with prednisone at low-dose (LD) versus the previous high-dose (HD) immunosuppressive dosage used after percutaneous coronary interventions (PCIs) with bare metal stents in patients with multivessel coronary artery disease."( Comparison of efficacy and safety of lower-dose to higher-dose oral prednisone after percutaneous coronary interventions (the IMPRESS-LD study).
Brunelleschi, S; Ferrero, V; Marino, P; Ribichini, F; Rognoni, A; Vassanelli, C, 2007
)
0.8
" Secondary end points were time to first relapse, biomarkers, cumulative glucocorticosteroid dose, and the number of patients who remained relapse-free while the glucocorticosteroid dosage was tapered to 10 mg/d."( Infliximab for maintenance of glucocorticosteroid-induced remission of giant cell arteritis: a randomized trial.
Cid, MC; Hoffman, GS; Merkel, PA; Rahman, MU; Rendt-Zagar, KE; Salvarani, C; Stone, JH; Visvanathan, S; Weyand, CM; Xu, W, 2007
)
0.34
" A low dosage of infliximab was used, and the prednisone dosage was rapidly tapered."( Infliximab plus prednisone or placebo plus prednisone for the initial treatment of polymyalgia rheumatica: a randomized trial.
Boiardi, L; Cantini, F; Catanoso, MG; Cimmino, M; Gerli, R; Hunder, GG; Klersy, C; Macchioni, P; Manganelli, P; Manzini, C; Paolazzi, G; Salvarani, C; Trotta, A, 2007
)
0.94
" All consecutive patients starting long-term (> oir = 3 months), high dosage (> or = 20 mg day(-1)) prednisone therapy were enrolled."( Corticosteroid-induced clinical adverse events: frequency, risk factors and patient's opinion.
Cabane, J; Fardet, L; Flahault, A; Généreau, T; Kettaneh, A; Lebbé, C; Tiev, KP; Tolédano, C, 2007
)
0.56
"7 years; giant cell arteritis 39%; mean baseline prednisone dosage 54 +/- 17 mg day(-1))."( Corticosteroid-induced clinical adverse events: frequency, risk factors and patient's opinion.
Cabane, J; Fardet, L; Flahault, A; Généreau, T; Kettaneh, A; Lebbé, C; Tiev, KP; Tolédano, C, 2007
)
0.59
"The patient was treated with an increased dosage of prednisone."( [Pulmonary and cardiac recurrence of sarcoidosis in a heart transplant recipient].
Strecker, T; Wiest, GH; Zimmermann, I, 2007
)
0.59
" Once recurrence is diagnosed patients should be treated with an increased dosage of steroid in addition to standard immunosuppressives."( [Pulmonary and cardiac recurrence of sarcoidosis in a heart transplant recipient].
Strecker, T; Wiest, GH; Zimmermann, I, 2007
)
0.34
" EBV-related polymorphic PTLD was diagnosed and treated with discontinuation of cyclosporine, reduction in prednisone dosage and administration of EBV-specific cytotoxic T lymphocytes."( Conjunctival posttransplantation lymphoproliferative disorder.
Irshad, FA; Onciu, MM; Walton, RC; Wilson, TD, 2007
)
0.55
"Lomustine was administered at a median starting dosage of 67 mg/m(2), PO, every 21 days until 5 doses were given or disease progression was observed."( Lomustine and prednisone as a first-line treatment for dogs with multicentric lymphoma: 17 cases (2004-2005).
Bannink, EO; Kaneene, JB; Mullins, MN; Obradovich, JE; Sauerbrey, ML; Van Dorp, TE, 2007
)
0.7
" This analysis focused on patient characteristics, underlying disease, rituximab dosing schedule, and R-ILD characteristic-like symptoms, diagnosis, treatment, and outcomes."( Rituximab-induced interstitial lung disease.
Laber, DA; Mehta, AC; Wagner, SA, 2007
)
0.34
" Adverse events observed after treatment with chloroquine or prednisone (chloroquine maculopathy,cataract, glaucoma) are related to dosage and duration of the treatment."( [Ocular changes and general condition in lupus erythematosus (SLE)--own observation].
Brydak-Godowska, J, 2007
)
0.58
"Risk for new-onset diabetes (NOD) after renal transplantation is higher with tacrolimus (Tac) than with cyclosporine (CsA), but the extent to which the diabetogenic effect of Tac is dosage dependent or steroid dependent remains uncertain."( Influence of early posttransplantation prednisone and calcineurin inhibitor dosages on the incidence of new-onset diabetes.
Brennan, DC; Burroughs, TE; Hardinger, K; Irish, WD; Lentine, KL; Machnicki, G; Schnitzler, MA; Swindle, J; Takemoto, SK, 2007
)
0.61
" Non-steroidal anti-inflammatory drugs and colchicine are first-choice drugs, whereas corticosteroids should be considered only in patients with a frequent crisis unresponsive to non-steroidal anti-inflammatory drugs, and by using proper dosage and a careful slow tapering."( Treatment of refractory recurrent pericarditis.
Cecchi, E; Correndo, L; D'Oulx, EA; Doronzo, B; Imazio, M; Trinchero, R, 2007
)
0.34
" Besides prednisone was given to all patients orally, the initiating dosage used in the treated group was lesser than that in the control group."( [Effect of chinese herbs in enhancing prednisone for treatment of refractory rheumatoid arthritis].
Liu, W; Liu, XY; Wang, Y, 2007
)
1.03
" It is concluded that sodium selenite administration at the dosage and duration chosen acts as a down regulator of Bcl-2 and improves clinical outcome."( The impact of high-dose sodium selenite therapy on Bcl-2 expression in adult non-Hodgkin's lymphoma patients: correlation with response and survival.
Asfour, IA; El-Desoky, H; Fayek, M; Hegab, HM; Moussa, MA; Raouf, S; Saleh, R; Soliman, M, 2007
)
0.34
" The dosage of prednisone used was started from 20 mg/d and decreased step by step as possible after 2 weeks according to patient's condition."( [Clinical observation on effect of modified Yanghe Decoction combined with glycocorticoid for treatment of polymyalgia rheumatica].
Fu, HZ, 2007
)
0.69
"05); and the dosage of prednisone demanded in the treatment group was reduced faster than that in the control group (t = 10."( [Clinical observation on effect of modified Yanghe Decoction combined with glycocorticoid for treatment of polymyalgia rheumatica].
Fu, HZ, 2007
)
0.65
"YHD was helpful to shorten the therapeutic course for PMR, decrease the dosage of glucocorticoid used and raise the therapeutic efficacy."( [Clinical observation on effect of modified Yanghe Decoction combined with glycocorticoid for treatment of polymyalgia rheumatica].
Fu, HZ, 2007
)
0.34
"All 6 enrolled patients responded to etanercept with sustained remission (improvement of at least 70% according to European League Against Rheumatism response criteria for PMR in 4 patients and at least 50% in 2 patients) and were able to significantly reduce their median prednisone daily dosage without experiencing a disease relapse (8."( Treatment of refractory polymyalgia rheumatica with etanercept: an open pilot study.
Boiardi, L; Catanoso, MG; Macchioni, P; Pipitone, N; Salvarani, C, 2007
)
0.52
" Proficiency testing is designed to help ensure that execution of a dissolution procedure for solid oral dosage forms adequately supports administrative and legal decisions so that measurements made at different times, by different analysts, or with different methods can be confidently compared."( The USP Performance Verification Test, Part I: USP Lot P Prednisone Tablets: quality attributes and experimental variables contributing to dissolution variance.
Ashley, AJ; Brown, WE; Deng, G; Eaton, JW; Glasgow, MJ; Hauck, WW; Kikwai, LC; Liddell, MR; Manning, RG; Munoz, JM; Nithyanandan, P; Stippler, E; Wahab, SZ; Williams, RL, 2008
)
0.59
" In addition, the good disintegration and very good dissolution performance of the developed tablets without the addition of superdisintegrant highlighted the suitability of these formulated dosage forms."( Development of prednisone:polyethylene glycol 6000 fast-release tablets from solid dispersions: solid-state characterization, dissolution behavior, and formulation parameters.
Barrera, MG; Lamas, MC; Leonardi, D; Salomón, CJ, 2007
)
0.69
"5 mg/d or less within 1 year of reaching the maximum dosage of the study drug."( Multicenter randomized, double-blind, placebo-controlled, clinical trial of dapsone as a glucocorticoid-sparing agent in maintenance-phase pemphigus vulgaris.
Albrecht, J; Chen, D; Fivenson, D; Jacobus, D; Pandya, AG; Rico, MJ; Werth, VP, 2008
)
0.35
" Furthermore, patients with BP positive for IgE anti-BP180 Abs required longer duration for remission, higher dosage of prednisolone, and more intensive therapies for remission."( Correlation of IgE autoantibody to BP180 with a severe form of bullous pemphigoid.
Hara, T; Iwata, Y; Kodera, M; Komura, K; Muroi, E; Ogawa, F; Sato, S; Takenaka, M; Usuda, T; Yokoyama, Y, 2008
)
0.35
" The effect of signalment, staging, CBC, and serum chemistry profile and dosage on these outcomes was examined."( Efficacy and toxicosis of VELCAP-C treatment of lymphoma in cats.
Cotter, SM; Davis, RM; Hadden, AG; Moore, AS; Morrissey, P; Rand, W,
)
0.13
" For patients with severe ulcerative colitis (UC), steroid dosing has been clarified, and a mega-analysis of steroid outcomes and toxicities has been reported."( Optimizing drug therapy in inflammatory bowel disease.
Kornbluth, A; Swaminath, A, 2007
)
0.34
" The dosage of prednisone was reduced by a similar amount in both groups during the open-label phase."( A trial of mycophenolate mofetil with prednisone as initial immunotherapy in myasthenia gravis.
, 2008
)
0.97
" This may be due to greater than predicted benefit from the prednisone dosage used, the short duration of the study, or the absence of any benefit of MMF in this population of patients with myasthenia gravis."( A trial of mycophenolate mofetil with prednisone as initial immunotherapy in myasthenia gravis.
, 2008
)
0.86
" Individualized dosing schedules and the emergence of non-steroidal medications are realistic expectations."( Safety issues in the management of autoimmune hepatitis.
Czaja, AJ, 2008
)
0.35
" However, its optimal dosing in this subgroup has not been studied."( Thymoglobulin dose optimization for induction therapy in high risk kidney transplant recipients.
Airee, R; Drachenberg, C; Gurk-Turner, C; Haririan, A; Kukuruga, D; Philosophe, B, 2008
)
0.35
"To evaluate the effect of total rATG dosing on graft outcomes in such patients, we conducted a retrospective cohort study of 96 adult patients who received repeat transplants (85%) or had panel reactive antibody more than 40% (19%) and were maintained on tacrolimus, mycophenolate mofetil, and steroid."( Thymoglobulin dose optimization for induction therapy in high risk kidney transplant recipients.
Airee, R; Drachenberg, C; Gurk-Turner, C; Haririan, A; Kukuruga, D; Philosophe, B, 2008
)
0.35
"All consecutive patients starting long-term, high dosage corticosteroid therapy were photographed at baseline and after 3 months of therapy."( Digital photography as an operational tool for assessing corticosteroid-induced lipodystrophy.
Cabane, J; Fabre, B; Fardet, L; Flahault, A; Kettaneh, A; Tiev, KP; Tolédano, C, 2008
)
0.35
" The aim of this study is to evaluate the impact of dosing time on the PK/PD of prednisolone with a simulation approach using an interactive algorithm."( Assessment of the impact of dosing time on the pharmacokinetics/pharmacodynamics of prednisolone.
Derendorf, H; Sabarinath, SN; Winkler, J; Xu, J, 2008
)
0.35
" Steroids are the standard treatment for PMR but their dosage requires adjustment depending on clinical picture, co-morbid conditions and adverse effects."( Polymyalgia rheumatica: clinical picture and principles of treatment.
Zimmermann-Górska, I, 2008
)
0.35
" Afterwards the patients who responded to MMF received another 6 months MMF treatment at a dosage of 10-20 mg/kg daily."( [A prospective multicenter clinical control trial on treatment of refractory nephrotic syndrome with mycophenolate mofetil in children].
Feng, SP; Liu, AM; Wei, MJ; Wu, XC; Wu, YB; Xu, H; Yang, Q; Yi, ZW; Yu, L; Zeng, ZF; Zhou, JH; Zhou, LJ; Zhu, GH, 2008
)
0.35
" Thirty-five patients with DCHF were enrolled in the study, and prednisone (1 mg/kg/day with maximum dosage of 60 mg/day) was added to the standard treatment."( Prednisone adding to usual care treatment for refractory decompensated congestive heart failure.
Ao, YG; Deng, B; Ji, L; Ji, Z; Liu, C; Liu, G; Liu, K; Tian, L; Wang, L; Zhang, H; Zhao, Q; Zhen, Y, 2008
)
2.03
" Steroid dosage was increased, and the patient exhibited right-side hearing improvement within 2 months."( Course of auditory impairment in Cogan's syndrome.
Son, HJ; Ulualp, SO,
)
0.13
" Initial therapy comprises the oral administration of prednisolone in a dosage between 2-3 mg/kg/day."( [Medical treatment of children with hemangiomas and its limitations].
Haxhija, EQ; Höllwarth, ME; Lackner, H, 2009
)
0.35
" Optimal dosing for infliximab in PUK has not been established, and increasing dose frequency to every 4 weeks may be necessary."( Infliximab for the treatment of refractory progressive sterile peripheral ulcerative keratitis associated with late corneal perforation: 3-year follow-up.
Keystone, EC; Ma, JJ; Odorcic, S, 2009
)
0.35
"The current guidelines recommend a dosage of prednisone of 60 mg/m(2) body surface area per day (BSA PRED) for the initial therapy of nephrotic syndrome (NS)."( Prednisone dosing per body weight or body surface area in children with nephrotic syndrome: is it equivalent?
Al-Matrafi, J; Farhadi, E; Feber, J; Vaillancourt, R; Wolfish, N, 2009
)
2.06
" Since survival rates for patients receiving risk-adapted programs (DAL-Hd, SPBLKH-05) were higher than in control (MOPP), relevant protocols using lower drug dosage should be recommended in groups of favorable and intermediate risk."( [Use of risk-adapted programs of treatment of Hodgkin's disease in children and adolescents].
Kuleva, SA, 2008
)
0.35
" Dosing is less frequent than many medications currently available."( Rituximab for treatment of ocular inflammatory disease: a series of four cases.
Choi, D; Kurz, PA; Rosenbaum, JT; Suhler, EB, 2009
)
0.35
" However, the necessity of dosage adjustment based on renal graft function requires further studies."( Influence of renal graft function on mycophenolic acid pharmacokinetics during the early period after kidney transplant.
Abtahi, B; Mohammadpur, AH; Naghibi, M; Nazemian, F, 2008
)
0.35
"These results suggest that the combination of ixabepilone and mitoxantrone is feasible and active in CRPC and requires dosing with pegfilgrastim."( Phase I study of ixabepilone, mitoxantrone, and prednisone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel-based therapy: a study of the department of defense prostate cancer clinical trials consortium.
Beer, TM; Harzstark, AL; Hussain, M; Mathew, P; Pagliaro, LC; Rosenberg, JE; Ryan, CJ; Ryan, CW; Sharib, J; Small, EJ; Smith, DC; Weinberg, VK, 2009
)
0.61
" The results of our study strongly support the use of steroids to control allergic fungal sinusitis and prevent its recurrence, and we recommend further study to identify the optimal dosage and duration of therapy."( Management of allergic fungal sinusitis with postoperative oral and nasal steroids: a controlled study.
Abbas, A; Akhtar, S; Ikram, M; Iqbal, M; Onali, MA; Suhail, A, 2009
)
0.35
"Randomised trials comparing different routes of administration and dosage schemes of corticosteroid or adrenocorticotrophic hormone therapy versus a control group where no therapy considered effective for this condition was administered, unless it was also given in a similar way to the experimental group."( WITHDRAWN: Corticosteroids for Bell's palsy (idiopathic facial paralysis).
Alvarez, G; Ferreira, J; Salinas, RA, 2009
)
0.35
" A moderate dosage of prednisone (0."( Premature atherosclerosis in pediatric systemic lupus erythematosus: risk factors for increased carotid intima-media thickness in the atherosclerosis prevention in pediatric lupus erythematosus cohort.
Ardoin, SP; Barnhart, HX; Bowyer, SL; Brunner, HI; Eberhard, A; Evans, GW; Higgins, GC; Ilowite, NT; Jung, L; Kimura, Y; Klein-Gitelman, M; Levy, DM; McCurdy, D; Mieszkalski, KL; Punaro, L; Reed, A; Sandborg, C; Schanberg, LE; Sherry, DD; Silver, R; Silverman, E; Singer, NG; Soep, JB; von Scheven, E; Wagner-Weiner, L; Wallace, C; Yow, E, 2009
)
0.67
"Data were collected retrospectively for 37 patients with an established diagnosis of RFP (the diagnosis was proven by biopsy in 31 patients), all of whom met the following inclusion criteria: 1) availability of a recorded baseline ESR and/or CRP level and results of computed tomography or magnetic resonance imaging, 2) availability of followup CRP level and/or ESR with radiographic imaging 12-24 weeks after initiation of therapy, and 3) treatment with prednisone monotherapy at a starting dosage of 40-60 mg daily."( Do acute-phase reactants predict response to glucocorticoid therapy in retroperitoneal fibrosis?
Calabrese, LH; Husni, ME; Kushner, I; Magrey, MN, 2009
)
0.52
" Six healthy volunteers were phototested with a xenon arc monochromator and then dosed with 30 mg of oral prednisolone or matching placebo daily for 4 days."( Delayed ultraviolet erythema not suppressed by oral prednisolone: a randomized crossover study.
Dawe, RS; Ferguson, J; Marshall, RP; McHugh, SM; Muller, FM; Murdoch, RD; Sanderson, B; Sousa, A, 2009
)
0.35
" The actual CCNU dosage administered did not affect response rate or remission duration."( Combination chemotherapy with continuous L-asparaginase, lomustine, and prednisone for relapsed canine lymphoma.
Hafeman, SD; Saba, CF; Thamm, DH; Vail, DM,
)
0.36
" We used ketoconazole and prednisone with dosing titrated according to serum testosterone levels to suppress sleep related erections in an attempt to prevent recurrent episodes."( Ketoconazole and prednisone to prevent recurrent ischemic priapism.
Abern, MR; Levine, LA, 2009
)
0.99
" Testosterone was measured on initial presentation, and ketoconazole and prednisone dosing was titrated to approximately 200 ng/dl testosterone and based on the presence or absence of recurrent ischemic priapism episodes."( Ketoconazole and prednisone to prevent recurrent ischemic priapism.
Abern, MR; Levine, LA, 2009
)
0.92
"Rituximab has dramatically improved the survival of patients with non-Hodgkin's lymphomas (NHL), but the dosing regimen currently used should be optimized."( Development of a drug-disease simulation model for rituximab in follicular non-Hodgkin's lymphoma.
Cartron, G; Girard, P; Hénin, E; Paintaud, G; Ternant, D; Tod, M, 2009
)
0.35
" It can be used to simulate new dosing regimens of rituximab in populations of FL patients and should improve the design of future clinical trials."( Development of a drug-disease simulation model for rituximab in follicular non-Hodgkin's lymphoma.
Cartron, G; Girard, P; Hénin, E; Paintaud, G; Ternant, D; Tod, M, 2009
)
0.35
" Treatment was successful with prednisone, started at a dosage of 1 mg/kg/d, for 5 months."( A case of linear immunoglobulin A bullous dermatosis in a patient exposed to sun and an analgesic.
Caldarola, G; Cozzani, E; Parodi, A; Pellicano, R, 2009
)
0.64
" It is suggested that total focal dosage used after chemotherapy be reviewed since total dosage for the entire lymph collector in excess of 30 Gy might contribute to hazards of cardiopathology."( [Multivariate analysis of risk of cardiac complications in Hodgkin's lymphoma].
Bozhenko, VK; Datsenko, PV; Ivashin, AV; Mel'nik, IuD; Pan'shin, GA; Podol'skiĭ, PN; Sotnikov, VM, 2009
)
0.35
" All patients were treated with routine administration of prednisone, but to the treated group GS Capsule (50 mg) was given additionally twice every day, while to the control group placebo capsule of equal dosage was given instead."( [Efficacy of combined therapy with ginsenosides and prednisone in treating systemic lupus erythematosus--a randomized, controlled and double-blinded trial].
Feng, YL; Ling, CQ; You, YL, 2009
)
0.85
" Changes of SLEDAI and OPN, as well as the daily dosage of prednisone used were observed after 2 courses of treatment."( [Effect of yangyin jiedu huoxue recipe on hormone withdrawal and disease activity in patients with systemic lupus erythematosus].
Fan, YS; Han, YM; Wu, GL, 2009
)
0.6
" The dosage of prednisone daily used in the treated group (10."( [Effect of yangyin jiedu huoxue recipe on hormone withdrawal and disease activity in patients with systemic lupus erythematosus].
Fan, YS; Han, YM; Wu, GL, 2009
)
0.71
"Patients with active lupus nephritis (renal biopsy class III, IV, or V) were recruited for the study (n = 370) and treated with mycophenolate mofetil (target dosage 3 gm/day) or intravenous cyclophosphamide (0."( Nonrenal disease activity following mycophenolate mofetil or intravenous cyclophosphamide as induction treatment for lupus nephritis: findings in a multicenter, prospective, randomized, open-label, parallel-group clinical trial.
Dooley, MA; Ginzler, EM; Gordon, C; Isenberg, D; Lisk, L; Wofsy, D, 2010
)
0.36
" Systemic corticosteroid dosage was reduced to 10 mg of prednisone or less, while maintaining sustained control of inflammation, in 41% and 55% of patients in 6 months and 1 year respectively."( Mycophenolate mofetil for ocular inflammation.
Daniel, E; Foster, CS; Jabs, DA; Kaçmaz, RO; Kempen, JH; Levy-Clarke, GA; Newcomb, CW; Nussenblatt, RB; Pujari, SS; Rosenbaum, JT; Suhler, EB; Thorne, JE, 2010
)
0.61
" In summary, modern immunosuppression today allows us to reduce the dosage of steroids and to avoid the prolonged use of cyclophosphamide."( Induction and maintenance therapy in proliferative lupus nephritis.
Glassock, RJ; Moroni, G; Ponticelli, C,
)
0.13
" Tocilizumab treatment led to dosage-related decreases in the absolute neutrophil count, with a median decrease of 38% in the 4 mg/kg dosage group and 56% in the 8 mg/kg dosage group."( Tocilizumab in systemic lupus erythematosus: data on safety, preliminary efficacy, and impact on circulating plasma cells from an open-label phase I dosage-escalation study.
Balow, JE; Daruwalla, J; Fleisher, T; Illei, GG; Lipsky, PE; Shirota, Y; Tackey, E; Takada, K; Yarboro, CH, 2010
)
0.36
"Although neutropenia may limit the maximum dosage of tocilizumab in patients with SLE, the observed clinical and serologic responses are promising and warrant further studies to establish the optimal dosing regimen and efficacy."( Tocilizumab in systemic lupus erythematosus: data on safety, preliminary efficacy, and impact on circulating plasma cells from an open-label phase I dosage-escalation study.
Balow, JE; Daruwalla, J; Fleisher, T; Illei, GG; Lipsky, PE; Shirota, Y; Tackey, E; Takada, K; Yarboro, CH, 2010
)
0.36
" Remaining issues concern biology-based approaches and the guidance of therapy by PET, the definition of the optimal dosage and schedule of rituximab for DLBCL, as well as the optimal chemotherapy regimen partner for rituximab."( Unresolved issues in diffuse large B-cell lymphomas.
Murawski, N; Pfreundschuh, M; Zwick, C, 2010
)
0.36
"Randomised trials comparing different routes of administration and dosage schemes of corticosteroid or adrenocorticotrophic hormone therapy versus a control group where no therapy considered effective for this condition was administered, unless it was also given in a similar way to the experimental group."( Corticosteroids for Bell's palsy (idiopathic facial paralysis).
Alvarez, G; Daly, F; Ferreira, J; Salinas, RA, 2010
)
0.36
" We reviewed outcomes and prednisone dosage for all our acetylcholine-receptor (AChR)-antibody positive MG patients treated with MMF alone or with prednisone for at least 3 months."( Mycophenolate mofetil in AChR-antibody-positive myasthenia gravis: outcomes in 102 patients.
Alpers, J; Burns, TM; Conaway, MR; Hehir, MK; Sanders, DB; Sawa, M, 2010
)
0.66
" It is generally agreed that dexamethasone is the steroid of choice for groups using a delayed intensification phase, but dosing schedules (intermittent versus continuous) vary."( The optimal use of steroids in paediatric acute lymphoblastic leukaemia: no easy answers.
McNeer, JL; Nachman, JB, 2010
)
0.36
" This dosage is diminished very gradually according to a uniform treatment schedule during a period of 3 months, thereafter depending on the clinical course."( [Dutch College of General Practitioner's practice guideline on polymyalgia rheumatica and temporal arteritis].
Dubbeld, P; Eizenga, WH; Geijer, RM; Goudswaard, AN; Hakvoort, L, 2010
)
0.36
" Details of drug dosage history, sampling time and tacrolimus concentration in 63 patients (44 males and 19 females), 27 - 57 years old (age mean 40."( Population pharmacokinetics of tacrolimus in kidney transplant patients.
Catic-Djordjevic, A; Djordjevic, V; Jankovic, SM; Milovanovic, JR; Paunovic, G; Velickovic-Radovanovic, R, 2010
)
0.36
"The derived model describes well tacrolimus clearance in terms of characteristics of Serbian kidney transplant patients, offering basis for rational individualization of tacrolimus dosing regimens."( Population pharmacokinetics of tacrolimus in kidney transplant patients.
Catic-Djordjevic, A; Djordjevic, V; Jankovic, SM; Milovanovic, JR; Paunovic, G; Velickovic-Radovanovic, R, 2010
)
0.36
"De novo renal transplant patients were randomized to receive intensified dosing of MMF (1."( The CLEAR study: a 5-day, 3-g loading dose of mycophenolate mofetil versus standard 2-g dosing in renal transplantation.
Barama, AA; Cardella, CJ; Dandavino, R; Gourishankar, S; Houde, I; Keown, PA; Kiberd, BA; Landsberg, D; Pirc, L; Shoker, A; Wrobel, MM, 2010
)
0.36
" Further studies are required to determine whether limited intensified MMF dosing can reduce acute rejection."( The CLEAR study: a 5-day, 3-g loading dose of mycophenolate mofetil versus standard 2-g dosing in renal transplantation.
Barama, AA; Cardella, CJ; Dandavino, R; Gourishankar, S; Houde, I; Keown, PA; Kiberd, BA; Landsberg, D; Pirc, L; Shoker, A; Wrobel, MM, 2010
)
0.36
" Attempt has been made to identify clinical variables to predict patients at risk for hematologic toxicity, but an approach for individualizing drug dosing should be continued."( Weight and body composition changes during R-CHOP chemotherapy in patients with non-Hodgkin's lymphoma and their impact on dose intensity and toxicity.
Marisavljevic, DZ; Stanisavljevic, NS,
)
0.13
" The drug was given by multiple intralesional injections, with the dosage calculated according to the age of the patient and size of the lesion."( How to use bleomycin A5 for infantile maxillofacial haemangiomas: clinical evaluation of 82 consecutive cases.
Luo, Q; Zhao, F, 2011
)
0.37
" In this study, we calculated the area under the blood concentration-time curve (AUC) of CSA microemulsion in 15 patients with progressive IP complicating DM, and analyzed its correlation with CSA levels at blood sampling time points to investigate the optimum monitoring and dosing regimen."( Therapeutic drug monitoring of cyclosporine microemulsion in interstitial pneumonia with dermatomyositis.
Fujiki, Y; Hanafusa, T; Hata, K; Isoda, K; Kotani, T; Makino, S; Nagai, K; Shiba, H; Takeuchi, T; Yoshida, S, 2011
)
0.37
" Primary therapies were divided into four groups: radiotherapy alone, moderately dosed COPP/ABVD-like chemotherapies for intermediate and advanced stages and BEACOPP escalated."( Impact of first- and second-line treatment for Hodgkin's lymphoma on the incidence of AML/MDS and NHL--experience of the German Hodgkin's Lymphoma Study Group analyzed by a parametric model of carcinogenesis.
Diehl, V; Engert, A; Franklin, J; Hasenclever, D; Josting, A; Loeffler, M; Scholz, M, 2011
)
0.37
" When the dosage of prednisone was reduced, symptoms returned."( Autoimmune dysfunction and subsequent renal insufficiency in a collegiate female athlete: a case report.
Colandreo, RM; Kern, A; Leone, JE; Williamson, JD,
)
0.45
" This study verified that the alterations in the bone metabolism of the dogs submitted to the therapy with prednisone in a dosage of 2 mg/kg occur rapidly, which recommends a monitoring of the patients for the prevention of pathologic fractures."( Bone demineralization in the lumbar spine of dogs submitted to prednisone therapy.
Costa, FS; Costa, LA; De Oliveira, DC; Giannotti, JG; Lanis, AB; Lopes, BF, 2010
)
0.81
" Results showed that administration of prednisone at a dosage of 1 mg/kg, orally, once daily for 7 days decreased total T(4) , while fT(4) was unchanged, suggesting that fT(4) may be less affected by daily prednisone administration."( Effect of an anti-inflammatory dose of prednisone on thyroid hormone monitoring in hypothyroid dogs.
Frank, LA; O'Neill, SH; Reynolds, LM, 2011
)
0.91
" To evaluate the utility of preemptive warfarin dosage adjustment for preventing non-therapeutic INR following prednisone-warfarin co-administration."( Empiric warfarin dose adjustment with prednisone therapy. A randomized, controlled trial.
Delate, T; Dowd, MB; Martinez, K; Vavra, KA; Witt, DM, 2011
)
0.85
"Patients were randomized to receive either intensified dosing of mycophenolate mofetil (1."( The role of proton pump inhibitors on early mycophenolic acid exposure in kidney transplantation: evidence from the CLEAR study.
Dandavino, R; Gourishankar, S; Keown, P; Kiberd, BA; Wrobel, M, 2011
)
0.37
" The dosage of glucocorticoids was higher among women than men (11."( Glucocorticoid-related osteoporotic fractures.
Al-Elq, AH; Al-Omran, AS; Al-Osail, AM; Azzam, Q; Sadat-Ali, M, 2010
)
0.36
" All patients were taking prednisone (the median dosage 50 mg/day [range 30-80]) when diagnosed as having PCP."( Pneumocystis jiroveci pneumonia in giant cell arteritis: A case series.
Kermani, TA; Warrington, KJ; Ytterberg, SR, 2011
)
0.67
" A randomized phase II study is under way to further compare toxicity and efficacy of the 2 dosing schedules."( Phase I trial of weekly and twice-weekly bortezomib with rituximab, cyclophosphamide, and prednisone in relapsed or refractory non-Hodgkin lymphoma.
Dumitrescu, O; Gerecitano, J; Hamlin, P; Horanlli, E; Iasonos, A; Mo, Q; Moskowitz, CH; Noy, A; O'Connor, OA; Pappanicholaou, J; Portlock, C; Rojas, CN; Sarasohn, D; Schulman, P; Straus, D; Zelenetz, AD; Zhang, Z, 2011
)
0.59
" GC dosing during the year before and the year after TNFi initiation were compared."( Tumour necrosis factor-α inhibitors are glucocorticoid-sparing in rheumatoid arthritis.
Christensen, AF; Junker, P; Lindegaard, HM; Nilsson, AC, 2011
)
0.37
" Increasing the dosage of oral steroid and minocycline resulted in relief of bullous pemphigoid, although patchy skin pigmentation remained especially in the irradiated skin."( A case of bullous pemphigoid exacerbated by irradiation after breast conservative radiotherapy.
Isohashi, F; Koizumi, M; Konishi, K; Tanei, T; Umegaki, N; Yoshioka, Y, 2011
)
0.37
"Steroids are useful in alleviating the symptoms of the acute presentation of autoimmune pancreatitis, but some questions remain open such as the dosage of steroids in the acute phase and the duration of steroid therapy; finally, it should be assessed if other immunosuppressive non-steroidal drugs may become the first-line therapy in patients with AIP without jaundice and without atrophic pancreas."( Therapeutic management and clinical outcome of autoimmune pancreatitis.
Calculli, L; Cariani, G; Casadei, R; Corinaldesi, R; Morselli-Labate, AM; Pezzilli, R; Santini, D, 2011
)
0.37
" In conclusion, the regular dosage and systematic albuminuria to microalbuminuria appears to be a reliable means for diagnosis of lupus glomerulonephritis in the subclinical stage to prevent renal complications that occur during the Supported Lupus erythematosus."( [Interest of microalbuminuria in preventing kidney damage during systemic lupus erythematosus (SLE) under corticoid therapy].
Camara, C; Djessou, P; Ferdinand Djohan, Y; Koffi, G; Kouadio, LD; Monde, AA; Niamke, G; Sess, D; Tiahou, G,
)
0.13
" Principal outcomes included adverse events, time from randomization to treatment failure (inability to wean off prednisone on schedule), and average prednisone dosage after week 24."( A randomized, pilot trial of etanercept in dermatomyositis.
, 2011
)
0.58
" The median of the average prednisone dosage after week 24 was 29."( A randomized, pilot trial of etanercept in dermatomyositis.
, 2011
)
0.67
"Mycophenolate mofetil (MMF) is now commonly used in pediatric liver transplant recipients, but no clear recommendations about the dosing regimen have been made for this population."( Optimization of the dosing regimen of mycophenolate mofetil in pediatric liver transplant recipients.
Barau, C; Barrail-Tran, A; Debray, D; Furlan, V; Habes, D; Hemerziu, B; Taburet, AM, 2011
)
0.37
"Equivalence was met for weekend and daily dosing of prednisone for the primary outcomes of quantitative muscle testing (QMT) arm score and QMT leg score."( Randomized, blinded trial of weekend vs daily prednisone in Duchenne muscular dystrophy.
Arrieta, A; Bertorini, TE; Clemens, PR; Cnaan, A; Connolly, AM; Day, JW; Escolar, DM; Florence, J; Hache, LP; Henricson, E; Hu, F; Kornberg, AJ; Lotze, T; Mayhew, J; McDonald, CM; Monasterio, E; Nevo, Y; Pestronk, A; Ryan, MM; Viswanathan, V; Zimmerman, A, 2011
)
0.88
"Weekend dosing of prednisone is equally beneficial to the standard daily dosing of prednisone."( Randomized, blinded trial of weekend vs daily prednisone in Duchenne muscular dystrophy.
Arrieta, A; Bertorini, TE; Clemens, PR; Cnaan, A; Connolly, AM; Day, JW; Escolar, DM; Florence, J; Hache, LP; Henricson, E; Hu, F; Kornberg, AJ; Lotze, T; Mayhew, J; McDonald, CM; Monasterio, E; Nevo, Y; Pestronk, A; Ryan, MM; Viswanathan, V; Zimmerman, A, 2011
)
0.96
"This study provides Class I evidence that weekend prednisone dosing is as safe and effective as daily prednisone in preserving muscle strength and preventing body mass index increases in boys with DMD over a 12-month period."( Randomized, blinded trial of weekend vs daily prednisone in Duchenne muscular dystrophy.
Arrieta, A; Bertorini, TE; Clemens, PR; Cnaan, A; Connolly, AM; Day, JW; Escolar, DM; Florence, J; Hache, LP; Henricson, E; Hu, F; Kornberg, AJ; Lotze, T; Mayhew, J; McDonald, CM; Monasterio, E; Nevo, Y; Pestronk, A; Ryan, MM; Viswanathan, V; Zimmerman, A, 2011
)
0.88
"Although prednisone is the treatment of choice for nephrotic syndrome (NS) in childhood, the dosing regimen varies between 60 mg/m(2)/day, as recommended in early studies, to the often prescribed 2 mg/kg/day dose, which is used in common practice."( Weight or body surface area dosing of steroids in nephrotic syndrome: is there an outcome difference?
Baracco, R; Jain, A; Kapur, G; Mattoo, TK; Saadeh, SA; Valentini, RP, 2011
)
0.79
" There was no difference between the AZA- and MTX-groups in respect of prednisone dosing (apart from months 10 and 12), in quantitative MG Score improvement, proportions in sustained remission, frequencies of MG relapses, or adverse reactions and/or withdrawals."( A single-blinded trial of methotrexate versus azathioprine as steroid-sparing agents in generalized myasthenia gravis.
Badri, M; Bateman, K; Heckmann, JM; Rawoot, A; Renison, R, 2011
)
0.6
"Current prednisone dosing in the treatment of young patients with childhood-onset systemic lupus erythematosus (cSLE) is largely based on achieving balance between therapeutic efficacy and toxicity, with weight-based dosing a common clinical practice."( Pharmacokinetics of prednisolone at steady state in young patients with systemic lupus erythematosus on prednisone therapy: an open-label, single-dose study.
Brunner, HI; Rieder, MJ; Sagcal-Gironella, AC; Sherwin, CM; Tirona, RG; Vinks, AA, 2011
)
1.02
" At each visit, they assessed disease activity using a visual analog scale for physician's global assessment (VASph) and recorded whether a flare was diagnosed and/or the GC dosage was changed."( Contribution of the polymyalgia rheumatica activity score to glucocorticoid dosage adjustment in everyday practice.
Berthelot, JM; Binard, A; Cleuziou, C; De Bandt, M; Saraux, A, 2012
)
0.38
" No guidelines exist for chemotherapy dosing in the elderly population, and a clear assessment of treatment toxicity and benefits has not been previously reported."( Toxicities and outcomes among septuagenarians and octogenarians with diffuse large B-cell lymphoma treated with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone therapy.
Greer, JP; Huntington, SF; Morgan, DS; Reddy, N; Talbott, MS, 2012
)
0.57
" Disease severity score and prednisone dosage served as assessing measures."( Methotrexate is an effective and safe adjuvant therapy for pemphigus vulgaris.
Barzilai, A; Baum, S; Greenberger, S; Lyakhovitsky, A; Samuelov, L; Solomon, M; Trau, H,
)
0.43
" The patient worsened over the course of one week despite broad-spectrum antimicrobial therapy, but subsequently improved promptly with augmentation of prednisone dosed to 50 mg daily and addition of N-acetylcysteine."( Acute exacerbation of pulmonary fibrosis following single lung transplantation.
Bai, C; Khalil, N; Levy, RD; Wilcox, PG; Wilson, JM; Yang, D; Yee, J,
)
0.33
" A significant decrease in the pemphigus severity score and the mean dosage of prednisone was observed at 3 and 6 months."( Effect of a single-cycle alternative dosing regimen for rituximab for recalcitrant pemphigus: a case series of 9 patients.
Knowles, SR; Matsukura, S; Shear, NH; Walsh, S, 2012
)
0.61
"73 m(2) for a total dosage of 10 g/1."( Tacrolimus versus intravenous pulse cyclophosphamide therapy in Chinese adults with steroid-resistant idiopathic minimal change nephropathy: a multicenter, open-label, nonrandomized cohort trial.
Chen, J; Li, H; Li, X; Shen, H; Shi, X; Wang, H; Xu, G, 2012
)
0.38
"In our patient, sarcoidosis developed after 3 years of continuous recombinant interferon-beta therapy, dosed 3 times a week."( Sarcoidosis triggered by interferon-Beta treatment of multiple sclerosis: a case report and focused literature review.
Chakravarty, SD; Crow, MK; Harris, ME; Schreiner, AM, 2012
)
0.38
"Corticosteroid treatment is the standard of care in Duchenne muscular dystrophy (DMD), but the optimal age to initiate treatment and dosage pattern remain a matter of discussion."( Early corticosteroid treatment in 4 Duchenne muscular dystrophy patients: 14-year follow-up.
Armaroli, A; Cecconi, I; Cicognani, A; Ferlini, A; Franzoni, E; Gennari, M; Gnudi, S; Malaspina, E; Merlini, L; Talim, B, 2012
)
0.38
" Prospective pharmacokinetic studies to devise a rational dosing strategy for vinblastine in patients receiving ritonavir/lopinavir are warranted."( Incidence, predictors and significance of severe toxicity in patients with human immunodeficiency virus-associated Hodgkin lymphoma.
Boro, J; Cheung, MC; Ezzat, HM; Harris, M; Hicks, LK; Leitch, HA; Lima, VD; Montaner, JS, 2012
)
0.38
" Blood samples were collected in four 12-hour dosing intervals during the first 3 weeks posttransplant, including samples drawn at 13 time points."( The pharmacokinetics of prednisolone and prednisone in adult liver transplant recipients early after transplantation.
Bergan, S; Line, PD; Sæves, I, 2012
)
0.64
" The results suggest that current prednisolone dosing early after liver transplantation might be too high, in particular when coadministered with methylprednisolone."( The pharmacokinetics of prednisolone and prednisone in adult liver transplant recipients early after transplantation.
Bergan, S; Line, PD; Sæves, I, 2012
)
0.64
" Both reported spectroscopic techniques can be used as fast and convenient alternatives to the standard pharmacopeial methods of prednisone and prednisolone quantification in solid dosage forms."( Quantitative determination of prednisone in tablets by infrared attenuated total reflection and Raman spectroscopy.
Mazurek, S; Szostak, R,
)
0.62
" The calf pain and limited range of motion of ankle dorsiflexion subsided from day 1 on administration of oral corticosteroid at high dosage and were completely resolved by 4 months."( Muscular polyarteritis nodosa.
Cho, NS; Choi, HS; Choi, SJ; Kim, DH; Yang, SN; Yoon, ES, 2012
)
0.38
" By the late 1960s, extended dosing with melphalan and prednisone tripled survival from diagnosis and became the standard of care for newly diagnosed MM."( Evolving therapeutic paradigms for multiple myeloma: back to the future.
Cherry, BM; Korde, N; Kwok, M; Landgren, O; Roschewski, M, 2013
)
0.64
"We recommend monitoring MPA levels only in patients not responding to the standard 2-g/d dosage of MMF."( Therapeutic dose monitoring of mycophenolate mofetil in dermatologic diseases.
el-Azhary, RA; Langman, LJ; Sokumbi, O, 2013
)
0.39
" Tacrolimus (FK-506) was administered at an initial dosage of 1 mg every 12 hours, and FK-506 concentration in the blood was monitored monthly."( Tacrolimus on Kimura's disease: a case report.
Bing, G; Da-Long, S; Wei, R; Xiang-Zhen, L; Xin, L; Yun-Yan, Z, 2014
)
0.4
" Neutropenia in cycle 1 may be a pharmacodynamic marker for docetaxel, which may enable tailored dosing in metastatic castration-resistant prostate cancer (mCRPC)."( Neutropenia as a potential pharmacodynamic marker for docetaxel-based chemotherapy in men with metastatic castration-resistant prostate cancer.
Berry, WR; Galsky, MD; Leopold, L; Pond, GR; Sonpavde, G; Wood, BA, 2012
)
0.38
" Within the dosage range used in transplantation, prednisolone and prednisone exhibit concentration-dependent non-linear pharmacokinetics when parameters are measured with reference to total drug concentration."( Clinical pharmacokinetics and pharmacodynamics of prednisolone and prednisone in solid organ transplantation.
Barraclough, KA; Bergmann, TK; Lee, KJ; Staatz, CE, 2012
)
0.85
" Intetumumab serum concentrations increased with repeated dosing and did not reach steady-state."( A randomized, double-blind, multicenter, phase 2 study of a human monoclonal antibody to human αν integrins (intetumumab) in combination with docetaxel and prednisone for the first-line treatment of patients with metastatic castration-resistant prostate c
Bogdanova, N; Dawkins, F; de Boer, CJ; Dirix, L; Heidenreich, A; Rawal, SK; Schrijvers, D; Stenzl, A; Szkarlat, K; Wang, G; Welslau, M, 2013
)
0.59
"Cbz at a dosage of 25mg/m(2) intravenously every 3 wk combined with 5mg of oral prednisone twice a day."( Cabazitaxel plus prednisone for metastatic castration-resistant prostate cancer progressing after docetaxel: results from the German compassionate-use programme.
Albers, P; Arsov, C; Bokemeyer, C; Ecstein-Fraisse, E; Gschwend, J; Heidenreich, A; Heinrich, E; Honecker, F; Keck, B; Miller, K; Müller, SC; Otremba, B; Pfister, D; Retz, M; Rogenhofer, S; Scholz, HJ; Steiner, U; Trojan, L; Volkmer, B; Wirth, M, 2013
)
0.96
" There is a strong need for optimization of both specific type of glucocorticoid (eg, prednisone, vs deflazacort or others) and the dosing regimen."( Novel approaches to corticosteroid treatment in Duchenne muscular dystrophy.
Bushby, K; Connor, EM; Damsker, J; Hoffman, EP; McCall, JM; Nagaraju, K; Reeves, E, 2012
)
0.6
" During the gestational period, the dosage of glucocorticoid was adjusted in one pregnancy."( [Pregnancy outcomes of eight pregnant women with congenital adrenal hyperplasia due to 21-hydroxylase deficiency].
Bian, XM; Hu, XY; Liu, JT; Yu, H; Zhou, Q, 2012
)
0.38
" The dosage of glucocorticoid should be carefully adjusted during the pregnancy individually according to serum level of 17-OHP."( [Pregnancy outcomes of eight pregnant women with congenital adrenal hyperplasia due to 21-hydroxylase deficiency].
Bian, XM; Hu, XY; Liu, JT; Yu, H; Zhou, Q, 2012
)
0.38
"01) and dosage of immunosuppressant."( APRIL, a proliferation-inducing ligand, as a potential marker of lupus nephritis.
Avihingsanon, Y; Benjachat, T; Eiam-ong, S; Hirankarn, N; Kittikowit, W; Leelahavanichkul, A; Somparn, P; Tantivitayakul, P; Treamtrakanpon, W, 2012
)
0.38
" Lenalidomide even in lower dosed combined with steroids can induce complete responses in patients with refractory AITL."( Therapy refractory angioimmunoblastic T-cell lymphoma in complete remission with lenalidomide.
Beckers, MM; Huls, G, 2013
)
0.39
" Bone loss occurs early after the initiation of corticosteroid therapy and is correlated to dosage and treatment duration."( [Corticosteroid-induced osteoporosis].
Briot, K; Roux, C, 2013
)
0.39
" Rituximab treatment reduces the steroid dosage and the need for immunosuppressive therapy in pediatric patients."( Rituximab is an efficient and safe treatment in adults with steroid-dependent minimal change disease.
Audard, V; Bouachi, K; Dahan, KY; Deschênes, G; Lang, P; Mojaat, R; Munyentwali, H; Plaisier, EM; Remy, P; Ronco, PM, 2013
)
0.39
" A favourable outcome was gradually achieved after increasing the dosage of corticosteroids."( [Infliximab-induced hepatitis during treatment of vulvar Crohn's disease].
Bouquin, R; Caussé, S; Dréno, B; Flamant, M; Joubert, M; Quéreux, G; Wylomanski, S, 2013
)
0.39
" The dosage of prednisone was safely tapered using MMF, and the patient did not experience any flares or significant side effects during the course of treatment."( Mycophenolate mofetil as a first-line steroid-sparing agent in the treatment of pemphigus vulgaris.
Cohen, GF; Patel, NS; Vyas, N, 2013
)
0.74
" However, the optimal dosing regimen and mechanism of action remain unclear."( Therapy of relapsing minimal-change disease in adults: a new approach?
Glassock, RJ, 2013
)
0.39
" Findings suggest low comparative bioavailability of oral prednisone compared to prednisolone in cats and consideration of lean body mass or ideal body weight for dosing practices."( Influence of body condition on plasma prednisolone and prednisone concentrations in clinically healthy cats after single oral dose administration.
Center, SA; Randolph, JF; Rishniw, M; Simpson, KW; Warner, KL, 2013
)
0.88
"Pediatric patients (4-12 years of age) with minimal change nephropathy were consecutively assigned to receive prednisone monotherapy (1-2 mg/kg/d; maximal total dose, ≤60 mg) or prednisone at the same dosage plus fluvastatin (5 mg/d if aged <5 years; 10 mg/d if aged ≥5 years), for 6 weeks."( Effects of combined prednisone + fluvastatin on cholesterol and bilirubin in pediatric patients with minimal change nephropathy.
Gong, J; Li, A; Ma, L; Song, M; Xie, Y; Yan, Y; Yang, D; Zhou, X, 2013
)
0.93
" There were no adverse drug-related events and its use resulted in a significant reduction in steroid dosage during follow-up."( Adjuvant rituximab therapy in pemphigus: a single-center experience of 18 cases.
Barzilai, A; Baum, S; Gilboa, S; Greenberger, S; Pavlotsky, F; Trau, H, 2013
)
0.39
" Further study needs to examine rituximab dosage and scheduling as well as its place within the treatment algorithm."( Adjuvant rituximab therapy in pemphigus: a single-center experience of 18 cases.
Barzilai, A; Baum, S; Gilboa, S; Greenberger, S; Pavlotsky, F; Trau, H, 2013
)
0.39
" We hypothesize that these differences in dosing requirement may be due to an interethnic polymorphism in the expression of enzymes involved in tacrolimus metabolism."( Tacrolimus therapeutic drug monitoring in Tunisian renal transplant recipients: effect of post-transplantation period.
Aloui, S; Aouam, K; Ben Fredj, N; Boughattas, NA; Chaabane, A; Chadly, Z; Hammouda, M; Skhiri, H, 2013
)
0.39
" The dosage was adjusted according to the severity of SLE activity index and the condition: 40 -60 mg per day for severe active stage; 20-40 mg per day for moderate active stage; 15 -20 mg per day for light active stage; and less than 15 mg per day for those in the stable stage, respectively."( [Effects of qingyang toujie mixture in combination with prednisone tablet on Th1/Th2 cytokines in patients suffering from systemic lupus erythematosus].
Chen, YH; Duan, HY; He, YP; Huang, GH; Linag, XF; Liu, Y; Wen, XM; Xu, QY; Zeng, ZL; Zhong, JX, 2013
)
0.64
" Although the patient had a relapse of the liver abscesses in association with the tapering of prednisone, the augmentation of prednisone dosage yielded a response."( Behçet's disease complicated by multiple aseptic abscesses of the liver and spleen.
Himeno, K; Inoue, M; Ishii, K; Maeshima, K; Seike, M, 2013
)
0.61
" Steroid dosing may be a modifiable risk factor."( Association between steroid dosage and death with a functioning graft after kidney transplantation.
Döhler, B; Opelz, G, 2013
)
0.39
"9), the mean initial CK was 4720 U/L (range, 23-38, 461; SD 6, 795), and initial mean prednisone dosage was 48 mg/d (range, 0-100, SD 22)."( Corticosteroid Monotherapy Is Usually Insufficient Treatment for Idiopathic Inflammatory Myopathy.
Block, JA; Hota, B; Manadan, AM; Mathur, T; Thiagarajan, S,
)
0.35
" The dosage of prednisone and/or mizoribine was tapered according to the urinary protein-to-creatinine ratio (P/C)."( Efficacy of mizoribine followed by low-dose prednisone in patients with idiopathic membranous nephropathy and nephrotic-range proteinuria.
Matsumoto, Y; Moriki, T; Nojima, Y; Shimada, Y, 2013
)
1
" The changes in plasma exposures of DTG in healthy individuals as a result of prednisone dosing were not clinically significant."( Effect of prednisone on the pharmacokinetics of the integrase inhibitor dolutegravir.
Borland, J; Chen, S; Peppercorn, AF; Piscitelli, S; Savina, P; Song, IH, 2013
)
1.02
" Adequate glucocorticoid dosing and gradual tapering are key to treatment success."( Polymyalgia rheumatica and giant cell arteritis: how best to approach these related diseases.
Freeman, AC; Rapoport, RJ, 2013
)
0.39
" There was no relation between dosage and age (p=0."( Analysis of docetaxel therapy in elderly (≥70 years) castration resistant prostate cancer patients enrolled in the Netherlands Prostate Study.
Blaisse, RJ; de Wit, R; Erjavec, Z; Gerritse, FL; Los, M; Meulenbeld, HJ; Roodhart, JM; Smilde, TJ; van der Velden, AM, 2013
)
0.39
"During dissolution testing of solid dosage forms in the United States Pharmacopoeia (USP) Apparatus 2, samples are manually withdrawn from the medium in the vessel prior to the analysis."( Dissolution of prednisone tablets in the presence of an arch-shaped fiber optic probe in a USP dissolution testing apparatus 2.
Armenante, PM; Bredael, G; Zhang, Y, 2013
)
0.74
" Due to its delayed onset of efficacy and the necessary slow titration of dosage for tolerability reasons prednisone is frequently added by clinicians to the initial prophylactic treatment of a cluster episode."( Study protocol of Prednisone in episodic Cluster Headache (PredCH): a randomized, double-blind, placebo-controlled parallel group trial to evaluate the efficacy and safety of oral prednisone as an add-on therapy in the prophylactic treatment of episodic c
Burmeister, J; Diener, HC; Holle, D; Obermann, M; Ose, C; Scherag, A, 2013
)
0.94
" Low dosage of hormone replacement therapy based on their symptoms can help the patients reach a stable level of hormone within three months."( [Pituitary functional recovery and hormone replacement therapy of patients with pituitary adenoma surgery].
Fu, XH; Jiang, S; Xue, XC; Yin, SL; Zhou, PZ, 2013
)
0.39
"These results suggest that the combination of ixabepilone and mitoxantrone is both feasible and active in castration-resistant prostate cancer and requires dosing with pegfilgrastim."( Ixabepilone, mitoxantrone, and prednisone for metastatic castration-resistant prostate cancer after docetaxel-based therapy: a phase 2 study of the Department Of Defense Prostate Cancer Clinical Trials Consortium.
Beer, TM; Harzstark, AL; Liu, G; Pagliaro, LC; Rosenberg, JE; Ryan, CJ; Sharib, J; Small, EJ; Smith, DC; Weinberg, VK, 2011
)
0.66
"72 Wistar rats were randomly divided into 6 groups: blank control group, model group, prednisone group, Hedysari Radix flavonoids low, medium and high dosage group."( [Effect of flavonoids from hedysari radix on pulmonary functions of pulmonary fibrosis rat].
Jing, M; Li, J; Li, JT; Li, XY; Lin, XY; Liu, GW; Liu, YQ; Su, Y; Sun, SB; Zhang, Y, 2013
)
0.61
" To achieve these levels, AA RTRs require a significantly higher dosage of TAC compared to C patients (5."( African American renal transplant recipients (RTR) require higher tacrolimus doses to achieve target levels compared to white RTR: does clotrimazole help?
Dayton, M; Feng, L; Kohli, R; Laftavi, MR; Nader, N; Pankewycz, O; Patel, S; Said, M, 2013
)
0.39
" Standard deviation scores (SDS) of the nocturnal diastolic BP of the ABPM were positively correlated with the prednisolone dosage per kilogram (p = 0."( Post-transplant hypertension in pediatric kidney transplant recipients.
Aki, FT; Beşbaş, N; Bilginer, Y; Gülhan, B; Karabulut, E; Ozaltın, F; Topaloğlu, R, 2014
)
0.4
"005) and mean daily prednisone dosage (29."( Prolonged improvement of childhood onset systemic lupus erythematosus following systematic administration of rituximab and cyclophosphamide.
Adams, A; Alperin, R; Barinstein, L; Lehman, TJ; Moorthy, N; Ramanathan, A; Singh, C, 2014
)
0.73
"Israeli rheumatologists who treated AOSD with TCZ filled in questionnaires on symptoms, number of tender and swollen joints, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and dosage of prednisone at initial TCZ administration, after 6 months, and at the end of followup."( Tocilizumab in adult-onset Still's disease: the Israeli experience.
Ablin, J; Abu-Shakra, M; Caspi, D; Dranitzki, Z; Elkayam, O; Jiries, N; Kivity, S; Levy, O; Lidar, M; Padova, H; Rosner, I; Savargyl-Maman, H, 2014
)
0.59
" After 6 months of treatment and at the end of followup, the number of tender and swollen joints, the ESR and CRP levels, and the prednisone dosage decreased significantly."( Tocilizumab in adult-onset Still's disease: the Israeli experience.
Ablin, J; Abu-Shakra, M; Caspi, D; Dranitzki, Z; Elkayam, O; Jiries, N; Kivity, S; Levy, O; Lidar, M; Padova, H; Rosner, I; Savargyl-Maman, H, 2014
)
0.61
" These findings may assist clinicians in selecting the appropriate glucocorticoid dosage for RA patients who require these agents."( Glucocorticoid dose thresholds associated with all-cause and cardiovascular mortality in rheumatoid arthritis.
Battafarano, DF; del Rincón, I; Erikson, JM; Escalante, A; Restrepo, JF, 2014
)
0.4
" After 6 months, treatment response with respect to symptomatic, radiological, and laboratory improvement was comparable for the different dosage groups."( Comparable efficacy of low- versus high-dose induction corticosteroid treatment in autoimmune pancreatitis.
Beuers, UH; Biermann, K; Brink, MA; Bruno, MJ; Buijs, J; de Buy Wenniger, LJ; Hansen, BE; Kuipers, EJ; Rauws, EA; van Buuren, HR; van Heerde, MJ; Verheij, J; Vleggaar, FP, 2014
)
0.4
" When used in a dosage of 5-10 mg, most adverse effects can adequately be monitored, though accurate monitoring and awareness for infections are important."( Glucocorticoids in the treatment of rheumatoid arthritis: still used after 65 years.
Bijlsma, JW; Jacobs, JW, 2014
)
0.4
"Reduced dosage of G-CSF allows dose-dense chemotherapy scheduling, limits exposure to G-CSF and also represents an opportunity for cost savings."( Feasibility and safety of a reduced duration of therapy of colony-stimulating factor in a dose-dense regimen.
Bonizzoni, E; Bosi, A; Fabbri, E; Kovalchuk, S; Perrone, T; Puccini, B; Rigacci, L, 2014
)
0.4
"Results from 2 observational studies reported high levels of adherence to AA dosing and administration patterns consistent with prescribing information."( Adherence patterns for abiraterone acetate and concomitant prednisone use in patients with prostate cancer.
Ellis, L; Grittner, AM; Kozma, C; Lafeuille, MH; Lefebvre, P; McKenzie, RS; Slaton, T, 2014
)
0.65
"Substantial efficacy has been demonstrated with bortezomib-melphalan-prednisone in phase III studies in transplant-ineligible myeloma patients using various twice-weekly and once-weekly bortezomib dosing schedules."( Bortezomib cumulative dose, efficacy, and tolerability with three different bortezomib-melphalan-prednisone regimens in previously untreated myeloma patients ineligible for high-dose therapy.
Boccadoro, M; Bringhen, S; Desai, A; Di Raimondo, F; Esseltine, DL; García-Sanz, R; Lahuerta, JJ; Larocca, A; Londhe, A; Mateos, MV; Oriol, A; Palumbo, A; Richardson, PG; San Miguel, JF; van de Velde, H, 2014
)
0.85
" Intermittent dosage of prednisone was administered 5 mg/kg per day on 2 consecutive days weekly for 3 months."( Short-term effects of corticosteroid therapy on cardiac and skeletal muscles in muscular dystrophies.
Fawaz, L; Ghafar, HA; Hussein, G; Mansour, L; Mostafa, FA, 2014
)
0.71
" Secondary outcome measures were corticosteroid dosage during the entire hospitalization, length of stay, hospital follow-up rates, and 30-day readmission rates."( Improving adherence for management of acute exacerbation of chronic obstructive pulmonary disease.
Clark, C; Seidensticker, S; Sharma, G; Sonstein, L; Zeng, L, 2014
)
0.4
" Then the dosage was reduced once daily per every other day."( [Intervention of Shenkangling Decoction on the renal injury of primary nephrotic syndrome children patients of Shen deficiency blood stasis syndrome: a clinical observation].
Ai, S; Lu, XL; Qiu, CX; Yang, F; Zheng, J, 2014
)
0.4
" There was no statistically significant difference regarding number of rituximab courses or cumulative rituximab dosage between episodes with and without infections, respectively."( The risk of infections in hematologic patients treated with rituximab is not influenced by cumulative rituximab dosage - a single center experience.
Brade, J; Buchheidt, D; Hofmann, WK; Hummel, M; Kruth, J; Nissen, JC; Reinwald, M, 2014
)
0.4
" Prednisone was dosed at ."( A phase II study of bortezomib plus prednisone for initial therapy of chronic graft-versus-host disease.
Alyea, EP; Antin, JH; Armand, P; Bindra, B; Blazar, BR; Cutler, CS; Herrera, AF; Ho, VT; Jones, KT; Kim, HT; Koreth, J; Nikiforow, S; Ritz, J; Soiffer, RJ, 2014
)
1.59
" It is possible that in patients treated with high-dose CS, the main objective of the clinician is to reduce dosage of CS rather than RA activity."( Tocilizumab induces corticosteroid sparing in rheumatoid arthritis patients in clinical practice.
Constant, E; Devilliers, H; Fortunet, C; Gaudin, P; Godfrin-Valnet, M; Jorgensen, C; Lambert, J; Maillefert, JF; Pers, YM; Prades, BP; Wendling, D, 2015
)
0.42
" It is not known how antifolate dose and dosing frequency affect efficacy in AD, but a primary mechanism is thought to involve the antifolate-mediated accumulation of 5-aminoimidazole-4-carboxamide ribonucleotide (AICAR)."( LD-aminopterin in the canine homologue of human atopic dermatitis: a randomized, controlled trial reveals dosing factors affecting optimal therapy.
Griffin, CE; Kahn, SJ; Messinger, L; Mundell, A; Schuler, AD; Zebala, JA, 2014
)
0.4
" Twice-weekly dosing negated efficacy despite having the same daily and weekly dose as effective once-weekly regimens."( LD-aminopterin in the canine homologue of human atopic dermatitis: a randomized, controlled trial reveals dosing factors affecting optimal therapy.
Griffin, CE; Kahn, SJ; Messinger, L; Mundell, A; Schuler, AD; Zebala, JA, 2014
)
0.4
" Futhermore, this is the first study to suggest a standardized starting point (CRP ≤ 4 mg/dl) and dosing schedule (oral prednisone 1 mg/kg for 7 days) for children with orbital cellulitis."( C-Reactive Protein As a Marker for Initiating Steroid Treatment in Children With Orbital Cellulitis.
Davies, BW; Durairaj, VD; Hink, EM; Smith, JM,
)
0.34
"Plasma concentration monitoring is commonly used to adjust immunosuppressant dosage in transplant recipients, but adjustment is often based on clinical experience rather than rigorous quantitative indicators."( Retrospective evaluation of the effect of mycophenolate mofetil dosage on survival of kidney grafts based on biopsy results.
Chen, JS; Cheng, DP; Cheng, DR; Ji, SM; Li, X; Liu, ZH; Ni, XF; Wen, JQ; Xie, KN, 2014
)
0.4
"We examined the effect of mycophenolate mofetil (MMF) dosage on graft survival by pathologic and immunologic analysis of 88 kidney recipients who were given a postoperative immunosuppressive regimen of tacrolimus (FK506), MMF, and corticosteroids."( Retrospective evaluation of the effect of mycophenolate mofetil dosage on survival of kidney grafts based on biopsy results.
Chen, JS; Cheng, DP; Cheng, DR; Ji, SM; Li, X; Liu, ZH; Ni, XF; Wen, JQ; Xie, KN, 2014
)
0.4
"These results indicate the importance of using an appropriate dosage of MMF in kidney transplant recipients."( Retrospective evaluation of the effect of mycophenolate mofetil dosage on survival of kidney grafts based on biopsy results.
Chen, JS; Cheng, DP; Cheng, DR; Ji, SM; Li, X; Liu, ZH; Ni, XF; Wen, JQ; Xie, KN, 2014
)
0.4
" Rescue dosage of leucovorin in variant group was higher than that in wild-type group [(312."( [SLCO1B1c. 521T>C gene polymorphisms are associated with high-dose methotrexate pharmacokinetics and clinical outcome of pediatric acute lymphoblastic leukemia].
Chen, Y; Gao, P; He, X; Li, J; Niu, C; Wang, C; Wang, Y; Zhang, H, 2014
)
0.4
" These findings illustrate that the HSD11B1 genotypes are closely correlated with tacrolimus trough concentrations, suggesting that these polymorphisms may be useful for safer dosing of tacrolimus."( Associations of HSD11B1 polymorphisms with tacrolimus concentrations in Chinese renal transplant recipients with prednisone combined therapy.
Fu, Q; Huang, M; Li, J; Liu, S; Liu, X; Wang, C; Wang, H; Wang, X; Zhang, Y; Zhu, C, 2015
)
0.63
" Within 1 month after initiating dapsone therapy and increasing the dosage of prednisone, skin lesions promptly resolved."( Detection of Type VII Collagen Autoantibodies Before the Onset of Bullous Systemic Lupus Erythematosus.
Chong, BF; Grabell, DA; Matthews, LA; Yancey, KB, 2015
)
0.65
" In the phase 1 portion of the study, 24 patients received CMP at carfilzomib dosing levels of 20 mg/m(2), 27 mg/m(2), 36 mg/m(2), and 45 mg/m(2)."( Phase 1/2 study of carfilzomib plus melphalan and prednisone in patients aged over 65 years with newly diagnosed multiple myeloma.
Attal, M; Avet-Loiseau, H; Benboubker, L; Caillot, D; Chaleteix, C; Chiffoleau, A; Facon, T; Fortin, J; Hulin, C; Kolb, B; Leleu, X; Mary, JY; Moreau, P; Planche, L; Roussel, M; Tiab, M; Touzeau, C, 2015
)
0.67
" An attempt will be made to clarify the best and most suitable drug for treatment, and the dosage duration."( [RS3PE syndrome: An update on its treatment using the presentation of a case].
Amodeo, MC; Poyato, M; Rodríguez, M,
)
0.13
" Details regarding the natural course of this disorder, the effects of specific therapies on its progression, and the optimal therapeutic dosage and duration of prednisone are limited."( Disease course and therapeutic approach in dermatomyositis: A four-center retrospective study of 100 patients.
Amato, AA; Arnold, WD; Barohn, RJ; Dimachkie, MM; Gwathmey, K; Heatwole, CR; Hebert, D; Johnson, NE; Kissel, J; McDermott, MP; McVey, AL; Pasnoor, M, 2015
)
0.61
" Short-term dosing with food did not alter abiraterone acetate safety."( Food effects on abiraterone pharmacokinetics in healthy subjects and patients with metastatic castration-resistant prostate cancer.
Acharya, M; Bernard, A; Chi, KN; Chien, C; Gonzalez, M; Griffin, TW; Jiao, J; Kheoh, T; Kollmannsberger, C; North, S; Pankras, C; Peng, L; Spratlin, J; Stieltjes, H; Tran, NP; Yu, MK, 2015
)
0.42
"Dissolution testing is an in vitro procedure which is widely used in quality control (QC) of solid oral dosage forms and, given that real biorelevant test conditions are applied, can also be used as a predictive tool for the in vivo performance of such formulations."( Impact of vibration and agitation speed on dissolution of USP prednisone tablets RS and various IR tablet formulations.
Klein, S; Lange, S; Seeger, N, 2015
)
0.66
" Altogether, colchicine avoided the use (n = 2) or increase in dosage (n = 5) of steroids in seven cases; the increase in steroids dosage was minimal for two patients."( Colchicine: a simple and effective treatment for pericarditis in systemic lupus erythematosus? A report of 10 cases.
Bonjour, M; Costedoat-Chalumeau, N; Le Guern, V; Le Jeunne, C; Morel, N; Mouthon, L; Piette, JC, 2015
)
0.42
"Although rabbit anti-thymocyte globulin (rATG) is commonly used as induction therapy for kidney transplantation, dosing is not standardized."( Evaluation of a Weight-based Rabbit Anti-thymocyte Globulin Induction Dosing Regimen for Kidney Transplant Recipients.
Lee, E; Lee, S; Park, JM; Pennington, CA; Sindelar, J; Tischer, SM, 2015
)
0.42
" Differences in standards of care and dosing complicate interpretation of this finding, but stratification by PRED/DFZ might be considered in clinical trials."( Prednisone/prednisolone and deflazacort regimens in the CINRG Duchenne Natural History Study.
Bello, L; Cnaan, A; Duong, T; Gordish-Dressman, H; Henricson, EK; Hoffman, EP; McDonald, CM; Morgenroth, LP, 2015
)
1.86
" During omalizumab treatment, spirometry, the asthma control test (ACT) score and eosinophilia were evaluated, and prednisone dosage was recorded."( Omalizumab in patients with eosinophilic granulomatosis with polyangiitis: a 36-month follow-up study.
Detoraki, A; Di Capua, L; Genovese, A; Marone, G; Spadaro, G; Varricchi, G, 2016
)
0.64
" The primary outcome will be measured by using the asthma control test and the secondary outcomes will be measured by using the percentage of symptom-free days, the average dosage of salbutamol aerosol and/or prednisone tablets, lung functions, daily asthma symptom scores, asthma quality of life questionnaire, and so on."( Efficacy of acupuncture for chronic asthma: study protocol for a randomized controlled trial.
Fan, L; Feng, JT; Hu, CP; Liu, YY; Shao, SJ; Wang, PY; Wang, WQ; Wang, Y; Xu, YD; Yang, YQ; Yin, LM; Zhang, TF, 2015
)
0.6
" Thus, salvage Ox-P chemotherapy for patients with relapsed or refractory MZL at the stated dosage and schedule showed moderate clinical activity and was considerable in very few selected patients (NCT01068392)."( A phase II study of oxaliplatin and prednisone for patients with relapsed or refractory marginal zone lymphoma: Consortium for Improving Survival of Lymphoma trial.
Chae, YS; Eom, HS; Hong, J; Hong, JY; Kim, HJ; Kim, JS; Kim, SJ; Kim, WS; Lee, GW; Lee, S; Lee, SM; Oh, SY; Park, E; Park, J; Ryoo, HM; Suh, C; Won, JH; Yang, DH; Yoon, DH, 2016
)
0.71
" The pemphigus disease area index (PDAI) score, direct immunofluorescence (DIF), indirect immunofluorescence (IIF), and corticosteroid dosage were evaluated before IVIG therapy, after each cycle, and at 6 and 12 months' follow up."( IVIG therapy in pemphigus vulgaris has corticosteroid-sparing and immunomodulatory effects.
Svecova, D, 2016
)
0.43
"0 and baseline prednisone dosage was 201."( IVIG therapy in pemphigus vulgaris has corticosteroid-sparing and immunomodulatory effects.
Svecova, D, 2016
)
0.79
" for preparation of extemporaneous dosage forms."( Stability of Prednisone in Oral Mix Suspending Vehicle.
Danopoulos, P; Friciu, M; Leclair, G; Plourde, K; Savji, T,
)
0.5
" This analysis of the pivotal phase 3 FIRST trial examined the impact of renally adapted dosing of lenalidomide and dexamethasone on outcomes of patients with different degrees of renal impairment."( Impact of renal impairment on outcomes with lenalidomide and dexamethasone treatment in the FIRST trial, a randomized, open-label phase 3 trial in transplant-ineligible patients with multiple myeloma.
Belhadj, K; Bensinger, W; Chen, G; Cheung, MC; Derigs, HG; Dib, M; Dimopoulos, MA; Eom, H; Ervin-Haynes, A; Facon, T; Gamberi, B; Hall, R; Jaccard, A; Jardel, H; Karlin, L; Kolb, B; Lenain, P; Leupin, N; Liu, T; Marek, J; Rigaudeau, S; Roussel, M; Schots, R; Tosikyan, A; Van der Jagt, R, 2016
)
0.43
" To establish safety, lenalidomide dosing in this combination was escalated in a conventional 3 + 3 design (15, 20 and 25 mg daily for 2 weeks followed by 1 week off)."( Phase II trial of docetaxel, bevacizumab, lenalidomide and prednisone in patients with metastatic castration-resistant prostate cancer.
Adesunloye, BA; Arlen, PM; Beedie, SL; Chen, C; Chun, G; Cordes, L; Couvillon, A; Dahut, WL; Dawson, NA; Figg, WD; Gulley, JL; Harold, N; Huang, X; Karzai, FH; Lee, MJ; Lee, S; Madan, RA; McLeod, DG; Ning, YM; Rosner, I; Sissung, T; Steinberg, SM; Theoret, MR; Tomita, Y; Trepel, JB, 2016
)
0.68
" Compared with the results before MMF therapy, the steroid dosage in both groups was significantly reduced at the 6- and 12-month follow-ups."( The Value of Monitoring the Serum Concentration of Mycophenolate Mofetil in Children with Steroid-Dependent/Frequent Relapsing Nephrotic Syndrome.
Du, L; Fu, H; Liu, A; Mao, J; Shen, H; Shu, Q; Tong, K, 2016
)
0.43
" Growth curve comparisons and linear mixed-effects modeling, adjusted for race/ethnicity and birth year, were used to evaluate growth and steroid treatment patterns (age at initiation, dosing interval, duration, cumulative dose)."( Corticosteroid Treatment and Growth Patterns in Ambulatory Males with Duchenne Muscular Dystrophy.
Ciafaloni, E; DiGuiseppi, C; James, K; Lamb, MM; Ouyang, L; Pandya, S; Weitzenkamp, D; West, NA; Yang, M, 2016
)
0.43
" Daily prednisone dosing predicted lighter weight, but longer duration, and greater dosages predicted heavier weight."( Corticosteroid Treatment and Growth Patterns in Ambulatory Males with Duchenne Muscular Dystrophy.
Ciafaloni, E; DiGuiseppi, C; James, K; Lamb, MM; Ouyang, L; Pandya, S; Weitzenkamp, D; West, NA; Yang, M, 2016
)
0.89
" Inter- and intraindividual variability in dosing requirements conventionally use physician-guided titrated drug administration, which results in frequent deviations from the target trough ranges, particularly during the critical postoperative phase."( Individualizing liver transplant immunosuppression using a phenotypic personalized medicine platform.
Agopian, V; Busuttil, R; Datta, N; Eriksen, C; Farmer, D; Ho, CM; Ho, D; Kaldas, F; Kee, T; Lee, DK; Silva, A; Wang, SE; Weigle, K; Zarrinpar, A, 2016
)
0.43
"We have extended the scope of this updated review to include comparisons of different corticosteroids and dosing regimens."( Corticosteroids for the treatment of Duchenne muscular dystrophy.
Brassington, R; Jichi, F; Kuntzer, T; Manzur, AY; Matthews, E, 2016
)
0.43
" Cox's proportional hazards models estimated fracture risk adjusted for demographics and baseline clinical characteristics to assess dose-response relationships with current (daily) and prior (cumulative) dose, and by time since discontinuation."( Glucocorticoid exposure and fracture risk in patients with new-onset rheumatoid arthritis.
Adler, RA; Balasubramanian, A; Curtis, JR; Lin, CJF; Maricic, M; O'Malley, CD; Saag, K; Wade, SW, 2016
)
0.43
" Adjunctive methotrexate may reduce cumulative glucocorticoid dosage by 20% to 44% and relapses by 36% to 54% in both PMR and GCA."( Polymyalgia Rheumatica and Giant Cell Arteritis: A Systematic Review.
Buttgereit, F; Dasgupta, B; Dejaco, C; Matteson, EL, 2016
)
0.43
" This study was conducted to characterize the safety and pharmacodynamic (PD) dose-response of a 7-day course of oral prednisone on biomarkers of GC receptor agonism."( Safety and pharmacodynamic dose response of short-term prednisone in healthy adult subjects: a dose ranging, randomized, placebo-controlled, crossover study.
Daniel, S; Fleishaker, DL; Mukherjee, A; Whaley, FS; Zeiher, BG, 2016
)
0.89
"This characterization provides important and relevant information on safety and PD responses of short-term prednisone dosing over the commonly-used clinical dose range, and also provides a reference for early clinical development of dissociated agents targeting a differentiated PD profile."( Safety and pharmacodynamic dose response of short-term prednisone in healthy adult subjects: a dose ranging, randomized, placebo-controlled, crossover study.
Daniel, S; Fleishaker, DL; Mukherjee, A; Whaley, FS; Zeiher, BG, 2016
)
0.89
"Randomised trials and quasi-randomised trials comparing different routes of administration and dosage schemes of corticosteroid or adrenocorticotrophic hormone therapy versus a control group receiving no therapy considered effective for this condition, unless the same therapy was given in a similar way to the experimental group."( Corticosteroids for Bell's palsy (idiopathic facial paralysis).
Daly, F; Gagyor, I; Gammie, F; Madhok, VB; Somasundara, D; Sullivan, F; Sullivan, M, 2016
)
0.43
"Therapeutic drug monitoring leading to individualized dosing may improve the efficacy of mycophenolate mofetil in steroid-dependent nephrotic syndrome."( Mycophenolic Acid Pharmacokinetics and Relapse in Children with Steroid-Dependent Idiopathic Nephrotic Syndrome.
Bandin, F; Bouchet, S; Brochard, K; Dallocchio, A; Decramer, S; Gandia, P; Godron, A; Guigonis, V; Harambat, J; Ichay, L; Llanas, B; Marquet, P; Morin, D; Saint-Marcoux, F; Tellier, S, 2016
)
0.43
" In order to reduce the ocular side effects of the GCs there are some advisements, including a complete history, regular examination, GC should be prescribed in minimal dosage and minimal course, and as possible GC-sparing drugs should always be considered."( Early onset steroid induced posterior subcapsular cataract in a patient with common variable immunodeficiency: case reports and review of literature.
Abolhassani, H; Aghamohammadi, A; Azizi, G; Ghareje Daghi, M; Marefat, H, 2016
)
0.43
" The area under the curves (AUC) of immunosuppressants was calculated by the plot of plasma trough level or dosage of each immunosuppressant versus time and was interpreted as the extent of drug exposure."( Effect of Immunosuppressive Drugs on the Changes of Serum Galactose-Deficient IgA1 in Patients with IgA Nephropathy.
Barratt, J; Kim, MJ; Koller, MT; Molyneux, K; Schaub, S; Stampf, S, 2016
)
0.43
" Although daily glucocorticoid therapy has been shown to extend ambulatory function in DMD, less frequent dosing is often used because of side effect concerns."( Long-Term Outcome of Interdisciplinary Management of Patients with Duchenne Muscular Dystrophy Receiving Daily Glucocorticoid Treatment.
Jefferies, JL; McMahon, MA; Rutter, MM; Rybalsky, I; Sawnani, H; Shellenbarger, KC; Tian, C; Wong, BL, 2017
)
0.46
"Oral administration of prednisone was initiated at a dosage of 20 mg/day."( Case report-malignant transformation in Cronkhite-Canada syndrome polyp.
Ji, M; Wu, Y; Yu, L; Zhang, S; Zhao, H; Zong, Y, 2017
)
0.77
" The treatment was repeated with prednisone at a dosage of 20 mg/day resulting in subsided symptoms."( Case report-malignant transformation in Cronkhite-Canada syndrome polyp.
Ji, M; Wu, Y; Yu, L; Zhang, S; Zhao, H; Zong, Y, 2017
)
0.74
" The addition of methotrexate to a tapered dosage of prednisone 10 mg daily was unsuccessful, and she remains on prednisone 20 mg daily for disease control."( Upper Airway Obstruction Requiring Emergent Tracheostomy Secondary to Laryngeal Sarcoidosis: A Case Report.
Gulati, M; Herzog, EL; Homer, R; Pan, H; Ryu, C, 2017
)
0.7
" Requirement of mean daily dosage of prednisone was significantly lower in RTX group [p = 0."( Efficacy and safety of rituximab in comparison with common induction therapies in pediatric active lupus nephritis.
Babu, BG; Basu, B; Roy, B, 2017
)
0.73
" Although there is evidence in the literature regarding specific OCS dosing protocols, it is not known to what extent these recommendations are being followed."( Oral corticosteroid prescribing habits for rhinosinusitis: The American Rhinologic Society membership.
Ernst, HM; Rotenberg, BW; Rudmik, L; Scott, JR; Sowerby, LJ, 2017
)
0.46
"Mammalian target of rapamycin inhibitors were neither protective nor permissive for de novo donor-specific antibody formation versus mycophenolate when used with clinically relevant tacrolimus dosing regimens."( De Novo Donor-Specific Antibody Formation in Tacrolimus-Based, Mycophenolate Versus Mammalian Target of Rapamycin Immunosuppressive Regimens.
Adebiyi, O; Cooper, JE; Gralla, J; Klem, P; Mithani, Z; Wiseman, AC, 2018
)
0.48
" The dose of prednisone was modified by the clinician who was blinded to the patient's dosage of RCI."( Repository corticotropin for Chronic Pulmonary Sarcoidosis.
Baughman, RP; Birring, SS; Keijsers, R; Lower, EE; Saketkoo, LA; Shipley, R; Sweiss, N, 2017
)
0.82
" On day 1 of cycle 1, seven whole-blood samples were collected for 3 h after dosing completion to obtain the maximum plasma concentration and area under the time-concentration curve during 3 h postdose (AUC0-3) in each patient."( Bortezomib pharmacokinetics in tumor response and peripheral neuropathy in multiple myeloma patients receiving bortezomib-containing therapy.
Choi, K; Han, S; Hong, T; Lee, J; Lee, SE; Min, CK; Park, GJ; Yim, DS, 2017
)
0.46
" Chronic steroid use usually involves once-daily dosing, although weekly dosing in children has been suggested for its reduced side effects on behavior."( Intermittent glucocorticoid steroid dosing enhances muscle repair without eliciting muscle atrophy.
Barefield, DY; Demonbreun, AR; Earley, JU; Hadhazy, M; McNally, EM; Quattrocelli, M; Vo, AH; Warner, JL, 2017
)
0.46
" Mean prednisone dosage decreased from 11."( Glucocorticoid-sparing effect of first-year anti-TNFα treatment in rheumatoid arthritis (CORPUS Cohort).
Benichou, J; Duquenne, C; Flipo, RM; Guillemin, F; Guillevin, L; Job-Deslandre, C; Saraux, A; Sibilia, J; Wendling, D,
)
0.61
"Bullous pemphigoid is the most common autoimmune bullous disease, treated with low dosage local or systemic corticosteroids."( [BULLOUS PEMPHIGOID RESISTANT TO CORTICOSTEROIDS].
Cohen, E; Rozenman, D; Sah, M; Ziv, M, 2016
)
0.43
"The mean systemic prednisone (or equivalent) dosage significantly decreased at 3- and 6-month follow-up evaluations compared to baseline (P = 0."( Systemic Steroid Sparing Effect of Intravitreal Dexamethasone Implant in Chronic Noninfectious Uveitic Macular Edema.
Bacherini, D; Cantarini, L; Emmi, G; Fabiani, C; Favale, RA; Franceschini, R; Frediani, B; Fusco, F; Galeazzi, M; Guerriero, S; Iannone, F; Lopalco, G; Tosi, GM; Vannozzi, L; Vitale, A, 2017
)
0.79
" Incidence of PIs, radiological features, patients' characteristics, underlying NHL type, rituximab/chemotherapy dosing schedules, and symptoms were recorded."( 18F-FDG-PET/CT Pulmonary Infiltrates in Non-Hodgkin Lymphoma Patients Treated with Combined Immunochemotherapy: Incidence and Clinical Characteristics.
Bairey, O; Berger, T; Cohen, YC; Eshel, L; Raanani, P; Shpilberg, O; Stern, D, 2017
)
0.46
" This study examines the association between corticosteroid dosage and incidence rates of corticosteroid-related AEs."( Corticosteroid-Related Adverse Events Systematically Increase with Corticosteroid Dose in Noninfectious Intermediate, Posterior, or Panuveitis: Post Hoc Analyses from the VISUAL-1 and VISUAL-2 Trials.
Bao, Y; Betts, KA; Camez, A; Joshi, A; Mittal, M; Suhler, EB; Tari, S; Thorne, JE, 2017
)
0.46
" Dosing of prednisone and safety were also assessed."( Trial of Tocilizumab in Giant-Cell Arteritis.
Aringer, M; Blockmans, D; Brouwer, E; Cid, MC; Collinson, N; Dasgupta, B; Dimonaco, S; Klearman, M; Rech, J; Salvarani, C; Schett, G; Schulze-Koops, H; Spiera, R; Stone, JH; Tuckwell, K; Unizony, SH, 2017
)
0.84
" QMGS, MMT and MG-ADL were significantly improved and the average steroid dosage reduction was 43% (p=0."( Responsiveness to low-dose rituximab in refractory generalized myasthenia gravis.
Huang, Y; Jing, S; Lu, J; Pang, S; Quan, C; Song, J; Song, Y; Xi, J; Zhao, C; Zhou, L, 2017
)
0.46
" Herein, we assessed the efficacy of steroid dosing on sarcolemmal repair, muscle function, histopathology, and the regenerative capacity of primary muscle cells."( Intermittent Glucocorticoid Dosing Improves Muscle Repair and Function in Mice with Limb-Girdle Muscular Dystrophy.
Demonbreun, AR; McNally, EM; Page, PG; Quattrocelli, M; Salamone, IM; Warner, JL, 2017
)
0.46
" The changes in their pulmonary function for 12 months following treatment with rituximab were followed, along with other intervention performed and daily average dosing of prednisone."( Effect of Rituximab on Pulmonary Function in Bronchiolitis Obliterans Syndrome due to Graft-Versus-Host-Disease.
Abhyankar, S; Brownback, KR; Ganguly, S; McGuirk, JP; Streiler, C; Thomas, LA, 2017
)
0.65
" The dosage of prednisone, the severity of symptoms, blood samples, the serum concentration of tacrolimus, and titers of antiacetylcholine receptor antibodies were evaluated every four weeks."( Tacrolimus Improves Symptoms of Children With Myasthenia Gravis Refractory to Prednisone.
Bu, B; Cao, Y; Gui, M; Ji, S; Li, Y; Lin, J; Liu, C, 2017
)
1.04
" At the end point, the dosage of prednisone was significantly decreased (P < 0."( Tacrolimus Improves Symptoms of Children With Myasthenia Gravis Refractory to Prednisone.
Bu, B; Cao, Y; Gui, M; Ji, S; Li, Y; Lin, J; Liu, C, 2017
)
0.96
"Although G-CSF is widely used to prevent or ameliorate leukopenia during cytotoxic chemotherapies, its optimal use is still under debate and depends on many therapy parameters such as dosing and timing of cytotoxic drugs and G-CSF, G-CSF pharmaceuticals used and individual risk factors of patients."( Model-based optimization of G-CSF treatment during cytotoxic chemotherapy.
Engel, C; Loeffler, M; Loibl, S; Schirm, S; Scholz, M, 2018
)
0.48
" What dosing strategy has the best balance between effect and side-effects is largely unknown."( No evidence found for an association between prednisone dose and FVC change in newly-treated pulmonary sarcoidosis.
Broos, CE; Grootenboers, MJJH; Heller, R; Hoogsteden, HC; In 't Veen, JCCM; Kool, M; Looman, CWN; Poell, LHC; van den Blink, B; van den Toorn, LM; Wapenaar, M; Wijsenbeek, MS, 2018
)
0.74
" All six patients in the placebo arm crossed over to the 5mg/kg dosing regimen after week 16, and two of those responded to infliximab."( A randomized, double-blind, placebo-controlled trial of infliximab in refractory polymyositis and dermatomyositis.
Cabalar, IV; Castro, C; Faghihi-Kashani, S; Garg, M; Gourley, M; Harris-Love, MO; Joe, G; Miller, FW; Plotz, PH; Pokrovnichka, A; Schiffenbauer, A; Shrader, J, 2018
)
0.48
" Twelve SAE occurred within the first 3 months on prednisone (at dosage >0."( Unfavourable outcome of glucocorticoid treatment in suspected idiopathic pulmonary fibrosis.
Grutters, JC; van Es, HW; van Moorsel, CHM; van Oosterhout, MFM; Vorselaars, ADM; Wiertz, IA; Wuyts, WA, 2018
)
0.73
" For the clinical study, 26 patients with NS, all prescribed the recommended dosage of prednisone (1 mg/kg/day), were randomly assigned to two groups."( Massive Proteinuria-Induced Injury of Tubular Epithelial Cells in Nephrotic Syndrome is Not Exacerbated by Furosemide.
Jing, KP; Li, JJ; Liu, HF; Liu, WJ; Pan, Q; Tang, HX; Wang, S; Wu, HL; Xu, C; Ye, L; Zou, T, 2018
)
0.7
" In conclusion, prednisone-treated dogs fed ad libitum had greater glucocorticoid-induced renal effects than those dosed with fosdagrocorat."( Renal and Hematologic Comparative Effects of Dissociated Agonist of the Glucocorticoid Receptor and Prednisone in Dogs With and Without Food Restriction.
Dybowski, JA; LaBranche, T; Lettiere, DJ; Peraza, MA; Portugal, SS; Radi, ZA; Vogel, WM,
)
0.69
"In real-life, belimumab is efficacious in achieving low disease activity in over 40% of unselected patients, in combination with reduction of corticosteroid dosage and number of flares."( Low disease activity-irrespective of serologic status at baseline-associated with reduction of corticosteroid dose and number of flares in patients with systemic lupus erythematosus treated with belimumab: A real-life observational study.
Adamichou, C; Bertsias, G; Boki, KA; Boumpas, DT; Dimopoulou, D; Elezoglou, A; Erden, A; Fanouriakis, A; Katsikas, G; Klagou, A; Konsta, S; Konstantopoulou, P; Koutsoviti, S; Liossis, SN; Mavragani, CP; Ntali, S; Panopoulos, S; Pantazi, L; Sfikakis, PP; Sidiropoulos, P; Staveri, C; Tektonidou, M; Tsalapaki, C; Vassilopoulos, D, 2018
)
0.48
" Conclusion Low-dose AA (with low-fat breakfast) is noninferior to standard dosing with respect to PSA metrics."( Prospective International Randomized Phase II Study of Low-Dose Abiraterone With Food Versus Standard Dose Abiraterone In Castration-Resistant Prostate Cancer.
Carthon, B; Chiong, E; Figg, WD; Fishkin, P; Harvey, RD; Ibraheem, A; Karrison, T; Kozloff, MF; Martinez, E; Nabhan, C; Peer, CJ; Ratain, MJ; Stadler, WM; Szmulewitz, RZ; Yong, WP, 2018
)
0.48
" Serial blood and urine samples were collected over 1 dosing interval."( Prednisone Pharmacokinetics During Pregnancy and Lactation.
Ahmed, MS; Bennett, B; Caritis, SN; Clark, S; Easterling, TR; Hays, K; Hebert, MF; Honaker, MT; Kantrowitz-Gordon, I; Ryu, RJ; Shen, DD; Thummel, KE; Umans, JG; Venkataramanan, R, 2018
)
1.92
" oral dexamethasone versus oral prednisone), with consideration for dosing and pharmacokinetic properties, to better identify the optimal IM or oral corticosteroid regimens to improve patient outcomes."( Intramuscular versus oral corticosteroids to reduce relapses following discharge from the emergency department for acute asthma.
Campbell, S; Cross, E; Kirkland, SW; Rowe, BH; Villa-Roel, C, 2018
)
0.76
" Because the dosing interval used for BV therapy was longer than that in the recommended schedule, we could not definitively attribute her recurrence to BV resistance."( [Successful treatment with brentuximab vedotin maintenance therapy after autologous stem cell transplantation in high-risk Hodgkin lymphoma].
Azuma, Y; Fujita, S; Hotta, M; Ishii, K; Ito, T; Konishi, A; Miyaji, M; Nakanishi, T; Nakaya, A; Nomura, S; Satake, A; Tsubokura, Y; Yoshimura, H,
)
0.13
"Drug release testing plays a major role along all parts of the dosage form development and manufacturing process."( Small volume method for drug release screening using ultrasonic agitation.
Acevedo, AJ; Desai, D; Holt, RG; Zaman, MH, 2018
)
0.48
"This study causally examined the dose-response relationship between oral corticosteroids (OCS) exposure and long-term complications among noninfectious uveitis adult patients in the United States."( Oral corticosteroid exposure and increased risk of related complications in patients with noninfectious intermediate, posterior, or panuveitis: Real-world data analysis.
Chirikov, VV; Kwon, Y; Patel, D; Shah, R, 2019
)
0.51
"A moderate dose-response relationship was found between the long-term use of OCS monotherapy and the risk of developing complications in noninfectious intermediate, posterior, or panuveitis patients."( Oral corticosteroid exposure and increased risk of related complications in patients with noninfectious intermediate, posterior, or panuveitis: Real-world data analysis.
Chirikov, VV; Kwon, Y; Patel, D; Shah, R, 2019
)
0.51
" The clinical efficacy during an average follow-up of 21 months (range, 14-24 months) was assessed by evaluating the changes of serum creatine kinase (CK) levels, the Medical Research Council (MRC) grading of the weakest muscle groups and dosage of oral prednisone."( Tacrolimus combined with corticosteroids effectively improved the outcome of a cohort of patients with immune-mediated necrotising myopathy.
Bu, B; Feng, F; Ji, S; Li, Y; Wang, Q,
)
0.31
" In addition, the daily dosage of prednisone was statistically significantly reduced (p<0."( Tacrolimus combined with corticosteroids effectively improved the outcome of a cohort of patients with immune-mediated necrotising myopathy.
Bu, B; Feng, F; Ji, S; Li, Y; Wang, Q,
)
0.41
" Thirty patients were treated with the study regimen, consisting of alemtuzumab on day 1 of a 21 day cycle with standard dosing of DA-EPOCH for 6-8 cycles."( Phase 1/2 study of alemtuzumab with dose-adjusted EPOCH in untreated aggressive T and NK cell lymphomas.
Jaffe, ES; Lucas, A; Melani, C; Pittaluga, S; Roschewski, M; Roswarski, J; Steinberg, SM; Waldmann, TA; Wilson, WH, 2019
)
0.51
" The primary objective was to investigate the steroid dosage required to control brain oedema on the last day of RT in each arm."( Angiotensin II receptor blockers, steroids and radiotherapy in glioblastoma-a randomised multicentre trial (ASTER trial). An ANOCEF study.
Carpentier, AF; Charissoux, M; Chinot, O; Cuzzubbo, S; Ducray, F; Hoang-Xuan, K; Le Rhun, E; Levy-Piedbois, C; Mandonnet, E; Portal, JJ; Psimaras, D; Quillien, V; Ricard, D; Sejalon, F; Thomas, L; Tibi, A; Ursu, R; Vicaut, E, 2019
)
0.51
" No difference in the steroid dosage required to control brain oedema on the last day of RT, or one month after completion of RT, was seen between both arms."( Angiotensin II receptor blockers, steroids and radiotherapy in glioblastoma-a randomised multicentre trial (ASTER trial). An ANOCEF study.
Carpentier, AF; Charissoux, M; Chinot, O; Cuzzubbo, S; Ducray, F; Hoang-Xuan, K; Le Rhun, E; Levy-Piedbois, C; Mandonnet, E; Portal, JJ; Psimaras, D; Quillien, V; Ricard, D; Sejalon, F; Thomas, L; Tibi, A; Ursu, R; Vicaut, E, 2019
)
0.51
"3years, 48% of patients were successfully weaned from prednisone completely, and 20% were weaned to a maintenance dosage of 5-10mg/d."( Serial Cardiac FDG-PET for the Diagnosis and Therapeutic Guidance of Patients With Cardiac Sarcoidosis.
Fowler, M; Guo, HH; Iagaru, A; Mittra, E; Ning, N; Witteles, R, 2019
)
0.76
"Patients with GCA were randomly assigned to receive double-blind dosing with either subcutaneous tocilizumab (TCZ) 162 mg weekly plus 26-week prednisone taper (TCZ-QW + Pred-26), every-other-week TCZ plus 26-week prednisone taper (TCZ-Q2W + Pred-26), placebo plus 26-week prednisone taper (PBO + Pred-26), or placebo plus 52-week prednisone taper (PBO + Pred-52)."( Glucocorticoid Dosages and Acute-Phase Reactant Levels at Giant Cell Arteritis Flare in a Randomized Trial of Tocilizumab.
Aringer, M; Blockmans, D; Brouwer, E; Cid, MC; Collinson, N; Dasgupta, B; Dimonaco, S; Klearman, M; Rech, J; Salvarani, C; Schett, G; Schulze-Koops, H; Spiera, R; Stone, JH; Tuckwell, K; Unizony, SH, 2019
)
0.72
" Efficacy assessment was based on incidence of FN and serious neutropenia (neutrophil count <500/μL), hospitalization days and chemotherapy dosage level."( [Comparison of Pegfilgrastim and Filgrastim for the Primary Prophylactic Effect for Preventing Febrile Neutropenia in Patients Undergoing Rituximab with Dose-adjusted EPOCH Chemotherapy].
Izumitani, S; Kataoka, T; Matsuo, H; Murase, T; Nishigakiuchi, R; Saeki, Y; Sakurashita, H; Taogoshi, T, 2019
)
0.51
" In agreement with the gastroenterologists, patient started a new biological therapy with golimumab, and oral prednisone with slow tapering of steroid dosage following the improvement of both cutaneous and intestinal symptoms."( Pyoderma gangrenosum successfully treated with golimumab: Case report and review of the literature.
Brancorsini, D; Brisigotti, V; Campanati, A; Diotallevi, F; Molinelli, E; Offidani, A; Radi, G, 2019
)
0.73
" We also conducted a dose-response meta-analysis to analyze the cumulative dosage and SONFH risk in mutation carriers."( Association between genetic polymorphisms and osteonecrosis in steroid treatment populations: a detailed stratified and dose-response meta-analysis.
Jing, M; Yang, J; Yang, X, 2019
)
0.51
"5), dosing in fasted state (n = 13, DTL 12."( Inter- and intra-patient variability in pharmacokinetics of abiraterone acetate in metastatic prostate cancer.
Arasaratnam, M; Bhatnagar, A; Crumbaker, M; Gurney, H; McKay, MJ; Molloy, MP, 2019
)
0.51
"Our cohort demonstrated high inter- and intra-patient variability in both abiraterone and D4A with fixed dosing of AA, with no effect from choice of corticosteroids, prior use of chemotherapy, or dosing in fasting state."( Inter- and intra-patient variability in pharmacokinetics of abiraterone acetate in metastatic prostate cancer.
Arasaratnam, M; Bhatnagar, A; Crumbaker, M; Gurney, H; McKay, MJ; Molloy, MP, 2019
)
0.51
"Methotrexate (MTX), often combined with low moderately dosed prednisone, is still the cornerstone of initial treatment for early rheumatoid arthritis (RA)."( Initiating tocilizumab, with or without methotrexate, compared with starting methotrexate with prednisone within step-up treatment strategies in early rheumatoid arthritis: an indirect comparison of effectiveness and safety of the U-Act-Early and CAMERA-I
Bijlsma, JW; Borm, ME; de Hair, MJ; Jacobs, JW; Lafeber, FP; Linn-Rasker, SP; Pethoe-Schramm, A; Teitsma, XM; Tekstra, J; Ter Borg, EJ; van Laar, JM; Verhoeven, MM; Welsing, PM, 2019
)
0.97
" The definition of remission included a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of 0, prednisone daily dosage of ≤5 mg/day, and immunosuppressive drugs on maintenance dose."( Better Health-Related Quality of Life in Systemic Lupus Erythematosus Predicted by Low Disease Activity State/Remission: Data From the Peruvian Almenara Lupus Cohort.
Alarcón, GS; Cucho-Venegas, JM; Elera-Fitzcarrald, C; Gamboa-Cárdenas, RV; Medina-Chinchón, M; Pastor-Asurza, CA; Perich-Campos, R; Pimentel-Quiroz, V; Reátegui-Sokolova, C; Rodríguez-Bellido, Z; Ugarte-Gil, MF; Zevallos, F, 2020
)
0.77
" Also, the daily prednisone dosage was significantly decreased in 20/24 patients across all three serotype groups."( Stopping oral steroid-sparing agents at initiation of rituximab in myasthenia gravis.
Corse, AM; Doherty, L; Roda, RH, 2019
)
0.85
"Treatment of DMD patients with the corticosteroids prednisone or deflazacort remains the standard of care, and recent data shows that early treatment (as young as 5 months) with a weekend dosing regimen results in measurable improvement in motor outcomes."( Update in Duchenne and Becker muscular dystrophy.
Flanigan, KM; Waldrop, MA, 2019
)
0.77
"We found that a standard dose of prednisone of 5 mg/day as recommended previously may be inadequate to achieve physiologic glucocorticoid replacement in some patients with prostate cancer while on abiraterone treatment and as a result adrenal insufficiency due to inadequate dosing might be more common than initially thought."( Recognition and Treatment of Adrenal Insufficiency Secondary to Abiraterone: A Case Report and Literature Review.
Baloch, HM; Grice-Patil, ZJ; Hoang, TD; Mai, VQ; Selig, DJ; Shakir, MK, 2019
)
0.8
" We observed the efficacy and safety of tocilizumab combined with methotrexate (MTX) in the treatment of refractory AOSD, and to explore the possibility of reducing the dosage of tocilizumab after disease control."( Refractory adult-onset Still disease treated by tocilizumab combined with methotrexate: A STROBE-compliant article.
Guo, SH; Shen, HL; Wang, CY; Wang, LP, 2019
)
0.51
" Dosing of ETN was weight-based with a mean dosage over the first year of 31 mg per week."( Reduction in the utilization of prednisone or methotrexate in Canadian claims data following initiation of etanercept in pediatric patients with juvenile idiopathic arthritis.
Jones, H; Khraishi, M; Marshall, L; Millson, B; Ruperto, N; Woolcott, J, 2019
)
0.8
" A decline in both MTX and PRD use and dosage was observed and may be associated with benefits related to safety, tolerability, and overall healthcare costs."( Reduction in the utilization of prednisone or methotrexate in Canadian claims data following initiation of etanercept in pediatric patients with juvenile idiopathic arthritis.
Jones, H; Khraishi, M; Marshall, L; Millson, B; Ruperto, N; Woolcott, J, 2019
)
0.8
" Further analysis indicated that risk factors, such as skin rash, pericarditis, splenomegaly and delayed diagnosis, are highly related to the dosage of prednisone for remission."( Clinical features and current treatments of adult-onset Still's disease: a multicentre survey of 517 patients in China.
Chen, LJ; Cheng, XB; Chi, HH; Ding, TT; Hu, QY; Ji, ZF; Jiang, LD; Lin, J; Liu, HL; Liu, S; Lu, A; Luo, CN; Shi, H; Su, YT; Sun, CY; Sun, Y; Teng, JL; Wu, LJ; Xu, J; Yang, CD; Ye, JN; Yimaiti, K; Zeng, T; Zhou, ZC,
)
0.33
" In patients with skin rash, pericarditis, splenomegaly or delayed diagnosis, a higher dosage of prednisone was needed to obtain remission."( Clinical features and current treatments of adult-onset Still's disease: a multicentre survey of 517 patients in China.
Chen, LJ; Cheng, XB; Chi, HH; Ding, TT; Hu, QY; Ji, ZF; Jiang, LD; Lin, J; Liu, HL; Liu, S; Lu, A; Luo, CN; Shi, H; Su, YT; Sun, CY; Sun, Y; Teng, JL; Wu, LJ; Xu, J; Yang, CD; Ye, JN; Yimaiti, K; Zeng, T; Zhou, ZC,
)
0.35
" Intermittent steroid dosing has been proposed in Duchenne Muscular Dystrophy patients to mitigate the side effects seen with daily steroid intake."( Pulsed glucocorticoids enhance dystrophic muscle performance through epigenetic-metabolic reprogramming.
Barish, GD; Bass, J; Demonbreun, AR; Haldar, SM; Jiang, Z; Kuntz, NL; McNally, EM; Peek, CB; Quattrocelli, M; Zelikovich, AS, 2019
)
0.51
" Survey items evaluated PCP preferred oral glucocorticoid and dosing regimen for children with acute asthma exacerbations, provider- and patient-level factors contributing to glucocorticoid preferences, and perception of glucocorticoid regimens in terms of treatment failure, resolution of symptoms and adherence."( Primary care provider preferences for glucocorticoid management of acute asthma exacerbations in children.
Hoch, H; Mistry, RD; Moran, E; Navanandan, N; Smith, H, 2021
)
0.62
" The attributes included efficacy and withdrawals due to adverse events, as well as dosing and other rare risks of treatment."( Patient preferences for maintenance therapy in Crohn's disease: A discrete-choice experiment.
Bombardier, C; Deardon, R; Hazlewood, GS; Kaplan, GG; Ma, C; Marshall, DA; Panaccione, R; Pokharel, G; Seow, CH; Tomlinson, G, 2020
)
0.56
" No organ-oriented toxicity increased with tazemetostat dosage escalation (severity and incidence)."( A LYSA Phase Ib Study of Tazemetostat (EPZ-6438) plus R-CHOP in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) with Poor Prognosis Features.
Cullières-Dartigues, P; Dubois, R; Dubois, S; Herbaux, C; Jardin, F; Karlin, L; Le Gouill, S; Michot, JM; Molina, T; Morschhauser, F; Picquenot, JM; Ribrag, V; Salles, G; Sarkozy, C; Suttle, B; Tilly, H, 2020
)
0.56
" Secondary objectives are to describe variation in practice between different specialties and to identify the commonly used dosing and frequency for dexamethasone."( Dexamethasone Versus Prednisone for Pediatric Acute Asthma Exacerbations: Specialists' Practice Patterns.
Peterson, R; Young, KD, 2021
)
0.94
"To determine whether a dose-response relationship exists between short-term oral prednisone administration and common clinicopathologic variables, cardiovascular biomarkers, and systolic arterial blood pressure (SAP) in healthy dogs."( Evaluation of dose-response effects of short-term oral prednisone administration on clinicopathologic and hemodynamic variables in healthy dogs.
Mahaffey, AL; Mochel, JP; Murphy, SD; Seo, YJ; Tinklenberg, RL; Ward, JL; Yan, Y, 2020
)
1.03
" The phase III VISTA trial established the bortezomib dosing schedule for VMP."( Comparative Efficacy of Bortezomib, Melphalan, and Prednisone (VMP) With or Without Daratumumab Versus VMP Alone in the Treatment of Newly Diagnosed Multiple Myeloma: Propensity Score Matching of ALCYONE and VISTA Phase III Studies.
Cavo, M; Deraedt, W; Dimopoulos, MA; He, J; Jakubowiak, A; Kampfenkel, T; Lam, A; Mateos, MV; Qi, M; San-Miguel, J, 2020
)
0.81
"The SLEDAI-2KG provides a novel concept for the assessment of lupus disease activity while accounting for glucocorticoids dosage to reflect on disease activity overall at a particular visit."( Identifying a Response for the Systemic Lupus Erythematosus Disease Activity 2000 Glucocorticoid Index.
Anderson, N; Gladman, DD; Su, J; Touma, Z; Urowitz, MB; Zandy, M, 2021
)
0.62
"A questionnaire was developed to evaluate practices and beliefs around steroid dosing in a simplified case of uncomplicated AECOPD."( Provider perceptions on steroid dosing in AECOPD: Laying the groundwork for steroid stewardship.
Cole, JL; Smith, S, 2020
)
0.56
"Initial dosing ranged from 40 to 625 mg/day with only four responders (13%) selecting 40 mg/day."( Provider perceptions on steroid dosing in AECOPD: Laying the groundwork for steroid stewardship.
Cole, JL; Smith, S, 2020
)
0.56
" Only systemic corticosteroids have consistently proven successful in suppressing the rash; however, the response is often only partial, and symptoms tend to recur as the dosage is tapered."( Eosinophilic dermatosis of hematologic malignancy effectively controlled with omalizumab maintenance therapy.
Gates, G; Lor, M; Yu, Y, 2020
)
0.56
"07, and no difference in prednisone dosing between the 2 groups."( Effect of Initial Prednisone Dosing on Ocular Myasthenia Gravis Control.
Carey, AR; Henderson, AD; Shah, YS, 2021
)
1.26
" An abbreviated profile within the first 4 hours after PL dosing provides a good prediction of PL exposure in renal Tx recipients."( Prednisolone and Prednisone Pharmacokinetics in Adult Renal Transplant Recipients.
Andersen, AM; Åsberg, A; Bergan, S; Bjerre, A; Gustavsen, MT; Midtvedt, K; Skauby, RH; Vethe, NT, 2021
)
0.96
" A highest daily dosage of prednisone of 40 mg or higher, even when administered for a month or less, significantly increased the risk of ON."( Predictors of Osteonecrosis in Systemic Lupus Erythematosus: A Prospective Cohort Study.
Kallas, R; Li, J; Petri, M, 2022
)
1.02
" Four trials included European cohorts using dosing schedules according to the regimens studied."( Steroid treatment for the first episode of childhood nephrotic syndrome: comparison of the 8 and 12 weeks regimen using an individual patient data meta-analysis.
Dorresteijn, EM; Schijvens, AM; Schreuder, MF; Teeninga, N; Teerenstra, S; Webb, NJ, 2021
)
0.62
"A human mechanistic physiology-based pharmacokinetic (PBPK) model of vincristine following intravenous dosing was developed to predict potential DDI interactions with combination therapy."( Mechanistic physiology-based pharmacokinetic modeling to elucidate vincristine-induced peripheral neuropathy following treatment with novel kinase inhibitors.
Chen, B; Fretland, AJ; McGinnity, DF; Pilla Reddy, V; Sharma, S; Vishwanathan, K; Ware, JA; Xu, Y; Zhou, D, 2021
)
0.62
" A patient presented with acute onset encephalopathy, mainly characterized by agitation and confusion, rapidly responsive to high dosage steroid therapy and complete remission within 3 days from onset."( Hyperacute reversible encephalopathy related to cytokine storm following COVID-19 vaccine.
Amore, G; Baldelli, L; Cortelli, P; D'Angelo, R; Guarino, M; Montini, A; Panzera, I; Rinaldi, R; Rossi, S, 2021
)
0.62
" More aggressive dosing initiation of NPH based on steroid dose may allow for earlier achievement of euglycemia without a difference in hypoglycemia."( Insulin NPH for steroid-induced hyperglycemia: Predictors for success.
Dungan, K; Gaborcik, JW; Stone, AC, 2021
)
0.62
"028) and prednisone dosage during pregnancy ≥12."( Good pregnancy outcomes in lupus nephritis patients with complete renal remission.
Chen, D; Chen, Y; Hu, W; Li, K; Liu, Z; Yang, L; Zhang, H, 2022
)
1.14
" Age, anti-C1q and anti-phospholipid antibodies, and prednisone dosage during pregnancy were risk factors for adverse pregnancy outcomes."( Good pregnancy outcomes in lupus nephritis patients with complete renal remission.
Chen, D; Chen, Y; Hu, W; Li, K; Liu, Z; Yang, L; Zhang, H, 2022
)
0.97
" The primary efficacy results evaluated were hospitalization rate related to HES, morbidity (new or worsening), relapses/failure, treatment-related adverse effects, prednisone dosage ≤10 mg/day for ≥8 weeks, and eosinophil count <600/μL for ≥8 weeks."( Mepolizumab in Hypereosinophilic Syndrome: A Systematic Review and Meta-analysis.
Alves Júnior, JM; Bernardo, WM; Bley, F; Prota, FE; Villagelin, D, 2021
)
0.82
" In this setting, the personalization of steroid dosage might prevent an over exposure to the drug, but this strategy is not available yet."( [Steroidi tra necessità e tossicità].
Affatato, S; Lucca, B; Sandrini, S, 2021
)
0.62
" However, its long-term benefits in new-onset vs relapsing disease are uncertain, and the value of weekly vs every-other-week dosing has not been evaluated."( New-onset versus relapsing giant cell arteritis treated with tocilizumab: 3-year results from a randomized controlled trial and extension.
Aringer, M; Bao, M; Blockmans, D; Brouwer, E; Cid, MC; Dasgupta, B; Rech, J; Salvarani, C; Spiera, R; Spotswood, H; Stone, JH; Unizony, SH, 2022
)
0.72
"A multifaceted stewardship intervention significantly reduced steroid dosing in hospitalized AECOPD patients."( A multifaceted stewardship intervention helps curb steroid overprescribing in hospitalized patients with acute exacerbations of COPD.
Cole, JL; Smith, SE, 2022
)
0.72
" Five hundred and seventy-two patients were excluded due to insufficient documentation of oral corticosteroid dosage, no radiographic evidence supporting the diagnosis of AVN, insufficient data confirming the temporal relationship between oral corticosteroids and AVN, and/or a cumulative dosing of >10,000 mg prednisone."( Oral corticosteroid use and the risk of developing avascular necrosis: A large retrospective review.
Campbell, DA; Grond, SE; Little, RE; Loehrl, TA; Poetker, DM, 2022
)
0.9
"2%) were subject to dosing adjustments."( The physical exam's role in determining dose-limiting toxicity prior to immunochemotherapy administration in lymphoma.
Brown, AB; Carty, SA; Kaminski, MS; Phillips, TJ; Runge, JS; Wilcox, RA, 2023
)
0.91
" One month of once-weekly glucocorticoid dosing improved muscle specific force in both males and females."( Intermittent glucocorticoid treatment enhances skeletal muscle performance through sexually dimorphic mechanisms.
Barefield, DY; Hadhazy, M; McNally, EM; Page, PG; Quattrocelli, M; Salamone, IM; Tahtah, I; Tomar, G, 2022
)
0.72
" Here, we investigated whether dosage time affected prednisone effects on muscle bioenergetics."( Muscle mitochondrial remodeling by intermittent glucocorticoid drugs requires an intact circadian clock and muscle PGC1α.
Bass, J; Levine, DC; McNally, EM; Miz, K; Peek, CB; Quattrocelli, M; Wintzinger, M, 2022
)
0.97
"Immunosuppressive dosing of corticosteroids at the start of treatment impairs immune checkpoint inhibitor (ICI) efficacy in advanced non-small cell lung cancer (NSCLC)."( Impact of previous corticosteroid exposure on outcomes of patients receiving immune checkpoint inhibitors for advanced non-small cell lung cancer: a retrospective observational study.
Berrios, JRG; Fabbri, A; Giannarelli, D; Marrucci, E; Nelli, F; Ruggeri, EM; Virtuoso, A, 2022
)
0.72
" A prednisone equivalent threshold of 700 mg defined low (LCD) or high (HCD) cumulative dosing during the 90 days before starting ICIs."( Impact of previous corticosteroid exposure on outcomes of patients receiving immune checkpoint inhibitors for advanced non-small cell lung cancer: a retrospective observational study.
Berrios, JRG; Fabbri, A; Giannarelli, D; Marrucci, E; Nelli, F; Ruggeri, EM; Virtuoso, A, 2022
)
1.34
"These findings imply that immunosuppressive corticosteroid dosing before ICIs, even of short duration, might affect survival."( Impact of previous corticosteroid exposure on outcomes of patients receiving immune checkpoint inhibitors for advanced non-small cell lung cancer: a retrospective observational study.
Berrios, JRG; Fabbri, A; Giannarelli, D; Marrucci, E; Nelli, F; Ruggeri, EM; Virtuoso, A, 2022
)
0.72
"Initial algorithm-based dosing appears to be effective in predicting tacrolimus dose requirement."( Model-Based Tacrolimus Follow-up Dosing in Adult Renal Transplant Recipients: A Simulation Trial.
Andrews, LM; de Winter, BCM; Francke, MI; Hesselink, DA; Keizer, RJ; van Gelder, T, 2022
)
0.72
" For every measured tacrolimus predose concentration (C 0,obs ), model-based dosing advice was simulated using the InsightRX software."( Model-Based Tacrolimus Follow-up Dosing in Adult Renal Transplant Recipients: A Simulation Trial.
Andrews, LM; de Winter, BCM; Francke, MI; Hesselink, DA; Keizer, RJ; van Gelder, T, 2022
)
0.72
"The combination of an algorithm-based tacrolimus starting dose with model-based follow-up dosing has the potential to minimize under- and overexposure to tacrolimus in the early posttransplant phase, although the additional effect of model-based follow-up dosing on initial algorithm-based dosing seems small."( Model-Based Tacrolimus Follow-up Dosing in Adult Renal Transplant Recipients: A Simulation Trial.
Andrews, LM; de Winter, BCM; Francke, MI; Hesselink, DA; Keizer, RJ; van Gelder, T, 2022
)
0.72
" The protective effect of HCQ was dosage related."( Low-dose glucocorticoids withdrawn in systemic lupus erythematosus: a desirable and attainable goal.
Deng, X; Gao, D; Geng, Y; Hao, Y; Huang, H; Ji, L; Wang, Y; Zhang, Z, 2022
)
0.72
"Variation in dose and duration of corticosteroids for childhood-onset steroid-sensitive nephrotic syndrome occurs worldwide, likely reflecting the evolving evidence on optimal dosing and variable severity of the disease observed between patients."( Characteristics Associated with Variation in Corticosteroid Exposure in Children with Steroid-Sensitive Nephrotic Syndrome: Results from a Canadian Longitudinal Study.
Brobbey, A; Chanchlani, R; Dart, AB; Lapeyraque, AL; Morgan, CJ; Nettel-Aguirre, A; Perinpanayagam, MA; Rodriguez-Lopez, S; Samuel, S; Tee, JB, 2021
)
0.62
" Furthermore, incremental increases in the dosage of SCs were associated with a greater risk for these outcomes."( Association between Immunosuppressive Drugs and Coronavirus Disease 2019 Outcomes in Patients with Noninfectious Uveitis in a Large US Claims Database.
Acharya, NR; Akpandak, I; Arnold, BF; Chen, EM; Miller, DC; Sun, Y, 2022
)
0.72
" Glucocorticoids regulate the circadian cycle of energy metabolism, but little is known about how circadian timing of exogenous glucocorticoid dosing directly regulates heart metabolism through cardiomyocyte-autonomous mechanisms."( Impact of circadian time of dosing on cardiomyocyte-autonomous effects of glucocorticoids.
Bass, J; Durumutla, HB; Miz, K; Molkentin, JD; Panta, M; Peek, CB; Prabakaran, AD; Quattrocelli, M; Sargent, M; Wintzinger, M, 2022
)
0.72
"Our study identifies cardiac-autonomous mechanisms through which circadian-specific intermittent dosing reconverts glucocorticoid drugs to metabolic boosters for the heart."( Impact of circadian time of dosing on cardiomyocyte-autonomous effects of glucocorticoids.
Bass, J; Durumutla, HB; Miz, K; Molkentin, JD; Panta, M; Peek, CB; Prabakaran, AD; Quattrocelli, M; Sargent, M; Wintzinger, M, 2022
)
0.72
" The prednisone dosage played no role in CH incidence in patients with HL."( Does transitory steroid-induced central hypothyroidism in children treated for haematological malignancies warrant clinical intervention?
Grizelj, A; Kranjčec, I; Matijašić, N; Oletić, L; Štromar, L, 2022
)
1.24
" Clinical response in short-term follow-up was independent of prednisone dosage and underlying etiology."( Cohort study of infantile epileptic spasms syndrome: etiological analysis and treatment of corticosteroids.
Cheng, M; Hong, S; Jiang, L; Jiang, Y; Li, T; Liang, X; Liao, S; Luo, Y; Zhong, M; Zou, N, 2022
)
0.96
" The dosage of pyridostigmine bromide was reduced for 69."( Effect of treatment with Fufang Huangqi decoction on dose reductions and discontinuation of pyridostigmine bromide tablets, prednisone, and tacrolimus in patients with type I or II myasthenia gravis.
Caifeng, S; Haiou, P; Jingsheng, Z; Wenjun, Q; Xueshi, H; Yi, L; Zhanyou, W, 2022
)
0.93
" The results from this study suggest that dosing ipatasertib after an evening meal followed by overnight fasting can be an effective strategy for managing increased glucose levels."( Mitigating ipatasertib-induced glucose increase through dose and meal timing modifications.
Agarwal, P; Gallo, JD; Hinton, H; Huang, KC; Miles, DR; Rasuo, G; Rotmensch, J; Sane, RS; Sutaria, DS, 2022
)
0.72
" However, the optimal protocol and dosage of rituximab combined with first-line therapy for NSAbs-associated AE remains unclear so far."( Simplified regimen of combined low-dose rituximab for autoimmune encephalitis with neuronal surface antibodies.
Du, Y; Hao, Y; Li, C; Li, L; Liu, J; Si, H; Yan, Q; Yao, D; Zhang, W; Zhao, C; Zhao, Y, 2022
)
0.72
" While changes of mRS, MMSE and NPI scores, as secondary endpoint, were all markedly accelerating improvement between baseline and each visit, as well as both oral prednisone dosage and relapse were also greatly reduced during follow-up."( Simplified regimen of combined low-dose rituximab for autoimmune encephalitis with neuronal surface antibodies.
Du, Y; Hao, Y; Li, C; Li, L; Liu, J; Si, H; Yan, Q; Yao, D; Zhang, W; Zhao, C; Zhao, Y, 2022
)
0.92
"Our simplified regimen of combined low-dose rituximab firstly showed significantly accelerating short-term recovery and long-term improvement for AE with NSAbs, in parallel with markedly reduced prednisone dosage and clinical relapses."( Simplified regimen of combined low-dose rituximab for autoimmune encephalitis with neuronal surface antibodies.
Du, Y; Hao, Y; Li, C; Li, L; Liu, J; Si, H; Yan, Q; Yao, D; Zhang, W; Zhao, C; Zhao, Y, 2022
)
0.91
" In the past, attempts to reduce the dosage of glucocorticoids were made using cyclophosphamide, cyclosporin A, mofetil mycophenolate, and their combinations."( [Efficacy of rituximab in minimal change disease, an atypical renal manifestation of antiphospholipid syndrome].
Długosz, G; Masajtis-Zagajewska, A; Nowicki, M, 2022
)
0.72
" Heterogeneous dosing practices were observed."( A multi-center analysis of the impact of DA-EPOCH-R dose-adjustment on clinical outcomes of patients with double/triple-hit lymphoma.
Cerdeña, S; Cortese, MJ; Grover, NS; Haverkos, B; Hill, BT; Hughes, ME; Jodon, G; Kahl, BS; Kaiser, J; Kamdar, M; Landsburg, DJ; Namoglu, E; Olson, M; Orellana-Noia, V; Portell, C; Rainey, M; Rudoni, J; Snow, A; Sohail, M; Voorhees, T; Watkins, MP; Wei, W, 2023
)
0.91
"The potential effects of glucocorticoid administration on rivaroxaban's anticoagulant bioactivity in dogs, and an appropriate rivaroxaban dosage regimen for dogs receiving glucocorticoid therapy are unknown."( Anticoagulant effects of rivaroxaban, prednisone, alone and in combination, in healthy dogs.
Brooks, MB; Hafner, PM; Mackin, AJ; Thomason, JM; Wills, RW, 2022
)
0.99
" Prednisone administration had no apparent influence on the anticoagulant effects of rivaroxaban in healthy dogs, suggesting that combined therapy will not require dosage adjustments."( Anticoagulant effects of rivaroxaban, prednisone, alone and in combination, in healthy dogs.
Brooks, MB; Hafner, PM; Mackin, AJ; Thomason, JM; Wills, RW, 2022
)
1.9
" In unfit older patients, a dynamic dosing strategy is often applied."( How I treat older patients with DLBCL in the frontline setting.
Lugtenburg, PJ; Mutsaers, PGNJ, 2023
)
0.91
" The primary outcome was to evaluate cumulative prednisone dosage at 12 and 24 months of follow-up in the two groups."( Treatment of idiopathic nephrotic syndrome at onset: a comparison between 8- and 12-week regimens in everyday clinical practice.
Emma, F; Gatto, A; Gianviti, A; Lucchetti, L; Massella, L; Vivarelli, M, 2023
)
1.17
" However, when the dosage of prednisone was tapered and finally stopped, the eosinophil count increased and the infiltrative shadow returned."( [A CASE OF ALLERGIC BRONCHOPULMONARY MYCOSIS WITH NONTUBERCULOUS MYCOBACTERIOSIS SUCCESSFULLY TREATED WITH BENRALIZUMAB FOR STEROID WITHDRAWAL].
Fukunishi, Y; Kajiwara, K; Kikuchi, T; Makino, H; Nagai, A; Yamamoto, H, 2022
)
1.01
" Longitudinal changes in outcomes, progression to key disease milestones, and dosing and body composition metrics were analyzed descriptively and in multivariate models."( Functional and Clinical Outcomes Associated with Steroid Treatment among Non-ambulatory Patients with Duchenne Muscular Dystrophy1.
Frean, M; Freimark, J; Goemans, N; Henricson, EK; Hor, KN; Koladicz, K; Lane, H; Marden, JR; Mayer, OH; McDonald, CM; Miller, D; Signorovitch, J; Trifillis, P; Zhang, A, 2023
)
0.91
"9) and higher baseline prednisone dosage (RR = 1."( Predictors of complete 24-month remission and flare in patients with polymyalgia rheumatica.
Bartoloni, E; Bogdanos, D; Bursi, R; Cafaro, G; Fiumicelli, E; Gerli, R; Perricone, C; Riccucci, I, 2023
)
1.22
" However, the relationship between prednisone dosage and infection risk is ill-defined."( Does Prednisone Dose Affect Rates of Periprosthetic Joint Infection Following Primary Total Hip and Total Knee Arthroplasty?
Christ, AB; Heckmann, ND; Kebaish, KJ; Lieberman, JR; Mills, ES; Oakes, DA; Piple, AS; Wang, JC, 2023
)
1.7
" Univariate and multivariate regression analyses were performed to assess the 90-day risk of infectious complications based on prednisone dosage as follows: 0 to 5, 6 to 10, 11 to 20, 21 to 30, and >30 milligrams."( Does Prednisone Dose Affect Rates of Periprosthetic Joint Infection Following Primary Total Hip and Total Knee Arthroplasty?
Christ, AB; Heckmann, ND; Kebaish, KJ; Lieberman, JR; Mills, ES; Oakes, DA; Piple, AS; Wang, JC, 2023
)
1.63
"Glucocorticoids are associated with serious side effects related to dosing and time of use."( Development of a web tool to calculate the cumulative dose of glucocorticoids.
Díaz-González, F; Guerra-Rodríguez, M; Loricera, J; Montero-Pastor, N; Moriano, C; Sánchez-Alonso, F; Sánchez-Costa, JT, 2023
)
0.91
" We designed a therapy combining a gradual reduction of prednisone with a long-term, stable dosage of sirolimus."( Combined therapy of prednisone and mTOR inhibitor sirolimus for treating retroperitoneal fibrosis.
Gao, H; Liu, S; Luo, C; Mai, Y; Pan, C; Wang, Y; Zhang, X; Zheng, S, 2023
)
1.48
" However, pediatric clinical trials to identify the correct dosage and tolerability of TRF-budesonide are urgently needed."( A pediatric case of IgA nephropathy benefitting from targeted release formulation-budesonide.
Antonucci, L; Colucci, M; Emma, F; Vivarelli, M, 2023
)
0.91
"Dissolution is used to determine the rate and extent of drug release from the dosage form into a dissolution medium, which allow to assess the batch-to-batch variability."( Measurement uncertainty arising from sampling and analytical steps of dissolution test of prednisone tablets.
Lourenço, FR; Sano, AY, 2023
)
1.13
" Adverse events were noted regardless of starting dosage or regimen."( Perception and usage of short-term prednisone and prednisolone in dogs.
Gober, M; Hillier, A, 2023
)
1.19
"For children with OMG, the addition of various immunosuppressants can reduce the dosage of GC and adverse reactions."( [Clinical effect of different immunosuppressive treatment regimens in children with ocular myasthenia gravis: a retrospective analysis].
Chen, H; Chen, Y; Huang, ZX; Wang, RY; Zhong, JM, 2023
)
0.91
" Optimizing prednisone (and prednisolone) dosing by measuring their concentrations and calculating their pharmacokinetic parameters will allow for personalized treatments for patients, producing more effective and safer treatments for GVHD."( Simultaneous Determination of Prednisone and Prednisolone in Serum by Turbulent Flow Liquid Chromatography-Tandem Mass Spectrometry.
Carlow, DC; Schofield, RC; Scordo, M; Shah, G, 2024
)
2.11
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (5)

RoleDescription
prodrugA compound that, on administration, must undergo chemical conversion by metabolic processes before becoming the pharmacologically active drug for which it is a prodrug.
anti-inflammatory drugA substance that reduces or suppresses inflammation.
antineoplastic agentA substance that inhibits or prevents the proliferation of neoplasms.
immunosuppressive agentAn agent that suppresses immune function by one of several mechanisms of action. Classical cytotoxic immunosuppressants act by inhibiting DNA synthesis. Others may act through activation of T-cells or by inhibiting the activation of helper cells. In addition, an immunosuppressive agent is a role played by a compound which is exhibited by a capability to diminish the extent and/or voracity of an immune response.
adrenergic agentAny agent that acts on an adrenergic receptor or affects the life cycle of an adrenergic transmitter.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (9)

ClassDescription
20-oxo steroidAn oxo steroid carrying an oxo group at position 20.
11-oxo steroidAny oxo steroid that has an oxo substituent at position 11.
21-hydroxy steroid
17alpha-hydroxy steroidThe alpha-stereoisomer of 17-hydroxy steroid.
glucocorticoidGlucocorticoids are a class of steroid hormones that regulate a variety of physiological processes, in particular control of the concentration of glucose in blood.
3-oxo-Delta(1),Delta(4)-steroidA 3-oxo-Delta(1) steroid containing an additional double bond between positions 4 and 5.
primary alpha-hydroxy ketoneAn alpha-hydroxy ketone in which the carbonyl group and the hydroxy group are linked by a -CH2 (methylene) group.
tertiary alpha-hydroxy ketoneAn alpha-hydroxy ketone in which the carbonyl group and the hydroxy group are linked by a carbon bearing two organyl groups.
C21-steroidA steroid that has a structure based on a 21-carbon (pregnane) skeleton. Note that individual examples may have ring substituents at other positions and/or contain double bonds, aromatic A-rings, expanded/contracted rings etc., so the formula and mass may vary from that given for the generic structure.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (2)

PathwayProteinsCompounds
Prednisone Action Pathway13
Prednisone Metabolism Pathway13

Protein Targets (33)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Chain A, TYROSYL-DNA PHOSPHODIESTERASEHomo sapiens (human)Potency63.09570.004023.8416100.0000AID485290
Chain A, HADH2 proteinHomo sapiens (human)Potency15.84890.025120.237639.8107AID893
Chain B, HADH2 proteinHomo sapiens (human)Potency15.84890.025120.237639.8107AID893
pregnane X receptorRattus norvegicus (Norway rat)Potency50.11870.025127.9203501.1870AID651751
TDP1 proteinHomo sapiens (human)Potency26.40390.000811.382244.6684AID686978
GLI family zinc finger 3Homo sapiens (human)Potency10.11220.000714.592883.7951AID1259369; AID1259392
AR proteinHomo sapiens (human)Potency6.66790.000221.22318,912.5098AID1259243; AID1259247; AID1259381; AID588515; AID588516; AID743035; AID743036; AID743040; AID743042; AID743053; AID743054; AID743063
thioredoxin glutathione reductaseSchistosoma mansoniPotency4.46680.100022.9075100.0000AID485364
aldehyde dehydrogenase 1 family, member A1Homo sapiens (human)Potency10.00000.011212.4002100.0000AID1030
hypoxia-inducible factor 1, alpha subunit (basic helix-loop-helix transcription factor)Homo sapiens (human)Potency35.48130.00137.762544.6684AID2120
estrogen receptor 2 (ER beta)Homo sapiens (human)Potency68.86870.000657.913322,387.1992AID1259377
nuclear receptor subfamily 1, group I, member 3Homo sapiens (human)Potency38.93100.001022.650876.6163AID1224838; AID1224893
progesterone receptorHomo sapiens (human)Potency41.13120.000417.946075.1148AID1346795
glucocorticoid receptor [Homo sapiens]Homo sapiens (human)Potency7.59980.000214.376460.0339AID588533; AID720692
retinoic acid nuclear receptor alpha variant 1Homo sapiens (human)Potency63.96850.003041.611522,387.1992AID1159552; AID1159555
estrogen-related nuclear receptor alphaHomo sapiens (human)Potency0.00840.001530.607315,848.9004AID1224848
pregnane X nuclear receptorHomo sapiens (human)Potency61.64700.005428.02631,258.9301AID1346982
estrogen nuclear receptor alphaHomo sapiens (human)Potency28.93290.000229.305416,493.5996AID743069; AID743075; AID743078; AID743079
vitamin D (1,25- dihydroxyvitamin D3) receptorHomo sapiens (human)Potency34.66540.023723.228263.5986AID743223
cytochrome P450, family 19, subfamily A, polypeptide 1, isoform CRA_aHomo sapiens (human)Potency4.90450.001723.839378.1014AID743083
v-jun sarcoma virus 17 oncogene homolog (avian)Homo sapiens (human)Potency49.49620.057821.109761.2679AID1159526; AID1159528
vitamin D3 receptor isoform VDRAHomo sapiens (human)Potency112.20200.354828.065989.1251AID504847
nuclear factor erythroid 2-related factor 2 isoform 2Homo sapiens (human)Potency0.07500.00419.984825.9290AID504444
thyroid hormone receptor beta isoform 2Rattus norvegicus (Norway rat)Potency38.72770.000323.4451159.6830AID743067
nuclear factor erythroid 2-related factor 2 isoform 1Homo sapiens (human)Potency57.32240.000627.21521,122.0200AID651741; AID743202; AID743219
nuclear receptor ROR-gamma isoform 1Mus musculus (house mouse)Potency3.54810.00798.23321,122.0200AID2551
Cellular tumor antigen p53Homo sapiens (human)Potency2.51190.002319.595674.0614AID651743
Nuclear receptor ROR-gammaHomo sapiens (human)Potency7.49780.026622.448266.8242AID651802
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Glucocorticoid receptorHomo sapiens (human)IC50 (µMol)1.14600.00000.495310.0000AID625263
Glucocorticoid receptorHomo sapiens (human)Ki0.52100.00010.38637.0010AID625263
Glycine receptor subunit alpha-1Rattus norvegicus (Norway rat)IC50 (µMol)1.14600.00150.76005.0740AID625263
Glycine receptor subunit alpha-1Rattus norvegicus (Norway rat)Ki0.52100.00070.76537.0010AID625263
Glycine receptor subunit betaRattus norvegicus (Norway rat)IC50 (µMol)1.14600.00150.76005.0740AID625263
Glycine receptor subunit betaRattus norvegicus (Norway rat)Ki0.52100.00070.78467.0010AID625263
Glycine receptor subunit alpha-2Rattus norvegicus (Norway rat)IC50 (µMol)1.14600.00150.80445.0740AID625263
Glycine receptor subunit alpha-2Rattus norvegicus (Norway rat)Ki0.52100.00070.78467.0010AID625263
Glycine receptor subunit alpha-3Rattus norvegicus (Norway rat)IC50 (µMol)1.14600.00150.76005.0740AID625263
Glycine receptor subunit alpha-3Rattus norvegicus (Norway rat)Ki0.52100.00070.78467.0010AID625263
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Glucocorticoid receptorHomo sapiens (human)Kd0.02900.01500.02200.0290AID1685579
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (158)

Processvia Protein(s)Taxonomy
negative regulation of transcription by RNA polymerase IIGlucocorticoid receptorHomo sapiens (human)
regulation of gluconeogenesisGlucocorticoid receptorHomo sapiens (human)
chromatin organizationGlucocorticoid receptorHomo sapiens (human)
regulation of DNA-templated transcriptionGlucocorticoid receptorHomo sapiens (human)
apoptotic processGlucocorticoid receptorHomo sapiens (human)
chromosome segregationGlucocorticoid receptorHomo sapiens (human)
signal transductionGlucocorticoid receptorHomo sapiens (human)
glucocorticoid metabolic processGlucocorticoid receptorHomo sapiens (human)
gene expressionGlucocorticoid receptorHomo sapiens (human)
microglia differentiationGlucocorticoid receptorHomo sapiens (human)
adrenal gland developmentGlucocorticoid receptorHomo sapiens (human)
regulation of glucocorticoid biosynthetic processGlucocorticoid receptorHomo sapiens (human)
synaptic transmission, glutamatergicGlucocorticoid receptorHomo sapiens (human)
maternal behaviorGlucocorticoid receptorHomo sapiens (human)
intracellular glucocorticoid receptor signaling pathwayGlucocorticoid receptorHomo sapiens (human)
glucocorticoid mediated signaling pathwayGlucocorticoid receptorHomo sapiens (human)
positive regulation of neuron apoptotic processGlucocorticoid receptorHomo sapiens (human)
negative regulation of DNA-templated transcriptionGlucocorticoid receptorHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIGlucocorticoid receptorHomo sapiens (human)
astrocyte differentiationGlucocorticoid receptorHomo sapiens (human)
cell divisionGlucocorticoid receptorHomo sapiens (human)
mammary gland duct morphogenesisGlucocorticoid receptorHomo sapiens (human)
motor behaviorGlucocorticoid receptorHomo sapiens (human)
cellular response to steroid hormone stimulusGlucocorticoid receptorHomo sapiens (human)
cellular response to glucocorticoid stimulusGlucocorticoid receptorHomo sapiens (human)
cellular response to dexamethasone stimulusGlucocorticoid receptorHomo sapiens (human)
cellular response to transforming growth factor beta stimulusGlucocorticoid receptorHomo sapiens (human)
neuroinflammatory responseGlucocorticoid receptorHomo sapiens (human)
positive regulation of miRNA transcriptionGlucocorticoid receptorHomo sapiens (human)
intracellular steroid hormone receptor signaling pathwayGlucocorticoid receptorHomo sapiens (human)
regulation of transcription by RNA polymerase IIGlucocorticoid receptorHomo sapiens (human)
negative regulation of cell population proliferationCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycleCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycle G2/M phase transitionCellular tumor antigen p53Homo sapiens (human)
DNA damage responseCellular tumor antigen p53Homo sapiens (human)
ER overload responseCellular tumor antigen p53Homo sapiens (human)
cellular response to glucose starvationCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
positive regulation of miRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
negative regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
mitophagyCellular tumor antigen p53Homo sapiens (human)
in utero embryonic developmentCellular tumor antigen p53Homo sapiens (human)
somitogenesisCellular tumor antigen p53Homo sapiens (human)
release of cytochrome c from mitochondriaCellular tumor antigen p53Homo sapiens (human)
hematopoietic progenitor cell differentiationCellular tumor antigen p53Homo sapiens (human)
T cell proliferation involved in immune responseCellular tumor antigen p53Homo sapiens (human)
B cell lineage commitmentCellular tumor antigen p53Homo sapiens (human)
T cell lineage commitmentCellular tumor antigen p53Homo sapiens (human)
response to ischemiaCellular tumor antigen p53Homo sapiens (human)
nucleotide-excision repairCellular tumor antigen p53Homo sapiens (human)
double-strand break repairCellular tumor antigen p53Homo sapiens (human)
regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
protein import into nucleusCellular tumor antigen p53Homo sapiens (human)
autophagyCellular tumor antigen p53Homo sapiens (human)
DNA damage responseCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediator resulting in cell cycle arrestCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediator resulting in transcription of p21 class mediatorCellular tumor antigen p53Homo sapiens (human)
transforming growth factor beta receptor signaling pathwayCellular tumor antigen p53Homo sapiens (human)
Ras protein signal transductionCellular tumor antigen p53Homo sapiens (human)
gastrulationCellular tumor antigen p53Homo sapiens (human)
neuroblast proliferationCellular tumor antigen p53Homo sapiens (human)
negative regulation of neuroblast proliferationCellular tumor antigen p53Homo sapiens (human)
protein localizationCellular tumor antigen p53Homo sapiens (human)
negative regulation of DNA replicationCellular tumor antigen p53Homo sapiens (human)
negative regulation of cell population proliferationCellular tumor antigen p53Homo sapiens (human)
determination of adult lifespanCellular tumor antigen p53Homo sapiens (human)
mRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
rRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
response to salt stressCellular tumor antigen p53Homo sapiens (human)
response to inorganic substanceCellular tumor antigen p53Homo sapiens (human)
response to X-rayCellular tumor antigen p53Homo sapiens (human)
response to gamma radiationCellular tumor antigen p53Homo sapiens (human)
positive regulation of gene expressionCellular tumor antigen p53Homo sapiens (human)
cardiac muscle cell apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of cardiac muscle cell apoptotic processCellular tumor antigen p53Homo sapiens (human)
glial cell proliferationCellular tumor antigen p53Homo sapiens (human)
viral processCellular tumor antigen p53Homo sapiens (human)
glucose catabolic process to lactate via pyruvateCellular tumor antigen p53Homo sapiens (human)
cerebellum developmentCellular tumor antigen p53Homo sapiens (human)
negative regulation of cell growthCellular tumor antigen p53Homo sapiens (human)
DNA damage response, signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
negative regulation of transforming growth factor beta receptor signaling pathwayCellular tumor antigen p53Homo sapiens (human)
mitotic G1 DNA damage checkpoint signalingCellular tumor antigen p53Homo sapiens (human)
negative regulation of telomere maintenance via telomeraseCellular tumor antigen p53Homo sapiens (human)
T cell differentiation in thymusCellular tumor antigen p53Homo sapiens (human)
tumor necrosis factor-mediated signaling pathwayCellular tumor antigen p53Homo sapiens (human)
regulation of tissue remodelingCellular tumor antigen p53Homo sapiens (human)
cellular response to UVCellular tumor antigen p53Homo sapiens (human)
multicellular organism growthCellular tumor antigen p53Homo sapiens (human)
positive regulation of mitochondrial membrane permeabilityCellular tumor antigen p53Homo sapiens (human)
cellular response to glucose starvationCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of apoptotic processCellular tumor antigen p53Homo sapiens (human)
entrainment of circadian clock by photoperiodCellular tumor antigen p53Homo sapiens (human)
mitochondrial DNA repairCellular tumor antigen p53Homo sapiens (human)
regulation of DNA damage response, signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of neuron apoptotic processCellular tumor antigen p53Homo sapiens (human)
transcription initiation-coupled chromatin remodelingCellular tumor antigen p53Homo sapiens (human)
negative regulation of proteolysisCellular tumor antigen p53Homo sapiens (human)
negative regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
positive regulation of DNA-templated transcriptionCellular tumor antigen p53Homo sapiens (human)
positive regulation of RNA polymerase II transcription preinitiation complex assemblyCellular tumor antigen p53Homo sapiens (human)
positive regulation of transcription by RNA polymerase IICellular tumor antigen p53Homo sapiens (human)
response to antibioticCellular tumor antigen p53Homo sapiens (human)
fibroblast proliferationCellular tumor antigen p53Homo sapiens (human)
negative regulation of fibroblast proliferationCellular tumor antigen p53Homo sapiens (human)
circadian behaviorCellular tumor antigen p53Homo sapiens (human)
bone marrow developmentCellular tumor antigen p53Homo sapiens (human)
embryonic organ developmentCellular tumor antigen p53Homo sapiens (human)
positive regulation of peptidyl-tyrosine phosphorylationCellular tumor antigen p53Homo sapiens (human)
protein stabilizationCellular tumor antigen p53Homo sapiens (human)
negative regulation of helicase activityCellular tumor antigen p53Homo sapiens (human)
protein tetramerizationCellular tumor antigen p53Homo sapiens (human)
chromosome organizationCellular tumor antigen p53Homo sapiens (human)
neuron apoptotic processCellular tumor antigen p53Homo sapiens (human)
regulation of cell cycleCellular tumor antigen p53Homo sapiens (human)
hematopoietic stem cell differentiationCellular tumor antigen p53Homo sapiens (human)
negative regulation of glial cell proliferationCellular tumor antigen p53Homo sapiens (human)
type II interferon-mediated signaling pathwayCellular tumor antigen p53Homo sapiens (human)
cardiac septum morphogenesisCellular tumor antigen p53Homo sapiens (human)
positive regulation of programmed necrotic cell deathCellular tumor antigen p53Homo sapiens (human)
protein-containing complex assemblyCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to endoplasmic reticulum stressCellular tumor antigen p53Homo sapiens (human)
thymocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of thymocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
necroptotic processCellular tumor antigen p53Homo sapiens (human)
cellular response to hypoxiaCellular tumor antigen p53Homo sapiens (human)
cellular response to xenobiotic stimulusCellular tumor antigen p53Homo sapiens (human)
cellular response to ionizing radiationCellular tumor antigen p53Homo sapiens (human)
cellular response to gamma radiationCellular tumor antigen p53Homo sapiens (human)
cellular response to UV-CCellular tumor antigen p53Homo sapiens (human)
stem cell proliferationCellular tumor antigen p53Homo sapiens (human)
signal transduction by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
cellular response to actinomycin DCellular tumor antigen p53Homo sapiens (human)
positive regulation of release of cytochrome c from mitochondriaCellular tumor antigen p53Homo sapiens (human)
cellular senescenceCellular tumor antigen p53Homo sapiens (human)
replicative senescenceCellular tumor antigen p53Homo sapiens (human)
oxidative stress-induced premature senescenceCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathwayCellular tumor antigen p53Homo sapiens (human)
oligodendrocyte apoptotic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of execution phase of apoptosisCellular tumor antigen p53Homo sapiens (human)
negative regulation of mitophagyCellular tumor antigen p53Homo sapiens (human)
regulation of mitochondrial membrane permeability involved in apoptotic processCellular tumor antigen p53Homo sapiens (human)
regulation of intrinsic apoptotic signaling pathway by p53 class mediatorCellular tumor antigen p53Homo sapiens (human)
positive regulation of miRNA transcriptionCellular tumor antigen p53Homo sapiens (human)
negative regulation of G1 to G0 transitionCellular tumor antigen p53Homo sapiens (human)
negative regulation of miRNA processingCellular tumor antigen p53Homo sapiens (human)
negative regulation of glucose catabolic process to lactate via pyruvateCellular tumor antigen p53Homo sapiens (human)
negative regulation of pentose-phosphate shuntCellular tumor antigen p53Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to hypoxiaCellular tumor antigen p53Homo sapiens (human)
regulation of fibroblast apoptotic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
positive regulation of reactive oxygen species metabolic processCellular tumor antigen p53Homo sapiens (human)
negative regulation of stem cell proliferationCellular tumor antigen p53Homo sapiens (human)
positive regulation of cellular senescenceCellular tumor antigen p53Homo sapiens (human)
positive regulation of intrinsic apoptotic signaling pathwayCellular tumor antigen p53Homo sapiens (human)
negative regulation of transcription by RNA polymerase IINuclear receptor ROR-gammaHomo sapiens (human)
xenobiotic metabolic processNuclear receptor ROR-gammaHomo sapiens (human)
regulation of glucose metabolic processNuclear receptor ROR-gammaHomo sapiens (human)
regulation of steroid metabolic processNuclear receptor ROR-gammaHomo sapiens (human)
intracellular receptor signaling pathwayNuclear receptor ROR-gammaHomo sapiens (human)
circadian regulation of gene expressionNuclear receptor ROR-gammaHomo sapiens (human)
cellular response to sterolNuclear receptor ROR-gammaHomo sapiens (human)
positive regulation of circadian rhythmNuclear receptor ROR-gammaHomo sapiens (human)
regulation of fat cell differentiationNuclear receptor ROR-gammaHomo sapiens (human)
positive regulation of DNA-templated transcriptionNuclear receptor ROR-gammaHomo sapiens (human)
adipose tissue developmentNuclear receptor ROR-gammaHomo sapiens (human)
T-helper 17 cell differentiationNuclear receptor ROR-gammaHomo sapiens (human)
regulation of transcription by RNA polymerase IINuclear receptor ROR-gammaHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (47)

Processvia Protein(s)Taxonomy
RNA polymerase II transcription regulatory region sequence-specific DNA bindingGlucocorticoid receptorHomo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingGlucocorticoid receptorHomo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificGlucocorticoid receptorHomo sapiens (human)
core promoter sequence-specific DNA bindingGlucocorticoid receptorHomo sapiens (human)
DNA-binding transcription repressor activity, RNA polymerase II-specificGlucocorticoid receptorHomo sapiens (human)
DNA-binding transcription activator activity, RNA polymerase II-specificGlucocorticoid receptorHomo sapiens (human)
DNA-binding transcription factor activityGlucocorticoid receptorHomo sapiens (human)
RNA bindingGlucocorticoid receptorHomo sapiens (human)
nuclear receptor activityGlucocorticoid receptorHomo sapiens (human)
nuclear glucocorticoid receptor activityGlucocorticoid receptorHomo sapiens (human)
steroid bindingGlucocorticoid receptorHomo sapiens (human)
protein bindingGlucocorticoid receptorHomo sapiens (human)
zinc ion bindingGlucocorticoid receptorHomo sapiens (human)
TBP-class protein bindingGlucocorticoid receptorHomo sapiens (human)
protein kinase bindingGlucocorticoid receptorHomo sapiens (human)
identical protein bindingGlucocorticoid receptorHomo sapiens (human)
Hsp90 protein bindingGlucocorticoid receptorHomo sapiens (human)
steroid hormone bindingGlucocorticoid receptorHomo sapiens (human)
sequence-specific double-stranded DNA bindingGlucocorticoid receptorHomo sapiens (human)
estrogen response element bindingGlucocorticoid receptorHomo sapiens (human)
transcription cis-regulatory region bindingCellular tumor antigen p53Homo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
cis-regulatory region sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
core promoter sequence-specific DNA bindingCellular tumor antigen p53Homo sapiens (human)
TFIID-class transcription factor complex bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription repressor activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription activator activity, RNA polymerase II-specificCellular tumor antigen p53Homo sapiens (human)
protease bindingCellular tumor antigen p53Homo sapiens (human)
p53 bindingCellular tumor antigen p53Homo sapiens (human)
DNA bindingCellular tumor antigen p53Homo sapiens (human)
chromatin bindingCellular tumor antigen p53Homo sapiens (human)
DNA-binding transcription factor activityCellular tumor antigen p53Homo sapiens (human)
mRNA 3'-UTR bindingCellular tumor antigen p53Homo sapiens (human)
copper ion bindingCellular tumor antigen p53Homo sapiens (human)
protein bindingCellular tumor antigen p53Homo sapiens (human)
zinc ion bindingCellular tumor antigen p53Homo sapiens (human)
enzyme bindingCellular tumor antigen p53Homo sapiens (human)
receptor tyrosine kinase bindingCellular tumor antigen p53Homo sapiens (human)
ubiquitin protein ligase bindingCellular tumor antigen p53Homo sapiens (human)
histone deacetylase regulator activityCellular tumor antigen p53Homo sapiens (human)
ATP-dependent DNA/DNA annealing activityCellular tumor antigen p53Homo sapiens (human)
identical protein bindingCellular tumor antigen p53Homo sapiens (human)
histone deacetylase bindingCellular tumor antigen p53Homo sapiens (human)
protein heterodimerization activityCellular tumor antigen p53Homo sapiens (human)
protein-folding chaperone bindingCellular tumor antigen p53Homo sapiens (human)
protein phosphatase 2A bindingCellular tumor antigen p53Homo sapiens (human)
RNA polymerase II-specific DNA-binding transcription factor bindingCellular tumor antigen p53Homo sapiens (human)
14-3-3 protein bindingCellular tumor antigen p53Homo sapiens (human)
MDM2/MDM4 family protein bindingCellular tumor antigen p53Homo sapiens (human)
disordered domain specific bindingCellular tumor antigen p53Homo sapiens (human)
general transcription initiation factor bindingCellular tumor antigen p53Homo sapiens (human)
molecular function activator activityCellular tumor antigen p53Homo sapiens (human)
promoter-specific chromatin bindingCellular tumor antigen p53Homo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingNuclear receptor ROR-gammaHomo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificNuclear receptor ROR-gammaHomo sapiens (human)
DNA-binding transcription repressor activity, RNA polymerase II-specificNuclear receptor ROR-gammaHomo sapiens (human)
DNA-binding transcription factor activityNuclear receptor ROR-gammaHomo sapiens (human)
protein bindingNuclear receptor ROR-gammaHomo sapiens (human)
oxysterol bindingNuclear receptor ROR-gammaHomo sapiens (human)
zinc ion bindingNuclear receptor ROR-gammaHomo sapiens (human)
ligand-activated transcription factor activityNuclear receptor ROR-gammaHomo sapiens (human)
sequence-specific double-stranded DNA bindingNuclear receptor ROR-gammaHomo sapiens (human)
nuclear receptor activityNuclear receptor ROR-gammaHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (24)

Processvia Protein(s)Taxonomy
nucleusGlucocorticoid receptorHomo sapiens (human)
nucleusGlucocorticoid receptorHomo sapiens (human)
nucleoplasmGlucocorticoid receptorHomo sapiens (human)
cytoplasmGlucocorticoid receptorHomo sapiens (human)
mitochondrial matrixGlucocorticoid receptorHomo sapiens (human)
centrosomeGlucocorticoid receptorHomo sapiens (human)
spindleGlucocorticoid receptorHomo sapiens (human)
cytosolGlucocorticoid receptorHomo sapiens (human)
membraneGlucocorticoid receptorHomo sapiens (human)
nuclear speckGlucocorticoid receptorHomo sapiens (human)
synapseGlucocorticoid receptorHomo sapiens (human)
chromatinGlucocorticoid receptorHomo sapiens (human)
protein-containing complexGlucocorticoid receptorHomo sapiens (human)
nuclear bodyCellular tumor antigen p53Homo sapiens (human)
nucleusCellular tumor antigen p53Homo sapiens (human)
nucleoplasmCellular tumor antigen p53Homo sapiens (human)
replication forkCellular tumor antigen p53Homo sapiens (human)
nucleolusCellular tumor antigen p53Homo sapiens (human)
cytoplasmCellular tumor antigen p53Homo sapiens (human)
mitochondrionCellular tumor antigen p53Homo sapiens (human)
mitochondrial matrixCellular tumor antigen p53Homo sapiens (human)
endoplasmic reticulumCellular tumor antigen p53Homo sapiens (human)
centrosomeCellular tumor antigen p53Homo sapiens (human)
cytosolCellular tumor antigen p53Homo sapiens (human)
nuclear matrixCellular tumor antigen p53Homo sapiens (human)
PML bodyCellular tumor antigen p53Homo sapiens (human)
transcription repressor complexCellular tumor antigen p53Homo sapiens (human)
site of double-strand breakCellular tumor antigen p53Homo sapiens (human)
germ cell nucleusCellular tumor antigen p53Homo sapiens (human)
chromatinCellular tumor antigen p53Homo sapiens (human)
transcription regulator complexCellular tumor antigen p53Homo sapiens (human)
protein-containing complexCellular tumor antigen p53Homo sapiens (human)
plasma membraneGlycine receptor subunit betaRattus norvegicus (Norway rat)
nucleusNuclear receptor ROR-gammaHomo sapiens (human)
nucleoplasmNuclear receptor ROR-gammaHomo sapiens (human)
nuclear bodyNuclear receptor ROR-gammaHomo sapiens (human)
chromatinNuclear receptor ROR-gammaHomo sapiens (human)
nucleusNuclear receptor ROR-gammaHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (196)

Assay IDTitleYearJournalArticle
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347425Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1347424RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347407qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID504810Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID504812Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID504749qHTS profiling for inhibitors of Plasmodium falciparum proliferation2011Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043
Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
AID588214FDA HLAED, liver enzyme composite activity2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID732420Efflux ratio of permeability from basolateral to apical side over apical to basolateral in pig LLC-PK1 cells overexpressing human MDR1 relative to efflux ratio in parental cell line2013ACS medicinal chemistry letters, Jan-10, Volume: 4, Issue:1
De novo prediction of p-glycoprotein-mediated efflux liability for druglike compounds.
AID678712Inhibition of human CYP1A2 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using ethoxyresorufin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID22293Delta logD (logD6.5 - logD7.4)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID588217FDA HLAED, serum glutamic pyruvic transaminase (SGPT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID678717Inhibition of human CYP3A4 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 7-benzyloxyquinoline as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID28236Unbound fraction (tissues)2002Journal of medicinal chemistry, Jun-20, Volume: 45, Issue:13
Prediction of volume of distribution values in humans for neutral and basic drugs using physicochemical measurements and plasma protein binding data.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1135055Antitumor activity against mouse L1210 cells allografted in C3D2F1/J mouse assessed as increase in life span at 27 mg/kg, ip qd administered for 5 days relative to control1979Journal of medicinal chemistry, Nov, Volume: 22, Issue:11
Nucleoside conjugates as potential antitumor agents. 2. Synthesis and biological activity of 1-(beta-D-arabinofuranosyl)cytosine conjugates of prednisolone and prednisone.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID19262Aqueous solubility2000Bioorganic & medicinal chemistry letters, Jun-05, Volume: 10, Issue:11
Prediction of drug solubility from Monte Carlo simulations.
AID1703889Permeability of the compound incubated for 8 hrs by PAMPA-TGI assay2020European journal of medicinal chemistry, Oct-15, Volume: 204Discovery of sulfonyl hydrazone derivative as a new selective PDE4A and PDE4D inhibitor by lead-optimization approach on the prototype LASSBio-448: In vitro and in vivo preclinical studies.
AID444056Fraction escaping gut-wall elimination in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID386623Inhibition of 4-(4-(dimethylamino)styryl)-N-methylpyridinium uptake at human OCT1 expressed in HEK293 cells at 100 uM by confocal microscopy2008Journal of medicinal chemistry, Oct-09, Volume: 51, Issue:19
Structural requirements for drug inhibition of the liver specific human organic cation transport protein 1.
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID624606Specific activity of expressed human recombinant UGT1A12000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID588219FDA HLAED, gamma-glutamyl transferase (GGT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588215FDA HLAED, alkaline phosphatase increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID19427HPLC capacity factor (k)2000Journal of medicinal chemistry, Jul-27, Volume: 43, Issue:15
ElogPoct: a tool for lipophilicity determination in drug discovery.
AID540214Clearance in rat after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID681354TP_TRANSPORTER: transepithelial transport in MDR1-expressing LLC-PK1 cells2003Pharmaceutical research, Nov, Volume: 20, Issue:11
Structural determinants of P-glycoprotein-mediated transport of glucocorticoids.
AID1703888Drug absorption of the compound incubated for 8 hrs by PAMPA-TGI assay2020European journal of medicinal chemistry, Oct-15, Volume: 204Discovery of sulfonyl hydrazone derivative as a new selective PDE4A and PDE4D inhibitor by lead-optimization approach on the prototype LASSBio-448: In vitro and in vivo preclinical studies.
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID444054Oral bioavailability in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID540215Volume of distribution at steady state in rat after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID127352Binding affinity against human monoclonal antibody (mAb)-7F22002Journal of medicinal chemistry, Jul-18, Volume: 45, Issue:15
Three-dimensional quantitative structure-activity relationship analysis of ligand binding to human sequence antidigoxin monoclonal antibodies using comparative molecular field analysis.
AID540218Clearance in monkey after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID127350Binding affinity against human monoclonal antibody (mAb)-1B32002Journal of medicinal chemistry, Jul-18, Volume: 45, Issue:15
Three-dimensional quantitative structure-activity relationship analysis of ligand binding to human sequence antidigoxin monoclonal antibodies using comparative molecular field analysis.
AID26380Dissociation constant (pKa)2004Journal of medicinal chemistry, Feb-26, Volume: 47, Issue:5
Prediction of human volume of distribution values for neutral and basic drugs. 2. Extended data set and leave-class-out statistics.
AID1738913Cytotoxicity against human A375 cells assessed as reduction in cell viability incubated for 72 hrs by SRB assay2020European journal of medicinal chemistry, Aug-01, Volume: 199Synthesis of some steroidal mitocans of nanomolar cytotoxicity acting by apoptosis.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1685581Induction of translocation of human glucocorticoid receptor expressed in HEK293T cells transduced with lentiviral vector expressing H2B-mCherry and GFP-GR assessed as the time at which half of the GFP-GR is translocated to the nucleus measured every 7 to 2021RSC medicinal chemistry, Mar-04, Volume: 12, Issue:2
Deacylcortivazol-like pyrazole regioisomers reveal a more accommodating expanded binding pocket for the glucocorticoid receptor.
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1669400Antiinflammatory activity in Balb/c mouse model of Imiquimod-induced psoriasis-like skin lesions assessed as reduction of serum IL-1beta level at 5 mg/kg, ig by ELISA2020Journal of medicinal chemistry, 08-13, Volume: 63, Issue:15
Discovery of an Orally Active Small-Molecule Tumor Necrosis Factor-α Inhibitor.
AID588218FDA HLAED, lactate dehydrogenase (LDH) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID310931Partition coefficient, log P of the compound2007Journal of medicinal chemistry, Feb-22, Volume: 50, Issue:4
In silico and in vitro filters for the fast estimation of skin permeation and distribution of new chemical entities.
AID425653Renal clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID29360Ionization constant (pKa)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID1669401Antiinflammatory activity in Balb/c mouse model of Imiquimod-induced psoriasis-like skin lesions assessed as reduction of serum IL6 level at 5 mg/kg, ig by ELISA2020Journal of medicinal chemistry, 08-13, Volume: 63, Issue:15
Discovery of an Orally Active Small-Molecule Tumor Necrosis Factor-α Inhibitor.
AID1197745Inhibition of human OATP1B3-mediated [3H]CCK-8 at 100 uM after 5 mins relative to control2015European journal of medicinal chemistry, Mar-06, Volume: 92Interaction of human organic anion transporter polypeptides 1B1 and 1B3 with antineoplastic compounds.
AID1543290Inhibition of LPS-stimulation dependent TLR4-induced NF-kappaB/AP-1 signaling cascade in human THP1-XBlue-MD2-CD14 cells at 1 uM pre-incubated for 1 hr before LPS-stimulation for 24 hrs by spectrophotometry2019Journal of natural products, 07-26, Volume: 82, Issue:7
Prenylated Stilbenoids Affect Inflammation by Inhibiting the NF-κB/AP-1 Signaling Pathway and Cyclooxygenases and Lipoxygenase.
AID1738915Cytotoxicity against human MCF7 cells assessed as reduction in cell viability incubated for 72 hrs by SRB assay2020European journal of medicinal chemistry, Aug-01, Volume: 199Synthesis of some steroidal mitocans of nanomolar cytotoxicity acting by apoptosis.
AID1685582Induction of translocation of human glucocorticoid receptor expressed in HEK293T cells transduced with lentiviral vector expressing H2B-mCherry and GFP-GR assessed as the time at which half of the GFP-GR is translocated to the nucleus measured every 130 s2021RSC medicinal chemistry, Mar-04, Volume: 12, Issue:2
Deacylcortivazol-like pyrazole regioisomers reveal a more accommodating expanded binding pocket for the glucocorticoid receptor.
AID444055Fraction absorbed in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID127351Binding affinity against human monoclonal antibody (mAb)-5C22002Journal of medicinal chemistry, Jul-18, Volume: 45, Issue:15
Three-dimensional quantitative structure-activity relationship analysis of ligand binding to human sequence antidigoxin monoclonal antibodies using comparative molecular field analysis.
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID540221Volume of distribution at steady state in human after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID588216FDA HLAED, serum glutamic oxaloacetic transaminase (SGOT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1703908Permeability of the compound by PAMPA-TGI assay2020European journal of medicinal chemistry, Oct-15, Volume: 204Discovery of sulfonyl hydrazone derivative as a new selective PDE4A and PDE4D inhibitor by lead-optimization approach on the prototype LASSBio-448: In vitro and in vivo preclinical studies.
AID171531Percentage content of calcium in femur tested in the compound using male ICR rats when compared to vehicle2003Bioorganic & medicinal chemistry letters, Jan-06, Volume: 13, Issue:1
Studies on the synthesis and anti-Osteoporosis of estrogen-GHRPs linkers.
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID540220Clearance in human after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID1537442Permeability of the compound at 100 uM after 6 hrs by PAMPA2019ACS medicinal chemistry letters, Feb-14, Volume: 10, Issue:2
Identification of Portimine B, a New Cell Permeable Spiroimine That Induces Apoptosis in Oral Squamous Cell Carcinoma.
AID680436TP_TRANSPORTER: inhibition of Ouabain uptake (Ouabain: 100 uM, Prednisone: 100 uM) in Xenopus laevis oocytes1996The Journal of pharmacology and experimental therapeutics, Mar, Volume: 276, Issue:3
Polyspecific drug and steroid clearance by an organic anion transporter of mammalian liver.
AID444053Renal clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID1738914Cytotoxicity against human HT29 cells assessed as reduction in cell viability incubated for 72 hrs by SRB assay2020European journal of medicinal chemistry, Aug-01, Volume: 199Synthesis of some steroidal mitocans of nanomolar cytotoxicity acting by apoptosis.
AID187204Percentage content of phosphor in femur tested in the compound using male ICR rats2003Bioorganic & medicinal chemistry letters, Jan-06, Volume: 13, Issue:1
Studies on the synthesis and anti-Osteoporosis of estrogen-GHRPs linkers.
AID19006Calculated membrane partition coefficient (Kmemb)2004Journal of medicinal chemistry, Mar-25, Volume: 47, Issue:7
Surface activity profiling of drugs applied to the prediction of blood-brain barrier permeability.
AID192036Weight of rat body tested after intramuscular administration of 18 ug/kg of compound when compared to vehicle2003Bioorganic & medicinal chemistry letters, Jan-06, Volume: 13, Issue:1
Studies on the synthesis and anti-Osteoporosis of estrogen-GHRPs linkers.
AID678716Inhibition of human CYP3A4 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using diethoxyfluorescein as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID678715Inhibition of human CYP2D6 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 4-methylaminoethyl-7-methoxycoumarin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID28235Unbound fraction (plasma)2002Journal of medicinal chemistry, Jun-20, Volume: 45, Issue:13
Prediction of volume of distribution values in humans for neutral and basic drugs using physicochemical measurements and plasma protein binding data.
AID444052Hepatic clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID311524Oral bioavailability in human2007Bioorganic & medicinal chemistry, Dec-15, Volume: 15, Issue:24
Hologram QSAR model for the prediction of human oral bioavailability.
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID19424Partition coefficient (logD7.4)2001Journal of medicinal chemistry, Jul-19, Volume: 44, Issue:15
ElogD(oct): a tool for lipophilicity determination in drug discovery. 2. Basic and neutral compounds.
AID444057Fraction escaping hepatic elimination in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID7783Unbound fraction (plasma)2004Journal of medicinal chemistry, Feb-26, Volume: 47, Issue:5
Prediction of human volume of distribution values for neutral and basic drugs. 2. Extended data set and leave-class-out statistics.
AID588210Human drug-induced liver injury (DILI) modelling dataset from Ekins et al2010Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 38, Issue:12
A predictive ligand-based Bayesian model for human drug-induced liver injury.
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID171528Activity tested for the content of calcium in serum of rat when 18 ug/kg of compound was administered intramuscularly when compared to vehicle2003Bioorganic & medicinal chemistry letters, Jan-06, Volume: 13, Issue:1
Studies on the synthesis and anti-Osteoporosis of estrogen-GHRPs linkers.
AID404304Effect on human MRP2-mediated estradiol-17-beta-glucuronide transport in Sf9 cells inverted membrane vesicles relative to control2008Journal of medicinal chemistry, Jun-12, Volume: 51, Issue:11
Prediction and identification of drug interactions with the human ATP-binding cassette transporter multidrug-resistance associated protein 2 (MRP2; ABCC2).
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID540219Volume of distribution at steady state in monkey after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1669394Antiinflammatory activity in Balb/c mouse model of collagen-induced arthritis assessed as reduction in degree of cartilage and bone destruction and inflammation at 5 mg/kg, ig for 2 weeks by H and E staining based histopathological analysis2020Journal of medicinal chemistry, 08-13, Volume: 63, Issue:15
Discovery of an Orally Active Small-Molecule Tumor Necrosis Factor-α Inhibitor.
AID127349Binding affinity against human monoclonal antibody (mAb)-11E62002Journal of medicinal chemistry, Jul-18, Volume: 45, Issue:15
Three-dimensional quantitative structure-activity relationship analysis of ligand binding to human sequence antidigoxin monoclonal antibodies using comparative molecular field analysis.
AID678722Covalent binding affinity to human liver microsomes assessed per mg of protein at 10 uM after 60 mins presence of NADPH2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1685580Cytotoxicity against human REH cells overexpressing GR assessed as reduction in cell viability measured after 3 days by resazurin based assay2021RSC medicinal chemistry, Mar-04, Volume: 12, Issue:2
Deacylcortivazol-like pyrazole regioisomers reveal a more accommodating expanded binding pocket for the glucocorticoid receptor.
AID29811Oral bioavailability in human2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID1685579Induction of translocation of human glucocorticoid receptor expressed in HEK293T cells transduced with lentiviral vector expressing H2B-mCherry and GFP-GR assessed as effective dissociation constant measured every 130 sec for 22 mins by fluorescence imagi2021RSC medicinal chemistry, Mar-04, Volume: 12, Issue:2
Deacylcortivazol-like pyrazole regioisomers reveal a more accommodating expanded binding pocket for the glucocorticoid receptor.
AID678720Metabolic stability in human liver microsomes assessed as low signal/noise ratio (S/N of 1 to 10) by measuring GSH adduct formation at 100 uM after 90 mins by HPLC-MS analysis2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID540217Volume of distribution at steady state in dog after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID1135063Toxicity in C3D2F1/J mouse allografted with mouse L1210 cells assessed as body weight change at 27 mg/kg, ip qd administered for 5 days measured on day 8 (Rvb = 1.81 +/- 0.79 g)1979Journal of medicinal chemistry, Nov, Volume: 22, Issue:11
Nucleoside conjugates as potential antitumor agents. 2. Synthesis and biological activity of 1-(beta-D-arabinofuranosyl)cytosine conjugates of prednisolone and prednisone.
AID977599Inhibition of sodium fluorescein uptake in OATP1B1-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM2013Molecular pharmacology, Jun, Volume: 83, Issue:6
Structure-based identification of OATP1B1/3 inhibitors.
AID444051Total clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID27580Partition coefficient (logP)2000Journal of medicinal chemistry, Jul-27, Volume: 43, Issue:15
ElogPoct: a tool for lipophilicity determination in drug discovery.
AID678713Inhibition of human CYP2C9 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 7-methoxy-4-trifluoromethylcoumarin-3-acetic acid as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID540216Clearance in dog after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID29421Partition coefficient (logP) (HPLC)2000Journal of medicinal chemistry, Jul-27, Volume: 43, Issue:15
ElogPoct: a tool for lipophilicity determination in drug discovery.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID1132664Glucocorticoid activity in sc dosed bilaterally adrenalectomized rat assessed as glycogen deposition in liver administered for 5 days relative to cortisol1978Journal of medicinal chemistry, May, Volume: 21, Issue:5
A Fujita--Ban structure--activity analysis of 44 steroids.
AID444050Fraction unbound in human plasma2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID168222Activity of alkaline phosphatase (ALP) tested in serum of rat when 18 ug/kg of compound was administered intramuscularly2003Bioorganic & medicinal chemistry letters, Jan-06, Volume: 13, Issue:1
Studies on the synthesis and anti-Osteoporosis of estrogen-GHRPs linkers.
AID588209Literature-mined public compounds from Greene et al multi-species hepatotoxicity modelling dataset2010Chemical research in toxicology, Jul-19, Volume: 23, Issue:7
Developing structure-activity relationships for the prediction of hepatotoxicity.
AID192044Weight of rat femur tested after intramuscular administration of 18 ug/kg of compound when compared to vehicle2003Bioorganic & medicinal chemistry letters, Jan-06, Volume: 13, Issue:1
Studies on the synthesis and anti-Osteoporosis of estrogen-GHRPs linkers.
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID977602Inhibition of sodium fluorescein uptake in OATP1B3-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM2013Molecular pharmacology, Jun, Volume: 83, Issue:6
Structure-based identification of OATP1B1/3 inhibitors.
AID1135042Cytotoxicity against mouse L1210 cells assessed as growth inhibition measured at 72 hrs by trypan blue exclusion assay1979Journal of medicinal chemistry, Nov, Volume: 22, Issue:11
Nucleoside conjugates as potential antitumor agents. 2. Synthesis and biological activity of 1-(beta-D-arabinofuranosyl)cytosine conjugates of prednisolone and prednisone.
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1135048Antitumor activity against mouse L1210 cells allografted in C3D2F1/J mouse assessed as median survival time at 27 mg/kg, ip qd administered for 5 days (Rvb = 10 days)1979Journal of medicinal chemistry, Nov, Volume: 22, Issue:11
Nucleoside conjugates as potential antitumor agents. 2. Synthesis and biological activity of 1-(beta-D-arabinofuranosyl)cytosine conjugates of prednisolone and prednisone.
AID425652Total body clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID310933Permeability across PAMPA membrane after 7 hrs2007Journal of medicinal chemistry, Feb-22, Volume: 50, Issue:4
In silico and in vitro filters for the fast estimation of skin permeation and distribution of new chemical entities.
AID467613Volume of distribution at steady state in human2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Prediction of volume of distribution values in human using immobilized artificial membrane partitioning coefficients, the fraction of compound ionized and plasma protein binding data.
AID680285TP_TRANSPORTER: increase in Calcein-AM intracellular accumulation (Calcein-AM: 0.5 uM, Prednisone: 200 uM) in MDR1-expressing NIH-3T3 cells2004Biochemical and biophysical research communications, Mar-19, Volume: 315, Issue:4
Distinct groups of multidrug resistance modulating agents are distinguished by competition of P-glycoprotein-specific antibodies.
AID8002Observed volume of distribution2004Journal of medicinal chemistry, Feb-26, Volume: 47, Issue:5
Prediction of human volume of distribution values for neutral and basic drugs. 2. Extended data set and leave-class-out statistics.
AID192040Weight of rat femur ash tested after intramuscular administration of 18 ug/kg of compound when compared to vehicle2003Bioorganic & medicinal chemistry letters, Jan-06, Volume: 13, Issue:1
Studies on the synthesis and anti-Osteoporosis of estrogen-GHRPs linkers.
AID28233Fraction ionized (pH 7.4)2002Journal of medicinal chemistry, Jun-20, Volume: 45, Issue:13
Prediction of volume of distribution values in humans for neutral and basic drugs using physicochemical measurements and plasma protein binding data.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID678714Inhibition of human CYP2C19 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 3-butyryl-7-methoxycoumarin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID33556The ability concentration.)2000Journal of medicinal chemistry, May-18, Volume: 43, Issue:10
Biosensor analysis of the interaction between immobilized human serum albumin and drug compounds for prediction of human serum albumin binding levels.
AID467612Fraction unbound in human plasma2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Prediction of volume of distribution values in human using immobilized artificial membrane partitioning coefficients, the fraction of compound ionized and plasma protein binding data.
AID1738917Cytotoxicity against human FaDu cells assessed as reduction in cell viability incubated for 72 hrs by SRB assay2020European journal of medicinal chemistry, Aug-01, Volume: 199Synthesis of some steroidal mitocans of nanomolar cytotoxicity acting by apoptosis.
AID1197743Inhibition of human OATP1B1-mediated [3H]estrone 3-sulfate at 100 uM after 5 mins relative to control2015European journal of medicinal chemistry, Mar-06, Volume: 92Interaction of human organic anion transporter polypeptides 1B1 and 1B3 with antineoplastic compounds.
AID26304Partition coefficient (logD6.5)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID444058Volume of distribution at steady state in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID29925Volume of distribution in man (IV dose)2002Journal of medicinal chemistry, Jun-20, Volume: 45, Issue:13
Prediction of volume of distribution values in humans for neutral and basic drugs using physicochemical measurements and plasma protein binding data.
AID1738918Cytotoxicity against mouse NIH3T3 cells assessed as reduction in cell viability incubated for 72 hrs by SRB assay2020European journal of medicinal chemistry, Aug-01, Volume: 199Synthesis of some steroidal mitocans of nanomolar cytotoxicity acting by apoptosis.
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID29423HPLC capacity factor (k')2002Journal of medicinal chemistry, Jun-20, Volume: 45, Issue:13
Prediction of volume of distribution values in humans for neutral and basic drugs using physicochemical measurements and plasma protein binding data.
AID1347411qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Mechanism Interrogation Plate v5.0 (MIPE) Libary2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID540299A screen for compounds that inhibit the MenB enzyme of Mycobacterium tuberculosis2010Bioorganic & medicinal chemistry letters, Nov-01, Volume: 20, Issue:21
Synthesis and SAR studies of 1,4-benzoxazine MenB inhibitors: novel antibacterial agents against Mycobacterium tuberculosis.
AID588519A screen for compounds that inhibit viral RNA polymerase binding and polymerization activities2011Antiviral research, Sep, Volume: 91, Issue:3
High-throughput screening identification of poliovirus RNA-dependent RNA polymerase inhibitors.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
AID1159550Human Phosphogluconate dehydrogenase (6PGD) Inhibitor Screening2015Nature cell biology, Nov, Volume: 17, Issue:11
6-Phosphogluconate dehydrogenase links oxidative PPP, lipogenesis and tumour growth by inhibiting LKB1-AMPK signalling.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (37,977)

TimeframeStudies, This Drug (%)All Drugs %
pre-199016059 (42.29)18.7374
1990's6262 (16.49)18.2507
2000's6500 (17.12)29.6817
2010's7190 (18.93)24.3611
2020's1966 (5.18)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 126.04

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index126.04 (24.57)
Research Supply Index10.75 (2.92)
Research Growth Index4.49 (4.65)
Search Engine Demand Index247.20 (26.88)
Search Engine Supply Index2.03 (0.95)

This Compound (126.04)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials5,274 (12.79%)5.53%
Reviews3,077 (7.46%)6.00%
Case Studies13,180 (31.97%)4.05%
Observational168 (0.41%)0.25%
Other19,523 (47.36%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (1498)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase 2, Open-label, Multicenter Study to Evaluate the Safety and Clinical Activity of Durvalumab in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (R-CHOP) or With Lenalidomide Plus R-CHOP (R2-CHOP) in Subjects With [NCT03003520]Phase 246 participants (Actual)Interventional2017-02-28Completed
An Open-label, Prospective, Randomized, Controlled Clinical Trial of the Use of Reduced Duration Versus Standard Duration Steroid Replacement Therapy for Acute Adrenal Insufficiency in Patients With Septic Shock [NCT00842933]Phase 432 participants (Anticipated)Interventional2007-05-31Terminated(stopped due to Unable to meet enrollment goal prior to PI transfer)
Prednisone in Chronic Rhinosinusitis Without Nasal Polyps. A Double-blind, Randomized, Placebo-controlled Trial [NCT02367118]Phase 390 participants (Anticipated)Interventional2015-06-30Recruiting
Effect of Prednisone and Aspirin on Pregnancy Outcomes After Embryo Transfer Among Patients With Thyroid Autoimmunity: a Randomized Clinical Trial [NCT05578456]Phase 4540 participants (Anticipated)Interventional2022-11-01Not yet recruiting
A Randomized Phase II Study of OGX-427 (a Second-Generation Antisense Oligonucleotide to Heat Shock Protein-27) in Patients With Castration Resistant Prostate Cancer Who Have Not Previously Received Chemotherapy for Metastatic Disease [NCT01120470]Phase 274 participants (Actual)Interventional2010-09-30Completed
A Randomized Multicenter Phase II Trial of Patupilone (EPO906) Plus Prednisone Versus Docetaxel Plus Prednisone in Patients With Metastatic Hormone Refractory Prostate Cancer [NCT00411528]Phase 2185 participants (Actual)Interventional2006-09-30Completed
The Assessment of Prednisone In Remission Trial (TAPIR) - Patient Centric Approach [NCT01933724]Phase 312 participants (Actual)Interventional2014-02-17Active, not recruiting
Glucocorticoids Associated With Antihistamines Versus Antihistamines Randomized Double Blinded for the Management of Acute Urticaria in Emergency [NCT02565680]Phase 2/Phase 3100 participants (Actual)Interventional2012-02-29Completed
Comparing Two Dosing Regimens of the Efficacy of Short-term Oral Prednisone Therapy on Acute Subjective Tinnitus [NCT06124703]162 participants (Anticipated)Interventional2023-11-10Not yet recruiting
Multi-center Randomized Study to Compare Efficacy and Safety of Decitabine Plus CHOP (D-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma [NCT03553537]Phase 3100 participants (Anticipated)Interventional2018-06-30Not yet recruiting
A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus [NCT00539838]Phase 333 participants (Actual)Interventional2007-12-19Terminated(stopped due to The study was terminated prematurely when the decision was made that ocrelizumab was not likely to benefit this patient population.)
S1312, A Phase I Study of Inotuzumab Ozogamicin (NSC-772518) in Combination With CVP (Cyclophosphamide, Vincristine, Prednisone) for Patients With Relapsed/Refractory CD22-Positive Acute Leukemia (Including B-ALL, Mixed Phenotypic Leukemia, and Burkitt's [NCT01925131]Phase 150 participants (Actual)Interventional2014-06-13Completed
Pixantrone (BBR 2778) Versus Other Chemotherapeutic Agents for Third-line Single Agent Treatment of Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma: A Randomized, Controlled, Phase III Comparative Trial [NCT00088530]Phase 3140 participants (Actual)Interventional2004-07-31Completed
A Phase I Trial of Docetaxel and Sirolimus in Patients With Advanced Malignancies [NCT01054313]Phase 1103 participants (Actual)Interventional2010-01-31Completed
A Multicenter, Open-label, Phase Ii Study of Dasatinib in Combination With Melphalan and Prednisone (D-MP) in Advanced, Relapsed / Refractory Multiple Myeloma Patients [NCT01116128]Phase 28 participants (Actual)Interventional2008-02-29Terminated(stopped due to difficulty in enrolling patients)
ALinC 17, Classification ©), B-precursor Induction Treatment (I) [NCT01225874]3,762 participants (Actual)Interventional1999-12-31Completed
Medical Therapy in Idiopathic Retroperitoneal Fibrosis: a Multicenter, Randomized, Controlled Trial of Prednisone vs Low-dose Prednisone Plus Methotrexate [NCT01240850]Phase 3200 participants (Anticipated)Interventional2007-05-31Recruiting
EDOCH Alternating With DHAP Regimen Combined Rituximab or Not to Treat New Diagnosed Younger (Age≤65 Years) Mantle Cell Lymphoma in China: A Multicentre Phase III Trial [NCT02858804]Phase 455 participants (Anticipated)Interventional2016-01-31Recruiting
A Phase 2, Randomized, Non-Comparative, Two-Arm Open Label, Multiple-Center Study Of CP-751,871 In Combination With Docetaxel/Prednisone In Chemotherapy- Naive (Arm A) And Docetaxel/Prednisone Refractory (Arm B) Patients With Hormone Insensitive Prostate [NCT00313781]Phase 2204 participants (Actual)Interventional2006-05-31Completed
Allogeneic HSCT Without Preparative Chemotherapy or With Low-Intensity Preparative Chemotherapy Using Sirolimus and Sirolimus-Generated Donor Th2 Cells for Therapy of Refractory Leukemia, Lymphoma, Myeloma, or Myelodysplastic Syndrome [NCT00074490]Phase 2442 participants (Actual)Interventional2004-01-01Terminated(stopped due to Premature closure due to inability to accrue to ARM IVD, cohorts 1 and 2)
A Phase II Study of R-CHOP and Ibritumomab Tiuxetan (Zevalin) for Elderly Patients With Previously Untreated Diffuse Large B-Cell Lymphoma [NCT00058422]Phase 265 participants (Actual)Interventional2003-02-10Completed
An Open Label Study Evaluating The Effect Of Single Doses Of PF-04171327 And Prednisone On Carbohydrate Metabolism Utilizing An Oral Glucose Tolerance Test In Healthy Adult Subjects [NCT01199900]Phase 118 participants (Actual)Interventional2010-08-31Completed
A Phase III Study for the Treatment of Children and Adolescents With Newly Diagnosed Low Risk Hodgkin Disease [NCT00302003]Phase 3287 participants (Actual)Interventional2006-02-28Completed
Open-label Multi-center Randomized Non-inferiority Study to Compare Efficacy and Safety of Pegylated Liposomal Doxorubicin Versus Doxorubicin for Newly Diagnosed Peripheral T-cell Lymphoma [NCT03952572]Phase 3244 participants (Anticipated)Interventional2019-05-10Recruiting
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With ISN/RPS Class III or IV Lupus Nephritis [NCT00282347]Phase 3144 participants (Actual)Interventional2006-01-31Completed
Vestibular Prognosis Assessment of the Idiopathic Sudden Sensorineural Hearing Loss With Vestibular Dysfunction Treated With Oral or Intratympanic Glucocorticoids [NCT03974867]72 participants (Anticipated)Interventional2019-07-31Not yet recruiting
A Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic Anemia [NCT01345708]Phase 223 participants (Actual)Interventional2009-01-31Completed
A Phase 1 and Phase 2 Study of Lenalidomide (Revlimid) in Combination With Cyclophosphamide (Endoxan) and Prednison (REP) in Relapsed/Refractory Multiple Myeloma [NCT01352338]Phase 1/Phase 282 participants (Actual)Interventional2011-08-31Completed
"A Phase III Trial Comparing ARA-C/High-Dose Mitoxantrone (ALL-2') to A Standard Vincristine/Prednisone Based Regimen ('L-20') as Induction Therapy For Adult Patients With Acute Lymphoblastic Leukemia (ALL): The ALL-4 Protocol" [NCT00002766]Phase 3170 participants (Actual)Interventional1996-03-31Completed
Risk-Adapted Stanford V-C With Radiotherapy for Clinical Stage I and IIA Favorable Hodgkin's Disease: The G5 Study [NCT00026208]Phase 276 participants (Actual)Interventional2001-06-30Completed
A Phase III, Multicenter, Randomized, Open-Label Study Comparing the Efficacy and Safety of Glofitamab (RO7082859) in Combination With Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) Versus Pola-R-CHP in Prev [NCT06047080]Phase 31,130 participants (Anticipated)Interventional2023-09-18Recruiting
A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular D [NCT05811351]Phase 2300 participants (Anticipated)Interventional2023-03-06Recruiting
An Open-label, Randomized Study to Assess the Relative Bioavailability (BA) and Bioequivalence (BE) of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer [NCT04577833]Phase 1136 participants (Actual)Interventional2020-11-13Active, not recruiting
A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Re [NCT04497844]Phase 3696 participants (Actual)Interventional2020-09-23Active, not recruiting
A Phase 3, Multicenter, Randomized, Controlled, Open-label Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High [NCT03217812]Phase 3220 participants (Actual)Interventional2017-11-23Active, not recruiting
Registry of IgA Nephropathy in Chinese Children [NCT03015974]1,200 participants (Anticipated)Observational [Patient Registry]2016-01-31Recruiting
Gulf War Illness Inflammation Reduction Trial [NCT02506192]Phase 283 participants (Actual)Interventional2015-07-31Completed
Evaluation of CHOP Plus Involved Field Radiotherapy Followed by Yttrium-90 Ibritumomab Tiuxetan for Stages I, IE, and Non-Bulky Stages II and IIE, CD20 Positive, High-Risk Localized, Aggressive Histologies of Non-Hodgkin Lymphoma, Phase II [NCT00070018]Phase 246 participants (Actual)Interventional2004-02-29Completed
A Phase II Study of Lenalidomide (CC-5013) in Combination With Prednisone for the Treatment of Myelofibrosis With Myeloid Metaplasia [NCT00227591]Phase 248 participants (Actual)Interventional2005-12-31Completed
A Randomized, Open-label,Controlled Phase II b Study to Demonstrate Efficacy and Safety of Sirolimus Chronic Rejection After Lung Transplant [NCT04415476]Phase 20 participants (Actual)Interventional2020-06-30Withdrawn(stopped due to Study did not proceed to IRB approval.)
A Phase 1b Clinical Trial of Cabozantinib and Abiraterone With Checkpoint Inhibitor Immunotherapy in Metastatic Hormone Sensitive Prostate Cancer (CABIOS Trial) [NCT04477512]Phase 118 participants (Actual)Interventional2021-02-19Active, not recruiting
Rituximab From the First Episode of Minimal Change Nephrotic Syndrome for Preventing Relapse Risk in Adult Patients: a Multicenter Randomized Controlled Trial [NCT03970577]Phase 2148 participants (Anticipated)Interventional2020-07-29Recruiting
A Bidimensional Early Intervention Strategy of Standard of Care Combined With Host Immunomodulation in Elderly Patients With Mild or Moderate COVID-19: A Multicentre, Randomized, Controlled, Adaptive Platform Study [NCT05855395]5,815 participants (Anticipated)Interventional2023-05-26Recruiting
Prospective, Multi-center Phase I/II Trial of Lenalidomide and Dose-Adjusted EPOCH-R in MYC-Associated B-Cell Lymphomas [NCT02213913]Phase 1/Phase 246 participants (Anticipated)Interventional2014-07-29Active, not recruiting
A Multicenter Phase 2 Single-arm Proof-of-concept Trial to Assess the Efficacy and Safety of Ustekinumab in Association With Prednisone for the Treatment of Non-infectious Severe Uveitis (NISU) [NCT03847272]Phase 229 participants (Anticipated)Interventional2019-08-01Recruiting
An Open-Label, Multicenter, Follow-up Trial of ARGX-113-1904 to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Pemphigus [NCT04598477]Phase 3213 participants (Anticipated)Interventional2021-07-15Recruiting
The Effect of Some Drugs Used in Treatment of Vasculitis on the Complement System in Children Attending Assiut University Hospital. [NCT03692416]Phase 370 participants (Anticipated)Interventional2018-11-11Active, not recruiting
A Randomised, Double-Blind, Multicentre Phase Ⅲ Study to Evaluate Abiraterone Acetate Versus Placebo Combined With Prednisone in Subjects With Asymptomatic or Mild Symptoms Without Chemotherapy, Metastatic Castration Resistant Prostate Cancer. [NCT04056754]Phase 3268 participants (Actual)Interventional2014-07-16Completed
H-9926-LCH III: Treatment Protocol of the Third International Study for Langerhans Cell Histiocytosis [NCT00488605]Phase 30 participants (Actual)Interventional2023-08-01Withdrawn(stopped due to This is a duplicate record and the sponsor has registered the study.)
CArdiac Sarcoidosis Response TO steRoids (CASTOR) Trial [NCT01210677]Phase 40 participants (Actual)Interventional2014-04-30Withdrawn(stopped due to No funding obtained.)
An Open Label Study of Abiraterone Acetate in Subjects With Metastatic Castration-Resistant Prostate Cancer Who Have Progressed After Taxane-Based Chemotherapy [NCT01217697]0 participants Expanded AccessApproved for marketing
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Giant Cell Arteritis [NCT03600805]Phase 383 participants (Actual)Interventional2018-11-20Terminated(stopped due to Protracted recruitment timeline exacerbated by COVID-19 pandemic)
A Trial to Evaluate the Long Term Prognosis in Rosai-Dorfman Disease [NCT05284942]Phase 420 participants (Anticipated)Interventional2011-10-01Recruiting
"Randomized Phase II Study Evaluating the Feasibility of a Chemotherapy With Docetaxel-Prednisone in a Weekly Schedule or Every 3 Weeks, for Castration-resistant Metastatic Prostate Cancer Elderly Patients (>=75), Vulnerable or Frail , as Defined by the C [NCT01254513]Phase 266 participants (Actual)Interventional2010-12-09Completed
GRAVITAS-309: A Phase 2/3 Study of Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease [NCT03584516]Phase 2/Phase 3155 participants (Actual)Interventional2019-01-17Active, not recruiting
Research Institute of Nephrology, Jinling Hospital [NCT01161459]100 participants (Anticipated)Interventional2010-06-30Completed
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China. [NCT01269021]176 participants (Actual)Interventional2010-11-30Completed
A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT Vs AS and 3DCTR/IMRT Followed by Chemotherapy With Docetaxel and Prednisone for Localized, High-Risk, Prostate Cancer [NCT00288080]Phase 3612 participants (Actual)Interventional2005-12-31Completed
A Phase III, Multicenter, Open-Label Randomized Trial Comparing the Efficacy of GA101 (RO5072759) in Combination With CHOP (G-CHOP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With CD20-Positive Diffuse Large B-Cell Lymphoma (DLBCL [NCT01287741]Phase 31,418 participants (Actual)Interventional2011-07-26Terminated(stopped due to The study was closed by the Sponsor according to the protocol-specified minimum post-treatment follow-up period of 3 years.)
Pilot Study of Idiotype Vaccine and EPOCH-Rituximab Chemotherapy in Untreated Mantle Cell Lymphoma [NCT00005780]Phase 226 participants (Actual)Interventional2000-06-01Completed
Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil - a Prospective Collaborative Study [NCT05959720]180 participants (Anticipated)Observational [Patient Registry]2023-09-05Recruiting
A Dose Escalation and Expansion Study of the Safety and Pharmacokinetics of XL102 as Single-Agent and Combination Therapy in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors [NCT04726332]Phase 1373 participants (Anticipated)Interventional2021-02-10Recruiting
A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Cyclosporine and Prednisone on the Pharmacokinetics and Safety of EDP-938 in Healthy Adult Subjects [NCT03750383]Phase 148 participants (Actual)Interventional2018-11-02Completed
IL-7 and IL-7R Expression in Peripheral Blood Mononuclear Cells, Peripheral Blood Monocytes or Differentiated Macrophages of Rheumatoid Arthritis Patients With Active vs. Inactive Disease Treated With DMARD and/or CIMZIA [NCT02451748]Phase 432 participants (Actual)Interventional2015-08-31Completed
A Prospective Phase II Study of Pegaspargase-COEP Chemotherapy Combined With Radiotherapy for Patients With Newly Diagnosed Extra-nodal NK/T-cell Lymphoma [NCT04484506]Phase 2150 participants (Anticipated)Interventional2011-10-20Recruiting
Efficacy of Consolidative Involved-site Radiotherapy Following Effective Chemotherapy for Patients With Limited-stage Follicular Lymphoma: Wuhan University Cancer Center -NHL01 Trial [NCT02449252]Phase 3120 participants (Anticipated)Interventional2015-10-31Recruiting
Leflunomide Treatment for IgG4-RD [NCT03715699]70 participants (Anticipated)Interventional2018-07-01Recruiting
A Phase I/II Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib in Patients With Metastatic Castration-resistant Prostate Cancer Following Standard of Care Treatment [NCT04060394]Phase 1/Phase 274 participants (Anticipated)Interventional2019-09-13Active, not recruiting
Prospective Study of Rituximab Combined With Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia [NCT01358253]Phase 4100 participants (Actual)Interventional2010-12-31Completed
A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- and Active-controlled Study With Double-Blind Extension to Assess the Efficacy and Safety of Vamorolone in Ambulant Boys With Duchenne Muscular Dystrophy (DMD) [NCT03439670]Phase 2121 participants (Actual)Interventional2018-06-29Completed
Analysis of Next Generation PET and Liquid Biopsy to Monitor mCRPC Treated With Abiraterone: ANGELA Trial [NCT05188911]30 participants (Anticipated)Observational2020-07-15Recruiting
A Three-arm, Multicenter, Open-label Randomized Controlled Trial of Hydroxychloroquine and Low-dose Prednisone on Recurrent Spontaneous Abortion With Undifferentiated Connective Tissue Diseases: Protocol for the Immunosuppressant Regimens for Living FEtus [NCT03671174]420 participants (Anticipated)Interventional2019-08-02Recruiting
A Randomised Phase II Evaluation of Molecular Guided Therapy for Diffuse Large B-Cell Lymphoma With Acalabrutinib [NCT04546620]Phase 2453 participants (Anticipated)Interventional2021-10-19Recruiting
[NCT01569204]Phase 2100 participants (Anticipated)Interventional2012-10-31Completed
A Single-arm, Multi-center, Phase Ib/II Study of Selinexor in Combination With R-CHOP Followed by Selinexor Maintenance for Untreated EBV-positive DLBCL Patients (Xplore Trial) [NCT05577364]Phase 1/Phase 254 participants (Anticipated)Interventional2022-11-01Recruiting
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial Testing Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Asymptomatic or M [NCT03072238]Phase 31,101 participants (Actual)Interventional2017-06-30Active, not recruiting
Cyclosporine A in the TReatment of Interstitial Pneumonitis Associated With Sjogren's Syndrome(CTRIPS): A Prospective, Randomized, Multicenter, Double-Blind Placebo-Controlled Trial [NCT02370550]Phase 4240 participants (Anticipated)Interventional2015-03-31Recruiting
Comparison of Gemcitabine, Oxaliplatin and Pegaspargase and Etoposide, Vincristine, Doxorubicin, Cyclophosphamide and Prednisone as First-line Chemotherapy in Patients With NK/T-cell Lymphoma:a Prospective Randomized Phase III Study [NCT02359162]Phase 350 participants (Actual)Interventional2015-05-31Terminated(stopped due to The study is out of date)
Phase 2 Trial of Alemtuzumab and Dose-Adjusted Epoch in Chemotherapy Naive Aggressive T and NK-Cell Lymphomas [NCT00069238]Phase 231 participants (Actual)Interventional2003-09-19Completed
A Randomized, Multicenter, Parallel-group, Open-label Study to Evaluate the Therapeutic Benefit of an Initially Intensified Dosing Regimen of Mycophenolate Sodium Versus a Standard Dosing Regimen, in Combination With Cyclosporine and Corticosteroids in de [NCT00419926]Phase 4313 participants (Actual)Interventional2006-12-31Completed
Randomized, Multicentric, Open Label, Parallel Group Trial to Compare the Efficacy of 6-months Versus 3-months Therapy With Prednisolone for the First Episode of Idiopathic Nephrotic Syndrome in Children Younger Than 4 Years [NCT03141970]Phase 3170 participants (Actual)Interventional2015-07-01Active, not recruiting
Phase II Trial of Radiation With Androgen Deprivation: Abiraterone Acetate, Prednisone and Luteinizing Hormone Releasing Hormone Agonist Prior to Radiation Therapy [NCT01023061]Phase 224 participants (Actual)Interventional2010-03-31Completed
A Randomized, Controlled, Single Center Clinical Trial to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Androgen Deprivation Therapy Combined With Docetaxel for High Risk and Very High Risk Prostate Cancer [NCT04869371]Phase 275 participants (Anticipated)Interventional2018-12-12Active, not recruiting
Comprehensive Geriatric Assessment to Predict Toxic Events in Older Patients With Non-Hodgkin Lymphoma With Imbedded Pilot Study of Pre-Phase Therapy [NCT01829958]201 participants (Actual)Interventional2013-04-30Active, not recruiting
A Phase II Study of Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) as Front-Line Therapy for Adults With Acute Lymphoblastic Leukemia/Lymphoma [NCT03023046]Phase 254 participants (Actual)Interventional2017-02-23Completed
Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients : a Prospective, Randomized Controlled, Open Label, Phase II Clinical Trial [NCT03617432]Phase 2114 participants (Anticipated)Interventional2018-08-28Recruiting
An Open-Label, Dose-Escalation, Phase 1/2 Study of the Oral Form of Ixazomib (MLN9708), a Next-Generation Proteasome Inhibitor, Administered in Combination With a Standard Care Regimen of Melphalan and Prednisone in Patients With Newly Diagnosed Multiple [NCT01335685]Phase 1/Phase 261 participants (Actual)Interventional2011-06-27Completed
Multimodal Analysis and Electroretinogram in VKH From Acute Onset - a Prospective Study [NCT03811366]12 participants (Actual)Interventional2011-06-01Completed
A Multicenter Randomized Trial of First Line Treatment for Newly Diagnosed Immune Thrombocytopenia: Standard Steroid Treatment Versus Combined Steroid and Cyclosporin [NCT05459649]Phase 2253 participants (Anticipated)Interventional2022-07-20Not yet recruiting
Everolimus in Association With Very Low-dose Tacrolimus Versus Enteric-coated Mycophenolate Sodium With Low-dose Tacrolimus in de Novo Renal Transplant Recipients - A Prospective Single Center Study [NCT02084446]Phase 4120 participants (Actual)Interventional2012-12-31Completed
Trial of Early Aggressive Therapy in Juvenile Idiopathic Arthritis (TREAT in JIA) [NCT00443430]Phase 485 participants (Actual)Interventional2007-05-31Completed
A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177Lu-PSMA-I&T Versus Hormone Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer [NCT05204927]Phase 3400 participants (Anticipated)Interventional2022-02-14Recruiting
Immune Checkpoint Blockade for Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers [NCT03816332]Phase 112 participants (Actual)Interventional2019-11-08Active, not recruiting
Randomized Phase II Open Label Study of Lenalidomide R-CHOP (R2CHOP) vs. RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) in Patients With Newly Diagnosed Diffuse Large B Cell Lymphoma [NCT01856192]Phase 2349 participants (Actual)Interventional2013-08-27Active, not recruiting
Prednisone in Uric Acid Lowering in Symptomatic Heart Failure PATients With Hyperuricemia (PUSH-PATH Study 2) [NCT02129764]Phase 2/Phase 3205 participants (Actual)Interventional2013-12-31Completed
Total XV - Total Therapy Study XV for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia [NCT00137111]Phase 3501 participants (Actual)Interventional2000-07-08Completed
Randomized Phase II Study About the Application of Pegfilgrastim (Neulasta) at Day 2 or Day 4 Within the Treatment in Patients With Aggressive Non-Hodgkin's Lymphoma Aged 61 to 80 Years With 6 or 8 Cycles of Chemotherapy With CHOP (Cyclophosphamide, Doxor [NCT00726700]Phase 2109 participants (Actual)Interventional2004-05-31Completed
Phase II Study of Intensified CVP, Rituximab, and High Dose Cyclophosphamide for Adult Burkitt or Burkitt-Like Lymphoma [NCT00133991]Phase 223 participants (Actual)Interventional2005-07-31Completed
Study 200622: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Adolescent and Adult Subjects With Severe Hypereosinophilic Syndrome [NCT02836496]Phase 3108 participants (Actual)Interventional2017-03-07Completed
Abiraterone Acetate Maintenance in Combination With Docetaxel After Disease Progression to Abiraterone Acetate in Metastatic Castration Resistant Prostate Cancer. Randomized Phase II Study. [NCT02036060]Phase 2119 participants (Actual)Interventional2014-02-07Completed
A Randomized, Controlled, Single-blind Study of Effects of Enteral Nutrition and Corticosteroid on Intestinal Flora in Induction Remission of Crohn Disease in Adult [NCT02056418]Phase 430 participants (Anticipated)Interventional2014-01-31Active, not recruiting
Phase I/II Study of Ruxolitinib Plus L-asparaginase, Vincristine, and Prednisone in Adult Patients With Relapsed or Refractory Early T Precursor Acute Lymphocytic Leukemia [NCT03613428]Phase 1/Phase 212 participants (Anticipated)Interventional2018-12-01Not yet recruiting
Impact and Interplay of Corticosteroid Regimen and Exercise Training on DMD Muscle Function [NCT04322357]Phase 289 participants (Anticipated)Interventional2020-07-30Recruiting
High-dose Dexamethasone and Conventional Dose Prednisone, for the First-line Treatment of Adults With ITP: a Multicenter, Randomized Controlled, Clinical Trial [NCT01356511]Phase 4261 participants (Actual)Interventional2010-09-30Completed
Randomized Phase-II Trial of Abiraterone Acetate Plus LHRH-therapy Versus Abiraterone Acetate Sparing LHRH-therapy in Patients With Progressive Chemotherapy-naïve Castration-resistant Prostate Cancer (SPARE) [NCT02077634]Phase 268 participants (Actual)Interventional2014-05-31Completed
A Phase I/II Study of Carfilzomib in Combination With R-CHOP (CR-CHOP) for Patients With Diffuse Large B-cell Lymphoma [NCT02073097]Phase 1/Phase 248 participants (Actual)Interventional2015-01-28Active, not recruiting
Double-blind, Placebo-controlled, Randomized Study of the Safety and Tolerability of Isoxsuprine HCL Combined With High Dose Steroid Treatment of Multiple Sclerosis (MS) Relapse [NCT03752307]Phase 1/Phase 22 participants (Actual)Interventional2019-02-15Completed
A Phase 1 Adaptive Dose, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered CORT113176 in Healthy Subjects, With an Optional Pharmacological Effects [NCT04249323]Phase 1110 participants (Actual)Interventional2020-01-27Completed
[NCT01376401]Phase 260 participants (Anticipated)Interventional2011-07-31Completed
Effects of Rifaximin Treatment in Patients With Acute Alcoholic Hepatitis: A Comparative Pilot Study [NCT02116556]Phase 229 participants (Actual)Interventional2013-04-30Enrolling by invitation
A Phase Ib/II Trial of Combined SGN-35 (BrentuximabVedotin) Therapy With Cyclophosphamide, Procarbazine, Prednisone, Etoposide and Mitoxantrone (BrEPEM) for Older Patients With Untreated Hodgkin Lymphoma (HL) [NCT03576378]Phase 1/Phase 241 participants (Actual)Interventional2018-08-08Active, not recruiting
A Phase III Randomized Trial of Intravenous Gammaglobulin Therapy for Patients With Neuroblastoma Associated Opsoclonus-Myoclonus-Ataxia Syndrome Treated With Chemotherapy and Prednisone [NCT00033293]Phase 353 participants (Actual)Interventional2004-03-15Completed
A Phase 2a, Randomized, Open-Label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients [NCT02921789]Phase 267 participants (Actual)Interventional2017-05-22Completed
Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial [NCT03593759]Phase 3194 participants (Anticipated)Interventional2019-01-15Recruiting
Diffuse Large B Cell Non-Hodgkin's Lymphoma in the Vulnerable/Frail Elderly. A Multicentric Randomized Phase II Trial With Emphasis on Geriatric Assessment and Quality of Life [NCT00911183]Phase 267 participants (Actual)Interventional2008-12-02Completed
A PHASE 4, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF CONTINUED ENZALUTAMIDE TREATMENT BEYOND PROGRESSION IN PATIENTS WITH CHEMOTHERAPY-NAÏVE METASTATIC CASTRATION-RESISTANT PROSTATE CANCER [NCT01995513]Phase 4509 participants (Actual)Interventional2013-10-22Completed
A Phase II Neoadjuvant Study of Enzalutamide, Abiraterone Acetate, Dutasteride and Degarelix in Men With Localized Prostate Cancer Pre-prostatectomy [NCT02159690]Phase 20 participants (Actual)Interventional2014-09-30Withdrawn(stopped due to loss of funding)
Ib Dose Finding Study of LDE225 Plus Docetaxel/Prednisone in Patients With Advanced or Metastatic Castration Resistant Prostate Cancer Who Experience Disease Progression After Receiving Docetaxel [NCT02182622]Phase 10 participants (Actual)Interventional2014-07-31Withdrawn
Long-term Prednisone Use in Patients With Advanced Heart Failure (ACCF/AHA Stage D) and Hyperuricemia [NCT02282683]Phase 2/Phase 390 participants (Anticipated)Interventional2013-12-31Recruiting
A Multi-National Phase III Study of Satraplatin Plus Prednisone or Placebo Plus Prednisone in Patients With Hormone Refractory Prostate Cancer Previously Treated With One Cytotoxic Chemotherapy Regimen [NCT00069745]Phase 30 participants Interventional2003-09-30Completed
A Randomized Phase III Randomized Study to Compare R-CHOP Versus R-mini-CEOP in Elderly Patients (>65 Years) With Diffuse Large B Cell Lymphoma (DLBCL) [NCT01148446]Phase 3226 participants (Actual)Interventional2003-01-31Completed
A Phase II Study Of Pegylated Liposomal Doxorubicin (Doxil) In Combination With Rituxan, Cyclophosphamide, Vincristine and Prednisone (DR-COP) In Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas [NCT00184002]Phase 268 participants (Actual)Interventional2003-01-10Completed
Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy: A Randomized, Open, Controlled, Multicenter Clinical Trial [NCT03864250]124 participants (Anticipated)Interventional2018-11-26Recruiting
DELTA Study Dutch Evaluation in Liver Transplantation To Assess the Efficacy of Cyclosporine A Microemulsion With C-2h Monitoring Versus Tacrolimus With Trough Monitoring in de Novo Liver Transplant Recipients [NCT00149994]Phase 4171 participants (Actual)Interventional2002-12-31Completed
A Prospective, Randomized, Multi-Center Double-Blind Study of Early Corticosteroid Cessation vs. Long Term Corticosteroid Therapy With Prograf and CellCept in Primary Renal Transplant Patients [NCT00650468]Phase 4397 participants (Actual)Interventional1999-11-30Completed
A New Timed-Release Tablet Formulation of Prednisone Compared to Standard Prednisone in Patients With Rheumatoid Arthritis- A Randomized, Multi-Centre, Double-Blind, Active Controlled Study With Open Extension on the New Drug Only [NCT00146640]Phase 3288 participants (Actual)Interventional2004-08-31Completed
Low Steroid Dose Combined With Mycophenolic Acid (Myfortic) Compared With High Dose Steroid for Minimal Change Nephrotic Syndrome [NCT01197040]Phase 3117 participants (Actual)Interventional2009-10-31Completed
A Randomized Double-Blinded Placebo Controlled Phase III Trial Comparing Doctaxel and Prednisone With and Without Bevacizumab (IND #7921, NSC #704865) in Men With Hormone Refractory Prostate Cancer [NCT00110214]Phase 31,050 participants (Actual)Interventional2005-04-30Completed
Reducing the Acute Care Burden of Childhood Asthma on Health Services in British Columbia [NCT01326494]Phase 492 participants (Actual)Interventional2011-04-30Completed
A Phase II Study of Punctual, Cyclic, and Intensive Chemotherapy With Liposomal Cytarabine (Depocyt®) CNS Prophylaxis for Adults With Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma [NCT02043587]Phase 231 participants (Actual)Interventional2014-01-31Terminated(stopped due to Original investigator for the trial has left)
A Phase 1/2 Safety And Pharmacokinetic Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Metastatic Hormone Refractory Prostate Cancer (HRPC) [NCT00137436]Phase 1/Phase 293 participants (Actual)Interventional2005-10-31Completed
A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept vs Placebo on a Background of Oral Glucocorticosteroids in the Treatment of Subjects With Systemic Lupus Erythematosus and the P [NCT00119678]Phase 2183 participants (Actual)Interventional2005-09-30Completed
"First Line Treatment in HIV-related Large Cell Non Hodgkin Lymphoma at High Risk, Including Early Consolidation With High Dose Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation" [NCT01045889]Phase 227 participants (Actual)Interventional2007-01-31Completed
A Randomized Phase-II Pilot Trial of Docetaxel and Prednisone Versus Radiation Therapy Plus Docetaxel and Prednisone in Patients With Nonmetastatic and Oligometastatic Castrate Resistant Prostate Cancer [NCT01087580]Phase 20 participants (Actual)Interventional2011-03-31Withdrawn
A Phase 1b, Open-Label, Multicenter Study of FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma [NCT05934097]Phase 10 participants (Actual)Interventional2022-12-31Withdrawn(stopped due to This study was withdrawn (Sponsor decision).)
The Role of Budesonide Intrapolyp Injection in the Management of Type 2 Chronic Rhinosinusitis . A Randomized Clinical Trial [NCT05931744]Phase 2/Phase 3120 participants (Actual)Interventional2021-05-01Completed
A Phase I Study of Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin Plus Escalating Doses of Inotuzumab Ozogamicin (DA-EPOCH-InO) in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia [NCT03991884]Phase 124 participants (Actual)Interventional2019-09-24Completed
A Phase 3 Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer [NCT03009981]Phase 3504 participants (Anticipated)Interventional2017-03-06Active, not recruiting
LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis [NCT02205762]Phase 2/Phase 31,400 participants (Anticipated)Interventional2016-11-02Recruiting
A Single-Cohort, Phase 2 Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1) [NCT02953678]Phase 271 participants (Actual)Interventional2016-12-30Completed
A Phase II Study of Combination Rituximab-CHOP and Bortezomib (Velcade®) (R-CHOP-V) Induction Therapy Followed by Bortezomib Maintenance (VM) Therapy for Patients With Newly Diagnosed Mantle Cell Lymphoma [NCT00376961]Phase 268 participants (Actual)Interventional2006-08-31Completed
A Phase 1, Open-label, Functional Imaging Study to Assess Whether CC-90011 Reverses the Castration Resistance Due to Lineage Switch in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Have Failed Enzalutamide as Last Prior Therapy [NCT04628988]Phase 16 participants (Actual)Interventional2021-07-28Completed
A Phase II Study of Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18F-DCFPyL-PET/CT in Newly Diagnosed Prostate Cancer [NCT03860987]Phase 211 participants (Actual)Interventional2019-04-30Active, not recruiting
A Phase 2, Randomized Study of Duvelisib Administered in Combination With Rituximab vs R-CHOP in Subjects With Relapsed/Refractory Follicular Lymphoma (FRESCO) [NCT02605694]Phase 20 participants (Actual)Interventional2015-12-31Withdrawn(stopped due to Sponsor is focusing on studies which can enable registration of duvelisib)
Romidepsin in Combination With CHOEP as First Line Treatment Before Hematopoietic Stem Cell Transplantation in Young Patients With Nodal Peripheral T-cell Lymphomas: a Phase I-II Study [NCT02223208]Phase 1/Phase 289 participants (Actual)Interventional2014-09-30Active, not recruiting
A Multicenter, Single-arm, Open II Phase Clinical Trial Evaluating the Efficacy of Chidamide Combined With Prednisone, Cyclophosphamide, Etoposide, and Methotrexate (PECM) in Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) [NCT03321890]Phase 2102 participants (Anticipated)Interventional2017-03-07Recruiting
A Phase I Adaptive Dose, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacological Effects of Orally Administered CORT118335 in Healthy Subjects [NCT03315338]Phase 1143 participants (Actual)Interventional2017-09-15Completed
Phase II Study of Oral PRednisone 5 mg Bid Plus EVerolimus in Patients With Metastatic Renal Cell Cancer After Failure of Vascular Endothelial Growth Factor Receptor-tyrosine Kinase Inhibitors [NCT02479490]Phase 28 participants (Actual)Interventional2015-09-22Terminated
A Phase 1/2 Study of Ixazomib as a Replacement for Bortezomib or Carfilzomib for Multiple Myeloma (MM) Patients Recently Relapsed or Refractory to Their Last Combination Regimen Containing Either Bortezomib or Carfilzomib [NCT02206425]Phase 1/Phase 245 participants (Actual)Interventional2014-09-30Completed
A Study Comparing the Efficacy and Safety of Genotype-guided R-CHOP-X Versus R-CHOP in Patients With Diffuse Large B-Cell Lymphoma [NCT05351346]Phase 31,100 participants (Anticipated)Interventional2022-06-01Recruiting
A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO-CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS [NCT00938587]Phase 286 participants (Actual)Interventional2009-10-07Completed
Phase II Study of Combination of Hyper-CVAD and Dasatinib (NSC-732517) With or Without Allogeneic Stem Cell Transplant in Patients With Philadelphia (Ph) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) (A BMT Study) [NCT00792948]Phase 297 participants (Actual)Interventional2009-09-01Active, not recruiting
Safety and Efficacy Study of Mitoxantrone Hydrochloride Liposome Injection Plus Cyclophosphamide,Vincristine and Prednison (CNOP)in Diffuse Large B Cell Lymphoma [NCT02595242]Phase 10 participants (Actual)Interventional2015-06-30Withdrawn
A Prospective, Multicentric, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Remission MAINtenance Using Extended Administration of Prednisone in Systemic Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis. [NCT03290456]146 participants (Anticipated)Interventional2019-08-20Recruiting
A Phase 1/2 Open-Label Multicenter Study of Avadomide (CC-122) in Combination With R-CHOP-21 for Previously Untreated Poor Risk (IPI>=3) Diffuse Large B-Cell Lymphoma [NCT03283202]Phase 135 participants (Actual)Interventional2017-10-04Completed
A Randomized Trial of Treatment in Patients With IgG4-Related Disease [NCT02458196]Phase 260 participants (Anticipated)Interventional2015-04-30Recruiting
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prochymal® Infusion in Combination With Corticosteroids for the Treatment of Newly Diagnosed Acute GVHD [NCT00562497]Phase 3192 participants (Actual)Interventional2008-01-31Completed
Phase II Trial of Anti-Angiogenic Therapy With RT-PEPC in Patients With Relapsed Mantle Cell Lymphoma [NCT00151281]Phase 225 participants (Actual)Interventional2004-11-30Completed
Randomized Phase II Study to Compare Efficacy of CHOP Versus Fractionated ICED in Transplant-eligible Patients With Previously Untreated Peripheral T-cell Lymphoma [NCT02445404]Phase 2134 participants (Anticipated)Interventional2015-09-23Recruiting
Phase II Randomized Study of R-CHOP V. Dose-Adjusted EPOCH-R in Untreated De Novo Diffuse Large B-Cell Lymphomas [NCT03188198]Phase 260 participants (Anticipated)Interventional2016-06-01Recruiting
A Phase III, Randomized, Active-Controlled, Parallel-Group Clinical Trial to Study the Efficacy and Long-Term Safety of Mometasone Furoate/Formoterol Fumarate (MF/F, MK-0887A [SCH418131]), Compared With Mometasone Furoate (MF, MK-0887 [SCH032088]), in Chi [NCT02741271]Phase 3181 participants (Actual)Interventional2016-05-11Completed
An Open-Label, Multinational, Multicenter, Phase IIIB Study to Assess Safety of Rituximab Following Subcutaneous Administration in Patients With CD20+ DLBCL or CD20+ Follicular NHL Grade 1 to 3A [NCT02406092]Phase 3122 participants (Actual)Interventional2015-10-13Completed
A Phase I Adaptive Dose, Double-Blind, Placebo-Controlled, SAD and MAD Study to Measure the Safety, Tolerability, Pharmacokinetics and Pharmacological Effects of Orally Administered CORT125134 in Healthy Subjects [NCT03508635]Phase 1130 participants (Actual)Interventional2014-09-30Completed
Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions [NCT02190994]Phase 4100 participants (Anticipated)Interventional2013-08-31Recruiting
Efficacy and Safety of Budesonide Inhalation Suspension Via Transnasal Nebulization Compared With Budesonide Aqueous Nasal Spray and Oral Steroids for the Treatment of Chronic Rhinosinusitis With Polyposis. [NCT03687515]Phase 391 participants (Actual)Interventional2015-01-01Completed
Effectiveness Evaluation of Mixed Gel of Hydrocortisone and Aluminium Phosphate Preventing Endoscopic Submucosal Dissection Postoperative Stenosis for Patients With Early Esophageal Cancer Invading More Than 2/3 Esophageal Perimeter [NCT03165344]66 participants (Actual)Interventional2017-02-10Completed
CYCLONES - CYClophosphamide LOw Dose and No Extra Steroid [NCT03492255]49 participants (Actual)Interventional2018-04-12Terminated(stopped due to Significative difference between percentage of renal response (primary outcome) between the two study arms.)
A Phase 1b/2 Study to Assess the Safety and Efficacy of AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer [NCT00770848]Phase 1/Phase 2162 participants (Actual)Interventional2008-11-30Completed
A Phase I-II Trial of DA-EPOCH-R Plus Ixazomib as Frontline Therapy for Patients With MYC-aberrant Lymphoid Malignancies: The DACIPHOR Regimen [NCT02481310]Phase 1/Phase 238 participants (Actual)Interventional2015-10-28Active, not recruiting
A Phase 1, Open-label, Multicenter Trial of Oral Azacitidine (CC-486) Plus R-CHOP in Subjects With High Risk (IPI 3 or More) Previously Untreated Diffuse Large B-cell Lymphoma or Grade 3B Follicular Lymphoma. [NCT02343536]Phase 159 participants (Actual)Interventional2015-04-29Completed
Bendamustine, Prednisone and Velcade® for First-line Treatment of Patients With Symptomatic Multiple Myeloma Not Eligible for High-dose Chemotherapy Followed by Autologous Stem Cell Transplantation (BPV). [NCT02237261]Phase 246 participants (Actual)Interventional2014-11-30Completed
An Open Label Phase 2 Study of Denintuzumab Mafodotin (SGN-CD19A) in Combination With RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) or RCHP (Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone) Compared With RCHOP Alon [NCT02855359]Phase 224 participants (Actual)Interventional2016-08-31Terminated(stopped due to Sponsor decision based on portfolio prioritization)
Efficacy of Mycophenolate Mofetil Versus Leflunomide as Maintenance Treatment for IgG4-RD Patients With Internal Organ Involvement [NCT05789017]60 participants (Anticipated)Interventional2022-07-01Recruiting
An Open-label, Phase 1/2 Study to Evaluate the Safety and Efficacy of Single-dose LY3884961 in Infants With Type 2 Gaucher Disease [NCT04411654]Phase 1/Phase 215 participants (Anticipated)Interventional2021-06-29Recruiting
A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination With Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects With Metastatic Castration-Resistant Prostate Cancer [NCT04446117]Phase 3575 participants (Actual)Interventional2020-06-30Active, not recruiting
Phase I Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile of Lenalidomide (Revlimid® CC-5013) With Every Three Week Docetaxel (Taxotere®) In Subjects With Androgen Independent Prostate Cancer [NCT01378091]Phase 164 participants (Actual)Interventional2005-08-31Completed
LAL-BR/2001: Study Treatment to Low Risk ALL [NCT00526175]Phase 4150 participants (Anticipated)Interventional2001-06-30Completed
A Phase II Study of Initial Treatment With Methotrexate in Large Granular Lymphocytic (LGL) Leukemia [NCT00003910]Phase 259 participants (Actual)Interventional1999-09-15Terminated
A Comparison of Effects of Standard Dose vs. Low Dose Advagraf® With IL-2 Receptor Antibody Induction, MMF and Steroids, With or Without ACEi/ARB - Based Antihypertensive Therapy on Renal Allograft Histology, Function, and Immune Response [NCT00933231]Phase 3281 participants (Actual)Interventional2009-08-17Completed
Safety and Efficacy of Low Dose Colchicine or Prednisone Combining With Standard Drug in Patients With Recurrent In-stent Restenosis: a Prospective, Randomized, Open-label Trial [NCT06090890]Phase 4252 participants (Anticipated)Interventional2023-10-30Not yet recruiting
Effect of Short-Term Prednisone Therapy on C-Reactive Protein Change in Emergency Department Patients With Acute Heart Failure and Elevated Inflammatory Marker [NCT05668676]Phase 2/Phase 3120 participants (Anticipated)Interventional2023-02-16Recruiting
CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination With Abiraterone Plus Prednisone in Men With High-Risk Metastatic Hormone-Sensitive Prostate Cancer [NCT05288166]Phase 3900 participants (Anticipated)Interventional2022-04-14Recruiting
Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout: A Randomized Controlled Trial [NCT04875702]650 participants (Anticipated)Interventional2023-11-15Not yet recruiting
An Investigator-sponsored Phase 2 Trial of Afatinib Plus Prednisone for Advanced Squamous Non-small Cell Lung Cancer [NCT04497584]Phase 237 participants (Anticipated)Interventional2021-08-04Recruiting
A Phase 1b Study of Adaptive Androgen Deprivation Therapy for State IV Castration Sensitive Prostate Cancer [NCT03511196]Early Phase 117 participants (Actual)Interventional2018-09-17Active, not recruiting
A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects With Active Noninfectious Uveitis [NCT03207815]Phase 274 participants (Actual)Interventional2017-07-26Terminated(stopped due to Development program terminated)
A Phase II, Randomized Study to Evaluate the Safety and Efficacy of Prochymal® (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) For the Treatment of Acute GVHD in Patients Who Receive Allogeneic Hematopoietic Stem Cell Transplantation [NCT00136903]Phase 232 participants (Actual)Interventional2005-04-27Completed
The Efficacy of Omega-3 in Treatment of Atrophic/Erosive Lichen Planus and Improvement of Quality of Life: A Randomized, Double Blind, Controlled Study [NCT02106468]Phase 230 participants (Actual)Interventional2013-05-31Completed
A Pilot Study Assessing the Efficacy of Steroids in the Treatment of Achalasia [NCT01903486]Phase 40 participants (Actual)Interventional2013-03-31Withdrawn(stopped due to Unable to recruit participants.)
A Phase II Study of the Bruton's Tyrosine Kinase Inhibitor, Zanubrutinib, in Combination With Lenalidomide Plus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma [NCT05200312]Phase 236 participants (Anticipated)Interventional2022-02-01Recruiting
A Pilot Study to Estimate the Safety and Tolerability of the Combination of Polatuzumab Vedotin With Dose Adjusted Rituximab, Etoposide, Cyclophosphamide, and Doxorubicin (DA-EPCH-PR) for Upfront Treatment of Aggressive B-Cell Non-Hodgkin Lymphomas [NCT04231877]Phase 150 participants (Anticipated)Interventional2020-10-27Recruiting
Effect of High-dose Glucocorticoids on Markers of Inflammation and Bone Metabolism in Patients With Primary Glomerular Disease [NCT04987450]40 participants (Anticipated)Observational2018-10-01Recruiting
A Phase II Study to Determine the Response Kinetics, Safety, and Efficacy of Brentuximab Vedotin and Nivolumab Alone and Then Combined With Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone for Patients With Untreated Primary Mediastinal Large B-Ce [NCT04745949]Phase 240 participants (Anticipated)Interventional2021-05-10Recruiting
Stop LCNP: High Dose Steroid Therapy for Late Radiation-Associated Lower Cranial Neuropathy: A Phase I/II Dose Finding Trial and Data Registry [NCT04151082]Phase 1/Phase 215 participants (Actual)Interventional2019-10-31Active, not recruiting
A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Metastatic Prostate Cancer [NCT03748641]Phase 3765 participants (Actual)Interventional2019-01-25Active, not recruiting
A Phase 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer [NCT03431350]Phase 1/Phase 2136 participants (Actual)Interventional2018-03-02Active, not recruiting
A Multicenter Phase 2 Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens [NCT03412565]Phase 2265 participants (Actual)Interventional2018-04-26Active, not recruiting
A Phase 3, Randomized, Controlled, Open-label Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High-dose Therapy [NCT02195479]Phase 3706 participants (Actual)Interventional2014-12-09Active, not recruiting
A Drug-Drug Interaction, Safety and Efficacy Study With JNJ-56021927 (ARN-509) and Abiraterone Acetate in Subjects With Metastatic Castration-Resistant Prostate Cancer [NCT02123758]Phase 157 participants (Actual)Interventional2014-07-09Active, not recruiting
A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults [NCT02003222]Phase 3488 participants (Actual)Interventional2014-05-19Active, not recruiting
An Open-Label, Multicenter, Phase 1b Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Regimens for the Treatment of Subjects With Multiple Myeloma [NCT01998971]Phase 1242 participants (Actual)Interventional2014-02-18Active, not recruiting
Phase Ib, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Ascending Doses of ARN-509 in Combination With Abiraterone Acetate in Patients With Metastatic Castrate Resistant Prostate Cancer (CRPC [NCT01792687]Phase 16 participants (Actual)Interventional2013-02-05Active, not recruiting
A Multicenter, Open-label, Single-arm, Phase 2 Study of Abiraterone Acetate Plus Prednisone in Subjects With Advanced Prostate Cancer Without Radiographic Evidence of Metastatic Disease [NCT01314118]Phase 2131 participants (Actual)Interventional2011-05-04Active, not recruiting
A Phase II Study Of Rituximab-CHOP With Pegylated Liposomal Doxorubicin In Patients Older Than 60 Years Of Age With Untreated Aggressive B-Cell Non-Hodgkin's Lymphoma [NCT00101010]Phase 280 participants (Actual)Interventional2005-09-30Completed
Characterization of the Molecular Mechanisms Involved in Delayed-Type Hypersensitivity Reactions to House Dust Mite, Diphencyprone, Nickel, and Tuberculin Purified Protein Derivative in Healthy Volunteers [NCT03625219]54 participants (Actual)Interventional2018-07-26Completed
A Phase II, Prospective, Single-center Study of Lenalidomide in Combination With R-DA-EPOCH in Patients With Untreated DLBCL With MYC Rearrangement [NCT04432714]Phase 1/Phase 281 participants (Anticipated)Interventional2020-06-09Recruiting
Prospective Controlled Trial in Clinical Stages I-II Supradiaphragmatic Hodgkin's Disease: Evaluation of Treatment Efficacy, (Long Term) Toxicity and Quality of Life in Two Different Prognostic Subgroups [NCT00005584]Phase 31,649 participants (Actual)Interventional1998-10-31Active, not recruiting
Hydroxychloroquine as Steroid-Sparing Agent in Pulmonary Sarcoidosis (HySSAS). A Multicenter, Prospective, Controlled, Randomized Trial. [NCT02200146]Phase 394 participants (Actual)Interventional2009-03-31Completed
A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway-Mutant Acute Lymphoblastic Leukemia [NCT02723994]Phase 2171 participants (Actual)Interventional2016-09-30Active, not recruiting
Phase II Study of Combination of Hyper-CVAD and Dasatinib in Patients With Philadelphia (Ph) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) [NCT00390793]Phase 2107 participants (Actual)Interventional2006-09-28Active, not recruiting
An Assessment of Aspirin Plus Prednisone Treatment for Euthyroid Women With Thyroid Autoimmunity Undergoing In Vitro Fertilization [NCT04943146]402 participants (Anticipated)Observational2021-03-01Recruiting
Randomized, Controlled (Comparative), Open, Prospective Study Evaluating an Efficacy of R-DA-EPOCH-21, R-BL-M-04 and Autologous Stem Cells Transplantation in Patients With High-Grade B-cell Lymphoma Double-hit and High-Grade B-cell Lymphoma Not Otherwise [NCT03479918]Phase 380 participants (Anticipated)Interventional2018-03-15Recruiting
Abiraterone Dose De-Escalation Study: A Prospective Study Evaluating Decreasing Dosing Regimens of Abiraterone 500 mg in Men With Prostate Cancer to Find Lowest Recommended Dose. [NCT05276492]Phase 150 participants (Anticipated)Interventional2025-06-01Recruiting
Phase Ib/II Clinical Study of TQB3616 Capsules in Combination With Abiraterone Acetate Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer [NCT05156450]Phase 230 participants (Anticipated)Interventional2022-01-01Not yet recruiting
A Phase II Study of Metronomic Chemotherapy in Elderly Non-fit Patients (>65 Years) With Aggressive B-Cell Lymphomas [NCT03161054]Phase 221 participants (Actual)Interventional2017-09-12Completed
CINRG0513: A Trial of Chronotherapy of Corticosteroids in Duchenne Muscular Dystrophy [NCT02036463]Phase 20 participants (Actual)Interventional2014-11-30Withdrawn(stopped due to No funding for project.)
A Randomized, Phase II, Multicenter, Open Label, Study Evaluating Sirolimus and Prednisone in Patients With Refined Minnesota Standard Risk, Ann Arbor 1/2 Confirmed Acute Graft-Versus-Host Disease (BMT CTN 1501) [NCT02806947]Phase 2127 participants (Actual)Interventional2016-10-31Completed
OPV117059: A Long-Term Extension Study of Ofatumumab Injection for Subcutaneous Use in Subjects With Pemphigus Vulgaris [NCT02613910]Phase 31 participants (Actual)Interventional2015-12-23Terminated(stopped due to Novartis has acquired the rights to ofatumumab and terminated the OPV116910 and OPV117059 studies. This decision is not linked to any safety consideration.)
Adcetris (Brentuximab Vedotin), Substituting Vincristine in the OEPA/COPDac Regimen [Treatment Group 3 (TG3) of Euro-Net C1] With Involved Node Radiation Therapy for High Risk Pediatric Hodgkin Lymphoma (HL) [NCT01920932]Phase 277 participants (Actual)Interventional2013-08-12Active, not recruiting
Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy (REFRACT): A Randomised Phase II Trial of Investigator Choice Standard Therapy Versus Sequential Novel Therapy Experimental Arms [NCT05848765]Phase 2284 participants (Anticipated)Interventional2023-09-04Recruiting
An Open-label Extension Study of ARGX-113-2009 to Evaluate the Long Term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid [NCT05681481]Phase 3160 participants (Anticipated)Interventional2023-03-22Recruiting
Early Discontinuation of Steroid Treatment in Negative FDG-PET/CT Patients With Idiopathic Retroperitoneal Fibrosis. A Prospective Multicentric Study [NCT05428826]Phase 441 participants (Anticipated)Interventional2022-11-25Recruiting
Phase 1/2 Study of VIP152, Venetoclax, and Prednisone (VVIP) in Relapsed/Refractory Lymphoid Malignancies [NCT05371054]Phase 1/Phase 2130 participants (Anticipated)Interventional2023-04-05Recruiting
A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid [NCT05267600]Phase 2/Phase 3160 participants (Anticipated)Interventional2022-06-09Recruiting
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to R-CHOP Versus R-CHOP in Previously Untreated, High-intermediate and High-risk Patients With Newly- [NCT04824092]Phase 3899 participants (Actual)Interventional2021-05-11Active, not recruiting
International Collaborative Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017 [NCT03643276]Phase 35,000 participants (Anticipated)Interventional2018-07-15Recruiting
A Phase II Trial of Brief Duration Combination Chemotherapy and Rituximab With Prophylactic Pegfilgrastim, Followed by Maintenance Rituximab, in Elderly/Poor Performance Status Patients With Large B-Cell Non-Hodgkin's Lymphoma [NCT00193479]Phase 251 participants (Actual)Interventional2003-04-30Completed
A Phase II Study With a Lead-in Safety Phase of Abiraterone in Combination With PDMX1001/Niclosamide in Castration-Resistant Prostate Cancer (CRPC) [NCT02807805]Phase 237 participants (Actual)Interventional2016-10-31Active, not recruiting
Phase II Study of Combination of Hyper-CVAD and Ponatinib in Patients With Philadelphia (PH) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) [NCT01424982]Phase 288 participants (Actual)Interventional2011-10-05Active, not recruiting
A 12 Month, Multicenter, Randomized, Parallel, Open-label Study, to Evaluate Renal Function and Efficacy of Everolimus With Basiliximab and Cyclosporine Microemulsion Discontinuation at 3 Month Post-transplant Versus Minimization, in de Novo Kidney Transp [NCT00154284]Phase 3114 participants (Actual)Interventional2005-07-31Completed
A Pilot Randomized Controlled Trial of De Novo Belatacept-Based Immunosuppression in Lung Transplantation [NCT03388008]Phase 227 participants (Actual)Interventional2019-12-17Completed
Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia (PREDCOVID) [NCT04451174]Phase 360 participants (Actual)Interventional2020-06-23Terminated(stopped due to Corticosteroid use approval)
Multicentre, Single Arm, Open Label, Non Controlled Phase IV Clinical Trial to Evaluate Safety of Cabazitaxel (Jevtana) in Combination With Oral Prednisone (or Prednisolone) for the Treatment of Patients With Metastatic Hormone Refractory Prostate Cancer [NCT02074137]Phase 410 participants (Actual)Interventional2014-07-31Completed
A Phase II Comparative, Open-Label, Randomized, Multicenter, China-Only Study to Investigate the Pharmacokinetics, Efficacy and Safety of Subcutaneous Rituximab Versus Intravenous Rituximab Both in Combination With CHOP in Previously Untreated Patients Wi [NCT04660799]Phase 250 participants (Actual)Interventional2021-02-24Completed
The Role of Exclusive Enteral Nutrition in the Pediatric Inflammatory Bowel Disease Microbiome: a Pilot Study [NCT02521064]31 participants (Actual)Observational2015-07-31Completed
A Phase II Study of Carboplatin, Cabazitaxel and Abiraterone in High Volume Metastatic Castration Sensitive Prostate Cancer [NCT03934840]Phase 261 participants (Anticipated)Interventional2019-10-10Recruiting
STAMPEDE: Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy: A Multi-Stage Multi-Arm Randomised Controlled Trial [NCT00268476]Phase 2/Phase 311,992 participants (Actual)Interventional2005-07-08Active, not recruiting
[NCT00000524]Phase 20 participants Interventional1986-07-31Completed
A Randomized, Open Label Multi-Center Study of XRP6258 at 25 mg/m^2 in Combination With Prednisone Every 3 Weeks Compared to Mitoxantrone in Combination With Prednisone For The Treatment of Hormone Refractory Metastatic Prostate Cancer Previously Treated [NCT00417079]Phase 3755 participants (Actual)Interventional2007-01-31Completed
Random, Open, Control and Monocentric Clinical Research on Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy (IMN) [NCT03549663]108 participants (Anticipated)Interventional2018-07-04Recruiting
Evaluation of Acute Rejection Rates in de Novo Renal Transplant Recipients Following Thymoglobulin Induction, CNI-free, Nulojix (Belatacept)-Based Immunosuppression [NCT02137239]Phase 258 participants (Actual)Interventional2015-12-31Completed
Clinical and Laboratory Evaluation of Acute Rejection, Myocyte Growth, Repair, and Oxidative Stress Following de Novo Cardiac Transplant: A Comparison Between Tacrolimus- and Cyclosporine- Based Immunoprophylactic Regimens With MPA TDM [NCT00157014]Phase 3111 participants (Actual)Interventional2004-05-10Completed
CABAzitaxel With or Without Prednisone in Patients With Metastatic CAstration REsistant Prostate Cancer (mCRPC) Progressed During or After a Previous Docetaxel-based Chemotherapy:a Multi-center,Prospective,Two-arm, Open Label, Non Inferiority Phase II Stu [NCT03356912]Phase 2220 participants (Anticipated)Interventional2017-11-22Enrolling by invitation
Impact of Metadoxine in the Oxidative Stress and Early Mortality in Patients With Severe Alcoholic Hepatitis [NCT02161653]Phase 4135 participants (Actual)Interventional2010-04-30Completed
Phase I/II Study of Pomalidomide Combined With Modified DA-EPOCH and Rituximab in KSHV-Associated Lymphomas (Primary Effusion Lymphoma and Large Cell Lymphoma Arising in KSHV-Associated Multicentric Castleman Disease) [NCT02228512]Phase 1/Phase 20 participants (Actual)Interventional2014-08-15Withdrawn
A Pilot Study of EPOCH-F/R Induction Chemotherapy and Reduced-Intensity, HLA-Matched, Related Allogeneic Hematopoietic Stem Cell Transplantation, With Cyclosporine & Methotrexate GVHD Prophylaxis for Refractory or Relapsed Hematologic Malignancies [NCT00051311]Phase 262 participants (Actual)Interventional2003-01-03Completed
A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma [NCT00049673]Phase 3332 participants (Actual)Interventional2002-10-15Completed
Pilot Study of Allogeneic/Syngeneic Blood Stem Cell Transplantation in Patients With High-Risk and Recurrent Pediatric Sarcomas [NCT00043979]Phase 260 participants (Actual)Interventional2002-09-19Completed
Myfortic (Enteric-coated Mycophenolate Sodium) for the Treatment of Non-infectious Intermediate Uveitis - a Prospective, Controlled, Randomized Multicenter Trial [NCT01092533]Phase 344 participants (Actual)Interventional2010-03-31Completed
A Phase II Study of Rituximab, Lenalidomide, and Ibrutinib Combined With Chemotherapy for Patients With High Risk Diffuse Large B-Cell Lymphoma [NCT02636322]Phase 260 participants (Actual)Interventional2016-03-29Completed
Randomized Controlled Trial of Prednisone in Cystic Fibrosis Pulmonary Exacerbations [NCT03070522]Phase 384 participants (Anticipated)Interventional2017-05-01Recruiting
Assessment of Glucocorticoid Responsiveness and Mechanisms of Resistance in Hypereosinophilic Syndromes [NCT01524536]Phase 426 participants (Actual)Interventional2012-02-16Completed
Adjuvant Androgen Deprivation Versus Mitoxantrone Plus Prednisone Plus Androgen Deprivation in Selected High-Risk Prostate Cancer Patients Following Radical Prostatectomy [NCT00004124]Phase 3983 participants (Actual)Interventional1999-10-15Completed
A Pilot Study of Liver Protection Using Prednisone for Patients Receiving Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma [NCT05901519]Phase 220 participants (Anticipated)Interventional2024-01-31Not yet recruiting
A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study Evaluating the Efficacy and Safety of Orelabrutinib Plus R-CHOP Versus Placebo Plus R-CHOP in Treatment-naïve Patients With MCD Subtype DLBCL [NCT05234684]Phase 3150 participants (Anticipated)Interventional2022-11-02Recruiting
"A Novel Pediatric-Inspired Regimen With Reduced Myelosuppressive Drugs for Adults (Aged 18-60) With Newly Diagnosed Ph Negative Acute Lymphoblastic Leukemia" [NCT01920737]Phase 239 participants (Actual)Interventional2013-08-31Active, not recruiting
A Phase I/II Trial of Vorinostat (SAHA) (NSC-701852) in Combination With Rituximab-CHOP in Patients With Newly Diagnosed Advanced Stage Diffuse Large B-Cell Lymphoma (DLBCL) [NCT00972478]Phase 1/Phase 283 participants (Actual)Interventional2010-11-15Active, not recruiting
Investigator Initiated Pilot Study of Microarray Directed Therapy for Diffuse Large B-cell Lymphoma Using Genasense With CHOP-R [NCT00736450]Early Phase 137 participants (Actual)Interventional2008-07-23Terminated(stopped due to Manufacturer is no longer making the drug.)
A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination With Other Agents in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) [NCT04663347]Phase 1/Phase 2662 participants (Anticipated)Interventional2020-11-03Recruiting
Multicenter Phase II Single Arm Open-label Study on the Feasibility, Safety and Efficacy of Combination of CHOP-21 Supplemented With Obinutuzumab and Ibrutinib in Untreated Young High Risk Diffuse Large B-cell Lymphoma (DLBCL) Patients. [NCT02670317]Phase 21 participants (Actual)Interventional2016-09-30Terminated(stopped due to GA101-CHOP not advantage from rituximab-CHOP)
A Randomized, Double-blind Double Dummy, Parallel Control and Multi-center Clinical Trial to Compare the Efficacy and Safety of Tacrolimus Capsules in Treatment of Lupus Nephritis With Leflunomide Tablets [NCT01342016]Phase 384 participants (Actual)Interventional2011-04-30Terminated(stopped due to Due to safety concern of active control drug)
A Two-Stage Phase III, International, Multi-Center, Randomized, Controlled, Open-Label Study to Investigate the Pharmacokinetics, Efficacy and Safety of Rituximab SC in Combination With CHOP or CVP Versus Rituximab IV in Combination With CHOP or CVP in Pa [NCT01200758]Phase 3410 participants (Actual)Interventional2011-02-15Completed
A Phase IB Open-label, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK525762 in Combination With Androgen Deprivation Therapy and Other Agents in Subjects With Castrate-resista [NCT03150056]Phase 173 participants (Actual)Interventional2017-07-18Terminated(stopped due to This study has been terminated due to meeting protocol defined futility.)
A Sequential Multiple Assignment Randomized Trial (SMART) Developing and Optimizing Patient-Tailored Adaptive Treatment Strategies (ATS) for Acute Severe Ulcerative Colitis [NCT05867329]Phase 4162 participants (Anticipated)Interventional2023-09-30Recruiting
A Phase II Study of Split-Dose R-CHOP in Older Adults With Diffuse Large B-cell Lymphoma [NCT03943901]Phase 226 participants (Anticipated)Interventional2021-02-17Recruiting
Phase I and Dose-Expansion Study of Ibrutinib and R-da-EPOCH for Front Line Treatment of AIDS-Related Lymphomas [NCT03220022]Phase 154 participants (Anticipated)Interventional2018-03-16Recruiting
Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement [NCT05789030]90 participants (Anticipated)Interventional2022-07-01Recruiting
A Sequential Phase I/Randomized Phase II Trial of Vorinostat and Risk-Adapted Chemotherapy With Rituximab in HIV-Related B-Cell Non-Hodgkin's Lymphoma [NCT01193842]Phase 1/Phase 2107 participants (Actual)Interventional2010-10-06Completed
An Intergroup Phase III Randomized Controlled Trial Comparing Melphalan, Prednisone and Thalidomide (MPT) Versus Melphalan, Prednisone and Lenalidomide (Revlimid(TM))(MPR) in Newly Diagnosed Multiple Myeloma Patients Who Are Not Candidates for High-Dose T [NCT00602641]Phase 3306 participants (Actual)Interventional2008-02-29Active, not recruiting
Intensified Methotrexate, Nelarabine (Compound 506U78) and Augmented BFM Therapy for Children and Young Adults With Newly Diagnosed T-cell Acute Lymphoblastic Leukemia (ALL) or T-cell Lymphoblastic Lymphoma [NCT00408005]Phase 31,895 participants (Actual)Interventional2007-01-22Active, not recruiting
Multicentre Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIg in Patients With Chronic Inflammatory Demyelinating Polyneuropathy on a One Year Follow up [NCT01349270]Phase 340 participants (Actual)Interventional2004-06-30Completed
HD17 for Intermediate Stages - Treatment Optimization Trial in the First-Line Treatment of Intermediate Stage Hodgkin Lymphoma [NCT01356680]Phase 31,100 participants (Actual)Interventional2012-01-13Completed
GRAVITAS-301: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease [NCT03139604]Phase 3439 participants (Actual)Interventional2017-07-19Completed
A National, Open-label, Multicenter, Randomized, Comparative Phase IIb Study of Treatment for Newly Diagnosed Multiple Myeloma Patients Older Than 65 Years With Sequential Melphalan/Prednisone/Velcade (MPV) Followed by Revlimid/Low Dose Dexamethasone (Rd) [NCT01237249]Phase 2250 participants (Actual)Interventional2011-02-28Completed
A Phase II Neoadjuvant Study of Apalutamide, Abiraterone Acetate, Prednisone, Degarelix and Indomethacin in Men With Localized Prostate Cancer Pre-Prostatectomy [NCT02849990]Phase 222 participants (Actual)Interventional2017-03-09Completed
Phase II Study of Octreotide Treatment of Advanced, Recurrent Thymoma [NCT00003283]Phase 238 participants (Anticipated)Interventional1998-10-13Completed
A Phase 1b/2 Study of CPI-1205, a Small Molecule Inhibitor of EZH2, Combined With Enzalutamide or Abiraterone/Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer [NCT03480646]Phase 1/Phase 2242 participants (Anticipated)Interventional2017-11-15Active, not recruiting
High Risk B-Precursor Acute Lymphoblastic Leukemia (ALL) [NCT00075725]Phase 33,154 participants (Actual)Interventional2003-12-29Completed
A Phase III Groupwide Study of Dose-Intensive Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents With Newly Diagnosed Intermediate Risk Hodgkin Disease [NCT00025259]Phase 31,734 participants (Actual)Interventional2002-09-30Completed
A Prospective Randomized Phase III, Trial Comparing Consolidation Therapy With or Without Strontium-89 Following Induction Chemotherapy in Androgen-Independent Prostate Cancer [NCT00024167]Phase 3265 participants (Actual)Interventional2002-04-30Terminated(stopped due to Terminated due to slow accrual)
SWOG-9704 A Randomized Phase III Trial Comparing Early High Dose Chemoradiotherapy and an Autologous Stem Cell Transplant to Conventional Dose CHOP Chemotherapy Plus Rituximab for CD20+ B Cell Lymphomas (With Possible Late Autologous Stem Cell Transplant) [NCT00004031]Phase 3397 participants (Actual)Interventional1997-07-31Completed
The Effect of Low Doses of Intermediate Acting Corticosteroids on the Prolongation of Pregnancy in Threatened Preterm Birth [NCT06103227]Phase 2/Phase 326 participants (Anticipated)Interventional2023-12-01Not yet recruiting
Phase I/Ib Study of Parsaclisib (INCB50465), Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (PaR-CHOP) Immunochemotherapy for Patients With Newly Diagnosed High Risk Diffuse Large B-Cell Lymphoma [NCT04323956]Phase 150 participants (Actual)Interventional2020-06-15Active, not recruiting
Randomized Phase II Study of Olaparib Maintenance Following Cabazitaxel-Carboplatin Induction Chemotherapy in Men With Aggressive Variant Prostate Cancer (AVPC) [NCT03263650]Phase 2119 participants (Actual)Interventional2017-10-03Active, not recruiting
An Open Label Study Evaluating The Effect Of Single Doses Of Pf-04308515 And Prednisone On Carbohydrate Metabolism Utilizing An Oral Glucose Tolerance Test In Healthy Adult Subjects [NCT01199029]Phase 118 participants (Actual)Interventional2010-08-31Completed
A Pilot Study of Percutaneous Cryotherapy as Treatment for Stage I Lung Cancer or Solitary Metastatic Lung Cancer [NCT00890617]Phase 19 participants (Actual)Interventional2009-03-31Completed
Intensive Treatment For T-CELL Acute Lymphoblastic Leukemia and Advanced Stage Lymphoblastic Non-Hodgkin's Lymphoma: A Pediatric Oncology Group Phase III Study [NCT01230983]Phase 3573 participants (Actual)Interventional1996-06-30Completed
Multicenter Registry of Pediatric Lupus Nephritis in China [NCT03791827]1,200 participants (Anticipated)Observational2018-12-01Recruiting
A Phase 1 Study of Brentuximab Vedotin Administered Sequentially and Concurrently With Multi-Agent Chemotherapy as Front-Line Therapy in Patients With CD30-Positive Mature T-Cell and NK-Cell Neoplasms, Including Systemic Anaplastic Large Cell Lymphoma [NCT01309789]Phase 139 participants (Actual)Interventional2011-02-28Completed
The Role of Oral Steroids in the Management of Chronic Rhinosinusitis Without Nasal Polyps [NCT02927834]24 participants (Actual)Interventional2015-08-31Completed
Interest of Oral Corticosteroids in the Treatment of Chronic Subdural Hematomas. Prospective Randomized Multicenter Trial [NCT01380028]Phase 3162 participants (Actual)Interventional2011-07-22Terminated(stopped due to successfull Interim Analysis)
Immune Reconstitution and Biomarker Identification in Patients With Newly Diagnosed Low and Intermediate Risk Hodgkins Lymphoma Receiving Chemotherapy With or Without Radiation Therapy: TXCH-HD-12A [NCT01858922]Phase 240 participants (Actual)Interventional2012-12-19Active, not recruiting
A Pilot Study to Evaluate the Efficacy and Safety of Budesonide as an Alternative to Prednisone for Liver Transplant Immune Suppression [NCT03304626]Phase 240 participants (Actual)Interventional2017-06-27Completed
Prospective Randomized Comparison of ABVD Versus BEACOPP Chemotherapy With or Without Radiotherapy for Advanced Stage or Unfavorable Hodgkin's Lymphoma (HL) [NCT01251107]Phase 3331 participants (Actual)Interventional2000-03-31Completed
In Vivo Prednisolone/Prednisone Pharmacokinetic Pilot Study in Children With Asthma Exacerbations [NCT01260623]20 participants (Actual)Observational2009-09-09Completed
A Phase I Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Docetaxel in Castration-resistant Prostate Cancer [NCT01155791]Phase 12 participants (Actual)Interventional2010-04-30Terminated
A Randomized, Partially Blinded, Pilot Study of the Effects of Pioglitazone on HCV RNA in Overweight Subjects With Chronic HCV Genotypes 1 or 4 Infection. [NCT01157975]Phase 20 participants (Actual)Interventional2008-10-31Withdrawn(stopped due to Study was completed in another site)
Young Adult Acute Lymphoid Leukemia (ALL): Intensification of Pediatric AIEOP LLA-2000 Treatment [NCT01156883]76 participants (Actual)Interventional2010-04-30Completed
Short Term Study on the Effect of a Fixed Dose of 12.5 mg of Prednisone as Starting Dose in Polymyalgia Rheumatica [NCT01169597]Phase 460 participants (Actual)Interventional2009-01-31Completed
A Randomized, Double Blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma [NCT03782532]Phase 3486 participants (Actual)Interventional2019-01-25Completed
An Open, Single Centre, Randomised, Parallel Group Study to Investigate Three Different Immunosuppressive Regimens for de Novo Renal Transplant Recipients: A Comparison of a Sirolimus / EC-MPS (Myfortic) / Tacrolimus Regimen, an Everolimus / EC-MPS / Tacr [NCT01183247]Phase 463 participants (Actual)Interventional2008-07-31Completed
A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-b [NCT06136624]Phase 31,200 participants (Anticipated)Interventional2023-12-22Not yet recruiting
The Applicability of Different Scoring Systems and Use of Steroids in the Treatment of Hospital Acquired Pneumonia [NCT03121690]Phase 4500 participants (Anticipated)Interventional2017-12-01Active, not recruiting
A Double-blind, Randomised, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAD and MAD of CORT125281 in Healthy Subjects [NCT03335956]Phase 148 participants (Actual)Interventional2017-09-21Completed
A Single Arm, Multi-center, Phase II Clinical Trial of Zanubrutinib Combined With Standard Chemotherapy in the Treatment for Patients With Diffuse Large B Cell Lymphoma and CD79A/CD79B Genetic Abnormality [NCT04668365]Phase 259 participants (Anticipated)Interventional2020-12-25Recruiting
A Single Arm, Multi-center, Phase II Clinical Trial of VR-CAP in the First-line Treatment for Patients With Marginal Zone Lymphoma [NCT04433156]Phase 260 participants (Anticipated)Interventional2020-04-22Recruiting
A Phase I and Feasibility Study of Everolimus (RAD001) Plus R-CHOP for New Untreated Diffuse Large B-Cell Lymphoma (DLBCL) [NCT01334502]Phase 126 participants (Actual)Interventional2012-03-31Completed
Budesonide in Liver Transplantation [NCT03315052]Phase 40 participants (Actual)Interventional2019-01-31Withdrawn(stopped due to Delay in IRB approval)
A Randomized Phase III Study to Compare Bortezomib, Melphalan, Prednisone (VMP) With High Dose Melphalan Followed by Bortezomib, Lenalidomide, Dexamethasone (VRD) Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma [NCT01208766]Phase 31,503 participants (Actual)Interventional2011-01-31Active, not recruiting
Randomized, Open Label, Multi-Center Study Comparing Cabazitaxel at 25 mg/m^2 and at 20 mg/m^2 in Combination With Prednisone Every 3 Weeks to Docetaxel in Combination With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer Not Pr [NCT01308567]Phase 31,168 participants (Actual)Interventional2011-05-05Completed
A Phase I, Single Center, Placebo-Controlled, Blinded Pilot Study of Ipratropium Bromide in Children Admitted to the Intensive Care Unit With Status Asthmaticus [NCT02872597]Phase 130 participants (Actual)Interventional2016-09-05Completed
A Phase II Study Evaluating Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Double and Triple Hit Lymphoma, Double Expressor Lymphoma and High-Gr [NCT04479267]Phase 249 participants (Anticipated)Interventional2020-08-21Recruiting
Phase II Trial of Alemtuzumab (Campath) and Dose-Adjusted EPOCH-Rituximab (DA-EPOCH-R) in Relapsed or Refractory Diffuse Large B-Cell and Hodgkin Lymphomas [NCT01030900]Phase 250 participants (Actual)Interventional2009-10-22Completed
A Non-Randomized Phase III Study of Response Adapted Therapy for the Treatment of Children With Newly Diagnosed High Risk Hodgkin Lymphoma [NCT01026220]Phase 3166 participants (Actual)Interventional2009-12-07Completed
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis (REGENCY) [NCT04221477]Phase 3252 participants (Anticipated)Interventional2020-08-10Active, not recruiting
Glucocorticoid Effects in Patients With DM Type 2 [NCT03661684]Early Phase 110 participants (Actual)Interventional2016-06-03Completed
Randomized Three-Arm Trial to Evaluate the Effect of Neoadjuvant Apalutamide Alone or in Combination With Abiraterone Acetate and GnRH Agonist on Enhancing Surgical Outcome of Nerve-Sparing Radical Prostatectomy in Men With High-Risk Prostate Cancer [NCT02949284]Phase 290 participants (Anticipated)Interventional2017-06-20Recruiting
A Phase III Trial of CHOP Plus Rituximab vs CHOP Plus Iodine-131-Labeled Monoclonal Anti-B1 Antibody (Tositumomab) for Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas [NCT00006721]Phase 3571 participants (Actual)Interventional2001-03-31Active, not recruiting
Initial Treatment of Patients With Immune Thrombocytopenic Purpura: The ITP^2 Study [NCT00991939]Phase 38 participants (Actual)Interventional2010-01-31Terminated(stopped due to The study was closed due to accrual futility there were only a total of 8 subjects enrolled.)
Alloantibodies in Pediatric Heart Transplantation [NCT01005316]290 participants (Actual)Observational2010-01-31Terminated(stopped due to Inability to meet accrual goals within the funding period.)
A Phase II Study of Iodine-131-Labeled Tositumomab in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients With Advanced Stage Follicular Non-Hodgkin's Lymphoma [NCT00770224]Phase 287 participants (Actual)Interventional2009-04-30Completed
A Phase 1 Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Abiraterone in Patients With Castrate Resistant Prostate Cancer Progressing on Abiraterone [NCT04296578]Phase 10 participants (Actual)Interventional2020-10-31Withdrawn(stopped due to Study did not start)
Cinobufacini Tablets Combined With R-CHOP Protocol (Rituximab + Vindesine + Cyclophosphamide + Epirubicin + Prednisone)/CHOP in Treatment of Diffuse Large B Cell Lymphoma: A Phase II Randomized, Controlled and Multi-center Study [NCT02871869]Phase 2/Phase 3316 participants (Anticipated)Interventional2016-09-30Recruiting
A Phase 3 Study to Evaluate the Efficacy and Safety of Docetaxel and Prednisone With or Without Lenalidomide in Subjects With Castrate-Resistant Prostate Cancer (CRPC) [NCT00988208]Phase 31,059 participants (Actual)Interventional2009-11-11Completed
Open-Label, Randomized, Multicenter, Parallel-Group Efficacy and Safety Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation [NCT00717379]Phase 450 participants (Actual)Interventional2007-05-31Completed
Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Chimeric Anti-CD20 Monoclonal Antibody (Rituximab) for Stage IV Indolent Lymphoma [NCT00577993]Phase 3210 participants (Actual)Interventional1998-03-16Completed
A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma [NCT00686335]Phase 212 participants (Actual)Interventional2008-06-30Completed
A Phase I/II Study of RAD001 With Docetaxel in the Treatment of Metastatic, Androgen Independent Prostate Cancer [NCT00459186]Phase 1/Phase 219 participants (Actual)Interventional2005-11-30Completed
Intra-articular Doxycycline: A Novel Treatment of Adhesive Capsulitis [NCT03479502]Phase 41 participants (Actual)Interventional2018-01-05Terminated(stopped due to Lack of personnel to help with recruiting)
A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study To Evaluate The Safety And Efficacy Of TRU-015 In Subjects With Active Seropositive Rheumatoid Arthritis On A Stable Background Of Methotrexate [NCT00634933]Phase 2222 participants (Actual)Interventional2008-03-31Terminated(stopped due to The study was terminated on 21 June 2010 due to results not meeting the primary endpoint. No safety reasons contributed to the termination of the study.)
A Six-week Evaluator-Blind, Randomized, Active-Controlled Evaluation of the Effects of Three Doses of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI), Montelukast, and Beclomethasone Dipropionate (BDP HFA) on the HPA Axis in Asthm [NCT01615874]Phase 20 participants (Actual)Interventional2013-01-31Withdrawn
The Safety and Effectiveness of Four Courses of R-CHOP Plus Four Courses of Rituximab Versus Six Courses of R-CHOP Plus Two Courses of Rituximab in the Treatment of Naive, Low-risk, Non-mass Diffuse Large B-cell Lymphoma: a Multi-center, Prospective, Rand [NCT05018520]Phase 3800 participants (Anticipated)Interventional2021-09-17Recruiting
An Open-Label, Randomized, Pharmacokinetic Study of vinCRIStine Sulfate LIPOSOME Injection Ready-to-Use (VSLI-RTU) Formulation (1-Vial) and Marqibo® Formulation (3-Vials) in Patients With Hematological Malignancies [NCT04243434]Phase 156 participants (Anticipated)Interventional2020-08-15Not yet recruiting
Phase III Study of the Interest of Radiotherapy After 4 or 6 Cycles of CHOP 14 Rituximab Regimen of Chemotherapy , Patients With Agressive Localized Lymphoma [NCT00841945]Phase 3334 participants (Actual)Interventional2005-04-30Terminated(stopped due to other drugs other studies)
Th2 Effects on Eicosanoid Pathways: Implications for Altered Innate Responses in Asthma [NCT00853411]0 participants (Actual)Interventional2008-12-31Withdrawn(stopped due to Terminated by Investigator due to lack of eligible subjects.)
A Phase II Trial of Bortezomib (Velcade) Plus Prednisone for Initial Therapy of Chronic Graft Versus Host Disease [NCT00815919]Phase 222 participants (Actual)Interventional2008-12-31Completed
A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Chidamide Combined With CHOP(Cyclophosphamide, Doxorubicin, Vincristine, Prednisone ) in Untreated Subjects With Angioimmunoblastic T Cell Lymphoma [NCT03853044]Phase 223 participants (Anticipated)Interventional2018-12-29Active, not recruiting
Shortened vs Standard Chemotherapy Combined With Immunotherapy for the Initial Treatment of Patients With High Tumor Burden Follicular Lymphoma. A Randomized, Open Label, Phase III Study by Fondazione Italiana Linfomi. [NCT05058404]Phase 3602 participants (Anticipated)Interventional2021-12-01Recruiting
Phase 1 Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma [NCT04739813]Phase 155 participants (Anticipated)Interventional2021-07-09Recruiting
Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤75 Years With Previously Untreated Non-GCB DLBCL [NCT04529772]Phase 3600 participants (Anticipated)Interventional2020-10-08Recruiting
A Phase 1 Study of Lenalidomide in Combination With EPOCH Chemotherapy for HTLV-Associated Adult T-Cell Leukemia-Lymphoma (ATLL) [NCT04301076]Phase 130 participants (Anticipated)Interventional2021-08-31Recruiting
Safety and Feasibility of Stem Cell Gene Transfer Following R-EPOCH for Non-Hodgkin Lymphoma in AIDS Patients Using Peripheral Blood Stem/Progenitor Cells Treated With a Lentivirus Vector-Encoding Multiple Anti-HIV RNAs [NCT02337985]Phase 110 participants (Anticipated)Interventional2015-11-20Active, not recruiting
A Phase II Study to Evaluate Low-Dose Alemtuzumab as a Glucocorticoid-Sparing Agent for Initial Systemic Treatment of Acute Graft-Versus-Host Disease [NCT00410657]Phase 253 participants (Anticipated)Interventional2006-07-31Completed
A Randomized Phase II Study of Reolysin in Combination With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Patients With Metastatic Castration Resistant Prostate Cancer [NCT01619813]Phase 285 participants (Actual)Interventional2012-12-14Completed
A Multi-Centre Phase II Trial Investigating the Efficacy and Tolerability of Bortezomib Added to Cyclophosphamide, Vincristine, Prednisone, and Rituximab (BCVP-R) for Patients With Advanced Stage Follicular Non-Hodgkin's Lymphoma Requiring Systemic First- [NCT00428142]Phase 295 participants (Actual)Interventional2007-05-01Completed
A Randomized Phase II Study of OGX-011 in Combination With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Patients With Metastatic Hormone Refractory Prostate Cancer [NCT00258388]Phase 282 participants (Actual)Interventional2005-09-28Completed
Exploratory Study of Molecular Phenotype Changes and Personalized Treatment for Patients With Castration Resistant Prostate Cancer [NCT02208583]150 participants (Anticipated)Interventional2014-06-30Recruiting
Early Steroid Use in Infants With Clinical Pneumocystis Jiroveci Pneumonia (PCP) in the Queen Elizabeth Central Hospital, Blantyre, Malawi [NCT02149433]78 participants (Actual)Interventional2012-05-31Completed
A Prospective, Single Arm, Open Label, Clinical Trial to Evaluate the Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage [NCT04440267]Phase 250 participants (Anticipated)Interventional2020-06-20Not yet recruiting
Selinexor Combined With Prednisone, Etoposide, and Lenalidomide as Introductive Treatment Following Immune-chemotherapy as Consolidated Therapy for Refractory Diffuse Large B-cell Lymphoma With p53 and/or c-Myc Expression [NCT05498636]Phase 1/Phase 267 participants (Anticipated)Interventional2022-10-01Not yet recruiting
A Randomized Phase 3 Study Comparing Cabazitaxel/Prednisone in Combination With Custirsen (OGX-011) to Cabazitaxel/Prednisone for Second-Line Chemotherapy in Men With Metastatic Castrate Resistant Prostate Cancer (AFFINITY) [NCT01578655]Phase 3630 participants (Actual)Interventional2012-08-31Completed
Predictive Factors for Treatment Response in Patients With Newly-diagnosed Polymyalgia Rheumatica and Giant Cell Arteritis [NCT05479448]30 participants (Anticipated)Observational2022-06-03Recruiting
A Phase 2, Randomized, Double Blind Assessment Of Efficacy And Safety Of Pf 04171327(1, 5, 10, 15 Mg Dose, Daily) Compared To 5 Mg And 10 Mg Prednisone Daily And Placebo Daily In Subjects With Rheumatoid Arthritis Over An 8 Week Period Followed By A 4 Wee [NCT01393639]Phase 2323 participants (Actual)Interventional2011-09-30Completed
A Randomized Phase 3 Study Comparing Standard First-Line Docetaxel/Prednisone to Docetaxel/Prednisone in Combination With Custirsen (OGX-011) in Men With Metastatic Castrate Resistant Prostate Cancer [NCT01188187]Phase 31,022 participants (Actual)Interventional2010-11-30Completed
A Multicenter, Phase 2 Study Evaluating the Value of Radiotherapy in Advanced Diffuse Large B-cell Lymphoma Patients With Extranodal Involvement and Large Tumors Who Had Complete Remission as Assessed by PET-CT After Immune-chemotherapy [NCT05874778]Phase 2108 participants (Anticipated)Interventional2023-05-15Not yet recruiting
Moscow-Berlin 2008 Multicenter Randomised Study for Treatment of Acute Lymphoblastic Leukemia in Children and Adolescents [NCT01953770]3,000 participants (Anticipated)Interventional2008-02-29Active, not recruiting
A Multicenter, Randomized, Open-label, Controlled Study of Nevirapine (VIRAMUNE®) and a Short Course of Prednisone to Determine the Safety and Effectiveness of This Strategy in Preventing Nevirapine (VIRAMUNE®) Associated Rash. [NCT02184299]Phase 4138 participants (Actual)Interventional1999-04-30Completed
Dexamethasone Versus Prednisone for Asthma Treatment in the Pediatric Inpatient Population; a Feasibility Study [NCT03133897]Phase 320 participants (Actual)Interventional2018-03-05Terminated(stopped due to it was felt by the sponsoring institution that the current standard of oversight expected by the Health Canada regulations, would not be possible to achieve)
A Phase I/II Multicenter, Open-Label Study of YM155 Plus Docetaxel in Subjects With Advanced Hormone Refractory Prostate Cancer and Other Solid Tumors [NCT00514267]Phase 1/Phase 232 participants (Actual)Interventional2007-05-31Completed
The Combination of Prednisone and Recombinant Human Thrombopoietin vs Prednisone Monotherapy for Treatment in Immune Thrombocytopenia in Pregnancy [NCT05333744]Phase 290 participants (Anticipated)Interventional2021-06-01Recruiting
Phase II Study of Multimodality Therapy in Mantle Cell Lymphoma [NCT00004231]Phase 20 participants Interventional1999-10-31Completed
The Effect of Prednisone and Solu-Medrol on Physical Exercise in COPD Patients and the Inflammaroty Response During and After Exercis. [NCT01978665]Phase 414 participants (Actual)Interventional2013-04-30Completed
A Phase 1b Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone or Apalutamide in mCRPC (ARES: Androgen Receptor Eradication Study) [NCT05295927]Phase 13 participants (Actual)Interventional2022-03-23Terminated(stopped due to Administrative Decision)
A Phase II Study of Durvalumab Treatment Substudy A: In Patients Who Discontinued Prior Checkpoint Therapy Due to Immune Related Toxicity Substudy B: For Continued Treatment (+/- Tremelimumab) of Patients Previously Enrolled to Completed CCTG Studies [NCT03847649]Phase 260 participants (Anticipated)Interventional2020-03-09Recruiting
Advanced ChemoHormonal Therapy for Treatment Naïve Metastatic Prostate Cancer: Apalutamide and Abiraterone Acetate With Prednisone and Androgen Deprivation Therapy After Treatment With Docetaxel and Androgen Deprivation Therapy [NCT04267887]Phase 27 participants (Actual)Interventional2020-05-11Active, not recruiting
Phase II Pilot Study of Brentuximab Vedotin, Rituximab and Dose Attenuated CHP in Elderly Patients With DLBCL [NCT02734771]Phase 224 participants (Anticipated)Interventional2016-06-30Active, not recruiting
A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cance [NCT02257736]Phase 3982 participants (Actual)Interventional2014-11-30Active, not recruiting
A Randomised, Double-Blind, Placebo-Controlled, Multicentre Phase II Study to Compare the Efficacy, Safety and Tolerability of Olaparib Versus Placebo When Given in Addition to Abiraterone Treatment in Patients With Metastatic Castrate-Resistant Prostate [NCT01972217]Phase 2158 participants (Actual)Interventional2014-04-01Completed
A Randomized Study of Finite Androgen Ablation vs. Finite Androgen Ablation in Combination With Abiraterone Acetate and Prednisone in Patients With Prostate Cancer Who Have PSA Progression After Prostatectomy and/or Radiotherapy [NCT01786265]Phase 2310 participants (Anticipated)Interventional2013-02-05Active, not recruiting
A Prospective, Multi-center, Single-arm, Interventional Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant in China [NCT03099122]Phase 4115 participants (Actual)Interventional2017-08-16Completed
Systemic Corticosteroids in the Perioperative Management of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) [NCT02119273]Phase 40 participants (Actual)Interventional2014-09-30Withdrawn(stopped due to Lack of enrollment)
Belatacept for the Management of Moderately Sensitized Patients at Risk for Delayed Graft Function (DGF) [NCT02130817]Phase 40 participants (Actual)Interventional2014-09-24Withdrawn(stopped due to Organ transplant criteria made recruitment difficult. Closed with IRB 10/09/2015.)
A Prospective, Randomized, Controlled Pilot Study of Early-Use Long Acting Tacrolimus (Envarsus XR) in Lung Transplant Recipients [NCT04469842]Early Phase 148 participants (Anticipated)Interventional2023-08-31Not yet recruiting
Prostate Specific Membrane Antigen (PSMA) or Fluciclovine (FACBC) PET/CT Site-Directed Therapy of OLigometASTatic Prostate Cancer (P-Flu-BLAST-PC): A Multicenter Study [NCT04175431]Phase 2100 participants (Anticipated)Interventional2020-09-30Recruiting
A Phase II Study of Double Induction Chemotherapy for Newly Diagnosed Non-L3 Adult Acute Lymphoblastic Leukemia With Investigation of Minimal Residual Disease and Risk of Relapse Following Maintenance Chemotherapy [NCT00109837]Phase 279 participants (Actual)Interventional2005-04-30Completed
Phase III Randomized Trial of Adjuvant Involved-Field Radiotherapy vs No Adjuvant Therapy Following Remission Induction With MOPP/ABV Hybrid Chemotherapy in Patients With Stage III/IV Hodgkin's Disease [NCT00002462]Phase 3615 participants (Actual)Interventional1989-09-30Active, not recruiting
Pethema LAL-RI/2008: Treatment for Patients With Standard Risk Acute [NCT02036489]Phase 4107 participants (Actual)Interventional2008-01-31Completed
Comparisons Of Inflammatory Biomarkers And Cardiovascular Risk Scores Before And After Conversion To Full Dose Myfortic® Using Two Hour Neoral® Monitoring. [NCT02058875]Phase 40 participants (Actual)Interventional2014-02-28Withdrawn(stopped due to The study funder retracted their grant funding offer before contract signed.)
Off-label Use of Tacrolimus in Children With Henoch-Schönlein Purpura Nephritis: Effectiveness and Safety [NCT03222687]Phase 425 participants (Actual)Interventional2015-09-01Completed
A Multicenter, Randomized, Double-blind Phase Ib/III Clinical Study of Dalpiciclib Isethionate Tablets Combined With Abiraterone Acetate Tablets (I) and Prednisone Tablets (AA-P) Versus Placebo Combined With AA-P in Treatment of High-volume, Metastatic, H [NCT06099990]Phase 1660 participants (Anticipated)Interventional2023-10-31Not yet recruiting
Phase 2 Study of Pembrolizumab and Chemotherapy in Patients With Newly Diagnosed Classical Hodgkin Lymphoma (KEYNOTE-C11) [NCT05008224]Phase 2146 participants (Actual)Interventional2021-10-07Active, not recruiting
Randomized, Parallel-group, Double-blind, Comparative Bioequivalence Trial of MabionCD20 Compared to MabThera (Rituximab by Hoffman-La Roche) in Patients With Diffuse Large B-cell Lymphoma [NCT02617485]Phase 3143 participants (Actual)Interventional2015-12-31Completed
An Open-label Phase 2 Multi-center Study of Enzalutamide and Abiraterone and Biomarkers of Androgen Response and Resistance During Rising PSA: BARRIER-P Trial [NCT02429193]Phase 216 participants (Anticipated)Interventional2016-03-31Completed
Effect and Security of Steroids Therapy for Patients of IgA Nephropathy With Crescents : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial. [NCT04833374]Phase 3200 participants (Anticipated)Interventional2021-05-24Recruiting
Effect of a Combination of Local Steroid Injection With Oral Steroid Administration for the Prevention on Esophageal Stricture After Endoscopic Submucosal Dissection for Early Esophageal Neoplasm:a Randomized Controlled Trial [NCT03039608]72 participants (Actual)Interventional2017-02-10Completed
Prospective Evaluation of the Predictive Value of PET in Patients With Diffuse Large B-cell-lymphoma Under R-CHOP-14. A Multicenter Study [NCT00544219]156 participants (Actual)Interventional2007-09-30Completed
A Pragmatic Phase II Study Evaluating Tolerability in Prostate Cancer Patients Treated With Abiraterone + Prednisone or Darolutamide [NCT06173362]Phase 275 participants (Anticipated)Interventional2023-11-09Recruiting
Efficacy and Safety of Induction and Tapering Therapy With Tofacitinib and Glucocorticoid in Patients With Polymyalgia Rheumatica (ITTG PMR): An Open-label 52-week Randomized Controlled Trial [NCT06172361]Phase 398 participants (Anticipated)Interventional2024-01-15Not yet recruiting
A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 X Anti-CD3 Bispecific Antibody Versus Investigator's Choice in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-1) [NCT06091254]Phase 3478 participants (Anticipated)Interventional2023-12-12Recruiting
A Phase 1/2 Study of Nivolumab and Ipilimumab in Combination With Sirolimus and Prednisone in Kidney Transplant Recipients With Selected Unresectable or Metastatic Cutaneous Cancers [NCT05896839]Phase 1/Phase 216 participants (Anticipated)Interventional2024-08-11Recruiting
Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Randomized Controlled Trial [NCT05674994]Phase 3110 participants (Anticipated)Interventional2023-10-26Recruiting
A Dual-cohort, Open-label, Phase 2 Study of Brentuximab Vedotin and CHP (A+CHP) in the Frontline Treatment of Subjects With Peripheral T-cell Lymphoma (PTCL) With Less Than 10% CD30 Expression [NCT04569032]Phase 280 participants (Anticipated)Interventional2020-11-12Recruiting
Maximal Androgen Depletion Followed by Randomization of Maximal Androgen Ablation With Molecular Targeted Therapies [NCT01254864]Phase 2190 participants (Actual)Interventional2011-03-16Completed
Does Inactive Takayasu Arteritis(NIH Criteria) Need Anti-inflammatory Treatment? [NCT03550781]Phase 2/Phase 340 participants (Anticipated)Interventional2018-06-01Not yet recruiting
A Phase 1 Study to Evaluate Safety, Toxicity, and Potential Mechanisms of Interferon Gamma-primed Mesenchymal Stromal Cells (MSCs) for Moderate-to-severe Persistent Asthma [NCT05035862]Phase 112 participants (Anticipated)Interventional2022-03-16Recruiting
A Phase II Study of Nivolumab in Combination With DA-REPOCH Followed by Short Course Nivolumab Consolidation in Patients With Aggressive B-Cell Non-Hodgkin's Lymphoma [NCT03749018]Phase 230 participants (Anticipated)Interventional2019-01-02Active, not recruiting
Maintaining or Stopping Immunosuppressive Therapy in Patients With ANCA Vasculitis and End-stage Renal Disease: a Prospective, Multicenter, Randomized, Open-label, Clinical Trial [NCT03323476]Phase 3136 participants (Anticipated)Interventional2018-02-02Recruiting
Prospective, Multicentre, Placebo-controlled, Double-blind Interventional Study to Compare the Efficacy of Maintenance Treatment With Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis Patients [NCT02573012]Phase 4314 participants (Actual)Interventional2016-03-29Completed
PROUD Study - Preventing Opioid Use Disorders [NCT04766996]Phase 457 participants (Actual)Interventional2021-05-17Terminated(stopped due to Loss of surgery team member deemed the study procedures impossible to achieve, and no replacement could be found in a timely manner to complete trial as initially planned.)
A Phase 1 Study Combining Venetoclax With a Pediatric-Inspired Regimen for Newly Diagnosed Adults With B Cell Ph-Like Acute Lymphoblastic Leukemia [NCT05157971]Phase 16 participants (Anticipated)Interventional2022-03-17Recruiting
Utility of Prednisone in the Treatment of Cellulitis [NCT00893048]Phase 20 participants (Actual)Interventional2010-01-15Withdrawn(stopped due to Study never enrolled any subjects before auto-terminated by the internal IRB.)
Using SMART Design to Develop Dynamic Treatment Regimens for Glucocorticoid Tapering [NCT06072768]Phase 2200 participants (Anticipated)Interventional2023-03-09Recruiting
A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone Versus Placebo Plus Docetaxel Plus Prednisone in Participants With Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Prog [NCT04907227]Phase 381 participants (Actual)Interventional2020-09-23Terminated(stopped due to The data did not support study endpoints)
A Phase II Study of Blinatumomab and POMP (Prednisone, Vincristine, Methotrexate, 6-Mercaptopurine) for Patients ≥ 65 Years of Age With Newly Diagnosed Philadelphia-Chromosome Negative (Ph-) Acute Lymphoblastic Leukemia (ALL) and of Dasatinib, Prednisone [NCT02143414]Phase 253 participants (Actual)Interventional2015-06-30Active, not recruiting
An Open Label Case Series on the Effects of Xolair (Omalizumab) in Bullous Pemphigoid [NCT00472030]Phase 42 participants (Actual)Interventional2007-08-31Completed
A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis Treated Concomitantly With Rituximab or Cyclophosphamide/Azathioprine [NCT02994927]Phase 3331 participants (Actual)Interventional2017-03-15Completed
A Phase II Trial to Evaluate the Rate of Immune Response Using Idiotype Immunotherapies Produced by Molecular Biological Means for Treatment of Aggressive B Cell Lymphoma [NCT00004197]Phase 20 participants Interventional1999-06-25Completed
CSP #553 - Adjuvant Therapy in Prostate Carcinoma Treatment [NCT00132301]Phase 3298 participants (Actual)Interventional2006-06-30Completed
A Multicenter, Randomized, Double Blind Study Comparing the Efficacy and Safety of Aflibercept Versus Placebo Administered Every 3 Weeks in Patients Treated With Docetaxel/ Prednisone for Metastatic Androgen-independent Prostate Cancer [NCT00519285]Phase 31,224 participants (Actual)Interventional2007-08-31Completed
A Pilot Study of Adefovir Dipivoxil Alone and After Prednisone Priming for the Treatment of Asian Patients With HBeAg-positive Chronic Hepatitis B [NCT00715715]0 participants (Actual)Interventional2008-04-30Withdrawn(stopped due to Withdrawn studies.)
A Phase II Study of Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin Plus Asparaginase (DA-EPOCH-A) for Adults With Acute Lymphoblastic Leukemia/Lymphoma [NCT02538926]Phase 20 participants (Actual)Interventional2018-07-01Withdrawn(stopped due to Drugs unavailable)
Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit/Frail Patients or Anthracycline-Ineligible Adult Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma [NCT06045247]Phase 240 participants (Anticipated)Interventional2024-03-31Not yet recruiting
A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma [NCT06043323]Phase 220 participants (Anticipated)Interventional2024-03-31Not yet recruiting
Efficacy and Safety of Tofacitinib (TF) Combined With Iguratimod(IGU) in the Treatment of Moderate to Severe Active Rheumatoid Arthritis (RA) [NCT04928066]Phase 4100 participants (Actual)Interventional2020-03-01Completed
The Clinical Features and Pregnancy Outcomes of Patients With Connective Tissue Disease :a Prospective Cohort Study [NCT04918524]126 participants (Anticipated)Observational2018-09-11Recruiting
Prospective Clinical Study to Observe the Efficacy and Safety of Iguratimod in Rheumatoid Arthritis and Early Rheumatoid Arthritis Patients for 6 Months Treatment in China [NCT03855007]Phase 4400 participants (Actual)Interventional2016-01-01Completed
Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With Blinatumomab With or Without Inotuzumab Ozogamicin as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia [NCT02877303]Phase 280 participants (Anticipated)Interventional2016-11-01Recruiting
A Phase 3, Open-Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20x Anti-CD3 Bispecific Antibody, Combined With Chemotherapy Versus Rituximab Combined With Chemotherapy in Previously Untreated Participants [NCT06097364]Phase 3733 participants (Anticipated)Interventional2023-11-14Recruiting
Randomized Open-label Study of the Impact of Prolonged Systemic Corticosteroid Therapy on the Course and Relapse Risk of Checkpoint Inhibitor Interstitial Lung Disease (Pneumonitis) Related to the Treatment of Solid Tumors With Anti-programmed-death Type [NCT04036721]Phase 485 participants (Anticipated)Interventional2019-10-01Suspended(stopped due to SARS-CoV-2 cases stopped the recruitment in Organisation since July 2020)
A Multicentric, Open-Label, Single Arm Study of Obinutuzumab Short Duration Infusion (SDI) in Patients With Previously Untreated Advanced Follicular Lymphoma [NCT03817853]Phase 4114 participants (Actual)Interventional2019-02-26Completed
Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia [NCT00549848]Phase 3600 participants (Actual)Interventional2007-10-29Completed
Rituximab Therapy for the Induction of Remission and Tolerance in ANCA-Associated Vasculitis (ITN021AI) [NCT00104299]Phase 2/Phase 3197 participants (Actual)Interventional2005-01-31Completed
A Phase II, Randomized Study to Evaluate the Safety and Efficacy of Ex-Vivo Cultured Allogenic Mesenchymal Stem Cells For the Treatment of Extensive Chronic Graft Versus Host Disease [NCT00972660]Phase 252 participants (Anticipated)Interventional2009-09-30Enrolling by invitation
Dexamethasone-suppression-test Predicts Later Development of Adrenal Insufficiency After a 14 Days' Course of Prednisone in Healthy Volunteers [NCT00975078]Phase 439 participants (Actual)Interventional2009-05-31Completed
A Phase 1b, Open-Label, Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of Loncastuximab Tesirine in Combination With R-CHOP in Patients With Previously Untreated Diffuse Large B-cell Lymphoma (LOTIS-8) [NCT04974996]Phase 10 participants (Actual)Interventional2022-02-01Withdrawn(stopped due to Decision to not proceed with study.)
An Observational Study of Continuous Oral Dosing of an Irreversible CYP17 Inhibitor, Abiraterone Acetate (CB7630), in Castration-Resistant Prostate Cancer Patients Evaluating Androgens and Steroid Metabolites in Bone Marrow Plasma [NCT00544440]Phase 257 participants (Actual)Interventional2007-10-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study Comparing AT-101 in Combination With Docetaxel and Prednisone Versus Docetaxel and Prednisone in Men With Chemotherapy-Naïve Metastatic Hormone Refractory Prostate Cancer (HRPC) [NCT00571675]Phase 2220 participants (Actual)Interventional2007-10-31Completed
A Multicenter Randomized Open Label Study to Assess Efficacy and Safety of a Steroid Avoidance Regimen in Comparison to a Treatment With Steroids, in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS) 2.16 g/d for 6 Weeks and Cyclosporine Micro [NCT00413920]Phase 3222 participants (Actual)Interventional2007-04-30Completed
A Feasibility Pilot and Phase II Study Of Chemoimmunotherapy With Epratuzumab (IND #12034) for Children With Relapsed CD22-Positive Acute Lymphoblastic Leukemia (ALL) [NCT00098839]Phase 1/Phase 2134 participants (Actual)Interventional2005-02-28Completed
(REASON) Double-blind, Randomized Phase II Study to Evaluate the Safety and Efficacy of Acetyl-l-carnitine in the Prevention of Sagopilone-induced Peripheral Neuropathy. [NCT00751205]Phase 2150 participants (Actual)Interventional2008-08-31Completed
Corticosteroid Treatment for Community-Acquired Pneumonia A Randomized, Double-blind Study- The STEP Trial [NCT00973154]Phase 3800 participants (Actual)Interventional2009-12-31Completed
Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone (RCP) for Patients With Newly Diagnosed Multiple Myeloma [NCT00540644]Phase 270 participants (Actual)Interventional2007-10-31Completed
Comparison of Two Tapering Strategies of Prednisone in Patients With Generalised Myasthenia Gravis Treated With Prednisone and Azathioprine: a Single-blind Randomised Controlled Multicenter Study [NCT00987116]Phase 4118 participants (Actual)Interventional2009-06-30Completed
A Multicenter, Phase III, Open-Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) Plus Chemotherapy Compared With Rituximab Plus Chemotherapy Followed by GA101 [NCT01332968]Phase 31,401 participants (Actual)Interventional2011-07-06Completed
A Pilot Study To Determine The Toxicity Of The Addition Of Rituximab To The Induction And Consolidation Phases And The Addition Of Rasburicase To The Reduction Phase In Children With Newly Diagnosed Advanced B-Cell Leukemia/Lymphoma Treated With LMB/FAB T [NCT00057811]Phase 297 participants (Actual)Interventional2004-06-30Completed
Phase II Study of Cyclophosphamide, Prednisone and Rituximab (CPR) in Children, Adolescents and Young Adults With B-lymphocyte Antigen CD20 (CD20) Positive Post-Transplant Lymphoproliferative Disease (PTLD) Following Solid Organ Transplantation (SOT) [NCT00066469]Phase 255 participants (Actual)Interventional2004-04-30Completed
First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.A Multicentre, Phase III Randomized Study by the PLRG. [NCT00801281]Phase 3250 participants (Actual)Interventional2007-02-28Completed
Evaluation of Aprepitant's Effect on Drug Metabolism in Multi-Day Combination (CHOP/R-CHOP) Chemotherapy Regimen in Patients With Non-Hodgkin's Lymphoma [NCT00651755]23 participants (Actual)Interventional2008-03-31Completed
A Phase II Study of Pre-operative Docetaxel for Progressive Localized Castration Resistant Prostate Cancer [NCT00811031]Phase 20 participants (Actual)InterventionalWithdrawn
Open, Single Center, Randomised, Parallel Group Pilot Study to Investigate a Calcineurin Free Immunosuppressive Treatment for de Novo Renal Transplant Recipients: A Comparison of a Rapamycin/MMF/Steroids Regime to a Cyclosporine A Neoral/MMF/Steroids Regi [NCT00812123]Phase 4127 participants (Actual)Interventional2001-01-31Completed
A Phase III Trial of Treatment of Advanced-Stage Anaplastic Large Cell Lymphoma (ALCL) With Standard APO (Doxorubicin, Prednisone, Vincristine) Versus Consolidation With a Regimen Including Vinblastine [NCT00059839]Phase 3129 participants (Actual)Interventional2003-11-30Completed
An Abiraterone Acetate Plus Prednisone Drug-Drug Interaction Study With Dextromethorphan and Theophylline in Patients With Metastatic Castration-Resistant Prostate Cancer [NCT01017939]Phase 134 participants (Actual)Interventional2010-01-31Completed
A Pilot Study on the Use of Rituximab in the Treatment of Churg- Strauss Syndrome With Renal Involvement [NCT00424749]Phase 24 participants (Actual)Interventional2007-06-30Terminated(stopped due to Company providing study drug terminated study due to lack of funds)
Phase II Study of Pembrolizumab In Combination With R-CHOP for Patients With Untreated, High-Risk, Non-Germinal Center-Derived DLBCL [NCT03995147]Phase 251 participants (Anticipated)Interventional2019-08-29Recruiting
Active Immunization of Sibling Stem Cell Transplant Donors Against Purified Myeloma Protein of the Stem Cell Recipient With Multiple Myeloma in the Setting of Non-Myeloablative, HLA-Matched Allogeneic Peripheral Blood Stem Cell Transplantation [NCT00006184]Phase 220 participants (Actual)Interventional2001-02-08Completed
Randomized Phase III Study for the Treatment of Newly Diagnosed Disseminated Lymphoblastic Lymphoma or Localized Lymphoblastic Lymphoma [NCT00004228]Phase 3393 participants (Actual)Interventional2000-06-30Completed
A Randomized, Double-Blind Phase 3 Study of Ibrutinib in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Subjects With New Onset Chronic Graft Versus Host Disease (cGVHD) [NCT02959944]Phase 3193 participants (Actual)Interventional2017-05-11Completed
A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, 6-Week Study Designed to Investigate the Effects of BDP HFA Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal (HPA) Axis When Administered in Adolescent and Adult Subjects (12 t [NCT01133626]Phase 3107 participants (Actual)Interventional2010-06-30Completed
Phase III,Randomized Controlled Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma [NCT02767674]Phase 3258 participants (Anticipated)Interventional2016-05-31Recruiting
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer [NCT00887198]Phase 31,088 participants (Actual)Interventional2009-04-28Completed
Impact of Obesity on the Pharmacokinetics of Anticancer Therapy in Children With High Risk Acute Lymphoblastic Leukemia (ALL) [NCT00900445]0 participants (Actual)Observational2008-03-24Withdrawn
Safety and Efficacy of Cemiplimab (PD-1 Blockade) in Selected Organ Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma (CONTRAC) [NCT04339062]Phase 112 participants (Anticipated)Interventional2020-07-15Active, not recruiting
Targeting Inflammation and Alloimmunity in Heart Transplant Recipients With Tocilizumab (RTB-004) [NCT03644667]Phase 2200 participants (Anticipated)Interventional2018-12-20Recruiting
Phase I Study of Inotuzumab Ozogamicin With 3 and 4 Drug Augmented Berlin-Frankfurt-Münster (BFM) Re-Induction for Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) [NCT03962465]Phase 136 participants (Anticipated)Interventional2022-07-22Active, not recruiting
A Phase II Trial Using a Universal GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) in the Formulation of Autologous Tumor Cell-Based Vaccines for Patients With Mantle Cell Lymphoma [NCT00101101]Phase 243 participants (Actual)Interventional2004-07-31Completed
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Grass (Phleum Pratense) Sublingual Tablet (SCH 697243) in Adult Subjects With a History of Grass Pollen Induced Rhinoconjunctivitis Wit [NCT00562159]Phase 3439 participants (Actual)Interventional2007-11-30Completed
Phase 1 Study to Evaluate the Safety of REducing the Prophylactic Dose of DEXamethasone Around Docetaxel Infusion in Patients With Early or Advanced Breast Cancer and Prostate Cancer [NCT02776436]Phase 146 participants (Actual)Interventional2016-01-31Active, not recruiting
Clinical, Multicenter, Single-arm, Treatment With a Scheme With Low Doses of Bortezomib / Melphalan / Prednisone (MPV) in Patients With Multiple Myeloma (MM) Newly Diagnosed Symptomatic ≥75 Years [NCT02773550]Phase 424 participants (Actual)Interventional2014-01-31Terminated(stopped due to Low recruiment.)
A Randomized, Open-label, Dose-ranging Study of Oral Delayed Release Prednisone in Patients With Untreated Polymyalgia Rheumatic (PMR) [NCT02702778]Phase 28 participants (Actual)Interventional2016-02-29Terminated(stopped due to lack of study recruitment)
Anti-Androgens and Cabazitaxel in Defining Complete Response in Prostatectomy (ACDC-RP Trial): A Randomized, Open-label, Multi-centre Phase-2 Study Evaluating the Pathological Complete Response (pCR) Rate Following Neoadjuvant Therapy in Participants With [NCT02543255]Phase 276 participants (Actual)Interventional2016-09-30Completed
Randomized Phase II Study of Docetaxel Versus Cabazitaxel Post Abiraterone or Enzalutamide Progression [NCT03764540]Phase 2214 participants (Anticipated)Interventional2019-04-01Recruiting
A Study of Safety and Efficacy of Leflunomide for Maintenance of Remission in IgG4 Related Disease [NCT02703194]Phase 468 participants (Actual)Interventional2016-03-31Completed
Sequential, Related Donor Partial Liver Transplantation Followed by Bone Marrow Transplantation for Fibrolamellar or Non-fibrolamellar Hepatocellular Carcinoma (HCC) Including Fibrolamellar HCC [NCT02702960]Phase 20 participants (Actual)Interventional2016-03-31Withdrawn(stopped due to This study was withdrawn due to lack of necessary resources from the liver transplant surgical group.)
Multicenter, Randomized, Controlled (Comparative), Open, Prospective Study Evaluating an Efficacy of R-DA-EPOCH-21, R-mNHL-BFM-90 and (Auto-SCT)in Patients With DLBCL [NCT02842931]Phase 3300 participants (Anticipated)Interventional2015-02-28Recruiting
A Phase 2, Randomized, Double-blind Placebo-controlled Study to Test the Efficacy and Safety of KPL-301 in Giant Cell Arteritis [NCT03827018]Phase 270 participants (Actual)Interventional2018-09-20Completed
European Network-Paediatric Hodgkin Lymphoma Study Group (EuroNet-PHL) Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents [NCT02684708]Phase 32,200 participants (Anticipated)Interventional2015-10-01Active, not recruiting
Mycophenolate Mofetil Treatment With Neuromyelitis Optica Spectrum Disorders in Chinese Patients [NCT02809079]Phase 4100 participants (Anticipated)Interventional2016-01-31Enrolling by invitation
Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis [NCT00956059]40 participants (Anticipated)Interventional2009-09-30Not yet recruiting
A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel Group, 6-Week Study to Evaluate the Effect of Multiple Doses of FlutiForm™ 250/10 Microgram HFA pMDI Twice Daily, FlutiForm™ 100/10 Microgram HFA pMDI Twice Daily, Prednisone and Placebo [NCT00657774]Phase 1160 participants (Anticipated)Interventional2008-04-30Completed
Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma [NCT00644306]Phase 3232 participants (Actual)Interventional2002-04-30Terminated(stopped due to survival advantage demonstrated)
A Phase II Pilot Trial of Bortezomib (PS-341, Velcade) in Combination With Intensive Re-Induction Therapy for Children With Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL) [NCT00873093]Phase 2148 participants (Actual)Interventional2009-03-31Completed
An Open, Multicentre, Randomised, Parallel Group Pilot-Study to Compare Safety and Efficacy of Discontinuation of Mycophenolate Mofetil From a Tacrolimus/MMF/Steroid Triple Regimen Following Kidney Transplantation [NCT00693381]Phase 3152 participants (Actual)Interventional2003-02-28Completed
A Prospective Phase II Trial of Modified MRC UKALL Ⅻ/ECOG E2993 Regimen in the Treatment of Low Risk Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia for Young Adults [NCT02660762]Phase 2100 participants (Anticipated)Interventional2016-01-31Recruiting
A QT/QTc and Multi-dose PK Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration- Resistant Prostate Cancer [NCT00910754]Phase 133 participants (Actual)Interventional2009-05-31Completed
A Phase 2, Randomized, Open-Label Study of Infliximab and Lower Exposure Corticosteroids vs Methylprednisolone and Higher Exposure Oral Corticosteroids for the Management of Immune-Related Severe or Persistent Diarrhea in Patients Treated With Yervoy (Ipi [NCT02763761]Phase 20 participants (Actual)Interventional2016-08-16Withdrawn(stopped due to Insufficient enrollment)
An Open-Label, Multi-Centre, Randomised, Phase Ib Study to Investigate the Safety and Efficacy of RO5072759 Given in Combination With CHOP, FC or Bendamustine Chemotherapy in Patients With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma [NCT00825149]Phase 1137 participants (Actual)Interventional2009-02-28Completed
DFCI ALL Adult Consortium Protocol: Adult ALL Trial [NCT01005758]Phase 2180 participants (Anticipated)Interventional2009-01-31Not yet recruiting
Phase I/II Randomized, Double-blind, Placebo-controlled Cross-over Study of Prednisone on Airway Inflammatory Response to Inhaled Wood Smoke. [NCT03861390]Phase 1/Phase 214 participants (Anticipated)Interventional2019-03-22Recruiting
Randomization of Cytarabine Monotherapy Versus Standard-of-Care Vinblastine/Prednisone for Frontline Treatment of Langerhans Cell Histiocytosis (TXCH LCH0115) [NCT02670707]Phase 3124 participants (Anticipated)Interventional2016-03-07Recruiting
Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD) [NCT04918147]Phase 275 participants (Anticipated)Interventional2021-10-13Recruiting
Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3×CD20) in Japanese Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma - A Phase 1/2, Open-Label, Dose-Escalation Trial With Expansion Cohorts [NCT04542824]Phase 1/Phase 2102 participants (Anticipated)Interventional2020-08-20Active, not recruiting
A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects With Active Proliferative Glomeru [NCT00430677]Phase 2/Phase 3423 participants (Actual)Interventional2007-06-30Terminated(stopped due to Terminated due to failure to meet the primary efficacy endpoint in the Short-term Period)
A Randomized, Open-label, Multi-center Phase III Trial Comparing Tisagenlecleucel to Standard of Care in Adult Participants With Relapsed or Refractory Follicular Lymphoma (FL) [NCT05888493]Phase 3108 participants (Anticipated)Interventional2023-10-02Recruiting
A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy With Immuno-oncology Therapy for Children and Adults With Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma [NCT05675410]Phase 31,875 participants (Anticipated)Interventional2023-05-11Recruiting
An Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of Caplacizumab and Immunosuppressive Therapy Without Firstline Therapeutic Plasma Exchange in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura [NCT05468320]Phase 361 participants (Anticipated)Interventional2022-11-21Recruiting
Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination With Anti-Neoplastic Agents in Subjects With Non-Hodgkin Lymphoma [NCT05283720]Phase 2394 participants (Anticipated)Interventional2022-06-14Recruiting
A Phase II/III Randomized Study of R-MiniCHOP With or Without CC-486 (Oral Azacitidine) in Participants Age 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma, Grade IIIB Follicular Lymphoma, Transformed Lymphoma, and High-Grade B-Cell L [NCT04799275]Phase 2/Phase 3422 participants (Anticipated)Interventional2021-05-20Recruiting
A Phase 3 Trial Investigating Blinatumomab (NSC# 765986) in Combination With Chemotherapy in Patients With Newly Diagnosed Standard Risk or Down Syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients With Localized B-Lymphoblastic Lymphom [NCT03914625]Phase 36,720 participants (Anticipated)Interventional2019-07-03Recruiting
Phase I/II Study of Lenalidomide (Revlimid), Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R2CHOP) Chemoimmunotherapy in Patients With Newly Diagnosed Diffuse Large Cell and Follicular Grade IIIA/B B Cell Lymphoma [NCT00670358]Phase 1/Phase 2138 participants (Actual)Interventional2008-08-25Active, not recruiting
A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Pemphigus (Vulgaris or Foliaceus) [NCT04598451]Phase 3222 participants (Actual)Interventional2020-12-01Completed
A Phase 1 PK and Dose Escalation and Expansion Study of DST-2970 in Patients With Prostate Cancer With Rising PSA on Treatment With Abiraterone Acetate [NCT04291664]Phase 154 participants (Anticipated)Interventional2020-01-31Active, not recruiting
A Multicenter, Randomized, Open-lable, Parallel-controlled, Phase I/II Trial to Study Efficacy and Safety of Substitution of Glucocorticoid for BDB-001 Injection in Patients With ANCA-associated Vasculitis [NCT05197842]Phase 1/Phase 2100 participants (Anticipated)Interventional2022-02-22Recruiting
A Phase II Study of Modified VR-CAP and Acalabrutinib as First Line Therapy for Transplant-Eligible Patients With Mantle Cell Lymphoma [NCT04626791]Phase 245 participants (Anticipated)Interventional2021-08-03Recruiting
A Phase II Study of Cyclophosphamide, Etoposide, Vincristine and Prednisone (CEOP) Alternating With Pralatrexate (P) as Front Line Therapy for Patients With Stage II, III and IV Peripheral T-Cell Non-Hodgkin Lymphoma [NCT01336933]Phase 234 participants (Actual)Interventional2011-07-06Completed
Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin Lymphoma [NCT00352027]Phase 281 participants (Actual)Interventional2006-07-20Completed
A Phase 1 Study of R-CHOP Plus SYK Inhibitor TAK-659 for the Front-Line Treatment of High-Risk Diffuse Large B Cell Lymphoma (DLBCL) [NCT03742258]Phase 112 participants (Actual)Interventional2019-03-13Active, not recruiting
A Comparison of Three Different Formulations of Topical Prednisolone Acetate 1% for Control of Post Glaucoma and/or Cataract Surgery Inflammation. [NCT00345046]Phase 460 participants (Actual)Interventional2002-09-30Completed
An Open Label, Multicenter, Non Randomized Phase II Study to Evaluate Antitumor Efficacy and Safety of GM-CSF (Sargramostim, Leukine®) Associated With RCHOP Chemotherapy and Rituximab (MabThera®) Maintenance in Patients With First-line Advanced Follicular [NCT00896519]Phase 230 participants (Anticipated)Interventional2009-03-31Not yet recruiting
The Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis With Mild Proteinuria in Children [NCT02532790]Phase 2100 participants (Anticipated)Interventional2015-08-31Recruiting
A Prospective, Phase II/III Randomized, Mult-institutional Controlled, Open-label, Phase II Trial of Rituximab Versus Oral Cyclophosphamide to Eradicate or Suppress Autoimmune Anti-Factor VIII Antibodies in Patients With Acquired Hemophilia A [NCT00306670]Phase 2/Phase 32 participants (Actual)Interventional2006-04-30Terminated(stopped due to Sponsor no longer funding study.)
Multicenter Study of Phase II With Rituximab, Cyclophosphamide, Doxorubicin Liposomal (Myocet ®), Vincristine, Prednisone, (R-COMP) in Non-Hodgkin's Lymphoma Diffuse Large B Cell in Cardiopathic Patients [NCT01009970]Phase 250 participants (Anticipated)Interventional2010-05-31Recruiting
A Phase I/II Study of Azacitidine (Vidaza), Docetaxel and Prednisone for Patients With Hormone Refractory Metastatic Prostate Cancer Previously Treated With a Taxotere Containing Regimen. [NCT00503984]Phase 1/Phase 222 participants (Actual)Interventional2007-05-31Terminated(stopped due to Withdrawal of Funding)
A Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study With and Without Enzastaurin in Combination With Docetaxel and Prednisone, Followed By Enzastaurin Maintenance as First-Line Treatment in Hormone Refractory Metastatic Prostate Cancer Patient [NCT00466440]Phase 2108 participants (Actual)Interventional2007-06-30Completed
A Phase 2, Multicenter, Open-Label Study of CNTO 328 (Anti-IL-6 Monoclonal Antibody) in Combination With Mitoxantrone Versus Mitoxantrone in Subjects With Metastatic Hormone-Refractory Prostate Cancer (HRPC) [NCT00385827]Phase 2106 participants (Actual)Interventional2006-11-30Terminated(stopped due to Prematurely stopped after Independent Data Monitoring Committee (IDMC) evaluation for lack of efficacy.)
An Open-labeled, Randomized, Two-dose, Parallel Group Trial of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Combination With CHOP, in Patients With Previously Untreated Follicular Lymphoma (FL). [NCT00494780]Phase 259 participants (Actual)Interventional2007-06-30Completed
Randomized Phase 3b Study of Three Treatment Regimens in Subjects With Previously Untreated Multiple Myeloma Who Are Not Considered Candidates for High-Dose Chemotherapy and Autologous Stem Cell Transplantation: VELCADE, Thalidomide, and Dexamethasone Ver [NCT00507416]Phase 3502 participants (Actual)Interventional2007-06-30Completed
The Effects of Glucocorticoids on Mortality and Renal Function in Patients With Acute Decompensated Heart Failure [NCT00953303]Phase 2/Phase 3102 participants (Actual)Interventional2009-01-31Completed
Treatment of Shentong Granules Plus Prednisone on Patients With Severe IgA Nephropathy(Ying-deficiency of the Liver and Kidney Pattern): a Randomized, Double-blind,Placebo-controlled Multicentre Clinical Trial [NCT02712697]140 participants (Anticipated)Interventional2016-06-30Not yet recruiting
A Multi-Center, Single-Blind, Randomized Study Comparing Thymectomy to No Thymectomy in Non-Thymomatous Myasthenia Gravis (MG) Patients Receiving Prednisone [NCT00294658]Phase 3126 participants (Actual)Interventional2006-06-30Completed
Phase II Trial of Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab Plus Bevacizumab for Advanced Stage Diffuse Large B-Cell NHL [NCT00121199]Phase 273 participants (Actual)Interventional2005-06-30Completed
Phase II Study of the Dose Adjusted EPOCH Regimen in Combination With Ofatumumab/Rituximab as Therapy for Patients With Newly Diagnosed or Relapsed/Refractory Burkitt Leukemia or Relapsed/Refractory Acute Lymphoblastic Leukemia [NCT02199184]Phase 26 participants (Actual)Interventional2015-01-14Completed
SIMPLE Study: A Prospective and Randomized Trial of a Simplified Immunosuppressive Protocol Utilizing Low Dose EnvarsusXR [NCT04773392]Phase 480 participants (Anticipated)Interventional2021-11-23Recruiting
SAABR: Single Arm Phase II Study of AR Targeted Therapy + Atezolizumab + GnRH Analog and Stereotactic Body Radiotherapy (SBRT) to the Prostate in Men With Newly Diagnosed Hormone-sensitive Metastatic Prostate Cancer [NCT04262154]Phase 228 participants (Actual)Interventional2020-03-03Active, not recruiting
Phase 2 Clinical Trial for Comprehensive Treatment Program for Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN): Tagraxofusp (SL-401) in Combination With HCVAD/Mini-CVD and VENETOCLAX [NCT04216524]Phase 240 participants (Anticipated)Interventional2020-05-29Recruiting
A Phase 1 Study of ABL001 in Combination With Dasatinib, Prednisone, and Blinatumomab in Patients With BCR-ABL Positive (BCR-ABL+) B-cell Acute Lymphoblastic Leukemia (B-ALL) and Chronic Myeloid Leukemia (CML) [NCT03595917]Phase 140 participants (Anticipated)Interventional2018-07-24Recruiting
Efficacy of Alternating Immunochemotherapy Consisting of R-CHOP + R-HAD vs R-CHOP Alone, Followed by Maintenance Therapy Consisting of Additional Lenalidomide + Rituximab vs Rituximab Alone for Older Patients With Mantle Cell Lymphoma [NCT01865110]Phase 3623 participants (Actual)Interventional2013-11-30Active, not recruiting
International Phase II Study Evaluating the Association of CHOP-rituximab With Consolidation by Early Ibritumomab Tiuxetan-Y90 in Patients Aged 65 to 80 Years With CD20+ Large Cell Malignant Lymphoma and no Prior Therapy [NCT00690560]Phase 230 participants (Actual)Interventional2007-05-31Completed
A Randomized, Double-Blind, Controlled, Phase II Multicenter Trial of CTLA4Ig (Abatacept) Plus Cyclophosphamide vs Cyclophosphamide Alone in the Treatment of Lupus Nephritis [NCT00774852]Phase 2137 participants (Actual)Interventional2008-11-30Completed
An Open, Randomized, Multicentre Clinical Study to Compare the Safety and Efficacy of a Combination of Sequential Therapy of Tacrolimus (FK506) With Monoclonal Anti-IL2R Antibodies and Mycophenolate Mofetil Versus Tacrolimus (FK506) With Steroids in Liver [NCT00693524]Phase 294 participants (Actual)Interventional2002-11-30Completed
Pilot Study of RCVELP as First Line Therapy for Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL) [NCT00772668]3 participants (Actual)Interventional2009-09-25Terminated(stopped due to Funding)
Adjusted Steroid Therapy in Children With Idiopathic Nephrotic Syndrome [NCT02649413]Phase 475 participants (Anticipated)Interventional2016-03-31Not yet recruiting
Renal Allograft Tolerance Through Mixed Chimerism [NCT00801632]Phase 25 participants (Actual)Interventional2008-12-31Completed
Phase II Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis [NCT02496585]Phase 233 participants (Anticipated)Interventional2015-07-31Active, not recruiting
Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer Who Have Relapse in Biochemistry Whilst Androgenic Blockage [NCT00705822]Phase 354 participants (Actual)Interventional2006-08-31Terminated(stopped due to low recruitment rate)
A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging [NCT00822120]Phase 2371 participants (Actual)Interventional2009-07-31Completed
Short Term Low Dose Corticosteroids for Management of Post Covid-19 Pulmonary Fibrosis [NCT04551781]450 participants (Actual)Interventional2020-04-01Completed
Prospective Multicenter Randomized Open-label Controlled Trial Assessing Efficacy and Safety of DAPSone as a Second-line Option in Adult Immune Thrombocytopenia [NCT02627417]Phase 3216 participants (Anticipated)Interventional2015-12-31Recruiting
"Reduction of Corticosteroid Use in Outpatient Treatment of Exacerbated COPD - a Randomized, Double-blind, Non-inferiority Study (The RECUT-Trial)" [NCT02386735]470 participants (Anticipated)Interventional2015-03-31Recruiting
The Use of Thymoglobulin in a Calcineurin Inhibitor and Steroid Minimization Protocol [NCT00706680]Phase 430 participants (Anticipated)Interventional2008-02-29Recruiting
Prospective Observational Trial to Evaluate Clinical Prognosis and the Risk Factors for Progression for Myasthenia Gravis Patients [NCT04101578]2,000 participants (Anticipated)Observational2017-02-08Recruiting
Circadian Variation in Cytokines and the Effect of Timed Release Tablet Prednisone in Polymyalgia Rheumatica [NCT00836810]Phase 2/Phase 312 participants (Actual)Interventional2009-10-31Completed
A Phase III Multicenter, Open-label Study of Rituximab Alternative Dosing Rate in Patients With Previously Untreated Diffuse Large B-cell or Follicular Non-Hodgkin's Lymphoma [NCT00719472]Phase 3451 participants (Actual)Interventional2008-07-31Completed
Phase II Study to Establish Gene Expression Models Predicting Survival of Diffuse Large B-Cell Lymphoma Patients Treated With R-CHOP [NCT00450385]Phase 257 participants (Actual)Interventional2007-04-24Terminated(stopped due to Investigator Decision due to insufficient accrual.)
Randomized Study Comparing 4 and 6 Cycles of Chemotherapy With CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) at 21-day Intervals, Both With 6 Cycles of Immunotherapy With the Monoclonal Anti-CD20-Positive B-Cell Lymphoma Aged 18-60 Year [NCT00278421]Phase 3592 participants (Actual)Interventional2005-11-30Completed
A Phase I/II of Vorinostat Plus CHOP in Untreated T-cell Non-Hodgkin's Lymphoma [NCT00787527]Phase 1/Phase 214 participants (Actual)Interventional2008-11-30Completed
Corticosteroids and Azathioprine Versus Corticosteroids Alone in IgA Nephropathy: a Randomized Controlled Trial. [NCT00755859]Phase 4206 participants (Actual)Interventional1998-05-31Completed
A Prospective, Single Arm, Open-label, Phase II Study of Chidamide in Combination With R-CHOP in the Treatment of de Novo, Elderly, High-risk Diffuse Large B-cell Lymphoma [NCT02753647]Phase 249 participants (Anticipated)Interventional2016-04-30Recruiting
A Two-Arm, Non-Randomized, Multicenter, Phase 2 Study of VELCADE (Bortezomib) in Combination With Rituximab, Cyclophosphamide, and Prednisone With or Without Doxorubicin Followed by Rituximab Maintenance in Patients With Relapsed Follicular Lymphoma. [NCT00715208]Phase 255 participants (Actual)Interventional2008-09-30Completed
A Phase 2, Multicenter, Randomized Study of IMC-A12 or IMC-1121B Plus Mitoxantrone and Prednisone in Metastatic Androgen-Independent Prostate Cancer (AIPC) Following Disease Progression on Docetaxel-Based Chemotherapy [NCT00683475]Phase 2138 participants (Actual)Interventional2008-08-31Completed
Colchicine or Prednisone for the Treatment of Acute Calcium Pyrophosphate Deposition (CPPD) Arthritis: Open-label, Randomized, Multicenter, Equivalence Trial of Efficacy and Safety [NCT03128905]Phase 3111 participants (Actual)Interventional2018-02-05Completed
Comparison of the Efficacy and Safety of Leflunomide Versus Placebo Combine With the Basic Prednisone Therapy in Patients With Active Phase of Takayasu's Arteritis: a Randomized Controlled Double-blinded Trial [NCT02981979]116 participants (Anticipated)Interventional2016-12-31Recruiting
Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment (Prednisone 5 Milligram Per Day) in Quiescent Systemic Lupus [NCT02558517]Phase 3136 participants (Anticipated)Interventional2014-01-31Recruiting
A Randomized Trial of the I-BFM-SG for the Management of Childhood Non-B Acute Lymphoblastic Leukemia [NCT00764907]Phase 34,000 participants (Anticipated)Interventional2002-11-30Recruiting
Optimum Immunosuppression in Renal Transplant Recipients at High Risk of Developing New Onset Diabetes After Transplantation: A Multicenter, Prospective, Controlled and Randomized Trial. [NCT01002339]Phase 4134 participants (Actual)Interventional2010-02-28Terminated(stopped due to Terminated: higher rate of acute rejection in the Cyclosporin A group)
An Open-Label, Randomized, Phase 2 Study to Assess the Effectiveness of RCHOP With or Without VELCADE in Previously Untreated Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma Patients [NCT00931918]Phase 2206 participants (Actual)Interventional2009-10-31Completed
Randomized Phase II Trial of Docetaxel With or Without PSA-TRICOM Vaccine in Patients With Castrate-Resistant Metastatic Prostate Cancer [NCT01145508]Phase 210 participants (Actual)Interventional2010-08-31Terminated(stopped due to Poor accrual)
Phase III Randomized Trial of Autologous and Allogeneic Stem Cell Transplantation Versus Intensive Conventional Chemotherapy in Acute Lymphoblastic Leukemia in First Remission [NCT00002514]Phase 31,929 participants (Actual)Interventional1993-05-07Completed
A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Inactive Non-infectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis - Including a Sub-study in Japanese Patients [NCT01124838]Phase 3261 participants (Actual)Interventional2010-08-31Completed
A Multicenter, Four Arm, Randomized, Open Label Clinical Study Investigating Optimized Dosing in a Prograf®-/Advagraf®-Based Immunosuppressive Regimen in Kidney Transplant Subjects (OSAKA Study) [NCT00717470]Phase 41,252 participants (Actual)Interventional2008-05-14Completed
A Randomized, Double-blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of Belumosudil in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chro [NCT06143891]Phase 3240 participants (Anticipated)Interventional2023-11-30Recruiting
Smart Stop: A Phase II Trial of Rituximab, Lenalidomide, Acalabrutinib, Tafasitamab Prior to and With Standard Chemotherapy for Patients With Newly Diagnosed DLBCL [NCT04978584]Phase 260 participants (Anticipated)Interventional2022-03-03Recruiting
A Phase 1/2 Study of Intravenous Gene Transfer With an AAV9 Vector Expressing Human Beta-galactosidase in Type I and Type II GM1 Gangliosidosis [NCT03952637]Phase 1/Phase 217 participants (Actual)Interventional2019-08-19Active, not recruiting
Glucocorticoid Withdrawal and Glucocorticoid-induced Adrenal Insufficiency: a Randomized Controlled Multicenter Trial [NCT03153527]Phase 4573 participants (Anticipated)Interventional2017-05-31Recruiting
Targeted Oncolytic Virotherapy and Natural History Study of KSHV-Associated Multicentric Castleman's Disease With Laboratory and Clinical Correlates of Disease Activity [NCT00092222]Phase 275 participants (Actual)Interventional2004-10-28Active, not recruiting
P-CO-Li (Pulmonary Covid-19 Longterm Intervention Study) [NCT04782700]0 participants (Actual)Interventional2021-04-01Withdrawn(stopped due to Due to recruitment we decided to withdraw the study.)
Pilot Study for Therapy Optimising for Hodgkin's Lymphoma in Childhood and Adolescence; Optimising Therapy for Boys With Hodgkin's Lymphoma in Intermediate and Advanced Stages. Safety and Efficacy Study for Drug Combination VECOPA [NCT00398554]Phase 216 participants (Actual)Interventional2005-06-30Completed
Randomized, Prospective Single-center Study Comparing a Rapid Discontinuation of Corticosteroids (Steroid Withdrawal) With Corticosteroid Therapy in Kidney Transplantation Using Mycophenolate Mofetil and Tacrolimus Maintenance Therapy [NCT00596947]Phase 418 participants (Actual)Interventional2005-10-31Terminated(stopped due to due to low study enrollment)
The Effects of Treatment of Subclinical Rejection on Renal Histology and Graft Function in Renal Transplant Patients Receiving Tacrolimus and Mycophenolate Mofetil [NCT00885820]Phase 4240 participants (Actual)Interventional2001-09-30Completed
A Prospective Study of Bortezomib Combined With CHEP Regimen in the Treatment of Primary Peripheral T Cell Lymphoma [NCT04061772]Phase 254 participants (Anticipated)Interventional2019-08-12Recruiting
A Phase II Study of Satraplatin and Prednisone in Metastatic Androgen Independent Prostate Cancer (AIPC) [NCT00634647]Phase 224 participants (Actual)Interventional2008-02-19Completed
Vaginal Prednisone Administration for Prevention of Adrenal Crisis - a Bioequivalence Study [NCT02689960]Phase 212 participants (Actual)Interventional2017-01-31Completed
A Phase I Study Evaluating the Safety, Tolerability and Biological Activity of EZN-3042, a Survivin mRNA Antagonist, Administered With Re-induction Chemotherapy in Children With Relapsed Acute Lymphoblastic Leukemia (ALL) [NCT01186328]Phase 16 participants (Actual)Interventional2010-08-24Terminated(stopped due to Enzon Pharmaceuticals decided to end its development of EZN-3042.)
Budesonide Inhalation Suspension for Acute Asthma in Children [NCT00393367]Phase 4179 participants (Actual)Interventional2006-12-31Completed
An Open Label, Multicenter, Phase I/II Study of IBI377 in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease [NCT04220632]Phase 1/Phase 21 participants (Actual)Interventional2020-06-18Terminated(stopped due to Adverse events of the first patient)
Effects of p38 Inhibitor AZD7624 in Corticosteroid Resistant Asthma [NCT02753764]Phase 22 participants (Actual)Interventional2017-01-31Completed
Single Center, Open-label Randomized Prospective Trial: Effect of Sirolimus on Polycystic Liver Disease [NCT00934791]2 participants (Actual)Interventional2009-02-28Terminated(stopped due to Terminated due to inadequate enrollment)
A Phase 1 Study Of Palbociclib (IND#141416), A CDK 4/6 Inhibitor, In Combination With Chemotherapy In Children With Relapsed Acute Lymphoblastic Leukemia (ALL) Or Lymphoblastic Lymphoma (LL) [NCT03792256]Phase 115 participants (Anticipated)Interventional2019-04-11Active, not recruiting
AN OPEN-LABEL, PHASE 1 STUDY OF R-CVP OR R-GDP IN COMBINATION WITH INOTUZUMAB OZOGAMICIN IN SUBJECTS WITH CD22-POSTIVE NON-HODGKIN'S LYMPHOMA [NCT01055496]Phase 1103 participants (Actual)Interventional2010-03-31Completed
Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery [NCT02703376]Phase 18 participants (Anticipated)Interventional2016-01-31Recruiting
Phase II Study of Treatment of Relapsed Agressive Lymphomas [NCT00842595]Phase 250 participants (Actual)Interventional2003-12-31Completed
A Phase I/Ib Study of Alisertib Plus R-EPOCH for Treatment of Myc-Positive Aggressive B-Cell Lymphomas [NCT02700022]Phase 11 participants (Actual)Interventional2016-10-31Terminated(stopped due to Lack of funding)
Serum Free Fatty Acids Desaturase Activity Indices in Sera of Patients on Long-term High-dose Corticosteroid Treatment [NCT02872584]20 participants (Anticipated)Observational2016-09-30Not yet recruiting
Explore the Relationship Between Single Nucleotide Polymorphisms and Abiraterone Response and Toxicity in Patients With Prostate Cancer. [NCT03348670]Phase 2/Phase 3600 participants (Anticipated)Interventional2023-08-18Active, not recruiting
A Phase 2a, Randomized, Open-label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients [NCT01780844]Phase 2149 participants (Actual)Interventional2013-03-05Completed
A Phase Ib/II Study Evaluating the Safety, Tolerability and Anti-Tumor Activity of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With B-Cell Non-Hodgkin's Lymphoma [NCT01992653]Phase 1/Phase 285 participants (Actual)Interventional2013-11-29Completed
A Study of HSP90 Inhibitor AT13387 Alone or in Combination With Abiraterone Acetate in the Treatment of Castration-Resistant Prostate Cancer (CRPC) no Longer Responding to Abiraterone [NCT01685268]Phase 1/Phase 249 participants (Actual)Interventional2012-09-30Completed
Phase I Study of Docetaxel, Prednisone and Pazopanib in Men With Metastatic Castrate-Resistant Prostate Cancer (mCRPC) and Poor-Risk Factors [NCT01385228]Phase 136 participants (Actual)Interventional2011-06-30Completed
A Multicenter, Randomized, Double-Blind, Phase 3 Study Of Sunitinib Plus Prednisone Versus Prednisone In Patients With Progressive Metastatic Castration-Resistant Prostate Cancer After Failure Of A Docetaxel-Based Chemotherapy Regimen [NCT00676650]Phase 3873 participants (Actual)Interventional2008-07-31Terminated(stopped due to Study A6181120 was prematurely discontinued due to futility on 27 September 2010. No new or unexpected safety issues were identified.)
A Multicenter Phase IB Dose Escalation Study to Evaluate the Safety, Feasibility and Efficacy of the Torisel-Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (T-R-CHOP), Torisel-Rituximab-Fludarabine-Cyclophosphamide (T-R-FC) and Torisel-Ritu [NCT01389427]Phase 1/Phase 241 participants (Actual)Interventional2011-11-30Completed
Steroids and Azathioprine in Early and Advanced IgA Nephropathy: Amendments to a Prospective Randomised Multicenter Trial [NCT01392833]Phase 346 participants (Actual)Interventional1999-12-31Completed
Phase 1b/2, Open-Label Trial to Evaluate Safety and Preliminary Efficacy of Epcoritamab As Monotherapy or Combined With Standard-of-Care Therapies in Chinese Subjects With B-Cell Non-Hodgkin Lymphoma [NCT05201248]Phase 149 participants (Actual)Interventional2022-03-10Active, not recruiting
A Randomised, Double Blind, Controlled Mechanistic Study of Rituximab and Belimumab Combination Therapy in PR3 ANCA-associated Vasculitis [NCT03967925]Phase 231 participants (Actual)Interventional2019-02-01Active, not recruiting
Diagnosis and Treatment of Male Infertility Related to Inflammatory Syndrome: Therapeutic Trial [NCT01407484]200 participants (Actual)Interventional2011-03-02Completed
Inflammatory, Functional and Image Composite Measure to Define Asthma Control [NCT00597064]Phase 470 participants (Anticipated)Interventional2006-07-31Recruiting
Phase IV Study of Oral Prednisone Taper vs. Placebo Following Intravenous Steroids for the Treatment of Acute Relapses in Multiple Sclerosis Within the Ticino Cohort [NCT01411514]Phase 427 participants (Actual)Interventional2011-08-31Terminated(stopped due to Difficulties to recruit patients)
A Therapeutic Exploratory Study to Determine the Efficacy and Safety of Calcineurin-Inhibitor-Free De-novo Immunosuppression After Liver Transplantation [NCT00890253]Phase 229 participants (Anticipated)Interventional2010-01-31Recruiting
A Phase 2 Trial of Rituximab and Corticosteroid Therapy for Newly Diagnosed Chronic Graft Versus Host Disease [NCT00350545]37 participants (Actual)Interventional2006-08-31Completed
A Multi-Centered, Randomized, Double-Blind, Placebo Controlled Study Assessing the Add-on Effect of Oral Steroids in Relapsing Remitting Multiple Sclerosis Subjects Treated With Glatiramer Acetate (GA) [NCT00203047]Phase 4414 participants (Actual)Interventional2005-01-31Terminated(stopped due to Slow enrollment decreased sample size; No unexpected safety issues.)
Randomized, Multi-Center Comparative Trial of Tacrolimus w/Steroids and Standard Daclizumab Induction vs a Novel Steroid-Free Tacrolimus Based Immunosuppression Protocol w/ Extended Daclizumab Induction in Pediatric Renal Transplantation [NCT00141037]Phase 1/Phase 2130 participants (Actual)Interventional2004-03-31Completed
A Phase II, Open-Label, Multi-Center, Prospective, Randomized Study of LCP-Tacro Tablets vs. Azathioprine, in Combination With Corticosteroids, for the Treatment of Autoimmune Hepatitis [NCT00608894]Phase 213 participants (Actual)Interventional2007-12-31Terminated(stopped due to Study was discontinued due to slow enrollment)
A Randomized Phase II Study of Dose-Adjusted EPOCH-R and R-VACOP-B in Primary Mediastinal (Thymic) Large B-Cell Lymphoma [NCT00983944]Phase 20 participants (Actual)Interventional2009-09-30Withdrawn(stopped due to Inadequate Accrual)
A Randomized, Phase III, Placebo-Controlled Multicenter Study to Demonstrate the Effectiveness and Safety of the Combination Enzyme Tablet (Wobe-Mugos E) as Adjuvant Therapy to Standard of Care Treatment in Patients With Stages II or III Multiple Myeloma [NCT00014339]Phase 30 participants Interventional2000-03-31Active, not recruiting
A Phase III, Randomized, Open-label, 3-arm Study to Determine the Efficacy and Safety of Lenalidomide(REVLIMID) Plus Low-dose Dexamethasone When Given Until Progressive Disease or for 18 Four-week Cycles Versus the Combination of Melphalan, Prednisone, an [NCT00689936]Phase 31,623 participants (Actual)Interventional2008-08-21Completed
A Pilot Study of Intravenous EZN-2285 (SC-PEG E. Coli L-asparaginase) or Intravenous Oncaspar® in the Treatment of Patients With High-Risk Acute Lymphoblastic Leukemia (ALL) [NCT00671034]Phase 3166 participants (Actual)Interventional2008-07-21Completed
A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Adjuvant Azathioprine Therapy in New Cases of Pemphigus Vulgaris Receiving Prednisone [NCT00626678]Phase 248 participants (Anticipated)Interventional2008-01-31Completed
A Randomized, Parallel-Cohort Phase 1 Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute Graft Versus Host Disease [NCT02614612]Phase 131 participants (Actual)Interventional2015-12-31Completed
A Phase 1 Study of Combining Ibrutinib, Dasatinib and Prednisone in Patients 60 Years or Older With Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia [NCT02815059]Phase 10 participants (Actual)Interventional2016-09-28Withdrawn(stopped due to Termination of Investigator Initiated Studies using Ibrutinib)
ACADEMIC: A Randomized Phase II Clinical Trial of ADT Combined With Abiraterone or Docetaxel in Metastatic Hormone Sensitive Prostate Cancer [NCT03827473]Phase 21 participants (Actual)Interventional2019-02-08Terminated(stopped due to The trial was closed because the changing standard of care landscape, making this trial not impactful anymore.)
Prospective Study of Apalutamide and Abiraterone Acetate iN ChemoTHerapy-Naïve mEn With mCRPC Stratified by Race [NCT03098836]Phase 293 participants (Actual)Interventional2017-07-10Active, not recruiting
The Combination of Lower Dosage of Chemotherapy With Tyrosine Kinase Inhibitor to Treat Newly Diagnosed ph+ Acute Lymphoblastic Leukemia Patients [NCT02690922]Phase 440 participants (Anticipated)Interventional2016-03-31Not yet recruiting
An Open-label, Randomized, Phase 3 Study Of Inotuzumab Ozogamicin (Cmc-544) Administered In Combination With Rituximab Compared To A Defined Investigator's Choice Therapy In Subjects With Relapsed Or Refractory, Cd22- Positive, Follicular B-cell Non Hodgk [NCT00562965]Phase 329 participants (Actual)Interventional2007-11-30Terminated(stopped due to See termination reason in detailed description.)
A Randomised Multicentric Phase III Study for the Treatment of Young Patients With High Risk (IPI 2-3) Diffuse Large B-Cell Lymphoma. Dose Dense Chemotherapy + Rituximab +/- Intensified High Dose Chemoimmunotherapy With Support of Peripheral Autologous St [NCT00499018]Phase 3399 participants (Anticipated)Interventional2006-01-31Active, not recruiting
A Randomized, Single-blind, Placebo-controlled, Crossover Studyto Assess The Dose Response Of Prednisone On Biochemical Andclinical Markers Of Efficacy And Safety In Adult Healthyvolunteers [NCT02767089]Phase 137 participants (Actual)Interventional2005-10-31Completed
Phase 1/2, Open Label, Sequential Cohort Study of a Single Intracranial Dose of AVASPA Gene Therapy for Treatment of Children With Typical Canavan Disease [NCT04833907]Phase 1/Phase 224 participants (Anticipated)Interventional2021-04-01Active, not recruiting
Multicenter Randomized Double-blind Study Comparing the Efficacy and Safety of Rituximab in Combination With Corticosteroids to Corticosteroids Plus Placebo in the Treatment of Non-infectious Active Mixed Cryoglobulinemia Vasculitis [NCT02556866]Phase 214 participants (Actual)Interventional2015-07-17Terminated(stopped due to lack of recruitment)
PITT0503: Clinical Trial of Coenzyme Q10 and Prednisone in Duchenne Muscular Dystrophy [NCT00308113]Phase 33 participants (Actual)Interventional2007-04-30Terminated(stopped due to New enrollment has been suspended, currently following previously enrolled participants)
An Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Subjects >=1 and <=30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic L [NCT03384654]Phase 247 participants (Actual)Interventional2018-05-14Completed
Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365) [NCT02861573]Phase 1/Phase 21,200 participants (Anticipated)Interventional2016-11-17Recruiting
A Randomized Phase 3 Study of Brentuximab Vedotin (SGN-35) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Young Adults [NCT02166463]Phase 3600 participants (Actual)Interventional2015-03-19Active, not recruiting
A Randomized Phase 2 Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Hormone Refractory Prostate Cancer [NCT00642018]Phase 2154 participants (Actual)Interventional2008-03-31Completed
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer [NCT01591122]Phase 3313 participants (Actual)Interventional2012-03-27Completed
Phase I/II, Open-Label Study to Determine Safety and Efficacy of Sotatercept (ACE-011) in Adults With Red Blood Cell Transfusion- Dependent Diamond Blackfan Anemia [NCT01464164]Phase 1/Phase 219 participants (Actual)Interventional2012-01-31Terminated(stopped due to Supporter terminated the study due to no active patients (secondary to travel restrictions due to COVID).)
Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL) [NCT00720109]Phase 2/Phase 363 participants (Actual)Interventional2008-07-14Completed
A Randomized, Open-Label, Multicenter Phase 3 Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone (VcR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Patients With Newly [NCT00722137]Phase 3487 participants (Actual)Interventional2008-05-01Completed
Compare the Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule Versus Combined With Levamisole for Primary Nephrotic Syndrome in Children: A Prospective, Multi-center, Randomized, Double-blind, Non-inferiority Study [NCT05772871]Phase 4402 participants (Anticipated)Interventional2023-04-26Recruiting
A Phase 1b, Open Label, Global, Multicenter, Dose Determination, Randomized Dose Expansion Study to Determine the Maximum Tolerated Dose, Assess the Safety and Tolerability, Pharmacokinetics and Preliminary Efficacy of Iberdomide (CC-220) in Combination W [NCT04884035]Phase 1174 participants (Anticipated)Interventional2021-09-15Recruiting
A Randomized Study of Daily vs. High-dose Weekly Prednisone Therapy in Duchenne Muscular Dystrophy [NCT00110669]Phase 364 participants (Actual)Interventional2004-01-31Completed
Multicenter Randomized Phase II Study of Treatment With R-CHOP vs Bortezomib-R-CAP for Young Patients With Diffuse Large B-cell Lymphoma With Poor IPI. [NCT01848132]Phase 2121 participants (Actual)Interventional2013-10-03Completed
Study of Standardized Treatment of Integrative Medicine With the Severe IgA Nephropath [NCT01879514]200 participants (Anticipated)Interventional2010-01-31Recruiting
A Prospective, Randomized, Open-Label, Pilot Study To Compare The Effect On Carotid Atherosclerosis Of A Tacrolimus-Based Regimen With Conversion From A Tacrolimus- To A Sirolimus-Based Regimen At 3-4 Months Post-Transplant In De Novo Renal Transplant Rec [NCT00311311]Phase 372 participants (Actual)Interventional2006-04-30Terminated(stopped due to See termination reason in detailed description.)
A Multi-Center Phase II Study to Evaluate Tumor Response to Ipilimumab (BMS-734016) Monotherapy in Subjects With Melanoma Brain Metastases [NCT00623766]Phase 299 participants (Actual)Interventional2008-07-31Completed
An Open-label,Multicenter Randomised Study of CTOP/ITE/MTX Compared With CHOP as the First-line Therapy for the New Diagnosed Young Patients With T Cell Non-hodgkin Lymphoma [NCT01746992]Phase 4200 participants (Anticipated)Interventional2012-09-30Active, not recruiting
Treatment of High Risk Adult Acute Lymphoblastic Leukemia [NCT00853008]Phase 4100 participants (Anticipated)Interventional2003-01-31Completed
Randomized Phase II Study of Dose-Adjusted EPOCH vs. NHL-15 Chemotherapy for Patients With Previously Untreated Aggressive Non-Hodgkin's Lymphoma (NHL) [NCT00005964]Phase 259 participants (Actual)Interventional2000-05-31Completed
[NCT00006054]0 participants Interventional2000-03-31Terminated
A Phase II Study of GTI-2040 in Combination With Docetaxel and Prednisone in Hormone-Refractory Prostate Cancer [NCT00087165]Phase 222 participants (Actual)Interventional2005-01-31Completed
[NCT00006055]10 participants Interventional2000-03-31Active, not recruiting
The Efficacy of Oral Prednisone in Treating Langerhans Cell Histiocytosis of Bone in Childhood and Adolescence: A Multi-center, Open-label, Randomized-controlled, Phase II Study [NCT06078969]Phase 2118 participants (Anticipated)Interventional2023-11-01Recruiting
Serologically Active, Clinically Stable Systemic Lupus Erythematosus (SLE) [NCT00000421]Phase 2154 participants (Actual)Interventional1997-09-30Completed
A Multicenter, Randomized, Double Blinded, Placebo-controlled Clinical Trial of Anakinra (Plus Zinc) or Prednisone in Patients With Severe Alcoholic Hepatitis by the AlcHepNet Consortium [NCT04072822]Phase 2147 participants (Actual)Interventional2020-07-10Completed
"Nutritional Ergogenic Aids: The Effects of Carbohydrate-Protein Supplementation During Endurance Exercise" [NCT00972387]12 participants (Actual)Interventional2009-08-31Completed
A National, Multi-Center, Open-Label Study of Velcade in Combination With Melphalan and Prednisone (V-MP) in Older Untreated Multiple Myeloma Patients. [NCT00388635]Phase 1/Phase 260 participants (Actual)Interventional2004-04-30Completed
Prospective , Multicentric, Randomized Phase II Study, Evaluating the Role of Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue After Conventional Chemotherapy for Primary Central Nervous System in Young Patients (< 60 y) [NCT00863460]Phase 2140 participants (Actual)Interventional2008-10-03Active, not recruiting
[NCT00000147]0 participants Interventional1988-07-31Active, not recruiting
Lenalidomide, Melphalan, Prednisone, and Thalidomide (RMPT) for Relapsed/Refractory Multiple Myeloma [NCT00961467]Phase 244 participants (Actual)Interventional2007-02-28Completed
Immunosuppressive Drug Therapy in Membranous Lupus Nephropathy [NCT00001212]Phase 245 participants Interventional1986-11-30Completed
[NCT00014755]Phase 135 participants Interventional1997-12-31Completed
A Phase III Trial To Evaluate The Safety And Efficacy Of Specific Immunotherapy, Recombinant Idiotype Conjugated To KLH With GM-CSF, Compared To Non-Specific Immunotherapy, KLH With GM-CSF, In Patients With Follicular Non-Hodgkin's Lymphoma [NCT00017290]Phase 30 participants Interventional2000-11-30Active, not recruiting
Phase I/II Trial of Decitabine + R-CHOP in Diffuse Large B-Cell Lymphoma [NCT02951728]Phase 1/Phase 258 participants (Anticipated)Interventional2016-10-31Active, not recruiting
Intensification Therapy of Mature B-ALL, Burkitt and Burkitt Like and Other High Grade Non-Hodgkin's Lymphoma in Adults [NCT00797810]Phase 425 participants (Anticipated)Interventional2006-12-31Recruiting
Feasibility Study of CO-administering Combination Antiretroviral Therapy (cART) and R-EPOCH Chemotherapy for the Management of Acquired Immunodeficiency Syndrome (AIDS)-Related Lymphoma [NCT00799136]Phase 26 participants (Actual)Interventional2008-02-29Completed
PVAG - Phase I/II Dose Finding Trial in Elderly Patients (> 60 Years) With Advanced Stages Hodgkin's Lymphoma [NCT00147875]Phase 1/Phase 260 participants (Actual)Interventional2004-03-31Completed
Therapy of Adults Affected by Idiopathic Thrombocytopenic Purpura With 3 Cycles Pulses of High-dose Dexamethasone (HD-DXM) [NCT02914054]Phase 2/Phase 336 participants (Actual)Interventional2016-10-01Completed
A Comparative Study of the Use of Beta Blocker and Oral Corticosteroid in the Treatment of Proliferative and Involuting Cutaneous Infantile Hemangioma [NCT01072045]Phase 250 participants (Actual)Interventional2010-01-31Completed
Non-interventional Study for Determining the Improvement in the Activity Status / Life Quality of Patients With Rheumatoid Arthritis Being Treated With the Tempus Tablet [NCT01075711]2,728 participants (Actual)Observational2009-04-30Completed
Phase 3 Study of Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome [NCT00362531]Phase 2/Phase 30 participants Interventional2004-11-30Completed
Pharmacogenomic Study to Predict Survival, Best Response and Toxicity in Newly Diagnosed Myeloma Patients Above the Age of 65 Treated With Either a Combination of Melphalan-prednisone-thalidomide or Lenalidomide-dexamethasone [NCT00907452]143 participants (Actual)Interventional2009-07-29Completed
A Phase II Study of AZD2171 in Metastatic Androgen Independent Prostate Cancer [NCT00436956]Phase 259 participants (Actual)Interventional2006-10-16Completed
Eosinophil-guided Prednisone Administration in COPD Exacerbation Requiring Ventilatory Support [NCT03981081]Phase 4192 participants (Anticipated)Interventional2019-04-02Recruiting
An Open-label, Randomized, Phase 2 Study of R-CHOP Plus Enzastaurin Versus R-CHOP in the First-Line Treatment of Patients With Intermediate and High-Risk Diffuse Large B-Cell Lymphoma [NCT00451178]Phase 2101 participants (Actual)Interventional2007-05-31Completed
A Phase III, Multicentre, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Parallel Group Study To Determine The Efficacy And Safety Of Lenalidomde (Revlimid®) In Combination With Melphalan And Prednisone Versus Placebo Plus Melphalan And Prednisone In [NCT00405756]Phase 3459 participants (Actual)Interventional2007-01-31Completed
The Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis in Children [NCT02532777]Phase 2100 participants (Anticipated)Interventional2015-08-31Recruiting
A Phase II Trial of Sirolimus as Treatment of Steroid-Refractory or Steroid-Dependent Chronic Graft-Versus-Host Disease [NCT00388362]Phase 236 participants (Actual)Interventional2005-11-30Completed
A Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma [NCT00301821]Phase 2107 participants (Actual)Interventional2006-01-31Completed
A Randomized, Multicenter, Open-label, 6-month Study to Explore the Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare [NCT00423098]Phase 281 participants (Actual)Interventional2007-02-28Completed
A Prospective, Open-label, Controlled Multicenter Trial to Assess the Efficacy and Safety of an Induction Regimen of Cyclosporine Micro Emulsion, Enteric-coated Mycophenolate Sodium (EC-MPS) and Corticosteroids, Followed by Administration of Everolimus an [NCT00371826]Phase 4126 participants (Actual)Interventional2006-03-31Completed
A Phase II Study to Assess the Feasibility and Activity of Concomitant Radiation and Docetaxel Chemotherapy Followed by Docetaxel Chemotherapy in Prostate Cancer Patients With a Persistent or Rising PSA After Radical Prostatectomy [NCT00348816]Phase 221 participants (Actual)Interventional2006-05-31Terminated(stopped due to Loss of funding)
A Collaborative Trial for the Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia [NCT00136084]Phase 3238 participants (Actual)Interventional2002-08-31Completed
A Phase II Trial to Assess the Safety of Immunosuppression Withdrawal in Liver Transplant Recipients [NCT00135694]Phase 2275 participants (Actual)Interventional2005-10-31Completed
Phase III Study of Docetaxel and Atrasentan Versus Docetaxel and Placebo for Patients With Advanced Hormone Refractory Prostate Cancer [NCT00134056]Phase 31,038 participants (Actual)Interventional2006-08-31Completed
Phase 1 Study of Copanlisib With Dose-adjusted EPOCH-R in Relapsed and Refractory Burkitt Lymphoma and Other High-Grade B-cell Lymphomas [NCT04933617]Phase 18 participants (Actual)Interventional2022-03-24Completed
A Phase 3, Randomized, Open-Label, Controlled, Multicenter Study of Zandelisib (ME- 401) in Combination With Rituximab Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non Hodgkin's Lymphoma (iNHL) - The COASTAL Study [NCT04745832]Phase 382 participants (Actual)Interventional2021-08-13Terminated(stopped due to Discontinuation of zandelisib program)
COrticosteroids in acUte uRticAria in emerGency dEpartment [NCT03545464]Phase 3240 participants (Anticipated)Interventional2019-09-21Recruiting
A Phase I/II Trial of CHOEP Chemotherapy Plus Lenalidomide as Front Line Therapy for Patients With Stage II, III and IV Peripheral T-Cell Non-Hodgkin's Lymphoma [NCT02561273]Phase 1/Phase 254 participants (Actual)Interventional2015-09-28Completed
Abiraterone Acetate Treatment for Prostate Cancer Patients With a PSA of More Than Four Following Initial Androgen Deprivation Therapy Phase II [NCT01309672]Phase 241 participants (Actual)Interventional2011-08-09Active, not recruiting
Intensive Treatment for Intermediate-Risk Relapse of Childhood B-precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies [NCT00381680]Phase 3275 participants (Actual)Interventional2007-03-31Completed
A Phase II Open Label Study of CB7630 (Abiraterone Acetate) and Prednisone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy [NCT00485303]Phase 258 participants (Actual)Interventional2007-06-30Completed
Phase I/II Trial of Epothilone Analog BMS-247550 (Ixabepilone), Mitoxantrone, and Prednisone in Hormone Refractory Prostate Cancer (HRPC) Patients Previously Treated With Chemotherapy [NCT00331344]Phase 1/Phase 2100 participants (Actual)Interventional2006-04-30Completed
Clinical Implementation and Outcomes Evaluation of Blood-Based Biomarkers for COPD Management: COPD Prednisone Sub-Study [NCT02534402]Phase 440 participants (Actual)Interventional2015-08-31Active, not recruiting
A Phase II Study of the Novel Proteasome Inhibitor Bortezomib in Combination With Rituximab, Cyclophosphamide and Prednisone in Patients With Relapsed/Refractory Indolent B-Cell Lymphoproliferative Disorders and Mantle Cell Lymphoma (MCL) [NCT00295932]Phase 1/Phase 279 participants (Actual)Interventional2005-12-13Completed
A Multicenter, National, Open-label, Prospective, Randomized Study to Evaluate Efficacy and Tolerability of Enteric-coated Mycophenolate Sodium 1440 mg/Day With Tacrolimus Reduced Dose Versus Enteric-coated Mycophenolate Sodium 720 mg/Day With Tacrolimus [NCT00284934]Phase 394 participants (Actual)Interventional2005-12-31Completed
Steroid Free Immunosuppression in Liver Transplantation [NCT00296244]Phase 440 participants (Actual)Interventional2006-02-28Completed
A Phase 2, Prospective, Randomized, Multicenter, Double-blind, Active-control, Parallel-group Study to Determine the Safety of and to Select a Treatment Regimen of CC-4047 (Pomalidomide) Either as Single-agent or in Combination With Prednisone to Study Fu [NCT00463385]Phase 288 participants (Actual)Interventional2007-04-01Completed
A Phase II Randomized Study of Rituximab-HCVAD Alternating With Rituximab-Methotrexate-Cytarabine Versus Standard Rituximab-CHOP Every 21 Days for Patients With Newly Diagnosed High Risk Aggressive B-Cell Non-Hodgkin's Lymphomas in Patients 60 Years Old o [NCT00290498]Phase 267 participants (Actual)Interventional2005-08-01Completed
A Phase II Study of High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, Melphalan, Thymoglobulin and Autologous CD34+ Hematopoietic Stem Cell Transplant for the Treatment of Poor Prognosis Multiple Sclerosis [NCT00288626]Phase 225 participants (Actual)Interventional2006-07-31Completed
A Single-arm, Multi-center, Phase II Clinical Trial of R-CHOP Combined With Lenalidomide in the First-line Treatment for Patients With Medium to High Risk/High Risk Diffuse Large B Cell Lymphoma [NCT04214626]Phase 260 participants (Actual)Interventional2020-01-02Active, not recruiting
RANDOMIZED, MULTICENTRIC STUDY COMPARING THE EFFECT OF TWO REGIMENS OF COMBINED IMMUNOSUPPRESSIVE THERAPY IN THE TREATMENT OF INFLAMMATORY CARDIOMYOPATHY CZECH-ICIT (CZECH INFLAMMATORY CARDIOMYOPATHY IMMUNOSUPPRESSION TRIAL) [NCT01877746]Phase 3234 participants (Anticipated)Interventional2013-01-31Recruiting
Phase I/II Open Label Dose Escalation Study of the 17α-Hydroxylase/ C17,20-Lyase Inhibitor, Abiraterone Acetate in Hormone Refractory Prostate Cancer [NCT00473746]Phase 1/Phase 266 participants (Actual)Interventional2006-06-30Completed
An Open-Label, Phase 1 Study to Examine the Pharmacokinetic Interactions Between VX-509 and Prednisone or Methylprednisolone in Healthy Male Subjects [NCT01886209]Phase 128 participants (Anticipated)Interventional2013-06-30Completed
[NCT01895049]Phase 4171 participants (Actual)Interventional2013-08-31Completed
Regulatory T Cell Modulation in Kidney Transplantation With Biologic Blockade of Dual Effector Pathways, CD28 and IL-6 (CTOT-24) [NCT04066114]Phase 1/Phase 210 participants (Actual)Interventional2019-12-11Completed
A Phase 1b/2 Study of Docetaxel and Prednisone, With or Without ISIS 183750 (an eIF4E Inhibitor), in Patients With Castrate-Resistant Prostate Cancer [NCT01234025]Phase 1/Phase 2113 participants (Actual)Interventional2010-11-30Completed
A Placebo-controlled, Randomized, Double-blind Comparison of Placebo vs Short Course Low Dose Corticosteroids on Posttraumatic Stress Disorder (PTSD) [NCT00204737]Phase 412 participants (Actual)Interventional2004-12-31Completed
An Adaptive Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Axicabtagene Ciloleucel Versus Standard of Care Therapy as First-Line Therapy in Subjects With High-Risk Large B-Cell Lymphoma (ZUMA-23) [NCT05605899]Phase 3300 participants (Anticipated)Interventional2023-02-10Recruiting
International, Multi-center, Prospective, Double Randomized, Open Phase III Study Evaluating Thalidomide/Dexamethasone Versus Melphalan/Prednisone as Induction Therapy and Thalidomide/Interferon-alpha Versus Interferon-alpha as Maintenance Therapy in Newl [NCT00205751]Phase 2/Phase 3350 participants (Anticipated)Interventional2001-08-31Completed
Efficacy of 6x R-CHOP Followed by Myeloablative Radiochemotherapy and Autologous Stem Cell Transplantation vs. 3 x (R-CHOP/R-DHAP) Followed by a High Dose ARA-C Containing Myeloablative Regimen and Autologous Stem Cell Transplantation [NCT00209222]Phase 3360 participants (Anticipated)Interventional2004-07-31Recruiting
Autologous Blood or Marrow Transplantation for Aggressive Non-Hodgkin's Lymphoma Based on Early [18F] FDG-PET Scanning [NCT00238368]Phase 259 participants (Actual)Interventional2004-02-29Completed
A Prospective Phase II Study of Zanubrutinib Combined With R-CHOP in Newly-diagnosed Intravascular Large B-cell Lymphoma [NCT04899570]Phase 220 participants (Anticipated)Interventional2021-04-01Recruiting
A Randomized, Prospective Double Blind Placebo Control Clinical Trial of Prednisone as Adjunctive Therapy for the Treatment of Hospitalized Patients With Pulmonary TB and HIV Co-infection [NCT00414414]Phase 30 participants (Actual)Interventional2007-02-28Withdrawn(stopped due to Funding not awarded)
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica [NCT03600818]Phase 3118 participants (Actual)Interventional2018-10-09Terminated(stopped due to Protracted recruitment timeline exacerbated by COVID-19 pandemic)
A Randomized, Controlled Mutiple-center Clinical Research on the Treatment With Yangzhengxiaoji Capsule Combination Chemotherapy for III/IV Diffuse Large B Cell Lymphoma [NCT01949818]Phase 4120 participants (Anticipated)Interventional2012-09-30Recruiting
A Prospective, Open, Randomized Controlled Stage II Trial Investigating the Efficacy and Safety of Thymosin Alpha-1 in Treating Moderate to Severe Immune-related Adverse Events [NCT06178146]Phase 440 participants (Anticipated)Interventional2023-09-01Recruiting
Phase II Study of Mogamulizumab With DA-EPOCH in Patients With Aggressive T Cell Lymphoma [NCT05996185]Phase 236 participants (Anticipated)Interventional2024-01-31Not yet recruiting
Investigator-Initiated, Pilot Translational Study of Circulating Tumor Cells to Identify Predictive Factors of Response to Abiraterone Acetate in Men With Castration-Resistant Prostate Cancer [NCT01961843]40 participants (Actual)Interventional2013-10-31Active, not recruiting
A Phase 2, Randomized, Open-Label, Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer [NCT05848011]Phase 2150 participants (Anticipated)Interventional2023-09-28Recruiting
A Randomized Trial of Intravenous Pulse Versus Sequential Steroid Therapy for Patients With Graves' Orbitopathy [NCT01969019]Phase 470 participants (Anticipated)Interventional2010-01-31Recruiting
A Phase III Randomized Trial of Steroids + Tyrosine Kinase Inhibitor (TKI) Induction With Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL) in Adults [NCT04530565]Phase 3348 participants (Anticipated)Interventional2021-01-25Recruiting
An Open-Label, Phase I/II Study of ME-401 and R-CHOP in Newly Diagnosed Diffuse Large B-Cell Lymphoma [NCT04517435]Phase 1/Phase 213 participants (Actual)Interventional2021-04-28Active, not recruiting
Steroid-induced Mood Changes in Patients With Inflammatory Bowel Disease [NCT01981889]Phase 453 participants (Actual)Interventional2013-10-31Completed
DRESS - Setting of Corticosteroid Treatment. [NCT01987076]112 participants (Anticipated)Interventional2013-10-31Recruiting
A Randomized Phase 2 Study of Cabozantinib (XL184) in Combination With Abiraterone in Chemotherapy Naïve Subjects With Bone-Metastatic Castration-Resistant Prostate Cancer [NCT01995058]Phase 254 participants (Actual)Interventional2013-12-31Terminated(stopped due to Study stopped after results of cabozantinib Phase 3 CRPC study XL184-307.)
A Phase II Randomized Prospective Trial of Docetaxel/Prednisone Versus Docetaxel/Prednisone and Enzalutamide in Castration-Resistant Prostate Cancer (CRPC) Patients Progressing on Enzalutamide [NCT02685267]Phase 29 participants (Actual)Interventional2016-02-29Terminated
Glucocorticoids Promote Osteoclast Survival [NCT00572299]3 participants (Actual)Observational2004-01-31Terminated(stopped due to Terminated due to recruitment problems)
A Phase II Trial of Stanford VI ± Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease With 3+ Risk Factors: the G6 Study [NCT00225173]Phase 245 participants (Anticipated)Interventional2001-10-31Terminated
Frontline Selinexor(ATG-010) Plus R-CHOP Therapy for High-risk GCB-subtype Diffuse Large B-Cell Lymphoma [NCT05422066]Phase 250 participants (Anticipated)Interventional2022-07-26Recruiting
Phase II Study of Talazoparib With Androgen Deprivation Therapy and Abiraterone in Castration Sensitive Prostate Cancer [NCT04734730]Phase 270 participants (Anticipated)Interventional2021-05-04Recruiting
A Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC) [NCT02913196]Phase 116 participants (Actual)Interventional2016-12-30Active, not recruiting
An Open, Single-arm, Multicenter Study of R-CMOP Protocol for Primary Treatment of Diffuse Large B-cell Lymphoma Based on Cardiac Function Screening [NCT05777369]30 participants (Anticipated)Interventional2023-03-31Not yet recruiting
An Exploratory, Randomized, Double-blind, Placebo Controlled, Multi-center Study to Assess the Efficacy, Safety and Tolerability of a Single and a Repeated Dose of Oral BCT197 in Patients With an Acute COPD Exacerbation [NCT01332097]Phase 2183 participants (Actual)Interventional2011-03-31Completed
Phase II, Randomised, Multicentre Study With Two Treatment Arms (R-COMP Versus R-CHOP) in Newly Diagnosed Elderly Patients (≥60 Years) With Non-localised Diffuse Large B-cell Lymphoma (DLBCL)/Follicular Lymphoma Grade IIIb. [NCT02012088]Phase 291 participants (Actual)Interventional2013-10-11Active, not recruiting
A Phase 1/2 Dose Escalation Study of Subretinally Injected SAR439483 Administered in Patients With Leber Congenital Amaurosis Caused by Biallelic Mutations in GUCY2D [NCT03920007]Phase 1/Phase 215 participants (Actual)Interventional2019-09-12Active, not recruiting
Treatment of Older Adults With Acute Lymphoblastic Leukemia [NCT00973752]Phase 230 participants (Actual)Interventional2009-08-31Completed
Phase II Trial of Rituximab in Combination With CHOP Chemotherapy in Patients With Previously Untreated Intermediate or High Grade Non-Hodgkin's Lymphoma [NCT00005959]Phase 20 participants Interventional1999-12-31Active, not recruiting
Phase II Trial of EPOCH and Rituxan Combined Therapy in Patients With Refractory or Relapsed CD20 Positive Intermediate Grade B-cell Non-Hodgkin's Lymphoma [NCT00006669]Phase 20 participants (Actual)Interventional1999-09-30Withdrawn
A Phase 3, Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hor [NCT06136650]Phase 31,500 participants (Anticipated)Interventional2023-12-18Recruiting
Optimizing Immunosuppression for Steroid-Refractory Anti-PD-1/PD-L1 Pneumonitis [NCT04438382]Phase 21 participants (Actual)Interventional2021-01-07Active, not recruiting
Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma [NCT03269669]Phase 295 participants (Anticipated)Interventional2018-01-23Recruiting
A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab as Maintenance Therapy in Subjects Requiring High Dose Corticosteroids for Active Non-infectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis - I [NCT01138657]Phase 3239 participants (Actual)Interventional2010-08-31Completed
A Phase II Clinical Trial of Lenalidomide and Prednisone in Low and Intermediate-1 IPSS Risk, Non-del (5q) MDS Patients [NCT01133275]Phase 228 participants (Actual)Interventional2010-04-28Completed
Phase II Trial of Response-Adapted Chemotherapy Based on Positron Emission Tomography for Non-Bulky Stage I and II Hodgkin Lymphoma [NCT01132807]Phase 2164 participants (Actual)Interventional2010-05-31Completed
A Randomized, Open-Label, Neoadjuvant Prostate Cancer Trial of Abiraterone Acetate Plus LHRHa Versus LHRHa Alone [NCT01088529]Phase 266 participants (Actual)Interventional2009-12-31Completed
A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Active Lupus Nephritis Patients, in Combination With Standard of Care (Mycophenolate Mofetil and Steroid [NCT01085097]Phase 246 participants (Actual)Interventional2010-09-01Completed
A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating the Pain Palliation Benefit of Adding Custirsen to a Taxane for Second-Line Chemotherapy in Men With Castrate Resistance Prostate Cancer [NCT01083615]Phase 314 participants (Actual)Interventional2010-03-31Terminated(stopped due to Unable to enroll due to criteria for stable baseline pain)
A Randomized Multicenter Trial of Antenatal Treatment of Alloimmune Thrombocytopenia [NCT00194987]Phase 2/Phase 3102 participants (Actual)Interventional2001-04-30Completed
An Open-label Phase 1/2 Study of TAK-700 in Combination With Docetaxel and Prednisone in Men With Metastatic Castration-Resistant Prostate Cancer [NCT01084655]Phase 1/Phase 238 participants (Actual)Interventional2010-07-31Completed
Programma di Terapia Per Pazienti Affetti da Linfoma Diffuso a Grandi Cellule B CD20 Positive [NCT00556127]Phase 294 participants (Actual)Interventional2002-06-30Completed
Phase I/II Trial of Melphalan, Prednisone Plus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Stem Cell Transplant [NCT00477750]Phase 1/Phase 233 participants (Actual)Interventional2005-06-30Completed
Low Dose Prednisone Therapy in Women With Recurrent Pregnancy Loss [NCT04558268]Phase 2/Phase 3242 participants (Anticipated)Interventional2020-12-31Not yet recruiting
A Randomized Phase 2 Study of Human Anti-PDGFRα Monoclonal Antibody IMC-3G3 Plus Mitoxantrone Plus Prednisone or Mitoxantrone Plus Prednisone in Metastatic Castration-Refractory Prostate Cancer Following Disease Progression or Intolerance on Docetaxel-bas [NCT01204710]Phase 2123 participants (Actual)Interventional2010-10-31Completed
Aprepitant in the Management of Biological Therapies-related Severe Pruritus: a Pilot Study in 45 Cancer Patients [NCT01683552]Phase 245 participants (Actual)Interventional2010-09-30Completed
Comparisons of Different Forms of Glucocorticoid on the Recovery of Reproductive Function in Patients With 21α-hydroxylase Deficiency [NCT04536662]Phase 4120 participants (Anticipated)Interventional2020-10-01Not yet recruiting
Randomized, Open, Parallel, Single-center, Non-inferiority Clinical Trial, With an Active Control Group, Comparing Two Oral Prednisone Regimens With the Aim of Optimizing the Therapeutic Strategy in Patients With Organizing Pneumonia Post-COVID-19 Infecti [NCT04534478]Phase 4120 participants (Anticipated)Interventional2020-09-07Not yet recruiting
Treatment of Nephrotic Syndrome Relapse With Low Steroid Dose [NCT02216747]Phase 4100 participants (Anticipated)Interventional2014-09-30Not yet recruiting
Phase I Trial of Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas [NCT05389423]Phase 120 participants (Anticipated)Interventional2023-06-27Recruiting
Eosinophil-driven Corticotherapy for Patients Hospitalized for COPD Exacerbation: a Double-blind, Randomized, Controlled Trial [NCT04234360]Phase 3600 participants (Anticipated)Interventional2021-10-12Recruiting
Open Label Safety and Efficacy of Once Weekly Steroid in Patients With LGMD and Becker Muscular Dystrophy [NCT04054375]Phase 220 participants (Actual)Interventional2019-07-01Completed
Evaluation of Response to Abiraterone/Prednisone by Race/Ethnicity, PSA Decline and Genetic Variation in Proteins Involved in Androgen Metabolism in Metastatic Hormone Naive Prostate Cancer [NCT03833921]Phase 2130 participants (Anticipated)Interventional2019-05-23Recruiting
A Dynamic Allocation Modular Sequential Trial of Approved and Promising Therapies in Men With Metastatic Castrate Resistant Prostate Cancer [NCT02703623]Phase 2196 participants (Actual)Interventional2016-05-18Active, not recruiting
A Feasibility Trial of Everolimus (RAD001),an mTOR Inhibitor, Given in Combination With Multiagent Re-Induction Chemotherapy in Pediatric Patients With Relapsed Acute Lymphoblastic Leukemia (ALL) [NCT01523977]Phase 122 participants (Actual)Interventional2011-11-30Completed
A Randomized Phase II Trial of Dasatinib Plus Abiraterone Compared to Abiraterone Alone for Metastatic, Castration-Resistant Prostate Cancer Prior to Chemotherapy [NCT01685125]Phase 296 participants (Anticipated)Interventional2012-09-30Active, not recruiting
Treatment of Children With Newly-Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease (LPHD) [NCT00107198]Phase 2188 participants (Actual)Interventional2006-01-02Active, not recruiting
Research of Predictive Factors to Immune Thrombopenic Purpura in Front of a Thrombopenia in Appearance Isolated in the Elderly [NCT01648556]200 participants (Anticipated)Interventional2012-09-30Recruiting
A New Clinical Therapy for Bell's Palsy [NCT01686464]882 participants (Actual)Interventional1998-06-30Completed
A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Ther [NCT01193257]Phase 31,099 participants (Actual)Interventional2010-11-15Completed
A Prospective, Multicenter, Randomized Controlled Trial of Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN) [NCT00657059]Phase 3151 participants (Actual)Interventional2007-09-30Completed
Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without Immunosuppressants [NCT00307671]Phase 4108 participants (Actual)Interventional2005-07-31Completed
Radiation Therapy Followed by Chemotherapy for Newly Diagnosed Patients With Stage I/II Nasal NK Cell Lymphoma [NCT01321008]Phase 1/Phase 21 participants (Actual)Interventional2011-05-31Terminated(stopped due to Slow Accrual)
An International Single-Arm Study to Provide Further Safety and Efficacy Data on the Bortezomib(Velcade)/Melphalan/Prednisone Regimen in Previously Untreated Transplant Ineligible Multiple Myeloma Patients [NCT00799539]0 participants Expanded AccessNo longer available
Lenalidomide and Low Dose Dexamethasone Induction Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy for Newly Diagnosed High-risk Multiple Myeloma [NCT00691704]Phase 218 participants (Actual)Interventional2008-08-31Completed
A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study [NCT02960022]Phase 2900 participants (Anticipated)Interventional2016-12-22Recruiting
A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined With Dasatinib to Docetaxel Combined With Placebo in Castration-Resistant Prostate Cancer [NCT00744497]Phase 31,930 participants (Actual)Interventional2008-10-31Completed
Open Label Randomized Study of Thymoglobulin Versus Daclizumab Induction Therapies for the Reduction of Acute Rejection in Live Donor Kidney Transplant Recipients With a Positive Crossmatch [NCT00275509]Phase 356 participants (Actual)Interventional2007-01-31Completed
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy [NCT00638690]Phase 31,195 participants (Actual)Interventional2008-05-31Completed
Efficacy and Safety of Budesonide Capsules (3x3mg/d)Versus Prednisone in Patients With a Diagnose of Active Autoimmune Hepatitis. A Double-blind, Randomized, Active-controlled, Multicentre Study [NCT00838214]Phase 2/Phase 3208 participants (Actual)Interventional2001-03-31Completed
A Randomized, Double-blind, Multicenter, Phase 2 Study of a Human Monoclonal Antibody to Human av Integrins (CNTO 95) in Combination With Docetaxel for the First-Line Treatment of Subjects With Metastatic Hormone Refractory Prostate Cancer [NCT00537381]Phase 2131 participants (Actual)Interventional2007-05-31Completed
Glucocorticosteroid Action in Inflammatory Disease [NCT00841802]Phase 40 participants (Actual)Interventional2008-07-31Withdrawn(stopped due to Realized there was a design flaw.)
Association of Rituximab to Immunochemotherapy With CVP + Interferon in Newly Diagnosed Follicular Lymphoma Patients With Intermediate-high FLIPI Score. Phase II Study. [NCT00842114]Phase 250 participants (Actual)Interventional2006-02-28Completed
Intensified PEG-Asparaginase in High Risk Acute Lymphoblastic Leukemia (ALL): A Pilot Study [NCT00866307]Phase 1104 participants (Actual)Interventional2009-02-23Completed
Treatment With Lenalidomide, Bendamustine and Prednisone (RBP) in Patients With Relapsed or Refractory Multiple Myeloma After Autologous Stem Cell Transplantation or Conventional Chemotherapy OSHO #077 [NCT01002703]Phase 1/Phase 250 participants (Anticipated)Interventional2009-09-30Recruiting
Randomized Study of the Treatment of Primary Immune Thrombocytopenic Purpura (ITP) in Newly Diagnosed Untreated Adult Patients. Comparison of Standard Dose Prednisone Versus High-dose Dexamethasone. [NCT00657410]Phase 3150 participants (Actual)Interventional2008-04-30Completed
AIEOP LLA 2000 Multicenter Study for the Diagnosis and Treatment of Childhood Acute Lymphoblastic Leukemia [NCT00613457]Phase 32,039 participants (Actual)Interventional2000-09-30Completed
Oral Corticosteroids Therapy and Interstitial Fibrosis in Patients With Pneumocystis Jirovecii Pneumonia (PCP) and pO2 of >70 at Presentation. [NCT00636935]Phase 40 participants (Actual)Interventional2008-02-29Withdrawn(stopped due to No patient completed protocol)
Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients in Low Disease Activity or Remission. [NCT02997605]Phase 4102 participants (Actual)Interventional2017-01-31Completed
A Phase 2 Study of SNDX-5613 in Combination With Chemotherapy for Patients With Relapsed or Refractory KMT2A-Rearranged Infant Leukemia [NCT05761171]Phase 278 participants (Anticipated)Interventional2023-11-20Recruiting
A Phase II Study Evaluating the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell [NCT04980222]Phase 240 participants (Anticipated)Interventional2022-03-22Recruiting
A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer [NCT01193244]Phase 31,560 participants (Actual)Interventional2010-10-01Completed
Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients: A Prospective Randomized Controlled Trial [NCT02683291]Phase 448 participants (Actual)Interventional2014-01-31Completed
Ozurdex as Monotherapy for Treatment of Non-infectious Intermediate, Posterior, or Panuveitis [NCT05101928]Phase 484 participants (Anticipated)Interventional2021-11-30Recruiting
Modified BFM-95 Regimen for the Treatment of Newly Diagnosed T-lymphoblastic Lymphoma in Adults:a Prospective Phase II Study [NCT02396043]Phase 250 participants (Anticipated)Interventional2015-03-31Recruiting
A 2 Year Prospective Multicentre Randomised Controlled Trial Comparing Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis. [NCT01172639]Phase 4400 participants (Actual)Interventional2009-02-28Completed
Ustekinumab for the Treatment of Relapse of Refractory Giant Cell Arteritis [NCT03711448]Phase 238 participants (Anticipated)Interventional2019-01-07Recruiting
Different Immunosuppressive Treatment in Idiopathic Membranous Nephropathy: a Prospective Cohort [NCT04745728]Phase 3200 participants (Anticipated)Interventional2021-04-14Recruiting
A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma (IELSG 26) [NCT00689845]120 participants (Anticipated)Interventional2007-06-30Recruiting
Phase 2 Randomized Study Evaluating 3 Chemotherapy Regimens as Second-line Treatment in Patients With Hormone-refractory Metastatic Prostate Cancer [NCT00627354]Phase 290 participants (Anticipated)Interventional2006-09-30Completed
Phase II Study Of Dose-Adjusted Epoch-Rituximab (EPOCH-R) Chemotherapy For Patients With Previously Untreated Aggressive CD20+ B-Cell Non-Hodgkin's Lymphoma (NHL) [NCT00032019]Phase 278 participants (Actual)Interventional2002-02-28Completed
Diffuse Large B Cell And Peripheral T-Cell Non-Hodgkin's Lymphoma In The Frail Elderly. Progressive And Cautious Treatment Strategy In Poor Status Patients. A Phase II Trial With Emphasis On Geriatric Assessment And Quality Of Life [NCT00039351]Phase 232 participants (Actual)Interventional2002-03-31Completed
Phase II Randomized Study of Abiraterone Acetate Plus ADT Versus APALUTAMIDE Versus Abiraterone and APALUTAMIDE in Patients With Advanced Prostate Cancer With Non-castrate Testosterone Levels [NCT02867020]Phase 2128 participants (Actual)Interventional2017-10-11Completed
"Screening Protein Predictive of Response to Tumor Necrosis Factor-α Inhibitors Treatment in Chinese Rheumatoid Arthritis From Real World and Investigating Its Mechanism Through Signal Pathway" [NCT02878161]Phase 4240 participants (Anticipated)Interventional2016-01-31Enrolling by invitation
Prospective Study of Prednisone Versus Sirolimus in the Treatment of Idiopathic Retroperitoneal Fibrosis [NCT04047576]Phase 2/Phase 360 participants (Anticipated)Interventional2018-07-01Recruiting
A Randomized Controlled Trial to Compare Oral Itraconazole Versus Combination of Systemic Glucorticoids and Oral Itraconazole in Chronic Pulmonary and Allergic Bronchopulmonary Aspergillosis Overlap Syndrome [NCT05444946]104 participants (Anticipated)Interventional2022-06-15Recruiting
A Phase I Adaptive Dose, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered CORT125236 in Healthy Subjects, With an Optional Pharmacological Effects [NCT05003713]Phase 182 participants (Actual)Interventional2021-08-03Completed
Selective CD28 Blockade With Lulizumab Compared to CNI Inhibition With Tacrolimus in Renal Transplant Recipients [NCT04903054]Phase 20 participants (Actual)Interventional2022-01-10Withdrawn(stopped due to Limited period of availability of a supply of the study drug and difficulties in enrollment)
A Randomized, Open-Label, Phase 2 Study of CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone Compared With VELCADE-Melphalan-Prednisone for the Treatment of Previously Untreated Multiple Myeloma [NCT00911859]Phase 2118 participants (Actual)Interventional2009-06-30Completed
Treatment Intensification With R-ICE and High-Dose Cyclophosphamide for Diffuse Large B-Cell Non-Hodgkin's Lymphoma Based on Early [18F] FDG-PET Scanning [NCT00809341]Phase 227 participants (Actual)Interventional2009-01-31Terminated(stopped due to Low accrual)
An Open-Label, Randomized, Parallel-Group Study of Bendamustine Hydrochloride and Rituximab (BR) Compared With Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHO [NCT00877006]Phase 3447 participants (Actual)Interventional2009-04-30Completed
Multicenter Prospective Observational Study Assessing Outcomes, Adverse Events, Treatment Patterns and Related Costs in Patients Diagnosed With Bullous Pemphigoid [NCT02837965]150 participants (Anticipated)Observational2013-04-30Recruiting
ProBio: An Outcome-adaptive and Randomized Multi-arm Biomarker Driven Study in Patients With Metastatic Prostate Cancer [NCT03903835]Phase 3750 participants (Anticipated)Interventional2019-02-01Recruiting
Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia [NCT05660473]Phase 2100 participants (Anticipated)Interventional2022-10-31Recruiting
An Open-label, Multi-center, Phase Ib Clinical Trial of Chidamide Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphoma Patients [NCT02809573]Phase 130 participants (Actual)Interventional2016-08-11Completed
Efficacy of High-dose Corticosteroid Pulses Added to Conventional Oral Corticosteroid Course for Moderate Flares of Ulcerative Colitis. [NCT02921555]Phase 475 participants (Actual)Interventional2018-10-11Completed
An International, Multicentre, Randomised Controlled Trial. Treatment for Classical Hodgkin Lymphoma in Children and Adolescents Standard Treatment (Chemotherapy and RT) Compared With Experimental Treatment (Chemotherapy Without RT or Restricted to RT) [NCT02797717]2,200 participants (Anticipated)Interventional2015-11-30Recruiting
Phase II Prospective Trial of Addition of Rituximab to Reduced Dose CHOP Chemotherapy in DLBC L Patients Aged 65 Years and Over [NCT02792491]Phase 257 participants (Actual)Interventional2012-08-31Active, not recruiting
Counteracting Deleterious Metabolic Glucocorticoid Effects With Metformin - A Double-blind, Randomized, Placebo-controlled, Cross-over Study [NCT04659915]Phase 419 participants (Actual)Interventional2021-02-25Completed
A Phase II Randomized Study of Enzalutamide+Leuprolide Versus Enzalutamide+Leuprolide+Abiraterone Acetate+Prednisone as Neoadjuvant Therapy for HIgh-Risk Prostate Cancer Undergoing Prostatectomy [NCT02268175]Phase 275 participants (Actual)Interventional2014-10-31Completed
Oral Dexamethasone Versus Oral Prednisone in Children Hospitalized With Asthma: A Randomized Control Study [NCT02780479]Phase 46 participants (Actual)Interventional2017-03-20Terminated(stopped due to insufficient number of participants met the enrollment criteria.)
Impact of Medical Treatment on Sexual Function in Patients With Crohn's Disease [NCT02619552]50 participants (Actual)Observational2011-08-31Completed
Study the Link Between Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis [NCT01400464]Phase 4150 participants (Anticipated)Interventional2009-07-31Active, not recruiting
Phase I/II Study of MLN4924 Alone Followed by Dose-Adjusted EPOCH-Rituximab + MLN4924 With Gene Expression Profiling and Mutational Analysis in Relapsed/Refractory de Novo Diffuse Large B-Cell Lymphoma [NCT01415765]Phase 1/Phase 20 participants (Actual)Interventional2011-07-15Withdrawn
Phase II Dose Study of Doxil in a Dose Dense, 14 Day CDOP/Rituximab Regimen for Patients With Diffuse Large B-Cell NHL > 60 Years or With Compromised Cardiac Status [NCT00333008]Phase 227 participants Interventional2006-05-31Recruiting
An Multicenter, Randomized Study of Comparison of Docetaxel Plus Prednisone With Mitoxantrone Plus Prednisone in the Patients With Hormone-refractory (Androgen-independent) Metastatic Prostate Cancer [NCT00436839]Phase 3228 participants (Actual)Interventional2007-01-31Completed
An Adaptive, Two Part, Two Period, Single Sequence, Drug Interaction Study Between Dolutegravir 50 mg and Prednisone in Adult Healthy Volunteers [NCT01425099]Phase 112 participants (Actual)Interventional2011-09-30Completed
Does Increasing Immunosuppression Prevent Transplant-associated Lung-disease Triggered by Viral Respiratory Tract Infection Following Allogeneic Stem Cell Transplant? A Pilot Study [NCT01432080]Phase 212 participants (Actual)Interventional2011-09-30Terminated(stopped due to Not meeting recruitment targets)
Toward Improved Understanding of Pathogenesis and Treatment of Childhood Onset Dermatomyositis [NCT00035958]Phase 2/Phase 375 participants Interventional2002-08-31Terminated(stopped due to Incorporating the recommendations of the NIH-formed DSMB in the study procedures would make the project budget over the limit for this funding mechanism.)
A Multicenter, Open-Label, Parallel, Phase 1b/2a Study of PLX2853 in Combination With Abiraterone Acetate and Prednisone and Phase 1b/2a Study of PLX2853 in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) [NCT04556617]Phase 1/Phase 219 participants (Actual)Interventional2020-09-21Terminated(stopped due to study terminated due to business realignment)
"Protocol CCAM 05-02 Phase I-II Study of Dose Dense of PEG Filgrastim and GM-CSF as Support for Dose Desnse CHOP-R Front Line Therapy for Aggressive Non Hodgkin's Lymphoma" [NCT01527422]Phase 1/Phase 260 participants (Actual)Interventional2006-01-31Completed
A Phase I Study Of G3139 Antisense Oligonucleotide (Oblimersen) In Combination With CHOP And Rituximab In Untreated Advanced Stage Diffuse Large B Cell Lymphoma [NCT00070083]Phase 10 participants Interventional2003-07-31Completed
Phase 1b/2, Multicenter, Open-label Study of Oprozomib, Melphalan, and Prednisone in Transplant Ineligible Patients With Newly Diagnosed Multiple Myeloma [NCT02072863]Phase 1/Phase 29 participants (Actual)Interventional2014-01-31Completed
Phase II Study of Dose-Adjusted EPOCH+/-Rituximab in Adults With Untreated Burkitt Lymphoma, c-MYC Positive Diffuse Large B-Cell Lymphoma and Plasmablastic Lymphoma [NCT01092182]Phase 2194 participants (Actual)Interventional2010-03-25Completed
A Phase I Trial of Docetaxel/Prednisone Plus Fractionated 177Lu- J591 Anti-prostate-specific Membrane Antigen Monoclonal Antibody in Patients With Metastatic, Castrate-resistant Prostate Cancer [NCT00916123]Phase 115 participants (Actual)Interventional2009-05-31Completed
Prednisone Versus Allopurinol for Symptomatic Heart Failure Patients With Hyperuricemia [NCT00919243]Phase 440 participants (Anticipated)Interventional2009-02-28Completed
A Multicenter Phase 1, Open-Label Trial of Loncastuximab Tesirine in Combination With DA-EPOCH-R in Patients With Previously Untreated Aggressive B-cell Lymphoid Malignancies [NCT05270057]Phase 133 participants (Anticipated)Interventional2023-01-26Recruiting
A Phase II Study of Taxotere (Docetaxel) Plus Adriamycin (Doxorubicin) and Prednisone (TAP) in Hormone-Refractory Prostate Cancer [NCT00416533]Phase 247 participants (Anticipated)Interventional2004-08-31Completed
Positron Emission Tomography Guided Therapy of Aggressive Non-Hodgkin's Lymphomas [NCT00554164]Phase 31,073 participants (Actual)Interventional2007-11-30Completed
Treatment Bell´s Palsy: Prednisone vs Prednisone Valacyclovir [NCT00561106]42 participants (Actual)Interventional2002-12-31Completed
Treatment for Newly Diagnosed Patients With Stage III/IV Non-Hodgkin Lymphoma-Study XIII (A Therapeutic Pilot Study) [NCT00187122]42 participants (Actual)Interventional1993-03-31Completed
Phase II Study of DN-101 (High Dose Pulse Calcitriol), Mitoxantrone, Prednisone in Androgen-Independent Prostate Cancer (AIPC) [NCT00182741]Phase 219 participants (Actual)Interventional2004-09-30Completed
A Randomized Phase II Study of Prednisone, Vinblastine, Doxorubicin, and Gemcitabine in Patients With Intermediate Stage Hodgkin's Lymphoma [NCT00512980]Phase 20 participants Interventional2008-08-31Terminated(stopped due to lower recruitment rates as expected)
Large Cell Lymphoma, Pilot Study III [NCT00187070]8 participants (Actual)Interventional1997-12-31Completed
Phase Ib/II Clinical Study of TQB3823 Tablets Combined With Abiraterone Acetate Tablets and Prednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer [NCT05405439]Phase 1/Phase 239 participants (Actual)Interventional2022-08-25Terminated(stopped due to The sponsor voluntarily terminated the study)
A Phase 2 Study of Pomalidomide as a Replacement for Lenalidomide for Multiple Myeloma Patients Relapsed or Refractory to a Lenalidomide-Containing Combination Regimen [NCT02188368]Phase 245 participants (Actual)Interventional2014-07-07Terminated(stopped due to Lack of enrollment)
Evaluation of Ruxolitinib and Lenalidomide Combination as a Therapy for Patients With Myelofibrosis [NCT01375140]Phase 231 participants (Actual)Interventional2011-09-22Completed
International Collaborative Treatment Protocol for Infants Under One Year With Acute Lymphoblastic or Biphenotypic Leukemia [NCT00550992]445 participants (Anticipated)Interventional2006-01-31Recruiting
Investigating the Efficacy of Short-term Oral Prednisone Therapy on Acute Subjective Tinnitus [NCT05591144]129 participants (Actual)Interventional2022-10-30Completed
Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus: a Randomized Placebo-controlled Equivalence Trial [NCT03804723]321 participants (Anticipated)Interventional2019-06-30Not yet recruiting
Phase I/II Trial of Azacytidine + R-CHOP in Diffuse Large B-Cell Lymphoma [NCT01004991]Phase 1/Phase 214 participants (Actual)Interventional2010-01-31Completed
Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With Inotuzumab Ozogamicin as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia [NCT03488225]Phase 24 participants (Actual)Interventional2018-03-28Terminated(stopped due to the study was closed early due to competing trials)
A Selective Frontline Cabazitaxel Therapeutic Pathway for Castration-Resistant Prostate Cancer With Integrated Biomarkers [NCT02844582]Phase 22 participants (Actual)Interventional2017-12-20Terminated(stopped due to Poor accrual of subjects onto study)
TNF-alpha Antagonists for Acute Exacerbations of COPD: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial [NCT00789997]Phase 2/Phase 381 participants (Actual)Interventional2008-11-30Completed
Randomized Phase III Study in Low Grade Lymphoma Comparing Maintenance Anti-CD20 Antibody Versus Observation Following Induction Therapy [NCT00003204]Phase 3515 participants (Actual)Interventional1998-03-31Completed
[NCT00004482]Phase 240 participants Interventional1999-12-31Completed
[NCT00004686]Phase 2300 participants Interventional1994-02-28Completed
Alemtuzumab and CHOP Chemotherapy for Aggressive Histology Peripheral T Cell Lymphomas: A Multi-Centre Phase I and II Study [NCT00363090]Phase 1/Phase 284 participants (Anticipated)Interventional2006-09-30Recruiting
Iberoamerican Phase III International Study, Open, Multicenter, Randomized, Comparative of Thalidomide / Cyclophosphamide / Dexamethasone Versus Thalidomide / Dexamethasone Versus Thalidomide / Melphalan / Prednisone as Induction Therapy Followed by Maint [NCT01532856]Phase 364 participants (Actual)Interventional2007-01-31Active, not recruiting
Phase 2 Study of ZK-Epothilone (ZK-Epo; ZK219477) Plus Prednisone as First-line Chemotherapy in Patients With Metastatic Androgen-independent Prostate Cancer [NCT00350051]Phase 253 participants (Actual)Interventional2006-08-01Completed
ALL-BFM 2000 Multi-Center Study for the Treatment of Children and Adolescents With Acute Lymphoblastic Leukemia [NCT00430118]Phase 34,559 participants (Actual)Interventional2000-07-31Completed
The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy. [NCT00440219]Phase 334 participants (Anticipated)Interventional2010-11-30Completed
A Randomised Trial of Prednisone and Tamoxifen in Patients With Idiopathic Retroperitoneal Fibrosis [NCT00440349]Phase 238 participants Interventional2000-10-31Active, not recruiting
A National, Open-Label, Multicenter, Randomized, Comparative Phase III Study of Induction Treatment With Melphalan/Prednisone/Velcade Versus Thalidomide / Prednisone / Velcade and Maintenance Treatment With Thalidomide / Velcade Versus Prednisone / Velcad [NCT00443235]Phase 3260 participants (Anticipated)Interventional2005-03-31Completed
A Comprehensive Study of Clinically Staged Pediatric Hodgkin's Disease: Chemotherapy for All Patients; Supplementary Low Dose Involved Field Irradiation for Selected Patients (CCG 5942) [NCT00592111]Phase 221 participants (Actual)Interventional1996-03-31Completed
Preventing Tuberculosis-associated Immune Reconstitution Inflammatory Syndrome in High-risk Patients: a Randomized Placebo-controlled Trial of Prednisone [NCT01924286]Phase 3240 participants (Actual)Interventional2013-08-30Completed
The Clinical Efficacy and Safety of Telitacicept Followed With Rituximab Therapy on APS Secondary to SLE ,a Multicentre Observational Study [NCT05644210]80 participants (Anticipated)Observational2022-10-01Recruiting
A Phase II, Double-blind, Controlled, Multi-center, Randomized, Long Term Safety Trial of z102 and Prednisone (5 mg or 7.5 mg) in Patients With Moderate to Severe Rheumatoid Arthritis [NCT01612377]Phase 218 participants (Actual)Interventional2012-03-31Terminated(stopped due to missed endpoint of meaningful clinical benefit, compared to prednisolone 2.7mg)
PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia [NCT00494897]Phase 4374 participants (Actual)Interventional1996-06-30Completed
A Multicenter, Randomized, Open-label, Controlled Study to Evaluate the Efficacy and Safety of corticoSTEROids Added to Standard Therapy in Patients With Acute Heart Failure (STERO-AHF) [NCT05809011]Phase 2/Phase 3120 participants (Anticipated)Interventional2023-04-24Recruiting
A Phase Ib Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Venetoclax in Combination With Polatuzumab Vedotin Plus Rituximab (R) and Cyclophosphamide, Doxorubicin, Prednisone (CHP) in Patients With Untreated BCL-2 Immunohistochemistry (IHC) [NCT04790903]Phase 150 participants (Anticipated)Interventional2021-07-02Active, not recruiting
A Randomized Double-Blind Controlled Trial of Single Oral Dose Dexamethasone Versus Five Days of Oral Prednisone in Acute Mild to Moderate Adult Asthma [NCT01241006]Phase 4376 participants (Actual)Interventional2011-01-31Completed
LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive [NCT00526305]Phase 4100 participants (Anticipated)Interventional2000-01-31Completed
Evaluation of Birdshot RETINE CHOROIDOPATHY Treatment by Either Steroid or Interferon alpha2a [NCT00508040]Phase 258 participants (Actual)Interventional2007-09-30Completed
A Pilot Study of the Efficacy of the Chop-Montak Regimen in Patients With Newly Diagnosed Peripheral T Cell Lymphoma [NCT00513188]0 participants (Actual)Interventional2007-02-28Withdrawn
A Safety and Pharmacokinetics Study of Niraparib Plus Androgen Receptor-Targeted Therapy (Apalutamide or Abiraterone Acetate Plus Prednisone) in Men With Metastatic Castration-Resistant Prostate Cancer [NCT02924766]Phase 134 participants (Actual)Interventional2016-10-03Completed
Effects of Fluticasone/Salmeterol (Advair®) in Outpatients With Chronic Obstructive Pulmonary Disease (COPD) Acute Exacerbation [NCT00531791]Phase 314 participants (Actual)Interventional2007-11-30Completed
Evaluation of Lenalidomide (CC-5013) and Prednisone as a Therapy for Patients With Myelofibrosis (MF) [NCT00352794]Phase 240 participants (Actual)Interventional2006-07-07Completed
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for OligoRecurrenT Prostate Cancer (VA STARPORT) [NCT04787744]Phase 2/Phase 3464 participants (Anticipated)Interventional2021-07-01Recruiting
Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Tucidinostat in Combination With R-CHOP in Patients With Newly Diagnosed MYC/BCL2 Double-Expressor DLBCL [NCT04231448]Phase 3423 participants (Actual)Interventional2020-05-21Active, not recruiting
Treatment of Primary Minimal Change Nephropathy: A Randomized Open-labeled Non-inferiority Study on Prednisolone and Vitamin D [NCT03210688]Phase 464 participants (Anticipated)Interventional2018-05-01Recruiting
Modified BFM (Berlin-Frankfurt-Munster)Backbone Therapy for Chinese Children or Adolescents With Newly Diagnosed Lymphoblastic Lymphoma [NCT02845882]Phase 3150 participants (Anticipated)Interventional2016-01-31Active, not recruiting
A Phase III Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; NSC#617807) [NCT00557193]Phase 3218 participants (Actual)Interventional2008-01-15Active, not recruiting
P-Gemoxd Regimen Followed by Radiotherapy Versus P-CHOP Regimen Followed by Radiotherapy in ENKTL With Early Stage: a Randomized, Multicenter, Open-label, Phase 2 Study [NCT02918747]Phase 2100 participants (Actual)Interventional2016-09-30Active, not recruiting
Phase II Study to Determine the Effects of Neoadjuvant Docetaxel on Newly Diagnosed Intermediate and High Grade Cancer of the Prostate in Patients Who Are Scheduled for Radical Prostatectomy With Genomic Correlates of Pathological Response [NCT00598858]Phase 20 participants (Actual)Interventional2009-01-31Withdrawn(stopped due to Halted due to zero accrual and lack of funding)
Medical Ethics Committee of Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University [NCT04356430]Phase 275 participants (Anticipated)Interventional2019-04-01Active, not recruiting
A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib in Patients With Metastatic Castration-Resistant Prostate Cancer [NCT03706365]Phase 2/Phase 3350 participants (Anticipated)Interventional2018-11-26Active, not recruiting
LBL 2018 - International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma [NCT04043494]Phase 3683 participants (Anticipated)Interventional2019-08-23Recruiting
First International Inter-Group Study for Classical Hodgkin's Lymphoma in Children and Adolescents [NCT00433459]Phase 32,134 participants (Actual)Interventional2007-01-31Completed
A Phase I/II Study of Lenalidomide and Obinutuzumab With CHOP for Diffuse Large B Cell Lymphoma [NCT02529852]Phase 1/Phase 259 participants (Actual)Interventional2015-11-04Completed
Prognostic Significance of Early Positron Emission Tomography (PET) With Fluorine-18 Fluorodeoxyglucose ([18F] FDG) in Intermediate and High Grade Non-Hodgkin's Lymphoma [NCT00110006]0 participants (Actual)Interventional2004-12-31Withdrawn(stopped due to No accrual)
Belimumab Treatment for IgG4-related Disease, a Prospective, Open-label Clinical Trial [NCT04660565]Phase 460 participants (Anticipated)Interventional2021-01-31Recruiting
Randomized Phase Ii Trial Of Weekly Docetaxel, Estramustine And Prednisone Versus Docetaxel And Prednisone In Patient With Hormone-Resistant Prostate Cancer [NCT00541281]Phase 2150 participants (Actual)Interventional2003-12-31Completed
A Phase 2 Study to Investigate the Safety, Tolerability and Anti-tumor Activity of Golidocitinib in Combination With CHOP as the Front-line Treatment for Participants With Peripheral T-cell Lymphomas (PTCL) [NCT05963347]Phase 245 participants (Anticipated)Interventional2023-08-03Recruiting
A Double-blind, Placebo-controlled Study to Evaluate the Effects of Oral Steroids on Skin of Patients With Moderate to Severe Atopic Dermatitis Patients [NCT02908698]16 participants (Actual)Interventional2017-01-24Terminated(stopped due to Primary outcome was met in the 16 patients that completed the study per protocol)
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in Subjects With Polymyalgia Rheumatica [NCT02899026]Phase 30 participants (Actual)Interventional2018-03-15Withdrawn(stopped due to GSK decision to return rights to sirukumab to Janssen and discontinue sirukumab development in polymyalgia rheumatica.)
A Study Comparing Measures of Ventilatory Heterogeneity (VH) in Asthma Patients [NCT01621386]Phase 134 participants (Actual)Interventional2013-01-31Completed
An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects With Moderate to Severe Crohn's Disease [NCT01235689]Phase 3252 participants (Actual)Interventional2011-02-11Completed
Randomized Phase II/III Study of Venetoclax (ABT199) Plus Chemoimmunotherapy for MYC/BCL2 Double-Hit and Double Expressing Lymphomas [NCT03984448]Phase 2/Phase 3363 participants (Anticipated)Interventional2019-10-22Active, not recruiting
An Open-label, Randomized, Titration-blinded, Phase III Study of Efficacy, Safety and Tolerability Of Chronocort® Compared With Standard Glucocorticoid REeplacement Therapy in the Treatment of Participants Aged 16 Years and Over With Congenital Adrenal Hy [NCT03532022]Phase 30 participants (Actual)Interventional2018-10-04Withdrawn(stopped due to Protocol re-design required following EU Phase III results)
A Multicenter, Phase III, Randomized Study to Evaluate the Efficacy of Response-adapted Strategy to Define Maintenance After Standard Chemoimmunotherapy in Patients With Advanced-stage Follicular Lymphoma. [NCT02063685]Phase 3807 participants (Actual)Interventional2012-07-31Completed
Efficacy of Optimized Thiopurine Therapy in Ulcerative Colitis (OPTIC) [NCT02910245]Phase 3136 participants (Anticipated)Interventional2016-11-30Recruiting
A Phase Ib Study Evaluating Glofitamab (RO7082859) in Combination With Rituximab (R) or Obinutuzumab (G) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin (POLA) Plus Rituximab (R), Cyclophosphamide, Doxorubici [NCT03467373]Phase 1172 participants (Anticipated)Interventional2018-03-13Active, not recruiting
Multicenter Open-label Study Evaluating the Safety and Efficacy of Standardized Initial Therapy Using Either Mesalamine or Corticosteroids Then Mesalamine to Treat Children and Adolescents With Newly Diagnosed Ulcerative Colitis. [NCT01536535]Phase 4431 participants (Actual)Interventional2012-07-10Completed
Testing New Strategies for Patients Hospitalised With HIV-associated Disseminated Tuberculosis [NCT04951986]Phase 3732 participants (Anticipated)Interventional2021-08-11Recruiting
[NCT00854061]Phase 3172 participants (Actual)Interventional2009-02-28Completed
Multitarget Therapy for Idiopathic Membranous Nephropathy [NCT04424862]Phase 482 participants (Actual)Interventional2020-06-09Completed
Phase II Trials of CHOP Chemotherapy and Interferon Alpha or Rituximab Anti-CD20 Monoclonal Antibody as Initial Treatment of Patients With Stage III and IV High-Risk Indolent B-Cell Lymphoma and Intermediate Grade B-Cell Lymphoma [NCT00004039]Phase 20 participants (Actual)Interventional1998-06-30Withdrawn(stopped due to No patient accruals)
Open-Label Study of Abiraterone Acetate Plus Prednisone in Asymptomatic or Mildly Symptomatic Subjects With Metastatic Castration-Resistant Prostate Cancer [NCT01834209]0 participants Expanded AccessNo longer available
Glucocorticosteroid Treatment in Acute Unilateral Vestibulopathy, a Multicentric, Randomized, Double-blind, Placebo-controlled Study [NCT05024448]Phase 496 participants (Actual)Interventional2013-08-27Completed
A Randomized, Open-Label, Multicenter Phase 2 Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germi [NCT01040871]Phase 2164 participants (Actual)Interventional2010-01-31Completed
A Phase 1 Study of LY3039478 in Patients With Advanced or Metastatic Cancer [NCT01695005]Phase 1237 participants (Actual)Interventional2012-10-31Completed
A Phase II Open Label Study of Brentuximab Vedotin in Combination With CHEP in Patients With Previously Untreated CD30-expressing Peripheral T-cell Lymphomas (PTCL) [NCT05006664]Phase 233 participants (Anticipated)Interventional2021-10-31Not yet recruiting
A Phase 2, Study of Apalutamide and Abiraterone Acetate in Castration-Resistant Metastatic Prostate Cancer Patients Evaluating a Predetermined Biomarker Signature [NCT03360721]Phase 27 participants (Actual)Interventional2018-03-06Active, not recruiting
An Exploratory Randomized Phase II Multicenter Trial of Abiraterone Acetate With or Without Cabazitaxel in Treatment of Metastatic Castration Resistant Prostate Cancer [NCT02218606]Phase 280 participants (Actual)Interventional2014-08-31Completed
The Assessment of Prednisone In Remission Trial (TAPIR) - Centers of Excellence Approach [NCT01940094]Phase 3159 participants (Actual)Interventional2014-02-28Active, not recruiting
Phase Ib Study of BKM120 Combined With Abiraterone Acetate for Docetaxel-pretreated, Castrate-resistant, Metastatic Prostate Cancer [NCT01741753]Phase 14 participants (Actual)Interventional2012-11-30Terminated(stopped due to Due to slow accrual the supllier of BKM120 asked we cease further enrollment.)
A Multicenter Phase II Study of Subcutaneous Velcade Plus Oral Melphalan and Prdnisone or Plus Cycloposphamide and Prednisone or Plus Prednisone in Newly Diagnosed Elderly Multiple Myeloma Patients [NCT01190787]Phase 2150 participants (Anticipated)Interventional2010-07-31Active, not recruiting
The Treatment of Multiple Myeloma Utilizing VBMCP Chemotherapy Alternating With High-Dose Cyclophosphamide and Alpha2b-Interferon Versus VBMCP: A Phase III Study for Previously Untreated Multiple Myeloma [NCT00002556]Phase 3312 participants (Actual)Interventional1994-07-31Completed
A RANDOMIZED PHASE III TRIAL COMPARING DEXAMETHASONE WITH PREDNISONE IN INDUCTION TREATMENT AND BONE MARROW TRANSPLANTATION WITH INTENSIVE MAINTENANCE TREATMENT IN ADOLESCENT AND ADULT ACUTE LYMPHOBLASTIC LEUKEMIA (ALL-4) [NCT00002700]Phase 3392 participants (Anticipated)Interventional1995-08-31Completed
Phase III Trial of CHOP Versus CHOP and Chimeric Anti-CD20 Monoclonal Antibody (IDEC-C2B8) in Older Patients With Diffuse Mixed, Diffuse Large Cell and Immunoblastic Large Cell Histology Non-Hodgkin's Lymphoma [NCT00003150]Phase 3630 participants (Anticipated)Interventional1997-12-31Completed
A Phase II Study to Evaluate Efficacy and Tolerability of Methotrexate in Combination With Glucocorticoids for the Treatment of Newly Diagnosed Acute Graft-Versus-Host Disease After Nonmyeloablative Hematopoietic Cell Transplantation [NCT00357084]Phase 253 participants (Anticipated)Interventional2006-05-31Completed
Advanced Stage Hodgkins Disease - A Pediatric Oncology Group Phase III Study [NCT00005578]Phase 3219 participants (Actual)Interventional1997-03-31Completed
Investigating Biomarkers of Steroid Resistant Asthma [NCT00361920]40 participants (Actual)Interventional2006-08-31Completed
An Open-Label Study to Determine the Short-Term Safety of Continuous Dosing of Abiraterone Acetate and Prednisone in Modified Fasting and Fed States to Subjects With Metastatic Castration-Resistant Prostate Cancer [NCT01424930]Phase 225 participants (Actual)Interventional2011-10-31Completed
A Phase II Clinical Trial of Cabazitaxel Plus Prednisone With Octreotide in the Treatment of Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel [NCT01469338]Phase 29 participants (Actual)Interventional2012-07-31Terminated(stopped due to lack of funding)
Mitoxantrone, Prednisone Plus Sorafenib in Taxane-Refractory Metastatic Hormone Refractory Prostate Cancer (HRPC) [NCT00452387]Phase 222 participants (Actual)Interventional2007-05-31Terminated(stopped due to Early stopping rule)
Metformin With Standard Taxotere and Prednisone in the Treatment of Castration Resistant Prostate Cancer [NCT01478308]Phase 20 participants (Actual)Interventional2011-06-30Withdrawn(stopped due to No accrual in initial period, PI decided to close study.)
Phase II Trial of Zileuton Compared to Azathioprine/Prednisone for the Treatment of Idiopathic Pulmonary Fibrosis [NCT00262405]Phase 244 participants (Actual)Interventional2001-01-31Completed
Phase 3 Study of Leflunomide Combined With Prednisone Treatment of Proliferative Lupus Nephritis as Induction Therapy [NCT00268567]Phase 2/Phase 30 participants Interventional2002-10-31Completed
Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss [NCT00416143]Phase 2/Phase 360 participants Interventional2006-06-30Recruiting
A Single Center, Open Label, Comparative, Controlled Trial to Assess the Risks and Benefits of Steroid Elimination vs. Steroid Therapy After Renal Transplantation [NCT00273559]60 participants (Anticipated)Observational2006-01-31Active, not recruiting
Treatment of Children and Adolescents With Diffuse Intrinsic Pontine Glioma and High Grade Glioma [NCT00278278]Phase 3150 participants (Anticipated)Interventional2003-09-30Active, not recruiting
REPLACE: Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids [NCT00284947]Phase 47 participants (Actual)Interventional2006-01-31Completed
Phase II, Randomized, Open-label, Multicenter Study in Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Who Have PRIMary Resistance to Abiraterone Acetate or Enzalutamide Treatment Comparing the Anti-tumor Effect of CABa [NCT02379390]Phase 28 participants (Actual)Interventional2015-06-17Terminated(stopped due to Unsatisfactory patient accrual)
A Randomized Double Blinded Placebo-Controlled Phase III Trial Comparing Cyclosporine Plus Steroids With or Without Myfortic as Primary Treatment for Extensive Chronic Graft Versus Host Disease [NCT00298324]Phase 334 participants (Actual)Interventional2006-09-30Terminated(stopped due to Due to slow accrual)
Pilot Study of Umbilical Cord Blood Transplantation in Adult Patients With Advanced Hematopoietic Malignancies [NCT00304018]Phase 15 participants (Actual)Interventional2002-10-31Completed
Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis [NCT00307645]Phase 3160 participants Interventional2003-05-31Terminated
A Phase I/II Study of Docetaxel/Prednisone and PTK 787/ZK 222584 in Previously Untreated Metastatic Hormone Refractory Prostate Cancer [NCT00293371]Phase 1/Phase 26 participants (Actual)Interventional2005-02-28Terminated(stopped due to low accrual)
A Phase III Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer Who Are Chemotherapy-Naïve [NCT00089856]Phase 3626 participants (Actual)Interventional2004-07-31Terminated(stopped due to Based on futility analysis showing <30% chance of meeting primary endpoint.)
A Phase I Study of CHOP and Campath-1H in Previously Untreated Aggressive T/NK-Cell Lymphomas [NCT00323323]Phase 124 participants (Actual)Interventional2004-03-31Completed
Serial Response and Biomarker-Guided Steroid Taper for Children With GVHD [NCT05090384]Phase 250 participants (Anticipated)Interventional2022-10-20Recruiting
A Dose-Finding Phase Ib Study of the Oral BCL-2 Inhibitor Venetoclax (ABT-199) in Combination With Standard Induction Therapy, Dasatinib, Prednisone, (and Rituximab in CD20+ Patients) in Adult Patients With Newly Diagnosed and Relapsed Philadelphia Chromo [NCT04872790]Phase 120 participants (Anticipated)Interventional2022-09-02Recruiting
A Phase 2 Course Determining Study for Men With Hormone-Naïve Metastatic Prostate Cancer (HNMPCa) [NCT03821792]Phase 260 participants (Anticipated)Interventional2019-07-22Active, not recruiting
Phase II Study Of Rituximab And Short Duration, High Intensity Chemotherapy With G-CSF Support In Previously Untreated Patients With Burkitt Lymphoma/Leukemia [NCT00039130]Phase 2105 participants (Actual)Interventional2002-05-31Completed
Phase I Cinical Sudy of Lposomal Mitoxantrone Hydrochloride Combined With Cyclophosphamide, Vincristine, Etoposide and Prednisone (CMOEP) in Previously Untreated Peripheral T-cell Lymphoma [NCT05458180]Phase 118 participants (Anticipated)Interventional2022-07-07Not yet recruiting
Three-Arm Randomized Phase II Clinical Study of Irofulven/Prednisone, Irofulven/Capecitabine/Prednisone or Mitoxantrone/Prednisone in Docetaxel-Pretreated Hormone-Refractory Prostate Cancer Patients [NCT00124566]Phase 2135 participants (Actual)Interventional2004-06-30Completed
Three-dimensional Facial Swelling Evaluation of Pre-operative Single-dose of Prednisone in Third Molar Surgery: a Split-mouth Randomized Controlled Trial [NCT05830747]Phase 434 participants (Actual)Interventional2022-02-01Completed
A Multicenter,Randomized, Controlled (Comparative), Open, Prospective Study Evaluating an Efficacy of R-DA-EPOCH and R-CEOP90, With or Without Upfront Auto-HSCT,in Newly Diagnosed Young Patients With Intermediate/High-risk DLBCL [NCT03213977]Phase 3475 participants (Anticipated)Interventional2017-02-01Recruiting
A Phase III Randomized, Open-Label Study of Docetaxel in Combination With CG1940 and CG8711 Versus Docetaxel and Prednisone in Taxane-Naïve Patients With Metastatic Hormone-Refractory Prostate Cancer With Pain [NCT00133224]Phase 3408 participants (Actual)Interventional2005-07-31Terminated(stopped due to Accrual and treatment with CG1940/CG8711 stopped due to IDMC recommendation.)
Phase II Study of Response Adapted Therapy Using Single Agent Lenalidomide in Older Adults With Newly Diagnosed, Standard Risk Multiple Myeloma [NCT01054144]Phase 227 participants (Actual)Interventional2010-01-14Completed
A Phase II Open-label, Parallel Group Study of Abiraterone Acetate Plus Prednisone in African American and Caucasian Men With Metastatic Castrate-resistant Prostate Cancer [NCT01940276]Phase 2100 participants (Actual)Interventional2013-10-31Completed
"Phase II Study of the Combination of Low-Dose Thalidomide, Prednisone, and Oral Cyclophosphamide (TPC) in the Therapy of Myelofibrosis With Myeloid Metaplasia (MMM)" [NCT00445900]Phase 222 participants (Anticipated)Interventional2004-10-31Completed
A Pilot Study of Rituximab in Combination With Corticosteroids for the Initial Treatment of Immune Thrombocytopenic Purpura [NCT00486421]Early Phase 122 participants (Anticipated)Interventional2007-01-31Completed
Evaluation of the Long-term Safety and Efficacy of a Tacrolimus-based 5-day Steroid Rapid Withdrawal Immunoprophylactic Regimen in de Novo Renal Transplantation [NCT00133172]Phase 485 participants (Actual)Interventional2005-07-31Terminated(stopped due to Varience of supply chain from that required by protocol)
A Phase II Study Evaluating the Efficacy and Safety of Bortezomib (Velcade™) Combined With ACVBP Regimen in Patients With Previously Untreated Peripheral T-cell Lymphoma [NCT00136565]Phase 260 participants (Actual)Interventional2006-01-08Completed
The Effect of Glucocorticosteroid and Vitamin D3 Administration and Montelukast Treatment on Early Clinical and Immunological Effect of Allergen-Specific Immunotherapy in Asthmatic Children, Double-Blind, Placebo-Controlled Study [NCT00504946]Phase 385 participants (Actual)Interventional2005-09-30Completed
Mechanism and Response of Thymoglobulin in Patients With Myelodysplastic Syndrome (MDS) [NCT00466843]Phase 254 participants (Anticipated)Interventional2007-04-30Recruiting
A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Subjects With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) [NCT05578976]Phase 3900 participants (Anticipated)Interventional2023-02-08Recruiting
A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Follicular Lymphoma [NCT05371093]Phase 3230 participants (Anticipated)Interventional2022-09-12Recruiting
A Randomized Phase 3 Trial of Nivolumab (NSC# 748726) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma [NCT04759586]Phase 3244 participants (Anticipated)Interventional2021-10-05Recruiting
A Phase I/II Study of M9241 With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and M9241 With Docetaxel in Castration Resistant Prostate Cancer [NCT04633252]Phase 1/Phase 286 participants (Anticipated)Interventional2021-02-23Recruiting
Randomized Controlled Trial of Preoperative Steroids in Autoimmune Thyroid Disease [NCT04542278]Phase 430 participants (Actual)Interventional2020-11-13Completed
Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma [NCT03436654]Phase 2112 participants (Anticipated)Interventional2018-06-21Recruiting
The Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques: An Investigator-Blinded Study [NCT02784210]Phase 230 participants (Anticipated)Interventional2016-10-05Recruiting
Phase I/II Study of the Combination of Inotuzumab Ozogamycin (CMC-544) With Low-Intensity Chemotherapy in Patients With Acute Lymphoblastic Leukemia (ALL) [NCT01371630]Phase 1/Phase 2276 participants (Anticipated)Interventional2011-08-26Recruiting
A Phase III Randomized Trial of CHOP Chemotherapy Plus Rituxan (IDEC-C2B8) Versus CHOP Chemotherapy Alone for Newly Diagnosed, Previously Untreated, Aggressive Non-Hodgkin's Lymphoma [NCT00004112]Phase 30 participants Interventional1999-09-01Completed
[NCT00378443]0 participants Interventional2006-01-31Active, not recruiting
A Randomized, Phase II Trial of AZD2171, Docetaxel, and Prednisone Compared to Docetaxel and Prednisone in Patients With Metastatic, Hormone Refractory Prostate Cancer [NCT00527124]Phase 257 participants (Actual)Interventional2007-11-30Terminated(stopped due to Closure was recommended by CTEP due to slow accrual.)
A Multicenter Double-blind Randomized Controlled Trial of Systemic Corticosteroid Therapy in AECOPD Patients Admitted to Hospital With Higher Blood Eosinophil Levels [NCT05059873]Phase 4456 participants (Anticipated)Interventional2023-03-05Not yet recruiting
A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC) [NCT01715285]Phase 31,209 participants (Actual)Interventional2013-02-12Completed
Study on the Effect of Glucocorticoid Intervention on the Improvement of Blood Glucose in Patients With Exogenous Insulin Antibody Syndrome [NCT04357392]Early Phase 120 participants (Anticipated)Interventional2020-05-20Not yet recruiting
Corticosteroids During Covid-19 Viral Pneumonia Related to SARS-Cov-2 Infection [NCT04344288]Phase 211 participants (Actual)Interventional2020-04-21Terminated(stopped due to Competent Authority's decision)
Role of Short Term Systemic Corticosteroid Therapy in the Management of Chronic Rhinosinusitis Without Nasal Polyps [NCT01676415]Phase 49 participants (Actual)Interventional2012-08-31Terminated(stopped due to participants are no longer receiving intervention due to clinical logistics)
A Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naive Patients With Castration-Resistant Prostate Cancer [NCT01666314]Phase 1/Phase 2137 participants (Actual)Interventional2012-08-20Completed
Chidamide Plus CHOEP Combined With Upfront ASCT in Untreated Peripheral T-cell Lymphoma [NCT02987244]Phase 1/Phase 2100 participants (Anticipated)Interventional2016-03-31Recruiting
Phase II Study of Hyper-CVAD Plus Nelarabine in Previously Untreated T-ALL and Lymphoblastic Lymphoma [NCT00501826]Phase 2160 participants (Anticipated)Interventional2007-07-11Recruiting
Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer [NCT04812366]Phase 2315 participants (Anticipated)Interventional2021-09-21Recruiting
The CAPISCE-Trial: Community-Acquired Pneumonia; an Intervention Study With Corticosteroids [NCT00170196]Phase 3216 participants (Actual)Interventional2005-08-31Completed
Treatment Of Newly Diagnosed Adult Acute Lymphoblastic Leukemia With Intensified Post Remission Therapy Containing PEG-Asparaginase. [NCT00184041]Phase 247 participants (Actual)Interventional2004-07-31Completed
A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-Cell Lymphoma (DLBCL) [NCT01359592]Phase 2159 participants (Actual)Interventional2011-09-30Active, not recruiting
Total Therapy Study XIV for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia [NCT00187005]Phase 353 participants (Actual)Interventional1998-07-31Terminated(stopped due to Toxicity)
A Phase I-II Study of the Combination of Ruxolitinib or Dasatinib With Chemotherapy in Patients With Philadelphia Chromosome (Ph)-Like Acute Lymphoblastic Leukemia (ALL) [NCT02420717]Phase 211 participants (Actual)Interventional2015-07-15Terminated(stopped due to Study was closed early due to low accrual and lack of response.)
HD21 for Advanced Stages Treatment Optimization Trial in the First-line Treatment of Advanced Stage Hodgkin Lymphoma; Comparison of 6 Cycles of Escalated BEACOPP With 6 Cycles of BrECADD [NCT02661503]Phase 31,500 participants (Anticipated)Interventional2016-07-31Recruiting
A Randomized, Double-blind, Placebo-controlled, Phase 2a Study With an Open-label Cohort to Assess the Safety, Tolerability, and Efficacy of Namilumab in Subjects With Active Cardiac Sarcoidosis [NCT05351554]Phase 21 participants (Actual)Interventional2022-08-23Terminated(stopped due to Sponsor business decision not related to safety)
A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer [NCT04100018]Phase 3984 participants (Anticipated)Interventional2020-02-06Active, not recruiting
A Phase III Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Abiraterone Acetate and Prednisone/Prednisolone in the Treatment of Asymptomatic or Mildly Symptomatic Chemotherapy-naïve Subjects With Bone Predom [NCT02043678]Phase 3806 participants (Actual)Interventional2014-03-30Active, not recruiting
Gene Transfer for Patients With Fanconi Anemia Complementation Group A (FANCA) [NCT01331018]Phase 13 participants (Actual)Interventional2012-02-22Active, not recruiting
A Phase III Study to Determine Efficacy and Safety of Low-Dose Glucocorticoids for Initial Treatment of Acute Graft-versus-Host Disease [NCT00929695]Phase 3164 participants (Actual)Interventional2009-06-30Completed
A Phase 2 Open-Label, Randomized, Multi-center Study of Neoadjuvant Abiraterone Acetate (CB7630) Plus Leuprolide Acetate and Prednisone Versus Leuprolide Acetate Alone in Men With Localized High Risk Prostate Cancer [NCT00924469]Phase 258 participants (Actual)Interventional2009-11-30Completed
A Phase IV Multicenter, Randomized, Double-blind Study. prospeCtive Study on Intensive Early Rheumatoid Arthritis Treatment With adalimUmab: Induction of REmission and Maintenance [NCT00480272]Phase 4251 participants (Actual)Interventional2007-05-31Completed
Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Re [NCT01308580]Phase 31,200 participants (Actual)Interventional2011-04-30Completed
Immune Monitoring to Facilitate Belatacept Monotherapy [NCT04177095]Phase 417 participants (Actual)Interventional2020-02-11Completed
The Effect of Mycophenolate Mofetil and Cyclophosphamide on the Lymphocyte Subsets and Relationship With Relapse [NCT02954939]50 participants (Anticipated)Interventional2017-03-01Recruiting
A Phase II Study of Rituximab Intense Dosing With CHOP-21 (RID-CHOP) in Patients With Previously Untreated High or High-Intermediate Risk IPI (3-5) Diffuse Large B-Cell Lymphoma (DLBCL) [NCT01539174]Phase 20 participants (Actual)InterventionalWithdrawn(stopped due to No Funding Source and Competing Trials)
[NCT01540812]418 participants (Actual)Observational2012-02-29Completed
A Phase III Study of Large Cell Lymphomas in Children and Adolescents: Comparison of APO vs APO + IDMTX/HDARA-C and Continuous vs Bolus Infusion of Doxorubicin [NCT00002618]Phase 3242 participants (Anticipated)Interventional1994-12-31Completed
Randomized Comparisons of Oral Mercaptopurine vs Oral Thioguanine and IT Methotrexate vs ITT for Standard Risk Acute Lymphoblastic Leukemia [NCT00002744]Phase 31,970 participants (Actual)Interventional1996-05-31Completed
Induction Intensification in Infant ALL: A Children's Oncology Group Study [NCT00002756]Phase 2221 participants (Actual)Interventional1996-06-30Completed
A Randomized Phase II Dose Finding Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant In Patients With Multiple Myeloma [NCT00006890]Phase 267 participants (Actual)Interventional2000-07-12Completed
A Randomized Open-label Phase IIa Study Evaluating Quantified Bone Scan Response Following Treatment With Radium-223 Dichloride Alone or in Combination With Abiraterone Acetate or Enzalutamide in Subjects With Castration-resistant Prostate Cancer Who Have [NCT02034552]Phase 268 participants (Actual)Interventional2014-03-07Completed
Four Cycles of R-CHOP Followed by Four Cycles of Rituximab Versus Six Cycles of R-CHOP Followed by Two Cycles of Rituximab in the Treatment of de Novo, Low-risk, Non-bulky Diffuse Large B-cell Lymphoma. [NCT02752815]Phase 4290 participants (Anticipated)Interventional2016-06-14Active, not recruiting
Phase II Trial of Sequential Modification of Immunosuppression, Interferon Alpha, and Promace-Cytabom For Treatment of Post-Cardiac Transplant Lymphoproliferation. [NCT00002657]Phase 220 participants (Actual)Interventional1995-05-31Completed
A Phase 2, Single-Arm, Open-Label, Multicenter Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorubicin), Prednisone (CHP) in the Frontline Treatment of Chinese Patients With CD30-Positive (CD30+) Peripheral T-Ce [NCT05673785]Phase 252 participants (Anticipated)Interventional2023-02-10Recruiting
[NCT00000146]Phase 30 participants Interventional1988-07-31Active, not recruiting
Phase II Study Of Iodine-131 Anti-B1 Antibody Plus CHOP For Patients With Previously Untreated Mantle Cell Lymphoma [NCT00022945]Phase 20 participants InterventionalCompleted
Randomized Multicenter, Phase III Trial Evaluating the Safety of 2 Schedules of Cabazitaxel (Bi-weekly Versus Tri-weekly) Plus Prednisone in Elderly Men (≥ 65years) With mCRPC Previously Treated With a Docetaxel-containing Regimen [NCT02961257]Phase 3196 participants (Actual)Interventional2017-05-05Completed
A Phase I Study To Evaluate The Safety Of Cellular Immunotherapy Using Genetically Modified Autologous Cd20-Specific Cd8+ T Cell Clones For Patients With Relapsed Cd20+ Indolent Lymphomas [NCT00012207]Phase 112 participants (Anticipated)Interventional2000-09-30Completed
A Randomized Phase III Study Of Chimeric Anti-CD20 Monoclonal Antibody (Rituximab) With 2-Weekly CHOP Chemotherapy In Elderly Patients With Intermediate Or High-Risk Non-Hodgkin's Lymphoma [NCT00028717]Phase 3400 participants (Anticipated)Interventional2001-02-28Active, not recruiting
[NCT00000596]Phase 20 participants Interventional1978-06-30Completed
Allogeneic Stem Cell Transplantation Following Nonmyeloablative Chemotherapy in Patients With Hemoglobinopathies [NCT00034528]Phase 22 participants (Actual)Interventional2001-09-30Terminated(stopped due to Due to slow recruitment)
The Use of Modified BFM +/- Compound 506U78 (Nelarabine) (NSC# 686673, IND #52611) in an Intensive Chemotherapy Regimen for the Treatment of T-Cell Leukemia [NCT00016302]100 participants (Actual)Interventional2001-04-30Completed
A Phase III, Randomized, Placebo-Controlled, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Oral Beclomethasone 17, 21-Dipropionate (BDP) in Conjunction With Ten Days of High-Dose Prednisone Therapy in the Treatment of Patients With Gr [NCT00043147]Phase 30 participants Interventional2002-04-30Completed
Randomised Study Comparing 6 And 8 Cycles Of Chemotherapy With CHOP ( Cyclophosphamide, Doxorubicin, Vincristine And Prednisone) At 14-Day Intervals (CHOP-14), Both With Or Without The Monoclonal Anti-CD20 Antibody Rituximab In Patients Aged 61 To 80 Year [NCT00052936]Phase 31,506 participants (Actual)Interventional2001-01-31Completed
A Randomized Phase II Study Of BMS 247550 Or Mitoxantrone And Prednisone In Patients With Taxane Resistant Hormone Refractory Prostate Cancer [NCT00058084]Phase 280 participants (Actual)Interventional2003-03-31Completed
Diffuse Large B Cell And Peripheral T Cell Non-Hodgkin's Lymphomas (NHL) In The Elderly. Influence Of Prolonged Oral Etoposide Added To CHOP Combination Chemotherapy In Patients With Good Physiological Status. An EORTC Randomized Phase II-III Trial Includ [NCT00060385]Phase 2/Phase 33 participants (Actual)Interventional2003-03-31Terminated(stopped due to low accrual)
Phase II Study of Rituximab (NSC 687451) + CHOP Followed by 90Y-Ibritumomab Tiuxetan (NSC 710085) in Patients With Previously Untreated Mantle Cell Lymphoma [NCT00070447]Phase 20 participants Interventional2003-11-30Completed
2-CDA and Rituximab as Remission Induction and Rituximab as In Vivo Purging Prior to Peripheral Stem Cell Mobilization in Patients With Chronic Lymphocytic Leukemia (CLL) - A Prospective Multicenter Phase II Trial [NCT00072007]Phase 243 participants (Actual)Interventional2002-06-30Completed
Gem-CHOP: A Randomized Phase II Study of Gemcitabine Combined With CHOP in Untreated Aggressive Non-Hodgkin's Lymphoma [NCT00079261]Phase 225 participants (Actual)Interventional2004-01-31Completed
Randomized Study of ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Non Previously Treated Patients Aged From 60 to 65 Years With Diffuse Large B-Cell Lymphoma [NCT00135499]Phase 3138 participants (Actual)Interventional2001-10-16Terminated(stopped due to Recruitment too low)
Treatment of Patients With Membranous Nephropathy and Renal Insufficiency With Mycophenolate Mofetil and Prednisone: a Pilot Study [NCT00135967]Phase 2/Phase 330 participants Interventional2002-05-31Completed
Phase II Study of Efficacy and Safety of Tofacitinib in Patients With Polymyalgia Rheumatica [NCT04799262]Phase 214 participants (Actual)Interventional2021-01-01Completed
A Prospective, Randomized Trial of Calcineurin-Inhibitor Withdrawal in Renal Allograft Recipients [NCT00275535]Phase 4165 participants (Actual)Interventional2001-04-30Completed
A Phase I/II Trial of STI-571 and Chemotherapy in Lymphoid Blast Crisis of Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Lymphoid Leukemia [NCT00015860]Phase 1/Phase 20 participants Interventional2001-05-31Completed
PILOT MULTINATIONAL PROTOCOLS IN ACUTE LYMPHOBLASTIC LEUKEMIA AND DIFFUSE NON-HODGKIN'S LYMPHOMA [NCT00018954]Phase 20 participants Interventional1992-10-31Completed
A Phase II Study Of Intensive Induction Chemotherapy Followed By Autologous Stem Cell Transplantation Plus Immunotherapy For Mantle Cell Lymphoma [NCT00020943]Phase 279 participants (Actual)Interventional2001-06-30Completed
A Double-Blind Randomized Trial of Steroid Withdrawal in Sirolimus- and Cyclosporine-Treated Primary Transplant Recipients [NCT00023244]Phase 2274 participants (Actual)Interventional2001-01-31Terminated(stopped due to Effective August 13, 2004: Unanticipated high incidence of post-transplant lymphoproliferative disorder)
A Randomized, Open-label, Multi-center, Phase III Study of Orelabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) vs. R-CHOP Alone in Patients With Treatment-naїve Mantle Cell Lymphoma [NCT05051891]Phase 3356 participants (Anticipated)Interventional2021-12-22Recruiting
Phase III Trial of Hydroxychloroquine + Standard Therapy for Chronic Graft-Versus-Host Disease [NCT00031824]Phase 382 participants (Actual)Interventional2002-04-30Completed
High Dose Oral Steroids in Sudden Sensorineural Hearing Loss [NCT03255473]Phase 24 participants (Actual)Interventional2017-08-30Completed
Induction Therapy for Lupus Nephritis With no Added Oral Steroids: An Open Label Randomised Multicentre Controlled Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF [NCT04702256]Phase 3196 participants (Anticipated)Interventional2021-12-09Recruiting
A Phase 2 Study of Nivolumab in Combination With Either Rucaparib, Docetaxel, or Enzalutamide in Men With Castration-resistant Metastatic Prostate Cancer [NCT03338790]Phase 2292 participants (Actual)Interventional2017-12-19Active, not recruiting
A Randomized Study of Two Methods of CNS Prophylaxis in Patients With Acute Lymphoblastic Leukemia [NCT00019409]Phase 30 participants (Actual)Interventional1999-10-31Withdrawn
Intensive Induction Therapy for Children With Acute Lymphoblastic Leukemia (ALL) Who Experience a Bone Marrow Relapse [NCT00049569]126 participants (Anticipated)Interventional2003-01-31Completed
Calcineurin Inhibitor Sparing Protocol in Living Donor Pediatric Kidney Transplantation [NCT00023231]35 participants (Actual)Interventional2001-02-28Completed
A Multi-Center Phase I/II Trial of Vorinostat in Combination With Cyclophosphamide, Etoposide, Prednisone and Rituximab for Elderly Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL) [NCT00667615]Phase 1/Phase 230 participants (Actual)Interventional2008-04-30Completed
[NCT02115997]Phase 430 participants (Actual)Interventional2015-07-06Completed
Pilot Study Using Induction Chemo-immunotherapy Followed by Consolidation With Reduced Toxicity Conditioning and Allogenic Stem Cell Transplant in Advanced Stage Mature Non-anaplastic T-Cell or NK Lymphoma/Leukemia in Children, Adolescents and Young Adult [NCT03719105]Early Phase 140 participants (Anticipated)Interventional2019-03-01Recruiting
A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis. [NCT00580229]Phase 2/Phase 350 participants (Actual)Interventional2007-12-31Completed
Phase II, Randomized, Open-Label, Two-Arm, Multicenter Study of MEDI-522, a HuMA Directed Against the Human Alpha V Beta 3 Integrin, in Combination With Docetaxel, Prednisone, and Zoledronic Acid in the Treatment of Patients With Metastatic Androgen-Indep [NCT00072930]Phase 2150 participants Interventional2003-12-31Completed
Efficacy of Maintenance Therapy With Rituximab After Induction Chemotherapy (R-CHOP vs. R-FC) for Elderly Patients With Mantle Cell Lymphoma Not Suitable for Autologous Stem Cell Transplantation [NCT00209209]Phase 3570 participants (Anticipated)Interventional2004-01-14Active, not recruiting
A Phase 1 Trial of the Combination of Perifosine and Docetaxel With or Without Prednisone [NCT00399087]Phase 139 participants (Actual)Interventional2004-11-30Completed
Protocol for a Randomized Phase III Study of the Stanford V Regimen, Compared With ABVD for the Treatment of Advanced Hodgkin's Disease [NCT00041210]Phase 3850 participants (Anticipated)Interventional2001-10-31Active, not recruiting
Phase II Trial Of Induction Therapy With EPOCH Chemotherapy And Maintenance Therapy With Combivir/Interferon ALPHA-2a For HTLV-1 Associated T-Cell Non-Hodgkin's Lymphoma [NCT00041327]Phase 219 participants (Actual)Interventional2002-10-31Completed
A Phase I Trial Of UCN-01 And Prednisone In Patients With Refractory Solid Tumors And Lymphomas [NCT00045500]Phase 10 participants Interventional2002-06-30Completed
Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab, or Rituximab and G3139 Phosphorothioate Oligonucleotide (BCL-2 Antisense - NSC-683428) Therapy for Young Patients (< Age 60) With Advanced Stage Diffuse Large B-Cel [NCT00080847]Phase 2160 participants (Actual)Interventional2004-03-31Terminated
T-Cell Depleted, Reduced-Intensity Allogeneic Stem Cell Transplantation From Haploidentical Related Donors For Hematologic Malignancies [NCT00080925]Phase 120 participants (Anticipated)Interventional2004-02-29Completed
Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis [NCT04882683]50 participants (Anticipated)Interventional2021-06-01Recruiting
A Phase I/II, Multi-Center, Open Label Study of Melphalan, Prednisone, Thalidomide and Defibrotide in Advanced and Refractory Multiple Myeloma Patients [NCT00406978]Phase 1/Phase 224 participants (Actual)Interventional2006-02-28Completed
LAMPP Trial for Peripheral and Cutaneous T-Cell Lymphoma [NCT00161239]64 participants (Anticipated)Interventional2005-02-28Terminated(stopped due to toxicity)
Randomised Trial Comparing Chemotherapy Mit CHOEP (Cyclophosphamid, Doxorubicin, Vincristin, Etoposid Und Prednison) In 21-Day Intervals In Standard And Escalated Doses In Patients Aged 18-60 Years Of Age With Aggresive Non-Hodgkin-Lymphomas Favourable Pr [NCT00053768]Phase 3392 participants (Actual)Interventional2002-04-30Completed
Treatment of Acute Lymphoblastic Leukemia in Children [NCT00165178]Phase 3498 participants (Actual)Interventional2000-09-30Completed
Study of the Efficacy and the Safety of First Line Treatment With CHOP Plus Rituximab (R-CHOP) in Patients Aged 60 to 80 Years With Previously Untreated T-cell Angioimmunoblastic Lymphoma (AIL). [NCT00169156]Phase 227 participants (Actual)Interventional2005-12-31Completed
Molecular Risk Guided Treatment Of Diffuse Large B-Cell Non-Hodgkin's Lymphoma [NCT00055640]Phase 29 participants (Actual)Interventional2002-10-31Completed
Pilot Study I for Treatment of Cancer in Children With Ataxia-Telangiectasia [NCT00187057]6 participants (Actual)Interventional2002-09-30Completed
A Phase II Trial Of Thalidomide/Dexamethasone Induction Followed By Tandem Melphalan Transplant And Prednisone/Thalidomide Maintenance (A BMT Study) [NCT00040937]Phase 2147 participants (Actual)Interventional2002-06-30Completed
A Multicenter, Phase 2 Study, to Evaluate Safety and Efficacy of an Acute Lymphoblastic Leukemia (ALL) Intensive Chemotherapy for Adult Lymphoblastic Lymphoma (LL). [NCT00195871]Phase 2155 participants (Actual)Interventional2004-02-29Active, not recruiting
A Phase I, Open-Label, Dose-Finding Study of Afuresertib Administered in Combination With Either Enzalutamide (Xtandi) or Abiraterone (Zytiga) in Male Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) [NCT02380313]Phase 10 participants (Actual)Interventional2015-10-31Withdrawn(stopped due to Study cancelled: Withdrawn before enrollment of any participants)
Phase II Trial of Abiraterone Acetate Combined With Dutasteride With Correlative Assessment of Tumor Androgen Levels and Androgen Receptor Sequence and Signaling at Baseline and at Progression [NCT01393730]Phase 240 participants (Actual)Interventional2011-09-30Completed
A Pilot Phase II Study to Determine the Safety of the Combination of ONTAK (DAB389IL-2), an Interleukin-2 Fusion Toxin, in Combination With CHOP in Peripheral T-Cell Lymphoma [NCT00337987]Phase 249 participants (Actual)Interventional2005-11-30Completed
Combination Therapy of Sirolimus and Glucocorticoids for the Maintenance of Remission in Patients With IgG4-related Disease [NCT05746689]20 participants (Anticipated)Interventional2023-03-01Not yet recruiting
TheRapeutic Effect of Different immunosuppressAnts on Non-Thymoma Ocular Myasthenia Gravis: a Real-world Study [NCT04182984]200 participants (Anticipated)Observational [Patient Registry]2019-11-04Recruiting
A Single Center, Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients Utilizing a Tacrolimus/Mycophenolate Mofetil Based Maintenance Immunosuppression Protocol [NCT00374231]Phase 440 participants (Actual)Interventional2002-10-31Completed
An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma With Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667) [NCT03407144]Phase 2340 participants (Anticipated)Interventional2018-04-09Active, not recruiting
Phase I/II Study of Lenalidomide Combined With Modified DA-EPOCH and Rituximab (EPOCH-R2) in Primary Effusion Lymphoma or KSHV-Associated Large Cell Lymphoma [NCT02911142]Phase 1/Phase 212 participants (Actual)Interventional2017-07-03Active, not recruiting
Randomized, Open-Label Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone With or Without Exemestane in Postmenopausal Women With ER+ Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy [NCT01381874]Phase 2297 participants (Actual)Interventional2011-08-24Completed
Olverembatinib Combined With Reduced-Intensity Chemotherapy and Venetoclax for Newly Diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia: A Prospective, Single-arm, Single-center Clinical Trial [NCT05594784]Phase 260 participants (Anticipated)Interventional2022-10-08Recruiting
Phase 1b/2 Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma [NCT03223610]Phase 1/Phase 2145 participants (Anticipated)Interventional2018-02-09Recruiting
Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC): Open, Non-Randomised, Uncontrolled, Multicentre, Dose Escalation, First-in-man Study With a Dose Expansion [NCT02344017]Phase 1/Phase 223 participants (Actual)Interventional2015-02-28Completed
A Randomised, Double-blind, Placebo-controlled Trial Assessing the Efficacy of SLITone in House Dust Mite Allergic Patients [NCT00633919]Phase 2/Phase 3124 participants (Actual)Interventional2006-07-31Completed
A Phase II Study of Combination Nilotinib and Hyper-CVAD in Patients Newly Diagnosed With Philadelphia-Chromosome Positive Acute Lymphoblastic Leukemia or Chronic Myeloid Leukemia Blast-Phase Lymphoid Lineage [NCT01670084]Phase 20 participants (Actual)Interventional2012-12-31Withdrawn(stopped due to No Accrual)
A Phase 2 Study of Brentuximab Vedotin Plus Cyclophosphamide, Doxorubicin, Etoposide, and Prednisone (CHEP-BV) Followed by BV Consolidation in Patients With CD30-Positive Peripheral T-Cell Lymphomas [NCT03113500]Phase 248 participants (Actual)Interventional2017-05-25Active, not recruiting
Phase I/II Study to Evaluate the Safety and Efficacy of Nivolumab in Combination With R-CHOP in a Cohort of Patients With DLBCL/tFL/ High Grade B-NHL [NCT03704714]Phase 1/Phase 230 participants (Anticipated)Interventional2018-11-20Suspended(stopped due to Protocol being amended for stats/accrual changes as per PI)
Short Term Effect of Glucocorticoids on Brown Adipose Tissue Thermogenesis in Humans [NCT03269747]Phase 416 participants (Actual)Interventional2017-12-06Completed
Tofacitinib Hypothesis-generating, Pilot Study for Corticosteroid-Dependent Sarcoidosis [NCT03793439]Phase 15 participants (Actual)Interventional2019-05-15Completed
An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Itacitinib in Combination With Corticosteroids for the Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Pediatric Subjects [NCT03721965]Phase 1/Phase 22 participants (Actual)Interventional2019-12-31Terminated(stopped due to The study was terminated due to insufficient efficacy in a separate phase III study)
[NCT00699803]Phase 264 participants (Actual)Interventional2008-05-31Completed
Multicenter, Open-Label, Randomized Study on Steroid-Free Immunosuppression, in Comparison With Daily Steroid Therapy, in Pediatric Renal Transplant : Impact on Growth, Bone Metabolism and Acute Rejection [NCT00707759]Phase 328 participants (Actual)Interventional2008-06-30Completed
A Randomized Clinical Trial to Study the Effects of Single Dose of Corticosteroid on Response to Nasal Allergen Challenge in Patients [NCT00828061]Phase 119 participants (Actual)Interventional2009-02-04Completed
Reduction in Symptomatic Esophageal Stricture Formation Post-two Stage Complete Barrett's Excision for High Grade Dysplasia or Early Adenocarcinoma With Short-term Steroid Therapy: A Randomized, Double-blinded, Placebo-controlled, Multicenter Trial. [NCT02039115]Phase 43 participants (Actual)Interventional2014-03-31Terminated(stopped due to Closed for low enrollment and the inability to complete the study.)
A Phase I Study of PCUR-101 in Combination With Androgen Directed Therapy in the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer [NCT04677855]Phase 148 participants (Anticipated)Interventional2021-03-30Recruiting
Phase 1 Dose Finding Study of Belinostat Plus Cyclophosphamide/Vincristine/Doxorubicin/Prednisone (CHOP) Regimen (BelCHOP) for Treatment of Patients With Peripheral T-cell Lymphoma(PTCL) [NCT01839097]Phase 123 participants (Actual)Interventional2013-05-31Completed
The Role of Perioperative Systemic Steroids in Patients With Chronic Rhinosinusitis Without Polyps (CRSsNP) [NCT02748070]81 participants (Actual)Interventional2015-08-31Completed
Randomized, Open Label, Multicenter Study of Belatacept-based Early Steroid Withdrawal Regimen With Alemtuzumab or rATG Induction Compared to Tacrolimus-based Early Steroid Withdrawal Regimen With rATG Induction in Renal Transplantation [NCT01729494]Phase 4316 participants (Actual)Interventional2012-09-30Completed
Efficacy and Safety of Single-dose Rituximab Biosimilar in the Initial Episode of Paediatric Steroid-sensitive Nephrotic Syndrome: A Multicenter, Open-Label, Noninferiority, Randomized Controlled Trial [NCT05850546]Phase 3138 participants (Anticipated)Interventional2023-09-01Not yet recruiting
A Randomized, Open-label Phase 3 Study of Carfilzomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma [NCT01818752]Phase 3955 participants (Actual)Interventional2013-07-08Completed
A Randomized, Double-Blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH) [NCT01086540]Phase 257 participants (Actual)Interventional2011-06-24Completed
Steroid Withdrawal and Novo Donor-specific Anti-HLA Antibodies in Renal Transplant Patients: a Prospective, Randomized and Controlled Study in Parallel Groups [NCT02284464]Phase 4230 participants (Actual)Interventional2015-02-28Completed
An Open-label, Prospective, Randomized, Pilot Clinical Study to Study the Efficacy of MEDIHONEY® Rinses Compared to Intranasal Corticosteroid Rinses in Chronic Rhinosinusitis With Nasal Polyposis After Functional Endoscopic Sinus Surgery [NCT02562924]40 participants (Actual)Interventional2015-11-30Completed
One Year Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Pediatric Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study [NCT03560466]Phase 3365 participants (Actual)Interventional2018-06-21Active, not recruiting
Randomized Placebo-Controlled Trial of Mitoxantrone/Prednisone and Clodronate Versus Mitoxantrone/Prednisone Alone in Patients With Hormone Refractory Metastatic Prostate Cancer and Pain [NCT00003232]Phase 3227 participants (Actual)Interventional1997-11-24Completed
A Phase III Study of Efficacy, Safety and Tolerability of Chronocort® Compared With Standard Glucocorticoid Replacement Therapy in the Treatment of Congenital Adrenal Hyperplasia [NCT02716818]Phase 3122 participants (Actual)Interventional2016-02-22Completed
a 3 Arm Randomized Study on Health-related Quality of Life of Elderly Patients With Advanced Soft Tissue Sarcoma Undergoing Doxorubicin Alone Every Three Weeks or Doxorubicin Weekly or Cyclophosphamide Plus Predniso(lo)ne Treatment [NCT04780464]Phase 3185 participants (Anticipated)Interventional2022-04-11Recruiting
Phase Ib/II Study of the Combination of Low-Intensity Chemotherapy and Tagraxofusp in Patients With Acute Lymphoblastic Leukemia (ALL) [NCT05032183]Phase 1/Phase 240 participants (Anticipated)Interventional2022-02-17Recruiting
A Phase III Trial Comparing Docetaxel Every Third Week to Biweekly Docetaxel Monotherapy in Metastatic Hormone Refractory Prostate Cancer Patients - PROSTY Trial [NCT00255606]Phase 3360 participants (Anticipated)Interventional2005-08-31Completed
Therapeutic Approach in Colchicine-resistant Recurrent pEricarditis in Children: an Open-label Randomized Trial Comparing Anakinra vs sTEroids [NCT05805930]Phase 348 participants (Anticipated)Interventional2023-06-01Not yet recruiting
A Randomized, Placebo-controlled, Double-blind, Multicenter Study Investigating Basiliximab in Combination With MMF, Cyclosporine Microemulsion and Prednisone in the Prevention of Acute Rejection in Pediatric Renal Allograft Recipients [NCT00228020]Phase 3212 participants (Actual)Interventional2001-05-31Completed
[NCT00268515]Phase 20 participants Interventional1998-04-30Completed
Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Liposomal Mitoxantrone Hydrochloride Injection Combined With Cyclophosphamide, Vincristine and Prednisone in the Treatment of Untreated PTCL [NCT04548700]Phase 163 participants (Anticipated)Interventional2020-12-24Recruiting
A Randomised Phase II Study of Two Dose Schedules of PI-88 in Combination With Docetaxel in Patients With Androgen-independent Prostate Cancer [NCT00268593]Phase 248 participants (Actual)Interventional2005-08-31Completed
Comparative Study of 3 or 6 Months Initial Steroid Treatment in Children Under 6 Years of Age With Steroid Sensitive Nephrotic Syndrome:a Randomized, Double-blind, Placebo-controlled Study [NCT04536181]Phase 30 participants (Actual)Interventional2021-01-01Withdrawn(stopped due to lack of funding)
A Phase IV, Multicenter, National, Non-comparative, Open-label Study of Cabazitaxel, Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Second-line Treatment of Patients With Metastatic Castration-resistant Prostate Cancer and Af [NCT01649635]Phase 445 participants (Actual)Interventional2012-07-31Completed
Cyclophosphamide, Oncovin, Myocet, Prednisone and Rituximab (R-COMP) in the Treatment of Elderly Patients With Aggressive NHL. [NCT00244127]Phase 275 participants Interventional2002-10-31Active, not recruiting
[NCT00284271]Phase 265 participants (Actual)Interventional2004-01-31Completed
Optimising Therapy for Boys With Hodgkin's Lymphoma and Quality Assurance of Therapy for Girls With Hodgkin's Lymphoma Until Start of a New Prospective Trial for Hodgkin's Lymphoma in Childhood and Adolescence [NCT00416832]Phase 2648 participants (Anticipated)Interventional2002-11-30Completed
Focal Cerebral Arteriopathy Steroid Trial [NCT06040255]Phase 480 participants (Anticipated)Interventional2023-10-01Not yet recruiting
Iodine-131-Labeled Monoclonal Anti-B1 Antibody (I-131 Tositumomab) in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients ≥ Age 60 With Advanced Stage Diffuse Large B-Cell NHL: A Phase II Study [NCT00107380]Phase 286 participants (Actual)Interventional2005-11-30Completed
2-Weekly CHOP Chemotherapy With Dose-Dense Rituximab for the Treatment of Patients Aged 61 to 80 Years With Aggressive CD-20 Positive B-Cell Lymphomas: A Phase-II/Pharmacokinetic Study (CHOP-R-ESC) [NCT00290667]Phase 2586 participants (Actual)Interventional2004-02-29Completed
A Pilot Phase II Study to Determine the Safety and Efficacy of the Combination of ONTAK With CHOP in Peripheral T-Cell Lymphoma. [NCT00211185]Phase 249 participants (Actual)Interventional2004-03-14Completed
Prednisone Treatment for Vestibular Neuronitis [NCT00271791]Phase 217 participants (Actual)Interventional2005-09-30Completed
[NCT00264953]Phase 31,395 participants (Actual)Interventional1998-05-31Completed
[NCT00265031]Phase 30 participants Interventional1999-01-31Completed
A Single-arm, Prospective Clinical Study on the Antitumor Activity and Safety of Zanubrutinib Combined With R-CHOP Regimen in the Treatment of Newly Diagnosed DLBCL With High-risk Factors [NCT05887726]Phase 230 participants (Anticipated)Interventional2023-08-01Not yet recruiting
Randomized Study Comparing an Immuno-Chemotherapy With 6 Cycles of the Monoclonal Anti-CD20 Antibody Rituximab in Combination With 6 Cycles of Chemotherapy With CHOP ( Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) at 21-day Intervals or 14-d [NCT00278408]Phase 3700 participants (Actual)Interventional2005-11-30Completed
A Phase II Trial of Docetaxel/Prednisone in Combination With Sargramostim as Treatment for Hormone-refractory Prostate Cancer [NCT00313482]Phase 235 participants (Actual)Interventional2006-04-30Terminated(stopped due to Low accrual)
Phase II Study of Polatuzumab Vedotin in Combination With Chemotherapy in Subjects With Richter's Transformation [NCT04679012]Phase 220 participants (Anticipated)Interventional2021-09-24Recruiting
Phase III, Double-Blind, Randomized, Placebo-Controlled Trial of FavID® (Id/KLH) and GM-CSF Following CHOP/Rituximab as First-Line Therapy in Subjects With High-Intermediate and High-Risk Diffuse Large B-Cell Lymphoma [NCT00324831]Phase 3480 participants (Anticipated)InterventionalSuspended
Five-Year Single-Blind, Phase III Effectiveness Randomised Actively Controlled Clinical Trial in New Onset Juvenile Systemic Lupus Erythematosus Nephritis: Oral Cyclophosphamide Versus High Dose Intravenous Cyclophosphamide Versus Intermediate Dose Intrav [NCT00336414]Phase 30 participants (Actual)Interventional2006-06-30Withdrawn(stopped due to the study is withdrawn due to low and unexpected enrollment rate)
CHOP Plus Rituximab (CHOP-R) in Fludarabine Refractory Chronic Lymphocytic Leukemia (CLL) or CLL With Autoimmune Haemolytic Anemia (AIHA) or Richter's Transformation (RT) [NCT00309881]Phase 275 participants (Anticipated)Interventional2003-04-30Completed
Phase Ib - II Study of Entospletinib (ENTO) in Newly Diagnosed Diffuse Large B Cell Lymphoma (DLBCL) Patients With aaIPI>=1 Treated by Rituximab, Cyclophosphamide, Hydroxydaunomycin, Oncovin, and Prednisone (R-CHOP) [NCT03225924]Phase 1/Phase 225 participants (Actual)Interventional2017-07-26Terminated(stopped due to Stop of drug development)
A Phase III, International, Multicenter, Randomised Open Label Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Patients With Childhood Onset Idiopathic Nephrotic Syndrome [NCT05627557]Phase 380 participants (Anticipated)Interventional2023-03-29Recruiting
A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours [NCT05489211]Phase 2670 participants (Anticipated)Interventional2022-09-06Recruiting
Phase 1 Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (VIPOR) for Diffuse Large B-cell Lymphoma Involving the Central Nervous System [NCT05211336]Phase 112 participants (Anticipated)Interventional2022-04-19Recruiting
Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis [NCT03804931]Phase 2/Phase 3120 participants (Anticipated)Interventional2019-01-20Recruiting
Phase IA Study of AAVrh.10hFXN Gene Therapy for the Cardiomyopathy of Friedreich's Ataxia [NCT05302271]Phase 110 participants (Anticipated)Interventional2022-02-22Recruiting
Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma [NCT01622439]Phase 1/Phase 250 participants (Actual)Interventional2012-06-30Completed
Standard Chemotherapy (CHOP Regimen) Versus Sequential High-Dose Chemotherapy With Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas and Poor Prognostic Factors: A Randomized Phase III Study (MISTRAL) [NCT00003215]Phase 3400 participants (Anticipated)Interventional1997-04-30Completed
Immunosuppression in Renal Transplantation in The Elderly: Time to Rethink. - nEverOld Study [NCT01631058]Phase 490 participants (Anticipated)Interventional2012-07-31Recruiting
CELLO-1: A Phase 1b/2 Open-Label Study Evaluating Tazemetostat in Combination With Enzalutamide or Abiraterone/Prednisone in Chemotherapy Naive Subjects With Metastatic Castration-Resistant Prostate Cancer [NCT04179864]Phase 1/Phase 2104 participants (Anticipated)Interventional2019-11-18Active, not recruiting
Postoperative Steroids and Recovery After Spine Fusion [NCT04568837]Phase 4420 participants (Anticipated)Interventional2021-03-01Not yet recruiting
Randomized Phase III Study Using a Pet-driven Strategy and Comparing GA101 OR Rituximab Associated to a Chemotherapy Delivered Every 14 Days (ACVBP or CHOP) in DLBCL CD20+ Lymphoma Untreated Patients From 18 to 60 Presenting With 1 or More Adverse Prognos [NCT01659099]Phase 3671 participants (Actual)Interventional2012-09-30Terminated(stopped due to experimental treatment not Superior to standard - no need to continue the follow-up)
A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome [NCT04623541]Phase 1/Phase 2184 participants (Anticipated)Interventional2020-11-25Recruiting
Post-marketing Surveillance Study on the Safety and Effectiveness of Abiraterone Acetate Among Adult Filipino Male Patients With Metastatic Advanced Prostate Cancer [NCT01692483]0 participants (Actual)Observational2013-07-31Withdrawn(stopped due to Sponsor determined study is not required according to PFDA Circular 2013-004)
Dexamethasone Versus Prednisone in Heart Failure Patients, Hospitalized With Exacerbation of Chronic Obstructive Pulmonary Disease. [NCT02237820]Phase 480 participants (Anticipated)Interventional2014-11-30Recruiting
Congenital Adrenal Hyperplasia: Innovative Once Daily Dual Release Hydrocortisone Treatment [NCT03760835]Phase 4150 participants (Anticipated)Interventional2016-08-11Recruiting
A Phase 1, Open-label, Sequential Study of the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Prednisone in Healthy Adult Subjects [NCT01711827]Phase 121 participants (Actual)Interventional2012-02-29Completed
A Phase 1, Three-Part, Open-Label, Parallel-Cohort Safety and Tolerability Study of Relugolix in Combination With Abiraterone Acetate Plus a Corticosteroid, Apalutamide, or Docetaxel With or Without Prednisone in Men With Metastatic Castration-Sensitive P [NCT04666129]Phase 172 participants (Anticipated)Interventional2021-02-18Recruiting
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 (Abatacept) or Placebo on a Background of Mycophenolate Mofetil and Corticosteroids in the Treatment of Subjects With Active Class III or IV Lup [NCT01714817]Phase 3695 participants (Actual)Interventional2013-01-22Terminated(stopped due to Inability to meet protocol objectives.)
Determining Optimal Dose of Corticosteroids in COPD Exacerbations: A Pilot Study [NCT01742338]Phase 4125 participants (Anticipated)Interventional2012-05-03Suspended(stopped due to The study has been suspended to address research staffing and the feasibility of continued recruitment)
An Intention-to-Treat Study of Salvage Chemotherapy Followed by Allogeneic Hematopoietic Stem Cell Transplant for the Treatment of High-Risk or Relapsed Hodgkin Lymphoma [NCT00574496]Phase 225 participants (Actual)Interventional2007-11-13Completed
Study of R-ACVBP and DA-EPOCH-R in Patients With Newly Diagnosed Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma [NCT03018626]Phase 3402 participants (Anticipated)Interventional2017-07-27Recruiting
A Phase 2 Study of Loncastuximab Tesirine and Rituximab (Lonca-R) Followed by DA-EPOCH-R in Previously Untreated High-Risk Diffuse Large B-Cell Lymphoma [NCT05600686]Phase 224 participants (Anticipated)Interventional2023-05-24Recruiting
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Polatuzumab Vedotin in Combination With Rituximab and CHP (R-CHP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With Di [NCT03274492]Phase 31,000 participants (Actual)Interventional2017-11-16Active, not recruiting
Efficacy and Toxicity of Cabazitaxel in Men 75 Years of Age or Older With Castration-Resistant Prostate Cancer With Progression After Treatment With Docetaxel [NCT01750866]Phase 20 participants (Actual)Interventional2013-02-28Withdrawn(stopped due to No accrual)
Phase II Trial to Evaluate Benefit of Early Switch From First-Line Docetaxel/Prednisone to Cabazitaxel/Prednisone and the Opposite Sequence, Exploring Molecular Markers and Mechanisms of Taxane Resistance in Men With Metastatic Castration-Resistant Prosta [NCT01718353]Phase 263 participants (Actual)Interventional2013-03-31Completed
A Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy [NCT01758120]Phase 4135 participants (Actual)Interventional2012-12-31Active, not recruiting
A Randomized Trial of Glucocorticoids in Patients With IgG4-Related Disease [NCT01758393]Phase 2/Phase 340 participants (Anticipated)Interventional2012-12-31Recruiting
Use of Dose Adjusted EPOCH-R in the Treatment of Childhood Mature B Cell Malignancies [NCT01760226]Early Phase 14 participants (Actual)Interventional2013-01-31Completed
A Phase III, Randomized, Open, Parallel-controlled, Multi-center Study to Compare the Efficacy and Safety of Tacrolimus Capsules and Cyclophosphamide Injection in Treatment of Lupus Nephritis [NCT02457221]Phase 3314 participants (Actual)Interventional2015-03-10Completed
Prednisone Plus Chloroquine Versus Chloroquine for the Treatment of Hyper-reactive Malarial Splenomegaly in Papua New Guinea: a Randomized Open-label Trial [NCT01785979]Phase 30 participants (Actual)Interventional2016-01-31Withdrawn(stopped due to Lack of funding)
The Effect of Prednisone Versus Doxycycline in Active, Moderately Severe Graves' Orbitopathy: A Randomized, Multi-center, Double-blind, Parallel-controlled Trial [NCT01809444]Phase 2/Phase 3146 participants (Anticipated)Interventional2012-11-30Recruiting
Outcome of Muscle Function and Disease Activity in Patients With Recent Onset Polymyositis and Dermatomyositis - a 1-year Follow-up Register Study [NCT01813617]72 participants (Actual)Observational [Patient Registry]2010-09-30Completed
Pre-operative Assessment of the Anti-Proliferative Effects and Genomic Alterations of 2 Weeks of Abiraterone Acetate Compared to 2 Weeks of an Aromatase Inhibitor in Post-menopausal Hormone Receptor Positive Operable Breast Cancer [NCT01814865]Phase 20 participants (Actual)Interventional2013-05-31Withdrawn(stopped due to Funding was not acquired)
A Prospective, Single-arm, Open-label, Phase 2 Study to Evaluate Efficacy and Safety of DA-EPOCH Regimen for Non-Hodgkin's Lymphoma With Hemophagocytic Lymphohistiocytosis [NCT01818908]Phase 250 participants (Anticipated)Interventional2012-06-30Active, not recruiting
A Randomised, Multi-centre, Double-blind, Active-controlled, Parallel Group Study to Assess the Efficacy and Safety of Modified Release Prednisone (Lodotra®) Compared to Immediate Release Prednisone (Prednisone IR) in Subjects Suffering From Polymyalgia R [NCT01821040]Phase 362 participants (Actual)Interventional2013-03-31Terminated
Efficiency and Safety Study of Short-term Prednisone to Treat Moderate and Severe Subacute Thyroiditis [NCT01837433]Phase 440 participants (Actual)Interventional2013-03-31Completed
An Exploratory Evaluation of Early Use of Everolimus (EVE) on Tacrolimus (TAC)-Based Immunosuppressive Regiment vs. Mycophenolate Sodium (MPS) on Cytomegalovirus (CMV) Infection in Renal Transplant Recipients. [NCT01927588]Phase 450 participants (Anticipated)Interventional2013-08-31Not yet recruiting
The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy [NCT01451710]30 participants (Actual)Interventional2011-03-31Completed
Phase 2 Trial Pembrolizumab or Pembrolizumab in Combination With Intratumoral SD-101 Therapy in Patients With Hormone-Naïve Oligometastatic Prostate Cancer Receiving Stereotactic Body Radiation Therapy and Intermittent Androgen Deprivation Therapy [NCT03007732]Phase 223 participants (Actual)Interventional2017-05-17Active, not recruiting
Use of Oral Steroids Before Circumferential Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation to Improve Outcomes [NCT01206452]Phase 460 participants (Actual)Interventional2010-09-30Completed
A Randomized Clinical Trial Comparing 7 Days Treatment With Corticosteroids Versus Placebo for Early COVID-19 [NCT04795583]Phase 30 participants (Actual)Interventional2021-08-01Withdrawn(stopped due to Funding Issues)
A Phase 1b, Open-Label, Dose-Escalation, Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Orally Administered SM08502 Combined With Hormonal Therapy or Chemotherapy in Subjects With Advanced Solid Tumors [NCT05084859]Phase 130 participants (Actual)Interventional2021-11-03Active, not recruiting
A Phase I/II Trial of VR-CHOP for Patients With Untreated Follicular Lymphoma and Other Low Grade B-Cell Lymphomas [NCT00634179]Phase 1/Phase 237 participants (Actual)Interventional2008-02-29Completed
A Randomized Phase II Trial of EPOCH Given Either Concurrently or Sequentially With Rituximab in Patients With Intermediate- or High-Grade HIV-Associated B-cell Non-Hodgkin's Lymphoma [NCT00049036]Phase 2106 participants (Actual)Interventional2003-03-31Completed
Phase I/II Trial to Establish the Safety and Preliminary Efficacy of the Combination of Docetaxel, Prednisone, and SOM 230 (Pasireotide) in Metastatic Castrate Resistant Prostate Cancer (CRPC). [NCT01468532]Phase 1/Phase 218 participants (Actual)Interventional2011-10-31Completed
A Phase 3, Open Label, Randomized Study Comparing the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 × Anti-CD3 Bispecific Antibody, in Combination With CHOP (O-CHOP) Versus Rituximab in Combination With CHOP (R-CHOP) in Previously Untreated [NCT06091865]Phase 3904 participants (Anticipated)Interventional2023-12-11Recruiting
An Open Label Study of the Effects of a Combination of NeoRecormon, CellCept and Prednisone on Hematological Parameters and Cytogenesis in Patients With Low or Intermediate Risk Myelodysplastic Syndromes.¿ [NCT00551291]Phase 210 participants (Actual)Interventional2007-08-31Completed
A Prospective Clinical Study of the Safety and Efficacy of Pamiparib Combined With Abiraterone Acetate in Neoadjuvant Treatment of High-risk or Very High-risk Localized Prostate Cancer [NCT05376722]Phase 230 participants (Anticipated)Interventional2022-02-22Recruiting
Open Label Study to Test the Safety and Efficacy of Ustekinumab in Patients With Giant Cell Arteritis [NCT02955147]Phase 1/Phase 213 participants (Actual)Interventional2016-12-01Terminated(stopped due to Inefficacy)
A Multicentre, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel-group Study to Determine the Efficacy and Safety of Nebulized Fluticasone Propionate 1mg Twice Daily Compared With Oral Prednisone Administered for 7 Days to Chinese Pediat [NCT01687296]Phase 3261 participants (Actual)Interventional2012-11-12Completed
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Sublingual Immunotherapy With SCH 697243 (Phleum Pratense) in Children 5 to <18 Years of Age With a History of Grass Pollen Induced Rhinoconjunctivi [NCT00550550]Phase 3345 participants (Actual)Interventional2007-11-30Completed
A Phase 3b Multicenter, Open-label Abiraterone Acetate Long-term Safety Study [NCT01517802]Phase 332 participants (Actual)Interventional2012-03-28Completed
Phase 0/1 Biomarker and Pharmacodynamic Study of Roflumilast in Patients With Advanced B-Cell Hematologic Malignancies (CTRC# 13-0013) [NCT01888952]Early Phase 110 participants (Actual)Interventional2013-07-31Completed
Effect of Short-Term Prednisone Therapy on C-reactive Protein Change in Emergency Department Patients With Acute Heart Failure and Elevated Inflammatory Markers [NCT05916586]120 participants (Anticipated)Interventional2023-08-11Recruiting
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescent Patients With Active Class III or IV Lupus Nephritis, Including an Evaluation of Open Label Sa [NCT05039619]Phase 240 participants (Anticipated)Interventional2022-05-12Recruiting
A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN) [NCT00000819]Phase 254 participants InterventionalCompleted
A Phase II, Randomized, Placebo-Controlled Study of the Immunologic and Virologic Effects of Prednisone on HIV-1 Infection [NCT00000921]Phase 2118 participants Interventional1996-08-31Completed
Corticosteroid Treatment for Community-Acquired Pneumonia to Improve Long-term Cognition: A Pilot Randomized Controlled Trial [NCT04652414]Phase 20 participants (Actual)Interventional2020-12-01Withdrawn(stopped due to Limited enrollment due to the COVID-19 pandemic. Sponsor withdrew funding.)
Phase II Study of Methotrexate, Mechlorethamine, Vincristine, Prednisone, and Procarbazine (MMOPP) as Primary Therapy in Infants or Young Children With Primitive Neuroectodermal Tumors or High-Grade Astrocytoma [NCT00002463]Phase 24 participants (Actual)Interventional1989-02-28Completed
TREATMENT OF ALL IN FIRST BONE MARROW RELAPSE AFTER BFM PROTOCOLS [NCT00002499]Phase 2/Phase 30 participants Interventional1990-01-31Active, not recruiting
"RANDOMIZED COMPARISON OF ALTERNATING TRIPLE THERAPY (ATT) VERUS CHOP IN PATIENTS WITH INTERMEDIATE GRADE LYMPHOMAS AND IMMUNOBLASTIC LYMPHOMAS WITH INTERNATIONAL INDEX 2-5" [NCT00002565]Phase 361 participants (Actual)Interventional1994-05-25Completed
Study of Promace-Cytabom With Trimethoprim Sulfamethoxazole, Zidovudine (AZT), and Granulocyte Colony Stimulating Factor (G-CSF) in Patients With AIDS-Related Lymphoma, Phase II [NCT00002571]Phase 252 participants (Actual)Interventional1994-06-30Completed
A Phase II Pilot Study of Short Term (12 Week) Combination Chemotherapy (Stanford V) in Unfavorable Hodgkin's Disease [NCT00002715]Phase 250 participants (Anticipated)Interventional1989-04-30Completed
FAB LMB 96 -- Treatment of Mature B-CELL Lymphoma/Leukemia: A SFOP LMB 96/CCG 5961/UKCCSG NHL 9600 Cooperative Study [NCT00002757]Phase 31,148 participants (Actual)Interventional2001-06-30Completed
Do We Need to Taper Down Steroid Therapy for Bell's Palsy: A Prospective Randomized Controlled Trial [NCT04406376]Phase 4124 participants (Anticipated)Interventional2020-05-12Recruiting
A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma [NCT03758989]Phase 240 participants (Anticipated)Interventional2019-05-08Recruiting
Multi-center Randomized Study to Compare Efficacy and Safety of Lenalidomide Plus CHOP (L-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma [NCT04922567]Phase 2289 participants (Anticipated)Interventional2021-04-01Recruiting
Once Daily Dosing to Improve Medication Adherence and Patient Satisfaction in Kidney Transplant Recipients: A Pilot Study [NCT02426502]76 participants (Actual)Interventional2016-04-30Active, not recruiting
A Randomized Phase III Trial of ABVD Versus Stanford V (+/-) Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease [NCT00003389]Phase 3854 participants (Actual)Interventional1999-06-17Completed
Early Adalimumab Induction for Treatment of Steroid Dependent Immune Checkpoint Inhibitor Associated Inflammatory Arthritis: A Pragmatic Randomized Clinical Trial [NCT06037811]Phase 230 participants (Anticipated)Interventional2023-11-30Not yet recruiting
Pre-Approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination) [NCT05401214]0 participants Expanded AccessApproved for marketing
High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) + Thymoglobulin Followed by Syngeneic or Autologous Hematopoietic Cell Transplantation for Patients With Autoimmune Neurologic Diseases [NCT00716066]Phase 280 participants (Anticipated)Interventional2008-06-30Recruiting
A Randomized Phase III Study - Conventional Androgen Deprivation Therapy With or Without Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and Androgen Deprivation Therapy [NCT03777982]Phase 3400 participants (Anticipated)Interventional2020-04-20Active, not recruiting
A Prospective Multicenter Study on HIV-associated Hodgkin Lymphoma [NCT01468740]Phase 2130 participants (Anticipated)Interventional2004-03-31Recruiting
Phase I/II Trial of Dose-Adjusted EPOCH Chemotherapy With Bortezomib Combined With Integrase Inhibitor Therapy for HTLV-1 Associated T-Cell Leukemia Lymphoma [NCT01000285]Phase 1/Phase 218 participants (Actual)Interventional2010-09-30Completed
A Phase II/III Randomized, Multicenter Trial Comparing Sirolimus Plus Prednisone and Sirolimus/Calcineurin Inhibitor Plus Prednisone for the Treatment of Chronic Graft-versus-Host Disease (BMT CTN Protocol #0801) [NCT01106833]Phase 2/Phase 3151 participants (Actual)Interventional2010-04-30Completed
A Prospective Clinical Study of Hanlikang and BTK Inhibitors in the Treatment of Newly Diagnosed Mantle Cell Lymphoma [NCT05506410]100 participants (Anticipated)Observational [Patient Registry]2022-08-12Recruiting
Denosumab Plus Enzalutamide, Abiraterone and Prednisone Compared to Denosumab Plus Enzalutamide Alone for Men With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastases: Clinical Testing and Feasibility of a Serum-based Metabolomics Profile [NCT02758132]Phase 21 participants (Actual)Interventional2016-03-01Terminated(stopped due to Low accruals)
A Randomized, Controlled, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of Prostatectomy for Castration-Naive Oligometastatic Prostate Cancer [NCT04992026]Phase 2128 participants (Anticipated)Interventional2021-01-01Active, not recruiting
A Phase I/II Study of Bevacizumab and Erlotinib in Combination With Docetaxel and Prednisone for Patients With Hormone Refractory Prostate Cancer [NCT00996502]Phase 1/Phase 24 participants (Actual)Interventional2006-07-31Terminated(stopped due to Poor enrollment; PI left the institution)
Multicenter Trial of Prednisone in Alzheimer's Disease [NCT00000178]Phase 30 participants InterventionalCompleted
Short-Course Glucocorticoids and Rituximab in ANCA-Associated Vasculitis [NCT02169219]Phase 420 participants (Actual)Interventional2014-06-30Completed
HIGH INTENSITY, BRIEF DURATION CHEMOTHERAPY FOR DIFFUSE SMALL NONCLEAVED CELL LYMPHOMA AND THE L-3 SUBTYPE OF ALL: A PILOT STUDY OF A MULTIDRUG REGIMEN [NCT00002494]Phase 2134 participants (Actual)Interventional1992-05-31Completed
Pilot Study in AIDS-Related Lymphomas [NCT00002524]Phase 246 participants (Actual)Interventional1993-06-30Completed
Standard Dose Versus Myeloablative Therapy for Previously Untreated Symptomatic Multiple Myeloma, A Phase III Intergroup Study [NCT00002548]Phase 3899 participants (Actual)Interventional1994-01-31Completed
A Pilot Study For The Treatment of Newly-Diagnosed Disseminated Anaplastic Large Cell Ki-1 Lymphoma and T-Large Cell Lymphoma [NCT00002590]Phase 2221 participants (Actual)Interventional1994-07-31Completed
Phase II to Treat Multiple Myeloma Patients With Cytoxan and Vincristine After Cycling Myeloma Cells With rHuGM-CSF [NCT00003490]Phase 230 participants (Anticipated)Interventional1998-10-31Completed
Treatment of Patients With Acute Lymphoblastic Leukemia With Unfavorable Features: A Phase III Group-wide Study [NCT00002812]Phase 32,078 participants (Actual)Interventional1996-09-30Completed
"Prospective Non Randomized Study With Chemotherapy in Patients With Hodgkin's Disease and HIV Infection: Stanford V Regimen For Low Risk Patients, EBVP Regimen For High Risk Patients" [NCT00003262]Phase 230 participants (Anticipated)Interventional1997-05-31Active, not recruiting
Phase II Study in Adults With Untreated Acute Lymphoblastic Leukemia Testing Increased Doses of Daunorubicin During Induction, and Cytarabine During Consolidation, Followed by High-Dose Methotrexate and Intrathecal Methotrexate in Place of Cranial Irradia [NCT00003700]Phase 2163 participants (Actual)Interventional1999-01-31Completed
A Phase II Pilot Trial of CHOP Followed by Iodine-131-Labeled Monoclonal Anti-B1 Antibody for Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas [NCT00003784]Phase 2102 participants (Actual)Interventional1999-05-31Completed
Sudden Hearing Loss Multicenter Treatment Trial [NCT00097448]Phase 3255 participants (Actual)Interventional2004-12-31Completed
A Randomized, Phase 2 Study of Biomarker Guided Treatment in DLBCL [NCT04025593]Phase 2128 participants (Anticipated)Interventional2019-07-17Recruiting
Community Care for Croup (RCT) [NCT01042145]Phase 487 participants (Actual)Interventional2009-10-31Completed
Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prostate Cancer [NCT03565835]Phase 232 participants (Actual)Interventional2018-06-13Active, not recruiting
A Study to Evaluate the Efficacy of CellCept, Administered in a Sequential Treatment Scheme, in Delaying Progressive Renal Damage in Patients With Lupus Nephritis [NCT02081183]Phase 316 participants (Actual)Interventional2006-03-31Terminated
Monoinstitutional Phase II Trial Addressing Tolerability and Activity of RCHOP Chemoimmunotherapy Preceded by BBB Permeabilization by t-NGR Necrosis Factor in Patients With Relapsed/Refractory Primary Central Nervous System Lymphoma [NCT03536039]Phase 228 participants (Actual)Interventional2016-01-27Completed
A Two-Part, Randomized Clinical Trial to Study the Effects of a Single Dose of Prednisone on Biomarkers of Allergen Responses in Asthmatics [NCT01193049]Phase 111 participants (Actual)Interventional2010-08-31Completed
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Either Bendamustine and Rituximab (BR) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednis [NCT01974440]Phase 3405 participants (Actual)Interventional2014-01-31Completed
Bevacizumab and CHOP (A-CHOP) in Combination for Patients With Peripheral T-Cell or Natural Killer Cell Neoplasms [NCT00217425]Phase 246 participants (Actual)Interventional2006-09-14Completed
A Prospective, Multicenter, Randomized, Double Blind, Placebo-controlled, 2-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib in Combination With Docetaxel to Placebo in Combination With Docetaxel in First Line Metastatic Cast [NCT03761225]Phase 3714 participants (Actual)Interventional2014-09-30Completed
A Corticosteroid Taper for Acute Sciatica Treatment (The ACT FAST Study) [NCT00668434]Phase 2269 participants (Actual)Interventional2008-11-30Completed
Glucocorticosteroid Therapy on Drug-induced Liver Injury: a Prospective Non-randomized Concurrent Control Trial [NCT04553003]Phase 480 participants (Anticipated)Interventional2020-08-01Recruiting
Intracanalicular Dexamethasone Used in Conjunction With ILUX for the Treatment of Meibomian Gland Dysfunction (MGD) in Patients With Evaporative Dry Eye and Evidence of Clinically Significant Inflammation. [NCT04658927]Phase 430 participants (Actual)Interventional2021-01-04Completed
A 26-Week Randomized, Double-Blinded, Active Controlled Study Comparing the Safety of Mometasone Furoate/Formoterol Fumarate MDI Fixed Dose Combination Versus Mometasone Furoate MDI Monotherapy in Adolescents and Adults With Persistent Asthma (Protocol No [NCT01471340]Phase 411,744 participants (Actual)Interventional2012-01-09Completed
A Prospective Institutional Study for the Treatment of Children With Newly Diagnosed Langerhans Cell Histiocytosis Using a Cytarabine Contained Protocol [NCT04773366]Phase 3200 participants (Anticipated)Interventional2018-07-01Recruiting
A Phase II Trial of Docetaxel, Thalidomide, Prednisone and Bevacizumab in Patients With Androgen-Independent Prostate Cancer [NCT00089609]Phase 273 participants (Actual)Interventional2005-04-19Completed
Use of a Single Dose of Oral Prednisone in the Treatment of Cellulitis [NCT01671423]42 participants (Actual)Interventional2012-08-31Completed
PS-341 and PS-341 + Epoch Chemotherapy and Molecular Profiling in Relapsed or Refractory Diffuse Large B-Cell Lymphomas [NCT00054665]Phase 250 participants (Actual)Interventional2003-02-28Completed
Risk-Adapted Therapy for Patients With Untreated Age-Adjusted International Prognostic Index II or III Diffuse Large B Cell Lymphoma [NCT00039195]Phase 298 participants (Actual)Interventional2006-11-30Completed
A Phase II Randomized Trial of Growth Hormone Therapy in Pediatric Crohn's Disease [NCT00109473]Phase 222 participants (Actual)Interventional2005-04-30Completed
A Phase II Trial of Abiraterone Acetate, Radiotherapy and Short-Term Androgen Deprivation in Men With Unfavorable Risk Localized Prostate Cancer [NCT01717053]Phase 237 participants (Actual)Interventional2014-01-17Completed
The Pacific Clinical Trial: A Randomized Phase II Study Evaluating OGX-427 in Patients With Metastatic Castrate-Resistant Prostate Cancer (MCRPC)Who Have Prostate-Specific Antigen (PSA) Progression While Receiving Abiraterone: Hoosier Oncology Group GU12- [NCT01681433]Phase 272 participants (Actual)Interventional2012-12-31Terminated(stopped due to lack of accrual)
A Prospective Phase II Study of Bendamustine in Patients Aged Over 60 Years With Classical Hodgkin Lymphoma Treated by Prednisone, Vinblastine and Doxorubicin [NCT02414568]Phase 290 participants (Actual)Interventional2015-07-17Completed
Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With Moderate to Severe Systemic Lupus Erythematosus [NCT00137969]Phase 2/Phase 3262 participants (Actual)Interventional2005-05-10Completed
The Effect of Low-dose Corticosteroids and Theophylline on the Risk of Acute Exacerbations of COPD: the TASCS Randomised Clinical Trial [NCT02261727]Phase 41,670 participants (Actual)Interventional2014-06-30Completed
A Phase Ib/II, Open-Label, Multicenter, Randomized, Controlled Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Patients With B-Cell Non-Hodgki [NCT03677141]Phase 1/Phase 2117 participants (Actual)Interventional2019-03-08Completed
Phase 3 Multi-center Randomized Study to Compare Efficacy and Safety of Azacitidine and Chidamide Combined With CHOP (AC-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma With T-follicular Helper Phenotype (PTCL-TFH) [NCT05678933]Phase 3200 participants (Anticipated)Interventional2023-01-01Enrolling by invitation
Lenalidomide Combined With Anti-CD20 Monoclonal Antibodies-CHOP in Untreated Diffuse Large B-Cell Lymphoma Patients With MYC and BCL2 Co-expression : An Open-lable,Multicenter,Phase II Study [NCT04842487]Phase 280 participants (Anticipated)Interventional2021-04-10Not yet recruiting
A Phase 1b/2 Study of the Oral CDK4/6 Inhibitor LEE011 (Ribociclib) in Combination With Docetaxel Plus Prednisone in Metastatic Castration Resistant Prostate Cancer [NCT02494921]Phase 1/Phase 243 participants (Actual)Interventional2015-11-20Completed
A Therapeutic Trial of Decitabine and Vorinostat in Combination With Chemotherapy (Vincristine, Prednisone, Doxorubicin and PEG-Asparaginase) for Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL) [NCT00882206]Phase 215 participants (Actual)Interventional2009-04-30Terminated(stopped due to Slow accrual)
A Multi-Center, Randomized Study of Cyclosporine or Corticosteroids as an Adjunct to Plasma Exchange in the Initial Therapy of Thrombotic Thrombocytopenic Purpura (TTP) [NCT00713193]Phase 326 participants (Actual)Interventional2007-11-30Completed
Randomized Dose-comparison Study of Prednisone in Patients With Symptomatic Heart Failure [NCT01559727]Phase 340 participants (Actual)Interventional2012-03-31Completed
A Phase II Study of SGN-30 in Combination With CHOP in Anaplastic Large Cell Lymphoma [NCT00365274]Phase 26 participants (Actual)Interventional2006-08-31Terminated
Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia. [NCT01579110]Phase 2100 participants (Anticipated)Interventional2012-04-30Active, not recruiting
A Single-center, Single-arm, Prospective Study to Investigate the Efficacy and Safety of Olaparib Combined With Abiraterone and Prednisone in mHSPC Patients With HRR Gene Mutation [NCT05167175]Phase 230 participants (Anticipated)Interventional2022-03-01Recruiting
A Phase I Study of Cabazitaxel, Mitoxantrone, and Prednisone (CAMP) for Patients With Metastatic Castration-Resistant Prostate Cancer and no Prior Chemotherapy [NCT01594918]Phase 125 participants (Actual)Interventional2012-06-30Completed
A Phase II Study of CHOEP Induction Followed by Gemcitabine/Busulfan/Melphalan Autologous Stem Cell Transplantation for Patients With Newly Diagnosed T-Cell Lymphoma [NCT01746173]Phase 25 participants (Actual)Interventional2013-07-31Terminated(stopped due to Slow accrual and futility)
Belatacept Therapy for the Failing Renal Allograft [NCT01921218]Phase 313 participants (Actual)Interventional2013-08-31Completed
Randomized, Phase II Trial of CHOP vs. Oral Chemotherapy With Concomitant Antiretroviral Therapy in Patients With HIV-Associated Lymphoma in Sub-Saharan Africa [NCT01775475]Phase 27 participants (Actual)Interventional2016-09-15Completed
A Multi-center, Prospective Clinical Study of Zanubrutinib, Rituximab and Combination Chemotherapy in Patients With Newly-diagnosed Aggressive B-cell Non-Hodgkin Lymphoma [NCT05164770]Phase 3160 participants (Anticipated)Interventional2021-03-01Recruiting
Treatment Regimen or Children or Adolescent With Mature B-cell NHL or B-AL in China [NCT02405676]Phase 2/Phase 3200 participants (Anticipated)Interventional2015-01-31Active, not recruiting
Novel Form of Acquired Long QT Syndrome [NCT04169100]Phase 425 participants (Anticipated)Interventional2011-09-28Recruiting
A Randomized, Open-label and Multicenter Trial Comparing Withdrawal of Steroids or Tacrolimus From Sirolimus-based Immunosuppressive Regimen in de Novo Renal Allograft Recipients [NCT00195429]Phase 447 participants (Actual)Interventional2005-08-31Completed
Oral Steroids in the Treatment of Acute Sciatica A Randomized Controlled Study [NCT00317447]Phase 3160 participants Interventional2002-02-28Completed
A Multicenter Phase I/II Trial of Abiraterone Acetate + BEZ235 in Metastatic, Castration-Resistant Prostate Cancer [NCT01717898]Phase 1/Phase 26 participants (Actual)Interventional2013-01-31Terminated(stopped due to Dose limiting toxicities on lowest dose level)
Phase II Trial Investigating Tailoring First-Line Therapy For Advanced Stage Diffuse Large B-Cell Non-Hodgkin's Lymphoma Based on Mid-Treatment Positron Emission Tomography (PET) Scan Results [NCT00324467]Phase 2150 participants (Actual)Interventional2006-08-31Active, not recruiting
Efficacy and Safety of Corticosteroids in Oxygen-dependent Patients With COVID-19 Pneumonia in Grand Ouest Interregion France [NCT04359511]Phase 30 participants (Actual)Interventional2020-07-03Withdrawn(stopped due to COMPETITOR TEST (RECOVERY))
[NCT00425724]Phase 420 participants (Anticipated)Interventional2000-01-31Completed
Cognitive Effects of Androgen Receptor (AR) Directed Therapies for Advanced Prostate Cancer [NCT03016741]Phase 4100 participants (Anticipated)Interventional2017-03-31Recruiting
A Phase III, Randomized, Double-blind, Controlled Multicenter Study of Intravenous PI3K Inhibitor Copanlisib in Combination With Standard Immunochemotherapy Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL [NCT02626455]Phase 3547 participants (Actual)Interventional2016-01-06Terminated(stopped due to The study did not meet the primary endpoint. The addition of copanlisib to standard immunochemo therapy did not improve progression-free survival compared to the control arm. Base on the study results, company decided to terminate the study.)
An Open Trial of the Efficacy of Glucocorticoids and Methotrexate (MTX) in the Treatment of Systemic Vasculitis [NCT00001256]Phase 2100 participants Interventional1990-03-31Completed
Comparative Study of Dexamethasone vs Prednisone (Both in Combination With Melphalan) as Induction Therapy in Untreated Symptomatic Myeloma With an Additional Assessment of Dexamethasone vs no Additional Treatment as Maintenance Therapy in Non-Progressing [NCT00002678]Phase 3595 participants (Actual)Interventional1995-06-02Completed
A 2-week Single-blind, Randomized, 3-arm Proof of Concept Study of the Effects of AIN457 (Anti-IL17 Antibody), ACZ885 (Canakinumab, Anti-IL1b Antibody), or Corticosteroids in Patients With Polymyalgia Rheumatica, Followed by an Open Label Phase to Assess [NCT01364389]Phase 216 participants (Actual)Interventional2011-02-14Terminated(stopped due to Data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period.)
A Pilot Phase I/II Study to Evaluate the Effects of Taxotere/Prednisone Plus Sunitinib in Chemotherapy-Naïve, Hormone Refractory Prostate Cancer Patients With Biochemical Relapse [NCT00879619]Phase 1/Phase 24 participants (Actual)Interventional2009-07-31Terminated(stopped due to Terminated due to slow accrual.)
Randomized Controlled Trial of Infliximab (Remicade®) Induction Therapy for Deceased Donor Kidney Transplant Recipients (CTOT-19) [NCT02495077]Phase 2290 participants (Actual)Interventional2015-11-02Completed
Marrow-Ablative Chemo-Radiotherapy and Autologous Stem Cell Transplantation Followed by Interferon-Alpha Maintenance Treatment Versus Interferon-Alpha Maintenance Treatment Alone After a Chemotherapy-Induced Remission in Patients With Stages III or IV Fol [NCT00003152]Phase 3469 participants (Anticipated)Interventional1997-03-31Terminated(stopped due to low accrual)
MYELOMA VII MEDICAL RESEARCH COUNCIL WORKING PARTY ON LEUKEMIA IN ADULTS: MYELOMATOSIS THERAPY TRIAL [NCT00002599]Phase 3750 participants (Anticipated)Interventional1994-09-30Active, not recruiting
The Clinical Features and Pregnancy Outcomes of Patients With Rheumatoid Arthritis :a Prospective Cohort Study [NCT05651373]100 participants (Anticipated)Observational2021-07-30Recruiting
VIIITH MYELOMATOSIS TRIAL: A RANDOMISED TRIAL OF TREATMENT FOR INDUCING FIRST PLATEAU PHASE ABCM VS 3 COURSES OF ABCM FOLLOWED BY ORAL WEEKLY CYCLOPHOSPHAMIDE [NCT00002653]Phase 31,000 participants (Anticipated)Interventional1993-09-30Active, not recruiting
TREATMENT OF ADULT ACUTE LYMPHOBLASTIC LEUKEMIA: PHASE II TRIALS OF AN INDUCTION REGIMEN INCLUDING PEG-L-ASPARAGINASE, WITH OR WITHOUT PIXY, IN PREVIOUSLY UNTREATED PATIENTS, FOLLOWED BY ALLOGENEIC BONE MARROW TRANSPLANTATION OR FURTHER CHEMOTHERAPY IN FI [NCT00002665]Phase 250 participants (Anticipated)Interventional1995-07-31Completed
Pilot Study for the Treatment of Children With Newly Diagnosed Advanced Stage Hodgkin's Disease: Upfront Dose Intensive Chemotherapy [NCT00004010]Phase 299 participants (Actual)Interventional1999-10-31Completed
Rituxan in the Management of Multiple Myeloma [NCT00003554]Phase 20 participants Interventional1998-11-30Completed
A Randomized Trial to Evaluate Early High Dose Therapy and Autologous Bone Marrow Transplantation as Part of Planned Initial Therapy for Poor Risk Intermediate/High Grade NHL [NCT00003578]Phase 3500 participants (Anticipated)Interventional1993-01-31Active, not recruiting
A Phase II Trial of Combination Vinorelbine-Estramustine With or Without Prednisone for High Risk and Recurrent, Advanced and Metastatic Renal Cell Carcinoma [NCT00003584]Phase 235 participants (Anticipated)Interventional1998-07-31Completed
A Non-Interventional Study to Evaluate the Effectiveness of Delayed-Release Prednisone (RAYOS) on Clinical Assessments and Serologic Disease Activity in Patients With Active Rheumatoid Arthritis in the Clinical Practice Setting [NCT02287610]75 participants (Actual)Observational2014-11-30Completed
Phase III Study of Combination Chemotherapy in Children With T Cell and Pre-B Cell Non-Hodgkin's Lymphoma [NCT00003650]Phase 3179 participants (Actual)Interventional1997-02-28Completed
Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Infants Less Than 1 Year of Age. [NCT00002785]Phase 20 participants Interventional1996-07-31Completed
Augmenting Bone Marrow With CD34 Enriched Peripheral Blood Hematopoietic Stem Cells for Allogeneic Transplantation of Hematologic Malignancies [NCT00004232]Phase 10 participants Interventional1999-10-31Completed
[NCT00004436]30 participants Interventional1993-07-31Completed
[NCT00004448]Phase 2123 participants Interventional1997-11-30Completed
[NCT00004646]Phase 320 participants Interventional1995-04-30Completed
Study on the Treatment Strategy of Patients With Rheumatoid Arthritis During Pregnancy, a Randomized Control Trial in China [NCT04569890]100 participants (Anticipated)Interventional2020-12-01Not yet recruiting
High Dose Combined Modality Therapy With Peripheral Blood Progenitor Cell Transplantation as Primary Treatment for Patients With Mantle Cell Lymphoma [NCT00003541]Phase 1/Phase 224 participants (Anticipated)Interventional1998-06-30Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients With Giant Cell Arteritis [NCT02531633]Phase 3161 participants (Actual)Interventional2015-10-16Terminated(stopped due to GSK decision to return rights to sirukumab to Janssen and discontinue sirukumab development in giant cell arteritis.)
Randomized Trial of CHOP Chemotherapy With or Without Rituximab (Chimeric Anti-CD20 Antibody) for HIV-Associated Non-Hodgkin's Lymphoma [NCT00003595]Phase 3120 participants (Actual)Interventional1999-01-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Matrix Metalloprotease Inhibitor AG3340 in Combination With Mitoxantrone and Prednisone With Provision for Subsequent Change in Therapy in Patients Having Hormone-Refractory Prostate C [NCT00003343]Phase 3525 participants (Anticipated)Interventional1998-03-31Completed
Evaluation of CHOP Plus Rituximab Plus Involved Field Radiotherapy for Stages I, IE, and Non-Bulky Stages II and IIE, CD20 Positive, High-Risk Localized Aggressive Histologies of Non-Hodgkin's Lymphoma [NCT00005089]Phase 271 participants (Actual)Interventional2000-04-30Completed
A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly [NCT01855750]Phase 3838 participants (Actual)Interventional2013-09-03Completed
A Randomized, Open Label, Multicenter Study of Cabazitaxel Versus an Androgen Receptor (AR)-Targeted Agent (Abiraterone or Enzalutamide) in mCRPC Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent (CARD) [NCT02485691]Phase 4255 participants (Actual)Interventional2015-11-09Completed
Bone Marrow Transplantation and High Dose Post-Transplant Cyclophosphamide for Chimerism Induction and Renal Allograft Tolerance (ITN054ST) [NCT02029638]Phase 24 participants (Actual)Interventional2014-01-07Terminated(stopped due to Slow accrual)
Augmented Berlin-Frankfurt-Munster Therapy Plus Ofatumumab for Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma [NCT02419469]Phase 21 participants (Actual)Interventional2015-11-13Terminated(stopped due to Slow Accrual)
Repeat Emergency Department Visits Among Patients With Asthma and COPD [NCT02499887]6 participants (Actual)Interventional2016-01-31Terminated(stopped due to Exclusion criteria prevented enrollment of adequate # of participants)
Phase 3 Study Investigating the Efficacy and Safety of TAVT-45 (Abiraterone Acetate) Granules for Oral Suspension (Novel Abiraterone Acetate Formulation) Relative to a Reference Abiraterone Acetate Formulation in Patients With mCSPC & mCRPC [NCT04887506]Phase 3107 participants (Actual)Interventional2021-04-14Completed
Short-course High-dose Prednisone and Dexamethasone in Children With Immune A Multicenter, Randomized Controlled Study of Thrombocytopenia [NCT05522465]Phase 4608 participants (Anticipated)Interventional2022-10-11Recruiting
A Phase I/II Trial of Isatuximab, Bendamustine, and Prednisone in Refractory Multiple Myeloma [NCT04083898]Phase 115 participants (Actual)Interventional2020-04-03Active, not recruiting
De Novo Everolimus Versus Tacrolimus in Combination With Mofetil Mycophenolate and Low Dose Corticosteroids to Reduce Tacrolimus Induced Nephrotoxicity in Liver Transplantation: a Prospective, Multicentric, Randomised Study [NCT02909335]Phase 30 participants (Actual)Interventional2016-11-30Withdrawn
Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis (ITN055AI) [NCT02260934]Phase 243 participants (Actual)Interventional2015-07-09Completed
A Phase I/II Study of Alisertib in Combination With Abiraterone and Prednisone for Patients With Castration-Resistant Prostate Cancer After Progression on Abiraterone [NCT01848067]Phase 1/Phase 29 participants (Actual)Interventional2013-08-14Completed
A Phase I and Randomized Phase II Multicenter Study of Cabozantinib (XL184) Plus Docetaxel and Prednisone in Metastatic Castrate Resistant Prostate Cancer [NCT01683994]Phase 1/Phase 249 participants (Actual)Interventional2012-09-07Completed
Effectiveness and Safety of Tacrolimus Combined With Low-dose Prednisone for Treatment of Myasthenia Gravis: A Real-world Study [NCT04768465]160 participants (Anticipated)Observational [Patient Registry]2021-01-01Recruiting
Phase 2/3, Randomized, Open Study to Compare the Efficacy and Safety of Colchicine and Glucocorticoids Compared With the Standard of Treatment for Moderate/Severe COVID-19 in a Fragile and Vulnerable Population, Admitted to a Geriatric Hospital Unit or in [NCT04492358]Phase 2/Phase 354 participants (Actual)Interventional2020-10-22Terminated(stopped due to No candidates for the recruitment)
Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids [NCT03023891]Phase 125 participants (Actual)Interventional2017-02-15Completed
A Prospective, Randomized Trial Comparing the Efficacy of Body-weight Based Versus Fixed Corticosteroid Dosage on Remission in Patients With Moderate to Severe Crohn's Disease Flares [NCT02392286]Phase 415 participants (Actual)Interventional2015-03-31Terminated(stopped due to insufficient enrollment)
A Phase 2 Trial of the Efficacy and Safety of the Interleukin-17A Inhibitor Izokibep (ABY-035) in the Treatment of Non-infectious Intermediate, Posterior or Pan-uveitis (LINNAEA) [NCT04706741]Phase 27 participants (Actual)Interventional2022-01-06Completed
A Multicenter, Open-Label Feasibility Study of Daratumumab With Dose-Adjusted EPOCH in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV [NCT04139304]Early Phase 115 participants (Anticipated)Interventional2021-05-24Recruiting
A Phase ll Study Evaluating the Efficacy and Safety of Metformin in Combination With Standard Induction Therapy (RM-CHOP) for Previously Untreated Aggressive Diffuse Large B-cell Lymphoma [NCT02531308]Phase 25 participants (Actual)Interventional2015-07-31Terminated(stopped due to poor accrual)
A Phase I/II Trial of Concurrent Chemohormonal Therapy Using Enzalutamide (MDV-3100) and Cabazitaxel in Patients With Metastatic Castration Resistant Prostate Cancer [NCT02522715]Phase 1/Phase 237 participants (Actual)Interventional2015-10-13Active, not recruiting
Initiation of a Deceased Donor Uterine Transplantation Program at the University of Nebraska Medical Center [NCT02409147]0 participants (Actual)Interventional2016-01-31Withdrawn(stopped due to Lack of funding)
Short-Course EPOCH - Rituximab in Untreated CD-20+ HIV-Associated Lymphomas [NCT00006436]Phase 268 participants (Actual)Interventional2001-01-29Active, not recruiting
Efficacy of Rituximab in Comparison to Continued Corticosteroid Treatment in Idiopathic Nephrotic Syndrome Unresponsive to 8 Weeks of High Dose Prednisone [NCT03298698]Phase 340 participants (Anticipated)Interventional2018-08-22Recruiting
An Open-Label, Phase 2 Study to Evaluate the Activity of Belumosudil in Subjects With New Onset and Incipient Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Cell Transplantation [NCT05922761]Phase 245 participants (Anticipated)Interventional2023-12-31Not yet recruiting
Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) When Placed Within the Lower Eye Lid Canaliculus or Both the Upper and Lower Canaliculi for the Treatment of Pain, Inflammation, and Cystoid Macular Edema Foll [NCT04501367]Phase 460 participants (Anticipated)Interventional2021-04-27Recruiting
A RANDOMIZED, MULTICENTER, OPEN LABEL STUDY COMPARING TWO STANDARD TREATMENTS, BORTEZOMIB-MELPHALAN-PREDNISONE (VMP) WITH OR WITHOUT DARATUMUMAB (Dara-VMP) VS LENALIDOMIDE-DEXAMETHASONE (Rd) WITH OR WITHOUT DARATUMUMAB (Dara-Rd) IN AUTOLOGOUS STEM CELL TR [NCT03829371]Phase 4450 participants (Anticipated)Interventional2019-01-03Recruiting
Phase II Trial of Response-Adapted Therapy Based on Positron Emission Tomography (PET) for Bulky Stage I and II Classical Hodgkin Lymphoma (HL) [NCT01390584]Phase 26 participants (Actual)Interventional2013-05-24Terminated(stopped due to slow accrual)
A Phase I/II, Multi-center, Open Label Study of Pomalidomide, Cyclophosphamide and Prednisone (PCP) in Patients With Multiple Myeloma Relapsed and/or Refractory to Lenalidomide [NCT01166113]Phase 1/Phase 267 participants (Actual)Interventional2010-07-31Completed
A Multicenter, Open Label Study Of Oral Revlimid And Prednisone (Rp) Followed By Oral Revlimid Melphalan And Prednisone (Mpr) In Newly Diagnosed Elderly Multiple Myeloma Patients [NCT01160107]Phase 246 participants (Actual)Interventional2008-07-31Completed
A PHASE III, MULTI-CENTER, RANDOMIZED OPEN LABEL STUDY OF VELCADE, MELPHALAN, PREDNISONE AND THALIDOMIDE (V-MPT) Versus VELCADE, MELPHALAN, PREDNISONE (V-MP) IN ELDERLY UNTREATED MULTIPLE MYELOMA PATIENTS [NCT01063179]Phase 3511 participants (Actual)Interventional2006-05-31Completed
A PHASE 3, MULTICENTRE, RANDOMIZED, CONTROLLED STUDY TO DETERMINE THE EFFICACY AND SAFETY OF LENALIDOMIDE, MELPHALAN AND PREDNISONE (MPR) Versus MELPHALAN (200 mg/m2) FOLLOWED BY STEM CELL TRANSPLANT IN NEWLY DIAGNOSED MULTIPLE MYELOMA SUBJECTS [NCT00551928]Phase 3402 participants (Actual)Interventional2007-06-30Active, not recruiting
Response-Adapted Therapy for Aggressive Non-Hodgkin's Lymphomas Based on Early [18F] FDG-PET Scanning [NCT00274924]Phase 2100 participants (Actual)Interventional2006-09-26Completed
Phase II Pilot Study Of Rituximab Plus CHOP In Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia [NCT00060346]Phase 216 participants (Actual)Interventional2004-10-05Terminated(stopped due to slow accrual)
Anakinra vs Prednisone to Treat Gout Flare in Patients With Chronic Kidney Disease Stage 4/5 or Renal Transplantation: a Randomized, Double Blinded, Multicenter Study [NCT04844814]Phase 2204 participants (Anticipated)Interventional2022-06-02Recruiting
Phase II Study of CHOP/Rituxan Plus VELCADE in Mediastinal Large B-cell Lymphoma [NCT00361621]Phase 23 participants (Actual)Interventional2006-07-31Terminated(stopped due to Closed due to slow accrual)
Donor-derived Mesenchymal Stromal Cells, Alemtuzumab, Co-stimulation Blockade and Sirolimus for Tolerance Induction in Adult Kidney Allograft Recipients (ITN062ST) [NCT03504241]Phase 18 participants (Actual)Interventional2018-07-30Active, not recruiting
Treatment of Prostate Cancer by Induction of Alternate Cell Death Pathways: A Phase I Trial of Docetaxel, Estramustine, Mitoxantrone and Prednisone [NCT00003633]Phase 112 participants (Anticipated)Interventional1998-08-31Active, not recruiting
A Randomized, Open-Label Phase II/III Study of SU101 Plus Mitoxantrone/Prednisone Compared to Mitoxantrone/Prednisone Alone in Patients With Hormone-Refractory Prostate Cancer [NCT00004071]Phase 2/Phase 30 participants Interventional1999-08-31Completed
Chimeric Anti-CD20 Monoclonal Antibody (Mabthera) in Remission Induction and Maintenance Treatment of Relapsed Follicular Non-Hodgkin's Lymphoma: A Phase III Randomized Clinical Trial - Intergroup Collaborative Study [NCT00004179]Phase 3475 participants (Actual)Interventional1999-05-31Completed
ALinC 17: Continuous Intensification for Very High Risk Acute Lymphocytic Leukemia (A.L.L.): A Pediatric Oncology Group Pilot Study [NCT00003783]Phase 236 participants (Actual)Interventional1999-03-31Completed
MK-3475 in Combination With Standard RCHOP Therapy for Previously Untreated Diffuse Large B-Cell Lymphoma [NCT02541565]Phase 130 participants (Actual)Interventional2015-11-24Completed
Randomized Controlled Trial Testing the Effect of Hydroxychloroquine Combined With Low-dose Corticosteroid Therapy in Pulmonary Sarcoidosis [NCT05247554]Phase 3200 participants (Anticipated)Interventional2022-03-01Not yet recruiting
Characterization of Heart Rate Variability in Individuals With Duchenne Muscular Dystrophy - Influence of Corticosteroids and Betablockers [NCT04740554]40 participants (Actual)Observational2013-03-01Completed
Beijing Children's Hospital, Capital Medical University [NCT03598725]Phase 455 participants (Anticipated)Interventional2016-01-01Recruiting
Clinical and Angiographic Outcome of Patients Treated With Bare Metal Stent (BMS) Implantation Compared With Drug Eluting Stents or BMS Plus Systemic Prednisone Therapy. A Randomized, Multicentre Study. [NCT00369356]Phase 2/Phase 3375 participants (Actual)Interventional2006-10-31Completed
Chronic Administration of Prednisone in Management of Patients With Decompensated Congestive Heart Failure [NCT00369044]Phase 2/Phase 360 participants (Anticipated)Interventional2006-10-31Suspended
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Immunosuppression in Biopsy-proven Virus Negative Myocarditis or Inflammatory Cardiomyopathy [NCT04654988]Phase 4100 participants (Anticipated)Interventional2022-05-01Not yet recruiting
Once-daily Regimen With Envarsus® to Optimize Immunosuppression Management and Outcomes in Kidney Transplant Recipients [NCT02954198]40 participants (Actual)Interventional2016-12-01Completed
Randomized Phase II Study of Salvage XRT + ADT +/- Abiraterone Acetate and Apalutamide (ARN-509) for Rising PSA After Radical Prostatectomy With Adverse Features.(FORMULA-509 Trial) [NCT03141671]Phase 2345 participants (Actual)Interventional2017-11-24Active, not recruiting
Thalidomide, Cyclophosphamide and Prednisone in Newly Diagnosed Multicentric Castleman's Disease: a Prospective, Single-center, Single-arm, Phase-II Pilot Trial [NCT03043105]Phase 225 participants (Actual)Interventional2017-01-01Active, not recruiting
Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients Converted From Twice-daily Tacrolimus [NCT02953873]Phase 425 participants (Actual)Interventional2017-05-05Completed
A Phase 2 Study of Docetaxel Plus Apalutamide in Castration-Resistant Prostate Cancer Patients Post Abiraterone Acetate [NCT03093272]Phase 29 participants (Actual)Interventional2017-06-23Terminated(stopped due to Safety concerns)
Phase II Multicenter Study Of Natalizumab Plus Standard Steroid Treatment For High Risk Acute Graft-Versus-Host Disease [NCT02133924]Phase 276 participants (Actual)Interventional2016-08-31Completed
A Phase I Study of Subcutaneous Rituximab Hyaluronidase Combined With Local Standard-of-Care Chemotherapy for the Treatment of Burkitt Lymphoma, Diffuse Large B-Cell Lymphoma or as Monotherapy for Kaposi Sarcoma Herpesvirus Associated Multicentric Castlem [NCT03864419]Phase 140 participants (Anticipated)Interventional2019-10-24Recruiting
A Phase 2, Open-Label, Single-Arm, Multidose Study to Investigate the Effects of Orteronel on the QT/QTc Interval in Patients With Metastatic Castration-Resistant Prostate Cancer [NCT01549951]Phase 250 participants (Actual)Interventional2012-05-31Completed
Efficacy and Safety of Oral Corticosteroids for the Treatment of Acute Exacerbations of COPD in General Practice [NCT02330952]Phase 4189 participants (Actual)Interventional2015-02-10Completed
Radiation Enhancement of Local and Systemic Anti-Prostate Cancer Immune Responses [NCT03649841]Phase 210 participants (Actual)Interventional2020-06-29Terminated(stopped due to Terminated due to low accrual.)
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus Nephritis [NCT02550652]Phase 2126 participants (Actual)Interventional2015-11-13Completed
Evaluation of Mechanism(s)Limiting Expiratory Airflow in Chronic, Stable Asthmatics Who Are Non-smokers [NCT00576069]60 participants (Anticipated)Observational2007-10-25Recruiting
Open Label Pharmacodynamic Study of Abiraterone Acetate in the Treatment of Metastatic, Castration Resistant Prostate Cancer [NCT01503229]Phase 232 participants (Actual)Interventional2012-12-31Completed
A Multicenter, Open-Label Study to Estimate the Effect Sizes of HRCT Endpoints in Response to GLUCOCORTICOID Induction Therapy in Subjects With Pulmonary Sarcoidosis [NCT03324503]8 participants (Actual)Interventional2017-12-08Completed
Protocol H8 for a Prospective Controlled Trial in Clinical Stage I-II Supradiaphragmatic Hodgkin's Disease. Evaluation of Treatment Efficacy and (Long Term) Toxicity in Three Different Prognostic Subgroups [H8 Trial] [NCT00379041]Phase 31,158 participants (Anticipated)Interventional1993-09-01Active, not recruiting
NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma [NCT01451515]Phase 223 participants (Actual)Interventional2012-05-25Completed
SHR0302 and Prednisone as First Line Therapy for Chronic Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation [NCT04146207]Early Phase 173 participants (Anticipated)Interventional2020-04-02Recruiting
CHemotherapy Plus Enzalutamide In First Line Therapy for Castration Resistant prOstate caNcer [NCT02453009]Phase 2232 participants (Anticipated)Interventional2014-10-31Recruiting
A Randomized, Multicenter Study of Belatacept, Everolimus, rATG and Early Steroid Withdrawal Versus Belatacept, Mycophenolate, rATG and Chronic Steroids in Renal Transplantation [NCT04849533]Phase 4120 participants (Anticipated)Interventional2021-04-09Recruiting
A PHASE II TRIAL OF EIGHT-WEEK STANFORD V CHEMOTHERAPY PLUS MODIFIED INVOLVED FIELD RADIOTHERAPY IN FAVORABLE, LIMITED STAGE HODGKIN'S DISEASE [NCT00002714]Phase 20 participants Interventional1995-04-30Completed
A Phase IB/II Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Either Obinutuzumab Plus Bendamustine or Obinutuzumab Plus CHOP in Patients With Follicular Lymphoma or Rituximab Plus CHOP in Patients With Diffuse Large B-Cell Ly [NCT02596971]Phase 1/Phase 291 participants (Actual)Interventional2015-12-22Completed
Rituximab, Cyclophosphamide, Vincristine, and Prednisone in Combination With Doxorubicin (R-CHOP) Versus in Combination With Pegylated-liposomal Doxorubicin (R-CDOP) as First-line Treatment for Elderly Patients With Diffuse Large-B-cell Lymphoma: a Random [NCT02428751]Phase 3216 participants (Anticipated)Interventional2015-09-30Recruiting
A Phase Ib/II, Open-Label Study Evaluating the Safety, Efficacy and Pharmacokinetics of GDC-0199 (ABT-199) in Combination With Rituximab (R) or Obinutuzumab (G) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Patients With B-Cell [NCT02055820]Phase 1/Phase 2267 participants (Actual)Interventional2013-11-17Completed
A Randomized Gene Fusion Stratified Phase 2 Trial of Abiraterone With or Without ABT-888 for Patients With Metastatic Castration-Resistant Prostate Cancer [NCT01576172]Phase 2159 participants (Actual)Interventional2012-03-30Completed
A Phase II Study of Dovitinib (TKI258) Combined With Abiraterone Acetate in Patients With Metastatic Castrate-Resistant Prostate Cancer Evaluating Markers of FGF and AR Signaling in Bone Marrow and Plasma [NCT01994590]Phase 24 participants (Actual)Interventional2014-05-19Terminated(stopped due to Sponsor stopped supplying study drug)
Efficacy of Consolidative Involved-site Radiotherapy Following Sufficient Chemotherapy for Patients With Limited-stage Diffuse Large B-cell Lymphoma: Wuhan University Cancer Center -NHL03 Trial [NCT02449265]Phase 3160 participants (Anticipated)Interventional2015-10-31Recruiting
A Phase 1, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Single-Ascending Dose Study of LY3872386 in Healthy Participants, a Multiple-Ascending Dose Study of LY3872386 in Patients With Atopic Dermatitis, and an Open-Label Multiple-Dose Evalua [NCT06119529]Phase 1179 participants (Anticipated)Interventional2023-11-01Not yet recruiting
A Phase 3, Randomized, Open-Label Study Comparing the Efficacy and Safety of the Combination of Beleodaq-CHOP or Folotyn-COP to the CHOP Regimen Alone in Newly Diagnosed Patients With Peripheral T-Cell Lymphoma [NCT06072131]Phase 3504 participants (Anticipated)Interventional2023-10-04Recruiting
A Prospective, Two-center, Clinical Study to Optimize the Treatment for Allergic Bronchopulmonary Aspergillosis (ABPA) [NCT05129033]100 participants (Anticipated)Interventional2021-11-15Not yet recruiting
A Real-world Study of the Efficacy and Safety of Obinutuzumab-based Therapy for Previously Untreated Follicular Lymphoma [NCT05899621]332 participants (Anticipated)Observational2023-06-01Recruiting
Immunostart: Prephase Tafasitamab, Retifanlimab, and Rituximab (TRR), Followed by TRR-CHOP, for Previously Untreated Diffuse Large B-Cell Lymphoma [NCT05455697]Phase 1/Phase 235 participants (Anticipated)Interventional2023-01-26Recruiting
Treatment of Mature B-ALL and Burkitt Lymphoma (BL) in Adult Patients. BURKIMAB-14. [NCT05049473]Phase 2100 participants (Anticipated)Interventional2014-01-31Recruiting
A Randomized Controlled Study of Dasatinib Combined With Reduced Intensive Consolidation Chemotherapy in Newly Diagosed Philadelphia Chromesome Positive Adult Lymphoblastic Leukemia [NCT05026229]60 participants (Anticipated)Interventional2021-09-06Recruiting
Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer [NCT03678025]Phase 31,273 participants (Anticipated)Interventional2018-09-24Recruiting
Cabazitaxel With Abiraterone Versus Abiraterone Alone Randomized Trial for Extensive Disease Following Docetaxel: The CHAARTED2 Trial [NCT03419234]Phase 2223 participants (Actual)Interventional2018-04-26Active, not recruiting
A Phase II Study of Doxil (Liposomal Doxorubicin), Cyclophosphamide, Vincristine and Prednisone for AIDS-Related Systemic Lymphoma [NCT00003388]Phase 238 participants (Anticipated)Interventional1999-07-26Completed
The Effectivity of Anti Tuberculosis Therapy in Idiopathic Uveitis With Positive Interferon Gamma Release Assay (IGRA): A Randomized Clinical Trial [NCT05005637]Phase 280 participants (Anticipated)Interventional2021-07-27Enrolling by invitation
Tocilizumab Plus a Short Prednisone Taper for Giant Cell Arteritis (GCA) [NCT03726749]Phase 430 participants (Actual)Interventional2018-11-28Completed
Immune Monitoring and Calcineurin Inhibitor (CNI) Withdrawal in Low Risk Recipients of Kidney Transplantation [NCT01517984]Phase 252 participants (Actual)Interventional2010-11-30Terminated(stopped due to Absence of equipoise on the basis of predetermined stopping rules.)
Concurrent Ponatinib With Chemotherapy for Young Adults With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia [NCT02776605]Phase 230 participants (Actual)Interventional2016-06-30Active, not recruiting
A Phase II, Open-Label, Multicenter Study of Efficacy, Safety, and Biomarkers in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma Treated With GA101 (RO5072759) in Combination With CHOP Chemotherapy [NCT01414855]Phase 2100 participants (Actual)Interventional2011-08-31Completed
The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss [NCT02990403]Phase 4500 participants (Anticipated)Interventional2014-10-31Recruiting
An Extended Follow-up of the Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced Stage IgA Nephropathy [NCT03218852]Phase 4133 participants (Actual)Interventional2016-12-31Active, not recruiting
Prednisolon Behandling Ved Akut Interstitiel Nefritis - et Randomiseret, Prospektivt Studie [NCT04376216]Phase 4110 participants (Anticipated)Interventional2017-09-01Recruiting
Open, Non-Interventional, Multicenter Trial of MabThera in Combination With CHOP (or CHOP-like) Chemotherapy in Patients With Aggressive B-Cell Lymphoma [NCT02486952]154 participants (Actual)Observational2005-08-31Completed
A Phase 2 Trial of Bevacizumab, Lenalidomide, Docetaxel, and Prednisone (ART-P) for Treatment of Metastatic Castrate-Resistant Prostate Cancer [NCT00942578]Phase 263 participants (Actual)Interventional2009-07-16Completed
Intratympanic Steroid Injection for Treatment of Idiopathic Facial Nerve Paralysis [NCT03508440]Phase 2/Phase 311 participants (Actual)Interventional2018-01-31Completed
A Randomized, Controlled Trial to Evaluate Leflunomide Plus Low Dose Corticosteroid Therapy in Progressive IgA Nephropathy With Renal Insufficiency [NCT04020328]Phase 470 participants (Anticipated)Interventional2019-09-12Recruiting
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy [NCT01695135]Phase 3214 participants (Actual)Interventional2012-08-09Completed
A Pre-Operative Study to Assess the Effects of Apalutamide Plus LHRH Agonist or Apalutamide Plus Abiraterone Acetate Plus LHRH Agonist for Six Months for Prostate Cancer Patients at High Risk for Recurrence [NCT03279250]Phase 286 participants (Actual)Interventional2017-10-13Completed
A Phase 3, Intergroup Multicentre, Randomized, Controlled 3 Arm Parallel Group Study to Determine the Efficacy and Safety of Lenalidomide in Combination With Dexamethasone (RD) Versus Melphalan, Prednisone and Lenalidomide (MPR) Versus Cyclophosphamide, P [NCT01093196]Phase 3660 participants (Anticipated)Interventional2009-10-31Active, not recruiting
Phase I Study of Venetoclax Plus DA-EPOCH-R for the Treatment of Aggressive B-Cell Lymphomas [NCT03036904]Phase 131 participants (Actual)Interventional2017-02-06Completed
Phase II Study of Neoadjuvant Androgen Deprivation Therapy Plus Abiraterone With or Without Apalutamide for Patients With High-Risk Localized Prostate Cancer Prior to Radical Prostatectomy [NCT02789878]Phase 264 participants (Actual)Interventional2019-01-24Completed
Xolair (Omalizumab) for Treatment of Drug-induced Acute Tubulointerstitial Nephritis (AIN) [NCT01893658]Phase 20 participants (Actual)Interventional2018-06-01Withdrawn(stopped due to Lack of patients with a condition of interest that resulted in failure to recruit)
A Novel Immunosuppression Intervention for the Treatment of Amyotrophic Lateral Sclerosis (ALS) [NCT01884571]Phase 231 participants (Actual)Interventional2013-10-31Completed
A 12-Month, Open Label Study of Extended Release Tacrolimus (Envarsus XR®, LCPT) With Mycophenolate, Rabbit Antithymocyte Globulin (rATG) and Early Steroid Withdrawal in de Novo Kidney Transplant Recipients [NCT03828682]Phase 460 participants (Anticipated)Interventional2019-06-21Recruiting
Efficacy of Prednisone in Patients With Severe Systemic Atheroembolism (Cholesterol Cristal Embolism) [NCT01452100]Phase 239 participants (Actual)Interventional2011-06-30Terminated(stopped due to Inclusion default)
Dasatinib Plus Multi-agent Chemotherapy for New Diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia [NCT02523976]Phase 230 participants (Actual)Interventional2015-08-01Completed
MEthotrexate Versus TOcilizumab for Treatment of GIant Cell Arteritis: a Multicenter, Randomized, Controlled Trial [NCT03892785]Phase 3230 participants (Anticipated)Interventional2020-01-27Recruiting
Proteomics Combined With Metabolomics Studies on the Efficacy of Telitacicept in Chinese Patients of Systemic Lupus Erythematosus [NCT05666336]Phase 430 participants (Anticipated)Interventional2022-12-31Recruiting
An Open-Label Phase 1/2 Multi-Arm Study of DS-1594b as a Single-Agent and in Combination With Azacitidine and Venetoclax or Mini-HCVD for the Treatment of Patients With Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL) [NCT04752163]Phase 1/Phase 217 participants (Actual)Interventional2021-03-25Completed
Phase II Randomized Study Of Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide For Intermediate-High Risk Prostate Cancer Undergoing Prostatectomy [NCT02903368]Phase 2118 participants (Actual)Interventional2016-10-19Active, not recruiting
BRCAAway: A Randomized Phase II Trial of Abiraterone, Olaparib, or Abiraterone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects [NCT03012321]Phase 270 participants (Anticipated)Interventional2017-01-12Active, not recruiting
A Phase 3, Randomized, Double-blind, Controlled Trial of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer [NCT01522443]Phase 3119 participants (Actual)Interventional2012-03-31Terminated(stopped due to Stopped after the outcome of cabozantinib Phase 3 CRPC study XL184-307.)
Phase II Study of Adult Acute Lymphoblastic Leukaemia (ALL): Imatinib in Combination With Chemotherapy in Ph+ Patients, and Post-remissional Treatment Intensification in High-risk Ph- Patients, With Minimal Residual Disease Monitoring. [NCT00458848]Phase 2470 participants (Actual)Interventional2004-10-31Completed
A Phase II Trial of Doxil, Rituximab, Cyclophosphamide, Vincristine, and Prednisone (DR-COP) in Patients With Newly Diagnosed AIDS-Associated B-Cell Non-Hodgkin's Lymphoma [NCT00389818]Phase 243 participants (Actual)Interventional2007-01-31Completed
A Randomized Trial of Daily Prednisone Versus Pulsed Dexamethasone in Treatment-naïve Adult Patients With Immune Thrombocytopenia [NCT02334813]Phase 326 participants (Actual)Interventional2002-07-31Completed
Phase 1 Trial of Siplizumab and Dose-Adjusted EPOCH-Rituximab (DA-EPOCH-R) in T and NK-Cell Lymphomas [NCT01445535]Phase 115 participants (Actual)Interventional2009-01-13Completed
Treatment of Myelodysplastic Syndrome (MDS) With Cytokine-Immunotherapy for Low-Risk MDS [NCT00520468]Phase 215 participants (Actual)Interventional2004-06-30Completed
Demonstrated Study on Children Henoch-Schönlein Purpura Nephritis With Multistep Treatment of Traditional Chinese Medicine Combined Disease and Syndrome Differentiation [NCT03591471]Phase 1/Phase 2500 participants (Anticipated)Interventional2014-09-30Recruiting
Focal Radiation With Pulsed Systemic Therapy of Abiraterone, ADT, Lynparza Towards Castration Sensitive Oligometastatic Prostate Cancer (FAALCON): A Phase II, Single Arm, Single Institution Study [NCT04748042]Phase 229 participants (Anticipated)Interventional2021-05-28Recruiting
Phase 1/2a, Open-Label, Multicenter Study of Intramuscular PRL-02 Depot in Patients With Advanced Prostate Cancer [NCT04729114]Phase 1/Phase 2100 participants (Anticipated)Interventional2021-06-14Recruiting
Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17 [NCT03755804]Phase 2250 participants (Anticipated)Interventional2018-12-12Recruiting
Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma [NCT03117751]Phase 2/Phase 3790 participants (Actual)Interventional2017-03-29Active, not recruiting
A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (NSC#732517) in Patients With Ph-like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations [NCT02883049]Phase 35,937 participants (Actual)Interventional2012-02-29Active, not recruiting
Phase III Trial of Enzalutamide (NSC# 766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer [NCT01949337]Phase 31,311 participants (Actual)Interventional2014-01-22Active, not recruiting
Emergency Department (ED) Use of Nebulized Budesonide as an Adjunct to Standardized Therapy in Acutely Ill Adults With Refractory Asthma: a Randomized, Double-blinded, Placebo-controlled Trial [NCT00588406]Phase 395 participants (Actual)Interventional2007-09-30Completed
A Prospective, Randomised, Assessor-blind, Multicenter Study of Efficacy and Safety of Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With Polymyositis and Dermatomyositis. [NCT00651040]Phase 331 participants (Actual)Interventional2008-05-31Completed
A Randomized, Double-Blind, Parallel Group, Placebo Controlled Study to Access the Effects of Oral Prednisone on Clinical Efficacy and the Power Doppler Ultrasound Signal of Synovium in Patients With Rheumatoid Arthritis [NCT00746512]Phase 145 participants (Actual)Interventional2008-09-30Completed
A Rand. Trial Comp Higher Doses of Rituximab (Rituxan) With Standard Doses of Rituxan in Combination With CVP (Cyclophosphamide, Vincristine, and Prednisone) in Patients With Chronic ITP Who Have Failed/Relapsed After Rituxan Treatment [NCT00774202]Phase 2/Phase 317 participants (Actual)Interventional2003-11-30Completed
Effect of Steroids Given Over 24 Hours on Cytokine Release, Urinary Desmosine Level and Thrombogenic Markers in Patients Undergoing Unilateral Total Hip Replacement [NCT01782859]40 participants (Actual)Interventional2012-10-31Completed
A Pre-Operative Study to Assess the Effects of Abiraterone Acetate Plus LHRH Agonist and Abiraterone Acetate Plus LHRH Agonist and Enzalutamide for Six Months for Prostate Cancer Patients at High-Risk for Recurrence [NCT01946165]Phase 269 participants (Actual)Interventional2013-10-31Completed
A Single Arm, Multicentre, Phase IIIB Study to Evaluate Safety, Efficacy and Pharmacokinetic (PK) of Subcutaneous (SC) Rituximab Administered During Induction Phase or Maintenance in Previously Untreated Patients With CD20+ Diffuse Large B Cell Lymphoma ( [NCT01889069]Phase 3159 participants (Actual)Interventional2013-07-31Completed
Mature B-Cell Lymphoma And Leukemia Study III [NCT01046825]Phase 2/Phase 3128 participants (Actual)Interventional2010-09-09Active, not recruiting
A Phase II Trial of R-CHOP Followed by Zevalin Radioimmunotherapy for Patients With Previously Untreated Stages I and II CD20+ Diffuse Large Cell Non-Hodgkin's Lymphoma [NCT00088881]Phase 262 participants (Actual)Interventional2004-12-31Terminated
A Phase II, Prospective, Open Label Study (PO-MMM-PI-0011) to Determine the Safety and Efficacy of Pomalidomide (CC-4047) in Subjects With Primary, Post Polycythemia Vera, or Post Essential Thrombocythemia Myelofibrosis (PMF; Post-PV MF, or Post-ET MF) [NCT00946270]Phase 270 participants (Actual)Interventional2009-07-22Completed
Efficacy of Prednisone In the Treatment of Ocular Myasthenia: The EPITOME' Study [NCT00995722]Phase 311 participants (Actual)Interventional2011-12-31Terminated(stopped due to Slow recruitment rate)
Phase II Trial of Carboplatin and Everolimus (RAD001) in Metastatic Castrate Resistant Prostate Cancer (CRPC) Pretreated With Docetaxel Chemotherapy. [NCT01051570]Phase 226 participants (Actual)Interventional2010-02-28Completed
Comparison of Pharmocokinetics of Mycophenolate Mofetil and Enteric Coated Mycophenolate Sodium in Calcineurininhibitor-free Treated Patients After Renal Transplantation [NCT01033864]Phase 423 participants (Actual)Interventional2009-11-30Completed
A Randomized International Phase 3 Trial of Imatinib and Chemotherapy With or Without Blinatumomab in Patients With Newly-Diagnosed Philadelphia Chromosome-Positive or Philadelphia Chromosome-Like ABL-Class B-Cell Acute Lymphoblastic Leukemia [NCT06124157]Phase 3680 participants (Anticipated)Interventional2024-01-22Not yet recruiting
A Phase 1/2 Ascending Dose Study to Evaluate the Safety and Effects on Progranulin Levels of LY3884963 in Patients With Fronto-Temporal Dementia With Progranulin Mutations (FTD-GRN) [NCT04408625]Phase 1/Phase 223 participants (Anticipated)Interventional2020-11-09Recruiting
BEACOPP (4 Cycles Escalated + 4 Cycles Baseline) Versus ABVD (8 Cycles) In Stage III & IV Hodgkin's Lymphoma [NCT00049595]Phase 3552 participants (Actual)Interventional2002-08-31Completed
International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia [NCT01117441]Phase 36,136 participants (Actual)Interventional2010-06-30Completed
Phase II Study of Infliximab for the Treatment of Ipilimumab Colitis [NCT04305145]Phase 242 participants (Anticipated)Interventional2020-08-31Recruiting
Efficacy and Safety of Adalimumab Plus Medium Dose Oral Glucocorticosteroid for Refractory Behçet's Uveitis, Compared With Adalimumab Plus High Dose Oral Glucocorticosteroid, a Non-inferior, Multi-center, Randomized Controlled Trial. [NCT05105347]Phase 4130 participants (Anticipated)Interventional2021-11-10Not yet recruiting
A Multicenter Phase II Study in Adults With Untreated Acute Lymphoblastic Leukemia: Testing Pharmacokinetically Individualized Doses of L-Asparaginase Following the DFCI Pediatric Consortium Protocol [NCT00136435]Phase 2100 participants (Anticipated)Interventional2002-06-30Active, not recruiting
A Randomized Trial Using a Modified COG ABFM Regimen Backbone to Investigate Capizzi Escalating Methotrexate Versus High Dose Methotrexate in Children With Newly Diagnosed T-cell Lymphoblastic Lymphoma (T-LBL) [NCT05681260]Phase 3200 participants (Anticipated)Interventional2023-02-06Recruiting
The Efficacy of Prednisone Alone and Combination Therapy With Methylprednisolone and Cyclophosphamide in the Treatment of Membranous Nephropathy in Stage I. [NCT03466801]6 participants (Actual)Interventional2018-03-20Terminated(stopped due to the clinical significance is little)
Fluzoparib and Abiraterone in the preSurgery Treatment of Prostate Cancer: FAST Trial [NCT05223582]Phase 234 participants (Anticipated)Interventional2021-05-01Active, not recruiting
Role of Microbiome in the Realm of Immune-Checkpoint Inhibitor Induced GI Complications In Cancer Population [NCT03819296]Phase 1/Phase 2800 participants (Anticipated)Interventional2021-02-21Recruiting
Phase III Randomized Study of R-CHOP V. Dose-Adjusted EPOCH-R With Molecular Profiling in Untreated De Novo Diffuse Large B-Cell Lymphomas [NCT00118209]Phase 3524 participants (Actual)Interventional2005-05-31Completed
Docetaxel and Estramustine Versus Mitoxantrone and Prednisone for Advanced, Hormone Refractory Prostate Cancer [NCT00004001]Phase 3770 participants (Actual)Interventional1999-10-31Completed
A Phase Ib/II Study of Ipatasertib (GDC-0068) or Apitolisib (GDC-0980) With Abiraterone Acetate Versus Abiraterone Acetate in Patients With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy [NCT01485861]Phase 1/Phase 2298 participants (Actual)Interventional2012-01-11Completed
ALinC 17: Protocol for Patients With Newly Diagnosed High Risk Acute Lymphoblastic Leukemia (ALL) - Evaluation of the Augmented BFM Regimen: A Phase III Study [NCT00005603]Phase 3276 participants (Actual)Interventional2000-03-31Completed
A Phase 1 Adaptive Dose, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered CORT125329 in Healthy Subjects, With an Optional Pharmacological Effects [NCT04672512]Phase 1115 participants (Actual)Interventional2020-10-23Completed
A Phase Ib Trial of Zanubrutinib in Combination With R-CHOP (ZaR-CHOP) for Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma [NCT04850495]Phase 124 participants (Anticipated)Interventional2021-11-16Suspended(stopped due to Pending amendment)
An Investigator-Initiated, Phase II, Randomized, Withdrawal Study of Mycophenolate Mofetil (MMF) in Patients With Stable, Quiescent Systemic Lupus Erythematosus (SLE) [NCT01946880]Phase 2102 participants (Actual)Interventional2013-11-20Terminated(stopped due to Slow enrollment.)
A Randomized Phase 2 Study Evaluating Abiraterone Acetate With Different Steroid Regimens for Preventing Symptoms Associated With Mineralocorticoid Excess in Asymptomatic, Chemotherapy-naïve and Metastatic Castration-resistant Prostate Cancer (mCRPC) Pati [NCT01867710]Phase 2164 participants (Actual)Interventional2013-07-16Completed
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Severe Steroid Dependent Asthma [NCT02528214]Phase 3210 participants (Actual)Interventional2015-10-15Completed
Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids for Treatment of Minnesota High-Risk Acute GVHD (aGVHD): A Phase I/II Study [NCT05123040]Phase 1/Phase 255 participants (Anticipated)Interventional2023-06-05Recruiting
A Phase II, Randomized, Clinical Trial Assessing Efficacy And Safety Of Oral Prednisolone vs Intravenous Vincristine In The Treatment Of Infantile [NCT00555464]Phase 28 participants (Actual)Interventional2007-11-30Terminated(stopped due to The introduction of oral propranolol as a highly efficacious agent for infantile hemangiomas)
A Randomized Multi-Center, Double-Blind, Placebo-Controlled Study of a New Modified-Release Tablet Formulation of Prednisone (Lodotra®) in Patients With Rheumatoid Arthritis [NCT00650078]Phase 3350 participants (Actual)Interventional2008-03-31Completed
Phase I/II Trial of Carfilzomib Plus Melphalan and Prednisone in Elderly Untreated Patients With Multiple Myeloma. [NCT01279694]Phase 1/Phase 272 participants (Actual)Interventional2010-10-31Completed
A Phase II, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Withdrawal Design Trial Using Adaptive Randomization Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis [NCT01369745]Phase 2294 participants (Actual)Interventional2011-06-30Completed
A Phase III, Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab in Subjects With Giant Cell Arteritis [NCT01791153]Phase 3251 participants (Actual)Interventional2013-07-22Completed
A Phase 2 Study of Brentuximab Vedotin in Combination With Standard of Care Treatment (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone [RCHOP]) or RCHP (Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone) as Front-line Therapy [NCT01925612]Phase 287 participants (Actual)Interventional2013-08-31Terminated(stopped due to Sponsor decision based on portfolio prioritization and changing treatment landscape in frontline DLBCL)
A Two-part Study Exploring the Efficacy, Safety, and Pharmacodynamics of Acthar in Systemic Lupus Erythematosus Patients With a History of Persistently Active Disease [NCT01753401]Phase 438 participants (Actual)Interventional2013-01-31Completed
Clinical Trial of a Rapidly Cycling, Non-Cross Reactive Regimen of Approved Therapeutic Agents to Treat Prostate Cancer [NCT02903160]Phase 240 participants (Actual)Interventional2017-01-13Completed
A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma [NCT05800366]Phase 240 participants (Anticipated)Interventional2023-04-06Recruiting
The Impact of Prednisone on Semen Parameters and Pregnancy Rates Post Vasectomy Reversal: A Randomized, Controlled Trial [NCT04788823]Phase 4100 participants (Anticipated)Interventional2021-02-24Active, not recruiting
Anti-PD-1 Antibody (Camrelizumab) Plus R-CHOP Regimen for the Primary Extranodal Treatment-Naive Diffuse Large B Cell Lymphoma (CREDIT): a Prospective, Multicenter, Single-Arm, Phase II Trial [NCT05093140]Phase 230 participants (Anticipated)Interventional2022-06-01Not yet recruiting
Phase Ib/II Study of Toripalimab In Combination With Rituximab Followed by R-CHOP Regimen (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) for Elderly Naïve Patients With Diffuse Large B-cell Lymphoma [NCT04058470]Phase 1/Phase 2140 participants (Anticipated)Interventional2020-04-24Recruiting
A Randomized, Open-label, Mutli-centre Study to Evaluate Patient Preference With Subcutaneous Administration of Rituximab Versus Intravenous Rituximab in Previously Untreated Patients With CD20+ Diffuse Large B-cell Lymphoma or CD20+ Follicular Non-Hodgki [NCT01724021]Phase 3743 participants (Actual)Interventional2012-12-31Completed
Management of Imatinib-associated Severe Skin Rash in Patients With Gastrointestinal Stromal Tumor [NCT03440515]Phase 229 participants (Actual)Interventional2014-08-31Completed
Risk-stratified Sequential Treatment of Post-transplant Lymphoproliferative Disease (PTLD) With 4 Courses of Rituximab SC Followed by 4 Courses of Rituximab SC, 4 Courses of Rituximab SC Combined With CHOP-21 or 6 Courses of Rituximab SC Combined With Alt [NCT02042391]Phase 260 participants (Actual)Interventional2015-02-03Completed
A Randomized Phase II Study Comparing Inotuzumab Plus Chemotherapy Versus Standard Chemotherapy in Older Adults With Philadelphia-Chromosome-Negative B-Cell Acute Lymphoblastic Leukemia [NCT05303792]Phase 266 participants (Anticipated)Interventional2023-02-27Recruiting
A Randomized Phase II Study of CHO(E)P vs CC-486-CHO(E)P vs Duvelisib-CHO(E)P in Previously Untreated CD30 Negative Peripheral T-Cell Lymphomas [NCT04803201]Phase 2170 participants (Anticipated)Interventional2021-07-30Recruiting
A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202, a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Subjects With Selected Tumor Types [NCT04300556]Phase 1/Phase 2142 participants (Anticipated)Interventional2020-08-06Recruiting
The Effect of Prednisone on Atherogenesis as Studied in the Macrophage Foam Cell Formation Model System. [NCT03367663]Early Phase 110 participants (Actual)Interventional2018-01-17Completed
A Phase 2 Study of PCM-075 (Onvansertib) in Combination With Abiraterone and Prednisone in Adult Patients With Metastatic Castration-Resistant Prostate Cancer [NCT03414034]Phase 272 participants (Actual)Interventional2018-06-18Completed
A Phase 2 Study of Weekly 70 mg/m2 Carfilzomib for Multiple Myeloma Patients Refractory to 27 mg/m2 Carfilzomib [NCT02294357]Phase 245 participants (Anticipated)Interventional2014-12-31Terminated(stopped due to Early termination due to the difficulties to enroll subjects.)
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in the Frontline Treatment of Patients With CD30-positive Mature T-cell Lymphomas [NCT01777152]Phase 3452 participants (Actual)Interventional2013-01-31Completed
A Phase 3, Randomized Open-label Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Are Unselected for Homologous Recombination Repair [NCT03834519]Phase 3793 participants (Actual)Interventional2019-05-02Active, not recruiting
Phase I/II Study of the Combination of Low-Intensity Chemotherapy and Venetoclax (ABT-199) in Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) [NCT03808610]Phase 1/Phase 250 participants (Anticipated)Interventional2019-04-03Recruiting
MEA115575: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Mepolizumab Adjunctive Therapy to Reduce Steroid Use in Subjects With Severe Refractory Asthma [NCT01691508]Phase 3135 participants (Actual)Interventional2012-10-31Completed
An Open-labeled, Multi-center, Randomized, Prospective Phase III Study Comparing CMAB304 in Combination With CHOP to CHOP Alone With CMAB304 Maintenance in Patients With DLBCL [NCT01459887]Phase 3278 participants (Actual)Interventional2006-09-30Completed
A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone Versus Placebo Plus Docetaxel Plus Prednisone in Participants With Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Prog [NCT03834506]Phase 31,030 participants (Actual)Interventional2019-05-02Completed
A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer [NCT02985957]Phase 2351 participants (Actual)Interventional2017-03-26Active, not recruiting
Induction Therapy With Bortezomib-melphalan and Prednisone (VMP) Followed by Lenalidomide and Dexamethasone (Rd) Versus Carfilzomib, Lenalidomide and Dexamethasone (KRd) Plus/Minus Daratumumab, 18 Cycles, Followed by Consolidation and Maintenance Therapy [NCT03742297]Phase 3462 participants (Actual)Interventional2018-10-22Active, not recruiting
Compared the Efficacy and Safety of CDOP Combined With Chidamide and CDOP in de Novo Peripheral T Cell Lymphoma Patients [NCT03023358]Phase 3174 participants (Anticipated)Interventional2017-02-28Not yet recruiting
A Phase 3, Randomised, Parallel-Group, Active-Controlled, Double-Blind Study to Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan, Each Administered in Combination With Cyclophosphamide, Vincr [NCT02162771]Phase 3140 participants (Actual)Interventional2014-07-14Completed
A Phase 3, Randomized, Open-label, Multicenter Study Comparing Ponatinib Versus Imatinib, Administered in Combination With Reduced-Intensity Chemotherapy, in Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ [NCT03589326]Phase 3245 participants (Actual)Interventional2018-10-04Active, not recruiting
Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II Hodgkin's Lymphoma and FDG-PET Positivity After 2 Cycles of ABVD [NCT02298283]Phase 240 participants (Actual)Interventional2015-04-30Completed
A Multicenter Open Label Phase 2 Study of Carfilzomib Weekly Plus Melphalan and Prednisone in Untreated Symptomatic Elderly Multiple Myeloma [NCT02302495]Phase 280 participants (Anticipated)Interventional2014-01-31Active, not recruiting
The Effect of Multiple Doses of BIIL 284 BS on the Pharmacokinetics of a Single Dose of Prednisone in Healthy Male Subjects (A Randomized, Double-blind, Placebo-controlled, Two Period, Two-way Cross-over Study) [NCT02268149]Phase 120 participants (Actual)Interventional2000-04-30Completed
Phase 3 Randomized, Double-Blind, Placebo Controlled, Multicenter Study to Compare the Efficacy and Safety of Lenalidomide (CC-5013) Plus R-CHOP Chemotherapy (R2-CHOP) Versus Placebo Plus R-CHOP Chemotherapy in Subjects With Previously Untreated Activated [NCT02285062]Phase 3570 participants (Actual)Interventional2015-02-17Completed
A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Co-Administration of FOV1101-00 (Cyclosporine 0.01% or 0.02%) and Prednisolone Acetate 0.12% (PredMild®) Compared to Prednisolone Acetate 1% Alone or Vehicle Alone in Patients With Mi [NCT00833495]Phase 2155 participants (Actual)Interventional2009-01-31Completed
Effect of Pre-operative Oral Steroids on Blood Loss in Endoscopic Sinus Surgery for Chronic Rhinosinusitis Without Polyps [NCT05095961]Phase 2/Phase 30 participants (Actual)Interventional2023-03-31Withdrawn(stopped due to Technical difficulties encountered with recording intraoperative blood loss; unable to proceed with study.)
A National Prospective Study of Patients With Hepatitis Induced by Immune Checkpoint Inhibitors; Characterization of Liver Injury, Outcome of Therapy and Randomization to Either Prednisolone or Mycophenolate Mofetil Treatment in Case of Relapse [NCT04810156]Phase 260 participants (Anticipated)Interventional2021-04-07Recruiting
A Prospective Observational Study to Assess the Efficacy an Safety of Glucocorticoid Therapy in the Treatment of Adult Idiopathic Nephrotic Syndrome [NCT02298335]235 participants (Actual)Interventional2014-05-13Completed
Duchenne Muscular Dystrophy: Double-blind Randomized Trial to Find Optimum Steroid Regimen [NCT01603407]Phase 3196 participants (Actual)Interventional2013-01-31Completed
The Efficacy of Thalidomide Plus Prednisone and Methotrexate for the Symptomatic Large Granular Lymphocytic Leukemia - a Prospective Multicenter Clinical Trial From China [NCT04453345]Phase 2/Phase 342 participants (Anticipated)Interventional2013-05-20Recruiting
A Trial of Prednisone and Acetaminophen Versus Acetaminophen Alone in Minimizing Flu-like Symptoms From Pegylated Interferon Beta-1a [NCT03424733]Phase 450 participants (Anticipated)Interventional2017-09-25Recruiting
Phase 2 Study of CJNJ-67652000 (Niraparib/Abiraterone Acetate Fixed-Dose Combination) and Prednisone for Metastatic Castration-Resistant Prostate Cancer Associated With SPOP Mutation With or Without Homologous Recombination Deficiency [NCT05689021]Phase 230 participants (Anticipated)Interventional2023-07-07Recruiting
Phase II Trial of Primary Radiotherapy With Androgen Ablation With or Without Adjuvant Niraparib for Selected High-Risk Locoregional Prostate Cancer [NCT04947254]Phase 2200 participants (Anticipated)Interventional2021-08-05Recruiting
A Randomized Phase II Pilot of Tailored Prednisone Reduction Versus Usual Care for the Treatment of Hyperglycemia During R-CHOP Chemotherapy [NCT03505762]Phase 280 participants (Anticipated)Interventional2018-07-19Recruiting
A Prospective Study of Bortezomib in Combination With Melphalan and Prednisone for Patients With Previously Untreated Multiple Myeloma [NCT00734149]Phase 245 participants (Actual)Interventional2004-07-31Completed
The Study of Pegylated Liposomal Doxorubicin Contrast Epirubicin for the Initial Treatment of Patients With Diffuse Large B-cell Lymphoma [NCT03022123]270 participants (Anticipated)Interventional2016-11-30Recruiting
A Randomized, Double-blind, Double-dummy, Active-controlled, Multicenter, 2-part Phase II Study on Replacement of Steroids by IFX-1 in Active Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) [NCT03895801]Phase 257 participants (Actual)Interventional2019-04-03Completed
[NCT01274403]Phase 2130 participants (Actual)InterventionalCompleted
A Randomized, Double-Masked and Placebo-Controlled Study to Evaluate the Efficacy and Safety of Sarilumab Administered Subcutaneously Every 2 Weeks in Patients With Non-Infectious, Intermediate, Posterior or Pan-Uveitis (NIU) [NCT01900431]Phase 258 participants (Actual)Interventional2013-10-31Completed
First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial [NCT01829295]Phase 3216 participants (Actual)Interventional2013-08-31Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant P [NCT04691804]Phase 3804 participants (Anticipated)Interventional2021-03-18Recruiting
A Randomized, Open-label Study to Assess the Efficacy and Safety of Olaparib Versus Enzalutamide or Abiraterone Acetate in Chinese Men With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have [NCT05457257]Phase 442 participants (Anticipated)Interventional2022-07-29Recruiting
A Multicenter, Open-label, Phase 2 Dose Escalation and Confirmation, and Efficacy Expansion Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP in Participants With DLBCL (waveLINE) [NCT05406401]Phase 260 participants (Anticipated)Interventional2022-07-14Recruiting
A Randomized Controlled Pilot Trial of Cyclosporine vs Steroids in DRESS [NCT04988256]Early Phase 150 participants (Anticipated)Interventional2021-09-27Enrolling by invitation
An Randomized, Open-label, Phase III Study Comparing Thalidomide Combined With R-CHOP and R-CHOP in Newly Diagnosed Double-expressor Diffuse Large B-Cell Lymphoma Patients [NCT03318835]Phase 3162 participants (Anticipated)Interventional2017-08-22Recruiting
A Prospective, Open-label, Multicenter, Observational Study to Evaluate the Efficacy and Safety of Bortezomib, Melphalan, Prednisone(VMP) for Initial Treatment in Patients With Multiple Myeloma Who do Not Undergo Autologous Stem Cell Transplantation [NCT02474563]171 participants (Actual)Observational2011-05-31Completed
A Randomized, Double-Blind, Active Comparator-Controlled, Crossover Study to Assess the Capacity of RAYOS® Compared to Immediate-Release Prednisone to Improve Fatigue and Control Morning Symptoms in Subjects With Systemic Lupus Erythematosus [NCT03098823]Phase 462 participants (Actual)Interventional2017-09-12Completed
Phase II Study of Pedi-cRIB: Mini-Hyper-CVD With Condensed Rituximab, Inotuzumab Ozogamicin and Blinatumomab (cRIB) for Relapsed Therapy for Pediatric With B-Cell Lineage Acute Lymphocytic Leukemia [NCT05645718]Phase 227 participants (Anticipated)Interventional2023-07-14Recruiting
Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) +/- Rituximab (R) + Tafasitamab-cxix for the Treatment of Newly-Diagnosed Adults With Philadelphia Chromosome-Negative (Ph-) B-cell Lymphoblastic Lymphoma/Leuke [NCT05453500]Phase 230 participants (Anticipated)Interventional2023-03-27Recruiting
A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) Versus Prednisone in Metastatic Castration-resistant Prostate Cancer Patients Who Have Received Prior Docetaxel and Prior Abiraterone or MDV3100 [NCT01605227]Phase 31,028 participants (Actual)Interventional2012-07-31Completed
The Palliative Benefit of Involved-site Radiotherapy Following Effective Chemotherapy for Patients With Advanced-stage Diffuse Large B-cell Lymphoma: Wuhan University Cancer Center - NHL04 Trial [NCT02449278]Phase 3120 participants (Anticipated)Interventional2015-10-31Recruiting
Synergistic Effect of Exclusive Enteral Nutrition Formula in Addition to Corticosteroids Therapy to Induce Clinical Remission in Patients With Crohn's Disease: a Pilot Study Involving a Multidimensional Assessment of Potential Mechanisms [NCT03833596]Phase 43 participants (Actual)Interventional2018-10-25Terminated(stopped due to Low recruitment)
Open Label Phase Two Trial of Radium Ra 223 Dichloride With Concurrent Administration of Abiraterone Acetate Plus Prednisone in Symptomatic Castration-Resistant (Hormone-Refractory) Prostate Cancer Subjects With Bone Metastasis [NCT02097303]Phase 236 participants (Actual)Interventional2014-03-31Completed
Phase 2 Study of Polatuzumab Vedotin, Rituximab and Dose Attenuated CHP in Older Patients With DLBCL [NCT04594798]Phase 239 participants (Anticipated)Interventional2021-09-20Recruiting
A Multicenter, Prospective Clinical Study of Olverembatinib Combined With Chemotherapy in the Treatment of de Novo Adult Philadelphia Chromosome-positive Acute Lymphoid Leukemia [NCT05466175]Phase 255 participants (Anticipated)Interventional2022-10-01Not yet recruiting
Possible Role of Chloroquine in Conjunction to Prednisone to Induce a Complete Remission in the Treatment of Autoimmune Hepatitis: a Randomized Trial [NCT02463331]Phase 457 participants (Actual)Interventional2003-05-31Completed
Donor-Alloantigen-Reactive Regulatory T Cell (darTreg) Therapy in Liver Transplantation (RTB-002) [NCT02188719]Phase 115 participants (Actual)Interventional2014-12-17Terminated(stopped due to The trial could not be completed within the grant timeline.)
A Phase 2 Study Determining Safety and Tolerability of Enzalutamide (Formerly MDV3100) in Combination With Abiraterone Acetate in Bone Metastatic Castration-Resistant Prostate Cancer Patients [NCT01650194]Phase 260 participants (Actual)Interventional2012-07-09Completed
Corticosteroids as Co-Induction Agents With Vedolizumab in Crohn's Disease: a Double-blind Placebo Controlled Randomized Trial [NCT02324699]Phase 41 participants (Actual)Interventional2016-04-30Terminated(stopped due to Difficult recruitment)
An Open, Multi-center, Phase Ⅱ Clinical Study of Fluzoparib Combined With Apatinib or Fluzoparib in the Treatment of Metastatic Castration-resistant Prostate Cancer [NCT04869488]Phase 293 participants (Actual)Interventional2021-07-26Active, not recruiting
Zanubrutinib Combination With R-CHOP in Treating Patients With Newly Diagnosed Untreated Non-GCB DLBCL [NCT04835870]Phase 278 participants (Anticipated)Interventional2021-04-01Recruiting
A Phase II Study of Increased-Dose Abiraterone Acetate in Patients With Castration Resistant Prostate Cancer (CRPC) [NCT01637402]Phase 241 participants (Actual)Interventional2013-03-13Completed
A New Modified-Release Tablet Formulation of Prednisone in Patients With Rheumatoid Arthritis- Multicenter, Phase IV, Interventional Study to Assess Reduction of Morning Stiffness [NCT02072200]Phase 4147 participants (Actual)Interventional2013-09-30Completed
Abiraterone Acetate in Patients With Metastatic Castration-Resistant Prostate Cancer, Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy [NCT02217566]Phase 246 participants (Actual)Interventional2014-09-23Completed
A Phase II Multicenter Study of AMG 386 and Abiraterone in Metastatic Castration Resistant Prostate Cancer [NCT01553188]Phase 236 participants (Actual)Interventional2012-02-08Completed
A 24 Month, Multicenter, Randomized, Open-label Safety and Efficacy Study of Concentration-controlled Everolimus With Reduced Calcineurin Inhibitor vs Mycophenolate With Standard Calcineurin Inhibitor in de Novo Renal Transplantation [NCT01950819]Phase 42,037 participants (Actual)Interventional2013-12-03Completed
A Phase I/II Study of Cabazitaxel Combined With Abiraterone Acetate and Prednisone in Patients With Metastatic Castrate-Resistant Prostate Cancer (CRPC) Whose Disease Has Progressed After Docetaxel Chemotherapy [NCT01511536]Phase 1/Phase 238 participants (Actual)Interventional2012-03-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00002766 (1) [back to overview]Complete Remission (CR)
NCT00003389 (3) [back to overview]Failure-free Survival at 5 Years
NCT00003389 (3) [back to overview]5-year Overall Survival
NCT00003389 (3) [back to overview]Incidence of Second Cancers
NCT00003910 (2) [back to overview]Proportion of Patients With Complete or Partial Response to Treatment With MTX
NCT00003910 (2) [back to overview]Proportion of Patients With Complete or Partial Response to Treatment of CY Among Patients Failing to Respond to MTX
NCT00004031 (3) [back to overview]2-year Overall Survival Rates
NCT00004031 (3) [back to overview]Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
NCT00004031 (3) [back to overview]2 Year Progression-free Survival
NCT00004124 (3) [back to overview]Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients
NCT00004124 (3) [back to overview]Overall Survival
NCT00004124 (3) [back to overview]Disease Free Survival
NCT00004228 (2) [back to overview]Percentage of Patients With Overall Survival as Assessed by Time to Death
NCT00004228 (2) [back to overview]Event-free Survival
NCT00005780 (10) [back to overview]Progression Free Survival (PFS) in Participants Who Received Idiotype Vaccine
NCT00005780 (10) [back to overview]Percentage of Participants With Antibodies to Keyhole Limpet Haemocyanin (KLH)
NCT00005780 (10) [back to overview]Percentage of Participants With an Antibody Response to Idiotype Vaccine
NCT00005780 (10) [back to overview]Median Progression-free Survival (PFS) in Participants Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R)
NCT00005780 (10) [back to overview]Percentage of Participants With Induction of Type 1 Cytokine T-cell Response
NCT00005780 (10) [back to overview]Time to Recovery of CD4 T Lymphocytes (CD4+)
NCT00005780 (10) [back to overview]Overall Survival (OS)
NCT00005780 (10) [back to overview]Percentage of Participants With Grade 3 or Higher Serious and/or Non-serious Toxicity That Occurred That is at Least Possibly Related to Drug or Vaccine
NCT00005780 (10) [back to overview]Here is the Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC v2.0).
NCT00005780 (10) [back to overview]Percentage of Participants Whose Cancer Shrinks or Disappears After Treatment With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R)
NCT00006184 (2) [back to overview]Immune Response
NCT00006184 (2) [back to overview]Number of Participants With Adverse Events
NCT00006436 (16) [back to overview]Median Duration of Complete Response/Complete Response Unconfirmed
NCT00006436 (16) [back to overview]Median Overall Survival
NCT00006436 (16) [back to overview]1 Year Overall Survival
NCT00006436 (16) [back to overview]Median Progression Free Survival (PFS)
NCT00006436 (16) [back to overview]Number of Participants With at Least One Hematologic Toxicity Event of Febrile Neutropenia
NCT00006436 (16) [back to overview]Recovery of CD4 T Cells (CD4) Counts
NCT00006436 (16) [back to overview]Recovery of Human Immunodeficiency Virus (HIV) Viral Load
NCT00006436 (16) [back to overview]1 Year Interim Positron Emission Tomography (PET) Positive Progression Free Survival (PFS)
NCT00006436 (16) [back to overview]Number of Cycles of Hematologic Toxicity
NCT00006436 (16) [back to overview]Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity
NCT00006436 (16) [back to overview]Overall Response
NCT00006436 (16) [back to overview]Percentage of Participants With Complete Response
NCT00006436 (16) [back to overview]Median Interim Positron Emission Tomography (PET) Positive Progression Free Survival (PFS)
NCT00006436 (16) [back to overview]Percentage of Participants With CR/CRu Lasting 1 Year
NCT00006436 (16) [back to overview]Progression Free Survival at 1 Year
NCT00006436 (16) [back to overview]Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC v2.0)
NCT00006721 (6) [back to overview]Overall Survival at 2 Years
NCT00006721 (6) [back to overview]Overall Survival at 5 Years
NCT00006721 (6) [back to overview]Objective Response (Confirmed and Unconfirmed Complete and Partial Responses)
NCT00006721 (6) [back to overview]Progression-free Survival at 5 Years
NCT00006721 (6) [back to overview]Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
NCT00006721 (6) [back to overview]Progression-free Survival at 2 Years
NCT00024167 (2) [back to overview]Overall Survival From Registration
NCT00024167 (2) [back to overview]Overall Survival From Randomization
NCT00025259 (4) [back to overview]Disease Response Assessed by Modified RECIST Criteria
NCT00025259 (4) [back to overview]Event-free Survival
NCT00025259 (4) [back to overview]Overall Survival
NCT00025259 (4) [back to overview]Grade 3 or 4 Non-hematologic Toxicity
NCT00026208 (7) [back to overview]Early Treatment-related Toxicity
NCT00026208 (7) [back to overview]Second Hodgkin's Disease Progression
NCT00026208 (7) [back to overview]Late Treatment-related Toxicity
NCT00026208 (7) [back to overview]Survival at 5 and 10 Years
NCT00026208 (7) [back to overview]Progression-free Survival (PFS)
NCT00026208 (7) [back to overview]Overall Survival (OS)
NCT00026208 (7) [back to overview]Frequency of Complete Response
NCT00033293 (5) [back to overview]Number of Responders
NCT00033293 (5) [back to overview]Tumor Outcome in Terms of Overall Survival (OS) Rate
NCT00033293 (5) [back to overview]Tumor Outcome in Terms of Event-free Survival (EFS) Rate Defined as a Relapse or Progression of Neuroblastoma, a Second Malignancy, or Death
NCT00033293 (5) [back to overview]Functional Outcome as Assessed by Age-appropriate Neuropsychological Testing
NCT00033293 (5) [back to overview]Motor Coordination as Assessed by Neurological Examination and Vineland Adaptive Behavior Scale (VABS)
NCT00039130 (3) [back to overview]2 Year Overall Survival
NCT00039130 (3) [back to overview]2 Year Event Free Survival
NCT00039130 (3) [back to overview]Complete Response Rate
NCT00039195 (1) [back to overview]Progression Free Survival
NCT00040937 (2) [back to overview]Overall Survival
NCT00040937 (2) [back to overview]Assess Toxicity of Thalidomide/Dexamethasone as a Pre-transplant Induction Regimen.
NCT00043979 (14) [back to overview]Early Post Transplantation Relapse
NCT00043979 (14) [back to overview]Median Time to Reach Absolute Neutrophil Count of 500/mm(3)
NCT00043979 (14) [back to overview]Median Progression Free Survival
NCT00043979 (14) [back to overview]Median Time to Reach a Platelet Count of 50,000/mm(3)
NCT00043979 (14) [back to overview]Two Year Survival Rate for Patients Undergoing Allo-Hematopoietic Stem Cell Transplant
NCT00043979 (14) [back to overview]Post-Hematopoietic Stem Cell Transplant (HSCT) Radiotherapy
NCT00043979 (14) [back to overview]Number of Participants With Acute and Chronic GVHD
NCT00043979 (14) [back to overview]Cluster of Differentiation 4 (CD4) Reconstitution
NCT00043979 (14) [back to overview]Number of Participants to Complete Conversion to >95% Donor Chimerism
NCT00043979 (14) [back to overview]Median Survival From Date of Progression
NCT00043979 (14) [back to overview]Best Response Post-Hematopoietic Stem Cell Transplant EOCH (Etoposide, Vincristine, Cyclophosphamide, and Doxorubicin)
NCT00043979 (14) [back to overview]Toxicity
NCT00043979 (14) [back to overview]Number of Participants With Engraftment
NCT00043979 (14) [back to overview]Number of Participants Who Experienced Graft Versus Tumor Effect (GVT)
NCT00049036 (1) [back to overview]Complete Response Proportion as Measured by Tumor Response After Completion of Study Treatment
NCT00051311 (9) [back to overview]Median Cycles of Induction Chemotherapy With Fludarabine, Cyclophosphamide, Etoposide, Doxorubicin, Vincristine, and Prednisone Given to Recipients
NCT00051311 (9) [back to overview]Median Time to Neutrophil Recovery
NCT00051311 (9) [back to overview]Number of Recipients With a Response to Reduced-intensity Stem Cell Transplantation (RIST)
NCT00051311 (9) [back to overview]Number of Recipients Who Developed Grades I-IV Acute Graft Versus Host Disease (GVHD) Following a Combination of Cyclosporine and a Mini-dose Methotrexate Regimen for Graft Versus Host Disease (GVHD) Prophylaxis
NCT00051311 (9) [back to overview]Percentage of Recipients Who Achieved Donor Chimerism at Day +14
NCT00051311 (9) [back to overview]Number of Recipients With Non-serious Adverse Events
NCT00051311 (9) [back to overview]Number of Recipients Who Developed Chronic Graft Versus Host Disease (GVHD) Following a Combination of Cyclosporine and a Mini-dose Methotrexate Regimen for Graft Versus Host Disease (GVHD) Prophylaxis
NCT00051311 (9) [back to overview]Number of Recipients Evaluable Who Achieved Full Donor Chimerism at Day+100
NCT00051311 (9) [back to overview]Median Time to Platelet Recovery
NCT00054665 (2) [back to overview]Number of Participants With Adverse Events
NCT00054665 (2) [back to overview]Clinical Response Rate
NCT00057811 (4) [back to overview]Minimal Residual Disease
NCT00057811 (4) [back to overview]Response Rate
NCT00057811 (4) [back to overview]Grade ≥ 3 Stomatitis
NCT00057811 (4) [back to overview]Toxic Death
NCT00058422 (1) [back to overview]Incidence of Adverse Experiences
NCT00059839 (1) [back to overview]Event-free Survival (EFS)
NCT00060346 (1) [back to overview]Objective Response to Treatment
NCT00066469 (1) [back to overview]Event-free Survival
NCT00069238 (2) [back to overview]Maximum Tolerated Dose (MTD) of Alemtuzumab
NCT00069238 (2) [back to overview]Number of Participants With Adverse Events
NCT00070018 (1) [back to overview]Progression-free Survival
NCT00074490 (4) [back to overview]Percentage of Patients With Opportunistic Infection
NCT00074490 (4) [back to overview]Percentage of Patients With ≥ Grade 2 Acute Graft Versus Host Disease (GVHD)
NCT00074490 (4) [back to overview]Percentage of Patients to Receive T Cell Infusion
NCT00074490 (4) [back to overview]Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0)
NCT00075725 (7) [back to overview]Correlation of Early Marrow Response Status With MRD Negative.
NCT00075725 (7) [back to overview]Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions
NCT00075725 (7) [back to overview]Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS)
NCT00075725 (7) [back to overview]Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS)
NCT00075725 (7) [back to overview]Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS).
NCT00075725 (7) [back to overview]Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS).
NCT00075725 (7) [back to overview]Correlation of Early Marrow Response Status With MRD Positive.
NCT00088530 (4) [back to overview]Overall Response Rate (ORR) Lasting at Least 4 Months
NCT00088530 (4) [back to overview]Overall Survival
NCT00088530 (4) [back to overview]Progression-Free Survival (PFS)
NCT00088530 (4) [back to overview]Complete Response (CR) and Complete Response Unconfirmed (CRu)
NCT00088881 (4) [back to overview]Functional CR in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.
NCT00088881 (4) [back to overview]Complete Response (CR) +Complete Response/Uncertain (CRu) in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.
NCT00088881 (4) [back to overview]3-year Overall Survival (OS) Rate
NCT00088881 (4) [back to overview]3-year Time to Treatment Failure (TTF) Rate
NCT00089609 (6) [back to overview]Disease Progression by Clinical and Radiographic Criteria Without the Use of Prostate-Specific Antigen (PSA)
NCT00089609 (6) [back to overview]Time to Progression Using Bubley Criteria
NCT00089609 (6) [back to overview]Number of Participants With Adverse Events
NCT00089609 (6) [back to overview]Number of Participants With a Significant Increase in Circulating Apoptotic Endothelial Cell (CAEC) Level
NCT00089609 (6) [back to overview]Number of Participants Who Had a Prostate-specific Antigen (PSA) Response
NCT00089609 (6) [back to overview]Number of Participants Who Died After a Follow Up of 34 Months Following Treatment
NCT00097448 (1) [back to overview]Hearing Improvement
NCT00098839 (4) [back to overview]Rate of Minimal Residual Disease (MRD) < 0.01%
NCT00098839 (4) [back to overview]Remission Re-induction (CR2) Rate
NCT00098839 (4) [back to overview]Event-free Survival Rate
NCT00098839 (4) [back to overview]Pharmacokinetics
NCT00101010 (2) [back to overview]Number of Participants Experienced Grade 3 or Higher Cardiac Toxicity After Treatment: Cardiac Toxicity as Measured by Left Ventricular Ejection Fraction (LVEF) on Echocardiogram (ECHO) After 8 Courses
NCT00101010 (2) [back to overview]Disease Response (Complete, Complete Unconfirmed, and Partial Responses) After 4 Courses
NCT00101101 (3) [back to overview]Median Event Free Survival (EFS)
NCT00101101 (3) [back to overview]Rate of Immunological Response to Vaccination
NCT00101101 (3) [back to overview]Occurrence of Related Serious Adverse Events (SAEs)
NCT00104299 (8) [back to overview]Disease Remission
NCT00104299 (8) [back to overview]Percentage of Participants Who Have a BVAS/WG Score of 0 and Have Successfully Completed the Glucocorticoid Taper by 6 Months Post-randomization
NCT00104299 (8) [back to overview]Number of Subjects Experiencing Serious Adverse Events
NCT00104299 (8) [back to overview]Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy
NCT00104299 (8) [back to overview]The Duration of Complete Remission (BVAS=0, Off Glucocorticoids), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups
NCT00104299 (8) [back to overview]The Duration of Remission (BVAS=0), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups
NCT00104299 (8) [back to overview]Time to Complete Remission (BVAS=0, Off Glucocorticoids) From the Visit 1 Baseline Visit in the Two Treatment Groups
NCT00104299 (8) [back to overview]Time to Remission (BVAS=0) From the Visit 1 Baseline Visit in the Two Treatment Groups
NCT00107198 (5) [back to overview]Event-free Survival
NCT00107198 (5) [back to overview]Grade 3 or 4 Toxicity
NCT00107198 (5) [back to overview]Cure by Surgery Alone in Stage I Resected Patients
NCT00107198 (5) [back to overview]Cure by AV-PC x 3 or AV-PC x 3 + IFRT for Stage I Unresected, Stage I Resected Whose Disease Recurred, and Stage II Patients
NCT00107198 (5) [back to overview]Failure-free Survival (FFS)
NCT00107380 (3) [back to overview]Response Rate (Complete, Complete Unconfirmed, and Partial)
NCT00107380 (3) [back to overview]Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
NCT00107380 (3) [back to overview]Progression-free Survival (PFS) at 2 Years
NCT00109473 (8) [back to overview]Crohn's Disease Endoscopic Index of Severity (CDEIS)
NCT00109473 (8) [back to overview]Crohn's Disease Histologic Index of Severity (CDHIS)
NCT00109473 (8) [back to overview]Fecal Calprotectin
NCT00109473 (8) [back to overview]Pediatric Crohn's Disease Activity Index (PCDAI)
NCT00109473 (8) [back to overview]Serum IGF-1 (Insulin-like Growth Factor 1)z Score
NCT00109473 (8) [back to overview]Total Corticosteroid Use
NCT00109473 (8) [back to overview]IMPACT III Score
NCT00109473 (8) [back to overview]Height Velocity
NCT00109837 (2) [back to overview]Continuous Complete Remission at 1 Year
NCT00109837 (2) [back to overview]Toxicity
NCT00110214 (4) [back to overview]Proportion of Participants Who Experienced at Least a 50% Post-therapy PSA (Prostate-Specific Antigen) Decline
NCT00110214 (4) [back to overview]Proportion of Participants Who Experience (Maximum) Grade 3 or Higher Toxicities
NCT00110214 (4) [back to overview]Progression-free Survival (PFS)
NCT00110214 (4) [back to overview]Overall Survival
NCT00118209 (3) [back to overview]Progression-Free Survival Rate at 2 and 5 Years
NCT00118209 (3) [back to overview]Overall Survival Rate at 2 and 5 Years
NCT00118209 (3) [back to overview]Response Rate
NCT00119678 (23) [back to overview]OL; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)
NCT00119678 (23) [back to overview]OL; Number of Participants With MAs in Serum Chemistry: Alkaline Phosphatase (ALP), Aspartate-aminotransferase (AST), Alanine-aminotransferase (ALT), Gamma-glutamyl Transferase (GGT), Bilirubin(Total), Blood Urea Nitrogen (BUN), Creatinine
NCT00119678 (23) [back to overview]OL; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides
NCT00119678 (23) [back to overview]OL; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total), Protein (Total)
NCT00119678 (23) [back to overview]Open Label Period (OL); Number of Participants Who Died, Experienced Adverse Events (AEs), Serious AEs, Drug Related AEs or SAEs and Discontinued Due to AEs
NCT00119678 (23) [back to overview]OL; Number of Participants With Significant AEs of Special Interest
NCT00119678 (23) [back to overview]OL; Number of Participants With MAs in Urinalysis
NCT00119678 (23) [back to overview]OL; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment
NCT00119678 (23) [back to overview]DB; Median Number of Days to the First Occurrence of a New SLE Flare
NCT00119678 (23) [back to overview]DB; Number of Participants With a New SLE Flare During the Initial 6 Months
NCT00119678 (23) [back to overview]DB; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment
NCT00119678 (23) [back to overview]Double Blind Period (DB); Number of Participants Experiencing a New SLE Flare
NCT00119678 (23) [back to overview]DB; Number of Participants Who Died, Experienced AEs, Other SAEs or Discontinuations Due to AEs, Drug Related AEs
NCT00119678 (23) [back to overview]DB; Number of Participants With a Change in the SLICC/ACR Damage Index at 1 Year Compared to Baseline
NCT00119678 (23) [back to overview]DB; Number of Participants With MAs in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count
NCT00119678 (23) [back to overview]DB; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)
NCT00119678 (23) [back to overview]DB; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides
NCT00119678 (23) [back to overview]DB; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total),Protein (Total)
NCT00119678 (23) [back to overview]DB; Number of Participants With MAs in Urinalysis
NCT00119678 (23) [back to overview]DB; Number of Participants With Significant AEs of Special Interest
NCT00119678 (23) [back to overview]DB; Total Number of New SLE Flares Each Participant Experienced
NCT00119678 (23) [back to overview]DB: Number of Participants With MAs in Serum Chemistry: ALP, AST, ALT, GGT, Bilirubin (Total), BUN and Creatinine
NCT00119678 (23) [back to overview]OL; Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count
NCT00121199 (4) [back to overview]Progression-free Survival at 1 Year
NCT00121199 (4) [back to overview]Objective Response (Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR))
NCT00121199 (4) [back to overview]Progression-free Survival at 2 Year
NCT00121199 (4) [back to overview]Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
NCT00132301 (1) [back to overview]Number of Participants With Progression-Free Survival
NCT00133991 (5) [back to overview]Percentage of Participants Experiencing Grade 3-5 Toxicity
NCT00133991 (5) [back to overview]Event-free Survival
NCT00133991 (5) [back to overview]Overall Response Rate
NCT00133991 (5) [back to overview]Overall Survival
NCT00133991 (5) [back to overview]Relapse Pattern
NCT00134056 (7) [back to overview]Compare Qualitative and Quantitative Toxicity Between the Two Study Arms
NCT00134056 (7) [back to overview]Number of Patients With a Change in Functional Status
NCT00134056 (7) [back to overview]Compare Elements of Quality of Life Between Treatment Arms: Pain Palliation Response, as Measured by the Brief Pain Inventory (BPI)
NCT00134056 (7) [back to overview]Compare Pain Progression Between the Two Study Arms.
NCT00134056 (7) [back to overview]Compare Progression-free Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer.
NCT00134056 (7) [back to overview]Compare Prostate Specific Antigen (PSA) Response Rates Between the Experimental Arm and the Standard Arm.
NCT00134056 (7) [back to overview]Compare Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer.
NCT00135694 (8) [back to overview]Number of Participants Who Qualify for Random Assignment
NCT00135694 (8) [back to overview]Total Immunosuppression From Month 21 to Month 24 Post-randomization
NCT00135694 (8) [back to overview]Number of Hepatitis C Infected Participants With Progression of Hepatitis C Related Liver Disease, Defined as Stage 4 or Higher Fibrosis on the Ishak Scale
NCT00135694 (8) [back to overview]Immunosuppression-free Duration
NCT00135694 (8) [back to overview]Number of Participants Experiencing Graft Loss or Death
NCT00135694 (8) [back to overview]Total Burden of Immunosuppression From Random Assignment to Month 24
NCT00135694 (8) [back to overview]Number of Participants With Clinical Complications Usually Attributed to Immunosuppression
NCT00135694 (8) [back to overview]Number of Participants Who Successfully Stop Taking Immunosuppression for at Least 6 Months
NCT00136084 (7) [back to overview]Relationship of Inhibition of DNA Synthesis and Clinical Response
NCT00136084 (7) [back to overview]To Assess Whether Inhibition of DNA Synthesis is Greater After High-dose Ara-C (HDAC) Than After Low-dose Ara-C (LDAC) Therapy
NCT00136084 (7) [back to overview]To Estimate the Overall Event-free Survival (EFS) of AML Patients Who Undergo Risk-adapted and Genotype-directed Therapy
NCT00136084 (7) [back to overview]Minimal Residual Disease (MRD).
NCT00136084 (7) [back to overview]Proportion of Minimal Residual Disease (MRD)+ Patients Who Become MRD- After One Course of Gemtuzumab Ozogamicin (GO)
NCT00136084 (7) [back to overview]Proportion of MRD Reduction After One Course of Cytarabine + Daunomycin + Etoposide (ADE) + GO
NCT00136084 (7) [back to overview]Proportion of Patients Experienced Toxicity of Cytarabine + Daunomycin + Etoposide (ADE) + GO.
NCT00137111 (7) [back to overview]Median Difference in CASP1 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs Glucocorticoid-sensitive Cells
NCT00137111 (7) [back to overview]Overall Event-free Survival (EFS)
NCT00137111 (7) [back to overview]Mean Difference of Active Methotrexate Polyglutamates (MTXPG) in Leukemia Cells Between Two Arms (4 Hours vs. 24 Hours).
NCT00137111 (7) [back to overview]Continuous Complete Remission Since Week 56 Therapy.
NCT00137111 (7) [back to overview]Circulating Leukemia Cells in Peripheral Blood Change From Prior to the Methotrexate Infusion to Three Days After Between Two Arms (4 Hours vs. 24 Hours)
NCT00137111 (7) [back to overview]Median Difference in NLRP3 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs. Glucocorticoid-sensitive Cells
NCT00137111 (7) [back to overview]Minimal Residual Disease (MRD)
NCT00137436 (13) [back to overview]Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale)
NCT00137436 (13) [back to overview]Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G)
NCT00137436 (13) [back to overview]Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC
NCT00137436 (13) [back to overview]Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC
NCT00137436 (13) [back to overview]Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2
NCT00137436 (13) [back to overview]Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3
NCT00137436 (13) [back to overview]Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2
NCT00137436 (13) [back to overview]Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3
NCT00137436 (13) [back to overview]Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5)
NCT00137436 (13) [back to overview]Duration of PSA Response (DPR)
NCT00137436 (13) [back to overview]Percentage of Participants With Objective Response Rate (ORR)
NCT00137436 (13) [back to overview]Time to PSA Progression
NCT00137436 (13) [back to overview]Percentage of Participants With Prostate Specific Antigen (PSA) Response
NCT00137969 (8) [back to overview]Time to First Moderate or Severe Flare
NCT00137969 (8) [back to overview]Number of Participants Who Achieved an MCR in The ITT Population
NCT00137969 (8) [back to overview]Number of Participants Who Achieved an MCR (Excluding PCR)
NCT00137969 (8) [back to overview]Number of Participants Who Achieved a BILAG C or Better in All Domains
NCT00137969 (8) [back to overview]Change in SLE Expanded Health Survey Physical Function Score From Baseline
NCT00137969 (8) [back to overview]Number of Participants Who Achieved a PCR (Including MCR)
NCT00137969 (8) [back to overview]Time-adjusted Area Under The Curve Minus Baseline (AUCMB) of BILAG Score Over The 52-week Treatment Period
NCT00137969 (8) [back to overview]Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period
NCT00141037 (2) [back to overview]Comparison by Treatment Assignment in the Number of Biopsy-Proven Acute Rejections Within 12 Months Post Kidney Transplantation
NCT00141037 (2) [back to overview]The Difference in Linear Growth by Treatment Assignment at 1 Year Post Kidney Transplantation
NCT00146640 (8) [back to overview]Relative Change From Baseline in Quality of Sleep at Week 12
NCT00146640 (8) [back to overview]Relative Change From Baseline in Pain Intensity at Week 12
NCT00146640 (8) [back to overview]Relative Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
NCT00146640 (8) [back to overview]Relative Change From Baseline in Duration of Morning Stiffness at Week 12
NCT00146640 (8) [back to overview]Relative Change From Baseline in 28-Joint Disease Activity Score (DAS28) at Week 12
NCT00146640 (8) [back to overview]Relative Change From Baseline in Short-Form 36 (SF36) Mental Component Score (MCS) at Week 12
NCT00146640 (8) [back to overview]Relative Change From Baseline in SF36 Physical Component Score (PCS) at Week 12
NCT00146640 (8) [back to overview]Percentage of Participants With Recurrence of Joint Stiffness at Week 12
NCT00149994 (1) [back to overview]Percentage of Participants With an Occurrence of Biopsy Proven Acute Rejection (BPAR) During the First 3 Months Post de Novo Liver Transplantation.
NCT00151281 (4) [back to overview]Overall Survival and Progression Free Survival
NCT00151281 (4) [back to overview]Asses the Toxicity Profiles
NCT00151281 (4) [back to overview]The Quality of Life (QoL) of Patients Receiving RT-PEPC Treatment
NCT00151281 (4) [back to overview]Dynamic Levels of Plasma VEGF
NCT00154284 (4) [back to overview]Number of Participants With Biopsy-proven Acute Rejection (BPAR) Episodes, Graft Loss, Death or Loss to Follow-up
NCT00154284 (4) [back to overview]Calculated Creatinine Clearance at 6 Month and 12 Month
NCT00154284 (4) [back to overview]Renal Function Measured by Calculated Glomerular Filtration Rate (GFR Calculated According to the Nankivell Formula)
NCT00154284 (4) [back to overview]Serum Creatinine at Month 6 and 12
NCT00157014 (36) [back to overview]Mean Cases of Acute Rejection (MCAR) Per Patient
NCT00157014 (36) [back to overview]The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies (Pediatric Population)
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Cystatin-C
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: E-selectin
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: F2 Isoprostanes
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Fibrinogen
NCT00157014 (36) [back to overview]Number of Patients Requiring Antilymphocyte Antibodies or Steroids for Treatment of Severe Acute Rejection (Pediatric Population)
NCT00157014 (36) [back to overview]Number of Patients Requiring Antilymphocyte Antibodies or Steroids for Treatment of Severe Acute Rejection
NCT00157014 (36) [back to overview]Number of Cardiac Rejection Episodes Requiring Treatment (Pediatric Population)
NCT00157014 (36) [back to overview]Number of Cardiac Rejection Episodes Requiring Treatment
NCT00157014 (36) [back to overview]Mean Cases of Acute Rejection (MCAR) Per Patient (Pediatric Population)
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: s-ICAM
NCT00157014 (36) [back to overview]Number of Patients With Successful Steroid Taper or Withdrawal at Weeks 26 and 52 (Pediatric Population)
NCT00157014 (36) [back to overview]Time to First Acute Rejection Episode Following de Novo Cardiac Transplant
NCT00157014 (36) [back to overview]Time to First Acute Rejection Episode Following de Novo Cardiac Transplant (Pediatric Population)
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation and Oxidation: Cystatin-C (Pediatric Population)
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Nitrotyrosine
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: MCP-1
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: GSH/GSSG
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: IL-6
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: IL-18
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation and Oxidation: F2 Isoprostanes (Pediatric Population)
NCT00157014 (36) [back to overview]Number of Patients With Treatment Failure and Crossover for Treatment Failure
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: hsCRP
NCT00157014 (36) [back to overview]Number of Patients With Treatment Failure and Crossover for Treatment Failure (Pediatric Population)
NCT00157014 (36) [back to overview]The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies
NCT00157014 (36) [back to overview]Number of Patients With Successful Steroid Taper or Withdrawal at Weeks 26 and 52
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Homocysteine
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation and Oxidation: hsCRP (Pediatric Population)
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation and Oxidation: Nitrotyrosine (Pediatric Population)
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: BNP
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Osteopontin
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Troponin T
NCT00157014 (36) [back to overview]Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: T-bars
NCT00157014 (36) [back to overview]Number of Acute Rejection Episodes by International Society of Heart and Lung Transplantation (ISHLT) Criteria
NCT00157014 (36) [back to overview]Number of Acute Rejection Episodes by International Society of Heart and Lung Transplantation (ISHLT) Criteria (Pediatric Population)
NCT00184002 (2) [back to overview]Number of Patients With Serious Adverse Events as a Measure of Safety and Tolerability
NCT00184002 (2) [back to overview]Percentage of Patients With Complete Response to the Combination Chemotherapy
NCT00193479 (1) [back to overview]Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
NCT00194987 (3) [back to overview]Number of Newborns With a Birth Platelet Count > 50,000/uL
NCT00194987 (3) [back to overview]Number of Fetal Platelet Counts > 50,000/uL
NCT00194987 (3) [back to overview]Intracranial Hemorrhage: Number Occurring in Fetuses and Newborns of Mothers in Study
NCT00195429 (2) [back to overview]Creatinine Clearance Rate
NCT00195429 (2) [back to overview]Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up.
NCT00203047 (4) [back to overview]Change From Baseline to Month 36 or Early Termination Visit in Volume of Hypointense Lesions
NCT00203047 (4) [back to overview]Percent Change From Baseline to Termination in Normalized Brain Volume Measured According to the SIENA (Structural Imaging Evaluation Using Normalization of Atrophy) Method
NCT00203047 (4) [back to overview]Cumulative Number of Enhancing Lesions at Months 12, 24 and 36
NCT00203047 (4) [back to overview]Change From Baseline to Month 36 or Early Termination Visit in Volume of T2-Lesions
NCT00204737 (9) [back to overview]Change in Salivary Cortisol (First 6 Participants)
NCT00204737 (9) [back to overview]Number of Other Adverse Events
NCT00204737 (9) [back to overview]Number of Participants Achieving CAPS Response
NCT00204737 (9) [back to overview]Change in Clinical Global Impression Severity (CGI-S) Score
NCT00204737 (9) [back to overview]Change in Clinician-Administered PTSD Scale (CAPS)
NCT00204737 (9) [back to overview]Change in Dehydroepiandrosterone Sulfate (DHEA-S)
NCT00204737 (9) [back to overview]Change in Hamilton Depression Rating Scale (HAM-D)
NCT00204737 (9) [back to overview]Change in PCL-PTSD Score
NCT00204737 (9) [back to overview]Change in Salivary Cortisol (Last 6 Participants)
NCT00211185 (9) [back to overview]Progression-Free Survival
NCT00211185 (9) [back to overview]Percentage of Participants With Overall Survival
NCT00211185 (9) [back to overview]Duration of Response
NCT00211185 (9) [back to overview]Summary of All Adverse Events by Frequency in Greater Than 20% of Treated Participants
NCT00211185 (9) [back to overview]Summary of All Treatment-Related Adverse Events by Frequency in Greater Than 10% of Treated Participants
NCT00211185 (9) [back to overview]Overall Response in the Intent To Treat (ITT) Population
NCT00211185 (9) [back to overview]Overall Response in the Efficacy Analyzable (EA) Population
NCT00211185 (9) [back to overview]Summary of Treatment-Related Adverse Events Greater Than or Equal to Grade 3 by System Organ Class
NCT00211185 (9) [back to overview]Summary of Study Drug-Related (Possible, Probable, or Definite) Serious Adverse Events
NCT00217425 (3) [back to overview]3-Year Overall Survival
NCT00217425 (3) [back to overview]12-Month Progression-Free Survival (PFS)
NCT00217425 (3) [back to overview]Overall Response Rate
NCT00227591 (1) [back to overview]Overall Response Rate
NCT00274924 (2) [back to overview]5-year Overall Survival
NCT00274924 (2) [back to overview]2-year Progression-Free Survival (PFS)
NCT00275509 (3) [back to overview]6-month Cumulative Rejection Incidence (Either CMR, AMR or Both)
NCT00275509 (3) [back to overview]6-month Acute Cellular-mediated Rejection Rate (CMR)
NCT00275509 (3) [back to overview]6-month Acute Antibody-mediated Rejection Rate (AMR)
NCT00282347 (9) [back to overview]Percentage of Participants Who Achieved a Complete Renal Response at Week 24 and Maintained it to Week 52
NCT00282347 (9) [back to overview]Change From Baseline in Anti-double-stranded DNA at Week 52
NCT00282347 (9) [back to overview]British Isles Lupus Assessment Group (BILAG) Index Score Over 52 Weeks
NCT00282347 (9) [back to overview]Percentage of Participants Who Achieved a Complete Renal Response (CRR), a Partial Renal Response (PRR), or no Renal Response (NRR) at Week 52
NCT00282347 (9) [back to overview]Change From Baseline in the Systemic Lupus Erythematosus Expanded Health Survey Physical Function Score at Week 52
NCT00282347 (9) [back to overview]Change From Baseline in C3 and C4 Complement Levels at Week 52
NCT00282347 (9) [back to overview]Time to Achieve a Complete Renal Response
NCT00282347 (9) [back to overview]Percentage of Participants With a Baseline Urine Protein to Creatinine Ratio of > 3.0 Who Achieved a Urine Protein to Creatinine Ratio of < 1.0 at Week 52
NCT00282347 (9) [back to overview]Percentage of Participants Who Achieved a Complete Renal Response at Week 52
NCT00284934 (4) [back to overview]Renal Function at 3 Months Assessed by Change in Estimated Glomerular Filtration Rate (eGFR)
NCT00284934 (4) [back to overview]Number of Participants With Treatment Failure Parameters (Biopsy-Proven Acute Rejection (BPAR), Graft Loss, Death, or Loss to Follow-up) at 6 Months
NCT00284934 (4) [back to overview]Number of Participants With Graft and Patient Survivals at 6 Months
NCT00284934 (4) [back to overview]Renal Function Assessed by Change in Estimated Glomerular Filtration Rate(eGFR)
NCT00288080 (6) [back to overview]Incidence of Adverse Events
NCT00288080 (6) [back to overview]Overall Survival
NCT00288080 (6) [back to overview]Local Control
NCT00288080 (6) [back to overview]Distant Metastasis
NCT00288080 (6) [back to overview]Disease-free Survival
NCT00288080 (6) [back to overview]Biochemical Control
NCT00288626 (20) [back to overview]Survival From MS-Related Mortality
NCT00288626 (20) [back to overview]Survival From Treatment-Related Mortality
NCT00288626 (20) [back to overview]Percent of Participants Who Experienced All-Cause Morbidity Within 12 Months of Post-HCT
NCT00288626 (20) [back to overview]Percent of Participants Who Experienced All-Cause Morbidity
NCT00288626 (20) [back to overview]Overall Survival
NCT00288626 (20) [back to overview]Event-Free Survival Probability During the 5 Years After Transplant
NCT00288626 (20) [back to overview]Number of New T2-Weighted Lesions From Baseline
NCT00288626 (20) [back to overview]Event-Free Survival Probability During the 3 Years After Transplant
NCT00288626 (20) [back to overview]Percent Change From Screening in Brain Volume
NCT00288626 (20) [back to overview]MS Relapse-Free Survival Probability After Transplant
NCT00288626 (20) [back to overview]MS Progression-Free Survival Probability After Transplant
NCT00288626 (20) [back to overview]MRI Activity-Free Survival Probability After Transplant
NCT00288626 (20) [back to overview]Event-Free Survival Probability After Transplant
NCT00288626 (20) [back to overview]Disease-Modifying Therapy Survival Probability After Transplant
NCT00288626 (20) [back to overview]Change From Baseline in T2-Weighted Lesion Volume
NCT00288626 (20) [back to overview]Change From Baseline in T1-Weighted Lesion Volume
NCT00288626 (20) [back to overview]Change From Baseline in Number of Gadolinium-Enhanced Lesions
NCT00288626 (20) [back to overview]Change From Baseline in Extended Disability Status Scale (EDSS)
NCT00288626 (20) [back to overview]Time to Neutrophil Engraftment
NCT00288626 (20) [back to overview]Time to Platelet Engraftment
NCT00290498 (2) [back to overview]Response Rate R-HCVAD vs. R-CHOP
NCT00290498 (2) [back to overview]Progression Free Survival (Rate)
NCT00294658 (29) [back to overview]Time-Weighted Average MG Activity of Daily Living (MG-ADL)
NCT00294658 (29) [back to overview]Time-weighted Average Alternate-day Prednisone Dose (mg) Measured Over 3 Years
NCT00294658 (29) [back to overview]Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 2: Penalized Using Dose at Time of Starting Azathioprine)
NCT00294658 (29) [back to overview]Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 1: Penalized Using Maximum Dose Before Azathioprine)
NCT00294658 (29) [back to overview]Number of Serious Adverse Events
NCT00294658 (29) [back to overview]Number of Patients With at Least One Serious Adverse Events
NCT00294658 (29) [back to overview]Intravenous Immunoglobulin Use
NCT00294658 (29) [back to overview]Cumulative Number of Hospital Days
NCT00294658 (29) [back to overview]Cumulative Days in Hospital for Myasthenia Gravis Exacerbation
NCT00294658 (29) [back to overview]Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Prednisone Use at Enrollment
NCT00294658 (29) [back to overview]Azathioprine Use
NCT00294658 (29) [back to overview]Treatment Associated Symptoms (TAS)
NCT00294658 (29) [back to overview]Hospitalization for Exacerbation of Myasthenia Gravis
NCT00294658 (29) [back to overview]Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Age at Disease Onset
NCT00294658 (29) [back to overview]Subgroup Analyses of Time-weighted Average Average Alternate-day Prednisone Dose (mg) by Age at Disease Onset
NCT00294658 (29) [back to overview]Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Sex
NCT00294658 (29) [back to overview]Short Form-36 Standardized Physical Component
NCT00294658 (29) [back to overview]Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Sex
NCT00294658 (29) [back to overview]Short Form-36 Standardized Mental Component
NCT00294658 (29) [back to overview]Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term
NCT00294658 (29) [back to overview]Minimal Manifestation (MM) Status at Month 12, 24 and 36
NCT00294658 (29) [back to overview]Classification of Serious Adverse Events
NCT00294658 (29) [back to overview]Plasma Exchange Use
NCT00294658 (29) [back to overview]Time-weighted Average Quantitative Myasthenia Gravis Weakness Score Over 3 Years
NCT00294658 (29) [back to overview]Time-weighted Average Prescribed Alternate Day Prednisone Dose (mg)
NCT00294658 (29) [back to overview]Time-Weighted Average MG Activity of Daily Living (MG-ADL) at Month 12, 24, and 36
NCT00294658 (29) [back to overview]Cumulative Days in Hospital for Myasthenia Gravis Exacerbation
NCT00294658 (29) [back to overview]Treatment Associated Complications (TAC)
NCT00294658 (29) [back to overview]Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Prednisone Use at Enrollment
NCT00295932 (2) [back to overview]Maximum Tolerated Dose
NCT00295932 (2) [back to overview]Toxicity of Participants Receiving Bortezomib, Rituximab, Cyclophosphamide, and Prednisone for Treatment of Non-Hodgkin's Lymphoma
NCT00296244 (6) [back to overview]New-onset Diabetes Mellitus (NODM) as Secondary Outcome
NCT00296244 (6) [back to overview]Infection as an Adverse Effect of Steroids
NCT00296244 (6) [back to overview]Incidence and Severity of HCV Recurrence Post-OLT
NCT00296244 (6) [back to overview]Patient Survival Rate
NCT00296244 (6) [back to overview]Graft Survival Rate
NCT00296244 (6) [back to overview]Acute Rejection Rate
NCT00301821 (4) [back to overview]Progression-free Survival (PFS)
NCT00301821 (4) [back to overview]Overall Survival
NCT00301821 (4) [back to overview]Overall Response Rate (ORR)
NCT00301821 (4) [back to overview]Event-free Survival After 12 Months
NCT00302003 (4) [back to overview]Intensive Therapy Free Survival (ITFS).
NCT00302003 (4) [back to overview]Event Free Survival (EFS)
NCT00302003 (4) [back to overview]Overall Survival
NCT00302003 (4) [back to overview]Event Free Survival Without Receiving Radiation Therapy (EFSnoRT).
NCT00306670 (1) [back to overview]To Evaluate the Total Number of Circulating Lymphocytes and Lymphocyte Phenotypes and to Correlate With the Effectiveness of Rituximab and Oral Cyclophosphamide to Achieve and Preserve Complete Eradication of the Refractory Autoantibody.
NCT00311311 (21) [back to overview]Change From Pre-conversion Baseline in Glycosylated Hemoglobin(HbA1C) at Months 12, 24, and 36 Post-transplant
NCT00311311 (21) [back to overview]Change From Pre-conversion Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Months 12, 24 and 36 Post-transplant.
NCT00311311 (21) [back to overview]Change From Pre-conversion Baseline in Homocysteine at Months 12, 24 and 36 Post-transplant
NCT00311311 (21) [back to overview]Change From Pre-conversion Baseline in Insulin at Months 12, 24, and 36 Post-transplant
NCT00311311 (21) [back to overview]Change From Pre-conversion Baseline in Interleukin-6 (IL-6) at Months 12, 24 and 36 Post-transplant
NCT00311311 (21) [back to overview]Change From Pre-conversion Baseline in Lipoprotein(a) at Months 12, 24 and 36 Post-transplant
NCT00311311 (21) [back to overview]Change From Pre-conversion Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) at Months 12, 24 and 36 Post-transplant
NCT00311311 (21) [back to overview]Change From Pre-conversion Baseline in Uric Acid at Months 12, 24 and 36 Post-transplant
NCT00311311 (21) [back to overview]Change From Pre-conversion Baseline in Vitamin B12 at Months 12, 24 and 36 Post-transplant
NCT00311311 (21) [back to overview]Number of Participants Who Used Anti-hypertensive Medications
NCT00311311 (21) [back to overview]Number of Participants Who Used Lipid Lowering Therapies
NCT00311311 (21) [back to overview]Annual Change Rate in Total Plaque Volume (TPV) From Pre-conversion Baseline to 12 Months Post-transplant
NCT00311311 (21) [back to overview]CIMT at Pre-conversion Baseline
NCT00311311 (21) [back to overview]TPV at Pre-conversion Baseline
NCT00311311 (21) [back to overview]Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant
NCT00311311 (21) [back to overview]Annual Rate of Change in TPV From Pre-conversion Baseline to 18, 24 and 36 Months Post Transplant
NCT00311311 (21) [back to overview]Change From Pre-conversion Baseline in Adiponectin at Months 12, 24 and 36 Post-transplant
NCT00311311 (21) [back to overview]Change From Pre-conversion Baseline in Endothelin-1 at Months 12, 24 and 36 Post-transplant
NCT00311311 (21) [back to overview]Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant
NCT00311311 (21) [back to overview]Change From Pre-conversion Baseline in Fibrinogen at Months 12, 24 and 36 Post-transplant
NCT00311311 (21) [back to overview]Change From Pre-conversion Baseline in Glucose at Months 12, 24 and 36 Post-transplant
NCT00313781 (6) [back to overview]Total Number of Circulation Tumor Cells (CTCs)
NCT00313781 (6) [back to overview]Human Anti-human Antibody (HAHA) at Baseline (Day 1 of Cycle 1)
NCT00313781 (6) [back to overview]Human Anti-human Antibody (HAHA) at the Last Follow-up Visit
NCT00313781 (6) [back to overview]Percentage of Participants With Prostate Specific Antigen (PSA) Best Response
NCT00313781 (6) [back to overview]Progression Free Survival (PFS)
NCT00313781 (6) [back to overview]Total Number of the Insulin Like Growth Factor Receptor Type 1 (IGF-1R) Positive CTCs
NCT00331344 (4) [back to overview]Proportion Responding to Treatment With of the Combination of Ixabepilone and Mitoxantrone Hydrochloride With Prednisone in Hormone Refractory Prostate Cancer Patients Who Have Had Prior Taxane Chemotherapy Based Upon a PSA Decline of > 50% (Phase II)
NCT00331344 (4) [back to overview]Safety of the Combination of Ixabepilone, Mitoxantrone Hydrochloride, and Prednisone in Patients With Hormone-refractory Metastatic Prostate Cancer That Progressed During or After Taxane-based Chemotherapy (Phase I)
NCT00331344 (4) [back to overview]Time to Progression (Phase II)
NCT00331344 (4) [back to overview]Dose Limiting Toxicities for Each Dose Level of Ixabepilone, Mitoxantrone Hydrochloride, and Prednisone in Patients With Hormone-refractory Metastatic Prostate Cancer That Progressed During or After Taxane-based Chemotherapy (Phase I).
NCT00337987 (2) [back to overview]Number of Patients That Achieved a Complete Response (CR)
NCT00337987 (2) [back to overview]Number of Patients That Achieved a Complete Response or a Partial Response (PR)
NCT00345046 (1) [back to overview]Percent Change in Flare at Resolution
NCT00348816 (2) [back to overview]Progression-free Survival Based on PSA Progression
NCT00348816 (2) [back to overview]Rate of Prostate-Specific Antigen (PSA) Decline Reported as the Number of Subjects Reaching a PSA Nadir of Zero Following the Intervention.
NCT00350545 (5) [back to overview]Participants Who Reduced Steroid Use at One Year After Enrollment on the Trial
NCT00350545 (5) [back to overview]Overall Survival
NCT00350545 (5) [back to overview]Number of Participants With Complete and/or Partial GVHD Response
NCT00350545 (5) [back to overview]Failure-free Survival at 6 and 12 Months Post-Rituximab Initiation
NCT00350545 (5) [back to overview]Number of Participants With the Ability to Successfully Taper Prednisone to a Dose Lower Dose.
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems
NCT00352027 (76) [back to overview]3-year Overall Survival (OS) Probability
NCT00352027 (76) [back to overview]3-year Local Failure-free Survival Probability
NCT00352027 (76) [back to overview]3-year Event-Free Survival Probability
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), Symptom Distress Scale
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.4.0: Total Score
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Worry
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Total Score
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Nausea
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems
NCT00352027 (76) [back to overview]Disease Failure Rate Within Radiation Fields
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Communication
NCT00352027 (76) [back to overview]Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)
NCT00352027 (76) [back to overview]3-year Event-free Survival (EFS) Probability
NCT00352027 (76) [back to overview]Toxicities With Grade >1
NCT00352027 (76) [back to overview]Prognostic Factors for Treatment Failure: Stage
NCT00352027 (76) [back to overview]Prognostic Factors for Treatment Failure: Histology
NCT00352027 (76) [back to overview]Prognostic Factors for Treatment Failure: Gender
NCT00352027 (76) [back to overview]Local and Distant Failure for Children Treated With Tailored-field Radiation
NCT00352027 (76) [back to overview]Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function)
NCT00352027 (76) [back to overview]Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram)
NCT00352027 (76) [back to overview]Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram)
NCT00352027 (76) [back to overview]Prognostic Factors for Treatment Failure: Age
NCT00352794 (1) [back to overview]Number of Patients With Objective Response (Complete and Partial Response + Hematological Improvement)
NCT00365274 (1) [back to overview]Objective Response Rate (ORR)
NCT00371826 (39) [back to overview]Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (12 Months Analysis)
NCT00371826 (39) [back to overview]Mean Urine Albumin/Creatinine Ratio (ACR) as Measurement of Proteinuria (12 Months Analysis)
NCT00371826 (39) [back to overview]Mean Serum Creatinine (12 Months Analysis)
NCT00371826 (39) [back to overview]Creatinine Clearance (CrCl) Calculated by the Cockcroft-Gault Formula (12 Months Analysis)
NCT00371826 (39) [back to overview]Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (12 Months Analysis)
NCT00371826 (39) [back to overview]Number of Participants With Antibody-mediated Rejection Per Treatment Group (36 Months Analysis)
NCT00371826 (39) [back to overview]Mean Urine Albumin/Creatinine Ratio [ACR] as Measurement of Proteinuria (36 Months Analysis)
NCT00371826 (39) [back to overview]Mean Short-form 36 Health Survey (SF-36) Score as a Measure of Quality of Life Assessment (36 Months Analysis)
NCT00371826 (39) [back to overview]Mean Short-form 36 Health Survey (SF-36) Score as a Measure of Quality of Life Assessment (12 Months Analysis)
NCT00371826 (39) [back to overview]Creatinine Clearance Calculated by the Cockcroft-Gault Formula (36 Months Analysis)
NCT00371826 (39) [back to overview]Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (36 Months Analysis)
NCT00371826 (39) [back to overview]Number of Participants With Erythropoietin Usage (36 Months Analysis)
NCT00371826 (39) [back to overview]Number of Participants With Erythropoietin Usage (12 Months Analysis)
NCT00371826 (39) [back to overview]Number of Participants With Composite Endpoint of Treatment Failure (12 Months Analysis)
NCT00371826 (39) [back to overview]Number of Participants With Any Wound Problems (36 Months Analysis)
NCT00371826 (39) [back to overview]Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (12 Months Analysis)
NCT00371826 (39) [back to overview]Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (36 Months Analysis)
NCT00371826 (39) [back to overview]Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (36 Months Analysis)
NCT00371826 (39) [back to overview]Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (12 Months Analysis)
NCT00371826 (39) [back to overview]Number of Participants With Employment Status (36 Months Analysis)
NCT00371826 (39) [back to overview]Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (36 Months Analysis)
NCT00371826 (39) [back to overview]Number of Participants With Composite Endpoint of Treatment Failure (36 Months Analysis)
NCT00371826 (39) [back to overview]Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (36 Months Analysis)
NCT00371826 (39) [back to overview]Number of Participants With Post Transplant Diabetes Mellitus (PTDM) and Impaired Fasting Glucose (12 Months Analysis)
NCT00371826 (39) [back to overview]Number of Participants With Sub Clinical Acute Rejection (36 Months Analysis)
NCT00371826 (39) [back to overview]Number of Participants With Wound Problems(12 Months Analysis)
NCT00371826 (39) [back to overview]Change in Bone Mineral Density Between Week 2 and Month 24 (36 Months Analysis)
NCT00371826 (39) [back to overview]Mean Serum Creatinine (36 Months Analysis)
NCT00371826 (39) [back to overview]Number of Patient Survival and Graft Survival (12 Months Analysis)
NCT00371826 (39) [back to overview]Number of Patient Survival and Graft Survival (36 Months Analysis)
NCT00371826 (39) [back to overview]Number of Participants With Employment Status (12 Months Analysis)
NCT00371826 (39) [back to overview]Number of Participants With Notable Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as Measurement of Effect of Treatment on Cardiovascular Health (36 Months Analysis)
NCT00371826 (39) [back to overview]Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (36 Months Analysis)
NCT00371826 (39) [back to overview]Number of Participants With Antibody-mediated Rejection Per Treatment Group (12 Months Analysis)
NCT00371826 (39) [back to overview]Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (12 Months Analysis)
NCT00371826 (39) [back to overview]Number of Participants With Sub Clinical Acute Rejection (12 Months Analysis)
NCT00371826 (39) [back to overview]Number of Participants With New Onset Diabetes Mellitus After Transplantation (NODAT) and Impaired Fasting Glucose (36 Months Analysis)
NCT00371826 (39) [back to overview]Number of Participants With Notable Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as Measurement of Effect of Treatment on Cardiovascular Health (12 Months Analysis)
NCT00371826 (39) [back to overview]Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (12 Months Analysis)
NCT00374231 (3) [back to overview]Patient Survival.
NCT00374231 (3) [back to overview]Time Post Transplant Corticosteroid Withdrawal
NCT00374231 (3) [back to overview]Incidence of Biopsy Confirmed Acute Rejection at 12 Months.
NCT00376961 (4) [back to overview]Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM).
NCT00376961 (4) [back to overview]Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
NCT00376961 (4) [back to overview]2-year Progression-free Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)
NCT00376961 (4) [back to overview]2-year Overall Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)
NCT00381680 (6) [back to overview]Event Free Survival. EFS
NCT00381680 (6) [back to overview]Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1
NCT00381680 (6) [back to overview]Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3
NCT00381680 (6) [back to overview]Adjusted Event Free Survival
NCT00381680 (6) [back to overview]Frequency and Severity of Adverse Effects
NCT00381680 (6) [back to overview]Event Free Survival (EFS)
NCT00385827 (5) [back to overview]Part 2: Progression Free Survival (PFS)
NCT00385827 (5) [back to overview]Number of Participants With Prostate Specific Antigen (PSA) Response
NCT00385827 (5) [back to overview]Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT00385827 (5) [back to overview]Time to Clinical Deterioration (TtCD)
NCT00385827 (5) [back to overview]Overall Survival (OS)
NCT00388362 (2) [back to overview]Clinical Activity
NCT00388362 (2) [back to overview]Overall Survival
NCT00389818 (1) [back to overview]Complete Response Rate (Complete Response and Complete Response Unconfirmed) Defined as Disappearance of All Evidence of Disease Based on Radiographic Findings on CT or MRI .
NCT00393367 (12) [back to overview]Serious Adverse Events
NCT00393367 (12) [back to overview]Number of Participants With Adverse Events (Non-serious).
NCT00393367 (12) [back to overview]Relapse / Readmission Numbers.
NCT00393367 (12) [back to overview]Oxygen Saturation.
NCT00393367 (12) [back to overview]Number of Subjects Remaining in the Severe Asthma Category
NCT00393367 (12) [back to overview]Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category
NCT00393367 (12) [back to overview]Number of Subjects Moving From the Severe Asthma to Mild Asthma Category
NCT00393367 (12) [back to overview]Number of Patients Hospitalized
NCT00393367 (12) [back to overview]Mean Change in Respiratory Rate.
NCT00393367 (12) [back to overview]Mean Change in Asthma Score at 2 Hours
NCT00393367 (12) [back to overview]Median Change in Asthma Score 2 Hours After Intervention
NCT00393367 (12) [back to overview]Change in Mean Heart Rate
NCT00405756 (28) [back to overview]Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale
NCT00405756 (28) [back to overview]Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale
NCT00405756 (28) [back to overview]Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale
NCT00405756 (28) [back to overview]Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale
NCT00405756 (28) [back to overview]Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale
NCT00405756 (28) [back to overview]Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale
NCT00405756 (28) [back to overview]Time to First Response
NCT00405756 (28) [back to overview]Kaplan Meier Estimates of Time to Progression (TTP) Based on the Response Assessment by the Central Adjudication Committee (CAC)
NCT00405756 (28) [back to overview]Kaplan Meier Estimates of Progression-free Survival (PFS) From Start of Maintenance Therapy Period Based on the Response Assessment by the Central Adjudication Committee (CAC)
NCT00405756 (28) [back to overview]Kaplan Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Central Adjudication Committee (CAC)
NCT00405756 (28) [back to overview]Kaplan Meier Estimates of Overall Survival (OS)
NCT00405756 (28) [back to overview]Kaplan Meier Estimates for Time to Next Antimyeloma Therapy
NCT00405756 (28) [back to overview]Kaplan Meier Estimates for Duration of Response as Determined by the Central Adjudication Committee (CAC)
NCT00405756 (28) [back to overview]Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period
NCT00405756 (28) [back to overview]Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period
NCT00405756 (28) [back to overview]Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale
NCT00405756 (28) [back to overview]Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale
NCT00405756 (28) [back to overview]Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale
NCT00405756 (28) [back to overview]Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale
NCT00405756 (28) [back to overview]Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale
NCT00405756 (28) [back to overview]Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale
NCT00405756 (28) [back to overview]Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale
NCT00405756 (28) [back to overview]Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale
NCT00405756 (28) [back to overview]Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale
NCT00405756 (28) [back to overview]Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale
NCT00405756 (28) [back to overview]Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale
NCT00405756 (28) [back to overview]Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale
NCT00405756 (28) [back to overview]Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale
NCT00408005 (8) [back to overview]Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort
NCT00408005 (8) [back to overview]Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I + Arm II vs. Arm III + Arm IV)
NCT00408005 (8) [back to overview]Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)
NCT00408005 (8) [back to overview]Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort
NCT00408005 (8) [back to overview]Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I + Arm III vs. Arm II + Arm IV)
NCT00408005 (8) [back to overview]Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)
NCT00408005 (8) [back to overview]Cumulative Incidence of CNS Relapse for T-ALL by Risk Group
NCT00408005 (8) [back to overview]Cumulative Incidence of CNS Relapse for T-ALL by Risk Group
NCT00413920 (6) [back to overview]Number of Participants With Treatment Failure, BPAR, Clinical Acute Rejection (AR) and Treated AR at 3 Months
NCT00413920 (6) [back to overview]Number of Participants With Treatment Failure at 3 Months by Graft Recovery Status
NCT00413920 (6) [back to overview]Number of Participants With Subclinical Histological Rejections
NCT00413920 (6) [back to overview]Number of Participants Requiring Steroids in Non-steroid Treatment Group
NCT00413920 (6) [back to overview]Number of Participants With the Occurrence of Treatment Failures at 6 Months Post-transplantation
NCT00413920 (6) [back to overview]The Number of Participants With BPAR, Clinical Acute Rejection (AR) and Treated AR at 6 Months
NCT00417079 (8) [back to overview]Time to Pain Progression
NCT00417079 (8) [back to overview]Time to Progression Free Survival (PFS)
NCT00417079 (8) [back to overview]Time to Prostatic Specific Antigen (PSA) Progression
NCT00417079 (8) [back to overview]Time to Tumor Progression
NCT00417079 (8) [back to overview]Pain Response
NCT00417079 (8) [back to overview]Overall Survival
NCT00417079 (8) [back to overview]Overall Tumor Response
NCT00417079 (8) [back to overview]PSA (Prostate-Specific Antigen) Response
NCT00419926 (3) [back to overview]Renal Function Assessed by Glomerular Filtration Rate (GFR)at Each Visit
NCT00419926 (3) [back to overview]Number of Patients With Treatment Failure 6-months Post Transplant Measured by the Combined Incidence of Biopsy Proven Acute Rejection, Graft Loss, and Death
NCT00419926 (3) [back to overview]Comparison of Overall Treatment Failure at Days 21 and 84 Post-transplantation Assessed by Biopsy Proven Acute Rejection (BPAR), GFL, and Death
NCT00423098 (10) [back to overview]Number of Patients With Complete Remission
NCT00423098 (10) [back to overview]Number of Patients With Complete Remission
NCT00423098 (10) [back to overview]Number of Patients With Adverse Events and Infections
NCT00423098 (10) [back to overview]Cumulative Dose of Prednisone Equivalent Corticosteroids (CS)
NCT00423098 (10) [back to overview]Change From Baseline in Overall Disease Activity With Systematic Lupus Erythematosus Disease Activity Index (SLEDAI)
NCT00423098 (10) [back to overview]Number of Patients With Partial Remission
NCT00423098 (10) [back to overview]Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG)
NCT00423098 (10) [back to overview]Duration of Exposure to Study Medication
NCT00423098 (10) [back to overview]Number of Patients With Moderate to Severe Flares
NCT00423098 (10) [back to overview]Number of Patients With Treatment Failure
NCT00424749 (2) [back to overview]Participants With Remission of Renal Disease Activity at 3 Months
NCT00424749 (2) [back to overview]Participants With Normalization of Eosinophil Count at 6 Months
NCT00430677 (42) [back to overview]Participants Achieving Renal Improvement (RI) or CRR at Month 12 During Short-term Period
NCT00430677 (42) [back to overview]Time to Achieve First Confirmed Renal Improvement (RI) During Short-term Period (as Determined by Kaplan-Meier Methodology)
NCT00430677 (42) [back to overview]Time to First Confirmed Complete Renal Response (CRR) During the Short-term (Double-blind) Period
NCT00430677 (42) [back to overview]Baseline and Post Baseline Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index During Short-term Period
NCT00430677 (42) [back to overview]Baseline Fatigue as Measured by Fatigue Severity Scale-Krupp During Short-term Period
NCT00430677 (42) [back to overview]Baseline Fatigue as Measured by the Fatigue Visual Analog Scale During Short-term Period
NCT00430677 (42) [back to overview]Baseline Mental Component Summary of the Short SF-36 During Short-term Period
NCT00430677 (42) [back to overview]Baseline Quantitative Immunoglobulins During the Short-term Period
NCT00430677 (42) [back to overview]Number of Participants With Confirmed Complete Renal Response (CRR) During Short-term Period
NCT00430677 (42) [back to overview]Baseline Renal Function Over Time During Short-term Period
NCT00430677 (42) [back to overview]Change From Baseline in Physical Component Summary of the SF-36 During Short-term Period
NCT00430677 (42) [back to overview]Change in Fatigue From Baseline as Measured by Fatigue Severity Scale-Krupp During Short-term Period
NCT00430677 (42) [back to overview]Change in Fatigue From Baseline as Measured by the Fatigue Visual Analog Scale During Short-term Period
NCT00430677 (42) [back to overview]Change in Quantitative Immunoglobulin From Baseline During Short-term Period
NCT00430677 (42) [back to overview]Change in Renal Function From Baseline Over Time During Short-term Period
NCT00430677 (42) [back to overview]Mean Change From Baseline in SLICC/ACR Damage Index
NCT00430677 (42) [back to overview]Number of Participants Achieving Complete Response by ACCESS Definition
NCT00430677 (42) [back to overview]Number of Participants Achieving Patient Response of Complete or Partial Response, Based on the June 2010 Food and Drug Administration Guidance Document for Lupus Nephritis
NCT00430677 (42) [back to overview]Number of Participants Achieving Renal Response
NCT00430677 (42) [back to overview]Number of Participants With Death, Serious Adverse Events (SAE), Treatment-related Adverse Events SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs During Long-term Extension Period
NCT00430677 (42) [back to overview]Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period
NCT00430677 (42) [back to overview]Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued)
NCT00430677 (42) [back to overview]Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued)
NCT00430677 (42) [back to overview]Number of Participants With Positive Abatacept-induced Responses (ECL Method) Over Time During the Short-term Period
NCT00430677 (42) [back to overview]Vital Signs Summary During the Short-term Period: Heart Rate
NCT00430677 (42) [back to overview]Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP)
NCT00430677 (42) [back to overview]Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs Reported During the Short-term Period
NCT00430677 (42) [back to overview]Participants With AEs of Special Interest During the Short-term Period
NCT00430677 (42) [back to overview]Participants With Marked Abnormalities Urinalysis During the Short-term Period
NCT00430677 (42) [back to overview]Participants With Marked Hematology Abnormalities During the Short-term Period
NCT00430677 (42) [back to overview]Participants With Marked Laboratory Abnormalities During the Short-term Period
NCT00430677 (42) [back to overview]Participants With Marked Liver and Kidney Function Abnormalities During the Short-term Period
NCT00430677 (42) [back to overview]Vital Signs Summary During the Short-term Period: Temperature
NCT00430677 (42) [back to overview]Number of Participants Achieving Patient Response (PR) at Month 12 During the Short-term Period
NCT00430677 (42) [back to overview]Baseline Physical Component Summary of the Short Form (SF)-36 During Short-term Period
NCT00430677 (42) [back to overview]Change in SLICC/ACR Damage Index From Baseline During Short-term Period
NCT00430677 (42) [back to overview]Number of Months CRR Was Maintained During Short-term Period
NCT00430677 (42) [back to overview]Number of Participants Achieving Renal Response (RR) at Month 12 During Short-term Period
NCT00430677 (42) [back to overview]Number of Participants With a Treatment-emergent Seropositive Result During the Long-term Extension Period
NCT00430677 (42) [back to overview]Change From Baseline in Mental Component Summary of the SF-36 During Short-term Period
NCT00430677 (42) [back to overview]Participants Achieving a Confirmed Complete Renal Response (CRR) at Month 12 During Short-term Period
NCT00430677 (42) [back to overview]Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP)
NCT00436956 (7) [back to overview]Percent Probability of Participants With 6-month Progression-free Survival (PFS)
NCT00436956 (7) [back to overview]Number of Grade 3 Toxicities
NCT00436956 (7) [back to overview]Response Per the Response Evaluation Criteria in Solid Tumors (RECIST)
NCT00436956 (7) [back to overview]Median Overall Survival
NCT00436956 (7) [back to overview]Number of Grade 2 Toxicities
NCT00436956 (7) [back to overview]Number of Participants With Adverse Events
NCT00436956 (7) [back to overview]Median Progression Free Survival (PFS)
NCT00443430 (3) [back to overview]Clinical Remission on Medication
NCT00443430 (3) [back to overview]Safety Profiles, Including the Number of Treatment-emergent, Serious, or Unexpected Adverse Events and Other Important Medical Events
NCT00443430 (3) [back to overview]Proportion of Participants Who Attain Inactive Disease by 6 Months
NCT00450385 (1) [back to overview]Number of Participants From Whom Fixed Tissue Samples Were Collected for Future Studies.
NCT00451178 (11) [back to overview]PFS of Participants With High or Low Expression of Protein Biomarkers and Correlation of Biomarkers to PFS
NCT00451178 (11) [back to overview]Percentage of Participants With Complete Response (CR and CRu) and Objective Response [CR, CRu, and Partial Response (PR)] (Overall Response Rate)
NCT00451178 (11) [back to overview]Participants Who Had Treatment-Emergent Adverse Events (TEAEs) or Died (Evaluate Toxicity and Tolerability of R-CHOP Plus Enzastaurin)
NCT00451178 (11) [back to overview]Progression-Free Survival (PFS) Time
NCT00451178 (11) [back to overview]Percentage of Participants With a PET-Negative Scan (PET-Negative Rate)
NCT00451178 (11) [back to overview]Percentage of Participants Alive Progression-Free at Year 2 (2-Year PFS Rate)
NCT00451178 (11) [back to overview]Overall Survival (OS)
NCT00451178 (11) [back to overview]Event-Free Survival (EFS)
NCT00451178 (11) [back to overview]Duration of Complete Response (CR or CRu)
NCT00451178 (11) [back to overview]Percentage of Participants With Complete Response (CR/CRu) and/or Post-Baseline PET-Negative Scan (Concordance Between Response and PET Scan)
NCT00451178 (11) [back to overview]PFS of Participants With High or Low Expression of Protein Biomarkers and Correlation of Biomarkers to PFS
NCT00452387 (3) [back to overview]Median Overall Survival (OS)
NCT00452387 (3) [back to overview]Correlation of Biochemical Criteria (PSA, Prostate-specific Antigen) With Objective Imaging
NCT00452387 (3) [back to overview]Quality of Life (QoL)
NCT00458848 (3) [back to overview]Percentage of Participants Reaching Overall Survival
NCT00458848 (3) [back to overview]Number of Patients Reaching Complete Hematological Response After Induction Therapy
NCT00458848 (3) [back to overview]Percentage of Participants Reaching Disease Free Survival
NCT00459186 (2) [back to overview]Response Based on PET Scan
NCT00459186 (2) [back to overview]Number of Patients Free of Dose Limiting Toxicity
NCT00463385 (10) [back to overview]Number of Participants With Adverse Events (AEs)
NCT00463385 (10) [back to overview]Percentage of Participants With a Clinical Response Within the First 6 Cycles of Treatment
NCT00463385 (10) [back to overview]Percentage of Participants With a Clinical Response Within the First 12 Cycles of Treatment
NCT00463385 (10) [back to overview]Duration of First Clinical Response
NCT00463385 (10) [back to overview]Change From Baseline in Hemoglobin Concentration for Responders
NCT00463385 (10) [back to overview]Change From Baseline in Hemoglobin Concentration for Non-Responders
NCT00463385 (10) [back to overview]Change From Baseline in Likert Abdominal Pain Scale
NCT00463385 (10) [back to overview]Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Subscale and Total Scores
NCT00463385 (10) [back to overview]Time to the First Clinical Response
NCT00463385 (10) [back to overview]Percentage of Participants With Clinical Response by Baseline JAK2 Assessment
NCT00466440 (12) [back to overview]Part 2: Progression Free Survival (PFS)
NCT00466440 (12) [back to overview]Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of Docetaxel
NCT00466440 (12) [back to overview]Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of Docetaxel
NCT00466440 (12) [back to overview]Prostate-Specific Androgen (PSA) Velocity at 2 Months
NCT00466440 (12) [back to overview]Prostate-Specific Androgen (PSA) Velocity at 3 Months
NCT00466440 (12) [back to overview]Part I: Pharmacokinetic (PK) Parameter: Maximum Observed Drug Concentration During a Dosing Interval at Steady State (Cmax,ss) of Enzastaurin, LSN326020, and Total Analyte (Enzastaurin + LSN326020)
NCT00466440 (12) [back to overview]Percentage of Participants Exhibiting a Decline in Prostate-Specific Androgen (PSA) From Baseline ≥30% Within First 3 Months of Treatment
NCT00466440 (12) [back to overview]Pharmacokinetic (PK) Parameter: Area Under the Concentration Versus Time Curve During 1 Dosing Interval at Steady State (AUCτ,ss) of Enzastaurin, LSN326020, and Total Analyte (Enzastaurin + LSN326020)
NCT00466440 (12) [back to overview]Part 2: Duration of Response
NCT00466440 (12) [back to overview]Part 2: Overall Survival (OS)
NCT00466440 (12) [back to overview]Part 2: Percentage of Participants With Objective Tumor Response (Response Rate)
NCT00466440 (12) [back to overview]Number of Participants With Adverse Events (AEs)
NCT00472030 (5) [back to overview]Median Time From First Dose of Omalizumab Treatment to Cessation of New Blisters.
NCT00472030 (5) [back to overview]Percent Decrease in the Total Body Surface Area Affected By Active Bullous Pemphigoid Skin Disease From Day 0 to Week 24.
NCT00472030 (5) [back to overview]Decrease in Anti-BP230 Antibody IgG (Anti-bullous Pemphigoid 230 Antibody Immunoglobulin G) At Baseline and Week 16
NCT00472030 (5) [back to overview]Decrease in Anti-BP180 IgG (Immunoglobulin G Anti-Bullous Pemphigoid 180 Antibody) Following Treatment With Omalizumab.
NCT00472030 (5) [back to overview]Decrease in Eosinophil Levels Following Treatment With Omalizumab.
NCT00473746 (17) [back to overview]Phase 1: Total Body Clearance (Cl_F_obs) of Abiraterone Acetate
NCT00473746 (17) [back to overview]Phase 2: Participants With Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score
NCT00473746 (17) [back to overview]Phase 1: Maximum Tolerated Dose (MTD) of Abiraterone Acetate
NCT00473746 (17) [back to overview]Phase 2: Duration of Objective Response
NCT00473746 (17) [back to overview]Phase 2: Duration of PSA Response
NCT00473746 (17) [back to overview]Phase 2: Overall Survival
NCT00473746 (17) [back to overview]Phase 2: PSA Progression Free Survival (PSA-PFS)
NCT00473746 (17) [back to overview]Phase 2: Time to PSA Progression
NCT00473746 (17) [back to overview]Phase 1: Area Under the Plasma-Concentration-time Curve From Time 0 to Infinite Time (AUCINF_obs) of Abiraterone Acetate
NCT00473746 (17) [back to overview]Phase 1: Area Under the Plasma-Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Abiraterone Acetate
NCT00473746 (17) [back to overview]Phase 1: Volume of Distribution (Vz_F_obs) of Abiraterone Acetate
NCT00473746 (17) [back to overview]Phase 2: Participants With Greater Than or Equal to 50 Percent Decline in Prostate Specific Antigen (PSA)
NCT00473746 (17) [back to overview]Phase 2: Radiographic Progression Free Survival (RAD-PFS)
NCT00473746 (17) [back to overview]Phase 2: Radiographic Objective Response Rate (RAD-ORR)
NCT00473746 (17) [back to overview]Phase 1: Maximum Plasma Concentration (Cmax) of Abiraterone Acetate
NCT00473746 (17) [back to overview]Phase 1: Terminal Half-life (HL_Lambda_z) of Abiraterone Acetate
NCT00473746 (17) [back to overview]Phase 1: Time to Reach the Maximum Plasma Concentration (Tmax) of Abiraterone Acetate
NCT00477750 (5) [back to overview]Patients With Overall Confirmed Response
NCT00477750 (5) [back to overview]Progression-free Survival
NCT00477750 (5) [back to overview]Percentage of Participants With Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (v3)
NCT00477750 (5) [back to overview]Duration of Response (DOR)
NCT00477750 (5) [back to overview]Overall Survival (OS) at 3 Years
NCT00485303 (9) [back to overview]Prostate-Specific Antigen Based Progression-free Survival (PSA-PFS)
NCT00485303 (9) [back to overview]Time to Radiographic Progression
NCT00485303 (9) [back to overview]Time to PSA Progression
NCT00485303 (9) [back to overview]Radiographic Progression Free Survival (PFS)
NCT00485303 (9) [back to overview]Percentage of Participants With Clinical Benefit
NCT00485303 (9) [back to overview]Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
NCT00485303 (9) [back to overview]Percentage of Participants With Prostate Specific Antigen (PSA) Response
NCT00485303 (9) [back to overview]Overall Survival (OS)
NCT00485303 (9) [back to overview]Percentage of Participants With Objective Radiographic Response
NCT00494780 (15) [back to overview]Median Percent Change From Visit 1 (Screening, Week -2) in Tumor Size at Visit 33 (24 Months After the Last Infusion of Ofatumumab)
NCT00494780 (15) [back to overview]Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 28, and 33
NCT00494780 (15) [back to overview]Number of Participants With the Indicated Overall Best Response (OBR) at Visit 26 (3 Months After the Last Infusion of Ofatumumab)
NCT00494780 (15) [back to overview]Percent Change From Visit 1 (Screening) in Peripheral CD19+ and CD20+ Cell Counts at Visit 33 (24 Months After the Last Infusion of Ofatumumab)
NCT00494780 (15) [back to overview]CL After the Sixth Infusion (Week 15, Visit 22)
NCT00494780 (15) [back to overview]AUC(0-inf) and AUC(0-504) After the Sixth Infusion (Week 15, Visit 22)
NCT00494780 (15) [back to overview]Duration of Response
NCT00494780 (15) [back to overview]Half Life (t1/2) of Ofatumumab at the Sixth Infusion (Week 15, Visit 22)
NCT00494780 (15) [back to overview]Median Percent Change From Visit 1 (Screening) in Serum Complement (CH50) Levels at Visit 22
NCT00494780 (15) [back to overview]Number of Participants Who Experienced Any Adverse Event (AEs) From First Treatment to Visit 33 (24 Months After Last Infusion)
NCT00494780 (15) [back to overview]Number of Participants With Complete Remission (CR) at Visit 26
NCT00494780 (15) [back to overview]Progression-Free Survival (PFS)
NCT00494780 (15) [back to overview]Time to New Anti-follicular Lymphoma (FL) Therapy
NCT00494780 (15) [back to overview]Vss at the Sixth Infusion (Week 15, Visit 22)
NCT00494780 (15) [back to overview]Cmax and Ctrough at the Sixth Infusion (Week 15, Visit 22)
NCT00503984 (8) [back to overview]Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Prednisone)
NCT00503984 (8) [back to overview]Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Azacitidine and Docetaxel)
NCT00503984 (8) [back to overview]Number of Participants Achieving Complete Response (CR) or Partial Response (CR) to Protocol Therapy.
NCT00503984 (8) [back to overview]Progression-Free Survival (PFS)
NCT00503984 (8) [back to overview]Overall Survival (OS)
NCT00503984 (8) [back to overview]Number of Participants Experiencing Adverse Events After Beginning Protocol Therapy.
NCT00503984 (8) [back to overview]Number of Participants Achieving Prostate-specific Antigen (PSA) Response.
NCT00503984 (8) [back to overview]Duration of Response
NCT00507416 (8) [back to overview]Duration of Response
NCT00507416 (8) [back to overview]Overall Survival
NCT00507416 (8) [back to overview]Percentage of Participants With a Complete Response
NCT00507416 (8) [back to overview]Percentage of Participants With a Complete Response or a Very Good Partial Response
NCT00507416 (8) [back to overview]Percentage of Participants With an Overall Response
NCT00507416 (8) [back to overview]Progression Free Survival (PFS)
NCT00507416 (8) [back to overview]Time to Alternative Therapy
NCT00507416 (8) [back to overview]Change From Baseline in EORTC QLQ-C30 - Global Health Status
NCT00519285 (11) [back to overview]Time to Skeletal Related Events
NCT00519285 (11) [back to overview]Tumor Response Rate in Participants With Measurable Disease
NCT00519285 (11) [back to overview]Change From Baseline in Functional Assessment of Cancer Therapy-Prostate Total Score as a Measure of Health Related Quality of Life
NCT00519285 (11) [back to overview]Number of Participants With Positive Anti-aflibercept Antibody Levels as a Measure of Immunogenicity of Aflibercept
NCT00519285 (11) [back to overview]Number of Participants With Adverse Events as a Measure of Safety
NCT00519285 (11) [back to overview]Overall Survival Time
NCT00519285 (11) [back to overview]Pain Progression-free Survival Time
NCT00519285 (11) [back to overview]Pain Response Rate
NCT00519285 (11) [back to overview]Progression Free Survival Time
NCT00519285 (11) [back to overview]Prostate Specific Antigen Progression-free Survival Time
NCT00519285 (11) [back to overview]Prostate Specific Antigen Response Rate
NCT00520468 (1) [back to overview]Number of Participants With Response
NCT00527124 (5) [back to overview]6-month Progression-free Survival (PFS) Proportion
NCT00527124 (5) [back to overview]Time to Progression
NCT00527124 (5) [back to overview]Overall Response Rate Evaluated by the RECIST Criteria
NCT00527124 (5) [back to overview]Prostate-specific Antigen (PSA) Response in Accordance With the Prostate Specific Antigen Working Group
NCT00527124 (5) [back to overview]Overall Survival
NCT00537381 (7) [back to overview]Number of Participants With Prostate Specific Antigen (PSA) Response
NCT00537381 (7) [back to overview]Percent Change From Baseline in 'Vascular Endothelial Growth Factor (VEGF)' Marker Concentration
NCT00537381 (7) [back to overview]Percent Change From Baseline in 'N-telopeptide of Type I Collagen (NTx)' Marker Concentration
NCT00537381 (7) [back to overview]Overall Survival
NCT00537381 (7) [back to overview]Number of Participants With Best Overall Response (OR)
NCT00537381 (7) [back to overview]Progression-Free Survival (PFS)
NCT00537381 (7) [back to overview]Percent Change From Baseline in 'C-telopeptide of Type I Collagen (CTx)' Marker Concentration
NCT00540644 (3) [back to overview]Quality of Life Using the FACT-G Data
NCT00540644 (3) [back to overview]Treatment Related Adverse Events Grade 3 or Higher
NCT00540644 (3) [back to overview]Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria
NCT00544440 (2) [back to overview]Number of Participants With Detectable Bone Marrow Testosterone Level (>1 Picograms/Mililiter)
NCT00544440 (2) [back to overview]Number of Participants With Detectable Bone Marrow Dihydrotestosterone (DHT) Level (>9 Picograms/Mililiter)
NCT00549848 (6) [back to overview]Probability of CNS Relapse
NCT00549848 (6) [back to overview]Probability of Event-free Survival
NCT00549848 (6) [back to overview]Probability of Overall Survival
NCT00549848 (6) [back to overview]Percentage of Participants With Continuous Complete Remission of Patients Receiving High-dose and Conventional Dose PEG-asparaginase.
NCT00549848 (6) [back to overview]Proportion of Participants With Minimal Residual Disease (MRD) on the 15th Day of Remission Induction ≥ 5%
NCT00549848 (6) [back to overview]Proportion of Participants With Minimal Residual Disease (MRD) at End of Remission Induction ≥ 0.01%
NCT00550550 (4) [back to overview]Participant Average Rhinoconjunctivitis Daily Symptom Scores (DSS) Over the Entire GPS
NCT00550550 (4) [back to overview]Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS
NCT00550550 (4) [back to overview]Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS)
NCT00550550 (4) [back to overview]Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) Total Score Over the Entire GPS
NCT00551291 (3) [back to overview]Mean Number of Blood Transfusions Per Visit
NCT00551291 (3) [back to overview]Percentage of Participants With Clinical Response as Measured by the International Working Group (IWG) Criteria for Hematological Improvement
NCT00551291 (3) [back to overview]Percentage of Participants With at Least One Adverse Event (AE)
NCT00555464 (2) [back to overview]Response of Hemangioma (IH) to Treatment
NCT00555464 (2) [back to overview]Toxicity to Medications
NCT00557193 (10) [back to overview]Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts
NCT00557193 (10) [back to overview]Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts
NCT00557193 (10) [back to overview]Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts
NCT00557193 (10) [back to overview]Describe in Vitro Sensitivity as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts
NCT00557193 (10) [back to overview]Number of Patients Who Experienced Lestaurtinib-related Dose Limiting Toxicity (DLT)
NCT00557193 (10) [back to overview]Percent Probability for Event-free Survival (EFS) for Patients on Arm A
NCT00557193 (10) [back to overview]Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)
NCT00557193 (10) [back to overview]Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2
NCT00557193 (10) [back to overview]Percent Probability of Event Free Survival (EFS) by MRD Status and Treatment Arm
NCT00557193 (10) [back to overview]Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy
NCT00562159 (4) [back to overview]Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS)
NCT00562159 (4) [back to overview]Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire With Standardized Activities (RQLQ(S)) Total Score Over the Entire GPS
NCT00562159 (4) [back to overview]Participant Average Rhinoconjunctivitis Daily Symptom Score (DSS) Over the Entire GPS
NCT00562159 (4) [back to overview]Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS
NCT00562965 (7) [back to overview]Percentage of Participants With Objective Response (OR)
NCT00562965 (7) [back to overview]Progression-Free Survival (PFS)
NCT00562965 (7) [back to overview]Number of Participants With Clinically Significant Change From Baseline in Laboratory Findings
NCT00562965 (7) [back to overview]Number of Participants With Clinically Significant Change From Baseline in QT Interval Findings
NCT00562965 (7) [back to overview]Number of Participants With Clinically Significant Change From Baseline in Vital Signs
NCT00562965 (7) [back to overview]Overall Survival Probability at Months 6, 12 and 24
NCT00562965 (7) [back to overview]Number of Participants With Grade 3 or 4 Treatment Emergent Adverse Events (TEAEs)
NCT00574496 (3) [back to overview]Overall Survival
NCT00574496 (3) [back to overview]Progression-free Survival at 1 Year
NCT00574496 (3) [back to overview]Disease Relapse or Progression as Measured by CT Scan or PET
NCT00577993 (2) [back to overview]Number of Participants With Progression Free Survival (10 Years) by Treatment
NCT00577993 (2) [back to overview]Number of Participants With Overall Survival (10 Years) by Treatment
NCT00580229 (3) [back to overview]Adverse Infusion Reactions Within 24 Hours Following the Second Rituximab Infusion.
NCT00580229 (3) [back to overview]Adverse Events Assessed From Day 15 Through Week 26.
NCT00580229 (3) [back to overview]Number of Acute Infusion Reactions in the First 24 Hours After Oral Prednisone Pretreatment to Initial Rituximab Infusion
NCT00588406 (2) [back to overview]FEV1 Percent Predicted
NCT00588406 (2) [back to overview]Hospitalization
NCT00602641 (4) [back to overview]Change in Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) Score From Baseline to Cycle 12
NCT00602641 (4) [back to overview]Very Good Partial Response (VGPR) Rate
NCT00602641 (4) [back to overview]Progression-Free Survival (PFS)
NCT00602641 (4) [back to overview]Overall Survival
NCT00608894 (3) [back to overview]Biochemical Remission of (AIH) at Month 6.
NCT00608894 (3) [back to overview]Biochemical Remission by Month 3.
NCT00608894 (3) [back to overview]Incomplete Response, Treatment Failure, or a Case of Relapse at 6 Months
NCT00623766 (9) [back to overview]Overall Survival (OS)
NCT00623766 (9) [back to overview]Best Overall Response Rate (BORR) by Modified World Health Organization (mWHO) Criteria and by Immune-relate Response Criteria (irRC)
NCT00623766 (9) [back to overview]Disease Control Rate by Immune-related Response Criteria (irRC)
NCT00623766 (9) [back to overview]Disease Control Rate by Modified World Health Organization (mWHO) Tumor Assessment Criteria
NCT00623766 (9) [back to overview]Duration of Response (DOR) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)
NCT00623766 (9) [back to overview]Number of Participants Surviving at 6, 12, 18, 24, and 36 Months (Overall Survival [OS] Rate)
NCT00623766 (9) [back to overview]Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation
NCT00623766 (9) [back to overview]Onset of Response by Modified World Health Organization (mWHO) Criteria and Immune-related Response Criteria (irRC)
NCT00623766 (9) [back to overview]Progression-free Survival (PFS) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)
NCT00633919 (5) [back to overview]Global Evaluation of Efficacy by Investigator at the End of the Evaluation Period in Autumn 2008
NCT00633919 (5) [back to overview]Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2008
NCT00633919 (5) [back to overview]Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2007
NCT00633919 (5) [back to overview]Global Evaluation of Efficacy by Subject at the End of The Evaluation Period in 2008
NCT00633919 (5) [back to overview]Global Evaluation of Efficacy by Subject and Investigator at the End of the Evaluation Period in Autumn 2007
NCT00634179 (2) [back to overview]An Estimate of the Overall Response Rate (ORR)(Complete Response [CR] + CR Unconfirmed [CRu] + Partial Response [PR]) to Bortezomib and Rituximab (VR)-CHOP According to International Workshop to Standardize Response Criteria (IWRC) Criteria
NCT00634179 (2) [back to overview]Maximal Tolerated Doses of Bortezomib and Vincristine When Used in Combination of Bortezomib, Rituximab and the CHOP Chemotherapy Regimen (Phase I)
NCT00634647 (3) [back to overview]Progression Free Survival.
NCT00634647 (3) [back to overview]Number of Participants With Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0)
NCT00634647 (3) [back to overview]Median Overall Survival (OS)
NCT00634933 (12) [back to overview]Visual Analogue Scale for Pain (VAS-pain)
NCT00634933 (12) [back to overview]Physician Global Assessment (PGA) of Disease Activity
NCT00634933 (12) [back to overview]Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
NCT00634933 (12) [back to overview]Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
NCT00634933 (12) [back to overview]Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
NCT00634933 (12) [back to overview]Patient Global Assessment (PtGA) of Disease Activity
NCT00634933 (12) [back to overview]Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
NCT00634933 (12) [back to overview]Number of Tender Joints
NCT00634933 (12) [back to overview]Number of Swollen Joints
NCT00634933 (12) [back to overview]Health Assessment Questionnaire Disability Index (HAQ-DI)
NCT00634933 (12) [back to overview]Disease Activity Score Based on 28-joints Count (DAS28)
NCT00634933 (12) [back to overview]Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24
NCT00638690 (4) [back to overview]Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%
NCT00638690 (4) [back to overview]Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria
NCT00638690 (4) [back to overview]Overall Survival
NCT00638690 (4) [back to overview]Radiographic Progression-free Survival
NCT00642018 (12) [back to overview]Prostate Specific Antigen (PSA) Kinetics: Percentage of Participants With PSA Response (Response Rate)
NCT00642018 (12) [back to overview]Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment
NCT00642018 (12) [back to overview]Functional Assessment of Cancer Therapy-Prostate Cancer (FACT-P) Total Score at 3 Months (Participant Reported Outcomes)
NCT00642018 (12) [back to overview]Functional Assessment of Cancer Therapy-General (FACT-G) Total Score at 3 Months (Evaluate Clinical Symptoms)
NCT00642018 (12) [back to overview]Estimate Overall Survival
NCT00642018 (12) [back to overview]Estimate Duration of Overall Response
NCT00642018 (12) [back to overview]Change From Baseline to Day 21 in Granulocyte Colony Stimulating Factor(G-CSF) (Assess Biomarker Responses)
NCT00642018 (12) [back to overview]Progression-free Survival (PFS) in Participants With Hormone Refractory Prostate Cancer (HRPC) Administered LY2181308 Sodium Plus Docetaxel Compared to Docetaxel Alone
NCT00642018 (12) [back to overview]Percentage of Participants With Complete Response or Partial Response (Overall Response Rate)
NCT00642018 (12) [back to overview]Number of Participants With Adverse Events (Safety)
NCT00642018 (12) [back to overview]Adverse Event Profile
NCT00642018 (12) [back to overview]Pharmacokinetics of Docetaxel: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-infinity)
NCT00650078 (2) [back to overview]ACR 20 Response Rate at Visit 4
NCT00650078 (2) [back to overview]Relative Reduction of Morning Stiffness
NCT00651040 (1) [back to overview]The Primary Endpoint is the Total Dose of Glucocorticoids Administered Between Baseline and the End of Treatment.
NCT00651755 (6) [back to overview]Geometric Mean Area Under Curve (AUC) of Analyte, 2-dechloro-cyclophosphamide(2-deCI-CP), in Aprepitant Treatment and Control Group
NCT00651755 (6) [back to overview]Geometric Mean Area Under Curve (AUC) of Analyte, Prednisolone (PL), in Aprepitant Treatment and Control Group
NCT00651755 (6) [back to overview]Geometric Mean Area Under Curve (AUC) of Analyte, 4-hydroxy-cyclophosphamide (4-OH-CP), in Aprepitant Treatment and Control Group
NCT00651755 (6) [back to overview]Geometric Mean Area Under Curve (AUC) of Analyte, Cyclophosphamide (CP), in Aprepitant Treatment and Control Group
NCT00651755 (6) [back to overview]Geometric Mean Area Under Curve (AUC) of Analyte, Vincristine (VC), in Aprepitant Treatment and Control Group
NCT00651755 (6) [back to overview]Geometric Mean Area Under Curve (AUC) of Analyte,Prednisone (PR), in Aprepitant Treatment and Control Group
NCT00667615 (2) [back to overview]Complete Response Rate to Rituximab and a Combination of Vorinostat With Cyclophosphamide, Etoposide, and Prednisone in Elderly Pts With Relapsed Diffuse Large B-cell Lymphoma Who Aren't Candidates for Autologous Stem Cell Transplantation.
NCT00667615 (2) [back to overview]Maximum Tolerated Dose (MTD) of Vorinostat Given Orally for 10 Days in Combination With Cyclophosphamide, Etoposide, Prednisone and Rituximab for Elderly Patients With Relapsed Diffuse Large B-cell Lymphoma
NCT00668434 (4) [back to overview]Oswestry Disability Index, v2
NCT00668434 (4) [back to overview]Oswestry Disability Index, v2
NCT00668434 (4) [back to overview]Pain Numerical Rating Scale
NCT00668434 (4) [back to overview]Pain Numerical Rating Scale
NCT00670358 (3) [back to overview]Event-free > Survival at 12 Months (Phase 2, DLBCL/Mixed Dose Level 3)
NCT00670358 (3) [back to overview]Toxicity as Assessed by NCI CTCAE v3.0 (Phase I)
NCT00670358 (3) [back to overview]Progression-free > Survival at 24 Months (Phase 2, Transformed/Composite)
NCT00671034 (9) [back to overview]Pharmacokinetics (PK) (Half-life of SC-PEG E. Coli L-asparaginase (EZN-2285) Compared to Pegaspargase During Induction and Consolidation Therapy)
NCT00671034 (9) [back to overview]Pharmacodynamics (PD)
NCT00671034 (9) [back to overview]Asparaginase Level
NCT00671034 (9) [back to overview]Percentage of Participants With Minimal Residual Disease (MRD)<0.01% at the End of Induction
NCT00671034 (9) [back to overview]Percentage of Participants With Complete Remission at the End of Induction
NCT00671034 (9) [back to overview]Immunogenicity
NCT00671034 (9) [back to overview]Percentage of Participants With Event-free Survival (EFS)
NCT00671034 (9) [back to overview]Plasma and CSF Concentrations of Asparagine in ug/ml
NCT00671034 (9) [back to overview]Toxicities During Post Induction Intensification Therapy (All Grades)
NCT00676650 (3) [back to overview]Percent of Participants With Objective Response (OR)
NCT00676650 (3) [back to overview]Overall Survival (OS)
NCT00676650 (3) [back to overview]Progression-Free Survival (PFS)
NCT00683475 (9) [back to overview]Composite Progression-free Survival (cPFS) at 6-months
NCT00683475 (9) [back to overview]Composite Progression-free Survival (cPFS) at 12-months
NCT00683475 (9) [back to overview]Prostate Specific Antigen (PSA) Response Rate
NCT00683475 (9) [back to overview]Overall Survival (OS)
NCT00683475 (9) [back to overview]Composite Progression-free Survival (cPFS)
NCT00683475 (9) [back to overview]Objective Response Rate (ORR)
NCT00683475 (9) [back to overview]Composite Progression-free Survival (cPFS) at 9-months
NCT00683475 (9) [back to overview]Summary Listing of Participants Reporting Treatment-Emergent Adverse Events
NCT00683475 (9) [back to overview]Time to Radiographic Evidence of Disease Progression
NCT00686335 (1) [back to overview]Total Number of Nocturnal Awakenings During the Last 2 Weeks of Treatment
NCT00689936 (43) [back to overview]Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC)
NCT00689936 (43) [back to overview]Percentage of Participants With a Myeloma Response by Adverse Risk Cytogenetic Risk Category Based on IRAC Review.
NCT00689936 (43) [back to overview]Percentage of Participants With a Myeloma Response by Favorable Hyperdiploidy Risk Cytogenetic Risk Category Based on IRAC Review
NCT00689936 (43) [back to overview]Kaplan Meier Estimates of Time to Treatment Failure (TTF) at the Time of Final Analysis
NCT00689936 (43) [back to overview]Percentage of Participants With a Myeloma Response by Normal Risk Cytogenetic Risk Category Based on IRAC Review
NCT00689936 (43) [back to overview]Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis
NCT00689936 (43) [back to overview]Percentage of Participants With a Myeloma Response by Uncertain Risk Cytogenetic Risk Category Based on IRAC Review
NCT00689936 (43) [back to overview]Percentage of Participants With an Objective Response After Second-line Anti-myeloma Treatment at the Time of Final Analysis
NCT00689936 (43) [back to overview]Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis
NCT00689936 (43) [back to overview]Percentage of Participants With an Objective Response Based on IRAC Review
NCT00689936 (43) [back to overview]Time to First Response Based on the Investigator Assessment at the Time of Final Analysis
NCT00689936 (43) [back to overview]Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain
NCT00689936 (43) [back to overview]Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain
NCT00689936 (43) [back to overview]Change From Baseline in the EORTC QLQ-C30 Constipation Domain
NCT00689936 (43) [back to overview]Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain
NCT00689936 (43) [back to overview]Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain
NCT00689936 (43) [back to overview]Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain
NCT00689936 (43) [back to overview]Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC
NCT00689936 (43) [back to overview]Kaplan Meier Estimates of Time to Treatment Failure (TTF)
NCT00689936 (43) [back to overview]Time to First Response Based on the Review by the IRAC
NCT00689936 (43) [back to overview]Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis
NCT00689936 (43) [back to overview]Kaplan Meier Estimates for Time to Second-line Anti-myeloma Treatment (AMT)
NCT00689936 (43) [back to overview]Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase.
NCT00689936 (43) [back to overview]Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase
NCT00689936 (43) [back to overview]Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase
NCT00689936 (43) [back to overview]Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase
NCT00689936 (43) [back to overview]Number of Participants With Adverse Events (AEs) During the Active Treatment Phase
NCT00689936 (43) [back to overview]Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score
NCT00689936 (43) [back to overview]Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale
NCT00689936 (43) [back to overview]Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale
NCT00689936 (43) [back to overview]Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale
NCT00689936 (43) [back to overview]Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale
NCT00689936 (43) [back to overview]Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain
NCT00689936 (43) [back to overview]Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain
NCT00689936 (43) [back to overview]Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain
NCT00689936 (43) [back to overview]Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
NCT00689936 (43) [back to overview]Change From Baseline in the EORTC QLQ-C30 Pain Domain
NCT00689936 (43) [back to overview]Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain
NCT00689936 (43) [back to overview]Change From Baseline in the EORTC QLQ-C30 Insomnia Domain
NCT00689936 (43) [back to overview]Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain
NCT00689936 (43) [back to overview]Change From Baseline in the EORTC QLQ-C30 Fatigue Domain
NCT00689936 (43) [back to overview]Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS)
NCT00689936 (43) [back to overview]Kaplan Meier Estimates of Time to Second Line Therapy AMT at the Time of Final Analysis
NCT00691704 (5) [back to overview]Progression Free Survival
NCT00691704 (5) [back to overview]Overall Survival
NCT00691704 (5) [back to overview]Time to Response
NCT00691704 (5) [back to overview]Duration of Response
NCT00691704 (5) [back to overview]Time to Progression
NCT00699803 (1) [back to overview]Mean Aqueous Humor Prednisolone Acetate Concentration
NCT00707759 (1) [back to overview]Stimulation of Growth After 12 Months (Delta Z-score)
NCT00713193 (2) [back to overview]Time in Days to Achieve a Clinical Response, Comparing the CSA/PEX Arm to the Steroids/PEX Arm.
NCT00713193 (2) [back to overview]Number of Participants With Exacerbations in the CSA/PEX Arm Compared to the Steroids/PEX Arm
NCT00715208 (5) [back to overview]Number of Patients Who Experienced at Least One Serious Adverse Event
NCT00715208 (5) [back to overview]Percentage of Participants With Progression-free Survival (PFS) at 1 Year
NCT00715208 (5) [back to overview]Number of Patients With Complete Response (CR)
NCT00715208 (5) [back to overview]Number of Participants With Overall Response (OR)
NCT00715208 (5) [back to overview]Duration of Response
NCT00719472 (6) [back to overview]Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 2 Through Cycle 6 or 8 (End of Study)
NCT00719472 (6) [back to overview]Percentage of Patients Who Had Undetectable Levels of CD19+ Lymphocytes at Cycle 2 and Either Cycle 6 or 8 (Last Cycle)
NCT00719472 (6) [back to overview]Maximum Serum Concentration (Cmax) of Rituximab Post-dose at the First Alternative Dosing Rate (Cycle 2) and the Last Cycle (Either Cycle 6 or 8)
NCT00719472 (6) [back to overview]Duration of Rituximab Infusion Including Dose Interruption Times
NCT00719472 (6) [back to overview]Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 1
NCT00719472 (6) [back to overview]Percentage of Patients Who Developed Grade 3 or 4 Infusion-related Reactions (IRR) Resulting From Faster Infusion of Rituximab During Days 1 and 2 of Cycle 2
NCT00720109 (5) [back to overview]Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events
NCT00720109 (5) [back to overview]Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation
NCT00720109 (5) [back to overview]Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy
NCT00720109 (5) [back to overview]Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib)
NCT00720109 (5) [back to overview]Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy
NCT00722137 (11) [back to overview]Overall Complete Response (CR + CRu)
NCT00722137 (11) [back to overview]Number of Participants Experiencing an Adverse Event (AE)
NCT00722137 (11) [back to overview]18-Month Survival
NCT00722137 (11) [back to overview]Duration of Response
NCT00722137 (11) [back to overview]Treatment-free Interval (TFI)
NCT00722137 (11) [back to overview]Time to Progression (TTP)
NCT00722137 (11) [back to overview]Time to Next Anti-lymphoma Treatment (TTNT)
NCT00722137 (11) [back to overview]Progression Free Survival (PFS)
NCT00722137 (11) [back to overview]Overall Survival (OS) in Long Term Follow-up Period
NCT00722137 (11) [back to overview]Overall Survival (OS)
NCT00722137 (11) [back to overview]Overall Response Rate (ORR)
NCT00734149 (3) [back to overview]Median Duration of Response
NCT00734149 (3) [back to overview]Number of Patients With Any Grade or Severe Adverse Event
NCT00734149 (3) [back to overview]Response
NCT00736450 (2) [back to overview]Time to Perform Microarray Study After Receipt of Tissue
NCT00736450 (2) [back to overview]Number of Participants With Microarray Testing Results Are Completed Within 7 Days.
NCT00744497 (15) [back to overview]Percentage of Participants With an Objective Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (RECIST)
NCT00744497 (15) [back to overview]Percentage of Participants With A Reduction in Urinary N-telopeptide (uNTx) Level From Baseline
NCT00744497 (15) [back to overview]Percentage of Participants With a Reduction in Pain Intensity From Baseline
NCT00744497 (15) [back to overview]Overall Survival: Time From Randomization to Date of Death
NCT00744497 (15) [back to overview]Number of Participants With Changes From Baseline in Fridericia-corrected QTc Interval
NCT00744497 (15) [back to overview]Number of Participants With Serious Adverse Event (SAEs), Drug-related SAEs, Drug-related AEs, Drug-related AEs Leading to Discontinuation, and All Deaths
NCT00744497 (15) [back to overview]Number of Participants With Drug-Related Adverse Events (AEs) of Special Interest
NCT00744497 (15) [back to overview]Number of Participants With and Without Pericardial Effusion at Baseline and On-study and With Left Ventricular Ejection Fraction (LVEF) <40% and >=40% On-study
NCT00744497 (15) [back to overview]Number of Participants With Abnormalities in Results of Clinical Laboratory Tests in Hematology
NCT00744497 (15) [back to overview]Number of Participants With Abnormalities in Results of Clinical Laboratory Tests Assessing Liver Function, Renal Function, and Electrolytes
NCT00744497 (15) [back to overview]Number of Participants With Abnormal Results in Urinalysis
NCT00744497 (15) [back to overview]Number of Participants by Maximal On-study Fridericia-corrected QTc Interval
NCT00744497 (15) [back to overview]Time to Prostate Specific Antigen (PSA) Progression
NCT00744497 (15) [back to overview]Time to First Skeletal-related Event (SRE)
NCT00744497 (15) [back to overview]Progression-free Survival (PFS)
NCT00746512 (2) [back to overview]Synovial Blood Flow
NCT00746512 (2) [back to overview]Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP])
NCT00770224 (4) [back to overview]Percentage of Participants With 3-year Progression-free Survival (PFS)
NCT00770224 (4) [back to overview]5-year Overall Survival
NCT00770224 (4) [back to overview]5-year Progression-free Survival
NCT00770224 (4) [back to overview]Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
NCT00772668 (3) [back to overview]Overall Survival (OS)
NCT00772668 (3) [back to overview]Progression-free Survival (PFS)
NCT00772668 (3) [back to overview]Rate of Toxicity in Study Participants
NCT00774202 (2) [back to overview]Relative Efficacy of the 2 Groups
NCT00774202 (2) [back to overview]Number of Participants With SAEs
NCT00774852 (17) [back to overview]Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study
NCT00774852 (17) [back to overview]Number of Participants Who Achieved a Complete Response by Week 24 and Maintained the Complete Response Through Week 52
NCT00774852 (17) [back to overview]Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Partial Response
NCT00774852 (17) [back to overview]Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Complete Response
NCT00774852 (17) [back to overview]Lupus Disease Activity - Total BILAG-2004
NCT00774852 (17) [back to overview]Number of Participants With a Complete or Partial Response
NCT00774852 (17) [back to overview]Lupus Disease Activity - Patient Global Assessment
NCT00774852 (17) [back to overview]Number of Participants With Complete Response
NCT00774852 (17) [back to overview]Number of Participants With Partial Response
NCT00774852 (17) [back to overview]Lupus Disease Activity - Frequency of Flares
NCT00774852 (17) [back to overview]Lupus Disease Activity - Presence of Hypocomplementemia
NCT00774852 (17) [back to overview]Lupus Disease Activity - SF-36 Scores
NCT00774852 (17) [back to overview]Lupus Disease Activity - SF-36 Scores Percent Change From Baseline
NCT00774852 (17) [back to overview]Lupus Disease Activity - Participants Who Were Anti-dsDNA Positive at Baseline and Negative at Week 104
NCT00774852 (17) [back to overview]Proportion of Vaccinated Participants With a Competent Immune Response
NCT00774852 (17) [back to overview]Lupus Disease Activity - Patient Global Assessment Percent Change From Baseline
NCT00774852 (17) [back to overview]Lupus Disease Activity - Negative Anti-dsDNA
NCT00787527 (3) [back to overview]Number of Participants With Dose Limiting Toxicity for Determination Phase I (Schedule A) MTD of Vorinostat
NCT00787527 (3) [back to overview]Phase II MTD of Vorinostat
NCT00787527 (3) [back to overview]Phase I Maximum Tolerated Dose (MTD) of Vorinostat
NCT00789997 (2) [back to overview]Number of Participants With Treatment Failure by 90 Days Assignment
NCT00789997 (2) [back to overview]Change in Lung Function (Forced Expiratory Volume in 1 Second (FEV1)
NCT00792948 (3) [back to overview]Overall Survival (OS)
NCT00792948 (3) [back to overview]Continuous Complete Remission (CCR) Rate
NCT00792948 (3) [back to overview]Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation
NCT00801632 (8) [back to overview]Change in Renal Function
NCT00801632 (8) [back to overview]Number of Participants Successfully Withdrawn Off of Immunosuppressant Medication for 104 Weeks
NCT00801632 (8) [back to overview]Percentage of Participants Experiencing Acute Rejection
NCT00801632 (8) [back to overview]Percentage of Participants Experiencing a Clinically Significant Invasive or Resistant Opportunistic Infection
NCT00801632 (8) [back to overview]Time to Platelet Recovery Following Transplant
NCT00801632 (8) [back to overview]Time to Neutrophil Recovery Following Transplant
NCT00801632 (8) [back to overview]Percentage of Participants With Graft Survival Through 156 Weeks
NCT00801632 (8) [back to overview]Percentage of Participants Surviving Through 156 Weeks
NCT00815919 (5) [back to overview]Proportion of Patients Tolerating >50% Steroid Dose Reduction After a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD
NCT00815919 (5) [back to overview]Overall Response Rate After a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD
NCT00815919 (5) [back to overview]Proportion of cGVHD Patients Requiring Prednisone by 1 Year After Therapy
NCT00815919 (5) [back to overview]The Toxicity of a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD
NCT00815919 (5) [back to overview]Overall and cGVHD Progression-free Survival by 1 Year After Therapy
NCT00822120 (8) [back to overview]Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging
NCT00822120 (8) [back to overview]Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS
NCT00822120 (8) [back to overview]Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD
NCT00822120 (8) [back to overview]Percentage of HIV-positive Patients With 5-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging.
NCT00822120 (8) [back to overview]Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
NCT00822120 (8) [back to overview]Percentage of HIV-positive Patients With 2-year Progression-free Survival (PFS) Treated With Initial 2 Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.
NCT00822120 (8) [back to overview]Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
NCT00822120 (8) [back to overview]Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.
NCT00828061 (2) [back to overview]Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration
NCT00828061 (2) [back to overview]Change From Baseline at Hour 8 in the Percent of Total Cells That Are Eosinophils
NCT00836810 (6) [back to overview]Percentage Change in Morning Stiffness
NCT00836810 (6) [back to overview]Change in Peak Serum IL-6 Concentration
NCT00836810 (6) [back to overview]Pain (Severity)
NCT00836810 (6) [back to overview]Clinician's Opinion of Disease Activity.
NCT00836810 (6) [back to overview]Change in Area Under the Curve (AUC) of Plasma IL-6
NCT00836810 (6) [back to overview]Patient's Opinion of Condition
NCT00854061 (1) [back to overview]Means Aqueous Humor Prednisolone Acetate Concentration
NCT00866307 (2) [back to overview]AALL08P1 Safety Outcome
NCT00866307 (2) [back to overview]AALL08P1 Feasibility Outcome
NCT00873093 (7) [back to overview]Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1
NCT00873093 (7) [back to overview]Severe Adverse Events (SAE) Rate.
NCT00873093 (7) [back to overview]Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy
NCT00873093 (7) [back to overview]Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3
NCT00873093 (7) [back to overview]Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2
NCT00873093 (7) [back to overview]Toxic Death Rate
NCT00873093 (7) [back to overview]Event Free Survival
NCT00877006 (17) [back to overview]Worst Overall CTCAE Grade for Hematology Laboratory Test Results
NCT00877006 (17) [back to overview]Kaplan-Meier Estimate for Duration of Response (DOR)
NCT00877006 (17) [back to overview]Kaplan-Meier Estimate for Event-free Survival (EFS)
NCT00877006 (17) [back to overview]Kaplan-Meier Estimate for Progression-free Survival (PFS)
NCT00877006 (17) [back to overview]Overall Survival (OS)
NCT00877006 (17) [back to overview]Participants With Disease Progression, Relapse or Death At the End of the Treatment Period or the Long-Term Follow-up Period
NCT00877006 (17) [back to overview]Percentage of Participants With Complete Response (CR) at End of Treatment Period
NCT00877006 (17) [back to overview]Percentage of Participants With Overall Response at End of Treatment Period
NCT00877006 (17) [back to overview]Clinically Significant Abnormal Vital Signs
NCT00877006 (17) [back to overview]Eastern Cooperative Oncology Group (ECOG) Performance Status at the End of Treatment Period
NCT00877006 (17) [back to overview]Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs at End of Treatment Period
NCT00877006 (17) [back to overview]Participants Who Died At the End of the Treatment Period or the Long-Term Follow-up Period
NCT00877006 (17) [back to overview]Potentially Clinically Significant Abnormal Weight
NCT00877006 (17) [back to overview]Therapeutic Classification of Concomitant Medications
NCT00877006 (17) [back to overview]Therapeutic Classification of Prior Medications
NCT00877006 (17) [back to overview]Worst Overall Common Terminology Criteria for Adverse Events (CTCAE) Grades for Serum Chemistry Laboratory Test Results
NCT00877006 (17) [back to overview]Change From Baseline to End of Treatment in the Global Health Status Score of the European Organization for Research and Treatment of Cancer (EORTC) 30-item Core Quality of Life Questionnaire (QLQ-C30)
NCT00882206 (4) [back to overview]Response to Treatment
NCT00882206 (4) [back to overview]Level of Methylation
NCT00882206 (4) [back to overview]Level of Methylation
NCT00882206 (4) [back to overview]Level of Methylation
NCT00887198 (7) [back to overview]Number of Participants With Treatment Emergent Adverse Events
NCT00887198 (7) [back to overview]Radiographic Progression-free Survival (rPFS)
NCT00887198 (7) [back to overview]Time to Opiate Use for Prostate Cancer Pain
NCT00887198 (7) [back to overview]Overall Survival
NCT00887198 (7) [back to overview]Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by >=1 Point
NCT00887198 (7) [back to overview]Time to Prostate-specific Antigen (PSA) Progression
NCT00887198 (7) [back to overview]Time to Initiation of Cytotoxic Chemotherapy
NCT00890617 (1) [back to overview]The Number of Patients With a Response (Complete Response and Partial Response)
NCT00911183 (4) [back to overview]Progression-free Survival Time
NCT00911183 (4) [back to overview]Number of Participants in Complete Remission 6 Months After Randomization
NCT00911183 (4) [back to overview]Number of Participants With Severe Toxicity
NCT00911183 (4) [back to overview]Overall Survival Time
NCT00911859 (9) [back to overview]Overall Survival
NCT00911859 (9) [back to overview]Percentage of Participants Who Achieved Complete Response (CR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria
NCT00911859 (9) [back to overview]Percentage of Participants Who Achieved Overall Response ie, Complete Response (CR) or Partial Response (PR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria
NCT00911859 (9) [back to overview]Percentage of Participants Who Achieved Stringent Complete Response (sCR) - International Myeloma Working Group (IMWG) Criteria
NCT00911859 (9) [back to overview]Progression-Free Survival (PFS)
NCT00911859 (9) [back to overview]1-year Survival Rate
NCT00911859 (9) [back to overview]Change From Baseline to Cycle 9 in Global Health Status/Quality of Life Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30)
NCT00911859 (9) [back to overview]Duration of Response (DOR)
NCT00911859 (9) [back to overview]1-year Progression-Free Survival (PFS) Rate
NCT00924469 (7) [back to overview]Testosterone Concentration in Prostate Tissue
NCT00924469 (7) [back to overview]Dihydrotestosterone (DHT) Concentration in Prostate Tissue
NCT00924469 (7) [back to overview]Percentage of Participants With Pathologic Complete Response (CR)
NCT00924469 (7) [back to overview]Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue
NCT00924469 (7) [back to overview]Percentage of Participants With Prostate-specific Antigen (PSA) Response
NCT00924469 (7) [back to overview]Serum Levels of Androgens
NCT00924469 (7) [back to overview]Testosterone and Dihydrotestosterone (DHT) Concentration in Prostate Tissue
NCT00929695 (12) [back to overview]Prednisone-associated Toxicity as Assessed by Hyperglycemia
NCT00929695 (12) [back to overview]Prednisone-associated Toxicity as Assessed by Hypertension
NCT00929695 (12) [back to overview]Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral)
NCT00929695 (12) [back to overview]Non-relapse Mortality
NCT00929695 (12) [back to overview]Chronic Extensive GVHD
NCT00929695 (12) [back to overview]Prednisone-associated Toxicity as Assessed by Quality of Life
NCT00929695 (12) [back to overview]Progression to Grade III-IV Acute GVHD
NCT00929695 (12) [back to overview]Recurrent or Progressive Malignancy
NCT00929695 (12) [back to overview]Secondary Therapy for Acute GVHD Beyond Prednisone
NCT00929695 (12) [back to overview]Prednisone-associated Toxicity as Assessed by Myopathy
NCT00929695 (12) [back to overview]Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment
NCT00929695 (12) [back to overview]Overall Survival
NCT00931918 (10) [back to overview]Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) by Category
NCT00931918 (10) [back to overview]Percentage of Participants With Chemistry and Hematology Laboratory Values Grade 3 or Higher
NCT00931918 (10) [back to overview]Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Negative Rate
NCT00931918 (10) [back to overview]Duration of Response
NCT00931918 (10) [back to overview]Overall Response Rate (ORR)
NCT00931918 (10) [back to overview]Complete Response Rate
NCT00931918 (10) [back to overview]Progression-Free Survival (PFS) in Patients With Non-germinal Center B-cell-like (Non-GCB) Diffuse Large B-cell Lymphoma (DLBCL)
NCT00931918 (10) [back to overview]Progression-Free Survival Rate
NCT00931918 (10) [back to overview]Time to Progression (TTP)
NCT00931918 (10) [back to overview]Overall Survival
NCT00938587 (28) [back to overview]Change From Baseline in Eosinophil Counts at Day 1, 7 and 14
NCT00938587 (28) [back to overview]Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 14
NCT00938587 (28) [back to overview]Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 7, 14 and 42
NCT00938587 (28) [back to overview]Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42
NCT00938587 (28) [back to overview]Change From Baseline in Body Weight at Day 7 and 14
NCT00938587 (28) [back to overview]Change From Baseline in Adiponectin Level at Day 7 and 14
NCT00938587 (28) [back to overview]Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14
NCT00938587 (28) [back to overview]Ratio of Apparent Oral Clearance on Day 1 to Day 14 of Methotrexate
NCT00938587 (28) [back to overview]Number of Participants With Clinically Significant Vital Signs Abnormalities
NCT00938587 (28) [back to overview]Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
NCT00938587 (28) [back to overview]Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
NCT00938587 (28) [back to overview]Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 7
NCT00938587 (28) [back to overview]Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14
NCT00938587 (28) [back to overview]Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14
NCT00938587 (28) [back to overview]Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Day 7 and 14
NCT00938587 (28) [back to overview]Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 7 and 14
NCT00938587 (28) [back to overview]Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Day 7 and 14
NCT00938587 (28) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT00938587 (28) [back to overview]Change From Baseline in Tender Joints Count at Day 7, 14, 42
NCT00938587 (28) [back to overview]Change From Baseline in Swollen Joints Count at Day 7, 14 and 42
NCT00938587 (28) [back to overview]Change From Baseline in Ratio of Urinary N-terminal Telopeptide of Type 1 Collagen (uNTX-I) Level to Urinary Creatinine (uCr) Level at Day 7 and 14
NCT00938587 (28) [back to overview]Change From Baseline in Physician Global Assessment (PhGA) of Arthritis at Day 7 and 14
NCT00938587 (28) [back to overview]Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Day 7 and 14
NCT00938587 (28) [back to overview]Change From Baseline in Participant Assessment of Arthritis Pain at Day 7 and 14
NCT00938587 (28) [back to overview]Change From Baseline in Osteocalcin Level at Day 1, 7 and 14
NCT00938587 (28) [back to overview]Change From Baseline in Neutrophil Counts at Day 1, 7 and 14
NCT00938587 (28) [back to overview]Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14
NCT00938587 (28) [back to overview]Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Day 7 and 14
NCT00942578 (10) [back to overview]Count of Participants With a Radiologic Response
NCT00942578 (10) [back to overview]Survival Based on Expression of T Cell Immunoglobulin and Mucin Domain (TIM-3) on Cluster of Differentiation 8 (CD8) + T Cells
NCT00942578 (10) [back to overview]Survival Based on Expression of Programmed Cell Death Protein 1 (PD-1) on Cluster of Differentiation 8 (CD8) + T Cells
NCT00942578 (10) [back to overview]Count of Participants With Prostatic Antigen-Specific (PSA) Declines
NCT00942578 (10) [back to overview]Count of Participants With Changes in Circulating Apoptotic Endothelial Cells (CAEC) From Baseline After Drug Administration
NCT00942578 (10) [back to overview]Recommended Phase 2 Dose (RP2D)
NCT00942578 (10) [back to overview]Median Time to Progression (TTP)
NCT00942578 (10) [back to overview]Median Overall Survival of Patients Studied
NCT00942578 (10) [back to overview]Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) Who Were Administered the Four-Drug Combination
NCT00942578 (10) [back to overview]Count of Participants With Dose-Limiting Toxicities (DLT)
NCT00946270 (1) [back to overview]Number of Participants With Best Overall Response
NCT00972478 (5) [back to overview]Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL
NCT00972478 (5) [back to overview]Safe Dose of Vorinostat to be Used in Combination With R-CHOP Assessed by CTCAE Version 4.0 (Phase I)
NCT00972478 (5) [back to overview]Response Rate (Complete Response [CR]+Partial Response [PR]) (Phase II)
NCT00972478 (5) [back to overview]Progression-free Survival (Phase II)
NCT00972478 (5) [back to overview]Overall Survival (Phase II)
NCT00973752 (1) [back to overview]Overall Survival at One Year
NCT00988208 (7) [back to overview]Percentage of Participants With Secondary Primary Malignancies During the Course of the Trial
NCT00988208 (7) [back to overview]Time to Onset of Secondary Primary Malignancies
NCT00988208 (7) [back to overview]Progression-Free Survival (PFS)
NCT00988208 (7) [back to overview]Number of Participants With Treatment Emergent Adverse Events (AEs)
NCT00988208 (7) [back to overview]Percentage of Participants With an Objective Response According to Response Evaluation Criteria in Solid Tumors - RECIST Version 1.1 Criteria
NCT00988208 (7) [back to overview]Percentage of Participants Who Received Post-Study Therapies
NCT00988208 (7) [back to overview]Overall Survival (OS)
NCT00991939 (1) [back to overview]The Percentage of Patients in Each Treatment Arm Who Remain Free of All ITP Therapy With a Platelet Count ≥ 50,000/μl From 60 Days Through 365 Days After Study Entry.
NCT00995722 (5) [back to overview]Change in Quality of Life as Measured by the 10-Item Neuro-ophthalmological Supplement to the NEI-VFQ-25
NCT00995722 (5) [back to overview]Treatment Failure
NCT00995722 (5) [back to overview]Change in Quality of Life as Measured by the MG-QOL-15 Score
NCT00995722 (5) [back to overview]Change in Ocular Quantitative Myasthenia Score From Baseline to Week 16
NCT00995722 (5) [back to overview]Change in Quality of Life as Measured by the NEI-VFQ-25 Measures
NCT01000285 (8) [back to overview]Effects of on HTLV-1 DNA After Treatment as Measured by Proviral Loads
NCT01000285 (8) [back to overview]Effects of HTLV-1 RNA Load After Treatment as Measured by Hbz Messenger RNA
NCT01000285 (8) [back to overview]Effects of HTLV-1 Integration Sites After Treatment
NCT01000285 (8) [back to overview]Effects of HTLV-1 Integrase Gene Sequence After Treatment as Measured by Nucleotide Divergence
NCT01000285 (8) [back to overview]Time to Progression
NCT01000285 (8) [back to overview]Relation of NFκB Gene Expression Profile on Response
NCT01000285 (8) [back to overview]Efficacy of Treatment as Measured by Best Overall Response
NCT01000285 (8) [back to overview]Tolerability of Treatment as Measured by Number of Participants With Grade 3 or Higher Adverse Events
NCT01002339 (16) [back to overview]Blood Pressure
NCT01002339 (16) [back to overview]Blood Pressure
NCT01002339 (16) [back to overview]Changes of Carotid Intima-media Thickness Over Time
NCT01002339 (16) [back to overview]Lipidic Profile (Cholesterol)
NCT01002339 (16) [back to overview]Lipidic Profile (HDL-c)
NCT01002339 (16) [back to overview]Lipidic Profile (LDL-c)
NCT01002339 (16) [back to overview]Lipidic Profile (Triglycerides)
NCT01002339 (16) [back to overview]"Primary Outcome Measure New Onset Diabetes After Renal Transplantation (NODAT)"
NCT01002339 (16) [back to overview]Number of Antihypertensive Drugs Patients Reported Taking.
NCT01002339 (16) [back to overview]Patients Treated With Insulin or Oral Antidiabetic Drugs
NCT01002339 (16) [back to overview]Percentage of Patients Using Acetylsalicylic Acid (ASA)
NCT01002339 (16) [back to overview]Percentage of Patients Using Statins
NCT01002339 (16) [back to overview]Primary Outcome Measure (Glucose Intolerance)
NCT01002339 (16) [back to overview]Proteinuria
NCT01002339 (16) [back to overview]Rejection
NCT01002339 (16) [back to overview]Renal Function
NCT01004991 (1) [back to overview]Complete Response
NCT01005316 (17) [back to overview]Percentage of Participants Positive for de Novo Donor-Specific Alloantibody Production in the First Year Post-Transplantation
NCT01005316 (17) [back to overview]Percentage of Participants Experiencing Acute Rejection
NCT01005316 (17) [back to overview]Percentage of Participants With the Presence of Anti-MICA Antibodies by Luminex TM Assay
NCT01005316 (17) [back to overview]Percentage of Participants -Quantification of Anti-HLA IgG Antibodies by Luminex SA Testing
NCT01005316 (17) [back to overview]Percentage of Participants With the Presence of Anti-HLA IgG Antibodies by Luminex SA Testing
NCT01005316 (17) [back to overview]Percentage of Participants With Occurrence of Re-Hospitalization(s)
NCT01005316 (17) [back to overview]Time to Production of Post-Transplant de Novo Donor-specific Alloantibodies
NCT01005316 (17) [back to overview]Time to Post-Transplantation Lymphoproliferative Disorder
NCT01005316 (17) [back to overview]Time to New-Onset Diabetes Mellitus
NCT01005316 (17) [back to overview]Time to Diagnosis of Chronic Rejection
NCT01005316 (17) [back to overview]Time to Acute Rejection
NCT01005316 (17) [back to overview]Time From Participant Listing on Organ Wait-List to Receiving Organ Transplant, Death or De-Listing
NCT01005316 (17) [back to overview]Presence of C4d on Endomyocardial Biopsy (EMB)
NCT01005316 (17) [back to overview]Percentage of Participants- Mortality While on Transplantation Wait-List
NCT01005316 (17) [back to overview]Percentage of Participants Positive for Severe Infection(s)
NCT01005316 (17) [back to overview]Percentage of Participants Positive for Event of Death, Graft Loss or Rejection With Hemodynamic Compromise at 12 Months Post-Transplantation
NCT01005316 (17) [back to overview]Percentage of Participants -Overall Participant and Graft Survival
NCT01023061 (3) [back to overview]Incidence of Acute and Chronic Grade 3 or Greater Toxicity as Evaluated Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0
NCT01023061 (3) [back to overview]Levels of Dihydrotestosterone (DHT) and Testosterone in Prostate Biopsy Sample Assessed by Mass Spectrometry
NCT01023061 (3) [back to overview]Median Time to Prostate Specific Antigen Progression
NCT01026220 (7) [back to overview]Overall Survival
NCT01026220 (7) [back to overview]Relapse-free Survival
NCT01026220 (7) [back to overview]Safety Analysis and Monitoring of Toxic Death
NCT01026220 (7) [back to overview]Second-event-free Survival
NCT01026220 (7) [back to overview]Event Free Survival
NCT01026220 (7) [back to overview]Event-free Survival for Rapid Early Response (RER) Positron Emission Tomography(PET)-1 Positive, RER PET-1 Negative
NCT01026220 (7) [back to overview]Grade 3 and 4 Non-hematologic Toxicities During Protocol Therapy
NCT01030900 (4) [back to overview]Clinical Response on Study and at Relapse After Dose Adjusted - Etoposide + Prednisone + Vincristine + Cyclophosphamide + Doxorubicin + Rituximab (DA-EPOCH-RC)
NCT01030900 (4) [back to overview]Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
NCT01030900 (4) [back to overview]Overall Survival (OS)
NCT01030900 (4) [back to overview]Progression Free Survival (PFS)
NCT01033864 (10) [back to overview]Dose-Normalized C0
NCT01033864 (10) [back to overview]Percentage of Participants By Time to Maximum Plasma Concentration (Tmax)
NCT01033864 (10) [back to overview]Pre-dose Trough Concentration (C0)
NCT01033864 (10) [back to overview]MPA Area Under the Curve From 0 to 12 Hours (AUC0-12)
NCT01033864 (10) [back to overview]Minimum Plasma Concentration (Cmin)
NCT01033864 (10) [back to overview]Maximum Plasma Concentration (Cmax)
NCT01033864 (10) [back to overview]Dose-Normalized MPA AUC0-12
NCT01033864 (10) [back to overview]Dose-Normalized Cmin
NCT01033864 (10) [back to overview]Dose-Normalized Cmax (mg/L)
NCT01033864 (10) [back to overview]Regression Coefficients For Participants Receiving MMF
NCT01040871 (7) [back to overview]Subsequent Anti-lymphoma Therapy Rate at 1-year
NCT01040871 (7) [back to overview]Rate of Durable Response
NCT01040871 (7) [back to overview]Rate of Durable Complete Response
NCT01040871 (7) [back to overview]Progression-free Survival (PFS)Rate at 1-year
NCT01040871 (7) [back to overview]Overall Survival Rate at 1-year
NCT01040871 (7) [back to overview]Complete Response (CR) Rate
NCT01040871 (7) [back to overview]Overall Response Rate
NCT01042145 (6) [back to overview]Number of Participants With Reported Side Effects
NCT01042145 (6) [back to overview]Time Missed From Work
NCT01042145 (6) [back to overview]Parental Stress
NCT01042145 (6) [back to overview]Additional Health Care
NCT01042145 (6) [back to overview]Duration of Croup Symptoms
NCT01042145 (6) [back to overview]Nights With Disturbed Sleep
NCT01051570 (6) [back to overview]Number of Participants With Toxicity as Measured by NCI CTCAE v3.0 Criteria
NCT01051570 (6) [back to overview]Association of PSA Response Rate With Correlative Markers (Phospho mTOR, pAKT, and p70S6)
NCT01051570 (6) [back to overview]PSA Response Rate
NCT01051570 (6) [back to overview]Pharmacokinetics: Observed Carboplatin AUC Was Estimated Based on the Concentration in the 2.75-h Sample.
NCT01051570 (6) [back to overview]Overall Survival
NCT01051570 (6) [back to overview]Time to Progression (TTP)
NCT01054144 (5) [back to overview]Single Agent - Median Progressive Free Survival (PFS)
NCT01054144 (5) [back to overview]Response Rate
NCT01054144 (5) [back to overview]Combined Therapy - Median Progression Free Survival
NCT01054144 (5) [back to overview]Number of Participants With 1 Year Overall Survival (OS)
NCT01054144 (5) [back to overview]Number of Participants With Serious Adverse Events
NCT01055496 (17) [back to overview]Participants Reporting Dose Limiting Toxicity (DLT) Adverse Events (AEs) for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 1
NCT01055496 (17) [back to overview]Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the DE Cohorts
NCT01055496 (17) [back to overview]Kaplan-Meier Estimate of the PFS in the MTD Confirmation/EE Cohorts
NCT01055496 (17) [back to overview]Kaplan-Meier Estimate of the Overall Survival (OS) in the DE Cohorts
NCT01055496 (17) [back to overview]Kaplan-Meier Estimate of the OS in the MTD Confirmation/EE Cohorts
NCT01055496 (17) [back to overview]Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the DE Cohorts
NCT01055496 (17) [back to overview]Percentage of Participants With Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) According to International Response Criteria for NHLs in the MTD and EE Cohorts
NCT01055496 (17) [back to overview]Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts.
NCT01055496 (17) [back to overview]Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts
NCT01055496 (17) [back to overview]Mean Inotuzumab Ozogamicin Serum Concentrations
NCT01055496 (17) [back to overview]Percentage of Participants With Any Grade 3/4 Hematology Abnormality During Therapy
NCT01055496 (17) [back to overview]Percentage of Participants With a Treatment Emergent AE
NCT01055496 (17) [back to overview]Mean Inotuzumab Ozogamicin Serum Concentrations
NCT01055496 (17) [back to overview]Percentage of Participants With Any Grade 3/4 Chemistry Abnormality During Therapy
NCT01055496 (17) [back to overview]Percentage of Participants With a Best OR of CR or PR According to International Response Criteria for NHLs in the DE Cohorts
NCT01055496 (17) [back to overview]Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in the DE Cohorts
NCT01055496 (17) [back to overview]Participants Reporting DLT AEs for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 2
NCT01084655 (14) [back to overview]Phase 2: Time to Radiographic Disease Progression
NCT01084655 (14) [back to overview]Phase 2: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Docetaxel
NCT01084655 (14) [back to overview]Phase 2: Best PSA Response
NCT01084655 (14) [back to overview]Phase 2: Time to PSA Progression
NCT01084655 (14) [back to overview]Phase 2: Cmax: Maximum Observed Plasma Concentration for Docetaxel
NCT01084655 (14) [back to overview]Phase 2: Cmax, ss: Maximum Observed Plasma Concentration at Steady State for Orteronel
NCT01084655 (14) [back to overview]Phase 2: AUC 0-tau: Area Under the Plasma Concentration Versus Time Curve Zero to the Time of the End of the Dosing Interval for Orteronel
NCT01084655 (14) [back to overview]Phase 2: Percentage of Participants With Prostate-specific Antigen (PSA) Response of 30 Percent (%), 50%, and 90%
NCT01084655 (14) [back to overview]Phase 2: Percentage of Participants With Objective Measurable Disease Response
NCT01084655 (14) [back to overview]Phase 2: Change From Baseline in Circulating Tumor Cells (CTCs)
NCT01084655 (14) [back to overview]Number of Participants With TEAEs Related to Vital Signs
NCT01084655 (14) [back to overview]Number of Participants With TEAEs Related to Hematology and Serum Chemistry
NCT01084655 (14) [back to overview]Number of Participants With TEAEs Related to Electrocardiogram (ECG)
NCT01084655 (14) [back to overview]Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) or Serious Adverse Events (SAE)
NCT01085097 (2) [back to overview]Number of Participants With Adverse Events (AEs)
NCT01085097 (2) [back to overview]Percent Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24
NCT01086540 (19) [back to overview]All-Cause Mortality: From Treatment Initiation to Week 104
NCT01086540 (19) [back to overview]Time to Clinical Worsening
NCT01086540 (19) [back to overview]Change From Baseline in Distance Walked During a Six Minute Walk Test
NCT01086540 (19) [back to overview]Treatment-Related Mortality: From Treatment Initiation to Week 48
NCT01086540 (19) [back to overview]Change in Carbon Monoxide Diffusing Capacity (DLCO)
NCT01086540 (19) [back to overview]Time to the Change or Addition of New Pulmonary Arterial Hypertension (PAH) Therapeutic Medications
NCT01086540 (19) [back to overview]Change in Quality of Life as Measured by the Disability Index of the Scleroderma Health Assessment Questionnaire (HAQ-DI)
NCT01086540 (19) [back to overview]Change in Severity of Raynaud's Phenomenon
NCT01086540 (19) [back to overview]Number of Grade 3 or Higher Adverse Events (AEs) Through Week 48
NCT01086540 (19) [back to overview]Number of Infusion-Related Toxicities
NCT01086540 (19) [back to overview]Oxygen Saturation Levels at Week 24 and Week 48
NCT01086540 (19) [back to overview]Percent Change From Baseline in Pulmonary Vascular Resistance Measured by Right Heart Catheterization
NCT01086540 (19) [back to overview]Number of Infection-Related Adverse Events (AEs) Through Week 48
NCT01086540 (19) [back to overview]Change From Baseline in Pulmonary Vascular Resistance Measured by Right Heart Catheterization at Week 24
NCT01086540 (19) [back to overview]Number of New Digital Ulcers
NCT01086540 (19) [back to overview]Change From Baseline in Quality of Life as Measured by the Short Form Health Survey (SF-36): Physical Component Summary Score
NCT01086540 (19) [back to overview]Change From Baseline in Distance Walked During a Six Minute Walk Test at Week 24 and Week 48
NCT01086540 (19) [back to overview]Change From Baseline in Quality of Life as Measured by the Short Form Health Survey (SF-36): Mental Component Summary Score
NCT01086540 (19) [back to overview]All-Cause Mortality: From Treatment Initiation to Week 48
NCT01088529 (3) [back to overview]Number of Participants With a Positive Surgical Margin at Radical Prostatectomy
NCT01088529 (3) [back to overview]Number of Participants With Prostate-Specific Antigen Response
NCT01088529 (3) [back to overview]Number of Participants With a Pathology Tumor Stage of Less Than or Equal to Prostate Cancer Stage at Which the Tumor is Confined to the Prostate (pT2)
NCT01092182 (5) [back to overview]Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
NCT01092182 (5) [back to overview]Percentage of Participants Kaplan-Meier Curve Overall Survival (OS) Constructed With an 95% Confidence Interval
NCT01092182 (5) [back to overview]Kaplan-Meier Progression Free Survival (PFS) Constructed With an 95% Confidence Interval in Participants Who Underwent Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) and/or Computed Tomography (CT) Scans After Cycle 2
NCT01092182 (5) [back to overview]Percentage of Participants With Kaplan-Meier Curve Event Free Survival (EFS) Constructed With an 95% Confidence Interval
NCT01092182 (5) [back to overview]Percentage of Participants With Kaplan-Meier Curve Progression Free Survival (PFS) Constructed With an 95% Confidence Interval
NCT01106833 (17) [back to overview]SF-36 Physical Component Summary
NCT01106833 (17) [back to overview]Percentage of Participants With Discontinuation of Systemic Immunosuppressive Therapy at Two Years
NCT01106833 (17) [back to overview]Percentage of Participants With Overall Survival
NCT01106833 (17) [back to overview]Percentage of Participants With Progression-free Survival
NCT01106833 (17) [back to overview]Prednisone Dose
NCT01106833 (17) [back to overview]Provider-reported Chronic GVHD Severity
NCT01106833 (17) [back to overview]Proportion of Participants With Treatment Success
NCT01106833 (17) [back to overview]Patient-reported Chronic GVHD Severity
NCT01106833 (17) [back to overview]NIH Consensus Criteria Chronic GVHD Severity
NCT01106833 (17) [back to overview]Percentage of Participants With Relapse
NCT01106833 (17) [back to overview]SF-36 Mental Component Summary
NCT01106833 (17) [back to overview]Serum Creatinine Level
NCT01106833 (17) [back to overview]Percentage of Participants With Secondary Immunosuppressive Therapy Initiated
NCT01106833 (17) [back to overview]Change in Prednisone Dose From Baseline
NCT01106833 (17) [back to overview]Change in Serum Creatinine Level From Baseline
NCT01106833 (17) [back to overview]Percentage of Participants With Failure-free Survival
NCT01106833 (17) [back to overview]FACT-BMT Score
NCT01124838 (10) [back to overview]Change in Visual Functioning Questionnaire 25 (VFQ-25) Total Score From Baseline to the Final/Early Termination Visit
NCT01124838 (10) [back to overview]Percent Change in Central Retinal Thickness in Each Eye From Baseline to the Final/Early Termination Visit.
NCT01124838 (10) [back to overview]Change in Vitreous Haze (VH) Grade in Each Eye From Baseline to the Final/Early Termination Visit
NCT01124838 (10) [back to overview]Change In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) In Each Eye From Baseline to the Final/Early Termination Visit
NCT01124838 (10) [back to overview]Change in Anterior Chamber (AC) Cell Grade in Each Eye From Baseline to the Final/Early Termination Visit
NCT01124838 (10) [back to overview]Time to Treatment Failure on or After Week 2
NCT01124838 (10) [back to overview]Time to Optimal Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Week 2
NCT01124838 (10) [back to overview]Change in VFQ-25 Subscore Ocular Pain From Baseline to the Final/Early Termination Visit
NCT01124838 (10) [back to overview]Change in VFQ-25 Subscore Near Vision From Baseline to the Final/Early Termination Visit
NCT01124838 (10) [back to overview]Change in VFQ-25 Subscore Distance Vision From Baseline to the Final/Early Termination Visit
NCT01132807 (3) [back to overview]36 Month Progression Free Survival Rate of Patients Receiving 4 Cycles of ABVD Versus Patients Receiving 2 Cycles of ABVD and 2 Cycles of BEACOPP and Radiation.
NCT01132807 (3) [back to overview]Complete Response Rate
NCT01132807 (3) [back to overview]Progression-Free Survival (PFS) at 36-Months for Patients Who Received 4 Cycles of ABVD
NCT01133275 (2) [back to overview]Number of Participants With Erythroid Response
NCT01133275 (2) [back to overview]Number of Participants With Grade 3 or 4 Adverse Events Possibly Related to Treatment
NCT01133626 (1) [back to overview]The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment
NCT01138657 (10) [back to overview]Time to Treatment Failure on or After Week 6
NCT01138657 (10) [back to overview]Change in Anterior Chamber (AC) Cell Grade in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit
NCT01138657 (10) [back to overview]Change In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) In Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit
NCT01138657 (10) [back to overview]Change in Vitreous Haze (VH) Grade in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit
NCT01138657 (10) [back to overview]Percent Change in Central Retinal Thickness in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit
NCT01138657 (10) [back to overview]Time to Optical Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Week 6
NCT01138657 (10) [back to overview]Change in VFQ-25 Distance Vision Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit
NCT01138657 (10) [back to overview]Change in VFQ-25 Near Vision Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit
NCT01138657 (10) [back to overview]Change in VFQ-25 Ocular Pain Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit
NCT01138657 (10) [back to overview]Change in Visual Functioning Questionnaire 25 (VFQ-25) Composite Score From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit
NCT01145508 (1) [back to overview]Overall Survival
NCT01172639 (7) [back to overview]Remission According to DAS28-CRP at Week 16
NCT01172639 (7) [back to overview]Remission According to DAS28-CRP at Week 104
NCT01172639 (7) [back to overview]Clinically Significant Change in HAQ Score
NCT01172639 (7) [back to overview]Remission According to SDAI at Week 52
NCT01172639 (7) [back to overview]Remission According to SDAI at Week 104
NCT01172639 (7) [back to overview]Remission According to SDAI (Simple Disease Activity Index) at Week 16
NCT01172639 (7) [back to overview]Remission According to DAS28-CRP at Week 52
NCT01193049 (8) [back to overview]Geometric Mean Fold Change From Baseline in Interleukin-1β (IL-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
NCT01193049 (8) [back to overview]Geometric Mean Fold Change From Baseline in Eotaxin-3 From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
NCT01193049 (8) [back to overview]Geometric Mean Fold Change From Baseline in Interleukin-13 (IL-13) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
NCT01193049 (8) [back to overview]Geometric Mean Fold Change From Baseline in Interleukin-17 (IL-17) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
NCT01193049 (8) [back to overview]Geometric Mean Fold Change From Baseline in Interleukin-5 (IL-5) Concentration From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
NCT01193049 (8) [back to overview]Geometric Mean Fold Change From Baseline in Macrophage Inflammatory Protein-1β (MIP-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
NCT01193049 (8) [back to overview]Geometric Mean Fold Change From Baseline in RNA Expression for Genes Encoding IL-5 and IL-13 From Sputum at 7 Hours Post-allergen Challenge
NCT01193049 (8) [back to overview]Geometric Mean Fold Change From Baseline in Thymus and Activation Regulated Chemokine (TARC) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge
NCT01193244 (23) [back to overview]Time to Deterioration in Global Health Status
NCT01193244 (23) [back to overview]Time to Docetaxel Chemotherapy
NCT01193244 (23) [back to overview]Time to Pain Progression
NCT01193244 (23) [back to overview]Time to PSA Progression
NCT01193244 (23) [back to overview]Time to SRE
NCT01193244 (23) [back to overview]Overall Survival
NCT01193244 (23) [back to overview]Time to Subsequent Antineoplastic Therapy
NCT01193244 (23) [back to overview]Worst Change From Baseline Over Time in Cardiac Ejection Fraction
NCT01193244 (23) [back to overview]Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
NCT01193244 (23) [back to overview]Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Coagulation
NCT01193244 (23) [back to overview]Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings
NCT01193244 (23) [back to overview]Radiographic Progression-free Survival (rPFS)
NCT01193244 (23) [back to overview]Percentage of Participants Achieving 90 Percent Reduction From Baseline in Prostate Specific Antigen (PSA90 Response) at Week 12
NCT01193244 (23) [back to overview]Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50) Response at Week 12
NCT01193244 (23) [back to overview]Percentage of Participants With Favorable Circulating Tumor Cell Count (CTC) Levels at Week 12
NCT01193244 (23) [back to overview]Percentage of Participants With Objective Response
NCT01193244 (23) [back to overview]Number of Participants With TEAEs Related to Vital Signs
NCT01193244 (23) [back to overview]Percentage of Participants With Skeletal Related Events (SRE)
NCT01193244 (23) [back to overview]Percentage of Participants Achieving PSA50 Response at Any Time During the Study
NCT01193244 (23) [back to overview]Percentage of Participants Achieving PSA90 Response at Any Time During the Study
NCT01193244 (23) [back to overview]Number of Participants With TEAEs Related to Weight
NCT01193244 (23) [back to overview]Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to (>=) Grade 3
NCT01193244 (23) [back to overview]Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status
NCT01193257 (21) [back to overview]Time to Pain Progression
NCT01193257 (21) [back to overview]Radiographic Progression-free Survival (rPFS)
NCT01193257 (21) [back to overview]Time to Pain Response
NCT01193257 (21) [back to overview]Time to PSA Progression
NCT01193257 (21) [back to overview]Percentage of Participants With Pain Response at Week 12
NCT01193257 (21) [back to overview]Number of Participants With Shifts From Baseline Between Favorable and Unfavorable Categories in Circulating Tumor Cell Count (CTC)
NCT01193257 (21) [back to overview]Number of Participants With TEAEs Related to Vital Signs
NCT01193257 (21) [back to overview]Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings
NCT01193257 (21) [back to overview]Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
NCT01193257 (21) [back to overview]Percentage of Participants With Objective Response
NCT01193257 (21) [back to overview]Number of Participants With TEAEs Related to Weight
NCT01193257 (21) [back to overview]Percentage of Participants Achieving 90 Percent Reduction From Baseline in Prostate Specific Antigen (PSA90 Response) at Week 12
NCT01193257 (21) [back to overview]Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status
NCT01193257 (21) [back to overview]Number of Participants With Abnormal Physical Examination Findings
NCT01193257 (21) [back to overview]Overall Survival
NCT01193257 (21) [back to overview]Percentage of Participants With Health-related Quality of Life (HRQOL) Response at Week 12
NCT01193257 (21) [back to overview]Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50 Response) at Week 12
NCT01193257 (21) [back to overview]Percentage of Participants Achieving PSA50 Response at Any Time During the Study
NCT01193257 (21) [back to overview]Percentage of Participants Achieving PSA90 Response at Any Time During the Study
NCT01193257 (21) [back to overview]Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Steroid Hormone Panel
NCT01193257 (21) [back to overview]Number of Participants With Best Pain Response
NCT01193842 (14) [back to overview]Tumor Response (Phase I)
NCT01193842 (14) [back to overview]Pharmacokinetic Clearance (Phase I)
NCT01193842 (14) [back to overview]Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II)
NCT01193842 (14) [back to overview]Changes in Human Immunodeficiency Virus (HIV) Viral Load
NCT01193842 (14) [back to overview]Changes in Absolute CD4 Cell Counts (Phase I)
NCT01193842 (14) [back to overview]Change in Plasma Associated Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (Phase I)
NCT01193842 (14) [back to overview]Change in CD8 Cell Counts (Phase I)
NCT01193842 (14) [back to overview]Event-free Survival (EFS) (Phase II)
NCT01193842 (14) [back to overview]Overall Survival (OS) (Phase II)
NCT01193842 (14) [back to overview]Recommended Phase II Dose of Vorinostat Determined According to Dose-limiting Toxicities Graded Using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase I)
NCT01193842 (14) [back to overview]Percentage of Participants With Complete Response (CR) as Assessed by Response Evaluation Criteria in Solid Tumors (Phase II)
NCT01193842 (14) [back to overview]Changes in Human Herpes Virus (HHV)-8 Viral Load
NCT01193842 (14) [back to overview]Changes in Human Herpes Virus (HHV)-8 Viral Load
NCT01193842 (14) [back to overview]Changes in Epstein-Barr Virus (EBV) Viral Load
NCT01200758 (26) [back to overview]Stage I and II (Pooled): Event-Free Survival Assessed Using International Working Group Response Criteria for NHL
NCT01200758 (26) [back to overview]Percentage of Participants Who Died
NCT01200758 (26) [back to overview]Stage I and II (Pooled): Percentage of Participants With Disease Progression/Relapse or Death
NCT01200758 (26) [back to overview]Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL
NCT01200758 (26) [back to overview]Stage I and II (Pooled): Percentage of Participants With Disease Progression/Relapse, New Anti-Lymphoma Treatment or Death Assessed Using International Working Group Response Criteria for NHL
NCT01200758 (26) [back to overview]Overall Survival (OS)
NCT01200758 (26) [back to overview]Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL
NCT01200758 (26) [back to overview]Percentage of Responses Who Showed Rituximab SC Formulation Convenient as Compared to Rituximab IV Formulation as Assessed by Physician/Nurse Opinion
NCT01200758 (26) [back to overview]Percentage of Participants With B-Cell Depletion by Cycle for Maintenance Phase
NCT01200758 (26) [back to overview]Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
NCT01200758 (26) [back to overview]Percentage of Participants With B-Cell Depletion by Cycle for Induction Phase
NCT01200758 (26) [back to overview]Stage II: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for Non-Hodgkin Lymphoma (NHL)
NCT01200758 (26) [back to overview]Stage II: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
NCT01200758 (26) [back to overview]Stage I: Observed Area Under the Serum Concentration-Time Curve (AUC) of Rituximab
NCT01200758 (26) [back to overview]Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
NCT01200758 (26) [back to overview]Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab
NCT01200758 (26) [back to overview]Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Human Antibodies (HAHAs) to Rituximab
NCT01200758 (26) [back to overview]Stage I and II (Pooled): Ctrough of Rituximab at Each Induction Treatment Cycle
NCT01200758 (26) [back to overview]Stage I: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
NCT01200758 (26) [back to overview]Stage I: Maximum Serum Concentrations (Cmax) of IV and SC Rituximab
NCT01200758 (26) [back to overview]Stage I and II (Pooled): Progression-Free Survival (PFS) Assessed Using International Working Group Response Criteria for NHL
NCT01200758 (26) [back to overview]Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL
NCT01200758 (26) [back to overview]Stage I and II (Pooled): Rituximab Levels 12 Weeks, 24 Weeks, and 36 Weeks After the Last Rituximab Administration
NCT01200758 (26) [back to overview]Stage I and II (Pooled): Percentage of Responses Showing Time Saved of Staff as Per Physician/Nurse Opinions With Each Administration of Rituximab SC as Compared to Rituximab IV at the End of Cy 8, 15 and 20
NCT01200758 (26) [back to overview]Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Chimeric Antibodies (HACAs) to Rituximab
NCT01200758 (26) [back to overview]Stage I and II (Pooled): Ctrough of Rituximab at Each Maintenance Treatment Cycle
NCT01204710 (11) [back to overview]OS Based on Baseline CTC Counts
NCT01204710 (11) [back to overview]Progression-Free Survival (PFS)
NCT01204710 (11) [back to overview]Number of Participants Who Died During Study
NCT01204710 (11) [back to overview]Number of Participants With Negative Platelet-Derived Growth Factor Receptor Alpha (PDGFRα) Protein Expression by Immunohistochemistry (IHC)
NCT01204710 (11) [back to overview]Summary Listing of Participants Reporting Treatment-Emergent Adverse Events (TEAE)
NCT01204710 (11) [back to overview]Overall Survival (OS)
NCT01204710 (11) [back to overview]Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
NCT01204710 (11) [back to overview]Percentage of Participants With Anti-Olaratumab Antibody Assessment (Immunogenicity)
NCT01204710 (11) [back to overview]PFS Based on Baseline Circulating Tumor Cells (CTC) Counts
NCT01204710 (11) [back to overview]Percentage of Participants With a ≥30% Decrease in PSA From Pretreatment to Week 12
NCT01204710 (11) [back to overview]Percentage of Participants With a ≥50% Decrease in Prostate Specific Androgen (PSA) From Pretreatment to Any Time
NCT01206452 (5) [back to overview]Inflammatory Cytokine Response to Ablation Procedure
NCT01206452 (5) [back to overview]Number of Participants With Atrial Fibrillation Recurrence From 6 Months up to 12 Months
NCT01206452 (5) [back to overview]Number of Participants With Atrial Fibrillation Recurrence From 0 Months up to 3 Months
NCT01206452 (5) [back to overview]Number of Participants With Atrial Fibrillation Recurrence From 3 Months up to 6 Months
NCT01206452 (5) [back to overview]Inflammatory Cytokine Response to Ablation Procedure
NCT01235689 (31) [back to overview]Percentage of Participants With Endoscopic Response 48 Weeks After Randomization
NCT01235689 (31) [back to overview]Change From Baseline in CDAI Over Time
NCT01235689 (31) [back to overview]Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Over Time
NCT01235689 (31) [back to overview]Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores
NCT01235689 (31) [back to overview]Change From Baseline in Work Productivity Activity Index - Crohn's Disease (WPAI:CD)
NCT01235689 (31) [back to overview]Percentage of Participants in Clinical Remission Over Time
NCT01235689 (31) [back to overview]Percentage of Participants in Steroid-free Remission Over Time
NCT01235689 (31) [back to overview]Percentage of Participants With Complete Mucosal Healing 48 Weeks After Randomization
NCT01235689 (31) [back to overview]Percentage of Participants in Deep Remission 48 Weeks After Randomization
NCT01235689 (31) [back to overview]Percentage of Participants in Biologic Remission 48 Weeks After Randomization
NCT01235689 (31) [back to overview]Percentage of Participants With Mucosal Healing 48 Weeks After Randomization
NCT01235689 (31) [back to overview]Percentage of Participants With Mucosal Healing and CDEIS < 4 in Every Segment 48 Weeks After Randomization
NCT01235689 (31) [back to overview]Percentage of Participants With Mucosal Healing and No Deep Ulcerations
NCT01235689 (31) [back to overview]Number of Major Crohn's Disease-related Surgeries After Randomization
NCT01235689 (31) [back to overview]Number of Crohn's Disease-related Surgical Procedures After Randomization
NCT01235689 (31) [back to overview]Number of Crohn's Disease-related Hospitalizations Due to Emergency
NCT01235689 (31) [back to overview]Number of Crohn's Disease-related Hospitalizations After Randomization
NCT01235689 (31) [back to overview]Number of All-cause Hospitalizations After Randomization
NCT01235689 (31) [back to overview]Change From Baseline in Quality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
NCT01235689 (31) [back to overview]Change From Baseline in Patient Health Questionnaire - 9 (PHQ9)
NCT01235689 (31) [back to overview]Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
NCT01235689 (31) [back to overview]Change From Baseline in CDEIS at 48 Weeks After Randomization
NCT01235689 (31) [back to overview]Time to All-cause Hospitalization
NCT01235689 (31) [back to overview]Time to Clinical Remission
NCT01235689 (31) [back to overview]Time to Crohn's Disease Flare
NCT01235689 (31) [back to overview]Time to Crohn's Disease-related Hospitalization Due to Emergency
NCT01235689 (31) [back to overview]Time to Crohn's Disease-related Hospitalization or Hospitalization Due to Adverse Event Relating to Study Medication
NCT01235689 (31) [back to overview]Time to Steroid-free Remission
NCT01235689 (31) [back to overview]Total Dose of Prednisone
NCT01235689 (31) [back to overview]Total Length of Stay in Hospital for All-cause Hospitalizations
NCT01235689 (31) [back to overview]Total Length of Stay in Hospital for Crohn's Disease-related Hospitalizations
NCT01287741 (18) [back to overview]Duration of Response (DOR), Investigator-Assessed
NCT01287741 (18) [back to overview]Median Time to Overall Survival (OS)
NCT01287741 (18) [back to overview]Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
NCT01287741 (18) [back to overview]Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
NCT01287741 (18) [back to overview]Time to Next Anti-Lymphoma Treatment (TTNALT)
NCT01287741 (18) [back to overview]Overall Response Rate (ORR), IRC-Assessed
NCT01287741 (18) [back to overview]Median Time to Progression-Free Survival (PFS), Investigator-Assessed
NCT01287741 (18) [back to overview]Percentage of Participants With Adverse Events (AEs)
NCT01287741 (18) [back to overview]Median Time to Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed
NCT01287741 (18) [back to overview]Overall Response Rate (ORR), Investigator-Assessed
NCT01287741 (18) [back to overview]Complete Response (CR) at the End of Treatment, IRC-Assessed
NCT01287741 (18) [back to overview]Complete Response (CR) at the End of Treatment, Investigator-Assessed
NCT01287741 (18) [back to overview]Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score
NCT01287741 (18) [back to overview]Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
NCT01287741 (18) [back to overview]Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score
NCT01287741 (18) [back to overview]Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
NCT01287741 (18) [back to overview]Median Time to Event-Free Survival (EFS), Investigator-Assessed
NCT01287741 (18) [back to overview]Median Time to Disease-Free Survival (DFS), Investigator-Assessed
NCT01308567 (11) [back to overview]Time to Prostate Serum Antigen Progression Free Survival (PSA-PFS)
NCT01308567 (11) [back to overview]Time to Tumor Progression Free Survival
NCT01308567 (11) [back to overview]Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score as a Measure of Health Related Quality of Life (HRQoL)
NCT01308567 (11) [back to overview]Percentage of Participants With PSA Response
NCT01308567 (11) [back to overview]Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of HRQoL
NCT01308567 (11) [back to overview]Time to Pain Progression Free Survival (Pain PFS)
NCT01308567 (11) [back to overview]Percentage of Participants With Pain Response
NCT01308567 (11) [back to overview]Percentage of Participants With Overall Objective Tumor Response
NCT01308567 (11) [back to overview]Overall Survival (OS)
NCT01308567 (11) [back to overview]Progression Free Survival (PFS)
NCT01308567 (11) [back to overview]Skeletal Related Events (SRE) Free Survival
NCT01308580 (18) [back to overview]Percentage of Participants With FACT-P Total Score Response
NCT01308580 (18) [back to overview]Plasma Clearance (CL) for Cabazitaxel
NCT01308580 (18) [back to overview]Plasma Steady State Volume of Distribution (Vss) for Cabazitaxel
NCT01308580 (18) [back to overview]Progression Free Survival (PFS)
NCT01308580 (18) [back to overview]Time to Definitive Deterioration of ECOG PS Score From Baseline
NCT01308580 (18) [back to overview]Time to First Definitive Consumption of Narcotic Medication
NCT01308580 (18) [back to overview]Time to Pain Progression
NCT01308580 (18) [back to overview]Time to PSA Progression
NCT01308580 (18) [back to overview]Time to Tumor Progression
NCT01308580 (18) [back to overview]Percentage of Participants With Pain Response
NCT01308580 (18) [back to overview]Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
NCT01308580 (18) [back to overview]Time to Definitive Weight Loss by 5% and 10% From Baseline
NCT01308580 (18) [back to overview]Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of Health Related Quality of Life (HRQoL)
NCT01308580 (18) [back to overview]Time to Definitive Deterioration of Score by 10% From Baseline on FACT-P Sub-Scales
NCT01308580 (18) [back to overview]Overall Survival (OS)
NCT01308580 (18) [back to overview]Change From Baseline in FACT-P:Total Score as a Measure of HRQoL
NCT01308580 (18) [back to overview]Percentage of Participants With PSA Response
NCT01308580 (18) [back to overview]Percentage of Participants With Overall Objective Tumor Response
NCT01309672 (5) [back to overview]Overall Survival
NCT01309672 (5) [back to overview]Number of Patients With Toxicity of Abiraterone Acetate
NCT01309672 (5) [back to overview]Number of Patients With PSA Partial Response
NCT01309672 (5) [back to overview]Number of Patients With Undetectable PSA
NCT01309672 (5) [back to overview]Objective Progression-free Survival
NCT01314118 (4) [back to overview]Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) Levels After 3 Cycles of Treatment
NCT01314118 (4) [back to overview]Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) During the Core Study
NCT01314118 (4) [back to overview]Time to Radiographic Evidence of Disease Progression (TTRP)
NCT01314118 (4) [back to overview]Time to Prostate-Specific Antigen (PSA) Progression
NCT01332097 (2) [back to overview]Rolling Average Improvement From Day 1 to Day 29 Using the EXACT-PRO 14 Point Patient Reported Outcome Measure: EXACT-PRO
NCT01332097 (2) [back to overview]Change in FEV1 From Baseline to Day 5 or Baseline to Day 10 Measure: FEV1 Change in Forced Expiry Volume in 1 Second
NCT01332968 (32) [back to overview]Overall Survival (Follicular Lymphoma Population)
NCT01332968 (32) [back to overview]Event-Free Survival (Overall Study Population)
NCT01332968 (32) [back to overview]Overall Survival (Overall Study Population)
NCT01332968 (32) [back to overview]Disease-Free Survival (Follicular Lymphoma Population)
NCT01332968 (32) [back to overview]Percentage of Participants With Adverse Events
NCT01332968 (32) [back to overview]Overall Response (Overall Study Population), IRC-Assessed
NCT01332968 (32) [back to overview]Overall Response (Overall Study Population), Investigator-Assessed
NCT01332968 (32) [back to overview]Overall Response (Follicular Lymphoma Population), IRC-Assessed
NCT01332968 (32) [back to overview]Overall Response (Follicular Lymphoma Population), Investigator-Assessed
NCT01332968 (32) [back to overview]Complete Response (Overall Study Population), IRC-Assessed
NCT01332968 (32) [back to overview]Complete Response (Overall Study Population), Investigator-Assessed
NCT01332968 (32) [back to overview]Complete Response (Follicular Lymphoma Population), IRC-Assessed
NCT01332968 (32) [back to overview]Complete Response (Follicular Lymphoma Population), Investigator-Assessed
NCT01332968 (32) [back to overview]Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population)
NCT01332968 (32) [back to overview]Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population)
NCT01332968 (32) [back to overview]Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population)
NCT01332968 (32) [back to overview]Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase
NCT01332968 (32) [back to overview]Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase
NCT01332968 (32) [back to overview]Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase
NCT01332968 (32) [back to overview]Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Follow Up Phase
NCT01332968 (32) [back to overview]Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population)
NCT01332968 (32) [back to overview]Time to Next Anti-Lymphoma Treatment (Overall Study Population)
NCT01332968 (32) [back to overview]Time to Next Anti-Lymphoma Treatment (Follicular Lymphoma Population)
NCT01332968 (32) [back to overview]Progression-Free Survival in the Overall Study Population, Investigator-Assessed
NCT01332968 (32) [back to overview]Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed
NCT01332968 (32) [back to overview]Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC)
NCT01332968 (32) [back to overview]Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed
NCT01332968 (32) [back to overview]Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed
NCT01332968 (32) [back to overview]Duration of Response (DOR) (Follicular Lymphoma Population), Investigator-Assessed
NCT01332968 (32) [back to overview]Duration of Response (DOR) (Overall Study Population), Investigator-Assessed
NCT01332968 (32) [back to overview]Event-Free Survival (Follicular Lymphoma Population)
NCT01332968 (32) [back to overview]Disease-Free Survival (Overall Study Population)
NCT01335685 (27) [back to overview]Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Ixazomib (Phase 1)
NCT01335685 (27) [back to overview]Overall Response Rate (ORR)
NCT01335685 (27) [back to overview]Overall Survival (Phase 2)
NCT01335685 (27) [back to overview]Progression Free Survival (Phase 2)
NCT01335685 (27) [back to overview]Time to First Response (Phase 2)
NCT01335685 (27) [back to overview]Time to Progression (TTP) (Phase 2)
NCT01335685 (27) [back to overview]Very Good Partial Response (VGPR) or Better Response Rate (Phase 2)
NCT01335685 (27) [back to overview]AUCtau: Area Under the Plasma Concentration-time Curve Over the Dosing Interval for Ixazomib (Phase 1)
NCT01335685 (27) [back to overview]AUCtau: Area Under the Plasma Concentration-time Curve Over the Dosing Interval for Ixazomib (Phase 1)
NCT01335685 (27) [back to overview]Cmax: Maximum Observed Plasma Concentration for Ixazomib (Phase 1)
NCT01335685 (27) [back to overview]Cmax: Maximum Observed Plasma Concentration for Ixazomib (Phase 1)
NCT01335685 (27) [back to overview]Cmax: Maximum Observed Plasma Concentration for Ixazomib (Phase 1)
NCT01335685 (27) [back to overview]Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
NCT01335685 (27) [back to overview]Observed Accumulation Ratio for AUCtau (Rac) (Phase 1)
NCT01335685 (27) [back to overview]Observed Accumulation Ratio for AUCtau (Rac) (Phase 1)
NCT01335685 (27) [back to overview]Observed Accumulation Ratio for AUCtau (Rac) (Phase 1)
NCT01335685 (27) [back to overview]Terminal Elimination Rate Constant (λz) for Ixazomib (Phase 1)
NCT01335685 (27) [back to overview]Terminal Elimination Rate Constant (λz) for Ixazomib (Phase 1)
NCT01335685 (27) [back to overview]Terminal Elimination Rate Constant (λz) for Ixazomib (Phase 1)
NCT01335685 (27) [back to overview]Terminal Phase Elimination Half-life (T1/2) for Ixazomib (Phase 1)
NCT01335685 (27) [back to overview]Terminal Phase Elimination Half-life (T1/2) for Ixazomib (Phase 1)
NCT01335685 (27) [back to overview]Terminal Phase Elimination Half-life (T1/2) for Ixazomib (Phase 1)
NCT01335685 (27) [back to overview]Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib (Phase 1)
NCT01335685 (27) [back to overview]Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib (Phase 1)
NCT01335685 (27) [back to overview]AUCtau: Area Under the Plasma Concentration-time Curve Over the Dosing Interval for Ixazomib (Phase 1)
NCT01335685 (27) [back to overview]Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib (Phase 1)
NCT01335685 (27) [back to overview]Duration of Response (DOR) (Phase 2)
NCT01336933 (6) [back to overview]Complete Response Rate of Cyclophosphamide, Etoposide, Vincristine and Prednisone (CEOP) and Pralatrexate (P) Treatment
NCT01336933 (6) [back to overview]Event Free Survival (EFS)
NCT01336933 (6) [back to overview]Overall Response Rates (ORR)= (Complete Response Rates (CR) + Partial Response Rates (PR))
NCT01336933 (6) [back to overview]To Evaluate the Safety and Tolerability of the Regimen by the Percent of Participants With Indicated Adverse Events
NCT01336933 (6) [back to overview]Percent of Patients Who Proceeded With Transplant
NCT01336933 (6) [back to overview]Overall Survival (OS)
NCT01359592 (4) [back to overview]Overall Survival of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL)
NCT01359592 (4) [back to overview]Five-year Progression-free Survival (PFS) Rate in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma (DLBCL)
NCT01359592 (4) [back to overview]Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
NCT01359592 (4) [back to overview]Progression-free Survival (PFS) Within the PET+ and PET- Subgroups of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL)
NCT01364389 (16) [back to overview]Polymyalgia Rheumatica Activity Score (PMR-AS)
NCT01364389 (16) [back to overview]Effect on Health-related Quality of Life Via the Health Assessment Questionnaire (HAQ) - % Change From Baseline in the Standard Disability Score at EOS / Month 6
NCT01364389 (16) [back to overview]Mean Steroid Dose Over a 6 Month Period
NCT01364389 (16) [back to overview]Number of Flares Over a 6 Month Period
NCT01364389 (16) [back to overview]Pharmacokinetics of AIN457 and ACZ885 - CL
NCT01364389 (16) [back to overview]Time to Complete Clinical Response
NCT01364389 (16) [back to overview]Pharmacokinetics of AIN457 and ACZ885 - T1/2
NCT01364389 (16) [back to overview]Pharmacokinetics of AIN457 and ACZ885 - Tmax
NCT01364389 (16) [back to overview]Pharmacokinetics of AIN457 and ACZ885 - AUCinf and AUClast
NCT01364389 (16) [back to overview]Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Deaths
NCT01364389 (16) [back to overview]Effect on Health-related Quality of Life Via the Short Form-36 (SF-36) Questionnaire
NCT01364389 (16) [back to overview]Effect on Health-related Quality of Life Via the Health Assessment Questionnaire (HAQ)
NCT01364389 (16) [back to overview]Pharmacokinetics of AIN457 and ACZ885 - Vz
NCT01364389 (16) [back to overview]Time to First Flare
NCT01364389 (16) [back to overview]Time to Partial Clinical Response
NCT01364389 (16) [back to overview]Pharmacokinetics of AIN457 and ACZ885 - Cmax
NCT01369745 (1) [back to overview]Change From Baseline in DAS28-CRP at 12 Weeks
NCT01375140 (1) [back to overview]Participants With Objective Response
NCT01381874 (7) [back to overview]Change From Baseline in Serum Endocrine Biomarkers (Estradiol and Estrone) at End of Treatment
NCT01381874 (7) [back to overview]Progression-Free Survival (PFS)
NCT01381874 (7) [back to overview]Overall Survival (OS)
NCT01381874 (7) [back to overview]Overall Response Rate (ORR)
NCT01381874 (7) [back to overview]Duration of Response
NCT01381874 (7) [back to overview]Clinical Benefit Rate
NCT01381874 (7) [back to overview]Change From Baseline in Serum Endocrine Biomarkers (Progesterone and Testosterone) at End of Treatment
NCT01390584 (5) [back to overview]Progression-free Survival Rate
NCT01390584 (5) [back to overview]Overall Survival
NCT01390584 (5) [back to overview]Proportion of Patients Who Are PET Negative After Induction Treatment
NCT01390584 (5) [back to overview]Progression-free Survival at 36 Months Among Patients Who Are PET Positive After Induction Treatment
NCT01390584 (5) [back to overview]Complete Response (CR) Rate After Induction Treatment
NCT01393730 (8) [back to overview]Best Overall Response
NCT01393730 (8) [back to overview]Change in Serum Androgen Levels
NCT01393730 (8) [back to overview]Change in Serum Levels of Testosterone
NCT01393730 (8) [back to overview]Number of Participants With Androgen Receptor (AR) Related Mutations
NCT01393730 (8) [back to overview]Presence of AR Amplification
NCT01393730 (8) [back to overview]Prostate-Specific Antigen (PSA) Response
NCT01393730 (8) [back to overview]Time to Progression (TTP)
NCT01393730 (8) [back to overview]Time to PSA Progression
NCT01414855 (13) [back to overview]Pharmacokinetics: Terminal Half-Life (t1/2) for Obinutuzumab
NCT01414855 (13) [back to overview]Pharmacokinetics: Volume of Distribution (V) for Obinutuzumab
NCT01414855 (13) [back to overview]Complete Response (CR) Rate as Assessed by the Investigator at the End of Treatment
NCT01414855 (13) [back to overview]Complete Response (CR) Rate as Assessed by the Independent Review Facility (IRF) at the End of Treatment
NCT01414855 (13) [back to overview]Duration of Response (DOR)
NCT01414855 (13) [back to overview]Overall Response Rate (ORR) as Assessed by the Investigator at the End of Treatment
NCT01414855 (13) [back to overview]Overall Response Rate (ORR) as Assessed by the IRF at the End of Treatment
NCT01414855 (13) [back to overview]Percentage of Participants With Adverse Events as a Measure of Safety
NCT01414855 (13) [back to overview]Progression-Free Survival (PFS) as Assessed by the Investigator
NCT01414855 (13) [back to overview]Number of Participants With Grade 3 to 4 Infusion-Related (IRR) Adverse Events (AE) in Participants Receiving Shorter Duration Infusion (SDI)
NCT01414855 (13) [back to overview]Pharmacokinetics (PK): Maximum Concentration Observed (Cmax) for Obinutuzumab
NCT01414855 (13) [back to overview]Pharmacokinetics: Area Under the Concentration-Time Curve 7 Day (AUC7day)
NCT01414855 (13) [back to overview]Pharmacokinetics: Clearance (Cl) for Obinutuzumab
NCT01424930 (4) [back to overview]Number of Participants With Grade 3 or Higher Adverse Events (AEs) of Special Interest or Grade 3 or Higher Serious AEs Due to Study Medication
NCT01424930 (4) [back to overview]Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)
NCT01424930 (4) [back to overview]Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone
NCT01424930 (4) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Abiraterone
NCT01445535 (6) [back to overview]Overall Progression Free Survival (PFS)
NCT01445535 (6) [back to overview]Number of Participants With Serious and Non-serious Adverse Events
NCT01445535 (6) [back to overview]Number of Dose-Limiting Toxicities (DLT)
NCT01445535 (6) [back to overview]Number of Participants With a Response to Therapy
NCT01445535 (6) [back to overview]Maximum Tolerated Dose (MTD) of Siplizumab
NCT01445535 (6) [back to overview]Overall Survival (OS)
NCT01451515 (4) [back to overview]Probability of Event-free Survival (EFS)
NCT01451515 (4) [back to overview]Probability of Overall Survival (OS)
NCT01451515 (4) [back to overview]Minimal Residual Disease (MRD)
NCT01451515 (4) [back to overview]Minimal Disseminated Disease (MDD)
NCT01464164 (2) [back to overview]Number of Participants With Complete Response and Partial Response
NCT01464164 (2) [back to overview]Severe Adverse Events Attributable to Study Drug
NCT01468532 (9) [back to overview]Maximum Tolerated Dose (MTD) of Pasireotide in Combination With Docetaxel and Prednisone by the Occurrence of Adverse Events and the Associated Grade Per NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
NCT01468532 (9) [back to overview]The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
NCT01468532 (9) [back to overview]Pharmacokinetics (PK) of SOM230
NCT01468532 (9) [back to overview]Percentage Prostate-specific Antigen (PSA) Change Noted
NCT01468532 (9) [back to overview]Measurements of CTC Counts, the Change Between Time-points Pre-therapy, Post-therapy
NCT01468532 (9) [back to overview]Measurement of Levels of IGF-1, Serum Chromogranin A (SCA), and Neuron Specific Enolase (NSE), the Change Between Time Points Pre-therapy, Post-therapy
NCT01468532 (9) [back to overview]Time to Progression (TTP)
NCT01468532 (9) [back to overview]Overall Survival (OS)
NCT01468532 (9) [back to overview]Measurements of Tumor Using Response Evaluation Criteria In Solid Tumors (RECIST) Criteria Before and After Treatment With the Combination of Pasireotide in Combination With Docetaxel
NCT01471340 (3) [back to overview]Time-to-First Severe Asthma Exacerbation (SAEX): Number of First SAEX in the MF/F vs MF Arms
NCT01471340 (3) [back to overview]Number of SAO Components in MF/F Participants vs MF Participants
NCT01471340 (3) [back to overview]Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms
NCT01485861 (46) [back to overview]Phase II: Duration of Tumor Response in Participants With ICR PTEN Loss
NCT01485861 (46) [back to overview]Phase II: Overall Survival (ITT Population)
NCT01485861 (46) [back to overview]Phase II: Overall Survival in Participants With ICR IHC PTEN Loss
NCT01485861 (46) [back to overview]Phase II: Percentage of Participants With Adverse Events (AEs)
NCT01485861 (46) [back to overview]Phase II: Percentage of Participants With Circulating Tumor Cells (CTC) Reduction Response (ITT Population)
NCT01485861 (46) [back to overview]Phase II: Percentage of Participants With CTC Conversion (ITT Population)
NCT01485861 (46) [back to overview]Phase II: Percentage of Participants With CTC Conversion in Participants With ICR PTEN Loss
NCT01485861 (46) [back to overview]Phase II: Percentage of Participants With CTC Reduction Response in Participants With ICR PTEN Loss
NCT01485861 (46) [back to overview]Phase II: Percentage of Participants With Objective Response (ITT Population)
NCT01485861 (46) [back to overview]Phase II: Percentage of Participants With Objective Response in Participants With ICR PTEN Loss
NCT01485861 (46) [back to overview]Phase II: Percentage of Participants With Pain Progression (ITT Population)
NCT01485861 (46) [back to overview]Phase II: Percentage of Participants With Pain Progression in Participants With ICR PTEN Loss
NCT01485861 (46) [back to overview]Phase II: Percentage of Participants With PSA Progression (ITT Population)
NCT01485861 (46) [back to overview]Phase II: Percentage of Participants With PSA Progression in Participants With ICR PTEN Loss
NCT01485861 (46) [back to overview]Phase II: Percentage of Participants With PSA Response (ITT Population)
NCT01485861 (46) [back to overview]Phase II: Percentage of Participants With PSA Response in Participants With ICR PTEN Loss
NCT01485861 (46) [back to overview]Phase II: Radiographic Progression Free Survival (rPFS) (Intent-To-Treat [ITT] Population)
NCT01485861 (46) [back to overview]Phase II: rPFS in Participants With Institute of Cancer Research (ICR) Phosphatase and Tensin Homolog (PTEN) Loss
NCT01485861 (46) [back to overview]Phase II: Time to Pain Progression (ITT Population)
NCT01485861 (46) [back to overview]Phase II: Time to Pain Progression in Participants With ICR PTEN Loss
NCT01485861 (46) [back to overview]Phase II: Time to PSA Progression (ITT Population)
NCT01485861 (46) [back to overview]Phase II: Time to PSA Progression in Participants With ICR PTEN Loss
NCT01485861 (46) [back to overview]Phase Ib: Area Under The Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of Ipatasertib When Co-Administered With Abiraterone
NCT01485861 (46) [back to overview]Phase Ib: AUC0-24 of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
NCT01485861 (46) [back to overview]Phase Ib: AUC0-24 of Apitolisib When Co-Administered With Abiraterone
NCT01485861 (46) [back to overview]Phase Ib: AUC0-24 of G-037720 (Metabolite of Ipatasertib)
NCT01485861 (46) [back to overview]Phase Ib: Cmax of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
NCT01485861 (46) [back to overview]Phase Ib: Cmax of Apitolisib When Co-Administered With Abiraterone
NCT01485861 (46) [back to overview]Phase Ib: Cmax of G-037720 (Metabolite of Ipatasertib)
NCT01485861 (46) [back to overview]Phase Ib: Maximum Plasma Concentration (Cmax) of Ipatasertib When Co-Administered With Abiraterone
NCT01485861 (46) [back to overview]Phase Ib: Plasma Half-Life of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
NCT01485861 (46) [back to overview]Phase Ib: Recommended Phase II Dose (RP2D) of Ipatasertib and Apitolisib
NCT01485861 (46) [back to overview]Phase Ib: Recommended Phase II Dose (RP2D) of Ipatasertib and Apitolisib
NCT01485861 (46) [back to overview]Phase Ib: Time to Cmax (Tmax) of Ipatasertib When Co-Administered With Abiraterone
NCT01485861 (46) [back to overview]Phase Ib: Tmax of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
NCT01485861 (46) [back to overview]Phase Ib: Tmax of Apitolisib When Co-Administered With Abiraterone
NCT01485861 (46) [back to overview]Phase Ib: Tmax of G-037720 (Metabolite of Ipatasertib)
NCT01485861 (46) [back to overview]Phase II: G-037720 (Metabolite of Ipatasertib) Plasma Concentrations
NCT01485861 (46) [back to overview]Phase II: Ipatasertib Plasma Concentrations When Co-Administered With Abiraterone
NCT01485861 (46) [back to overview]Phase Ib: Percentage of Participants With Dose-Limiting Toxicities (DLTs)
NCT01485861 (46) [back to overview]Phase Ib: Total Body Clearance (CL/F) of Ipatasertib When Co-Administered With Abiraterone
NCT01485861 (46) [back to overview]Phase II: Duration of Tumor Response (ITT Population)
NCT01485861 (46) [back to overview]Phase Ib: Accumulation Ratio of Abiraterone When Co-Administered With Ipatasertib or Apitolisib
NCT01485861 (46) [back to overview]Phase Ib: Accumulation Ratio of G-037720 (Metabolite of Ipatasertib)
NCT01485861 (46) [back to overview]Phase Ib: Accumulation Ratio of Ipatasertib When Co-Administered With Abiraterone
NCT01485861 (46) [back to overview]Phase Ib: Percentage of Participants With Adverse Events (AEs)
NCT01503229 (1) [back to overview]Change in Tissue Testosterone and Dihydrotestosterone
NCT01511536 (15) [back to overview]Phase 2: PSA Progression Free Survival
NCT01511536 (15) [back to overview]Phase 1: Maximally Tolerated Dose (MTD) of Cabazitaxel in Combination With Abiraterone Acetate
NCT01511536 (15) [back to overview]Phase 2: Objective Progression Free Survival (PFS)
NCT01511536 (15) [back to overview]Phase 2: Overall Survival
NCT01511536 (15) [back to overview]Phase 2: Percentage of Participants With Objective Response
NCT01511536 (15) [back to overview]Phase 2: Percentage of Participants With Prostate Specific Antigen (PSA) Response
NCT01511536 (15) [back to overview]Phase 2: Pharmacokinetic of Abiraterone : Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC 0-24)
NCT01511536 (15) [back to overview]Phase 2: Pharmacokinetic of Abiraterone : Concentration Observed Just Before Treatment Administration During Repeated Dosing at Steady State (Ctrough ss)
NCT01511536 (15) [back to overview]Phase 2: Pharmacokinetic of Abiraterone : First Time to Reach Cmax (Tmax)
NCT01511536 (15) [back to overview]Phase 2: Pharmacokinetic of Abiraterone : Maximum Plasma Concentration Observed (Cmax)
NCT01511536 (15) [back to overview]Phase 2: Pharmacokinetic of Cabazitaxel : Area Under the Plasma Concentration Versus Time Curve (AUC)
NCT01511536 (15) [back to overview]Phase 2: Pharmacokinetic of Cabazitaxel : Maximum Plasma Concentration Observed (Cmax)
NCT01511536 (15) [back to overview]Phase 2: Pharmacokinetic of Cabazitaxel : Terminal Half-life (t 1/2z)
NCT01511536 (15) [back to overview]Phase 2: Pharmacokinetic of Cabazitaxel : Total Plasma Clearance (CL)
NCT01511536 (15) [back to overview]Phase 2: Pharmacokinetic of Cabazitaxel : Volume of Distribution at Steady State (Vss)
NCT01517802 (1) [back to overview]Number of Participants With Serious Adverse Events (SAEs)
NCT01517984 (6) [back to overview]Percentage of Participants With New Donor Specific Antibodies (DSAs)
NCT01517984 (6) [back to overview]Estimated GFR Using the Chronic Kidney Disease Epidemiology (CKD-EPI) Equation
NCT01517984 (6) [back to overview]Incidence of Acute Rejection
NCT01517984 (6) [back to overview]Percentage of Participants in the Experimental Arm Off Tacrolimus
NCT01517984 (6) [back to overview]Participant Survival Rate
NCT01517984 (6) [back to overview]Allograft Survival Rate
NCT01522443 (3) [back to overview]Bone Scan Response (BSR)
NCT01522443 (3) [back to overview]Overall Survival (OS)
NCT01522443 (3) [back to overview]Pain Response at Week 6 Confirmed at Week 12, Week 12 Reported
NCT01524536 (9) [back to overview]Participants With Glucocorticoid Responsiveness - Cardiac Involvement
NCT01524536 (9) [back to overview]Participants With Glucocorticoid Responsiveness - LHES Variant
NCT01524536 (9) [back to overview]Participants With Glucocorticoid Responsiveness - Overlap HES Subtypes
NCT01524536 (9) [back to overview]Participants With Glucocorticoid Responsiveness - Pulmonary Involvement
NCT01524536 (9) [back to overview]Participants With Glucocorticoid Responsiveness - MHES Variant
NCT01524536 (9) [back to overview]Mean Baseline Absolute Eosinophil Count
NCT01524536 (9) [back to overview]Participants With Glucocorticoid Responsiveness - IHES Variant
NCT01524536 (9) [back to overview]Mean Percent Change in Eosinophil Count After Glucocorticoid Challenge
NCT01524536 (9) [back to overview]Mean Baseline IgE Level
NCT01536535 (3) [back to overview]Number of Participants Who Needed Additional Therapy or Colectomy
NCT01536535 (3) [back to overview]Number of Participants With Corticosteroid Free Remission (SFR)
NCT01536535 (3) [back to overview]Number of Participants Receiving a Colectomy
NCT01549951 (13) [back to overview]Number of Participants Reporting Change From Baseline in ECG Morphology
NCT01549951 (13) [back to overview]Number of Participants Reporting One or More Treatment-emergent Adverse Events
NCT01549951 (13) [back to overview]AUC(0-6): Area Under the Plasma Concentration-Time Curve From Time 0 to 6 Hours Postdose for Orteronel and M-I Metabolite
NCT01549951 (13) [back to overview]Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite
NCT01549951 (13) [back to overview]Maximum Change From Baseline in QTc Based on the Bazett Correction (QTcB) Method, PR, QRS and Uncorrected QT Interval
NCT01549951 (13) [back to overview]Number of Participants Reporting Clinically Significant Abnormalities in ECG
NCT01549951 (13) [back to overview]Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite
NCT01549951 (13) [back to overview]Maximum Change From Baseline in QTc Interval Based on the Fridericia Correction (QTcF) Method
NCT01549951 (13) [back to overview]Number of Participants Reporting Clinically Significant Abnormalities in Physical Findings
NCT01549951 (13) [back to overview]Number of Participants Reporting Clinically Significant Abnormalities in Vital Signs
NCT01549951 (13) [back to overview]Number of Participants Reporting Clinically Significant Abnormalities in Laboratory Values
NCT01549951 (13) [back to overview]Correlation Between the QTcF Change From Baseline and Plasma Concentrations of Orteronel
NCT01549951 (13) [back to overview]Changes From Baseline in Heart Rate
NCT01553188 (6) [back to overview]Radiographic Progression Free Survival
NCT01553188 (6) [back to overview]Progression Free Survival (PFS)
NCT01553188 (6) [back to overview]Overall Survival
NCT01553188 (6) [back to overview]Dose Limiting Toxicity (DLT)
NCT01553188 (6) [back to overview]Count of Participants With Serious and Non-serious Adverse Events
NCT01553188 (6) [back to overview]Maximum Tolerated Dose (MTD)
NCT01576172 (5) [back to overview]Rates of PSA Decline
NCT01576172 (5) [back to overview]Progression-free Survival (PFS)
NCT01576172 (5) [back to overview]Objective Response Rates in Patients With Measurable Disease.
NCT01576172 (5) [back to overview]Confirmed Prostate-specific Antigen (PSA) Response Rate
NCT01576172 (5) [back to overview]Grade 4 or 5 Adverse Events
NCT01603407 (17) [back to overview]Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction With Treatment Score
NCT01603407 (17) [back to overview]Rise From the Floor Velocity
NCT01603407 (17) [back to overview]Range of Motion (Goniometry) of Right Ankle
NCT01603407 (17) [back to overview]Range of Motion (Goniometry) of Left Ankle
NCT01603407 (17) [back to overview]Quality of Life- Child
NCT01603407 (17) [back to overview]Quality of Life - Parent
NCT01603407 (17) [back to overview]PR Interval
NCT01603407 (17) [back to overview]Participant Weight
NCT01603407 (17) [back to overview]Participant Height
NCT01603407 (17) [back to overview]Participant Body Mass Index
NCT01603407 (17) [back to overview]Number of Participants Who Tolerated the Regimen
NCT01603407 (17) [back to overview]North Star Ambulatory Assessment (NSAA) Score
NCT01603407 (17) [back to overview]Left Ventricular Ejection Fraction Percent
NCT01603407 (17) [back to overview]Heart Rate
NCT01603407 (17) [back to overview]Forced Vital Capacity
NCT01603407 (17) [back to overview]6 Minute Walk Test
NCT01603407 (17) [back to overview]Fractional Shortening Percent
NCT01605227 (3) [back to overview]Progression-free Survival (PFS)
NCT01605227 (3) [back to overview]Bone Scan Response (BSR)
NCT01605227 (3) [back to overview]Overall Survival (OS)
NCT01637402 (9) [back to overview]Comparison of Circulating Androstenedione Levels Between Primary-Resistant Patients and Responders
NCT01637402 (9) [back to overview]Comparison of Circulating DHEA-S Levels Between Primary-Resistant Patients and Responders
NCT01637402 (9) [back to overview]Comparison of Circulating Testosterone Levels Between Primary-Resistant Patients and Responders
NCT01637402 (9) [back to overview]Correlation of Circulating Dehydroepiandrosterone (DHEA) Levels From Baseline to Week 12
NCT01637402 (9) [back to overview]Number of Patients With PSA Response From Dose Escalation
NCT01637402 (9) [back to overview]Serum Concentration Levels of Abiraterone Acetate Over Time
NCT01637402 (9) [back to overview]Number of Participants With Worst-grade, Treatment-related Toxicities for Dose Escalation Group
NCT01637402 (9) [back to overview]Time to PSA Progression for Dose Escalation Cohort
NCT01637402 (9) [back to overview]Comparison of Circulating DHEA Levels Between Primary-Resistant and Responders
NCT01650194 (17) [back to overview]Change From Baseline to EoT in Bone Specific Alkaline Phosphatase
NCT01650194 (17) [back to overview]Change From Baseline in Progesterone Concentration in Blood
NCT01650194 (17) [back to overview]Change From Baseline in Pregnenolone in Bone Marrow Aspirate
NCT01650194 (17) [back to overview]Change From Baseline in Pregnenolone Concentration in Blood
NCT01650194 (17) [back to overview]Percentage of Participants With Objective Response for Soft Tissue Lesions According to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST)
NCT01650194 (17) [back to overview]Progression Free Survival (PFS)
NCT01650194 (17) [back to overview]Bone Scan Response at EoT
NCT01650194 (17) [back to overview]Change From Baseline in Cortisol in Bone Marrow Aspirate
NCT01650194 (17) [back to overview]Change From Baseline in Androstenedione Concentration in Blood
NCT01650194 (17) [back to overview]Change From Baseline in Cortisol Concentration in Blood
NCT01650194 (17) [back to overview]Change From Baseline to End-of-Treatment (EoT) in Prostate-Specific Antigen (PSA) Levels
NCT01650194 (17) [back to overview]Change From Baseline in Progesterone in Bone Marrow Aspirate
NCT01650194 (17) [back to overview]Change From Baseline in Testosterone Concentration in Blood
NCT01650194 (17) [back to overview]Change From Baseline in Testosterone Concentration in Bone Marrow Aspirate
NCT01650194 (17) [back to overview]Change From Baseline in Urine N-Telopeptide
NCT01650194 (17) [back to overview]Number of Participants With Adverse Events (AEs)
NCT01650194 (17) [back to overview]Change From Baseline in Androstenedione in Bone Marrow Aspirate
NCT01666314 (22) [back to overview]Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment
NCT01666314 (22) [back to overview]Percentage of Participants With Prostate-Specific Antigen Reduction ≥ 50% (PSA50) After 4 Weeks of Treatment
NCT01666314 (22) [back to overview]Absolute Values for Prostate-Specific Antigen (PSA)
NCT01666314 (22) [back to overview]AUC(0-12): Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours Post-dose for Orteronel and M-I Metabolite
NCT01666314 (22) [back to overview]AE (0-24) Cumulative Amount of Drug Excreted Into the Urine for Orteronel and MI-Metabolite
NCT01666314 (22) [back to overview]Absolute Values for Testosterone
NCT01666314 (22) [back to overview]Absolute Values for Dehydroepiandrosterone Sulfate (DHEA-S)
NCT01666314 (22) [back to overview]Absolute Values for Cortisol
NCT01666314 (22) [back to overview]Absolute Values for Corticosterone
NCT01666314 (22) [back to overview]Percent Change From Baseline in Serum Testosterone Level After 12 Weeks of Treatment
NCT01666314 (22) [back to overview]Absolute Values for Adrenocorticotropic Hormone (ACTH)
NCT01666314 (22) [back to overview]Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL in Ex-Japan
NCT01666314 (22) [back to overview]Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL After 4 Weeks of Treatment in Japan
NCT01666314 (22) [back to overview]Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite
NCT01666314 (22) [back to overview]Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax), Equal to Time (Hours) to Cmax at Steady State for Orteronel and M-I Metabolite
NCT01666314 (22) [back to overview]Rac: Accumulation Index for Orteronel and M-I Metabolite
NCT01666314 (22) [back to overview]Percentage of Participants With PSA50 After 12 Weeks of Treatment
NCT01666314 (22) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01666314 (22) [back to overview]Ctrough,ss: Observed Predose Plasma Concentration at Steady State for Orteronel and M-I Metabolite
NCT01666314 (22) [back to overview]Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite
NCT01666314 (22) [back to overview]Cmax,ss: Maximum Observed Plasma Concentration at Steady State for Orteronel and MI-Metabolite
NCT01666314 (22) [back to overview]AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Orteronel and M-I Metabolite
NCT01671423 (2) [back to overview]Amount of Pain Medication - Day 1 to 48 Hours
NCT01671423 (2) [back to overview]Visual Analog Scale(VAS) for Pain - Day 1 to 48 Hours
NCT01676415 (3) [back to overview]SNOT-22 Questionnaire
NCT01676415 (3) [back to overview]Medication Side-effect and Compliance Inventory
NCT01676415 (3) [back to overview]Taskforce Symptom Inventory
NCT01681433 (5) [back to overview]Time to Disease Progression
NCT01681433 (5) [back to overview]PSA Response
NCT01681433 (5) [back to overview]Objective Response
NCT01681433 (5) [back to overview]Circulating Tumor Cell (CTC) Counts
NCT01681433 (5) [back to overview]Progression-Free Survival
NCT01683994 (5) [back to overview]Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
NCT01683994 (5) [back to overview]Progression Free Survival (PFS) of Cabozantinib + Docetaxel + Prednisone Compared to Docetaxel + Prednisone Alone
NCT01683994 (5) [back to overview]Number of Participants Achieving Prostatic-Specific Antigen (PSA) Decline of 30% or 50% From Baseline
NCT01683994 (5) [back to overview]Number of Participants With a Dose Limiting Toxicities (DLTs)
NCT01683994 (5) [back to overview]Maximum Tolerated Dose (MTD)
NCT01687296 (8) [back to overview]Mean Global Evaluation for Efficacy by Participant/Parent and Investigator
NCT01687296 (8) [back to overview]Mean Evening PEF on Diary Card Over the Treatment Assessment Period
NCT01687296 (8) [back to overview]Mean Morning Peak Expiratory Flow (AM PEF) on Diary Card Over the Treatment Assessment Period in Intent-to-Treat (ITT) Population
NCT01687296 (8) [back to overview]Mean Morning PEF on Diary Card Over the Treatment Assessment Period in Per Protocol (PP) Population
NCT01687296 (8) [back to overview]Median Number of Use of Rescue Medications During Day and Night Over the Treatment Assessment Period
NCT01687296 (8) [back to overview]Clinical Assessment of Lung Function of Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) During the Treatment Period
NCT01687296 (8) [back to overview]Mean Change From Baseline in Clinical Scoring Index at Day 5 and Day 8
NCT01687296 (8) [back to overview]Median Day-time and Night-time Symptom Scores Over the Treatment Assessment Period
NCT01691508 (5) [back to overview]Number of Participants Who Achieved a Reduction of Their Daily OCS Dose to <=5.0 mg During Weeks 20 to 24 While Maintaining Asthma Control
NCT01691508 (5) [back to overview]Median Percentage Change From Baseline in Daily OCS Dose During Weeks 20 to 24 While Maintaining Asthma Control
NCT01691508 (5) [back to overview]Number of Participants Who Achieved a Reduction of >=50% in Their Daily Oral Corticosteroid (OCS) Dose Compared With Baseline Dose, During Weeks 20 to 24 While Maintaining Asthma Control
NCT01691508 (5) [back to overview]Number of Participants With the Indicated Percent Reduction From Baseline in Oral Corticosteroid (OCS) Dose During Weeks 20 to 24 While Maintaining Asthma Control
NCT01691508 (5) [back to overview]Number of Participants Who Achieved a Total Reduction of OCS Dose During Weeks 20 to 24 While Maintaining Asthma Control
NCT01695135 (8) [back to overview]DB Phase: Objective Response Rate (ORR)
NCT01695135 (8) [back to overview]DB Phase: Overall Survival
NCT01695135 (8) [back to overview]DB Phase: Percentage of Participants Experiencing Pain Palliation
NCT01695135 (8) [back to overview]DB Phase: Percentage of Participants Who Achieved PSA Response
NCT01695135 (8) [back to overview]DB Phase: Time to Pain Progression
NCT01695135 (8) [back to overview]DB Phase: Time to Prostate-Specific Antigen Progression (PSA)
NCT01695135 (8) [back to overview]DB Phase: Change From Baseline in Brief Fatigue Inventory (BFI) Score at End of Treatment
NCT01695135 (8) [back to overview]DB Phase: Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire: Total Scores at the End of Treatment
NCT01714817 (45) [back to overview]AUC (TAU): Area Under the Serum Concentration Time Curve Over a Dosing Interval
NCT01714817 (45) [back to overview]Adjusted Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 365 of the Double-blind Period in Nephrotic Participants
NCT01714817 (45) [back to overview]Adjusted Mean Change From Baseline in UPCR at Day 365 of the Double-blind Period in Overall Population
NCT01714817 (45) [back to overview]Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During Year 1 of the Double-blind Period
NCT01714817 (45) [back to overview]Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (Percentage of Blood)
NCT01714817 (45) [back to overview]Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During the Double-blind Period
NCT01714817 (45) [back to overview]Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period
NCT01714817 (45) [back to overview]Summary Statistics for Systolic Blood Pressure
NCT01714817 (45) [back to overview]Summary Statistics for Heart Rate
NCT01714817 (45) [back to overview]Summary Statistics for Diastolic Blood Pressure
NCT01714817 (45) [back to overview]Percentage of Participants With Ranked Outcome of Complete Renal Response, Partial Renal Response (PR), and No Renal Response (NR) During the Double-blind Period
NCT01714817 (45) [back to overview]Percentage of Participants in Treatment Failure Over Time During the Double-blind Period
NCT01714817 (45) [back to overview]Number of Participants With Sustained Change From Higher Level of Response to no Response During the Double-blind Period
NCT01714817 (45) [back to overview]Number of Participants With Other Marked Chemistry Laboratory Abnormalities in the Double Blind Period
NCT01714817 (45) [back to overview]Number of Participants With Other Marked Chemistry Laboratory Abnormalities During Year 1 of the Double Blind Period
NCT01714817 (45) [back to overview]Number of Participants With Marked Urinalysis Laboratory Abnormalities in the Double Blind Period
NCT01714817 (45) [back to overview]Number of Participants With Marked Urinalysis Laboratory Abnormalities During Year 1 of the Double Blind Period
NCT01714817 (45) [back to overview]Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period
NCT01714817 (45) [back to overview]Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period
NCT01714817 (45) [back to overview]Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period
NCT01714817 (45) [back to overview]Number of Participants With Marked Electrolyte Laboratory Abnormalities in the Double Blind Period
NCT01714817 (45) [back to overview]Number of Participants With Marked Electrolyte Laboratory Abnormalities During Year 1 of the Double Blind Period
NCT01714817 (45) [back to overview]Number of Participants With Any Adverse Events (AEs) During Year 2 of the Double-blind Period and Long-term Extension
NCT01714817 (45) [back to overview]Number of Participants With Any Adverse Events (AEs) During Year 1 of the Double-blind Period
NCT01714817 (45) [back to overview]Number of Participants With Abatacept Induced Antibody Response Over Time in the Double-blind Period
NCT01714817 (45) [back to overview]Median Time to Partial Renal Response During the Double-blind Period in Nephrotic Participants
NCT01714817 (45) [back to overview]Median Time to Partial Renal Response During the Double-blind Period in All Participants
NCT01714817 (45) [back to overview]Median Time to First Treatment Failure and Overall Treatment Failure During the Double-blind Period
NCT01714817 (45) [back to overview]Median Time to First Sustained Change to No Response During the Double-blind Period
NCT01714817 (45) [back to overview]Median Time to Complete Renal Response During the Double-blind Period in Nephrotic Participants
NCT01714817 (45) [back to overview]Median Time to Complete Renal Response During the Double-blind Period in All Participants
NCT01714817 (45) [back to overview]Median Percent Change From Baseline in UPCR Over Time
NCT01714817 (45) [back to overview]Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (x10^9 Cells/L)
NCT01714817 (45) [back to overview]Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (Umol/L)
NCT01714817 (45) [back to overview]Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (mmol/L)
NCT01714817 (45) [back to overview]Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (g/L)
NCT01714817 (45) [back to overview]Cmin (ug/mL): Trough Level Serum Concentration of Abatacept Prior to the Administration of the IV Infusion
NCT01714817 (45) [back to overview]Cmax: Maximum Observed Serum Concentration Following Participants Receiving Active Abatacept IV
NCT01714817 (45) [back to overview]Adjusted Mean Change From Baseline in UPCR Over Time
NCT01714817 (45) [back to overview]Adjusted Mean Change From Baseline in eGFR Over Time
NCT01714817 (45) [back to overview]Percentage of Participants in Overall Population in Complete Renal Response of Lupus Glomerulonephritis at Day 729 of the Double-blind Period
NCT01714817 (45) [back to overview]Percentage of Participants in Complete Renal Response (CR) of Lupus Glomerulonephritis at Day 365 of the Double-blind Period
NCT01714817 (45) [back to overview]Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 729 of the Double-blind Period
NCT01714817 (45) [back to overview]Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 365 of the Double-blind Period
NCT01714817 (45) [back to overview]Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (U/L)
NCT01715285 (7) [back to overview]Time to Prostate-Specific Antigen (PSA) Progression
NCT01715285 (7) [back to overview]Time to Skeletal-Related Event
NCT01715285 (7) [back to overview]Time to Subsequent Therapy for Prostate Cancer
NCT01715285 (7) [back to overview]Time to Pain Progression
NCT01715285 (7) [back to overview]Overall Survival (OS)
NCT01715285 (7) [back to overview]Radiographic Progression-Free Survival (PFS)
NCT01715285 (7) [back to overview]Time to Initiation of Chemotherapy
NCT01717053 (8) [back to overview]Metastasis or Systemic Therapy
NCT01717053 (8) [back to overview]Safety and Tolerability
NCT01717053 (8) [back to overview]Percentage of Patients With Undetectable PSA (Prostate-Specific Antigen) at 1 Year
NCT01717053 (8) [back to overview]Testosterone Recovery
NCT01717053 (8) [back to overview]Time to PSA Nadir
NCT01717053 (8) [back to overview]Percentage of Participants With Biochemical Progression-free Survival (BPFS)
NCT01717053 (8) [back to overview]PSA < 1.5ng/ml in Setting of Non-castrate Testosterone
NCT01717053 (8) [back to overview]PSA Nadir Value
NCT01717898 (3) [back to overview]Number of Reported Dose Limiting Toxicities When Combining BEZ235 With Abiraterone Acetate (Phase I).
NCT01717898 (3) [back to overview]Maximum Tolerated Dose for BEZ235 + Abiraterone Acetate (Phase I).
NCT01717898 (3) [back to overview]Anti-tumor Responses as Defined by a Decline in PSA of > 50%
NCT01718353 (9) [back to overview]Radiographic Progression-free Survival (rPFS)
NCT01718353 (9) [back to overview]Clinical Progression-free Survival (cPFS)
NCT01718353 (9) [back to overview]Drug-target Engagement in Circulating Tumor Cells (CTCs): Change From Baseline at Cycle 1 Day 8 in Percent Androgen Receptor Nuclear Localization (%ARNL) by Categories of PSA Decrease From Baseline (≥50%, Not ≥50%) After Cycle 4
NCT01718353 (9) [back to overview]Drug-target Engagement in CTCs: Change From Baseline at Cycle 1 Day 8 in MTB by Categories of PSA Decrease From Baseline (≥30%, Not ≥30%) After Cycle 4
NCT01718353 (9) [back to overview]Overall Survival
NCT01718353 (9) [back to overview]Percentage of Participants With ≥30% and ≥50% Reduction in PSA Response
NCT01718353 (9) [back to overview]Percentage of Participants With PSA Response
NCT01718353 (9) [back to overview]Progression Free Survival (PFS)
NCT01718353 (9) [back to overview]PSA Progression Free Survival
NCT01724021 (14) [back to overview]Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV])
NCT01724021 (14) [back to overview]Cancer Therapy Satisfaction Questionnaire (CTSQ) Score
NCT01724021 (14) [back to overview]Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time
NCT01724021 (14) [back to overview]Percentage of Participants With Anti-Rituximab Antibodies Over Time
NCT01724021 (14) [back to overview]Rituximab Administration Satisfaction Questionnaire (RASQ) Score
NCT01724021 (14) [back to overview]Summary of Observed Serum Rituximab Concentration
NCT01724021 (14) [back to overview]Number of Participants With Treatment Emergent Adverse Events (AEs)
NCT01724021 (14) [back to overview]Event-free Survival (EFS)
NCT01724021 (14) [back to overview]Disease-free Survival (DFS)
NCT01724021 (14) [back to overview]Complete Response (CR) Rate
NCT01724021 (14) [back to overview]Overall Survival (OS)
NCT01724021 (14) [back to overview]Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6
NCT01724021 (14) [back to overview]Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8
NCT01724021 (14) [back to overview]Progression-free Survival (PFS)
NCT01729494 (21) [back to overview]Steroid Therapy
NCT01729494 (21) [back to overview]eGFR (MRDRD) < 45 ml/Min/1.73m2
NCT01729494 (21) [back to overview]New Onset Diabetes After Transplantation (NODAT)
NCT01729494 (21) [back to overview]Delayed Graft Function
NCT01729494 (21) [back to overview]Discontinuation of Mycophenolate
NCT01729494 (21) [back to overview]Requirement of T-cell Depleting Therapy for Biopsy Proven Acute Rejection (BPAR)
NCT01729494 (21) [back to overview]Time to First BPAR
NCT01729494 (21) [back to overview]Mean eGFR (MDRD) (ml/Min/1.73m2)
NCT01729494 (21) [back to overview]Discontinuation of Study Treatment (Belatacept or Tacrolimus)
NCT01729494 (21) [back to overview]Leukopenia (WBC < 2000/mm3)
NCT01729494 (21) [back to overview]Proteinuria UPC Ratio > 0.8
NCT01729494 (21) [back to overview]Patient Death
NCT01729494 (21) [back to overview]Biopsy Proven Mixed Acute Rejection
NCT01729494 (21) [back to overview]Biopsy Proven Acute Rejection
NCT01729494 (21) [back to overview]# of Patients Developing Denovo Donor Specific Antibody (DSA) Post-transplant
NCT01729494 (21) [back to overview]# Patients Experiencing a First Biopsy-proven ACR With Severity Banff > or = 2a Grade
NCT01729494 (21) [back to overview]# Patients Experiencing a Graft Loss But Not Including Patients Who Died With Functioning Graft (Death-censored Graft Loss)
NCT01729494 (21) [back to overview]# Patients With Composite Endpoint of Either Experiencing Death, Graft Loss, or eGFR < 45ml/Min at 24 Months
NCT01729494 (21) [back to overview]# Patients With Composite Endpoint of Experiencing Either Death, Graft Loss, or eGFR < 45ml/Min
NCT01729494 (21) [back to overview]Biopsy Proven Acute Antibody Mediated Rejection
NCT01729494 (21) [back to overview]Biopsy Proven Acute Cellular Rejection
NCT01746173 (2) [back to overview]Induction Response
NCT01746173 (2) [back to overview]24-month Progression-Free Survival Rate
NCT01753401 (17) [back to overview]Mean Score on the Mental Component Scale (MCS) of the Short Form 36 Health Status Questionnaire (SF-36) Within 8 Weeks
NCT01753401 (17) [back to overview]Krupp Fatigue Severity Score (FSS) Within 8 Weeks
NCT01753401 (17) [back to overview]Number of Participants Who Meet the Definition of a Responder Within 4 Weeks
NCT01753401 (17) [back to overview]Number of Participants Who Meet the Definition of a Responder Within 8 Weeks
NCT01753401 (17) [back to overview]Cutaneous Lupus Activity as Measured by the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Within 8 Weeks
NCT01753401 (17) [back to overview]Number of Participants With a Relapse Within 52 Weeks
NCT01753401 (17) [back to overview]Number of Tender or Swollen Joints at Week 52
NCT01753401 (17) [back to overview]Score on the SELENA-SLEDAI at Week 52
NCT01753401 (17) [back to overview]Mean Score on the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) at Week 52
NCT01753401 (17) [back to overview]Mean Score on the Mental Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) at Week 52
NCT01753401 (17) [back to overview]BILAG Total Score Within 8 Weeks
NCT01753401 (17) [back to overview]Krupp Fatigue Severity Score (FSS) at Week 52
NCT01753401 (17) [back to overview]Cutaneous Lupus Activity as Measured by the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) at Week 52
NCT01753401 (17) [back to overview]Number of Participants Who Meet the Definition of a Responder at Week 52
NCT01753401 (17) [back to overview]Number of Tender or Swollen Joints Within 8 Weeks
NCT01753401 (17) [back to overview]Mean Score on the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) Within 8 Weeks
NCT01753401 (17) [back to overview]Score on the SELENA-SLEDAI Within 8 Weeks
NCT01775475 (8) [back to overview]Change in Absolute CD4 Count From Baseline to Post-treatment
NCT01775475 (8) [back to overview]Participants Who Experienced an Adverse Event
NCT01775475 (8) [back to overview]Progression-free Survival
NCT01775475 (8) [back to overview]Proportion of Patients Who Are Adherent to Chemotherapy
NCT01775475 (8) [back to overview]Proportion of Patients Who Are Adherent to Antiretroviral Therapy
NCT01775475 (8) [back to overview]Overall Response Rate
NCT01775475 (8) [back to overview]Overall Survival
NCT01775475 (8) [back to overview]Number of Patients Who Complete Treatment
NCT01777152 (7) [back to overview]Objective Response Rate (ORR) Per IRF at End of Treatment
NCT01777152 (7) [back to overview]Complete Remission (CR) Rate Per IRF at End of Treatment (EOT)
NCT01777152 (7) [back to overview]Overall Survival (OS)
NCT01777152 (7) [back to overview]Progression-free Survival Per Independent Review Facility (IRF)
NCT01777152 (7) [back to overview]Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)
NCT01777152 (7) [back to overview]Incidence of Adverse Events (AEs)
NCT01777152 (7) [back to overview]Incidence of Laboratory Abnormalities
NCT01782859 (4) [back to overview]Serum Prothrombin Fragment 1 and 2 (PF 1.2)
NCT01782859 (4) [back to overview]Plasmin-a 2 Antiplasmin Complex (PAP)
NCT01782859 (4) [back to overview]Pain at 3 Months Post-op
NCT01782859 (4) [back to overview]Interleukin (IL)-6 Cytokine Release (Inflammatory Marker)
NCT01791153 (15) [back to overview]Minimum Serum Concentration at Steady State (Cmin,ss) of Tocilizumab
NCT01791153 (15) [back to overview]Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 26 Weeks Prednisone Taper)
NCT01791153 (15) [back to overview]Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 52 Weeks Prednisone Taper)
NCT01791153 (15) [back to overview]Percentage of Participants With Anti-Tocilizumab Antibodies
NCT01791153 (15) [back to overview]Serum Interleukin-6 (IL-6) Level
NCT01791153 (15) [back to overview]Serum Soluble IL-6 Receptor (sIL-6R) Level
NCT01791153 (15) [back to overview]Minimum Observed Serum Concentration (Ctrough) of Tocilizumab
NCT01791153 (15) [back to overview]Erythrocyte Sedimentation Rate (ESR)
NCT01791153 (15) [back to overview]Change From Baseline in Short Form (SF)-36 Questionnaire Score at Week 52
NCT01791153 (15) [back to overview]Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Assessed Using Visual Analogue Scale (VAS) at Week 52
NCT01791153 (15) [back to overview]C-Reactive Protein (CRP) Level
NCT01791153 (15) [back to overview]Total Cumulative Prednisone Dose
NCT01791153 (15) [back to overview]Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Steady State of Tocilizumab
NCT01791153 (15) [back to overview]Maximum Serum Concentration at Steady State (Cmax,ss) of Tocilizumab
NCT01791153 (15) [back to overview]Time to First GCA Disease Flare
NCT01818752 (7) [back to overview]Overall Survival (OS)
NCT01818752 (7) [back to overview]Complete Response Rate
NCT01818752 (7) [back to overview]Overall Response Rate
NCT01818752 (7) [back to overview]Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy
NCT01818752 (7) [back to overview]Progression-Free Survival (PFS)
NCT01818752 (7) [back to overview]European Organisation for Research and Treatment of Cancer Quality of Life Core Module (EORTC QLQ-C30) Global Health Status/Quality of Life (QOL) Scores
NCT01818752 (7) [back to overview]Number of Participants With Adverse Events
NCT01829295 (3) [back to overview]Number of Participants Achieving Treatment Success at 6 Months (Phase I, 0-6 Months)
NCT01829295 (3) [back to overview]Number of Participants Achieving Treatment Success at 12 Months on Same Medication (Phase I, 6-12 Months)
NCT01829295 (3) [back to overview]Number of Participants Achieving Treatment Success After Switching to Other Medication (Phase II, 0-6 Months)
NCT01848067 (2) [back to overview]Number of Participants With a PSA Value Equal to or Greater Than 25%
NCT01848067 (2) [back to overview]Phase I: Frequency of Dose Limiting Toxicities of Alisertib, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.1
NCT01855750 (6) [back to overview]Event-Free Survival (EFS) - Intent-to-Treat (ITT) Population
NCT01855750 (6) [back to overview]Event-Free Survival (EFS) - Activated B-Cell (ABC) Population
NCT01855750 (6) [back to overview]Time to Worsening in the Lymphoma Subscale of Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
NCT01855750 (6) [back to overview]Progression-Free Survival (PFS)
NCT01855750 (6) [back to overview]Percentage of Participants Who Achieved Complete Response (CR)
NCT01855750 (6) [back to overview]Overall Survival
NCT01856192 (4) [back to overview]Proportion of Patients With Complete Response
NCT01856192 (4) [back to overview]Overall Survival Rate at 3 Years
NCT01856192 (4) [back to overview]3-year Progression-free Survival Rate
NCT01856192 (4) [back to overview]Proportion of Patients With Response
NCT01867710 (15) [back to overview]Time to Opiate Use for Cancer-related Pain
NCT01867710 (15) [back to overview]Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Interference Subscale
NCT01867710 (15) [back to overview]Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Worst Pain
NCT01867710 (15) [back to overview]Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): EQ-VAS
NCT01867710 (15) [back to overview]Percentage of Participants Experiencing Neither of the 2 Mineralocorticoid Excess Toxicity During the First 24 Weeks of Treatment
NCT01867710 (15) [back to overview]Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by 1 Point
NCT01867710 (15) [back to overview]Progression-Free Survival (PFS)
NCT01867710 (15) [back to overview]Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response Rate [Greater Than or Equal to (>=) 50 Percent (%) Decline From Baseline] at Week 12
NCT01867710 (15) [back to overview]Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score
NCT01867710 (15) [back to overview]Time to Prostate-Specific Antigen (PSA) Progression
NCT01867710 (15) [back to overview]Overall Survival
NCT01867710 (15) [back to overview]Objective Response Rate (ORR)
NCT01867710 (15) [back to overview]Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): Index Score
NCT01867710 (15) [back to overview]Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Intensity Subscale
NCT01867710 (15) [back to overview]Time to Next Prostate Cancer Therapy
NCT01884571 (8) [back to overview]Mean Rate of Change in Grip Strength Treatment Compared to Pre-Treatment
NCT01884571 (8) [back to overview]Mean Rate of Change of ALSFRS-R Scores During Treatment Compared to Pre-Treatment
NCT01884571 (8) [back to overview]Collection of Cerebrospinal Fluid for Future Analysis of Cytokine Levels
NCT01884571 (8) [back to overview]Mean Rate of Change of Hand-Held Dynamometry (HHD) During Treatment Compared to Pre-Treatment
NCT01884571 (8) [back to overview]Mean Rate of Change of Slow Vital Capacity (SVC) During Treatment Compared to Pre-Treatment
NCT01884571 (8) [back to overview]Mean Rate of Change of T-cell Subsets in Blood Treatment Compared to Pre-Treatment
NCT01884571 (8) [back to overview]Number of Participants With an Average Increase in ALSFRS-R Score of One Point Per Month
NCT01884571 (8) [back to overview]Collection of Blood for Future Analysis of Peripheral Blood Mononuclear Cells (PBMCs)
NCT01888952 (1) [back to overview]Total Number of Adverse Events.
NCT01889069 (23) [back to overview]DLBCL: Plasma Concentrations During Different Scheduling of Rituximab SC R-CHOP-14 or R-CHOP-21
NCT01889069 (23) [back to overview]DLBCL: Plasma Concentrations During Different Scheduling of Rituximab SC R-CHOP-14 or R-CHOP-21
NCT01889069 (23) [back to overview]Percentage of Participants With Progression-Free Survival (PFS) According to IWG Response Criteria
NCT01889069 (23) [back to overview]Percentage of Participants With Overall Survival (OS)
NCT01889069 (23) [back to overview]Percentage of Participants With Event-Free Survival (EFS) According to IWG Response Criteria
NCT01889069 (23) [back to overview]Percentage of Participants With Disease-Free Survival (DFS) According to IWG Response Criteria
NCT01889069 (23) [back to overview]Percentage of Participants With Complete Response (CR) According to IWG Response Criteria
NCT01889069 (23) [back to overview]Percentage of Participants With At Least One Treatment-Emergent Serious Adverse Events
NCT01889069 (23) [back to overview]Percentage of Participants With At Least One Grade ≥ 3 Treatment-Emergent Adverse Events (TEAEs)
NCT01889069 (23) [back to overview]Percentage of Participants With At Least One Grade ≥ 3 Infusion/ Injection Related Reactions (IIRRs)
NCT01889069 (23) [back to overview]FL: Overall Geometric Least Square (LS) Mean Plasma Trough Concentrations of Rituximab
NCT01889069 (23) [back to overview]DLBCL: Maximum Plasma Concentration (Cmax) of Rituximab
NCT01889069 (23) [back to overview]DLBCL: Apparent Total Clearance (CL/F) of Rituximab
NCT01889069 (23) [back to overview]DLBCL: Area Under the Plasma Concentration-Time Curve (AUC) of Rituximab
NCT01889069 (23) [back to overview]Rituximab Administration Satisfaction Questionnaire (RASQ) Convenience and Satisfaction Domain Scores
NCT01889069 (23) [back to overview]DLBCL: Overall Geometric Least Square (LS) Mean Plasma Trough Concentrations of Rituximab
NCT01889069 (23) [back to overview]FL: Plasma Trough Concentrations of Rituximab
NCT01889069 (23) [back to overview]Rituximab Administration Satisfaction Questionnaire (RASQ) Convenience and Satisfaction Domain Scores
NCT01889069 (23) [back to overview]Percentage of Participants With Administration-Associated Reactions (AAR)
NCT01889069 (23) [back to overview]FL: Plasma Trough Concentrations of Rituximab in Participants With Complete Response/Complete Response Unconfirmed (CR/CRu)
NCT01889069 (23) [back to overview]DLBCL: Plasma Trough Concentrations of Rituximab in Participants With Complete Response/Complete Response Unconfirmed (CR/CRu)
NCT01889069 (23) [back to overview]DLBCL: Plasma Trough Concentrations of Rituximab
NCT01889069 (23) [back to overview]DLBCL: Plasma Concentrations of Rituximab
NCT01900431 (8) [back to overview]Change From Baseline in Central Retinal Thickness (CRT) At Week 16
NCT01900431 (8) [back to overview]Percentage of Participants With Anterior Chamber (AC) Cell Score = 0 or At Least 2-step Reduction in Score at Week 16
NCT01900431 (8) [back to overview]Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 16
NCT01900431 (8) [back to overview]Percentage of Participants With at Least 2-step Reduction in Vitreous Haze (VH) or Prednisone Dose <10 mg/Day at Week 16
NCT01900431 (8) [back to overview]Percentage of Participants With Prednisone Dose of ≤5 mg/Day (or Equivalent Oral Corticosteroid) at Week 16
NCT01900431 (8) [back to overview]Percent Change From Baseline in CRT at Week 16
NCT01900431 (8) [back to overview]Change From Baseline in VH Scale at Week 16
NCT01900431 (8) [back to overview]Pharmacokinetics (PK) Assessment: Serum Functional Sarilumab Concentration
NCT01920932 (11) [back to overview]Descriptive of Hematological Adverse Events
NCT01920932 (11) [back to overview]Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control
NCT01920932 (11) [back to overview]Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control
NCT01920932 (11) [back to overview]Local Failure Rate in High Risk HL Patients Treated With AEPA/CAPDac.
NCT01920932 (11) [back to overview]Descriptive of Infectious Adverse Events
NCT01920932 (11) [back to overview]To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0)
NCT01920932 (11) [back to overview]Complete Response Rate Estimate for All Evaluable Participants
NCT01920932 (11) [back to overview]Comparison of the Event-free (EFS) Survival in High Risk HL Patients Treated With AEPA/CAPDac to the Historical Control HOD99 Unfavorable Risk 2 Arm (UR2).
NCT01920932 (11) [back to overview]To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0)
NCT01920932 (11) [back to overview]To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0)
NCT01920932 (11) [back to overview]Descriptive of Neuropathic Adverse Events
NCT01921218 (6) [back to overview]Number of Infectious Complications
NCT01921218 (6) [back to overview]Number of Participants With Donor-specific Antibody Formation
NCT01921218 (6) [back to overview]Glomerular Filtration Rate (GFR)
NCT01921218 (6) [back to overview]Glomerular Filtration Rate (GFR)
NCT01921218 (6) [back to overview]Time to Initiation of Dialysis
NCT01921218 (6) [back to overview]Number of Participants With Anti-human Leukocyte Antigen (HLA) Alloantibodies
NCT01925131 (3) [back to overview]MTD of Inotuzumab Ozogamicin With CVP for Patients With Relapsed or Refractory CD22+ Acute Leukemia
NCT01925131 (3) [back to overview]Frequency and Severity of Toxicities
NCT01925131 (3) [back to overview]Response Rate (CR+CRi) Among Expansion Cohort
NCT01925612 (6) [back to overview]Complete Remission Rate
NCT01925612 (6) [back to overview]Incidence of Adverse Events
NCT01925612 (6) [back to overview]Objective Response Rate
NCT01925612 (6) [back to overview]Incidence of Laboratory Abnormalities
NCT01925612 (6) [back to overview]Progression-free Survival
NCT01925612 (6) [back to overview]Overall Survival
NCT01940276 (6) [back to overview]Change in PSA Response
NCT01940276 (6) [back to overview]Overall Survival
NCT01940276 (6) [back to overview]Median Radiographic Progression Free Survival (PFS)
NCT01940276 (6) [back to overview]Median Time to PSA Progression
NCT01940276 (6) [back to overview]Number of Men With PSA Decline to < 0.1 and < 0.2 ng/ml
NCT01940276 (6) [back to overview]Percent of Subjects Experiencing Hypertension
NCT01946165 (2) [back to overview]Proportion of Participants With Pathologic Stage Less Than or Equal to ypT2N0
NCT01946165 (2) [back to overview]Proportion of Participants With Positive Surgical Margins
NCT01946880 (36) [back to overview]Number of Grade 3, 4, or 5 Hematological Adverse Events (AEs).
NCT01946880 (36) [back to overview]Number of Grade 3, 4, or 5 Adverse Events (AEs) Related to Systemic Lupus Erythematosus (SLE)
NCT01946880 (36) [back to overview]Number of Grade 3, 4, or 5 Adverse Events (AEs) Related to Mycophenolate Mofetil (MMF)
NCT01946880 (36) [back to overview]Number of Grade 3, 4, or 5 Adverse Events (AEs)
NCT01946880 (36) [back to overview]Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Disease Damage Index for Systemic Lupus Erythematosus (SLICC/DI): Total Score
NCT01946880 (36) [back to overview]Change From Baseline in the Short Form Health Survey (SF-36) Physical Functioning (PF) Score
NCT01946880 (36) [back to overview]Change From Baseline in the Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
NCT01946880 (36) [back to overview]Change From Baseline in the Lupus Quality of Life (QoL)Score
NCT01946880 (36) [back to overview]Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT-F) Fatigue Scale (FS): Total Score
NCT01946880 (36) [back to overview]Time to First Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare
NCT01946880 (36) [back to overview]Time to First Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare
NCT01946880 (36) [back to overview]Time to Clinically Significant Disease Reactivation
NCT01946880 (36) [back to overview]Time From Clinically Significant Disease Reactivation to Return to Pre-Flare Steroid Dose
NCT01946880 (36) [back to overview]Time From Clinically Significant Disease Reactivation to Recovery to Baseline British Isles Lupus Assessment Group (BILAG) Score or BILAG C
NCT01946880 (36) [back to overview]Time From Clinically Significant Disease Reactivation to Improvement in British Isles Lupus Assessment Group (BILAG) From Maximum Level During Flare
NCT01946880 (36) [back to overview]The Addition of Aggressive Adjunctive Therapy to Mycophenolate Mofetil (MMF) or Change in MMF Therapy to Cytotoxic Drug Due to Flare by Week 60
NCT01946880 (36) [back to overview]Number of Serious Adverse Events (SAEs).
NCT01946880 (36) [back to overview]Number of Participants in the Lupus Nephritis Subgroup Experiencing a British Isles Lupus Assessment Group (BILAG) A Renal Flare by Week 60
NCT01946880 (36) [back to overview]Number of Participants Experiencing Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF <2000 mg/Day Subgroup
NCT01946880 (36) [back to overview]Number of Participants Experiencing Clinically Significant Disease Reactivation by Week 60
NCT01946880 (36) [back to overview]Number of Participants Experiencing Any British Isles Lupus Assessment Group (BILAG) A Flare by Week 60
NCT01946880 (36) [back to overview]Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Non-Lupus Nephritis Subgroup
NCT01946880 (36) [back to overview]Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Lupus Nephritis Subgroup
NCT01946880 (36) [back to overview]Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60
NCT01946880 (36) [back to overview]Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Non-Lupus Nephritis Subgroup
NCT01946880 (36) [back to overview]Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF ≥ 2000 mg/Day Subgroup
NCT01946880 (36) [back to overview]Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60
NCT01946880 (36) [back to overview]Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Lupus Nephritis Subgroup
NCT01946880 (36) [back to overview]Number of Malignancies Reported as Adverse Events (AEs).
NCT01946880 (36) [back to overview]Number of Infection-Related Adverse Events (AEs)
NCT01946880 (36) [back to overview]Mortality Related to Systemic Lupus Erythematosus (SLE)
NCT01946880 (36) [back to overview]Cumulative Systemic Steroid Dose by Week 60
NCT01946880 (36) [back to overview]Cumulative Excess Systemic Steroid Dose From Time of Clinically Significant Disease Reactivation to Return to Pre-Flare Dose or End of Trial Participation
NCT01946880 (36) [back to overview]All-Cause Mortality
NCT01946880 (36) [back to overview]Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF<2000 mg/Day Subgroup
NCT01946880 (36) [back to overview]Number of Participants Experiencing Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF ≥ 2000 mg/Day Subgroup
NCT01949337 (2) [back to overview]Overall Survival (OS)
NCT01949337 (2) [back to overview]Number of Participants Who Has Experienced at Least One Toxicity (Defined as a Grade 3 or Higher Adverse Event Deemed at Least Possibly Related to Treatment)
NCT01950819 (22) [back to overview]Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported
NCT01950819 (22) [back to overview]Evolution of Renal Function, as eGFR, Over Time by Slope Analysis.
NCT01950819 (22) [back to overview]Incidence of Adverse Events, Serious Adverse Events and Adverse Events Leading to Study Regimen Discontinuation.
NCT01950819 (22) [back to overview]Incidence of Major Cardiovascular Events.
NCT01950819 (22) [back to overview]Incidence of Malignancies.
NCT01950819 (22) [back to overview]Incidence of Composite of tBPAR (Treated Biopsy-proven Acute Rejection)or eGRF<50 mL/Min/1.73m2 by Subgroup
NCT01950819 (22) [back to overview]Incidence of Cytomegalovirus and BK Virus, New Onset Diabetes Mellitus, Chronic Kidney Disease With Associated Proteinuria and Calcineurin Inhibitor Associated Adverse Events.
NCT01950819 (22) [back to overview]Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection
NCT01950819 (22) [back to overview]Incidence of Failure on the Composite Endpoint of Graft Loss or Death.
NCT01950819 (22) [back to overview]Incidence of eGFR < 50 mL/Min/1.73m2
NCT01950819 (22) [back to overview]Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios.
NCT01950819 (22) [back to overview]Incidence of Failure on the Composite Endpoint of tBPAR, Graft Loss, Death or eGFR < 50 mL/Min/1.73m2
NCT01950819 (22) [back to overview]Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death
NCT01950819 (22) [back to overview]Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2.
NCT01950819 (22) [back to overview]Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death or Loss to Follow-up
NCT01950819 (22) [back to overview]Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2 Among Compliant Subjects.
NCT01950819 (22) [back to overview]Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants)
NCT01950819 (22) [back to overview]Incidence of tBPAR (Excluding Grade IA Rejections) or GFR<50 mL/Min/1.73m2
NCT01950819 (22) [back to overview]Incidence of tBPAR (Treated Biopsy-proven Acute Rejection) Excluding Grade IA Rejections
NCT01950819 (22) [back to overview]Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events)
NCT01950819 (22) [back to overview]Renal Allograft Function : Mean Estimated Glomerular Filtration Rate, eGFR
NCT01950819 (22) [back to overview]Renal Function Assessed by Creatinine Lab Values
NCT01972217 (28) [back to overview]Part A: Percentage of Patients Experiencing Adverse Events (AEs)
NCT01972217 (28) [back to overview]Part A PK: Abiraterone Tmax,ss
NCT01972217 (28) [back to overview]Part A PK: Abiraterone Tmax,ss
NCT01972217 (28) [back to overview]Part A PK: Abiraterone Cmin,ss
NCT01972217 (28) [back to overview]Part A PK: Abiraterone Cmin,ss
NCT01972217 (28) [back to overview]Part A PK: Abiraterone Cmax,ss
NCT01972217 (28) [back to overview]Part A PK: Abiraterone Cmax,ss
NCT01972217 (28) [back to overview]Part A PK: Abiraterone AUCss
NCT01972217 (28) [back to overview]Part A PK Analysis: Olaparib Time to Reach Maximum Plasma Concentration at Steady State (Tmax,ss)
NCT01972217 (28) [back to overview]Part A PK Analysis: Olaparib Time to Reach Maximum Plasma Concentration at Steady State (Tmax,ss)
NCT01972217 (28) [back to overview]Part A PK Analysis: Olaparib Minimum Plasma Concentration at Steady State (Cmin,ss)
NCT01972217 (28) [back to overview]Part A PK Analysis: Olaparib Minimum Plasma Concentration at Steady State (Cmin,ss)
NCT01972217 (28) [back to overview]Part A PK Analysis: Olaparib Area Under the Plasma Concentration-Time Curve at Steady State (AUCss)
NCT01972217 (28) [back to overview]Part A PK Analysis: Olaparib Area Under the Plasma Concentration-Time Curve at Steady State (AUCss)
NCT01972217 (28) [back to overview]Part A Pharmacokinetics (PK): Olaparib Maximum Plasma Concentration at Steady State (Cmax,ss)
NCT01972217 (28) [back to overview]Part A Pharmacokinetics (PK): Olaparib Maximum Plasma Concentration at Steady State (Cmax,ss)
NCT01972217 (28) [back to overview]Part B: Median Overall Survival (OS)
NCT01972217 (28) [back to overview]Part B: Percentage of Patients With Progression Events or Death (rPFS)
NCT01972217 (28) [back to overview]Part A PK: Abiraterone AUCss
NCT01972217 (28) [back to overview]Part B: Percentage of Patients With PSA Responses
NCT01972217 (28) [back to overview]Part B: Percentage of Patients Experiencing AEs
NCT01972217 (28) [back to overview]Part B: Median Radiological Progression-Free Survival (rPFS) Time
NCT01972217 (28) [back to overview]Part B: Percentage of Patients With at Least One Objective Response (Objective Response Rate [ORR])
NCT01972217 (28) [back to overview]Part B: Median Time to Second Progression or Death (PFS2)
NCT01972217 (28) [back to overview]Part B: Median Best Percentage Change From Baseline in Prostate Specific Antigen (PSA) Levels
NCT01972217 (28) [back to overview]Part B: Median Best Percentage Change From Baseline in Circulating Tumour Cell (CTC) Level
NCT01972217 (28) [back to overview]Part A: Number of Patients With Dose Limiting Toxicities (DLTs)
NCT01972217 (28) [back to overview]Median Time to First Subsequent Therapy (TFST) and Median Time to Second Subsequent Therapy (TSST)
NCT01974440 (14) [back to overview]Primary Analysis: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
NCT01974440 (14) [back to overview]Primary Analysis: Overall Response Rate (ORR): Stratified Analysis
NCT01974440 (14) [back to overview]Primary Analysis: Overall Survival (OS): Stratified Analysis
NCT01974440 (14) [back to overview]Primary Analysis: Progression Free Survival (PFS): Stratified Analysis
NCT01974440 (14) [back to overview]Supplementary Analysis: Duration of Response: Unstratified Analysis - Participants With MZL
NCT01974440 (14) [back to overview]Primary Analysis: Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Questionnaire
NCT01974440 (14) [back to overview]Supplementary Analysis: Number of Participants With TEAEs: Participants With MZL
NCT01974440 (14) [back to overview]Supplementary Analysis: Overall Response Rate: Unstratified Analysis - Participants With MZL
NCT01974440 (14) [back to overview]Primary Analysis: Complete Response Rate (CRR): Stratified Analysis
NCT01974440 (14) [back to overview]Supplementary Analysis: Progression Free Survival: Unstratified Analysis - Participants With Marginal Zone Lymphoma (MZL)
NCT01974440 (14) [back to overview]Supplementary Analysis: Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Questionnaire: Participants With MZL
NCT01974440 (14) [back to overview]Primary Analysis: Duration of Response (DOR): Stratified Analysis
NCT01974440 (14) [back to overview]Supplementary Analysis: Complete Response Rate: Unstratified Analysis - Participants With MZL
NCT01974440 (14) [back to overview]Supplementary Analysis: Overall Survival: Unstratified Analysis - Participants With MZL
NCT01992653 (29) [back to overview]Number of Participants With DLTs in Non-DLBCL Population
NCT01992653 (29) [back to overview]Number of Participants With Anti-Polatuzumab Vedotin Antibodies
NCT01992653 (29) [back to overview]Number of Participants With Anti-Obinutuzumab Antibodies
NCT01992653 (29) [back to overview]Number of Participants With Adverse Events in Non-DLBCL Population
NCT01992653 (29) [back to overview]Number of Participants With Adverse Events in Diffuse Large B-Cell Lymphoma (DLBCL) Population
NCT01992653 (29) [back to overview]Maximum Concentration (Cmax) of Polatuzumab Vedotin
NCT01992653 (29) [back to overview]Event Free Survival, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population
NCT01992653 (29) [back to overview]Event Free Survival, as Assessed by Investigator Using Cheson Criteria for DLBCL Population
NCT01992653 (29) [back to overview]Duration of Response, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population
NCT01992653 (29) [back to overview]Duration of Response, as Assessed by Investigator Using Cheson Criteria for DLBCL Population
NCT01992653 (29) [back to overview]Clearance (CL) of Polatuzumab Vedotin
NCT01992653 (29) [back to overview]Area Under the Concentration-Time Curve (AUC) of Polatuzumab Vedotin
NCT01992653 (29) [back to overview]Plasma Levels of Cyclophosphamide
NCT01992653 (29) [back to overview]Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score
NCT01992653 (29) [back to overview]Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score
NCT01992653 (29) [back to overview]Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score
NCT01992653 (29) [back to overview]Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score
NCT01992653 (29) [back to overview]Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population
NCT01992653 (29) [back to overview]Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for DLBCL Population
NCT01992653 (29) [back to overview]Terminal Half-Life (t1/2) of Polatuzumab Vedotin
NCT01992653 (29) [back to overview]Steady-State Volume of Distribution (Vss) of Polatuzumab Vedotin
NCT01992653 (29) [back to overview]Relative Dose Intensity of Polatuzumab Vedotin (Ratio of the Amount of Drug Actually Administered to the Amount Planned) for Non-DLBCL Population
NCT01992653 (29) [back to overview]Relative Dose Intensity of Polatuzumab Vedotin (Ratio of the Amount of Drug Actually Administered to the Amount Planned) for DLBCL Population
NCT01992653 (29) [back to overview]Progression Free Survival, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population
NCT01992653 (29) [back to overview]Progression Free Survival, as Assessed by Investigator Using Cheson Criteria for DLBCL Population
NCT01992653 (29) [back to overview]Overall Survival for Non-DLBCL Population
NCT01992653 (29) [back to overview]Overall Survival for DLBCL Population
NCT01992653 (29) [back to overview]Number of Participants With Dose Limiting Toxicities (DLTs) in DLBCL Population
NCT01992653 (29) [back to overview]Plasma Levels of Doxorubicin
NCT01994590 (1) [back to overview]Safety and Tolerability
NCT01995513 (27) [back to overview]Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
NCT01995513 (27) [back to overview]Percentage of Participants With Adverse Events (AEs) Leading to Death
NCT01995513 (27) [back to overview]Progression Free Survival (PFS)
NCT01995513 (27) [back to overview]Rate of Pain Progression
NCT01995513 (27) [back to overview]Time to Degradation of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
NCT01995513 (27) [back to overview]Time to First Use of New Antineoplastic Therapy for Prostate Cancer
NCT01995513 (27) [back to overview]Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01995513 (27) [back to overview]Prostate Specific Antigen (PSA) Response Rate
NCT01995513 (27) [back to overview]Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01995513 (27) [back to overview]Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01995513 (27) [back to overview]Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation
NCT01995513 (27) [back to overview]Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
NCT01995513 (27) [back to overview]Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
NCT01995513 (27) [back to overview]Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
NCT01995513 (27) [back to overview]Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
NCT01995513 (27) [back to overview]Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
NCT01995513 (27) [back to overview]Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
NCT01995513 (27) [back to overview]Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01995513 (27) [back to overview]Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation
NCT01995513 (27) [back to overview]Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
NCT01995513 (27) [back to overview]Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
NCT01995513 (27) [back to overview]Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
NCT01995513 (27) [back to overview]Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
NCT01995513 (27) [back to overview]Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
NCT01995513 (27) [back to overview]Objective Response Rate (ORR)
NCT01995513 (27) [back to overview]Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation
NCT01995513 (27) [back to overview]Time to Prostate Specific Antigen (PSA) Progression
NCT02029638 (18) [back to overview]Number of Days Post-Transplant to the First Episode of Acute Rejection Requiring Treatment
NCT02029638 (18) [back to overview]Number of Days From Transplant to Platelet Count Recovery
NCT02029638 (18) [back to overview]Number of Days From Neutrophil Nadir to Absolute Neutrophil Recovery
NCT02029638 (18) [back to overview]Duration in Days of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy
NCT02029638 (18) [back to overview]Percent of Participants Who Achieved Operational Tolerance
NCT02029638 (18) [back to overview]Duration in Days of Graft-versus-Host Disease in Transplanted Participants
NCT02029638 (18) [back to overview]Histological Severity of Biopsies Demonstrating Acute Rejection as Defined by Banff 2007 Classification Renal Allograft Pathology
NCT02029638 (18) [back to overview]Number of Adverse Events (AEs) by Severity- Including Infection, Wound Complications, Post-Transplant Diabetes, Hemorrhagic Cystitis and Malignancy
NCT02029638 (18) [back to overview]Number of Transplanted Participants Who Developed Donor-Specific Antibody During Study Participation
NCT02029638 (18) [back to overview]Number of Transplanted Participants Who Developed Donor- Specific Antibody After Initiation of Immunosuppression Withdrawal
NCT02029638 (18) [back to overview]Number of Participants Free From Return to Immunosuppression for the Duration of the Study
NCT02029638 (18) [back to overview]Number of Participants Experiencing an Incidence of Graft-versus-Host Disease Post-Transplant
NCT02029638 (18) [back to overview]Number of Transplanted Participants With Engraftment Syndrome
NCT02029638 (18) [back to overview]Number of Transplanted Participants With Chronic T Cell-Mediated or Antibody-Mediated Rejection
NCT02029638 (18) [back to overview]Number of Transplanted Participants With Acute Renal Allograft Rejection
NCT02029638 (18) [back to overview]Number of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy
NCT02029638 (18) [back to overview]Number of Transplanted Participants Who Died
NCT02029638 (18) [back to overview]Number of Transplanted Participants Who Remained Off Immunosuppression for at Least 52 Weeks, Including Those in Whom the 52 Week Biopsy Was Not Performed
NCT02034552 (8) [back to overview]Time to Radiological Progression
NCT02034552 (8) [back to overview]Time to Radiological Bone Progression
NCT02034552 (8) [back to overview]Time to First Symptomatic Skeletal Event
NCT02034552 (8) [back to overview]Symptomatic Skeletal Event-free Survival
NCT02034552 (8) [back to overview]Radiological Progression Free Survival
NCT02034552 (8) [back to overview]Overall Survival
NCT02034552 (8) [back to overview]Bone Scan Lesion Area
NCT02034552 (8) [back to overview]Patient Bone Scan Response Rate
NCT02039115 (1) [back to overview]Stricture Formation
NCT02043678 (14) [back to overview]Number of Participants With Treatment-emergent Bone Fractures
NCT02043678 (14) [back to overview]Number of Participants With Any Study Drug-related Post-treatment Adverse Events Per Maximum Intensity
NCT02043678 (14) [back to overview]Time to Pain Progression
NCT02043678 (14) [back to overview]Time to Opiate Use for Cancer Pain
NCT02043678 (14) [back to overview]Symptomatic Skeletal Event Free Survival (SSE-FS)
NCT02043678 (14) [back to overview]Radiological Progression Free Survival (rPFS)
NCT02043678 (14) [back to overview]Overall Survival (OS)
NCT02043678 (14) [back to overview]Number of Participants With Any Treatment-emergent Additional Primary Malignancies
NCT02043678 (14) [back to overview]Time to Cytotoxic Chemotherapy
NCT02043678 (14) [back to overview]Number of Participants With Post-treatment Adverse Events
NCT02043678 (14) [back to overview]Number of Participants With Treatment-emergent Adverse Events
NCT02043678 (14) [back to overview]Number of Participants With Post-treatment Chemotherapy-related Blood and Lymphatic System Disorders
NCT02043678 (14) [back to overview]Number of Participants With Post-treatment Bone Fractures
NCT02043678 (14) [back to overview]Number of Subjects With Radium-223/Placebo-related Treatment-emergent Adverse Events Per Maximum Intensity
NCT02055820 (22) [back to overview]Cyclophosphamide PK: Cmax
NCT02055820 (22) [back to overview]Doxorubicin PK: Cmax
NCT02055820 (22) [back to overview]Prednisone Plasma PK: Cmax
NCT02055820 (22) [back to overview]Safety: Percentage of Participants Maintaining Relative Dose Intensity of CHOP Chemotherapy
NCT02055820 (22) [back to overview]Relative Dose Intensity of Venetoclax
NCT02055820 (22) [back to overview]Prednisone Plasma PK: Tmax
NCT02055820 (22) [back to overview]Prednisone Plasma PK: AUC
NCT02055820 (22) [back to overview]Vincristine PK: Cmax
NCT02055820 (22) [back to overview]Venetoclax Plasma PK: Time to Maximum Observed Plasma Concentration (Tmax)
NCT02055820 (22) [back to overview]Venetoclax Plasma PK: Minimum Plasma Concentration (Cmin) Within the Dosing Interval
NCT02055820 (22) [back to overview]Venetoclax Plasma PK: Maximum Observed Plasma Concentration (Cmax)
NCT02055820 (22) [back to overview]Venetoclax Plasma PK: Area Under the Plasma Concentration-Time Curve (AUC)
NCT02055820 (22) [back to overview]Safety: Percentage of Participants With Adverse Events
NCT02055820 (22) [back to overview]Safety: Number of Participants With Dose-Limiting Toxicities (DLTs)
NCT02055820 (22) [back to overview]Rituximab PK: Cmin Within the Dosing Interval
NCT02055820 (22) [back to overview]Rituximab PK: Cmax
NCT02055820 (22) [back to overview]Percentage of Previously Untreated DLBCL Participants With Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Scan Using the Modified Lugano Classification Assessed by Independent Review Committee (IRC)
NCT02055820 (22) [back to overview]Percentage of Participants With Objective Response Defined as Partial Response (PR) or Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Using the Modified Lugano Classification Assessed by IRC
NCT02055820 (22) [back to overview]Percentage of Participants With CR Defined by PET/CT Scan in Previously Untreated DLBCL Co-Expressing Both Bcl-2 and c-Myc Proteins (DE-DLBCL) Participants Assessed by IRC
NCT02055820 (22) [back to overview]Percentage of Participants With CR Defined by Computed Tomography (CT) Scan Using the Modified Lugano Classification
NCT02055820 (22) [back to overview]Percentage of Participants Who Are Alive and Without Disease Progression at Month 12
NCT02055820 (22) [back to overview]Obinutuzumab PK: Cmax
NCT02072200 (3) [back to overview]Change From Baseline in Morning Stiffness Duration at Week 12 as Assessed by Patient Diary
NCT02072200 (3) [back to overview]Change of Baseline Severity of Morning Stiffness at Week 12 Using Visual Analog Scale (VAS) Scale
NCT02072200 (3) [back to overview]Change of Functional Disability Index of the Korea Health Assessment Questionnaire (KHAQ) From Baseline to Week 12
NCT02097303 (7) [back to overview]Alkaline Phosphatase (ALP) and Prostate Specific Antigen (PSA) Levels Before and After Treatment
NCT02097303 (7) [back to overview]Safety Data Was Analyzed and Summarized in Subjects Who Receive at Least One Infusion of Radium Ra 223 Dichloride. Number of Adverse Events Are Being Reported.
NCT02097303 (7) [back to overview]Radiologic Assessment Mean Number of Bone Lesions Before and After the Treatment
NCT02097303 (7) [back to overview]Overall Response Rate
NCT02097303 (7) [back to overview]Number and Percentage of Participants With Clinically Meaningful Improvement (CMI) in Pain (Between Baseline and End of Treatment)
NCT02097303 (7) [back to overview]Number and Percentage of Participants With Clinically Meaningful Improvement (Between Baseline and End of Treatment) in Quality-of-Life Determined by the Minimum Increase From Baseline in Scores as Per the QOL CMI Criteria
NCT02097303 (7) [back to overview]Bone Imaging Response (Number of Participants With Progression and Stable Disease)
NCT02133924 (8) [back to overview]Time to Discontinuation of Steroid Therapy
NCT02133924 (8) [back to overview]Number of Participants With Non-Relapse Mortality (NRM)
NCT02133924 (8) [back to overview]Number of Participants Who Received Additional GVHD Therapies
NCT02133924 (8) [back to overview]Number of Participants With Complete Response (CR)
NCT02133924 (8) [back to overview]Number of Participants With Overall Response Rate (CR + PR)
NCT02133924 (8) [back to overview]Number of Participants With Overall Survival (OS)
NCT02133924 (8) [back to overview]Number of Participants With SR GVHD
NCT02133924 (8) [back to overview]Number of Serious Infections
NCT02137239 (28) [back to overview]Absolute Calculated Glomerular Filtration Rate (cGFR): Mean
NCT02137239 (28) [back to overview]Time to Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR).
NCT02137239 (28) [back to overview]Treatment Differences in Therapeutic Modalities
NCT02137239 (28) [back to overview]Number of Participants Who Experience Graft Loss Post Transplant
NCT02137239 (28) [back to overview]Percentage of Participants With Serious Adverse Events (SAEs)
NCT02137239 (28) [back to overview]Number of Participants Who Survive With a Functioning Graft
NCT02137239 (28) [back to overview]Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection
NCT02137239 (28) [back to overview]Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA)
NCT02137239 (28) [back to overview]Absolute Values of Blood Pressure: Mean
NCT02137239 (28) [back to overview]Absolute Values of Blood Pressure: Median
NCT02137239 (28) [back to overview]Absolute Values of Fasting Lipid Values: Mean
NCT02137239 (28) [back to overview]Absolute Values of Fasting Lipid Values: Median
NCT02137239 (28) [back to overview]Mean and Mean Change From Baseline in Blood Glucose
NCT02137239 (28) [back to overview]Mean and Mean Change From Baseline in Whole Blood HbA1c
NCT02137239 (28) [back to overview]Mean Change From Month 3 in cGFR
NCT02137239 (28) [back to overview]Mean Changes From Baseline Values for Blood Pressure
NCT02137239 (28) [back to overview]Mean Changes From Baseline Values of Lipid Values
NCT02137239 (28) [back to overview]Median Calculated Glomerular Filtration Rate (cGFR)
NCT02137239 (28) [back to overview]Percentage of Participants With Adverse Events (AEs)
NCT02137239 (28) [back to overview]Percentage of Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6 Months
NCT02137239 (28) [back to overview]Number of Participants Deaths Post Transplant
NCT02137239 (28) [back to overview]Time to Event: Graft Loss and Death
NCT02137239 (28) [back to overview]Urine Protein Creatinine Ratio (UPr/Cr)
NCT02137239 (28) [back to overview]Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA)
NCT02137239 (28) [back to overview]Percentage of Participants With Events of Special Interest (ESIs)
NCT02137239 (28) [back to overview]Percentage of Participants With New Onset Diabetes After Transplant
NCT02137239 (28) [back to overview]Percentage of Particpants With Laboratory Test Abnormalities (LTAs)
NCT02137239 (28) [back to overview]Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6, 12 and 24 Months
NCT02143414 (6) [back to overview]Disease-free Survival (Cohort II)
NCT02143414 (6) [back to overview]Overall Survival Rate (Cohort I)
NCT02143414 (6) [back to overview]Complete Response Rate (Cohort I)
NCT02143414 (6) [back to overview]Incidence of Dose-limiting Toxicity (Cohort II)
NCT02143414 (6) [back to overview]Minimal Residual Disease Negativity
NCT02143414 (6) [back to overview]Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
NCT02162771 (4) [back to overview]B-cell Kinetics (B-cell Depletion and Recovery)
NCT02162771 (4) [back to overview]Overall Response Rate (ORR) According to the 1999 International Working Group (IWG) Criteria
NCT02162771 (4) [back to overview]Maximum Serum Concentration at Steady State (Cmax,ss)
NCT02162771 (4) [back to overview]Area Under the Serum Concentration-time Curve at Steady State (AUCtau)
NCT02166463 (3) [back to overview]Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death
NCT02166463 (3) [back to overview]Percentages of Patients With Early Response Defined as no Slow Responding Lesions (SRL) and no Progressive Disease (PD) at Any Disease Sites Determined by Positron Emission Tomography (PET) Per Deauville Criteria Through Central Review
NCT02166463 (3) [back to overview]Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale
NCT02169219 (8) [back to overview]Vasculitis Damage Index (VDI)
NCT02169219 (8) [back to overview]Sustained Complete Remission
NCT02169219 (8) [back to overview]Severe Flares
NCT02169219 (8) [back to overview]Partial Remission
NCT02169219 (8) [back to overview]Limited Flares
NCT02169219 (8) [back to overview]Early Treatment Failures
NCT02169219 (8) [back to overview]Disease Response
NCT02169219 (8) [back to overview]Complete Remission
NCT02188719 (5) [back to overview]Percent of Participants With Grade 3 or Higher Wound Complication(s) Adverse Event(s)
NCT02188719 (5) [back to overview]Percent of Participants With Biopsy-Proven Acute and/or Chronic Rejection
NCT02188719 (5) [back to overview]Percent of Participants With Grade 2 or Higher Hematologic Adverse Events (AEs) of Anemia, Neutropenia, and/or Thrombocytopenia
NCT02188719 (5) [back to overview]Percent of Participants With Adverse Events (AEs) Attributable to the Donor Alloantigen Reactive Tregs (darTregs) Infusion
NCT02188719 (5) [back to overview]Percent of Participants With Grade 3 or Higher Infectious Adverse Event(s)
NCT02195479 (16) [back to overview]Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30: Emotional Functioning Score
NCT02195479 (16) [back to overview]Time to Response
NCT02195479 (16) [back to overview]Time to Next Treatment (TNT)
NCT02195479 (16) [back to overview]Time to Disease Progression (TTP)
NCT02195479 (16) [back to overview]Progression Free Survival on Next Line of Therapy (PFS2)
NCT02195479 (16) [back to overview]Progression Free Survival (PFS)
NCT02195479 (16) [back to overview]Percentage of Participants With Very Good Partial Response (VGPR) or Better
NCT02195479 (16) [back to overview]Percentage of Participants With Stringent Complete Response (sCR)
NCT02195479 (16) [back to overview]Percentage of Participants With Negative Minimal Residual Disease (MRD)
NCT02195479 (16) [back to overview]Percentage of Participants With Complete Response (CR) or Better
NCT02195479 (16) [back to overview]Overall Response Rate (ORR)
NCT02195479 (16) [back to overview]Duration of Response (DOR)
NCT02195479 (16) [back to overview]Overall Survival (OS)
NCT02195479 (16) [back to overview]Percentage of Participants With Best M-protein Response
NCT02195479 (16) [back to overview]Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L): Visual Analogue Scale (VAS)
NCT02195479 (16) [back to overview]Change From Baseline in EuroQol 5 Dimensions-5 Level (EQ-5D-5L) Utility Score
NCT02217566 (6) [back to overview]Overall Survival
NCT02217566 (6) [back to overview]Percentage of Participants Who Achieved Prostate-Specific Antigen (PSA) Response
NCT02217566 (6) [back to overview]Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Severity Score
NCT02217566 (6) [back to overview]Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Interference Score
NCT02217566 (6) [back to overview]Time to Prostate-specific Antigen (PSA) Progression
NCT02217566 (6) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT02257736 (5) [back to overview]Radiographic Progression-free Survival (rPFS)
NCT02257736 (5) [back to overview]Overall Survival (OS)
NCT02257736 (5) [back to overview]Time to Chronic Opioid Use
NCT02257736 (5) [back to overview]Time to Initiation of Cytotoxic Chemotherapy
NCT02257736 (5) [back to overview]Time to Pain Progression
NCT02260934 (15) [back to overview]Percentage of Participants With an Negative Anti-dsDNA Result at Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With At Least One Grade 3 or Higher Infectious Adverse Event By Week 24, Week 48 and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With B Cell Reconstitution at Week 24, Week 48 and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With Grade 4 Hypogammaglobulinemia by Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Frequency of Specific Adverse Events of Interest By Event by Week 96
NCT02260934 (15) [back to overview]Frequency of Specific Adverse Events of Interest By Participant, By Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With an Overall Response at Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With Treatment Failure by Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Count of Participants: Frequency of Non-renal Flares by Week 96
NCT02260934 (15) [back to overview]Count of Participants: Frequency of Non-renal Flares by Week 48
NCT02260934 (15) [back to overview]Count of Participants: Frequency of Non-renal Flares by Week 24
NCT02260934 (15) [back to overview]Percentage of Participants With a Sustained Complete Response
NCT02260934 (15) [back to overview]Percentage of Participants With a Complete Response at Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants Hypocomplementemic for Complement Component C4 at Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants Hypocomplementemic for Complement Component C3 at Week 24, Week 48, and Week 96
NCT02261727 (6) [back to overview]Post Bronchodilator FEV1
NCT02261727 (6) [back to overview]Change in COPD Assessment Test (CAT) Score
NCT02261727 (6) [back to overview]Quality of Life Measured by St. George's Respiratory Questionnaire (SGRQ)
NCT02261727 (6) [back to overview]Total COPD Exacerbation Rate
NCT02261727 (6) [back to overview]Time to First COPD Exacerbation
NCT02261727 (6) [back to overview]Hospitalisations
NCT02268175 (4) [back to overview]Median Prostate Specific Antigen (PSA) Nadir
NCT02268175 (4) [back to overview]Participants With Pathologic Complete Response (pCR)
NCT02268175 (4) [back to overview]Percentage of Participants With Pathologic Complete Response (pCR) or Minimal Residual Disease (MRD)
NCT02268175 (4) [back to overview]Residual Cancer Burden (RCB)
NCT02284464 (11) [back to overview]Renal Function
NCT02284464 (11) [back to overview]Assess the Adherence to Immunosuppressive Therapy in the Two Treatment Groups
NCT02284464 (11) [back to overview]Number of Participants With Acute Rejection Lesions
NCT02284464 (11) [back to overview]Mean Score on the Protocol Biopsies in the Two Treatment Groups
NCT02284464 (11) [back to overview]Patient Survival
NCT02284464 (11) [back to overview]Graft Survival
NCT02284464 (11) [back to overview]Cases of Kidney Transplant Patients With DSA
NCT02284464 (11) [back to overview]Lipid Profile
NCT02284464 (11) [back to overview]Blood Pressure
NCT02284464 (11) [back to overview]Renal Function
NCT02284464 (11) [back to overview]Incidence of Diabetes Mellitus
NCT02285062 (15) [back to overview]Kaplan-Meier (K-M) Estimate of Event Free Survival (EFS)
NCT02285062 (15) [back to overview]Kaplan-Meier Estimate of Progression Free Survival (PFS)
NCT02285062 (15) [back to overview]Percentage of Participants Who Achieved a Complete Response (CR)
NCT02285062 (15) [back to overview]Mean Change From Baseline in the EQ-5D-3L Visual Analogue Scale (VAS)
NCT02285062 (15) [back to overview]Mean Change From Baseline in the Euroqol 5-Dimension 3-Level (EQ-5D-3L) Index Score
NCT02285062 (15) [back to overview]Mean Change From Baseline in the FACT-Lym Additional Concerns Subscale
NCT02285062 (15) [back to overview]Mean Change From Baseline in the FACT-Lym Functional Well-Being Subscale
NCT02285062 (15) [back to overview]Percentage of Participants Who Achieved an Objective Response
NCT02285062 (15) [back to overview]K-M Estimate of Overall Survival (OS)
NCT02285062 (15) [back to overview]Mean Change From Baseline in the FACT-Lym Trial Outcome Index (TOI)
NCT02285062 (15) [back to overview]Percentage of Participants Who Completed the Euroqol 5-Dimension 3-Level (EQ-5D-3L) Health Related Quality of Life (HR-QoL) Questionnaire
NCT02285062 (15) [back to overview]Percentage of Participants Who Completed the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Questionnaire
NCT02285062 (15) [back to overview]Mean Change From Baseline in the FACT-Lym Physical Well-Being Subscale
NCT02285062 (15) [back to overview]K-M Estimate of Duration of Complete Response
NCT02285062 (15) [back to overview]K-M Estimate of Time to Next Lymphoma Therapy (TTNLT)
NCT02287610 (29) [back to overview]Change in Multidimensional Health Assessment Questionnaire (MDHAQ) the Rheumatoid Arthritis Disease Activity Index (RADAI) Patient Self-report Joint Count (PTJT) Component From Baseline to Final Visit (Final Follow-up Visit)
NCT02287610 (29) [back to overview]Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Review of Symptoms (ROS) Component From Baseline to Final Visit (Final Follow-up Visit)
NCT02287610 (29) [back to overview]Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Recent Medical History Component From Baseline to Final Visit (Final Follow-up Visit)
NCT02287610 (29) [back to overview]Mean Change in Severity of Morning Stiffness (Using 100mm VAS) From Baseline (Week 0) to Final Follow-Up Visit
NCT02287610 (29) [back to overview]Percentage of Participants With American College of Rheumatology 20% Improvement (ACR20) Response From Baseline to Final Visit (Final Follow-up Visit)
NCT02287610 (29) [back to overview]Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Psychological Status (PS) Component From Baseline to Final Visit (Final Follow-up Visit)
NCT02287610 (29) [back to overview]Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Patient Global Assessment (PTGL) Component From Baseline to Final Visit (Final Follow-up Visit)
NCT02287610 (29) [back to overview]Percentage of Participants With European League Against Rheumatism (EULAR) Response From Baseline to Final Visit (Final Follow-up Visit)
NCT02287610 (29) [back to overview]Percentage of Participants With American College of Rheumatology 50% Improvement (ACR50) Response From Baseline to Final Visit (Final Follow-up Visit)
NCT02287610 (29) [back to overview]Percentage of Participants With American College of Rheumatology 70% Improvement (ACR70) Response From Baseline to Final Visit (Final Follow-up Visit)
NCT02287610 (29) [back to overview]ACR-N From Baseline to Final Visit (Final Follow-up Visit)
NCT02287610 (29) [back to overview]Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Pain (PN) Component From Baseline to Final Visit (Final Follow-up Visit)
NCT02287610 (29) [back to overview]Change in Physician's Overall Assessment in Disease Activity From Baseline to Final Visit (Final Follow-up Visit)
NCT02287610 (29) [back to overview]Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Neck and Back (NB) Component From Baseline to Final Visit (Final Follow-up Visit)
NCT02287610 (29) [back to overview]Change in Routine Assessment of Patient Index Data (RAPID3) From Baseline to Final Visit (Final Follow-up Visit)
NCT02287610 (29) [back to overview]"Change in Multidimensional Health Assessment Questionnaire (MDHAQ) How do You Feel Today (Compared to One Week Ago) Component From Baseline to Final Visit (Final Follow-up Visit)"
NCT02287610 (29) [back to overview]Change in Patient's Overall Assessment in Disease Activity From Baseline to Final Visit (Final Follow-up Visit)
NCT02287610 (29) [back to overview]Corticosteroid Sparing Effect - Change in Total Daily Prednisone Dose From Baseline to Final Visit (Final Follow-up Visit)
NCT02287610 (29) [back to overview]Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Morning Stiffness Component From Baseline to Final Visit (Final Follow-up Visit)
NCT02287610 (29) [back to overview]Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Function (FN) Component From Baseline to Final Visit (Final Follow-up Visit)
NCT02287610 (29) [back to overview]Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Fatigue (FAT) Component From Baseline to Final Visit (Final Follow-up Visit)
NCT02287610 (29) [back to overview]Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Exercise (EX) Component From Baseline to Final Visit (Final Follow-up Visit)
NCT02287610 (29) [back to overview]Change in Duration of Morning Stiffness (Minutes) From Baseline to Final Visit (Final Follow-Up Visit)
NCT02287610 (29) [back to overview]Change in Simple Disease Activity Index (SDAI) From Baseline to Final Visit (Final Follow-up Visit)
NCT02287610 (29) [back to overview]Change in Disease Activity Score in 28 Joints Calculated With Erythrocyte Sedimentation Rate (DAS28-ESR) From Baseline to Final Visit (Final Follow-up Visit)
NCT02287610 (29) [back to overview]Change in Disease Activity Score in 28 Joints Calculated With C-reactive Protein (DAS28-CRP) From Baseline to Final Visit (Final Follow-up Visit)
NCT02287610 (29) [back to overview]Change in Clinical Disease Activity Index (CDAI) From Baseline to Final Visit (Final Follow-up Visit)
NCT02287610 (29) [back to overview]Assessment of Unsolicited Serious Adverse Events
NCT02287610 (29) [back to overview]Assessment of Unsolicited Adverse Events
NCT02324699 (3) [back to overview]Crohn's Disease Activity Index (CDAI)
NCT02324699 (3) [back to overview]Change in Simple Endoscopic Score for Crohn's Disease (SES-CD)
NCT02324699 (3) [back to overview]Change in C-Reactive Protein (CRP)
NCT02334813 (1) [back to overview]Remission Duration
NCT02392286 (6) [back to overview]Number of Participants With Response or Remission at End of 4 Weeks
NCT02392286 (6) [back to overview]Number of Participants With Response at End of 2 Weeks
NCT02392286 (6) [back to overview]Number of Participants With Response or Remission at End of 1 Week
NCT02392286 (6) [back to overview]Number of Participants in Remission at End of 2 Weeks
NCT02392286 (6) [back to overview]Number of Participants With Corticosteroid-associated Side Effects
NCT02392286 (6) [back to overview]Number of Participants With Response or Remission at End of 12 Weeks
NCT02419469 (1) [back to overview]Event Free Survival (EFS)
NCT02420717 (4) [back to overview]Maximal Tolerated Dose (MTD) of Ruxolitinib in Combination With Chemotherapy Defined as the Highest Dose Level at Which no More Than 1 Out of 6 Patients Experience a Dose Limiting Toxicity (Phase I)
NCT02420717 (4) [back to overview]Overall Survival
NCT02420717 (4) [back to overview]Participants With Complete Response (Complete Response [CR]/CR With Incomplete Marrow Recovery [CRi]) (Phase II)
NCT02420717 (4) [back to overview]Progression-free Survival
NCT02463331 (2) [back to overview]Histopathological Response to Therapy
NCT02463331 (2) [back to overview]Biochemical Response to Therapy
NCT02481310 (2) [back to overview]12-month PFS (Progression Free Survival) of Treatment With Ixazomib in Combination With DA-EPOCH-R (Phase II)
NCT02481310 (2) [back to overview]To Determine the Recommended Phase II Dose (RP2D) of Ixazomib in Combination With DA-EPOCH-R.
NCT02485691 (14) [back to overview]Radiographic Progression-Free Survival (rPFS)
NCT02485691 (14) [back to overview]Time to Pain Progression
NCT02485691 (14) [back to overview]Time to PSA Progression (TTPP)
NCT02485691 (14) [back to overview]Time to Symptomatic Skeletal Event
NCT02485691 (14) [back to overview]Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Utility Single Index and Visual Analogue Scale (VAS) Scores at Cycle 2, 3, 4, 5, 6, 7, 8 and End of Treatment
NCT02485691 (14) [back to overview]Health-Related Quality of Life (HRQOL): Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score at Cycle 2, 3, 4, 5, 6, 7, 8 and End of Treatment
NCT02485691 (14) [back to overview]Radiographic Progression-Free Survival (rPFS) in Participants With Presence and Absence of Biomarker
NCT02485691 (14) [back to overview]Percentage of Participants With Prostate Specific Antigen (PSA) Response
NCT02485691 (14) [back to overview]Progression Free Survival (PFS)
NCT02485691 (14) [back to overview]Percentage of Participants With Overall Objective Tumor Response
NCT02485691 (14) [back to overview]Duration of Tumor Response
NCT02485691 (14) [back to overview]Number of Symptomatic Skeletal Events (SSE)
NCT02485691 (14) [back to overview]Overall Survival (OS)
NCT02485691 (14) [back to overview]Percentage of Participants Achieving Pain Response Assessed Using Brief Pain Inventory-Short Form (BPI-SF) Pain Intensity Score
NCT02486952 (2) [back to overview]Probability of Event Free Survival (EFS)
NCT02486952 (2) [back to overview]Percentage of Participants Who Were Alive
NCT02494921 (13) [back to overview]Number of Participants With Treatment-Related Adverse Events
NCT02494921 (13) [back to overview]Objective Response Rate (ORR) (Phase1b/2 RP2D)
NCT02494921 (13) [back to overview]RP2D of Docetaxel (Phase 1b)
NCT02494921 (13) [back to overview]Prostate-Specific Antigen (PSA) Response Rate (Phase 1b/2 RP2D)
NCT02494921 (13) [back to overview]Percentage of Participants With Radiographic Progression-free Survival at 6 Months (Phase 1b/2 RP2D)
NCT02494921 (13) [back to overview]Maximally Tolerated Dose (MTD) (Phase 1b)
NCT02494921 (13) [back to overview]Mean Maximum Serum Concentration of Ribociclib (Cmax) (Phase 1b)
NCT02494921 (13) [back to overview]Mean Maximum Serum Concentration of Ribociclib (Cmax) (Phase 1b)
NCT02494921 (13) [back to overview]Mean Area Under Curve (AUC) 0-24 Hour (Phase 1b)
NCT02494921 (13) [back to overview]Median Duration of Response (Phase1b/2 RP2D)
NCT02494921 (13) [back to overview]Median PSA Progression-Free Survival (Phase 1b/2 RP2D)
NCT02494921 (13) [back to overview]Median Radiographic Progression-free Survival (Phase1b/2 RP2D)
NCT02494921 (13) [back to overview]Mean Area Under Curve (AUC) 0-24 Hour (Phase 1b)
NCT02495077 (44) [back to overview]Percent of Participants With Death or Graft Failure.
NCT02495077 (44) [back to overview]Percent of Participants With Impaired Wound Healing Manifested by Wound Dehiscence, Wound Infection, or Hernia at the Site of the Transplant Incision
NCT02495077 (44) [back to overview]Percent of Participants With Locally Treated Rejection, Defined as Treatment Administered for Rejection Based on Clinical Signs or Biopsy Findings.
NCT02495077 (44) [back to overview]Percent of Participants With Locally Treated Rejection, Defined as Treatment Administered for Rejection Based on Clinical Signs or Biopsy Findings.
NCT02495077 (44) [back to overview]Percent of Participants With Malignancy.
NCT02495077 (44) [back to overview]Percent of Participants With Mycobacterial or Fungal Infections
NCT02495077 (44) [back to overview]Percent of Participants With Only Graft Failure.
NCT02495077 (44) [back to overview]Percent of Participants With Primary Non-Function (PNF), Defined as Dialysis-dependency for More Than 3 Months.
NCT02495077 (44) [back to overview]The Difference Between the Mean eGFR (Modified MDRD) in the Experimental vs. Control Groups.
NCT02495077 (44) [back to overview]The Percent of Participants Who Need Dialysis After Week 1.
NCT02495077 (44) [back to overview]The Percent of Participants Whose Day 2 Serum CRR Was Less Than 30%.
NCT02495077 (44) [back to overview]The Percent of Participants Whose Day 5 Serum CRR Was Less Than 70%.
NCT02495077 (44) [back to overview]The Percent of Participants With a Serum Creatinine of More Than 3 mg/dL.
NCT02495077 (44) [back to overview]Change From Baseline (Immediately After Surgery) in Serum Creatinine.
NCT02495077 (44) [back to overview]eGFR Values as Measured by CKD-EPI
NCT02495077 (44) [back to overview]eGFR Values as Measured by MDRD
NCT02495077 (44) [back to overview]BANFF Grades of First AMR.
NCT02495077 (44) [back to overview]Change in eGFR Between 3 Months and 24 Months as Measured by CKD-EPI
NCT02495077 (44) [back to overview]Change in eGFR Between 3 Months and 24 Months as Measured by MDRD
NCT02495077 (44) [back to overview]Change in eGFR Between 6 Months and 24 Months as Measured by CKD-EPI
NCT02495077 (44) [back to overview]Change in eGFR Between 6 Months and 24 Months as Measured by MDRD
NCT02495077 (44) [back to overview]Change in eGFR Between Post-transplant Nadir and 24 Months as Measured by CKD-EPI
NCT02495077 (44) [back to overview]Change in eGFR Between Post-transplant Nadir and 24 Months as Measured by MDRD
NCT02495077 (44) [back to overview]Percent of Participants That Required at Least One Dialysis Treatment.
NCT02495077 (44) [back to overview]Creatinine Reduction Ratio (CRR), Defined as the First Creatinine on Day 2 Divided by he First Creatinine After Surgery
NCT02495077 (44) [back to overview]Creatinine Reduction Ratio (CRR), Defined as the First Creatinine on Day 5 Divided by the First Creatinine After Surgery.
NCT02495077 (44) [back to overview]Days From Transplantation Until Event (ACR, AMR, or Hospitalization for Infection and/or Malignancy)
NCT02495077 (44) [back to overview]Duration of Delayed Graft Function (DGF), Defined as Time From Transplantation to the Last Required Dialysis Treatment.
NCT02495077 (44) [back to overview]eGFR Values as Measured by CKD-EPI
NCT02495077 (44) [back to overview]eGFR Values as Measured by MDRD
NCT02495077 (44) [back to overview]Number of Dialysis Sessions.
NCT02495077 (44) [back to overview]Percent of Participants With Any Infection Requiring Hospitalization or Resulting in Death.
NCT02495077 (44) [back to overview]Percent of Participants With BANFF Chronicity Scores > or Equal 2 on the 24 Month Biopsy.
NCT02495077 (44) [back to overview]Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection (AMR)
NCT02495077 (44) [back to overview]Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection (AMR).
NCT02495077 (44) [back to overview]Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection AMR or Suspicious for AMR
NCT02495077 (44) [back to overview]Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection AMR or Suspicious for AMR.
NCT02495077 (44) [back to overview]Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR)
NCT02495077 (44) [back to overview]Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR) or Borderline Rejection
NCT02495077 (44) [back to overview]Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR) or Borderline Rejection.
NCT02495077 (44) [back to overview]Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR).
NCT02495077 (44) [back to overview]Percent of Participants With BK Viremia That Require a Change in Immunosuppression or Anti-viral Treatment as Per Standard of Care at the Site.
NCT02495077 (44) [back to overview]Percent of Participants With CMV Viremia That Require a Change in Immunosuppression or Anti-viral Treatment as Per Standard of Care at the Site
NCT02495077 (44) [back to overview]Percent of Participants With de Novo DSA.
NCT02506192 (2) [back to overview]Change From Baseline of Veterans RAND 36-Item Health Survey Mental Component Summary Score (MCS) Scores at 8 and 16 Weeks
NCT02506192 (2) [back to overview]Change From Baseline of Veterans RAND 36-Item Health Survey Physical Component Summary Score (PCS) Scores at 8 and 16 Weeks
NCT02522715 (4) [back to overview]Percentage of Participants With Dose Limiting ToxicitiesGgraded by National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (Phase I)
NCT02522715 (4) [back to overview]PSA Response 1, Defined as >= 90% PSA Decline From Baseline
NCT02522715 (4) [back to overview]PSA Response 2, Defined as >= 50% PSA Decline From Baseline
NCT02522715 (4) [back to overview]PSA Response 3, Defined as >= 30% PSA Decline From Baseline
NCT02528214 (14) [back to overview]Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 12 and Week 24
NCT02528214 (14) [back to overview]Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Weeks 12 and 24
NCT02528214 (14) [back to overview]Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Score at Week 12 and Week 24
NCT02528214 (14) [back to overview]Change From Baseline in Sino Nasal Outcome Test-22 (SNOT-22) Global Score at Week 12 and Week 24
NCT02528214 (14) [back to overview]Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Week 12 and Week 24
NCT02528214 (14) [back to overview]Annualized Rate of Severe Exacerbation Events During The 24-Week Treatment Period
NCT02528214 (14) [back to overview]Percentage of Participants Achieving >= 50% Reduction in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control
NCT02528214 (14) [back to overview]Percentage of Participants Achieving a Reduction in Oral Corticosteroids Dose to <5 mg/Day at Week 24 While Maintaining Asthma Control
NCT02528214 (14) [back to overview]Percentage of Participants Achieving Maximum Possible Reduction in Oral Corticosteroids Dose Per Protocol at Week 24 While Maintaining Asthma Control
NCT02528214 (14) [back to overview]Percentage of Participants Who No Longer Required Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control
NCT02528214 (14) [back to overview]Percentage Reduction From Baseline in Oral Corticosteroids (OCS) Dose at Week 24 While Maintaining Asthma Control
NCT02528214 (14) [back to overview]Supplementary Presentation of Primary Outcome Measure Data: Median Percentage Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control
NCT02528214 (14) [back to overview]Absolute Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control
NCT02528214 (14) [back to overview]Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Score at Weeks 2, 4, 8, 12, 16, 20, and 24
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Number of Disease Flares Over Time
NCT02531633 (196) [back to overview]Part B: Number of Disease Flares Over Time
NCT02531633 (196) [back to overview]Part B: Number of Disease Flares Over Time
NCT02531633 (196) [back to overview]Part B: Number of Disease Flares Over Time
NCT02531633 (196) [back to overview]Part B: Number of Disease Flares Over Time
NCT02531633 (196) [back to overview]Part B: Number of Participants in Sustained Remission Over Time
NCT02531633 (196) [back to overview]Part B: Number of Participants in Sustained Remission Over Time
NCT02531633 (196) [back to overview]Part B: Number of Participants in Sustained Remission Over Time
NCT02531633 (196) [back to overview]Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
NCT02531633 (196) [back to overview]Part B: Number of Participants Who Remained in Sustained Remission Without Requirement for Rescue Therapy or Treatment Change at Week 24
NCT02531633 (196) [back to overview]Part B: Number of Participants Requiring at Least One Hospitalization for Disease Flare
NCT02531633 (196) [back to overview]Part B: Number of Hospitalizations for Disease Flare Over Time
NCT02531633 (196) [back to overview]Part A: Time to First Disease Flare After Clinical Remission
NCT02531633 (196) [back to overview]Part B: Time to First Disease Flare for Participants in Sustained Remission
NCT02531633 (196) [back to overview]Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
NCT02531633 (196) [back to overview]Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
NCT02531633 (196) [back to overview]Part A: Number of Participants in Sustained Remission at Week 52
NCT02531633 (196) [back to overview]Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
NCT02531633 (196) [back to overview]Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
NCT02531633 (196) [back to overview]Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
NCT02531633 (196) [back to overview]Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time
NCT02531633 (196) [back to overview]Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume
NCT02531633 (196) [back to overview]Part A: Change From Baseline in Hematology Parameter-Hematocrit
NCT02531633 (196) [back to overview]Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
NCT02531633 (196) [back to overview]Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
NCT02531633 (196) [back to overview]Part A: Change From Baseline in Pulse Rate
NCT02531633 (196) [back to overview]Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time
NCT02531633 (196) [back to overview]Part A: Change From Baseline in Temperature
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part A: Cumulative Prednisone Dose Over Time
NCT02531633 (196) [back to overview]Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B
NCT02531633 (196) [back to overview]Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time
NCT02531633 (196) [back to overview]Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time
NCT02531633 (196) [back to overview]Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time
NCT02531633 (196) [back to overview]Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time
NCT02531633 (196) [back to overview]Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time
NCT02531633 (196) [back to overview]Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time
NCT02531633 (196) [back to overview]Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time
NCT02531633 (196) [back to overview]Part A: Number of Disease Flares Over Time
NCT02531633 (196) [back to overview]Part A: Number of Hospitalizations for Disease Flare Over Time
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part A: Number of Participants With at Least One Hospitalization for Disease Flare
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part A:Change From Baseline in Hematology Parameter- Erythrocytes
NCT02531633 (196) [back to overview]Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
NCT02531633 (196) [back to overview]Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
NCT02541565 (1) [back to overview]Number of Participants With a Grade 3 or Higher Toxicity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
NCT02550652 (22) [back to overview]Terminal Plasma Half-Life (t1/2) of Obinutuzumab
NCT02550652 (22) [back to overview]Volume of Distribution Under Steady State (Vss) of Obinutuzumab
NCT02550652 (22) [back to overview]Change From Baseline in Anti-Double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Antibody Levels at Week 52
NCT02550652 (22) [back to overview]Change From Baseline in C4 Levels at Week 52
NCT02550652 (22) [back to overview]Change From Baseline in Complement Component 3 (C3) Levels at Week 52
NCT02550652 (22) [back to overview]Percentage of Participants Who Achieve Protocol Defined Complete Renal Response (CRR) at Week 52
NCT02550652 (22) [back to overview]Percentage of Participants Who Achieve Protocol Defined CRR at Week 24
NCT02550652 (22) [back to overview]Percentage of Participants Who Achieve Protocol Defined Modified CRR (mCRR1) at Week 52
NCT02550652 (22) [back to overview]Percentage of Participants Who Achieve Protocol Defined Overall Response (OR) at Week 52
NCT02550652 (22) [back to overview]Percentage of Participants Who Achieve Protocol Defined Partial Renal Response (PRR) at Week 52
NCT02550652 (22) [back to overview]Percentage of Participants Who Achieve Protocol Defined Second mCRR (mCRR2) at Week 52
NCT02550652 (22) [back to overview]Percentage of Participants Who Achieve Protocol Defined Third mCRR (mCRR3) at Week 52
NCT02550652 (22) [back to overview]Percentage of Participants With Anti-Drug Antibody (ADA) to Obinutuzumab
NCT02550652 (22) [back to overview]Area Under the Plasma Concentration Versus Time Curve (AUC) of Obinutuzumab
NCT02550652 (22) [back to overview]Change From Baseline of Participant's Global Assessment of Disease Activity Visual Analog Scale (VAS) Score
NCT02550652 (22) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Obinutuzumab
NCT02550652 (22) [back to overview]Percent Change From Baseline in Circulating CD19-Positive B-Cell Levels
NCT02550652 (22) [back to overview]Percentage of Participants With Adverse Events (AEs)
NCT02550652 (22) [back to overview]Percentage of Participants With Adverse Events of Special Interest: Infusion Related Reactions, Grade 3 or Higher Infections, Drug-related Neutropenia and Drug-related Thrombocytopenia
NCT02550652 (22) [back to overview]Percentage of Participants With First Protocol Defined CRR Over the Course of 52 Weeks
NCT02550652 (22) [back to overview]Percentage of Participants With First Protocol Defined Overall Response Over the Course of 52 Weeks
NCT02550652 (22) [back to overview]Systemic Clearance of Obinutuzumab
NCT02561273 (7) [back to overview]Number of Participants With Adverse Events Graded According to CTC (Phase II)
NCT02561273 (7) [back to overview]Complete Response Rate (Phase II)
NCT02561273 (7) [back to overview]Maximum Tolerated Dose (MTD) of Lenalidomide and CHOEP
NCT02561273 (7) [back to overview]Overall Response Rate
NCT02561273 (7) [back to overview]Overall Survival
NCT02561273 (7) [back to overview]Progression-free Survival
NCT02561273 (7) [back to overview]Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I)
NCT02562924 (3) [back to overview]Change in Lund-Kennedy Endoscopic Scores
NCT02562924 (3) [back to overview]Change in SNOT-22 Nasal Symptom Scores
NCT02562924 (3) [back to overview]Change in Sinonasal Outcome Test (SNOT-22) Questionnaire Score
NCT02573012 (23) [back to overview]Treatment Success
NCT02573012 (23) [back to overview]Changes From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) Score
NCT02573012 (23) [back to overview]Cumulative Prednisone Exposure (Dose)
NCT02573012 (23) [back to overview]Number of Administrations of Flare Rescue Medication
NCT02573012 (23) [back to overview]Percentage of Participants Who Maintain LDA (DAS28 ESR Score <=3.2) or Remission (DAS28 ESR Score <2.6) and the Percentage of Participants Who Maintain the Baseline Disease Activity Level
NCT02573012 (23) [back to overview]Time to First RA Flare
NCT02573012 (23) [back to overview]Percentage of Participants With >=1 Flare
NCT02573012 (23) [back to overview]Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Tender 68 Joint Counts
NCT02573012 (23) [back to overview]Changes From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Final Score
NCT02573012 (23) [back to overview]Percentage of Participants Who Permanently Discontinue Study Treatment Due to Insufficient Flare Control
NCT02573012 (23) [back to overview]Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24
NCT02573012 (23) [back to overview]Time to First Administration of Flare Rescue Medication
NCT02573012 (23) [back to overview]Change From Baseline in Disease Activity Score in 28 Joints - Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 24 Post-randomization
NCT02573012 (23) [back to overview]Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 24
NCT02573012 (23) [back to overview]Percentage of Participants With >=1 Administration of Flare Rescue Medication
NCT02573012 (23) [back to overview]Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Patient's Global Assessment of Disease Activity
NCT02573012 (23) [back to overview]Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Patient's Assessment of Pain
NCT02573012 (23) [back to overview]Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: High Sensitivity C-Reactive Protein (hsCRP)
NCT02573012 (23) [back to overview]Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Health Assessment Questionnaire-Disability Index (HAQ-DI)
NCT02573012 (23) [back to overview]Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Erythrocyte Sedimentation Rate (ESR)
NCT02573012 (23) [back to overview]Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Physician's Global Assessment of Disease Activity
NCT02573012 (23) [back to overview]Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Swollen 66 Joint Counts
NCT02573012 (23) [back to overview]Percentage of Visits With RA Flares
NCT02596971 (18) [back to overview]Observed Serum Rituximab Concentration
NCT02596971 (18) [back to overview]Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
NCT02596971 (18) [back to overview]Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
NCT02596971 (18) [back to overview]Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab
NCT02596971 (18) [back to overview]Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
NCT02596971 (18) [back to overview]Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Lugano 2014 Criteria
NCT02596971 (18) [back to overview]Percentage of Participants With Adverse Events
NCT02596971 (18) [back to overview]Percentage of Participants With Best Response of CR or PR During Study, as Determined by Investigator Using Modified Cheson 2007 Criteria
NCT02596971 (18) [back to overview]Percentage of Participants With Complete Response (CR) at End of Induction (EOI), as Determined by the Independent Review Committee (IRC) Using Modified Lugano 2014 Criteria
NCT02596971 (18) [back to overview]Percentage of Participants With CR at EOI, as Determined by the Investigator Using Lugano 2014 Criteria
NCT02596971 (18) [back to overview]Percentage of Participants With CR at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria
NCT02596971 (18) [back to overview]Percentage of Participants With CR at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria
NCT02596971 (18) [back to overview]Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Lugano 2014 Criteria
NCT02596971 (18) [back to overview]Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria
NCT02596971 (18) [back to overview]Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria
NCT02596971 (18) [back to overview]Observed Serum Atezolizumab Concentration
NCT02596971 (18) [back to overview]Observed Serum Atezolizumab Concentration
NCT02596971 (18) [back to overview]Observed Serum Obinutuzumab Concentration
NCT02613910 (11) [back to overview]Number of Participants With Serious Adverse Events (SAEs) and AEs of Special Interest (AESI)
NCT02613910 (11) [back to overview]Number of Participants With Adverse Events(AEs) and AEs Leading to Permanent Discontinuation of Ofatumumab SC (AELD)
NCT02613910 (11) [back to overview]Number of Participants With Clinically-significant Electrocardiogram (ECG) Abnormalities
NCT02613910 (11) [back to overview]Number of Participants With Adverse Events Related to Ofatumumab SC
NCT02613910 (11) [back to overview]Number of Participants With Injection Site Reactions
NCT02613910 (11) [back to overview]Number of Participants Withdrawn Due to Treatment-related AEs
NCT02613910 (11) [back to overview]Number of Participants With Vital Signs of Clinical Concern
NCT02613910 (11) [back to overview]Number of Participants With Severe Adverse Events
NCT02613910 (11) [back to overview]Number of Participants With Post-injection Systemic Reactions
NCT02613910 (11) [back to overview]Number of Participants With Laboratory Results of Potential Clinical Concern
NCT02613910 (11) [back to overview]Number of Participants With Infections
NCT02617485 (12) [back to overview]Area Under the Serum Concentration-time Curve From Day 1 to Week 4 (AUC[1-4])
NCT02617485 (12) [back to overview]Area Under the Serum Concentration-time Curve From Week 13 to Week 26 (AUC[W13-W26])
NCT02617485 (12) [back to overview]AUC (W1-W26)
NCT02617485 (12) [back to overview]AUC (W1-W26) B-cell
NCT02617485 (12) [back to overview]Ctrough (Before 8th Infusion)
NCT02617485 (12) [back to overview]Adverse Events
NCT02617485 (12) [back to overview]Efficacy Assessment at Week 26
NCT02617485 (12) [back to overview]Cmax (Post 5th and 8th Infusion)
NCT02617485 (12) [back to overview]T1/2 (Post 5th and 8th Infusions)
NCT02617485 (12) [back to overview]Kel (Post 5th and 8th Infusions)
NCT02617485 (12) [back to overview]CLss (Post 5th and 8th Infusions)
NCT02617485 (12) [back to overview]Immunogenicity
NCT02685267 (3) [back to overview]PSA Response in the Standard Treatment Arm and Experimental Treatment Arm
NCT02685267 (3) [back to overview]Overall Survival
NCT02685267 (3) [back to overview]Progression-free Survival (Radiographic or Per PCWG2 Criteria)
NCT02716818 (6) [back to overview]Change From Baseline to 24 Weeks of the Mean of the 24-hour Standard Deviation Score (SDS) Profile for 17-OHP
NCT02716818 (6) [back to overview]Number of Participants With 17-OHP and A4 Levels in the Optimal Range at 9:00 at Week 24 Visit
NCT02716818 (6) [back to overview]Changes Relative to Standard Glucocorticoid Therapy in Body Composition (DEXA - Fat Mass and Lean Mass)
NCT02716818 (6) [back to overview]Changes Relative to Standard Glucocorticoid Therapy in Body Composition (DEXA - Bone Mineral Density) - Measured at All Sites Except Germany.
NCT02716818 (6) [back to overview]17-OHP and A4 by Individual Baseline Treatment Strata.
NCT02716818 (6) [back to overview]Change From Baseline to 24 Weeks of the Mean of the 24-hour Standard Deviation Score (SDS) Profile for A4
NCT02741271 (13) [back to overview]Time to Maximum Plasma Concentration (Tmax) of Mometsone Furoate
NCT02741271 (13) [back to overview]Mean Change From Baseline in Total Daily Use of Short-Acting Beta-Agonist (SABA) Rescue Medication With MF/F MDI 100/10 mcg BID or MF MDI 100 mcg BID Over the First 12 Weeks of Treatment
NCT02741271 (13) [back to overview]Change From Baseline AM Post-Dose Percent Predicted FEV1 on Day 1 of Treatment
NCT02741271 (13) [back to overview]Participants Using SABA Rescue Medication Across Weeks 1-12 of the Treatment Period
NCT02741271 (13) [back to overview]Area Under the Plasma Concentration-Time Curve of Mometasone Furoate From Time 0 to Time of Last Measurable Concentration (AUC0-last)
NCT02741271 (13) [back to overview]Count (Percentage) of Participants Discontinuing From Study Medication Due to An AE
NCT02741271 (13) [back to overview]Count (Percentage) of Participants Experiencing At Least One Adverse Event (AE)
NCT02741271 (13) [back to overview]Change From Baseline AM Post-Dose % Predicted FEV1 AUC 0-4 Hours on Day 1 and Week 12 of Treatment
NCT02741271 (13) [back to overview]Change From Baseline in Morning (AM) Post-Dose % Predicted Forced Expiratory Volume in One Second (FEV1) in the Area Under the Curve (AUC)0-60
NCT02741271 (13) [back to overview]Change From Baseline in AM Pre-Dose % Predicted FEV1 With MF/F MDI 100/10 mcg BID or MF MDI 100 mcg BID Over the First 12 Weeks of Treatment
NCT02741271 (13) [back to overview]Area Under the Plasma Concentration-Time Curve of Mometasone Furoate From Time 0 to 12 Hours (AUC0-12)
NCT02741271 (13) [back to overview]Participants Whose SABA Rescue Medication Use Increased Across Weeks 1-12 of the Treatment Period
NCT02741271 (13) [back to overview]Maximum Plasma Concentration (Cmax) of Mometsone Furoate
NCT02748070 (2) [back to overview]Lund Kennedy Endoscopy Score Over Time
NCT02748070 (2) [back to overview]Sino-nasal Outcome Test (SNOT-22) Over Time
NCT02806947 (11) [back to overview]Percentage of Participants With Overall Survival
NCT02806947 (11) [back to overview]Percentage of Participants With Complete or Partial Response (CR/PR) to Acute GVHD Treatment
NCT02806947 (11) [back to overview]Percentage of Participants With Non-relapse Mortality
NCT02806947 (11) [back to overview]Percentage of Participants With Malignancy Relapse
NCT02806947 (11) [back to overview]Acute GVHD Response
NCT02806947 (11) [back to overview]Percentage of Participants With Chronic GVHD
NCT02806947 (11) [back to overview]Proportion of Participants With Event-free Survival
NCT02806947 (11) [back to overview]Percentage of Participants With Treatment Failure
NCT02806947 (11) [back to overview]Percentage of Participants With Serious Infections
NCT02806947 (11) [back to overview]Percentage of Participants With Disease-free Survival
NCT02806947 (11) [back to overview]Percentage of Participants With GVHD-free Survival
NCT02836496 (5) [back to overview]Number of HES Flares Per Participant Per Year
NCT02836496 (5) [back to overview]Percentage of Participants Who Experienced an HES Flare or Who Withdrew From the Study During the 32-Week Study Treatment Period
NCT02836496 (5) [back to overview]Number of Participants With Change From Baseline in Fatigue Severity Based on Brief Fatigue Inventory (BFI) in Item 3 (Worst Level of Fatigue During Past 24 Hours) at Week 32 by Category
NCT02836496 (5) [back to overview]Time to First HES Flare
NCT02836496 (5) [back to overview]Percentage of Participants Who Experienced a HES Flare or Who Withdrew From the Study During Week 20 Through Week 32
NCT02844582 (2) [back to overview]PSA Response Rate, Defined as >= 50% Decline in PSA From Baseline Maintained for at Least 3 Weeks and Measured by the Same Laboratory, and Without Evidence of Other Disease Progression Documented at Time of Confirmatory Values
NCT02844582 (2) [back to overview]Incidence of Adverse Events, Serious Adverse Events, and Discontinuations, Described and Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03
NCT02849990 (7) [back to overview]Number of Participants Without Biochemical Failure at 2 Years
NCT02849990 (7) [back to overview]Number of Patients With a Near Pathologic Complete Response After 3 Months of Treatment
NCT02849990 (7) [back to overview]Number of Patients With Pathologic T3 Disease After 3 Months of Treatment.
NCT02849990 (7) [back to overview]Overall Survival (OS)
NCT02849990 (7) [back to overview]Pathologic Complete Response Rate as Assessed From Prostatectomy Specimens Following Neoadjuvant Treatment
NCT02849990 (7) [back to overview]The Proportion of Men Who Receive Adjuvant Radiation Therapy
NCT02849990 (7) [back to overview]Number of Patients With no Nodal Metastases After 3 Months of Treatment.
NCT02855359 (2) [back to overview]Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
NCT02855359 (2) [back to overview]Part A and Part B Outcome Measure: Incidence of Adverse Events
NCT02903368 (17) [back to overview]Biochemical Progression Free Survival (bPFS) Rate at 4 Years Post RP [Part 2]
NCT02903368 (17) [back to overview]Rate of Freedom From Further Anti-cancer Therapy at 2-years Post RP (Part 2)
NCT02903368 (17) [back to overview]Percent of Participants With Nadir PSA < 0.2 ng/mL Prior to RP (Part 1)
NCT02903368 (17) [back to overview]Median of Residual Cancer Burden (RCB) at RP (Part 1)
NCT02903368 (17) [back to overview]Combined pCR or MRD Rate [Part 1]
NCT02903368 (17) [back to overview]Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 12-months Post-RP (Part 2)
NCT02903368 (17) [back to overview]Frequency of Presenting Intraductal Carcinoma at RP (Part 1)
NCT02903368 (17) [back to overview]Frequency of Presenting Intra-operative Complications Following RP (Part 1)
NCT02903368 (17) [back to overview]Biochemical Progression Free Survival (bPFS) Rate at 2 Years Post RP [Part 2]
NCT02903368 (17) [back to overview]Biochemical Progression Free Survival (bPFS) Rate at 3 Years Post RP [Part 2]
NCT02903368 (17) [back to overview]Frequency of Presenting Cribriform at RP (Part 1)
NCT02903368 (17) [back to overview]Frequency of Positive Surgical Margins at RP (Part 1)
NCT02903368 (17) [back to overview]Rate of Freedom From Further Anti-cancer Therapy at 3-years Post RP (Part 2)
NCT02903368 (17) [back to overview]Rate of Freedom From Further Anti-cancer Therapy at 4-years Post RP (Part 2)
NCT02903368 (17) [back to overview]Rate of pCR at RP (Part 1)
NCT02903368 (17) [back to overview]Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 24-months Post-RP (Part 2)
NCT02903368 (17) [back to overview]Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 6-months Post-RP (Part 2)
NCT02921789 (5) [back to overview]Percentage of Participants With Recurrence of Focal Segmental Glomerulosclerosis (rFSGS) or Death or Graft Loss or Lost to Follow-up Through 3 Months Post Transplant
NCT02921789 (5) [back to overview]Percentage of Participants With rFSGS or Death or Graft Loss or Lost to Follow-up Through 6 and 12 Months Post Transplant
NCT02921789 (5) [back to overview]Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) Through 3, 6, and 12 Months Post Transplant
NCT02921789 (5) [back to overview]Percentage of Participants With Biopsy Proven rFSGS Through 3, 6 and 12 Months Post-Transplant
NCT02921789 (5) [back to overview]Percentage of Participants With Efficacy Failure Through 12 Months Post Transplant
NCT02927834 (3) [back to overview]CT Scan Changes
NCT02927834 (3) [back to overview]Nasal Endoscopy
NCT02927834 (3) [back to overview]Sinonasal Outcome Test (SNOT 20)
NCT02953678 (10) [back to overview]Nonrelapse Mortality (NRM)
NCT02953678 (10) [back to overview]Relapse Rate
NCT02953678 (10) [back to overview]Relapse-related Mortality Rate
NCT02953678 (10) [back to overview]Overall Response Rate (ORR) at Day 28
NCT02953678 (10) [back to overview]Failure-free Survival (FFS)
NCT02953678 (10) [back to overview]Overall Survival (OS)
NCT02953678 (10) [back to overview]Overall Response Rate (ORR)
NCT02953678 (10) [back to overview]Percentage of Participants With Six-month Duration of Response (DOR)
NCT02953678 (10) [back to overview]Percentage of Participants With Three-month DOR
NCT02953678 (10) [back to overview]Number of Participants With Treatment-emergent Adverse Events (TEAES), Serious TEAEs, And Grade 3 or Higher TEAEs
NCT02953873 (5) [back to overview]Weight-Based Dose Requirement
NCT02953873 (5) [back to overview]Total Daily Dose
NCT02953873 (5) [back to overview]Number of Days to Reach Therapeutic Trough Goal
NCT02953873 (5) [back to overview]Dose-normalized Trough
NCT02953873 (5) [back to overview]Dose Modifications
NCT02954198 (4) [back to overview]Self-reported Medication Adherence From Baseline to 6 Months.
NCT02954198 (4) [back to overview]Subject Specific Change on Medication Side Effect Scale
NCT02954198 (4) [back to overview]Percent of Participants Who Experienced Kidney Transplant Graft Loss
NCT02954198 (4) [back to overview]Percent of Participants Experiencing Acute Allograft Rejection
NCT02955147 (4) [back to overview]Number of Participants With Disease Flare
NCT02955147 (4) [back to overview]Percentage of Patients in Glucocorticoid-free Remission
NCT02955147 (4) [back to overview]Cumulative Prednisone Dose
NCT02955147 (4) [back to overview]Number of Participants With at Least One Adverse Event
NCT02959944 (19) [back to overview]Final Analysis: Percentage of Participants Who Achieved Reduction of Prednisone Dose Level to Less Than 0.15 mg/kg/Day at 24 Weeks Sustained for at Least 30 Days
NCT02959944 (19) [back to overview]Final Analysis: Percentage of Participants With Improvement in Overall Score on Lee cGVHD Symptom Scale at Two Consecutive Visits
NCT02959944 (19) [back to overview]Final Analysis: Response Rate at 24 Weeks
NCT02959944 (19) [back to overview]Final Analysis: Response Rate at 48 Weeks
NCT02959944 (19) [back to overview]Primary Analysis: Duration of Response (DOR) for Participants Who Had PR or CR at Any Time
NCT02959944 (19) [back to overview]Primary Analysis: Overall Survival (OS)
NCT02959944 (19) [back to overview]Primary Analysis: Percentage of Participants Who Achieved Reduction of Prednisone Dose Level to Less Than 0.15 mg/kg/Day at 24 Weeks Sustained for at Least 30 Days
NCT02959944 (19) [back to overview]Primary Analysis: Percentage of Participants With Improvement in Overall Score on Lee cGVHD Symptom Scale at Two Consecutive Visits
NCT02959944 (19) [back to overview]Primary Analysis: Response Rate at 24 Weeks
NCT02959944 (19) [back to overview]Primary Analysis: Response Rate at 48 Weeks
NCT02959944 (19) [back to overview]Final Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD
NCT02959944 (19) [back to overview]Final Analysis: Cumulative Incidence of Withdrawal of All Immunosuppressants
NCT02959944 (19) [back to overview]Final Analysis: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs Placebo in Combination With Prednisone
NCT02959944 (19) [back to overview]Primary Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD
NCT02959944 (19) [back to overview]Primary Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD
NCT02959944 (19) [back to overview]Primary Analysis: Cumulative Incidence of Withdrawal of All Immunosuppressants
NCT02959944 (19) [back to overview]Primary Analysis: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs Placebo in Combination With Prednisone
NCT02959944 (19) [back to overview]Final Analysis: DOR for Participants Who Had PR or CR at Any Time
NCT02959944 (19) [back to overview]Final Analysis: OS
NCT02985957 (33) [back to overview]Objective Response Rate (ORR) Cohorts B and C Per BICR
NCT02985957 (33) [back to overview]Objective Response Rate (ORR) Cohort D
NCT02985957 (33) [back to overview]Overall Survival (OS) Cohorts B and C
NCT02985957 (33) [back to overview]The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
NCT02985957 (33) [back to overview]The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D
NCT02985957 (33) [back to overview]The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
NCT02985957 (33) [back to overview]Change in Cancer-Related Symptoms and Quality of Life (QoL) by Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire Cohort D
NCT02985957 (33) [back to overview]Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohorts B and C
NCT02985957 (33) [back to overview]The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort D
NCT02985957 (33) [back to overview]The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort A, B and C
NCT02985957 (33) [back to overview]The Number of Participants With Liver Function Laboratory Abnormalities in Cohorts A, B and C
NCT02985957 (33) [back to overview]The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohort D
NCT02985957 (33) [back to overview]The Number of Participants With Liver Function Laboratory Abnormalities in Cohort D
NCT02985957 (33) [back to overview]The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohorts A, B and C
NCT02985957 (33) [back to overview]The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohort D
NCT02985957 (33) [back to overview]The Number of Participants Experiencing Adverse Events (AEs) in Cohorts A, B and C
NCT02985957 (33) [back to overview]The Number of Participants Experiencing Adverse Events (AEs) in Cohort D
NCT02985957 (33) [back to overview]Radiographic/Clinical Progression Free Survival (rcPFS) for Cohorts B and C
NCT02985957 (33) [back to overview]Radiographic/Clinical Progression Free Survival (rcPFS) for Cohort D
NCT02985957 (33) [back to overview]Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohort D
NCT02985957 (33) [back to overview]Radiographic Progression-Free Survival (rPFS) for Cohort D
NCT02985957 (33) [back to overview]Radiographic Progression Free Survival (rPFS) for Cohorts B and C Per BICR
NCT02985957 (33) [back to overview]Prostate-Specific Antigen Response Rate (PSA-RR) Cohorts B and C
NCT02985957 (33) [back to overview]Prostate-Specific Antigen Response Rate (PSA-RR) Cohort D
NCT02985957 (33) [back to overview]Overall Survival (OS) Cohort D
NCT02985957 (33) [back to overview]The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohorts A, B and C
NCT02985957 (33) [back to overview]The Number of Participants Who Died in Cohort D
NCT02985957 (33) [back to overview]The Number of Participants Who Died in Cohorts A, B and C
NCT02985957 (33) [back to overview]The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C
NCT02985957 (33) [back to overview]Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohort D
NCT02985957 (33) [back to overview]Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohorts B and C
NCT02985957 (33) [back to overview]The Number of Participants Experiencing Immune Mediated Adverse Events in Cohort D
NCT02985957 (33) [back to overview]The Number of Participants Experiencing Immune Mediated Adverse Events in Cohorts A, B and C
NCT02994927 (28) [back to overview]Certain Safety Endpoints of Interest: Infections, Hepatic System Abnormalities, WBC Count Decreases, and Hypersensitivity
NCT02994927 (28) [back to overview]Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving BVAS=0 at Any Time During the Treatment Period
NCT02994927 (28) [back to overview]Percentage of Subjects Achieving Sustained Disease Remission at Week 52
NCT02994927 (28) [back to overview]Percentage of Subjects Achieving Disease Remission at Week 26
NCT02994927 (28) [back to overview]Percentage of Participants With BVAS of 0 at Week 4, Regardless of Whether the Subjects Received Glucocorticoids During This Period of Time and Based on Assessment by the Blinded AC
NCT02994927 (28) [back to overview]Number of Subjects With Clinically Significant ECG Changes From Baseline
NCT02994927 (28) [back to overview]Number of Subjects Experiencing a Relapse After Previously Achieving BVAS=0 During the Study
NCT02994927 (28) [back to overview]Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission at Week 26 in the Study
NCT02994927 (28) [back to overview]Change From Baseline in Vital Signs (4/5)
NCT02994927 (28) [back to overview]Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs
NCT02994927 (28) [back to overview]Number of Subjects Where a Relationship Between Avacopan/Placebo, Glucocorticoid Use, Cyclophosphamide, Rituximab, and Azathioprine or Mycophenolate Use to an AE Was Determined by the Investigator
NCT02994927 (28) [back to overview]In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Percent Change in Urinary MCP-1:Creatinine Ratio From Baseline Over 52 Weeks
NCT02994927 (28) [back to overview]In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Change in eGFR From Baseline Over 52 Weeks
NCT02994927 (28) [back to overview]In Subjects With Renal Disease and Albuminuria at Baseline (Based in the BVAS Renal Component), the Percent Change in UACR From Baseline Over 52 Weeks
NCT02994927 (28) [back to overview]Glucocorticoid-induced Toxicity as Measured by Change From Baseline Over the First 26 Weeks in the GTI
NCT02994927 (28) [back to overview]Change in the VDI From Baseline Over 52 Weeks, Including the Week 26 and Week 52 Time Points
NCT02994927 (28) [back to overview]Change From Baseline Over 52 Weeks in Health-related Quality of Life as Measured by the Domains and Component Scores of the SF-36v2 and EQ-5D-5L VAS and Index
NCT02994927 (28) [back to overview]Change From Baseline in Vital Signs (5/5)
NCT02994927 (28) [back to overview]Change From Baseline in Vital Signs (3/5)
NCT02994927 (28) [back to overview]Change From Baseline in Vital Signs (2/5)
NCT02994927 (28) [back to overview]Change From Baseline in Vital Signs (1/5)
NCT02994927 (28) [back to overview]Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (2/2)
NCT02994927 (28) [back to overview]Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (1/2)
NCT02994927 (28) [back to overview]Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (5/5)
NCT02994927 (28) [back to overview]Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (4/5)
NCT02994927 (28) [back to overview]Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (3/5)
NCT02994927 (28) [back to overview]Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (2/5)
NCT02994927 (28) [back to overview]Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (1/5)
NCT03003520 (8) [back to overview]Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for Immunohistochemistry (IHC) Programmed Death Ligand - 1 (PDL1) Total Percentage
NCT03003520 (8) [back to overview]Percentage of Participants Who Responded During Induction and Continued Into Consolidation Therapy (Database Cutoff Date: 02-Aug-2018)
NCT03003520 (8) [back to overview]Participants With Treatment Emergent Adverse Events (TEAE)
NCT03003520 (8) [back to overview]Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for Immunohistochemistry (IHC) Programmed Death Ligand - 1 (PDL1) Percentage of Tumor Cells
NCT03003520 (8) [back to overview]Percentage of Participants Who Achieved a Complete Response (CR) at the End of Induction Therapy
NCT03003520 (8) [back to overview]Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for the Interferon Gamma Score (IFNG-Score) From Ribonucleic Acid (RNA)-Sequencing Data
NCT03003520 (8) [back to overview]Participants With Treatment Emergent Adverse Events (TEAE)
NCT03003520 (8) [back to overview]Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for Immunohistochemistry (IHC) CD8 T-Cell Density
NCT03023046 (5) [back to overview]Number of Participants With Complete Measurable Residual Disease (MRD) Response Rate
NCT03023046 (5) [back to overview]Overall Survival
NCT03023046 (5) [back to overview]Number of Participants With Morphological Complete Response Rate
NCT03023046 (5) [back to overview]Number of Participants With Adverse Events
NCT03023046 (5) [back to overview]Event-free Survival
NCT03023891 (4) [back to overview]Glucose Tolerance Test: Area Under the Curve (AUC) for C-peptide Levels
NCT03023891 (4) [back to overview]Glucose Tolerance Test: Area Under the Curve (AUC) for Insulin Levels
NCT03023891 (4) [back to overview]White Blood Cell Counts
NCT03023891 (4) [back to overview]Glucose Tolerance Test: Area Under the Curve (AUC) for Plasma Glucose
NCT03043105 (6) [back to overview]Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 ( ≥1 Grade)
NCT03043105 (6) [back to overview]Number of Participants With Treatment-related Serious Adverse Events as Assessed by CTCAE v4.0 ( ≥3 Grade)
NCT03043105 (6) [back to overview]Number of Patients With Durable Tumor and Symptomatic Response
NCT03043105 (6) [back to overview]Overall Survival
NCT03043105 (6) [back to overview]Progression-free Survival
NCT03043105 (6) [back to overview]Change in SF-36 Score
NCT03072238 (4) [back to overview]Investigator-Assessed Radiographic Progression-Free Survival (rPFS) Per PCWG3 Criteria (Intent-To-Treat (ITT) Population)
NCT03072238 (4) [back to overview]Plasma Concentrations of Abiraterone at Specified Timepoints
NCT03072238 (4) [back to overview]Investigator-Assessed Radiographic Progression-Free Survival (rPFS) Per PCWG3 Criteria (PTEN Loss Population)
NCT03072238 (4) [back to overview]Plasma Concentrations of Ipatasertib at Specified Timepoints
NCT03093272 (5) [back to overview]To Evaluate Progression-free Survival on the Combination of Docetaxel Plus Apalutamide
NCT03093272 (5) [back to overview]Serum PSA Change From Baseline to 12 Weeks on Treatment
NCT03093272 (5) [back to overview]Maximum Blood Concentration (Cmax) for Docetaxel Pharmacokinetic Analysis
NCT03093272 (5) [back to overview]Area Under the Curve (AUC) for Docetaxel Pharmacokinetic Analysis
NCT03093272 (5) [back to overview]Overall Survival
NCT03113500 (2) [back to overview]Complete Response (CR) Rate After Cyclophosphamide, Doxorubicin, Etoposide, Prednisone, and Brentuximab Vedotin (CHEP-BV) Induction Therapy
NCT03113500 (2) [back to overview]Overall Survival at 1 Year
NCT03139604 (20) [back to overview]Incidence Rate of aGVHD Flares
NCT03139604 (20) [back to overview]Failure-free Survival
NCT03139604 (20) [back to overview]Duration of Response
NCT03139604 (20) [back to overview]Time to Response
NCT03139604 (20) [back to overview]Number of Treatment-emergent Adverse Events With INCB39110
NCT03139604 (20) [back to overview]Cmin of Itacitinib When Administered in Combination With Corticosteroids
NCT03139604 (20) [back to overview]Cmax of Itacitinib When Administered in Combination With Corticosteroids
NCT03139604 (20) [back to overview]CL/F of Itacitinib When Administered in Combination With Corticosteroids
NCT03139604 (20) [back to overview]AUC of Itacitinib When Administered in Combination With Corticosteroids
NCT03139604 (20) [back to overview]Proportion of Subjects Who Discontinue Corticosteroids
NCT03139604 (20) [back to overview]Objective Response Rate
NCT03139604 (20) [back to overview]Nonrelapse Mortality
NCT03139604 (20) [back to overview]Incidence Rate of cGVHD
NCT03139604 (20) [back to overview]Tmax of Itacitinib When Administered in Combination With Corticosteroids
NCT03139604 (20) [back to overview]Relapse Rate of Malignant and Nonmalignant Hematologic Disease
NCT03139604 (20) [back to overview]Overall Survival (OS)
NCT03139604 (20) [back to overview]Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response Index
NCT03139604 (20) [back to overview]Proportion of Subjects Who Discontinue Immunosuppressive Medications
NCT03139604 (20) [back to overview]Malignancy Relapse-related Mortality Rate
NCT03139604 (20) [back to overview]Incidence Rate of Secondary Graft Failure
NCT03150056 (39) [back to overview]Number of Participants With AEs Leading to Any Dose Reduction or Delays Until End of the Study
NCT03150056 (39) [back to overview]Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
NCT03150056 (39) [back to overview]Cmax of Abiraterone
NCT03150056 (39) [back to overview]Ctrough of Enzalutamide
NCT03150056 (39) [back to overview]Maximum Observed Plasma Concentration (Cmax) of GSK525762 and Its Active Metabolites GSK3529246
NCT03150056 (39) [back to overview]Number of Participants With AEs Leading to Any Dose Reduction or Delays
NCT03150056 (39) [back to overview]Number of Participants Who Withdrew Due to Toxicity and Changes in Safety Assessment Until End of the Study
NCT03150056 (39) [back to overview]Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Until End of the Study
NCT03150056 (39) [back to overview]Number of Participants With Worst-Case Post Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
NCT03150056 (39) [back to overview]Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
NCT03150056 (39) [back to overview]Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
NCT03150056 (39) [back to overview]Cmax of Enzalutamide
NCT03150056 (39) [back to overview]Circulating Tumor Cells (CTC) Response Rate
NCT03150056 (39) [back to overview]AUC(0-tau) of Enzalutamide
NCT03150056 (39) [back to overview]Ctrough of Abiraterone
NCT03150056 (39) [back to overview]Prostate-specific Antigen (PSA) Response Rate at Week 4
NCT03150056 (39) [back to overview]Radiographic Progression-free Survival (rPFS)
NCT03150056 (39) [back to overview]Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT03150056 (39) [back to overview]Number of Participants Who Withdrew Due to Toxicity and Changes in Safety Assessment
NCT03150056 (39) [back to overview]Tmax of Enzalutamide
NCT03150056 (39) [back to overview]Time to Cmax (Tmax) of GSK525762 and Its Active Metabolites GSK3529246
NCT03150056 (39) [back to overview]Tmax of Abiraterone
NCT03150056 (39) [back to overview]Trough Concentration (Ctrough) of GSK525762 and Its Active Metabolites GSK3529246
NCT03150056 (39) [back to overview]Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUC[0-tau]) of GSK525762 and Its Active Metabolites GSK3529246
NCT03150056 (39) [back to overview]Disease Control Rate at Week 24
NCT03150056 (39) [back to overview]Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUC[0-tau]) of GSK525762 and Its Active Metabolites GSK3529246
NCT03150056 (39) [back to overview]Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
NCT03150056 (39) [back to overview]Time to Disease Progression
NCT03150056 (39) [back to overview]Objective Response Rate
NCT03150056 (39) [back to overview]Trough Concentration (Ctrough) of GSK525762 and Its Active Metabolites GSK3529246
NCT03150056 (39) [back to overview]Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
NCT03150056 (39) [back to overview]Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)
NCT03150056 (39) [back to overview]Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours
NCT03150056 (39) [back to overview]Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours
NCT03150056 (39) [back to overview]Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours
NCT03150056 (39) [back to overview]Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours
NCT03150056 (39) [back to overview]AUC(0-tau) of Abiraterone
NCT03150056 (39) [back to overview]Percentage of Participants With Greater Than or Equals to (>=)50 Percent (%) Decrease in Prostate-specific Antigen From Baseline (PSA50)
NCT03150056 (39) [back to overview]Composite Response Rate
NCT03207815 (9) [back to overview]Percentage of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24
NCT03207815 (9) [back to overview]Time to Development of Macular Edema in At Least One Eye on or After Week 6
NCT03207815 (9) [back to overview]Change in Anterior Chamber (AC) Cell Grade in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET
NCT03207815 (9) [back to overview]Change in Logarithm of the Minimal Angle of Resolution (logMAR) Best Corrected Visual Acuity (BCVA) in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET
NCT03207815 (9) [back to overview]Change in Vitreous Haze (VH) Grade in Each Eye (NEI/SUN Criteria), From Best State Achieved Prior to Week 6 to Week 52 or End of Treatment (EOT) Visit or Early Termination (ET)
NCT03207815 (9) [back to overview]Log Change in Central Retinal Thickness in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET
NCT03207815 (9) [back to overview]Plasma Concentration of Filgotinib
NCT03207815 (9) [back to overview]Plasma Concentration of Metabolite, GS-829845
NCT03207815 (9) [back to overview]Time to Treatment Failure on or After Week 6
NCT03279250 (2) [back to overview]The Number of Participants With Rate of Pathologic Stage =< pT2N0 at Prostatectomy
NCT03279250 (2) [back to overview]Number of Participants With Incidence of Adverse Events
NCT03304626 (4) [back to overview]Number of Participants With Acute Cellular Rejection Between Study and Control Groups
NCT03304626 (4) [back to overview]Rate of New Onset Diabetes After Transplant
NCT03304626 (4) [back to overview]Number of Participants With Adrenal Suppression
NCT03304626 (4) [back to overview]Number of Participants With Adverse Events
NCT03338790 (9) [back to overview]Number of Participants With Laboratory Values Change From Baseline
NCT03338790 (9) [back to overview]Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3)
NCT03338790 (9) [back to overview]Prostate-Specific Antigen Response Rate (RR-PSA)
NCT03338790 (9) [back to overview]Number of Deaths
NCT03338790 (9) [back to overview]Number of Participants With Adverse Events (AEs)
NCT03338790 (9) [back to overview]Number of Participants With Laboratory Abnormalities in Specific Liver Tests
NCT03338790 (9) [back to overview]Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
NCT03338790 (9) [back to overview]Number of Participants With Laboratory Values Change From Baseline
NCT03338790 (9) [back to overview]Number of Participants With Laboratory Values Change From Baseline
NCT03384654 (13) [back to overview]Cohort 1: Percentage of Participants With Complete Response (CR) for B-cell Acute Lymphoblastic Leukemia (ALL)
NCT03384654 (13) [back to overview]Overall Response Rate (ORR)
NCT03384654 (13) [back to overview]Concentration of Daratumumab in Cerebrospinal Fluid (CSF)
NCT03384654 (13) [back to overview]Concentration of Daratumumab in Cerebrospinal Fluid (CSF)
NCT03384654 (13) [back to overview]Minimum Observed Serum Concentration (Cmin) of Daratumumab
NCT03384654 (13) [back to overview]Cohort 2: Percentage of Participants With Complete Response (CR) for T-cell ALL
NCT03384654 (13) [back to overview]Event-free Survival (EFS)
NCT03384654 (13) [back to overview]Maximum Observed Serum Concentration (Cmax) of Daratumumab
NCT03384654 (13) [back to overview]Minimal Residual Disease (MRD) Negative Rate
NCT03384654 (13) [back to overview]Overall Survival (OS)
NCT03384654 (13) [back to overview]Number of Participants With Anti-daratumumab Antibodies
NCT03384654 (13) [back to overview]Relapse-free Survival (RFS)
NCT03384654 (13) [back to overview]Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
NCT03388008 (1) [back to overview]Donor-specific HLA Antibodies, Re-transplantation, or Death
NCT03412565 (14) [back to overview]Maximum Observed Serum Concentration (Cmax) of Daratumumab
NCT03412565 (14) [back to overview]Maximum Observed Serum Concentration (Cmax) of Daratumumab
NCT03412565 (14) [back to overview]Maximum Observed Serum Concentration (Cmax) of Daratumumab
NCT03412565 (14) [back to overview]Maximum Observed Serum Concentration (Cmax) of Daratumumab
NCT03412565 (14) [back to overview]D-VRd Cohort: Overall Response Rate (ORR)
NCT03412565 (14) [back to overview]D-VMP, D-Rd, and D-Kd Cohorts: Percentage of Participants With VGPR or Better Response
NCT03412565 (14) [back to overview]D-VMP, D-Rd, and D-Kd Cohorts: Percentage of Participants With Minimal Residual Disease (MRD) Negative Rate
NCT03412565 (14) [back to overview]D-VMP, D-Rd, and D-Kd Cohorts: Overall Response Rate (ORR)
NCT03412565 (14) [back to overview]D-VMP, D-Rd and D-Kd Cohorts: Duration of Response (DOR)
NCT03412565 (14) [back to overview]D-VRd Cohort: Percentage of Participants With Very Good Partial Response (VGPR) or Better Response
NCT03412565 (14) [back to overview]Percentage of Participants With CR or Better Response
NCT03412565 (14) [back to overview]Percentage of Participants With Anti-rHuPH20 Antibodies
NCT03412565 (14) [back to overview]Percentage of Participants With Infusion-Related Reactions (IRRs)
NCT03412565 (14) [back to overview]Percentage of Participants With Anti-Daratumumab Antibodies
NCT03431350 (11) [back to overview]Combination 3: Area Under the Plasma Concentration-Time Curve From Time Zero to 168 Hours (AUC [0-168hr]) of Niraparib Administered With AA After a Single Dose
NCT03431350 (11) [back to overview]Combination 1: Part 2: Objective Response Rate (ORR)
NCT03431350 (11) [back to overview]Combination 2: Number of Participants With Adverse Events (AEs) of Grade >=3 Severity
NCT03431350 (11) [back to overview]Combination 1: Part 2: Number of Participants With Adverse Events (AEs) of Grade >=3 Severity
NCT03431350 (11) [back to overview]Combination 1: Part 2: Number of Participants With Adverse Events (AEs)
NCT03431350 (11) [back to overview]Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib and Abiraterone Acetate After a Single Dose
NCT03431350 (11) [back to overview]Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib Normalized by the Dose(Niraparib) (Cmax/Dose) of Niraparib Administered With AA After a Single Dose
NCT03431350 (11) [back to overview]Combination 2: Composite Response Rate (RR)
NCT03431350 (11) [back to overview]Combination 3: Area Under the Plasma Concentration-Time Curve for Niraparib From Time Zero to 168 Hours (AUC [0-168 Hours]/Dose) of Niraparib Administered With AA After a Single Dose
NCT03431350 (11) [back to overview]Combination 2: Number of Participants With Adverse Events (AEs)
NCT03431350 (11) [back to overview]Combination 1: Part 1: Number of Participants With Specified Toxicity
NCT03439670 (1) [back to overview]Efficacy Measured by Time to Stand Test (TTSTAND) Velocity in Rises/Second Change From Baseline
NCT03488225 (5) [back to overview]Number of Participants With Minimal Residual Disease (MRD) Negativity
NCT03488225 (5) [back to overview]Overall Survival
NCT03488225 (5) [back to overview]Event-Free Survival
NCT03488225 (5) [back to overview]Participants to Achieve Complete Remission (CR):
NCT03488225 (5) [back to overview]Number of Participants With Adverse Events
NCT03589326 (1) [back to overview]Number of Participants With Minimal Residual Disease (MRD)-Negative Complete Remission (CR) at The End of Induction Phase
NCT03600805 (24) [back to overview]Number of Participants With Absence of Disease Flare From Week 12 Through Week 24: ITT Population
NCT03600805 (24) [back to overview]Pharmacodynamics: Change From Baseline in Interleukin-6 (IL-6) at Weeks 2, 12, 24, and 52
NCT03600805 (24) [back to overview]Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab
NCT03600805 (24) [back to overview]Pharmacodynamics: Change From Baseline in Soluble Interleukin-6 Receptor (sIL-6R) Level at Weeks 2, 12, 24, and 52
NCT03600805 (24) [back to overview]Pharmacodynamics: Change From Baseline in Soluble Interleukin-6 Receptor (sIL-6R) Level at Weeks 2, 12, 24, and 52
NCT03600805 (24) [back to overview]Pharmacodynamics: Change From Baseline in Soluble Interleukin-6 Receptor (sIL-6R) Level at Weeks 2, 12, 24, and 52
NCT03600805 (24) [back to overview]Pharmacodynamics: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52
NCT03600805 (24) [back to overview]Pharmacodynamics: Change From Baseline in C-reactive Protein (CRP) Level at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52
NCT03600805 (24) [back to overview]Percentage of Participants With Treatment-emergent Antidrug Antibodies (ADA) Response
NCT03600805 (24) [back to overview]Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
NCT03600805 (24) [back to overview]Composite Glucocorticoid Toxicity Index: Cumulative Worsening Score and Aggregate Improvement Score at Week 52
NCT03600805 (24) [back to overview]Composite Glucocorticoid Toxicity Index (C-GTI): Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 24: ITT Population
NCT03600805 (24) [back to overview]Total Cumulative Corticosteroid (Including Prednisone) Dose
NCT03600805 (24) [back to overview]Time to First Giant Cell Arteritis Disease Flare
NCT03600805 (24) [back to overview]Pharmacokinetics: Serum Drug Concentration of Sarilumab Post-dose at Week 24
NCT03600805 (24) [back to overview]Percentage of Participants Who Achieved Sustained Disease Remission at Week 52
NCT03600805 (24) [back to overview]Percentage of Participants Who Achieved Sustained Disease Remission at Week 24
NCT03600805 (24) [back to overview]Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 52: Week 52 Analysis Set
NCT03600805 (24) [back to overview]Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 24: ITT Population
NCT03600805 (24) [back to overview]Number of Participants With Normalization of C-Reactive Protein From Week 12 Through Week 52: Week 52 Analysis Set
NCT03600805 (24) [back to overview]Number of Participants With Normalization of C-Reactive Protein (CRP) From Week 12 Through Week 24: ITT Population
NCT03600805 (24) [back to overview]Number of Participants With Achievement of Disease Remission up to Week 12: Week 52 Analysis Set
NCT03600805 (24) [back to overview]Number of Participants With Achievement of Disease Remission up to Week 12: Intent-to-treat (ITT) Population
NCT03600805 (24) [back to overview]Number of Participants With Absence of Disease Flare From Week 12 Through Week 52: Week 52 Analysis Set
NCT03600818 (17) [back to overview]Number of Participants With Absence of Disease Flare From Week 12 Through Week 52
NCT03600818 (17) [back to overview]Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During TEAE Period
NCT03600818 (17) [back to overview]Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
NCT03600818 (17) [back to overview]Number of Participants With Treatment-emergent Antidrug Antibodies (ADA) Response
NCT03600818 (17) [back to overview]Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function
NCT03600818 (17) [back to overview]Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameter
NCT03600818 (17) [back to overview]Total Cumulative Corticosteroid Dose
NCT03600818 (17) [back to overview]Number of Participants Who Achieved Disease Remission up to Week 12
NCT03600818 (17) [back to overview]Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab
NCT03600818 (17) [back to overview]Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 52
NCT03600818 (17) [back to overview]Number of Participants With Sustained Reduction of CRP From Week 12 Through Week 52
NCT03600818 (17) [back to overview]Percentage of Participants Achieving Sustained Remission at Week 52
NCT03600818 (17) [back to overview]Pharmacokinetics: Serum Drug Concentration of Sarilumab Post-dose at Week 24
NCT03600818 (17) [back to overview]Time to First Polymyalgia Rheumatica Flare After Clinical Remission up to Week 52
NCT03600818 (17) [back to overview]Composite Glucocorticoid Toxicity Index (C-GTI): Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 52
NCT03600818 (17) [back to overview]Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters
NCT03600818 (17) [back to overview]Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function
NCT03649841 (2) [back to overview]Rate of Undetectable Prostate Specific Antigen (PSA) (< 0.2)
NCT03649841 (2) [back to overview]Incidence of Adverse Events
NCT03721965 (1) [back to overview]Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
NCT03726749 (5) [back to overview]Adverse Events
NCT03726749 (5) [back to overview]Cumulative Prednisone Dose
NCT03726749 (5) [back to overview]Disease Flares
NCT03726749 (5) [back to overview]Serious Adverse Events
NCT03726749 (5) [back to overview]Sustained Remission
NCT03748641 (1) [back to overview]Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)
NCT03793439 (2) [back to overview]Number of Participants With Significantly Decreased Expression of STAT1 Mediated Genes as Determined by RNA Sequencing
NCT03793439 (2) [back to overview]Number of Participants With 50% Reduction in Corticosteroid Requirement
NCT03816332 (4) [back to overview]Duration of Overall Survival After Receiving Nivolumab, Tacrolimus, and Prednisone
NCT03816332 (4) [back to overview]Duration of Progression-free Survival After Receiving Nivolumab, Tacrolimus, and Prednisone
NCT03816332 (4) [back to overview]Rate of Allograft Loss After Receiving Ipilimumab, Nivolumab, Tacrolimus, and Prednisone
NCT03816332 (4) [back to overview]Number (and Percentage) of Outcome Responses After Receiving Nivolumab, Tacrolimus, and Prednisone
NCT03817853 (8) [back to overview]Objective Response Rate (ORR) at the End of Induction (EOI) Therapy
NCT03817853 (8) [back to overview]Duration (In Minutes) of Obinutuzumab Administration by Cycle
NCT03817853 (8) [back to overview]Time to IRR From Infusion to Onset of the IRR During Cycle 2
NCT03817853 (8) [back to overview]Percentage of Participants With Adverse Events (AEs)
NCT03817853 (8) [back to overview]Percentage of Grade >=3 Infusion-Related Reactions (IRRs) During Cycle 2 in Patients Who Had Previously Received Obinutuzumab at the Standard Infusion Rate During Cycle 1 Without Experiencing a Grade 3 or 4 IRR
NCT03817853 (8) [back to overview]Duration of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle
NCT03817853 (8) [back to overview]Percentage of IRRs Regardless of Grade by Cycle
NCT03817853 (8) [back to overview]Type of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle
NCT03827018 (10) [back to overview]Time to Signs/Symptoms of Giant Cell Arteritis (GCA) or New or Worsening Vasculitis on Imaging by Week 26
NCT03827018 (10) [back to overview]Time to Elevated Erythrocyte Sedimentation Rate (ESR) by Week 26
NCT03827018 (10) [back to overview]Time to Elevated C-Reactive Protein (CRP) by Week 26
NCT03827018 (10) [back to overview]Cumulative Corticosteroid Dose at the End of the Washout Safety Follow-up Period
NCT03827018 (10) [back to overview]Cumulative Corticosteroid Dose at Week 26
NCT03827018 (10) [back to overview]Percentage of Participants Who Completed the 26-Week Corticosteroid Taper and Who Had a Normal CRP Level
NCT03827018 (10) [back to overview]Percentage of Participants Who Completed the 26-Week Corticosteroid Taper and Who Had a Normal ESR
NCT03827018 (10) [back to overview]Percentage of Participants Who Completed the 26-week Corticosteroid Taper and Who Had No Signs or Symptoms of GCA Nor New or Worsening Vasculitis by Imaging by Week 26
NCT03827018 (10) [back to overview]Sustained Remission Rate at Week 26
NCT03827018 (10) [back to overview]Time to Flare by Week 26
NCT03827473 (5) [back to overview]Prostate Specific Antigen Progression Free Survival (PSA-PFS)
NCT03827473 (5) [back to overview]Prostate-specific Antigen (PSA) Response
NCT03827473 (5) [back to overview]Change in Quality of Life - FACT-P
NCT03827473 (5) [back to overview]Change in Quality of Life - FACT/GOG-NTX
NCT03827473 (5) [back to overview]Change in Quality of Life - PROMIS Fatigue
NCT03834506 (12) [back to overview]Time to Radiographic Soft Tissue Progression Per Soft Tissue Rules of Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
NCT03834506 (12) [back to overview]Time to Prostate-specific Antigen (PSA) Progression
NCT03834506 (12) [back to overview]Time to Initiation of the First Subsequent Anti-cancer Therapy (TFST)
NCT03834506 (12) [back to overview]Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)
NCT03834506 (12) [back to overview]Duration of Response (DOR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review
NCT03834506 (12) [back to overview]"Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 (Worst Pain in 24 Hours) and Opiate Analgesic Use Assessed by the Analgesic Quantification Algorithm [AQA] Score"
NCT03834506 (12) [back to overview]Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
NCT03834506 (12) [back to overview]Overall Survival (OS)
NCT03834506 (12) [back to overview]Objective Response Rate (ORR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review
NCT03834506 (12) [back to overview]Number of Participants Who Experienced an Adverse Event (AE)
NCT03834506 (12) [back to overview]Prostate-specific Antigen (PSA) Response Rate
NCT03834506 (12) [back to overview]Time to First Symptomatic Skeletal-related Event (SSRE)
NCT03834519 (2) [back to overview]Radiographic Progression-Free Survival (rPFS)
NCT03834519 (2) [back to overview]Overall Survival (OS)
NCT03895801 (12) [back to overview]IFX-1 Blocking Activity 10 nM
NCT03895801 (12) [back to overview]Vasculitis Damage Index (VDI)
NCT03895801 (12) [back to overview]Change From Baseline in BVASv3 Total Score
NCT03895801 (12) [back to overview]Plasma Concentrations of C5a
NCT03895801 (12) [back to overview]Physician Global Assessment (PGA)
NCT03895801 (12) [back to overview]IFX-1 Plasma Concentrations (Pre-dose)
NCT03895801 (12) [back to overview]IFX-1 Blocking Activity 2.5 nM
NCT03895801 (12) [back to overview]Glucocorticoid Toxicity Index (GTI)
NCT03895801 (12) [back to overview]Percentage of Subjects With Clinical Remission
NCT03895801 (12) [back to overview]Percentage of Subjects Achieving Clinical Response
NCT03895801 (12) [back to overview]Number and Percentage of Subjects Who Had a Treatment-emergent Adverse Event (TEAE)
NCT03895801 (12) [back to overview]Estimated Glomerular Filtration Rate
NCT04054375 (15) [back to overview]Fasting Glucose
NCT04054375 (15) [back to overview]Fasting Lipid Profile
NCT04054375 (15) [back to overview]Muscle Strength Test
NCT04054375 (15) [back to overview]Functional Assessments - Upper Limb Strength
NCT04054375 (15) [back to overview]Respiratory Changes
NCT04054375 (15) [back to overview]Creatine Kinase
NCT04054375 (15) [back to overview]Brooke Scale Score
NCT04054375 (15) [back to overview]Bone Density
NCT04054375 (15) [back to overview]Vignos Scale Score
NCT04054375 (15) [back to overview]HbgA1c
NCT04054375 (15) [back to overview]6 Minute Walk Test
NCT04054375 (15) [back to overview]10 Meter Run Timed
NCT04054375 (15) [back to overview]Muscle Imaging
NCT04054375 (15) [back to overview]Lean Mass %
NCT04054375 (15) [back to overview]Functional Assessments - NSAD Change
NCT04072822 (15) [back to overview]Number of Participants With AKI (Acute Kidney Injury)
NCT04072822 (15) [back to overview]Number of Participants With Changes in Sequential Organ Failure Assessment (SOFA) Scores and Proportions Requiring Hemodynamic Support for MAP < 65 mm Hg and Lactate > 2 mmol/l, Renal Replacement Therapy or Mechanical Ventilation.
NCT04072822 (15) [back to overview]Number of Participants Requiring Transfer to ICU for Care, Intubation for Airway Control, Need for Ventilator Support or RRT.
NCT04072822 (15) [back to overview]Number of Participants With Infections
NCT04072822 (15) [back to overview]Percentage of Participants With Renal Dysfunction
NCT04072822 (15) [back to overview]Survival at 90 Days
NCT04072822 (15) [back to overview]To Measure the Changes in Lille Score
NCT04072822 (15) [back to overview]Transplant Free Survival Rate
NCT04072822 (15) [back to overview]Changes in Liver Function
NCT04072822 (15) [back to overview]Number of Participants With Progression of Sepsis
NCT04072822 (15) [back to overview]Number of Transfers to ICU
NCT04072822 (15) [back to overview]Survival
NCT04072822 (15) [back to overview]Changes in MELD Score
NCT04072822 (15) [back to overview]Development of Multi-organ Failure
NCT04072822 (15) [back to overview]Development of SIRS (Systemic Inflammatory Response Syndrome)
NCT04177095 (6) [back to overview]Incidence of Acute Rejection
NCT04177095 (6) [back to overview]Incidence of Acute Rejection
NCT04177095 (6) [back to overview]Incidence of de Novo Donor Specific Antibodies
NCT04177095 (6) [back to overview]Increase in eGFR
NCT04177095 (6) [back to overview]Survival
NCT04177095 (6) [back to overview]Rate of New-onset Proteinuria
NCT04542278 (7) [back to overview]Percent Change From Baseline Mean in Autoantibody Levels
NCT04542278 (7) [back to overview]Change in Thyroid-specific Quality of Life Patient-reported Outcome Measure for Benign Thyroid Disorders (ThyPRO) Score
NCT04542278 (7) [back to overview]Change in Short Form Health Survey (SF-12) Physical Component Score (PCS)
NCT04542278 (7) [back to overview]Change in Short Form Health Survey (SF-12) Mental Component Score (MCS)
NCT04542278 (7) [back to overview]Thyroid Difficulty Scale Score
NCT04542278 (7) [back to overview]Surgical Complications: Parathyroid Hormone (PTH) Level
NCT04542278 (7) [back to overview]Number of Participants With Surgical Complications: Recurrent Laryngeal Nerve (RLN) Injury
NCT04660799 (14) [back to overview]Observed SC and IV Rituximab Area Under the Curve (AUCsc and AUCiv)
NCT04660799 (14) [back to overview]Subcutaneous Serum Rituximab Trough Concentration (Ctrough SC) and Intravenous Serum Rituximab Trough Concentration (Ctrough IV)
NCT04660799 (14) [back to overview]Area Under the Curve (AUC) of Rituximab
NCT04660799 (14) [back to overview]Maximum Observed Serum Concentration (Cmax) of Rituximab
NCT04660799 (14) [back to overview]Number of Participants Positive for Anti-drug Antibodies (ADAs) to Rituximab
NCT04660799 (14) [back to overview]Number of Participants Positive for Anti-rHuPH20 Antibodies
NCT04660799 (14) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT04660799 (14) [back to overview]Objective Response Rate (ORR), Complete Response (CR) or Partial Response (PR), as Determined by Investigator and IRC Using Lugano Response Criteria (LRC) for Malignant Lymphoma
NCT04660799 (14) [back to overview]Time to Cmax (Tmax) of Rituximab
NCT04660799 (14) [back to overview]Trough Serum Concentration (Ctrough) of Rituximab
NCT04660799 (14) [back to overview]Number of Participants With Rituximab Administration-related Reactions (ARRs)
NCT04660799 (14) [back to overview]Complete Response Rate (CRR) as Determined by the Independent Review Committee (IRC) Using Lugano Response Criteria (LRC) for Malignant Lymphoma
NCT04660799 (14) [back to overview]CRR, as Determined by IRC Using International Working Group (IWG) Response Criteria for Non-Hodgkin's Lymphoma (NHL) 1999 Guidelines
NCT04660799 (14) [back to overview]CRR, as Determined by the Investigator Using Lugano Response Criteria for Malignant Lymphoma
NCT04745832 (2) [back to overview]Number of SAEs (Zandelisib When Combined With Rituximab)
NCT04745832 (2) [back to overview]Number of Treatment Emergent AEs (Zandelisib When Combined With Rituximab)
NCT04766996 (2) [back to overview]Nebraska Interprofessional Education Attitude Scale (NIPEAS) Score for Professional Staff Arm
NCT04766996 (2) [back to overview]Total Post-operative Opioid Requirements With Non-opioid Drug Regimen
NCT04907227 (12) [back to overview]Time to Initiation of the First Subsequent Anti-cancer Therapy (TFST)
NCT04907227 (12) [back to overview]Time to First Symptomatic Skeletal-related Event (SSRE)
NCT04907227 (12) [back to overview]Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
NCT04907227 (12) [back to overview]Prostate-specific Antigen (PSA) Response Rate
NCT04907227 (12) [back to overview]Objective Response Rate (ORR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review
NCT04907227 (12) [back to overview]Number of Participants Who Experienced an Adverse Event (AE)
NCT04907227 (12) [back to overview]Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)
NCT04907227 (12) [back to overview]"Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 (Worst Pain in 24 Hours) and Opiate Analgesic Use Assessed by the Analgesic Quantification Algorithm [AQA] Score"
NCT04907227 (12) [back to overview]Overall Survival (OS)
NCT04907227 (12) [back to overview]Time to Radiographic Soft Tissue Progression Per Soft Tissue Rules of Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
NCT04907227 (12) [back to overview]Time to Prostate-specific Antigen (PSA) Progression
NCT04907227 (12) [back to overview]Duration of Response (DOR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review

Complete Remission (CR)

complete remission (CR) Disappearance of all clinical evidence of leukemia for a minimum of four weeks. The patient should have a neutrophil count > 1,000 x 10^6/1, a platelet count > 100,000 x 10^9/1, no circulating blasts, and < than or = to blasts on bone marrow differential in a qualitatively normal or hypercellular marrow. Progressive disease or failure: Increasing bone marrow infiltrate or development of organ failure or extramedullary infiltrates due to leukemia. (NCT00002766)
Timeframe: 2 years

,
Interventionparticipants (Number)
Complete RemissionComplete Response (CR)FailureFailure-ProgressionRelapse
All-25014581
L-20501114100

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Failure-free Survival at 5 Years

"Failure-free survival is defined as the time from randomization to the earlier of progression/relapse or death. The 5-year failure-free survival is the probability a patient is failure-free and survives 5 years.~Progression is defined as an increase in size of 25% of the sum of the products of the pretreatment measurements or appearance of new lesions. Significant enlargement of the liver or spleen is evidence of progression. A significant increase in size is defined as > 2.0 cm in distance between costal margin and the inferior margin of either organ.~Relapse is defined as the re-appearance of any clinical evidence of Hodgkin's disease in a patient who has had a complete response. Relapse for partial responders is defined as progressive disease relative to disease status during the partial remission." (NCT00003389)
Timeframe: Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5

InterventionProportion of patients (Number)
Arm A (ABVD)0.74
Arm B (Stanford V)0.71

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5-year Overall Survival

Overall survival is defined as the time from randomization to death or last known alive. The 5-year survival rate is the probability a patient survives 5 years. (NCT00003389)
Timeframe: Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years

InterventionProportion of patients (Number)
Arm A (ABVD)0.88
Arm B (Stanford V)0.88

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Incidence of Second Cancers

Number of patients who developed second primary cancers (NCT00003389)
Timeframe: Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years

Interventionparticipants (Number)
Arm A (ABVD)15
Arm B (Stanford V)19

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Proportion of Patients With Complete or Partial Response to Treatment With MTX

We will report the overall response rate below. Complete remission requires that all of the following be present for at least four weeks: The patient must have a normal CBC including neutrophil count > 1500/mm3, lymphocyte count< 4000/mm3, hemoglobin > 11 g/dl, and platelet count > 100,000/mm3. In addition, the patient must have a normal LGL count. A complete response will be attained if CD8+ cells were less than 760/mm³. A partial response will be defined as achievement of any one of the following in the absence of CR. The response must last for at least four weeks:In patients being treated for severe neutropenia (less than 500 neutrophils/mm3) an improvement to over 500 neutrophils/mm3 will be considered a partial response, as long as that improvement represents at least a 50% improvement. (NCT00003910)
Timeframe: Assessed during the first 4 months, then at least every three months for two years. Then every six months until five years after study entry, and every 12 months thereafter until full study stop date.

Interventionproportion of participants (Number)
Methotrexate0.39

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Proportion of Patients With Complete or Partial Response to Treatment of CY Among Patients Failing to Respond to MTX

We will report the overall response rate below. Complete remission requires that all of the following be present for at least four weeks: The patient must have a normal CBC including neutrophil count > 1500/mm3, lymphocyte count< 4000/mm3, hemoglobin > 11 g/dl, and platelet count > 100,000/mm3. In addition, the patient must have a normal LGL count. A complete response will be attained if CD8+ cells were less than 760/mm³. A partial response will be defined as achievement of any one of the following in the absence of CR. The response must last for at least four weeks:In patients being treated for severe neutropenia (less than 500 neutrophils/mm3) an improvement to over 500 neutrophils/mm3 will be considered a partial response, as long as that improvement represents at least a 50% improvement. (NCT00003910)
Timeframe: Assessed during the first 4 months of treatment and followed until reaching full study stop date

Interventionproportion of participants (Number)
Cyclophosphamide (Cy)0.64

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2-year Overall Survival Rates

Percentage of participants surviving 2 years post registration (NCT00004031)
Timeframe: up to 2 years post registration

Interventionpercentage of participants (Number)
CHOP/CHOP-R x 371.1
CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant73.7

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2 Year Progression-free Survival

Percentage of participants without disease progression up to 2 years post-registration. (NCT00004031)
Timeframe: From registration until death

Interventionpercentage of participants (Number)
CHOP/CHOP-R x 355.4
CHOP/CHOP-R x 1 + Autologous Stem Cell Transplant69.1

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Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients

Number of patients with adverse events that are related to study drug (NCT00004124)
Timeframe: Up to 22 months from registration

,
InterventionParticipants (Number)
Abdominal pain/crampingAbscessAlkaline phosphatase increaseAllergic reactionAllergic rhinitisAlopeciaAnal incontinenceAnemiaAnorexiaAnxiety/agitationApneaArrhythmia, NOSArthralgiaArthritisAtaxia (incoordination)Bilirubin increaseBlurred visionBone painBruisingCPK increaseCardiac ischemia/infarctionCardiovascular-otherCataractCerebrovascular ischemiaChest pain,not cardio or pleurConduction abnormality/blockConfusionConjunctivitisConstipation/bowel obstructionCoughCreatinine increaseCushingoid appearanceDehydrationDepressionDiarrhea without colostomyDizziness/light headednessDry eyeDry skinDysmenorrheaDyspepsia/heartburnDyspneaDysuriaEar-otherEdemaEndocrine-otherEpistaxisErectile impotenceEryth/rash/eruption/desq, NOSEsophagitis/dysphagiaEye-otherFatigue/malaise/lethargyFebrile neutropeniaFeminization of maleFever without neutropeniaFever, NOSFlatulenceFlu-like symptoms-otherFlushingGGT increaseGI Mucositis, NOSGI-otherGU-otherGastritisGastritis/ulcer, NOSGlaucomaGynecomastiaHeadacheHematologic-otherHematuriaHemolysisHemoptysisHemorrhage-otherHiccoughsHot flashesHypercalcemiaHypercholesterolemiaHyperglycemiaHyperkalemiaHypermagnesemiaHypernatremiaHypertensionHypertriglyceridemiaHypoalbuminemiaHypocalcemiaHypoglycemiaHypokalemiaHypomagnesemiaHyponatremiaHypotensionHypothyroidismHypoxiaIncontinenceInfection w/o 3-4 neutropeniaInfection with 3-4 neutropeniaInfection, unk ANCInner ear-hearing lossInsomniaInvol. movement/restlessnessJoint,muscle,bone-otherLVEF decrease/CHFLeukopeniaLibido lossLocal injection site reactionLung-otherLymphopeniaMale infertilityMelena/ GI bleedingMemory lossMetabolic-otherMiddle ear-hearing loss/otitisMood/consciousness change, NOSMouth drynessMuscle weakness (not neuro)MyalgiaMyalgia/arthralgia, NOSMyocarditisNail changesNauseaNeuro-otherNeuropathic painNeutropenia/granulocytopeniaPRBC transfusionPain-otherPalpitationsPelvic painPericar. effusion/pericarditisPersonality/behavioral changePhlebitisPigmentation changes/yellowingPleural effusionsPneumonitis/infiltratesProctitisProteinuriaPruritusRT-GI mucositis, NOSRT-focal dermatitis, NOSRT-late bladder morbidityRT-late intestinal morbidityRT-painRash/desquamationRectal bleeding/hematocheziaRectal/perirectal painRespiratory infect w/o neutropRespiratory infection, unk ANCRigors/chillsSGOT (AST) increaseSGPT (ALT) increaseSalivary change, NOSSecond primarySeizuresSensory neuropathySexual/reproductive-otherSinus bradycardiaSkin-otherSpeech impairmentStomatitis/pharyngitisSupraventricular arrhythmiaSurgery-wound infectionSweatingSyncopeTaste disturbanceTearingThrombocytopeniaThrombosis/embolismTremorTroponin T (cTnT) increaseUrinary frequency/urgencyUrinary retentionUrinary tr infect w/ neutropUrinary tr infect w/o neutropUrinary tr infection, unk ANCUrine color changeUrticariaVentricular arrhythmiaVertigoVision,NOSVoice change/stridor/larynxVomitingWeakness (motor neuropathy)Weight gainWeight loss
Arm I: Bicalutamide + Goserelin19011129125275210431715319101051111605710700805533111072114040301810212580101225101292021403719001043945440003821108133208850137921101416311042015002105526104265011011219012000043130312146127117422200137201105001380103200861301333110010317912
Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin411115161312141416211641712063414215601901441173417868575715281444911256221462136357209636401020901010082113114442252784143806711112110471102429222783171331724932121131377451215720541239312761111153114123110106310578244226161571411149211293466355211017122444011651615129

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Overall Survival

Measured from date of randomization to date of death from any cause. Patient known to be alive are censored at date of last contact. (NCT00004124)
Timeframe: at 10 Years

Interventionpercentage of probability of survival (Number)
Arm I: Bicalutamide + Goserelin87
Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin86

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Disease Free Survival

Measured from date of randomization to date of first observation of recurrence or death due to any cause. Patients without recurrence are censored at date of last contact. (NCT00004124)
Timeframe: at 10 Years

Interventionpercentage of probability of survival (Number)
Arm I: Bicalutamide + Goserelin72
Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin72

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Percentage of Patients With Overall Survival as Assessed by Time to Death

Overall survival will be computed by measuring the rate of deaths during induction due primarily to treatment toxicity and cumulative incidence of toxic deaths in induction or deaths in remission overall and separately for treatment groups defined by the two design factors. (NCT00004228)
Timeframe: 5 years

Interventionpercentage of participants (Number)
A0 (Localized Disease Stg I/II) Modified CCG BFM96
A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens84
A2 (Disseminated, No CNS - CCG Mod BFM w/Intens88
B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy81
B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens85
B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens85
B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment92

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Event-free Survival

Assessed by time to treatment failure, occurrence of second malignant neoplasm, or death from any cause. Statistical analysis will be to estimate the difference in the proportion of patients treated with each therapy who are long-term event-free survivors due either to the difference between the backbone therapy regimens (CCG BFM vs NHL/BFM-95), or due to the intensification. (NCT00004228)
Timeframe: 5 years

Interventionpercentage of particpants (Number)
A0 (Localized Disease Stg I/II) Modified CCG BFM88
A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens82
A2 (Disseminated, No CNS - CCG Mod BFM w/ Intens80
B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy63
B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens82
B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens84
B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment90

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Progression Free Survival (PFS) in Participants Who Received Idiotype Vaccine

PFS is defined as the time from start of treatment until disease relapse or progression, death, or last follow-up. Progression was measured by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphoma and is defined as ≥50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously involved node or the appearance of any new lesion (NCT00005780)
Timeframe: Time from treatment start date until date of disease relapse or progression, death, or date last follow-up, an average of 25 months

InterventionMonths (Median)
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab25.0

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Percentage of Participants With Antibodies to Keyhole Limpet Haemocyanin (KLH)

Participants with an immune response against carrier molecule KLH measured by enzyme-linked immunosorbent assay (ELISA) to detect antibody binding to tumor cells. Positive response was defined as at least a fourfold increase in antibody titer. (NCT00005780)
Timeframe: After vaccinations administered at 0, 1, 2, 3 and 5 months

Interventionpercentage of participants (Number)
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab74

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Percentage of Participants With an Antibody Response to Idiotype Vaccine

Participants with an immune response to idiotype vaccine measured by enzyme-linked immunosorbent assay (ELISA) to detect antibody binding to tumor cells. Positive response was defined as at least a fourfold increase in antibody titer. (NCT00005780)
Timeframe: Weeks 12 to 32

Interventionpercentage of participants (Number)
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab30

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Median Progression-free Survival (PFS) in Participants Treated With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R)

PFS is time from on study date until disease relapse or progression, death, or date of last follow-up. Progression was measured by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphoma and is defined as ≥50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously involved node or the appearance of any new lesion. (NCT00005780)
Timeframe: From participants on study date until date of disease relapse or progression, death, or date of last follow-up, assessed up to 245.8 months

InterventionMonths (Median)
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab23.5

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Percentage of Participants With Induction of Type 1 Cytokine T-cell Response

Participants with tumor specific T-cell responses during B-cell recovery was assessed in a Clinical Laboratory Improvement Amendments (CLIA) certified lab and were measured by flow cytometry and/or enzyme-linked immunosorbent spot (ELISPOT). A positive response required the response to be at least twice the negative controls. (NCT00005780)
Timeframe: After vaccinations administered at 0, 1, 2, 3 and 5 months

Interventionpercentage of participants (Number)
Peripheral blood mononuclear cells (PBMC)Granulocyte macrophage colony-stimulating factor (GM-CSF)Tumor necrosis factor α (TNFα)Interferon-gamma (IFN-γ)
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab87655274

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Time to Recovery of CD4 T Lymphocytes (CD4+)

Recovery of CD4+ was measured by flow cytometry. Blood samples were collected via apheresis and analyzed by multicolor flow cytometry in peripheral blood mononuclear cells (PBMCs) for cluster of differentiation 4 (CD4). Time to recovery of CD4 T lymphocytes was defined as the time required for CD4 T lymphocytes to increase above the lower limit of normal of the normal laboratory value range of 359 cells/mcL (NCT00005780)
Timeframe: After chemotherapy before vaccination, up to 6 months

InterventionMonths (Median)
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab3

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Overall Survival (OS)

OS was determined by the Kaplan-Meier method and is defined as the time from treatment start date until date of death or last follow-up. (NCT00005780)
Timeframe: Time from treatment start date until date of death or date last follow-up, up to 250 months

InterventionMonths (Median)
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab89.7

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Here is the Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC v2.0).

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Toxicity Criteria (CTC v2.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT00005780)
Timeframe: Up to 30 days after last intervention, up to 12.5 months or 1.04 years

InterventionParticipants (Count of Participants)
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab26

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Percentage of Participants Whose Cancer Shrinks or Disappears After Treatment With Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab (EPOCH-R)

Response was measured by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphoma. Complete Response (CR) is a complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g., Lactate dehydrogenase (LDH) definitely assignable to the lymphoma. Complete Response Unconfirmed (CRu) is as per CR criteria except that if a residual node is > 1.5cm, it must have regressed by > 75% in the sum of the products of the greatest diameters (SPD). Partial Response (PR) is ≥50% decreased in the SPD of 6 largest dominant nodes or nodal masses. Stable Disease (SD) is defined as less than a PR but not progressive disease. Progression is ≥50% increase from nadir in the SPD of any previously involved node or the appearance of any new lesion. (NCT00005780)
Timeframe: After 6 cycles of EPOCH-R therapy, an average of 18 weeks

Interventionpercentage of participants (Number)
Complete ResponseComplete Response UnconfirmedPartial ResponseStable DiseaseProgression
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab80.87.77.703.8

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Immune Response

Immune cell depletion is defined as immunosuppression of participants T cells prior to transplant measured by cluster of differentiation 4 (CD4) counts (i.e. cells) > 50 cells per ul.Immune T-cell depletion helps to reduce the ability to reject allogeneic cells in participants and is required for engraftment. Engraftment is the body's ability to accept donor cells. (NCT00006184)
Timeframe: 105 days

InterventionParticpants (Number)
Recipient - Chemotherapy Group7

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Number of Participants With Adverse Events

Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. (NCT00006184)
Timeframe: 9 years

InterventionParticipants (Count of Participants)
Recipient - Chemotherapy Group10
Donor - Vaccination Generation Group10

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Median Duration of Complete Response/Complete Response Unconfirmed

"Complete response (CR) was assessed by the Cheson response criteria. Complete response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size (1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy).~Complete response unconfirmed (CRu) is when a residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by > 75% in sum of the products of the greatest diameters, does not change over the last two treatments, and any biopsies obtained are negative will be considered to be in CR. In organs involved by disease, any residual lesions that have decreased by > 75% in sum of the products of the greatest diameters or are < 1 cm, are consistent with scar, and stable over the last two treatments will be considered to fulfill criteria for CR." (NCT00006436)
Timeframe: The participants were followed for duration of complete response or complete response unconfirmed for a median of 15.4 years.

Interventionyears (Median)
Arm 1-Combination Chemo and Biological Therapy13.9

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Median Overall Survival

Overall survival is time from treatment start date until date of death or date last known alive. (NCT00006436)
Timeframe: The participants were followed for survival for a median of 15.4 years.

Interventionyears (Median)
Arm 1-Combination Chemo and Biological Therapy14.2

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1 Year Overall Survival

Overall survival is time from treatment start date until date of death or date last known alive. (NCT00006436)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Arm 1-Combination Chemo and Biological Therapy83.7

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Median Progression Free Survival (PFS)

PFS is the time interval from study entry to documented evidence of disease progression or death due to any cause. Progression is defined according to the Cheson response criteria. Disease progression is defined as increase of 25% or more in the sum of the products of the longest perpendicular diameters of all measured lesions compared to the smallest previous measurements, or the appearance of any new lesion(s). Confidence intervals were made, and a Kaplan-Meier curve of progression free survival was constructed. (NCT00006436)
Timeframe: The participants were followed for a median of 15.4 years.

Interventionyears (Median)
Arm 1-Combination Chemo and Biological Therapy13.8

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Number of Participants With at Least One Hematologic Toxicity Event of Febrile Neutropenia

Toxicity was assessed by the Common Toxicity Criteria (CTC v2.0). Febrile neutropenia is defined as a life-threatening complication requiring hospitalization and urgent broad-spectrum antibiotics. (NCT00006436)
Timeframe: Date treatment consent signed to date off study, approximately 209 months and 17 days.

InterventionParticipants (Count of Participants)
Arm 1-Combination Chemo and Biological Therapy18

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Recovery of CD4 T Cells (CD4) Counts

Participants with human immunodeficiency virus (HIV) who undergo chemotherapy may have a delay in the recovery of their normal CD4+ T-cells. This delay could result in an increased risk of infection. Recovery of CD4 cells counts is the time from end of therapy until the time that the CD4 counts first reached above 200 cells/uL. (NCT00006436)
Timeframe: From the end of chemotherapy every 3 months for the first 2 years

Interventionmonths (Median)
Arm 1-Combination Chemo and Biological Therapy2.5

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Recovery of Human Immunodeficiency Virus (HIV) Viral Load

The HIV viral load is a measure of actively replicating virus in the blood. If no anti-retroviral therapy is given, then reduction of this HIV viral load to manageable levels might risk infection. In our study, the recovery of HIV viral load was measured the time from the initiation of antiretroviral therapy until the viral load was undetectable or < 50 copies. (NCT00006436)
Timeframe: Either following or concurrently with combination chemo and biological therapy, approximately every 6 to 8 weeks after therapy was completed up to 16 months

Interventionmonths (Median)
Arm 1-Combination Chemo and Biological Therapy2

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1 Year Interim Positron Emission Tomography (PET) Positive Progression Free Survival (PFS)

"1-year PFS is defined as participants who remain free of disease progression or death at one year from study entry. We compared the 1-year PFS of participants with negative results on interim positron emission tomography (PET) scans to those with positive results on interim PET scans.~PFS is defined as the time interval from start of treatment to documented evidence of disease progression or death from any cause. Disease progression was assessed by positron emission tomography scans after 2 cycles of therapy using the Deauville criteria. Deauville score of 4 or 5 is considered positive on interim PET scan while a Deauville score of 1 or 2 or 3 is considered negative. The outcomes of the Deauville score was compared to determine PET positive progression free survival." (NCT00006436)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Interim PET scan positive 1-year PFSInterim PET scan negative 1 year PFS
Arm 1-Combination Chemo and Biological Therapy61.589.3

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Number of Cycles of Hematologic Toxicity

Cumulative number of cycles of hematologic toxicity. Hematologic (i.e., decrease in bone marrow and blood cells) toxicity was assessed by the Common Toxicity Criteria (CTC v2.0). (NCT00006436)
Timeframe: Up to 112 cycles (each cycle is 21 days + 7 days window)

Interventioncycles (Number)
Febrile neutropeniaNeutropenia with a Nadir <500 cells/mm^3Neutropenia with a Nadir <100 cells/mm^3Thrombocytopenia with a Nadir <50,000 platelets/mm^3Thrombocytopenia with a Nadir <25,000 platelets/mm^3Anemia: hemoglobin <8 g/dL
Arm 1-Combination Chemo and Biological Therapy251127740636

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Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity

Non-hematologic (i.e., not begin in bone marrow or blood) toxicity was assessed by the Common Toxicity Criteria (CTC v2.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. (NCT00006436)
Timeframe: Date treatment consent signed to date off study, approximately 209 months and 17 days.

,,
InterventionParticipants (Count of Participants)
Serious infectionNeurologic eventSyncopeConfusionMotor neuropathyVision disturbanceHyperglycemiaHypophosphatemiaHypocalcemiaHypokalemiaHyponatremiaDehydrationMucositis/StomatitisLiver test abnormalitiesPancreatitisDiarrheaConstipationSerious hemorrhageFatigueHeadacheBone painNauseaAnorexiaHypoxiaMyelodysplastic syndrome
Grade 317011014221116612152510000
Grade 40000100101000100010001140
Grade 50000000000000000000000011

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Overall Response

Overall response was determined by the Cheson Response Criteria. Participants with either a complete response (CR), complete response unconfirmed or partial response were considered responders. Less than a partial response was considered a non-response to therapy (i.e., Stable Disease and/or Progressive Disease). Complete response was defined as the disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size. Complete response unconfirmed is a residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by > 75% in sum of the products of the greatest diameters, does not change over the last two treatments, and any biopsies obtained are negative will be considered to be in CR. Partial response is defined as a 50% or greater decrease in the sum of the products of the longest perpendicular diameters of all measured lesions lasting for a period of at least one month. (NCT00006436)
Timeframe: The participants were followed for an average of 6 months to determine response to therapy.

InterventionParticipants (Count of Participants)
Complete ResponseComplete Response UnconfirmedPartial ResponseNon-Responder - Stable DiseaseNon-Responder - Progressive Disease
Arm 1-Combination Chemo and Biological Therapy5310111

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Percentage of Participants With Complete Response

Complete response was assessed by the Cheson Response Criteria. Complete response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size (1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy). (NCT00006436)
Timeframe: The participants were followed for an average of 6 months to determine response to therapy.

Interventionpercentage of participants (Number)
Arm 1-Combination Chemo and Biological Therapy95

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Median Interim Positron Emission Tomography (PET) Positive Progression Free Survival (PFS)

PFS is the time interval from start of treatment to documented evidence of disease progression or death from any cause. Disease progression was assessed by positron emission tomography scans after 2 cycles (each cycle is 21 days + 7 days window) of therapy using the Deauville criteria. Deauville score of 4 or 5 is considered positive on interim PET scan while a Deauville score of 1 or 2 or 3 is considered negative. The outcomes of the Deauville score was compared to determine PET positive progression free survival. (NCT00006436)
Timeframe: Participants were followed for up to 10.2 years to determine their response on interim PET scans.

Interventionyears (Median)
Interim PET positive participantsInterim PET negative participants
Arm 1-Combination Chemo and Biological Therapy10.2NA

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Percentage of Participants With CR/CRu Lasting 1 Year

"Complete response (CR) was assessed by the Cheson response criteria. Complete response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. All lymph nodes and nodal masses must have regressed to normal size (1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy).~Complete response unconfirmed (CRu) is when a residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by > 75% in sum of the products of the greatest diameters, does not change over the last two treatments, and any biopsies obtained are negative will be considered to be in CR. In organs involved by disease, any residual lesions that have decreased by > 75% in sum of the products of the greatest diameters or are < 1 cm, are consistent with scar, and stable over the last two treatments will be considered to fulfill criteria for CR." (NCT00006436)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Arm 1-Combination Chemo and Biological Therapy82.5

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Progression Free Survival at 1 Year

PFS is the time interval from start of treatment to documented evidence of disease progression. Progression is defined according to the Cheson response criteria. Disease progression as indicated by imaging scans at one year following therapy. Disease progression is defined as increase of 25% or more in the sum of the products of the longest perpendicular diameters of all measured lesions compared to the smallest previous measurements, or the appearance of any new lesion(s). (NCT00006436)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Arm 1-Combination Chemo and Biological Therapy79.1

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Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC v2.0)

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Toxicity Criteria (CTC v2.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT00006436)
Timeframe: Date treatment consent signed to date off study, approximately 209 months and 17 days.

InterventionParticipants (Count of Participants)
Arm 1-Combination Chemo and Biological Therapy66

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Overall Survival at 2 Years

Measured from date of registration to date of death due to any cause (NCT00006721)
Timeframe: 0-2 years

Interventionpercentage of participants (Number)
CHOP + Rituximab97
CHOP + Tositumomab93

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Overall Survival at 5 Years

Measured from date of registration to date of death due to any cause (NCT00006721)
Timeframe: 0-5 years

Interventionpercentage of participants (Number)
CHOP + Rituximab92
CHOP + Tositumomab86

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Objective Response (Confirmed and Unconfirmed Complete and Partial Responses)

Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. (NCT00006721)
Timeframe: Assessed 200 days and 365 days after initiation of therapy and then every 6 months until death

Interventionparticipants (Number)
CHOP + Rituximab224
CHOP + Tositumomab223

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Progression-free Survival at 5 Years

Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date (NCT00006721)
Timeframe: 0-5 years

Interventionpercentage of participants (Number)
CHOP + Rituximab60
CHOP + Tositumomab66

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Progression-free Survival at 2 Years

Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date (NCT00006721)
Timeframe: 0-2 years

Interventionpercentage of participants (Number)
CHOP + Rituximab76
CHOP + Tositumomab80

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Overall Survival From Registration

Overall survival (OS) was computed using the number of months from the date of registration to the date of death. Participants still alive were censored at the last follow-up date. Kaplan-Meier methodology was used to evaluate OS. (NCT00024167)
Timeframe: Followed every 4 weeks from registration until death, up to 7 years.

Interventionmonths (Median)
Induction Treatment + Strontium-8927.9
Induction Treatment + No Strontium-8926.6

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Overall Survival From Randomization

Overall survival (OS) was computed using the number of months from the date of randomization to the date of death. Participants still alive were censored at the last follow-up date. Kaplan-Meier methodology was used to evaluate OS. (NCT00024167)
Timeframe: Followed every 4 weeks from randomization until death, up to 7 years.

Interventionmonths (Median)
Induction Treatment + Strontium-8924.2
Induction Treatment + No Strontium-8922.8

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Disease Response Assessed by Modified RECIST Criteria

Number of participants with complete response and very good partial response at the end of protocol therapy. (NCT00025259)
Timeframe: Protocol therapy: the overall duration of which is: (n=1527) an average of 137.1 days, median 133.0 days, interquartile range: 101.0, 164.0 days.

InterventionNumber of participants (Number)
Arm I (Patients Off-therapy Before Callback-Induction Only)5
Arm II (RER With CR [ABVE-PC, IFRT])370
Arm III (RER With CR [ABVE-PC])380
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])538
Arm V (RER With PD)29
Arm VI (SER [DECA, ABVE-PC, IFRT])105
Arm VII (SER [ABVE-PC, IFRT])100

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Event-free Survival

Probability of event-Free survival which is defined as the time from study entry to treatment failure (disease progression, disease recurrence, biopsy positive residual after completion of all protocol therapy), occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact. (NCT00025259)
Timeframe: 5 years

InterventionProbability of survival (Number)
Arm I (Patients Off-therapy Before Callback-Induction Only)0.89
Arm II (RER With CR [ABVE-PC, IFRT])0.87
Arm III (RER With CR [ABVE-PC])0.84
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])0.87
Arm V (RER With PD)0.70
Arm VI (SER [DECA, ABVE-PC, IFRT])0.79
Arm VII (SER [ABVE-PC, IFRT])0.74

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Overall Survival

Probability of overall survival which is defined as the time from study entry to death from any cause. Patients alive where censored at last contact. (NCT00025259)
Timeframe: 5 years

InterventionProbability of survival (Number)
Arm I (Patients Off-therapy Before Callback-Induction Only)0.93
Arm II (RER With CR [ABVE-PC, IFRT])0.98
Arm III (RER With CR [ABVE-PC])0.98
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])0.98
Arm VI (SER [DECA, ABVE-PC, IFRT])0.96
Arm VII (SER [ABVE-PC, IFRT])0.93

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Grade 3 or 4 Non-hematologic Toxicity

Occurrence of any grade 4 non-hematologic toxicity or grade 3 non-hematologic toxicity which doesn't respond to treatment within 7 days despite recommended therapy modification, or toxic death, which is any death primarily attributable to treatment. Grade 3 is defined to be severe or medically significant but not immediate life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 refers to toxicities with life-threatening consequences; urgent intervention indicated. (NCT00025259)
Timeframe: Protocol therapy: the overall duration of which is: (n=1684) an average of 137.3 days, median 133.0 days, interquartile range: 101.0, 164.0 days.

InterventionNumber of participants (Number)
Arm I (Patients Off-therapy Before Callback-Induction Only)10
Arm II (RER With CR [ABVE-PC, IFRT])153
Arm III (RER With CR [ABVE-PC])130
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])216
Arm V (RER With PD)11
Arm VI (SER [DECA, ABVE-PC, IFRT])62
Arm VII (SER [ABVE-PC, IFRT])45

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Second Hodgkin's Disease Progression

Second Hodgkin's disease progression is reported as the number of participants experiencing 2 instances of progression of the underlying Hodgkin's disease, assessed at up to 16 years from date of diagnosis. (NCT00026208)
Timeframe: 16 years

InterventionParticipants (Count of Participants)
Stanford V-C + Low-dose Radiotherapy3
Stanford V-C Only1

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Survival at 5 and 10 Years

Survival at 5 and 10 years is expressed at the percentage of subjects known to remain alive at those timepoints. (NCT00026208)
Timeframe: 5 and 10 years

,
InterventionParticipants (Count of Participants)
5 years10 years
Stanford V-C + Low-dose Radiotherapy6741
Stanford V-C Only33

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Progression-free Survival (PFS)

Progression-free survival was assessed for 3 years from the completion of treatment. Progression-free survival was considered to mean the proportion of patients (percentage) still alive without disease recurrence or progression. (NCT00026208)
Timeframe: up to 3 years

Interventionpercentage of participants (Number)
Stanford V-C + Low-dose Radiotherapy89.7
Stanford V-C Only50

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Overall Survival (OS)

Overall survival was assessed at up to 16 years from date of diagnosis, and reported as the median years of survival with standard deviation. (NCT00026208)
Timeframe: 16 years

Interventionyears (Median)
Stanford V-C + Low-dose Radiotherapy10.4
Stanford V-C Only13.2

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Frequency of Complete Response

"The frequency of complete response (CR) is reported as the number (proportion) of subjects in complete response, as assessed during weeks 4 to 5 of chemotherapy. Per protocol, CR is defined as complete regression of all palpable and radiographic demonstrable disease by computed tomography (CT) scan or positron emission tomography-CT (PET-CT)." (NCT00026208)
Timeframe: 5 weeks

InterventionParticipants (Count of Participants)
Stanford V-C + Low-dose Radiotherapy31

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Number of Responders

A multi-stage design followed by a test of proportions between the treatment arms (chemo vs. chemo + therapeutic immune globulin (IVIG)) will be performed. The first stage of the multi-stage design will also function as an early stopping rule for insufficient activity of chemotherapy in OMA. (NCT00033293)
Timeframe: Changes from baseline to 2 months, 6 months, and 1 year

Interventionparticipants (Number)
Arm I (Chemotherapy, Immunoglobulin Therapy)21
Arm II (Chemotherapy, Observation)11

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Tumor Outcome in Terms of Overall Survival (OS) Rate

OS rate from time of study enrollment. (NCT00033293)
Timeframe: Up to 3 years

Intervention3 year OS (Number)
Arm I (Chemotherapy, Immunoglobulin Therapy)100
Arm II (Chemotherapy, Observation)96.0

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Tumor Outcome in Terms of Event-free Survival (EFS) Rate Defined as a Relapse or Progression of Neuroblastoma, a Second Malignancy, or Death

EFS rate for neuroblastoma event from time of study enrollment. (NCT00033293)
Timeframe: Up to 3 years

Intervention3 year EFS (Number)
Arm I (Chemotherapy, Immunoglobulin Therapy)92.3
Arm II (Chemotherapy, Observation)96.0

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Functional Outcome as Assessed by Age-appropriate Neuropsychological Testing

"The Bayley Scales of infant development mental scale best score of two time points will be used in the analysis. For a given patient, this score will be used to calculate the change from baseline." (NCT00033293)
Timeframe: Changes from baseline to the better of 6 months or 1 year

InterventionChange in Bayley's score (Mean)
Arm I (Chemotherapy, Immunoglobulin Therapy)117.5
Arm II (Chemotherapy, Observation)100.75

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Motor Coordination as Assessed by Neurological Examination and Vineland Adaptive Behavior Scale (VABS)

"The best score at the two time points will be used in this analysis. For a given patient, this best score will be used to calculate the change from baseline. The mean change from baseline for each treatment group will be calculated." (NCT00033293)
Timeframe: Changes from baseline to the better of 6 months or 1 year

InterventionChange in VABS score (Mean)
Arm I (Chemotherapy, Immunoglobulin Therapy)84.53
Arm II (Chemotherapy, Observation)144.73

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2 Year Overall Survival

Percentage of participants who were alive at 2 years. The 2 year survival, with 95% confidence interval, was estimated using the Kaplan Meier method. (NCT00039130)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Rituximab With High Intensity Chemotherapy80

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2 Year Event Free Survival

Percentage of patients who were event free at 2 years. The 2-year event free rate was estimated using the Kaplan Meier method. An event is defined as death, progression or treatment failure. (NCT00039130)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Rituximab With High Intensity Chemotherapy78

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Complete Response Rate

Response is assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Complete response requires disappearance of all evidence of disease. (NCT00039130)
Timeframe: 6 months

Interventionpercentage of participants (Number)
Rituximab With High Intensity Chemotherapy83

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Progression Free Survival

Kaplan-Meier estimates will be used to verify the progression free survival. (NCT00039195)
Timeframe: 2 years

Interventionpercentage of patients progression free (Number)
Induction R-CHOPac Therapy79

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Overall Survival

(NCT00040937)
Timeframe: 4-7 years

Interventionproportion surviving at 4 years (Number)
Treatment Arm.64

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Assess Toxicity of Thalidomide/Dexamethasone as a Pre-transplant Induction Regimen.

To assess Grade 3-5 AE related to thalidomide/dexamethasone when administered as a pre-transplant induction regimen. (NCT00040937)
Timeframe: Induction

InterventionParticipants (Number)
Induction/PBSC Mobilization2

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Early Post Transplantation Relapse

Participants who experienced recurrence or progression of disease following transplant. (NCT00043979)
Timeframe: up to 300 days

InterventionDays (Median)
Arm 2-Recipients100

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Median Time to Reach Absolute Neutrophil Count of 500/mm(3)

Days for participants to achieve a neutrophil count of 500/mm(3). (NCT00043979)
Timeframe: up to 12 days

InterventionDays (Median)
Arm 2-Recipients9

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Median Progression Free Survival

Progression free survival was based on the time from on-study date until progression or last follow-up. (NCT00043979)
Timeframe: up to 77 months

InterventionMonths (Median)
Arm 2-Recipients15.9

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Median Time to Reach a Platelet Count of 50,000/mm(3)

Days for participants to achieve a platelet count of 50,000/mm(3). (NCT00043979)
Timeframe: up to 43 days

InterventionDays (Median)
Arm 2-Recipients15

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Two Year Survival Rate for Patients Undergoing Allo-Hematopoietic Stem Cell Transplant

Participants who are alive at two years following Allo-Hematopoietic Stem Cell Transplant. (NCT00043979)
Timeframe: 2 years

Interventionpercentage of participants (Number)
From date of enrollmentFrom date of transplantation
Arm 2-Recipients39.134.8

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Post-Hematopoietic Stem Cell Transplant (HSCT) Radiotherapy

Site of radiotherapy (high energy radiation) and/or toxicity experienced by the participants post HSCT radiotherapy. Grading was preformed using the Modified Glucksberg Criteria. (NCT00043979)
Timeframe: up to 6 cycles or 168 days

InterventionParticipants (Count of Participants)
Chest wall; G2 skinAbdomen; G4 GIPancreas; G4 LFTs, G4 pancreatitisPleura, mediastinum; G4 LFTs, G2 mucositisChest wall; G4 skin, G3 mucositisSpine, skull; G2 nausea+vomiting, G2 fatiguePelvis; G4 enteritisPulmonary (cyberknife)Brain; B3 mucositisWhole lung; G3 mucositis, G3 skin, G5 lungL arm, R shoulder, B/L femur
Arm 2-Recipients11111111111

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Number of Participants With Acute and Chronic GVHD

Acute GVHD as by Modified Glucksberg Criteria occurring before day 100. Chronic GVHD as per Seattle criteria occurring after day 100. (NCT00043979)
Timeframe: up to 5 years or death

,
Interventionparticipants (Number)
acute GVHDchronic GVHD
Recipients -Cyclosporine GVHD Prophylaxis1212
Recipients -Tacrolimus/Sirolimus GVHD Prophylaxis55

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Cluster of Differentiation 4 (CD4) Reconstitution

The median CD4 count with a range of 85-1565 (absolute count) was used to determine recovery and were considered recovered if in this range. The CD4 count was established by flow cytometry testing. (NCT00043979)
Timeframe: Day +28-42

Interventionmm(3) (Median)
Arm 2-Recipients284

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Number of Participants to Complete Conversion to >95% Donor Chimerism

Participants who tolerated the transplantation regimen and accepted >95% of the donors blood, marrow, and/or tissue. (NCT00043979)
Timeframe: up to 30 days

InterventionParticipants (Count of Participants)
Day +14Day +28
Arm 2-Recipients2323

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Median Survival From Date of Progression

Median survival from date of progression is based on the time from on-study date until progression or last follow-up. (NCT00043979)
Timeframe: up to 77 months

InterventionMonths (Median)
Participants who did not receive a transplant(n=7)Participants who received a transplant (n=23)
Arm 2-Recipients3.319.1

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Best Response Post-Hematopoietic Stem Cell Transplant EOCH (Etoposide, Vincristine, Cyclophosphamide, and Doxorubicin)

Response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST). RECIST criteria offer a simplified, conservative, extraction of imaging data for wide application in clinical trials. They presume that linear measures are an adequate substitute for 2-D (dimensional) methods and registers four response categories: Complete response (CR) is disappearance of all target lesions. Partial response (PR) is 30% increase in the sum of the longest diameter of target lesions. Progressive disease (PD) is 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) is small changes that do not meet above criteria. For the purposes of this study very good partial response ((VGPR) is >75% reduction in disease) was also employed. (NCT00043979)
Timeframe: up to 10 cycles of therapy or 280 days

InterventionParticipants (Count of Participants)
Complete Response (CR)Progressive Disease (PD)Partial Response (PR)Very Good Partial Response (VGPR)
Arm 2-Recipients2442

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Toxicity

Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. (NCT00043979)
Timeframe: 16.5 months

InterventionParticipants (Number)
Arm 2-Recipients30

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Number of Participants With Engraftment

Engraftment is defined as rapid conversion to complete donor chimerism and is assessed by blood counts and chimerism, >95% donor engraftment at day 100 in >75% of patients. (NCT00043979)
Timeframe: 100 days

InterventionParticipants (Number)
Arm 2-Recipients23

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Number of Participants Who Experienced Graft Versus Tumor Effect (GVT)

GVT is defined as tumor response after day 42 post-transplantation without cytotoxic therapy. (NCT00043979)
Timeframe: up to day 100

InterventionParticipants (Count of Participants)
Arm 2-Recipients0

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Complete Response Proportion as Measured by Tumor Response After Completion of Study Treatment

Complete response defined by the International Response Criteria for Non-Hodgkin's Lymphoma (NCT00049036)
Timeframe: 60 days

Interventionproportion (Number)
EPOCH + Concurrent Rituximab0.69
EPOCH Followed by Rituximab0.53

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Median Cycles of Induction Chemotherapy With Fludarabine, Cyclophosphamide, Etoposide, Doxorubicin, Vincristine, and Prednisone Given to Recipients

Median cycles of induction chemotherapy with fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone given to recipients. (NCT00051311)
Timeframe: Up to cycle 3

InterventionCycles (Median)
Recipient2

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Median Time to Neutrophil Recovery

Neutrophil recovery is defined as a neutrophil count ≥5000 µl for three consecutive days. (NCT00051311)
Timeframe: Up to 2 months after stem cell transplant

InterventionDays (Median)
Recipient14

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Number of Recipients With a Response to Reduced-intensity Stem Cell Transplantation (RIST)

Complete remission (CR) is complete disappearance of all detectable signs and symptoms of lymphoma for a period of at least one month. Complete remission unconfirmed (CRu) is a residual lymph node mass > 1.5 cm in greatest transverse diameter will be considered CRu if it has regressed by more than 75% in the SPD, does not change over at least one month, is negative by PET or gallium, and is negative on any biopsies obtained (biopsy not required). Progressive disease (PD) is a 25% or greater increase in SPD of all measured lesions compared to the smallest previous measurements, or appearance of any new lesion(s). (NCT00051311)
Timeframe: At least 100 days after post reduced-intensity stem cell transplantation (RIST).

InterventionParticipants (Count of Participants)
Complete Remission or Complete Remission UnconfirmedProgressive Disease
Recipient1516

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Number of Recipients Who Developed Grades I-IV Acute Graft Versus Host Disease (GVHD) Following a Combination of Cyclosporine and a Mini-dose Methotrexate Regimen for Graft Versus Host Disease (GVHD) Prophylaxis

Here is the number of recipients who developed grades I-IV acute graft versus host disease (GVHD) following a combination of cyclosporine and a mini-dose methotrexate regimen for graft-versus-host disease (GVHD) prophylaxis. Grades I-IV acute GVHD clinical staging was assessed by the Glucksberg Criteria. Grade I-IV acute GVHD can occur in the skin, liver, and/or gut. Grade 1: rash < 25% body surface area (BSA), total bilirubin 2-3 mg/dl, and diarrhea 500-1000 ml/d. Grade 2: 25-50% BSA, total bilirubin 3-6 mg/dl, and diarrhea 1000-1500 ml/d. Grade 3: generalized erythroderma, total bilirubin 6-15 mg/dl, and diarrhea >1500 ml/d. Grade 4: desquamation and bullae, total bilirubin >15 mg/dl, and pain +/- ileus. (NCT00051311)
Timeframe: At least 100 days of follow-up post reduced-intensity stem cell transplantation (RIST)

InterventionParticipants (Count of Participants)
Grade I GVHDGrade II GVHDGrade III GVHDGrade IV GVHD
Recipient1760

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Percentage of Recipients Who Achieved Donor Chimerism at Day +14

Recipients who achieved engraftment with donor chimerism. Engraftment is defined as a target peripheral blood cluster of differentiation 4 (CD4) count of 100 cells/ul after induction therapy. (NCT00051311)
Timeframe: Day+14

Interventionpercentage of recipients (Number)
Recipient90

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Number of Recipients With Non-serious Adverse Events

Here is the number of recipients with non-serious adverse events assessed by the Common Toxicity Criteria version 2.0. A non-serious adverse event is any untoward medical occurrence. (NCT00051311)
Timeframe: Date treatment consent signed to date off study, approximately 58 months and 13 days.

InterventionParticipants (Count of Participants)
Recipient31

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Number of Recipients Who Developed Chronic Graft Versus Host Disease (GVHD) Following a Combination of Cyclosporine and a Mini-dose Methotrexate Regimen for Graft Versus Host Disease (GVHD) Prophylaxis

Here is the number of recipients who developed chronic graft versus host disease (GVHD) following a combination of cyclosporine and a mini-dose methotrexate regimen for graft-versus-host disease (GVHD) prophylaxis. Grades I-IV chronic GVHD clinical staging was assessed by the Glucksberg Criteria. Grade I-IV chronic GVHD can occur in the skin, liver, and/or gut. Grade 1: rash < 25% body surface area (BSA), total bilirubin 2-3 mg/dl, and diarrhea 500-1000 ml/d. Grade 2: 25-50% BSA, total bilirubin 3-6 mg/dl, and diarrhea 1000-1500 ml/d. Grade 3: generalized erythroderma, total bilirubin 6-15 mg/dl, and diarrhea >1500 ml/d. Grade 4: desquamation and bullae, total bilirubin >15 mg/dl, and pain +/- ileus. (NCT00051311)
Timeframe: At least 100 days of follow-up post reduced-intensity stem cell transplantation (RIST)

InterventionParticipants (Count of Participants)
Recipient23

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Number of Recipients Evaluable Who Achieved Full Donor Chimerism at Day+100

Recipients who achieved engraftment with donor chimerism. Engraftment is defined as a target peripheral blood cluster of differentiation 4 (CD4) count of 100 cells/ul after induction therapy. (NCT00051311)
Timeframe: Day+100

InterventionParticipants (Count of Participants)
Recipient29

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Median Time to Platelet Recovery

Platelet recovery is defined as >50,000 mm3 platelet cell count after transfusion. (NCT00051311)
Timeframe: Up to 2 months after stem cell transplant

InterventionDays (Median)
Recipient13

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Number of Participants With Adverse Events

Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. (NCT00054665)
Timeframe: 43 months

InterventionParticipants (Number)
Part A: PS-341 Alone23
Part B: PS-341 & EPOCH44

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Clinical Response Rate

Clinical Response Rate is the number of participants with a partial and complete response assessed by the criteria for lymphoma. A complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy and normalization of those biochemical abnormalities. Partial response is a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease (NCT00054665)
Timeframe: 18 weeks

,
InterventionParticipants (Number)
Partial responseComplete response
Part A: PS-341 Alone10
Part B: PS-341 & EPOCH78

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Minimal Residual Disease

The presence or absence of tumor cells at the end of induction assessed by studying tissue and/or blood/marrow. Details of methods and criteria used can be found in Shiramizu at al. BJH 153:758-763, 2011 (full citation in the citation section). (NCT00057811)
Timeframe: Not Provided

Interventionpercentage of samples analyzed (Number)
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)22
Group C (Chemotherapy, Monoclonal Antibody Therapy)70

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Response Rate

Response includes both complete and partial responses. Per protocol, complete Response is defined as the complete disappearance of all clinical evidence of disease by physical examination, by imaging studies, by bone marrow biopsy (where indicated), by CNS evaluation (where indicated) and by biopsy where there is a residual abnormality on an imaging study. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present. Partial response is defined as: at least a 50% reduction in the size of all measurable tumor areas. Each site is to be defined by the product of the maximum length, width and depth (3 dimensions). No lesion may progress. No new lesion may appear. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present.. (NCT00057811)
Timeframe: Up to 5 years

Interventionpercentage of participants analyzed (Number)
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)88
Group C (Chemotherapy, Monoclonal Antibody Therapy)83

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Grade ≥ 3 Stomatitis

The incidence of grade ≥ 3 stomatitis. Grade 3 stomatitis: Confluent ulcerations or pseudomembranes; bleeding with minor trauma. Grade 4 stomatitis: Tissue necrosis; Significant spontaneous bleeding; life-threatening consequences (NCT00057811)
Timeframe: Up to 1 year

,
Interventionparticipants (Number)
Incidence of grade ≥ 3 stomatitisNo incidence of grade ≥ 3 stomatitis
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)441
Group C (Chemotherapy, Monoclonal Antibody Therapy)634

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Toxic Death

Implementation of the toxic death rate stopping rule, a death must be possibly, probably or definitely attributable to Rituximab and/or chemotherapy to be considered a toxic death. (NCT00057811)
Timeframe: Up to 1 year

,
Interventionparticipants (Number)
Toxic deathNo toxic death
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)045
Group C (Chemotherapy, Monoclonal Antibody Therapy)238

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Incidence of Adverse Experiences

Determine the incidence of adverse experiences, hematologic toxicity (WBC, hemoglobin, and platelet nadirs; and transfusion requirements), cardiac toxicity (incidence of left ventricular dysfunction and cardiomyopathy by echocardiography), and the development of human antimouse antibody/human anti-chimeric antibody in patients treated with this regimen. (NCT00058422)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
R-CHOP and Ibritumomab Tiuxetan (Zevalin)65

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Event-free Survival (EFS)

Percentage of EFS patients. This is measured as the time from study entry until disease progression, disease recurrence, occurrence of a second malignant neoplasm, or death from any cause. To measure Event Free Survival, repeated one-sided logrank tests will be performed The upper critical values are based on the one-sided alpha-spending functions of t2 (alpha=0.05) and the lower critical values are based on testing the alternative hypothesis at 0.005 level. (NCT00059839)
Timeframe: From first enrollment up to 3 years.

Interventionpercentage of participants (Number)
Standard (APO) With Vincristine (Arm I)74
Consolidation (Includes Vinblastine) (Arm II)79

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Objective Response to Treatment

Objective response assessed using standard myeloma response criteria. Objective response is defined as a > 50% reduction in the quantitative IgM or M-Spike levels from baseline levels. Response must be documented by two measurements separated by at least 3 weeks. (NCT00060346)
Timeframe: Every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry

Interventionproportion of participants (Number)
Rituximab + CHOP0.938

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Event-free Survival

Alive in continuous complete remission with functioning original allograft. The Event Free Survival (EFS) will be estimated by the Kaplan-Meier method. (NCT00066469)
Timeframe: 2 years

Interventionpercentage of participants analyzed (Number)
Cyclophosphamide, Prednisone, Rituximab71

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Maximum Tolerated Dose (MTD) of Alemtuzumab

MTD was achieved by increasing doses of Alemtuzumab on three cohorts. Cohort 1 received 30mg of Alemtuzumab, cohort 2 received 60mg of Alemtuzumab, and cohort 3 received 90mg of Alemtuzumab intravenously up to 2 cycles. The MTD reflects the highest dose of Alemtuzumab in which no more than 1 of 6 participants entered at a specific dose level experienced a dose limiting toxicity (DLT). (NCT00069238)
Timeframe: up to 2 cycles of therapy, approximately 42 days

Interventionmg (Number)
All Participants30

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Number of Participants With Adverse Events

Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. (NCT00069238)
Timeframe: 67 months and 9 days

InterventionParticipants (Count of Participants)
All Participants31

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Progression-free Survival

Measured from date of registration to date of first observation of progression or symptomatic deterioration. Progression is defined as one or more of the following must occur. Unequivocal progression of disease in the opinion of the treating physician (an explanation must be provided). Appearance of a new lesion/site. Death due to disease without documented progression or symptomatic deterioration. Symptomatic deterioration is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression. (NCT00070018)
Timeframe: at 6 weeks after treatment, then every 6 months for 2 years, then annually thereafter

Interventionpercentage of participants (Number)
CHOP + RT + Zevalin89

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Percentage of Patients With Opportunistic Infection

Participants are susceptible to opportunistic infections such as bacterial, fungal, viral, protozoan infections and more due to immune suppression from chemotherapy drugs used to treat their disease. (NCT00074490)
Timeframe: First 100 days post-transplant

Interventionpercentage of participants (Number)
Arm IVD Cohort 1 (Th2 DLI)0
Arm IVD Cohort 3 (Multiple Th2 DLI)11.11
Arm IVA (12-day Expanded Th2 DLI)7.50
Arm IVB (6-day Expanded Th2 DLI)9.09
Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus)11.90

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Percentage of Patients With ≥ Grade 2 Acute Graft Versus Host Disease (GVHD)

GVHD of the skin, liver and gut were graded on a scale of 1, 2, 3, and 4 (e.g. the grades are not added together) using the National Institutes of Health Consensus Criteria. Grade 1 is minimal GVHD, Grade 2 is moderate GVHD, Grade 3 is severe GVHD and Grade 4 is very severe GVHD. Grade 4 is a worse outcome than Grade 1. (NCT00074490)
Timeframe: first 100 days post-transplant

Interventionpercentage of patients (Number)
Arm IVD Cohort 1 (Th2 DLI)0
Arm IVD Cohort 3 (Multiple Th2 DLI)11.11
Arm IVA (12-day Expanded Th2 DLI)10
Arm IVB (6-day Expanded Th2 DLI)40.91
Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus)40.48

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Percentage of Patients to Receive T Cell Infusion

T cells administered by intravenous infusion after patient received transplant. (NCT00074490)
Timeframe: first 100 days post-transplant

Interventionpercentage of patients (Number)
Arm IVD Cohort 1 (Th2 DLI)100
Arm IVD Cohort 3 (Multiple Th2 DLI)100
Arm IVA (12-day Expanded Th2 DLI)100
Arm IVB (6-day Expanded Th2 DLI)100
Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus)100

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Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0)

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT00074490)
Timeframe: Date treatment consent signed to date off study, approximately 5 years

InterventionParticipants (Count of Participants)
Arm IVD Cohort 1 (Th2 DLI)1
Arm IVD Cohort 3 (Multiple Th2 DLI)27
Arm IVA (12-day Expanded Th2 DLI)40
Arm IVB (6-day Expanded Th2 DLI)44
Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus)42

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Correlation of Early Marrow Response Status With MRD Negative.

Bone marrow status is defined as: M1: < 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: > 25% lymphoblasts. Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells. (NCT00075725)
Timeframe: Day 29

Interventionparticipants (Number)
Dexamethasone and Capizzi Methotrexate Patients < 10 Years182
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)72
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old198
Dexamethasone, High Dose Methotrexate (IM) < 10 Years188
Prednisone, Capizzi Methotrexate <10 Years195
Prednisone, Capezzi Methotrexate >= 10 Years471
Prednisone and High Dose Methotrexate < 10 Yrs Old190
Prednisone and High Dose Methotrexate >=10 Years479
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years208
Prednisone, Capezzi Methotrexate (Down's Syndrome)25
Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)3
Prednisone and High Dose Methotrexate (Non Randomly Assigned)18

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Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions

Event Free Probability. (NCT00075725)
Timeframe: 5 years

Interventionpercentage of participants (Number)
Dexamethasone and Capizzi Methotrexate Patients < 10 Years83.2
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)81.6
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old69.1
Dexamethasone, High Dose Methotrexate (IM) < 10 Years91.2
Prednisone, Capizzi Methotrexate <10 Years82.1
Prednisone, Capezzi Methotrexate >= 10 Years73.5
Predisone and High Dose Methotrexate < 10 Yrs Old80.8
Prenisone and High Dose Methotrexate >=10 Years75.8
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years77.0
Prenisone, Capezzi Methotrexate (Down's Syndrome)61.8
Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)44.4

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Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS)

Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells. (NCT00075725)
Timeframe: 5 Years

Interventionpercentage of participants (Number)
Dexamethasone and Capizzi Methotrexate Patients < 10 Years79.2
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)69.9
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old65.6
Dexamethasone, High Dose Methotrexate (IM) < 10 Years86.2
Prednisone, Capizzi Methotrexate <10 Years93.8
Prednisone, Capizzi Methotrexate >= 10 Years63.1
Predisone and High Dose Methotrexate < 10 Yrs Old84.2
Prednisone and High Dose Methotrexate >=10 Years73.6
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years74.6

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Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS)

Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells. (NCT00075725)
Timeframe: 5 years

Interventionpercentage of participants (Number)
Dexamethasone and Capizzi Methotrexate Patients < 10 Years66.5
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)43.3
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old35.4
Dexamethasone, High Dose Methotrexate (IM) < 10 Years80
Prednisone, Capizzi Methotrexate <10 Years34.7
Prednisone, Capizzi Methotrexate >= 10 Years39
Prednisone and High Dose Methotrexate < 10 Yrs Old55
Prednisone and High Dose Methotrexate >=10 Years47.8
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years49.4

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Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS).

Bone marrow MRD status is defined as negative with < .01 detectable leukemia cells. (NCT00075725)
Timeframe: 5 years

Interventionpercentage of participants (Number)
Dexamethasone and Capizzi Methotrexate Patients < 10 Years95.4
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)92.9
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old87.4
Dexamethasone, High Dose Methotrexate (IM) < 10 Years98.1
Prednisone, Capizzi Methotrexate <10 Years93.3
Prednisone, Capizzi Methotrexate >= 10 Years90.2
Prednisone and High Dose Methotrexate < 10 Yrs Old94.5
Prednisone and High Dose Methotrexate >=10 Years90.5
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years91.6
Prednisone, Capizzi Methotrexate (Down's Syndrome)78.3
Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)25.0

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Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS).

Bone marrow MRD status is defined as negative with < 0.1 detectable leukemia cells. (NCT00075725)
Timeframe: 5 years

Interventionpercentage of participants (Number)
Dexamethasone and Capizzi Methotrexate Patients < 10 Years86.4
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)93.6
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old80.5
Dexamethasone, High Dose Methotrexate (IM) < 10 Years93.1
Prednisone, Capizzi Methotrexate <10 Years86.5
Prednisone, Capezzi Methotrexate >= 10 Years83.4
Prednisone and High Dose Methotrexate < 10 Yrs Old84.2
Prednisone and High Dose Methotrexate >=10 Years83.9
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years85.3
Prednisone, Capezzi Methotrexate (Down's Syndrome)74.4
Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)25

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Correlation of Early Marrow Response Status With MRD Positive.

Bone marrow status is defined as: M1: < 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: > 25% lymphoblasts. Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells. (NCT00075725)
Timeframe: Day 29

Interventionparticipants (Number)
Dexamethasone and Capizzi Methotrexate Patients < 10 Years26
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)12
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old43
Dexamethasone, High Dose Methotrexate (IM) < 10 Years14
Prednisone, Capizzi Methotrexate <10 Years16
Prednisone, Capezzi Methotrexate >= 10 Years95
Prednisone and High Dose Methotrexate < 10 Yrs Old17
Prednisone and High Dose Methotrexate >=10 Years98
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years39
Prednisone, Capezzi Methotrexate (Down's Syndrome)3
Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)3
Prednisone and High Dose Methotrexate (Non Randomly Assigned)3

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Overall Response Rate (ORR) Lasting at Least 4 Months

The proportion of patients with Complete response or Partial Response with a difference from the first documented objective response to disease progression or death of at least 4 months. (NCT00088530)
Timeframe: approximately 24 months

Interventionparticipants (Number)
Experimental Group12
Comparator Group6

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Overall Survival

The time between the date of randomization and the date of death due to any cause. (NCT00088530)
Timeframe: 18 months after 6 cycles of treatment; approximately 24 months

InterventionMonths (Median)
Experimental Group10.2
Comparator Group7.6

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Progression-Free Survival (PFS)

The time between the date of randomization and the date of the initial documentation of progressive/relapsed disease or death due to any cause. (NCT00088530)
Timeframe: 18 months after 6 cycles of treatment; approximately 24 months

Interventionmonths (Median)
Experimental Group5.3
Comparator Group2.6

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Complete Response (CR) and Complete Response Unconfirmed (CRu)

Proportion of patients with a best response of complete response (CR) or Complete Response unconfirmed (CRu) in the End Of Treatment (EOT) or End Of Study (EOS) analyses by independent assessment in the Intent-to-treat (ITT) population through the End of Treatment (EOT) (NCT00088530)
Timeframe: EOT; approximately 6 months

,
Interventionpercentage of randomized patients (Number)
END OF TREATMENT: CR/CRu, n (%)END OF STUDY: CR/CRu, n (%)
Comparator Group5.77.1
Experimental Group20.024.3

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Functional CR in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.

Patients will be considered a functional CR if they meet the criteria for a CR, or if they meet the criteria for a CRu or partial response (PR) by CT and are PET negative. Please see primary outcome #1 for the definition of CR and CRu. PR is defined as: A decrease of >50% in the SPD (sum of products of the diameters) of the six largest (or less) dominant nodes or extra-nodal masses. No increase in the size of the liver or the spleen. No unequivocal progression in any non-measurable or non-dominant site. Splenic and hepatic nodules must regress by >50% in SPD (sum of the products of the diameters). Bone marrow assessment is not relevant for determination of a PR because it is assessable and not measurable disease. No new sites of disease. (NCT00088881)
Timeframe: Assessed after 2 cycles of R-CHOP, after completion of R-CHOP, and at Week 12 After 90-Yttrium Zevalin

Interventionproportion of participants (Number)
Treatment0.89

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Complete Response (CR) +Complete Response/Uncertain (CRu) in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.

Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma (Cheson, 1999). CR is defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms if present prior to therapy, as well as normalization (normal limits of institutional labs) of those biochemical abnormalities (e.g., LDH) definitely attributed to NHL. CRu is defined as meeting the criteria of CR except one or more of the followings: A residual dominant node (or extra-nodal mass) that is currently > 1.5 cm in greatest diameter that has decreased by > 75% from baseline in the product of its diameters. Individual dominant nodes (or extra-nodal masses) that were previously confluent must have decreased by > 75% in SPD compared with the size of the original mass. Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia). (NCT00088881)
Timeframe: Assessed after 2 cycles of R-CHOP, after completion of R-CHOP, and at Week 12 After 90-Yttrium Zevalin

Interventionproportion of participants (Number)
Treatment0.87

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3-year Overall Survival (OS) Rate

Overall survival (OS) is defined as the time from step 1 registration to death of any cause. OS is censored at the date last known alive for cases that are alive. The 3-year OS rate is defined as the probability of patients remaining alive at 3 years. (NCT00088881)
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 years; then annually to 10 years from patient entry.

Interventionprobability (Number)
Treatment0.98

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3-year Time to Treatment Failure (TTF) Rate

Time to treatment failure (TTF) is defined as the time from step 1 registration to disease progression or death. TTF is censored at last documented progression free for cases without progression. The 3-year TTF rate is defined as the probability of patients remaining free from treatment failure at 3 years. (NCT00088881)
Timeframe: Assessed every 3 months for one year; every 4 months for the second year; then every 6 months for 3 years; then annually to 10 years from patient entry.

Interventionprobability (Number)
Treatment0.92

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Disease Progression by Clinical and Radiographic Criteria Without the Use of Prostate-Specific Antigen (PSA)

Clinical and radiographic response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking s reference the smallest sum LD since the treatment started. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded or the appearance of one or more new lesions. (NCT00089609)
Timeframe: up to 34 months

InterventionParticipants (Count of Participants)
Complete Response (CR)Partial Response (PR)Stable Disease (SD)Progressive Disease (PD)
Main Cohort - Prostate Cancer219111

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Time to Progression Using Bubley Criteria

Time to disease progression was based on the Prostate-Specific Antigen (PSA) Working Group 1 Criteria (Bubley Criteria) and standard Response Evaluation Criteria in Solid Tumors (RECIST) for measurable disease. Per the criteria, investigators report at a minimum a PSA decline of at least 50% and this must be confirmed by a second PSA value 4 or more weeks later. Patients may not demonstrate clinical or radiographic evidence of disease progression during this time period. (NCT00089609)
Timeframe: up to 40 months

InterventionMonths (Median)
Main Cohort - Prostate Cancer18.3

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Number of Participants With Adverse Events

Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. (NCT00089609)
Timeframe: 37 months

InterventionParticipants (Count of Participants)
Main Cohort - Prostate Cancer60
Expansion Cohort - Prostate Cancer13

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Number of Participants With a Significant Increase in Circulating Apoptotic Endothelial Cell (CAEC) Level

"The assay utilized has no standard curve. Categorizing patients with ≥ 75% PSA decline in one group and < PSA decline in another group, every patient is their own control with comparison of CAEC at baseline vs. 6 weeks (after two cycles of treatment). Blood is drawn from the patient and a million viable mononuclear cells are counted and then it is determined how many CAECs are in the specimen. The cell count is then compared from baseline to post 2 cycles of treatment. Thus, significant increase is dependent upon this comparison and varies between patients." (NCT00089609)
Timeframe: Baseline and at 6 weeks (after two cycles of treatment)

InterventionParticipants (Count of Participants)
Main Cohort - Particpants With ≥75% PSA Decline14
Main Cohort - Particpants With <75% PSA Decline0

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Number of Participants Who Had a Prostate-specific Antigen (PSA) Response

PSA response was assessed by the PSA Consensus Criteria. PSA decline is defined as a decline in PSA of at least 50% with no other evidence of disease progression. (NCT00089609)
Timeframe: 21.6 months

InterventionParticipants (Count of Participants)
Main Cohort - Prostate Cancer52

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Number of Participants Who Died After a Follow Up of 34 Months Following Treatment

From on study date to date of death at 34 months. (NCT00089609)
Timeframe: 34 months

InterventionParticipants (Count of Participants)
Main Cohort - Prostate Cancer38

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Hearing Improvement

Change from baseline to 2mos of 4-frequency (500, 1000, 2000, 4000Hz) pure tone average. (NCT00097448)
Timeframe: 2 months

InterventiondB (Mean)
Oral Steroids30.7
IT Steroids28.7

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Rate of Minimal Residual Disease (MRD) < 0.01%

Proportion of patients (evaluable and had MRD measured at the end of Block 1) who had MRD < 0.01%. (NCT00098839)
Timeframe: At the end of Block 1 of re-induction therapy (day 36)

InterventionProportion of participants (Number)
Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly.195
Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly.295

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Remission Re-induction (CR2) Rate

The proportion of patients who achieved complete response at the end Block 1 of re-induction therapy. Complete Remission (CR) - Attainment of M1 bone marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (ANC >1000/uL and platelet count >100,000/uL). Partial Remission (PR) - Complete disappearance of circulating blasts and achievement of M2 marrow status (5% or < 25% blast cells and adequate cellularity). Partial Remission Cytolytic (PRCL) - Complete disappearance of circulating blasts and achievement of at least 50% reduction from baseline in bone marrow blast count. Minimal Response Cytolytic (MRCL) - 50% reduction in the peripheral blast count with no increase in peripheral white blood cell count. (NCT00098839)
Timeframe: At the end of Block 1 of re-induction therapy (day 36)

Interventionproportion of participants (Number)
Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly.646
Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly.660

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Event-free Survival Rate

Proportion of patients who were event free at 4 months (NCT00098839)
Timeframe: At 4 months after enrollment

InterventionProportion of participants (Number)
Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly.604
Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly.640

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Pharmacokinetics

Mean trough serum concentration measured before final dose of epratuzumab. (NCT00098839)
Timeframe: Up to day 36

Interventionug/mL (Mean)
Twice Weekly Dosing Schedule501

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Number of Participants Experienced Grade 3 or Higher Cardiac Toxicity After Treatment: Cardiac Toxicity as Measured by Left Ventricular Ejection Fraction (LVEF) on Echocardiogram (ECHO) After 8 Courses

Ejection fraction ( EF) refers to the amount, or percentage, of blood that is pumped (or ejected) out of the ventricles with each contraction. Cardiology evaluation performed before second dose of pegylated liposomal doxorubicin or before entry onto trial, re-evaluation by cardiologist obtained in asymptomatic patients after chemotherapy cycle 4 and again after completion of therapy, and more often if symptomatic. Severe cardiac toxicity considered to be both Grade 3 and 4, and are graded according to NCI common toxicity criteria, CTCAE version 3.0. (NCT00101010)
Timeframe: Up to 24 weeks (8 cycles of 21 days)

Interventionparticipants (Number)
Rituximab - Combination Chemotherapy10

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Disease Response (Complete, Complete Unconfirmed, and Partial Responses) After 4 Courses

Response was defined as participants with a complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on International Workshop Criteria (IWG) for Tumor Response Criteria assessed with CT & FDG-PET scans at 4 cycles (12 weeks). CR defined as disappearance of all target and non-target lesions in liver & spleen, & all lymph node masses regressed to normal size. PR defined as ≥50% reduction in sum of product of diameters (SPD) for measured lymph nodes, splenic & liver lesions separately compared to baseline SPD. CRu does not qualify for CR above, due to a residual nodal mass or an indeterminate bone marrow. (NCT00101010)
Timeframe: Evaluation after 12 weeks (4 cycles of 21 days)

InterventionParticipants (Count of Participants)
Complete Response (CR)Uncomfirmed Complete Response (CRu)Partial Response (PD)
Rituximab - Combination Chemotherapy47814

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Median Event Free Survival (EFS)

Vaccine Response - EFS among participants who received vaccination. Event free survival (EFS) was calculated from date of enrollment until progression or death from any cause. Progressive disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT00101101)
Timeframe: 18 months

Interventionmonths (Median)
Vaccine and Conventional Therapy9

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Rate of Immunological Response to Vaccination

"Immunological response to vaccination, as measured by in vitro testing of peripheral blood mononuclear cells (PBMCs) for interferon gamma secretion, delayed type hypersensitivity reaction (DTH) in response to irradiated autologous tumor cells, and lymphocyte accumulation at DTH and vaccine injection sites.~DTH Skin Testing was performed within 2 weeks prior to first vaccine, and again after fourth vaccine was administered. Aliquots containing 10^6 irradiated autologous tumor cells were re-suspended in 0.2 mL of Plasma-Lyte A and injected intradermally in the forearm and marked. 48 hours later, injection site was inspected for induration and erythema.~3mm punch biopsy of DTH injection site and vaccine site was obtained 48 hours after administration of irradiated tumor cells before and after the vaccine series. Vaccine site biopsy was obtained 2-5 days after the second vaccine had been given. Granulocytic and lymphocytic accumulation at these sites was graded by a pathologist." (NCT00101101)
Timeframe: 4 months per participant

Interventionparticipants (Number)
Clinical DTHIncrease in Interferon Gamma Secretion
Vaccine and Conventional Therapy015

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Disease Remission

A Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) score of 0 with prednisone taper successfully completed at six months. The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease. (NCT00104299)
Timeframe: 6 months post-randomization

InterventionParticipants (Number)
Rituximab63
Control Group52

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Percentage of Participants Who Have a BVAS/WG Score of 0 and Have Successfully Completed the Glucocorticoid Taper by 6 Months Post-randomization

"The 2-sided 95% CI of the percentage of participants who have a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and have successfully completed the glucocorticoid taper by 6 months post-randomization and the 2-sided 95% CI of the difference between two arms for assessing the superiority of rituximab to control~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease" (NCT00104299)
Timeframe: 6 months post-randomization

Interventionparticipants (Number)
Rituximab62
Control Group51

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Number of Subjects Experiencing Serious Adverse Events

Number of subjects according to originally received treatment that experienced a serious adverse event through 18 months post-randomization or prior to being censored from analyses due to crossover, switching to open-label treatment, or best medical judgment for censor. Events are categorized by coded system organ classes (SOC). Within each SOC, a participant was counted once if the participant reported one or more events coded to that SOC. (NCT00104299)
Timeframe: Randomization to censor at Crossover, Open-label or Best Medical Judgment (up to 18 months post-randomization)

,
Interventionparticipants (Number)
# Participants with at least one SAEBlood and Lymphatic System DisordersCardiac DisordersEye DisordersGastrointestinal DisordersGeneral Disorders and Administration SiteImmune System DisordersInfections and InfestationsInjury, Poisoning, and Procedural ComplicationsInvestigationsMetabolism and Nutrition DisordersMusculoskeletal and Connective Tissue DisordersNeoplasms Benign, Malignant, and UnspecifiedNervous System DisordersPregnancy, Puerperium, and Perinatal ConditionsPsychiatric DisordersRenal and Urinary DisordersRespiratory, Thoracic, and Mediastinal DisordersVascular Disorders
Control Group375211321200232001387
Rituximab424214521222221111481

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Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy

The adverse event rate for the following events considered related to vasculitis: Death; Grade 2 or higher leukopenia or thrombocytopenia; Grade 3 or higher infections; Hemorrhagic cystitis (grade 2 or lower needs confirmation by cytoscopy); Malignancy; Venous thromboembolic event (deep venous thrombosis or pulmonary embolism); Hospitalization resulting either from the disease or from a complication due to study treatment; Infusion reactions (within 24 hours of infusion) that result in the cessation of further infusions (including cytokine release allergic reaction); Cerebrovascular accident (NCT00104299)
Timeframe: Through common close-out (defined as 18 months after the last participant is enrolled in the trial)

,
Interventionparticipants (Number)
DeathGrade 2 or Higher LeukopeniaGrade 2 or Higher ThrombocytopeniaGrade 3 or Higher InfectionsHemorrhagic Cystitis (Grade 2 or Lower)MalignancyVenous Thromboembolic EventHospitalization Resulting from the DiseaseCerebrovascular Accident (CVA)Infusion Reactions Leading to Infusion Disc.
Control Group223116128710
Rituximab274182561611

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The Duration of Complete Remission (BVAS=0, Off Glucocorticoids), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups

"Duration of complete remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and a completing taper of Prednisone to the first flare, BVAS/WG score of greater than 0, or an increase in Prednisone dosing.~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease" (NCT00104299)
Timeframe: 18 months post-randomization

,
InterventionDays (Number)
25% Quartile (95%CI)50% Quartile (95%CI)75% Quartile (95%CI)
Control Group230NANA
Rituximab243NANA

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The Duration of Remission (BVAS=0), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups

Duration of remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and a completing taper of glucocorticoid by 6 months post-randomization to the first flare, BVAS/WG score of greater than 0, or an increase in Prednisone dosing. (NCT00104299)
Timeframe: 18 months post-randomization

,
InterventionDays (Number)
25% Quartile (95%CI)50% Quartile (95%CI)75% Quartile (95%CI)
Control Group168NANA
Rituximab246NANA

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Time to Complete Remission (BVAS=0, Off Glucocorticoids) From the Visit 1 Baseline Visit in the Two Treatment Groups

"Time to complete remission is defined as the number of days from baseline visit (Visit 1) to a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and completing taper of glucocorticoid by 6 months post-randomization.~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease" (NCT00104299)
Timeframe: 18 months post-randomization

,
InterventionDays (Number)
25% Quartile (95%CI)50% Quartile (95%CI)75% Quartile (95%CI)
Control Group177183266
Rituximab176180189

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Time to Remission (BVAS=0) From the Visit 1 Baseline Visit in the Two Treatment Groups

"Time to complete remission is defined as the number of days from baseline visit (Visit 1) to a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0.~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease" (NCT00104299)
Timeframe: 18 months post-randomization

,
InterventionDays (Number)
25% Quartile (95%CI)50% Quartile (95%CI)75% Quartile (95%CI)
Control Group2943112
Rituximab3057119

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Event-free Survival

Failure includes one of the following occurrences as a first event: relapse/progression or second malignancy from enrollment. (NCT00107198)
Timeframe: At 5 years

InterventionProbability participants (Number)
Surgery or Combination Chemotherapy, With/Without Radiotherapy0.85

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Grade 3 or 4 Toxicity

(NCT00107198)
Timeframe: Any time during chemoradiotherapy, up to the end of 3-cycles of AV-PC induction. Each cycle is 21 days.

InterventionParticipants (Number)
Surgery or Combination Chemotherapy, With/Without Radiotherapy26

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Cure by Surgery Alone in Stage I Resected Patients

To estimate the proportion of Stage I patients (with a single involved lymph node that is totally resected) who can be cured with surgery alone. (NCT00107198)
Timeframe: At 2 years

InterventionProbability participants (Number)
Surgery or Combination Chemotherapy, With/Without Radiotherapy0.82

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Cure by AV-PC x 3 or AV-PC x 3 + IFRT for Stage I Unresected, Stage I Resected Whose Disease Recurred, and Stage II Patients

To estimate the proportions of Stage I unresected, Stage I resected (whose disease has recurred after observation), and Stage II LPHD patients who can be cured with AV-PC x 3, with IFRT for those who are not in a CR after chemotherapy. (NCT00107198)
Timeframe: At 5 years

InterventionProbability participants (Number)
Surgery or Combination Chemotherapy, With/Without Radiotherapy0.89

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Failure-free Survival (FFS)

The time to a treatment (strategy) failure, where failure includes one of the following occurrences as a first event: disseminated disease (> Stage I/II) progression or recurrence at any time, local disease progression or recurrence anytime during or after treatment with AV-PC +/- IFRT, occurrence of a second malignant neoplasm, death from any cause. (NCT00107198)
Timeframe: At 5 years

InterventionProbability participants (Number)
Surgery or Combination Chemotherapy, With/Without Radiotherapy0.91

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Response Rate (Complete, Complete Unconfirmed, and Partial)

Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. (NCT00107380)
Timeframe: 6 months

Interventionparticipants (Number)
Partial ResponseConfirmed ResponseUnconfirmed ResponseNo Response
R-CHOP + I-131-tositumomab21411012

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Progression-free Survival (PFS) at 2 Years

Clinical responses were evaluated according to International Workshop NHL criteria (Cheson et al, 1999). Progression disease was defined as if a (CR, CRU) was not achieved at a previous assessment, a 50% increase in the SPD of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Appearance of a new lesion/site. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Death due to disease without prior documentation of progression. PFS is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. (NCT00107380)
Timeframe: 0-2 years

Interventionpercentage of participants (Number)
R-CHOP + I-131-tositumomab69

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Crohn's Disease Endoscopic Index of Severity (CDEIS)

Measure of mucosal disease at baseline and week 12 obtained during colonoscopy. The CDEIS score generally ranges from 0-30. A higher score indicates more severe mucosal inflammation. (NCT00109473)
Timeframe: Baseline and 12 weeks

,
InterventionScores on a scale (Mean)
BaselineWeek 12
Corticosteroid (CTX)86
Growth Hormone Plus Corticosteroid (CTX)93

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Crohn's Disease Histologic Index of Severity (CDHIS)

The CDHIS was developed and validated in order to determine the effect of therapies upon histologic disease activity in Crohn's Disease. It has been used to assess mucosal healing in response to infliximab and 6-MP/AZA.It contains eight items which reflect epithelial injury, mucosal inflammation, and the extent of involvement. Scores range from 0-16, with patients with moderate to severely active CD typically having scores of 6-12. It was computed by a GI pathologist. The higher the score indicates worsening of disease, the lowest score is 0 and highest possible is 16 (NCT00109473)
Timeframe: Baseline and 12 weeks

,
Interventionscores on a scale (Number)
BaselineWeek 12
Corticosteroid (CTX)88
Growth Hormone Plus Corticosteroid (CTX)76

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Fecal Calprotectin

Fecal calprotectin is a previously validated stool marker of intestinal inflammation in Crohn's Disease. (NCT00109473)
Timeframe: At 24 and 64 weeks

,
Interventionmicrograms per gram (microg/g) (Mean)
BaselineWeek 12
Corticosteroid (CTX)904656
Growth Hormone Plus Corticosteroid (CTX)863868

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Pediatric Crohn's Disease Activity Index (PCDAI)

The PCDAI is a previously validated measure of clinical disease activity for children with CD. It contains three self-report items which reflect patient abdominal pain, diarrhea, and general well being; three laboratory values; height and weight velocity; and three physical examination parameters reflecting abdominal tenderness, perirectal disease, and extra-intestinal manifestations. Scores may range from 0-100. Remission is defined as 0-10, mild disease as 10-30, and moderate to severe disease as greater than 30. (NCT00109473)
Timeframe: Baseline, 12 and 24 weeks

,
InterventionScores on a scale (Mean)
BaselineWeek 12Week 24
Corticosteroid (CTX)33226
Growth Hormone Plus Corticosteroid (CTX)3289

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Serum IGF-1 (Insulin-like Growth Factor 1)z Score

"Elevated serum IGF-1 levels have been implicated in the development of colorectal cancer, both in the general population and in patients with an excess of growth hormone production. The serum IGF-1 levels were monitored to maintain them in the physiologic range during growth hormone therapy to reduce the risk of tumorigenesis.~The levels are reported as a z score, a statistical way of standardizing data. The standard deviation is the unit of measurement of the z-score. Each z score corresponds to a point in a normal distribution, describing how much a point deviates from a mean." (NCT00109473)
Timeframe: Baseline, 12 weeks, 24 weeks

,
InterventionZ score (Mean)
BaselineWeek 12Week 24
Corticosteroid (CTX)-0.7-13.8
Growth Hormone Plus Corticosteroid (CTX)-0.41.83.3

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Total Corticosteroid Use

The total corticosteroid use over 12 weeks between groups, using the unpaired t test. (NCT00109473)
Timeframe: 12 weeks

,
Interventionmg (Mean)
prednisonebudesonide
Cortecosteroids Alone288
Growth Hormone Plus Cortecosteroid227

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IMPACT III Score

Health-related quality of life (QOL)was assessed using the IMPACT 111 questionnnaire. It is a self-administered 35 item questionnaire which typically takes 10-15 minutes to complete. Scores range from 0-350, with higher scores reflecting better perceived quality of life. (NCT00109473)
Timeframe: Baseline, 12 weeks, 24 weeks

,
InterventionScores on a scale (Mean)
BaselineWeek 12
Corticosteroid (CTX)132136
Growth Hormone Plus Corticosteroid (CTX)134143

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Height Velocity

"Height velocity was computed every 12 weeks up to week 64 and then yearly during the Maintenance study. Since 40 to 80% of children with Crohn's disease have significant growth failure at diagnosis, height velocity is used to track for changes in height.~It is calculated by measuring height at two points of time and then dividing the change by the amount of time." (NCT00109473)
Timeframe: Baseline, week 12, 24 and 48

,
Interventioncm/year (Mean)
BaselineWeek 12Week 24
Corticosteroid (CTX)337
Growth Hormone Plus Corticosteroid (CTX)589

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Continuous Complete Remission at 1 Year

A patient has a continuous complete remission at 1 year if they achieve a CR and are alive 365 days after registering to the study. (NCT00109837)
Timeframe: After induction, after consolidation, every 3 months during maintenance, and every three months after off treatment for up to a year

Interventionparticipants (Number)
Treatment21

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Toxicity

Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event (NCT00109837)
Timeframe: Patients were assessed for adverse events after the induction cycle

InterventionParticipants with a given type of AE (Number)
ALT, SGPT (serum glutamic pyruvic transaminase)AST, SGOT (serum glut oxaloacetic transaminase)Albumin, serum-low (hypoalbuminemia)Alkaline phosphataseAnorexiaAscites (non-malignant)Bilirubin (hyperbilirubinemia)Calcium, serum-low (hypocalcemia)CholecystitisCholesterol, serum-high (hypercholesterolemia)Coagulation-Other (Specify)Colitis, infectious (e.g., Clostridium difficile)ConstipationDIC (disseminated intravascular coagulation)Death not assoc with CTCAE term-Multi-organ failEdema: limbFatigue (asthenia, lethargy, malaise)Febrile neutropeniaFever (in the abs of neutropenia)FibrinogenGlucose, serum-high (hyperglycemia)Glucose, serum-low (hypoglycemia)HemoglobinHypertensionHypotensionHypoxiaIleus, GI (functional obstruction of bowel)Infec(doc clin or mibio) w/ Gr 3/4 neut-AnalInfec(doc clin or mibio) w/ Gr 3/4 neut-BladderInfec(doc clin or mibio) w/ Gr 3/4 neut-BloodInfec(doc clin or mibio) w/ Gr 3/4 neut-BronchusIInfec(doc clin or mibio) w/ Gr 3/4 neut-CatheterInfec(doc clin or mibio) w/ Gr 3/4 neut-Eye NOSInfec(doc clin or mibio) w/ Gr 3/4 neut-LungInfec(doc clin or mibio) w/ Gr 3/4 neut-NoseInfec(doc clin or mibio) w/ Gr 3/4 neut-PharynxInfec(doc clin or mibio) w/ Gr 3/4 neut-Ur tractInfec with nor ANC or Gr 1/2 neut-Lung (pneumonia)Infection-Other (Specify)Leukocytes (total WBC)LipaseLiver dysfunction/failure (clinical)LymphopeniaMagnesium, serum-high (hypermagnesemia)Mucositis/stomatitis (clinical exam) - Oral cavityMucositis/stomatitis (funct/symp) - Oral cavityMucositis/stomatitis (func/symp) - PharynxMuscle weak,gen spec area-Whole bodyNauseaNeuropathy: motorNeutrophils/granulocytes (ANC/AGC)Pain - Abdomen NOSPain - BonePain - NeckPancreatic endocrine: glucose intolerancePancreatitisPhosphate, serum-low (hypophosphatemia)PlateletsPotassium, serum-high (hyperkalemia)Potassium, serum-low (hypokalemia)Rash/desquamationRenal failureSodium, serum-low (hyponatremia)Thrombosis/thrombus/embolismThrombotic microangiopathyTriglyceride, serum-high (hypertriglyceridemia)Tumor lysis syndromeTyphlitis (cecal inflammation)Uric acid, serum-high (hyperuricemia)Vomiting
Induction171332216712111211318111161332321111111111122143121912112314711111144171261215111

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Proportion of Participants Who Experienced at Least a 50% Post-therapy PSA (Prostate-Specific Antigen) Decline

PSA decline will be reported on all patients and will be defined as a decrease in PSA value by >= 50% for two successive evaluations at least 4 weeks apart. The reference PSA value for these declines should be measured within 2 weeks before starting therapy. (NCT00110214)
Timeframe: Duration of study (up to 5 years)

Interventionpercentage of participants (Number)
Docetaxel + Placebo57.9
Docetaxel + Bevacizumab69.5

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Proportion of Participants Who Experience (Maximum) Grade 3 or Higher Toxicities

"The National Cancer Institute (NCI) Criteria for Adverse Events(CTCAE) Version 3.0 was used to evaluate toxicity. These events were considered at least possibly related to treatment.~Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death" (NCT00110214)
Timeframe: During treatment (up to 2 years)

Interventionpercentage of participants (Number)
Docetaxel + Placebo56.2
Docetaxel + Bevacizumab75.4

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Progression-free Survival (PFS)

"PFS was defined as the data of randomization to date of progression or death due to any cause, whichever occurs first. PFS was estimated using the Kaplan Meier method.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions" (NCT00110214)
Timeframe: Duration of study (up to 5 years)

Interventionmonths (Median)
Docetaxel + Placebo7.5
Docetaxel + Bevacizumab9.9

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Overall Survival

Overall Survival (OS) was measured from the date of randomization to date of death due to any cause. OS was estimated using the Kaplan Meier method. (NCT00110214)
Timeframe: Duration of study (up to 5 years)

Interventionmonths (Median)
Docetaxel + Placebo21.5
Docetaxel + Bevacizumab22.6

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Progression-Free Survival Rate at 2 and 5 Years

"Progression-free survival (PFS) is defined as the time from randomization to progression, relapse, or death from any cause, whichever occurred first. Progression (PD) or Relapse>~≥ 50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders.>~Appearance of any new lesion during or after completion of therapy.>~PET+ is not a criterion for progressive disease. Patients only with PET+ findings must have evidence of progression on CT or biopsy proven.>~The PFS rate (percentage of participants who are alive and progression-free) at 2 and 5 years Kaplan Meier estimates and 95% Confidence Intervals are reported below." (NCT00118209)
Timeframe: Up to 5 years post-registration

,
Interventionpercentage of participants (Number)
2-year PFS5-year PFS
Arm A - R-CHOP75.566.0
Arm B - DA-EPOCH-R78.968.0

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Overall Survival Rate at 2 and 5 Years

Overall survival is defined as the time from randomization to death due to any cause. The overall survival (OS) rate (percentage of participants who are still alive) at 2 and 5 years Kaplan Meier estimates and 95% confidence intervals are reported below. (NCT00118209)
Timeframe: Up to 5 years post-registration

,
Interventionpercentage of participants (Number)
2-year OS rate5-year OS rate
Arm A - R-CHOP85.778.5
Arm B - DA-EPOCH-R86.577.5

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Response Rate

The overall response rate is defined as the percentage of participants with a response (Complete Response or Partial Response) (NCT00118209)
Timeframe: Up to 5 years post-registration

Interventionpercentage of participants (Number)
Arm B - DA-EPOCH-R86.7
Arm A - R-CHOP88.0

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OL; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)

MMAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Leukocytes: <0.75* LLN or >1.25* ULN (or, if pre-Rx value ULN. If pre-Rx value >ULN, then >1.2* pre-Rx or 7.50* 10^3 c/uL; Monocytes (absolute): >2000/mm^3; Basophils (absolute): >0.40* 10^3 c/uL; Eosinophils (absolute): >0.75* 10^3 c/uL. (NCT00119678)
Timeframe: From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period

Interventionparticipants (Number)
LeukocytesNeutrophils+bands (absolute)Lymphocytes (absolute)Monocytes (absolute)Basophils (absolute)Eosinophils (absolute)
Abatacept18632003

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OL; Number of Participants With MAs in Serum Chemistry: Alkaline Phosphatase (ALP), Aspartate-aminotransferase (AST), Alanine-aminotransferase (ALT), Gamma-glutamyl Transferase (GGT), Bilirubin(Total), Blood Urea Nitrogen (BUN), Creatinine

MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP, GGT: >2* ULN (if pre-Rx >ULN, then >3* pre-Rx); AST, ALT: >3* ULN (if pre-Rx >ULN, then >4* pre-Rx). Bilirubin (total): >2* ULN (if pre-Rx >ULN, then >4* pre-Rx), BUN:>2* pre-Rx; Creatinine:>1.5* pre-Rx. (NCT00119678)
Timeframe: From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period

Interventionparticipants (Number)
ALPASTALTGGTBilirubin (total)BUNCreatinine
Abatacept0346037

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OL; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides

MAs are laboratory measurements marked as abnormal, as per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Glucose: <65 mg/dL or >220 mg/dL; Glucose (fasting serum): <0.8* LLN or >1.5 ULN (if pre-Rx ULN. If pre-Rx >ULN, then >2.0* pre-Rx or 2* pre-Rx; triglycerides: >=2.5* ULN, or if pre Rx>ULN then use >2.5* pre Rx; fasting triglycerides: >=2.0* ULN, or if pre Rx>ULN then use >2.0* pre Rx. (NCT00119678)
Timeframe: From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period

Interventionparticipants (Number)
Glucose (serum) (n = 110)Glucose (fasting serum) (n = 55)Albumin (n = 110)Cholesterol (total) (n = 15)Triglycerides (n = 10)Triglycerides (fasting) (n = 9)
Abatacept2166000

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OL; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total), Protein (Total)

MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Sodium (serum): <0.95x LLN or >1.05x ULN (if pre-RxULN. If pre-Rx >ULN, then >1.05x pre-Rx or 1.1xULN (if pre-Rx ULN. If pre-Rx >ULN, then >1.1xpre-Rx or 1.2xULN (if pre-Rx ULN. If pre-Rx >ULN, then >1.25x pre-Rx or NCT00119678)
Timeframe: From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period

Interventionparticipants (Number)
Sodium (serum)Potassium (serum)Chloride (serum)Calcium (total)Protein (total)
Abatacept07014

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OL; Number of Participants With Significant AEs of Special Interest

An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs of particular importance were associated with the use of immunomodulatory agents. Number of participants with infections, malignant Neoplasms, pre-specified autoimmune disorders, acute-infusional AEs and peri-infusional AEs were recorded. (NCT00119678)
Timeframe: From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period

Interventionparticipants (Number)
InfectionsMalignant neoplasmsPre-specified autoimmune disordersAcute-infusional AEsPeri-infusional AEs
Abatacept8214315

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OL; Number of Participants With MAs in Urinalysis

MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis, Protein, glucose, blood, Leukocyte esterase, red blood cells (RBC), white blood cells (WBC): >=2+ (or, if value >=4, or if pre-Rx value = 0 or 0.5, then >= 2* or if pre-Rx value =1, then >=3, or if pre-Rx = 2 or 3, then >=4); protein (24 hour urine): >1000 mg/24 hrs and >=2* pre-Rx; Glomerular filtration rate (GFR): <=60 mL/min/1.73m^2 or > 15% change from baseline; Protein/creatinine ratio: > 100 mg/mmol. (NCT00119678)
Timeframe: From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period

Interventionparticipants (Number)
Protein (n = 110)Glucose (n= 110)Blood (n = 110)Leukocyte esterase (n = 104)WBC (n = 105)RBC (n = 101)GFR (n = 110)Protein/creatinine ratio (n = 109)
Abatacept12041285735910

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OL; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment

MSD technology was used to detect antibodies specific for CTLA4-T and for abatacept. (NCT00119678)
Timeframe: After the first dose of open-label period

Interventionparticipants (Number)
Abatacept30

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DB; Median Number of Days to the First Occurrence of a New SLE Flare

Elapsed days between start of corticosteroid taper & first day of flare.Scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved.Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:first BILAG 'A' or 'B' event adjudicated to be flare following resolution of entry flare and/or start of corticosteroid taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29). (NCT00119678)
Timeframe: From start of corticosteroid taper to confirmation of disease flare or the end of double-blind period

InterventionDays (Median)
Abatacept107.0
Placebo92.0

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DB; Number of Participants With a New SLE Flare During the Initial 6 Months

SLE flares scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved.Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:first BILAG 'A' or 'B' event adjudicated to be flare following resolution of entry flare and/or start of prednisone/prednisone-equivalent taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29). (NCT00119678)
Timeframe: From start of corticosteroid taper to 6 months.

InterventionParticipants (Number)
Abatacept75
Placebo36

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DB; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment

Electrochemiluminescence (ECL) immunoassay based on Meso Scale Discovery (MSD) technology was used to detect antibodies specific for CTLA4-T and for abatacept. (NCT00119678)
Timeframe: From Day 1 to Day 365

Interventionparticipants (Number)
Abatacept2

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Double Blind Period (DB); Number of Participants Experiencing a New SLE Flare

SLE flares scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved. Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:first BILAG 'A' or 'B' event adjudicated to be flare following resolution of entry flare and start of prednisone/prednisone-equivalent taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29). (NCT00119678)
Timeframe: From start of corticosteroid taper to Day 365

InterventionParticipants (Number)
Abatacept94
Placebo47

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DB; Number of Participants With a Change in the SLICC/ACR Damage Index at 1 Year Compared to Baseline

SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as non-reversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 48, and increasing score indicates increasing disease severity. (NCT00119678)
Timeframe: From start of study drug treatment to Day 365

,
Interventionparticipants (Number)
No changeIncreased 1Increased >1
Abatacept10133
Placebo4421

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DB; Number of Participants With MAs in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count

MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: >3 g/dL decrease from pre-treatment (pre-Rx) value; hematocrit: <0.75* pre-Rx value; erythrocyte count: <0.75* pre-Rx value; platelet count: <0.67* LLN or >1.5* ULN (or, if pre-Rx value NCT00119678)
Timeframe: Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier

,
Interventionparticipants (Number)
Hemoglobin (n = 120, 58)Hematocrit (n=120, 58)Erythrocytes (n=120, 58)Platelet count (n= 118, 58)
Abatacept1113
Placebo1110

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DB; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)

MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Leukocytes: <0.75* LLN or >1.25* ULN (or, if pre-Rx value ULN. If pre-Rx value >ULN, then >1.2* pre-Rx or 7.50* 10^3 c/uL; Monocytes (absolute): >2000/mm^3; Basophils (absolute): >0.40* 10^3 c/uL; Eosinophils (absolute): >0.75* 10^3 c/uL. (NCT00119678)
Timeframe: Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier

,
Interventionparticipants (Number)
Leukocytes (n = 120, 58)Neutrophils+bands (absolute) (n = 120, 59)Lymphocytes (absolute) (n = 120, 59)Monocytes (absolute) (n = 120, 59)Basophils (absolute) (n = 120, 59)Eosinophils (absolute) (n = 120, 59)
Abatacept26846106
Placebo11230002

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DB; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides

MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Glucose: <65 mg/dl or >220 mg/dl; Glucose (fasting serum): <0.8* LLN or >1.5 ULN (if pre-Rx ULN. If pre-Rx >ULN, then >2.0* pre-Rx or 2* pre-Rx; triglycerides: >=2.5* ULN, or if pre Rx>ULN then use >2.5* pre Rx; fasting triglycerides: >=2.0* ULN, or if pre Rx>ULN then use >2.0* pre Rx. (NCT00119678)
Timeframe: Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier

,
Interventionparticipants (Number)
Glucose (serum) (n = 120, 59)Glucose, fasting (n = 77, 37)Albumin (n = 120, 59)Cholesterol (total) (n = 118, 58)Triglycerides (n = 75, 36)Triglycerides (fasting) (n = 64, 34)
Abatacept2754000
Placebo1011000

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DB; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total),Protein (Total)

MAs are laboratory measurements marked as abnormal as per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Sodium (serum): <0.95* LLN or >1.05* ULN (if pre-Rx ULN. If pre-Rx >ULN, then >1.05* pre-Rx or 1.1* ULN (if pre-Rx ULN. If pre-Rx >ULN, then >1.1* pre-Rx or 1.2* ULN (if pre-Rx ULN. If pre-Rx >ULN, then >1.25* pre-Rx or NCT00119678)
Timeframe: Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier

,
Interventionparticipants (Number)
Sodium (serum) (n = 120, 59)Potassium (serum) (n = 120, 59)Chloride (serum) (n = 120, 59)Calcium (total) (n= 120, 59)Protein (total) (n = 120, 59)
Abatacept11001
Placebo01000

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DB; Number of Participants With MAs in Urinalysis

MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis, Protein, glucose, blood, Leukocyte esterase, RBC, WBC: >=2+ (or, if value >=4, or if pre-Rx value = 0 or 0.5, then >= 2* pre-Rx, or if pre-Rx value =1, then >=3, or if pre-Rx = 2 or 3, then >=4); protein (24 hour urine): >1000 mg/24 hrs and >=2* pre-Rx; GFR: <=60 mL/min/1.73m^2 or > 15% change from baseline; Protein/creatinine ratio: > 100 mg/mmol. (NCT00119678)
Timeframe: Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier

,
Interventionparticipants (Number)
Protein (n = 120, 58)Glucose (n = 120, 58)Blood (n = 120, 58)Leukocyte esterase (n = 107, 51)RBC (n = 107, 55)WBC (n = 115, 54)Protein, 24 hours (n = 89, 40)GFR (n = 120, 59)Protein/creatinine ratio (n = 119, 58)
Abatacept151392338614711
Placebo921881626144

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DB; Number of Participants With Significant AEs of Special Interest

An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, AEs of special interest were associated with the use of immunomodulatory agents. Number of participants with infections, malignant neoplasms, pre-specified autoimmune disorders, acute infusional AEs and peri-infusional AEs were recorded. (NCT00119678)
Timeframe: Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier

,
Interventionparticipants (Number)
InfectionsMalignant neoplasmsPre-specified autoimmune disordersAcute-infusional AEsPeri-infusional AEs
Abatacept7114527
Placebo3802513

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DB; Total Number of New SLE Flares Each Participant Experienced

SLE flares scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved.Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:BILAG 'A' or 'B' event adjudicated to be flare following resolution of entry flare and/or start of prednisone/prednisone-equivalent taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29). (NCT00119678)
Timeframe: From start of corticosteroid taper to Day 365

,
InterventionParticipants (Number)
None12>=3Inception treatment failure
Abatacept244721179
Placebo102110115

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DB: Number of Participants With MAs in Serum Chemistry: ALP, AST, ALT, GGT, Bilirubin (Total), BUN and Creatinine

MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP, GGT: >2* ULN (if pre-Rx >ULN, then >3* pre-Rx); AST, ALT: >3* ULN (if pre-Rx >ULN, then >4* pre-Rx). Bilirubin (total): >2* ULN (if pre-Rx >ULN, then >4* pre-Rx), BUN:>2* pre-Rx; Creatinine:>1.5* pre-Rx. (NCT00119678)
Timeframe: Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier

,
Interventionparticipants (Number)
ALP (n = 120, 59)AST (n = 120, 59)ALT (n = 120, 59)GGT (n = 120, 59)Bilirubin (total) (n = 120, 59)BUN (n = 120, 59)Creatinine (n = 120, 59)
Abatacept2323046
Placebo0003034

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OL; Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count

MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: >3 g/dL decrease from pre-treatment (pre-Rx) value; hematocrit: <0.75* pre-Rx value; erythrocyte count: <0.75* pre-Rx value; platelet count: <0.67* lower limit of normal (LLN) or >1.5* upper limit of normal (ULN) (or, if pre-Rx value NCT00119678)
Timeframe: From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period

Interventionparticipants (Number)
Hemoglobin (n = 110)Hematocrit (n = 110)Erythrocytes (n = 110)Platelet count (n = 108)
Abatacept2323

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Progression-free Survival at 1 Year

Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date (NCT00121199)
Timeframe: 0-1 year

Interventionpercentage of participants (Number)
CHOP + Rituximab + Bevacizumab77

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Objective Response (Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR))

Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. (NCT00121199)
Timeframe: After Cycle 4 (Day 64) but prior to Cycle 5 (Day 85) and after Cycle 8 (Day 181). After completion of protocol treatment, every 6 months for 2 years, then annually for a maximum of five years.

Interventionparticipants (Number)
Complete Response (CR)Partial Response (PR)Unconfirmed Complete Response (UCR)Unconfirmed Partial Response (UPR)No Response
CHOP + Rituximab + Bevacizumab22206115

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Progression-free Survival at 2 Year

Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date (NCT00121199)
Timeframe: 0-2 years

Interventionpercentage of participants (Number)
CHOP + Rituximab + Bevacizumab69

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Number of Participants With Progression-Free Survival

The primary objective of this study is to determine whether adding early chemotherapy based on docetaxel plus prednisone compared to standard of care alone reduces disease progression as evidenced by detectable PSA in high risk patients with prostate cancer who have undergone radical prostatectomy. (NCT00132301)
Timeframe: Up to 100 months (centralized follow-up)

InterventionParticipants (Count of Participants)
Arm 1: Docetaxel and Prednisone66
Arm 2: Standard of Care84

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Percentage of Participants Experiencing Grade 3-5 Toxicity

Percentage of participants experiencing at least one grade 3-5 adverse event (by CTCAE 3.0 criteria). (NCT00133991)
Timeframe: Up to 2 years

InterventionParticipants (Count of Participants)
R-CVP + HiCy21

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Event-free Survival

Percentage of participants alive without relapse at 1 year and 3 years. (NCT00133991)
Timeframe: 1 year and 3 years

Interventionpercentage of participants (Number)
1 year3 years
R-CVP + HiCy5252

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Overall Response Rate

Number of participants who have a complete or partial remission (2007 International Working Group criteria). (NCT00133991)
Timeframe: Up to 3 months

InterventionParticipants (Count of Participants)
Complete remissionPartial remission
R-CVP + HiCy112

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Overall Survival

Percentage of participants alive at 1 year and at 3 years. (NCT00133991)
Timeframe: 1 year and 3 years

Interventionpercentage of participants (Number)
1 year3 years
R-CVP + HiCy5757

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Relapse Pattern

Percentage of participants experiencing central nervous system (CNS) and systemic relapse. (NCT00133991)
Timeframe: Up to 6 months

InterventionParticipants (Count of Participants)
Systemic relapse onlySystemic and CNS relapse
R-CVP + HiCy32

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Compare Qualitative and Quantitative Toxicity Between the Two Study Arms

Only adverse events that are possibly, probably or definitely related to study drug are reported. (NCT00134056)
Timeframe: Assessed every 3 weeks up to 52 weeks

,
InterventionParticipants (Number)
ALT, SGPT (serum glutamic pyruvic transaminase)AST, SGOTAdult respiratory distress syndrome (ARDS)Albumin, serum-low (hypoalbuminemia)Alkaline phosphataseAllergic reaction/hypersensitivityAllergy/Immunology-Other (Specify)AmylaseAnorexiaArthritis (non-septic)AspirationAuditory/Ear-Other (Specify)Bilirubin (hyperbilirubinemia)Blood/Bone Marrow-Other (Specify)CNS cerebrovascular ischemiaCPK (creatine phosphokinase)Calcium, serum-low (hypocalcemia)Cardiac Arrhythmia-Other (Specify)Cardiac General-Other (Specify)Cardiac troponin I (cTnI)Cardiac troponin T (cTnT)Cardiac-ischemia/infarctionConduction abnormality NOSConfusionConstipationCoughCreatinineDehydrationDiarrheaDizzinessDry mouth/salivary gland (xerostomia)Dysphagia (difficulty swallowing)Dyspnea (shortness of breath)Edema: head and neckEdema: limbEdema: trunk/genitalErectile dysfunctionEsophagitisFatigue (asthenia, lethargy, malaise)Febrile neutropeniaFever in absence of neutropenia, ANC lt1.0x10e9/LFractureGlucose, serum-high (hyperglycemia)Glucose, serum-low (hypoglycemia)Heartburn/dyspepsiaHemoglobinHemolysisHemorrhage, Respiratory tract NOSHemorrhage, GI - RectumHemorrhage, GI - StomachHemorrhage, GI - Upper GI NOSHemorrhage, GU - BladderHemorrhage/Bleeding-Other (Specify)HemorrhoidsHot flashes/flushesHypertensionHypotensionHypoxiaINR (of prothrombin time)Induration/fibrosis (skin and subcutaneous tissue)Inf (clin/microbio) w/Gr 3-4 neuts - BladderInf (clin/microbio) w/Gr 3-4 neuts - BloodInf (clin/microbio) w/Gr 3-4 neuts - BronchusInf (clin/microbio) w/Gr 3-4 neuts - EsophagusInf (clin/microbio) w/Gr 3-4 neuts - LungInf (clin/microbio) w/Gr 3-4 neuts - Nerve-periphInf (clin/microbio) w/Gr 3-4 neuts - SkinInf (clin/microbio) w/Gr 3-4 neuts - Soft tissueInf (clin/microbio) w/Gr 3-4 neuts - UTIInf (clin/microbio) w/Gr 3-4 neuts - Upper airwayInf w/normal ANC or Gr 1-2 neutrophils - BloodInf w/normal ANC or Gr 1-2 neutrophils - BronchusInf w/normal ANC or Gr 1-2 neutrophils - ColonInf w/normal ANC or Gr 1-2 neutrophils - LungInf w/normal ANC or Gr 1-2 neutrophils - MuscleInf w/normal ANC or Gr 1-2 neutrophils - ScrotumInf w/normal ANC or Gr 1-2 neutrophils - SinusInf w/normal ANC or Gr 1-2 neutrophils - SkinInf w/normal ANC or Gr 1-2 neutrophils - StomachInf w/normal ANC or Gr 1-2 neutrophils - TracheaInf w/normal ANC or Gr 1-2 neutrophils - UTIInf w/normal ANC or Gr 1-2 neutrophils - UngualInf w/unknown ANC - Middle ear (otitis media)Inf w/unknown ANC - Upper aerodigestive NOSInfection with unknown ANC - BloodInfection with unknown ANC - Lung (pneumonia)Infection with unknown ANC - Upper airway NOSInfection with unknown ANC - Urinary tract NOSInfection-Other (Specify)InsomniaLeft ventricular diastolic dysfunctionLeft ventricular systolic dysfunctionLeukocytes (total WBC)LipaseLymphopeniaMagnesium, serum-high (hypermagnesemia)Metabolic/Laboratory-Other (Specify)Mood alteration - agitationMood alteration - depressionMucositis/stomatitis (clinical exam) - Oral cavityMucositis/stomatitis (clinical exam) - PharynxMucositis/stomatitis (clinical exam) - StomachMucositis/stomatitis (functional/symp) - EsophagusMucositis/stomatitis (functional/symp) - Oral cavMucositis/stomatitis (functional/symp) - PharynxMucositis/stomatitis (functional/symp) - RectumMuscle weakness, not d/t neuropathy - Extrem-lowerMuscle weakness, not d/t neuropathy - body/generalMyocarditisNail changesNasal cavity/paranasal sinus reactionsNauseaNeuropathy: motorNeuropathy: sensoryNeutrophils/granulocytes (ANC/AGC)Opportunistic inf associated w/gt=Gr 2 lymphopeniaPTT (Partial thromboplastin time)Pain - Abdomen NOSPain - BackPain - BonePain - Chest wallPain - Chest/thorax NOSPain - Extremity-limbPain - JointPain - MusclePain - Neuralgia/peripheral nervePain - PelvisPain-Other (Specify)Phosphate, serum-low (hypophosphatemia)PlateletsPneumonitis/pulmonary infiltratesPneumothoraxPotassium, serum-high (hyperkalemia)Potassium, serum-low (hypokalemia)Pulmonary/Upper Respiratory-Other (Specify)Rash: hand-foot skin reactionRenal failureRenal/Genitourinary-Other (Specify)Right ventricular dysfunction (cor pulmonale)SVT and nodal arrhythmia - Atrial fibrillationSVT and nodal arrhythmia - Atrial flutterSVT and nodal arrhythmia - Sinus tachycardiaSodium, serum-low (hyponatremia)Somnolence/depressed level of consciousnessSpeech impairment (e.g., dysphasia or aphasia)Sudden deathSyncope (fainting)Thrombosis/embolism (vascular access-related)Thrombosis/thrombus/embolismVasovagal episodeVomitingWatery eye (epiphora, tearing)Weight gain
Arm I: Placebo22334500510102027212121131491031138016120608112011471011002022910311200111114021111011110000030141131010301011211030021110211710140114150112810037712110141031081023090800
Arm II: Atrasentan24006611501012101011010042187101171200140202024012201001112123310201160203211050102001111101131029813202002001311180105611154100281012311104001210201211301011112711

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Number of Patients With a Change in Functional Status

Functional status will be measured with the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Trial Outcome Index. The FACT-P also addresses four general domains of QOL (physical, functional, emotional, and social well-being subscales) as well as symptom concerns associated with prostate cancer and its treatment. (NCT00134056)
Timeframe: up to 18 months study period

InterventionParticipants (Count of Participants)
Arm I: Placebo118
Arm II: Atrasentan Hydrochloride139

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Compare Elements of Quality of Life Between Treatment Arms: Pain Palliation Response, as Measured by the Brief Pain Inventory (BPI)

"Pain palliation is the proportion of patients showing a two-point reduction in the Worst Pain score (WPS) maintained for two consecutive assessments with no increase in analgesic use. Increase in analgesic use is defined as an increase in Analgesic code Level to 2 (weak opioid) or 3 (strong opioid). Patients will be classified as pain palliated or not palliated. Patients with a WPS of 0 will be defined as stable if their WPS remains 0 for Weeks 7 and 10 with no increase in analgesic use, but they will not be categorized as responders. Pain palliation response is measured by BPI short form that has the following: yes/no question about pain today; 4 pain rating questions (worst pain, least pain, average pain, and current pain); pain medications and pain relief; 7 items addressing effect of pain on functioning. For patients who continue to receive treatment beyond 12 treatment cycles, the Worst Pain item is measured by Pain Medication Log and Pain Assessment" (NCT00134056)
Timeframe: up to 18 months study period

InterventionParticipants (Count of Participants)
Arm I: Placebo75
Arm II: Atrasentan83

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Compare Pain Progression Between the Two Study Arms.

Pain progression is defined as patients reporting an increase of at least two Worst Pain points, maintained for at least two consecutive assessments, increase to Level 3 (strong opioid) on the Pain Medication Log Analgesic Code for patients receiving Level 2 (weak opioid) analgesics at randomization, or an increase to Level 2 or 3 analgesics for patients receiving Level 0 or 1 analgesics at randomization. (NCT00134056)
Timeframe: Up to 52 weeks

InterventionParticipants (Count of Participants)
Arm I: Placebo59
Arm II: Atrasentan41

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Compare Progression-free Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer.

Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients without progression are censored at date of last contact. Disease progression is defined by confirmed bone disease progression, soft tissue or pain progression. (NCT00134056)
Timeframe: Up to 7 years after study opens

Interventionmonths (Median)
Arm I: Placebo9.1
Arm II: Atrasentan9.2

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Compare Prostate Specific Antigen (PSA) Response Rates Between the Experimental Arm and the Standard Arm.

PSA Partial Response: Greater than or equal to 50% reduction in baseline PSA. There must be no evidence of soft tissue progression, or confirmed none disease progression, or pain progression. (NCT00134056)
Timeframe: Up to 7 years after study opens

InterventionParticipants (Count of Participants)
Arm I: Placebo243
Arm II: Atrasentan249

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Compare Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer.

Measured from date of registration to date of death due to any cause. Patient last known to be alive are censored at date of last contact. (NCT00134056)
Timeframe: Up to 7 years after study opens

Interventionmonths (Median)
Arm I: Placebo17.6
Arm II: Atrasentan17.8

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Number of Participants Who Qualify for Random Assignment

(NCT00135694)
Timeframe: One to two years post-transplantation

Interventionparticipants (Number)
All Enrolled95

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Total Immunosuppression From Month 21 to Month 24 Post-randomization

Daily immunosuppression score in units per day averaged over the 3-month period from Month 21 to Month 24 post-randomization. Daily doses were assigned a score of 1 unit as follows: tacrolimus 1 mg, cyclosporine 100 mg, Sirolimus 1 mg, mycophenolate mofetil 1000 mg, Mycophenolic acid 720 mg, azathioprine 50 mg, and prednisone 5 mg. Any antibody use equaled 20 units. Unit scores based on Vasudev (Vasudev B, Hariharan S, Hussain SA, Zhu YR, Bresnahan BA et al. BK virus nephritis: risk factors, timing, and outcome in renal transplant recipients. Kidney Int. 2005; 8(4):1834-1839.) (NCT00135694)
Timeframe: Month 21 to Month 24 post-randomization

Interventionunits per day (Mean)
Randomized to Immunosuppression Withdrawal2.8
Randomized to Immunosuppression Maintenance3.7

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Immunosuppression-free Duration

Time (in days) from withdrawing off of all immunosuppressive drugs to re-starting immunosuppression or study termination/completion. (NCT00135694)
Timeframe: Discontinuation of all immunosuppression to end of trial participation or to time of restarting immunosuppression, whichever came first, assessed up to two years

InterventionDays (Mean)
Randomized to Immunosuppression Withdrawal555.2

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Number of Participants Experiencing Graft Loss or Death

Number of participants with graft loss or death. Graft loss is defined as subject death or re-transplantation. (NCT00135694)
Timeframe: Randomization to 2 years post-randomization.

Interventionparticipants (Number)
Randomized to Immunosuppression Withdrawal1
Randomized to Immunosuppression Maintenance0

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Total Burden of Immunosuppression From Random Assignment to Month 24

Total immunosuppression score in units taken as the sum of units per day over the 2-year period from randomization to Month 24 post-randomization. Daily doses were assigned a score of 1 unit as follows: tacrolimus 1 mg, cyclosporine 100 mg, Sirolimus 1 mg, mycophenolate mofetil 1000 mg, Mycophenolic acid 720 mg, azathioprine 50 mg, and prednisone 5 mg. Any antibody use equaled 20 units. Unit scores based on Vasudev (Vasudev B, Hariharan S, Hussain SA, Zhu YR, Bresnahan BA et al. BK virus nephritis: risk factors, timing, and outcome in renal transplant recipients. Kidney Int. 2005; 8(4):1834-1839.). (NCT00135694)
Timeframe: Randomization to Month 24 post-randomization

Interventionunits (Mean)
Randomized to Immunosuppression Withdrawal2198.5
Randomized to Immunosuppression Maintenance2708.4

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Number of Participants With Clinical Complications Usually Attributed to Immunosuppression

This is a composite endpoint comprising clinical complications related to immunosuppression and is defined as the occurrence of any of the following: death or graft loss, grade 4 secondary malignancy (graded by Common Terminology Criteria for Adverse Events [CTCAE] version 3.0), grade 4 opportunistic infection (graded by CTCAE version 3.0), stage 3 or higher fibrosis, or decrease in renal function. Decrease in renal function is defined as: a) the estimated glomerular filtration rate (eGFR) using creatinine obtained prior to and closest to randomization will be considered the baseline and will be compared to the eGFR using creatinine obtained at 24 months +/- 3 months after randomization; b) for those with a baseline eGFR 30-90 ml per min per 1.73 meter-squared, a 25% decrease in eGFR; c) for those with a baseline eGFR greater than 90 ml per min per 1.73 meter-squared, a 25% decrease in eGFR and a decrease in eGFR to less than 90 ml per min per 1.73 meter-squared. (NCT00135694)
Timeframe: Randomization to 2 years post-randomization

Interventionparticipants (Number)
Randomized to Immunosuppression Withdrawal12
Randomized to Immunosuppression Maintenance4

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Number of Participants Who Successfully Stop Taking Immunosuppression for at Least 6 Months

(NCT00135694)
Timeframe: Randomization until study completion or participant termination (up to six years post-transplant)

Interventionparticipants (Number)
Randomized to Immunosuppression Withdrawal12

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Relationship of Inhibition of DNA Synthesis and Clinical Response

Clinical response is defined as MRD (minimal residual disease) measured by flow cytometry at day 22. The MRD at day 22 is classified as positive (with MRD) or negative (no detectable MRD). The relation between inhibition of DNA synthesis and MRD was performed by logistic regression. In the model, logit of probability of MRD positive was regressed on inhibition of DNA synthesis. (NCT00136084)
Timeframe: Measurements were assessed in Induction I chemotherapy

InterventionPercent inhibition of DNA Synthesis (Mean)
Overall66.7

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To Assess Whether Inhibition of DNA Synthesis is Greater After High-dose Ara-C (HDAC) Than After Low-dose Ara-C (LDAC) Therapy

Inhibition of DNA synthesis is defined as the percentage of DNA synthesis rate at 24-hour post-araC treatment over DNA synthesis rate pre-araC treatment. (NCT00136084)
Timeframe: Measurements were assessed in Induction I chemotherapy

InterventionPercent Inhibition of DNA Synthesis (Mean)
Arm 1: (HDAC)60.6
Arm 2:(LDAC)72.8

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To Estimate the Overall Event-free Survival (EFS) of AML Patients Who Undergo Risk-adapted and Genotype-directed Therapy

Overall event-free survival (EFS) was defined as the time from study enrollment to induction failure, relapse, secondary malignancy, death, or study withdrawal for any reason, with event-free patients censored on the date of the last follow-up (NCT00136084)
Timeframe: Five Year

InterventionPercentage of Participants (Number)
Overall62.4

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Minimal Residual Disease (MRD).

Detection of Minimal Residual Disease following one course of chemotherapy where positive MRD was defined as one or more leukemic cell per 1000 mononuclear bone-marrow cells (>=0.1%). (NCT00136084)
Timeframe: Day 22 MRD measurement

,
Interventionparticipants (Number)
MRD PositiveMRD Negative
Arm 1: (HDAC)3168
Arm 2:(LDAC)4363

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Proportion of Minimal Residual Disease (MRD)+ Patients Who Become MRD- After One Course of Gemtuzumab Ozogamicin (GO)

To estimate the proportion of minimal residual disease (MRD)+ patients who become MRD- after one course of gemtuzumab ozogamicin (GO) (NCT00136084)
Timeframe: Consolidation I

InterventionParticipants (Number)
NegativePositive
Overall114

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Proportion of MRD Reduction After One Course of Cytarabine + Daunomycin + Etoposide (ADE) + GO

To estimate proportion of patients with MRD reduction after one course of Induction II (cytarabine + daunomycin + etoposide (ADE) + GO), who had no response to first course of induction therapy. (NCT00136084)
Timeframe: Induction II

InterventionParticipants (Number)
DecreaseIncrease or no change
Overall272

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Proportion of Patients Experienced Toxicity of Cytarabine + Daunomycin + Etoposide (ADE) + GO.

To estimate proportion of patients experiencing CTC Grade 3 or 4 toxicity during Induction II (Cytarabine + Daunomycin + Etoposide (ADE) + GO), who had no response to first course of induction therapy (NCT00136084)
Timeframe: Induction II

InterventionParticipants (Number)
Experienced Grade 3 or 4 toxicitiesDid not experience Grade 3 or 4 toxicities
Overall273

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Median Difference in CASP1 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs Glucocorticoid-sensitive Cells

Prednisolone sensitivity was measured in primary leukemia cells from bone marrow collected at diagnosis. Expression of CASP1 was determined by HG-U133A microarray. Values given are gene expression values, and the unit is arbitrary units (AU) defined as scaled fluorescence measured on microarray. (NCT00137111)
Timeframe: Pre-treatment

Interventionarbitrary units (Median)
Prednisolone-sensitive cellsPrednisolone-resistant cells
Total Therapy341.3447.9

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Overall Event-free Survival (EFS)

EFS was measured from the start of on-study to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Failure to enter remission was considered an event at time zero. Measurement was determined by Kaplan-Meyer estimate. (NCT00137111)
Timeframe: Median follow-up time (range) 5.6 (1.3 to 8.9) years

InterventionPercentage of Participants (Number)
Total Therapy87.3

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Mean Difference of Active Methotrexate Polyglutamates (MTXPG) in Leukemia Cells Between Two Arms (4 Hours vs. 24 Hours).

Children were randomly assigned to receive initial single-agent treatment with HDMTX (1g/m^2) as either a 24-hour infusion or a 4-hour infusion and the outcome measure was the accumulation of MTXPG in leukemia cells. (NCT00137111)
Timeframe: 42 hours after start of high dose methotrexate infusion (HDMTX)

Interventionpmol/1,000,000,000 cells (Mean)
4 hr1688
24 hr2521

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Continuous Complete Remission Since Week 56 Therapy.

CCR was measured from end of week 56 therapy to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Measurement was determined by Kaplan-Meyer estimate. (NCT00137111)
Timeframe: Median follow up time (range) 4.5 (1 to 7.8) years

InterventionPercentage of participants (Number)
Patients With High Risk of CNS Relapse92.2

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Circulating Leukemia Cells in Peripheral Blood Change From Prior to the Methotrexate Infusion to Three Days After Between Two Arms (4 Hours vs. 24 Hours)

"White blood cell (leukocytes) counts in peripheral blood by Complete Blood Count~Measurement: Percentage change of leukemia cells from baseline" (NCT00137111)
Timeframe: Immediately before the methotrexate infusion and three days after subsequent infusion

InterventionPercent change (Mean)
4 hr-44
24 hr-50

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Median Difference in NLRP3 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs. Glucocorticoid-sensitive Cells

Prednisolone sensitivity was measured in primary leukemia cells from bone marrow collected at diagnosis. Expression of NLRP3 was determined by HG-U133A microarray. Values given are gene expression values, and the unit is arbitrary units (AU) defined as scaled fluorescence measured on microarray. (NCT00137111)
Timeframe: Pre-treatment

Interventionarbitrary units (Median)
Prednisolone-sensitive cellsPrednisolone-resistant cells
Total Therapy41.2110.7

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Minimal Residual Disease (MRD)

Detection of MRD at end of induction where positive MRD was defined as one or more leukemic cell per 10,000 mononuclear bone-marrow cells (>=0.01%). (NCT00137111)
Timeframe: End of Induction (Day 46 MRD measurement)

Interventionparticipants (Number)
Negative <0.01%Positive >= 0.01%
Total Therapy390102

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Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale)

Assesses health related quality of life and advanced prostate cancer specific symptoms. FACT-General (FACT-G) assesses 4 domains: physical, social and family, emotional, and functional well-being. The prostate cancer subscale assesses prostate cancer symptoms focusing on pain, urination problems, and sexual functions. Individual scores range from 0 (not at all) to 4 (very much). Scores for some of the individual questions are reverse-coded in order for higher scores to correspond to better health status. FACT-P overall score range is 0 to 156; higher scores indicate better health status. (NCT00137436)
Timeframe: Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study)

Interventionscores on a scale (Mean)
Bsl mean C1.D1 (n=47)Change from Bsl - C2.D1 (n=42)Change from Bsl - C3.D1 (n=31)Change from Bsl - C4.D1 (n=30)Change from Bsl - C5.D1 (n=33)Change from Bsl - C6.D1 (n=31)Change from Bsl - C7.D1 (n=29)Change from Bsl - C8.D1 (n=25)Change from Bsl - C9.D1 (n=24)Change from Bsl - C10.D1 (n=22)Change from Bsl - C11.D1 (n=21)Change from Bsl - C12.D1 (n=18)Change from Bsl - C13.D1 (n=16)Change from Bsl - C14.D1 (n=17)Change from Bsl - C15.D1 (n=12)Change from Bsl - C16.D1 (n=12)Change from Bsl - EOT (n=36)
SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg112.06.47.26.64.98.24.43.60.22.03.14.15.67.94.16.20.6

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Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G)

The questionnaire assesses pain intensity (worst, least, average, and right now), level of relief in the last 24 hours, and the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). The pain interference index score (to measure how much pain had interfered with daily activities) was derived from Questions 7A-7G with a range from 0 (no interference) to 10 (completely interferes); higher scores indicate more interference. (NCT00137436)
Timeframe: Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study)

Interventionscores on a scale (Mean)
Bsl mean C1.D1 (n=48)Change from Bsl - C2.D1 (n=41)Change from Bsl - C3.D1 (n=34)Change from Bsl - C4.D1 (n=30)Change from Bsl - C5.D1 (n=31)Change from Bsl - C6.D1 (n=32)Change from Bsl - C7.D1 (n=29)Change from Bsl - C8.D1 (n=26)Change from Bsl - C9.D1 (n=24)Change from Bsl - C10.D1 (n=21)Change from Bsl - C11.D1 (n=21)Change from Bsl - C12.D1 (n=18)Change from Bsl - C13.D1 (n=17)Change from Bsl - C14.D1 (n=17)Change from Bsl - C15.D1 (n=12)Change from Bsl - C16.D1 (n=12)Change from Bsl - EOT (n=36)
SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg1.8-0.7-0.8-0.5-0.7-0.6-0.4-0.5-0.5-0.4-0.7-0.8-1.2-1.4-1.0-0.5-0.4

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Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC

Soluble protein biomarker Vascular Endothelial Growth Factor C (VEGFC) measured as picograms per milliliter (pg/mL). PSA responders are participants with a confirmed PSA response as per the Working Group criteria (>50% decrease from baseline) and non-responders are those not meeting the definition of responder. Ratio=value of soluble protein biomarkers at each time point to the value at baseline (C1D14 : C1D1). (NCT00137436)
Timeframe: Baseline (Cycle 1 Day 1 [C1.D1]), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14

Interventionpg/mL (Median)
Bsl median - PSA responderBsl median - PSA non-responderC1D14 : C1D1 - PSA responderC1D14 : C1D1 - PSA non-responderC2.D1 : C1D1 - PSA responderC2.D1 : C1D1 - PSA non-responderC2.D14 : C1D1 - PSA responderC2.D14 : C1D1 - PSA non-responderC3.D1 : C1D1 - PSA responderC3.D14 : C1D1 - PSA responderC3.D14 : C1D1 - PSA non-responder
SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg622.70639.701.061.070.880.930.920.951.510.970.96

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Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC

Soluble protein biomarker VEGFC measured as pg/mL. CBR defined as confirmed CR (disappearance of all target lesions) or confirmed PR (≥30% decrease in sum of longest dimensions [LD] of target lesions taking as reference the baseline sum LD) or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) ≥3 months versus PD (≥20% increase in sum LD of target lesions taking as reference the smallest sum LD recorded since treatment started, unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesions) or SD <3 months. (NCT00137436)
Timeframe: Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14

Interventionpg/mL (Median)
Bsl median - CR or PRBsl median - SD or PDC1D14 : C1D1 - CR or PRC1D14 : C1D1 - SD or PDC2.D1 : C1D1 - CR or PRC2.D1 : C1D1 - SD or PDC2.D14 : C1D1 - CR or PRC2.D14 : C1D1 - SD or PDC3.D14 : C1D1 - CR or PRC3.D14 : C1D1 - SD or PD
SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg581.05586.851.211.190.891.150.920.970.880.59

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Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2

Soluble protein biomarker VEGFR2 measured as pg/mL. CBR defined as confirmed CR (disappearance of all target lesions) or confirmed PR (≥30% decrease in sum of longest dimensions [LD] of target lesions taking as reference the baseline sum LD) or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) ≥3 months versus PD (≥20% increase in sum LD of target lesions taking as reference the smallest sum LD recorded since treatment started, unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesions) or SD <3 months. (NCT00137436)
Timeframe: Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14

Interventionpg/mL (Median)
Bsl median - CR or PRBsl median - SD or PDC1D14 : C1D1 - CR or PRC1D14 : C1D1 - SD or PDC2.D1 : C1D1 - CR or PRC2.D1 : C1D1 - SD or PDC2.D14 : C1D1 - CR or PRC2.D14 : C1D1 - SD or PDC3.D14 : C1D1 - CR or PRC3.D14 : C1D1 - SD or PD
SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg9837.509484.250.730.750.830.830.680.600.630.80

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Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3

Soluble protein biomarker VEGFR3 measured as pg/mL. CBR defined as confirmed CR (disappearance of all target lesions) or confirmed PR (≥30% decrease in sum of longest dimensions [LD] of target lesions taking as reference the baseline sum LD) or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) ≥3 months versus PD (≥20% increase in sum LD of target lesions taking as reference the smallest sum LD recorded since treatment started, unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesions) or SD <3 months. (NCT00137436)
Timeframe: Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14

Interventionpg/mL (Median)
Bsl median - CR or PRBsl median - SD or PDC1D14 : C1D1 - CR or PRC1D14 : C1D1 - SD or PDC2.D1 : C1D1 - CR or PRC2.D1 : C1D1 - SD or PDC2.D14 : C1D1 - CR or PRC2.D14 : C1D1 - SD or PDC3.D14 : C1D1 - CR or PRC3.D14 : C1D1 - SD or PD
SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg19975.0022495.000.720.680.780.830.690.800.610.78

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Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2

Soluble protein biomarker Vascular Endothelial Growth Factor receptor 2 (VEGFR2) measured as pg/mL. PSA responders are participants with a confirmed PSA response as per the Working Group criteria (>50% decrease from baseline) and non-responders are those not meeting the definition of responder. Ratio=value of soluble protein biomarkers at each time point to the value at baseline (C1D14 : C1D1). (NCT00137436)
Timeframe: Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14

Interventionpg/mL (Median)
Bsl median - PSA responderBsl median - PSA non-responderC1D14 : C1D1 - PSA responderC1D14 : C1D1 - PSA non-responderC2.D1 : C1D1 - PSA responderC2.D1 : C1D1 - PSA non-responderC2.D14 : C1D1 - PSA responderC2.D14 : C1D1 - PSA non-responderC3.D1 : C1D1 - PSA responderC3.D14 : C1D1 - PSA responderC3.D14 : C1D1 - PSA non-responder
SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg9889.0010324.000.730.680.800.790.670.600.810.630.67

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Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3

Soluble protein biomarker Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) measured as picograms per milliliter (pg/mL). PSA responders are participants with a confirmed PSA response as per the Working Group criteria (>50% decrease from baseline) and non-responders are those not meeting the definition of responder. Ratio=value of soluble protein biomarkers at each time point to the value at baseline (C1D14 : C1D1). (NCT00137436)
Timeframe: Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14

Interventionpg/mL (Median)
Bsl median - PSA responderBsl median - PSA non-responderC1D14 : C1D1 - PSA responderC1D14 : C1D1 - PSA non-responderC2.D1 : C1D1 - PSA responderC2.D1 : C1D1 - PSA non-responderC2.D14 : C1D1 - PSA responderC2.D14 : C1D1 - PSA non-responderC3.D1 : C1D1 - PSA responderC3.D14 : C1D1 - PSA responderC3.D14 : C1D1 - PSA non-responder
SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg22475.0022070.000.690.730.750.750.650.720.650.560.66

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Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5)

The questionnaire assesses pain intensity (worst, least, average, and right now), level of relief in the last 24 hours, and the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). The pain intensity index score was derived from Questions 2-5 with range from 0 to 10 (0: no pain; 1-4: mild pain; 5-6: moderate pain; 7-10: severe pain); higher scores indicate worse health status. (NCT00137436)
Timeframe: Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study)

Interventionscores on a scale (Mean)
Bsl mean C1.D1 (n=48)Change from Bsl - C2.D1 (n=42)Change from Bsl - C3.D1 (n=35)Change from Bsl - C4.D1 (n=30)Change from Bsl - C5.D1 (n=32)Change from Bsl - C6.D1 (n=32)Change from Bsl - C7.D1 (n=29)Change from Bsl - C8.D1 (n=26)Change from Bsl - C9.D1 (n=25)Change from Bsl - C10.D1 (n=22)Change from Bsl - C11.D1 (n=21)Change from Bsl - C12.D1 (n=18)Change from Bsl - C13.D1 (n=17)Change from Bsl - C14.D1 (n=17)Change from Bsl - C15.D1 (n=12)Change from Bsl - C16.D1 (n=12)Change from Bsl - EOT (n=37)
SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg1.9-1.0-1.1-0.8-0.8-0.8-0.8-0.7-0.5-0.7-1.2-0.8-1.2-1.3-1.1-0.5-0.3

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Duration of PSA Response (DPR)

Defined as time from first documentation of PSA response (≥50% decrease in PSA from baseline that is subsequently confirmed) to first documentation of PSA progression (defined for patients with a PSA response as a 50% increase over nadir [lowest] and increase in absolute-value PSA level by at least 5 ng/mL [or back to baseline] and for patients without a PSA response as a 25% increase over baseline [or nadir / lowest] and increase in absolute-value PSA level by at least 5 ng/mL, both confirmed by a second value). Calculated as (end date for DPR - first PSA response + 1)/7. (NCT00137436)
Timeframe: Baseline to first documentation of PSA progression up to 28 days after date of last dose

Interventionweeks (Median)
SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg39.1

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Percentage of Participants With Objective Response Rate (ORR)

Defined as confirmed complete response (CR: disappearance of all target lesions) or confirmed partial response (PR: ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD) according to response evaluation criteria in solid tumors (RECIST). Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response. (NCT00137436)
Timeframe: Baseline to first documentation of PSA progression up to 28 days after date of last dose

Interventionpercentage of participants (Number)
SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg42.4

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Time to PSA Progression

Defined as the time from start of study treatment to first documentation of PSA progression using the PSA Working Group criteria calculated as (first event date - first dose date + 1)/7. PSA progression is defined for patients with a PSA response, as a 50% increase over nadir (lowest) and increase in absolute-value PSA level by at least 5 nanograms per milliliter (ng/mL) [or back to baseline] and for patients without a PSA response as a 25% increase over baseline [or nadir (lowest)] and increase in absolute-value PSA level by at least 5 ng/mL, both confirmed by a second value. (NCT00137436)
Timeframe: Baseline to first documentation of PSA progression up to 28 days after date of last dose

Interventionweeks (Median)
SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg42.1

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Percentage of Participants With Prostate Specific Antigen (PSA) Response

PSA response rate, which is defined as a greater than or equal to a 50% decrease in PSA from baseline, that is subsequently confirmed. (NCT00137436)
Timeframe: Baseline, Day 1 of each 21-day cycle

Interventionpercentage of participants (Median)
SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg56.4

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Time to First Moderate or Severe Flare

The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. A severe flare = participants had BILAG A score(s) present in one or more domains or BILAG B scores present in three or more domains at the same visit following a visit of inactive disease state defined above. A moderate flare = participants had only BILAG B scores present in two domains at the same visit following a visit of inactive disease state. (NCT00137969)
Timeframe: 52 weeks

Interventiondays (Median)
Rituximab 1000 mg + Prednisone112.0
Placebo + Prednisone126.0

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Number of Participants Who Achieved an MCR in The ITT Population

The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24. (NCT00137969)
Timeframe: From Weeks 24 to 52

Interventionparticipants (Number)
Rituximab 1000 mg + Prednisone14
Placebo + Prednisone9

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Number of Participants Who Achieved an MCR (Excluding PCR)

The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24. PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6. (NCT00137969)
Timeframe: From baseline to 52 weeks

Interventionparticipants (Number)
Rituximab 1000 mg + Prednisone21
Placebo + Prednisone14

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Number of Participants Who Achieved a BILAG C or Better in All Domains

The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. (NCT00137969)
Timeframe: 24 weeks

Interventionparticipants (Number)
Rituximab 1000 mg + Prednisone42
Placebo + Prednisone24

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Change in SLE Expanded Health Survey Physical Function Score From Baseline

Short Form (36) with additional questions specific to lupus (scale = 0-100; with 100 representing the highest level of functioning possible) to measure the ability of rituximab to improve quality of life. A positive value for this outcome measure indicates that symptoms have improved. (NCT00137969)
Timeframe: From baseline to 52 weeks

Interventionscore on a scale (Mean)
Rituximab 1000 mg + Prednisone8.2
Placebo + Prednisone4.1

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Number of Participants Who Achieved a PCR (Including MCR)

The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6. MCR = participants who achieved BILAG C or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24. (NCT00137969)
Timeframe: From baseline to 52 Weeks

Interventionparticipants (Number)
Rituximab 1000 mg + Prednisone50
Placebo + Prednisone25

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Time-adjusted Area Under The Curve Minus Baseline (AUCMB) of BILAG Score Over The 52-week Treatment Period

The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. The AUCMB of BILAG Score Over 52 Weeks was calculated as: 1. Calculate the AUC of the BILAG global score versus time (in days) by 52 weeks. 2. Calculate the Time-Adjusted AUC by dividing the AUC by the number of days a patient was on the study. 3. Minus the Time-Adjusted AUC by the baseline BILAG global score (NCT00137969)
Timeframe: From baseline to 52 weeks

InterventionBILAG score unit (Mean)
Rituximab 1000 mg + Prednisone-5.8
Placebo + Prednisone-5.9

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Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period

The BILAG Index measures clinical disease activity in Systemic Lupus Erythematosus (SLE). A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24; PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6. (NCT00137969)
Timeframe: From baseline to 52 weeks

,
InterventionParticipants (Number)
MCR (excluding PCR)PCRNonclinical Response (NCR)
Placebo + Prednisone141163
Rituximab 1000 mg + Prednisone2129119

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Comparison by Treatment Assignment in the Number of Biopsy-Proven Acute Rejections Within 12 Months Post Kidney Transplantation

"Biopsy-proven acute renal (kidney) rejection [1, 2].~Diagnosis of acute rejection was made by renal biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection[2]~Ref: Racusen LC et al. The Banff 97 working classification of renal allograft pathology. Kidney Int, 55: 713-723, 1999" (NCT00141037)
Timeframe: Up to one year post kidney transplantation procedure

InterventionRejection Events (Number)
Steroid-Free Immunosuppression18
Steroid-Based Immunosuppression19

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The Difference in Linear Growth by Treatment Assignment at 1 Year Post Kidney Transplantation

Standardized Z-scores were computed following a formula using an age- and gender-specific calculation provided by the NHANES III 2000 Growth Data set. The Z-score system expresses anthropometric values of height as several standard deviations (SDs) below (e.g., a negative value) or above (a positive value) the reference mean or median value. In this study the measure was used to test whether there is a difference in the change in height between the treatment groups: Steroid-Based versus Steroid-Free (NCT00141037)
Timeframe: One year post kidney transplantation procedure

InterventionStandard Deviation Score (SDS) (Mean)
Steroid-Free Immunosuppression0.37
Steroid-Based Immunosuppression0.35

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Relative Change From Baseline in Quality of Sleep at Week 12

Participants assessed quality of sleep on a 100 mm VAS, where 0 mm = very good, 100 mm = very bad. Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100. (NCT00146640)
Timeframe: Baseline, Week 12

Interventionpercent change (Mean)
MR Prednisone4.63
IR Prednisone0.13

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Relative Change From Baseline in Pain Intensity at Week 12

Participants assessed pain intensity on a 100 millimeter (mm) visual analog scale (VAS), where 0 mm = no pain, 100 mm = worst pain. Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100. (NCT00146640)
Timeframe: Baseline, Week 12

Interventionpercent change (Mean)
MR Prednisone-8.57
IR Prednisone-6.53

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Relative Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100. (NCT00146640)
Timeframe: Baseline, Week 12

Interventionpercent change (Mean)
MR Prednisone0.07
IR Prednisone-4.7

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Relative Change From Baseline in Duration of Morning Stiffness at Week 12

Duration of morning stiffness was defined as the time elapsed (in minutes) between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100. (NCT00146640)
Timeframe: Baseline, Week 12

Interventionpercent change (Mean)
MR Prednisone-22.7
IR Prednisone-0.4

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Relative Change From Baseline in 28-Joint Disease Activity Score (DAS28) at Week 12

DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total DAS28 score range from 0 to approximately 10. DAS28 less than or equal to (≤) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity, and DAS28 >5.1 = severe disease activity. Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100. (NCT00146640)
Timeframe: Baseline, Week 12

Interventionpercent change (Mean)
MR Prednisone-9.03
IR Prednisone-12.30

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Relative Change From Baseline in Short-Form 36 (SF36) Mental Component Score (MCS) at Week 12

SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning). Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100. (NCT00146640)
Timeframe: Baseline, Week 12

Interventionpercent change (Mean)
MR Prednisone10.63
IR Prednisone18.08

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Relative Change From Baseline in SF36 Physical Component Score (PCS) at Week 12

SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning). Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100. (NCT00146640)
Timeframe: Baseline, Week 12

Interventionpercent change (Mean)
MR Prednisone19.43
IR Prednisone21.0

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Percentage of Participants With Recurrence of Joint Stiffness at Week 12

Participants recorded the status of recurrence of joint stiffness (Yes/No) in diary data. Percentage of participants who selected Yes for recurrence of joint stiffness, are reported. (NCT00146640)
Timeframe: Week 12

Interventionpercentage of participants (Number)
MR Prednisone47
IR Prednisone43

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Percentage of Participants With an Occurrence of Biopsy Proven Acute Rejection (BPAR) During the First 3 Months Post de Novo Liver Transplantation.

A BPAR is defined when the investigator had a suspicion of an acute rejection, where the final clinical diagnosis confirmed the occurrence of an acute rejection, where a biopsy was performed that confirmed the presence of an acute rejection, and where anti-rejection treatment intervention was initiated. The efficacy measured the first rejections (clinically and biopsy proven rejections) at 3 months. (NCT00149994)
Timeframe: Month 3

InterventionPercentage of Participants (Number)
Cyclosporine A33.3
Tacrolimus32.9

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Overall Survival and Progression Free Survival

measured by overall Response Rate (ORR), which includes Complete response and partial response. (NCT00151281)
Timeframe: 38 months

Interventionpercentage of patients (Number)
Study Treatment Arm73

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Asses the Toxicity Profiles

Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0. (NCT00151281)
Timeframe: 38 months

InterventionParticipants (Count of Participants)
Grade 3 or 4 neutropeniaAnemiaThrombocytopeniaFatigueConstipationCoughNauseaNeuropathyDyspneaRash
RT-PEPC Drug Therapy141422141413131110

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The Quality of Life (QoL) of Patients Receiving RT-PEPC Treatment

"QoL assessments were obtained with version 3 of the Functional Assessment of Cancer Therapy-General (FACT-G) instrument. The FACT-G is comprised of four subscales: physical well-being (7-items, score range 0-28), social/family well-being (7-items, score range 0-28), emotional well-being (6-items, score range 0-24), and functional well-being (7-items, score range 0-28). Users of the FACT-G are able to generate an overall score and four subscale scores with ranges and distributions that are sample-specific. All questions in the FACT-G use a 5-point rating scale (0 = Not at all to 4 = Very much) A higher number indicates a better Quality of Life, and has a possible range of 0-108 points.~ANOVA was used to compare the difference in the means of total score among the different time points (baseline, every 2M until 6M, and every 6M until PD). The mean of the total FACT-G scores at baseline and mean of total score at all timepoints (using ANOVA) are reported below." (NCT00151281)
Timeframe: baseline, every 2 months until Month 6, and every 6 months until disease progression

InterventionFACT-G score (Mean)
Mean FACT-G Score at baselineMean Total FACT-G Score between all time points
RT-PEPC Drug Therapy83.389.4

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Dynamic Levels of Plasma VEGF

Stromal angiogenesis was assessed using blood vascular and perivascular markers, including VEGFR-1, VEGFR-2, CD34, and a-SMA, as well as lymphatic vascular markers ofVEGFR-3, podoplanin, and Lyve-1. (NCT00151281)
Timeframe: 38 months

Interventionpg/mL (Median)
RT-PEPC Drug Therapy109.5

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Number of Participants With Biopsy-proven Acute Rejection (BPAR) Episodes, Graft Loss, Death or Loss to Follow-up

Renal biopsies were collected for all cases of suspected acute rejection. For these cases, regardless of initiation of anti-rejection treatment, a graft core biopsy had been performed within 48 hours. These biopsies were listed on the Kidney Allograft Biopsy eCRF and the results used for patient management for BPAR. Graft loss was defined as the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis as well as re-transplant. BPAR, graft loss, death, or loss to follow-up was analyzed by means of frequency tables. (NCT00154284)
Timeframe: Month 12

,
InterventionParticipants (Number)
Biopsy-proven Acute Rejection (BPAR)Graft LossDeathLoss to Follow-up
Everolimus (Certican) With Cyclosporine (Neoral) Continuation10000
Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal10000

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Calculated Creatinine Clearance at 6 Month and 12 Month

"Creatinine clearance calculated by Cockcroft-Gault formula and summarized by mean, and standard deviation. Cockcroft-Gault formula to calculate Creatinine Clearance (CrCl[mL/min]) is shown below:~CrCl[mL/min] = (140 - A) * W / (72 * C) * R. Where A is age at sample date [years], W is body weight at specific visit [kg], C is the serum concentration of creatinine [mg/dL], R = 1 if the patient is male and = 0.85 if female." (NCT00154284)
Timeframe: 6 month and 12 months

,
InterventionmL/min (Mean)
6 Month12 Month
Everolimus (Certican) With Cyclosporine (Neoral) Continuation63.665.6
Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal72.972.3

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Renal Function Measured by Calculated Glomerular Filtration Rate (GFR Calculated According to the Nankivell Formula)

"Nankivell's formula for calculated GFR is shown below:~GFR [mL/min] = 6.7/C + W/4 - UREA/2 - 100/H2+ 35 (25 for females). Where W is body weight at specific visit [kg], H is height at specific visit [m], C is the serum concentration of creatinine [mmol/L], and UREA is the serum concentration of urea [mmol/L]. UREA was calculated from blood urea nitrogen (BUN) lab data by: UREA = 2.1441*BUN. If a GFR value from Nankivell formula was less than 10 [mL/min], then the value was assigned as 10 [mL/min]." (NCT00154284)
Timeframe: At Month 3 and Month 12

,
InterventionmL/min per 1.73 m^2 (Mean)
GFR at 3 months (Pre-randomization)GFR at 12 months
Everolimus (Certican) With Cyclosporine (Neoral) Continuation68.563.6
Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal69.268.3

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Serum Creatinine at Month 6 and 12

serum creatinine summarized by mean and standard deviation (NCT00154284)
Timeframe: 6 month and 12 months

,
Interventionµmol/L (Mean)
6 Month12 Month
Everolimus (Certican) With Cyclosporine (Neoral) Continuation139.1135.6
Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal120.1123.0

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Mean Cases of Acute Rejection (MCAR) Per Patient

"MCAR represents the average number of acute rejections among all patients in each treatment group. Results were based on rejection episodes with endomyocardial biopsies.~Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection." (NCT00157014)
Timeframe: 52 Weeks

InterventionMCAR per patient (Mean)
Tacrolimus - Adult0.15
Cyclosporine - Adult0.17

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The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies (Pediatric Population)

"The markers assessed were p-ERK ½, p-JNK and p-p38 MAPK.~The data for each biopsy marker were expressed as a ratio of its densitometry / densitometry of glyceraldehyde-3-phosphate dehydrogenase (GAPDH).~Change is defined as Week 52 assessment- Week 2 assessment." (NCT00157014)
Timeframe: 2 Weeks and 52 Weeks

,
InterventionDensitometry / Densitometry of GAPDH (Mean)
p-ERK ½ - Week 2p-ERK ½ - Week 52p-ERK ½ - Change from Week 2p-JNK - Week 2p-JNK - Week 52p-JNK - Change from Week 2p-p38 MAPK - Week 2p-p38 MAPK - Week 52p-p38 MAPK - Change from Week 2
Cyclosporine - Pediatric1.671.22-0.270.910.820.040.430.580.34
Tacrolimus - Pediatric1.740.93-0.091.170.57-0.210.830.24-0.04

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Cystatin-C

Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionmg/L (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult1.291.480.27
Tacrolimus - Adult1.211.290.06

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: E-selectin

Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionng/mL (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult98.9680.93-19.16
Tacrolimus - Adult90.4068.60-18.58

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: F2 Isoprostanes

Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionpg/mL (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult53.9450.44-3.43
Tacrolimus - Adult52.0330.08-13.29

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Fibrinogen

Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventiong/L (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult4.43.8-0.5
Tacrolimus - Adult4.43.4-1.1

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Number of Patients Requiring Antilymphocyte Antibodies or Steroids for Treatment of Severe Acute Rejection (Pediatric Population)

Severe Acute Rejection was defined as rejection with ISHLT Grade 4. (NCT00157014)
Timeframe: 52 Weeks

InterventionPatients (Number)
Tacrolimus - Pediatric0
Cyclosporine - Pediatric0

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Number of Patients Requiring Antilymphocyte Antibodies or Steroids for Treatment of Severe Acute Rejection

Severe Acute Rejection is defined as rejection with ISHLT Grade 4. (NCT00157014)
Timeframe: 52 Weeks

InterventionPatients (Number)
Tacrolimus - Adult0
Cyclosporine - Adult0

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Number of Cardiac Rejection Episodes Requiring Treatment (Pediatric Population)

A summary of rejection episodes requiring treatment regardless of biopsy grade or presence of hemodynamic compromise. (NCT00157014)
Timeframe: 52 Weeks

InterventionRejection Episodes (Number)
Tacrolimus - Pediatric3
Cyclosporine - Pediatric3

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Number of Cardiac Rejection Episodes Requiring Treatment

The number of rejection episodes requiring treatment (medications started/ stopped, non-medication treatment, or both) regardless of biopsy grade or presence of hemodynamic compromise. (NCT00157014)
Timeframe: 52 Weeks

InterventionRejection Episodes (Number)
Tacrolimus - Adult12
Cyclosporine - Adult11

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Mean Cases of Acute Rejection (MCAR) Per Patient (Pediatric Population)

"MCAR represents the average number of acute rejections among all patients in each treatment group. Results were based on rejection episodes with endomyocardial biopsies.~Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection." (NCT00157014)
Timeframe: 52 Weeks

InterventionMCAR per patient (Mean)
Tacrolimus - Pediatric0.60
Cyclosporine - Pediatric0.50

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: s-ICAM

"Change is defined as Week 52 assessment - Pre-Transplant assessment.~s-ICAM= soluble-intracellular adhesion molecule" (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionng/mL (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult674.46503.71-183.96
Tacrolimus - Adult766.58590.30-227.58

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Number of Patients With Successful Steroid Taper or Withdrawal at Weeks 26 and 52 (Pediatric Population)

A successful steroid taper or withdrawal was defined as steroids (prednisone) being discontinued or tapered to the suggested dose level after week 26. (NCT00157014)
Timeframe: 26 Weeks and 52 Weeks

,
InterventionPatients (Number)
Week 26Week 52
Cyclosporine - Pediatric31
Tacrolimus - Pediatric21

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Time to First Acute Rejection Episode Following de Novo Cardiac Transplant

"Acute Rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.~Time to first acute rejection is defined as: date of onset - date of transplant." (NCT00157014)
Timeframe: 52 Weeks

InterventionDays (Mean)
Tacrolimus - Adult55.0
Cyclosporine - Adult35.60

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Time to First Acute Rejection Episode Following de Novo Cardiac Transplant (Pediatric Population)

"Acute Rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.~Time to first acute rejection is defined as: date of onset - date of transplant." (NCT00157014)
Timeframe: 52 Weeks

InterventionDays (Mean)
Tacrolimus - Pediatric56.3
Cyclosporine - Pediatric49.0

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Changes in Circulating Markers of Inflammation and Oxidation: Cystatin-C (Pediatric Population)

Change is defined as Week 52 assessment - Pre-Transplant assessment (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionmg/L (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Pediatric0.770.84-0.01
Tacrolimus - Pediatric0.860.87-0.11

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Nitrotyrosine

Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
InterventionnM (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult482.43368.95-99.79
Tacrolimus - Adult422.63451.8871.44

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: MCP-1

"Change is defined as Week 52 assessment - Pre-Transplant assessment.~MCP-1= monocyte chemoattractant protein-1" (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionpg/mL (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult193.63180.90-16.49
Tacrolimus - Adult233.05229.9642.92

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: GSH/GSSG

"Change is defined as Week 52 assessment - Pre-Transplant assessment.~GSH/GSSG= ratio of reduced to oxidised glutathione" (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
InterventionRatio (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult58.8353.72-5.55
Tacrolimus - Adult55.0751.69-2.07

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: IL-6

"Change is defined as Week 52 assessment - Pre-Transplant assessment.~IL= Interleukin" (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionpg/mL (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult2.540.90-1.56
Tacrolimus - Adult3.360.98-2.84

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: IL-18

Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionpg/mL (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult496.2427.2-71.0
Tacrolimus - Adult574.0534.65.2

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Changes in Circulating Markers of Inflammation and Oxidation: F2 Isoprostanes (Pediatric Population)

Change is defined as Week 52 assessment - Pre-Transplant assessment (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionpg/mL (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Pediatric104.6866.48-30.07
Tacrolimus - Pediatric106.0669.71-38.31

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Number of Patients With Treatment Failure and Crossover for Treatment Failure

"Treatment failure was defined as death, re-transplantation, withdrawal due to an Adverse Event, or a switch of main immunosuppressant medication, whichever came first.~Crossover was defined as a switch from originally administered primary immunosuppressant (tacrolimus or cyclosporine) to the alternate primary immunosuppressant." (NCT00157014)
Timeframe: 52 Weeks

,
InterventionPatients (Number)
Treatment FailuresCrossover for Treatment Failures
Cyclosporine - Adult118
Tacrolimus - Adult62

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: hsCRP

"Change is defined as Week 52 assessment - Pre-Transplant assessment.~hsCRP= high-sensitivity C Reactive Protein" (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionmg/L (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult21.833.95-18.69
Tacrolimus - Adult32.853.01-34.32

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Number of Patients With Treatment Failure and Crossover for Treatment Failure (Pediatric Population)

"Treatment failure was defined as death, re-transplantation, withdrawal due to an Adverse Event, or a switch of main immunosuppressant medication, whichever came first.~Crossover was defined as a switch from originally administered primary immunosuppressant (tacrolimus or cyclosporine) to the alternate primary immunosuppressant." (NCT00157014)
Timeframe: 52 Weeks

,
InterventionPatients (Number)
Treatment FailuresCrossover for Treatment Failures
Cyclosporine - Pediatric33
Tacrolimus - Pediatric10

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The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies

"The markers assessed were p-ERK ½ (phosphorylated extracellular signal-regulated kinase), p-JNK (phosphorylated jun N-terminal kinase) and p-p38 MAPK (phosphorylated mitogen-activated protein kinase).~The data for each biopsy marker were expressed as a ratio of its densitometry / densitometry of glyceraldehyde-3-phosphate dehydrogenase (GAPDH).~Change is defined as Week 52 assessment- Week 2 assessment." (NCT00157014)
Timeframe: 2 Weeks and 52 Weeks

,
InterventionDensitometry / Densitometry of GAPDH (Mean)
p-ERK ½ - Week 2p-ERK ½ - Week 52p-ERK ½ - Change from Week 2p-JNK - Week 2p-JNK - Week 52p-JNK - Change from Week 2p-p38 MAPK - Week 2p-p38 MAPK - Week 52p-p38 MAPK - Change from Week 2
Cyclosporine - Adult0.900.79-0.051.231.460.220.540.770.23
Tacrolimus - Adult0.700.870.051.101.330.030.480.630.14

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Number of Patients With Successful Steroid Taper or Withdrawal at Weeks 26 and 52

A successful steroid taper or withdrawal was defined as steroids (prednisone) being discontinued or tapered to the suggested dose level after week 26. (NCT00157014)
Timeframe: 26 Weeks and 52 Weeks

,
InterventionPatients (Number)
Week 26Week 52
Cyclosporine - Adult1629
Tacrolimus - Adult2233

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Homocysteine

Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionμmol/L (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult15.915.80.7
Tacrolimus - Adult14.213.50.3

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Changes in Circulating Markers of Inflammation and Oxidation: hsCRP (Pediatric Population)

Change is defined as Week 52 assessment - Pre-Transplant assessment (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionmg/L (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Pediatric12.082.43-13.94
Tacrolimus - Pediatric30.4626.31-7.85

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Changes in Circulating Markers of Inflammation and Oxidation: Nitrotyrosine (Pediatric Population)

Change is defined as Week 52 assessment - Pre-Transplant assessment (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
InterventionnM (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Pediatric12701.2141147.6221514.62
Tacrolimus - Pediatric233.085462.995148.42

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: BNP

"Change is defined as Week 52 assessment - Pre-Transplant assessment.~BNP= Brain Natriuretic Peptide" (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionng/L (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult4240.81856.8-1446.7
Tacrolimus - Adult4314.8670.1-4018.4

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Osteopontin

Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionng/mL (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult11.1410.490.20
Tacrolimus - Adult11.888.77-2.22

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Troponin T

Change is defined as Week 52 assessment - Pre-Transplant assessment. (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionug/L (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult0.280.04-0.27
Tacrolimus - Adult0.300.03-0.32

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Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: T-bars

"Change is defined as Week 52 assessment - Pre-Transplant assessment.~T-bars = thiobarbituric acid reactive substances" (NCT00157014)
Timeframe: Pre-Transplant and 52 Weeks

,
Interventionnmol/mL (Mean)
Pre-TransplantWeek 52Change from Pre-Transplant at Week 52
Cyclosporine - Adult3.913.14-0.77
Tacrolimus - Adult3.783.25-0.64

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Number of Acute Rejection Episodes by International Society of Heart and Lung Transplantation (ISHLT) Criteria

"Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.~Patients may report more than one acute rejection." (NCT00157014)
Timeframe: 52 Weeks

,
InterventionRejection Episodes (Number)
Total Acute Rejection EpisodesAcute Rejection Episodes with ISHLT Grade ≥3AAcute Rejection Episodes w/ Hemodynamic Compromise
Cyclosporine - Adult872
Tacrolimus - Adult836

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Number of Acute Rejection Episodes by International Society of Heart and Lung Transplantation (ISHLT) Criteria (Pediatric Population)

"Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.~Patients may report more than one rejection episode." (NCT00157014)
Timeframe: 52 Weeks

,
InterventionRejection Episodes (Number)
Total Acute Rejection EpisodesAcute Rejection Episodes with ISHLT Grade ≥3AAcute Rejection Episodes w/ Hemodynamic Compromise
Cyclosporine - Pediatric330
Tacrolimus - Pediatric330

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Number of Patients With Serious Adverse Events as a Measure of Safety and Tolerability

Summary of grade 3 or higher toxicities (per Common Toxicity Criteria version 2.0) which generally is described as severe adverse reaction or symptom. (NCT00184002)
Timeframe: At end of every cycle

InterventionParticipants (Count of Participants)
DR-COP35

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Percentage of Patients With Complete Response to the Combination Chemotherapy

"Initial disease response tests will be performed after cycle 4 on all patients. Subsequent assessments after cycles 6 and/or 8 will depend on response. If after 4 cycles of therapy complete response or partial response has been documented, therapy will continue. If stable or progressive disease has been documented, the patient will be withdrawn from the study.~Response to the study treatment will be determined according to the criteria proposed in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas by Cheson et al (23)." (NCT00184002)
Timeframe: At completion of cycle 4, 6, and 8

InterventionPercentage of participants (Number)
Complete ResponsePartial Response
DR-COP75.023.0

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Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00193479)
Timeframe: 18 Months

Interventionpercentage of patients (Number)
CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab81

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Number of Newborns With a Birth Platelet Count > 50,000/uL

this uses the birth platelet count of the fetuses from the study when they are born (NCT00194987)
Timeframe: 32-40 weeks (the endpoint is the birth which is not at the same number of weeks for all of the babies. This is why the weeks are not listed specifically eg week 40

Interventionnumber of newborns with >50,000 pets (Number)
IVIG 1g/kg Twice Per Week48
IVIG 1g/k/Week and Prednisone 0.5 mg/kg/Day47

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Number of Fetal Platelet Counts > 50,000/uL

Number of Fetal Platelet Counts > 50,000/uL Among Those Who Underwent Fetal Blood Sampling and Had a Fetal Platelet Count Determined (NCT00194987)
Timeframe: 32 +/- 2 weeks

Interventionnumber newborns with >50,000 pats (Number)
IVIG 1g/kg Twice Per Week44
IVIG 1g/k/Week and Prednisone 0.5 mg/kg/Day43

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Intracranial Hemorrhage: Number Occurring in Fetuses and Newborns of Mothers in Study

number of ICH assessed by fetal and neonatal ultrasound with MRI back up most commonly in utero so range from 20-40 weeks fo gestation (NCT00194987)
Timeframe: time of ICH (range 20-40 wks)

Interventionnumber of newborns with ICH (Number)
IVIG 1g/kg Twice Per Week0
IVIG 1g/k/Week and Prednisone 0.5 mg/kg/Day0

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Creatinine Clearance Rate

Creatinine clearance is a measure of kidney function. Creatinine clearance rate (CCr) is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, CCr was calculated using the Nakivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females, 90-125 ml/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function. (NCT00195429)
Timeframe: 12 months

Interventionml/min (Mean)
Sirolimus + Tacrolimus60
Sirolimus + Prednisone63.4

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Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up.

Diagnosis of acute rejection was made via kidney biopsy using the Banff criteria (a standardized model for interpretation of renal allograft biopsies). (NCT00195429)
Timeframe: 12 months

,
Interventionparticipants (Number)
Subjects with Acute RejectionSubjects without Acute Rejection
Sirolimus + Prednisone320
Sirolimus + Tacrolimus321

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Change From Baseline to Month 36 or Early Termination Visit in Volume of Hypointense Lesions

"Results represent the database as of January 29, 2009.~The difference in hypointense brain lesion volume as observed in MRIs from baseline to Month 36 or the early termination visit. Hypointense lesions display as dark areas on the MRI image, and represent areas of permanent axonal damage." (NCT00203047)
Timeframe: Day 0, Month 36 or early termination visit

Interventioncm^3 (Mean)
GA + Placebo0.43
GA + Prednisone0.17

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Percent Change From Baseline to Termination in Normalized Brain Volume Measured According to the SIENA (Structural Imaging Evaluation Using Normalization of Atrophy) Method

"Results represent the database as of January 29, 2009. Brain volume was measured at baseline and at months 24, 36 and at early termination visits by magnetic resonance imaging (MRI). Brain atrophy was measured by comparing the change in brain volume from baseline to the latest scan at the three during study timeframes. SIENA is a fully automated method of analyzing longitudinal brain change.~Adjusted (least square) mean values are presented." (NCT00203047)
Timeframe: Day 0, latest scan at month 24, 36 or early termination visit

Interventionpercent change of baseline brain volume (Least Squares Mean)
GA + Placebo-0.46
GA + Prednisone-0.43

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Cumulative Number of Enhancing Lesions at Months 12, 24 and 36

"Results represent the database as of January 29, 2009.~Enhancing lesions are lesions that show inflammation on an MRI and are assumed to be new lesions. The sum of enhancing lesions observed in MRIs taken at months 12, 24 and 36 are offered." (NCT00203047)
Timeframe: Months 12, 24, and 36

Interventionlesions (Mean)
GA + Placebo0.69
GA + Prednisone0.76

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Change From Baseline to Month 36 or Early Termination Visit in Volume of T2-Lesions

"Results represent the database as of January 29, 2009.~The difference in T2 brain lesion volume as observed in MRIs from baseline to Month 36 or the early termination visit. T2 lesions are hyperintense lesions meaning that they appear as bright spots on the MRI image. These tend to show the total number of lesions and disease burden." (NCT00203047)
Timeframe: Day 0, Month 36 or the early termination visit

Interventioncm^3 (Mean)
GA + Placebo0.07
GA + Prednisone0.09

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Change in Salivary Cortisol (First 6 Participants)

(NCT00204737)
Timeframe: Baseline, 2 weeks, 6 weeks, and 12 weeks

,
Interventionug/dl (Mean)
Baseline6 Weeks12 Weeks
Placebo0.080.090.07
Prednisone0.130.100.10

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Number of Other Adverse Events

The Systematic Assessment for Treatment Emergent Events-General Inquiry (SAFTEE-GI) was used to collect and analyze data about potential medication related side effects. Each of 12 subjects was queried using the SAFTEE-GI at 3 time points (1, 2 and 3 weeks) for a possible of 36 adverse event reports. (NCT00204737)
Timeframe: up to 3 weeks

,
Interventionincidence of adverse events (Number)
MusculoskeletalSleeplessnessReduced Blood SugarDecreased EnergyUpper Respiratory InfectionIncreased MoodMild Urinary Hesitancy
Placebo1001101
Prednisone2320110

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Number of Participants Achieving CAPS Response

CAPS response defined as a 30% reduction in CAPS score from baseline. (NCT00204737)
Timeframe: baseline, 2 weeks, 6 weeks, 12 weeks

,
InterventionParticipants (Count of Participants)
baseline to 2 weeksbaseline to 6 weeksbaseline to 12 weeks
Placebo000
Prednisone431

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Change in Clinical Global Impression Severity (CGI-S) Score

CGI-S is scored by a clinician. It is a 7 point scale where 1 = normal, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. (NCT00204737)
Timeframe: baseline, 2 weeks, 6 weeks, 12 weeks

,
Interventionscore on a scale (Mean)
Baseline2 Weeks6 Weeks12 Weeks
Placebo5.55.55.25.5
Prednisone5.54.74.84.5

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Change in Clinician-Administered PTSD Scale (CAPS)

This measure tests the hypothesis that there will be a 30% or greater improvement in the Clinician-Administered PTSD (Post Traumatic Stress Disorder) Scale over the course of the study. CAPS is a 30-item survey with a total possible range of scores from 0-120 where the higher the score, the more severe the symptoms. (NCT00204737)
Timeframe: baseline, 2 weeks, 6 weeks, 12 weeks

,
Interventionscore on a scale (Mean)
Baseline2 Weeks6 Weeks12 Weeks
Placebo90.786.281.582.5
Prednisone96.066.372.875.2

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Change in Dehydroepiandrosterone Sulfate (DHEA-S)

DHEA-S measured at baseline, 2 weeks, 6 weeks, and 12 weeks (NCT00204737)
Timeframe: Baseline, 2 weeks, 6 weeks, and 12 weeks

,
Interventionmcg/dl (Mean)
Baseline2 Weeks6 Weeks12 Weeks
Placebo201.2148.7156.8157.8
Prednisone123.887.7123.5112.3

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Change in Hamilton Depression Rating Scale (HAM-D)

HAM-D is a 21-item survey where scoring is based on the first 17-items. It has a total possible range of scores 0-50 where higher scores indicate more severe depression. (NCT00204737)
Timeframe: baseline, 2 weeks, 6 weeks, 12 weeks

,
Interventionscore on a scale (Mean)
Baseline2 Weeks6 Weeks12 Weeks
Placebo16.814.814.515.7
Prednisone19.213.211.712.3

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Change in PCL-PTSD Score

PCL-PTSD is a 17-item survey with a total possible range of scores 17-85 where higher scores indicate more severe symptoms. (NCT00204737)
Timeframe: baseline, 2 weeks, 6 weeks, 12 weeks

,
Interventionscore on a scale (Mean)
Baseline2 Weeks6 Weeks12 Weeks
Placebo64.259.860.364.2
Prednisone68.758.856.058.2

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Change in Salivary Cortisol (Last 6 Participants)

Participants provided saliva samples at 16:00, 24:00, and 08:00. After these samples are collected, participants take 0.5mg dexamethasone orally at 23:00, and a fourth sample is collected at 08:00 post dexamethasone. Post-dexamethasone data is reported here. (NCT00204737)
Timeframe: Baseline, 2 weeks, 6 weeks, and 12 weeks

,
Interventionug/dl (Mean)
Baseline6 Weeks12 Weeks
Placebo0.1380.1570.183
Prednisone0.10.1030.112

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Progression-Free Survival

PFS was defined as the period of time from treatment start to the first documentation of PD, recurrence, or death. PD was defined as a greater than or equal to 50% increase from baseline in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or non-responders, or the appearance of any new lesions during or at the end of therapy. PFS was censored at the last date for which the response assessment resulted in the absence of PD for participants who did not demonstrate objective progression or recurrence. Participants who withdrew prior to evidence of disease progression or recurrence, PFS was censored at the last date assessment showed an absence of PD. (NCT00211185)
Timeframe: From the date of first dose of study drug until date of first documentation of PD, recurrence, or death from any cause, assessed up to 5 years 9 months

InterventionWeeks (Mean)
Denileukin Diftitox in Combination With CHOP12.4

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Percentage of Participants With Overall Survival

Overall Survival (OS) was defined as the time from the date of registration to the date of the participant's death. OS was determined by reviewing all participant's records every 6 months until the study was administratively closed or all participants died, whichever occurred first. Participants who were lost to follow-up but were still alive at the date of last contact were censored at the date of last contact. Participants who did not have a recorded date of death were censored for OS at the last date at which they were known to be alive. (NCT00211185)
Timeframe: From date of randomization until death, or administrative close of study, whichever came first, assessed up to 5 years 9 months

InterventionPercentage of participants (Number)
Denileukin Diftitox in Combination With CHOP63.3

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Duration of Response

Duration of response was defined as the length of time from the first date at which the response criteria were met (taking the earliest date at which a PR, CRu, or the confirmed CR occurred) until the date that recurrent or PD or death was accurately documented, per the criteria defined for progression-free survival (PFS). All participants within the EA population who achieved a response per the criteria defined were included in the duration of the response analysis. Participants lost to follow-up prior to PD or death were censored at the date they were last known to still be responding to treatment. Duration of response was estimated using the Kaplan-Meier method with the median duration of response summarized. (NCT00211185)
Timeframe: From the date of the first documented CR (confirmed or unconfirmed) or PR until the date of first documentation of recurrent or PD or death, assessed up to 5 years 9 months

InterventionMonths (Median)
Denileukin Diftitox in Combination With CHOP29.7

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Summary of All Adverse Events by Frequency in Greater Than 20% of Treated Participants

An adverse event (AE) was any medical occurrence in a participant who was administered denileukin diftitox and cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP), and did not necessarily have a causal relationship with this treatment. An AE included any side effect, injury, toxicity, sensitivity reaction, or any undesirable clinical or laboratory event that was not normally observed in the participant. Safety was assessed for all participants who received at least one dose of study medication and was monitored throughout the study. Safety evaluations were based on the incidence, intensity, and type of AE, and clinically significant changes in the participant's medical history, physical examination findings, vital signs, and clinical laboratory results. Participants also notified the study staff of any problems that occurred between visits by telephone, and if necessary, were evaluated by the investigator or study staff at an unscheduled interim visit. (NCT00211185)
Timeframe: From date of first dose up to approximately 4 weeks after discontinuation of denileukin diftitox and CHOP, or after early withdrawal for any reason, up to approximately 5 years 9 months

InterventionPercentage of participants (Number)
FatigueNauseaHemoglobinNeuropathy-sensoryAlanine transaminaseHyperglycemiaHypoalbuminemiaLeukocytesFeverHypocalcemiaLymphopeniaAspartate transaminaseDyspneaPlateletsAlopeciaNeutrophilsConstipationEdema-limbHyponatremia
Denileukin Diftitox in Combination With CHOP63.346.940.840.834.734.734.734.732.730.630.628.628.628.626.526.524.520.420.4

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Overall Response in the Intent To Treat (ITT) Population

Response rate was defined as the percentage of the ITT population who achieved a Complete Response (CR), Unconfirmed Complete Response (CRu), or Partial Response (PR). The International Working Group recommendations on non-Hodgkin's lymphoma response criteria were used to determine response to therapy. Largely, the protocol defined the response criteria as: 1) CR, loss of all detectable clinical and radiographic evidence of disease and disease-related symptoms if present before therapy; 2) CRu, CR with the caveats, response to therapy was accompanied with a 75% reduction in measurable lesion size and/or an indeterminate bone marrow biopsy (if initially positive); and 3) PR, less than or equal to 50% decrease in the sum of the measurements of tumor diameters, no increase in the size of other nodes, liver, or spleen, hepatic or spleen nodules regressed by at least 50%, and/or no new sites of disease. (NCT00211185)
Timeframe: From the start of the treatment to the date of participant's death assessed up to 5 years 9 months

InterventionPercentage of participants (Number)
Confirmed complete responseUnconfirmed complete responsePartial responseStable diseaseDisease progressionEarly deathInadequate assessment
Denileukin Diftitox in Combination With CHOP51.04.110.26.14.14.120.4

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Overall Response in the Efficacy Analyzable (EA) Population

Response rate was defined as the percentage of the EA population who achieved a CR, CRu, or PR. The International Working Group recommendations on non-Hodgkin's lymphoma response criteria were used to determine response to therapy. Largely, the protocol defined the response criteria as: 1) CR, loss of all detectable clinical and radiographic evidence of disease and disease-related symptoms if present before therapy; 2) CRu, CR with the caveats, response to therapy was accompanied with a 75% reduction in measurable lesion size and/or an indeterminate bone marrow biopsy (if initially positive); and 3) PR, less than or equal to 50% decrease in the sum of the measurements of tumor diameters, no increase in the size of other nodes, liver, or spleen, hepatic or spleen nodules regressed by at least 50%, and/or no new sites of disease. (NCT00211185)
Timeframe: From the start of the treatment to the date of the participant's death assessed up to 5 years 9 months

InterventionPercentage of participants (Number)
Confirmed complete responseUnconfirmed complete responsePartial responseStable diseaseDisease progressionEarly deathInadequate assessment
Denileukin Diftitox in Combination With CHOP67.65.413.58.15.40.00.0

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3-Year Overall Survival

3-year overall survival is defined as the probability of patients surviving at 3 years from study entry. (NCT00217425)
Timeframe: Assessed every 3 months the first 2 years from study entry and every 6 months 3-5 years from study entry.

Interventionprobability (Number)
Treatment (A-CHOP Followed by MA)0.39

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12-Month Progression-Free Survival (PFS)

12-month progression-free survival is defined as the probability of patients remaining alive and progression-free at 12 months from study entry. (NCT00217425)
Timeframe: Assessed every 3 months the first 2 years from study entry and every 6 months 3-5 years from study entry.

Interventionprobability (Number)
Treatment (A-CHOP Followed by MA)0.44

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Overall Response Rate

Overall response rate is defined as proportion of patients who achieve complete remission [CR, unconfirmed CR (CRu) or Functional CR] or partial remission. Response is assessed using the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma (Chesen, 1999). (NCT00217425)
Timeframe: Assessed after cycle 3, cycle 6, and cycle 8 (if given).

Interventionproportion (Number)
Treatment (A-CHOP Followed by MA)0.90

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Overall Response Rate

"Response was evaluated for Anemia and Spleen:~Major anemia response: hemoglobin increase to within normal limits in the absence of transfusion. Minor anemia response: hemoglobin improvement of at least 2 grams per deciliter independent of transfusion support, or achievement of transfusion independence in transfusion-dependent patients. Major spleen response: normalization of spleen size to the range of 12-14 centimeters by ultrasound. Minor spleen response: a 50% or more decrease in excess spleen size by ultrasound. Complete remission (CR): complete resolution of disease-related symptoms, splenomegaly, normalization of peripheral blood count, white cell differential and smear, and normalization of bone marrow histology. Partial remission (PR): a major or minor response in anemia or splenomegaly. Overall Response (OR)=CR + PR, assessed among eligible, treated patients." (NCT00227591)
Timeframe: Assessed at the end of cycle 3

InterventionProportion of participants (Number)
Lenalidomide0.26

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5-year Overall Survival

5-year overall survival is defined as the probability of patients who remain alive at 5 years from study entry. The method of Kaplan and Meier (1958) was used to estimate overall survival. (NCT00274924)
Timeframe: Every 4 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then every 12 months if patient is 5-10 years from study entry.

Interventionprobability (Number)
Group I (PET Negative)0.77
Group II (PET Positive)0.69

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2-year Progression-Free Survival (PFS)

2-year progression-free survival is defined as the probability of patients who remain alive and progression free at 2 years from study entry. The method of Kaplan and Meier (1958) was used to estimate PFS. (NCT00274924)
Timeframe: Assessed every 4 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then every 12 months if patient is 5-10 years from study entry.

Interventionprobability (Number)
Group I (PET Negative)0.76
Group II (PET Positive)0.42

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6-month Cumulative Rejection Incidence (Either CMR, AMR or Both)

Biopsy shows evidence of either AMR or CMR or evidence both. (NCT00275509)
Timeframe: Up to 6 months

InterventionParticipants (Count of Participants)
Tymoglobulin21
Daclizumab23

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6-month Acute Cellular-mediated Rejection Rate (CMR)

Per 2007 international Banff Classification Criteria, CMR 1A was diagnosed on biopsies displaying significant interstitial infiltration (>25% of parenchyma affected, i2 or i3) and foci of moderate tubulitis (t2). CMR IB was diagnosed in cases with significant interstitial infiltration (>25% of parenchyma affected, i2 or i3) and foci of severe tubulitis (t3). CMR IIA were cases with mild-to-moderate intimal arteritis (v1), while CMR IIB were those with severe intimal arteritis comprising >25% of the luminal area (v2). CMR III were those cases with transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation (v3). (NCT00275509)
Timeframe: Up to 6 months

InterventionParticipants (Count of Participants)
Tymoglobulin14
Daclizumab20

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6-month Acute Antibody-mediated Rejection Rate (AMR)

A diagnosis of AMR was based on the 2013 international Banff Classification Criteria and is defined as the presence of circulating donor-specific antibody (DSA) and either: 1) peritubular capillary staining of C4d and at least one of the following: peritubular capillaritis (ptc) score>0, glomerulitis (g) score>0, acute thrombotic microangiopathy (TMA) in the absence of any other cause, or other features consistent with AMR (endothelial injury, fibrin thrombi, microinfarctions, interstitial hemorrhage), or 2) absence of capillary staining of C4d and the presence of ptc>0 and g>0 or ptc>0 or g>0 and acute TMA, in the absence of any other cause of TMA. (NCT00275509)
Timeframe: Up to 6 months

InterventionParticipants (Count of Participants)
Tymoglobulin17
Daclizumab16

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Percentage of Participants Who Achieved a Complete Renal Response at Week 24 and Maintained it to Week 52

A participant had a complete renal response if they met the following 3 criteria: (1) Normalization of serum creatinine as evidenced by a serum creatinine level ≤ the upper limit of the normal range of central laboratory values or a serum creatinine level ≤ 15% greater than Baseline, if Baseline serum creatinine was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field and absence of red cell casts; (3) Urinary protein to creatinine ratio < 0.5. (NCT00282347)
Timeframe: Week 24 to Week 52

InterventionPercentage of participants (Number)
Rituximab1.4
Placebo6.9

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Change From Baseline in Anti-double-stranded DNA at Week 52

(NCT00282347)
Timeframe: Baseline to Week 52

InterventionIU/mL (Mean)
Rituximab0.45
Placebo1.06

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British Isles Lupus Assessment Group (BILAG) Index Score Over 52 Weeks

The BILAG Index assesses 86 clinical signs and symptoms and laboratory measures of systemic lupus erythematosus in 8 organ system domains: General, mucocutaneous, neurological, musculoskeletal, cardiorespiratory, vasculitis, renal, and hematologic. Most of the 86 items are rated on the following scale: 0=Not present, 1=Improving, 2=Same, 3=Worse, 4=New. Some items are rated as either Yes or No. A single alphabetic score of A (very active) through E (not or never active) for each of the 8 domains is determined from the rating of the individual items in each domain. The total BILAG score is the sum of the scores of the 8 domains where A=9, B=3, C=1, D=0, and E=0. The total score ranges from 0 to 72 with a higher score indicating greater lupus activity. To calculate a BILAG score over the 52 week treatment period of the study, the area under the response-time curve of BILAG scores assessed every 4 weeks was divided by the number of days in the time curve minus the Baseline BILAG score. (NCT00282347)
Timeframe: Baseline to Week 52

InterventionUnits on a scale (Mean)
Rituximab-8.49
Placebo-8.58

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Percentage of Participants Who Achieved a Complete Renal Response (CRR), a Partial Renal Response (PRR), or no Renal Response (NRR) at Week 52

A participant had a CRR if they met the following 3 criteria: (1) Normalization of serum creatinine (SC) as evidenced by a SC level ≤ the upper limit of the normal range of central laboratory values or a SC level ≤ 15% greater than Baseline, if Baseline SC was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field (RBCs/HPF) and absence of red cell casts; (3) Urinary protein (UP) to creatinine ratio (CR) < 0.5. A participant had a PRR if they met the following 3 criteria: (1) A SC level ≤ 15% above Baseline; (2) RBCs/HPF ≤ 50% above Baseline and no RBC casts; (3) 50% improvement in the UP to CR, with 1 of the following conditions met: If the Baseline UP to CR was ≤ 3.0, then a UP to CR of < 1.0 or if the Baseline UP to CR was > 3.0, then a UP to CR of ≤ 3.0. A participant had a NRR if they did not achieve either a CRR or PRR. (NCT00282347)
Timeframe: Week 52

,
InterventionPercentage of participants (Number)
CRRPRRNRR
Placebo30.615.354.2
Rituximab26.430.643.1

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Change From Baseline in the Systemic Lupus Erythematosus Expanded Health Survey Physical Function Score at Week 52

The systemic lupus erythematosus Expanded Health Survey is based on the Short Form 36 Health survey with additional questions specific to lupus. The physical function component score of the survey can range from 0-100. A higher score indicates better health. A positive change score indicates improvement. (NCT00282347)
Timeframe: Baseline to Week 52

InterventionUnits on a scale (Mean)
Rituximab4.8
Placebo5.7

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Change From Baseline in C3 and C4 Complement Levels at Week 52

(NCT00282347)
Timeframe: Baseline to Week 52

,
Interventionmg/dL (Mean)
C3 ComplementC4 Complement
Placebo25.96.6
Rituximab37.59.9

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Time to Achieve a Complete Renal Response

(NCT00282347)
Timeframe: Baseline to Week 52

InterventionWeeks (Median)
Rituximab11.99
Placebo12.12

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Percentage of Participants With a Baseline Urine Protein to Creatinine Ratio of > 3.0 Who Achieved a Urine Protein to Creatinine Ratio of < 1.0 at Week 52

(NCT00282347)
Timeframe: Baseline to Week 52

InterventionPercentage of participants (Number)
Rituximab47.4
Placebo53.7

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Percentage of Participants Who Achieved a Complete Renal Response at Week 52

A participant had a complete renal response if they met the following 3 criteria: (1) Normalization of serum creatinine as evidenced by a serum creatinine level ≤ the upper limit of the normal range of central laboratory values or a serum creatinine level ≤ 15% greater than Baseline, if Baseline serum creatinine was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field and absence of red cell casts; (3) Urinary protein to creatinine ratio < 0.5. (NCT00282347)
Timeframe: Week 52

InterventionPercentage of participants (Number)
Rituximab26.4
Placebo30.6

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Renal Function at 3 Months Assessed by Change in Estimated Glomerular Filtration Rate (eGFR)

Change in estimated glomerular filtration rate from baseline to Month 3 calculated by using abbreviated MDRD formula. Modification of Diet in Renal Disease (MDRD) formula is: GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where -C is the serum concentration of creatinine [mg/dL], -A is patient age at sample collection date [years], -G=0.742 when gender is female, otherwise G=1, -R=1.21 when race is black, otherwise R=1. (NCT00284934)
Timeframe: Baseline and 3 months

,
InterventionmL/min/1.73m^2 (Mean)
Baseline (n= 47, 45)Month 3 (n= 44, 43)Change from Baseline to Month 3 (n= 44, 43)
High EC-MPS46.448.62.1
Standard Dose EC-MPS45.344.6-0.4

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Number of Participants With Treatment Failure Parameters (Biopsy-Proven Acute Rejection (BPAR), Graft Loss, Death, or Loss to Follow-up) at 6 Months

A biopsy-proven acute rejection (BPAR) is defined as a biopsy graded IA, IB, IIA, IIB, or III based on the Banff 1997 classification.The allograft was presumed lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient went through a graft nephrectomy, then the day of nephrectomy was the day of graft loss. (NCT00284934)
Timeframe: 6 months

,
InterventionParticipants (Number)
Biopsy proven acute rejectionTreated acute rejectionGraft lossDeath
High EC-MPS0000
Standard Dose EC-MPS0000

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Number of Participants With Graft and Patient Survivals at 6 Months

Graft survival was defined as the number of patients with no graft loss. The allograft was presumed lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient went through a graft nephrectomy, then the day of nephrectomy was the day of graft loss. Patient survival was defined as the number of patients alive with or without a functioning graft. (NCT00284934)
Timeframe: 6 months

,
InterventionParticipants (Number)
Graft survivalPatient survival
High EC-MPS4545
Standard Dose EC-MPS4747

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Renal Function Assessed by Change in Estimated Glomerular Filtration Rate(eGFR)

Change in estimated glomerular filtration rate from baseline to Month 6 calculated by using abbreviated Modification of Diet in Renal Disease (MDRD) formula. Modification of Diet in Renal Disease (MDRD) formula is: GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where -C is the serum concentration of creatinine [mg/dL], -A is patient age at sample collection date [years], -G=0.742 when gender is female, otherwise G=1, -R=1.21 when race is black, otherwise R=1. (NCT00284934)
Timeframe: Baseline and Month 6

,
InterventionmL/min/1.73m^2 (Mean)
Baseline (n= 47, 45)Month 6 (n= 45, 43)Change from Baseline - Month 6 (n= 45, 43)
High EC-MPS56.449.12.4
Standard Dose EC-MPS45.344.7-0.4

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Incidence of Adverse Events

Adverse events are graded using CTCAE v3.0. The worst grade of all adverse events for each patient is counted. (NCT00288080)
Timeframe: From start of treatment until the end of follow-up

,
Interventionpercentage of participants (Number)
Grade 1Grade 2Grade 3Grade 4Grade 5
Androgen Suppression + Radiation Therapy14.948.426.04.31.4
Androgen Suppression + Radiation Therapy + Chemotherapy2.125.940.128.40.7

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Overall Survival

Four-year rates are shown. Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. (NCT00288080)
Timeframe: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.

Interventionpercentage of participants (Number)
Androgen Suppression + Radiation Therapy88.7
Androgen Suppression + Radiation Therapy + Chemotherapy93.3

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Local Control

Local control is defined as the absence of local failure which is the first of either progression or recurrence within the prostate. Progression of the tumor was considered to have occurred when there was a 25% or greater increase in the product of the two largest perpendicular diameters of the prostate. Recurrence was defined as the reappearance of disease after a complete response. Patients who experienced death without local failure, biochemical failure prior to local failure, and development of distant metastases prior to local failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. Due to an insufficient number of events (2 in each arm), this endpoint was not statistically compared. Local control rates at 4 years were calculated using the Kaplan-Meier method. (NCT00288080)
Timeframe: From randomization to date of local failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.

Interventionpercentage of participants (Number)
Androgen Suppression + Radiation Therapy99.2
Androgen Suppression + Radiation Therapy + Chemotherapy99.5

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Distant Metastasis

Distant failure was considered when there was evidence of metastatic disease. Patients who experienced death without distant failure, local failure prior to distant failure, and biochemical failure prior to distant failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. Distant failure rates at 4 year were calculated using the Kaplan-Meier method. (NCT00288080)
Timeframe: From randomization to date of distant metastasis, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.

Interventionpercentage of participants (Number)
Androgen Suppression + Radiation Therapy2.6
Androgen Suppression + Radiation Therapy + Chemotherapy1.9

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Disease-free Survival

A failure for disease-free survival is the first of the following: biochemical failure, local failure, distant metastases, or death due to any cause. The corresponding outcome time was measured from the date of randomization. Disease-free survival rates at 4 years were calculated using the Kaplan-Meier method. (NCT00288080)
Timeframe: From randomization to date of progression, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.

Interventionpercentage of participants (Number)
Androgen Suppression + Radiation Therapy73.0
Androgen Suppression + Radiation Therapy + Chemotherapy78.5

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Biochemical Control

Four-year rates are shown (Kaplan-Meier estimates). Biochemical control is defined as freedom from biochemical failure. Biochemical failure was considered as the first of either prostate-specific antigen (PSA) failure or initiation of salvage hormone therapy. PSA failure was defined as a rise of 2 ng/ml over the nadir PSA. Patients who experienced death without biochemical failure, local failure prior to biochemical failure, or development of distant metastases prior to biochemical failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. (NCT00288080)
Timeframe: From randomization to date of biochemical failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.

Interventionpercentage of participants (Number)
Androgen Suppression + Radiation Therapy82.0
Androgen Suppression + Radiation Therapy + Chemotherapy84.1

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Percent of Participants Who Experienced All-Cause Morbidity Within 12 Months of Post-HCT

Morbidity is the occurrence of NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 adverse event grade 3 or higher. (NCT00288626)
Timeframe: From the time of Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT) to 1 year after HCT.

InterventionPercentage of Participants (Number)
HDIT and HCT95.8

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Percent of Participants Who Experienced All-Cause Morbidity

Morbidity is the occurrence of NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 adverse event grade 3 or higher. (NCT00288626)
Timeframe: From the time of enrollment until completion of the 5-year follow-up, an average of 6 years.

Interventionpercentage of participants (Number)
HDIT and HCT100

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Overall Survival

The probability that a participant did not experienced a death estimated at 1, 2, 3, 4, and 5 years following transplant via the Kaplan-Meier Method. Greenwood's formula for standard error was used to calculate 90% confidence intervals. Participants that did not die were censored at the time of last follow-up. (NCT00288626)
Timeframe: From study entry to death, loss to follow-up, or the end of the study, whichever came first, up to 6 years

InterventionProbability (Number)
1 Year Post Transplant2 Years Post Transplant3 Years Post Transplant4 Years Post Transplant5 Years Post Transplant
HDIT and HCT1.01.00.9570.9110.863

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Event-Free Survival Probability During the 5 Years After Transplant

Event-free survival (EFS) is survival without death or disease activity from any one of the following criteria: 1) loss of neurological function, defined as a change in pretransplant Extended Disability Status Scale (EDSS) of > 0.5. 2) Relapse, defined as the development of a new neurological sign and corresponding symptom, or worsening of an existing neurological sign and symptom, localized to central nervous system white matter, resulting in neurological deficit/disability, and lasting over 48 hours. 3) New lesions on magnetic resonance imaging (MRI), defined as presence of 2 or more independent multiple sclerosis brain lesions detected on MRI 1 year or more after stem cell transplant. Kaplan-Meier estimates of survival probability, with 90% confidence interval based on Greenwood's formula for standard error. (NCT00288626)
Timeframe: 5 years

InterventionProbability (Number)
HDIT and HCT0.692

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Number of New T2-Weighted Lesions From Baseline

A T2-weighted magnetic resonance imaging (MRI) scan was used to determine the number of new T2 lesions in the brain relative to Baseline. A value of 0 means that the participant didn't worsen. Values greater than 0 indicate an increase in disease activity from baseline. (NCT00288626)
Timeframe: 6 Months to 5 years after HCT

InterventionLesions per scan (Mean)
6 Months Post Transplant1 Year Post Transplant2 Years Post Transplant3 Years Post Transplant4 Years Post Transplant5 Years Post Transplant
HDIT and HCT0.20.20.20.10.40.1

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Event-Free Survival Probability During the 3 Years After Transplant

Event-free survival (EFS) is survival without death or disease activity from any one of the following criteria: 1) loss of neurological function, defined as a change in pretransplant Extended Disability Status Scale (EDSS) of > 0.5. 2) Relapse, defined as the development of a new neurological sign and corresponding symptom, or worsening of an existing neurological sign and symptom, localized to central nervous system white matter, resulting in neurological deficit/disability, and lasting over 48 hours. 3) New lesions on magnetic resonance imaging (MRI), defined as presence of 2 or more independent multiple sclerosis brain lesions detected on MRI 1 year or more after stem cell transplant. Kaplan-Meier estimates of survival probability, with 90% confidence interval based on Greenwood's formula for standard error. (NCT00288626)
Timeframe: 3 years

InterventionProbability (Number)
HDIT and HCT0.784

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Percent Change From Screening in Brain Volume

Magnetic resonance imaging (MRI) scan techniques measured ventricular volumes and grey and white matter brain volumes. Change from screening was computed as the value at the time point minus the screening value. (NCT00288626)
Timeframe: 8 weeks to 5 years after HCT

InterventionPercent Change (Mean)
8 Weeks Post Transplant6 Months Post Transplant1 Year Post Transplant2 Years Post Transplant3 Years Post Transplant4 Years Post Transplant5 Years Post Transplant
HDIT and HCT-0.8-1.1-1.2-1.6-2.2-2.0-2.3

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MS Relapse-Free Survival Probability After Transplant

"MS clinical relapse is defined as the development of a new neurological sign and corresponding symptom, or worsening of an existing neurological sign and symptom, localized to central nervous system white matter, resulting in neurological deficit or disability, and lasting over 48 hours. Clinical relapse was determined by the participant's neurologist and was measured as days from transplant to new or worsening neurological symptom relative to baseline.~Kaplan-Meier estimates of survival probability, with 90% confidence interval based on Greenwood's formula for standard error." (NCT00288626)
Timeframe: 1 to 5 years after HCT

InterventionProbability (Number)
1 Year Post Transplant2 Years Post Transplant3 Years Post Transplant4 Years Post Transplant5 Years Post Transplant
HDIT and HCT0.9580.9150.8690.8690.869

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MS Progression-Free Survival Probability After Transplant

"MS progression is measured as number of days from transplant to first Kurtzke's Expanded Disability Status Scale (EDSS) increase of more than 0.5 relative to the baseline measurement. EDSS assesses disability in Multiple Sclerosis patients. Eight functional systems are evaluated: visual, brain stem, pyramidal, cerebellar, sensory, bowel and bladder, cerebral, and ambulation. The overall score ranges from 0 (normal neurological exam) to 10 (death due to MS).~Kaplan-Meier estimates of survival probability, with 90% confidence intervals based on Greenwood's formula for standard error." (NCT00288626)
Timeframe: 1 to 5 years after HCT

InterventionProbability (Number)
1 Year Post Transplant2 Years Post Transplant3 Years Post Transplant4 Years Post Transplant5 Years Post Transplant
HDIT and HCT1.00.9130.9130.9130.913

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MRI Activity-Free Survival Probability After Transplant

MS disease activity is measured as days from transplant to first occurrence of >= 2 new MS lesions on Magnetic resonance imaging (MRI) relative to baseline. Kaplan-Meier estimates of survival probability, with 90% confidence intervals based on Greenwood's formula for standard error. (NCT00288626)
Timeframe: 1 to 5 years after HCT

InterventionProbability (Number)
1 Year Post Transplant2 Years Post Transplant3 Years Post Transplant4 Years Post Transplant5 Years Post Transplant
HDIT and HCT0.9580.9580.9580.9100.863

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Event-Free Survival Probability After Transplant

Event-free survival (EFS) is survival without death or disease activity from any one of the following criteria: 1) loss of neurological function, defined as a change in pretransplant Extended Disability Status Scale (EDSS) of > 0.5. 2) Relapse, defined as the development of a new neurological sign and corresponding symptom, or worsening of an existing neurological sign and symptom, localized to central nervous system white matter, resulting in neurological deficit/disability, and lasting over 48 hours. 3) New lesions on magnetic resonance imaging (MRI), defined as presence of 2 or more independent multiple sclerosis brain lesions detected on MRI 1 year or more after stem cell transplant. Kaplan-Meier estimates of survival probability, with 90% confidence intervals based on Greenwood's formula for standard error. (NCT00288626)
Timeframe: 1, 2, and 4 years after HCT

InterventionProbability (Number)
1 Year Post Transplant2 Years Post Transplant4 Years Post Transplant
HDIT and HCT0.9580.8280.738

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Disease-Modifying Therapy Survival Probability After Transplant

Treatment with disease-modifying therapy was measured by the number of days from transplant to the first treatment with an additional disease-modifying therapy. Examples of therapy include interferon beta-1a, glatiramer acetate, natalizumab, alemtuzumab, other immunosuppressive medications, or experimental therapies directed against MS activity. Kaplan-Meier estimates of survival probability, with 90% confidence interval based on Greenwood's formula for standard error. (NCT00288626)
Timeframe: 1 to 5 years after HCT

InterventionProbability (Number)
1 Year Post Transplant2 Years Post Transplant3 Years Post Transplant4 Years Post Transplant5 Years Post Transplant
HDIT and HCT1.01.01.01.00.950

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Change From Baseline in T2-Weighted Lesion Volume

A T2-weighted magnetic resonance imaging (MRI) scan was used to assess the volume of T2 lesions in the brain. Change from baseline was computed as the value at the time point minus the baseline value. (NCT00288626)
Timeframe: 8 weeks to 5 years after HCT

Interventionmilliliters (Mean)
8 Weeks Post Transplant6 Months Post Transplant1 Year Post Transplant2 Years Post Transplant3 Years Post Transplant4 Years Post Transplant5 Years Post Transplant
HDIT and HCT-0.8-0.7-1.0-1.6-1.9-1.9-2.3

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Change From Baseline in T1-Weighted Lesion Volume

A T1-weighted magnetic resonance imaging (MRI) scan was used to assess the volume of T1 lesions in the brain. Change from baseline was computed as the value at the time point minus the baseline value. (NCT00288626)
Timeframe: 8 weeks to 5 years after HCT

Interventionmilliliter (Mean)
8 Weeks Post Transplant6 Months Post Transplant1 Year Post Transplant2 Years Post Transplant3 Years Post Transplant4 Years Post Transplant5 Years Post Transplant
HDIT and HCT-0.10.00.20.30.40.40.3

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Change From Baseline in Number of Gadolinium-Enhanced Lesions

Multiple sclerosis disease-related lesions were assessed by gadolinium-enhanced magnetic resonance imaging (MRI). Change from baseline was computed as the value at the time point minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening. (NCT00288626)
Timeframe: 8 weeks to 5 years after HCT

InterventionLesions per scan (Mean)
8 Weeks Post Transplant6 Months Post Transplant1 Year Post Transplant2 Years Post Transplant3 Years Post Transplant4 Years Post Transplant5 Years Post Transplant
HDIT and HCT-2.1-2.3-2.5-2.5-1.3-2.2-2.7

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Change From Baseline in Extended Disability Status Scale (EDSS)

Kurtzke's Expanded Disability Status Scale (EDSS) assesses disability in Multiple Sclerosis patients. Eight functional systems are evaluated: visual, brain stem, pyramidal, cerebellar, sensory, bowel and bladder, cerebral, and ambulation. The overall score ranges from 0 (normal neurological exam) to 10 (death due to MS). Change from baseline was computed as the value at the time point minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening. A change of > 0.5 in EDSS was a treatment-failure criterion. (NCT00288626)
Timeframe: 6 months to 5 years after HCT

Interventionunits on a scale (Mean)
6 Months Post Transplant1 Year Post Transplant2 Years Post Transplant3 Years Post Transplant4 Years Post Transplant5 Years Post Transplant
HDIT and HCT-0.3-0.7-0.8-0.8-0.6-0.9

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Time to Neutrophil Engraftment

Neutrophil engraftment, or neutrophil count recovery, is defined as an Absolute Neutrophil Count (ANC) > 500/ μL for 2 consecutive measurements on different days. Normal range is 1500 to 8000/μL. Reference: http://www.medicinenet.com (NCT00288626)
Timeframe: From time of graft infusion to time of engraftment, up to 6 years

InterventionDays (Mean)
HDIT and HCT10.8

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Time to Platelet Engraftment

Platelet engraftment, or platelet count recovery, is defined as Platelets > 20,000/μL for two consecutive measurements on different days with no platelet transfusions in the preceding 7 days. Normal range is 150,000-450,000/μL. Reference: http://www.hopkinsmedicine.org/heart_vascular_institute/clinical_services/centers_excellence/womens_cardiovascular_health_center/patient_information/health_topics/platelets.html. (NCT00288626)
Timeframe: From time of graft infusion to time of engraftment, up to 6 years

InterventionDays (Mean)
HDIT and HCT18.5

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Response Rate R-HCVAD vs. R-CHOP

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00290498)
Timeframe: 3 years

,
InterventionParticipants (Count of Participants)
Complete RemissionInevaluableProgressive DiseasePartial RemissionComplete Remission Unconfirmed
R-CHOP71101
R-HCVAD402142

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Progression Free Survival (Rate)

Progression free survival (PFS) for three years following therapy with Rituxan-HCVAD alternating with Rituximab with high -dose methotrexate/ara-C and standard R-CHOP in patients with newly diagnosed B-cell aggressive non-Hodgkin's lymphomas younger than 60 years old and with adjusted IPI 2 or higher adverse prognostic features. (NCT00290498)
Timeframe: 3 years post-therapy

InterventionParticipants (Count of Participants)
R-HCVAD/MA35
R-CHOP7

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Time-Weighted Average MG Activity of Daily Living (MG-ADL)

MG Activity of Daily Living total scores range from 0 to 24, with the lower scores indicating better daily living quality of life. (NCT00294658)
Timeframe: baseline, month 4, 6 and every 3 months through 36 months

Interventionunits on a scale (Mean)
Thymectomy Plus Prednisone2.24
Prednisone Alone3.41

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Time-weighted Average Alternate-day Prednisone Dose (mg) Measured Over 3 Years

Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period. (NCT00294658)
Timeframe: baseline, month 1 , 2 , 3, 4, 6 and every 3 months through 36 months

Interventionmg (Mean)
Thymectomy Plus Prednisone32
Prednisone Alone54

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Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 2: Penalized Using Dose at Time of Starting Azathioprine)

For each participant who took azathioprine, we penalized them by taking the prednisone dose at the time azathioprine commenced. We then applied the same method to compute the time-weighted alternative day prednisone dose from baseline, month 3, 4, 6 and every 3 months through 36 months. (NCT00294658)
Timeframe: baseline, month 1 , 2 , 3, 4, 6 and every 3 months through 36 months

Interventionmg (Mean)
Thymectomy Plus Prednisone33.3
Prednisone Alone57.9

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Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 1: Penalized Using Maximum Dose Before Azathioprine)

For each participant who took azathioprine, we penalized them by taking the maximum dose of prednisone before azathioprine was added. We then applied the same method to compute the time-weighted alternative day prednisone dose from baseline, month 3, 4, 6 and every 3 months through 36 months. (NCT00294658)
Timeframe: baseline, month 3, 4, 6 and every 3 months through 36 months

Interventionmg (Mean)
Thymectomy Plus Prednisone34.4
Prednisone Alone64.4

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Number of Serious Adverse Events

Number of participant who experienced at least one serious adverse events over 3 years: Thymectomy plus prednisone n=25 (out of 66); Prednisone alone n=33 (out of 60) (NCT00294658)
Timeframe: baseline to 3 years

Interventionevents (Number)
Thymectomy Plus Prednisone48
Prednisone Alone93

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Number of Patients With at Least One Serious Adverse Events

Number of participant who experienced at least one serious adverse events over 3 years: Thymectomy plus prednisone n=25 (out of 66); Prednisone alone n=33 (out of 60) (NCT00294658)
Timeframe: baseline to 3 years

Interventionparticipants (Number)
Thymectomy Plus Prednisone25
Prednisone Alone33

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Intravenous Immunoglobulin Use

(NCT00294658)
Timeframe: baseline to 3 years

Interventionparticipants (Number)
Thymectomy Plus Prednisone11
Prednisone Alone23

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Cumulative Number of Hospital Days

Number who had hospitalization: Thymectomy plus prednisone n=15 (out of 66); Prednisone alone n=31 (out of 60) (NCT00294658)
Timeframe: baseline to 3 years

Interventiondays (Mean)
Thymectomy Plus Prednisone8.4
Prednisone Alone19.2

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Cumulative Days in Hospital for Myasthenia Gravis Exacerbation

Number of patients with MG exacerbation: Thymectomy plus prednisone=6 (out of 66); Prednisone alone=17 (out of 60) (NCT00294658)
Timeframe: baseline to 2 years

Interventiondays (Mean)
Thymectomy Plus Prednisone5.5
Prednisone Alone26.4

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Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Prednisone Use at Enrollment

Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period. (NCT00294658)
Timeframe: baseline, month 3, 4, 6 and every 3 months through 36 months

,
Interventionmg (Mean)
Not prednisone naïvePrednisone naïve
Prednisone Alone5645
Thymectomy Plus Prednisone3525

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Azathioprine Use

(NCT00294658)
Timeframe: baseline to 3 years

Interventionparticipants (Number)
Thymectomy Plus Prednisone11
Prednisone Alone28

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Treatment Associated Symptoms (TAS)

Treatment associated symptoms measured myasthenia gravis symptoms such as back pain and/or bruises. Report number of participant with at least one treatment associated symptoms by each visit. (NCT00294658)
Timeframe: Month 0, 1, 2, 3, 4 then every 3 months through Month 36

,
InterventionParticipants (Count of Participants)
Month 0Month 1Month 2Month 3Month 4Month 6Month 9Month 12Month 15Month 18Month 21Mpnth 24Mpnth 27Month 30Month 33Month 36
Prednisone Alone53525354545350525151505150504847
Thymectomy Plus Prednisone63556160596059565652525250495149

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Hospitalization for Exacerbation of Myasthenia Gravis

(NCT00294658)
Timeframe: baseline to 2 years and baseline to 3 years

,
Interventionparticipants (Number)
Months 0-24Months 0-36
Prednisone Alone1722
Thymectomy Plus Prednisone66

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Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Age at Disease Onset

Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease. (NCT00294658)
Timeframe: baseline, month 3, 4, 6 and every 3 months through 36 months

,
Interventionunits on a scale (Mean)
Age (years) at Disease Onset < 40Age (years) at Disease Onset ≥ 40
Prednisone Alone9.607.85
Thymectomy Plus Prednisone6.505.33

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Subgroup Analyses of Time-weighted Average Average Alternate-day Prednisone Dose (mg) by Age at Disease Onset

Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period. (NCT00294658)
Timeframe: baseline, month 3, 4, 6 and every 3 months through 36 months

,
Interventionmg (Mean)
Age (Years) at Disease Onset < 40Age (Years) at Disease Onset ≥ 40
Prednisone Alone5549
Thymectomy Plus Prednisone3527

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Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Sex

Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period. (NCT00294658)
Timeframe: baseline, month 3, 4, 6 and every 3 months through 36 months

,
Interventionmg (Mean)
FemaleMale
Prednisone Alone5455
Thymectomy Plus Prednisone3331

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Short Form-36 Standardized Physical Component

Range from 0 to 100, the higher the physical component value, the better the mental health. (NCT00294658)
Timeframe: Month 0, Month 12, Month 24 and Month 36

,
Interventionunits on a scale (Median)
Month 0Month 12Month 24Month 36
Prednisone Alone37.944.443.044.2
Thymectomy Plus Prednisone41.448.450.348.2

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Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Sex

Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease. (NCT00294658)
Timeframe: baseline, month 3, 4, 6 and every 3 months through 36 months

,
Interventionunits on a scale (Mean)
FemaleMale
Prednisone Alone9.737.45
Thymectomy Plus Prednisone6.475.23

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Short Form-36 Standardized Mental Component

Range from 0 to 100, the higher the mental component value, the better the mental health. (NCT00294658)
Timeframe: Month 0, Month 12, Month 24 and Month 36

,
Interventionunits on a scale (Median)
Month 0Month 12Month 24Month 36
Prednisone Alone46.241.746.748.2
Thymectomy Plus Prednisone49.139.149.951.7

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Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term

Number who had hospitalization: Thymectomy plus prednisone n=15 (out of 66); Prednisone alone n=31 (out of 60) (NCT00294658)
Timeframe: baseline to 3 years

,
Interventionevents (Number)
Gastrointestinal disorderHepatobiliary disorderInfection or infestationInjury, poisoning, or procedure complicationMetabolism or nutrition disorderNervous system disorderRespiratory, thoracic, or mediastinal disorderSurgical or medical procedureVascular disorder
Prednisone Alone2170022271
Thymectomy Plus Prednisone204218100

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Minimal Manifestation (MM) Status at Month 12, 24 and 36

Number of participants who were in minimal manifestation status at month 12, 24 and 36. (NCT00294658)
Timeframe: Month 12, 24 and 36

,
Interventionparticipants (Number)
Month 12Month 24Month 36
Prednisone Alone202024
Thymectomy Plus Prednisone413939

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Classification of Serious Adverse Events

(NCT00294658)
Timeframe: baseline to 3 years

,
Interventionparticipants (Number)
Life-threateningDisability or incapacityMedical or surgical interventionDeathComplication due to thytmectomyHospitalization
Prednisone Alone7251031
Thymectomy Plus Prednisone1890115

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Plasma Exchange Use

(NCT00294658)
Timeframe: baseline to 3 years

Interventionparticipants (Number)
Thymectomy Plus Prednisone10
Prednisone Alone9

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Time-weighted Average Quantitative Myasthenia Gravis Weakness Score Over 3 Years

Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease. The time weighted average is a calculation that provides an integrated measure of the outcome over the time of followup. The denominator that was used to compute the time-weighted average for the Quantitative Myasthenia Gravis (QMG) score and the prednisone dose was the number of days from randomization to the last visit. Computations used the trapezoidal method where in the QMG score is multiplied by the number of days at this level from one visit to the next and added up over the entire followup experience and divided by the total number of days from randomization. (NCT00294658)
Timeframe: baseline, month 3, 4, 6 and every 3 months through 36 months

Interventionunits on a scale (Mean)
Thymectomy Plus Prednisone6.15
Prednisone Alone8.99

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Time-weighted Average Prescribed Alternate Day Prednisone Dose (mg)

Physicians reported prescribed alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prescribed prednisone dosages had been weighted over the days of reporting period. (NCT00294658)
Timeframe: baseline-day 20, month 1,2, 3, 4, 6 and every 3 months through 36 months

Interventionmg (Mean)
Thymectomy Plus Prednisone34.3
Prednisone Alone55.6

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Time-Weighted Average MG Activity of Daily Living (MG-ADL) at Month 12, 24, and 36

MG Activity of Daily Living total scores range from 0 to 24 by visit, with the lower scores indicating better daily living quality of life. (NCT00294658)
Timeframe: Month 12, 24, and 36

,
Interventionunits on a scale (Mean)
Month 12Month 24Month 36
Prednisone Alone3.333.112.69
Thymectomy Plus Prednisone1.922.022.14

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Cumulative Days in Hospital for Myasthenia Gravis Exacerbation

Number of patients with MG exacerbation: Thymectomy plus prednisone=6 (out of 66); Prednisone alone=22 (out of 60) (NCT00294658)
Timeframe: baseline to 3 years

Interventiondays (Mean)
Thymectomy Plus Prednisone8.7
Prednisone Alone22.5

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Treatment Associated Complications (TAC)

Treatment associated complications measured complications occurred by myasthenia gravis patients. Report number of participant with at least one complications by each visit. (NCT00294658)
Timeframe: Month 0, 1, 2, 3, 4 then every 3 months through Month 36

,
InterventionParticipants (Count of Participants)
Month 0Month 1Month 2Month 3Month 4Month 6Month 9Month 12Month 15Month 18Month 21Mpnth 24Mpnth 27Month 30Month 33Month 36
Prednisone Alone17152016232226282424202317192323
Thymectomy Plus Prednisone22152221232137352928222825232423

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Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Prednisone Use at Enrollment

Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease. (NCT00294658)
Timeframe: baseline, month 3, 4, 6 and every 3 months through 36 months

,
Interventionunits on a scale (Mean)
Not prednisone naïvePrednisone naïve
Prednisone Alone9.108.84
Thymectomy Plus Prednisone6.305.66

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Maximum Tolerated Dose

Maximum tolerated dose of Bortezomib in combination with Rituximab, Cyclophosphamide and Prednisone in Phase I participants (NCT00295932)
Timeframe: 2 years

Interventionmg/m^2 of Bortezomib (Number)
Weekly BortezomibTwice-Weekly Bortezomib
Arm I1.81.5

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Toxicity of Participants Receiving Bortezomib, Rituximab, Cyclophosphamide, and Prednisone for Treatment of Non-Hodgkin's Lymphoma

Toxicity assessed using NCI-CTC v. 3.0 (NCT00295932)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide4
1.6 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamide6
1.6 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide3
1.8 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphamide4
Dose Level 1- 1.0 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid2
Dose Level 2 - 1.3 mg/m2 Bortezomib; 750 mg/m2 Cyclophosphamid18
Dose Level 3 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham3
Dose Level 4 - 1.5 mg/m2 Bortezomib; 1000 mg/m2 Cyclophosphami4
Dose Level 5 - 1.3 mg/m2 Bortezomib; 1000 mg/m2 Cyclophospham10
Weekly Bortezomib Dosing Schedule12
Twice-weekly Bortezomib Dosing Schedule13

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New-onset Diabetes Mellitus (NODM) as Secondary Outcome

The incidence of new-onset Diabetes mellitus (NODM, based on percentage of previously non-diabetic patients who developed DM post-transplantation, was similar between the 2 groups. (NCT00296244)
Timeframe: 6 months

InterventionPercentage of participants (Number)
Control Group40
Study Group42

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Infection as an Adverse Effect of Steroids

Incidence of bacterial infection was similar in the control group as well as study group, 4 patients in both groups had infection (NCT00296244)
Timeframe: 3 months post-transplant

InterventionPercentage of participants (Number)
Control Group20
Study Group21

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Incidence and Severity of HCV Recurrence Post-OLT

The incidence and severity of HCV recurrence based on Hepatitis C PCR levels and protocol liver biopsy findings were found to be similar between the 2 groups. (NCT00296244)
Timeframe: 6 months post-transplant

InterventionPercentage of participants (Number)
Control Group27
Study Group29

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Patient Survival Rate

Percentage of recipients who are still alive at the end of 1 and 2 years. (NCT00296244)
Timeframe: 1 and 2 years

,
InterventionPercentage of participants (Number)
1-year patient survival rate2-year patient survival rate
Control Group10090
Study Group94.784

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Graft Survival Rate

Percentage of recipients whose liver grafts are still working at the end of 1 and 2 years. (NCT00296244)
Timeframe: 1 and 2 years

,
Interventionpercentage of participants (Number)
1-year graft survival rate2-year graft survival rate
Control Group10090
Study Group94.784

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Acute Rejection Rate

Biopsy proven acute rejection defined by biochemical and histological changes as well as the need for temporary steroid use occurred in 1 patient in each group both of which were steroid responsive (NCT00296244)
Timeframe: 6 months post-transplant

InterventionPercentage of participants (Number)
Control Group5
Study Group5

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Progression-free Survival (PFS)

Percentage of participants Progression-free at different time points. Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance. (NCT00301821)
Timeframe: the time from study entry to 36 months

Interventionpercentage of participants (Number)
Progression Free Survival at 12 monthsProgression Free Survival at 24 monthsProgression Free Survival at 36 months
Epratuzumab + Rituximab + CHOP857776

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Overall Survival

Percentage of participants alive at different time points (NCT00301821)
Timeframe: time from study entry to 36 months

Interventionpercentage of Participants (Number)
Overall Survival at 12 monthsOverall Survival at 24 monthsOverall Survival at 36 months
Epratuzumab + Rituximab + CHOP898180

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Overall Response Rate (ORR)

Overall response rate will be estimated by the number of patients with objective status of partial response (PR), unconfirmed complete response (CRu), or complete response (CR) during the first 6 cycles of treatment divided by number of evaluable patients (met eligibility criteria, signed consent form, and started treatment). Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance. (NCT00301821)
Timeframe: Baseline to first 6 cycles of treatment

Interventionpercentage of participants (Number)
Epratuzumab + Rituximab + CHOP95

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Event-free Survival After 12 Months

The primary endpoint of the trial was the percentage of the eligible patients who were alive and event-free 12 months after enrollment to the study (EFS12). (NCT00301821)
Timeframe: From Baseline to 12 months

Interventionpercentage of participants (Number)
Epratuzumab + Rituximab + CHOP78

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Intensive Therapy Free Survival (ITFS).

Survival is defined as the minimum time from study entry to a relapse of higher risk at any time, any relapse following treatment with protocol mandated IFRT, death from any cause, or the occurrence of a second malignant neoplasm. This will be used to compute intensive therapy free survival (ITFS). Patients without report of such events where censored at last contact. This differs from traditional EFS in that relapse after AVPC* x3 therapy alone that does not place the patient in a higher risk category is not considered a treatment failure. In this definition, higher-risk relapse refers to relapse involving sites and extent of disease that place the patient in the current COG definition of intermediate or high-risk disease. If a patient with CR who experiences a LR relapse is not retreated with protocol-mandated chemotherapy and IFRT, subsequent disease relapses will nevertheless be counted in the analysis of the treatment strategy. (NCT00302003)
Timeframe: At 60 months

InterventionProbability of survival (Number)
Group 10.89

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Event Free Survival (EFS)

Survival is defined as the minimum time from study entry to a relapse of any kind, death from any cause, or occurrence of a second malignant neoplasm. Patients without report of such events where censored at last contact. This will be used to compute event free survival (EFS). (NCT00302003)
Timeframe: At 60 months

InterventionProbability of survival (Number)
Group 10.79

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Overall Survival

Survival is defined as time from study entry to death due to any cause. Patients alive at last contact where censored at last contact. (NCT00302003)
Timeframe: At 60 months

InterventionProbability of survival (Number)
Group 10.99

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Event Free Survival Without Receiving Radiation Therapy (EFSnoRT).

Survival is defined as the minimum time from study entry to requirement for additional chemotherapy and IFRT for retrieval, occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact. Patients who achieve less than CR after 3 cycles of AV-PC will require IFRT and hence will satisfy this definition at the time of response evaluation. Patients who achieve a CR but who relapse will receive addition chemotherapy and IFRT or intense retrieval and hence will satisfy this definition at the time of the first relapse of Hodgkin disease. This endpoint will be used to compute event free survival without receiving radiation therapy (EFSnoRT). (NCT00302003)
Timeframe: At 60 months

InterventionProbability of survival (Number)
Group 10.49

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To Evaluate the Total Number of Circulating Lymphocytes and Lymphocyte Phenotypes and to Correlate With the Effectiveness of Rituximab and Oral Cyclophosphamide to Achieve and Preserve Complete Eradication of the Refractory Autoantibody.

the 2 recruited patients did not eradicate their inhibitors with 3 weeks of corticosteroids and did not progress in clinical trial since funding was eliminated and study terminated (NCT00306670)
Timeframe: When 25 patients have completed the study.

InterventionParticipants (Count of Participants)
Oral Cyclophosphamide0

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Change From Pre-conversion Baseline in Glycosylated Hemoglobin(HbA1C) at Months 12, 24, and 36 Post-transplant

HbA1C, change = value at month x post-transplant - pre-conversion baseline. (NCT00311311)
Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

,
Interventionpercentage of glucose (Mean)
Change at 12 Months post-transplant (n=23,26)Change at 24 Months post-transplant (n=17,25)Change at 36 Months post-transplant (n=14,16)
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone0.0080.0090.012
Tacrolimus With Mycophenolate/Prednisone0.0010.006-0.001

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Change From Pre-conversion Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Months 12, 24 and 36 Post-transplant.

hsCRP is a biomarker of cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values. (NCT00311311)
Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

,
Interventionmg/L (Mean)
Change at 12 Months post-transplant (n=23,33)Change at 24 Months post-transplant (n=18,31)Change at 36 Months post-transplant (n=15,22)
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone1.611-0.5630.336
Tacrolimus With Mycophenolate/Prednisone1.3791.7233.164

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Change From Pre-conversion Baseline in Homocysteine at Months 12, 24 and 36 Post-transplant

Homocysteine is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values. (NCT00311311)
Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

,
Interventionmicromole/liter (µmol/L) (Mean)
Change at 12 Months post-transplant (n=23,33)Change at 24 Months post-transplant (n=19,31)Change at 36 Months post-transplant (n=15,22)
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone1.2781.3161.087
Tacrolimus With Mycophenolate/Prednisone0.5302.1582.459

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Change From Pre-conversion Baseline in Insulin at Months 12, 24, and 36 Post-transplant

Fasting insulin. Change = value at month x post-transplant - pre-conversion baseline. (NCT00311311)
Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

,
Interventionpicomole/liter (pmol/L) (Mean)
Change at 12 Months post-transplant (n=16,23)Change at 24 Months post-transplant (n=13,23)Change at 36 Months post-transplant (n=10,14)
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone-4.549-6.120-22.759
Tacrolimus With Mycophenolate/Prednisone17.95332.180-2.731

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Change From Pre-conversion Baseline in Interleukin-6 (IL-6) at Months 12, 24 and 36 Post-transplant

IL-6 is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion values. (NCT00311311)
Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

,
Interventionpg/mL (Mean)
Change at 12 Months post-transplant (n=23,32)Change at 24 Months post-transplant (n=18,29)Change at 36 Months post-transplant (n=15,22)
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone-0.2390.128-0.800
Tacrolimus With Mycophenolate/Prednisone0.4630.7830.164

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Change From Pre-conversion Baseline in Lipoprotein(a) at Months 12, 24 and 36 Post-transplant

Lipoprotein(a) is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values. (NCT00311311)
Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

,
Interventionmilligram per deciliter (mg/dL) (Mean)
Change at 12 Months post-transplant (n=23,30)Change at 24 Months post-transplant (n=18,26)Change at 36 Months post-transplant (n=13,17)
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone13.49612.51711.885
Tacrolimus With Mycophenolate/Prednisone-11.6806.0736.547

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Change From Pre-conversion Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) at Months 12, 24 and 36 Post-transplant

TNF-alpha is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values. (NCT00311311)
Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

,
Interventionpg/mL (Mean)
Change at 12 Months post-transplant (n=23,32)Change at 24 Months post-transplant (n=18,30)Change at 36 Months post-transplant (n=15,22)
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone0.991-0.367-0.441
Tacrolimus With Mycophenolate/Prednisone0.0001.8940.000

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Change From Pre-conversion Baseline in Uric Acid at Months 12, 24 and 36 Post-transplant

Uric Acid is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values. (NCT00311311)
Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

,
Interventionµmol/L (Mean)
Change at 12 Months post-transplant (n=23,33)Change at 24 Months post-transplant (n=19,31)Change at 36 Months post-transplant (n=15,22)
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone-51.53-29.02-19.03
Tacrolimus With Mycophenolate/Prednisone11.103.89-0.58

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Change From Pre-conversion Baseline in Vitamin B12 at Months 12, 24 and 36 Post-transplant

Vitamin B12 is a biomarker for cardiovascular disease and atherosclerosis risk. A lower level indicates a greater risk. Change = month x post-transplant values - pre-conversion values. (NCT00311311)
Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

,
Interventionpmol/L (Mean)
Change at 12 Months post-transplant (n=21,33)Change at 24 Months post-transplant (n=19,29)Change at 36 Months post-transplant (n=14,21)
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone-10.21-36.23-40.00
Tacrolimus With Mycophenolate/Prednisone-11.38-27.46-46.39

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Number of Participants Who Used Anti-hypertensive Medications

"Participants who reported yes for taking anti-hypertensive medications as concomitant medication." (NCT00311311)
Timeframe: From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant

,
Interventionparticipants (Number)
From consent to conversionFrom conversion to Month 12From Months 12 to Month 24From Months 24 to Month 36
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone19212118
Tacrolimus With Mycophenolate/Prednisone30303028

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Number of Participants Who Used Lipid Lowering Therapies

"Participants who reported yes for taking lipid lowering therapies as concomitant medication." (NCT00311311)
Timeframe: From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant

,
Interventionparticipants (Number)
From consent to conversionFrom conversion to Month 12From Months 12 to Month 24From Months 24 to Month 36
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone13222318
Tacrolimus With Mycophenolate/Prednisone24292827

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Annual Change Rate in Total Plaque Volume (TPV) From Pre-conversion Baseline to 12 Months Post-transplant

Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 12 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 12 post-transplant minus [-] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries. (NCT00311311)
Timeframe: Pre-conversion baseline and 12 months post-transplant

Interventionmillimeter cube/year (mmˆ3/year) (Mean)
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone-49.31
Tacrolimus With Mycophenolate/Prednisone0.66

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CIMT at Pre-conversion Baseline

Mean CIMT=average of left CIMT and right CIMT. (NCT00311311)
Timeframe: Pre-conversion baseline

Interventionmm (Mean)
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone0.735
Tacrolimus With Mycophenolate/Prednisone0.773

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TPV at Pre-conversion Baseline

TPV is the sum of the assessment in left and right distal common carotid arteries. (NCT00311311)
Timeframe: Pre-conversion baseline

Interventionmmˆ3 (Mean)
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone68.68
Tacrolimus With Mycophenolate/Prednisone48.57

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Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant

Within-subject annual change rate in CIMT as determined by ultrasound. Mean CIMT=average of left CIMT and right CIMT. Annual CIMT Change Rate (mm/year) = (CIMT at Month x Post-transplant Visit - CIMT at Conversion Baseline) / Imaging interval in years. (NCT00311311)
Timeframe: Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant

,
Interventionmillimeter/year (mm/year) (Mean)
Annual Change Rate at 12 months (n=16,28)Annual Change Rate at 18 months (n=15,26)Annual Change Rate at 24 months (n=15,23)Annual Change Rate at 36 months (n=8,13)
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone0.0480.0410.0230.028
Tacrolimus With Mycophenolate/Prednisone0.012-0.00020.015-0.007

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Annual Rate of Change in TPV From Pre-conversion Baseline to 18, 24 and 36 Months Post Transplant

Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 18, 24 and 36 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 18, 24 and 36 post-transplant minus [-] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries. (NCT00311311)
Timeframe: Pre-conversion baseline, and 18, 24 and 36 months post-transplant

,
Interventionmmˆ3/year (Mean)
Month 18 post-transplant (n=12,12)Month 24 post-transplant (n=11,14)Month 36 post-transplant (n=7,11)
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone17.1525.286.62
Tacrolimus With Mycophenolate/Prednisone19.719.108.98

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Change From Pre-conversion Baseline in Adiponectin at Months 12, 24 and 36 Post-transplant

Adiponectin is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates less risk. Change = month x post-transplant values - pre-conversion baseline values. (NCT00311311)
Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

,
Interventionmicrogram per milliliter (µg/mL) (Mean)
Change at 12 Months post-transplant (n=23,33)Change at 24 Months post-transplant (n=18,31)Change at 36 Months post-transplant (n=15,22)
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone5.3522.2441.487
Tacrolimus With Mycophenolate/Prednisone-2.205-0.267-1.413

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Change From Pre-conversion Baseline in Endothelin-1 at Months 12, 24 and 36 Post-transplant

Endothelin-1 is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates greater risk. Change = month x post-transplant values - pre-conversion baseline values. (NCT00311311)
Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

,
Interventionpg/mL (Mean)
Change at 12 Months post-transplant (n=22,30)Change at 24 Months post-transplant (n=18,30)Change at 36 Months post-transplant (n=14,22)
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone0.2940.4260.411
Tacrolimus With Mycophenolate/Prednisone0.0280.138-0.104

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Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant

Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL) and Triglyceride (Tg) blood concentrations. Higher levels of TC, LDL and Tg are less desirable. Lower levels of HDL are less desirable. Change for each parameter = value at 12, 18, 24 and 36 months post-transplant - value at pre-conversion baseline. (NCT00311311)
Timeframe: Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant

,
Interventionmillimole/liter (mmol/L) (Mean)
Change in TC 12 Months post-transplant (n=23,30)Change in LDL 12 Months post-transplant (n=21,30)Change in HDL 12 Months post-transplant (n=23,30)Change in Tg 12 Months post-transplant (n=23,30)Change in TC 18 Months post-transplant (n=21,29)Change in LDL 18 Months post-transplant (n=20,29)Change in HDL 18 Months post-transplant (n=21,29)Change in Tg 18 Months post-transplant (n=21,29)Change in TC 24 Months post-transplant (n=19,27)Change in LDL 24 Months post-transplant (n=16,27)Change in HDL 24 Months post-transplant (n=19,27)Change in Tg 24 Months post-transplant (n=19,27)Change in TC 36 Months post-transplant (n=15,21)Change in LDL 36 Months post-transplant (n=13,21)Change in HDL 36 Months post-transplant (n=15,21)Change in Tg 36 Months post-transplant (n=15,21)
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone0.5100.2770.0590.6170.3610.2220.1060.3590.2400.0670.0670.5470.3860.0270.0980.527
Tacrolimus With Mycophenolate/Prednisone-0.164-0.056-0.053-0.1170.0820.138-0.030-0.057-0.0080.054-0.019-0.088-0.323-0.2570.111-0.385

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Change From Pre-conversion Baseline in Fibrinogen at Months 12, 24 and 36 Post-transplant

Fibrinogen is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values. (NCT00311311)
Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

,
Interventiongram per liter (g/L) (Mean)
Change at 12 Months post-transplant (n=22,31)Change at 24 Months post-transplant (n=19,29)Change at 36 Months post-transplant (n=14,20)
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone0.620.450.40
Tacrolimus With Mycophenolate/Prednisone0.200.330.21

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Change From Pre-conversion Baseline in Glucose at Months 12, 24 and 36 Post-transplant

Fasting plasma glucose. Change = value at month x post-transplant - pre-conversion baseline values. (NCT00311311)
Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

,
Interventionmmol/L (Mean)
Change at 12 Months post-transplant (n=23,33)Change at 24 Months post-transplant (n=19,31)Change at 36 Months post-transplant (n=14,22)
Tacrolimus Then Sirolimus With Mycophenolate/Prednisone0.6060.8320.686
Tacrolimus With Mycophenolate/Prednisone-0.083-0.076-0.214

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Total Number of Circulation Tumor Cells (CTCs)

Blood samples were collected and processed to enumerate the number of total CTCs via Veridex CellSearch technology in which CTCs were identified based on cell surface positive epithelial cell adhesion molecule (EpCAM) and cytokeratin staining. (NCT00313781)
Timeframe: Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose)

,
InterventionNumber of CTCs/7.5 mL (Mean)
Baseline (Cycle 1 Day 1) (n=46, 39)Cycle 3 Day1 (n=28, 29)Cycle 5 Day 1 (n=25, 23)
CP-751,871+Docetaxel+Prednisone105.176.3915.20
Docetaxel+Prednisone213.2312.2117.78

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Human Anti-human Antibody (HAHA) at Baseline (Day 1 of Cycle 1)

Levels of HAHA in serum were detected at baseline. (NCT00313781)
Timeframe: Baseline (Day 1 of Cycle 1)

Interventionmg/deciliter (dl) (Mean)
CP-751,871+Docetaxel+Prednisone1130.3
Docetaxel+Prednisone1338.1

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Human Anti-human Antibody (HAHA) at the Last Follow-up Visit

Levels of HAHA in serum were detected at the last follow-up visit. (NCT00313781)
Timeframe: The last follow-up visit (150 days post last dose)

Interventionmg/dl (Mean)
CP-751,871+Docetaxel+Prednisone944.81
Docetaxel+Prednisone819.00
Docetaxel+Prednisone+CP-751,871 Crossover970.86

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Percentage of Participants With Prostate Specific Antigen (PSA) Best Response

Percentage of participants with PSA best response of either PSA normalization (PN) or partial PSA response (PR) relative to the total number of participants evaluable for response. PN was defined as PSA =< 0.2 nanogram/milliliter (ng/ml) on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression. PP was defined as >= 50% decrease in PSA from baseline on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression. (NCT00313781)
Timeframe: Baseline, Day 1 and Day 15 of each cycle, end of treatment (up to 28 days post last dose) and follow-up (monthly, up to 150 days post last dose)

InterventionPercentage of participants (Mean)
CP-751,871+Docetaxel+Prednisone51.7
Docetaxel+Prednisone60.2
Docetaxel+Prednisone+CP-751,871 Crossover28.1

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Progression Free Survival (PFS)

PFS was defined as the time from randomization to first event of disease progression. Disease progression events were defined as the following: PSA progression,objective disease progression as per RECIST, death, and discontinuation of treatment due to symptomatic deterioration. PSA progression was defined as the time-point of PSA progression on 2 successive evaluations taken 1 week apart after dosing in cycle 3. (NCT00313781)
Timeframe: Baseline, Day 15 of each cycle and follow-up (monthly, up to 150 days post last dose)

InterventionMonths (Median)
CP-751,871+Docetaxel+Prednisone4.9
Docetaxel+Prednisone7.7
Docetaxel+Prednisone+CP-751,871 Crossover4.0

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Total Number of the Insulin Like Growth Factor Receptor Type 1 (IGF-1R) Positive CTCs

Blood samples were collected to enumerate the number of total IGF-1R positive CTCs via Veridex CellSearch technology in which CTCs were identified based on cell surface positive EpCAM and cytokeratin staining. A separate CellSave tube of cells was also collected and processed with cell surface staining of IGF-1R to enumerate surfaces of IGF-1R-positive CTCs. (NCT00313781)
Timeframe: Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose)

,
InterventionNumber of IGF-1R positive CTCs/7.5 mL (Mean)
Baseline (Cycle 1 Day 1) (n=22, 18)Cycle 3 Day1 (n=12, 15)Cycle 5 Day 1 (n=11, 10)
CP-751,871+Docetaxel+Prednisone24.732.332.00
Docetaxel+Prednisone54.944.933.90

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Proportion Responding to Treatment With of the Combination of Ixabepilone and Mitoxantrone Hydrochloride With Prednisone in Hormone Refractory Prostate Cancer Patients Who Have Had Prior Taxane Chemotherapy Based Upon a PSA Decline of > 50% (Phase II)

"Descriptive statistics will be calculated to characterize the disease and treatment factors including the proportion responding with a 95% confidence interval. If accrual is completed and more than 15 of 58 patients show > 50% Prostate Specific Antigen (PSA) declines after 3 courses, then the null hypothesis of a 20% response proportion will be rejected. PSA declines for individual patients will be plotted in the form of a waterfall diagram of maximal PSA declines.~58 patients were enrolled for phase II, two were ineligible so 56 patients were analyzed." (NCT00331344)
Timeframe: Every 3 courses until cancer progression/excessive toxicity or death

InterventionParticipants (Count of Participants)
Treatment (Combination Chemotherapy)25

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Safety of the Combination of Ixabepilone, Mitoxantrone Hydrochloride, and Prednisone in Patients With Hormone-refractory Metastatic Prostate Cancer That Progressed During or After Taxane-based Chemotherapy (Phase I)

This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The cumulative grade 3 or higher adverse events for all dose levels are noted below and in the table of adverse events. (NCT00331344)
Timeframe: Every 21 days until cancer progression/excessive toxicity or death

InterventionAdverse Events (above threshold) (Number)
Phase I Treatment (Groups I-VIa)62

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Time to Progression (Phase II)

Measured from the start of protocol therapy until RECIST (Response Evaluation Criteria In Solid Tumors Criteria) v1.0 progression. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT00331344)
Timeframe: Every 3 months until cancer progression/excessive toxicity or death

Interventionmonths (Median)
Treatment (Combination Chemotherapy)4.4

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Dose Limiting Toxicities for Each Dose Level of Ixabepilone, Mitoxantrone Hydrochloride, and Prednisone in Patients With Hormone-refractory Metastatic Prostate Cancer That Progressed During or After Taxane-based Chemotherapy (Phase I).

Cohorts of 3 patients will be enrolled at each dose level; if 1 dose limiting toxicity (DLT) is observed then the cohort will be expanded to 6 patients. If a second DLT is observed, the previous dose level will be considered the maximum tolerated dose (MTD). If all observed DLT are due to neuropathy (specific to ixabepilone), then we would consider the previous dose level of Ixabepilone the MTD for that drug, and escalate mitoxantrone hydrochloride as described above to a maximum dose of 12 mg/m^2. Toxicities will be tabulated by grade for each dose cohort and overall for all patients accrued to the phase I study. (NCT00331344)
Timeframe: Course 1 (first 21 days)

InterventionParticipants (Count of Participants)
Phase I Group I0
Phase Group II0
Phase I Group III0
Phase I Group IV1
Phase I Group V2
Phase I Group VI2
Phase I Group Va0
Phase I Group VIa1

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Number of Patients That Achieved a Complete Response (CR)

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR (NCT00337987)
Timeframe: After 4 years

Interventionparticipants (Number)
Denileukin Diftitox/CHOP Administration27

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Number of Patients That Achieved a Complete Response or a Partial Response (PR)

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR (NCT00337987)
Timeframe: After 4 years

Interventionparticipants (Number)
Denileukin Diftitox/CHOP Administration32

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Percent Change in Flare at Resolution

(NCT00345046)
Timeframe: 2 months

InterventionPercent change in flare (Mean)
Pred Forte 1%64.8
Econo Pred Plus 1%68.3
Predisolone Acetate 1%65.7

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Progression-free Survival Based on PSA Progression

Subjects were monitored for PSA (Prostate Specific Antigen) for up to 5 years of follow-up. (NCT00348816)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Docetaxel (Single Arm)12

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Rate of Prostate-Specific Antigen (PSA) Decline Reported as the Number of Subjects Reaching a PSA Nadir of Zero Following the Intervention.

Subjects were followed after the intervention and monitored for PSA (Prostate Specific Antigen) decline for up to 5 years of follow-up, to determine how many had a decline and reached a PSA nadir of zero.. (NCT00348816)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Docetaxel (Single Arm)12

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Participants Who Reduced Steroid Use at One Year After Enrollment on the Trial

Participants that decreased total daily corticosteroids ≤ 0.25mg/kg one year after rituximab infusion began (NCT00350545)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Rituximab + Prednisone Arm14

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Overall Survival

Overall survival at 6 and 12 months (NCT00350545)
Timeframe: 6 and 12 months

InterventionParticipants (Count of Participants)
6 month overall survival12 month overall survival
Rituximab + Prednisone Arm3330

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Number of Participants With Complete and/or Partial GVHD Response

To have physician documentation of clinical GVHD response using organ staging and scoring scale- NIH clinical GVHD consensus response criteria applied 6 months after rituximab infusion began (NCT00350545)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Complete responsePartial response
Rituximab + Prednisone Arm1215

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Failure-free Survival at 6 and 12 Months Post-Rituximab Initiation

Failure-free survival (FFS) was defined as participants who are surviving with no relapse and second line of cGVHD treatment. (NCT00350545)
Timeframe: 6 and 12 Months

InterventionParticipants (Count of Participants)
6 month FFS12 month FFS
Rituximab + Prednisone Arm2821

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Number of Participants With the Ability to Successfully Taper Prednisone to a Dose Lower Dose.

Participants that have successfully tapered prednisone to a dose of 0.25 mg/kg/Day by 6 Months without clinical relapse. (NCT00350545)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Rituximab + Prednisone Arm14

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-2.31

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.35

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.46

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3-year Overall Survival (OS) Probability

Comparison of the 3-year OS probability along with the whole OS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99. (NCT00352027)
Timeframe: 3-years

Interventionprobability (Number)
HOD05 Participants1.00
HOD99 Participants0.978

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3-year Local Failure-free Survival Probability

Comparison of the 3-year local failure-free survival probability along with the whole local failure-free survival distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99. (NCT00352027)
Timeframe: 3 years

Interventionprobability (Number)
HOD05 Participants0.887
HOD99 Participants0.932

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3-year Event-Free Survival Probability

The survival probability for the time interval from treatment start to the time of the first failure (disease recurrence, second malignancy or death) within a 3-year time frame. (NCT00352027)
Timeframe: 3 years

Interventionprobability (Number)
Stanford V Chemotherapy0.887

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Patient Quality of Life (QoL), Symptom Distress Scale

"The patient's degree of discomfort from specific treatment-related symptoms across multiple time points.~Instrument interpretation: SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy17.3
Week 819.6
Week 1218.1
After Radiation15.1
Off-therapy14.3

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Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy90.9
Week 888.6
Week 1288.0
After Radiation90.1
Off-therapy91.1

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Patient Quality of Life (QoL), PedsQL v.4.0: Total Score

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy80.9
Week 874.4
Week 1275.3
After Radiation83.1
Off-therapy84.5

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Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy73.1
Week 869.5
Week 1272.6
After Radiation78.4
Off-therapy81.3

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Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy79.3
Week 877.6
Week 1278.6
After Radiation84.3
Off-therapy84.3

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Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy83.2
Week 868.4
Week 1269.1
After Radiation80.8
Off-therapy85.2

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Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy72.6
Week 875.3
Week 1275.7
After Radiation84.5
Off-therapy81.6

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Patient Quality of Life (QoL), PedsQL v.3.0: Worry

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 871.2
Week 1272.2
After Radiation74.5
Off-therapy76.0

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Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 889.2
Week 1282
After Radiation89.4
Off-therapy87.3

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Patient Quality of Life (QoL), PedsQL v.3.0: Total Score

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 874.1
Week 1274.2
After Radiation81.7
Off-therapy83.5

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-2.52

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Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 871.8
Week 1270.9
After Radiation68.1
Off-therapy80.1

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Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 877.6
Week 1281.3
After Radiation81.4
Off-therapy84.7

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Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 863.9
Week 1271.5
After Radiation79.9
Off-therapy88.0

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Patient Quality of Life (QoL), PedsQL v.3.0: Nausea

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 862.7
Week 1260.1
After Radiation76.7
Off-therapy81.6

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.41

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Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 879.1
Week 1278.2
After Radiation87.0
Off-therapy82.0

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Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy77.6
Week 869.1
Week 1272.3
After Radiation77.8
Off-therapy83.5

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Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy86.1
Week 883.0
Week 1280.7
After Radiation85.1
Off-therapy89.1

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Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy74.4
Week 862.8
Week 1270.8
After Radiation75.6
Off-therapy78.9

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Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy76.2
Week 871.0
Week 1274.1
After Radiation79.0
Off-therapy88.0

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Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy79.8
Week 865.3
Week 1267.3
After Radiation73.6
Off-therapy84.6

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Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy67.7
Week 865.4
Week 1268.1
After Radiation73.0
Off-therapy82.0

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 870
Week 1269.2
After Radiation71.9
Off-therapy78.7

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 881.9
Week 1272.6
After Radiation78.5
Off-therapy81.8

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 871.7
Week 1269.3
After Radiation74.5
Off-therapy80.0

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 870.0
Week 1260.0
After Radiation63.1
Off-therapy73.8

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 874.9
Week 1272.2
After Radiation73.7
Off-therapy76.3

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 861.2
Week 1261.8
After Radiation73.1
Off-therapy82.7

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 861.2
Week 1257.4
After Radiation72.2
Off-therapy83.2

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 879.2
Week 1280.4
After Radiation80.3
Off-therapy84.3

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 877.6
Week 1279.5
After Radiation78.6
Off-therapy79.9

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Disease Failure Rate Within Radiation Fields

Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks). (NCT00352027)
Timeframe: 3 years

Interventionproportion of participants (Number)
Stanford V Chemotherapy0.1125

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Pre-therapy-2.9
Parent and Patient Scores at Week 8-4.8
Parent and Patient Scores at Week 12-4.8
Parent and Patient Scores at After Radiation-5
Parent and Patient Scores at Off-therapy-2.9

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Pre-therapy-5.3
Parent and Patient Scores at Week 8-5.7
Parent and Patient Scores at Week 12-7.4
Parent and Patient Scores at After Radiation-5.0
Parent and Patient Scores at Off-therapy-3.3

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Pre-therapy1.3
Parent and Patient Scores at Week 8-5.3
Parent and Patient Scores at Week 12-4.1
Parent and Patient Scores at After Radiation-3.4
Parent and Patient Scores at Off-therapy-4.3

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Pre-therapy-2.8
Parent and Patient Scores at Week 8-6.4
Parent and Patient Scores at Week 12-6.3
Parent and Patient Scores at After Radiation-5.6
Parent and Patient Scores at Off-therapy-3.3

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Pre-therapy-2.9
Parent and Patient Scores at Week 8-2.3
Parent and Patient Scores at Week 12-1.9
Parent and Patient Scores at After Radiation-5.4
Parent and Patient Scores at Off-therapy-2

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Pre-therapy-4.9
Parent and Patient Scores at Week 8-9.4
Parent and Patient Scores at Week 12-8.0
Parent and Patient Scores at After Radiation-10.8
Parent and Patient Scores at Off-therapy-1.7

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-0.7
Parent and Patient Scores at Week 12-3.9
Parent and Patient Scores at After Radiation-2.7
Parent and Patient Scores at Off-therapy-0.5

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-6.1
Parent and Patient Scores at Week 12-8.8
Parent and Patient Scores at After Radiation-7.9
Parent and Patient Scores at Off-therapy-6.6

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-1.5
Parent and Patient Scores at Week 12-5.2
Parent and Patient Scores at After Radiation-4.5
Parent and Patient Scores at Off-therapy-5

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.20

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-0.2
Parent and Patient Scores at Week 12-9.3
Parent and Patient Scores at After Radiation-2.2
Parent and Patient Scores at Off-therapy-8.7

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-2.5
Parent and Patient Scores at Week 12-9.5
Parent and Patient Scores at After Radiation-5.9
Parent and Patient Scores at Off-therapy-9.3

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-0.87

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-2.0
Parent and Patient Scores at Week 12-9.5
Parent and Patient Scores at After Radiation-5.6
Parent and Patient Scores at Off-therapy-5.4

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-1.2
Parent and Patient Scores at Week 12-3.4
Parent and Patient Scores at After Radiation-3.0
Parent and Patient Scores at Off-therapy-1.1

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-0.3
Parent and Patient Scores at Week 12-3.6
Parent and Patient Scores at After Radiation-7.4
Parent and Patient Scores at Off-therapy-6.3

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-1.0
Parent and Patient Scores at Week 120.14
Parent and Patient Scores at After Radiation-8.0
Parent and Patient Scores at Off-therapy-4.0

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score

"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.46

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning

"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-0.79

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning

"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.21

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health

"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-0.92

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning

"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.9

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning

"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.56

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.06

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-0.96

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Patient Quality of Life (QoL), PedsQL v.3.0: Communication

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 880.7
Week 1283.0
After Radiation87.2
Off-therapy89.0

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Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)

For patients that received cervical radiation, TSH laboratory testing will be conducted at 1, 2, 5 and 10 years. TSH results will be categorized as Normal, Hypothyroid, Hyperthyroid, or Thyroid Nodule, depending on the test's findings. (NCT00352027)
Timeframe: 1, 2, 5, and 10 years post therapy

,,,
InterventionParticipants (Count of Participants)
NormalHypothyroidHyperthyroidThyroid Nodule
Year 1 Off Therapy60820
Year 10 Off Therapy20300
Year 2 Off Therapy541110
Year 5 Off Therapy37810

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3-year Event-free Survival (EFS) Probability

Comparison of thee-year EFS probability along with the whole EFS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99. (NCT00352027)
Timeframe: 3 years

Interventionprobability (Number)
HOD05 Participants0.887
HOD99 Participants0.844

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Toxicities With Grade >1

Comparison of the toxicities of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation (current HOD05 protocol) to those patients on HOD99 (NCT00145600). Grading of toxicities for HOD05 and HOD99 used the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. (NCT00352027)
Timeframe: 3 years

,,,,,,,
Interventionadverse events (Number)
Alanine transaminase (ALT)Aspartate transaminase (AST)Allergic reaction/hypersensitivityConstipationFebrile neutropeniaFever (in the absence of neutropenia)GlucoseGGT (gamma-Glutamyltranspeptidase)HemoglobinHypoxiaIleus, GI (functional obstruction of bowel)Infection with Grade 3 or 4 neutrophilsInfection - OtherInfection with normal ANC or Grade 1-2 neutrophilsInfection with unknown ANCInsomniaLeukocytes (total WBC)LymphopeniaMucositis/stomatitis (functional/symptomatic)NauseaNeuropathy: motorNeuropathy: sensoryNeutrophils/granulocytes (ANC/AGC)PainPhosphatePlateletsPotassiumSodiumSyndromes - OtherThrombosis/embolism (vascular access-related)Thrombosis/thrombus/embolismVomiting
HOD05 - Grade 200000000000000000000000000000000
HOD05 - Grade 3114072012611213014122010124510211202
HOD05 - Grade 40000100060000000157000032000000010
HOD05 - Grade 500000000000000000000000000000000
HOD99 - Grade 200000000000000000000000000000001
HOD99 - Grade 3000150002002011019012119103000004
HOD99 - Grade 4000020100000000050000030100000000
HOD99 - Grade 500000000000000000000000000000000

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Prognostic Factors for Treatment Failure: Stage

Ann Arbor staging classification was used to stage all patients. Stage was examined (I/II versus III) for the association with event-free survival (EFS), defined as the interval between date on study and of relapse/disease progression, second malignancy, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance. Stage NCT00352027)
Timeframe: 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up

Interventionevents (Number)
Stage Stage ≥III
Stanford V Chemotherapy83

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Prognostic Factors for Treatment Failure: Histology

Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance. (NCT00352027)
Timeframe: 3 years follow-up

Interventionevents (Number)
Classical, Nodular SclerosingOther
Stanford V Chemotherapy101

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Prognostic Factors for Treatment Failure: Gender

Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance. (NCT00352027)
Timeframe: 3 years follow-up

Interventionevents (Number)
MaleFemale
Stanford V Chemotherapy56

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Local and Distant Failure for Children Treated With Tailored-field Radiation

The cumulative incidence of local and distant failure will be estimated. Effect of competing risks will be taken into account. Local failure is defined as in-field, and distant failure is defined as out-of-field. (NCT00352027)
Timeframe: from first enrollment date up to 3 years follow-up

Interventionprobability that the event occurs (Number)
Cumulative incidence of distant failure at 3 yearsCumulative incidence of local failure at 3 years
Stanford V Chemotherapy0.03750.1127

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Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function)

Patient pulmonary function will undergo assessment at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, depending on the test results. (NCT00352027)
Timeframe: 1, 2, 5, and 10 years post therapy

,,,
InterventionParticipants (Count of Participants)
NormalAbnormal
Year 1 Off Therapy4620
Year 10 Off Therapy91
Year 2 Off Therapy4120
Year 5 Off Therapy2511

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Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram)

Electrocardiograms (EKGs) will be conducted on the patient at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, determined by the test outcome. (NCT00352027)
Timeframe: 1, 2, 5, and 10 years post therapy

,,,
InterventionParticipants (Count of Participants)
NormalAbnormal
Year 1 Off Therapy515
Year 10 Off Therapy106
Year 2 Off Therapy448
Year 5 Off Therapy244

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Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram)

Echocardiograms will be carried out on the patient at 1, 2, 5, and 10 years after therapy. Outcomes will be categorized. (NCT00352027)
Timeframe: 1, 2, 5, and 10 years post therapy

,,,
InterventionParticipants (Count of Participants)
NormalAbnormal
Year 1 Off Therapy680
Year 10 Off Therapy151
Year 2 Off Therapy571
Year 5 Off Therapy362

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Prognostic Factors for Treatment Failure: Age

Age was examined for the association with event-free survival (EFS) which was defined as the interval between date on study and date of relapse/disease progression, second malignant tumor, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance. (NCT00352027)
Timeframe: 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up

Interventionevents (Number)
Stanford V Chemotherapy11

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Number of Patients With Objective Response (Complete and Partial Response + Hematological Improvement)

Time to response defined as the time from start of therapy until the response criteria are fulfilled. Response duration defined as the time from response until relapse (progressive disease) or death. (NCT00352794)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Lenalidomide + Prednisone14

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Objective Response Rate (ORR)

Objective response rate (ORR) defined as the proportion of participants experiencing a Complete Response (CR) or Partial Response to a regimen of SGN-3- + CHOP using International Workshop Response Criteria (IWG) for Non-Hodgkin's Lymphomas (NHL). The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed. (NCT00365274)
Timeframe: Up to 5 years

Interventionpercentage of participants (Number)
Complete ResponsePartial Response
SGN-30 + Combination Chemotherapy8317

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Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (12 Months Analysis)

This analysis is reporting number of participants hospitalized for reasons (such as acute rejection, infection, gastrointestinal (GI) events, cardiovascular event, metabolic disorder and Other) other than primary transplantation. (NCT00371826)
Timeframe: Month 12

InterventionParticipants (Number)
Calcineurin Inhibitor (CNI) Withdrawal34
CNI+MPA+ Steroid31
Steroid Withdrawal13

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Mean Urine Albumin/Creatinine Ratio (ACR) as Measurement of Proteinuria (12 Months Analysis)

Proteinuria is measured by spot morning urine Albumin/Creatinine Ratio [ACR]. When the ACR is more than or equal to 30 mg/mmol then it is known as proteinuria. (NCT00371826)
Timeframe: At Month 12

Interventionmg/mg (Mean)
Calcineurin Inhibitor (CNI) Withdrawal0.2
CNI+MPA+ Steroid0.1
Steroid Withdrawal0.1

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Mean Serum Creatinine (12 Months Analysis)

(NCT00371826)
Timeframe: At Month 12

Interventionumol/L (Mean)
Calcineurin Inhibitor (CNI) Withdrawal118.9
CNI+MPA+ Steroid161.0
Steroid Withdrawal148.6

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Creatinine Clearance (CrCl) Calculated by the Cockcroft-Gault Formula (12 Months Analysis)

"Creatinine clearance were calculated according to the Cockcroft-Gault formula:~CrCl (males) = (140-A) × BW/(72 × Cr) CrCl (females) = CrCl (males) × 0.85 where A is age [years], BW is body weight [kg], and Cr is the serum concentration of creatinine [mg/dL].~The Cockcroft-Gault formula estimates creatinine clearance based on serum creatinine level, body weight, and age." (NCT00371826)
Timeframe: At Month 12

InterventionmL/min (Mean)
Calcineurin Inhibitor (CNI) Withdrawal66.1
CNI+MPA+ Steroid67.8
Steroid Withdrawal63.2

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Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (12 Months Analysis)

The glomerular filtration rate (GFR) was calculated by the Nankivell formula: GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)^ 2 + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. (NCT00371826)
Timeframe: At Month 12

InterventionmL/min per 1.73 m^2 (Mean)
Calcineurin Inhibitor (CNI) Withdrawal65.2
CNI+MPA+ Steroid69.3
Steroid Withdrawal66.9

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Number of Participants With Antibody-mediated Rejection Per Treatment Group (36 Months Analysis)

(NCT00371826)
Timeframe: At Month 12, 24 and 36

,,
InterventionParticipants (Number)
At Month 12At Month 24At Month 36
Calcineurin Inhibitor (CNI) Withdrawal111
CNI+MPA+ Steroid002
Steroid Withdrawal000

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Mean Urine Albumin/Creatinine Ratio [ACR] as Measurement of Proteinuria (36 Months Analysis)

Proteinuria is measured by spot morning urine Albumin/Creatinine Ratio [ACR]. When the ACR is more than or equal to 30 mg/mmol then it is known as proteinuria. (NCT00371826)
Timeframe: At Month 12, 18, 24 and 36

,,
Interventionmg/mmol (Mean)
At 12 Month (n = 18, 32, 2)At 18 Month (n= 17, 31, 2)At 24 Month ( n= 16, 29, 1)At 36 Month ( n= 15, 25, 0)
Calcineurin Inhibitor (CNI) Withdrawal23.528.230.030.6
CNI+MPA+ Steroid8.18.16.623.4
Steroid Withdrawal4.85.37.0NA

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Mean Short-form 36 Health Survey (SF-36) Score as a Measure of Quality of Life Assessment (36 Months Analysis)

"SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales. The 8 subscales are : Physical functioning (PF), Role-physical (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Role-emotional (RE) and Mental health (MH).~Score for each sub-scale has been standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL." (NCT00371826)
Timeframe: At Month 24

,,
Interventionunits on a scale (Mean)
Physical functioning (PF)Role-physical (RP)Bodily pain (BP)General health (GH)Vitality (VT)Social Functioning (SF)Role-emotional (RE)Mental health (MH)
Calcineurin Inhibitor (CNI) Withdrawal84.375.081.671.670.085.972.977.5
CNI+MPA+ Steroid87.677.485.069.872.780.683.977.9
Steroid Withdrawal90.0100.084.067.060.068.833.362.0

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Mean Short-form 36 Health Survey (SF-36) Score as a Measure of Quality of Life Assessment (12 Months Analysis)

"SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales. The 8 subscales are: Physical functioning (PF), Role-physical (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Role-emotional (RE) and Mental health (MH).~Score for eash sub-scale has been standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL." (NCT00371826)
Timeframe: At Month 12

,,
Interventionunits on a scale (Mean)
Physical functioning (PF)Role-physical (RP)Bodily pain (BP)General health (GH)Vitality (VT)Social Functioning (SF)Role-emotional (RE)Mental health (MH)
Calcineurin Inhibitor (CNI) Withdrawal78.772.973.667.162.774.572.273.3
CNI+MPA+ Steroid76.978.281.571.272.481.181.179.1
Steroid Withdrawal82.0100.096.886.885.097.5100.092.8

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Creatinine Clearance Calculated by the Cockcroft-Gault Formula (36 Months Analysis)

"Creatinine clearance were calculated according to the Cockcroft-Gault formula:~CrCl (males) = (140-A) × BW/(72 × Cr) CrCl (females) = CrCl (males) × 0.85 where A is age [years], BW is body weight [kg], and Cr is the serum concentration of creatinine [mg/dL].~The Cockcroft-Gault formula estimates creatinine clearance based on serum creatinine level, body weight, and age." (NCT00371826)
Timeframe: At Month 12, 24 and 36

,,
InterventionmL/min (Mean)
At Month 12 (n= 23, 39, 4)At Month 18 (n=22, 36, 4)At Month 24 (n= 23, 36, 4)At Month 36 (n= 23, 39, 4)
Calcineurin Inhibitor (CNI) Withdrawal69.869.965.666.3
CNI+MPA+ Steroid71.773.772.867.5
Steroid Withdrawal63.766.263.762.7

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Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (36 Months Analysis)

The glomerular filtration rate (GFR) was calculated by the Nankivell formula: GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)^ 2 + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. (NCT00371826)
Timeframe: At Month 24 and 36

,,
InterventionmL/min per 1.73 m^2 (Mean)
Month 24 (n= 23, 36, 4)Month 36 (n= 19, 35, 3)
Calcineurin Inhibitor (CNI) Withdrawal69.571.6
CNI+MPA+ Steroid71.869.1
Steroid Withdrawal67.061.0

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Number of Participants With Erythropoietin Usage (36 Months Analysis)

(NCT00371826)
Timeframe: Month 36

Interventionparticipants (Number)
Calcineurin Inhibitor (CNI) Withdrawal5
CNI+MPA+ Steroid7
Steroid Withdrawal2

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Number of Participants With Erythropoietin Usage (12 Months Analysis)

(NCT00371826)
Timeframe: Month 12

Interventionparticipants (Number)
Calcineurin Inhibitor (CNI) Withdrawal20
CNI+MPA+ Steroid10
Steroid Withdrawal8

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Number of Participants With Composite Endpoint of Treatment Failure (12 Months Analysis)

"Composite endpoint of treatment failure includes biopsy-proven acute rejection (BPAR), graft loss, death and loss-to-follow-up. A BPAR is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.~The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss." (NCT00371826)
Timeframe: Month 12

InterventionParticipants (Number)
Calcineurin Inhibitor (CNI) Withdrawal16
CNI+MPA+ Steroid8
Steroid Withdrawal11

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Number of Participants With Any Wound Problems (36 Months Analysis)

Patients with any wound healing problem such as infection related to kidney surgery, dehiscence, lymphocele, hernia, seroma, hematoma, ureteral anastomotic complication and other were reported in this analysis. (NCT00371826)
Timeframe: At Month 12, 24 and 36

,,
InterventionParticipants (Number)
At Month 12At Month 24At Month 36
Calcineurin Inhibitor (CNI) Withdrawal6910
CNI+MPA+ Steroid111313
Steroid Withdrawal222

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Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (12 Months Analysis)

The influence of demographic characteristics and comorbidities on incidence of BPAR were analyzed in the following way: Demographic characteristics were age (<55 years, ≥55 years), Expanded criteria Donor (ECD) organ (donor age >60 years or donor non heart-beating and donor age >50), gender, living vs. deceased donor, Body Mass Index (BMI) classes (underweight <18.5, normal 18.5 - <25.0, overweight 25.0 - <30.0, obesity 30.0 and above), years on dialysis before transplantation (<1, 1-5, >5 years). Comorbidities were diabetes, hypertension, cardiovascular diseases/events, nephrosclerosis, glomerulonephritis/glomerular disease, polycystic disease, and Cytomegalovirus status. (NCT00371826)
Timeframe: At Month 12

,,
InterventionParticipants (Number)
Age < 55 yearsAge > = 55 yearsECD OrganNO ECD OrganMaleFemaleLiving donorDeceased donorBMI < 18.5BMI 18.5 - <25BMI 25 - <30BMI >= 30Years on dialysis before transplantation: None< 1 Year on dialysis before transplantation1 - 5 Years on dialysis before transplantation> 5 Years on dialysis before transplantationDiabetes mellitus: NoDiabetes mellitus: YesHypertension: NoHypertension: YesCardiovascular disease : NoCardiovascular disease: YesNephrosclerosis: NoNephrosclerosis: YesGlomerulonephritis/glomerular disease : NoGlomerulonephritis/glomerular disease: YesCytomegalovirus : NegativeCytomegalovirus : Positive
Calcineurin Inhibitor (CNI) Withdrawal114312114960582138310521341115087213
CNI+MPA+ Steroid5106606012300312421533605124
Steroid Withdrawal4123412303110122410523413205

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Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (36 Months Analysis)

The influence of demographic characteristics and comorbidities on incidence of BPAR were analyzed in the following way: Demographic characteristics were age (<55 years, ≥55 years), Expanded Criteria Donor [ECD] organ (donor age >60 years or donor non heart-beating and donor age >50), gender, living vs. deceased donor, Body Mass Index (BMI) classes (underweight <18.5, normal 18.5 - <25.0, overweight 25.0 - <30.0, obesity 30.0 and above), years on dialysis before transplantation (<1, 1-5, >5 years). Comorbidities were diabetes, hypertension, cardiovascular diseases/events, nephrosclerosis, glomerulonephritis/glomerular disease, polycystic disease, and Cytomegalovirus status. (NCT00371826)
Timeframe: At Month 36

,,
InterventionParticipants (Number)
Age < 55 yearsAge > = 55 yearsECD OrganNO ECD OrganMaleFemaleLiving donorDeceased donorBMI < 18.5BMI 18.5 - <25BMI 25 - <30BMI >= 30Years on dialysis before transplantation: None< 1 Year on dialysis before transplantation1 - 5 Years on dialysis before transplantation> 5 Years on dialysis before transplantationDiabetes mellitus: NoDiabetes mellitus: YesHypertension: NoHypertension: YesCardiovascular disease : NoCardiovascular disease: YesNephrosclerosis: NoNephrosclerosis: YesGlomerulonephritis/glomerular disease : NoGlomerulonephritis/glomerular disease: YesCytomegalovirus : NegativeCytomegalovirus : Positive
Calcineurin Inhibitor (CNI) Withdrawal6006425111400321331533604215
CNI+MPA+ Steroid7108716203411421621753717144
Steroid Withdrawal0000000000000000000000000000

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Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (36 Months Analysis)

"Chronic rejection is characterized by a slow progressive decline in renal function and is typically preceded by the histological picture of chronic allograft nephropathy. The presence of biopsy confirmed Grade I, II or III chronic allograft nephropathy by Banff 97 criteria was assessed on all optional biopsies obtained for clinical suspicion of chronic rejection.~Data summarized by 3 categories. Yes - Patients with histological evidence of CAN ; No - Patients with histological evidence of CAN and Not Done - Central protocol defined kidney allograft biopsies were not done." (NCT00371826)
Timeframe: At Month 36

,,
InterventionParticipants (Number)
YESNONot Done
Calcineurin Inhibitor (CNI) Withdrawal288
CNI+MPA+ Steroid11614
Steroid Withdrawal111

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Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (12 Months Analysis)

"A per-protocol biopsy was performed at Baseline and Month 12 and read by an independent blinded pathologist in order to assess chronic allograft nephropathy. Chronic rejection is characterized by a slow progressive decline in renal function and is typically preceded by the histological picture of chronic allograft nephropathy. The presence of biopsy confirmed Grade I, II or III chronic allograft nephropathy by Banff 97 criteria was assessed on all optional biopsies obtained for clinical suspicion of chronic rejection.~Data summarized by 3 categories. Yes - Patients with histological evidence of CAN ; No - Patients with histological evidence of CAN and Not Done - Central protocol defined kidney allograft biopsies were not done." (NCT00371826)
Timeframe: At Month 12

,,
InterventionParticipants (Number)
YESNONot Done
Calcineurin Inhibitor (CNI) Withdrawal8157
CNI+MPA+ Steroid6268
Steroid Withdrawal253

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Number of Participants With Employment Status (36 Months Analysis)

"The various employment status reported are:~Employed/self employed full time~Employed part time~Unemployed~Homemaker~Volunteer~Permanently disabled~Non-permanently disable~Retired~Other" (NCT00371826)
Timeframe: At screening (at day 0 +/- 7 days ), At Month 36

,,
InterventionParticipants (Number)
Screening visit: Employed/self employed full timeMonth 36: Employed/self employed full timeScreening visit: Employed part timeMonth 36: Employed part timeScreening visit: UnemployedMonth 36: UnemployedScreening visit: HomemakerMonth 36 : HomemakerScreening visit: Permanently disabledMonth 36: Permanently disabledScreening visit: Non-permanently disabledMonth 36: Non-permanently disabledScreening visit: RetiredMonth 36: RetiredScreening visit: OtherMonth 36: Other
Calcineurin Inhibitor (CNI) Withdrawal5443533300000011
CNI+MPA+ Steroid101074763311112200
Steroid Withdrawal1100101100000000

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Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (36 Months Analysis)

A biopsy-proven acute rejection is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification. (NCT00371826)
Timeframe: At Month 12, 24 and 36

,,
InterventionParticipants (Number)
At Month 12At Month 24At Month 36
Calcineurin Inhibitor (CNI) Withdrawal456
CNI+MPA+ Steroid458
Steroid Withdrawal000

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Number of Participants With Composite Endpoint of Treatment Failure (36 Months Analysis)

"Composite endpoint of treatment failure includes biopsy-proven acute rejection (BPAR), graft loss, death and loss-to-follow-up. A BPAR is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.~The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss." (NCT00371826)
Timeframe: At Month 12, 24 and 36

,,
InterventionParticipants (Number)
At Month 12At Month 24At Month 36
Calcineurin Inhibitor (CNI) Withdrawal467
CNI+MPA+ Steroid4610
Steroid Withdrawal000

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Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (36 Months Analysis)

"Notable abnormal total cholesterol is defined as : High: >= 9.1 mmol/L , normal range is 0.00 - 5.17 mmol/L~Notable abnormal triglycerides is defined as : High: >= 8.5 mmol/L, normal range is 0.30 - 2.00 mmol/L" (NCT00371826)
Timeframe: Overall Post Baseline up to month 36

,,
InterventionParticipants (Number)
Total Cholesterol: HighTriglycerides : High
Calcineurin Inhibitor (CNI) Withdrawal60
CNI+MPA+ Steroid01
Steroid Withdrawal10

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Number of Participants With Post Transplant Diabetes Mellitus (PTDM) and Impaired Fasting Glucose (12 Months Analysis)

"The symptoms of post transplant diabetes mellitus (PTDM) and impaired fasting glucose are defined as any of the following conditions:~Patients receiving glucose lowering treatment~Fasting plasma glucose (FPG) >= 126 mg/dL on 2 separate occasions~Hemoglobin subtype A1c (HbA1c) > 6.5%~Diabetes reported as treatment emergent AE with end date > Day 15" (NCT00371826)
Timeframe: At Month 12

,,
InterventionParticipants (Number)
Glucose lowering treatmentFPG >= 126 mg/dL on 2 separate occasionsHbA1c > 6.5%Diabetes as treatment emergent AEAny of the above symptoms
Calcineurin Inhibitor (CNI) Withdrawal10612819
CNI+MPA+ Steroid903210
Steroid Withdrawal55538

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Number of Participants With Sub Clinical Acute Rejection (36 Months Analysis)

"Based on Banff 97 criteria, sub clinical acute rejection can be:~GRADE IA - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells).~GRADE IB - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells).~GRADE IIA - Cases with significant interstitial infiltration and mild to moderate intimal arteritis (v1).~GRADE IIB - Cases with moderate to severe intimal arteritis comprising >25% of the luminal area (v2).~GRADE III - Cases with transmural arteritis or fibrinoid change and necrosis of medial smooth muscle cells (v3).~Borderline' category is used when no intimal arteritis is present, but there are foci of mild tubulitis (1 to 4 mononuclear cells/tubular cross section)." (NCT00371826)
Timeframe: At Month 36

,,
InterventionParticipants (Number)
Month 36: NOMonth 36: BorderlineMonth 36: Grade IAMonth 36: Grade IBMonth 36: Grade IIAMonth 36: Grade IIBMonth 36: Grade IIIMonth 36: Not Done
Calcineurin Inhibitor (CNI) Withdrawal91000008
CNI+MPA+ Steroid1511000014
Steroid Withdrawal20000001

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Number of Participants With Wound Problems(12 Months Analysis)

Patients with any wound healing problem such as infection related to kidney surgery, dehiscence, lymphocele, hernia, seroma, hematoma, ureteral anastomotic complication and other were reported in this analysis. (NCT00371826)
Timeframe: At Month 12

,,
InterventionParticipants (Number)
Any wound healing problemInfection related to kidney surgeryDehiscenceLymphoceleHerniaSeromaHematomaUreteral anastomotic complicationOther
Calcineurin Inhibitor (CNI) Withdrawal1623334423
CNI+MPA+ Steroid1542429011
Steroid Withdrawal932313210

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Change in Bone Mineral Density Between Week 2 and Month 24 (36 Months Analysis)

Measurements of bone mineral density (BMD) by Dual Energy X-ray Absorptiometry (DEXA) were done at Week 2 and Month 24. Change in BMD between week 2 and Month 24 were done for neck of femur and lumbar spine. (NCT00371826)
Timeframe: Week 2, Month 24

,,
Interventiong/cm^2 (Mean)
Neck of Femur (Month 24- Week 2)Lumbar Spine (Month 24 - Week 2)
Calcineurin Inhibitor (CNI) Withdrawal0.2-0.0
CNI+MPA+ Steroid-0.1-0.1
Steroid Withdrawal-0.1-0.0

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Mean Serum Creatinine (36 Months Analysis)

(NCT00371826)
Timeframe: At Month 12, 18, 24 and 36

,,
Interventionumol/L (Mean)
At Month 12 (n= 23, 39, 4)At Month 18 (n= 22, 36, 4)At Month 24 (n = 23, 36, 4)At Month 36 (n= 19, 35, 3)
Calcineurin Inhibitor (CNI) Withdrawal112.7113.6119.9119.4
CNI+MPA+ Steroid123.0121.4123.7131.8
Steroid Withdrawal146.8146.3146.5176.0

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Number of Patient Survival and Graft Survival (12 Months Analysis)

(NCT00371826)
Timeframe: At Month 12

,,
InterventionParticipants (Number)
Patient SurvivalGraft Survival
Calcineurin Inhibitor (CNI) Withdrawal4949
CNI+MPA+ Steroid4645
Steroid Withdrawal3030

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Number of Patient Survival and Graft Survival (36 Months Analysis)

(NCT00371826)
Timeframe: At Month 12, 24 and 36

,,
InterventionParticipants (Number)
Month 12: Patient SurvivalMonth 12: Graft SurvivalMonth 24: Patient SurvivalMonth 24: Graft SurvivalMonth 36: Patient SurvivalMonth 36: Graft Survival
Calcineurin Inhibitor (CNI) Withdrawal232323232323
CNI+MPA+ Steroid393939393939
Steroid Withdrawal444444

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Number of Participants With Employment Status (12 Months Analysis)

"The various employment status reported are:~Employed/self employed full time~Employed part time~Unemployed~Homemaker~Volunteer~Permanently disabled~Non-permanently disable~Retired~Other" (NCT00371826)
Timeframe: At screening (at day 0 +/- 7 days ), At Month 12

,,
InterventionParticipants (Number)
Screening visit: Employed/self employed full timeMonth 12: Employed/self employed full timeScreening visit: Employed part timeMonth 12: Employed part timeScreening visit: UnemployedMonth 12: UnemployedScreening visit: HomemakerMonth 12 : HomemakerScreening visit: VolunteerMonth 12: VolunteerScreening visit: Permanently disabledMonth 12: Permanently disabledScreening visit: Non-permanently disabledMonth 12: Non-permanently disabledScreening visit: RetiredMonth 12: RetiredScreening visit: OtherMonth 12: Other
Calcineurin Inhibitor (CNI) Withdrawal18693106321121114111
CNI+MPA+ Steroid21147581550022202200
Steroid Withdrawal9240106520000001010

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Number of Participants With Notable Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as Measurement of Effect of Treatment on Cardiovascular Health (36 Months Analysis)

"Notable abnormal systolic blood pressure is defined as :~Either an increase of >=30 that results in >=180 or >200 (mm/Hg)~OR a decrease of >=30 that results in <=90 or <75 (mm/Hg) from baseline~Notable abnormal diastolic blood pressure is defined as :~Either an increase of >=20 that results in >=105 or >115 (mm/Hg)~OR a decrease of >=20 that results in <=50 or <40 (mm/Hg) from baseline" (NCT00371826)
Timeframe: Baseline, Overall post baseline up to Month 36

,,
InterventionParticipants (Number)
SBP: >=180 mm/Hg or 200 mm/HgSBP: < = 90 mm/Hg or < 200 mm/HgDBP : >=105 mm/Hg or >115 mm/HgDBP: <=50 mm/Hg or <40 mm/Hg
Calcineurin Inhibitor (CNI) Withdrawal3121
CNI+MPA+ Steroid4054
Steroid Withdrawal1010

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Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (36 Months Analysis)

This analysis is reporting number of participants hospitalized for reasons (such as acute rejection, infection, gastrointestinal (GI) events, cardiovascular event, metabolic disorder and Other) other than primary transplantation. (NCT00371826)
Timeframe: Month 36

InterventionParticipants (Number)
Calcineurin Inhibitor (CNI) Withdrawal16
CNI+MPA+ Steroid30
Steroid Withdrawal1

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Number of Participants With Antibody-mediated Rejection Per Treatment Group (12 Months Analysis)

(NCT00371826)
Timeframe: At Month 12

InterventionParticipants (Number)
Calcineurin Inhibitor (CNI) Withdrawal5
CNI+MPA+ Steroid2
Steroid Withdrawal2

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Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (12 Months Analysis)

A biopsy-proven acute rejection is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification. (NCT00371826)
Timeframe: At Month 12

InterventionParticipants (Number)
Calcineurin Inhibitor (CNI) Withdrawal15
CNI+MPA+ Steroid6
Steroid Withdrawal5

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Number of Participants With Sub Clinical Acute Rejection (12 Months Analysis)

"Based on Banff 97 criteria, sub clinical acute rejection can be:~GRADE IA - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells).~GRADE IB - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells).~GRADE IIA - Cases with significant interstitial infiltration and mild to moderate intimal arteritis (v1).~GRADE IIB - Cases with moderate to severe intimal arteritis comprising >25% of the luminal area (v2).~GRADE III - Cases with transmural arteritis or fibrinoid change and necrosis of medial smooth muscle cells (v3).~Borderline category is used when no intimal arteritis is present, but there are foci of mild tubulitis (1 to 4 mononuclear cells/tubular cross section)." (NCT00371826)
Timeframe: At Month 12

,,
InterventionParticipants (Number)
NOBorderlineGrade IAGrade IBGrade IIAGrade IIBGrade IIINot Done
Calcineurin Inhibitor (CNI) Withdrawal202100007
CNI+MPA+ Steroid292010008
Steroid Withdrawal52000003

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Number of Participants With New Onset Diabetes Mellitus After Transplantation (NODAT) and Impaired Fasting Glucose (36 Months Analysis)

"The symptoms of new onset diabetes mellitus after transplantation (NODAT) and impaired fasting glucose are defined as any of the following conditions:~Patients receiving glucose lowering treatment~2 fasting plasma glucose (FPG) values >= 126 mg/dL or 2 random plasma glucose (RPG) values >= 200 mg/dL or FPG value >= 126 mg/dL and 1 RPG value >= 200 mg/dL~Diabetes reported as treatment emergent AE with end date > Day 15" (NCT00371826)
Timeframe: At Month 36

,,
InterventionParticipants (Number)
Glucose lowering treatmentFPG or RPGDiabetes as treatment emergent AEAny of the above symptoms
Calcineurin Inhibitor (CNI) Withdrawal5356
CNI+MPA+ Steroid102411
Steroid Withdrawal2122

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Number of Participants With Notable Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as Measurement of Effect of Treatment on Cardiovascular Health (12 Months Analysis)

"Notable abnormal systolic blood pressure is defined as :~Either an increase of >=30 that results in >=180 or >200 (mm/Hg)~OR a decrease of >=30 that results in <=90 or <75 (mm/Hg)from baseline~Notable abnormal diastolic blood pressure is defined as :~Either an increase of >=20 that results in >=105 or >115 (mm/Hg)~OR a decrease of >=20 that results in <=50 or <40 (mm/Hg) from baseline" (NCT00371826)
Timeframe: Baseline, Overall post-baseline up to 12 month

,,
InterventionParticipants (Number)
SBP: >=180 mm/Hg or 200 mm/HgSBP: < = 90 mm/Hg or < 200 mm/HgDBP : >=105 mm/Hg or >115 mm/HgDBP: <=50 mm/Hg or <40 mm/Hg
Calcineurin Inhibitor (CNI) Withdrawal5131
CNI+MPA+ Steroid5064
Steroid Withdrawal7050

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Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (12 Months Analysis)

"Notable abnormal total cholesterol is defined as : High: >= 9.1 mmol/L , normal range is 0.00 - 5.17 mmol/L~Notable abnormal triglycerides is defined as : High: >= 8.5 mmol/L, normal range is 0.30 - 2.00 mmol/L" (NCT00371826)
Timeframe: Overall post baseline up to month 12

,,
InterventionParticipants (Number)
Total Cholesterol: High (n = 48, 47,30)Triglycerides : High (n= 48, 46, 30)
Calcineurin Inhibitor (CNI) Withdrawal61
CNI+MPA+ Steroid00
Steroid Withdrawal30

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Patient Survival.

(NCT00374231)
Timeframe: 12 months

Interventionparticipants (Number)
Corticosteroid Withdrawal39

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Time Post Transplant Corticosteroid Withdrawal

The mean days from post transplant corticosteroid withdrawal. (NCT00374231)
Timeframe: 12 months

Interventiondays (Mean)
Corticosteroid Withdrawal257

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Incidence of Biopsy Confirmed Acute Rejection at 12 Months.

(NCT00374231)
Timeframe: 12 months

Interventionparticipants (Number)
Corticosteroid Withdrawa.5

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Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM).

Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. (NCT00376961)
Timeframe: At the time of restaging (between Cycles 6 and 7), every 6 months during Cycles 7-14, and at the end of protocol treatment

Interventionparticipants (Number)
Complete ResponsePartial ResponseUnconfirmed Complete ResponseUnconfirmed Partial ResponseNo ResponseAssessment Inadequate
R-CHOP-V Followed by VM1716131414

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2-year Progression-free Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)

Measured from date of registration to date of first observation of relapsed or progressive disease, or death due to any cause. (NCT00376961)
Timeframe: 0-2 years

Interventionpercentage of participants (Number)
R-CHOP-V Followed by VM62

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2-year Overall Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)

Measured from date of registration to date of death due to any cause or last contact (NCT00376961)
Timeframe: 0-2 years

Interventionpercentage of participants (Number)
R-CHOP-V Followed by VM85

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Event Free Survival. EFS

Percentage of patients who were event free at 3 years among those on Standard VCR dosing who did not undergo Hematopoietic Stem Cell Transplant (SCT). (NCT00381680)
Timeframe: 3 years after enrollment

Interventionpercentage of participants EFS at 3 yrs3 (Number)
Regimen A: Standard Vincristine Dosing66.0

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Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1

Percentage of patients who had minimal residual disease (MRD) < 0.01% among those with isolated BM or combined BM relapse >= 36 months and had successful MRD determinations at End Block 1 (NCT00381680)
Timeframe: End of Block 1 (35 days) of Induction therapy

Interventionpercentage of participants (Number)
Regimen A50.8
Regimen B41.5

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Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3

Percentage of patients who had minimal residual disease (MRD) < 0.01% among those with isolated BM or combined BM relapse >= 36 months and had successful MRD determinations at End Block 3. (NCT00381680)
Timeframe: End of Block 3 (105 days) of Induction therapy

Interventionpercentage of participants (Number)
Regimen A81.4
Regimen B88.9

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Adjusted Event Free Survival

Adjusted percentage of patients who were event free at 3 years. For patients who received matched donor SCT, EFS was adjusted to start from the actual SCT date. For patients who did not undergo SCT, EFS was adjusted to start from median time to SCT based on patients who received matched related SCT (where patients who had events prior to SCT date were excluded from the calculation of median time to SCT). (NCT00381680)
Timeframe: 3 years

Interventionadjusted percentage of participants (Number)
Received SCTDid not receive SCT
Regimen A: Standard Vincristine Dosing82.264.2

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Frequency and Severity of Adverse Effects

Percentage of patients who developed at least 1 episode of grade 2 to 4 neuropathy. (NCT00381680)
Timeframe: Up to 107 weeks

Interventionpercentage of participants (Number)
CC or CT genotypeHigh-risk CEP72 genotype (TT at rs924607)
All Patients17.344.4

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Event Free Survival (EFS)

Percentage of patients who were event free at 3 years among those with isolated BM or combined BM relapse >= 36 months. (NCT00381680)
Timeframe: 3 years

,
Interventionpercentage of participants (Number)
MRD < 0.01% BL1MRD >= 0.01% BL1MRD < 0.01% BL3MRD >= 0.01% BL3
Regimen A88.560.083.861.5
Regimen B77.346.283.333.3

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Part 2: Progression Free Survival (PFS)

The PFS is the time from the date of randomization until the first documented sign of progression (at least a 20 percent increase in the sum of the longest diameter [LD] of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new target or non-target lesions as per Response Evaluation Criteria in Solid Tumors [RECIST] or 3 or more new skeletal lesions on bone scan with confirmation of second bone scan or with clinical deterioration) or death, whichever occurs first. (NCT00385827)
Timeframe: Randomization, Week 12, then every 9 weeks until 1 month after last dose administration, then every 3 months until disease progression or death, up to 2 years

Interventiondays (Median)
Part 2: Mitoxantrone + Prednisone228.0
Part 2: Mitoxantrone + Prednisone + Siltuximab97.0

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Number of Participants With Prostate Specific Antigen (PSA) Response

The PSA response is defined as at least a 50% reduction in PSA from the Baseline value, confirmed by a second PSA value at least 3 weeks after initial documentation of PSA response. (NCT00385827)
Timeframe: Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months until disease progression, up to 2 years

Interventionparticipants (Number)
Part 1: Mitoxantrone + Prednisone + Siltuximab4
Part 2: Mitoxantrone + Prednisone12
Part 2: Mitoxantrone + Prednisone + Siltuximab7

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Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. (NCT00385827)
Timeframe: Baseline up to 12 weeks after last dose administration

Interventionparticipants (Number)
AEsSAEs
Part 1: Mitoxantrone + Prednisone + Siltuximab95

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Time to Clinical Deterioration (TtCD)

The TtCD is defined as the time from the start of treatment (for participants in Part 1) or randomization (for participants in Part 2) until the first documented clinical deterioration (consists of pain requiring palliative (intended to relieve pain) intervention (a treatment given during the course of a research study), or death due to any cause, whichever occurs earlier. (NCT00385827)
Timeframe: Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months until clinical deterioration or death, up to 2 years

Interventiondays (Median)
Part 1: Mitoxantrone + Prednisone + Siltuximab199.0
Part 2: Mitoxantrone + Prednisone298.0
Part 2: Mitoxantrone + Prednisone + Siltuximab183.0

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Overall Survival (OS)

The OS is defined as the time from the date of start of treatment (for participants in Part 1) or randomization (for participants in Part 2) to death due to any cause. For participants who were alive at the time of analysis, OS was censored at the last contact date. (NCT00385827)
Timeframe: Start of treatment (Part 1)/Randomization (Part 2) until death, up to 2 years

Interventiondays (Median)
Part 1: Mitoxantrone + Prednisone + Siltuximab368.0
Part 2: Mitoxantrone + Prednisone394.0
Part 2: Mitoxantrone + Prednisone + Siltuximab311.0

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Clinical Activity

Determined by discontinuation of immunosuppression with resolution of all reversible CGVHD manifestations. Evaluated at 2 years after enrollment (NCT00388362)
Timeframe: 3 month intervals after the initiation of sirolimus until 2 years after the initiation of sirolimus

Interventionparticipants (Number)
Complete RemissionPartial Remission
Sirolimus Therapy44

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Overall Survival

Administration of Sirolimus and Prednisone (NCT00388362)
Timeframe: 3 month intervals after the initiation of sirolimus until 2 years after the initiation of sirolimus

Interventionparticipants (Number)
Sirolimus Therapy21

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Complete Response Rate (Complete Response and Complete Response Unconfirmed) Defined as Disappearance of All Evidence of Disease Based on Radiographic Findings on CT or MRI .

(NCT00389818)
Timeframe: After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation

Interventionproportion of patients (Number)
DR-COP0.475

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Serious Adverse Events

Serious Adverse Events (NCT00393367)
Timeframe: 0-5 days

,
Interventionparticipants (Number)
Return within 5 days with hosptial admissionIncreased level of care
Budesonide Inhalation Suspension (BIS)21
Placebo (Saline)20

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Number of Participants With Adverse Events (Non-serious).

(NCT00393367)
Timeframe: within 30 days of the ED visit

,
InterventionParticipants (Number)
RhinorrheaHeadacheDiarrheaSore throatCoughHyperglycemia
Budesonide Inhalation Suspension (BIS)653422
Placebo (Normal Saline)1197330

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Relapse / Readmission Numbers.

Participants admitted to the hospital within 5 days of the ED visit (NCT00393367)
Timeframe: within 5 days of ED visit

InterventionParticipants (Number)
Budesonide Inhalation Suspension (BIS)2
Placebo (Normal Saline)2

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Oxygen Saturation.

Mean oxygen saturation (non-invasive pulse-oximetry, % hemoglobin saturation) 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator minus mean oxygen saturation before treatment. (NCT00393367)
Timeframe: 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator

InterventionPercent Hemoglobin Saturation (Mean)
Budesonide Inhalation Suspension (BIS)1.0
Placebo (Normal Saline)1.0

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Number of Subjects Remaining in the Severe Asthma Category

Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who remained in this category 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator. (NCT00393367)
Timeframe: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator

InterventionParticipants (Number)
Budesonide Inhalation Suspension (BIS)4
Placebo (Normal Saline)4

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Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category

Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the moderate category (Asthma Severity score 8-11) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator. (NCT00393367)
Timeframe: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator

InterventionParticipants (Number)
Budesonide Inhalation Suspension (BIS)22
Placebo (Normal Saline)11

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Number of Subjects Moving From the Severe Asthma to Mild Asthma Category

Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the mild category (Asthma Severity score 5-7) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator. (NCT00393367)
Timeframe: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator

InterventionParticipants (Number)
Budesonide Inhalation Suspension (BIS)8
Placebo (Normal Saline)10

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Number of Patients Hospitalized

The number of patients requiring hospital admission 4 hours after budesonide/albuterol intervention or saline/albuterol comparator. All hospitalization decisions are made at the discretion of the attending physician. (NCT00393367)
Timeframe: within 4 hours after the budesonide/albuterol intervention or saline/albuterol placebo

InterventionParticipants (Number)
Budesonide Inhalation Suspension (BIS)56
Placebo (Saline)55

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Mean Change in Respiratory Rate.

Mean respiratory rate in breaths per minute before treatment minus respiratory rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator. (NCT00393367)
Timeframe: Initial rate, minus rate taken 2 hours after budesonide/albuterol intervention or saline/albuterol comparator

InterventionBreaths per minute (Mean)
Budesonide Inhalation Suspension (BIS)-6
Placebo (Normal Saline)-6

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Mean Change in Asthma Score at 2 Hours

The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator. (NCT00393367)
Timeframe: Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator

InterventionUnits on a scale (Mean)
Budesonide Inhalation Suspension (BIS)-2.9
Placebo (Normal Saline)-3.0

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Median Change in Asthma Score 2 Hours After Intervention

The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator. (NCT00393367)
Timeframe: Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator

InterventionUnits on a scale (Median)
Budesonide Inhalation Suspension (BIS)-3
Placebo (Normal Saline)-3

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Change in Mean Heart Rate

Mean of heart rate in beats per minute before treatment minus mean of heart rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol (NCT00393367)
Timeframe: From the initial heart rate to heart rate 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator

InterventionBeats per minute (Mean)
Budesonide Inhalation Suspension (BIS)12
Placebo (Normal Saline)13

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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale

Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the dyspnoea scale = higher level of symptomatology/problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16

,,
Interventionunits on a scale (Mean)
Cycle 4 - approximately Month 4 (n=117,126,126)Cycle 7 - approximately Month 7 (n=100,110,110)Cycle 10 - approximately Month 10 (n=86,93,96)Cycle 13 - approximately Month 13 (n=73,73,81)Cycle 16 - approximately Month 16 (n=62,53,62)
MPp+p-0.02.13.8-0.01.6
MPR+p-6.4-8.5-4.3-2.3-6.3
MPR+R-2.6-1.7-4.3-5.0-3.2

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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale

Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the diarrhea scale = higher level of symptomatology/problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16

,,
Interventionunits on a scale (Mean)
Cycle 4 - approximately Month 4 (n=115,125,124)Cycle 7 - approximately Month 7 (n=98,109,112)Cycle 10 - approximately Month 10 (n=87,92,95)Cycle 13 - approximately Month 13 (n=73,73,80)Cycle 16 - approximately Month 16 (n=63,52,61)
MPp+p3.20.9-0.00.80.5
MPR+p1.9-1.21.4-1.41.3
MPR+R2.33.41.15.510.6

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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale

Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the constipation scale = higher level of symptomatology/problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16

,,
Interventionunits on a scale (Mean)
Cycle 4 - approximately Month 4 (n=114,124,128)Cycle 7 - approximately Month 7 (n=96,111,112)Cycle 10 - approximately Month 10 (n=86,93,97)Cycle 13 - approximately Month 13 (n=73,73,81)Cycle 16 - approximately Month 16 (n=63,51,62)
MPp+p-4.9-2.7-1.7-3.3-2.2
MPR+p4.80.6-1.1-2.7-5.2
MPR+R-1.8-3.5-5.0-5.0-1.6

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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale

Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of cognitive functioning. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16

,,
Interventionunits on a scale (Mean)
Cycle 4 - approximately Month 4 (n=115,125,128)Cycle 7 - approximately Month 7 (n=98,111,113)Cycle 10 - approximately Month 10 (n=87,92,97)Cycle 13 - approximately Month 13 (n=73,73,83)Cycle 16 - approximately Month 16 (n=63,52,63)
MPp+p1.30.7-2.7-1.4-4.0
MPR+p-2.00.1-4.4-3.0-3.5
MPR+R0.32.91.0-0.00.3

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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale

Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the appetite loss scale = higher level of symptomatology/problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16

,,
Interventionunits on a scale (Mean)
Cycle 4 - approximately Month 4 (n=119,125,130)Cycle 7 - approximately Month 7 (n=99,111,111)Cycle 10 - approximately Month 10 (n=87,93,96)Cycle 13 - approximately Month 13 (n=75,72,83)Cycle 16 - approximately Month 16 (n=64,52,63)
MPp+p-5.6-5.7-8.0-4.8-6.4
MPR+p1.9-5.7-5.4-8.8-16.0
MPR+R1.7-3.7-5.0-6.2-7.8

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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale

Data as of 11 May 2010 cutoff. EORTC QLC-C30 is a 30-item questionnaire to assess the quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); two used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better quality of life. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16

,,
Interventionunits on a scale (Mean)
Cycle 4 - approximately Month 4 (n=114,121,125)Cycle 7 - approximately Month 7 (n=96,108,110)Cycle 10 - approximately Month 10 (n=84,86,96)Cycle 13 - approximately Month 13 (n=70,70,82)Cycle 16 - approximately Month 16 (n=61,50,62)
MPp+p6.14.26.25.48.1
MPR+p5.68.18.88.87.2
MPR+R2.38.012.47.610.7

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Time to First Response

Data as of 11 May 2010 cutoff. Time to first response was defined as the time from start of treatment until first response as assessed by the Central Assessment Committee (CMC) based on European Group for Blood and Marrow Transplantation (EBMT) criteria. (NCT00405756)
Timeframe: Up to 66 weeks

Interventionweeks (Mean)
MPR+R10.0
MPR+p9.3
MPp+p16.2

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Kaplan Meier Estimates of Time to Progression (TTP) Based on the Response Assessment by the Central Adjudication Committee (CAC)

"Data as of 11 May 2010 cutoff. TTP was the time between randomization and disease progression as determined by the CAC. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.~PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia." (NCT00405756)
Timeframe: up to 165 weeks

Interventionweeks (Median)
MPR+R148.1
MPR+p62.7
MPp+p61.3

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Kaplan Meier Estimates of Progression-free Survival (PFS) From Start of Maintenance Therapy Period Based on the Response Assessment by the Central Adjudication Committee (CAC)

"Data as of 11 May 2010 cutoff. PFS calculated from the start of the Maintenance period to the earlier of the first documentation of progressive disease (PD) as determined by the CAC, or death on study due to any cause.~PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.~PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia." (NCT00405756)
Timeframe: Approximately week 37 (start of cycle 10) to week 165

Interventionweeks (Median)
MPR+R112.0
MPR+p32.3

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Kaplan Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Central Adjudication Committee (CAC)

"Data as of 11 May 2010 cutoff. PFS was calculated as the time from randomization to the earlier of the first documentation of progressive disease (PD) as determined by the CAC, or death on study due to any cause. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.~PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia." (NCT00405756)
Timeframe: up to 165 weeks

Interventionweeks (Median)
MPR+R136.1
MPR+p62.1
MPp+p56.1

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Kaplan Meier Estimates of Overall Survival (OS)

Data as of 11 May 2010 cutoff. Overall survival (OS) was defined as the time between randomization and death. Participants who died, regardless of the cause of death, were considered to have had an event. Participants who were lost to follow-up prior to the end of the trial, or who were withdrawn from the trial, were censored at the time of last contact. Participants who were still being treated were censored at the last available date available, or clinical cut-off date, if it was earlier. (NCT00405756)
Timeframe: up to 177 weeks

Interventionweeks (Median)
MPR+RNA
MPR+pNA
MPp+pNA

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Kaplan Meier Estimates for Duration of Response as Determined by the Central Adjudication Committee (CAC)

"Data as of 11 May 2010 cutoff. Duration of myeloma response was defined as the time from the initial response date to the earlier of progressive disease (PD) as determined by the CAC or death on study. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.~PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia." (NCT00405756)
Timeframe: Up to 149 weeks

Interventionweeks (Median)
MPR+R121.6
MPR+p56.1
MPp+p55.4

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Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period

Data as of 11 May 2010 cutoff. Participant counts in different categories of TEAEs during the double-blind treatment period. A TEAE is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. Dose reduction includes reduction with or without interruption. (NCT00405756)
Timeframe: Up to 169 weeks (Double-blind therapy period plus 4 weeks)

,,
Interventionparticipants (Number)
>=1 adverse event (AE)>=1 CTCAE grade 3-4 AE>=1 CTCAE grade 5 AE>=1 serious AE (SAE)>=1 AE related to Lenaldomide/Placebo>=1 AE related to Melphalan>=1AE related to Prednisone>=1 Grade 3-4 AE related to Lenaldomide/Placebo>=1 Grade 3-4 AE related to Melphalan>=1 Grade 3-4 AE related to Prednisone>=1 Grade 5 AE related to Lenalidomide/Placebo>=1 Grade 5 AE related to Melphalan>=1 Grade 5 AE related to Prednisone>=1 SAE related to Lenalidomide/Placebo>=1 SAE related to Melphalan>=1 SAE related to Prednisone>=1 AE leading to Lenalidomide/Placebo withdrawal>=1 AE leading to Melphalan withdrawal>=1 AE leading to Prednisone withdrawal>=1 AE leading to Lenalidomide/Plac dose reduction>=1 AE leading to Melphalan dose reduction>=1 AE leading to Prednisone dose reduction>=1 AE leading to Lenalidomide/Plac dose interrupt>=1 AE leading to Melphalan dose interruption>=1 AE leading to Prednisone dose interruption
MPp+p15310775613112693686222231111151410102621551015
MPR+p15112966214513494117110292113224162419197058782139
MPR+R150137766148140871281183233138271926202071471592528

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Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period

Data as of 11 May 2010 cutoff. Best response was determined by the Central Assessment Committee (CAC) based on the European Group for Blood and Marrow Transplantation (EBMT) criteria: Complete Response (CR)-absence of serum and urine monoclonal paraprotein for 6 weeks, plus no increase in size or number of bone lesions, plus other factors); Partial Response (PR)-not all CR criteria, plus >=50% reduction in serum monoclonal paraprotein plus others; Stable Disease (SD)- not PR or PD; Progressive Disease (PD)- reappearance of monoclonal paraprotein, bone lesions, other; Not Evaluable (NE). (NCT00405756)
Timeframe: Up to 165 weeks

,,
Interventionparticipants (Number)
Complete response (CR)Partial response (PR)Stable disease (SD)Progressive disease (PD)Response not evaluable (NE)
MPp+p5727007
MPR+p5994027
MPR+R151022807

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Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale

Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the side effects scale = higher level of symptomatology. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16

,,
Interventionunits on a scale (Mean)
Cycle 4 - approximately Month 4 (n=113,120,125)Cycle 7 - approximately Month 7 (n=95,108,111)Cycle 10 - approximately Month 10 (n=85,89,94)Cycle 13 - approximately Month 13 (n=72,72,81)Cycle 16 - approximately Month 16 (n=62,50,61)
MPp+p0.61.80.30.3-0.9
MPR+p0.1-1.70.0-1.0-2.9
MPR+R1.30.4-1.6-3.8-2.1

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Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale

Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16

,,
Interventionunits on a scale (Mean)
Cycle 4 - approximately Month 4 (n=112,121,124)Cycle 7 - approximately Month 7 (n=93,108,112)Cycle 10 - approximately Month 10 (n=83,88,97)Cycle 13 - approximately Month 13 (n=71,73,81)Cycle 16 - approximately Month 16 (n=62,52,62)
MPp+p7.69.814.511.914.4
MPR+p4.37.76.66.37.7
MPR+R4.714.617.317.318.5

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Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale

Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the body image scale, higher scores = better body image. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16

,,
Interventionunits on a scale (Mean)
Cycle 4 - approximately Month 4 (n=110,117,119)Cycle 7 - approximately Month 7 (n=88,104,108)Cycle 10 - approximately Month 10 (n=79,83,94)Cycle 13 - approximately Month 13 (n=68,72,79)Cycle 16 - approximately Month 16 (n=59,52,61)
MPp+p4.55.23.95.12.7
MPR+p-0.32.6-4.0-0.56.4
MPR+R2.13.87.61.03.4

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Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale

Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the disease symptoms scale = higher level of symptomatology. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16

,,
Interventionunits on a scale (Mean)
Cycle 4 - approximately Month 4 (n=113,121,127)Cycle 7 - approximately Month 7 (n=96,109,112)Cycle 10 - approximately Month 10 (n=85,91,95)Cycle 13 - approximately Month 13 (n=72,73,82)Cycle 16 - approximately Month 16 (n=62,51,62)
MPp+p-5.4-6.0-5.4-6.3-3.3
MPR+p-8.7-9.7-7.1-8.8-5.9
MPR+R-8.9-9.0-7.9-7.2-10.5

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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale

Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of social functioning. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16

,,
Interventionunits on a scale (Mean)
Cycle 4 - approximately Month 4 (n=115,125,127)Cycle 7 - approximately Month 7 (n=98,111,112)Cycle 10 - approximately Month 10 (n=87,92,97)Cycle 13 - approximately Month 13 (n=72,73,83)Cycle 16 - approximately Month 16 (n=63,52,63)
MPp+p6.06.14.16.29.8
MPR+p0.34.44.57.56.1
MPR+R5.18.310.911.813.2

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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale

Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of role functioning. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16

,,
Interventionunits on a scale (Mean)
Cycle 4 - approximately Month 4 (n=119,127,130)Cycle 7 - approximately Month 7 (n=99,112,113)Cycle 10 - approximately Month 10 (n=86,95,95)Cycle 13 - approximately Month 13 (n=74,74,82)Cycle 16 - approximately Month 16 (n=64,53,63)
MPp+p7.46.95.65.77.1
MPR+p3.08.07.511.78.5
MPR+R1.85.79.39.712.2

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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale

Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16

,,
Interventionunits on a scale (Mean)
Cycle 4 - approximately Month 4 (n=120,127,130)Cycle 7 - approximately Month 7 (n=100,112,112)Cycle 10 - approximately Month 10 (n=88,95,96)Cycle 13 - approximately Month 13 (n=75,74,83)Cycle 16 - approximately Month 16 (n=64,53,63)
MPp+p4.52.75.13.31.1
MPR+p3.38.18.59.77.6
MPR+R1.98.28.98.610.0

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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale

Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the pain scale = higher level of symptomatology/problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16

,,
Interventionunits on a scale (Mean)
Cycle 4 - approximately Month 4 (n=120,127,129)Cycle 7 - approximately Month 7 (n=100,112,113)Cycle 10 - approximately Month 10 (n=88,95,97)Cycle 13 - approximately Month 13 (n=74,74,83)Cycle 16 - approximately Month 16 (n=64,53,63)
MPp+p-13.4-11.5-9.8-12.1-12.2
MPR+p-13.8-16.5-15.6-14.9-11.0
MPR+R-14.4-17.8-17.2-13.7-20.3

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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale

Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the nausea/vomiting scale = higher level of symptomatology/problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16

,,
Interventionunits on a scale (Mean)
Cycle 4 - approximately Month 4 (n=120,127,130)Cycle 7 - approximately Month 7 (n=99,112,112)Cycle 10 - approximately Month 10 (n=87,95,97)Cycle 13 - approximately Month 13 (n=75,72,83)Cycle 16 - approximately Month 16 (n=64,52,62)
MPp+p-0.00.70.3-0.4-1.3
MPR+p-1.3-0.7-1.4-3.0-4.2
MPR+R3.30.51.90.71.0

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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale

Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the insomnia scale = higher level of symptomatology/problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16

,,
Interventionunits on a scale (Mean)
Cycle 4 - approximately Month 4 (n=118,124,128)Cycle 7 - approximately Month 7 (n=100,109,111)Cycle 10 - approximately Month 10 (n=87,94,96)Cycle 13 - approximately Month 13 (n=75,73,83)Cycle 16 - approximately Month 16 (n=64,53,63)
MPp+p-5.0-5.7-1.7-6.8-3.7
MPR+p-1.6-6.4-2.50.9-0.6
MPR+R2.0-1.0-5.0-4.9-4.7

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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale

Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a problem scale like the financial problems scale = higher level of financial problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16

,,
Interventionunits on a scale (Mean)
Cycle 4 - approximately Month 4 (n=111,123,125)Cycle 7 - approximately Month 7 (n=94,111,112)Cycle 10 - approximately Month 10 (n=84,92,97)Cycle 13 - approximately Month 13 (n=70,72,83)Cycle 16 - approximately Month 16 (n=61,52,63)
MPp+p-2.9-2.1-1.7-4.0-5.3
MPR+p-1.1-0.60.7-0.5-0.6
MPR+R2.42.16.04.81.6

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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale

Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale = higher level of symptomatology/problems. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16

,,
Interventionunits on a scale (Mean)
Cycle 4 - approximately Month 4 (n=120,127,129)Cycle 7 - approximately Month 7 (n=100,112,110)Cycle 10 - approximately Month 10 (n=87,95,95)Cycle 13 - approximately Month 13 (n=74,74,82)Cycle 16 - approximately Month 16 (n=64,53,62)
MPp+p-5.1-5.7-6.9-7.5-4.1
MPR+p-5.5-9.5-7.5-10.7-9.7
MPR+R-3.0-7.6-7.5-7.1-10.0

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Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale

Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of emotional functioning. (NCT00405756)
Timeframe: Baseline (Day 0), Months 4, 7, 10, 13, 16

,,
Interventionunits on a scale (Mean)
Cycle 4 - approximately Month 4 (n=115,125,128)Cycle 7 - approximately Month 7 (n=98,111,112)Cycle 10 - approximately Month 10 (n=86,92,97)Cycle 13 - approximately Month 13 (n=73,73,83)Cycle 16 - approximately Month 16 (n=63,52,63)
MPp+p6.85.04.76.66.9
MPR+p2.74.21.61.1-0.2
MPR+R4.88.89.08.29.9

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Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort

Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00408005)
Timeframe: 4 years from end of induction

Interventionpercent probability (Number)
High RiskInduction Failure
ARM II (Combination Chemotherapy)85.0100

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Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I + Arm II vs. Arm III + Arm IV)

Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00408005)
Timeframe: 4 years from randomization at the end of induction

Interventionpercent probability (Number)
ARM I and ARM II (Combination Chemotherapy)91.45
ARM III and ARM IV (Combination Chemotherapy)85.78

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Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)

Disease-free survival defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, remission death) or date of last contact for those who are event-free. (NCT00408005)
Timeframe: 4 years from randomization at the end of induction

Interventionpercent probability (Number)
ARM I (Combination Chemotherapy)91.76
ARM II (Combination Chemotherapy)90.53
ARM III (Combination Chemotherapy)86.06
ARM IV (Combination Chemotherapy)84.89

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Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort

Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00408005)
Timeframe: 4 years from end of induction

Interventionpercent probability (Number)
Standard RiskHigh Risk
ARM I (Combination Chemotherapy)87.485.1

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Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I + Arm III vs. Arm II + Arm IV)

Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event (NCT00408005)
Timeframe: 4 years from randomization at the end of induction

Interventionpercent probability (Number)
ARM I and ARM III (Combination Chemotherapy)82.96
ARM II and ARM IV (Combination Chemotherapy)88.30

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Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)

Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00408005)
Timeframe: 4 years from randomization at the end of induction

Interventionpercent probability (Number)
ARM I (Combination Chemotherapy)89.01
ARM II (Combination Chemotherapy)90.53
ARM III (Combination Chemotherapy)78.07
ARM IV (Combination Chemotherapy)86.46

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Cumulative Incidence of CNS Relapse for T-ALL by Risk Group

Cumulative incidence of CNS relapse adjusting for DFS events, was calculated using the method Gray et. al. High risk patients receive cranial radiation and low risk patients receive no cranial radiation. (NCT00408005)
Timeframe: 4 years from randomization at the end of induction

,
Interventionpercent probability (Number)
Intermediate RiskHigh Risk
ARM II (Combination Chemotherapy)1.080
ARM IV (Combination Chemotherapy)0.853.45

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Cumulative Incidence of CNS Relapse for T-ALL by Risk Group

Cumulative incidence of CNS relapse adjusting for DFS events, was calculated using the method Gray et. al. High risk patients receive cranial radiation and low risk patients receive no cranial radiation. (NCT00408005)
Timeframe: 4 years from randomization at the end of induction

,
Interventionpercent probability (Number)
Low RiskIntermediate RiskHigh Risk
ARM I (Combination Chemotherapy)1.851.163.64
ARM III (Combination Chemotherapy)1.929.16.52

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Number of Participants With Treatment Failure, BPAR, Clinical Acute Rejection (AR) and Treated AR at 3 Months

A treatment failure is a Biopsy Proven Acute Rejection (BPAR), a graft loss, a death, or a loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: The allograft will be presumed lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis. (NCT00413920)
Timeframe: Month 3

,
InterventionNumber of participants (Number)
Treatment FailureBiopsy Proven Acute RejectionGraft LossDeathLoss to Follow-upAcute RejectionTreated Acute Rejection
With Steroids851201916
Without Steroids17105203231

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Number of Participants With Treatment Failure at 3 Months by Graft Recovery Status

"The number of participants with treatment failure defined as a Biopsy Proven Acute Rejection (BPAR), a graft loss, a death, or a loss to follow-up at 3 months by graft recovery status.~Delayed graft function is defined as the need for dialysis within the first 7 days post-transplantation, excluding the first post-transplantation day.~Slow graft function is defined as a serum creatinine value > 250 µmol/L at day 5." (NCT00413920)
Timeframe: Month 3

,
InterventionNumber of participants (Number)
Delayed Graft Function [N= 25,24]Slow Graft Function [N= 36,23]Immediate Graft Function [N= 51,63]
With Steroids413
Without Steroids863

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Number of Participants With Subclinical Histological Rejections

The number of participants with subclinical histological rejections was determined by renal biopsy screening at 3 months in 125 patients, providing adequate samples for 112 biopsies. (NCT00413920)
Timeframe: Month 3

,
InterventionNumber of participants (Number)
Sample quality inadequateSubclinical rejectionBorderline lesionsBPAR
With Steroids617512
Without Steroids712210

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Number of Participants Requiring Steroids in Non-steroid Treatment Group

(NCT00413920)
Timeframe: Months 3 and 6

InterventionNumber of participants (Number)
3 Months6 Months
Without Steroids2520

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Number of Participants With the Occurrence of Treatment Failures at 6 Months Post-transplantation

Treatment failures defined as Biopsy Proven Acute Rejection (BPAR), graft loss, death or loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: allograft will be presumed to be lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis. (NCT00413920)
Timeframe: 6 months post transplantation

InterventionNumber of participants (Number)
Without Steroids20
With Steroids16

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The Number of Participants With BPAR, Clinical Acute Rejection (AR) and Treated AR at 6 Months

If a participant experienced several BPAR, only the rejection with highest grade is taken into account. Only events that occurred before study treatment discontinuation are taken into account. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. (NCT00413920)
Timeframe: Month 6

,
InterventionNumber of participants (Number)
Biopsy Proven Acute RejectionGraft LossDeathLoss to Follow-upAcute RejectionTreated Acute Rejection
With Steroids83502119
Without Steroids135203736

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Time to Pain Progression

"Pain Progression is defined as an increase of ≥1 point in the median Personal Pain Intensity (PPI) from its nadir noted on 2 consecutive 3-week-apart visits or ≥25 % increase in the mean analgesic score compared with the baseline score & noted on 2 consecutive 3-week-apart visits or requirement for local palliative radiotherapy.~Evaluation of the PPI & analgesic scores are based on the short-form McGill Pain Questionnaire which consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0=none (best) 1=mild 2=moderate 3=severe (worst) (TOTAL: 0=best 45=worst)" (NCT00417079)
Timeframe: from baseline up to 104 weeks (study cut-off)

InterventionMonths (Median)
Mitoxantrone + PrednisoneNA
Cabazitaxel + Prednisone11.1

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Time to Progression Free Survival (PFS)

Progression free survival was defined as a composite endpoint evaluated from the date of randomization to the date of tumor progression, PSA progression, pain progression, or death due to any cause, whichever occurred first (NCT00417079)
Timeframe: From the date of randomization up to 104 weeks (study cut-off)

InterventionMonths (Median)
Mitoxantrone + Prednisone1.4
Cabazitaxel + Prednisone2.8

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Time to Prostatic Specific Antigen (PSA) Progression

"In PSA non-responders, progression will be defined as a 25% increase over nadir and increase in the absolute value PSA level by at least 5 ng/ml and confirmed by a second value at least 4 weeks later.~In PSA responders and in patients not evaluable for PSA response at baseline, progression will be defined as a ≥50% increase over nadir, provided that the increase is a minimum of 5 ng/ml and confirmed by a second value at least 1 week later." (NCT00417079)
Timeframe: at screening, day 1 of every treatment cycle, up to 104 weeks (study cut-off)

InterventionMonths (Median)
Mitoxantrone + Prednisone3.1
Cabazitaxel + Prednisone6.4

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Time to Tumor Progression

Time to tumor progression is defined as the number of months from randomization until evidence of progressive disease (RECIST) (NCT00417079)
Timeframe: From the date of randomization up to 104 weeks (study cut-off)

InterventionMonths (Median)
Mitoxantrone + Prednisone5.4
Cabazitaxel + Prednisone8.8

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Pain Response

Pain Response was defined as a two-point or greater reduction from baseline median Present Pain Intensity (PPI) score without an increased Analgesic Score (AS) or a decrease of ≥50% in the AS without an increase in the PPI score, maintained for at least 3 weeks. (NCT00417079)
Timeframe: from baseline up to 104 weeks (study cut-off)

InterventionPercentage of participants (Number)
Mitoxantrone + Prednisone7.7
Cabazitaxel + Prednisone9.2

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Overall Survival

"Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause.~In the absence of confirmation of death, the survival time was censored at the last date patient was known to be alive or at the cut-off date, whichever had come first." (NCT00417079)
Timeframe: From the date of randomization up to 104 weeks (study cut-off)

InterventionMonths (Median)
Mitoxantrone + Prednisone12.7
Cabazitaxel + Prednisone15.1

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Overall Tumor Response

"Tumor Overall Response Rate (ORR) (only in patients with measurable disease):~Objective responses (Complete Response and Partial Response) for measurable disease as assessed by investigators according to RECIST criteria.~Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: At least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference baseline sum LD.~Confirmation of objective responses will be performed by repeat tumor imaging (CT scans, MRI, bone scans) after the first documentation of response." (NCT00417079)
Timeframe: From the date of randomization up to 104 weeks (study cut-off)

Interventionpercentage of participants (Number)
Mitoxantrone + Prednisone4.4
Cabazitaxel + Prednisone14.4

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PSA (Prostate-Specific Antigen) Response

PSA response was defined as a ≥ 50% reduction in serum PSA, determined only for patients with a serum PSA ≥ 20ng/mL at baseline, confirmed by a repeat PSA ≥ 3 weeks later. (NCT00417079)
Timeframe: from baseline up to 104 weeks (study cut-off)

InterventionPercentage of participants (Number)
Mitoxantrone + Prednisone17.8
Cabazitaxel + Prednisone39.2

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Renal Function Assessed by Glomerular Filtration Rate (GFR)at Each Visit

The Modification of Diet in Renal Disease (MDRD) formula was used to calculate the GFR. Serum creatinine levels, age, sex and race were used to estimate the GFR levels in mL/min/1.73m^2. (NCT00419926)
Timeframe: at 21 days, 84 days and 180 days

,
Intervention(mL/min/1.73m^2) (Mean)
At 21 daysAt 84 daysAt 180 days
Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen47.352.153.5
Standard Mycophenolate Sodium (Myfortic) Dosing Regimen46.851.851.3

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Number of Patients With Treatment Failure 6-months Post Transplant Measured by the Combined Incidence of Biopsy Proven Acute Rejection, Graft Loss, and Death

To evaluate therapeutic benefit by comparing the efficacy defined as the number of participants with treatment failure (biopsy-proven acute rejection [BPAR], graft loss [GFL] or death) at 6 months post-transplant. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III using Banff 2000 classification. A graft core biopsy was performed within 24 hours of initiation of anti-rejection therapy. GFL was defined as the day the allograft was presumed lost (the day the patient started dialysis, the day of nephrectomy or the day of irreversible graft loss demonstrated by imaging techniques.) (NCT00419926)
Timeframe: 6 months

Interventionnumber of participants (Number)
Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen33
Standard Mycophenolate Sodium (Myfortic) Dosing Regimen36
Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen26
Standard Mycophenolate Sodium (Myfortic) Dosing Regimen35

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Comparison of Overall Treatment Failure at Days 21 and 84 Post-transplantation Assessed by Biopsy Proven Acute Rejection (BPAR), GFL, and Death

The overall treatment differences of the number of participants with at least one occurrence of the composite event BPAR, GFL or death at study days 21 and 84 post-transplantation. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III using Banff 2000 classification. A graft core biopsy was performed within 24 hours of initiation of anti-rejection therapy. GFL was defined as the day the allograft was presumed lost (the day the patient started dialysis, the day of nephrectomy or the day of irreversible graft loss demonstrated by imaging techniques.) (NCT00419926)
Timeframe: 21 and 84 days

,
Interventionnumber of participants (Number)
Day 84Day 21
Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen20331426
Standard Mycophenolate Sodium (Myfortic) Dosing Regimen21342033

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Number of Patients With Complete Remission

Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal value. (NCT00423098)
Timeframe: 12 Weeks

,
Interventionparticipants (Number)
YesNo
Low Dose534
Standard Dose933

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Number of Patients With Complete Remission

Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal range according to local lab. (NCT00423098)
Timeframe: 24 Weeks

,
InterventionParticipants (Number)
YesNo
Low Dose831
Standard Dose834

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Number of Patients With Adverse Events and Infections

Safety assessments included collecting all adverse events (AEs), serious adverse events (SAEs), with their severity and relationship to study drug. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening ( NIH criteria Grade 4), causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. (NCT00423098)
Timeframe: 24 weeks

,
Interventionparticipants (Number)
At least one adverse eventAny severe adverse eventAny drug related adverse eventAny serious adverse eventAny infectionAny severe infectionAny drug related infectionAny serious infection
Low Dose30316417161
Standard Dose357188253104

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Cumulative Dose of Prednisone Equivalent Corticosteroids (CS)

Corticosteroid use was measured as cumulative dose until 12 and 24 weeks of treatment as well as daily doses at baseline, 12 and 24 weeks. (NCT00423098)
Timeframe: 12 Weeks and 24 Weeks

,
Interventionmg/kg (Mean)
Week 12Week 24
Low Dose68.273.0
Standard Dose106.1114.2

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Change From Baseline in Overall Disease Activity With Systematic Lupus Erythematosus Disease Activity Index (SLEDAI)

SLEDAI stands for Systemic Lupus Erythematosus Disease Activity Index and was a well established global score index based on assessment of 24 items measuring a disease activity in the 10-day period prior to the assessment. SLEDAI item weights range from 1 for fever to 8 for seizures. A maximum theoretical score is 105. Total score range from 1 to 105. A flare has been defined as a SLEDAI score increase of 3 or more to a level of 8 or higher. During flares SLEDAI scores of 25 to 30 are common. (NCT00423098)
Timeframe: From Baseline to week 4, week 12 and week 24

,
InterventionUnits on a scale (Mean)
Change from Baseline to Week 4: (N= 39, 37)Change from Baseline to Week 12: (N= 41, 35)Change from Baseline to Week 24: (N= 39, 34)
Low Dose-7.7-10.3-9.8
Standard Dose-7.4-9.7-10.3

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Number of Patients With Partial Remission

Partial remission was defined as urine protein/creatinine ratio reduced by at least 50% from baseline and stable serum creatinine within 10% of baseline value) or improved. (NCT00423098)
Timeframe: Baseline to 12 and 24 weeks

,
InterventionParticipants (Number)
At 12 weeks - YesAt 12 weeks - NoAt 24 weeks - YesAt 24 weeks - No
Low Dose11281425
Standard Dose16262022

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Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG)

BILAG (British Isles Lupus Assessment Group) index divides lupus activity into 8 organs/systems and was based on the principle of the physician's intention to treat, assessing activity in the previous one month. Each organ or system was given a score of A to E, where A = disease that is sufficiently active to require disease modifying treatment; a B = problems requiring symptomatic treatment; C = stable mild disease; D = previously affected but currently inactive system; and E = the system or organ has never been involved. [A=9, B=3, C=1, D/E=0 the score range for each patient will be 0-72]. (NCT00423098)
Timeframe: From Baseline to week 4, week 12 and week 24

,
InterventionUnits on a scale (Mean)
Change from baseline Week 4: (N= 40, 37)Change from baseline Week 12: (N= 41, 35)Change from baseline Week 24: (N= 40, 34)
Low Dose-5.5-8.7-9.4
Standard Dose-4.8-8.6-8.6

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Duration of Exposure to Study Medication

The duration of exposure was calculated as the date of the last Mycophenolate sodium dose minus the date of the last Mycophenolate sodium dose +1. (NCT00423098)
Timeframe: 24 weeks

Interventiondays (Mean)
Standard Dose164.5
Low Dose157.7

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Number of Patients With Moderate to Severe Flares

A moderate to severe flare was defined as the occurrence of increased lupus activity after partial or complete remission, based on the presence of 1 BILAG A score or >=3 BILAG B scores. British Isles Lupus Assessment Group (BILAG) index divides lupus activity in 8 organs/systems which are each given a score of A to E. A=disease sufficiently active to need disease modifying treatment; B=problems requiring symptomatic treatment; C=mild stable disease; D=previously affected but currently inactive system; E=the system or organ has never been involved. BILAG score: A=9, B=3, C=1, D/E=0; range(0-72) (NCT00423098)
Timeframe: 12 and 24 weeks

,
Interventionparticipants (Number)
At week 12 - YesAt week 12 - NoAt week 24 - YesAt week 24 - No
Low Dose039039
Standard Dose042141

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Number of Patients With Treatment Failure

Treatment failure was defined as no therapeutic response (without complete or partial remission) or premature discontinuation during the first 24 weeks from study medication or the study for any reason except complete or partial remission. (NCT00423098)
Timeframe: 12 Weeks and 24 Weeks

,
Interventionparticipants (Number)
At 12 weeks - YesAt 12 weeks - NoAt 24 weeks - YesAt 24 weeks - No
Low Dose25142217
Standard Dose23192121

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Participants With Remission of Renal Disease Activity at 3 Months

Remission of renal disease activity was indicated by stable or falling creatinine, absence of active urinary sediment AND reduction of oral prednisone dose to less than 50% of average dose of preceding 3 months or less than 10 mg/day (whichever smaller) (NCT00424749)
Timeframe: 3 months after beginning of remission induction regimen

Interventionparticipants (Number)
Rituximab3

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Participants With Normalization of Eosinophil Count at 6 Months

Normalization of eosinophil counts was defined as total eosinophil counts <1.5 x 10^9/L. (NCT00424749)
Timeframe: 6 months after beginning of remission induction regimen

Interventionparticipants (Number)
Rituximab2

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Participants Achieving Renal Improvement (RI) or CRR at Month 12 During Short-term Period

CRR defined as meeting all of 5 criteria. RF: (Glomerular filtration rate [GFR] calculated using MDRD equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported. (NCT00430677)
Timeframe: At Month 12 from Day 1

InterventionParticipants (Number)
Abatacept 30/10 mg/kg38
Abatacept 10/10 mg/kg37
Placebo31

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Time to Achieve First Confirmed Renal Improvement (RI) During Short-term Period (as Determined by Kaplan-Meier Methodology)

RI is defined as meeting all of the following criteria. Renal function: If MDRD is abnormal at screening, within 10% of the MDRD at screening; if MDRD is 60-89 at screening, greater than or equal to 50% improvement based on the screening value or 90% or greater of MDRD at screening; if MDRD is 15-59 at screening, if MDRD is normal at screening-within 10% of the MDRD at screening. Proteinuria: improvement greater than or equal to 50% from screening. Hematuria: red blood cell (RBC)count within normal limit of central laboratory. Pyuria: white blood cell (WBC) count within normal limit of central laboratory. Cylindruria: No RBC or WBC casts. (NCT00430677)
Timeframe: Day 1 (randomization) to 12 months.

InterventionDays (Median)
Abatacept 30/10 mg/kg141
Abatacept 10/10 mg/kg136
Placebo144

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Time to First Confirmed Complete Renal Response (CRR) During the Short-term (Double-blind) Period

Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate [GFR] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported. (NCT00430677)
Timeframe: Day 1 (randomization) to 12 months.

Interventiondays (Number)
Abatacept 30/10 mg/kgNA
Abatacept 10/10 mg/kgNA
PlaceboNA

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Baseline and Post Baseline Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index During Short-term Period

SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as nonreversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 48, and increasing score indicates increasing disease severity. (NCT00430677)
Timeframe: Baseline (Day 1), Post baseline (Month 12 or 28 days after last dose)

,,
InterventionUnits on a scale (Mean)
Baseline (n=68, 67, 70)Post Baseline Mean (n=68, 67, 70)
Abatacept 10/10 mg/kg0.270.40
Abatacept 30/10 mg/kg0.340.53
Placebo0.290.44

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Baseline Fatigue as Measured by Fatigue Severity Scale-Krupp During Short-term Period

The reduction of fatigue assessed by Fatigue Severity Scale (FSS). The FSS questionnaire is comprised of 9 statements inquiring about the examinee's sleep habits over the preceding week. Participants are asked to rate their level of agreement (toward seven) or disagreement (toward zero) with the nine statements. A score of 36 and above (out of a maximum of 63) indicates the presence of significant fatigue. (NCT00430677)
Timeframe: Baseline (Day 1), Days 85, 169, 253, and 365

,,
InterventionUnits on a scale (Mean)
Baseline (Day 1) for Day 85 (n=90, 94, 95)Baseline (Day 1) for Day 169 (n=92, 94, 97)Baseline (Day 1) for Day 253 ( n=92, 94, 97)Baseline (Day 1) for Day 365 ( n=92, 94, 97)
Abatacept 10/10 mg/kg39.1439.1439.1439.14
Abatacept 30/10 mg/kg40.6040.4140.4140.41
Placebo39.6439.5939.5939.59

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Baseline Fatigue as Measured by the Fatigue Visual Analog Scale During Short-term Period

A visual analogue scale (VAS) is a psychometric response scale for measurement of subjective characteristics or attitudes that cannot be directly measured. The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue. (NCT00430677)
Timeframe: Baseline (Day 1), Days 85, 169, 253, and 365

,,
InterventionUnits on a scale (Mean)
Baseline (Day 1) for Day 85 (n=90, 94, 95)Baseline (Day 1) for Day 169 (n=92, 94, 97)Baseline (Day 1) for Day 253 (n=92, 94, 97)Baseline (Day 1) for Day 365 (n=92, 94, 97)
Abatacept 10/10 mg/kg41.9541.9541.9541.95
Abatacept 30/10 mg/kg48.8648.8048.8048.80
Placebo48.9348.2548.2548.25

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Baseline Mental Component Summary of the Short SF-36 During Short-term Period

The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value. (NCT00430677)
Timeframe: Baseline (Day 1), Days 85, 169, 253, and 365

,,
InterventionUnits on a scale (Mean)
Baseline (Day 1) for Day 85 ( n=89, 91, 93)Baseline (Day 1) for Day 169 (n=92,94,96)Baseline (Day 1) for Day 253 ( n=92,94,96)Baseline (Day 1) for Day 365 ( n=92,94,96)
Abatacept 10/10 mg/kg43.8041.8441.8441.84
Abatacept 30/10 mg/kg42.1844.0844.0844.08
Placebo42.6842.5942.5942.59

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Baseline Quantitative Immunoglobulins During the Short-term Period

A quantitative immunoglobulins (Igs) test is used to detect abnormal levels of the three major classes of Igs (IgG, IgA, and IgM). Abnormal test results typically indicate that there is something affecting the immune system which requires further testing. (NCT00430677)
Timeframe: Baseline (Day 1)

,,
Interventionmg/dL (Mean)
Immunoglobulin IgAImmunoglobulin IgGImmunoglobulin IgM
Abatacept 10/10 mg/kg218.04864.1297.10
Abatacept 30/10 mg/kg246.28939.80100.96
Placebo230.231013.1798.49

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Number of Participants With Confirmed Complete Renal Response (CRR) During Short-term Period

Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate [GFR] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported. (NCT00430677)
Timeframe: Day 1 to 12 months

InterventionParticipants (Number)
Abatacept 30/10 mg/kg22
Abatacept 10/10 mg/kg27
Placebo20

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Baseline Renal Function Over Time During Short-term Period

Baseline (BL) renal function, as estimated by calculation of the MDRD (Modification of Diet in Renal Disease) equation, over time. Renal MDRD is an equation (calculation) used to estimate Glomerular Filtration Rate (GFR) in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine. A negative value indicates worsening. (NCT00430677)
Timeframe: Baseline (Day 1), Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365

,,
Interventionmilliliters per minute (mL/min)/1.73 m^2 (Mean)
Baseline (Day 1) for Day 15 (n=98,94,98)Baseline (Day 1) for Day 29 (n=98,95,98)Baseline (Day 1) for Day 57 (n=94, 89, 96)Baseline (Day 1) for Day 85 (n=90, 91, 93)Baseline (Day 1) for Day 113 (n=91, 83, 91)Baseline (Day 1) for Day 141 (n=89, 83, 90)Baseline (Day 1) for Day 169 (n=83, 82, 85)Baseline (Day 1) for Day 197 (n=84, 81, 87)Baseline (Day 1) for Day 225 (n=84, 81, 84)Baseline (Day 1) for Day 253 (n=81, 76, 81)Baseline (Day 1) for Day 281 (n=78, 77, 80)Baseline (Day 1) for Day 309 (n=77, 76, 78)Baseline (Day 1) for Day 337 (n=74, 75, 79)Baseline (Day 1) for Day 365 (n=75, 73, 78)
Abatacept 10/10 mg/kg99.0998.5698.76100.22101.23101.05101.95101.85101.64101.25102.64100.64101.00101.30
Abatacept 30/10 mg/kg92.5793.0891.5494.5394.4393.6294.8394.5594.8794.8994.1794.7495.5195.04
Placebo91.0191.2391.5892.7692.4192.8392.5692.6993.2593.3893.1392.7192.9093.03

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Change From Baseline in Physical Component Summary of the SF-36 During Short-term Period

The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value. (NCT00430677)
Timeframe: Baseline (Day 1), Days 85, 169, 253, and 365

,,
InterventionUnits on a scale (Mean)
Day 85 (n=89, 91, 93)Day 169 (n=92, 94, 96)Day 253 (n=92, 94, 96)Day 365 (n=92, 94, 96)
Abatacept 10/10 mg/kg2.614.074.805.00
Abatacept 30/10 mg/kg4.174.184.234.24
Placebo2.863.393.453.77

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Change in Fatigue From Baseline as Measured by Fatigue Severity Scale-Krupp During Short-term Period

The reduction of fatigue assessed by Fatigue Severity Scale (FSS). The FSS questionnaire is comprised of 9 statements inquiring about the examinee's sleep habits over the preceding week. Participants are asked to rate their level of agreement (toward seven) or disagreement (toward zero) with the nine statements. A score of 36 and above (out of a maximum of 63) indicates the presence of significant fatigue. (NCT00430677)
Timeframe: Baseline (Day 1), Days 85, 169, 253, and 365

,,
InterventionUnits on a scale (Least Squares Mean)
Day 85 (n=90, 94, 95)Day 169 (n=92, 94, 97)Day 253 ( n=92, 94, 97)Day 365 ( n=92, 94, 97)
Abatacept 10/10 mg/kg-1.40-1.69-2.95-3.21
Abatacept 30/10 mg/kg-1.54-2.68-3.54-4.20
Placebo-0.67-1.08-3.06-4.79

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Change in Fatigue From Baseline as Measured by the Fatigue Visual Analog Scale During Short-term Period

"A visual analogue scale is a psychometric response scale for measurement of subjective characteristics or attitudes that cannot be directly measured.~The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue." (NCT00430677)
Timeframe: Baseline (Day 1), Days 85, 169, 253, and 365

,,
InterventionUnits on a scale (Mean)
Day 85 (n=90, 94, 95)Day 169 (n=92, 94, 97)Day 253 (n=92, 94, 97)Day 365 (n=92, 94, 97)
Abatacept 10/10 mg/kg-4.94-9.52-11.90-12.32
Abatacept 30/10 mg/kg-9.18-7.18-8.78-12.21
Placebo-6.20-4.71-7.35-11.07

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Change in Quantitative Immunoglobulin From Baseline During Short-term Period

"A quantitative immunoglobulin (Ig) test is used to detect abnormal levels of the 3 major classes of Ig (IgG, IgA, and IgM). Abnormal test results typically indicate that something is affecting the immune system and further testing is required.~Please refer to Outcome 31 for the respective baseline values" (NCT00430677)
Timeframe: Day 365

,,
Interventionmg/dL (Mean)
Ig A (n=76, 73, 78)IgG (n=76, 73, 78)IgM (n=76, 73, 78)
Abatacept 10/10 mg/kg-34.4827.21-19.38
Abatacept 30/10 mg/kg-32.8341.41-17.76
Placebo-26.5123.42-20.62

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Change in Renal Function From Baseline Over Time During Short-term Period

Mean change from baseline in renal function, as estimated by calculation of the MDRD equation, over time. Renal MDRD is an equation (calculation) used to estimate Glomerular Filtration Rate (GFR) in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine. A positive value indicates improvement. Change from baseline=Post-baseline-baseline value. (NCT00430677)
Timeframe: Baseline (Day 1), Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365

,,
Interventionmilliliters per minute (mL/min)/1.73 m^2 (Mean)
Day 15; (n=98,94,98)Day 29 (n=98, 95, 98)Day 57 (n=94 89 96)Day 85 (n=90, 91, 93)Day 113 (n=91, 83, 91)Day 141 (n=89, 83, 90)Day 169 (n=83, 82, 85)Day 197 (n=84, 81, 87)Day 225 (n=84, 81, 84)Day 253 (n=81, 76, 81)Day 281 (n=78, 77, 80)Day 309 (n=77, 76, 78)Day 337 (n=74, 75, 79)Day 365 (n=75, 73, 78)
Abatacept 10/10 mg/kg1.154.517.286.2010.237.9010.5510.677.727.226.819.5310.1511.03
Abatacept 30/10 mg/kg-0.242.265.968.565.318.338.127.717.324.705.686.345.345.17
Placebo0.621.702.382.894.123.627.346.797.195.865.386.004.395.68

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Mean Change From Baseline in SLICC/ACR Damage Index

SLICC=Systemic Lupus International Collaborating Clinics; ACR=American College of Rheumatology. The SLICC/ACR Damage Index measures organ damage (nonreversible change, unrelated to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months unless otherwise stated. The index assesses 47 items in 12 systems: Ocular, Neuropsychiatric, Renal, Pulmonary, Cardiovascular, Gastrointestinal, Peripheral Vascular, Musculoskeletal, Skin, Premature Gonadal Failure, Diabetes, Malignancy. Scores range from 0 to 2, and the same lesion cannot be scored twice. If damage is noted for a particular item, it is scored 1. No damage is scored 0. Some items may score 2 points if they occur more than once, so that the maximum possible score is 47. Scores can only increase with time, but scores rarely reach over 12. It is usually completed (or updated) yearly. (NCT00430677)
Timeframe: Day 365 to termination of the long-term extension phase

,,
InterventionUnits on a scale (Mean)
Day 365 (n=69, 65, 74)Day 729 (n=66, 65, 69)Day 1093 (n=41, 38, 44)
Abatacept 10/10 mg/kg-0.17-0.28-0.16
Abatacept 30/10 mg/kg-0.12-0.21-.27
Placebo-0.08-0.100.02

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Number of Participants Achieving Complete Response by ACCESS Definition

The Abatacept and Cyclophosphamide Combination Efficacy and Safety Study (ACCESS) defines complete response as a response meeting all of the following criteria: serum creatinine ≤upper limit of normal as defined by the central laboratory or ≤125% of the higher value at either screening or baseline; urine protein/creatinine ratio <50 mg/mmoL; and prednisone or prednisone-equivalent dose tapered to 10 mg per day. (NCT00430677)
Timeframe: End of short-term period (Day 365) to termination of the long-term extension period

,,
Interventionparticipants (Number)
Day 365Day 645 (n=55, 56, 61)
Abatacept 10/10 mg/kg3028
Abatacept 30/10 mg/kg2927
Placebo2525

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Number of Participants Achieving Patient Response of Complete or Partial Response, Based on the June 2010 Food and Drug Administration Guidance Document for Lupus Nephritis

Patient response=complete, partial, or no response. Complete response=serum creatinine (SCr) normal, inactive urinary sediment, no cellular casts, urinary protein/creatinine (UPCR) ratio<56.5 mg/mmol. Partial response=SCr normal or ≤25% above baseline value, RBCs at reference range, UPCR <56.5 mg/mmoL OR ≥50% improvement in UPCR with one of the following: UPCR <113 or <339 mg/mmoL, based on the baseline ratio. No response=Not achieving complete or partial response criteria. (NCT00430677)
Timeframe: At Day 365 (end of Short-term Period) and Day 645

,,
InterventionParticipants (Number)
Day 365Day 645 (n=59, 59, and 62)
Abatacept 10/10 mg/kg3929
Abatacept 30/10 mg/kg4345
Placebo4236

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Number of Participants Achieving Renal Response

Renal response=serum creatinine level ≤25% above baseline value and greater than or equal to 50% improvement in the urine protein/creatinine ratio with 1 of the following: urine protein/creatinine ratio (UPCR) <113 mg/mmol, if the baseline ratio was <= 339 mg/mmol OR UPCR <339 mg/mmol,if the baseline ratio >339 mg/mmol. (NCT00430677)
Timeframe: At Day 365 (end of short-term period) and Day 645

,,
Interventionparticipants (Number)
Day 365Day 645 (n=59, 59, 62)
Abatacept 10/10 mg/kg6659
Abatacept 30/10 mg/kg4647
Placebo7462

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Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period

preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Hemoglobin (g/dL): >3g/dL decrease from preRX value. Hematocrit(%): <0.75*preRX. Erythrocytes (*10^6 c/uL): <0.75*preRX. Platelet count (*10^9 c/L): <0.67*LLN, or >1.5*ULN, or if preRX 1.25*ULN, or if preRX ULN; if preRX>ULN, use >1.2*preRX or 7.50*10^3 c/uL. Monocytes (absolute) (*10^3 c/uL): If value >2000/mm^3. Basophils (absolute)(*10^3 c/uL): If value >.750*10^3 c/uL. Eosinophils (absolute) (*10^3 c/uL): If value >.750*10^3 c/uL. ALP (U/L): >2*ULN, or if preRX>ULN, use >3* preRX. AST (U/L): >3*ULN, or if preRX>ULN, use >4*preRX. ALT (U/L): >3*ULN, or if preRX>ULN, use >4*preRX. GGT (U/L):>2*ULN, or if preRX >ULN, use >3*preRX. Bilirubin, total (mg/dL): >2*ULN, or if preRX>ULN, use >4*preRX. BUN (mg/dL): >1.5*preRX. (NCT00430677)
Timeframe: From start of study drug on Day 365 up to 56 days after last dose in the long-term extension period

InterventionParticipants (Number)
Hemoglobin (low)Hemoglobin (high)Hematocrit (n=210) (low)Hematocrit (n=210) (high)Erythrocytes (low)Erythrocytes (high)Platelet count (n=210) (low)Platelet count (n=210) (high)Leukocytes (low)Leukocytes (high)Neutrophils + Bands (absolute) (low)Neutrophils + Bands (absolute) (high)Lymphocytes (absolute) (low)Lymphocytes (absolute) (high)Monocytes (absolute) (low)Monocytes (absolute) (high)Basophils (absolute) (low)Basophils (absolute) (high)Eosinophils (absolute) (low)Eosinophils (absolute) (high)Alkaline phosphatase (ALP) (low)ALP (high)Aspartate aminotransferase (AST) (low)AST (high)Alanine aminotransferase (ALT) (low)ALT (high)G-glutamyl transferase (GGT) (low)GGT (high)Bilirubin, total (low)Bilirubin, total (high)Blood urea nitrogen (BUN) (low)BUN (high)Creatinine (low)Creatinine (high)
Abatacept 10 mg/kg13NA11NA10NA104094NA590NA0NA0NA8NA3NA3NA5NA14NA0NA9NA16

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Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued)

LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Sodium, serum (mEq/L): <0.95*LLN or >1.05*ULN, or if preRXULN if preRX>ULN, use >1.05*preRX or 1.1*ULN, or if preRX ULN if preRX>ULN, use >1.1*preRX or 1.1*ULN, or if preRXULN. Calcium, total (mg/dL): <0.8*LLN or >1.2*ULN, or if preRXULN if preRX>ULN, use >1.25*preRX or 220 mg/dL. Glucose, fasting serum (mg/dL): <0.8*LLN or >1.5*ULN, or if preRX ULN if preRX>ULN, use >2.0*preRX or 2*preRX. Triglycerides (mg/dL): >=2.5*ULN, or if preRX>ULN, use >=2.5*preRX. Triglycerides, fasting (mg/dL): >=2*ULN, or if preRX>ULN, use >2.0*preRX. (NCT00430677)
Timeframe: From start of study drug on Day 365 up to 56 days after last dose in the long-term extension period

InterventionParticipants (Number)
Sodium, serum (low)Sodium, serum (high)Potassium, serum (n=210) (low)Potassium, serum (n=210) (high)Chloride, serum (low)Chloride, serum (high)Calcium, total (n=210) (low)Calcium, total (n=210) (high)Glucose, serum (low)Glucose, serum (high)Glucose, fasting serum (low) (n=143)Glucose, fasting serum (high) (n=143)Protein, total (low)Protein, total (high)Albumin (low)Albumin (high)Cholesterol, total (low) (n=32)Cholesterol, total (high) (n=32)Triglycerides (low) (n=20)Triglycerides (high) (n=20)Triglycerides, fasting (low) (n=18)Triglycerides, fasting (high) (n=18)Protein, urine (low)Protein, urine (high)Glucose, urine (low)Glucose, urine (high)Blood, urine (low)Blood, urine (high)Leukocyte esterase, urine (low) (n=185)Leukocyte esterase, urine (high) (n=185)
Abatacept 10 mg/kg1211300122322219012NA32NA20NA18NANA9NA1NA35NA27

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Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued)

preRX=pretreatment. Protein, urine: If missing preRX, use >=2, or if value >=4, or if preRX =0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 OR 3 then use >=4. Glucose, urine: If missing preRX, use >=2, or if value >=4, or if preRX=0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 or 3, use >=4. Blood, urine: If missing preRX, use >=2, or if value >=4, or if preRX =0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 or 3, use >=4. Leukocyte esterase, urine: If missing preRX, use >=2, or if value >=4, or if preRX=0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 or 3, use >=4. (NCT00430677)
Timeframe: From start of study drug on Day 365 to up to 56 days after last dose in the long-term extension period

InterventionParticipants (Number)
Protein, urine (low)Protein, urine (high)Glucose, urine (low)Glucose, urine (high)Blood, urine (low)Blood, urine (high)Leukocyte esterase, urine (low) (n=185)Leukocyte esterase, urine (high) (n=185)
Abatacept 10 mg/kgNA9NA1NA35NA27

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Number of Participants With Positive Abatacept-induced Responses (ECL Method) Over Time During the Short-term Period

A validated, sensitive electrochemiluminescence (ECL) immunoassay based on Meso-Scale Discovery instrumentation was used to evaluate immunogenicity. The ECL assay differentiated between two antibody specificities: (1) the 'Ig and/or Junction (Jn) Region' and (2) 'CLTA4 and possibly Ig'. A sample was considered positive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept with or without CTLA4-T. (NCT00430677)
Timeframe: Day 169, Day 365

,
InterventionParticipants (Number)
CTLA4 and possibly Ig; Day 169 (n=90)CTLA4 and possibly Ig; Day 365 (n=74)CTLA4 and possibly Ig;Overall on TRT visits (n=90)CTLA4 and possibly Ig; Overall Post visits (n=20)CTLA4 and possibly Ig; Overall (n=96)Ig/Jn region; Day 169 (n=90)Ig/Jn region; Day 365 (n=78)Ig/Jn region; Overall on TRT visits (n=90)Ig/Jn region; Overall on Post visits (n=20)Ig/Jn region; Overall (n=95)
Abatacept 10/10 mg/kg1015600011
Abatacept 30/10 mg/kg2137901101

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Vital Signs Summary During the Short-term Period: Heart Rate

(NCT00430677)
Timeframe: 0 - 12 Months

,,
Interventionbeats per minute (Mean)
Day 1: before infusion; n=99,98,100Day 1: 1hour after infusion; n=98,98,98Day 1: 2.5 hours after infusion; n=97,96,96Day 15: before infusion; n=97,93,99Day 15: 1hour after infusion; n=96,94,98Day 15: 2.5 hours after infusion; n=93,92,95Day 29: before infusion; n=94,93,99Day 29: 1hour after infusion; n=93,92,99Day 29: 2.5 hours after infusion; n=92,90,97Day 57: before infusion; n=93,88,84Day 57: 1hour after infusion; n=93,84,94Day 57: 2.5 hours after infusion; n=91,84,91Day 85: before infusion; n=89,86,91Day 85: 1hour after infusion; n=88,84,89Day 113: before infusion; n=88,82,92Day 113: 1hour after infusion; n=87,80,91Day 141: before infusion; n=84,82,89Day 141: 1hour after infusion; n=84,81,86Day 169: before infusion; n=85,82,86Day 169: 1hour after infusion; n=84,82,85Day 197: before infusion; n=83,82,84Day 197: 1hour after infusion; n=82,82,85Day 225: before infusion; n=83,76,81Day 225: 1hour after infusion; n=83,76,81Day 253: before infusion; n=78,77,81Day 253: 1hour after infusion; n=78,77,81Day 281: before infusion; n=75,76,77Day 281: 1hour after infusion; n=74,76,76Day 309: before infusion; n=76,75,77Day 309: 1hour after infusion; n=76,74,77Day 337: before infusion; n=73,75,80Day 337: 1hour after infusion; n=73,73,79
Abatacept 10/10 mg/kg79.279.682.281.080.181.780.879.982.182.281.683.482.380.480.480.279.379.178.078.878.178.777.678.079.179.378.377.676.577.476.477.4
Abatacept 30/10 mg/kg82.481.381.883.181.381.583.781.781.383.481.082.584.883.382.181.882.881.480.179.581.779.880.179.181.478.880.178.079.877.978.577.6
Placebo82.681.983.883.782.684.783.081.784.782.881.883.882.583.583.082.682.681.379.181.479.379.678.980.281.579.579.378.778.278.478.978.3

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Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP)

(NCT00430677)
Timeframe: 0 - 12 Months

,,
InterventionmmHg (Mean)
Day 1: SBP-before infusion; n=76,81,73Day 1: SBP-1hour after infusion; n=69,78,70Day 1: SBP-2.5 hours after infusion; n=79,81,76Day 15: SBP-before infusion; n=78,78,74Day 15: SBP- 1hour after infusion; n=72,75,71Day 15: SBP-2.5 hours after infusion; n=80,78,78Day 29: SBP-before infusion; n=77,79,75Day 29: SBP-1hour after infusion; n=72,75,74Day 29: SBP-2.5 hours after infusion; n=80,79,82Day 57: SBP-before infusion; n=74,76,70Day 57: SBP-1hour after infusion; n=74,69,68Day 57: SBP-2.5 hours after infusion; n=81,73,73Day 85: SBP- before infusion; n=73,71,67Day 85: SBP-1hour after infusion; n=73,69,72Day 113: SBP-before infusion; n=72,70,70Day 113: SBP-1hour after infusion; n=75,70,75Day 141: SBP-before infusion; n=66,70,66Day 141: SBP-1hour after infusion; n=72,71,70Day 169: SBP-before infusion; n=70,70,66Day 169: SBP-1hour after infusion; n=75,71,71Day 197: SBP-before infusion; n=68,70,64Day 197: SBP-1hour after infusion; n=72,73,70Day 225: SBP-before infusion; n=70,64,63Day 225: SBP-1hour after infusion; n=72,65,68Day 253: SBP-before infusion; n=63,66,63Day 253: SBP-1hour after infusion; n=69,67,67Day 281: SBP-before infusion; n=63,66,58Day 281: SBP-1hour after infusion; n=66,65,64Day 309: SBP-before infusion; n=63,63,59Day 309: SBP-1hour after infusion; n=67,66,64Day 337: SBP-before infusion; n=63,64,61Day 337: SBP-1hour after infusion; n=68,65,67
Abatacept 10/10 mg/kg127.8126.7127.8125.5125.9124.9126.2125.9126.4124.8122.1123.6118.7119.6121.7121.0119.2117.9117.6118.2118.9117.4118.8119.5120.2117.1116.5119.4116.3114.1117.3117.7
Abatacept 30/10 mg/kg128.2127.7127.1127.6126.9130.1125.6126.2126.3126.4124.6127.0122.0121.8122.6121.5121.4120.9118.5120.3119.0117.7118.2116.6120.6118.1120.7119.5119.4119.6119.9120.4
Placebo126.2126.0126.2129.2128.2131.2126.9128.6127.6123.0124.4126.1122.2122.0119.9120.1118.8120.4118.6118.9118.7120.4119.5118.8120.9119.7120.3121.0120.5119.2119.3119.3

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Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs Reported During the Short-term Period

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=possibly, probably, or certainly related to and of unknown relationship to study drug. (NCT00430677)
Timeframe: From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.

,,
InterventionParticipants (Number)
DeathsSAEsRelated SAEsAEsRelated AEsDiscontinued due to AEs
Abatacept 10/10 mg/kg22819895313
Abatacept 30/10 mg/kg53320936114
Placebo7311594559

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Participants With AEs of Special Interest During the Short-term Period

AEs of special interest were prospectively identified to be those that may be associated with the use of immunomodulatory agents. They are a subset of all AEs and may be either serious or non-serious. (NCT00430677)
Timeframe: From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.

,,
InterventionParticipants (Number)
Infections and InfestationsMalignanciesAutoimmune DisordersAcute Infusional AEsPeri-infusional AEs
Abatacept 10/10 mg/kg70151818
Abatacept 30/10 mg/kg75042323
Placebo75131717

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Participants With Marked Abnormalities Urinalysis During the Short-term Period

PTV=pretreatment value. Criteria for marked abnormality: Protein, glucose, blood, leukocyte esterase , if missing PTV then use >=2+ (or, if value >=4, or if PTV=0 or 0.5, >=2 or if PTV=1, >=3, or if PTV=2 or 3, >=4). (NCT00430677)
Timeframe: From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.

,,
InterventionParticipants (Number)
Urine Protein (n=99,98,99)Urine Glucose (n=99,98,99)Urine Blood (n=99,98,99)Urine Leukocyte esterase (n=85,91,90)
Abatacept 10/10 mg/kg33198
Abatacept 30/10 mg/kg611610
Placebo80178

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Participants With Marked Hematology Abnormalities During the Short-term Period

LLN=lower limit of normal; ULN=upper limit of normal; PTV=pretreatment value. Normal ranges are provided by the Central Laboratory and may vary according to sex and age. Low(↓)Hemoglobin:>3g/dL decrease from PTV; ↓Hematocrit:<0.75xPTV;↓Erythrocyte count:<0.75xPTV; high(↑)Platelet count:>1.5xULN;↓Platelet count:<0.67xLLN;↓Leukocyte count:<0.75X LLN;↑Leukocyte count:>1.25xULN;↓Absolute(AB)Neutrophils+Bands:<1.00x10^3c/uL;↑AB Lymphocyte count:>7.50x10^3 c/uL; ↓AB lymphocyte count:<0.750x10^3 c/uL;↑AB monocyte count:>2000/mm^3;↑AB basophil count:>400/mm^3;↑AB eosinophil count:>0.750x10^3 c/uL. (NCT00430677)
Timeframe: From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.

,,
InterventionParticipants (Number)
Low Hemoglobin (n=98, 98, 99)Low Hematocrit (n=97, 98, 99)Low Erythrocyte Count (n=98, 98, 99)High Platelet Count (n=98, 98, 98)Low Platelet Count (n=98, 98, 98)High Leukocyte Count (n=98, 98, 99)Low Leukocyte Count (n=98,98,99)Low Absolute Neutrophils + Bands (n=98,98,99)High Absolute Lymphocyte Count (n=98,98,99)Low Absolute Lymphocyte Count (n=98, 98, 99)High Absolute Monocyte Count (n=98, 98, 99)High Absolute Basophil Count (n=98, 98, 99)High Absolute Eosinophil Count (n=98, 98, 99)
Abatacept 10/10 mg/kg3110310182232103
Abatacept 30/10 mg/kg6541115131047100
Placebo9771111167053100

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Participants With Marked Laboratory Abnormalities During the Short-term Period

LLN=lower limit of normal; ULN=upper limit of normal; PTV=pretreatment value. Normal ranges are provided by the Central Laboratory and may vary according to sex and age. ↑Serum Sodium:>1.05x ULN;↓Serum Potassium:<0.9x LLN;↑Serum Potassium:>1.1x ULN;↓Total Calcium:<0.8X LLN;↑Total Calcium:>1.2x ULN; ↓Serum Glucose(SG):<65 mg/dL;↑SG:>220 mg/dL;↓Fasting SG:<0.8x LLN;↑Fasting SG:>1.5x ULN;↓Total Protein:<0.9x LLN;↓Albumin:<0.9x LLN;↑Total Cholesterol:>2x PTV;↑Triglycerides:>=2.5x ULN;↑Fasting Triglycerides:>=2x ULN (NCT00430677)
Timeframe: From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.

,,
InterventionParticipants (Number)
High Serum Sodium (n=98, 98, 99)Low Serum Potassium (n=98, 98, 99)High Serum Potassium (n=98, 98, 99)Low Total Calcium (n=98, 98, 99)High Total Calcium (n=98, 98, 99)Low Serum Glucose (n=98, 98, 99)High Serum Glucose (n=98, 98, 99)Low Fasting Serum Glucose (n=72, 73, 68)High Fasting Serum Glucose (n=72, 73, 68)Low Total Protein (n=98, 98, 99)Low Albumin (n=98, 98, 99)High Total Cholesterol (n=93,93,96)High Triglycerides (n=71, 79, 75)High Fasting Triglycerides (n=65, 64, 63)
Abatacept 10/10 mg/kg21401216221186000
Abatacept 30/10 mg/kg112401122311810223
Placebo01521118200254100

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Participants With Marked Liver and Kidney Function Abnormalities During the Short-term Period

"ULN=upper limit of normal; PTV=pretreatment value. Normal ranges are provided by the Central Laboratory and may vary according to sex and age.~Alkaline Phosphatase:>2x ULN; ↑Aspartate Aminotransferase: >3x ULN; ↑Alanine Aminotransferase : >3x ULN; G-Glutamyl Transferase : >2x ULN; ↑Total Bilirubin : >2x ULN or if PTV > ULN then > 4x PTV; ↑Blood Urea Nitrogen >2x PTV; ↑Creatinine >1.5x PTV." (NCT00430677)
Timeframe: From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.

,,
InterventionParticipants (Number)
High Alkaline PhosphataseHigh Aspartate AminotransferaseHigh Alanine AminotransferaseHigh G-Glutamyl TransferaseHigh Total BilirubinHigh Blood Urea NitrogenHigh Creatinine
Abatacept 10/10 mg/kg1047016
Abatacept 30/10 mg/kg12770516
Placebo10150612

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Vital Signs Summary During the Short-term Period: Temperature

(NCT00430677)
Timeframe: 0 - 12 Months

,,
Interventiondegree celcius (Mean)
Day 1: before infusion; n=99,98,99Day 1: 1hour after infusion; n=98,96,97Day 1: 2.5 hours after infusion; n=97,93,97Day 15: before infusion; n=97,94,99Day 15: 1hour after infusion; n=96,91,98Day 15: 2.5 hours after infusion; n=93,91,95Day 29: before infusion; n=94,93,99Day 29: 1hour after infusion; n=93,91,98Day 29: 2.5 hours after infusion; n=92,90,97Day 57: before infusion; n=93,88,93Day 57: 1hour after infusion; n=93,83,94Day 57: 2.5 hours after infusion; n=90,84,90Day 85: before infusion; n=89,86,91Day 85: 1hour after infusion; n=87,84,89Day 113: before infusion; n=88,82,92Day 113: 1hour after infusion; n=87,79,91Day 141: before infusion; n=84,81,89Day 141: 1hour after infusion; n=84,80,86Day 169: before infusion; n=85,81,86Day 169: 1hour after infusion; n=84,80,84Day 197: before infusion; n=83,82,85Day 197: 1hour after infusion; n=82,81,84Day 225: before infusion; n=83,76,81Day 225: 1hour after infusion; n=83,75,81Day 253: before infusion; n=78,77,80Day 253: 1hour after infusion; n=78,77,81Day 281: before infusion; n=75,76,77Day 281: 1hour after infusion; n=74,76,76Day 309: before infusion; n=76,75,77Day 309: 1hour after infusion; n=75,73,77Day 337: before infusion; n=73,75,79Day 337: 1hour after infusion; n=73,72,79
Abatacept 10/10 mg/kg36.536.536.536.536.536.536.436.536.536.436.436.536.436.436.436.436.436.436.436.436.336.336.436.436.436.436.436.436.336.436.436.4
Abatacept 30/10 mg/kg36.636.636.636.536.636.636.536.536.536.536.136.536.436.436.536.436.536.536.536.436.536.436.536.536.536.536.536.536.536.536.536.5
Placebo36.536.636.636.536.536.636.536.536.536.536.636.536.536.536.536.536.536.536.536.536.536.536.436.536.536.536.536.536.536.536.536.5

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Number of Participants Achieving Patient Response (PR) at Month 12 During the Short-term Period

"PR is either CRR, Partial Renal Response(PRR),or no Response(NR).~CRR= Serum creatinine(SC)is normal, Inactive urinary sediment, No cellular casts, Urinary protein/creatinine (UPCR) ratio <56.5 mg/mmoL; PRR= SC is normal OR SC not >25% above BL, RBCs at reference range, UPCR <56.5 mg/mmoL OR ≥50% improvement in UPCR with one of the following: UPCR <113 or <339 mg/mmoL, based on the BL ratio; NR= Not achieving either a CRR or a PRR. Participants achieved response if criteria at both months 11 and 12 (Days 337 and 365) were met. Participants who Early discontinuations were categorized as NR." (NCT00430677)
Timeframe: Month 12

,,
InterventionParticipants (Number)
No Renal ResponsePartial Renal ResponseComplete Renal Response
Abatacept 10/10 mg/kg69921
Abatacept 30/10 mg/kg611424
Placebo661420

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Baseline Physical Component Summary of the Short Form (SF)-36 During Short-term Period

The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value. (NCT00430677)
Timeframe: Baseline (Day 1), Days 85, 169, 253, and 365

,,
InterventionUnits on a scale (Mean)
Baseline (Day 1) for Day 85 (n=89, 91, 93)Baseline (Day 1) for Day 169 (n=92, 94, 96)Baseline (Day 1) for Day 253 (n=92, 94, 96)Baseline (Day 1) for Day 365 (n=92, 94, 96)
Abatacept 10/10 mg/kg43.8044.1744.1744.17
Abatacept 30/10 mg/kg42.1842.0442.0442.04
Placebo42.6842.4842.4842.48

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Change in SLICC/ACR Damage Index From Baseline During Short-term Period

SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as non-reversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 48, and increasing score indicates increasing disease severity. Change from baseline=Postbaseline - baseline value. (NCT00430677)
Timeframe: Baseline (Day 1), Postbaseline (Month 12 or 28 days after last dose)

InterventionUnits on a scale (Mean)
Abatacept 30/10 mg/kg0.17
Abatacept 10/10 mg/kg0.11
Placebo0.13

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Number of Months CRR Was Maintained During Short-term Period

Durability of CRR, defined as the number of months (number of consecutive planned visits beyond Day 15) a participant met the definition of CRR during the double-blind treatment period. Refer to outcome 1 for description of CRR. (NCT00430677)
Timeframe: Day 1 (randomization) to 12 Months

InterventionMonths (Median)
Abatacept 30/10 mg/kg0
Abatacept 10/10 mg/kg0
Placebo0

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Number of Participants Achieving Renal Response (RR) at Month 12 During Short-term Period

RR is defined as meeting BOTH of the following criteria:RENAL FUNCTION: Less than or equal to 25% increase from baseline;PROTEINURIA: Greater than or equal to 50% improvement in the urine protein/creatinine ratio with one of the following - urine protein/creatinine ratio (UPCR) <113 mg/mmol,, if the baseline ratio was <=339 mg/mmol OR UPCR <339 mg/mmol,if the baseline ratio > 339 mg/mmol. A participant was considered as achieving RR if response criteria at both months 11 and 12 (Days 337 and 365, respectively) were met. For 95% CI within each group, normal approximation is used if n>=5. (NCT00430677)
Timeframe: Month 12

InterventionParticipants (Number)
Abatacept 30/10 mg/kg45
Abatacept 10/10 mg/kg39
Placebo33

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Number of Participants With a Treatment-emergent Seropositive Result During the Long-term Extension Period

Collected in at least 1 sample. Assessment includes immunogenicity (detection of serum antibodies which bind to CTLA4-Ig in the in vitro assays) and exposure to corticosteroids (NCT00430677)
Timeframe: Day 365 to end of long-term extension period

InterventionParticipants (Number)
Abatacept 10 mg/kg17

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Change From Baseline in Mental Component Summary of the SF-36 During Short-term Period

The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value. (NCT00430677)
Timeframe: Baseline (Day 1), Days 85, 169, 253, and 365

,,
InterventionUnits on a scale (Mean)
Day 85 (n=89, 91, 93)Day 169 (n=92, 94, 96)Day 253 (n=92, 94, 96)Day 365 (n=92, 94, 96)
Abatacept 10/10 mg/kg3.105.084.834.23
Abatacept 30/10 mg/kg1.072.902.452.62
Placebo1.873.692.992.84

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Participants Achieving a Confirmed Complete Renal Response (CRR) at Month 12 During Short-term Period

Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate [GFR] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported. (NCT00430677)
Timeframe: At Month 12 from Day 1

InterventionParticipants (Number)
Abatacept 30/10 mg/kg9
Abatacept 10/10 mg/kg11
Placebo8

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Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP)

(NCT00430677)
Timeframe: 0 - 12 Months

,,
Interventionmm Hg (Mean)
Day 1: DBP-before infusion; n=76,81,73Day 1: DBP-1hour after infusion; n=69,78,70Day 1: DBP-2.5 hours after infusion; n=79,81,76Day 15: DBP-before infusion; n=78,78,74Day 15: DBP- 1hour after infusion; n=72,75,71Day 15: DBP-2.5 hours after infusion; n=80,78,78Day 29: DBP-before infusion; n=77,79,75Day 29: DBP-1hour after infusion; n=72,75,74Day 29: DBP-2.5 hours after infusion; n=80,79,82Day 57: DBP-before infusion; n=74,76,70Day 57: DBP-1hour after infusion; n=74,69,68Day 57: DBP-2.5 hours after infusion; n=81,73,73Day 85: DBP- before infusion; n=73,71,67Day 85: DBP-1hour after infusion; n=73,69,72Day 113: DBP-before infusion; n=72,70,70Day 113: DBP-1hour after infusion; n=75,70,75Day 141: DBP-before infusion; n=66,70,66Day 141: DBP-1hour after infusion; n=72,71,70Day 169: DBP-before infusion; n=70,70,66Day 169: DBP-1hour after infusion; n=75,71,71Day 197: DBP-before infusion; n=68,70,64Day 197: DBP-1hour after infusion; n=72,73,70Day 225: DBP-before infusion; n=70,64,63Day 225: DBP-1hour after infusion; n=72,65,68Day 253: DBP-before infusion; n=63,66,63Day 253: DBP-1hour after infusion; n=69,67,67Day 281: DBP-before infusion; n=63,66,58Day 281: DBP-1hour after infusion; n=66,65,64Day 309: DBP-before infusion; n=63,63,59Day 309: DBP-1hour after infusion; n=67,66,64Day 337: DBP-before infusion; n=63,64,61Day 337: DBP-1hour after infusion; n=68,65,67
Abatacept 10/10 mg/kg80.679.679.080.078.778.078.878.078.278.775.376.175.275.677.076.374.074.774.174.475.874.573.674.575.974.973.374.572.972.973.473.3
Abatacept 30/10 mg/kg80.879.679.381.179.681.479.679.978.580.078.979.579.778.178.576.178.877.875.576.576.876.174.575.076.174.577.675.978.176.478.078.1
Placebo80.480.180.982.680.482.881.380.879.578.778.780.278.778.176.776.976.576.177.076.475.875.475.776.077.175.776.676.677.476.676.276.1

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Percent Probability of Participants With 6-month Progression-free Survival (PFS)

PFS is the proportion of subjects who progress or die by 6 months after the start of the combined therapy. PFS is determined by prostatic specific antigen (PSA) consensus criteria and the Response Evaluation Criteria in Solid Tumors (RECIST). PSA consensus criteria is defined as PSA decline of >/= 50% or PSA progression. RECIST is defined as the following: Complete response (CR) is disappearance of all target lesions; partial response (PR) is at least a 30% decline in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; and stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease ((PD) at least a 20% increase in the sum of the LD of target lesions, or the appearance of one or more lesions), taking as reference the smallest sum LD since the treatment started. Data is estimated and the probability of PFS as a function of time was determined using the Kaplan-Meier method. (NCT00436956)
Timeframe: 6 months

Interventionpercent probability (Number)
All Participants - AZD2171 & Prednisone43.9

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Number of Grade 3 Toxicities

Here is the number of Grade 3 (severe) toxicities. (NCT00436956)
Timeframe: 61.5 months

,
Interventiontoxicities (Number)
HypertensionFatigueAnorexiaWeight lossHypothyroidismDehydrationProlonged QTcNauseaDiarrheaHypoalbuminemiaProteinuriaElevated alkaline phosphataseAspartate transaminaseVomitingHyperbilirubinemiaMuscle weakness
20 mg AZD2171 + 10mg Prednisone Daily0210031000000001
20 mg AZD2171 Daily0412031100052113

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Response Per the Response Evaluation Criteria in Solid Tumors (RECIST)

Response was evaluated by the RECIST. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD)is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. (NCT00436956)
Timeframe: Every 2 cycles (approximately 56 days)

InterventionParticipants (Count of Participants)
Complete ResponseConfirmed Partial ResponseUnconfirmed Partial ResponseNot Evaluable
All Participants - AZD2171 & Prednisone0611

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Median Overall Survival

Time from treatment start date until date of death or date last known alive. (NCT00436956)
Timeframe: 44 months

InterventionMonths (Median)
20 mg AZD2171 Daily11.7
20 mg AZD2171 + 10mg Prednisone Daily9.9

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Number of Grade 2 Toxicities

Here is the number of Grade 2 (moderate) toxicities. (NCT00436956)
Timeframe: 61.5 months

,
Interventiontoxicities (Number)
HypertensionFatigueAnorexiaWeight lossHypothyroidismDehydrationProlonged QTcNauseaDiarrheaHypoalbuminemiaProteinuriaElevated alkaline phosphataseAspartate transaminaseVomitingHyperbilirubinemiaMuscle weakness
20 mg AZD2171 + 10mg Prednisone Daily8464622303323211
20 mg AZD2171 Daily17151211788785543442

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Number of Participants With Adverse Events

Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. (NCT00436956)
Timeframe: Date treatment consent signed to date off study, approximately 61.5 months

InterventionParticipants (Count of Participants)
All Participants- AZD2171 & Prednisone59

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Median Progression Free Survival (PFS)

Time interval from start of treatment to documented evidence of disease progression. (NCT00436956)
Timeframe: up to 14.9 months based on a Kaplan-Meier analysis.

InterventionMonths (Median)
20 mg AZD2171 Daily3.6
20 mg AZD2171 + 10mg Prednisone Daily3.7

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Clinical Remission on Medication

6 months of clinical inactive disease (NCT00443430)
Timeframe: 12 months or end of study

Interventionparticipants (Number)
Methotrexate Arm3
Methotrexate-Prednisolone-Etanercept Arm9

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Safety Profiles, Including the Number of Treatment-emergent, Serious, or Unexpected Adverse Events and Other Important Medical Events

(NCT00443430)
Timeframe: Over 12 months maximum study participation per subject

Interventionevents (Number)
Methotrexate Arm1
Methotrexate-Prednisolone-Etanercept Arm2

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Proportion of Participants Who Attain Inactive Disease by 6 Months

(NCT00443430)
Timeframe: 6 months after initiation of study intervention

Interventionparticipants (Number)
Methotrexate Arm10
Methotrexate-Prednisolone-Etanercept Arm17

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Number of Participants From Whom Fixed Tissue Samples Were Collected for Future Studies.

Number of participants from whom paraffin-embedded DLBCL tissue samples were collected for future studies. (NCT00450385)
Timeframe: Baseline

InterventionParticipants (Count of Participants)
R-CHOP57

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PFS of Participants With High or Low Expression of Protein Biomarkers and Correlation of Biomarkers to PFS

Reported is PFS of participants (pts) with high or low biomarker expression levels. PFS: time from randomization to first date of PD/death from any cause. PD assessed according to International Working Group recommendations (Cheson et al. 1999). PD: Enlarging liver/spleen nodules, new/increased lymph node/masses and reappearance of bone marrow infiltrate. For pts who had subsequent anticancer therapy, PFS censored at date of last assessment prior to subsequent therapy. Biomarkers and number of pts censored: EIF4EBP1 Cytoplasm (C) 4,3,7,3; EIF4EBP1 Nucleus (N) 0,2,11,4; EIF4E C 5,2,6,4; EIF4E N 0,0,11,6; HDAC2 N 5,1,5,5; PCREB N 5,3,6,4; PEIF3746 C 4,2,7,4; PEIF3746 N 5,2,6,4; PEIFS209 C 5,2,5,4; PEIFS65 N 7,2,4,4; PEIFT70 C 5,2,6,4; PEIFT70 N 6,4,5,2; P GSK3B C 7,3,4,3; PKCb2 C 4,3,7,3; PS6 C 9,4,1,1; PTEN C 5,2,6,4; PTEN N 3,0,8,6. Correlation of biomarkers with PFS (statistical analyses) reported if high expression groups combined and low expression groups combined each had ≥10 pts. (NCT00451178)
Timeframe: Randomization to measured PD or death from any cause (up to 55 months)]

,,
Interventionmonths (Median)
Marker: EIF4EBP1 CytoplasmMarker: EIF4EBP1 NucleusMarker: EIF4E CytoplasmMarker: EIF4E NucleusMarker: HDAC2 NucleusMarker: PCREB NucleusMarker: PEIF3746 CytoplasmMarker: PEIF3746 NucleusMarker: PEIFS209 CytoplasmMarker: PEIFS65 NucleusMarker: PEIFT70 CytoplasmMarker: PEIFT70 NucleusMarker: P GSK3B CytoplasmMarker: PKCb2 CytoplasmMarker: PS6 CytoplasmMarker: PTEN CytoplasmMarker: PTEN Nucleus
High Biomarker Expression (R-CHOP)9.49NA21.424.5010.5510.5520.90NA9.20NANA32.3021.4210.5510.0221.426.34
Low Biomarker Expression (R-CHOP and Enzastaurin)27.96NA27.96NANANANANA27.9627.9627.9627.96NANA16.57NANA
Low Biomarker Expression (R-CHOP)32.3010.55NA32.30NANANA32.30NA32.3010.55NA9.4920.90NA9.4932.30

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Percentage of Participants With Complete Response (CR and CRu) and Objective Response [CR, CRu, and Partial Response (PR)] (Overall Response Rate)

CR, CRu, and PR were defined using International Working Group recommendations (Cheson et al. 1999). CR is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow must be negative if positive at baseline. Normalization of markers. CRu does not qualify for CR above, due to a residual nodal mass or an indeterminate bone marrow. PR is a 50% decrease in the sum of the products of diameters for up to 6 identified dominant lesions, including splenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. The percentage of participants with complete response (CR/CRu) and objective response (Cr/CRu/PR)=(Number of participants whose best overall response was CR/CRu or Cr/CRu/PR)/(Number of participants treated)*100. (NCT00451178)
Timeframe: Baseline through long-term follow-up (up to 2 years post last dose)

,
Interventionpercentage of participants (Number)
Complete ResponseObjective Response
R-CHOP42.985.7
R-CHOP and Enzastaurin51.883.9

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Participants Who Had Treatment-Emergent Adverse Events (TEAEs) or Died (Evaluate Toxicity and Tolerability of R-CHOP Plus Enzastaurin)

Data presented are the number of participants who experienced at least 1 TEAE, Grade 3 or 4 Common Terminology Criteria for Adverse Events (CTCAE), serious adverse event (SAE), as well as the number of participants who discontinued due to an adverse event (AE) or SAE, who died on therapy, died within 30 days post treatment or within 60 days of first dose. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. (NCT00451178)
Timeframe: First dose through 30 days post study treatment discontinuation (up to 56 months)

,
InterventionParticipants (Count of Participants)
At Least 1 TEAEAt Least 1 Grade 3/4 CTCAEAt Least 1 SAEDiscontinued due to AEDiscontinued due to SAEDied on Therapy (all causes)Died within 30 days post treatment discontinuationDied within 60 days of first dose
R-CHOP43301863332
R-CHOP and Enzastaurin565035104563

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Progression-Free Survival (PFS) Time

PFS time is the elapsed time from the date of randomization to the first date of objectively-determined PD or death from any cause. PD was assessed according to International Working Group recommendations (Cheson et al. 1999). PD: Enlarging liver/spleen nodules, new or increased lymph nodes/masses and reappearance of bone marrow infiltrate. For participants not known to have died as of the data cut-off date and who did not have objective PD, PFS was censored at the date of the last objective progression-free disease assessment. For participants who received subsequent anticancer therapy (other than enzastaurin maintenance therapy) prior to objectively determined disease progression or death, PFS was censored at the date of the last objective progression-free disease assessment prior to the date of subsequent therapy. (NCT00451178)
Timeframe: Randomization to measured PD or death from any cause (up to 55 months)

Interventionmonths (Median)
R-CHOP and Enzastaurin36.2
R-CHOP22.6

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Percentage of Participants With a PET-Negative Scan (PET-Negative Rate)

The percentage of participants with a PET-negative scan=(Number of participants who had a PET-negative scan at Cycle 6)/(Number of participants who had a PET-positive scan at baseline)*100. (NCT00451178)
Timeframe: Cycle 6 (21 days/cycle)

Interventionpercentage of participants (Number)
R-CHOP and Enzastaurin44.6
R-CHOP41.0

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Percentage of Participants Alive Progression-Free at Year 2 (2-Year PFS Rate)

PD was assessed according to International Working Group recommendations (Cheson et al. 1999). PD: Enlarging liver/spleen nodules, new or increased lymph nodes/masses and reappearance of bone marrow infiltrate. Percentage of participants alive progression-free at Year 2=(Number of participants alive progression free at Year 2)/(Number of participants assessed)*100. (NCT00451178)
Timeframe: Randomization to measured PD (up to Year 2)

Interventionpercentage of participants (Number)
R-CHOP and Enzastaurin59
R-CHOP49

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Overall Survival (OS)

OS is the elapsed time from the date of study enrollment (baseline) to the date of death from any cause. For participants not known to have died as of the data cutoff date, OS was censored at the last contact date or last date known to be alive, whichever was later. (NCT00451178)
Timeframe: Baseline to death from any cause (up to 55 months)

Interventionmonths (Median)
R-CHOP and EnzastaurinNA
R-CHOPNA

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Event-Free Survival (EFS)

EFS is the elapsed time from the date of randomization to the first date of objectively-determined PD, institution of a new anticancer treatment (other than maintenance therapy), or death from any cause. PD was assessed according to International Working Group recommendations (Cheson et al. 1999). PD: Enlarging liver/spleen nodules, new or increased lymph nodes/masses and reappearance of bone marrow infiltrate. For participants not known to have died as of the data cut-off date, who did not have objectively determined disease progression, and who were not treated with a new anticancer treatment, EFS was censored at the date of the last objectively determined disease-free assessment. (NCT00451178)
Timeframe: Randomization to measured PD, start of new therapy, or death from any cause (up to 55 months)

Interventionmonths (Median)
R-CHOP and Enzastaurin36.2
R-CHOP22.6

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Duration of Complete Response (CR or CRu)

Duration of response (DOR) either CR or CRu: Elapsed time from date CR or CRu criteria met to first objectively-determined PD. For responding participants (pts) who died without PD and pts not known to have died as of data cut-off date, who did not have PD, DOR censored at date of last objective progression-free disease assessment. For responding pts who received subsequent systemic anticancer therapy (other than enzastaurin maintenance therapy) prior to PD, DOR was censored at date of last objective progression-free disease assessment prior to subsequent therapy. CR and CRu defined using International Working Group recommendations (Cheson et al. 1999). CR is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. CRu does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. (NCT00451178)
Timeframe: Time of response to PD (up to 55 months)

Interventiondays (Median)
R-CHOP and EnzastaurinNA
R-CHOPNA

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Percentage of Participants With Complete Response (CR/CRu) and/or Post-Baseline PET-Negative Scan (Concordance Between Response and PET Scan)

Lesion response was assessed according to International Working Group recommendations (Cheson et al. 1999). CR is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow must be negative if positive at baseline. Normalization of markers. CRu does not qualify for CR above, due to a residual nodal mass or an indeterminate bone marrow. Percentage of participants with CR/CRu and/or PET-negative scan=(Number of participants with complete response and/or PET-negative scan at Cycle 6)/(Number of participants with a PET-positive scan at baseline)*100. (NCT00451178)
Timeframe: Cycle 6 (21 days/cycle)

,
Interventionpercentage of participants (Number)
CR/CRu and PET-Negative Post-BaselineCR/CRu or PET-Negative Post-Baseline
R-CHOP25.643.6
R-CHOP and Enzastaurin26.853.6

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PFS of Participants With High or Low Expression of Protein Biomarkers and Correlation of Biomarkers to PFS

Reported is PFS of participants (pts) with high or low biomarker expression levels. PFS: time from randomization to first date of PD/death from any cause. PD assessed according to International Working Group recommendations (Cheson et al. 1999). PD: Enlarging liver/spleen nodules, new/increased lymph node/masses and reappearance of bone marrow infiltrate. For pts who had subsequent anticancer therapy, PFS censored at date of last assessment prior to subsequent therapy. Biomarkers and number of pts censored: EIF4EBP1 Cytoplasm (C) 4,3,7,3; EIF4EBP1 Nucleus (N) 0,2,11,4; EIF4E C 5,2,6,4; EIF4E N 0,0,11,6; HDAC2 N 5,1,5,5; PCREB N 5,3,6,4; PEIF3746 C 4,2,7,4; PEIF3746 N 5,2,6,4; PEIFS209 C 5,2,5,4; PEIFS65 N 7,2,4,4; PEIFT70 C 5,2,6,4; PEIFT70 N 6,4,5,2; P GSK3B C 7,3,4,3; PKCb2 C 4,3,7,3; PS6 C 9,4,1,1; PTEN C 5,2,6,4; PTEN N 3,0,8,6. Correlation of biomarkers with PFS (statistical analyses) reported if high expression groups combined and low expression groups combined each had ≥10 pts. (NCT00451178)
Timeframe: Randomization to measured PD or death from any cause (up to 55 months)]

Interventionmonths (Median)
Marker: EIF4EBP1 CytoplasmMarker: EIF4E CytoplasmMarker: HDAC2 NucleusMarker: PCREB NucleusMarker: PEIF3746 CytoplasmMarker: PEIF3746 NucleusMarker: PEIFS209 CytoplasmMarker: PEIFS65 NucleusMarker: PEIFT70 CytoplasmMarker: PEIFT70 NucleusMarker: P GSK3B CytoplasmMarker: PKCb2 CytoplasmMarker: PS6 CytoplasmMarker: PTEN CytoplasmMarker: PTEN Nucleus
High Biomarker Expression (R-CHOP and Enzastaurin)NANA27.9624.1027.96NANANANANA27.9627.96NA27.9627.96

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Median Overall Survival (OS)

Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS. (NCT00452387)
Timeframe: Overall survival was measured from day 1 of treatment until the end of treatment and then every 3 months thereafter until death.

InterventionMonths (Median)
Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib12.32

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Correlation of Biochemical Criteria (PSA, Prostate-specific Antigen) With Objective Imaging

The test of association assesses the null hypothesis that the frequency of PSA response is the same for patients with and without a favorable imaging response. PSA response required a 50% reduction of the baseline PSA result that was confirmed three weeks later. Favorable imaging response is defined as stable disease, partial response, or complete response per RECIST guidelines. The Fisher's exact test was used to test this hypothesis. (NCT00452387)
Timeframe: PSA was evaluated on day 1 of every cycle (approximately every 3 weeks) during study treatment. Radiologic imaging was repeated after every 4 cycles (approximately every 12 weeks) during study treatment.

,
InterventionParticipants (Number)
PSA response (> 50% reduction)PSA response (< or = 50% reduction)
Imaging Response (Favorable)36
Imaging Response (Unfavorable)013

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Quality of Life (QoL)

The subject answers questions from the following 6 categories: general physical symptoms, treatment side effects, distress, despair, impaired performance, and impaired ambulation. Each question has a scale from 0 through 10, where 0 is not a problem and 10 is as bad as possible. The scores for the 6 categories are combined and normalized, and used to describe overall quality of life. Because normalized scores are created using a look-up index, there is no clearly defined maximum value. In practice, the maximum value for the combined scale is 73.5. (NCT00452387)
Timeframe: The Patient Care Monitor questionnaire was administered on day 1 of every cycle (approximately every 3 weeks) during study treatment.

Interventionunits on a scale (Mean)
BaselineCycle 1Cycle 2Cycle 3Cycle 4Cycle 5Cycle 6Cycle 7Cycle 8Cycle 9Cycle 10Cycle 11Cycle 12Cycle 13End of Study (at treatment discontinuation)
Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib50.2149.7151.0651.2051.6651.2249.7349.5048.2054.3455.8854.9554.0254.6545.13

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Percentage of Participants Reaching Overall Survival

Overall survival from diagnosis (NCT00458848)
Timeframe: At 60 months

Interventionpercentage of patients (Number)
Philadelphia Positive, Imatinib Only in Induction Therapy48.8

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Number of Patients Reaching Complete Hematological Response After Induction Therapy

(NCT00458848)
Timeframe: At the end of induction, day +50

Interventionparticipants (Number)
Philadelphia Positive, Imatinib Only in Induction Therapy49

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Percentage of Participants Reaching Disease Free Survival

(NCT00458848)
Timeframe: At 60 months

Interventionpercentage of participants (Number)
Philadelphia Positive, Imatinib Only in Induction Therapy45.8

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Response Based on PET Scan

Patients were scanned using Positron Emission Tomography (PET) before and after receiving single agent RAD001. Patients were classified as having partial metabolic response, stable metabolic disease, or progressive metabolic disease based on changes in PET imaging from baseline to post-treatment. A positive FDG-PET for the purposes of this study consisted of a visualized area of abnormal increased FDG uptake that matched the anatomic location of an abnormality seen on bone scan or CT. Metabolic response was assessed for percent change in SUVmax according to the criteria of the European Organization for Research and Treatment of Cancer (EORTC) : partial metabolic response (PMR) ≤ -25%; stable metabolic disease (SMD) -25% + 25%; progressive metabolic disease (PMD) > 25%. (NCT00459186)
Timeframe: 10 to 14 days after study entry

Interventionpercentage of participants (Number)
Partial Metabolic ResponseStable Metabolic DiseaseProgressive Metabolic Disease
RAD001 Followed by RAD001 + Docetaxel226711

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Number of Patients Free of Dose Limiting Toxicity

"A dose limiting toxicity was defined as an adverse event or laboratory abnormality that occurs to patients on the Phase I portion of the trial, during the first 21 days following the first dose of RAD001/docetaxel during cycle 1, judged to be related to RAD001/docetaxel and meeting any of the following criteria:~Hematologic Toxicity:~CTCAE grade 4 neutropenia > 7 days or any Grade 3 or 4 neutropenia with fever Or CTCAE grade 3 or 4 thrombocytopenia > 7 days~Non-hematologic toxicity:~The occurrence of non-hematologic CTCAE grade 3 or 4 adverse events will be considered dose limiting, except for the following:~CTCAE grade 3 nausea or grade 3 or 4 vomiting CTCAE grade 3 or 4 vomiting will only be considered dose limiting if it occurs despite the use of standard anti-emetics.~CTCAE grade 3 or 4 fever identified with a source (i.e. infection, tumor)~CTCAE grade 3 or 4 alkaline phosphatase." (NCT00459186)
Timeframe: 21 days

Interventionparticipants (Number)
RAD001 Followed by RAD001 + Docetaxel14

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Number of Participants With Adverse Events (AEs)

"A serious AE (SAE) was defined as any AE which resulted in death or was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or constituted an important medical event (events that may have jeopardized the patient or required intervention to prevent one of the outcomes listed above).~The severity of AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) or according to the following scale:~Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening; Grade 5 = Death.~The Investigator determined the relationship between study drug and the occurrence of an AE as Not Related or Related (since the study was double-blinded, a patient receiving only prednisone could have an AE that was judged as related to pomalidomide, and vice-versa)." (NCT00463385)
Timeframe: From date of the first dose of the study drug until discontinuation or the data cut-off date (up to approximately 45 months).

,,,
Interventionparticipants (Number)
At least one AEAt least one AE related to pomalidomideAt least one AE related to prednisoneAt least one Grade 3-4 AEAt least one Grade 3-4 AE related to pomalidomideAt least one Grade 3-4 AE related to prednisoneAt least one SAEAt least one SAE related to pomalidomideAt least one SAE related to prednisoneAE leading to discontinuation of pomalidomideAE leading to discontinuation of prednisoneAE leading to a dose reduction of pomalidomideAE leading to a dose interruption of pomalidomideAE leading to a dose interruption of prednisone
Pomalidomide 0.5 mg + Prednisone21155156383361173
Pomalidomide 2 mg21171014721063117298
Pomalidomide 2 mg + Prednisone18161113116118552196
Prednisone201510106564475052

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Percentage of Participants With a Clinical Response Within the First 6 Cycles of Treatment

"A clinical responder was defined as either:~A baseline red blood cell (RBC)-transfusion-dependent participant with a ≥ 56 consecutive day RBC transfusion-free period after the first dose of study drug, or~A baseline RBC-transfusion-independent participant with an increase in hemoglobin of 2.0 g/dL or more from baseline for ≥ 56 consecutive days in the absence of RBC transfusions, or~A participant with either a ≥ 50% reduction in palpable splenomegaly of a spleen that was ≥ 10 cm at baseline or a spleen that was palpable at > 5 cm and became not palpable.~Participants who discontinued the study early without achieving clinical response were counted as non-responders." (NCT00463385)
Timeframe: Up to 168 days

Interventionpercentage of participants (Number)
Prednisone55.0
Pomalidomide 2 mg23.5
Pomalidomide 2 mg + Prednisone21.1
Pomalidomide 0.5 mg + Prednisone47.6

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Percentage of Participants With a Clinical Response Within the First 12 Cycles of Treatment

"A clinical responder was defined as either:~A baseline red blood cell (RBC)-transfusion-dependent participant with a ≥ 56 consecutive day RBC transfusion-free period after the first dose of study drug, or~A baseline RBC-transfusion-independent participant with an increase in hemoglobin of 2.0 g/dL or more from baseline for ≥ 56 consecutive days in the absence of RBC transfusions, or~A participant with either a ≥ 50% reduction in palpable splenomegaly of a spleen that was ≥ 10 cm at baseline or a spleen that was palpable at > 5 cm and became not palpable.~Participants who discontinued the study early without achieving clinical response were counted as non-responders." (NCT00463385)
Timeframe: Up to 336 days

Interventionpercentage of participants (Number)
Prednisone50.0
Pomalidomide 2 mg18.2
Pomalidomide 2 mg + Prednisone18.2
Pomalidomide 0.5 mg + Prednisone45.5

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Duration of First Clinical Response

"For RBC-transfusion-dependent patients, duration of response was calculated as the last day of response - first day of response +1, where the last day of response was the date of the first RBC-transfusion administrated at or more than 56 days after the response started. For patients who did not receive a subsequent transfusion after the response started, the end date of response was censored at the day of last hemoglobin assessment.~For RBC-transfusion-independent patients, the duration of response was calculated as the last day of response - first day of response +1, where the last day of response was the earlier of the date of a hemoglobin increase of < 2.0 g/dL and the date of a RBC transfusion at ≥ 56 days after the response started. For patients whose hemoglobin measurements were always ≥ 2.0 g/dL and never received a RBC transfusion after response started, the end date of the response was censored at the date of last hemoglobin measurement.~Kaplan-Meier methodology was used." (NCT00463385)
Timeframe: Up to 40 months

Interventionmonths (Median)
Prednisone3.7
Pomalidomide 2 mgNA
Pomalidomide 2 mg + Prednisone6.0
Pomalidomide 0.5 mg + Prednisone10.6

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Change From Baseline in Hemoglobin Concentration for Responders

Change from Baseline in hemoglobin for participants with a clinical response within the first 6 cycles of treatment. (NCT00463385)
Timeframe: Baseline, Cycle 6 (168 days)

Interventiong/dL (Median)
Prednisone1.4
Pomalidomide 2 mg2.0
Pomalidomide 0.5 mg + Prednisone-0.1

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Change From Baseline in Hemoglobin Concentration for Non-Responders

Change from Baseline in hemoglobin for participants without a clinical response within the first 6 cycles of treatment. (NCT00463385)
Timeframe: Baseline, Cycle 6 (168 days)

Interventiong/dL (Median)
Prednisone1.2
Pomalidomide 2 mg0.1
Pomalidomide 2 mg + Prednisone-0.8
Pomalidomide 0.5 mg + Prednisone0.5

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Change From Baseline in Likert Abdominal Pain Scale

Participants rated abdominal discomfort or pain over the previous week on a scale from zero to ten, where zero is no discomfort or pain and ten is the worst pain imaginable. (NCT00463385)
Timeframe: Baseline and Cycle 6 (168 days)

Interventionunits on a scale (Mean)
Prednisone0.3
Pomalidomide 2 mg-1.0
Pomalidomide 2 mg + Prednisone0.3
Pomalidomide 0.5 mg + Prednisone-0.1

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Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Subscale and Total Scores

"The FACT-An comprises the four subscales of the 27-item FACT-General Scale (FACT-G), Physical Well-being, Social/Family Well-being, Emotion Well-being, Functional Well-Being, and the Additional Concerns Anemia subscale. Questions are rated on a scale from 0 to 4, where higher scores indicate more impact on quality of life.~Physical Well-being consists of 7 questions, the subscale score ranges from 0-28;~Social/Family Well-being consists of 7 questions, the subscale score ranges from 0-28;~Emotion Well-being consists of 6 questions, the subscale score ranges from 0-24;~Functional Well-Being consists of 7 questions, the subscale score ranges from 0-28;~Anemia subscale consists of 20 questions, the subscale score ranges from 0-80;~Total FACT-An score ranges from 0-188." (NCT00463385)
Timeframe: Baseline and Cycle 6 (168 days).

,,,
Interventionunits on a scale (Mean)
Physical Well-Being subscaleSocial/Family Well-Being subscaleEmotional Well-Being subscaleFunctional Well-Being subscaleAnemia subscaleTotal FACT-An score
Pomalidomide 0.5 mg + Prednisone2.30.91.72.55.811.4
Pomalidomide 2 mg0.4-1.90.0-2.12.31.6
Pomalidomide 2 mg + Prednisone5.31.7-0.32.719.327.3
Prednisone0.61.91.30.91.22.3

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Time to the First Clinical Response

"The time to the first clinical response achieved within 168 days after the first study drug dosing date was calculated for participants who achieved a clinical response as:~Start date of the first clinical response - the first study drug date +1.~A clinical responder was defined as either:~A baseline red blood cell (RBC)-transfusion-dependent participant with a ≥ 56 consecutive day RBC transfusion-free period after the first dose of study drug, or~A baseline RBC-transfusion-independent participant with an increase in hemoglobin of 2.0 g/dL or more from baseline for ≥ 56 consecutive days in the absence of RBC transfusions, or~A participant with either a ≥ 50% reduction in palpable splenomegaly of a spleen that was ≥ 10 cm at baseline or a spleen that was palpable at > 5 cm and became not palpable." (NCT00463385)
Timeframe: Up to 168 days

Interventionweeks (Median)
Prednisone0.3
Pomalidomide 2 mg8.0
Pomalidomide 2 mg + Prednisone10.1
Pomalidomide 0.5 mg + Prednisone1.2

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Percentage of Participants With Clinical Response by Baseline JAK2 Assessment

Percentage of participants who achieved a clinical response, presented by participants with positive and negative janus kinase 2 (JAK2) V617F mutation results at Baseline. (NCT00463385)
Timeframe: Up to 336 days

Interventionpercentage of participants (Number)
Prednisone, Positive JAK246.2
Pomalidomide 2 mg, PositiveJAK227.3
Pomalidomide 2 mg + Prednisone, Positive JAK230.0
Pomalidomide 0.5 mg + Prednisone, Positive JAK266.7
Prednisone, Negative JAK250.0
Pomalidomide 2 mg, Negative JAK228.6
Pomalidomide 2 mg + Prednisone, Negative JAK212.5
Pomalidomide 0.5 mg + Prednisone, Negative JAK225.0

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Part 2: Progression Free Survival (PFS)

PFS was defined as the time from the date of study enrollment to the first date of objectively determined progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST version 1.0). PD is ≥20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. For participants not known to have died and who did not have PD, PFS was censored at the date of the last progression-free assessment. For participants who received subsequent systemic anticancer therapy (after discontinuation from the study treatment) prior to disease progression or death, PFS was censored at the date of last progression-free assessment prior to the initiation of post-discontinuation systemic anticancer therapy. No participant completed a full cycle of therapy and thus no formal analysis was performed. (NCT00466440)
Timeframe: Baseline to measured PD (up to 487 days)

InterventionDays (Median)
Part 2: Docetaxel + Prednisone + Enzastaurin229
Part 2: Docetaxel + Prednisone + Placebo213

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Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of Docetaxel

AUC(0-∞) was calculated using concentration versus time data of docetaxel. Data are reported as Geometric Mean and Geometric Coefficient of Variation (%). (NCT00466440)
Timeframe: Part 1: Cycle 1, Day 1 - predose 0.5, 1, 1.5, 2, 3, 4, 8, and 24 hours postdose; Cycle 2, Day 1 - predose, 0.5, 1, 1.5, 2, 3, 4, 8, and 24 hours postdose

Interventionng*h/mL (Geometric Mean)
Docetaxel 75 mg/m^2 Alone2350
Enzastaurin 500 mg QD + Docetaxel 75 mg/m^2 + Prednisone1750

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Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of Docetaxel

Cmax was calculated using concentration versus time data of docetaxel. Data are reported as Geometric Mean and Geometric Coefficient of Variation (%). (NCT00466440)
Timeframe: Part 1: Cycle 1, Day 1 - predose 0.5, 1, 1.5, 2, 3, 4, 8, and 24 hours postdose; Cycle 2, Day 1 - predose, 0.5, 1, 1.5, 2, 3, 4, 8, and 24 hours postdose

Interventionnanograms per millimeter (ng/mL) (Geometric Mean)
Docetaxel 75 mg/m^2 Alone2230
Enzastaurin 500 mg QD + Docetaxel 75 mg/m^2 + Prednisone1840

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Prostate-Specific Androgen (PSA) Velocity at 2 Months

PSA is a protein produced by the cells of the prostate gland. PSA is present in small quantities in the serum of men with healthy prostates, but is often elevated in the presence of prostate cancer and in other prostate disorders. A blood test to measure PSA is considered the most effective test currently available for the early detection of prostate cancer. PSA velocity is computed for each participant by means of linear regression on the logarithm of PSA. The linear regression fits a line through the logarithm of the PSA value on the y-axis, and the time from baseline on the x-axis with the baseline PSA value at time zero. The resulting slope is PSA velocity. (NCT00466440)
Timeframe: Baseline up to 2 months

Interventionmicrogram per liter (ug/L) per month (Mean)
Part 1: Docetaxel + Prednisone + Enzastaurin-0.56
Part 2: Docetaxel + Prednisone + Enzastaurin-0.29
Part 2: Docetaxel + Prednisone + Placebo-0.55

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Prostate-Specific Androgen (PSA) Velocity at 3 Months

PSA is a protein produced by the cells of the prostate gland. PSA is present in small quantities in the serum of men with healthy prostates, but is often elevated in the presence of prostate cancer and in other prostate disorders. A blood test to measure PSA is considered the most effective test currently available for the early detection of prostate cancer. PSA velocity is computed for each participant by means of linear regression on the logarithm of PSA. The linear regression fits a line through the logarithm of the PSA value on the y-axis, and the time from baseline on the x-axis with the baseline PSA value at time zero. The resulting slope is PSA velocity. (NCT00466440)
Timeframe: Baseline up to 3 months

Interventionug/L per month (Mean)
Part 1: Docetaxel + Prednisone + Enzastaurin-0.45
Part 2: Docetaxel + Prednisone + Enzastaurin-0.30
Part 2: Docetaxel + Prednisone + Placebo-0.45

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Part I: Pharmacokinetic (PK) Parameter: Maximum Observed Drug Concentration During a Dosing Interval at Steady State (Cmax,ss) of Enzastaurin, LSN326020, and Total Analyte (Enzastaurin + LSN326020)

Cmax,ss was calculated using concentration versus time data of enzastaurin, LSN326020, and total analyte (enzastaurin + LSN326020). Data are reported as Geometric Mean and Geometric Coefficient of Variation (%). (NCT00466440)
Timeframe: Part 1: Cycle 1, Day 21 - predose 2, 4, 6, 8, and 24 hours postdose; Cycle 2, Day 1 - predose, 2, 3, 4, 8, and 24 hours postdose

,
Interventionnanomole per liter (nmol/L) (Geometric Mean)
EnzastaurinLSN326020Total Analyte
Enzastaurin 500 mg QD + Docetaxel 75 mg/m^2 + Prednisone7786671450
Enzastaurin 500 mg QD Alone8706641540

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Percentage of Participants Exhibiting a Decline in Prostate-Specific Androgen (PSA) From Baseline ≥30% Within First 3 Months of Treatment

PSA is a protein produced by the cells of the prostate gland. PSA is present in small quantities in the serum of men with healthy prostates, but is often elevated in the presence of prostate cancer and in other prostate disorders. A blood test to measure PSA is considered the most effective test currently available for the early detection of prostate cancer. Decline in PSA of ≥30% from baseline within the first 3 months of treatment was calculated. (NCT00466440)
Timeframe: Baseline up to 3 months

Interventionpercentage of participants (Number)
Part 1: Docetaxel + Prednisone + Enzastaurin69.2
Part 2: Docetaxel + Prednisone + Enzastaurin60.9
Part 2: Docetaxel + Prednisone + Placebo72.5

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Pharmacokinetic (PK) Parameter: Area Under the Concentration Versus Time Curve During 1 Dosing Interval at Steady State (AUCτ,ss) of Enzastaurin, LSN326020, and Total Analyte (Enzastaurin + LSN326020)

AUCτ,ss was calculated using concentration versus time data of enzastaurin, LSN326020, and total analyte (enzastaurin + LSN326020). Data are reported as Geometric Mean and Geometric Coefficient of Variation (%). (NCT00466440)
Timeframe: Part 1: Cycle 1, Day 21 - predose 2, 4, 6, 8, and 24 hours postdose; Cycle 2, Day 1 - predose, 2, 3, 4, 8, and 24 hours postdose; Part 2: Cycle 2, Day 1 - predose, 1-3, and 4-9 hours postdose

,,
Interventionnanomole*hour per liter (nmol*hr/L) (Geometric Mean)
EnzastaurinLSN326020Total Analyte
Enzastaurin 500 mg QD Alone129001520028700
Enzastaurin 500 mg QD+Docetaxel 75 mg/m^2+Prednisone (Part 1)131001570029000
Enzastaurin 500 mg QD+Docetaxel 75 mg/m^2+Prednisone (Part 2)208002480047800

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Part 2: Duration of Response

Duration of response is defined as the time from date of objective response to progressive disease (PD) or death or prostate-specific androgen (PSA) returning to at least 50% from original baseline value. (NCT00466440)
Timeframe: First objective response to PD/death/PSA returning to 50% or more than the original baseline value (up to 616 days)

Interventiondays (Median)
Part 2: Docetaxel + Prednisone + Enzastaurin231
Part 2: Docetaxel + Prednisone + Placebo201

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Part 2: Overall Survival (OS)

Overall survival (OS) time is defined as the time from the date of diagnosis to the date of death from any cause. For participants who are still alive at the time of analysis, survival time will be censored at the last contact date. (NCT00466440)
Timeframe: Baseline to death (up to 642 days)

Interventiondays (Median)
Part 2: Docetaxel + Prednisone + Enzastaurin462
Part 2: Docetaxel + Prednisone + Placebo448

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Part 2: Percentage of Participants With Objective Tumor Response (Response Rate)

Response using Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. Objective response rate (%)=number of objective responders divided by the number of participants qualified for efficacy analysis *100, where objective responders are those participants who have met criteria either for CR or PR. (NCT00466440)
Timeframe: Baseline up to 3 years

Interventionpercentage of participants (Number)
Part 2: Docetaxel + Prednisone + Enzastaurin15.2
Part 2: Docetaxel + Prednisone + Placebo15.0

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Number of Participants With Adverse Events (AEs)

A listing of serious AEs (SAEs) and all other non-serious AEs is included in the Reported Adverse Event Module. (NCT00466440)
Timeframe: Baseline through 3 years

,,
InterventionParticipants (Count of Participants)
SAEsOther Non-Serious AEs
Part 1: Docetaxel + Prednisone + Enzastaurin814
Part 2: Docetaxel + Prednisone + Enzastaurin1647
Part 2: Docetaxel + Prednisone + Placebo1441

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Median Time From First Dose of Omalizumab Treatment to Cessation of New Blisters.

The study subject underwent physical examination and was assessed for cessation of new blister formation via physical examination and photography. (NCT00472030)
Timeframe: Up to 24 weeks

Interventionweeks (Number)
Omalizumab Treatment Arm6

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Percent Decrease in the Total Body Surface Area Affected By Active Bullous Pemphigoid Skin Disease From Day 0 to Week 24.

Measurement of total body surface area affected by bullous pemphigoid active skin disease(active erosions, blisters, and/or lesions) was measured at Day 0 (prior to treatment with Omalizumab) and at 24 weeks (24 weeks is end of study). (NCT00472030)
Timeframe: Up to 24 weeks

Interventionpercentage of active skin disease (Number)
Omalizumab Treatment Arm22.5

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Decrease in Anti-BP230 Antibody IgG (Anti-bullous Pemphigoid 230 Antibody Immunoglobulin G) At Baseline and Week 16

(NCT00472030)
Timeframe: Up to 24 weeks

Interventionunits per milliliter (Number)
Omalizumab Treatment Arm62.6

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Decrease in Anti-BP180 IgG (Immunoglobulin G Anti-Bullous Pemphigoid 180 Antibody) Following Treatment With Omalizumab.

Anti-BP180 IgG levels were completed using an Elisa assay. Anti-BP180 IgG levels were obtained prior to baseline and at week 16 (NCT00472030)
Timeframe: Up to 24 weeks

Interventionunits per milliliter (Number)
Omalizumab Treatment Arm92.06

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Decrease in Eosinophil Levels Following Treatment With Omalizumab.

The subject's eosinophil count measured at baseline was compared to the eosinophil count at week 8. A normal eosinophil count at the University of Iowa Hospital lab is 0-0.4 cells per microliter (NCT00472030)
Timeframe: Baseline, 24 weeks.

Interventioncells/microliter (Number)
Omalizumab Treatment Arm2.16

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Phase 1: Total Body Clearance (Cl_F_obs) of Abiraterone Acetate

Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). (NCT00473746)
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3

,,,
Interventionliter per hour (l/hr) (Mean)
FastedFed
Phase I Dose Escalation (1000mg)2649.954231.383
Phase I Dose Escalation (250mg)4288.456529.606
Phase I Dose Escalation (500mg)5440.949391.046
Phase I Dose Escalation (750mg)1518.748246.643

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Phase 2: Participants With Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score

ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction. 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3=capable of limited self-care, confined to bed or chair >50% of waking hours. 4=completely disabled, not capable of any self-care, totally confined to bed or chair. 5=dead. (NCT00473746)
Timeframe: Up to 12 weeks from start of treatment

Interventionparticipants (Number)
Baseline ECOG 0Baseline ECOG 1Baseline ECOG 2Baseline ECOG 3Baseline ECOG 4Best Post-Baseline ECOG 0Best Post-Baseline ECOG 1Best Post-Baseline ECOG 2Best Post-Baseline ECOG 3Best Post-Baseline ECOG 4
Phase II Dose Treatment2013000285000

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Phase 1: Maximum Tolerated Dose (MTD) of Abiraterone Acetate

The MTD is the highest dose of a drug or treatment that does not cause unacceptable side effects. (NCT00473746)
Timeframe: Up to Cycle 12

Interventionmg/day (Number)
Phase I Dose EscalationNA

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Phase 2: Duration of Objective Response

Duration of objective response was assessed only in participants who achieved a CR or PR, and measured from the first documented date of response to the first documented date of disease progression according to the RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00473746)
Timeframe: Up to 12 weeks from start of treatment

Interventiondays (Median)
Phase II Dose TreatmentNA

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Phase 2: Duration of PSA Response

Duration of PSA response was defined as the duration between the date of confirmed PSA response and subsequent PSA progression date as defined by the PSAWG criteria. (NCT00473746)
Timeframe: Up to 12 weeks from start of treatment

Interventiondays (Median)
Phase II Dose Treatment477

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Phase 2: Overall Survival

Overall survival is the time interval from the date of first dose (cycle 1 day 1) of abiraterone acetate therapy to the date of death from any cause. (NCT00473746)
Timeframe: Up to Month 60

Interventiondays (Median)
Phase II Dose TreatmentNA

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Phase 2: PSA Progression Free Survival (PSA-PFS)

PSA-PFS is the time interval from the date of first dose of abiraterone acetate therapy to the date of death or the PSA progression as defined by the Prostate Specific Antigen Working Group (PSAWG) criteria. (NCT00473746)
Timeframe: Up to 12 weeks from start of treatment

Interventiondays (Median)
Phase II Dose Treatment473

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Phase 2: Time to PSA Progression

The time interval from the date of first dose of abiraterone acetate therapy to the date of the PSA progression as defined by the PSAWG criteria. (NCT00473746)
Timeframe: Up to 12 weeks from start of treatment

Interventiondays (Median)
Phase II Dose Treatment497

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Phase 1: Area Under the Plasma-Concentration-time Curve From Time 0 to Infinite Time (AUCINF_obs) of Abiraterone Acetate

Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). (NCT00473746)
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3

,,,
Interventionhr*nmol/L (Mean)
FastedFed
Phase I Dose Escalation (1000mg)3478.38514404.387
Phase I Dose Escalation (250mg)1411.2681386.939
Phase I Dose Escalation (500mg)1781.3743839.804
Phase I Dose Escalation (750mg)1665.4549358.743

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Phase 1: Area Under the Plasma-Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Abiraterone Acetate

Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). (NCT00473746)
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3

,,,
Interventionhr*nmol/L (Mean)
FastedFed
Phase I Dose Escalation (1000mg)3039.93713695.482
Phase I Dose Escalation (250mg)1329.1781310.715
Phase I Dose Escalation (500mg)1625.0593624.781
Phase I Dose Escalation (750mg)1565.6598920.790

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Phase 1: Volume of Distribution (Vz_F_obs) of Abiraterone Acetate

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Volume of distribution is normally calculated by using equation volume of distribution =dose/initial concentration. Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). (NCT00473746)
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3

,,,
InterventionLiter (L) (Mean)
FastedFed
Phase I Dose Escalation (1000mg)25494.3984068.885
Phase I Dose Escalation (250mg)653.7453940.400
Phase I Dose Escalation (500mg)10252.0773418.280
Phase I Dose Escalation (750mg)13688.3672739.655

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Phase 2: Participants With Greater Than or Equal to 50 Percent Decline in Prostate Specific Antigen (PSA)

Number of participants with greater than or equal to 50 percent decrease in PSA levels were assessed. PSA decline was evaluated according to (Prostate Specific Antigen Working Group) PSAWG criteria. Decrease in PSA levels represented improvement. (NCT00473746)
Timeframe: Up to 12 weeks from start of treatment

Interventionparticipants (Number)
ConfirmedNot ConfirmedTotal
Phase II Dose Treatment26228

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Phase 2: Radiographic Progression Free Survival (RAD-PFS)

RAD-PFS is the time interval from the date of first dose of abiraterone acetate therapy to the date of death or radiographic disease progression according to the RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00473746)
Timeframe: Up to 12 weeks from start of treatment

Interventiondays (Median)
Phase II Dose TreatmentNA

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Phase 2: Radiographic Objective Response Rate (RAD-ORR)

The objective response rate is defined as the proportion of participants with measurable lesions achieving a Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00473746)
Timeframe: Up to 12 weeks from start of treatment

Interventionparticipants (Number)
ConfirmedNot Confirmed
Phase II Dose Treatment91

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Phase 1: Maximum Plasma Concentration (Cmax) of Abiraterone Acetate

Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). (NCT00473746)
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3.

,,,
Interventionnanomoles per liter (nmol/L) (Mean)
FastedFed
Phase I Dose Escalation (1000mg)509.5002194.250
Phase I Dose Escalation (250mg)283.000421.000
Phase I Dose Escalation (500mg)330.633676.000
Phase I Dose Escalation (750mg)289.5331552.000

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Phase 1: Terminal Half-life (HL_Lambda_z) of Abiraterone Acetate

Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). (NCT00473746)
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3

,,,
Interventionhour (hr) (Mean)
FastedFed
Phase I Dose Escalation (1000mg)14.36112.454
Phase I Dose Escalation (250mg)5.2845.125
Phase I Dose Escalation (500mg)10.5916.913
Phase I Dose Escalation (750mg)7.0667.939

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Phase 1: Time to Reach the Maximum Plasma Concentration (Tmax) of Abiraterone Acetate

Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose) (NCT00473746)
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3

,,,
Interventionhour (hr) (Mean)
FastedFed
Phase I Dose Escalation (1000mg)1.8334.000
Phase I Dose Escalation (250mg)2.0002.044
Phase I Dose Escalation (500mg)1.5002.667
Phase I Dose Escalation (750mg)2.0332.000

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Patients With Overall Confirmed Response

"Response that was confirmed on 2 consecutive evaluations.>~Complete Response (CR): Complete disappearance of M-protein from serum and urine on immunofixations, normalization of Free Light Chain (FLC) ratio and <=5% plasma cells in bone marrow>~Very Good Partial Response (VGPR): >=90% reduction in serum M-spike, Urine M-spike <100mg per 24 hours>~Partial Response (PR): >=50% reduction in serum M-spike, Urine M-spike >=90% reduction or < 200mg per 24 hours, or >=50% decrease in difference between involved and uninvolved FLC levels or 50% decrease in bone marrow plasma cells" (NCT00477750)
Timeframe: Every cycle during treatment

Interventionparticipants (Number)
CRVGPRPR
Treatment (Lenalidomide, Melphalan, Prednisone)3510

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Progression-free Survival

"Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression was defined as any one or more of the following:~An increase of 25% from lowest confirmed response in:~Serum M-component (absolute increase >= 0.5g/dl)~Urine M-component (absolute increase >= 200mg/24hour~Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl~Bone marrow plasma cell percentage (absolute increase of >=10%)" (NCT00477750)
Timeframe: registration to progressive disease (up to 3 years)

Interventionmonths (Median)
Treatment (Lenalidomide, Melphalan, Prednisone)21.4

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Percentage of Participants With Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (v3)

The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below. (NCT00477750)
Timeframe: Every cycle during treatment up to 3 years

Interventionpercentage of patients (Number)
Grade 3Grade 4Grade 5
Treatment (Lenalidomide, Melphalan, Prednisone)33670

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Duration of Response (DOR)

Duration of response was calculated from documentation of first response to date of progression in the subset of patients who responded. Patients without progression were censored at the date of last tumor evaluation. (NCT00477750)
Timeframe: from first response to progression or death (up to 3 years)

Interventionmonths (Median)
Treatment (Lenalidomide, Melphalan, Prednisone)16.3

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Overall Survival (OS) at 3 Years

OS was defined as the time from registration to death due to any cause. Patients who were alive were censored at date of last follow-up. The overall survival at 3 years (a percentage) is reported below. (NCT00477750)
Timeframe: registration to death (up to 3 years)

Interventionpercentage of patients (Number)
Treatment (Lenalidomide, Melphalan, Prednisone)58

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Prostate-Specific Antigen Based Progression-free Survival (PSA-PFS)

The PSA-PFS is defined as time to first PSA failure (that is, two consecutive increases in PSA of 50 percent and greater than or equal to 5 nanogram per milliliter, as per Prostate-Specific Antigen Working Group [PSAWG] criterion) or death or the start of secondary anti-tumor therapy, whichever occurs first. If a PSA progression or death does not occur, subject will be censored at the last PSA evaluation. (NCT00485303)
Timeframe: Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months

Interventiondays (Median)
Abiraterone141

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Time to Radiographic Progression

Time to radiographic progression is defined as the time from first dose until the first radiographic progression date that was confirmed. (NCT00485303)
Timeframe: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months

Interventiondays (Median)
Abiraterone88

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Time to PSA Progression

The time interval from first dose of abiraterone acetate to the date of PSA progression as defined by the Prostate-Specific Antigen Working Group (PSAWG) criteria. If a PSA progression does not occur, subject will be censored at the last PSA evaluation. (NCT00485303)
Timeframe: Day 8 of Cycle 1, thereafter Day 1 of each cycle up to end of study (60 months)

Interventiondays (Median)
Abiraterone169

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Radiographic Progression Free Survival (PFS)

The RAD-PFS is defined as the time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0, as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. (NCT00485303)
Timeframe: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months

Interventiondays (Median)
Abiraterone126

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Percentage of Participants With Clinical Benefit

Clinical benefit was defined as an observation of at least 1 of the following: PSA response by PSAWG criteria; radiographic response by RECIST criteria; stable disease by RECIST criteria lasting 6 months; or improvement by at least 1 unit in ECOG performance status. (NCT00485303)
Timeframe: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months

Interventionpercentage of participants (Number)
Disease StabilizationChange in participant ECOG score
Abiraterone1216

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Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score

ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction. 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature, 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50 percent of waking hours, 3=capable of limited self-care, confined to bed or chair >50 percent of waking hours, 4=completely disabled, not capable of any self-care, totally confined to bed or chair and 5=dead. (NCT00485303)
Timeframe: Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months

Interventionparticipants (Number)
Baseline:0; Best Post-dose:0Baseline:0; Best Post-dose:1Baseline:0; Best Post-dose:2Baseline:0; Best Post-dose:3Baseline:0; Best Post-dose:4Baseline:1; Best Post-dose:0Baseline:1; Best Post-dose:1Baseline:1; Best Post-dose:2Baseline:1; Best Post-dose:3Baseline:1; Best Post-dose:4Baseline:2; Best Post-dose:0Baseline:2; Best Post-dose:1Baseline:2; Best Post-dose:2Baseline:2; Best Post-dose:3Baseline:2; Best Post-dose:4Baseline:0; Worst Post-dose:0Baseline:0; Worst Post-dose:1Baseline:0; Worst Post-dose:2Baseline:0; Worst Post-dose:3Baseline:0; Worst Post-dose:4Baseline:1; Worst Post-dose:0Baseline:1; Worst Post-dose:1Baseline:1; Worst Post-dose:2Baseline:1; Worst Post-dose:3Baseline:1; Worst Post-dose:4Baseline:2; Worst Post-dose:0Baseline:2; Worst Post-dose:1Baseline:2; Worst Post-dose:2Baseline:2; Worst Post-dose:3Baseline:2; Worst Post-dose:4
Abiraterone22200014152001100061710002461000200

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Percentage of Participants With Prostate Specific Antigen (PSA) Response

The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response. (NCT00485303)
Timeframe: Day 1 of each cycle (of 28 days each) up to Cycle 12

Interventionpercentage of participants (Number)
Abiraterone37.9

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Overall Survival (OS)

Overall survival is defined as the interval from the date of the first dose of abiraterone acetate to the date of death. (NCT00485303)
Timeframe: Every 3 months until death or up to 60 months

Interventiondays (Median)
Abiraterone492

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Percentage of Participants With Objective Radiographic Response

Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to RECIST Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. (NCT00485303)
Timeframe: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months

Interventionpercentage of participants (Number)
Complete response (CR)Partial Response (PR)
Abiraterone06.3

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Median Percent Change From Visit 1 (Screening, Week -2) in Tumor Size at Visit 33 (24 Months After the Last Infusion of Ofatumumab)

The tumor size for a participant was computed as the sum of product of diameters (SPD) for the indicator lesions. Reduction in tumor size was calculated as percent change from Visit 1 until Visit 33, separately by radiologist 1 and radiologist 2. Percent change from Visit 1 (Screening, Week -2) = (value at Visit 33 minus value at Visit 1 divided by value at Visit 1) * 100. (NCT00494780)
Timeframe: Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months)

,
InterventionPercent change in tumor size (Median)
Radiologist 1Radiologist 2
1000 mg Ofatumumab + CHOP-100-100
500 mg Ofatumumab + CHOP-100-100

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Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 28, and 33

HAHA are indicators of immunogenicity to ofatumumab. Blood samples were drawn from participants at Visits 1, 28, and 33 for analysis of HAHA. (NCT00494780)
Timeframe: Visits 1 (Screening), 28 (9 months after last dose), and 33 (24 months after last dose)

,
Interventionparticipants (Number)
Visit 1, n=29, 29Visit 28, n=18, 21Visit 33, n=16, 16
1000 mg Ofatumumab + CHOP000
500 mg Ofatumumab + CHOP000

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Number of Participants With the Indicated Overall Best Response (OBR) at Visit 26 (3 Months After the Last Infusion of Ofatumumab)

Based on standardized response criteria for NHL, responders included participants with CR (complete disappearance of all detectable clinical and radiographic evidence of disease), CRu (more than a 75% decrease in LN size compared to baseline), and PR (>=50% decrease in LN size and evidence of new lesions). Non-responders included participants with stable disease (SD; <50% decrease in LN size from baseline) and progressive disease (PD; >=50% increase in LN size and evidence of new lesions). (NCT00494780)
Timeframe: Maximum of 23 months after the start of treatment

,
Interventionparticipants (Number)
Responder, CRResponder, CRuResponder, PRNon-Responder, SDNon-Responder, PD
1000 mg Ofatumumab + CHOP971300
500 mg Ofatumumab + CHOP6101021

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Percent Change From Visit 1 (Screening) in Peripheral CD19+ and CD20+ Cell Counts at Visit 33 (24 Months After the Last Infusion of Ofatumumab)

The peripheral blood for each participant was collected and analyzed for CD19+ and CD20+ cell counts. CD19+ and CD20+ are B-cell types which are used as an index of a participant's response to treatment. (NCT00494780)
Timeframe: Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months)

,
InterventionPercent change in cell counts (Median)
CD19+CD20+
1000 mg Ofatumumab + CHOP307.9307.9
500 mg Ofatumumab + CHOP154.1154.1

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CL After the Sixth Infusion (Week 15, Visit 22)

CL is the clearance of drug from plasma, which is defined as the volume of plasma from which the drug is cleared per unit time. (NCT00494780)
Timeframe: Week 15 (Visit 22)

InterventionMilliliters per hour (mL/h) (Geometric Mean)
500 mg Ofatumumab + CHOP6.29
1000 mg Ofatumumab + CHOP5.92

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AUC(0-inf) and AUC(0-504) After the Sixth Infusion (Week 15, Visit 22)

AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-504) is AUC from the start of infusion to 504 hours after the start of the infusion; AUC(0-inf) is AUC from the start of infusion extrapolated to infinity. (NCT00494780)
Timeframe: Week 15 (Visit 22)

,
InterventionMilligrams * hours/liter (mg.h/L) (Geometric Mean)
AUC(0-inf), n=20, 28AUC(0-504), n=24, 28
1000 mg Ofatumumab + CHOP399676168866
500 mg Ofatumumab + CHOP17713379500

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Duration of Response

The duration of response is defined as the time from the initial response (the first visit at which response was observed) to progression or death. (NCT00494780)
Timeframe: Followed up to 5 years

Interventionmonths (Median)
500 mg Ofatumumab + CHOP21.0
1000 mg Ofatumumab + CHOP25.0

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Half Life (t1/2) of Ofatumumab at the Sixth Infusion (Week 15, Visit 22)

Half life is defined as the period of time required for the amount of drug in the body to be reduced by half. (NCT00494780)
Timeframe: Week 15 (Visit 22)

Interventionhours (Geometric Mean)
500 mg Ofatumumab + CHOP652
1000 mg Ofatumumab + CHOP644

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Median Percent Change From Visit 1 (Screening) in Serum Complement (CH50) Levels at Visit 22

The peripheral blood for each participant was collected and analyzed for serum complement CH50 levels. Cluster of Differentiation index 50 (CD50) is a human gene which is used as an index of immune response. CD50Percent change from Visit 1 (Screening, Week -2) = (value at Visit 22 minus value at Visit 1 divided by value at Visit 1) * 100. (NCT00494780)
Timeframe: Visit 1 (Screening, Week -2) and Visit 22 (Week 15)

InterventionPercent change in serum complement CH50 (Median)
500 mg Ofatumumab + CHOP42.0
1000 mg Ofatumumab + CHOP23.2

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Number of Participants Who Experienced Any Adverse Event (AEs) From First Treatment to Visit 33 (24 Months After Last Infusion)

An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. A list of AEs experienced in the study with a frequency threshold of 5% can be found in the AE section. (NCT00494780)
Timeframe: Up to 22 months after study start

Interventionparticipants (Number)
500 mg Ofatumumab + CHOP29
1000 mg Ofatumumab + CHOP29

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Number of Participants With Complete Remission (CR) at Visit 26

Participants were evaluated for response by an Independent Endpoint Review Committee in accordance with the standardized response criteria for NHL. Participants with CR were defined as those with the complete disappearance of all detectable clinical and radiographic evidence of disease. (NCT00494780)
Timeframe: Maximum of 23 months after the start of treatment

Interventionparticipants (Number)
500 mg Ofatumumab + CHOP6
1000 mg Ofatumumab + CHOP9

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Progression-Free Survival (PFS)

PFS is defined as the time from randomization until progression or death. (NCT00494780)
Timeframe: Followed up to 5 years

Interventionmonths (Median)
500 mg Ofatumumab + CHOP27.6
1000 mg Ofatumumab + CHOPNA

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Time to New Anti-follicular Lymphoma (FL) Therapy

Time to new FL therapy is defined as the time from randomization until the time of first administration of the new FL therapy other than ofatumumab. Time to new FL therapy will be censored if participants are lost to follow-up. The censoring date in such cases will be the date of the last attended visit at which the endpoint was assessed. (NCT00494780)
Timeframe: Followed up to 5 years

Interventionmonths (Median)
500 mg Ofatumumab + CHOP47.2
1000 mg Ofatumumab + CHOPNA

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Vss at the Sixth Infusion (Week 15, Visit 22)

Vss is defined as the volume of distribution at steady state of ofatumumab. (NCT00494780)
Timeframe: Week 15 (Visit 22)

InterventionLiters (Geometric Mean)
500 mg Ofatumumab + CHOP5.15
1000 mg Ofatumumab + CHOP5.32

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Cmax and Ctrough at the Sixth Infusion (Week 15, Visit 22)

Cmax is defined as the maximum concentration of drug in plasma samples. Ctrough is defined as the trough plasma concentration (measured concentration at the end of a dosing interval [taken directly before next administration]). (NCT00494780)
Timeframe: Week 15 (Visit 22)

,
Interventionmilligrams per liter (mg/L) (Geometric Mean)
CmaxCtrough
1000 mg Ofatumumab + CHOP497188
500 mg Ofatumumab + CHOP23278.5

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Number of Participants Achieving Complete Response (CR) or Partial Response (CR) to Protocol Therapy.

"Number of participants achieving Complete Response (CR) or Partial Response to protocol therapy according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 Criteria. Per RECIST 1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; " (NCT00503984)
Timeframe: Up to 4.5 years

,,,
Interventionparticipants (Number)
Complete Response (CR)Partial Response (PR)
Phase 1: Level 1 - 75 Aza + 60 Doc00
Phase 1: Level 3 - 100 Aza + 75 Doc10
Phase 1: Level 4 - 150 Aza + 75 Doc01
Phase 2 - Aza + Doc Initial RPTD01

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Progression-Free Survival (PFS)

The time from the date of start of treatment until the first documented or confirmed disease progression, or death related to prostate cancer, whichever is earlier. (NCT00503984)
Timeframe: Up to 4.5 years

Interventionmonths (Median)
All Study Participants4.9

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Overall Survival (OS)

The time from the date of initiation of study treatment until date of death from any cause. (NCT00503984)
Timeframe: Up to 4.5 years.

Interventionmonths (Median)
All Study Participants19.5

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Number of Participants Experiencing Adverse Events After Beginning Protocol Therapy.

(NCT00503984)
Timeframe: Up to 4.5 years

Interventionparticipants (Number)
Level 1 - 75 Aza + 60 Doc3
Level 2 - 75 Aza + 75 Doc4
Level 3 - 100 Aza + 75 Doc3
Level 4 - 150 Aza + 75 Doc12

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Number of Participants Achieving Prostate-specific Antigen (PSA) Response.

Number of participants achieving prostate-specific antigen (PSA) response according to Prostate Cancer Working Group 1 (PCWG1) criteria. PSA response according to PCWG1 is defined as an least 50 percent decline in PSA level from baseline that was maintained for at least three weeks. (NCT00503984)
Timeframe: Up to 4.5 years.

Interventionparticipants (Number)
Phase 1: Level 1 - 75 Aza + 60 Doc0
Phase 1: Level 2 - 75 Aza + 75 Doc1
Phase 1: Level 3 - 100 Aza + 75 Doc2
Phase 1: Level 4 - 150 Aza + 75 Doc4
Phase 2 - Aza + Doc Initial RPTD3
Phase 2 - Aza + Doc Reduced RPTD0

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Duration of Response

Length of time from the date of first observation of complete response (CR) or partial response (PR) to the date of first observation of disease progression, according to prostate-specific antigen (PSA) response according to Prostate Cancer Working Group 1 (PCWG1) criteria. PSA response according to PCWG1 is defined as an least 50 percent decline in PSA level from baseline that was maintained for at least three weeks. (NCT00503984)
Timeframe: Up to 4.5 years.

Interventionweeks (Median)
All Study Participants Achieving PSA Response20.5

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Duration of Response

Duration of response is defined in participants with an overall response as the time between first documentation of response and disease progression. Responders without disease progression were censored at the last clinical assessment of response. (NCT00507416)
Timeframe: From first documented response until disease progression. Median follow-up time was 43 months.

Interventionmonths (Median)
Bortezomib and Dexamethasone18.3
Bortezomib, Thalidomide, and Dexamethasone22.4
Bortezomib, Melphalan and Prednisone19.8

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Overall Survival

Overall survival is defined as the time between randomization and death. Participants still alive at the cutoff date or lost to follow-up were censored at the date of last contact. (NCT00507416)
Timeframe: From randomization until death. Median follow-up time was 43 months.

Interventionmonths (Median)
Bortezomib and Dexamethasone49.8
Bortezomib, Thalidomide, and Dexamethasone51.5
Bortezomib, Melphalan and Prednisone53.1

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Percentage of Participants With a Complete Response

Participants with a best overall response of complete response, defined as negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. Response was assessed by the Investigator using the IMWG uniform response criteria. (NCT00507416)
Timeframe: Response assessed every other cycle, for up to 13 cycles (49 weeks).

Interventionpercentage of participants (Number)
Bortezomib and Dexamethasone3
Bortezomib, Thalidomide, and Dexamethasone4
Bortezomib, Melphalan and Prednisone4

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Percentage of Participants With a Complete Response or a Very Good Partial Response

"Complete response is defined by negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow.~Very good partial response is defined by serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours.~Response was assessed by the Investigator using the IMWG uniform response criteria." (NCT00507416)
Timeframe: Response assessed every other cycle for up to 13 cycles (49 weeks).

Interventionpercentage of participants (Number)
Bortezomib and Dexamethasone37
Bortezomib, Thalidomide, and Dexamethasone51
Bortezomib, Melphalan and Prednisone41

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Percentage of Participants With an Overall Response

"Overall response defined as a best overall response of complete response (CR), very good partial response (VGPR) or partial response (PR), assessed by the Investigator using the IMWG uniform response criteria.~CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow.~VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours (h).~PR requires 1 of the following:~≥50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to <200 mg/24 h, or~If M-protein not measurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels, or~If FLC not measurable, a ≥ 50% reduction in plasma cells, provided baseline bone marrow plasma cell percentage was ≥30%.~If present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is also required." (NCT00507416)
Timeframe: Response assessed every other cycle for up to 13 cycles (49 weeks).

Interventionpercentage of participants (Number)
Bortezomib and Dexamethasone73
Bortezomib, Thalidomide, and Dexamethasone80
Bortezomib, Melphalan and Prednisone70

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Progression Free Survival (PFS)

"PFS is defined as the time from randomization to disease progression or death, whichever occurs first. Participants who did not progress and were still alive at the cut-off date were censored at the date of last contact. Response was assessed by the Investigator using the International Myeloma Working Group (IMWG) uniform response criteria.~Progressive disease requires 1 of the following:~Increase of ≥ 25% from nadir in:~Serum M-component (absolute increase ≥ 0.5 g/dl)~Urine M-component (absolute increase ≥ 200 mg/24 hours)~In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/dl)~Bone marrow plasma cell percentage (absolute % ≥ 10%)~Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas.~Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease" (NCT00507416)
Timeframe: From randomization until disease progression. Median follow-up time was 43 months.

Interventionmonths (Median)
Bortezomib and Dexamethasone14.7
Bortezomib, Thalidomide, and Dexamethasone15.4
Bortezomib, Melphalan and Prednisone17.3

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Time to Alternative Therapy

Time to alternative therapy is defined as the time between randomization and alternative therapy. Participants who did not receive alternative therapy were censored at the time of last contact. (NCT00507416)
Timeframe: From randomization until alternative therapy. Median follow-up time was 43 months.

Interventionmonths (Median)
Bortezomib and Dexamethasone19.7
Bortezomib, Thalidomide, and Dexamethasone24.5
Bortezomib, Melphalan and Prednisone19.0

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Change From Baseline in EORTC QLQ-C30 - Global Health Status

"The European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Global Health Status/QOL Scale is scored between 0 and 100, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement." (NCT00507416)
Timeframe: Baseline and Day 1 of Cycles 3, 5, 7, 9, 11 and 13

,,
Interventionunits on a scale (Mean)
Cycle 3, Day 1 (n=129, 115, 125)Cycle 5, Day 1 (n=114, 98, 107)Cycle 7, Day 1 (n=89, 79, 84)Cycle 9, Day 1 (n=87, 66, 67)Cycle 11, Day 1 (n=71, 61, 65)Cycle 13, Day 1 (n=67, 52, 61)
Bortezomib and Dexamethasone1.3-4.9-3.3-4.2-11.6-10.2
Bortezomib, Melphalan and Prednisone2.0-0.4-4.7-1.02.81.0
Bortezomib, Thalidomide, and Dexamethasone-4.4-6.1-8.6-8.1-7.9-8.5

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Tumor Response Rate in Participants With Measurable Disease

Tumor response was defined as either a Complete Response (disappearance of all target lesions) or a Partial Response (≥30% decrease from baseline in target lesions) as assessed by Response Evaluation Criteria In Solid Tumors (RECIST)version 1.0. (NCT00519285)
Timeframe: Before randomization (baseline) then every 3 months up to tumor progression (≥25% increase) or the cut-off date, whichever occurred first

Interventionpercentage of participants (Number)
Placebo28.1
Aflibercept38.7

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Number of Participants With Positive Anti-aflibercept Antibody Levels as a Measure of Immunogenicity of Aflibercept

"Serum for detection of anti-drug antibodies (ADA) was collected in patients treated in selected centers only. Samples were analyzed using a titer-based, bridging immunoassay developed and validated to detect ADAs in human serum.~Samples with positive antibody levels were further analyzed using a validated, non-quantitative ligand binding assay to detect neutralizing antibodies Ab).~A participant was considered to have positive antibody levels if antibodies were detected above the quantification limits." (NCT00519285)
Timeframe: Pre-dose of cycle 1 (baseline), pre-dose of each every other cycle, then 30 and 90 days after the last administration of the study drug

,
Interventionparticipants (Number)
At baselineAt any time post-baseline- Neutralizing Ab- Not neutralizing Ab- Neutralizing potential not evaluated
Aflibercept29252
Placebo04022

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Number of Participants With Adverse Events as a Measure of Safety

"Adverse Events (AE) are any unfavorable and unintended sign, symptom, syndrome or illness observed by the investigator or reported by the participant during the study.~AE were collected at regular intervals throughout the study then graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v.3.0)." (NCT00519285)
Timeframe: From first dose of study treatment (aflibercept/placebo or docetaxel whichever came first) to last dose of study treatment (aflibercept/placebo or docetaxel whichever came last) + 30 days

,
Interventionparticipants (Number)
Any Adverse Event- Grade 3-4 AE- Serious AE- AE leading to death--- Related AE leading to death- AE leading to permanent discontinuation- AE leading to premature discontinuation
Aflibercept6074703314619268116
Placebo58529018423812573

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Overall Survival Time

"Overall survival (OS) time was measured as the time from date of randomization to the date of death due to any cause.~The median OS time and its 95.6% confidence interval were estimated using the Kaplan-Meier method. In the absence of confirmation of death, the participant was censored at the last date he/she was known to be alive or the study cut-off date (when 873 deaths have occurred), whichever was earlier." (NCT00519285)
Timeframe: From randomization up to the cut-off date (median follow-up of 35.4 months)

Interventionmonths (Median)
Placebo21.22
Aflibercept22.14

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Pain Progression-free Survival Time

"Pain progression was defined as either ≥1-point increase in Present Pain Intensity (PPI) score or ≥25% increase in Analgesics Score (AS) confirmed at least 3 weeks later, or requirement for palliative radiotherapy. PPI scale is a self-report 0-5 scale to assess pain intensity - a score 0 reflects no pain, a score 5 reflects excruciating pain. AS is a scoring method to assess analgesics consumption. Each analgesic is scored 1 or 4 depending on the analgesic type and dose. AS is the sum of the analgesic scores.~Pain progression-free survival (PFS) time was measured as the time from the date of randomization up to the date of first pain progression or death due to any cause, whichever occurred first.~The median pain-PFS and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of event, the participant was censored at the the date of last assessment without evidence of pain progression or the study cut-off date, whichever was earlier." (NCT00519285)
Timeframe: From randomization up to the cut-off date (median follow-up of 35.4 months)

Interventionmonths (Median)
Placebo9.72
Aflibercept9.20

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Pain Response Rate

Pain response was defined as either a ≥2-point decrease from baseline in Present Pain Intensity (PPI) score without increase in Analgesics Score (AS), or a ≥50% decrease from baseline in AS without increase in the PPI score confirmed at least 3 weeks later. Increases in PPI or AS during the first 12 weeks were ignored in determining pain response. (NCT00519285)
Timeframe: Before randomization (baseline) then every 3 weeks up to pain progression or the cut-off date, whichever occurred first

Interventionpercentage of participants (Number)
Placebo46.3
Aflibercept35.8

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Progression Free Survival Time

"Disease progression was defined as a composite of: Radiological tumor progression (≥20% increase in target lesions, or appearance of at least 2 new bone lesions); PSA progression (≥25% increase in PSA level confirmed 3 weeks later); Pain progression (increase in pain intensity or in analgesic consumption for cancer related pain confirmed 3 weeks later); Radiotherapy for cancer related symptoms; Occurence of Skeletal related events (SRE).~Progression Free survival (PFS) time was measured as the time from the date of randomization up to the date of occurrence of the first event defining a disease progression or death due to any cause, whichever occurred first.~The median PFS time and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of disease progression, the participant was censored at the the date of last assessment without evidence of progression or the study cut-off date, whichever was earlier." (NCT00519285)
Timeframe: From randomization up to the cut-off date (median follow-up of 35.4 months)

Interventionmonths (Median)
Placebo6.24
Aflibercept6.90

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Prostate Specific Antigen Progression-free Survival Time

"Prostate specific antigen (PSA) progression was defined as ≥25% increase in PSA level confirmed 3 weeks later, above the nadir in participants who had achieved a PSA response, or above the baseline in participants who hadn't achieved a PSA response.~PSA progression-free survival (PFS) time was defined as the time from the date of randomization up to the date of the first documented PSA progression or death due to any cause, whichever occurred first.~The median PSA-PFS time and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of PSA progression or death, the participant was censored at the the date of last assessment without evidence of progression or the study cut-off date, whichever was earlier." (NCT00519285)
Timeframe: From randomization up to the cut-off date (median follow-up of 35.4 months)

Interventionmonths (Median)
Placebo8.11
Aflibercept8.25

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Prostate Specific Antigen Response Rate

Prostate specific antigen (PSA) response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed at least 3 weeks later. Increases of any magnitude during the first 12 weeks were ignored in determining PSA response. (NCT00519285)
Timeframe: Before randomization (baseline) then every 3 weeks up to PSA progression (≥25% increase) or the cut-off date, whichever occurred first

Interventionpercentage of participants (Number)
Placebo63.5
Aflibercept68.6

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Number of Participants With Response

Periodic bone marrow samples (every 3-6 months) to check cells related to disease before/during/after study. Response classifications categorized by the International Working Group Response Criteria for Myelodysplastic Syndrome (MDS) as: Complete Remission, Partial Response, Hematologic Improvement or No Response. (NCT00520468)
Timeframe: Response evaluation within first 3 months from start of therapy, then every 3 to 6 months

Interventionparticipants (Number)
Complete RemissionPartial ResponseHematologic ImprovementNo Response
Cytokine-Immunotherapy2246

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6-month Progression-free Survival (PFS) Proportion

The proportion of patients on each treatment arm who survive ≥ 6.00 months progression-free (NCT00527124)
Timeframe: Followed for 52 weeks at 3 month intervals after coming off treatment, time period equal to the length of treatment + up to 12 months

Interventionpercentage of patients (Number)
Arm I60
Arm II54

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Time to Progression

Analyzed with standard K-M methodology. Both point and 95% CI estimates of the median and other statistics (e.g., the 3-month rate, 6-month rate, etc.) will be computed from the censored distribution of TTP. These point and CI estimates will be reported for all patients combined, and separately for each treatment arm. (NCT00527124)
Timeframe: The time from registration date until documented clinical disease progression, or until date of death, whichever occurs first, assessed up to 52 weeks

Interventionmonths (Median)
Arm I8.0
Arm II6.4

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Overall Response Rate Evaluated by the RECIST Criteria

"The overall response is determined by combining the patient's status on target lesions, PSA, non-target lesions, and new disease as defined in the following table.~Target Lesions CR CR PR SD PD Any Any Any~PSA Response CR PR PR Non-PD Any Any PD Any~Non-Target Lesions CR Non-CR/Non-PD Non-PD Non-PD Any PD Any Any~New Lesions No No No No Yes or No Yes or No Yes or No Yes~Overall Response CR PR PR SD PD PD PD PD" (NCT00527124)
Timeframe: Up to 52 weeks

,
Interventionproportion of evaluable patients (Number)
SDPD
Arm I.92.08
Arm II.92.08

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Prostate-specific Antigen (PSA) Response in Accordance With the Prostate Specific Antigen Working Group

PSA < 4.0 ng/ml. is a CR. A 50% decline or better in PSA is a PR. Less than a 50% decline in PSA and less than a 25% increase in PSA is SD. A 25% or greater increase in PSA level by at least 5 ng/mL is PD by PSA only. The point estimate and 95% Wilson CI estimates of the proportion for the Prostate-specific antigen (PSA) response will be computed . (NCT00527124)
Timeframe: Up to 52 weeks

,
Interventionproportion of evaluable patients (Number)
CRPRSDPD
Arm I.35.27.35.04
Arm II.12.54.31.04

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Overall Survival

Analyzed with standard K-M methodology. A 12 month survival rate will be calculated since median survival was not reached by the end of the study period. (NCT00527124)
Timeframe: The time from registration date until death from any cause, assessed up to 52 weeks

Interventionpercentage of patients (Number)
Arm I71
Arm II76

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Number of Participants With Prostate Specific Antigen (PSA) Response

The PSA response is defined as at least a 50 percent decrease in PSA below the baseline value, confirmed by a second PSA value greater than or equal to 6 weeks later. A participant was considered to be a PSA responder if and only if the response occurs prior to PSA progression (increase of at least 25 percent and an increase of 5 nanogram per milliliter from the lowest observed PSA value since initiation of treatment, to be confirmed greater than or equal to 3 weeks later). (NCT00537381)
Timeframe: Baseline up to 6 months after last dose of study treatment or early withdrawal, assessed up to 601 days

InterventionParticipants (Number)
Docetaxel + Prednisone + Placebo43
Docetaxel + Prednisone + Intetumumab27

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Percent Change From Baseline in 'Vascular Endothelial Growth Factor (VEGF)' Marker Concentration

Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100. (NCT00537381)
Timeframe: Baseline, Week 6, 7, 10 and 13

,
InterventionPercent change (Mean)
Percent Change at Week 6 (n = 10, 48)Percent Change at Week 7 (n = 10, 54)Percent Change at Week 10 (n = 11, 51)Percent Change at Week 13 (n = 11, 41)
Docetaxel + Prednisone + Intetumumab-9.6411.6932.1120.19
Docetaxel + Prednisone + Placebo-10.00-3.103.968.22

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Percent Change From Baseline in 'N-telopeptide of Type I Collagen (NTx)' Marker Concentration

Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100. (NCT00537381)
Timeframe: Baseline, Week 6, 7, 10 and 13

,
InterventionPercent change (Mean)
Percent Change at Week 6 (n = 10, 48)Percent Change at Week 7 (n = 10, 54)Percent Change at Week 10 (n = 11, 51)Percent Change at Week 13 (n = 11, 40)
Docetaxel + Prednisone + Intetumumab-21.37-23.44-21.71-36.47
Docetaxel + Prednisone + Placebo-0.771.582.55-3.87

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Overall Survival

Overall Survival is defined as the time from the date of randomization to death due to any cause. For participants who were alive at the time of analysis, overall survival was censored at the last contact date. (NCT00537381)
Timeframe: Baseline until death (up to 887 days)

InterventionDays (Median)
Docetaxel + Prednisone + Placebo626.0
Docetaxel + Prednisone + Intetumumab522.0

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Number of Participants With Best Overall Response (OR)

Number of participants with best OR is based on assessment of confirmed complete response (CR) or confirmed partial response (PR). Confirmed CR is defined as disappearance of all target lesions. Confirmed PR is defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. (NCT00537381)
Timeframe: Baseline up to 6 months after last dose of study treatment, assessed up to 551 days

,
InterventionParticipants (Number)
Complete ResponsePartial Response
Docetaxel + Prednisone + Intetumumab08
Docetaxel + Prednisone + Placebo19

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Progression-Free Survival (PFS)

The PFS was assessed as median number of days from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier. (NCT00537381)
Timeframe: Baseline up to 6 months after last dose of study treatment, assessed up to 551 days

InterventionDays (Median)
Docetaxel + Prednisone + Placebo336.0
Docetaxel + Prednisone + Intetumumab232.0

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Percent Change From Baseline in 'C-telopeptide of Type I Collagen (CTx)' Marker Concentration

Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100. (NCT00537381)
Timeframe: Baseline, Week 6, 7, 10 and 13

,
InterventionPercent change (Mean)
Percent Change at Week 6 (n = 10, 48)Percent Change at Week 7 (n = 10, 54)Percent Change at Week 10 (n = 11, 51)Percent Change at Week 13 (n = 11, 41)
Docetaxel + Prednisone + Intetumumab-30.81-39.78-25.48-44.89
Docetaxel + Prednisone + Placebo1.45-11.582.395.22

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Quality of Life Using the FACT-G Data

"Change from baseline FACT-G scores. The quality of life questionnaire (FACT-G) was given at various timepoints during the study. The values for change from baseline to endpoint are provided.~Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28) ; Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108. Note: The higher the score, the better the outcome" (NCT00540644)
Timeframe: baseline and after last cycle (up to 6 cycles)

,
Interventionscores on a scale (Mean)
Physical Well-Being Change from BaselineSocial/Family Well-Being Change from BaselineEmotional Well-Beling Change from BaselineFunctional Well-Being Change from BaselineFACT-G Change from Baseline
Extension - Revlimid, Cyclophosphamide, Prednisone-2.81-0.230.60-1.17-3.61
Original Study - Revlimid, Cyclophosphamide, Prednisone1.57-0.032.523.387.44

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Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria

Evaluate the response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better using the proposed International Myeloma Working Group uniform response criteria. The percentage of patients achieving this and the exact 95% confidence interval will be calculated. (NCT00540644)
Timeframe: After 6 cycles

Interventionpercentage of participants (Number)
Original Study - Revlimid, Cyclophosphamide, Prednisone86.7
Extension - Revlimid, Cyclophosphamide, Prednisone71.4

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Number of Participants With Detectable Bone Marrow Testosterone Level (>1 Picograms/Mililiter)

(NCT00544440)
Timeframe: Baseline (predose Week 1 Day 1) and Week 8

InterventionNumber of Participants (Number)
Baseline (predose Week 1 Day 1) (n=49)Week 8 (n=44)
Abiraterone Acetate00

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Number of Participants With Detectable Bone Marrow Dihydrotestosterone (DHT) Level (>9 Picograms/Mililiter)

(NCT00544440)
Timeframe: Baseline (predose Week 1 Day 1) and Week 8

InterventionNumber of Participants (Number)
Baseline (predose Week 1 Day 1) (n=49)Week 8 (n=44)
Abiraterone Acetate22

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Probability of CNS Relapse

To assess whether intensification of CNS-directed intrathecal and systemic chemotherapy will improve outcome in patients at high-risk of CNS relapse. (NCT00549848)
Timeframe: For Total XVI: 3.5 years after the last enrollment, up to approximately 13.5 years For Total XV: patients are followed continuously, up to 20.5 years

InterventionPercentage of participants (Number)
TOTXVI PEG 35000.8
TOTXVI PEG 25001.8
TOTXVI Not Randomized2.7
All Eligible Patients in TOTXV5.7

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Probability of Event-free Survival

"To estimate the event-free survival of children with ALL who are treated with risk-directed therapy and to compare the EFS results of TOTXVI with that of TOTXV (NCT00137111).~EFS will be measured from the date of complete response to the date of initial failure for patients who fail. Failure includes the traditional endpoints of failure to achieve a complete remission, relapse in any site, secondary malignancy, and death during induction or remission. EFS time will be measured to the date of last contact for patients who are failure free at the time of analysis. The EFS time is defined to be zero (0) for patients who die during induction therapy or fail to achieve a complete remission." (NCT00549848)
Timeframe: For Total XVI: 3.5 years after the last enrollment, up to approximately 13.5 years For Total XV: patients are followed continuously, up to 20.5 years

InterventionPercentage of participants (Number)
TOTXVI PEG 350092.4
TOTXVI PEG 250091.1
TOTXVI Not Randomized86.3
All Eligible Patients in TOTXV87.1

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Probability of Overall Survival

To estimate the overall survival of children with ALL who are treated with risk-directed therapy and to compare the EFS results of TOTXVI with that of TOTXV. (NCT00549848)
Timeframe: For Total XVI: 3.5 years after the last enrollment, up to approximately 13.5 years For Total XV: patients are followed continuously, up to 20.5 years

InterventionPercentage of participants (Number)
TOTXVI PEG 350097.5
TOTXVI PEG 250095.6
TOTVI Not Randomized90.8
All Eligible Patients in TOTXV93.5

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Percentage of Participants With Continuous Complete Remission of Patients Receiving High-dose and Conventional Dose PEG-asparaginase.

"The primary objective of this study is to compare the distributions of continuous complete remission of patients randomized on the first day of the continuation phase to receive a higher dose of PEG-asparaginase or to receive the conventional dose (2,500 units/m2).~The randomization will occur on the starting day of the continuation phase, at which time all information necessary for performing the randomization should be available. In the rare case that immunophenotype and/or Day-15 MRD is not available, we will make the following assumptions: If immunophenotype is unknown at the time the randomization is to be executed, then it will be assumed B-lineage. If Day-15 MRD is unknown at the time of randomization, then it will be assumed negative (<0.01%). Past experience indicate that few patients will fall into these unknown categories." (NCT00549848)
Timeframe: 3.5 years after the last enrollment up to 12.5 years

InterventionPercentage of participants (Number)
PEG 3500 Units/m^291.6
PEG 2500 Units/m^290.7

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Proportion of Participants With Minimal Residual Disease (MRD) on the 15th Day of Remission Induction ≥ 5%

To study whether intensifying induction, including fractionated cyclophosphamide and thioguanine, in patients with day 15 MRD ≥ 5% will result in improved leukemia cytoreduction in this subgroup compared to therapy followed in the TOTXV protocol. (NCT00549848)
Timeframe: Middle of remission induction, Day 15 in Total XVI and Day 19 in Total XV

InterventionParticipants (Count of Participants)
TOTXVI PEG 350022
TOTXVI PEG 250026
TOTXVI Not Randomized31
All Eligible Patients in TOTXV55

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Proportion of Participants With Minimal Residual Disease (MRD) at End of Remission Induction ≥ 0.01%

To study whether intensifying induction, including fractionated cyclophosphamide and thioguanine, in patients with day 15 MRD ≥ 5% will result in improved leukemia cytoreduction in this subgroup compared to therapy followed in the TOTXV protocol. (NCT00549848)
Timeframe: End of remission induction; day 42 in Total XVI and day 46 in Total XV

InterventionParticipants (Count of Participants)
TOTXVI PEG 35007
TOTXVI PEG 250012
TOTXVI Not Randomized20
All Eligible Patients in TOTXV44

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Participant Average Rhinoconjunctivitis Daily Symptom Scores (DSS) Over the Entire GPS

The DSS is composed of six rhinoconjunctivitis symptoms which were recorded daily including runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy, and watery eyes, and the symptoms were measured on a scale of 0 (no symptom) to 3 (severe symptoms). A higher score indicated a higher level of symptoms and the total daily score could range from 0 (best) to 18 (worst). (NCT00550550)
Timeframe: Start of the GPS to the End of the GPS

InterventionUnits on a Scale (Mean)
SCH 6972433.71
Placebo4.91

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Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS

The DMS is composed of a sum of the scores associated with rescue medication use per day. Rescue medications were implemented when a participant had a symptom score >= 4. Rescue medications for allergic rhinoconjunctivitis were to be utilized in a step-wise fashion: loratadine, olopatadine hydrochloride 0.1% opthalmic solution, mometasone, and prednisone, in that sequence. The score for the DMS ranged from 0 (no use of rescue medication) to 36 (maximum use of rescue medication). A lower medication score indicated less impact on symptoms and was suggestive of less use of rescue medication. (NCT00550550)
Timeframe: Start of the GPS to the End of the GPS

InterventionUnits on a Scale (Mean)
SCH 6972430.91
Placebo1.33

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Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS)

The TCS is the sum of the rhinoconjunctivitis daily symptom score (DSS) and rhinoconjunctivitis daily medication score (DMS) averaged over the entire GPS. The TCS ranged from 0 (no symptoms and no rescue medication use) to 54 (most severe symptoms and maximum use of rescue medication), with increasing score indicating a higher level of symptom severity. The DSS is composed of 6 rhinoconjunctivitis symptoms with scores from 0 (best) to 18 (worst), with increasing score indicating increased severity. The DMS is composed of a sum of the scores associated with rescue medication use per day. The range for the DMS was 0 (no rescue medication use) to 36 (maximum use of rescue medication), with a lower score indicating less use of rescue medication. (NCT00550550)
Timeframe: From the Start of the GPS to the End of the GPS

InterventionUnits on a Scale (Mean)
SCH 6972434.62
Placebo6.25

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Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) Total Score Over the Entire GPS

The RQLQ has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0 (best) to 6 (worst), with a higher score indicating more significant impairment. (NCT00550550)
Timeframe: Start of the GPS to the End of the GPS

InterventionUnits on a Scale (Mean)
SCH 6972431.45
Placebo1.77

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Mean Number of Blood Transfusions Per Visit

(NCT00551291)
Timeframe: Up to approximately 2 years

Interventiontransfusions/visit (Mean)
Baseline (n=8)Week 12 (n=6)Week 18 (n=5)End of Study (n=3)
Mycophenolate Mofetil + Prednisone + Erythropoietin Beta4.135.832.802.33

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Percentage of Participants With Clinical Response as Measured by the International Working Group (IWG) Criteria for Hematological Improvement

International Working Group (IWG) criteria for hematological improvement was defined as having hemoglobin (Hgb) <11 g/dL (pretreatment) and an increase in Hgb ≥1.5 g/dL after ≥8 weeks of treatment. (NCT00551291)
Timeframe: Up to approximately 2 years

Interventionpercentage of participants (Number)
Week 12 (n=4)Week 18 (n=7)End of study (n=3)
Mycophenolate Mofetil + Prednisone + Erythropoietin Beta50.0071.43100.00

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Percentage of Participants With at Least One Adverse Event (AE)

An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. (NCT00551291)
Timeframe: Up to approximately 2 years

Interventionpercentage of participants (Number)
Mycophenolate Mofetil + Prednisone + Erythropoietin Beta90.00

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Response of Hemangioma (IH) to Treatment

"Response of IH not confined to the dermis will be coded using the following criteria: Progressive disease: >40% increase in volume by MRI, Partial response: >65% reduction in volume by MRI, Complete response: no visual or radiographic evidence of disease, Stable disease: none of the above or <40% increase or <65% decrease in volume by MRI.~Response of superficial IH will be coded using the following criteria (based on RECIST): Progressive disease: >30% increase in IH size, Partial response: >30% reduction in size, Complete response: no evidence of disease, Stable disease: none of the above.~Our first 3 patients showed limits to using MRI volume to measure IH size/response to therapy. Unlike other solid tumors, the superficial distribution of some IH made getting volume by MRI difficult, resulting in smaller tumor estimation compared to clinical assessment. Based on these observations, we amended the protocol to report response based on RECIST criteria instead of change in IH volume." (NCT00555464)
Timeframe: 6 weeks

,
Interventionparticipants (Number)
Progressive DiseasePartial ResponseComplete ResponseStable Disease
Oral Steroid Treatment Group1002
Vincristine Treatment Group0202

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Toxicity to Medications

"Adverse events were closely monitored and recorded at weekly visits during treatment period and for two years after treatment ceased. Laboratory values were taken every other week during the treatment period.~Please see Adverse Events module for more details." (NCT00555464)
Timeframe: Initial visit, 2, 4, 6, 10 and 12 weeks of therapy

,
Interventionparticipants (Number)
Patients with Serious Adverse EventsPatients with Other Adverse Events
Oral Steroid Treatment Group00
Vincristine Treatment Group03

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Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts

Described via means and standard deviations in available Arm C relapse samples (NCT00557193)
Timeframe: At relapse (up to 3 years)

InterventionqPCR fold expression ratio (Mean)
Arm C (Safety/Efficacy Dose Level 2)5.73

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Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts

Described via mean and standard deviation by group. (NCT00557193)
Timeframe: Sampled at the start of induction

InterventionqPCR fold expression ratio (Mean)
Arm A (Standard Risk MLL-G)1.25
Arm B (IR/HR MLL-R Chemotherapy)7.85
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)5.83

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Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts

Described via means and standard deviations in samples which have acquired resistance to lestaurtinib (NCT00557193)
Timeframe: At relapse (up to 3 years)

InterventionProportion of cells that are viable (Mean)
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)0.69

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Describe in Vitro Sensitivity as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts

Described via means and standard deviations in samples which have primary resistance to lestaurtinib (NCT00557193)
Timeframe: Sampled at the start of induction

InterventionProportion of cells that are viable (Median)
Arm A (Standard Risk MLL-G)0.75
Arm B (IR/HR MLL-R Chemotherapy)0.48
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)0.47

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Percent Probability for Event-free Survival (EFS) for Patients on Arm A

EFS time is defined as time from treatment assignment to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years

Interventionpercentage probability (Number)
Arm A (Standard Risk MLL-G)86.67

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Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)

EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years

Interventionpercentage probability (Number)
Arm C (Safety/Efficacy Dose Level 2)35.82

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Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2

Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. EFS will be compared between patients on treatment Arm C at DL2 to those on Arm B. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years.

Interventionpercent probability (Number)
Arm B (IR/HR MLL-R Chemotherapy)38.89
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)35.82

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Percent Probability of Event Free Survival (EFS) by MRD Status and Treatment Arm

Three-year EFS estimates and 90% CI will be reported by treatment arm and end-induction MRD status. (NCT00557193)
Timeframe: 3 Years from end of Induction)

Interventionpercent probability (Number)
Arm A (MRD Negative)86.05
Arm A (MRD Positive)87.5
Arm B (MRD Negative)47.37
Arm B (MRD Positive)22.73
Arm C (MRD Negative)51.85
Arm C (MRD Positive)27.03

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Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy

Summarized with mean and standard deviation for those with available data in Arm C (NCT00557193)
Timeframe: Sampled between weeks 6-12 from start of induction

InterventionActivity percentage (Mean)
Arm C (Safety/Efficacy Dose Level 2)69.00

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Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS)

The TCS is the sum of the rhinoconjunctivitis daily symptom score (DSS) and rhinoconjunctivitis daily medication score (DMS) averaged over the entire GPS. The TCS ranged from 0-54, with increasing score indicating a higher level of symptom severity. The DSS is composed of 6 rhinoconjunctivitis symptoms with scores from 0-18, with increasing score indicating increased severity. The DMS is composed of a sum of the scores associated with rescue medication use per day. The range for the DMS was 0-36, with a lower score indicating less use of rescue medication. (NCT00562159)
Timeframe: Start of the GPS to End of the GPS

InterventionUnits on a Scale (Mean)
SCH 6972435.08
Placebo6.39

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Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire With Standardized Activities (RQLQ(S)) Total Score Over the Entire GPS

The RQLQ(s) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment. (NCT00562159)
Timeframe: Start of the GPS to End of the GPS

InterventionUnits on a Scale (Mean)
SCH 6972431.30
Placebo1.57

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Participant Average Rhinoconjunctivitis Daily Symptom Score (DSS) Over the Entire GPS

The DSS is composed of six rhinoconjunctivitis symptoms which were recorded daily including runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy, and watery eyes, and the symptoms were measured on a scale of 0 (no symptom) to 3 (severe symptoms). A higher score indicated a higher level of symptoms and the total daily score could range from 0 to 18. (NCT00562159)
Timeframe: Start of the GPS to End of the GPS

InterventionUnits on a Scale (Mean)
SCH 6972433.83
Placebo4.69

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Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS

The DMS is composed of a sum of the scores associated with rescue medication use per day. Rescue medications were implemented when a participant had a symptom score >= 4. Rescue medications for allergic rhinoconjunctivitis were to be utilized in a step-wise fashion: loratadine, olopatadine hydrochloride 0.1% opthalmic solution, mometasone, and prednisone, in that sequence. The score for the DMS ranged from 0-36. A lower medication score indicated less impact on symptomology and was suggestive of less use of rescue medication. (NCT00562159)
Timeframe: Start of the GPS to End of the GPS

InterventionUnits on a Scale (Mean)
SCH 6972431.25
Placebo1.70

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Percentage of Participants With Objective Response (OR)

OR was based on assessment of complete response(CR),unconfirmed CR(Cru),partial response(PR) as per International Response Criteria for Non-Hodgkin's Lymphoma.Confirmed response=response persists on repeat imaging at least 4 weeks after initial response.CR=complete disappearance of all detectable clinical/radiographic evidence of disease,lymph nodes regressed to normal size [at least 1.5 centimeter(cm) or less],spleen regressed,not palpable on physical examination,bone marrow infiltrate cleared on repeat aspiration/biopsy.PR=at least 50 percent (%) decrease in sum of product diameters of 6 greatest dominant nodes,no increase in other nodes,liver/spleen,no new sites of disease. CRu=residual lymph node greater than 1.5 cm in transverse diameter that has regressed more than 75% in product diameter.Individual nodes previously confluent,regressed more than 75% in product diameters.Indeterminate bone marrow (increased number/size of lymph aggregates without cytologic/architectural atypia). (NCT00562965)
Timeframe: Baseline, every 6 to 12 weeks during treatment period, end of treatment (EOT) (42 days after last dose), every 12 weeks during follow-up for up to 1 year after the last dose of study drug

Interventionpercentage of participants (Number)
Rituximab + Inotuzumab Ozogamicin93.3
Control Regimens R-CVP + R-FND64.3

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Progression-Free Survival (PFS)

PFS was defined as the time from randomization to disease progression or death due to any cause, whichever occurred first, censored at the last tumor evaluation date. PFS calculated as (Months) = (first event date minus randomization date plus 1) divided by 30.44. (NCT00562965)
Timeframe: Baseline until disease progression or death or up to 1 year after last dose of study drug

Interventionmonths (Median)
Rituximab + Inotuzumab OzogamicinNA
Control Regimens R-CVP + R-FND16.4

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Number of Participants With Clinically Significant Change From Baseline in Laboratory Findings

Criteria for laboratory test abnormality: Blood Chemistry (alkaline phosphatase [greater than{>}5*upper limit of normal {ULN}, calcium [less than {<}1.75 millimole per liter {mmol/L}, creatinine [>3*ULN], glucose [>13.9 mmol/L], phosphorous [<0.6 mmol/L], potassium [<3 mmol/L], aspartate transaminase [>5.0*ULN], total bilirubin [>3*ULN]), Coagulation (international normalized ratio [>2*ULN]), Hematology (hemoglobin [<80 grams/Liter], lymphocytes [<0.5*10^9/L], absolute neutrophil count [<1*10^9/L], platelet count [<50*10^9/L], WBC [<2.0*10^9/L]). (NCT00562965)
Timeframe: Baseline up to 42 days post-treatment, disease follow up (every 12 weeks for a minimum of 1 year and up to 2 years)

,
Interventionparticipants (Number)
Baseline up to 42 days post-treatmentDisease follow up
Control Regimens R-CVP + R-FND127
Rituximab + Inotuzumab Ozogamicin118

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Number of Participants With Clinically Significant Change From Baseline in QT Interval Findings

Assessments of QT interval was performed only in rituximab + inotuzumab ozogamicinin group. QT interval corrected using Fridericia's formula (QTcF) and Bazett's formula (QTcB) was analyzed as per common terminology criteria for adverse events (CTCAE) version 3.0, where Grade 1 = mild AE, Grade 2 = moderate AE, Grade 3 = severe AE, Grade 4 = life-threatening or disabling AE, Grade 5 = death related to AE. Number of participants with change in CTCAE grading at post-baseline time point compared to the baseline were presented. The post-baseline value was defined as the maximum grade after the first dose date on or before the end of treatment. (NCT00562965)
Timeframe: Baseline up to 42 days post-treatment

Interventionparticipants (Number)
QTcB: BL normal, post-BL normalQTcB: BL normal, post-BL Grade 1QTcB: BL normal, post-BL Grade 2QTcF: BL normal, post-BL normalQTcF: BL normal, post-BL Grade 1
Rituximab + Inotuzumab Ozogamicin42363

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Number of Participants With Clinically Significant Change From Baseline in Vital Signs

Criteria for determining significant change from baseline in vital signs abnormalities: heart rate value of <40 beats per minute and value >150 beats per minute, systolic blood pressure (SBP) of <80 or >210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of <40 or >130 mmHg, temperature <32 or >40 degree centigrade, and body weight>=10% increase or decrease of body weight in kilogram (kg). (NCT00562965)
Timeframe: Baseline up to 42 days post-treatment, disease follow up (every 12 weeks for a minimum of 1 year and up to 2 years)

,
Interventionparticipants (Number)
Baseline up to 42 days post-treatmentDisease follow up
Control Regimens R-CVP + R-FND12
Rituximab + Inotuzumab Ozogamicin03

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Overall Survival Probability at Months 6, 12 and 24

Overall survival was defined as the time from randomization to death due to any cause, censoring at the date of last contact or the end of the study. Participants who withdrew or lost to follow-up from study without having death documented were censored at the date of last contact. Kaplan-Meier estimates of the probability of survival at 6, 12 and 24 months was used to estimate the survival function. (NCT00562965)
Timeframe: Baseline up to Month 6, 12, 24

,
Interventionpercent chance of survival (Number)
Overall Survival: Baseline up to Month 6Overall Survival: Baseline up to Month 12Overall Survival: Baseline up to Month 24
Control Regimens R-CVP + R-FND92.383.967.1
Rituximab + Inotuzumab Ozogamicin100.086.786.7

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Number of Participants With Grade 3 or 4 Treatment Emergent Adverse Events (TEAEs)

AE=any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. TEAE=between first dose of study drug and up to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state. (NCT00562965)
Timeframe: Baseline up to 42 days post-treatment

Interventionparticipants (Number)
Rituximab + Inotuzumab Ozogamicin12
Control Regimens R-CVP + R-FND13

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Overall Survival

(NCT00574496)
Timeframe: up to 8 years

Interventionmonths (Median)
High-Risk or Relapsed Hodgkin Lymphoma70.3

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Progression-free Survival at 1 Year

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT00574496)
Timeframe: 1 year

Interventionproportion of progression-free pts (Number)
High-Risk or Relapsed Hodgkin Lymphoma33.3

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Disease Relapse or Progression as Measured by CT Scan or PET

(NCT00574496)
Timeframe: 3 years

Interventionmonths (Median)
High-Risk or Relapsed Hodgkin Lymphoma34.3

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Number of Participants With Progression Free Survival (10 Years) by Treatment

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT00577993)
Timeframe: 10 years

InterventionParticipants (Count of Participants)
Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab59
Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)58

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Number of Participants With Overall Survival (10 Years) by Treatment

Overall Survival is the time from date of treatment start until date of death due to any cause or last Follow-up within 10 years. (NCT00577993)
Timeframe: 10 Years

InterventionParticipants (Count of Participants)
Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab59
Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)58

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Adverse Infusion Reactions Within 24 Hours Following the Second Rituximab Infusion.

Assessment of all adverse infusion reactions within 24 hours of receipt of the second rituximab infusion (NCT00580229)
Timeframe: 24 hours

Interventionacute infusion reactions (Number)
Oral Prednisone as a Pretreatment to Rituximab48

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Adverse Events Assessed From Day 15 Through Week 26.

All adverse events reported from day 15 (24 hours after second infusion) through week 26. (NCT00580229)
Timeframe: 24 weeks

Interventionevents (Number)
Oral Prednisone as a Pretreatment to Rituximab48

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Number of Acute Infusion Reactions in the First 24 Hours After Oral Prednisone Pretreatment to Initial Rituximab Infusion

Open-label assessment of AIR's during and/or within 24 hours in patients pretreated with 40mg oral prednisone 30 minutes prior to initial rituximab infusion (NCT00580229)
Timeframe: 24 hours

Interventionacute infusion reactions (Number)
Oral Prednisone as a Pretreatment to Rituximab50

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FEV1 Percent Predicted

(NCT00588406)
Timeframe: 4 hours post-randomization

Interventionpercent predicted of FEV1 (Mean)
Budesonide51.7
Placebo52.6

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Hospitalization

(NCT00588406)
Timeframe: 6 hours

Interventionpercentage of participants (Number)
Budesonide39
Placebo39

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Change in Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) Score From Baseline to Cycle 12

A combined scale was used to assess the quality of life (QOL) comprising of the well established and validated functional well-being (FWB) and physical well-being (PWB) components of FACT-G version 4 (14 questions), which will address the physical and functional well-being of multiple myeloma patients plus the FACT-neurotoxicity (NTX, 11 questions), which will evaluate symptoms of neurotoxicity. This pooled scale is referred to as the FACT Ntx TOI. The FACT-Ntx TOI has 25 items and the score ranges from 0 (worst possible outcome) to 100 (best possible outcome). (NCT00602641)
Timeframe: Administered at registration, the beginning of cycle 7 d1, the end of cycle 12 d28, then at the end of cycle 18, 24, and 38 d28. For patients who discontinue treatment early, assessed at time of discontinuation and at the next quarterly follow-up visit.

Interventionunits on a scale (Mean)
Arm I (MPT-T)-2.8
Arm II (mPR-R)3.3

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Very Good Partial Response (VGPR) Rate

Response evaluation was based on the International Myeloma Working Group (IMWG) response criteria. VGPR rate was defined as patients achieving at least VGPR which include patients who achieving complete response (CR) and VGPR. CR refers to patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow. VGPR refers to patients who meet the following criteria: Serum and urine M-component detectable by immunofixation but not on electrophoresis; Or 90% or greater reduction in serum M-component plus urine M-component <100 mg per 24 hours; If the serum and urine M protein are unmeasurable and the immunoglobulin free light chain parameter is being used to measure response, a ≥ 90% decrease in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M protein criteria. (NCT00602641)
Timeframe: Assessed every cycle (1 cycle=28 days) for the first 12 cycles, and then every 2 cycles while on treatment. Post treatment assessed every 3 months < 2 years from study entry, every 6 months if 2-5 years, every 12 months if 6-10 years from study entry.

Interventionproportion of participants (Number)
Arm I (MPT-T)0.247
Arm II (mPR-R)0.316

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Progression-Free Survival (PFS)

PFS is defined as the time from randomization to the earlier of progression or death of any cause. (NCT00602641)
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.

Interventionmonths (Median)
Arm I (MPT-T)21.0
Arm II (mPR-R)18.7

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Overall Survival

Overall survival was defined as time from randomization to death from any cause. (NCT00602641)
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.

Interventionmonths (Median)
Arm I (MPT-T)52.6
Arm II (mPR-R)47.7

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Biochemical Remission of (AIH) at Month 6.

Percent of patients that achieve biochemical remission of (AIH) at Month 6 during treatment with LCP-Tacro + prednisone or azathioprine + prednisone. Biochemical remission is defined as ALT, total bilirubin and gamma globulin within normal limits. (NCT00608894)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
LCP-Tacro3
Azathioprine4

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Biochemical Remission by Month 3.

Percent of patients who achieve biochemical remission by Month 3 during treatment with LCP-Tacro + prednisone or azathioprine + prednisone. Biochemical remission is defined as ALT, total bilirubin and gamma globulin within normal limits. (NCT00608894)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
LCP-Tacro2
Azathioprine4

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Incomplete Response, Treatment Failure, or a Case of Relapse at 6 Months

Percents of patients in each treatment group classified as having an incomplete response (defined as some or no improvement during therapy), a treatment failure (defined as permanent discontinuation of the regimen originally randomized to), or a case of relapse (recurrence following achievement of remission) (NCT00608894)
Timeframe: 6 months

,
InterventionParticipants (Count of Participants)
Incomplete responseTreatment failureRelapse
Azathioprine110
LCP-Tacro400

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Overall Survival (OS)

OS is defined as the time from date of first dose of study drug until the date of death. For those patients who did not die, OS was censored at the recorded last date of patient contact, and those missing a recorded last date of contact will be censored at the last date the patient was known to be alive. (NCT00623766)
Timeframe: From first dose to 24 months

InterventionMonths (Median)
Ipilimumab, 10 mg/kg, IV in Corticosteroid-free Patients6.97
Ipilimumab, 10 mg/kg, IV in Corticosteroid-dependent Patients3.75

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Best Overall Response Rate (BORR) by Modified World Health Organization (mWHO) Criteria and by Immune-relate Response Criteria (irRC)

BORR is defined as the number of patients whose global best overall response (BOR) was complete (CR) or partial response (PR), divided by the total number of participants who received treatment. CR=complete disappearance of all index lesions. PR=decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index lesions. The global BOR is the best overall response (OR) designation over the study as a whole for an individual in the study based on overall tumor burden. Both central nervous system (CNS) (brain lesions) and non-CNS compartments (lesions outside the brain) are considered for the global BOR. For the analysis of global BOR of CR or PR (by both modified WHO criteria and immune-related response criteria [irRC]), the OR assessment must be confirmed by a second (confirmatory) evaluation meeting the criteria for response and must be performed no less than 4 weeks after the criteria for response are first met. (NCT00623766)
Timeframe: From Day 1, first dose until the last tumor assessment, Week 12

,
InterventionPercentage of participants (Number)
Global BORR (mWHO criteria)BORR in brain (mWHO criteria)BORR in non-CNS compartment (mWHO criteria)Global BORR (irRC)BORR in brain (irRC)BORR in non-CNS compartment (irRC criteria )
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients4.84.84.84.84.84.8
Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients9.815.713.79.815.713.7

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Disease Control Rate by Modified World Health Organization (mWHO) Tumor Assessment Criteria

Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) (global, in brain, or outside of brain) based on mWHO criteria divided by the number of patients who received treatment. By mWHO criteria: CR=complete disappearance of all index lesions. PR=decrease, relative to baseline, of 50% or greater in the sum of the 2 largest perpendicular diameters of all index lesions. SD=does not meet criteria for CR or PR, in the absence of progressive disease (PD). Patients with PR or CR not confirmed after at least 4 weeks are scored as SD unless they have new primary lesions. PD=at least 25% increase in the sum of the diameters of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesions. CNS=central nervous system. (NCT00623766)
Timeframe: From Day 1, first dose to end of Week 12

,
InterventionPercentage of participants (Number)
Global disease control rateDisease control rate in brain
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients4.89.5
Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients17.623.5

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Number of Participants Surviving at 6, 12, 18, 24, and 36 Months (Overall Survival [OS] Rate)

OS is defined as the time from the first dose of study drug until the date of death. Overall survival rate is the percentage of participants known to be alive at a timepoint. For those patients who did not die, OS was censored at the recorded last date of patient contact, and those with a missing recorded last date of contact will be censored at the last date the patient was known to be alive. The survival rate at a specified time-point is the probability that a patient is alive at that time following randomization. The rate is calculated for each treatment group using the Kaplan-Meier product-limit method. A corresponding 2-sided 95% bootstrap confidence interval will be calculated. (NCT00623766)
Timeframe: From first dose to Months 6, 12, 18, 24, and 36 months

,
InterventionProbability of being alive (Number)
At 6 monthsAt 12 monthsAt 18 monthsAt 24 monthsAt 36 months
Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients0.380.190.190.100.10
Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients0.550.310.260.260.26

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Global Evaluation of Efficacy by Investigator at the End of the Evaluation Period in Autumn 2008

"The treatment efficacy was rated by investigators at the end of the evaluation period in autumn 2008. Investigators rated the asthma symptoms in comparison to when subjects entered the trial, using the categories: much worse, worse, the same, better, or much better.~The categories much better or better were grouped as improved. The categories the same, worse or much worse were grouped as not improved." (NCT00633919)
Timeframe: 8 weeks

,
InterventionParticipants (Number)
Investigator evaluation: ImprovedInvestigator evaluation: Not improvedInvestigator evaluation: Missing data
Active3070
Placebo24170

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Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2008

"Scoring per inhalation/tablet: 1-2 inhalations twice daily of salbutamol (200 ug per inhalation), 2 scores; 1-2 inhalation twice daily of budesonide/formoterol 80 (4.5 ug per inhalation), 4 scores; 1 inhalation twice daily of budesonide/formoterol 160 (4.5 ug per inhalation), 8 scores; up to 10 tablets once daily of prednisone (5 mg), 1.6 scores. The total maximum daily scores were 40.~The daily score for each medication step was calculated by multiplying the score per inhalation/tablet with the number of inhalations/tablets used (entered as units in the daily diary by the subject)." (NCT00633919)
Timeframe: 8 weeks

InterventionScores on a scale (Mean)
Active4.4
Placebo4.7

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Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2007

"Scoring per inhalation/tablet: 1-2 inhalations twice daily of salbutamol (200 ug per inhalation), 2 scores; 1-2 inhalation twice daily of budesonide/formoterol 80 (4.5 ug per inhalation), 4 scores; 1 inhalation twice daily of budesonide/formoterol 160 (4.5 ug per inhalation), 8 scores; up to 10 tablets once daily of prednisone (5 mg), 1.6 scores. The total maximum daily scores were 40.~The daily score for each medication step was calculated by multiplying the score per inhalation/tablet with the number of inhalations/tablets used (entered as units in the daily diary by the subject)." (NCT00633919)
Timeframe: 8 weeks

InterventionScores on a scale (Mean)
Active4.1
Placebo3.6

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Global Evaluation of Efficacy by Subject at the End of The Evaluation Period in 2008

"The treatment efficacy was rated by subjects at the end of the evaluation period in autumn 2008. Subjects rated their asthma symptoms in comparison to previous autumn using the categories: much worse, worse, the same, better, or much better.~The categories much better or better were grouped as improved. The categories the same, worse or much worse were grouped as not improved." (NCT00633919)
Timeframe: 8 weeks

,
InterventionParticipants (Number)
Subject evaluation: ImprovedSubject evaluation: Not improvedSubject evaluation: Missing data
Active2881
Placebo28130

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Global Evaluation of Efficacy by Subject and Investigator at the End of the Evaluation Period in Autumn 2007

"The treatment efficacy was rated by both subject and investigator at the end of the evaluation period in autumn 2007. Subjects rated their asthma symptoms in comparison to previous autumns and investigators rated the asthma symptoms in comparison to when subjects entered the trial, using the categories: much worse, worse, the same, better, or much better.~The categories much better or better were grouped as improved. The categories the same, worse or much worse were grouped as not improved." (NCT00633919)
Timeframe: 8 weeks

,
InterventionParticipants (Number)
Subject evalution: ImprovedSubject evaluation: Not improvedInvestigator evaluation: ImprovedInvestigator evaluation: Not improved
Active30173314
Placebo33143017

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An Estimate of the Overall Response Rate (ORR)(Complete Response [CR] + CR Unconfirmed [CRu] + Partial Response [PR]) to Bortezomib and Rituximab (VR)-CHOP According to International Workshop to Standardize Response Criteria (IWRC) Criteria

Response was assessed by computerized tomography (CT) after every 2 cycles of induction therapy, one time at least 4 weeks after completing induction (i.e., prior to maintenance), and then every 3 months while on maintenance therapy. At the conclusion of maintenance therapy, patients underwent one post-treatment scan, with further scans completed at the discretion of the treating physician. Positron emission tomography was permitted but only CT measurements were used to determine response. (NCT00634179)
Timeframe: Following completion of therapy, up to 2 years

,
Interventionparticipants (Number)
Complete Response (CR)Partial Response (PR)Overall Response Rate (ORR)
Phase I: Induction13619
Phase II: Maintenance191029

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Maximal Tolerated Doses of Bortezomib and Vincristine When Used in Combination of Bortezomib, Rituximab and the CHOP Chemotherapy Regimen (Phase I)

INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression. (NCT00634179)
Timeframe: Cycle 1 for MTD, following completion of therapy for CR, up to 24 weeks

Interventionmg/m^2 (Number)
MTD of Bortezomib With Vincristine Capped at 1.5 mg1.62

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Progression Free Survival.

Time between the start of therapy and progression. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive Disease is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT00634647)
Timeframe: 15 months

InterventionMonths (Median)
Satraplatin6.0

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Number of Participants With Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0)

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT00634647)
Timeframe: Date treatment consent signed to date off study, approximately 57 months.

InterventionParticipants (Count of Participants)
Satraplatin23

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Median Overall Survival (OS)

Overall Survival is the time between the first day of treatment to the day of death. (NCT00634647)
Timeframe: time between the first day of treatment to the day of death, approximately 15.7 months

InterventionMonths (Median)
Satraplatin16.0

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Visual Analogue Scale for Pain (VAS-pain)

100 millimeter (mm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionmm (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo65.453.053.656.454.351.151.149.2
TRU-015 Induction Dose61.649.649.047.044.840.839.143.9
TRU-015 Single Dose62.547.748.945.842.339.339.539.2

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Physician Global Assessment (PGA) of Disease Activity

Physician Global Assessment of Disease Activity was measured on a 0 to 10 point scale, where 0 = no disease activity and 10 = extreme disease activity. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionunits on a scale (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo6.85.55.05.04.84.64.44.3
TRU-015 Induction Dose6.65.24.94.44.33.63.63.6
TRU-015 Single Dose6.45.15.04.14.13.73.83.7

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Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28

The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. (NCT00634933)
Timeframe: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionpercentage of participants (Number)
Week 2: good responseWeek 2: moderate responseWeek 2: no responseWeek 4: good responseWeek 4: moderate responseWeek 4: no responseWeek 8: good responseWeek 8: moderate responseWeek 8: no responseWeek 12: good responseWeek 12: moderate responseWeek 12: no responseWeek 16: good responseWeek 16: moderate responseWeek 16: no responseWeek 20: good responseWeek 20: moderate responseWeek 20: no responseWeek 24: good responseWeek 24: moderate responseWeek 24: no response
Placebo1.433.864.95.439.255.48.144.647.39.539.251.418.940.540.517.637.844.614.944.640.5
TRU-015 Induction Dose2.739.757.58.245.246.612.353.434.216.452.131.520.556.223.326.054.819.230.150.719.2
TRU-015 Single Dose6.738.754.714.741.344.014.744.041.321.353.325.334.741.324.029.352.018.726.746.726.7

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Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response

ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP. (NCT00634933)
Timeframe: Week 2, 4, 8, 12, 16, 20, 28, 32, 36, 40, 44, 48, 52

,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 16Week 20
Placebo0.06.812.214.916.216.2
TRU-015 Induction Dose6.86.88.213.731.528.8
TRU-015 Single Dose8.08.010.716.030.728.0

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Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response

ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP. (NCT00634933)
Timeframe: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo0.01.41.41.46.82.72.7
TRU-015 Induction Dose1.40.01.42.76.86.89.6
TRU-015 Single Dose1.31.32.72.78.06.79.3

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Patient Global Assessment (PtGA) of Disease Activity

Measured using a 0-10 point scale, where 0 = no disease activity and 10 = extreme disease activity. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionunits on a scale (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo7.36.26.06.25.96.65.55.3
TRU-015 Induction Dose7.05.65.65.35.24.64.54.7
TRU-015 Single Dose6.95.65.45.24.84.44.54.6

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Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response

ACR20 response: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP. (NCT00634933)
Timeframe: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo17.631.131.131.141.947.343.2
TRU-015 Induction Dose26.034.242.549.361.664.467.1
TRU-015 Single Dose21.334.744.052.064.062.761.3

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Number of Tender Joints

The number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventiontender joints (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo17.013.611.911.711.09.49.09.4
TRU-015 Induction Dose17.713.011.610.19.68.47.67.6
TRU-015 Single Dose16.811.910.79.88.87.37.68.1

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Number of Swollen Joints

The number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. (NCT00634933)
Timeframe: Baseline. Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionswollen joints (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo12.29.57.87.07.66.16.06.2
TRU-015 Induction Dose13.910.29.07.77.15.95.15.0
TRU-015 Single Dose12.39.08.56.96.05.14.84.7

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Health Assessment Questionnaire Disability Index (HAQ-DI)

HAQ-DI: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The overall disability index computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionunits on a scale (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo1.81.51.41.51.51.41.41.4
TRU-015 Induction Dose1.61.31.31.21.11.11.01.0
TRU-015 Single Dose1.71.41.41.31.31.21.21.2

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Disease Activity Score Based on 28-joints Count (DAS28)

DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and participant's general health visual analog scale (scores ranging 0 [very well] to 100 mm [extremely bad]). DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity. (NCT00634933)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,
Interventionunits on a scale (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24
Placebo6.15.45.25.15.04.74.74.7
TRU-015 Induction Dose6.15.35.04.74.64.34.14.0
TRU-015 Single Dose5.85.14.94.64.33.94.04.1

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Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24

ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and C-Reactive Protein (CRP). (NCT00634933)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Placebo16.2
TRU-015 Single Dose29.3
TRU-015 Induction Dose27.4

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Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%

A prostate-specific antigen (PSA) response was defined as a >=50% decline from baseline. (NCT00638690)
Timeframe: Up to 12 months

InterventionParticipants (Number)
Abiraterone Acetate232
Placebo22

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Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria

The time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group (PSAWG) criteria, namely, a PSA level of at least 5 ng/ml that has risen on at least 2 successive occasions, at least 2 weeks apart. (NCT00638690)
Timeframe: Up to 12 months

InterventionDays (Median)
Abiraterone Acetate309.0
Placebo200.0

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Overall Survival

Overall survival is defined as the time interval from the date of randomization to the date of death from any cause. (NCT00638690)
Timeframe: Up to 60 months

InterventionDays (Median)
Abiraterone Acetate450.0
Placebo332.0

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Radiographic Progression-free Survival

Radiographic progression-free survival is based on imaging studies according to modified Response Evaluation Criteria in Solid Tumors (RECIST): baseline lymph node size must be >=2.0 cm to be considered a target lesion; progression on bone scans with >=2 new lesions not consistent with tumor flare, confirmed on a second scan >=6 weeks later that shows >=1 additional new lesion. (NCT00638690)
Timeframe: Up to 11 months

InterventionDays (Median)
Abiraterone Acetate171.0
Placebo110.0

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Prostate Specific Antigen (PSA) Kinetics: Percentage of Participants With PSA Response (Response Rate)

PSA response was defined as a post-baseline PSA level decline of at least 50% relative to the baseline value. Response rate calculated as 100*n/N where n=the number of participants with responses and N=the total number of participants treated. (NCT00642018)
Timeframe: Baseline, 18 months

Interventionpercentage of participants (Number)
Docetaxel56.9
LY2181308 + Docetaxel56.1

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Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment

(NCT00642018)
Timeframe: Study treatment discontinuation up to 30 days post study treatment discontinuation

InterventionParticipants (Count of Participants)
Docetaxel1
LY2181308 + Docetaxel0

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Functional Assessment of Cancer Therapy-Prostate Cancer (FACT-P) Total Score at 3 Months (Participant Reported Outcomes)

The FACT-P is a 39-item participant-rated questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-P score ranges from 0-156, with higher scores representing a better quality of life with fewer symptoms. (NCT00642018)
Timeframe: 3 months

Interventionunits on a scale (Median)
Docetaxel117
LY2181308 + Docetaxel115

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Functional Assessment of Cancer Therapy-General (FACT-G) Total Score at 3 Months (Evaluate Clinical Symptoms)

The total FACT-G is the sum of 4 subscale scores on the FACT-Prostate Cancer (FACT-P) participant-rated questionnaire representing general cancer symptoms: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), and functional well-being (7 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-G score ranges from 0-108, with higher scores representing a better quality of life with fewer symptoms. (NCT00642018)
Timeframe: 3 months

Interventionunits on a scale (Median)
Docetaxel84
LY2181308 + Docetaxel80

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Estimate Overall Survival

Overall survival is defined as the time from date of first treatment to the date of death due to any cause. For participants who were alive, overall survival was censored at their last contact. Participants were still followed for overall survival after they stopped receiving study drug. (NCT00642018)
Timeframe: First treatment to death due to any cause up to 45.54 months

Interventionmonths (Median)
Docetaxel29.04
LY2181308 + Docetaxel27.04

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Estimate Duration of Overall Response

The duration of response [complete response (CR) or partial response (PR)] was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. For participants who had no progression or death, the duration of response was censored at their last contact. (NCT00642018)
Timeframe: Time of response to time of measured progressive disease up to 41.00 months

Interventionmonths (Median)
Docetaxel10.81
LY2181308 + Docetaxel9.66

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Change From Baseline to Day 21 in Granulocyte Colony Stimulating Factor(G-CSF) (Assess Biomarker Responses)

G-CSF [international units per milliliter (IU/mL)] was used to estimate biomarker responses and is presented as the percentage change from baseline. (NCT00642018)
Timeframe: Baseline, 21 days

Interventionpercentage change (Number)
Docetaxel-32.5
LY2181308233.3

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Progression-free Survival (PFS) in Participants With Hormone Refractory Prostate Cancer (HRPC) Administered LY2181308 Sodium Plus Docetaxel Compared to Docetaxel Alone

PFS is defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. For participants who had no PD or death, PFS was censored at their last contact. Participants were still followed for PFS after they stopped receiving study drug. (NCT00642018)
Timeframe: Baseline to measured progressive disease or death due to any cause up to 44.68 months

Interventionmonths (Median)
Docetaxel9.00
LY2181308 + Docetaxel8.64

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Percentage of Participants With Complete Response or Partial Response (Overall Response Rate)

Overall response rate was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) per the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100. (NCT00642018)
Timeframe: Baseline to measured progressive disease up to 41.00 months

Interventionpercentage of participants (Number)
Docetaxel21.6
LY2181308 + Docetaxel10.2

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Number of Participants With Adverse Events (Safety)

Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study including the 30-day follow-up period. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section. The participants received maximum 24 cycles of treatment (1cycle = 3 weeks). Safety data were collected up to 24 cycles plus 30 days of follow-up for a total up to 19 months. (NCT00642018)
Timeframe: First treatment dose up to 19 months

,
InterventionParticipants (Count of Participants)
Serious Adverse EventsOther Nonserious Adverse Events
Docetaxel1150
LY2181308 + Docetaxel4794

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Adverse Event Profile

Data presented are the number of participants with all treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), discontinuations due to SAEs and AEs, and deaths that occurred in this study that were assessed by investigators as possibly related to study drug. The participants received maximum 24 cycles of treatment (1cycle = 3 weeks). Safety data were collected up to 24 cycles plus 30 days of follow-up for a total up to 19 months. (NCT00642018)
Timeframe: First treatment dose up to 19 months

,
InterventionParticipants (Count of Participants)
TEAEsSAEsDiscontinuations due to AEsDiscontinuations due to SAEsDeath
Docetaxel455610
LY2181308 + Docetaxel91272230

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Pharmacokinetics of Docetaxel: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-infinity)

(NCT00642018)
Timeframe: Predose up to 8 hours postdose in Cycle 1

Interventionnanograms*hour per milliliter (ng*h/mL) (Geometric Mean)
Docetaxel825
LY2181308 + Docetaxel799

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ACR 20 Response Rate at Visit 4

"Responders were defined as patients whose improvement from baseline to Visit 4 (Week 12) fulfilled all 3 of the following criteria:~> 20% reduction in the tender joint count (0-28)~> 20% reduction in the swollen joint count (0-28)~> 20% reduction in 3 out of the 5 following additional measures:~Patient's assessment of pain~Patient's global assessment of disease activity~Physician's global assessment of disease activity~Functional Disability Index of the Health Assessment Questionnaire~C-reactive protein or erythrocyte sedimentation rate" (NCT00650078)
Timeframe: Week 12

Interventionparticipants (Number)
NP01108
Placebo34

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Relative Reduction of Morning Stiffness

Data for the duration of morning stiffness were obtained from patient diaries. Duration of morning stiffness was the difference between the time of resolution of morning stiffness and the time of wake-up. Duration of morning stiffness is the average of the morning stiffness duration (minutes) over the last 7 days prior to visit day (including day of visit). If more than 4 assessments were missing, then the duration was set to missing. Baseline was the value recorded at Week -1 (Visit 0). (NCT00650078)
Timeframe: Week 12

InterventionRelative Change from Baseline (%) (Median)
NP01-55.22
Placebo-34.62

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The Primary Endpoint is the Total Dose of Glucocorticoids Administered Between Baseline and the End of Treatment.

The primary endpoint which has benn measured was the total dose of glucocorticoids administered between baseline and the end of treatment. (NCT00651040)
Timeframe: 1 year

Interventionmg/kg (Mean)
Prednison1124
Prednison Methotrexate 2135

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Geometric Mean Area Under Curve (AUC) of Analyte, 2-dechloro-cyclophosphamide(2-deCI-CP), in Aprepitant Treatment and Control Group

Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of 2-deCI-CP, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr). (NCT00651755)
Timeframe: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)

Interventionug/mL*hr (Geometric Mean)
Aprepitant4.5
Control6.0

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Geometric Mean Area Under Curve (AUC) of Analyte, Prednisolone (PL), in Aprepitant Treatment and Control Group

Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of PL, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr). (NCT00651755)
Timeframe: Time points over 8 hours of cyclophosphamide infusion for both cycles (21 day cycle)

Interventionng/mL*hr (Geometric Mean)
Aprepitant4416
Control3817

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Geometric Mean Area Under Curve (AUC) of Analyte, 4-hydroxy-cyclophosphamide (4-OH-CP), in Aprepitant Treatment and Control Group

Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of 4-hydroxy-cyclophosphamide (4-OH-CP), during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr). (NCT00651755)
Timeframe: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)

Interventionug/mL*hr (Geometric Mean)
Aprepitant3.9
Control4.0

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Geometric Mean Area Under Curve (AUC) of Analyte, Cyclophosphamide (CP), in Aprepitant Treatment and Control Group

Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of Cyclophosphamide (CP) during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr). (NCT00651755)
Timeframe: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)

Interventionug/mL*hr (Geometric Mean)
Aprepitant300
Control Group250

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Geometric Mean Area Under Curve (AUC) of Analyte, Vincristine (VC), in Aprepitant Treatment and Control Group

Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of VC, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr). (NCT00651755)
Timeframe: Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)

Interventionng/mL*hr (Geometric Mean)
Aprepitant41
Control39

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Geometric Mean Area Under Curve (AUC) of Analyte,Prednisone (PR), in Aprepitant Treatment and Control Group

Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of PR, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr). (NCT00651755)
Timeframe: Time points over 8 hours of cyclophosphamide infusion for both cycles (21 day cycle)

Interventionng/mL*hr (Geometric Mean)
Aprepitant287
Control265

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Complete Response Rate to Rituximab and a Combination of Vorinostat With Cyclophosphamide, Etoposide, and Prednisone in Elderly Pts With Relapsed Diffuse Large B-cell Lymphoma Who Aren't Candidates for Autologous Stem Cell Transplantation.

"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR., or similar definition that is accurate and appropriate." (NCT00667615)
Timeframe: through study completion, an average of 1 year

Interventionpercentage of participants with CR (Number)
Relapsed or Refractory Diffuse Large B-cell Lymphoma32

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Maximum Tolerated Dose (MTD) of Vorinostat Given Orally for 10 Days in Combination With Cyclophosphamide, Etoposide, Prednisone and Rituximab for Elderly Patients With Relapsed Diffuse Large B-cell Lymphoma

Maximum Tolerated Dose (MTD) of Vorinostat reflects the highest dose of Ridaforolimus and Vorinostat that did not cause a new Grade 2 toxicity in >= 50% of participants (NCT00667615)
Timeframe: through study completion, an average of 1 year

Interventionmg/m2 (Number)
Relapsed or Refractory Diffuse Large B-cell Lymphoma300

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Oswestry Disability Index, v2

The Oswestry Disability Index, v2 is a back-pain-specific measure of disability and functional status. It is measured on a 0-to-100 scale, with higher numbers indicating greater disability. (NCT00668434)
Timeframe: Baseline, Week 3 follow-up

Interventionunits on a scale (Mean)
Prednisone-19.0
Placebo-13.3

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Oswestry Disability Index, v2

The Oswestry Disability Index, v2 is a back-pain-specific measure of disability and functional status. It is measured on a 0-to-100 scale, with higher numbers indicating greater disability. (NCT00668434)
Timeframe: Baseline, Week 52 follow-up

Interventionunits on a scale (Mean)
Prednisone-37.8
Placebo-30.4

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Pain Numerical Rating Scale

Ordinal scale of average level of pain as perceived by the participant over the prior 3 days; measured on a 0-to-10 scale, with higher numbers indicating greater pain. (NCT00668434)
Timeframe: Baseline, Week 3 follow-up

Interventionunits on a scale (Mean)
Prednisone-3.0
Placebo-2.8

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Pain Numerical Rating Scale

Ordinal scale of average level of pain as perceived by the participant over the prior 3 days; measured on a 0-to-10 scale, with higher numbers indicating greater pain. (NCT00668434)
Timeframe: Baseline, Week 52 follow-up

Interventionunits on a scale (Mean)
Prednisone-5.2
Placebo-4.6

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Event-free > Survival at 12 Months (Phase 2, DLBCL/Mixed Dose Level 3)

Other Phase II Cohorts were not evaluable for event-free survival analysis. (NCT00670358)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Ph II, DLBCL/Mixed44

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Toxicity as Assessed by NCI CTCAE v3.0 (Phase I)

(NCT00670358)
Timeframe: 5 years

,,
InterventionParticipants (Count of Participants)
Grade 3+ Adverse EventGrade 4+ Adverse EventGrade 3+ Hem Adverse EventGrade 4+ Hem Adverse EventGrade 3+ Non-Hem Adverse Event
Ph 1, DL 132321
Ph1, DL 231311
Ph1, DL 354542

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Progression-free > Survival at 24 Months (Phase 2, Transformed/Composite)

"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions~Other Phase II Cohorts were not evaluable for progression-free survival analysis." (NCT00670358)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Ph II, Transformed/Composite27

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Pharmacokinetics (PK) (Half-life of SC-PEG E. Coli L-asparaginase (EZN-2285) Compared to Pegaspargase During Induction and Consolidation Therapy)

Mean half-life of plasma asparaginase during consolidation and Induction; half-life is defined as the time taken for drug concentration to decrease by half. (NCT00671034)
Timeframe: Post Day 29 of Induction and Post Day 22 of Consolidation

,,
Interventionhours (Mean)
Asparaginase half-life during ConsolidationAsparaginase half-life during Induction
Arm I (Calaspargase Pegol 2100)415.8305.1
Arm II ( Calaspargase Pegol 2500)355.9321.5
Arm III (Pegaspargase 2500)117.2126.9

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Pharmacodynamics (PD)

Plasma Asparaginase Concentration During consolidation and induction. (NCT00671034)
Timeframe: Day 29 of consolidation and induction

,,
InterventionmIU/mL (Median)
Plasma Asparaginase Concentration- ConsolidationPlasma Asparaginase Concentration- Induction
Arm I (Calaspargase Pegol 2100)575.9271.6
Arm II (Calaspargase Pegol 2500)617.2339.6
Arm III (Pegaspargase 2500)562.172.8

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Asparaginase Level

The proportion of patients with an asparaginase level of at least 0.1 IU/mL and the proportion with at least 0.4 IU/mL on Days 4, 15, 22 and 29 of Induction compared to Oncaspar (NCT00671034)
Timeframe: Days 4, 15, 22 and 29 of Induction

,,
Interventionpercentage of patients (Number)
Level at least 0.1 IU/mL day 4Level at least 0.1 IU/mL day 15Level at least 0.1 IU/mL day 22Level at least 0.1 IU/mL day 29Level at least 0.4 IU/mL day 4Level at least 0.4 IU/mL day 15Level at least 0.4 IU/mL day 22Level at least 0.4 IU/mL day 29
Arm I (Calaspargase Pegol 2100)098.498.294.9075.837.513.6
Arm II (Calaspargase Pegol 2500)010010095.0095.062.527.5
Arm III (Pegaspargase 2500)010095.128.6093.014.60

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Percentage of Participants With Minimal Residual Disease (MRD)<0.01% at the End of Induction

Percentage of participants with Negative MRD (MRD<0.01%). (NCT00671034)
Timeframe: End of induction (Day 29)

InterventionPercentage of participants (Number)
Arm I (Calaspargase Pegol 2100)65.2
Arm II (Calaspargase Pegol 2500)81
Arm III (Pegaspargase 2500)72.5

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Percentage of Participants With Complete Remission at the End of Induction

Complete Remission (CR) rate; where CR is defined as M1 marrow (< 5% lymphoblasts in the bone marrow) (NCT00671034)
Timeframe: End of induction (Day 29)

InterventionPercentage of participants (Number)
Arm I (Calaspargase Pegol 2100)92.4
Arm II (Calaspargase Pegol 2500)97.6
Arm III (Pegaspargase 2500)94.1

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Immunogenicity

Number of Patients with Positive Immunogenicity tests (NCT00671034)
Timeframe: 25 Days Post-dose (Day 29)

InterventionParticipants (Count of Participants)
Arm I (Calaspargase Pegol 2100)2
Arm II (Calaspargase Pegol 2500)2
Arm III (Pegaspargase 2500)4

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Percentage of Participants With Event-free Survival (EFS)

Percentage of participants who were event free. Event Free Probability defined as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignant neoplasm, remission death) or date of last contact for subjects who are event-free. (NCT00671034)
Timeframe: 5 Years

InterventionPercentage of participants (Number)
Arm I (Calaspargase Pegol 2100)72.35
Arm II (Calaspargase Pegol 2500)80.8
Arm III (Pegaspargase 2500)79.34

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Plasma and CSF Concentrations of Asparagine in ug/ml

The plasma and CSF concentrations of asparagine in ug/ml after administration of EZN-2285 compared to Oncaspar. (NCT00671034)
Timeframe: 25 Days Post-dose (Day 29)

,,
Interventionug/mL (Mean)
CSF asparagine concentration (ug/mL)Plasma asparagine concentration (ug/mL)
Arm I (Calaspargase Pegol 2100)0.20.2
Arm II (Calaspargase Pegol 2500)0.190.25
Arm III (Pegaspargase 2500)0.260.83

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Toxicities During Post Induction Intensification Therapy (All Grades)

The calculation of AE incidence will be based on the number of patients per AE category. For each patient who has multiple AEs classified to the same category, that patient will be tabulated under the worst toxicity grade for that AE category. The incidence of AEs will be tabulated by treatment arm and by organ class. Special attention will be paid to hypersensitivity, pancreatitis, coagulopathy, infection, neurologic dysfunction and thromboembolic events. (NCT00671034)
Timeframe: Up to 5 years

,,
InterventionPercentage of participants (Number)
Alergic Reaction - ConsolidationAlergic Reaction - Delayed Intensification IAlergic Reaction - Interim Maintenance ICNS - ConsolidationCNS - Delayed Intensification ICNS - Interim Maintenance IHyperbilirubinemia - ConsolidationHyperbilirubinemia - Delayed Intensification IHyperbilirubinemia - Interim Maintenance IHyperglycemia - ConsolidationHyperglycemia - Delayed Intensification IHyperglycemia - Interim Maintenance IHyperlipidemia - ConsolidationHyperlipidemia - Delayed Intensification IHyperlipidemia - Interim Maintenance I% patients w/INR increase - Consolidation% pts w/INR increase - Delayed Intensification I% patients w/INR increase - Interim Maintenance IPancreatitis - ConsolidationPancreatitis -Delayed Intensification IPancreatitis - Interim Maintenance I% pts w/prolongation of APT time - Consolidation% pts w/prolongation APT time -Delayed Intension I%pts w/prolongation APT time-Interim maintenance IThrombosis - ConsolidationThrombosis - Delayed Intensification IThrombosis - Interim Maintenance I
Arm I (Calaspargase Pegol 2100)20.44.40.00.00.00.053.128.941.344.944.434.82.02.22.26.16.72.210.22.22.28.28.96.50.02.20.0
Arm II (Calaspargase Pegol 2500)27.30.00.00.03.80.045.538.527.642.461.544.83.00.03.43.03.80.06.17.73.49.126.96.90.00.00.0
Arm III (Pegaspargase 2500)23.30.02.10.02.60.030.210.533.346.536.833.37.00.02.67.00.02.67.00.02.67.018.47.72.30.00.0

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Percent of Participants With Objective Response (OR)

OR defined as the percent (%) of participants with confirmed Complete Response (CR) (disappearance of all target lesions) or Partial Response (PR) (>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to the full analysis population. Confirmed responses were those that persist on repeat imagining study >= 4 weeks after initial documentation of response. (NCT00676650)
Timeframe: Baseline, every 8 weeks up to 123 weeks

Interventionpercentage of participants (Number)
Sunitinib and Prednisone6.1
Placebo and Prednisone1.8

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Overall Survival (OS)

OS is the duration from randomization to death. For participants who were alive, overall survival was censored at the last contact. OS (in months) calculated as (date of death minus [-] date of randomization plus [+] 1) divided (/) 30.4. (NCT00676650)
Timeframe: Baseline up to 32 months

Interventionmonths (Median)
Sunitinib and Prednisone13.1
Placebo and Prednisone11.8

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Progression-Free Survival (PFS)

PFS is the period from randomization until disease progression or death on study. PFS is censored on the date of last tumor assessment documenting absence of progressive disease. PFS (weeks) calculated as (first event date - randomization date + 1)/7.02 (NCT00676650)
Timeframe: Baseline, every 8 weeks up to 123 weeks

Interventionweeks (Median)
Sunitinib and Prednisone24.1
Placebo and Prednisone17.9

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Composite Progression-free Survival (cPFS) at 6-months

"Data presented are the percentage of participants without disease progression at 6 months.~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy." (NCT00683475)
Timeframe: 6 months

Interventionpercentage of participants (Number)
IMC-A12 + Mitoxantrone + Prednisone37.2
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone59.2

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Composite Progression-free Survival (cPFS) at 12-months

"Data presented are the percentage of participants without disease progression at 12 months.~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy." (NCT00683475)
Timeframe: 12 months

Interventionpercentage of participants (Number)
IMC-A12 + Mitoxantrone + Prednisone12.4
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone20.0

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Prostate Specific Antigen (PSA) Response Rate

PSA response rate is defined as the percentage of participants with a decrease in PSA >= 50 percent from baseline. (NCT00683475)
Timeframe: Baseline up to data cut-off date (up to 36.3 months)

Interventionpercentage of participants (Number)
IMC-A12 + Mitoxantrone + Prednisone18.5
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone21.4

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Overall Survival (OS)

Overall survival is defined as the time from randomization to the date of death due to any cause. Participants who were alive at the time of study completion were censored at the time the participant was last known to be alive. (NCT00683475)
Timeframe: First dose to death due to any cause up to 36.3 months

Interventionmonths (Median)
IMC-A12 + Mitoxantrone + Prednisone10.8
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone13.0

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Composite Progression-free Survival (cPFS)

"Defined as the median time from randomization to the earliest of:~Tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST);~Evidence of progression by bone scan, performed after completion of the first 3 cycles, demonstrating the appearance of >=2 new lesions;~New skeletal events (New pathologic bone fracture in the region of metastatic disease; New bone lesion requiring radiation or surgery; Spinal cord or nerve root compression)~Symptomatic progression (for participants without measurable disease);~Other clinical events attributable to prostate cancer that require major interventions; or~Death from any cause~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy." (NCT00683475)
Timeframe: Randomization to composite progressive disease, up to 23.4 months

Interventionmonths (Median)
IMC-A12 + Mitoxantrone + Prednisone4.1
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone6.7

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Objective Response Rate (ORR)

"Objective response is Complete Response (CR) + Partial Response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is a disappearance of all target and non-target lesions; PR is at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions.~Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100." (NCT00683475)
Timeframe: Baseline to date of progressive disease or death up to 36.3 months

Interventionpercentage of participants (Number)
IMC-A12 + Mitoxantrone + Prednisone15.2
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone31.6

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Composite Progression-free Survival (cPFS) at 9-months

"Data presented are the percentage of participants without disease progression at 9 months.~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy." (NCT00683475)
Timeframe: 9 months

Interventionpercentage of participants (Number)
IMC-A12 + Mitoxantrone + Prednisone20.7
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone35.9

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Summary Listing of Participants Reporting Treatment-Emergent Adverse Events

Data presented are the number of participants who experienced A12 or 1121B (ramucirumab) related treatment-emergent adverse events (TEAE), treatment related serious adverse events (SAE), or any Grade 3 or higher TEAE; any TEAE leading to discontinuation of A12 or 1121B (ramucirumab) treatment, and any TEAE leading to dose modification of A12 or 1121B (ramucirumab). A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Event section. (NCT00683475)
Timeframe: Randomization to 36.3 months

,
Interventionparticipants (Number)
A12/1121B Related TEAEA12/1121B Related Serious TEAEA12/1121B Related Grade >= 3 TEAETEAE Leading to Dose Modification of A12/1121BTEAE Leading to Discontinuation of A12/1121B
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone6316313525
IMC-A12 + Mitoxantrone + Prednisone6422353518

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Time to Radiographic Evidence of Disease Progression

"Time between date of randomization and earliest date of radiographic progression defined as either:~Tumor progression by RECIST;~Evidence of progression by bone scan;~New skeletal events (New pathologic bone fracture in the region of metastatic disease; New bone lesion requiring radiation or surgery; Spinal cord or nerve root compression).~Participants who were ongoing with no radiographic evidence of disease progression, who discontinued treatment for reasons other than progression,or died before progression were censored at date of last tumor or bone radiographic assessment. Participants who started a new anticancer treatment before progression were censored at date of last tumor or bone radiographic assessment before start of new anti-cancer therapy." (NCT00683475)
Timeframe: Randomization to date of radiographic progression, up to 36.3 months

Interventionmonths (Median)
IMC-A12 + Mitoxantrone + Prednisone7.5
IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone10.2

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Total Number of Nocturnal Awakenings During the Last 2 Weeks of Treatment

Variation in the total number of nocturnal awakenings during the last 2 weeks of run-in treatment with Cortancyl and the last 2 weeks of treatment with Lodotra. (NCT00686335)
Timeframe: 4 weeks and 8 weeks

Interventionnumber of nocturnal awakenings (Mean)
Lodotra2.1
Cortancyl10.0

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Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC)

PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's). (NCT00689936)
Timeframe: From date of randomization until the data cut-off date of 24 May 2013. Median follow-up time for all participants was 17.1 months.

Interventionmonths (Median)
Lenalidomide and Low-Dose Dexamethasone (Rd)25.5
Lenalidomide and Dexamethasone Rd1820.7
Melphalan + Prednisone + Thalidomide (MPT)21.2

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Percentage of Participants With a Myeloma Response by Adverse Risk Cytogenetic Risk Category Based on IRAC Review.

Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm

InterventionPercentage of participants (Number)
Lenalidomide and Low-Dose Dexamethasone (Rd)70.0
Lenalidomide and Dexamethasone Rd1869.7
Melphalan + Prednisone + Thalidomide (MPT)58.2

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Percentage of Participants With a Myeloma Response by Favorable Hyperdiploidy Risk Cytogenetic Risk Category Based on IRAC Review

Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm

Interventionpercentage of participants (Number)
Lenalidomide and Low-Dose Dexamethasone (Rd)80.4
Lenalidomide and Dexamethasone Rd1881.6
Melphalan + Prednisone + Thalidomide (MPT)70.6

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Kaplan Meier Estimates of Time to Treatment Failure (TTF) at the Time of Final Analysis

TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by the investigators assessment based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death. (NCT00689936)
Timeframe: From date of randomization until the data cut-off date of 21 January 2016; median follow up for all participants was 16.1 months.

Interventionmonths (Median)
Lenalidomide and Low-Dose Dexamethasone (Rd)16.9
Lenalidomide and Dexamethasone Rd1817.2
Melphalan + Prednisone + Thalidomide (MPT)14.1

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Percentage of Participants With a Myeloma Response by Normal Risk Cytogenetic Risk Category Based on IRAC Review

Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm

Interventionpercentage of particpants (Number)
Lenalidomide and Low-Dose Dexamethasone (Rd)80.4
Lenalidomide and Dexamethasone Rd1874.8
Melphalan + Prednisone + Thalidomide (MPT)61.0

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Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis

PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's). (NCT00689936)
Timeframe: From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 17.7 months

Interventionmonths (Median)
Lenalidomide and Low-Dose Dexamethasone (Rd)26.0
Lenalidomide and Dexamethasone Rd1821.0
Melphalan + Prednisone + Thalidomide (MPT)21.9

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Percentage of Participants With a Myeloma Response by Uncertain Risk Cytogenetic Risk Category Based on IRAC Review

Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm

Interventionpercentage of participants (Number)
Lenalidomide and Low-Dose Dexamethasone (Rd)60.5
Lenalidomide and Dexamethasone Rd1876.8
Melphalan + Prednisone + Thalidomide (MPT)57.5

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Percentage of Participants With an Objective Response After Second-line Anti-myeloma Treatment at the Time of Final Analysis

Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm

Interventionpercentage of participants (Number)
Lenalidomide and Low-Dose Dexamethasone (Rd)46.2
Lenalidomide and Dexamethasone Rd1853.1
Melphalan + Prednisone + Thalidomide (MPT)45.7

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Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis

Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm

Interventionpercentage of participants (Number)
Lenalidomide and Low-Dose Dexamethasone (Rd)80.7
Lenalidomide and Dexamethasone Rd1878.6
Melphalan + Prednisone + Thalidomide (MPT)67.5

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Percentage of Participants With an Objective Response Based on IRAC Review

Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined as: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm

Interventionpercentage of participants (Number)
Lenalidomide and Low-Dose Dexamethasone (Rd)75.1
Lenalidomide and Dexamethasone Rd1873.4
Melphalan + Prednisone + Thalidomide (MPT)62.3

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Time to First Response Based on the Investigator Assessment at the Time of Final Analysis

The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria assessed by the investigator. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm.

Interventionmonths (Median)
Lenalidomide and Low-Dose Dexamethasone (Rd)1.8
Lenalidomide and Dexamethasone Rd181.8
Melphalan + Prednisone + Thalidomide (MPT)2.8

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Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain

The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Appetite Loss Scale is scored between 0 and 100, with a high score indicating a higher level of appetite loss. Negative change from Baseline values indicate improvement in appetite and positive values indicate worsening of appetite. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd182.9-3.3-8.6-6.4-5.1-7.5
Lenalidomide and Low-Dose Dexamethasone (Rd)1.3-5.9-9.8-7.3-8.1-1.0
Melphalan + Prednisone + Thalidomide (MPT)1.0-6.2-13.5-10.5-12.2-2.6

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Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain

The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Cognitive Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00689936)
Timeframe: Cycle 1 Day 1, (Baseline) then Months 1, 3, 6, 12, 18 and Discontinuation visit

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd18-1.71.80.9-1.2-2.8-2.6
Lenalidomide and Low-Dose Dexamethasone (Rd)-1.2-0.7-0.9-1.6-2.2-4.9
Melphalan + Prednisone + Thalidomide (MPT)-1.8-1.5-0.3-0.6-0.7-7.1

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Change From Baseline in the EORTC QLQ-C30 Constipation Domain

The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Constipation Scale is scored between 0 and 100, with a high score indicating a higher level of constipation. Negative change from Baseline values indicate improvement in constipation and positive values indicate worsening of constipation. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd186.30.0-5.1-5.2-5.9-7.5
Lenalidomide and Low-Dose Dexamethasone (Rd)8.31.8-2.4-2.4-4.5-7.9
Melphalan + Prednisone + Thalidomide (MPT)18.413.96.83.70.0-2.2

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Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain

The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Diarrhea Scale is scored between 0 and 100, with a high score indicating a higher level of diarrhea. Negative change from Baseline values indicate improvement in diarrhea and positive values indicate worsening of diarrhea. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd182.33.46.09.110.96.4
Lenalidomide and Low-Dose Dexamethasone (Rd)3.83.78.211.814.810.8
Melphalan + Prednisone + Thalidomide (MPT)-0.6-2.4-2.2-2.5-1.7-0.5

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Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain

The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnoea Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd183.6-1.9-2.9-1.62.90.8
Lenalidomide and Low-Dose Dexamethasone (Rd)0.9-0.8-2.3-3.5-1.8-1.0
Melphalan + Prednisone + Thalidomide (MPT)4.22.00.1-1.60.47.8

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Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain

The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd180.13.95.84.93.13.7
Lenalidomide and Low-Dose Dexamethasone (Rd)0.63.84.64.65.82.6
Melphalan + Prednisone + Thalidomide (MPT)1.02.15.55.15.1-0.0

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Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC

Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median follow-up for responders was 20.1 months

Interventionmonths (Median)
Lenalidomide and Low-Dose Dexamethasone (Rd)35.0
Lenalidomide and Dexamethasone Rd1822.1
Melphalan + Prednisone + Thalidomide (MPT)22.3

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Kaplan Meier Estimates of Time to Treatment Failure (TTF)

TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by IRAC based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death. (NCT00689936)
Timeframe: From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 16.1 months.

Interventionmonths (Median)
Lenalidomide and Low-Dose Dexamethasone (Rd)16.9
Lenalidomide and Dexamethasone Rd1817.2
Melphalan + Prednisone + Thalidomide (MPT)14.1

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Time to First Response Based on the Review by the IRAC

The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm

Interventionmonths (Median)
Lenalidomide and Low-Dose Dexamethasone (Rd)1.8
Lenalidomide and Dexamethasone Rd181.8
Melphalan + Prednisone + Thalidomide (MPT)2.8

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Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis

Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median follow-up for responders was 19.9 months

Interventionmonths (Median)
Lenalidomide and Low-Dose Dexamethasone (Rd)31.5
Lenalidomide and Dexamethasone Rd1821.5
Melphalan + Prednisone + Thalidomide (MPT)22.1

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Kaplan Meier Estimates for Time to Second-line Anti-myeloma Treatment (AMT)

Time to second-line anti-myeloma therapy was defined as time from randomization to the start of another non-protocol anti-myeloma therapy. (NCT00689936)
Timeframe: From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 23.0 months

Interventionmonths (Median)
Lenalidomide and Low-Dose Dexamethasone (Rd)39.1
Lenalidomide and Dexamethasone Rd1828.5
Melphalan + Prednisone + Thalidomide (MPT)26.7

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Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase.

Improvement in platelets was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale. (NCT00689936)
Timeframe: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm

,,
Interventionparticipants (Number)
Normal Baseline Grade to Normal Postbaseline GradeNormal Baseline Grade to Grade 1 postbaselineNormal Baseline Grade to Grade 2 postbaselineNormal Baseline Grade to Grade 3 postbaselineNormal Baseline Grade to Grade 4 postbaselineGrade1 Baseline to Normal postbaseline GradeGrade 1 Baseline to Grade 1 postbaselineGrade 1 Baseline to Grade 2 postbaselineGrade 1 Baseline to Grade 3 postbaselineGrade 1 Baseline to Grade 4 postbaselineGrade 2 Baseline to normal postbaseline GradeGrade 2 Baseline to Grade 1 postbaselineGrade 2 Baseline to Grade 2 postbaselineGrade 2 Baseline to Grade 3 postbaselineGrade 2 Baseline to Grade 4 postbaselineGrade 3 Baseline to Normal postbaseline GradeGrade 3 Baseline to Grade 1 postbaselineGrade 3 Baseline to Grade 2 postbaselineGrade 3 Baseline to Grade 3 postbaselineGrade 3 Baseline to Grade 4 postbaseline
Lenalidomide and Dexamethasone Rd1819721130125338191210132000001
Lenalidomide and Low-Dose Dexamethasone (Rd)19721624154134151020033100002
Melphalan + Prednisone + Thalidomide (MPT)16520827311165171010212200110

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Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase

Hemoglobin was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale. (NCT00689936)
Timeframe: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm

,,
Interventionparticipants (Number)
Normal Baseline Grade to Normal Postbaseline GradeNormal Baseline Grade to Grade 1 postbaselineNormal Baseline Grade to Grade 2 postbaselineNormal Baseline Grade to Grade 3 postbaselineNormal Baseline Grade to Grade 4 postbaselineGrade 1 Baseline to Normal postbaselineGrade 1 Baseline to Grade 1 postbaselineGrade1 Baseline to Grade 2 postbaselineGrade 1 Baseline to Grade 3 postbaselineGrade 1 Baseline to Grade 4 postbaselineGrade 2 Baseline to normal postbaselineGrade 2 Baseline to Grade 1 postbaselineGrade 2 Baseline to Grade 2 postbaselineGrade 2 Baseline to Grade 3 postbaselineGrade 2 Baseline to Grade 4 postbaselineGrade 3 Baseline to Normal postbaselineGrade 3 Baseline to Grade 1 postbaselineGrade 3 Baseline to Grade 2 postbaselineGrade 3 Baseline to Grade 3 postbaselineGrade 3 Baseline to Grade 4 postbaselineGrade 4 Baseline to Normal postbaselineGrade 4 Baseline to Grade 1 postbaselineGrade 4 Baseline to Grade 2 postbaselineGrade 4 Baseline to Grade 3 postbaselineGrade 4 Baseline to Grade 4 postbaseline
Lenalidomide and Dexamethasone Rd18103081001261231750121354190148300011
Lenalidomide and Low-Dose Dexamethasone (Rd)639800010612825208125484001210500001
Melphalan + Prednisone + Thalidomide (MPT)92541001101232040141334711001010200102

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Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase

Renal function was assessed for participants from baseline to the most extreme value in creatinine clearance calculated using the Cockcroft-Gault estimation. (NCT00689936)
Timeframe: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm

,,
Interventionparticipants (Number)
CrCl< 30 mL/min to CrCl< 30 mL/minCrCl < 30 mL/min to CrCl ≥ 30 but < 50 mL/minCrCl < 30 mL/min to CrCl ≥ 50 but < 80 mL/minCrCl< 30 mL/min to ≥ 80 mL/minCrCl≥ 30 but < 50 mL/min to < 30 mL/minCrCl ≥ 30 but < 50 mL/min to CrCl ≥ 30 but < 50 mLCrCl ≥ 30 but < 50 mL/min to CrCl ≥ 50 but < 80 mLCrCl ≥ 30 but < 50 mL/min to ≥ 80 mL/minCrCl ≥ 50 but < 80 mL to CrCl< 30 mL/minCrCl ≥ 50 but < 80 mL to CrCl ≥ 30 but < 50 mL/minCrCl ≥ 50 but < 80 mL to CrCl ≥ 50 but < 80 mL/minCrCl ≥ 50 but < 80 mL to ≥ 80 mL/minCrCl ≥ 80 mL/min to CrCl< 30 mL/minCrCl ≥ 80 mL/min to CrCl ≥ 30 but < 50 mL/minCrCl ≥ 80 mL/min to CrCl ≥ 50 but < 80 mL/minCrCl ≥ 80 mL/min to CrCl ≥ 80 mL/min
Lenalidomide and Dexamethasone Rd18171482241551201130991010114
Lenalidomide and Low-Dose Dexamethasone (Rd)15187213767904112107006109
Melphalan + Prednisone + Thalidomide (MPT)1919500416520410297009121

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Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase

Neutrophil counts was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale. (NCT00689936)
Timeframe: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm

,,
Interventionparticipants (Number)
Normal Baseline Grade to Normal Postbaseline GradeNormal Baseline Grade to Grade 1 postbaselineNormal Baseline Grade to Grade 2 postbaselineNormal Baseline Grade to Grade 3 postbaselineNormal Baseline Grade to Grade 4 postbaselineGrade 1 Baseline to Normal postbaselineGrade1 Baseline to Grade 1 postbaselineGrade 1 Baseline to Grade 2 postbaselineGrade 1 Baseline to Grade 3 postbaselineGrade 1 Baseline to Grade 4 postbaselineGrade 2 Baseline to normal postbaselineGrade 2 Baseline to Grade 1 postbaselineGrade 2 Baseline to Grade 2 postbaselineGrade 2 Baseline to Grade 3 postbaselineGrade 2 Baseline to Grade 4 postbaselineGrade 3 Baseline to Normal postbaselineGrade 3 Baseline to Grade 1 postbaselineGrade 3 Baseline to Grade 2 postbaselineGrade 3 Baseline to Grade 3 postbaselineGrade3 Baseline to Grade 4 postbaselineGrade 4 Baseline to Normal postbaseline GradeGrade 4 Baseline to Grade 1 postbaseline GradeGrade 4 Baseline to Grade 2 postbaselineGrade 4 Baseline Grade to Grade 3 postbaselineGrade 4 Baseline to Grade 4 postbaseline
Lenalidomide and Dexamethasone Rd181338510971306111530401111850012200000
Lenalidomide and Low-Dose Dexamethasone (Rd)103961217021781725911141890022001000
Melphalan + Prednisone + Thalidomide (MPT)3779128141452211202101721100000100000

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Number of Participants With Adverse Events (AEs) During the Active Treatment Phase

A TEAE is any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. (NCT00689936)
Timeframe: From first dose of study drug through 28 days following the discontinuation visit from active treatment phase; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm

,,
InterventionParticipants (Number)
≥ 1 adverse event (AE)≥ 1 grade (Gr) 3 or 4 AE≥ 1 grade (Gr) 5 AE≥ 1 serious adverse event (SAE)≥ 1 AE related to Lenalidomide/Dex/Mel/Pred/Thal≥ 1 AE related to Lenalidomide≥ 1 AE related to dexamethasone≥ 1 AE related to melphalan≥ 1 AE related to prednisone≥ 1 AE related to thalidomide≥1 AE related to Lenalidomide/Dex or Mel/Pred/Thal≥ 1 Gr 3 or 4 AE related to Len/Dex/Mel/Pred/Thal≥ 1 grade 3 or 4 AE related to Lenalidomide≥ 1 grade 3 or 4 AE related to dexamethasone≥ 1 grade 3 or 4 AE related to melphalan≥ 1 grade 3 or 4 AE related to prednisone≥ 1 grade 3 or 4 AE related to Thalidomide≥1Gr 3 or 4 AE related to Len/Dex or Mel/Pred/Thal≥ 1 Grade 5 AE related to Len/Dex/Mel/Pred/Thal≥ 1 Grade 5 AE related to Lenalidomide≥ 1 Grade 5 AE related to Dexamethasone≥ 1 Grade 5 AE related to melphalan≥ 1 Grade 5 AE related to prednisone≥ 1 Grade 5 AE related to Thalidomide≥1 Grade 5 AE related to Len/Dex or Mel/Pred/Thal≥1 SAE related to Len/Dex/Mel/Pred/Thal≥1 SAE related to Lenalidomide≥1 SAE related to dexamethasone≥1 SAE related to melphalan≥1 SAE related to prednisone≥1 SAE related to thalidomide≥1 SAE related to Len/Dex or Mel/Pred/Thal≥1AE leading to Len/Dex/Mel/Pred/Thal Withdrawal≥1 AE leading to Lenalidomide withdrawal≥1 AE leading to dexamethasone withdrawal≥1 AE leading to melphalan withdrawal≥1 AE leading to prednisone withdrawal≥1 AE leading to Thalidomide withdrawal≥1AE leading to Len/DexOR Mel/Pred/Thal Withdrawal≥1AE leading to Len/Dex/Mel/Pred/Thal reduction≥1 AE leading to Lenalidomide reduction≥1 AE leading to dexamethasone reduction≥1 AE leading to melphalan reduction≥1 AE leading to prednisone reduction≥1 AE leading to thalidomide reduction≥1AE leading to Len/Dex or Mel/Pred/Thal reduction≥1 AE leading to Rd or MPT interruption≥1 AE leading to Lenalidomide interruption≥1 AE leading to dexamethasone interruption≥1 AE leading to melphalan interruption≥1 AE leading to prednisone interruption≥1 AE leading to Thalidomide interruption≥1 AE leading to Len and Dex or MPT interruption
Lenalidomide and Dexamethasone Rd1853643336308501481410000269326290177000104119700051581309700064109931040008421415511800020321301280000241
Lenalidomide and Low-Dose Dexamethasone (Rd)5294535035950648242900026937334222900013117121600011195165130000951571091520009627920317000030368353319000290
Melphalan + Prednisone + Thalidomide (MPT)53948038270527004413264931454230030711831649100065521420075629427153008378146713480019947254241900328324388249

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Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score

EQ-5D is a self-administered questionnaire that assesses health-related quality of life. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). A unique EQ-5D health state is defined by combining one level from each of the five dimensions into a single utility index score. EQ-5D index values range from -0.59 to 1.00 where higher EQ-5D scores represent better health status. A positive change from baseline score indicates improvement in health status and better health state. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd18-0.00.10.10.10.10.0
Lenalidomide and Low-Dose Dexamethasone (Rd)0.00.10.10.10.10.0
Melphalan + Prednisone + Thalidomide (MPT)0.00.10.10.10.10.0

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Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale

EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score represents a more severe overall side effect of treatment. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit

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Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd184.01.2-0.41.22.3-1.0
Lenalidomide and Low-Dose Dexamethasone (Rd)2.51.01.71.92.20.6
Melphalan + Prednisone + Thalidomide (MPT)5.63.52.94.74.33.8

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Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale

EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the future perspective scale, a higher score indicates a better perspective of the future. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd183.99.212.312.111.78.8
Lenalidomide and Low-Dose Dexamethasone (Rd)4.78.59.810.812.75.8
Melphalan + Prednisone + Thalidomide (MPT)3.36.38.010.09.53.2

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Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale

EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score indicates more severe disease symptom(s). (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd18-4.1-10.0-9.9-8.7-6.2-4.5
Lenalidomide and Low-Dose Dexamethasone (Rd)-4.0-9.1-8.8-7.8-8.7-3.5
Melphalan + Prednisone + Thalidomide (MPT)-4.4-7.0-7.9-6.5-7.9-3.7

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Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale

EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the body image scale, a higher score indicates a better body image. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd18-1.50.81.5-0.4-0.31.8
Lenalidomide and Low-Dose Dexamethasone (Rd)-4.5-1.7-1.4-1.4-2.3-5.6
Melphalan + Prednisone + Thalidomide (MPT)-1.6-3.0-2.8-2.6-1.1-5.6

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Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain

The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in QOL or functioning and positive values indicate improvement. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Study discontinuation
Lenalidomide and Dexamethasone Rd18-1.34.75.43.25.75.0
Lenalidomide and Low-Dose Dexamethasone (Rd)0.44.85.94.86.4-0.1
Melphalan + Prednisone + Thalidomide (MPT)1.04.36.16.54.80.3

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Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain

The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Social Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd18-2.22.05.23.83.22.7
Lenalidomide and Low-Dose Dexamethasone (Rd)-4.30.74.02.94.2-1.2
Melphalan + Prednisone + Thalidomide (MPT)-1.42.43.45.86.0-3.5

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Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain

The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Role Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd18-4.66.38.69.49.13.8
Lenalidomide and Low-Dose Dexamethasone (Rd)-2.72.46.37.88.0-0.3
Melphalan + Prednisone + Thalidomide (MPT)-2.44.18.211.814.5-1.0

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Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain

The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd18-1.44.77.67.46.83.0
Lenalidomide and Low-Dose Dexamethasone (Rd)-1.73.44.75.06.9-0.1
Melphalan + Prednisone + Thalidomide (MPT)-0.92.25.36.98.3-0.1

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Change From Baseline in the EORTC QLQ-C30 Pain Domain

The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd18-4.4-13.1-16.1-14.7-12.4-7.9
Lenalidomide and Low-Dose Dexamethasone (Rd)-5.4-13.4-14.4-14.0-14.4-8.0
Melphalan + Prednisone + Thalidomide (MPT)-7.8-12.1-13.4-14.3-14.7-6.0

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Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain

The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Nausea/Vomiting Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd18-0.5-2.5-4.0-3.6-2.7-4.2
Lenalidomide and Low-Dose Dexamethasone (Rd)1.8-1.1-1.3-2.2-2.30.4
Melphalan + Prednisone + Thalidomide (MPT)4.0-1.2-3.9-3.9-3.91.0

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Change From Baseline in the EORTC QLQ-C30 Insomnia Domain

The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Insomnia Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd183.2-1.3-1.91.11.4-1.6
Lenalidomide and Low-Dose Dexamethasone (Rd)2.10.2-1.2-1.0-0.5-5.2
Melphalan + Prednisone + Thalidomide (MPT)-10.5-8.9-11.6-9.6-6.0-4.5

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Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain

The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Financial Difficulties Scale is scored between 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicate improvement in financial difficulties and positive values indicate worsening of financial difficulties. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd18-0.3-0.4-0.31.61.80.5
Lenalidomide and Low-Dose Dexamethasone (Rd)2.11.91.40.42.01.9
Melphalan + Prednisone + Thalidomide (MPT)0.51.90.71.10.45.0

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Change From Baseline in the EORTC QLQ-C30 Fatigue Domain

The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation

,,
Interventionunits on a scale (Mean)
Month 1Month 3Month 6Month 12Month 18Discontinuation Visit
Lenalidomide and Dexamethasone Rd184.4-3.4-5.9-2.30.1-1.6
Lenalidomide and Low-Dose Dexamethasone (Rd)2.6-2.5-3.7-4.3-3.10.3
Melphalan + Prednisone + Thalidomide (MPT)2.8-1.8-4.5-3.9-4.32.7

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Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS)

Overall survival was defined as the time between randomization and death. Participants, who died, regardless of the cause of death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the participant was known to be alive. (NCT00689936)
Timeframe: From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 48.3 months

Interventionmonths (Median)
Lenalidomide and Low-Dose Dexamethasone (Rd)59.1
Lenalidomide and Dexamethasone Rd1862.3
Melphalan + Prednisone + Thalidomide (MPT)49.1

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Kaplan Meier Estimates of Time to Second Line Therapy AMT at the Time of Final Analysis

Time to second-line anti-myeloma therapy is defined as time from randomization to the start of another non-protocol anti-myeloma therapy. Those who do not receive another anti-myeloma therapy were censored at the last assessment or follow-up visit known to have received no new therapy. (NCT00689936)
Timeframe: From date of randomization until the data cut-off of date 21 January 2016; median follow-up for all participants was 23.0 months

Interventionmonths (Median)
Lenalidomide and Low-Dose Dexamethasone (Rd)36.7
Lenalidomide and Dexamethasone Rd1828.5
Melphalan + Prednisone + Thalidomide (MPT)26.7

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Progression Free Survival

Progression free survival (PFS) is defined for all subjects as the time from the date of initiation of treatment to the date of first documentation of relapse, progression, or death due to any cause. Full restaging was performed at 6, 12, 18, 24, 36, 48, 60, 72 months). PFS survival will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals. (NCT00691704)
Timeframe: 2 years

Interventionparticipants (Number)
PFS at 2 yearsPFS at 1 year
High-risk Multiple Myeloma39

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Overall Survival

Overall survival is defined as the time from the date of initiation of treatment to the date of death due to any cause. Overall response rate will be estimated with its 80% confidence interval, and the numbers of subjects achieving a sustained complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or stable disease (SD) will be tabulated. Overall survival will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals. (NCT00691704)
Timeframe: 6 years

Interventionmonths (Mean)
High-risk Multiple Myeloma36

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Time to Response

Time to response will be measured in the population of subjects with a confirmed response as the time from the date of initiation of treatment to the date of the first documentation of a confirmed response. Full restaging was performed at 6, 12, 18, 24, 36, 48, 60, 72 months). Time to response will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals. (NCT00691704)
Timeframe: 6 months

Interventionmonths (Mean)
High-risk Multiple Myeloma2

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Duration of Response

The duration of response, defined only among the responders, is measured from start of achieving Partial Response (PR) [first observation of PR before confirmation] to the time of disease progression, with deaths owing to causes other than progression not counted as events, but censored (Durie et al., 2006). Duration of response will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals. (NCT00691704)
Timeframe: 6 years

Interventionmonths (Mean)
High-risk Multiple Myeloma11

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Time to Progression

Time to progression (TTP) is defined for all patients as the time from initiation of treatment to disease progression with deaths owing to causes other than progression not counted as events, but censored (Durie et al., 2006). (NCT00691704)
Timeframe: 6 years

Interventionmonths (Mean)
High-risk Multiple Myeloma11

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Mean Aqueous Humor Prednisolone Acetate Concentration

(NCT00699803)
Timeframe: 4 hours

Interventionng/mL (Mean)
T-Pred102.5
Pred Forte127.5

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Stimulation of Growth After 12 Months (Delta Z-score)

(NCT00707759)
Timeframe: 12 months

Interventionunits on a scale (Mean)
A: Withdrawal Steroids1.2
B: Control Steroids0.6

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Time in Days to Achieve a Clinical Response, Comparing the CSA/PEX Arm to the Steroids/PEX Arm.

Days to achieve a clinical response, defined as a normal platelet count (>150 x 109/L), normal LDH, and no new end organ injury. (NCT00713193)
Timeframe: Time to starting treatment until 6 months after the last PEX procedure

InterventionDays (Median)
CSA Arm5
Prednisone Arm5

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Number of Participants With Exacerbations in the CSA/PEX Arm Compared to the Steroids/PEX Arm

Number of Participants with Exacerbations in the CSA/PEX Arm Compared to the Steroids/PEX Arm (NCT00713193)
Timeframe: From the start of treatment until 30 days after discharge from the last PEX procedure

Interventionparticipants (Number)
CSA Arm3
Prednisone Arm1

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Number of Patients Who Experienced at Least One Serious Adverse Event

(NCT00715208)
Timeframe: From completion of informed consent through 30 days after the last dose of study drug

Interventionparticipants (Number)
VELCADE R-CAP2
VELCADE R-CP12

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Percentage of Participants With Progression-free Survival (PFS) at 1 Year

PFS was defined as the time from the first dose to the date of progressive disease (PD)/relapse or death, whichever comes first. For a participant who had not progressed/relapsed or died, PFS was censored at the last response assessment that was stable disease (failure to attain complete response/partial response or PD or better). (NCT00715208)
Timeframe: Assessed at at the end of Cycle 2, at end of treatment visit, and every 12± 1 weeks for the first year (4 visits) until PD

Interventionpercentage of participants (Number)
VELCADE R-CAP67
VELCADE R-CP63

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Number of Patients With Complete Response (CR)

Disappearance of all evidence of disease assessed by computed tomography (CT) and PET (position-emission tomography) according to the revised International Working Group (IWG) Criteria. (NCT00715208)
Timeframe: 30 weeks

Interventionparticipants (Number)
VELCADE R-CAP1
VELCADE R-CP13

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Number of Participants With Overall Response (OR)

"OR = Complete Response (CR) + Partial Response (PR)according to the revised International Working Group (IWG) Criteria.~CR is the disappearance of all evidence of disease assessed by CT and PET. PR is the regression of measurable disease and no new sites assessed by CT and PET." (NCT00715208)
Timeframe: 30 weeks

Interventionparticipants (Number)
VELCADE R-CAP6
VELCADE R-CP37

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Duration of Response

"Time (in months) from the first documentation of a response (CR or partial response [PR]) to the date of first documentation of progressive disease or relapse from complete response.~CR is defined as disappearance of all evidence of disease assessed by CT or PET; PR is defined as regression of measurable disease and no new sites assessed by CT or PET according to the revised International Working Group (IWG) Criteria." (NCT00715208)
Timeframe: 2 years

InterventionMonths (Median)
VELCADE R-CP21.9

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Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 2 Through Cycle 6 or 8 (End of Study)

(NCT00719472)
Timeframe: Cycle 2 through Cycle 6 or 8 (end of study)

InterventionPercentage of participants (Number)
Rituximab 375 mg/m^298.6

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Percentage of Patients Who Had Undetectable Levels of CD19+ Lymphocytes at Cycle 2 and Either Cycle 6 or 8 (Last Cycle)

Serum samples for measurement of CD19+ lymphocytes were taken pre-dose (within 15 minutes before rituximab infusion). CD19+ lymphocyte counts were measured by flow cytometry using a fluorescent-activated cell sorter (FACS). (NCT00719472)
Timeframe: Day 1 of Cycle 2 and either Cycle 6 or 8 (last cycle)

InterventionPercentage of participants (Number)
Cycle 2 (n=338)Cycle 6 (n=240)Cycle 8 (n=32)
Rituximab 375 mg/m^250.568.387.5

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Maximum Serum Concentration (Cmax) of Rituximab Post-dose at the First Alternative Dosing Rate (Cycle 2) and the Last Cycle (Either Cycle 6 or 8)

Serum samples for rituximab pharmacokinetic analysis were taken pre-dose (within 15 minutes before rituximab infusion) and post-dose (within 15 minutes after the end of the rituximab infusion) after the first faster infusion (Cycle 2) and after the last infusion (either Cycle 6 or 8). An enzyme-linked immunosorbent assay (ELISA) was used to measure rituximab levels in the serum samples. (NCT00719472)
Timeframe: Day 1 of Cycles 2 and either 6 or 8 (last cycle)

Interventionµg/mL (Mean)
Cycle 2 (n=335)Cycle 6 (n=238)Cycle 8 (n=36)
Rituximab 375 mg/m^2228.0275.0299.0

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Duration of Rituximab Infusion Including Dose Interruption Times

The median duration of the rituximab infusion on Day 1 of each cycle, including the duration of dose interruptions, is reported. (NCT00719472)
Timeframe: Day 1 of each of Cycles 1 to 6 or 8

InterventionMinutes (Median)
Cycle 1 (n=362)Cycle 2 (n=363)Cycle 3 (n=344)Cycle 4 (n=329)Cycle 5 (n=312)Cycle 6 (n=303)Cycle 7 (n=59)Cycle 8 (n=59)
Rituximab 375 mg/m^224591919191919191

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Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 1

(NCT00719472)
Timeframe: Cycle 1

InterventionPercentage of participants (Number)
Rituximab 375 mg/m^291.8

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Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events

Number of patients in safety cohort with dose limiting toxicity (DLT)(including treatment delay) (NCT00720109)
Timeframe: Weeks 3 through 23 of treatment (From week 3 Induction through Intensification Block 1)

InterventionPts with DLTs (Number)
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)1

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Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation

A 1-sample Z-test of proportions (alpha=5%, 1-sided test) will be used. (NCT00720109)
Timeframe: At end of consolidation (at 11 weeks)

InterventionPercentage of participants (Number)
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)10.5
Standard-risk0
High-risk66.7

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Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy

Percent of patients MRD Positive (MRD > 0.01%) at End of Induction. (NCT00720109)
Timeframe: At the end of induction therapy (at 5 weeks)

InterventionPercentage of participants (Number)
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)40.7
Standard-risk29.2
High-risk100.0

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Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib)

An event is defined as: Induction failure, relapse at any site, secondary malignancy, or death. (NCT00720109)
Timeframe: From the time entry on study to first event or date of last follow-up, assessed up to 7 years

Interventionpercentage of patients (Number)
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)79.8
Standard-risk83.2
High-risk66.7

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Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy

Event-Free Survival (EFS) curves will be constructed using the Kaplan-Meier life table method with standard errors computed using the method of Peto and Peto. A 1-sided 95% confidence interval for EFS will be constructed. (NCT00720109)
Timeframe: At 3 years

InterventionPercent probability (Number)
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)79.8
Standard-risk83.2
High-risk66.7

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Overall Complete Response (CR + CRu)

Overall complete response was defined as the number of participants with complete response (CR) and those with unconfirmed complete response (CRu). Response assessment was carried out every 6 weeks for 18 weeks; thereafter, every 8 weeks until PD/initiation of alternate therapy/withdrawal from study/death. (NCT00722137)
Timeframe: Median duration of follow-up of 40 months

,
InterventionParticipants (Number)
Overall complete responseCRCRu
R-CHOP957916
VcR-CAP12210616

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Number of Participants Experiencing an Adverse Event (AE)

An AE was defined as any untoward medical occurrence associated with the use of a drug, whether or not considered drug related. AEs were collected from the first dose of study drug through 30 days after the last dose of study drug. Treatment was administered for up to 8 cycles (24 weeks) and AEs were collected for up to 30 days following the last dose of study drug. (NCT00722137)
Timeframe: Up to 107.4 months

InterventionParticipants (Number)
R-CHOP239
VcR-CAP240

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18-Month Survival

18-month survival was defined as the estimated probability of survival at 18 months (Kaplan-Meier estimate). (NCT00722137)
Timeframe: Up to month 18 from the time of randomization

InterventionPercentage of Participants (Mean)
R-CHOP83.8
VcR-CAP84.9

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Duration of Response

The duration of treatment response was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR, CRu, or PR as determined by the Independent Review Committee. The duration of response for complete responders was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR or CRu verified by bone marrow and lactate dehydrogenase (LDH). (NCT00722137)
Timeframe: Median duration of follow-up of 40 months

,
InterventionDays (Median)
Duration of responseDuration for Complete responders
R-CHOP459.0563.0
VcR-CAP1110.01282.0

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Treatment-free Interval (TFI)

The TFI was defined as the duration from the date of last dose plus 1 day to the start date of the new treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, treatment-free interval was censored at the date of death or the last date known to be alive. (NCT00722137)
Timeframe: Median duration of follow-up of 40 months

InterventionDays (Median)
R-CHOP624.0
VcR-CAP1236.0

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Time to Progression (TTP)

Time to progression was defined as the duration from the date of randomization until the date of first documented evidence of progressive disease (PD) or date of relapse for subjects who experienced complete response (CR) or complete response, unconfirmed (CRu). PD and response were based on the assessment of an Independent Review Committee. (NCT00722137)
Timeframe: Median duration of follow-up of 40 months

InterventionDays (Median)
R-CHOP490.0
VcR-CAP929.0

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Progression Free Survival (PFS)

PFS was defined as the interval between the date of randomization and the date of progressive disease (PD) or death, whichever occurred first. PD was based on the assessment of an Independent Review Committee. (NCT00722137)
Timeframe: Median duration of follow-up of 40 months

InterventionDays (Median)
R-CHOP437.0
VcR-CAP751.0

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Overall Survival (OS) in Long Term Follow-up Period

OS was measured from the date of randomization to the date of the participant's death. If the participant was alive or the vital status was unknown, OS was censored at the date that the subject was last known to be alive. (NCT00722137)
Timeframe: Up to 107.4 months

InterventionDays (Median)
R-CHOP1695.0
VcR-CAP2760.0

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Overall Survival (OS)

OS was measured from the date of randomization to the date of the participant's death. If the participant was alive or the vital status was unknown, OS was censored at the date that the subject was last known to be alive. (NCT00722137)
Timeframe: Median duration of follow-up of 40 months

InterventionDays (Median)
R-CHOP1714.0
VcR-CAPNA

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Overall Response Rate (ORR)

ORR was defined as complete response (CR) + complete response, unconfirmed (CRu) + partial response (PR) as determined by the Independent Review Committee. Response assessment was carried out every 6 weeks for 18 weeks; thereafter, every 8 weeks until PD/initiation of alternate therapy/withdrawal from study/death. (NCT00722137)
Timeframe: Median duration of follow-up of 40 months

InterventionParticipants (Number)
R-CHOP204
VcR-CAP211

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Median Duration of Response

Duration of response is measured from date of first confirmed response until date of disease progression. (NCT00734149)
Timeframe: up to 4 years

Interventionmonths (Median)
Bortezomib+Melphalan+Prednisone: Non-ASCT19.8
Bortezomib+Melphalan+Prednisone: ASCT27.9

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Number of Patients With Any Grade or Severe Adverse Event

Number of patients with any grade or severe, defined as ≥ grade 3 by Common Terminology Criteria for Adverse Events (CTCAE) v4.0, adverse events as a measure of safety (NCT00734149)
Timeframe: At any time during the study and up to 30 days after stopping the study drug

Interventionparticipants (Number)
Bortezomib+Melphalan+Prednisone34

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Response

Overall response rate equals complete response and partial response per Southwest Oncology Group Criteria. Measurable, quantifiable protein criteria must be present. Acceptable protein criteria are quantitative immunoglobulin IgG, IgA, IgD, IgE or IgM and/or urine M-component (Bence-Jones protein). If both are present, the quantitative immunoglobulin will be followed for response. Complete Remission: The absence of bone marrow or blood findings of multiple myeloma. This includes disappearance of all evidence of serum and urine M-components on electrophoresis as by immunofixation studies. There must also be no evidence of increasing anemia. Partial Remission: A 50-74% reduction in the quantitative immunoglobulin, and if present, a 50-89% reduction in the urine M-component (Bence-Jones protein). Stable/No Remission): A <50% reduction I nthe quantitative immunoglobulin, or if the patient has light-chain disease only, a <50% reduction in the urine M-component (Bence-Jones protein. (NCT00734149)
Timeframe: 6 weeks following completion of treatment

Interventionparticipants (Number)
Bortezomib+Melphalan+Prednisone42

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Time to Perform Microarray Study After Receipt of Tissue

The time from tissue harvest to release of microarray test and IHC assay results will be noted in days. (NCT00736450)
Timeframe: Upto 14 days

Interventiondays (Mean)
Arm I4.4

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Number of Participants With Microarray Testing Results Are Completed Within 7 Days.

(NCT00736450)
Timeframe: Upto 7 days

InterventionParticipants (Count of Participants)
results within 7 days or lessresults in more than 7 days
Arm I112

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Percentage of Participants With an Objective Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (RECIST)

Objective tumor response rate=the percentage of randomized participants with a best tumor response of partial (PR) or complete response (CR), within 42 days of end of dosing, divided by total number of patients who were evaluable (with at least 1 target lesion at baseline). By RECIST: CR=disappearance of clinical and radiologic evidence of target and nontarget lesions confirmed by another evaluation at least 6 weeks later. PR=a >30% or greater decrease in the sum of longest diameter (LD) of target lesions in reference to the baseline sum LD confirmed by another evaluation at least 6 weeks later. Stable disease=neither sufficient increase to qualify for PD nor shrinkage to qualify for PR, and at least 8 weeks since start of study therapy. Progressive disease=a 20% or greater increase in sum of LD of all target lesions, taking as reference the smallest sum of LD at or following baseline, or unequivocal progression on existing nontarget lesions, or new lesions are present. (NCT00744497)
Timeframe: At baseline and every 12 weeks thereafter to end of treatment, at end of treatment, and at follow-up (within 42 days of end of dosing)

InterventionPercentage of participants (Number)
Placebo31.85
Dasatinib30.45

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Percentage of Participants With A Reduction in Urinary N-telopeptide (uNTx) Level From Baseline

The percentage of participants who had an on-study uNTx value confirmed (at least 3 weeks later) within normal limits (or ≥3 and <60 nmol/mmol creatinine, if normal limits were missing) or an on-study uNTx level reduction from baseline of ≥35%, even when on-study uNTx value remained abnormal. (NCT00744497)
Timeframe: At baseline, prior to each docetaxel infusion (every 3 weeks) to end of treatment, at end of treatment, and at follow-up (within 14 days of end of dosing)

InterventionPercentage of participants (Number)
Placebo60.60
Dasatinib66.04

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Percentage of Participants With a Reduction in Pain Intensity From Baseline

The percentage of participants with a reduction in pain intensity from baseline was defined as the number of participants who achieved a 30% or more decrease in pain intensity from baseline for at least 2 consecutive pain assessments (at least 14 days apart) within 14 days of end of dosing divided by the number of randomized participants who had a baseline pain intensity of at least 2. Pain intensity was assessed based on question 3 of the brief pain inventory questionnaire. (NCT00744497)
Timeframe: At baseline, prior to each docetaxel infusion (every 3 weeks), at end of treatment, and at follow-up (within 14 days of end of dosing)

InterventionPercentage of participants (Number)
Placebo71.52
Dasatinib66.59

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Overall Survival: Time From Randomization to Date of Death

Overall survival is defined as time in months from the randomization date to the date of death due to any cause (in the randomized population). If the patient did not die, survival was censored on the last date he or she was known to be alive. (NCT00744497)
Timeframe: From randomization to death or date of last contact (maximum reached: 45 months)

InterventionMonths (Median)
Placebo21.2
Dasatinib21.5

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Number of Participants With Changes From Baseline in Fridericia-corrected QTc Interval

QTc interval measured by electrocardiogram (ECG). Although a participant may have had several ECGs, only the longest QTc interval was included. (NCT00744497)
Timeframe: At baseline, approximately 12 weeks after starting treatment, and then whenever clinically indicated up to within 30 days of end of dosing

,
InterventionParticipants (Number)
0 to 30 msecs increase (n=591, 540)>30 to 60 msecs increase (n=591, 540)>60 msecs increase (n=591, 540)Decrease (n=591, 540)
Dasatinib1994726268
Placebo2035232304

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Number of Participants With and Without Pericardial Effusion at Baseline and On-study and With Left Ventricular Ejection Fraction (LVEF) <40% and >=40% On-study

BL=baseline; OS=on-study (NCT00744497)
Timeframe: At baseline, approximately 12 weeks after start of treatment, and thereafter whenever clinically indicated

,
InterventionParticipants (Number)
Pericardial effusion at BL/absent OSPericardial effusion at BL/present OSPericardial effusion at BL/not reported OSPericardial effusion absent at BL/ absent OSPericardial effusion absent at BL/present OSPericardial effusion absent at BL/not reported OSPericardial not reported at BLLVEF OS <40%LVEF OS >=40%LVEF not reported OS
Dasatinib1105452618452566194
Placebo30158424132162607151

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Number of Participants With Abnormalities in Results of Clinical Laboratory Tests in Hematology

Abnormalities were graded according to the Common Toxicity Criteria (CTC), version 3.0, of the National Cancer Institute. CTC are graded from 1 (least severe) to 4 (life threatening ). Grade 3 and 4 criteria are defined as follows: Absolute neutrophil count, Grade 3, neutrophils <1.0-0.5*10^9/L; Grade 4, <0.5*10^9/L. Hemoglobin, Grade 3, <4.9-4.0 mmol/L; Grade 4, <4.0 mmol/L. Platelets, Grade 3, <50.0-25.0*10^9/L; Grade 4, <25.0*10^9/L. Leukocytes, Grade 3, <2.0-1.0*10^9/L; Grade 4, <1.0*10^9/L. (NCT00744497)
Timeframe: At baseline, within 3 days prior to each infusion of docetaxel (each cycle) and at end of treatment. If docetaxel is discontinued, every other cycle.

,
InterventionParticipants (Number)
Absolute neutrophil count (All grades)Absolute neutrophil count (Grades 3 and 4)Hemoglobin (All grades)Hemoglobin (Grades 3 and 4)Platelets (All grades)Platelets (Grades 3 and 4)Leukocytes (All grades)Leukocytes (Grades 3 and 4)
Dasatinib1614672059100314930
Placebo844171244108612832

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Number of Participants With Abnormalities in Results of Clinical Laboratory Tests Assessing Liver Function, Renal Function, and Electrolytes

ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal. Abnormalities were graded according to the Common Toxicity Criteria (CTC), version 3.0, of the National Cancer Institute. CTC are graded from 1 (least severe) to 4 (life threatening). ALP, ALT, and AST, Grade 3, >5.0-20.0*ULN; Grade 4, >20.0*ULN. Total bilirubin, Grade 3, >3.0-10.0*ULN; Grade 4, >10.0*ULN. Creatinine, Grade 3, >3.0-6.0*ULN; Grade 4, >6.0*ULN. Hypercalcemia(serum calcium, mmol/L), Grade 3, >3.1-3.4; Grade 4, >3.4. Hypocalcemia (serum calcium, mmol/L), Grade 3, <1.75-1.5; Grade 4, <1.5. Hyperkalemia(serum calcium, mmol/L), Grade 3, >6.0-7.0; Grade 4, >7.0. Hypokalemia(serum calcium, mmol/L), Grade 3, <3.0-2.5; Grade 4, <2.5. Hypernatremia (serum calcium, mmol/L), Grade 3, >155-160; Grade 4, >160. Hyponatremia (serum sodium, mmol/L), Grade 3, <130-120; Grade 4, <120. Phosphorus (serum sodium, mmol/L), Grade 3, <0.6-0.3; Grade 4, <0.3. (NCT00744497)
Timeframe: At baseline, within 3 days prior to each infusion of docetaxel (each cycle), to end of treatment. If docetaxel is discontinued, every other cycle.

,
InterventionParticipants (Number)
ALP (All grades)ALP (Grades 3 and 4)ALT (All grades)ALT (Grades 3 and 4)AST (All grades)AST (Grades 3 and 4)Total bilirubin (All grades)Total bilirubin (Grades 3 and 4)Creatinine (All grades)Creatinine (Grades 3 and 4)Hypercalcemia (All grades)Hypercalcemia (Grades 3 and 4)Hypocalcemia (All grades)Hypocalcemia (Grades 3 and 4)Hyperkalemia (All grades)Hyperkalemia (Grades 3 and 4)Hypokalemia (All grades)Hypokalemia (Grades 3 and 4)Hypernatremia (All grades)Hypernatremia (Grades 3 and 4)Hyponatremia (All grades)Hyponatremia (Grades 3 and 4)Phosporus (All grades)Phosphorus (Grades 3 and 4)
Dasatinib3756825662665413184534137725152141521610102414325793
Placebo44791186521244911533561308231641110769302303618943

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Number of Participants With Abnormal Results in Urinalysis

Abnormal=positive, defined as the presence of >=30 mg/dL of protein; a small, moderate, or large amount of blood; or >0 g/dL glucose in urine. BL=baseline; neg=negative (NCT00744497)
Timeframe: At baseline, within 3 days prior to each infusion of docetaxel (each cycle), to end of treatment. If docetaxel is discontinued, every other cycle.

,
InterventionParticipants (Number)
Protein, urine: postiveBlood, urine: positiveGlucose, urine: positive
Dasatinib336307154
Placebo246289179

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Number of Participants by Maximal On-study Fridericia-corrected QTc Interval

QTc interval measured by electrocardiogram (ECG). Although a participant may have had several ECGs, only the longest QTc interval was included. (NCT00744497)
Timeframe: At baseline, approximately 12 weeks after starting treatment, and then whenever clinically indicated up to within 30 days of end of dosing

,
InterventionParticipants (Number)
<450 msecs (n=600, 548)450-500 msecs (n=600, 548)>500 msecs (n=600, 548)
Dasatinib497483
Placebo550437

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Time to Prostate Specific Antigen (PSA) Progression

PSA progression is defined as the time from randomization to the date of the first PSA level measurement that led to confirmed PSA progression, for participants who had not started subsequent cancer therapy. For participants who did not progress or who progressed on cancer therapy, PSA progression is defined as the time from randomization to the date of the last PSA level measurement before the start of cancer therapy, if any. Participants who had no on-study PSA level measurements were censored on the day they were randomized. (NCT00744497)
Timeframe: From randomization to date of first PSA measurement leading to confirmed PSA progression (or to last bone scan assessment, if no progression or if cancer therapy started) (maximum reached: 30 months)

InterventionMonths (Median)
Placebo6.9
Dasatinib7.2

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Progression-free Survival (PFS)

PFS is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy. Those who progressed or died while on subsequent cancer therapy and those who did not die or progress were censored at their last radiologic bone scan/imaging, skeletal related-event, or tumor assessment or at measurement of prostate specific antigen levels, whichever occurred last prior to start of subsequent cancer therapy ,if any. Participants with no assessments were censored on the day of randomization. (NCT00744497)
Timeframe: From day of randomization to disease progression or death (or to last clinical assessment, if subsequent cancer therapy started or no progression or death) (maximum reached: approximately 43 months)

InterventionMonths (Median)
Placebo11.1
Dasatinib11.8

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Synovial Blood Flow

Synovial Blood Flow was measured as the 2-dimensional quantitative Transverse Power Doppler Area summed over each of the 10 metacarpophalangeal joints (10MCP 2D Trans PDA). The PDA is a count of the number of pixels with power Doppler signal, uncorrected by pixel intensity, within an expert drawn region of interest encompassing the synovium and excluding digital vessels in a standardized 2D transverse image of the joint. A higher pixel count relates to greater synovial blood flow. A decrease in pixel count relates to a reduction in synovial blood flow. (NCT00746512)
Timeframe: Baseline and Day 14

,,,
Interventionpixel count (Mean)
BaselineDay 14Change from Baseline at Day 14
Placebo 15 mg10.5513.372.82
Placebo 7.5 mg9.789.15-0.64
Prednisone 15 mg9.486.52-2.96
Prednisone 7.5 mg8.314.44-3.88

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Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP])

"The DAS28(CRP) is a measure of disease activity with components which include the tender joint count (TJC) & swollen joint count (SJC) (each out of 28 joints counted), a Global Health (GH) index (100 mm visual analog scale [VAS]), and the CRP (in mg/L measured from lab test). The scoring formula was:~DAS28(CRP) = 0.56*SQR(TJC28) + 0.28*SQR(SJC28) + 0.36*ln(CRP+1) + 0.014*GH(VAS) + 0.96.~Where SQR is square root and ln is natural log.~The formula produces a score from 0 to 10: >5.1 means high disease activity; <3.2 means low disease activity, <2.6 is generally considered remission." (NCT00746512)
Timeframe: Baseline and Day 14

,,,
Interventionscore on scale (Mean)
BaselineDay 14Change from Baseline at Day 14
Placebo 15 mg5.455.04-0.41
Placebo 7.5 mg5.625.38-0.23
Prednisone 15 mg5.173.57-1.61
Prednisone 7.5 mg5.314.57-0.74

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Percentage of Participants With 3-year Progression-free Survival (PFS)

Measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is ≥ 50% increase in the sum of products of greatest diameters (SPD) of target measurable nodal lesions over the smallest sum observed (over baseline if no decrease during therapy), or ≥ 50% increase in the greatest transverse diameter (GTD) of any node > 1 cm in shortest axis, or ≥ 50% increase in the SPD of other target measurable lesions (e.g., splenic or hepatic nodules) over the smallest sum observed. Appearance of any new bone marrow involvement; appearance of a new lesion/site; lymph nodes with the long axis is > 1.5 cm, or if the both the long and short axes are > 1 cm; in patients with no pretreatment PET scan or when the PET scan was positive before therapy, lesions should be PET positive; or death due to disease without prior documentation of progression. (NCT00770224)
Timeframe: 0-3 years

Interventionpercentage of participants (Number)
R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance90

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5-year Overall Survival

Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact. (NCT00770224)
Timeframe: 0-5 years

Interventionpercentage of participants (Number)
R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance94

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5-year Progression-free Survival

Measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is ≥ 50% increase in the sum of products of greatest diameters (SPD) of target measurable nodal lesions over the smallest sum observed (over baseline if no decrease during therapy), or ≥ 50% increase in the greatest transverse diameter (GTD) of any node > 1 cm in shortest axis, or ≥ 50% increase in the SPD of other target measurable lesions (e.g., splenic or hepatic nodules) over the smallest sum observed. Appearance of any new bone marrow involvement; appearance of a new lesion/site; lymph nodes with the long axis is > 1.5 cm, or if the both the long and short axes are > 1 cm; in patients with no pretreatment PET scan or when the PET scan was positive before therapy, lesions should be PET positive; or death due to disease without prior documentation of progression. (NCT00770224)
Timeframe: 0-5 years

Interventionpercentage of participants (Number)
R-CHOP+I-131 Tositumomab Followed by Rituximab Maintenance85

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Overall Survival (OS)

Overall survival (OS) will be measured as the time from date of enrollment to death from any cause. For patients who remain alive, survival time will be censored at the date of last contact. (NCT00772668)
Timeframe: Up to 5 years

Interventionmonths (Number)
RCVELPNA

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Progression-free Survival (PFS)

Progression free-survival will be assessed according to according to the International Workshop Criteria (IWC). Progression-free survival will be measured as the time from date of enrollment to relapse, progression or death due to follicular lymphoma (FL) or marginal zone lymphoma (MZL), whichever occurs first. Participants who do not experience relapse or progression, and those who die from causes other than cancer, will be censored at the date of last contact. (NCT00772668)
Timeframe: Up to 5 years

Interventionmonths (Number)
RCVELPNA

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Rate of Toxicity in Study Participants

Safety and tolerance to protocol therapy as evidenced by the rate of toxicity (serious adverse events and study-related adverse events) in study participants (NCT00772668)
Timeframe: Up to 5 years

Interventionparticipants (Number)
RCVELP1

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Relative Efficacy of the 2 Groups

The goal is to see if there are major differences between the two arms for each group in term of efficacy and of toxicity both overall and in comparison to the previous responses to rituximab alone. The comparisons are for level of response eg CR (>100k) vs PR (230-100k) vs NR (<30k) and for duration of response-----duration of response is controlled by comparison to duration of response from initial rituximab infusions (NCT00774202)
Timeframe: 2 years

,
Interventionnumber of responders (Number)
CRPRresponse longer than previous response
High Dose Rituximab400
Rituximab, C, V, P410

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Number of Participants With SAEs

How many participants had SAEs among those receiving R-CVP or among those receiving double dose rituximab and did participants in one arm have substantially more SAEs than those in the other arm (NCT00774202)
Timeframe: 2 years

Interventionnumber of patients with SAEs (Number)
Rituximab + CVP0
Double Dose Rituximab1

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Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study

A participant who did not meet the criteria for either a complete response or a partial response at Week 24 was considered a non-responder. After Week 24, non-responders were terminated from the study and treated according to best clinical judgment unless the site investigator judged that the participant could benefit from continued participation. Non responders did not respond to treatment and lupus activity is moderate to severe. (NCT00774852)
Timeframe: Week 104

Interventionparticipants (Number)
Week 24 Non-Responder: Abatacept0
Week 24 Non-Responder: Placebo0

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Number of Participants Who Achieved a Complete Response by Week 24 and Maintained the Complete Response Through Week 52

Complete response definition: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder (CR). Participants who discontinued treatment and/or terminated from the study were defined as response failures for all subsequent visits. CRs are those who successfully responded to treatment and had minimal activity of their lupus nephritis. (NCT00774852)
Timeframe: Week 52

Interventionparticipants (Number)
Week 24 Complete Response: Abatacept11
Week 24 Complete Response: Placebo13

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Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Partial Response

A partial proteinuria and prednisone response is defined as an improvement (reduction) of >=50% in the urine protein-to-creatinine ratio at either visit -1 or 0, and prednisone dose has been tapered to 10 mg/day. Subjects who discontinued treatment or terminated from the study in the first 24 weeks are defined as response failures for all subsequent visits. Partial responders are those who showed some response to treatment and low activity of their lupus nephritis. (NCT00774852)
Timeframe: Week 24

Interventionparticipants (Number)
Abatacept39
Placebo42

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Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Complete Response

A complete proteinuria and prednisone response is defined as urine protein-to-creatinine ratio <0.5 and prednisone dose tapered to <= 10mg/day. Subjects who discontinued treatment or terminated from the study in the first 24 weeks are defined as response failures for all subsequent visits. Complete responders are those who successfully responded to treatment and have minimal activity of their lupus nephritis. (NCT00774852)
Timeframe: Week 24

Interventionparticipants (Number)
Abatacept22
Placebo21

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Lupus Disease Activity - Total BILAG-2004

BILAG-2004 has 5 categories of scoring.Category A:defined by severe disease activity requiring any of the following treatments: 1) systemic high dose oral glucocorticoids, 2) IV pulse glucocorticoids, 3) systemic immunomodulators, or 4)therapeutic high dose anticoagulation in the presence of high dose steroids or immunomodulators. Category B:defined by moderate disease activity requiring any of the following treatments:1) systemic low dose oral glucocorticoids, 2) intramuscular or intra-articular or soft tissue glucocorticoids injection,3) topical glucocorticoids, 4) topical immunomodulators,5) antimalarials or thalidomide or prasterone or acitretin, or 6) symptomatic therapy.Category C:defined by mild disease.Category D is defined by inactive disease, previously affected.Category E is defined as the system never being involved.The categories are converted to a numeric score (A=9, B=3, C=1, D=0, E=0) and treated as a continuous variable. Higher score= more severe disease activity. (NCT00774852)
Timeframe: Week 52

Interventionunits on a scale (Mean)
Week 24 Complete Response: Abatacept1.8
Week 24 Complete Response: Placebo1.9
Week 24 Partial Response: Abatacept3.2
Week 24 Partial Response: Placebo3.5

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Number of Participants With a Complete or Partial Response

"Complete response: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder.~Partial response: a serum creatinine <= 1.2 mg/dL or <= to 125% of the higher value at either screening or baseline visit, and improvement >= to 50% in the urine protein to creatinine ratio at either screening or baseline visit, and prednisone dose has been tapered to 10 mg/day or according to protocol dosing allowances in protocol.~Participants who discontinued treatment and/or terminated from the study were defined as response failures for all subsequent visits. CRs successfully responded to treatment and have minimal activity of their lupus nephritis. Partial responders showed some response to treatment and low activity of their lupus nephritis." (NCT00774852)
Timeframe: Week 52

Interventionparticipants (Number)
Week 24 Complete Response: Abatacept12
Week 24 Complete Response: Placebo14
Week 24 Partial Response: Abatacept13
Week 24 Partial Response: Placebo13

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Lupus Disease Activity - Patient Global Assessment

"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment (PGA), SF36 total scores, and BILAG-2004 scores.~PGA is measured on a 100mm scale and assessed at Weeks 0, 12, 24, 52, and 104. Higher values indicate greater burden of disease." (NCT00774852)
Timeframe: Week 104

Interventionunits on a scale (Mean)
Abatacept13.2
Placebo18.7

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Number of Participants With Complete Response

Complete response definition: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder (CR). Participants who discontinued treatment and/or terminated from the study in the first 24 weeks were defined as CR failures for all subsequent visits. CRs are those who successfully responded to treatment and have minimal activity of their lupus nephritis. (NCT00774852)
Timeframe: Week 24

Interventionparticipants (Number)
Abatacept22
Placebo21

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Number of Participants With Partial Response

Outcome measure description: Partial response definition: a serum creatinine <= 1.2 mg/dL or <= to 125% of the higher value at either screening or baseline visit, and improvement (reduction) >= to 50% in the urine protein to creatinine ratio at either screening or baseline visit, and prednisone dose has been tapered to 10 mg/day or according to protocol dosing allowances in protocol. Participants who discontinued treatment and/or terminated from the study in the first 24 weeks were defined as complete response failures for all subsequent visits. Partial responders are those who showed some response to treatment and low activity of their lupus nephritis. (NCT00774852)
Timeframe: Week 24

Interventionparticipants (Number)
Abatacept39
Placebo40

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Lupus Disease Activity - Frequency of Flares

"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Flares can be renal or non-renal. A renal flare is defined as two successive evaluations at least 1 week apart as proteinuria >1 gm/24h for participants who attain a complete response at Week 12 and for all other participants either 1) Increasing serum creatinine and persistent proteinuria, or 2) Worsening proteinuria. A non-renal flare is defined as any new post-baseline BILAG A in a non-renal organ system using BILAG-2004. This outcome measures the number of participants with the presence of renal and non-renal flares from Week 24 through Week 52 by response status. Having flares is indicative of more lupus disease activity." (NCT00774852)
Timeframe: Week 52

,,,,,
Interventionparticipants (Number)
Participants with a Renal FlareParticipants with at least 1 Non-renal Flare
Week 24 Complete Response: Abatacept01
Week 24 Complete Response: Placebo21
Week 24 No Response: Abatacept11
Week 24 No Response: Placebo00
Week 24 Partial Response: Abatacept10
Week 24 Partial Response: Placebo31

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Lupus Disease Activity - Presence of Hypocomplementemia

"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Participants were categorized as having hypocomplementemia if their serum complement test results (C3, and C4) were below the normal range at the site. Below normal complement test results are indicative of active lupus erythematosus." (NCT00774852)
Timeframe: Week 104

,
Interventionparticipants (Number)
C3 HypocomplementemiaC4 Hypocomplementemia
Abatacept1211
Placebo118

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Lupus Disease Activity - SF-36 Scores

"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~The SF-36 is a quality of life assessment that was performed at Weeks 9, 24, 36, 52, and 104. Eight scale scores are derived from responses to the 36 items of the SF-36 questionnaire which were combined to produce the Physical Component Score and the Mental Component Score. The Physical Component Score is based on the Physical Functioning Scale (10 items), the Role-Physical Scale (4 items), the Bodily Pain Scale (2 items), and the General Health Scale (5 items). The Mental Component Score is based upon the Vitality Scale (4 items), the Social Functioning Scale (2 items), the Role-Emotional Scale (3 items) and the Mental Health Scale (5 items). Each component score is transformed into a 0-100 scale, with higher numbers indicating greater quality of life." (NCT00774852)
Timeframe: Week 104

,
InterventionScore (Mean)
Week 104 Physical Component ScoreWeek 104 Mental Component Score
Abatacept49.350.9
Placebo45.349.2

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Lupus Disease Activity - SF-36 Scores Percent Change From Baseline

"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~The SF-36 is a quality of life assessment that was performed at Weeks 9, 24, 36, 52, and 104. Eight scale scores are derived from responses to the 36 items of the SF-36 questionnaire which were combined to produce the Physical Component Score and the Mental Component Score. The Physical Component Score is based on the Physical Functioning Scale (10 items), the Role-Physical Scale (4 items), the Bodily Pain Scale (2 items), and the General Health Scale (5 items). The Mental Component Score is based upon the Vitality Scale (4 items), the Social Functioning Scale (2 items), the Role-Emotional Scale (3 items) and the Mental Health Scale (5 items). Each component score is transformed into a 0-100 scale, with higher numbers indicating greater quality of life." (NCT00774852)
Timeframe: Week 104

,
Interventionpercent change (Mean)
Percent Change From Baseline on Physical ComponentPercent Change from Baseline Mental Component Scor
Abatacept32.139.6
Placebo28.237.1

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Lupus Disease Activity - Participants Who Were Anti-dsDNA Positive at Baseline and Negative at Week 104

"Lupus disease activity was assessed by 7 different measures: reduction in anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Participants with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. One measure used to assess disease activity is the number of participants who were anti-dsDNA positive at baseline but negative at Week 104. Going from positive to negative is indicative of lowered lupus activity." (NCT00774852)
Timeframe: Week 104

Interventionparticipants (Number)
Abatacept3
Placebo3

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Proportion of Vaccinated Participants With a Competent Immune Response

"Among participants who are vaccinated, the number of who have a competent immune response at Week 52 as defined as having met both of the following criteria:~Pneumococcal vaccination response - absolute value >= 0.35 ug/mL and, when measured 4-6 weeks after vaccination, a >=2-fold increase from baseline in serotype-specific antibody titer for at least 50% of the serotypes tested.~Tetanus toxoid vaccination response - absolute value >=0.015 IU/mL and, when measured 4-6 weeks after vaccination, a 2-fold increase from baseline in antigen-specific antibody titer~Competent immune response is indicative of low disease activity." (NCT00774852)
Timeframe: Week 52

,
Interventionpercentage of participants (Number)
Pneumococcal VaccinesTetanus Toxoid Vaccines
Week 24 Complete Response: Abatacept6750
Week 24 Complete Response: Placebo100100

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Lupus Disease Activity - Patient Global Assessment Percent Change From Baseline

"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment (PGA), SF36 total scores, and BILAG-2004 scores.~PGA is measured on a 100mm scale and assessed at Weeks 0, 12, 24, 52, and 104. Higher values indicate greater burden of disease." (NCT00774852)
Timeframe: Week 104

Interventionpercent change (Mean)
Abatacept26
Placebo-35.2

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Lupus Disease Activity - Negative Anti-dsDNA

"Lupus disease activity was assessed by 7 different measures: reduction in anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Participants with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. This measure was the number of participants who had negative anti-dsDNA at Week 104. Having a negative score is indicative of low lupus disease activity." (NCT00774852)
Timeframe: Week 104

Interventionparticipants (Number)
Abatacept7
Placebo10

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Number of Participants With Dose Limiting Toxicity for Determination Phase I (Schedule A) MTD of Vorinostat

MTD of Vorinostat defined as highest dose level in which 6 patients have been treated with less than 2 instances of DLT. Continual reassessment during each 21-day cycle to assess DLT. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle. The dose of Vorinostat escalated in successive 3+3 cohorts of participants to determine the MTD. (NCT00787527)
Timeframe: 21 Days

Interventionparticipants (Number)
Schedule A - Vorinostat Once Daily1
Schedule A - Vorinostat Twice Daily2

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Phase II MTD of Vorinostat

MTD of Vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Continual reassessment during each 21-day cycle to assess dose limiting toxicity. Two schedules of Vorinostat were investigated: Phase I A) daily doses on days 5 to 14, or Phase II B) three times a day on days -2 to 3 of standard CHOP every 21 days. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle); Schedule B Vorinostat administered orally 300 mg orally three times daily from days -2 to 3 (4500 mg over 5 days per cycle). (NCT00787527)
Timeframe: 21 Days

Interventionmg/three times daily (Number)
Schedule B - Vorinostat Three Times Daily300

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Phase I Maximum Tolerated Dose (MTD) of Vorinostat

MTD of Vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Continual reassessment during each 21-day cycle to assess dose limiting toxicity. Two schedules of Vorinostat were investigated: Phase I A) daily doses on days 5 to 14, or Phase II B) three times a day on days -2 to 3 of standard CHOP every 21 days. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle); and for Phase II Schedule B Vorinostat administered orally 300 mg orally three times daily from days -2 to 3 (4500 mg over 5 days per cycle). (NCT00787527)
Timeframe: 21 Days

Interventionmg/day (Number)
Schedule A - Vorinostat Once or Twice Daily300

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Number of Participants With Treatment Failure by 90 Days Assignment

In the etanercept group 16/40 (40%) failed treatment compared with 12/38 (32%) in the prednisone group. (NCT00789997)
Timeframe: Day 0 to Day 90

Interventionparticipants (Number)
Etanercept16
Prednisone12

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Change in Lung Function (Forced Expiratory Volume in 1 Second (FEV1)

"FEV1 was obtained using calibrated spirometers at approximately the same time of day at all visits throughout the study. The highest acceptable FEV1 and the highest FVC measurement each obtained on any of three blows (even if not from the same curve) meeting the American Thoracic Society criteria constituted the data for that test set.~Not all participants had Day 14 FEV1 measures collected" (NCT00789997)
Timeframe: Day 0 to Day 14

Interventionpercentage of change in FEV1 (Mean)
Etanercept15.2
Prednisone20.1

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Overall Survival (OS)

OS will be estimated using the method of Kaplan-Meier. (NCT00792948)
Timeframe: From the date of initial registration on the study until death from any cause, assessed up to 5 years

InterventionProbability of surviving 12 months (Number)
Treatment0.88

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Continuous Complete Remission (CCR) Rate

Will be testing using an exact binomial test (NCT00792948)
Timeframe: 18 months

Interventionpercentage of participants (Number)
Treatment57

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Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation

Will be estimated using the method of Kaplan-Meier. (NCT00792948)
Timeframe: 12 months

InterventionProbability of 12-month RFS (Number)
Treatment0.83

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Change in Renal Function

Change in renal function as seen in serum creatinine values from baseline until study completion or participant termination. Baseline is defined as the lowest serum creatinine collected during stabilization period or in the four weeks following the end of the stabilization period. The stabilization period is defined as four consecutive creatinine values close in value (not differing more than 0.3 mg/dL). Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. (NCT00801632)
Timeframe: Transplantation until study completion or participant termination (up to five years)

Interventionmg/dL (Mean)
Baseline Serum CreatinineStudy Termination/CompletionChange from Baseline
MEDI-5071.93.21.2

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Number of Participants Successfully Withdrawn Off of Immunosuppressant Medication for 104 Weeks

A participant was considered a success if they were off immunosuppressive therapy for 104 consecutive weeks leading up to study week 208 (48 months post-transplant) or study termination, whichever occurred first. (NCT00801632)
Timeframe: 48 months post-transplant

Interventionparticipants (Number)
MEDI-5073

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Percentage of Participants Experiencing Acute Rejection

"The percentage of participants who experience an acute rejection. Acute rejection is defined as a biopsy with findings of Banff score of grade IA or higher. The Banff classification is as follows: grade IA is >25% of parenchyma affected and foci of moderate tubulitis; Grade IB is >25% of parenchyma affected and foci of severe tubulitis; Grade IIA is mild to moderate intimal arteritis; Grade IIB is severe intimal arteritis comprising >25% of the luminal area; Grade III is transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation." (NCT00801632)
Timeframe: Transplantation until study completion or participant termination (up to five years)

InterventionPercentage of Participants (Number)
MEDI-50740

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Percentage of Participants Experiencing a Clinically Significant Invasive or Resistant Opportunistic Infection

Clinically significant invasive or resistant opportunistic infections include cytomegalovirus, herpes zoster, and candida. (NCT00801632)
Timeframe: Transplantation until study completion or participant termination (participants followed up to five years)

InterventionPercentage of Participants (Number)
MEDI-5070

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Time to Platelet Recovery Following Transplant

Time (in days) until platelet recovery following transplant. Platelet recovery is defined as a platelet count >20,000 /mm^3 and where no transfusion is required. Time to recovery is time from transplantation until platelet value recovers. (NCT00801632)
Timeframe: Transplantation until study completion or participant termination (participants followed up to five years)

Interventiondays (Mean)
MEDI-5071.0

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Time to Neutrophil Recovery Following Transplant

Time (in days) until neutrophil recovery following transplant. Neutrophil recovery is defined as an absolute neutrophil count (ANC) > 500/mm^3 at three consecutive assessments on different days post-transplant. Time to recovery is time from transplantation until the first assessment date used to confirm the recovery. (NCT00801632)
Timeframe: Transplantation until study completion or participant termination (participants followed up to five years)

Interventiondays (Mean)
MEDI-50714.0

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Percentage of Participants With Graft Survival Through 156 Weeks

The percentage of participants with graft survival from transplantation through 156 weeks. Participants who terminated from the study prior to Week 156 without meeting the event were excluded. Graft survival is defined as the time to week 156 or graft loss. Graft loss is defined as the day on which a graft is deemed irreversibly nonfunctional and dialysis is begun, a transplantectomy is performed, or the participant is re-transplanted, whichever comes first. Six consecutive weeks of dialysis are required for the diagnosis of graft loss, though the date of graft loss will be defined as the date of first dialysis. (NCT00801632)
Timeframe: Transplantation until week 156

InterventionPercentage of Participants (Number)
MEDI-50780

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Percentage of Participants Surviving Through 156 Weeks

The percentage of participants who survived from transplantation through 156 weeks. Participants who terminated from the study prior to Week 156 without meeting the event were excluded. (NCT00801632)
Timeframe: Transplantation until week 156

InterventionPercentage of Participants (Number)
MEDI-507100

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Proportion of Patients Tolerating >50% Steroid Dose Reduction After a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD

The participants' total daily steroid dose was recorded at baseline and after a 15 week course of treatment. Starting at a dose of 0.5-1 mg/kg, dose reduction of steroids was permitted after 1 cycle of therapy. The suggested taper was 10-25% every 1-2 weeks. . (NCT00815919)
Timeframe: After 15 weeks of bortezomib plus prednisone therapy

Interventionparticipants (Number)
Velcade (Bortezomib)14

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Overall Response Rate After a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD

"Participants had their cGVHD evaluated per NIH consensus criteria:~Complete response: resolution of all reversible manifestations of cGVHD.~Partial response: a decrease ≥ 1 point on a 3-point organ-specific scale or 2 points or more on a 10-point global scale without progression in any organ sites.~Stable disease: no evidence of cGVHD response without evidence of progressive cGVHD.~Progressive cGVHD: increase of ≥ 1 point on an organ-specific 3-point scale, addition of a new immunosuppressive agent prior to the completion of 15 weeks of combination therapy, or requirement an increase in the total daily dose of corticosteroids above a participant's baseline corticosteroid dose during the 15-week combined treatment period.~Mixed response: a response in primary sites of cGVHD involvement but interval progressive cGVHD in other organs or sites.~Responses were not scored for oral or ocular cGVHD, since topical therapies were permitted during the study." (NCT00815919)
Timeframe: Patients had their cGVHD assessed at Baseline and at 15 weeks or end of therapy

Interventionparticipants (Number)
Participants with a complete response in cGVHDParticipants with an partial response in cGVHDParticipants with stable cGVHDParticipants with progressive cGVHDParticipants with mixed response
Velcade (Bortezomib)214121

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Proportion of cGVHD Patients Requiring Prednisone by 1 Year After Therapy

Participants who were still being followed 1 year after the start of therapy had their prednisone dose recorded. (NCT00815919)
Timeframe: 1 year after the start of study treatment

Interventionparticipants (Number)
Participants still requiring prednisoneParticipants off prednisone
Velcade (Bortezomib)116

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The Toxicity of a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD

Participants' toxicities were graded based on the CTCAE version 3.0. The toxicities were then given an attribution to the velcade treatment: unrelated, unlikely, possible, probable, definite. (NCT00815919)
Timeframe: Toxicities were collected from the start of treatment through 15 weeks of therapy or end of study treatmetn

Interventionparticipants (Number)
Participants with >= Grade 3, unrelated/unlikelyParticipants with >= Grade 3, possibleParticipants with >= Grade 3, probable/definite
Velcade (Bortezomib)710

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Overall and cGVHD Progression-free Survival by 1 Year After Therapy

(NCT00815919)
Timeframe: 2 years

Interventionpercentage of participants (Number)
2-year Cum-incidence of Non-relapse mortality2-year Cum-incidence of malignant relapse2 year progression-free survival2-year Overall survival
Velcade (Bortezomib)14147373

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Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging

Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact. (NCT00822120)
Timeframe: 2 years

Interventionpercentage of participants (Number)
HIV-negative:2 Cycles of ABVD Followed by PET-directed Therapy98

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Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS

Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is > 1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. (NCT00822120)
Timeframe: 2 years

Interventionpercentage of participants (Number)
HIV-negative: 2 Cycles of ABVD Followed by Escalated BEACOPP64

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Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD

Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site. (NCT00822120)
Timeframe: 7 months after registration

Interventionpercentage of patients (Number)
PET-negative: Continued ABVD After 2 Cycles of ABVD100
PET-positive: BEACOPP Escalated After 2 Cycles of ABVD93

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Percentage of HIV-positive Patients With 5-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging.

Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact. (NCT00822120)
Timeframe: 5 years

Interventionpercentage of participants (Number)
HIV-positive: 2 Cycles of ABVD Followed by PET-directed Therap89

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Percentage of HIV-positive Patients With 2-year Progression-free Survival (PFS) Treated With Initial 2 Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.

Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is >1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. (NCT00822120)
Timeframe: 2 years

Interventionpercentage of patients (Number)
HIV-positive: 2 Cycles of ABVD Followed by PET-directed Therap83

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Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.

Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is > 1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. (NCT00822120)
Timeframe: 2 years

Interventionpercentage of participants (Number)
HIV-negative: 2 Cycles of ABVD Followed by PET-directed Therap79

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Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration

Comparison of the Change in Allergen-induced Interleukin 5 (IL-5) as Measured in Nasal Exudates After a Single Dose of Low or High Dose of Oral Prednisone Relative to Placebo (NCT00828061)
Timeframe: Baseline and Hour 8 post nasal allergen challenge

InterventionFold Change (Geometric Mean)
Placebo26.94
10 mg Prednisone6.70
25 mg Prednisone1.86

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Change From Baseline at Hour 8 in the Percent of Total Cells That Are Eosinophils

Comparison of the Change in the Percent of Total Cells That Are Eosinophils Measured in Nasal Lavage After a Single Dose of 10 mg or 25 mg Prednisone Relative to Placebo (NCT00828061)
Timeframe: Baseline and Hour 8 post nasal allergen challenge

InterventionPercentage of cells that are eosinophils (Least Squares Mean)
Placebo2.28
10 mg Prednisone3.17
25 mg Prednisone6.02

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Percentage Change in Morning Stiffness

How long was your morning stiffness today? Pre-treatment (Night A) value minus post-treatment (Night B) value divided by pre-treatment value. (NCT00836810)
Timeframe: 2 weeks

Interventionpercentage of baseline morning stiffness (Mean)
Timed Release Tablet Prednisone75.0
Standard Prednisolone115.0

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Change in Peak Serum IL-6 Concentration

Pre-treatment (Night A) peak minus post-treatment (Night B) peak. Peaks defined as the highest value for each patient from measures at 0, 1.5, 3, 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 10.5, 11.5, 12.5, 13.5, 14.5, 15.5, 17, 19, 20.5, 22, and 24 hours after 16.30 on day before treatment (Night A) and last day of treatment (Night B) and the peak identified for each one. (NCT00836810)
Timeframe: 24 hours

Interventionpg/ml (Mean)
Timed Release Tablet Prednisone11.5
Standard Prednisolone29.3

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Pain (Severity)

100mm visual analogue scale. Question: How much pain have you had in the last 24 hours? Anchors: No pain; Severe pain. Min score 0, Max score 100. Higher value is worse outcome. (NCT00836810)
Timeframe: 24 hour period after 2 weeks of treatment

Interventionmm (Mean)
Timed Release Tablet Prednisone26.5
Standard Prednisolone19.5

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Clinician's Opinion of Disease Activity.

100mm visual analogue scale. Question: Clinician's opinion of disease activity. Anchors: None; Severe Min 0 Max 100 (worse) (NCT00836810)
Timeframe: Current at baseline and after 2 weeks treatment

Interventionmm (Mean)
Timed Release Tablet Prednisone19.0
Standard Prednisolone20.3

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Change in Area Under the Curve (AUC) of Plasma IL-6

Pre-treatment (Night A) AUC minus post-treatment (Night B) AUC. AUC calculated from measures at 0, 1.5, 3, 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 10.5, 11.5, 12.5, 13.5, 14.5, 15.5, 17, 19, 20.5, 22, and 24 hours after 16.30 on day before treatment (Night A) and last day of treatment (Night B). (NCT00836810)
Timeframe: 24 hour measurements 2 weeks apart

Interventionpg*hr/ml (Mean)
Timed Release Tablet Prednisone113.5
Standard Prednisolone97.9

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Patient's Opinion of Condition

100mm visual analogue scale. Question: Considering all the ways your pain and/or stiffness affect(s) you, please mark on the line how well you are doing. Anchors: Very well; Very badly. Min 0 Max 100 (poor outcome). (NCT00836810)
Timeframe: Current value at baseline and after 2 weeks treatment

Interventionmm (Mean)
Timed Release Tablet Prednisone17.8
Standard Prednisolone26.0

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Means Aqueous Humor Prednisolone Acetate Concentration

(NCT00854061)
Timeframe: 35 days

Interventionng/mL (Mean)
T-Pred100.02
Pred Forte131.65

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AALL08P1 Safety Outcome

Percentage of Group B (High Risk-High) patients taking less than 49 weeks from day 1 of consolidation to day 1 of maintenance therapy. Only Group B analyzed since this is prespecified in protocol. (NCT00866307)
Timeframe: Consolidation through Delayed Intensification

Interventionpercentage of participants (Number)
Group B (High Risk-High)50.0

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AALL08P1 Feasibility Outcome

Percentage of Group B (High Risk-High) patients that tolerate at least 8 of the 12-14 total doses of pegaspargase during Consolidation, Interim Maintenance, and Delayed Intensification periods. Only Grp B analyzed since this is prespecified in protocol. (NCT00866307)
Timeframe: Consolidation through Delayed Intensification

Interventionpercentage of participants (Number)
Group B (High Risk-High)53.3

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Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1

Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 1. (NCT00873093)
Timeframe: End of Block 1 (Day 36 of Block 1) of re-induction therapy

Interventionpercentage of participants (Number)
Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs35.4
Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs25

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Severe Adverse Events (SAE) Rate.

The proportion of SAE rate among all eligible patients (NCT00873093)
Timeframe: 4 months

Interventionpercentage of participants (Number)
Overall8.2

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Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy

The percentage of eligible and evaluable patients who have achieved complete response at the end Block 1 of re-induction therapy. (NCT00873093)
Timeframe: The outcome is measured the end of Block 1 (Day 36 of Block 1) of re-induction therapy.

InterventionPercentage of participants (Number)
Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs72.2
Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs63

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Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3

Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 3. (NCT00873093)
Timeframe: End of Block 3 (Day 36 of Block 3) of re-induction therapy

InterventionPercentage of participants (Number)
Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs80
Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs63.6

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Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2

Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 2. (NCT00873093)
Timeframe: End of Block 2 (Day 36 of Block 2) of re-induction therapy

Interventionpercentage of participants (Number)
Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs66.7
Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs42.1

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Toxic Death Rate

The proportion of toxic death rate among all eligible patients. (NCT00873093)
Timeframe: 4 months

Interventionpercentage of participants (Number)
Overall2.1

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Event Free Survival

Percentage of patients who were event free at 4 months (NCT00873093)
Timeframe: 4 months after enrollment

InterventionPercentage of participants (Number)
Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs68.5
Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs37.8

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Worst Overall CTCAE Grade for Hematology Laboratory Test Results

Hematology test data were graded according to National Cancer Institute's (NCI) CTCAE version 3, and graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). The table presents the worst CTCAE grades for hematology test results experienced by participants overall (i.e., the worst post-baseline grade value for each participant and hematology test across all cycles). (NCT00877006)
Timeframe: 32 weeks (conducted at screening, Day 1 of each cycle, weekly during treatment, and at the end-of-treatment visit)

,
Interventionparticipants (Number)
Absolute Neutrophil Count: Grade 1Absolute Neutrophil Count: Grade 2Absolute Neutrophil Count: Grade 3Absolute Neutrophil Count: Grade 4Absolute Neutrophil Count: Grades 1-4Hemoglobin: Grade 1Hemoglobin: Grade 2Hemoglobin: Grade 3Hemoglobin: Grade 4Hemoglobin: Grades 1-4Lymphocytes Absolute: Grade 1Lymphocytes Absolute: Grade 2Lymphocytes Absolute: Grade 3Lymphocytes Absolute: Grade 4Lymphocytes Absolute: Grades 1-4Platelets: Grade 1Platelets: Grade 2Platelets: Grade 3Platelets: Grade 4Platelets: Grades 1-4White Blood Cells: Grade 1White Blood Cells: Grade 2White Blood Cells: Grade 3White Blood Cells: Grade 4White Blood Cells: Grades 1-4
Bendamustine and Rituximab (BR)225148501711294251177155483143106149713641796519204
R-CHOP/R-CVP142047104185129517218965555912572147810122498927187

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Kaplan-Meier Estimate for Duration of Response (DOR)

DOR was defined as the time from first response (CR or PR) to disease progression or relapse, or death due to any cause. (NCT00877006)
Timeframe: Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)

Interventionmonths (Median)
Bendamustine and Rituximab (BR)26.5
R-CHOP/R-CVP32.1

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Kaplan-Meier Estimate for Event-free Survival (EFS)

"EFS was defined as the time from randomization to treatment failure, disease progression or relapse, other malignancies, or death from any cause, whichever occurred first.~Treatment failure was defined as failure to achieve a CR or PR after 6 cycles of treatment. If a patient failed to achieve CR or PR by the time of data analysis or early withdrawal, the treatment failure date was set at 126 days (6 cycles of treatment) after randomization or the new anticancer treatment date, whichever is earlier." (NCT00877006)
Timeframe: Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)

Interventionmonths (Median)
Bendamustine and Rituximab (BR)31.8
R-CHOP/R-CVP32.6

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Kaplan-Meier Estimate for Progression-free Survival (PFS)

PFS was defined as the time from randomization to disease progression or relapse, or death from any cause, whichever occurred first. (NCT00877006)
Timeframe: Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)

Interventionmonths (Median)
Bendamustine and Rituximab (BR)31.8
R-CHOP/R-CVP33.4

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Overall Survival (OS)

OS was defined as the time from randomization to death from any cause. (NCT00877006)
Timeframe: Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)

Interventionmonths (Median)
Bendamustine and Rituximab (BR)65.0
R-CHOP/R-CVP64.1

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Participants With Disease Progression, Relapse or Death At the End of the Treatment Period or the Long-Term Follow-up Period

"Relapsed disease (after CR) and progressive disease (PD) (after PR or SD):~Lymph nodes were considered abnormal if the long axis was greater than 1.5 cm. Lymph nodes with a long axis of 1.1 to 1.5 cm were considered abnormal if its short axis was greater than 1.0 cm.~In patients with no prior history of pulmonary lymphoma, new lung nodules identified by CT require histologic confirmation.~>= 50% increase from nadir in sum of the products of the greatest diameters (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules). To be considered progressive disease, a lymph node with a diameter of the short axis of less than 1.0 cm must have increased by 2: 50% and to a size of 1.5 cm by 1.5 cm, or more than 1.5 cm in the long axis~other conditions as specified in the protocol" (NCT00877006)
Timeframe: Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment Period

InterventionParticipants (Count of Participants)
Bendamustine and Rituximab (BR)36
R-CHOP/R-CVP30

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Percentage of Participants With Complete Response (CR) at End of Treatment Period

CR=complete disappearance of all detectable clinical evidence of disease and disease-related symptoms, if present pretherapy; protocol-specified positron emission tomography (PET) scan assessment criteria; (if the spleen and/or liver were enlarged on the basis of physical examination and/or anatomic imaging before treatment) the liver and/or spleen were considered normal size on physical examination and by anatomic imaging after therapy, with disappearance of all nodules related to lymphoma; (if the bone marrow was involved by lymphoma before treatment) the infiltrate must have cleared on subsequent bone marrow biopsies. (NCT00877006)
Timeframe: 6 to 8 21 or 28-day cycles (18-32 weeks)

Interventionpercentage of participants (Number)
Bendamustine and Rituximab (BR)31
R-CHOP/R-CVP25

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Percentage of Participants With Overall Response at End of Treatment Period

Overall Response=participants with Complete Remission (CR) + those with Partial Remission (PR). CR=see Outcome Measure 1 for details. PR= at least a 50% decrease in the sum of the product of the greatest diameters (SPD) of up to 6 of the largest dominant nodes/masses; at least a 50% decrease in the SPD of hepatic and splenic nodules in their greatest transverse diameter; no increase in the size of the liver, spleen, and other nodes; no measurable disease in organs other than the liver or spleen; no new sites of disease; protocol-specified PET scan and bone marrow criteria. (NCT00877006)
Timeframe: 6 to 8 21 or 28-day cycles (18-32 weeks)

Interventionpercentage of participants (Number)
Bendamustine and Rituximab (BR)97
R-CHOP/R-CVP91

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Clinically Significant Abnormal Vital Signs

(NCT00877006)
Timeframe: 32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)

,
Interventionparticipants (Number)
Heart Rate >=120 and ↑ >=15 bpmHeart Rate <=50 and ↓ >=15 bpmSystolic Blood Pressure(BP) >=180 and ↑ >=20 mm HgSystolic BP <=90 and ↓ >=20 mm HgDiastolic BP >=105 and ↑ from Baseline >=15 mm HgDiastolic BP <=50 and ↓ from Baseline >=15 mm Hg
Bendamustine and Rituximab (BR)022612
R-CHOP/R-CVP122222

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Eastern Cooperative Oncology Group (ECOG) Performance Status at the End of Treatment Period

Participants' ECOG Performance Status was evaluated at the end of treatment as improved, stayed the same, or worsened from baseline (see Baseline Characteristics for ECOG Performance Status). (NCT00877006)
Timeframe: Week 32

,
Interventionparticipants (Number)
ImprovedStayed the SameWorsened
Bendamustine/Rituximab3215334
R-CHOP/R-CVP2814142

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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs at End of Treatment Period

AE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. An AE can, therefore, be any unfavorable and unintended physical sign, symptom, or laboratory parameter that develops or worsens in severity during the course of the study, or significant worsening of the disease under study (or any concurrent disease), whether or not considered related to the study drug. AEs were graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). SAE=an adverse event occurring at any dose that results in: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity (a substantial disruption of one's ability to conduct normal life functions), a congenital anomaly/birth defect, or other important medical event. (NCT00877006)
Timeframe: 32 weeks

,
Interventionparticipants (Number)
Any AESevere AEs (grades 3, 4, 5)Treatment-related AEsDeathsSAEsWithdrawn due to AEs
Bendamustine and Rituximab (BR)221130209126010
R-CHOP/R-CVP213127NA9493

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Participants Who Died At the End of the Treatment Period or the Long-Term Follow-up Period

Death is due to any cause. Data are broken out by patients who died within 30 days of the last dose of study medications, and those who died greater than 30 days of the last dose of study medications. (NCT00877006)
Timeframe: Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment Period

,
InterventionParticipants (Count of Participants)
All DeathsDeaths within 30 days of study treatmentDeaths greater than 30 days of study treatment
Bendamustine and Rituximab (BR)40238
R-CHOP/R-CVP32131

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Potentially Clinically Significant Abnormal Weight

Participants were weighed at Baseline and at Endpoint (Week 32); those participants with an increase or decrease of >=10% were considered potentially clinically significant. (NCT00877006)
Timeframe: Baseline, Week 32

,
Interventionparticipants (Number)
Increase >=10%Decrease >=10%
Bendamustine and Rituximab (BR)818
R-CHOP/R-CVP58

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Therapeutic Classification of Concomitant Medications

(NCT00877006)
Timeframe: 32 weeks

,
Interventionparticipants (Number)
PsycholepticsSex Hormones and Modulators of the Genital SystemStomatological PreparationsThroat PreparationsThyroid TherapyTopical Preparations for Join and Muscular PainUnspecified HerbalUrologicalsVaccinesVasoprotectivesVitamins
Bendamustine and Rituximab (BR)696233313511116
R-CHOP/R-CVP744292125411821

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Therapeutic Classification of Prior Medications

(NCT00877006)
Timeframe: prior to start of treatment

,
Interventionparticipants (Number)
PsycholepticsSex Hormones and Modulators of the Genital SystemStomatological PreparationsThroat PreparationsThyroid TherapyTopical Products for Join and Muscular PainUnspecified HerbalUrologicalsVaccinesVasoprotectivesVitamins
Bendamustine and Rituximab (BR)57110016110202070
R-CHOP/R-CVP59120017010117061

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Worst Overall Common Terminology Criteria for Adverse Events (CTCAE) Grades for Serum Chemistry Laboratory Test Results

Clinical laboratory data were graded according to National Cancer Institute's (NCI) CTCAE version 3, and graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). The table presents the worst CTCAE grades for serum chemistry test results experienced by participants overall (i.e., the worst post-baseline grade value for each participant and laboratory test across all cycles). (NCT00877006)
Timeframe: 32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)

,
Interventionparticipants (Number)
Albumin: Grade 1Albumin: Grade 2Albumin: Grade 3Albumin: Grade 4Albumin: Grades 1-4Alkaline Phosphatase: Grade 1Alkaline Phosphatase: Grade 2Alkaline Phosphatase: Grade 3Alkaline Phosphatase: Grade 4Alkaline Phosphatase: Grades 1-4Creatinine: Grade 1Creatinine: Grade 2Creatinine: Grade 3Creatinine: Grade 4Creatinine: Grades 1-4Gamma-glutamyl transferase: Grade 1Gamma-glutamyl transferase: Grade 2Gamma-glutamyl transferase: Grade 3Gamma-glutamyl transferase: Grade 4Gamma-glutamyl transferase: Grades 1-4Hypercalcemia: Grade 1Hypercalcemia: Grade 2Hypercalcemia: Grade 3Hypercalcemia: Grade 4Hypercalcemia: Grades 1-4Hyperglycemia: Grade 1Hyperglycemia: Grade 2Hyperglycemia: Grade 3Hyperglycemia: Grade 4Hyperglycemia: Grades 1-4Hyperkalemia: Grade 1Hyperkalemia: Grade 2Hyperkalemia: Grade 3Hyperkalemia: Grade 4Hyperkalemia: Grades 1-4Hypernatremia: Grade 1Hypernatremia: Grade 2Hypernatremia: Grade 3Hypernatremia: Grade 4Hypernatremia: Grades 1-4Hypocalcemia: Grade 1Hypocalcemia: Grade 2Hypocalcemia: Grade 3Hypocalcemia: Grade 4Hypocalcemia: Grades 1-4Hypoglycemia: Grade 1Hypoglycemia: Grade 2Hypoglycemia: Grade 3Hypoglycemia: Grade 4Hypoglycemia: Grades 1-4Hypokalemia: Grade 1Hypokalemia: Grade 2Hypokalemia: Grade 3Hypokalemia: Grade 4Hypokalemia: Grades 1-4Hyponatremia: Grade 1Hyponatremia: Grade 2Hyponatremia: Grade 3Hyponatremia: Grade 4Hyponatremia: Grades 1-4Magnesium: Grade 1Magnesium: Grade 2Magnesium: Grade 3Magnesium: Grade 4Magnesium: Grades 1-4Phosphorus: Grade 1Phosphorus: Grade 2Phosphorus: Grade 3Phosphorus: Grade 4Phosphorus: Grades 1-4Aspartate Aminotransferase: Grade 1Aspartate Aminotransferase: Grade 2Aspartate Aminotransferase: Grade 3Aspartate Aminotransferase: Grade 4Aspartate Aminotransferase: Grades 1-4Alanine Aminotransferase: Grade 1Alanine Aminotransferase: Grade 2Alanine Aminotransferase: Grade 3Alanine Aminotransferase: Grade 4Alanine Aminotransferase: Grades 1-4Total Bilirubin: Grade 1Total Bilirubin: Grade 2Total Bilirubin: Grade 3Total Bilirubin: Grade 4Total Bilirubin: Grades 1-4Uric Acid: Grade 1Uric Acid: Grade 2Uric Acid: Grade 3Uric Acid: Grade 4Uric Acid: Grades 1-4
Bendamustine and Rituximab (BR)331430504110042193102331183052601079420150129731011800083681348151001618000184000040460004672530354221045466205414100154100142
R-CHOP/R-CVP44130057253002825100263710605360006743415112481009100001028600341000010160101728050334411046522313132210353831042700074200042

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Change From Baseline to End of Treatment in the Global Health Status Score of the European Organization for Research and Treatment of Cancer (EORTC) 30-item Core Quality of Life Questionnaire (QLQ-C30)

EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). This outcome reports the global health status on a scale of 0-100 with a high score for the global health status/QOL represents a high quality of life. (NCT00877006)
Timeframe: Day 1 (prior to treatment), 32 weeks

Interventionunits on a scale (Mean)
Bendamustine and Rituximab (BR)3.6
R-CHOP/R-CVP-5.1

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Response to Treatment

Response includes both complete remission (defined as <5% leukemic blasts in the bone marrow) and partial remission (defined as a greater than 35% reduction in the bone marrow leukemia blast percentage at day 33) (NCT00882206)
Timeframe: Day 33

Interventionparticipants (Number)
Decitabine / Vorinostat6

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Level of Methylation

the percentage of methylated DNA (NCT00882206)
Timeframe: Day 5

Interventionpercentage of DNA (Mean)
Decitabine / Vorinostat79.82

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Level of Methylation

the percentage of methylated DNA (NCT00882206)
Timeframe: Day 33

Interventionpercentage of DNA (Mean)
Decitabine / Vorinostat86.1

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Level of Methylation

the percentage of methylated DNA (NCT00882206)
Timeframe: Day 0

Interventionpercentage of DNA (Mean)
Decitabine / Vorinostat84.98

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Number of Participants With Treatment Emergent Adverse Events

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. (NCT00887198)
Timeframe: From first dose of study drug up to 30 days after the last dose of study drug

,,
InterventionParticipants (Number)
With Treatment-Emergent Adverse EventsWith Treatment-Emergent Serious Adverse Events
Abiraterone Acetate + Prednisone (AAP)541208
Placebo524148
Placebo to Abiraterone Acetate9339

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Radiographic Progression-free Survival (rPFS)

The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (>=) 2 new lesions compared to baseline was observed in less than (<) 12 weeks from randomization and was confirmed by a second bone scan taken >=6 weeks later showing >=2 additional new lesions (a total of >=4 new lesions compared to baseline), b) the first bone scan with >=2 new lesions compared to baseline was observed in >=12 weeks from randomization and the new lesions were verified on the next bone scan >=6 weeks later (a total of >=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI); 3) death from any cause. (NCT00887198)
Timeframe: From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)

InterventionMonths (Median)
Abiraterone Acetate + Prednisone (AAP)NA
Placebo8.28

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Time to Opiate Use for Prostate Cancer Pain

The time interval from the date of randomization to the date of opiate use for cancer pain. Participants who have no opiate use at the time of analysis were censored at the last known date of no opiate use for cancer pain. Participants with no assessment were censored at the date of randomization. (NCT00887198)
Timeframe: From randomization (Day 1) up to first opiate use or end of study (Month 60)

InterventionMonths (Median)
Abiraterone Acetate + Prednisone (AAP)33.38
Placebo23.39

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Overall Survival

Overall survival is defined as the time from randomization to date of death from any cause. (NCT00887198)
Timeframe: From randomization (Day 1) up to end of study (Month 60)

InterventionMonths (Median)
Abiraterone Acetate + Prednisone (AAP)34.66
Placebo30.29

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Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by >=1 Point

The time interval from the date of randomization to the first date at which there was at least a 1 grade change (worsening) in the ECOG performance status grade. Participants who had no deterioration in ECOG performance status grade at the time of the analysis were censored at the last known date of no deterioration. ECOG is a 5-point scale, where 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead. Participants with no assessment were censored at the date of randomization. (NCT00887198)
Timeframe: From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)

InterventionMonths (Median)
Abiraterone Acetate + Prednisone (AAP)12.29
Placebo10.87

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Time to Prostate-specific Antigen (PSA) Progression

The time interval from the date of randomization to the date of PSA progression as defined in the protocol-specific prostate cancer Working Group 2 (PCWG2) criteria. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanogram/milliliter ((ng/mL) or more, which is confirmed by a second value obtained in 3 or more weeks. Participants who had no PSA progression at the time of the analysis were censored at the last known date of no PSA progression. Participants with no on-study PSA assessment or no baseline PSA assessment were censored at the date of randomization. (NCT00887198)
Timeframe: From randomization (Day 1) up to date of PSA progerssion or cutoff date (Month 18)

InterventionMonths (Median)
Abiraterone Acetate + Prednisone (AAP)11.07
Placebo5.55

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Time to Initiation of Cytotoxic Chemotherapy

The time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer. Participants who had no cytotoxic chemotherapy administration at the time of analysis were censored at the last known date when no cytotoxic chemotherapy was administered. Participants with no assessment were censored at the date of randomization. (NCT00887198)
Timeframe: From randomization (Day 1) up to initiation of cytotoxic chemotherapy or cutoff date (Month 18)

InterventionMonths (Median)
Abiraterone Acetate + Prednisone (AAP)25.17
Placebo16.82

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The Number of Patients With a Response (Complete Response and Partial Response)

Treatment success was defined as > 75% of the resected ablated tissue showing no cancer on detailed histologic analysis. The primary statistical objective was to estimate the PCA success rate (p). (NCT00890617)
Timeframe: 3 weeks post-Percutaneous Cryotherapy (PTC)

InterventionParticipants (Count of Participants)
Prednisone & Cryotherapy8

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Progression-free Survival Time

Delay between the date of randomization and the date of progression or death. Progression is defined according to the Cheson criteria. (NCT00911183)
Timeframe: from randomization, up to 5 years

Interventionmonths (Median)
Arm I (R-COP Regimen)10.4
Arm II (R-COPY Regimen)18.0

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Number of Participants in Complete Remission 6 Months After Randomization

"Complete remission [CR] is defined according to Cheson criteria. CR requires the following:~Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities.~All lymph nodes and nodal masses must have regressed to normal size. Previously involved nodes that were 1.1 to 1.5 cm in their greatest transverse diameter before treatment must have decreased to ≤1 cm in their greatest transverse diameter after treatment, or by more than 75% in the sum of the products of the greatest diameters (SPD).~The spleen, if considered to be enlarged before therapy on the basis of a CT scan, must have regressed in size and must not be palpable on physical examination.~If the bone marrow was involved by lymphoma before treatment, the infiltrate must be cleared on repeat bone marrow aspirate and biopsy of the same site." (NCT00911183)
Timeframe: 6 months after randomization

InterventionParticipants (Count of Participants)
Arm I (R-COP Regimen)14
Arm II (R-COPY Regimen)9

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Number of Participants With Severe Toxicity

"Severe toxicity, defined as febrile neutropenia or toxic death. Febrile neutropenia is defined in the International CTC toxicity scale as fever of unknown origin without clinically or microbiologically documented infection: neutrophils < 1.0 x 109/l and fever ≥ 38.5° C.~Toxic death is defined as any death which occur during treatment (from day 1 of the first cycle of chemotherapy up to day 30 of the last cycle) and is not related to lymphoma." (NCT00911183)
Timeframe: 6 months after randomization

InterventionParticipants (Count of Participants)
Arm I (R-COP Regimen)10
Arm II (R-COPY Regimen)8

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Overall Survival Time

OS is defined as the delay between the date of randomization and the date of death (NCT00911183)
Timeframe: from randomization, up to 5 years

Interventionmonths (Median)
Arm I (R-COP Regimen)20.1
Arm II (R-COPY Regimen)25.4

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Overall Survival

Overall survival is defined as the time interval in days between the date of randomization and the participant's death from any cause. (NCT00911859)
Timeframe: From the date of randomization till the date of death, as assessed up to the end of study (approximately 3 years)

InterventionDays (Median)
Part 2: VMP (Velcade+Melphalan+Prednisone)NA
Part 2: VMP (Velcade+Melphalan+Prednisone) + SiltuximabNA

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Percentage of Participants Who Achieved Complete Response (CR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria

CR was assessed using EMBT criteria: disappearance of the original monoclonal paraprotein from the blood and urine on at least 2 determinations for a minimum of 6 weeks by immunofixation studies, <5% plasma cells in the bone marrow on at least 1 determination, if skeletal survey is available: no increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response), disappearance of soft tissue plasmacytomas for at least 6 weeks. (NCT00911859)
Timeframe: Up to disease progression, approximately 3 years

InterventionPercentage of participants (Number)
Part 2: VMP (Velcade+Melphalan+Prednisone)22.4
Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab26.5

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Percentage of Participants Who Achieved Overall Response ie, Complete Response (CR) or Partial Response (PR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria

CR or PR was assessed using EBMT criteria. CR: disappearance of the original monoclonal paraprotein from the blood and urine on at least 2 determinations for a minimum of 6 weeks by immunofixation studies, <5% plasma cells in the bone marrow on at least 1 determination, if skeletal survey is available: no increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response), disappearance of soft tissue plasmacytomas for at least 6 weeks; PR: >=50% reduction in the level of serum monoclonal paraprotein for at least 2 determinations 6 weeks apart, if present, reduction in 24-hour urinary light chain excretion by either >=90% or to <200 mg for at least 2 determinations 6 weeks apart, >=50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for at least 6 weeks, if skeletal survey is available: no increase in size or number of lytic bone lesions (NCT00911859)
Timeframe: Up to disease progression, approximately 3 years

InterventionPercentage of participants (Number)
Part 2: VMP (Velcade+Melphalan+Prednisone)79.6
Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab87.8

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Percentage of Participants Who Achieved Stringent Complete Response (sCR) - International Myeloma Working Group (IMWG) Criteria

sCR was assesses by IMWG Criteria: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, <=5% plasma cells in bone marrow, normal free light chain ratio, absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. sCR is a CR that has been confirmed by immunofixation + free light chain assay + either bone marrow immunohistochemistry or immunofluorescence (NCT00911859)
Timeframe: Up to disease progression, approximately 3 years

InterventionPercentage of participants (Number)
Part 2: VMP (Velcade+Melphalan+Prednisone)6.1
Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab4.1

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Progression-Free Survival (PFS)

PFS was defined as the time between randomization and either disease progression or death, whichever occurred first. (NCT00911859)
Timeframe: From the date of randomization until disease progression or death, whichever occurred first, as assessed up to the last efficacy assessment for disease progression (approximately 3 years)

InterventionDays (Median)
Part 2: VMP (Velcade+Melphalan+Prednisone)518
Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab519

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1-year Survival Rate

Percentage of participants who are alive at the end of year 1 after randomization (NCT00911859)
Timeframe: 1 year

InterventionPercentage of participants (Number)
Part 2: VMP (Velcade+Melphalan+Prednisone)87.8
Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab87.5

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Change From Baseline to Cycle 9 in Global Health Status/Quality of Life Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30)

"Global health status/quality of life is a subscale of the EORTC QOL C30, which comprises two questions related to overall health/quality of life during the past week. The raw score to each question ranged from 1 (very poor) to 7 (excellent). The raw mean score of health status/quality of life subscale is calculated for each participant and a linear transformation applied to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher (better) health and quality of life." (NCT00911859)
Timeframe: Baseline (Day 1 predose) and Cycle 9 (Week 54)

InterventionScores on a scale (Mean)
Part 2: VMP (Velcade+Melphalan+Prednisone)14.78
Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab8.33

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Duration of Response (DOR)

DOR was defined as length from the earliest date a participant achieved a complete response (CR) or partial response (PR) to either date for disease progression (including relapse from CR) or the censoring date for progressive disease. Responders without disease progression were censored at the last efficacy assessment for disease progression. (NCT00911859)
Timeframe: From the date participants achieved CR or PR to either date for disease progression (including relapse from CR) or the censoring date for progressive disease, as assessed Up to 30 days after last dose of study medication

InterventionDays (Median)
Part 2: VMP (Velcade+Melphalan+Prednisone)497
Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab583

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1-year Progression-Free Survival (PFS) Rate

The 1-year PFS rate was defined as the percentage of participants surviving 1 year after randomization without disease progression or death. (NCT00911859)
Timeframe: 1 year

InterventionPercentage of participants (Number)
Part 2: VMP (Velcade+Melphalan+Prednisone)77.5
Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab72.1

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Testosterone Concentration in Prostate Tissue

Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Abiraterone acetate affects sources of testosterone in the body (ie, adrendal gland and prostate tumor). Testosterone concentration was measured in prostate tissues after exposure to study treatments at Week 12. (NCT00924469)
Timeframe: Week 12

InterventionPicogram per milligram (pg/mg) (Mean)
Abiraterone Plus Leuprolide Plus Prednisone0.089
Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone0.228

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Dihydrotestosterone (DHT) Concentration in Prostate Tissue

The DHT is a potent androgenic metabolite of testosterone and the concentration of DHT was measured in prostate tissues after exposure to study treatments at Week 12. (NCT00924469)
Timeframe: Week 12

InterventionPicogram per milligram (pg/mg) (Mean)
Abiraterone Plus Leuprolide Plus Prednisone4.311
Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone2.170

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Percentage of Participants With Pathologic Complete Response (CR)

Complete response is defined as a disappearance of all target lesions and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criterion. (NCT00924469)
Timeframe: Week 24

InterventionPercentage of participants (Number)
Abiraterone Plus Leuprolide Plus Prednisone10.3
Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone3.7

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Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue

Androstenedione is a steroid (a group of polycyclic compounds closely related biochemically to terpenes, for example, cholesterol, numerous hormones), that is produced in the testis, ovary and the adrenal cortex, and depending on the tissue type, androstenedione can serve as a precursor to testosterone, estrone and estradiol. The DHEA is a major steroid produced by the adrenal cortex. It is also produced in small quantities in the testis and the ovary. Androstenedione and DHEA concentration was measured in prostate tissues at Week 12 and 24. (NCT00924469)
Timeframe: Week 12 and 24

,
InterventionPicogram per milligram (pg/mg) (Mean)
Androstenedione: Week 12 (n=28,27)Androstenedione: Week 24 (n=28,26)DHEA: Week 12 (n=28,27)DHEA: Week 24 (n=28,26)
Abiraterone Plus Leuprolide Plus Prednisone0.0820.0901.9943.138
Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone0.2770.07029.2412.170

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Percentage of Participants With Prostate-specific Antigen (PSA) Response

The PSA response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criterion which is, percentage of participants with PSA less than or equal to 0.2 nanogram/milliliter at Weeks 12 and 24 after androgen deprivation. (NCT00924469)
Timeframe: Weeks 12 and 24

,
InterventionPercentage of participants (Number)
Week 12Week 24
Abiraterone Plus Leuprolide Plus Prednisone86.786.7
Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone3.682.1

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Serum Levels of Androgens

Serum concentrations of testosterone, DHT, androsterone, DHEA, DHEA-Sulfate, DHEA-Glucuronide and delta-4-androstenedione were measured at Weeks 12 and 24. (NCT00924469)
Timeframe: Week 12 and 24

,
InterventionNanogram per deciliter (ng/dL) (Mean)
Testosterone: Week 12 (n=28,28)Testosterone: Week 24 (n=25,25)DHT: Week 12 (n=28,28)DHT: Week 24 (n=26,26)Androsterone: Week 12 (n=28,28)Androsterone: Week 24 (26,26)DHEA: Week 12 (n=28,28)DHEA: Week 24 (n=26,26)DHEA-Glucuronide: Week 12 (n=29,28)DHEA-Glucuronide: Week 24 (n=27,27)DHEA-Sulfate: Week 12 (n=28,28)DHEA-Sulfate: Week 24 (n=26,26)Delta-4-Androstenedione:Week 12(n=28,28)Delta-4-Androstenedione:Week 24(n=26,26)
Abiraterone Plus Leuprolide Plus Prednisone1.0490.6486.1435.9320.6191.75210.68420.92269.72451.6757156.2709047.4063.3155.192
Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone10.0143.1225.7976.7303.1000.500180.3077.617583.03651.759133338.8759207.34533.3302.831

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Testosterone and Dihydrotestosterone (DHT) Concentration in Prostate Tissue

Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Dihydrotestosterone (DHT) is a potent androgenic metabolite of testosterone. Testosterone and DHT concentration was measured in prostate tissues after exposure to study treatments at Week 24. (NCT00924469)
Timeframe: Week 24

,
InterventionPicogram per milligram (pg/mg) (Mean)
TestosteroneDHT
Abiraterone Plus Leuprolide Plus Prednisone0.2161.340
Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone0.0622.456

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Prednisone-associated Toxicity as Assessed by Hyperglycemia

Impact on blood glucose (BG) control will be assessed by comparing average BG and BG-variability between patients given standard-dose and low-dose prednisone. (NCT00929695)
Timeframe: Baseline and then through 42 days after starting treatment

Interventionmg/dL (Mean)
Group A (Low-dose)140
Group B (Standard-dose)142

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Prednisone-associated Toxicity as Assessed by Hypertension

The number of different anti-hypertensive medications administered to control hypertension were collected. The mean change in the number of medications from baseline to day 42 was measured. (NCT00929695)
Timeframe: Baseline and then through 42 days after starting treatment

Interventionmedications (Mean)
Group A (Low-dose)-0.29
Group B (Standard-dose)-0.24

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Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral)

The total number of invasive infections (bacterial, fungal and viral) occurring in patients in each group were collected. (NCT00929695)
Timeframe: Baseline and through 100 days of treatment

Interventionpercentage of participants (Number)
Group A (Low-dose)52
Group B (Standard-dose)53

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Non-relapse Mortality

Non-relapse mortality (NRM) is defined as death due to any cause in the absence of documented relapse/progression. (NCT00929695)
Timeframe: At 12 months after the start of prednisone therapy

Interventionpercentage of participants (Number)
Group A (Low-dose)15
Group B (Standard-dose)16

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Chronic Extensive GVHD

Percentage of patients with chronic extensive GVHD, estimated by cumulative incidence methods (NCT00929695)
Timeframe: At 12 months after the start of prednisone therapy

Interventionpercentage of participants (Number)
Group A (Low-dose)47
Group B (Standard-dose)54

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Prednisone-associated Toxicity as Assessed by Quality of Life

Patients completed the MD Anderson Symptom Inventory (MDASI), which is a quality of life questionnaire validated for oncology/transplant patients. On a 1-10 point scale, patients scored the degree of severity of symptoms or the degree of interference in feelings or function due to symptoms at baseline or in the previous week. A score of 1 indicates symptom is not present or does not interfere with feelings or function. A score of 10 indicates the symptom is as bad as you can imagine or interferes completely with feelings or function. The mean change in score from baseline to day 42 was measured. (NCT00929695)
Timeframe: Baseline and then every other week until 42 days after starting treatment

Interventionunits on a scale (Mean)
Group A (Low-dose)-2.3
Group B (Standard-dose)-1.9

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Progression to Grade III-IV Acute GVHD

Diagnosed and graded according to standard established criteria. Measure is percent of patients with baseline scores of IIa (Group A) or IIb (Group B) who progressed to more severe GVHD (Grade III/IV). Percentage estimated by cumulative incidence methods. (NCT00929695)
Timeframe: At approximately 100 days after transplant

Interventionpercentage of participants (Number)
Group A (Low-dose)6
Group B (Standard-dose)13

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Recurrent or Progressive Malignancy

Percentage of relapse estimated by cumulative incidence methods (NCT00929695)
Timeframe: At 12 months after the start of prednisone therapy

Interventionpercentage of participants (Number)
Group A (Low-dose)21
Group B (Standard-dose)21

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Secondary Therapy for Acute GVHD Beyond Prednisone

This includes any intervention intended to control acute GVHD through an immunosuppressive effect from oral or parenteral administration of any systemic medication not given previously. This does not include topical therapy, an increase in the dose of glucocorticoids or the resumption of treatment after previous discontinuation or any increase in the dose of immunosuppressive medication previously administered for GVHD prophylaxis, or reinstatement of GVHD prophylaxis previously discontinued. A change in treatment from cyclosporine to tacrolimus or vice versa because of drug toxicity is not considered secondary therapy, but any change made because of uncontrolled GVHD is considered secondary therapy. Percentage is estimated by cumulative incidence methods. (NCT00929695)
Timeframe: At approximately 100 days after transplant

Interventionpercentage of participants (Number)
Group A (Low-dose)23
Group B (Standard-dose)7

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Prednisone-associated Toxicity as Assessed by Myopathy

Assessed by mean change from baseline to day 42 using Manual Muscle Testing measure. The degree of resistance against pressure applied by tester was measured on a 5-point scale. A score of 5 indicates the patient can hold the position against maximum to strong resistance. A score of 0 indicates the patient has no resistance against pressure. Testing included upper and lower extremities: shoulder (deltoid at 90 degrees), and hip and knee in a sitting position. (NCT00929695)
Timeframe: Baseline and then weekly until 42 days after starting treatment

Interventionunits on a scale (Mean)
Group A (Low-dose)-0.18
Group B (Standard-dose)-0.18

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Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment

The total cumulative dose of prednisone (milligrams/kilogram) was calculated starting from the start of therapy through study day 42. (NCT00929695)
Timeframe: At day 42 after initiation of treatment

Interventionmilligrams per kilogram (Mean)
Grade IIa GVHD; 0.5 mg/kg/d Prednisone22.2
Grade IIa GVHD; 1.0 mg/kg/d Prednisone27.1
Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone38.4
Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone41.3

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Overall Survival

Percentage of patients surviving as estimated by Kaplan-Meier. (NCT00929695)
Timeframe: At 12 months after the start of prednisone therapy

Interventionpercentage of participants (Number)
Group A (Low-dose)77
Group B (Standard-dose)77

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Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) by Category

Percentage of participants in the following categories: • At least 1 TEAE • Drug-related, TEAEs • Grade 3 or higher TEAEs. Grade 3 are AEs of Severe Intensity • Grade 3 or higher drug-related, TEAEs • TEAEs resulting in study drug discontinuation • Serious TEAEs An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. (NCT00931918)
Timeframe: First dose of study drug through 30 days after the last dose of study drug (Up to 26 Weeks)

,
Interventionpercentage of participants (Number)
At Least 1 TEAEDrug-related, TEAEsGrade 3 or higher TEAEsGrade 3 or Higher Drug-related, TEAEsTEAEs Resulting in Study Drug DiscontinuationSerious TEAEs
RCHOP100887155431
Vc-RCHOP99957968634

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Percentage of Participants With Chemistry and Hematology Laboratory Values Grade 3 or Higher

Percentage of participants who shifted from a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 0, 1, or 2 at Baseline to a Grade 3 or higher on study (worst post-baseline grade). Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe or medically significant but not immediately life-threatening, Grade 4=Life-threatening consequences and 5=Death related to AE. (NCT00931918)
Timeframe: Days 1, 4 and 10 of each cycle and end of treatment visit (Median of 16 weeks on treatment)

,
Interventionpercentage of participants (Number)
LymphocytesWBC CountNeutrophilsPlateletsHemoglobinHyperglycemiaHypokalemiaHypophosphatemiaHyponatremiaAlanine aminotransferase (ALT) increasedAspartate aminotransferase (AST) increased
RCHOP706865181014137421
Vc-RCHOP866970391591410312

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Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Negative Rate

FDG-PET negative rate is defined as the percentage of participants FDG-PET negative at the given time-point. (NCT00931918)
Timeframe: End of Cycle 2 and End of Treatment (Cycle 6) [Median of 16 weeks on treatment]

,
Interventionpercentage of participants (Number)
End of Cycle 2End of Treatment (Cycle 6)
RCHOP4253
Vc-RCHOP3759

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Duration of Response

Duration of response is defined as the time (in months) from the date of first documentation of confirmed complete response (CR) or partial response (PR) to the date of first documentation of progressive disease (PD), relapse from CR or death related to disease. For a participant who has not progressed and is not known to have died due to disease under study at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), duration of response is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using IWG-revised response criteria for malignant lymphoma. CR=Disappearance of all evidence of disease and PR=Regression of measurable disease and no new sites and PD= any new lesion or increase by > 50% of previously involved sites from nadir. (NCT00931918)
Timeframe: Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm

Interventionmonths (Median)
RCHOPNA
Vc-RCHOPNA

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Overall Response Rate (ORR)

ORR is defined as the percentage of participants with the best overall response complete response (CR) + partial response (PR). Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. CR=disappearance of all evidence of disease and PR=regression of measurable disease and no new sites. (NCT00931918)
Timeframe: End of Cycle 2, End of Treatment (Cycle 6) [Median of 16 weeks on treatment]

,
Interventionpercentage of participants (Number)
End of Cycle 2End of Treatment (Cycle 6)Best Overall Response Rate
RCHOP938898
Vc-RCHOP908496

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Complete Response Rate

Complete Response Rate is defined as the percentage of participants with the best response of Complete Response (CR). Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. CR=Disappearance of all evidence of disease. (NCT00931918)
Timeframe: End of Cycle 2, End of Treatment (Cycle 6) [Median of 16 weeks on treatment]

,
Interventionpercentage of participants (Number)
End of Cycle 2End of Treatment (Cycle 6)Best Complete Response Rate
RCHOP234549
Vc-RCHOP165656

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Progression-Free Survival (PFS) in Patients With Non-germinal Center B-cell-like (Non-GCB) Diffuse Large B-cell Lymphoma (DLBCL)

PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir. (NCT00931918)
Timeframe: Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm

Interventionmonths (Median)
RCHOPNA
Vc-RCHOPNA

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Progression-Free Survival Rate

PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir. The progression-free survival rate is defined as the Kaplan-Meier (KM) estimate of progression-free survival at 2 years. (NCT00931918)
Timeframe: 2 Years (Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm)

Interventionpercentage of participants (Number)
RCHOP78
Vc-RCHOP82

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Time to Progression (TTP)

TTP is defined as the time from the date of randomization to the date of first documentation of progressive disease, relapse from CR, or death related to disease under study if participant did not have any documentation of disease progression prior to death caused by lymphoma or complications thereof. For a participant who has not progressed and is not known to have died due to disease under study at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), TTP is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir. (NCT00931918)
Timeframe: Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm

Interventionmonths (Median)
RCHOPNA
Vc-RCHOPNA

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Overall Survival

Overall survival is defined as the time from the date of randomization to the date of death from any cause. A participant who is alive at the end of his/her study follow-up is censored at the date of last contact. (NCT00931918)
Timeframe: Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm

Interventionmonths (Median)
RCHOPNA
Vc-RCHOPNA

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Change From Baseline in Eosinophil Counts at Day 1, 7 and 14

(NCT00938587)
Timeframe: Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14

,,,
Intervention10^3 cells per microliter (Mean)
BaselineChange at Day 1: 1 hourChange at Day 1: 2 hourChange at Day 1: 3 hourChange at Day 1: 4 hourChange at Day 7: 0 hourChange at Day 7: 1 hourChange at Day 7: 2 hourChange at Day 7: 3 hourChange at Day 7: 4 hourChange at Day 14: 0 hourChange at Day 14: 1 hourChange at Day 14: 2 hourChange at Day 14: 3 hourChange at Day 14: 4 hour
PF-04171327 10 mg + Placebo0.19-0.02-0.01-0.01-0.01-0.03-0.02-0.03-0.04-0.04-0.03-0.04-0.05-0.05-0.05
PF-04171327 25 mg + Placebo0.19-0.02-0.01-0.01-0.03-0.04-0.03-0.07-0.08-0.06-0.05-0.05-0.07-0.07-0.07
Placebo0.15-0.00-0.00-0.00-0.010.00-0.010.010.000.000.01-0.010.010.01-0.01
Prednisone 5 mg + Placebo0.20-0.02-0.03-0.03-0.04-0.02-0.02-0.04-0.07-0.09-0.02-0.03-0.05-0.09-0.11

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Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 14

DAS28-4 (CRP) examines progression or improvement of RA. It was assessed from swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, CRP (normal range of CRP is less than (<) 10 milligram per liter [mg/L], decrease in the level of CRP indicates reduction in inflammation) and participant global assessment (PGA) of disease activity (participant global assessment of diseases condition scores ranging from 0 [very well condition] to 100 [very poor condition], higher scores indicated greater affectation due to disease activity). Total DAS28-4 (CRP) transformed score range: 0 (least severe) to 10 (most severe), higher scores indicate more severe disease activity. DAS28-4 (CRP) scores: less than equal to (<=) 3.2 implied low disease activity; greater than (>) 3.2 to 5.1 implied moderate to high disease activity. (NCT00938587)
Timeframe: Baseline, Day 14

,,,
Interventionunits on a scale (Mean)
BaselineChange at Day 14
PF-04171327 10 mg + Placebo6.04-1.79
PF-04171327 25 mg + Placebo6.14-2.22
Placebo6.03-0.96
Prednisone 5 mg + Placebo5.92-1.15

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Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 7, 14 and 42

DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (normal range of CRP is <10 mg/L, decrease in the level of CRP indicates reduction in inflammation). Total DAS28-3 (CRP) score range: 0 (least severe) to 9.4 (most severe), higher scores indicate more disease activity. (NCT00938587)
Timeframe: Baseline, Day 7, 14, 42

,,,
Interventionunits on a scale (Mean)
BaselineChange at Day 7Change at Day 14Change at Day 42
PF-04171327 10 mg + Placebo5.80-1.07-1.57-0.81
PF-04171327 25 mg + Placebo5.87-1.51-2.01-1.26
Placebo5.72-0.50-0.87-1.12
Prednisone 5 mg + Placebo5.59-0.55-0.92-1.17

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Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is less than (<) 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. (NCT00938587)
Timeframe: Baseline, Day 7, 14, 42

,,,
Interventionmg/L (Mean)
BaselineChange at Day 7Change at Day 14Change at Day 42
PF-04171327 10 mg + Placebo20.24-13.78-18.133.14
PF-04171327 25 mg + Placebo30.15-23.60-24.12-13.09
Placebo16.971.31-1.32-5.11
Prednisone 5 mg + Placebo20.02-4.64-7.63-8.02

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Change From Baseline in Body Weight at Day 7 and 14

(NCT00938587)
Timeframe: Baseline, Day 7, 14

,,,
Interventionkilogram (Mean)
BaselineChange at Day 7Change at Day 14
PF-04171327 10 mg + Placebo83.70.120.35
PF-04171327 25 mg + Placebo74.1-0.040.20
Placebo75.0-0.05-0.04
Prednisone 5 mg + Placebo78.4-0.020.18

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Change From Baseline in Adiponectin Level at Day 7 and 14

(NCT00938587)
Timeframe: Baseline, Day 7 and 14

,,,
Interventionng/mL (Mean)
BaselineChange at Day 7Change at Day 14
PF-04171327 10 mg + Placebo7251.43-434.211023.16
PF-04171327 25 mg + Placebo8349.091664.762692.86
Placebo10080.95-430.95193.16
Prednisone 5 mg + Placebo7732.38-12.00438.50

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Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14

SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. Score for each of the 8 aspects are scaled from 0 (worst condition) to 100 (best condition), where higher scores indicate better health status. These 8 domains were also reported as two summary scores: physical component scores and mental component scores. Score range for each of the 2 summary scores = 0 (worst condition) to 100 (best condition), where higher scores represent better health status. (NCT00938587)
Timeframe: Baseline, Day 14 (D14)

,,,
Interventionunits on a scale (Mean)
Baseline: Physical functioningChange at D14: Physical functioningBaseline: Role physicalChange at D14: Role physicalBaseline: Bodily painChange at D14: Bodily painBaseline: General healthChange at D14: General healthBaseline: VitalityChange at D14: VitalityBaseline: Social functioningChange at D14: Social functioningBaseline: Role emotionalChange at D14: Role emotionalBaseline: Mental healthChange at D14: Mental healthBaseline: Physical componentChange at D14: Physical componentBaseline: Mental componentChange at D14: Mental component
PF-04171327 10 mg + Placebo29.924.5235.724.2731.4111.2530.914.4038.987.8839.504.2536.395.1837.717.0030.895.7441.195.91
PF-04171327 25 mg + Placebo30.694.5835.697.2732.8811.6037.333.9642.437.7039.057.6837.956.3142.404.6232.057.1044.425.72
Placebo32.740.5134.285.9733.434.3335.434.0939.984.1935.874.5735.372.6536.232.4933.933.7338.553.24
Prednisone 5 mg + Placebo29.144.7133.105.0131.357.7335.363.3139.704.7934.895.6535.492.6537.975.1330.915.4940.303.78

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Ratio of Apparent Oral Clearance on Day 1 to Day 14 of Methotrexate

Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Methotrexate was used as a background therapy by participants. (NCT00938587)
Timeframe: Pre-dose (0 hour), 1, 2, 3 and 4 hours post-dose

Interventionratio (Mean)
PF-04171327 10 mg + Placebo1.24
PF-04171327 25 mg + Placebo0.98
Prednisone 5 mg + Placebo1.14
Placebo0.93

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Number of Participants With Clinically Significant Vital Signs Abnormalities

Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, heart rate and body temperature. Vital sign measurements were performed with the participant in the seated position. Clinical significance vital sign abnormality was determined by investigator. (NCT00938587)
Timeframe: Baseline up to Day 45

Interventionparticipants (Number)
PF-04171327 10 mg + Placebo0
PF-04171327 25 mg + Placebo0
Prednisone 5 mg + Placebo0
Placebo0

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Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

Clinically significant ECG findings included PR interval >=300 milliseconds (msec) or >=25% increase from baseline (if baseline PR interval >200 msec) or >=50% increase (if baseline PR interval less than or equal to [<=] 200 msec); QRS interval >=200 msec or >=25% increase from baseline (if baseline PR interval >100 msec) or >=50% increase (if baseline PR interval <= 100 msec); QT interval >=500 msec, corrected QT interval >=500 msec. (NCT00938587)
Timeframe: Baseline up to Day 45

Interventionparticipants (Number)
PF-04171327 10 mg + Placebo0
PF-04171327 25 mg + Placebo0
Prednisone 5 mg + Placebo0
Placebo0

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Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities

Criteria for laboratory abnormalities: Hematology (hemoglobin, hematocrit <0.8*baseline; platelet count <75 or >700*10^3 per mm^3; leucocytes <2.5 or >17.5*10^3 per mm^3); chemistry (total bilirubin >1.5*upper limit of reference range [ULN]; aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transpeptidase, alkaline phosphatase, >3.0*ULN; total protein, albumin <0.8*lower limit of reference range [LLN] or >1.2*ULN; blood urea nitrogen [BUN]/urea, creatinine >1.3*ULN; glucose [fasting] <0.6*LLN or >1.5*ULN; uric acid >1.2*ULN; sodium <0.95*LLN or >1.05*ULN; potassium, calcium <0.9*LLN or >1.1*ULN; albumin, total protein <0.8*LLN or >1.2*ULN; urinalysis (urine white blood cell (WBC) =>6/ high power field (hpf); urine red blood cell (RBC) =>6/hpf). Number of participants with clinically significant change from baseline in laboratory abnormalities identified by investigator were reported. (NCT00938587)
Timeframe: Baseline up to Day 45

Interventionparticipants (Number)
PF-04171327 10 mg + Placebo0
PF-04171327 25 mg + Placebo0
Prednisone 5 mg + Placebo0
Placebo0

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Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 7

DAS28-4 (CRP) examines progression or improvement of RA. It was assessed from SJC and TJC using the 28 joints count, CRP (normal range of CRP is <10 mg/L, decrease in the level of CRP indicates reduction in inflammation) and PGA of disease activity (participant global assessment of diseases condition scores ranging from 0 [very well condition] to 100 [very poor condition], higher scores indicated greater affectation due to disease activity). Total DAS28-4 (CRP) transformed score range: 0 (least severe) to 10 (most severe), higher scores indicate more severe disease activity. DAS28-4 (CRP) scores: <=3.2 implied low disease activity; >3.2 to 5.1 implied moderate to high disease activity. (NCT00938587)
Timeframe: Baseline, Day 7

Interventionunits on a scale (Mean)
PF-04171327 10 mg + Placebo-1.21
PF-04171327 25 mg + Placebo-1.63
Prednisone 5 mg + Placebo-0.67
Placebo-0.55

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Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14

(NCT00938587)
Timeframe: Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14

,,,
Interventionng/mL (Mean)
BaselineChange at Day 1: 1 hourChange at Day 1: 2 hourChange at Day 1: 3 hourChange at Day 1: 4 hourChange at Day 7: 0 hourChange at Day 7: 1 hourChange at Day 7: 2 hourChange at Day 7: 3 hourChange at Day 7: 4 hourChange at Day 14: 0 hourChange at Day 14: 1 hourChange at Day 14: 2 hourChange at Day 14: 3 hourChange at Day 14: 4 hour
PF-04171327 10 mg + Placebo106.85-26.40-29.12-20.05-16.47-92.06-93.92-93.69-94.81-98.82-92.02-98.93-101.65-101.78-102.85
PF-04171327 25 mg + Placebo110.50-30.94-37.17-24.19-21.05-103.76-104.69-104.96-105.01-104.69-104.86-105.41-105.70-105.29-105.25
Placebo105.14-27.71-32.92-21.80-9.167.20-25.39-35.19-26.69-20.383.49-25.38-33.54-23.01-24.87
Prednisone 5 mg + Placebo106.38-13.81-22.81-14.95-21.496.72-51.94-66.70-77.36-83.46-14.46-55.14-70.60-81.66-86.27

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Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14

Plasma concentration of PF-00251802 versus time summary, a metabolite of PF-04171327 was reported in this outcome measure. (NCT00938587)
Timeframe: 0, 1, 2, 3 and 4 hours post-dose on Day 7, 14

,
Interventionnanogram per milliliter (ng/mL) (Mean)
Day 7 (0 hour)Day 7 (1 hour)Day 7 (2 hour)Day 7 (3 hour)Day 7 (4 hour)Day 14 (0 hour)Day 14 (1 hour)Day 14 (2 hour)Day 14 (3 hour)Day 14 (4 hour)
PF-04171327 10 mg + Placebo53.0790.28118.1116.3107.553.94115.7133.9123.7106.3
PF-04171327 25 mg + Placebo136.8257.9281.3230.7220.6136.3216.4284.9296.6243.3

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Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Day 7 and 14

ACR70 responder: participants who achieved at =70% improvement in tender and swollen 28-joints count, and >=70% improvement in at least 3 of the following 5 measures: 1) participant's assessment of arthritis pain (participant's self-assessed severity of arthritis pain, score range from 0[no pain] to 100[most severe pain], higher scores=more pain), 2) PGA of arthritis (participant's assessed overall arthritis activity, score range from 0[no arthritis] to 100[extreme arthritis], higher scores=higher degree of arthritis), 3) PhGA of arthritis (physician rated severity of participants overall arthritis activity, score range from 0[no arthritis] to 100[extreme arthritis], higher scores=higher degree of arthritis), 4) HAQ-DI (assessment of functional disability, score range from 0[no difficulty] to 3[extreme difficulty], higher scores=more functional limitation) and 5) CRP (assessment of inflammation, normal range of CRP is <10 mg/L, decrease in the level of CRP=reduction in inflammation). (NCT00938587)
Timeframe: Day 7, 14

,,,
Interventionpercentage of participants (Number)
Day 7Day 14
PF-04171327 10 mg + Placebo4.760.00
PF-04171327 25 mg + Placebo4.7614.29
Placebo0.000.00
Prednisone 5 mg + Placebo0.000.00

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Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 7 and 14

ACR50 responder: participants who achieved at =50% improvement in tender and swollen 28-joints count, and >=50% improvement in at least 3 of the following 5 measures: 1) participant's assessment of arthritis pain (participant's self-assessed severity of arthritis pain, score range from 0[no pain] to 100[most severe pain], higher scores=more pain), 2) PGA of arthritis (participant's assessed overall arthritis activity, score range from 0[no arthritis] to 100[extreme arthritis], higher scores=higher degree of arthritis), 3) PhGA of arthritis (physician rated severity of participants overall arthritis activity, score range from 0[no arthritis] to 100[extreme arthritis], higher scores=higher degree of arthritis), 4) HAQ-DI (assessment of functional disability, score range from 0[no difficulty] to 3[extreme difficulty], higher scores=more functional limitation) and 5) CRP (assessment of inflammation, normal range of CRP is <10 mg/L, decrease in the level of CRP=reduction in inflammation). (NCT00938587)
Timeframe: Day 7, 14

,,,
Interventionpercentage of participants (Number)
Day 7Day 14
PF-04171327 10 mg + Placebo9.5222.22
PF-04171327 25 mg + Placebo19.0547.62
Placebo0.0014.29
Prednisone 5 mg + Placebo0.0020.00

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Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Day 7 and 14

ACR20 responder: participants who achieved at =20% improvement in tender and swollen 28-joints count, and >=20% improvement in at least 3 of the following 5 measures: 1) participant's assessment of arthritis pain (participant's self-assessed severity of arthritis pain, score range from 0[no pain] to 100[most severe pain], higher scores=more pain), 2) PGA of arthritis (participant's assessed overall arthritis activity, score range from 0[no arthritis] to 100[extreme arthritis], higher scores=higher degree of arthritis), 3) PhGA of arthritis (physician rated severity of participants overall arthritis activity, score range from 0[no arthritis] to 100[extreme arthritis], higher scores=higher degree of arthritis), 4) HAQ-DI (assessment of functional disability, score range from 0[no difficulty] to 3[extreme difficulty], higher scores=more functional limitation) and 5) CRP (assessment of inflammation, normal range of CRP is <10 mg/L, decrease in the level of CRP=reduction in inflammation). (NCT00938587)
Timeframe: Day 7, 14

,,,
Interventionpercentage of participants (Number)
Day 7Day 14
PF-04171327 10 mg + Placebo28.5755.56
PF-04171327 25 mg + Placebo52.3866.67
Placebo27.2738.10
Prednisone 5 mg + Placebo14.2945.00

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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 31 days after last dose (Day 45) that were absent before treatment or that worsened relative to pretreatment state. (NCT00938587)
Timeframe: Baseline up to Day 45

,,,
Interventionparticipants (Number)
AESAE
PF-04171327 10 mg + Placebo80
PF-04171327 25 mg + Placebo30
Placebo120
Prednisone 5 mg + Placebo40

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Change From Baseline in Tender Joints Count at Day 7, 14, 42

Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. (NCT00938587)
Timeframe: Baseline, Day 7, 14, 42

,,,
Interventiontender joints (Mean)
BaselineChange at Day 7Change at Day 14Change at Day 42
PF-04171327 10 mg + Placebo17.10-5.14-7.22-5.21
PF-04171327 25 mg + Placebo16.86-5.95-8.14-6.52
Placebo17.09-4.18-5.67-6.81
Prednisone 5 mg + Placebo15.05-3.05-4.15-5.10

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Change From Baseline in Swollen Joints Count at Day 7, 14 and 42

Number of swollen joints was determined by examination of 28 joints and identifying if swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. (NCT00938587)
Timeframe: Baseline, Day 7, 14, 42

,,,
Interventionswollen joints (Mean)
BaselineChange at Day 7Change at Day 14Change at Day 42
PF-04171327 10 mg + Placebo11.95-3.19-5.50-3.26
PF-04171327 25 mg + Placebo11.73-5.19-6.71-4.81
Placebo11.64-2.91-5.24-4.71
Prednisone 5 mg + Placebo10.67-2.90-4.85-6.15

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Change From Baseline in Ratio of Urinary N-terminal Telopeptide of Type 1 Collagen (uNTX-I) Level to Urinary Creatinine (uCr) Level at Day 7 and 14

Unit of ratio of urinary N-terminal telopeptide of type 1 collagen (uNTX-I) level to urinary creatinine (uCr) level was nanomoles bone collagen equivalents (nmol bce) per millimole creatinine (mmol cr). (NCT00938587)
Timeframe: Baseline, Day 7 and 14

,,,
Interventionnmol BCE/mmol cr (Mean)
BaselineChange at Day 7Change at Day 14
PF-04171327 10 mg + Placebo63.567.9411.79
PF-04171327 25 mg + Placebo62.0016.4018.15
Placebo79.63-13.42-9.44
Prednisone 5 mg + Placebo77.75-3.58-3.84

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Change From Baseline in Physician Global Assessment (PhGA) of Arthritis at Day 7 and 14

PhGA included assessment of severity of arthritis pain where physicians were asked to rate the severity of the participant's overall arthritis. The physician's response was recorded using a visual analog scale between 0 mm (very good condition) to 100 mm (very poor condition). Higher scores indicate higher degree of arthritis. (NCT00938587)
Timeframe: Baseline, Day 7, 14

,,,
Interventionmm (Mean)
BaselineChange at Day 7Change at Day 14
PF-04171327 10 mg + Placebo58.10-13.38-22.16
PF-04171327 25 mg + Placebo62.27-20.42-32.19
Placebo59.87-13.58-14.87
Prednisone 5 mg + Placebo57.86-9.71-20.90

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Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Day 7 and 14

"PGA was a questionnaire where participants answered the following question, Considering all the ways your arthritis affects you, how are you feeling today? The participants' response were recorded using a 100 mm visual analog scale placing a mark on the scale, between 0 mm (very well condition) to 100 mm (very poor condition). Higher scores indicate higher degree of arthritis." (NCT00938587)
Timeframe: Baseline, Day 7, 14

,,,
Interventionmm (Mean)
BaselineChange at Day 7Change at Day 14
PF-04171327 10 mg + Placebo60.71-16.05-22.63
PF-04171327 25 mg + Placebo63.55-18.75-27.97
Placebo65.26-7.94-11.77
Prednisone 5 mg + Placebo65.89-11.87-22.43

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Change From Baseline in Participant Assessment of Arthritis Pain at Day 7 and 14

Participant assessment of arthritis pain included assessment of severity of arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). Participants placed a mark on the VAS between 0 mm (no pain) and 100 mm (most severe pain), which corresponded to the magnitude of their pain, higher scores indicate more pain. (NCT00938587)
Timeframe: Baseline, Day 7, 14

,,,
Interventionmm (Mean)
BaselineChange at Day 7Change at Day 14
PF-04171327 10 mg + Placebo62.45-12.03-25.83
PF-04171327 25 mg + Placebo60.49-16.95-27.29
Placebo66.65-11.00-14.69
Prednisone 5 mg + Placebo63.17-8.67-21.47

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Change From Baseline in Osteocalcin Level at Day 1, 7 and 14

(NCT00938587)
Timeframe: Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14

,,,
Interventionng/mL (Mean)
BaselineChange at Day 1: 1 hourChange at Day 1: 2 hourChange at Day 1: 3 hourChange at Day 1: 4 hourChange at Day 7: 0 hourChange at Day 7: 1 hourChange at Day 7: 2 hourChange at Day 7: 3 hourChange at Day 7: 4 hourChange at Day 14: 0 hourChange at Day 14: 1 hourChange at Day 14: 2 hourChange at Day 14: 3 hourChange at Day 14: 4 hour
PF-04171327 10 mg + Placebo21.76-1.78-2.22-2.67-3.15-5.26-5.88-5.71-5.77-5.78-6.01-6.28-5.80-6.42-7.45
PF-04171327 25 mg + Placebo17.52-1.45-2.07-1.07-1.77-3.82-4.42-4.22-3.68-3.87-4.56-4.90-5.11-5.74-5.40
Placebo15.29-0.50-0.73-1.30-0.930.69-0.37-0.52-0.33-1.050.63-0.25-0.350.56-0.41
Prednisone 5 mg + Placebo29.36-1.94-1.19-1.35-3.10-3.08-0.66-2.74-2.83-2.48-3.04-2.66-4.21-5.88-4.19

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Change From Baseline in Neutrophil Counts at Day 1, 7 and 14

(NCT00938587)
Timeframe: Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14

,,,
Intervention10^3 cells per microliter (Mean)
BaselineChange at Day 1: 1 hourChange at Day 1: 2 hourChange at Day 1: 3 hourChange at Day 1: 4 hourChange at Day 7: 0 hourChange at Day 7: 1 hourChange at Day 7: 2 hourChange at Day 7: 3 hourChange at Day 7: 4 hourChange at Day 14: 0 hourChange at Day 14: 1 hourChange at Day 14: 2 hourChange at Day 14: 3 hourChange at Day 14: 4 hour
PF-04171327 10 mg + Placebo5.430.040.01-0.06-0.280.160.630.791.191.130.320.400.561.101.09
PF-04171327 25 mg + Placebo5.530.420.120.490.340.060.210.801.190.840.771.001.111.571.39
Placebo5.030.09-0.07-0.05-0.25-0.210.07-0.06-0.13-0.47-0.11-0.16-0.35-0.41-0.65
Prednisone 5 mg + Placebo5.900.450.380.22-0.030.220.641.662.142.01-0.79-0.090.741.141.07

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Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14

(NCT00938587)
Timeframe: Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14

,,,
Intervention10^3 cells per microliter (Mean)
BaselineChange at Day 1: 1 hourChange at Day 1: 2 hourChange at Day 1: 3 hourChange at Day 1: 4 hourChange at Day 7: 0 hourChange at Day 7: 1 hourChange at Day 7: 2 hourChange at Day 7: 3 hourChange at Day 7: 4 hourChange at Day 14: 0 hourChange at Day 14: 1 hourChange at Day 14: 2 hourChange at Day 14: 3 hourChange at Day 14: 4 hour
PF-04171327 10 mg + Placebo1.85-0.010.280.210.280.790.640.760.770.720.890.810.740.810.77
PF-04171327 25 mg + Placebo1.800.020.050.070.050.830.620.760.850.690.820.660.620.750.57
Placebo1.790.040.090.040.030.05-0.030.100.150.19-0.07-0.030.040.200.08
Prednisone 5 mg + Placebo1.680.130.090.100.070.260.13-0.03-0.25-0.230.290.22-0.03-0.35-0.45

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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Day 7 and 14

HAQ-DI assessed the ability of participants to perform task in 8 domains of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene, and common activities. Each item was scored on a 4-point scale ranging from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do, higher scores indicate more difficulty. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible HAQ-DI score range: 0 (no difficulty) to 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities. (NCT00938587)
Timeframe: Baseline, Day 7, 14

,,,
Interventionunits on a scale (Mean)
BaselineChange at Day 7Change at Day 14
PF-04171327 10 mg + Placebo1.76-0.24-0.58
PF-04171327 25 mg + Placebo1.41-0.24-0.43
Placebo1.73-0.10-0.24
Prednisone 5 mg + Placebo1.62-0.24-0.25

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Count of Participants With a Radiologic Response

Radiologic response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 criteria. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. (NCT00942578)
Timeframe: median time of potential follow-up of 47.5 months

,,
InterventionParticipants (Count of Participants)
Confirmed radiologic PRComplete ResponseStable Disease
15 mg Lenalidomide301
20 mg Lenalidomide220
25 mg Lenalidomide2003

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Survival Based on Expression of T Cell Immunoglobulin and Mucin Domain (TIM-3) on Cluster of Differentiation 8 (CD8) + T Cells

Expression of TIM-3 on CD8 + T cells was evaluated by flow cytometry. (NCT00942578)
Timeframe: 46.5 months

,,
InterventionMonths (Median)
Low expressionHigh expression
15 mg Lenalidomide23.6NA
20 mg LenalidomideNANA
25 mg Lenalidomide20.212.7

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Survival Based on Expression of Programmed Cell Death Protein 1 (PD-1) on Cluster of Differentiation 8 (CD8) + T Cells

Expression of PD-1 on CD8 + T cells was evaluated by flow cytometry. High and low expression are based on the median values. Patients with a low expression of PD-1 proteins had better survival than those with a high expression. (NCT00942578)
Timeframe: median time of potential follow-up of 47.5 months

,,
InterventionMonths (Median)
Low expressionHigh expression
15 mg Dose Lenalidomide21.422.4
20 mg Dose Lenalidomide17.826.1
25 mg Dose Lenalidomide28.914.8

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Count of Participants With Prostatic Antigen-Specific (PSA) Declines

PSA decline is defined as a ≥50% decline in measurable disease. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20 mm by chest x-ray, as ≥10 mm with computed tomography, or ≥10 mm with calipers by clinical exam. (NCT00942578)
Timeframe: median time of potential follow-up of 47.5 months

,,
InterventionParticipants (Count of Participants)
Participants with PSA>30%Participants with PSA>50%Participants with PSA>90%Not Evaluable
15 mg Lenalidomide131251
20 mg Lenalidomide3310
25 mg Lenalidomide4140271

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Count of Participants With Changes in Circulating Apoptotic Endothelial Cells (CAEC) From Baseline After Drug Administration

The definition of an increase is any increase (any number greater than zero) in the percent CAEC among total peripheral blood mononuclear cells comparing each patient's percent CAEC among total peripheral blood mononuclear cells at baseline to each patient's percent CAEC among total peripheral blood mononuclear cells at cycle 3 day 1. The definition of a decrease is any decrease (any number less than zero) in the percent CAEC among total peripheral blood mononuclear cells comparing each patient's percent CAEC among total peripheral blood mononuclear cells at baseline to each patient's percent CAEC among total peripheral blood mononuclear cells at cycle 3 day 1. (NCT00942578)
Timeframe: After drug administration, an average of 3 months

InterventionParticipants (Count of Participants)
Increase in CAEC after 3 monthsdecrease in CAEC after 3 months
Single Arm - 4 Drug Combination3020

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Median Time to Progression (TTP)

TTP is evaluated from the on-study date until the date of progression or last follow-up after progression. (NCT00942578)
Timeframe: median time of potential follow-up of 47.5 months

InterventionMonths (Median)
Single Arm - 4 Drug Combination18.2

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Median Overall Survival of Patients Studied

OS is evaluated from the on-study date until the date of death or last follow-up. (NCT00942578)
Timeframe: median time of potential follow-up of 47.5 months

InterventionMonths (Median)
Single Arm - 4 Drug Combination24.6

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Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) Who Were Administered the Four-Drug Combination

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT00942578)
Timeframe: Date treatment consent signed to date off study, approximately 93 months and 22 days.

InterventionParticipants (Count of Participants)
15 mg Dose Lenalidomide14
20 mg Dose Lenalidomide3
25 mg Dose Lenalidomide46

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Count of Participants With Dose-Limiting Toxicities (DLT)

DLT is defined as a ≥grade 3 non-hematological toxicity related to lenalidomide. (NCT00942578)
Timeframe: First 28 days of treatment.

InterventionParticipants (Count of Participants)
Single Arm - 4 Drug Combination0

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Number of Participants With Best Overall Response

Primary endpoint is best overall response. An evaluable subject classified as a treatment success for the primary endpoint if the subject's best overall response is clinical improvement (CI) as determined by International Working Group Criteria over the first 6 cycles of study treatment. International Working Group (IWG) consensus criteria for treatment response in myelofibrosis - Clinical improvement (CI) in anemia 1/ A minimum 20g/L increase in hemoglobin level or 2. becoming transfusion independent for at least 8 week duration. (NCT00946270)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Group 1 CC-40470
Group 23
Group 3 CC-4047 + Prednisone6

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Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL

Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal. (NCT00972478)
Timeframe: Up to week 26

,
InterventionParticipants (Number)
Abdominal painAcute kidney injuryAlanine aminotransferase increasedAnemiaAnorexiaAspartate aminotransferase increasedAtrial fibrillationBladder spasmBronchial infectionCD4 lymphocytes decreasedCPK increasedCarbon monoxide diffusing capacity decreasedColitisCreatinine increasedCystitis noninfectiveDehydrationDepressionDiarrheaDisseminated intravascular coagulationDizzinessDuodenal perforationDysphagiaDyspneaElectrocardiogram QT corrected interval prolongedFatigueFebrile neutropeniaFecal incontinenceGastrointestinal disorders - Other, specifyGeneralized muscle weaknessHematuriaHiccupsHyperglycemiaHypoalbuminemiaHypocalcemiaHypokalemiaHyponatremiaHypophosphatemiaHypotensionInfections and infestations - Other, specifyJejunal perforationLeft ventricular systolic dysfunctionLeukocytosisLung infectionLymphocyte count decreasedMucosal infectionMucositis oralMulti-organ failureMyalgiaMyocardial infarctionNauseaNeutrophil count decreasedObstruction gastricPainParonychiaPeripheral motor neuropathyPlatelet count decreasedPneumonitisRecurrent laryngeal nerve palsyRespiratory failureSepsisSinus tachycardiaSinusitisSmall intestinal obstructionStoma site infectionSyncopeUrinary tract infectionUrinary tract painUrine output decreasedVasovagal reactionVisceral arterial ischemiaVomitingWeight lossWhite blood cell decreased
Ph I: R-CHOP+Vorinostat (400mg D1-9)1004100000001102121100013300210011201010000401110180001400030000000101007
Ph II: R-CHOP+Vorinostat31122211111110014020011119241120143086233111420130223371110221111111114320102332

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Safe Dose of Vorinostat to be Used in Combination With R-CHOP Assessed by CTCAE Version 4.0 (Phase I)

Safe dose of Vorinostat (in combination with R-CHOP) at which 3/10 or fewer patients have doselimiting toxicities (DLT). Toxicities graded according to the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0). DLT apply only during cycle 1 and should be drug-related (possible, probable, or definite). (NCT00972478)
Timeframe: 21 days

Interventionmg PO Once daily Days 1-9 (Number)
Ph I: R-CHOP+Vorinostat (400mg D1-9)400

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Response Rate (Complete Response [CR]+Partial Response [PR]) (Phase II)

Objective disease status is evaluated according to the 2007 revised Cheson et al. criteria. Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. (NCT00972478)
Timeframe: Up to week 26

Interventionpercentage of participants (Number)
Ph II: R-CHOP+Vorinostat81

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Progression-free Survival (Phase II)

From date of registration to date of first documentation of progressive disease, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact. (NCT00972478)
Timeframe: Up to 2 years

Interventionpercentage of participants (Number)
Ph II: R-CHOP+Vorinostat73

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Overall Survival (Phase II)

From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. (NCT00972478)
Timeframe: Up to 2 years

Interventionpercentage of participants (Number)
Ph II: R-CHOP+Vorinostat86

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Overall Survival at One Year

The number of participants alive one year after baseline. (NCT00973752)
Timeframe: 1 years

InterventionParticipants (Count of Participants)
Experimental19

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Percentage of Participants With Secondary Primary Malignancies During the Course of the Trial

Second primary malignancies were monitored as events of interest and reported as serious adverse events throughout the course of the trial. (NCT00988208)
Timeframe: The date when the first consent form was signed to the last date of AE data collection; up to the date of the final data analysis date of 30 November 2016; 7 years and 19 days

,
Interventionpercentage of participants (Number)
Invasive Secondary Primary MalignanciesNon-invasive Secondary Primary Malignancies
Docetaxel/Prednisone/Lenalidomide (DPL)1.71.0
Docetaxel/Prednisone/Placebo (DP)1.30.4

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Time to Onset of Secondary Primary Malignancies

Time of Onset of Secondary Primary Malignancies was considered an event of interest (NCT00988208)
Timeframe: The date when the first consent form was signed to the last date of AE data collection; up to the date of the final data analysis date of 30 November 2016; 7 years and 19 days

Interventionmonths (Median)
Docetaxel/Prednisone/Placebo (DP)29.7
Docetaxel/Prednisone/Lenalidomide (DPL)19.7

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Progression-Free Survival (PFS)

PFS was the time from randomization to disease progression, or death, whatever occurred first. Progression criteria was met by analysis of target and non-target lesions as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters while on study or the appearance of one or more new lesions; an increase of at least 5mm as a total sum. Lymph nodes identified as target lesions (≥ 15 mm diameter in short axis) will be followed and reported by changes in diameter of short axis; or the unequivocal progression of a non-target lesion defined as an increase in the overall disease burden based on the change in non-measurable disease that is comparable in scope to the increase required to declare PD for measurable disease; Two or more new bone lesions as detected by bone scan (NCT00988208)
Timeframe: From randomization until disease progression or death from any cause; up to the cut-off date of 13 Jan 2012; maximum time on study was approximately 26 months

InterventionWeeks (Median)
Docetaxel/Prednisone/Placebo (DP)46
Docetaxel/Prednisone/Lenalidomide (DPL)45

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Number of Participants With Treatment Emergent Adverse Events (AEs)

A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. A TESAE is defined as any serious adverse event (SAE) occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal; (NCT00988208)
Timeframe: From the time from of first dose of study drug administration to 28 days after the last dose of study drug and up to the data cut off date of 13 January 2012; the maximum duration of study drug was 93 weeks for DP and 90.6 weeks for DPL

,
Interventionparticipants (Number)
Any TEAEAny TEAE related to lenalidomide or placeboAny TEAE related to docetaxel/prednisoneAny severity grade 3-4 TEAEAny serious AE (SAE)Any SAE related to lenalidomide or placeboAny SAE related to docetaxel/prednisoneAny AE causing discontinuation of lenalidomide/PBOAny AE causing withdrawal of docetaxel/prednisoneAny TEAE leading to death
Docetaxel/Prednisone/Lenalidomide (DPL)51741248138127916718215016924
Docetaxel/Prednisone/Placebo (DP)51237947530317162868212716

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Percentage of Participants With an Objective Response According to Response Evaluation Criteria in Solid Tumors - RECIST Version 1.1 Criteria

Objective response (OR) is defined as having complete response (CR) or partial response (PR) as best overall response based on RECIST Criteria 1.1 and defines a CR = Disappearance of all target lesions except lymph nodes (LN); LN must have a decrease in the short axis to <10mm; PR = 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters; Progressed Disease (PD) = 20% increase in sum of diameters of target lesions taking as a reference the smallest sum of diameters and an absolute increase of ≥5 mm; the appearance of ≥1 new lesions; Stable Disease (SD)= Neither shrinkage to qualify for PR nor increase to qualify for PD taking the smallest sum diameters on study as reference. For non-target lesions a CR = Disappearance of all non-target lesions and all LN must be non-pathological in size <10 mm; Non-CR/Non PD: persistence of one or more non-target lesions; PD = unequivocal progression of existing non-target lesions or appearance of new ones (NCT00988208)
Timeframe: From day 1 to data cut-off 13 January 2012; maximum time on study was approximately 26 months

Interventionpercentage of participants (Number)
Docetaxel/Prednisone/Placebo (DP)24.3
Docetaxel/Prednisone/Lenalidomide (DPL)22.1

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Percentage of Participants Who Received Post-Study Therapies

Percentage of Participants Who Received Post-Study Therapies for advanced Prostate Cancer. (NCT00988208)
Timeframe: The date when the first consent form was signed to the last date of AE data collection;up to 5 years; up to the date of the final data analysis date of 20 April 2017

InterventionPercentage of Participants (Number)
Docetaxel/Prednisone/Placebo (DP)70.8
Docetaxel/Prednisone/Lenalidomide (DPL)69.0

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Overall Survival (OS)

Overall survival (OS) was the time from the date of randomization to the date of death from any cause. If no death was reported for a participant before the cut-off date for OS analysis, OS was censored at the last date at which the participant was alive. The median OS was calculated based on Kaplan-Meier estimates and corresponding 95% confidence interval (CI) was calculated using the method provided by Brookmeyer and Crowley. (NCT00988208)
Timeframe: From randomization until death from any cause up to the cut-off date of 13 January 2012; up to approximately 26 months

Interventionweeks (Median)
Docetaxel/Prednisone/Placebo (DP)NA
Docetaxel/Prednisone/Lenalidomide (DPL)77

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The Percentage of Patients in Each Treatment Arm Who Remain Free of All ITP Therapy With a Platelet Count ≥ 50,000/μl From 60 Days Through 365 Days After Study Entry.

(NCT00991939)
Timeframe: From 60 days through 365 days after study entry.

Interventionpercentage of subjects (Number)
High Dose Pulse Dexamethasone0
Standard Prednisone Therapy0

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Change in Quality of Life as Measured by the 10-Item Neuro-ophthalmological Supplement to the NEI-VFQ-25

(NCT00995722)
Timeframe: 4 months

Interventionunits on a scale (Mean)
Prednisone15.28
Placebo-1.7

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Treatment Failure

Failure to achive sustatined minimal manifestation status by week 16 (NCT00995722)
Timeframe: 4 months

Interventionpercentage of participants (Number)
Prednisone17
Placebo100

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Change in Quality of Life as Measured by the MG-QOL-15 Score

(NCT00995722)
Timeframe: 4 Months

Interventionunits on a scale (Mean)
Prednisone-6.3
Placebo-2.5

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Change in Ocular Quantitative Myasthenia Score From Baseline to Week 16

(NCT00995722)
Timeframe: 4 months

Interventionunits on a scale (Mean)
Prednisone-2.25
Placebo-0.05

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Change in Quality of Life as Measured by the NEI-VFQ-25 Measures

(NCT00995722)
Timeframe: 4 months

Interventionunits on a scale (Mean)
Prednisone10.7
Placebo4.14

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Effects of on HTLV-1 DNA After Treatment as Measured by Proviral Loads

(NCT01000285)
Timeframe: 6 months

,
Interventioncopies/peripheral blood mononuclear cell (Mean)
BaselineStudy completion
Non-responders0.4170.033
Responders0.3720.0128

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Effects of HTLV-1 RNA Load After Treatment as Measured by Hbz Messenger RNA

(NCT01000285)
Timeframe: 6 months

,
Interventioncopies/peripheral blood mononuclear cell (Mean)
BaselineStudy completion
Non-responders41.935.7
Responders37.07.33

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Effects of HTLV-1 Integration Sites After Treatment

(NCT01000285)
Timeframe: 6 months

Interventionnumber of integration sites (Mean)
BaselineStudy completion
EPOCH Chemotherapy & Bortezomib1.311.00

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Effects of HTLV-1 Integrase Gene Sequence After Treatment as Measured by Nucleotide Divergence

(NCT01000285)
Timeframe: 6 months

Interventionpercentage of nucleotide divergence (Mean)
BaselineStudy completion
EPOCH Chemotherapy & Bortezomib0.490.52

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Time to Progression

-The progression definitions used for this study are from the 2007 Cheson criteria. (NCT01000285)
Timeframe: Up to 4 years following completion of therapy

Interventiondays (Median)
Best response of complete responseBest response of partial responseBest response of stable diseaseAll participants
EPOCH Chemotherapy & Bortezomib19914388127

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Relation of NFκB Gene Expression Profile on Response

Standard error represents the standard error of the fold expression of protein coding transcripts for each gene indicated. (NCT01000285)
Timeframe: 6 months

,,,,,,,
Interventionfold expression (Mean)
BLKCADMICD25CD4CD45
Patient A (Responder) Post-Therapy0.1780.0110.0351.3801.718
Patient A (Responder) Pre-Therapy1.0001.0001.0001.0001.000
Patient B (Responder) Post-Therapy0.1720.0070.0150.6070.959
Patient B (Responder) Pre-Therapy0.8890.6230.3031.4372.049
Patient C (Non-responder) Post-Therapy77.5901.8160.6911.9231.640
Patient C (Non-responder) Pre-Therapy68.8561.4940.8621.3191.163
Patient D (Non-responder) Post-Therapy46.8010.4700.5120.6480.714
Patient D (Non-responder) Pre-Therapy233.1792.0132.8973.0570.594

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Efficacy of Treatment as Measured by Best Overall Response

-The response definitions used for this study are the 2007 Cheson criteria. (NCT01000285)
Timeframe: Up to 4 years following completion of therapy

Interventionparticipants (Number)
Progressive DiseaseStable diseasePartial responseComplete response
EPOCH Chemotherapy & Bortezomib3393

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Tolerability of Treatment as Measured by Number of Participants With Grade 3 or Higher Adverse Events

The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting. (NCT01000285)
Timeframe: Up to 30 days after completion of treatment

Interventionparticipants (Number)
FatigueVomitingSpontaneous bacterial peritonitisAbdominal distensionHemoglobinLeukocytes (WBC)LymphopeniaNeutrophilsPlateletsInfection without neutropeniaInfection with neutropeniaOmaya port infectionIV port infectionSepsisNeutropenic feverHypoglycemiaHyperglycemiaMagnesiumHypokalemiaHypertriglyceridemiaConfusionHeadacheEncephalitisAbdominal painCoughDyspnea
EPOCH Chemotherapy & Bortezomib11126716611112312111111111

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Blood Pressure

Diastolic pressure (mmHg) (NCT01002339)
Timeframe: 1 year

InterventionmmHg (Mean)
Tacrolimus With Rapid Steroid Withdrawal76.67
Tacrolimus With Steroids Minimization74.59
CsA With Steroid Minimization76.64

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Blood Pressure

Systolic pressure (mmHg) (NCT01002339)
Timeframe: 1 year

InterventionmmHg (Mean)
Tacrolimus With Rapid Steroid Withdrawal135.36
Tacrolimus With Steroids Minimization133.97
CsA With Steroid Minimization136.28

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Changes of Carotid Intima-media Thickness Over Time

absolute difference between carotid intima-media thickness at study end versus baseline. (NCT01002339)
Timeframe: 1 year

Interventionmm (Mean)
Tacrolimus With Rapid Steroid Withdrawal0.12
Tacrolimus With Steroids Minimization0.04
CsA With Steroid Minimization0.01

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Lipidic Profile (Cholesterol)

Lipidic Profile (total cholesterol) (NCT01002339)
Timeframe: 1 year

Interventionmg/dl (Mean)
Tacrolimus With Rapid Steroid Withdrawal169.05
Tacrolimus With Steroids Minimization178.24
CsA With Steroid Minimization168.89

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Lipidic Profile (HDL-c)

(NCT01002339)
Timeframe: 1 year

Interventionmg/dl (Mean)
Tacrolimus With Rapid Steroid Withdrawal44.84
Tacrolimus With Steroids Minimization49.29
CsA With Steroid Minimization48.35

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Lipidic Profile (LDL-c)

(NCT01002339)
Timeframe: 1 year

Interventionmg/dl (Mean)
Tacrolimus With Rapid Steroid Withdrawal94.00
Tacrolimus With Steroids Minimization95.43
CsA With Steroid Minimization88.65

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Lipidic Profile (Triglycerides)

(NCT01002339)
Timeframe: 1 year

Interventionmg/dl (Mean)
Tacrolimus With Rapid Steroid Withdrawal159.44
Tacrolimus With Steroids Minimization145.59
CsA With Steroid Minimization160.78

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"Primary Outcome Measure New Onset Diabetes After Renal Transplantation (NODAT)"

American Diabetes Association criteria (ADA) including an oral glucose tolerance test. (NCT01002339)
Timeframe: 1 year

,,
Interventionpercentage of participants (Number)
% of patients with NODAT% of patients without NODAT
CsA With Steroid Minimization7.992.1
Tacrolimus With Rapid Steroid Withdrawal34.165.9
Tacrolimus With Steroids Minimization23.176.9

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Number of Antihypertensive Drugs Patients Reported Taking.

(NCT01002339)
Timeframe: 1 year

Interventionnumber of antihypertensive drugs (Median)
Tacrolimus With Rapid Steroid Withdrawal2
Tacrolimus With Steroids Minimization2
CsA With Steroid Minimization2

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Patients Treated With Insulin or Oral Antidiabetic Drugs

(NCT01002339)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Tacrolimus With Rapid Steroid Withdrawal20
Tacrolimus With Steroids Minimization15.4
CsA With Steroid Minimization2.6

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Percentage of Patients Using Acetylsalicylic Acid (ASA)

(NCT01002339)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Tacrolimus With Rapid Steroid Withdrawal53.9
Tacrolimus With Steroids Minimization48.7
CsA With Steroid Minimization52.8

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Percentage of Patients Using Statins

(NCT01002339)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Tacrolimus With Rapid Steroid Withdrawal56.
Tacrolimus With Steroids Minimization61.5
CsA With Steroid Minimization73.7

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Primary Outcome Measure (Glucose Intolerance)

Glycemia >=140 and <200 mg/dl, 2 hours after a standard oral glucose tolerance test. Measured values: glucose intolerance at 1 year defined by ADA criteria. (NCT01002339)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Tacrolimus With Rapid Steroid Withdrawal26.9
Tacrolimus With Steroids Minimization31.0
CsA With Steroid Minimization33.3

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Proteinuria

(NCT01002339)
Timeframe: 1 year

Interventionmg/day (Mean)
Tacrolimus With Rapid Steroid Withdrawal208
Tacrolimus With Steroids Minimization241
CsA With Steroid Minimization343.2

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Rejection

Biopsy proven acute rejection. Measured variable: Rate of Biopsy proven acute rejection. (NCT01002339)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Tacrolimus With Rapid Steroid Withdrawal11.4
Tacrolimus With Steroids Minimization4.8
CsA With Steroid Minimization21.4

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Renal Function

Estimated Glomerular Filtration Rate (ml/min/1.73 m^2) (NCT01002339)
Timeframe: 1 year

Interventionml/min/1.73 m^2 (Mean)
Tacrolimus With Rapid Steroid Withdrawal51.9
Tacrolimus With Steroids Minimization47.4
CsA With Steroid Minimization44.6

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Complete Response

Complete Response (NCT01004991)
Timeframe: 13 months

InterventionParticipants (Count of Participants)
All Patients11

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Percentage of Participants Positive for de Novo Donor-Specific Alloantibody Production in the First Year Post-Transplantation

A de novo donor-specific alloantibody (DSA) is a newly developed alloantibody that is against the donor organ. This measure includes all de novo DSA (≥1000 MFI) regardless of is persistence or timing within the first year post-transplant. Alloantibodies are important mediators of acute and chronic rejection. (NCT01005316)
Timeframe: Transplantation to first year post transplant (up to 12 months post transplant).

Interventionpercentage of participants (Number)
Cohort A: Non-Sensitized22.7
Cohort B: Sensitized, Crossmatch Positive50.0
Cohort B: Sensitized, Crossmatch Negative37.8

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Percentage of Participants Experiencing Acute Rejection

Acute rejection is defined as any one of the following types of rejection: acute cellular rejection (International Society for Heart and Lung Transplant (ISHLT)) system for grading rejection grade 2R or greater), acute refractory cellular rejection (acute cellular rejection unresponsive to two sequential courses of corticosteroids), acute antibody mediated rejection (histological evidence of unequivocal acute capillary injury, with complement deposition and margination of macrophages with or without neutrophils), acute mixed rejection (evidence of acute antibody mediated rejection with ISHLT grade 1R or greater), or acute clinical rejection (clinically-based acute rejection, no matter the ISHLT grade, leading to an acute augmentation of immunosuppression). (NCT01005316)
Timeframe: Transplantation to the end of study.

Interventionpercentage of participants (Number)
Cohort A: Non-Sensitized27.8
Cohort B: Sensitized, Crossmatch Positive75.0
Cohort B: Sensitized, Crossmatch Negative49.6

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Percentage of Participants With the Presence of Anti-MICA Antibodies by Luminex TM Assay

Major histocompatibility complex class I chain-related gene A (MICA) is an antigen that is a potential marker of rejection. Luminex TM assay was used to detect its presence. (NCT01005316)
Timeframe: Pre-Transplantation

Interventionpercentage of participants (Number)
Cohort A: Non-Sensitized8.2
Cohort B: Sensitized, Crossmatch Positive18.8
Cohort B: Sensitized, Crossmatch Negative11.0

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Percentage of Participants -Quantification of Anti-HLA IgG Antibodies by Luminex SA Testing

Quantification of anti-HLA IgG antibodies is measured in mean fluorescence intensity (MFI). The maximum MFI for the given subject is provided. (NCT01005316)
Timeframe: Pre-transplantation

,,
Interventionpercentage of participants (Number)
MissingNoneMFI 1000-3999MFI 4000-7999MFI ≥8000
Cohort A: Non-Sensitized077.320.61.01.0
Cohort B: Sensitized, Crossmatch Negative2.429.129.914.224.4
Cohort B: Sensitized, Crossmatch Positive018.86.312.562.5

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Percentage of Participants With the Presence of Anti-HLA IgG Antibodies by Luminex SA Testing

Luminex SA testing was used to detect the presence of anti-HLA IgG Antibodies for all samples at a central laboratory. (NCT01005316)
Timeframe: Pre-transplantation

Interventionpercentage of participants (Number)
Cohort A: Non-Sensitized22.7
Cohort B: Sensitized, Crossmatch Positive81.3
Cohort B: Sensitized, Crossmatch Negative68.5

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Percentage of Participants With Occurrence of Re-Hospitalization(s)

Hospitalization is defined as any hospitalization lasting greater than 24 hours. (NCT01005316)
Timeframe: Transplantation to the end of study (up to 4 years post transplant).

Interventionpercentage of participants (Number)
Cohort A: Non-Sensitized66.0
Cohort B: Sensitized, Crossmatch Positive75.0
Cohort B: Sensitized, Crossmatch Negative62.2

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Time to Production of Post-Transplant de Novo Donor-specific Alloantibodies

Time (in days) from transplant to development of de novo donor-specific alloantibodies (DSA). This measure is calculated as time from transplant until the earliest time of development of any de novo DSA. The DSA is a newly developed alloantibody that is against the donor organ. Alloantibodies are important mediators of acute and chronic rejection. (NCT01005316)
Timeframe: Transplantation to first year post transplant (up to 12 months post transplant).

InterventionDays (Mean)
Cohort A: Non-Sensitized28.1
Cohort B: Sensitized, Crossmatch Positive15.4
Cohort B: Sensitized, Crossmatch Negative55.1

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Time to Post-Transplantation Lymphoproliferative Disorder

Time (in days) post-transplant lymphoproliferative disorder (PTLD). PTLD is defined as histopathological evidence of lymphoid proliferation (nodal or extranodal) fulfilling the criteria of the revised classification of the WHO 2008 (Swerdlow 2008). Time to PTLD is time from transplantation until the diagnosis of PTLD. (NCT01005316)
Timeframe: Transplantation to the end of study (up to 4 years post transplant).

InterventionDays (Mean)
Cohort A: Non-Sensitized910
Cohort B: Sensitized, Crossmatch PositiveNA
Cohort B: Sensitized, Crossmatch Negative118.7

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Time to New-Onset Diabetes Mellitus

Time (in days) to new-onset diabetes mellitus. New-onset diabetes mellitus is defined as the new onset of insulin dependency or the need for oral hypoglycemic agents lasting more than 30 days post-transplant. Time to new-onset diabetes is time from transplantation until the diagnosis of new-onset diabetes. (NCT01005316)
Timeframe: Transplantation to the end of study (up to 4 years post transplant).

InterventionDays (Mean)
Cohort A: Non-Sensitized73
Cohort B: Sensitized, Crossmatch Positive48
Cohort B: Sensitized, Crossmatch Negative283.4

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Time to Diagnosis of Chronic Rejection

Time (in days) to the diagnosis of chronic rejection. Chronic rejection is defined as stenosis, irregularity, or ectasia of the epicardial vessels, or severe peripheral pruning of the distal coronary artery tree. Time to diagnosis is time from transplantation until the first diagnosis of chronic rejection. (NCT01005316)
Timeframe: Transplantation to the end of study (up to 4 years post transplant).

InterventionDays (Mean)
Cohort A: Non-Sensitized606.8
Cohort B: Sensitized, Crossmatch PositiveNA
Cohort B: Sensitized, Crossmatch Negative398.9

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Time to Acute Rejection

Time (in days) to acute rejection. Acute rejection is defined as any one of the following types of rejection: acute cellular rejection (International Society for Heart and Lung Transplant (ISHLT) system for grading rejection grade 2R or greater), acute refractory cellular rejection (acute cellular rejection unresponsive to two sequential courses of corticosteroids), acute antibody mediated rejection (histological evidence of unequivocal acute capillary injury, with complement deposition and margination of macrophages with or without neutrophils), acute mixed rejection (evidence of acute antibody mediated rejection with ISHLT grade 1R or greater), or acute clinical rejection (clinically-based acute rejection, no matter the ISHLT grade, leading to an acute augmentation of immunosuppression). Time to acute rejection is time from transplantation to first acute rejection date. (NCT01005316)
Timeframe: Transplantation to the end of study.

InterventionDays (Mean)
Cohort A: Non-Sensitized151.0
Cohort B: Sensitized, Crossmatch Positive74.5
Cohort B: Sensitized, Crossmatch Negative124.7

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Time From Participant Listing on Organ Wait-List to Receiving Organ Transplant, Death or De-Listing

Time (in days) from listing on the organ wait-list to receiving an organ transplant, death or de-listing. This measure is calculated as time from listing on the organ wait-list until the earliest time among transplantation, death and de-listing. (NCT01005316)
Timeframe: Study enrollment to transplantation

InterventionDays (Mean)
Enrolled128.3

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Presence of C4d on Endomyocardial Biopsy (EMB)

The biopsy of the heart stained positive for the presence of C4d, a potential marker of rejection. (NCT01005316)
Timeframe: Transplantation to the end of study (up to 4 years post transplant).

Interventionpercentage of participants (Number)
Cohort A: Non-Sensitized18.6
Cohort B: Sensitized, Crossmatch Positive62.5
Cohort B: Sensitized, Crossmatch Negative34.6

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Percentage of Participants- Mortality While on Transplantation Wait-List

Death that occurred while on the transplantation wait-list, and thus before receiving a heart transplant. (NCT01005316)
Timeframe: Pre-transplantation

Interventionpercentage of participants (Number)
Enrolled, Not Transplanted39.2

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Percentage of Participants Positive for Severe Infection(s)

Severe infections are defined as a clinical illness considered likely infectious in origin that leads to hospitalization. (NCT01005316)
Timeframe: Transplantation to the end of study (up to 4 years post transplant).

Interventionpercentage of participants (Number)
Cohort A: Non-Sensitized34.0
Cohort B: Sensitized, Crossmatch Positive43.8
Cohort B: Sensitized, Crossmatch Negative30.7

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Percentage of Participants Positive for Event of Death, Graft Loss or Rejection With Hemodynamic Compromise at 12 Months Post-Transplantation

"This is a composite outcome of death, graft loss or rejection with hemodynamic compromise.~Rejection was considered to be with hemodynamic compromise if the rejection event had new onset echocardiographically measured from fractional shortening <26% with ≥5% fall from last echocardiogram or the rejection event had new onset of heart failure." (NCT01005316)
Timeframe: 12 months post-transplantation

Interventionpercentage of participants (Number)
Cohort A: Non-Sensitized5.2
Cohort B: Sensitized, Crossmatch Positive12.5
Cohort B: Sensitized, Crossmatch Negative11.8

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Percentage of Participants -Overall Participant and Graft Survival

This measure looks at the participants who did not die and/or did not receive a subsequent heart transplant. (NCT01005316)
Timeframe: Transplantation to the end of study (up to 4 years post transplant).

Interventionpercentage of participants (Number)
Cohort A: Non-Sensitized93.8
Cohort B: Sensitized, Crossmatch Positive93.8
Cohort B: Sensitized, Crossmatch Negative87.4

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Incidence of Acute and Chronic Grade 3 or Greater Toxicity as Evaluated Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0

Incidence of acute and chronic grade 3 or greater toxicity as evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0he distribution of time to late adverse events (observed severities of adverse events over time) will be estimated using the Kaplan-Meier method. (NCT01023061)
Timeframe: Up to 24 months after initiation of radiation therapy

InterventionParticipants (Count of Participants)
Treatment (Antihormone Therapy and Radiation Therapy)6

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Levels of Dihydrotestosterone (DHT) and Testosterone in Prostate Biopsy Sample Assessed by Mass Spectrometry

The levels from patients treated in this study will be compared to a control set of biopsies acquired from a separate but similar population of men with intermediate and high risk prostate cancer treated with three months of combined Luteinizing hormone releasing hormone agonist and bicalutamide as part of standard of care. (NCT01023061)
Timeframe: Week 12

Interventionpg/mg (Median)
Treatment (Antihormone Therapy and Radiation Therapy)0.050

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Median Time to Prostate Specific Antigen Progression

Defined as the date of an increase of 2ng/mL or more above the Prostate specific antigen nadir achieved after completion of radiation with the date of progression defined as the date on which that value was measured. Distribution of time-to-event variables will be estimated using the Kaplan-Meier product-limit method. Estimated with two-sided 95% confidence intervals. (NCT01023061)
Timeframe: 6 months

Interventionyears (Mean)
Treatment (Antihormone Therapy and Radiation Therapy)5

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Overall Survival

Survival from enrollment to death. (NCT01026220)
Timeframe: At 3 years from enrollment

InterventionProbability of survival (Number)
Group 10.97
Group 20.97
Group 30.97

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Relapse-free Survival

A description, survival to relapse, of patterns of relapse after Doxorubicin, Bleomycin, Vincristine, Etoposide - Prednisone, Cyclophosphamide (ABVE-PC) and risk-adapted radiotherapy. (NCT01026220)
Timeframe: 3 years from enrollment

InterventionProbability of survival (Number)
Group 10.82
Group 60.83
Group 70.79

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Safety Analysis and Monitoring of Toxic Death

The primary endpoint for safety analysis and monitoring is toxic death, which is death primarily attributable to treatment. (NCT01026220)
Timeframe: Within 30 days of protocol treatment at median follow-up of 48 months (range: 1 to 70 months).

Interventionparticipants (Number)
Group 10

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Second-event-free Survival

Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event. (NCT01026220)
Timeframe: At 4 years from enrollment

,
InterventionProbability of survival (Number)
Group 10.91
Group 20.94
Group 30.88

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Event Free Survival

Survival from enrollment to first event: relapse/progression, second malignancy, or death. (NCT01026220)
Timeframe: At 3 years from enrollment

InterventionProbability of survival (Number)
Group 10.81
Group 20.83
Group 30.78

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Event-free Survival for Rapid Early Response (RER) Positron Emission Tomography(PET)-1 Positive, RER PET-1 Negative

To investigate whether very early response assessment measured by Fluorodeoxyglucose-PET after 1 cycle of chemotherapy identifies a subject cohort that can be studied in future trials and that is distinguishable from currently defined RER after 2 cycles. (NCT01026220)
Timeframe: 3 years from enrollment

InterventionProbability of survival (Number)
Group 10.84
Group 40.82
Group 50.90

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Grade 3 and 4 Non-hematologic Toxicities During Protocol Therapy

The number of patients that experience Common Terminology Criteria (CTC) Version 4 grade 3 or higher non-hematologic toxicity at any time during protocol therapy. (NCT01026220)
Timeframe: During and after completion of study treatment.

Interventionparticipants (Number)
Group 172

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Clinical Response on Study and at Relapse After Dose Adjusted - Etoposide + Prednisone + Vincristine + Cyclophosphamide + Doxorubicin + Rituximab (DA-EPOCH-RC)

Clinical response was assessed by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphomas. Complete remission is complete disappearance of all detectable clinical and radiographic evidence of disease. Complete response unconfirmed is as per complete remission except that if a residual node is greater than 1.5cm, it must have decreased by greater than 75% in the sum of the products of the perpendicular diameters (SPD). Partial response is ≥50% decreased in the SPD of 6 largest dominant nodes or nodal masses. Relapsed disease is appearance of any new lesion or increase by ≥50% in the size of the previously involved sites. Stable disease is defined as less than a partial response but not progressive disease. Progression is ≥50% increase from nadir in the SPD of diameters of any previously identified abnormal node for partial response or non-responders; and an appearance of any new lesion during or at the end of therapy. (NCT01030900)
Timeframe: On study and at relapse after study treatment, approximately 10 months

InterventionParticipants (Count of Participants)
Complete remissionComplete response unconfirmedPartial responseStable diseaseRelapsed diseaseProgressive disease
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin + Rituximab + Campath170132014

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Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01030900)
Timeframe: Date treatment consent signed to date off study, approximately 58 months and 18 days.

InterventionParticipants (Count of Participants)
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin + Rituximab + Campath48

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Overall Survival (OS)

OS is from enrollment to the day of death estimated using the Kaplan-Meier curve. (NCT01030900)
Timeframe: Median overall survival from enrollment to the day of death, approximately 17.9 months

Interventionmonths (Median)
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin + Rituximab + Campath17.9

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Progression Free Survival (PFS)

PFS is the time interval from start of treatment to documented evidence of disease progression estimated using a Kaplan Meier curve. Progression was assessed by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphomas and is defined as ≥50% increase from nadir in the sum of the products of diameters of any previously identified abnormal node for partial response or non-responders. And an appearance of any new lesion during or at the end of therapy. (NCT01030900)
Timeframe: Time of progression or death, approximately 10 months

Interventionmonths (Median)
Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin + Rituximab + Campath6.6

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Dose-Normalized C0

"Dose normalized C0 was determined (in mg/L) from blood samples collected predose. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:~For the MMF group: Dose normalized C0 equals (=) C0 divided by (/) (actual dose taken/1000) For the EC-MPS group: Dose normalized C0 = C0 / (actual dose taken/720)" (NCT01033864)
Timeframe: Day 1 predose

Interventionmg/L (Mean)
MMF/Prednisone2.962
EC-MPS/Prednisone4.658

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Percentage of Participants By Time to Maximum Plasma Concentration (Tmax)

(NCT01033864)
Timeframe: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours

,
Interventionpercentage of participants (Number)
Tmax equals (=) 0.5333 hours (hrs)Tmax=0.6000 hrsTmax=0.7333 hrsTmax=0.7667 hrsTmax=1.0667 hrsTmax=1.0833 hrsTmax=1.1167 hrsTmax=1.2167 hrsTmax=2.0167 hrsTmax=2.0833 hrsTmax=2.1000 hrsTmax=2.1167 hrsTmax=2.1667 hrsTmax=3.1167 hrsTmax=3.1833 hrs
EC-MPS/Prednisone0.00.00.00.09.10.00.00.09.118.29.127.39.19.19.1
MMF/Prednisone16.716.716.78.38.316.78.38.30.00.00.00.00.00.00.0

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Pre-dose Trough Concentration (C0)

The mean mycophenolic acid (MPA) concentration in plasma was determined (in milligrams per liter [mg/L]) from blood samples collected predose (immediately before receiving study treatment). (NCT01033864)
Timeframe: Day 1 predose

Interventionmg/L (Mean)
MMF/Prednisone2.387
EC-MPS/Prednisone2.944

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MPA Area Under the Curve From 0 to 12 Hours (AUC0-12)

The mean MPA AUC0-12 in plasma was determined (in mg multiplied by hours, per Liter [mg*h/L]) from blood samples collected predose and postdose on Day 1. (NCT01033864)
Timeframe: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours

Interventionmg*h/L (Mean)
MMF/Prednisone50.36348
EC-MPS/Prednisone57.06682

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Minimum Plasma Concentration (Cmin)

The mean minimum MPA concentration in plasma was determined (in mg/L) from blood samples collected predose and postdose on Day 1. (NCT01033864)
Timeframe: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours

Interventionmg/L (Mean)
MMF/Prednisone1.385
EC-MPS/Prednisone1.620

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Maximum Plasma Concentration (Cmax)

The mean maximum MPA concentration in plasma was determined (in mg/L) in blood samples collected predose and postdose on Day 1. (NCT01033864)
Timeframe: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours

Interventionmg/L (Mean)
MMF/Prednisone15.385
EC-MPS/Prednisone17.827

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Dose-Normalized MPA AUC0-12

"Dose-normalized MPA AUC0-12 in plasma was determined (mg*h/L) from blood samples collected predose and postdose on Day 1. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:~For the MMF group: Dose normalized MPA AUC = MPA AUC / (actual dose taken/1000) For the EC-MPS group: Dose normalized MPA AUC = MPA AUC / (actual dose taken/720)" (NCT01033864)
Timeframe: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours

Interventionmg*h/L (Mean)
MMF/Prednisone61.53862
EC-MPS/Prednisone94.65765

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Dose-Normalized Cmin

"Dose-normalized Cmin was determined (in mg/L) from blood samples collected predose and postdose. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:~For the MMF group: Dose normalized Cmin = Cmin/ (actual dose taken/1000) For the EC-MPS group: Dose normalized Cmin = Cmin / (actual dose taken/720)" (NCT01033864)
Timeframe: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours

Interventionmg/L (Mean)
MMF/Prednisone1.702
EC-MPS/Prednisone2.613

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Dose-Normalized Cmax (mg/L)

"Dose-normalized Cmax in plasma was determined (in mg/L) from blood samples collected predose and postdose on Day 1. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:~For the MMF group: Dose normalized Cmax = Cmax / (actual dose taken/1000) For the EC-MPS group: Dose normalized Cmax = Cmax / (actual dose taken/720)" (NCT01033864)
Timeframe: Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours

Interventionmg/L (Mean)
MMF/Prednisone18.402
EC-MPS/Prednisone29.996

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Regression Coefficients For Participants Receiving MMF

The estimated regression coefficients for participants who received MMF presented in milligrams per liter (mg/L). (NCT01033864)
Timeframe: Day 1 at 30 minutes and 1 and 2 hours postdose

Interventionmg/L (Number)
InterceptConcentration at 30 minutes (C0.5)Concentration at 1 hour (C1)Concentration at 2 hours (C2)
MMF/Prednisone2.171920.740311.893232.85923

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Subsequent Anti-lymphoma Therapy Rate at 1-year

Kaplan-meier estimate of subsequent anti-lymphoma therapy at 1-year. Time to subsequent anti-lymphoma therapy was measured from the date of randomization to the start date of new treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, time to next anti-lymphoma treatment was censored at the date of death or the last date known to be alive. (NCT01040871)
Timeframe: 1 year

Interventionpercentage of participants (Number)
VR-CAP71.1
R-CHOP80.2

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Rate of Durable Response

Proportion of subjects who achieved a CR or PR with duration of at least 6 months. Duration of response (CR or PR) was calculated from the date of initial documentation of a response to the date of first documented evidence of disease progression or death due to disease progression. Response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma. (NCT01040871)
Timeframe: Median follow up approx. 12 months

Interventionpercentage of participants (Number)
VR-CAP53.9
R-CHOP67.6

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Rate of Durable Complete Response

Proportion of subjects who achieved a CR with duration of at least 6 months (NCT01040871)
Timeframe: Median follow up approx 12 months

Interventionpercentage of participants (Number)
VR-CAP44.7
R-CHOP47.3

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Progression-free Survival (PFS)Rate at 1-year

Kaplan-meier estimate of progression-free survival at 1-year. Progression-free survival was defined as the interval between the date of randomization and the date of first documented evidence of disease progression or death. (NCT01040871)
Timeframe: 1 year

Interventionpercentage of partipants (Number)
VR-CAP78.9
R-CHOP83.9

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Overall Survival Rate at 1-year

Kaplan-meier estimate of overall survival at 1-year measured from date of randomization. (NCT01040871)
Timeframe: 1 year

Interventionpercentage of partipants (Number)
VR-CAP94.1
R-CHOP84.2

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Complete Response (CR) Rate

"Complete response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, and end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.~Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.~PET scan was negative.~The spleen and/or liver, if enlarged before therapy on the basis of physical examination or CT scan, was not palpable on physical examination and was considered normal size by imaging studies; all splenic and hepatic nodules related to lymphomas disappeared.~If bone marrow was involved before treatment, the infiltrate cleared on repeated bone marrow biopsy.~No new sites of disease were detected." (NCT01040871)
Timeframe: 6 cycles

Interventionpercentage of participants (Number)
VR-CAP64.5
R-CHOP63.5

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Overall Response Rate

"Overall response = Complete Response (CR) + Partial Response (PR) Response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, and end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.~Complete Response: see primary endpoint Partial Response: At least a 50% decrease in the sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses." (NCT01040871)
Timeframe: 6 cycles

Interventionpercentage of participants (Number)
VR-CAP93.4
R-CHOP98.6

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Number of Participants With Reported Side Effects

(NCT01042145)
Timeframe: 12 days

Interventionpercentage of participants (Number)
Prednisone26
Dexamethasone24

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Time Missed From Work

(NCT01042145)
Timeframe: 12 days

InterventionHours (Mean)
Prednisone3.79
Dexamethasone4.06

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Parental Stress

Parental stress due to the child's illness was rated using a 4-point categorical scale (ranging from 3-very stressed to 0-not stressed). We report days until the stress rating was 0. (NCT01042145)
Timeframe: 12 days

Interventiondays (Mean)
Prednisone1.56
Dexamethasone1.39

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Additional Health Care

The primary outcome was the % of participants who had additional health care for croup within 11 days of randomization assessed by self-report. This dichotomous variable was positive if any of the following occurred: office visit, ED visit or hospitalization for croup care. (NCT01042145)
Timeframe: 11 days

Interventionpercentage of participants (Number)
Prednisone7
Dexamethasone2

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Duration of Croup Symptoms

(NCT01042145)
Timeframe: 12 days

Interventiondays (Mean)
Prednisone2.2
Dexamethasone2.8

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Nights With Disturbed Sleep

(NCT01042145)
Timeframe: 12 days

Interventionnights (Mean)
Prednisone1.21
Dexamethasone0.68

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Number of Participants With Toxicity as Measured by NCI CTCAE v3.0 Criteria

Number of Participants with Grade 3/4 Toxicity as measured by NCI CTCAE v3.0 criteria (NCT01051570)
Timeframe: Day 1 of each cycle (every 21 days), through study completion, an average of 6 months

InterventionParticipants (Count of Participants)
AnemiaThrombocytopeniaLymphopeniaLeukopeniaInfection without neutropeniaHypophosphatemiaNeutropeniaDehydrationHyperglycemiaHyponatremiaPulmonary embolismFatigueHypercholesterolemiaRashASTHypomagnesemiaHypokalemia
Carboplatin, RAD 001 & Prednisone109644433332211111

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Association of PSA Response Rate With Correlative Markers (Phospho mTOR, pAKT, and p70S6)

PSA response defined as a decrease of 30% or more will be tabled against mTOR, pAKT, and p70S6 (1+, 2+, 3+ vs ND) (NCT01051570)
Timeframe: Archival tissue will be collected if available. Optional biopsies pre-treatment and 24 hours after first everolimus and carboplatin dose

Interventionparticipants (Number)
pAKT(ND) vs RespondermTOR(ND) vs Responderp70S6(ND) vs Responder
Carboplatin, RAD 001 & Prednisone101

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PSA Response Rate

PSA response rate with response defined as => a 30% reduction in PSA (NCT01051570)
Timeframe: Day 1 of each cycle (every 21 days), through study completion, an average of 6 months

Interventionpercentage of participants (Number)
Carboplatin, RAD 001 & Prednisone15

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Pharmacokinetics: Observed Carboplatin AUC Was Estimated Based on the Concentration in the 2.75-h Sample.

Using a limited sampling model (i.e., AUC = 0.52 × C2.75h + 0.92) (Sorensen et al., 1993), observed carboplatin AUC was estimated based on the concentration in the 2.75-h sample. (NCT01051570)
Timeframe: Samples were collected Cycle 2, Day 1

Interventionmg/ml*min (Mean)
Carboplatin, RAD 001 & Prednisone5.8

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Overall Survival

Overall Survival as measured by the Kaplan-Meier method (NCT01051570)
Timeframe: After treatment, participants will be contacted every 3 months up to 4 years

Interventionmonths (Median)
Carboplatin, RAD 001 & Prednisone12.5

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Time to Progression (TTP)

Progression defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT01051570)
Timeframe: Up to 63 days while on treatment, then up 90 days thereafter. From date of registration to date of progressive disease.

Interventionmonths (Median)
Carboplatin, RAD 001 & Prednisone2.5

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Single Agent - Median Progressive Free Survival (PFS)

The progression free survival of patients treated with single agent lenalidomide (NCT01054144)
Timeframe: First measure at 8 weeks

Interventionmonths (Median)
Single Agent29

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Response Rate

Response rate in older adults with mildly symptomatic multiple myeloma to single agent lenalidomide, lenalidomide prednisone and lenalidomide low dose dexamethasone in patients with suboptimal responses to lenalidomide monotherapy. The study used the uniform response assessment of the International Myeloma Working Group with the addition of MR (minimal response) (Durie et al, 2006; Kumar et al, 2016). MR was defined as a 25-49% decrease in serum M spike, and a 50-89% improvement in urine M spike. For patients without a measurable serum or urine M spike, a 25-49% decrease in the difference between the involved and uninvolved free light chains was required. The response in this trial is defined as complete remission (CR), stringent complete remission (SRC), very good partial remission (VGPR) and partial remission (PR) and minimal response (MR). (NCT01054144)
Timeframe: Every 8 weeks up to 12 months

,
InterventionParticipants (Count of Participants)
Complete Response & Stringent Complete ResponseVery Good Partial Response (VGPR)Partial Response (PR)Minimal Response (MR)Stable DiseaseOverall Response >/= PR
Response Adapted Therapy112504
Single Agent Lenalidomide43124319

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Combined Therapy - Median Progression Free Survival

Progression free survival (PFS) of older adults with mildly symptomatic multiple myeloma treated on this response adapted approach (i.e. time from start of lenalidomide to failure of lenalidomide and low dose dexamethasone) (NCT01054144)
Timeframe: up to 36 months

Interventionmonths (Median)
Response Adapted Therapy36

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Number of Participants With 1 Year Overall Survival (OS)

The 1 year overall survival of older adults with mildly symptomatic multiple myeloma treated on this response adapted approach (NCT01054144)
Timeframe: 1 Year

Interventionparticipants (Number)
Response Adapted Therapy27

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Number of Participants With Serious Adverse Events

Number of participants with serious adverse events (NCT01054144)
Timeframe: Day 1 through Off Study Date, an average of 48 months

Interventionparticipants (Number)
Response Adapted Therapy20

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Participants Reporting Dose Limiting Toxicity (DLT) Adverse Events (AEs) for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 1

DLT was defined as: febrile neutropenia, Grade (Gr) 4 neutropenia ≥7 days, Gr 4 thrombocytopenia ≥7 days, Gr 3/4 thrombocytopenia associated with bleeding requiring a transfusion, Gr 3/4 non-hematologic toxicity (except alopecia) ≥7 days or treatment-related and clinically significant irrespective of duration, ≥Gr 3 QTc prolongation, Gr 4 alanine or aspartate aminotransferase, Gr 2 hyperbilirubinemia (greater than (>)1.5 x upper normal limit) >7 days, delayed recovery from a treatment-related toxicity that prevented re-dosing by >7 days, or Granulocyte-colony stimulating factor treatment during the first cycle. (NCT01055496)
Timeframe: From the first dose of study medication (Study Day 1) to the completion of the first 21-day cycle.

InterventionParticipants (Count of Participants)
Cohort 1, Arm 10
Cohort 2, Arm 10
Cohort 3, Arm 11
Cohort 4, Arm 12
MTD Confirmation Cohort, Arm 12

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Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the DE Cohorts

OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. (NCT01055496)
Timeframe: 6, 12, and 24 months

,
InterventionPercent Probability (Number)
6 months12 months24 months
DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin100.0080.0080.00
DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin74.0762.9655.09

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Kaplan-Meier Estimate of the PFS in the MTD Confirmation/EE Cohorts

PFS was defined as time from date of first dose to the earlier date of progression (including symptomatic deterioration), date of death from any cause, or initiation of new anticancer therapy for the lymphoma. Participants without an event were censored at the date of the last valid tumour assessment. A valid tumour assessment visit was defined as the tumour assessment visit with OR of CR, PR, SD, or PD, but not 'Not Done' or 'Unknown'. Participants without a post-baseline tumour assessment and without a PFS event were censored on the date of first dose. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks

InterventionMonths (Median)
MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin14.36
MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin6.14

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Kaplan-Meier Estimate of the Overall Survival (OS) in the DE Cohorts

OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period

InterventionMonths (Median)
DE Arm 1: (R-CVP) Plus Inotuzumab OzogamicinNA
DE Arm 2: (R-GDP) Plus Inotuzumab OzogamicinNA

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Kaplan-Meier Estimate of the OS in the MTD Confirmation/EE Cohorts

OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period

InterventionMonths (Median)
MTD/EE Arm 1: (R-CVP) Plus Inotuzumab OzogamicinNA
MTD/EE Arm 2: (R-GDP) Plus Inotuzumab OzogamicinNA

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Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the DE Cohorts

Measure includes death from any cause, PD (including symptomatic deterioration) during and after treatment or initiation of new anticancer therapy for the lymphoma. PD was defined as symptomatic deterioration and according to the International Response Criteria for NHL: 1) appearance of any new lesion >1.5 cm in any axis during or at EOT, even if other lesions are decreasing, 2) at least a 50% increase from nadir in the SPD of any previously involved or single involved nodes, or the size of other lesions (splenic or hepatic). Lymph nodes with a short axis diameter of <1.0 cm must increase by ≥50% and to a size of 1.5x1.5 cm or >1.5 cm in the long axis, 3) 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PD was defined as clinical PD, new non-nodal lesions or new nodal lesion ≥1.5 cm in GTD, progression of existing non-index lesions or bone marrow that was negative and now positive. (NCT01055496)
Timeframe: 6, 12 and 24 months

,
InterventionPercent Probability (Number)
6 months12 months24 months
DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin80.0066.6722.22
DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin60.9847.9233.54

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Percentage of Participants With Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) According to International Response Criteria for NHLs in the MTD and EE Cohorts

OR was evaluated according to the International Response Criteria for NHLs. CR was defined as complete disappearance of all lesions and disease-related symptoms; all nodes must have decreased to normal (less than or equal to [≤]1.5 centimeters [cm] in their greatest transverse diameter (GTD) for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the sum of the product diameters (SPD) of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or GTD (for single nodules). With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks.

InterventionPercentage of participants (Number)
MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin81.3
MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin53.6

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Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts.

Measure includes death from any cause, PD (including symptomatic deterioration) during and after treatment or initiation of new anticancer therapy for the lymphoma. PD was defined as symptomatic deterioration and according to the International Response Criteria for NHL: 1) appearance of any new lesion >1.5 cm in any axis during or at EOT, even if other lesions are decreasing, 2) at least a 50% increase from nadir in the SPD of any previously involved or single involved nodes, or the size of other lesions (splenic or hepatic). Lymph nodes with a short axis diameter of <1.0 cm must increase by ≥50% and to a size of 1.5x1.5 cm or >1.5 cm in the long axis, 3) 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PD was defined as clinical PD, new non-nodal lesions or new nodal lesion ≥1.5 cm in GTD, progression of existing non-index lesions or bone marrow that was negative and now positive. (NCT01055496)
Timeframe: 6, 12, and 24 months

,
InterventionPercent Probability (Number)
6 months12 months24 months
MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin61.8551.5444.67
MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin54.7424.88NA

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Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts

OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact. (NCT01055496)
Timeframe: 6, 12, and 24 Months

,
InterventionPercent Probability (Number)
6 months12 months24 months
MTD/EE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin84.3878.1371.61
MTD/EE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin88.0059.1153.74

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Mean Inotuzumab Ozogamicin Serum Concentrations

Pharmacokinetic (PK) samples were required for participants enrolled in the confirmatory and preliminary efficacy MTD cohorts only (Parts 2 and 3). Concentrations of inotuzumab ozogamicin in serum were determined using appropriate, validated unconjugated (also known as free) bioanalytical assays. (NCT01055496)
Timeframe: Pre-dose on Cycle 1, Day 2; Pre-dose, 1 and 3 hours post-dose on Cycle 3, Day 2; 24 hours post-dose on Cycle 3, Day 3 and 168 hours post-dose on Cycle 3, Day 8.

,,,
Interventionng/mL (Mean)
Cycle 1 Day 2, 0h
Cohort 1, Arm 2NA
Cohort 3b, Arm 2NA
Cohort 4, Arm 1NA
Cohort 4, Arm 2NA

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Percentage of Participants With Any Grade 3/4 Hematology Abnormality During Therapy

"The following parameters were analyzed for hematology: lymphocytes, basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, monocytes, neutrophils, platelets, prothrombin international normalized ratio, prothrombin time, fibrinogen, and activated partial thromboplastin time. Laboratory test results were graded using the NCI CTCAE v3.0 where CTCAE Grade 3 equals severe and CTCAE Grade 4 equals life threatening or disabling." (NCT01055496)
Timeframe: Within 3 days prior to the start of each cycle, Day 8 of each cycle, Day 15 of Cycles 1, 2, and 3, and the end-of-treatment visit. Each Cycle is 21 Days.

InterventionPercentage of Participants (Number)
Arm 1 (R-CVP) Plus Inotuzumab Ozogamicin91.7
Arm 2 (R-GDP) Plus Inotuzumab Ozogamicin96.4

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Percentage of Participants With a Treatment Emergent AE

An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event may not necessarily have had a causal relationship with the treatment or usage. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were defined as those occurring on or after the first study drug dose day through and including 56 days post last dose of study drug. The severity of all AEs was graded by the investigator using the National Cancer Institute Common Terminology Criteria for AE Version 3.0 (NCI CTCAE v3.0). (NCT01055496)
Timeframe: SAEs were assessed from informed consent through and including the end of treatment visit (at least 28 calendar days after last study drug administration). Non-SAEs were recorded from time of the first dose of study drug through last participant visit.

,
InterventionPercentage of Participants (Number)
Subjects with AEsSubjects with SAEsSubjects with Grade 3 or 4 AEsSubjects with Grade 5 AEsSubjects discontinued due to AEsSubjects with dose reduced due to AEsSubjects with temporary discontinuation due to AEs
Arm 1 (R-CVP) Plus Inotuzumab Ozogamicin10031.389.64.227.116.754.2
Arm 2 (R-GDP) Plus Inotuzumab Ozogamicin10045.596.45.536.432.767.3

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Mean Inotuzumab Ozogamicin Serum Concentrations

Pharmacokinetic (PK) samples were required for participants enrolled in the confirmatory and preliminary efficacy MTD cohorts only (Parts 2 and 3). Concentrations of inotuzumab ozogamicin in serum were determined using appropriate, validated unconjugated (also known as free) bioanalytical assays. (NCT01055496)
Timeframe: Pre-dose on Cycle 1, Day 2; Pre-dose, 1 and 3 hours post-dose on Cycle 3, Day 2; 24 hours post-dose on Cycle 3, Day 3 and 168 hours post-dose on Cycle 3, Day 8.

,
Interventionng/mL (Mean)
Cycle 1 Day 2, 0hCycle 3 Day 2, 0hCycle 3 Day 2, 1hCycle 3 Day 2, 3hCycle 3 Day 3, 24hCycle 3 Day 8, 168h
Cohort 2b/MTD/EE Arm 2: (R-GDP) Plus Inotuzumab OzogamicinNA25.00283.27280.33154.25NA
Cohort 3/MTD/EE Arm 1: (R-CVP) Plus Inotuzumab OzogamicinNANA189.74213.95110.39NA

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Percentage of Participants With Any Grade 3/4 Chemistry Abnormality During Therapy

"The following parameters were analyzed for blood chemistry: blood urea nitrogen (or urea), creatinine, glucose, calcium, sodium, potassium, phosphorus, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, total bilirubin (and direct bilirubin, if total bilirubin was elevated), alkaline phosphatase, uric acid (or urate), albumin and total protein. Laboratory test results were graded using the NCI CTCAE v3.0 where CTCAE Grade 3 equals severe and CTCAE Grade 4 equals life threatening or disabling." (NCT01055496)
Timeframe: Within 3 days prior to the start of each cycle, on Day 8 of each cycle, on Day 15 of Cycles 1, 2, and 3, and the end-of-treatment visit. Each Cycle is 21 Days.

InterventionPercentage of Participants (Number)
Arm 1 (R-CVP) Plus Inotuzumab Ozogamicin21.3
Arm 2 (R-GDP) Plus Inotuzumab Ozogamicin36.4

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Percentage of Participants With a Best OR of CR or PR According to International Response Criteria for NHLs in the DE Cohorts

OR was evaluated according to the International Response Criteria for NHLs. CR was defined as complete disappearance of all lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their GTD for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the SPD of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or GTD (for single nodules). With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks.

InterventionPercentage of participants (Number)
DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin81.3
DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin51.9

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Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in the DE Cohorts

PFS was defined as time from date of first dose to the earlier date of progression (including symptomatic deterioration), date of death from any cause, or initiation of new anticancer therapy for the lymphoma. Participants without an event were censored at the date of the last valid tumour assessment. A valid tumour assessment visit was defined as the tumour assessment visit with overall response of CR, PR, stable disease (SD), or disease progression (PD), but not 'Not Done' or 'Unknown'. Participants without a post-baseline tumour assessment and without a PFS event were censored on the date of first dose. (NCT01055496)
Timeframe: From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks

InterventionMonths (Median)
DE Arm 1: (R-CVP) Plus Inotuzumab Ozogamicin16.36
DE Arm 2: (R-GDP) Plus Inotuzumab Ozogamicin10.12

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Participants Reporting DLT AEs for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 2

DLT was defined as: febrile neutropenia, Grade (Gr) 4 neutropenia ≥7 days, Gr 4 thrombocytopenia ≥7 days, Gr 3/4 thrombocytopenia associated with bleeding requiring a transfusion, Gr 3/4 non-hematologic toxicity (except alopecia) ≥7 days or treatment-related and clinically significant irrespective of duration, ≥Gr 3 QTc prolongation, Gr 4 alanine or aspartate aminotransferase, Gr 2 hyperbilirubinemia (greater than (>)1.5 x upper normal limit) >7 days, delayed recovery from a treatment-related toxicity that prevented re-dosing by >7 days, or Granulocyte-colony stimulating factor treatment during the first cycle. (NCT01055496)
Timeframe: From the first dose of study medication (Study Day 1) to the completion of the first 21-day cycle.

InterventionParticipants (Count of Participants)
Cohort 1, Arm 20
Cohort 2a, Arm 22
Cohort 2b, Arm 21
Cohort 3b, Arm 22
Cohort 4, Arm 20
MTD Confirmation Cohort, Arm 23

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Phase 2: Time to Radiographic Disease Progression

Time to Radiographic Disease Progression was defined as (date of Radiographic Disease progression) - (date of first dose of drug) + 1. Radiographic disease progression is defined as the presence of progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) criteria and/or bone scan progression determined according to second Prostate Cancer Clinical Trials Working Group (PCWG2) bone scan criteria. (NCT01084655)
Timeframe: Baseline until disease progression or death, whichever occurred first (up to approximately 25.4 months)

Interventiondays (Median)
Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone393

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Phase 2: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Docetaxel

(NCT01084655)
Timeframe: Cycle 1 Day 1: pre-dose and at multiple time points (up to 24 hours) post-end of docetaxel infusion; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-end of docetaxel infusion

Interventionnanogram*hour per milliliter (ng*hr/mL) (Geometric Mean)
Phase 2 Cycle 1: Docetaxel 75 mg/m^2 + Prednisone 5 mg1180
Phase 2 Cycle 2: Orteronel 400 mg BID + Docetaxel + Prednisone1270

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Phase 2: Best PSA Response

Best PSA response was defined as the maximum PSA percent reduction from baseline at any time beyond Cycle 1. (NCT01084655)
Timeframe: Cycle 2 Day 1 up to Cycle 12 Day 21

Interventionpercent change (Mean)
Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone-61.72

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Phase 2: Time to PSA Progression

Time to PSA progression was defined as (date of PSA progression) - (date of first dose of drug) + 1, where PSA progression was defined as: For participants whose PSA concentrations never declined before the end of Cycle 4 of treatment: a) >=25% increase over the baseline level and an increase in absolute PSA concentration >=2 ng/mL; For participants who initially experienced a PSA decline: a) >=25% increase in PSA above the nadir concentration and an increase in absolute PSA concentration >=2 ng/mL. (NCT01084655)
Timeframe: Baseline until disease progression or death, whichever occurred first (up to approximately 25.4 months)

Interventiondays (Median)
Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone203

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Phase 2: Cmax: Maximum Observed Plasma Concentration for Docetaxel

(NCT01084655)
Timeframe: Cycle 1 Day 1: pre-dose and at multiple time points (up to 24 hours) post-end of docetaxel infusion; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-end of docetaxel infusion

Interventionnanogram per milliliter (ng/mL) (Geometric Mean)
Phase 2 Cycle 1: Docetaxel 75 mg/m^2 + Prednisone 5 mg1330
Phase 2 Cycle 2: Orteronel 400 mg BID + Docetaxel + Prednisone1600

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Phase 2: Cmax, ss: Maximum Observed Plasma Concentration at Steady State for Orteronel

(NCT01084655)
Timeframe: Cycle 1 Day 21: pre-dose and at multiple time points (up to 8 hours) post-dose for orteronel; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-dose for orteronel

Interventionng/mL (Geometric Mean)
Phase 2 Cycle 1: Orteronel 400 mg BID + Docetaxel + Prednisone2660
Phase 2 Cycle 2: Orteronel 400 mg BID + Docetaxel + Prednisone3000

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Phase 2: AUC 0-tau: Area Under the Plasma Concentration Versus Time Curve Zero to the Time of the End of the Dosing Interval for Orteronel

(NCT01084655)
Timeframe: Cycle 1 Day 21: pre-dose and at multiple time points (up to 8 hours) post-dose for orteronel; Cycle 2 Day 1: pre-dose and at multiple time points (up to 8 hours) post-dose for orteronel

Interventionng*hr/mL (Geometric Mean)
Phase 2 Cycle 1: Orteronel 400 mg BID + Docetaxel + Prednisone18000
Phase 2 Cycle 2: Orteronel 400 mg BID + Docetaxel + Prednisone871

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Phase 2: Percentage of Participants With Prostate-specific Antigen (PSA) Response of 30 Percent (%), 50%, and 90%

PSA response rates (PSA-30, PSA-50, and PSA-90) were defined as greater than or equal to (>=) 30%, 50%, and 90% reductions, respectively, from baseline in PSA concentration. (NCT01084655)
Timeframe: Cycle 4 Day 21

Interventionpercentage of participants (Number)
PSA-30PSA-50PSA-90
Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone685923

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Phase 2: Percentage of Participants With Objective Measurable Disease Response

Percentage of participants with objective measurable disease response based assessment of complete response (CR), partial response (PR), stable disease or PD according to RECIST (Version 1.1). A CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to less than (<)10 millimeter (mm). A PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of longest diameters of non-lymph node lesions and of the short diameter(s) or short axis of lymph nodes. (NCT01084655)
Timeframe: Baseline until disease progression or death, whichever occurred first (up to approximately 25.4 months)

Interventionpercentage of participants (Number)
Complete responsePartial responseStable DiseaseProgressive Disease
Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone070300

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Phase 2: Change From Baseline in Circulating Tumor Cells (CTCs)

Baseline is defined as the last scheduled observed measurement prior to the first dose of drug. (NCT01084655)
Timeframe: Cycle 2 Day 1, Cycle 5 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, Cycle 21 Day 1, End of treatment (approximately up to Cycle 48), Last assessment (30 days after last dose of study drug, approximately up to 1038 days)

Interventionmilliliter (mL) (Mean)
Baseline (n=21)Change at Cycle 2 Day 1 (n=12)Change at Cycle 5 Day 1 (n=16)Change at Cycle 9 Day 1 (n=6)Change at Cycle 13 Day 1 (n=7)Change at Cycle 17 Day 1 (n=5)Change at Cycle 21 Day 1 (n=1)Change at End of treatment (n=11)Change at Last assessment (n=18)
Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone47.9-11.9-39.0-25.5-11.3-18.8-5.0-40.2-35.0

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Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) or Serious Adverse Events (SAE)

(NCT01084655)
Timeframe: Baseline up to 30 days after last dose of study drug (Day of last dose for Phase 1: Cycle 84 Day 21; Phase 2: Cycle 48 Day 21)

,,
Interventionparticipants (Number)
TEAESAE
Phase 1: Orteronel 200 mg BID + Docetaxel + Prednisone65
Phase 1: Orteronel 400 mg BID + Docetaxel + Prednisone85
Phase 2: Orteronel 400 mg BID + Docetaxel + Prednisone2316

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Number of Participants With Adverse Events (AEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'. (NCT01085097)
Timeframe: Baseline up to Week 28

Interventionparticipants (Number)
Placebo14
Laquinimod 0.5 mg15
Laquinimod 1 mg15

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Percent Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24

Estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease (MDRD) formula. (NCT01085097)
Timeframe: Baseline, Week 24

Interventionpercent change (Mean)
Placebo12.1
Laquinimod 0.5 mg18.0
Laquinimod 1 mg24.3

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All-Cause Mortality: From Treatment Initiation to Week 104

Death from any cause occurring after randomization and ≤ Week 104. (NCT01086540)
Timeframe: Day 0 (Treatment Randomization) to Week 104

InterventionParticipants (Count of Participants)
Rituximab8
Placebo5

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Time to Clinical Worsening

"Assessment of time to clinical worsening, censored at Week 48, defined as the first occurrence of any of the following:~death,~hospitalization for Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH),~lung transplantation,~atrial septostomy,~addition of other Pulmonary Arterial Hypertension (PAH) therapeutic agents, or~worsening of the six minute walk distance by > 20% and an increase in New York Heart Association functional class.~Time to clinical worsening was defined as the first date that met any of the above criteria and was calculated in study days as: date of first event minus (-) date of treatment randomization. If a participant did not experience any of the referenced events by Week 48 or, if the date of death was after the 48 week follow-up period, time to clinical worsening was equal to the participant's duration of follow-up in the study." (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 48

InterventionWeeks (Mean)
Rituximab21.2
Placebo26.2

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Change From Baseline in Distance Walked During a Six Minute Walk Test

The six minute walk test measures the distance a participant is able to walk over a total of six minutes on a hard, flat surface. The goal is for the participant to walk as far as possible in six minutes. The participant is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The total distance walked, in meters, was recorded for each participant. Longer distances indicate better outcomes. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24

InterventionMeters (Least Squares Mean)
Rituximab23.6
Placebo0.5

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Change in Carbon Monoxide Diffusing Capacity (DLCO)

"Carbon Monoxide Diffusing Capacity (DLCO) is a measure of lung function. Predicted values for DLCO were computed according to the Global Lung Function Initiative (GLI) all-age reference values and corrected for hemoglobin. Lower DLCO values indicate worse disease activity.~DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide)" (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24 and Week 48

,
InterventionPercent Predicted Value (Least Squares Mean)
Change from Baseline to Week 24Change from Baseline to Week 48
Placebo0.40.7
Rituximab-0.3-0.5

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Time to the Change or Addition of New Pulmonary Arterial Hypertension (PAH) Therapeutic Medications

Per protocol, from the time of study entry, participants were to remain on background PAH medical therapy with either a single agent or a combination of prostanoid, endothelin receptor antagonist, PDE-5 inhibitor, and/or guanylate cyclase stimulators as per the entry criteria. Doses should have remained stable through the Week 24 primary outcome/endpoint visit. If a dose of a background PAH medication was changed or a new PAH medication was added during the course of the trial, the date of the first dose change or additional medication was recorded. Time to the addition or modification of PAH medications was defined in study days as: date of the first time a PAH medication was modified or added minus (-) date of randomization. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 48

InterventionWeeks (Mean)
Rituximab21.2
Placebo26.7

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Change in Quality of Life as Measured by the Disability Index of the Scleroderma Health Assessment Questionnaire (HAQ-DI)

The HAQ-DI is a self-reported questionnaire of functionality that includes questions in 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities) and addresses scleroderma related manifestations that contribute to disability. The final score ranges from 0 to 3, where a higher HAQ-DI score indicates a worse outcome. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24 and Week 48

,
InterventionUnits on a Scale (Least Squares Mean)
Change from Baseline to Week 24Change from Baseline to Week 48
Placebo0.00.0
Rituximab0.00.0

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Change in Severity of Raynaud's Phenomenon

"Severity of Raynaud's phenomenon was measured by a Visual Analog Scale (VAS) of the Scleroderma Health Assessment Questionnaire (SHAQ). The SHAQ VAS includes a question asking, In the past week, how much has your Raynaud's Phenomenon interfered with your activities? Participants were asked to place a mark on a 15 cm line, scaled from 0 (does not interfere) to 100 (very severe limitation), to describe the severity of their Raynaud's phenomenon in the past week. The distance from the left edge of the line to the vertical line placed by the participant was measured in centimeters; VAS scores were converted to a 0 to 100 scale." (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24 and Week 48

,
InterventionScore on a Scale (Least Squares Mean)
Change from Baseline to Week 24Change from Baseline to Week 48
Placebo0.10.1
Rituximab-2.2-4.4

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Number of Grade 3 or Higher Adverse Events (AEs) Through Week 48

Total number of Grade 3, 4, and 5 AEs. Ref: National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 48

,
InterventionEvents (Number)
Grade 3 AEsGrade 4 AEsGrade 5 AEs
Placebo1921
Rituximab2863

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Oxygen Saturation Levels at Week 24 and Week 48

Oxygen saturation is the amount of oxygen that is in your bloodstream and is measured as the percentage of blood hemoglobin that is carrying oxygen. Normal oxygen saturation levels are considered to be 95-100 percent; low oxygen saturation values indicate worse disease. Room air oxygen saturation by pulse oximetry and/or amount of supplemental oxygen used, if saturation <90%, were recorded. (NCT01086540)
Timeframe: Week 24 , Week 48

,
InterventionPercent Oxygen Saturation (Mean)
O2 Sat Level: Week 24O2 Sat Level: Week 48
Placebo96.196.2
Rituximab96.597.7

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Percent Change From Baseline in Pulmonary Vascular Resistance Measured by Right Heart Catheterization

"During a right heart catheterization, a catheter is guided to the right side of the heart and then into the pulmonary artery; blood flow through the heart is observed and is used to measure pressures in a participant's heart and lungs. Pulmonary vascular resistance (PVR) is measured in Woods Units. Higher PVR values indicate worse disease status.~Change in PVR is determined by Baseline value minus (-) Week 24 value." (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24

InterventionPercent Change (Least Squares Mean)
Rituximab-4.6
Placebo3.2

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Change From Baseline in Pulmonary Vascular Resistance Measured by Right Heart Catheterization at Week 24

During a right heart catheterization, a catheter is guided to the right side of the heart and then into the pulmonary artery; blood flow through the heart is observed and is used to measure pressures in a participant's heart and lungs. The calculation of Pulmonary Vascular Resistance (PVR) is measured in Woods Units. Change is derived by measuring the difference between Baseline and Week 24 PVR (Week 24 minus Baseline). Higher PVR values indicate worse disease status. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24

InterventionWoods Units (Least Squares Mean)
Rituximab-0.5
Placebo0.1

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Number of New Digital Ulcers

The total number of digital ulcers present on the dorsal and palmar surfaces for both the left and right fingers were captured at the Baseline study visit. The number of new digital ulcers since the last study visit (including any ulcers that had appeared and healed since the last study visit) on the dorsal and palmar surfaces for both the left and right fingers were captured at the post-Baseline study visits. The total number of digital ulcers on both hands was summed from the number present on the dorsal and palmar surfaces for both the left and right fingers. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24 and Week 48

,
InterventionNew Ulcers (Mean)
Total Ulcer Count at BaselineNew Ulcers at Week 24New Ulcers at Week 48
Placebo0.40.10.2
Rituximab0.60.00.1

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Change From Baseline in Quality of Life as Measured by the Short Form Health Survey (SF-36): Physical Component Summary Score

The SF-36 measures health-related quality of life. It has 36 items and 2 component scores, the Physical Component Score and the Mental Component Score. The SF-36 Physical component summary score is comprised of the Physical Functioning Scale, the Role-Physical Scale, the Bodily Pain Scale, and the General Health Scale. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 is equivalent to no disability. A negative value indicates a decrease in quality of life from Baseline. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 48

,
InterventionUnits on a Scale (Least Squares Mean)
Change from Baseline to Week 24Change from Baseline to Week 48
Placebo1.73.5
Rituximab0.61.3

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Change From Baseline in Distance Walked During a Six Minute Walk Test at Week 24 and Week 48

The six minute walk test measures the distance a participant is able to walk over a total of six minutes on a hard, flat surface. The goal is for the participant to walk as far as possible in six minutes. The participant is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The total distance walked, in meters, was recorded for each participant. Longer distances indicate better outcomes. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24 and Week 48

,
InterventionMeters (Least Squares Mean)
Change from Baseline to Week 24Change from Baseline to Week 48
Placebo0.4-7.0
Rituximab25.59.5

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Change From Baseline in Quality of Life as Measured by the Short Form Health Survey (SF-36): Mental Component Summary Score

The SF-36 measures health-related quality of life. It has 36 items and 2 component scores, the Physical Component Score and the Mental Component Score. The SF-36 Mental Health component summary score is comprised of the Vitality Scale, the Social Functioning Scale, the Role-Emotional Scale, and the Mental Health Scale. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 is equivalent to no disability. A negative value indicates a decrease in quality of life from Baseline. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24 and Week 48

,
InterventionUnits on a Scale (Least Squares Mean)
Change from Baseline to Week 24Change from Baseline to Week 48
Placebo0.40.9
Rituximab0.10.2

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All-Cause Mortality: From Treatment Initiation to Week 48

Death from any cause occurring after randomization and ≤ Week 48. (NCT01086540)
Timeframe: Day 0 (Treatment Randomization) to Week 48

InterventionParticipants (Count of Participants)
Rituximab4
Placebo1

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Number of Participants With a Positive Surgical Margin at Radical Prostatectomy

The table below shows number of participants in each treatment group who had positive surgical margins. A positive surgical margin is defined as tumor extending to the inked-surface or margin of the prostate. (NCT01088529)
Timeframe: At the end of Cycle 3 (at radical prostatectomy)

Interventionparticipants (Number)
AA+LHRHa6
LHRHa6

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Number of Participants With Prostate-Specific Antigen Response

The table below shows number of participants in each treatment group who achieved a prostate-specific antigen (PSA) response defined as a drop in PSA value to less than or equal to 0.2 ng/mL. (NCT01088529)
Timeframe: Cycle 3 Day 1

Interventionparticipants (Number)
AA+LHRHa32
LHRHa0

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Number of Participants With a Pathology Tumor Stage of Less Than or Equal to Prostate Cancer Stage at Which the Tumor is Confined to the Prostate (pT2)

The table below shows number of participants in each treatment group with a pathology tumor stage less than or equal to pT2. (NCT01088529)
Timeframe: At the end of Cycle 3 (at radical prostatectomy)

Interventionparticipants (Number)
AA+LHRHa24
LHRHa8

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Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01092182)
Timeframe: Date treatment consent signed to date off study, approximately 102 months and 25 days for Group A, 125 months and 28 days for Group B and 117 months and 29 days for group C.

InterventionParticipants (Count of Participants)
Group A - Low-risk Burkitt Lymphoma (BL)13
Group B - High-Risk Burkitt Lymphoma (BL)87
Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)72

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Percentage of Participants Kaplan-Meier Curve Overall Survival (OS) Constructed With an 95% Confidence Interval

OS was calculated from the enrolment date until date of death or last follow-up using the Kaplan Meier. Kaplan-Meier curves were constructed with an 95% confidence interval. (NCT01092182)
Timeframe: At 4 years

Interventionpercentage of participants (Number)
Group A - Low-risk Burkitt Lymphoma (BL)100
Group B - High-Risk Burkitt Lymphoma (BL)84.9
Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)76.7

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Kaplan-Meier Progression Free Survival (PFS) Constructed With an 95% Confidence Interval in Participants Who Underwent Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) and/or Computed Tomography (CT) Scans After Cycle 2

The predictive value of early FDG-PET/CT scans on PFS was assessed after cycle 2. PFS is the time interval from start of treatment to documented evidence of disease progression, assessed by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of < 1.5 cm (< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval. (NCT01092182)
Timeframe: After 2 cycles of therapy and prior to cycle 3

Interventionpercentage of participants (Number)
Group A - Low-risk Burkitt Lymphoma (BL)100
Group B - High-Risk Burkitt Lymphoma (BL)90.0
Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)78.7

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Percentage of Participants With Kaplan-Meier Curve Event Free Survival (EFS) Constructed With an 95% Confidence Interval

EFS was determined from the date of enrolment in the study until the date of progression, last documentation of disease at or after the last treatment cycle, death, or last follow-up (whichever occurred first). Disease progression was measured by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of < 1.5 cm (< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval. (NCT01092182)
Timeframe: At 4 years

Interventionpercentage of participants (Number)
Group A - Low-risk Burkitt Lymphoma (BL)100
Group B - High-Risk Burkitt Lymphoma (BL)82.1
Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)71.0

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Percentage of Participants With Kaplan-Meier Curve Progression Free Survival (PFS) Constructed With an 95% Confidence Interval

PFS is the time interval from start of treatment to documented evidence of disease progression. Disease progression was measured by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of < 1.5 cm (< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval. (NCT01092182)
Timeframe: Time of progression or death at 4 years

Interventionpercentage of participants (Number)
Group A - Low-risk Burkitt Lymphoma (BL)100
Group B - High-Risk Burkitt Lymphoma (BL)82.1
Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)71.0

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SF-36 Physical Component Summary

The Medical Outcome Study SF-36 Physical Component Summary (PCS) is a subscale of the SF-36 intended to measure physical well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being. (NCT01106833)
Timeframe: Baseline, 2 months, 6 months, 1 year, and 2 years post-randomization

,
Interventionscore on a scale (Mean)
Baseline2 Months6 Months1 Year2 Years
Sirolimus and Prednisone3842434343
Sirolimus, Calcineurin Inhibitor, and Prednisone3839384044

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Percentage of Participants With Discontinuation of Systemic Immunosuppressive Therapy at Two Years

The percentage of participants discontinuing all systemic immunosuppressive therapy by two years post-randomization is described. Death is considered a competing risk for this endpoint. (NCT01106833)
Timeframe: 2 years post-randomization

Interventionpercentage of participants (Number)
Sirolimus, Calcineurin Inhibitor, and Prednisone20
Sirolimus and Prednisone23.2

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Percentage of Participants With Overall Survival

Overall survival is defined as survival of death from any cause. (NCT01106833)
Timeframe: 6 months and 24 months post-randomization

,
Interventionpercentage of participants (Number)
6 Months24 Months
Sirolimus and Prednisone91.781.5
Sirolimus, Calcineurin Inhibitor, and Prednisone85.574.0

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Percentage of Participants With Progression-free Survival

Progression-free Survival is defined as survival without malignancy relapse. Relapse and death are considered failures for this endpoint. (NCT01106833)
Timeframe: 6 months and 24 months post-randomization

,
Interventionpercentage of participants (Number)
6 Months24 Months
Sirolimus and Prednisone90.378.6
Sirolimus, Calcineurin Inhibitor, and Prednisone84.067.3

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Prednisone Dose

Daily dose of prednisone is described by treatment arm at baseline, 6 months, and 1 year post-randomization. (NCT01106833)
Timeframe: Baseline, 6 months, and 1 year post-randomization

,
Interventionmg/kg/day (Median)
Baseline6 Months1 Year
Sirolimus and Prednisone0.90.20.1
Sirolimus, Calcineurin Inhibitor, and Prednisone0.90.20.2

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Provider-reported Chronic GVHD Severity

Each patient's care provider's perception of the severity of the chronic GVHD was collected at baseline and at 6 months, 1 year, and 2 years post-randomization. Severity is categorized as none, mild, moderate, and severe. (NCT01106833)
Timeframe: Baseline, 6 months, 1 year, and 2 years post-randomization

InterventionParticipants (Count of Participants)
Baseline72115479Baseline721154786 Months721154796 Months721154781 Year721154781 Year721154792 Years721154782 Years72115479
NoneMildModerateSevereRelapsedInitiated Secondary TherapyDead
Sirolimus, Calcineurin Inhibitor, and Prednisone13
Sirolimus and Prednisone17
Sirolimus, Calcineurin Inhibitor, and Prednisone46
Sirolimus and Prednisone48
Sirolimus, Calcineurin Inhibitor, and Prednisone6
Sirolimus and Prednisone2
Sirolimus, Calcineurin Inhibitor, and Prednisone27
Sirolimus and Prednisone33
Sirolimus and Prednisone13
Sirolimus, Calcineurin Inhibitor, and Prednisone3
Sirolimus and Prednisone14
Sirolimus, Calcineurin Inhibitor, and Prednisone8
Sirolimus and Prednisone19
Sirolimus and Prednisone9
Sirolimus, Calcineurin Inhibitor, and Prednisone1
Sirolimus and Prednisone1
Sirolimus, Calcineurin Inhibitor, and Prednisone5
Sirolimus and Prednisone3
Sirolimus, Calcineurin Inhibitor, and Prednisone15
Sirolimus and Prednisone21
Sirolimus, Calcineurin Inhibitor, and Prednisone7
Sirolimus and Prednisone7
Sirolimus, Calcineurin Inhibitor, and Prednisone10
Sirolimus and Prednisone11
Sirolimus, Calcineurin Inhibitor, and Prednisone0
Sirolimus and Prednisone0
Sirolimus and Prednisone5
Sirolimus, Calcineurin Inhibitor, and Prednisone18
Sirolimus and Prednisone28
Sirolimus and Prednisone4

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Proportion of Participants With Treatment Success

Treatment success was evaluated at 6 months in Phase II and is defined as a complete or partial response without secondary systemic immunosuppressive therapy and no recurrent malignancy or death. In Phase III, treatment success was evaluated at 24 months and is defined as a complete response without secondary systemic immunosuppressive therapy and no recurrent malignancy or death. (NCT01106833)
Timeframe: 6 months and 24 months post-randomization

InterventionParticipants (Count of Participants)
Phase II: 6 Months72115478Phase II: 6 Months72115479Phase III: 24 Months72115478Phase III: 24 Months72115479
YesNo
Sirolimus, Calcineurin Inhibitor, and Prednisone33
Sirolimus and Prednisone35
Sirolimus and Prednisone37
Sirolimus, Calcineurin Inhibitor, and Prednisone9
Sirolimus and Prednisone10
Sirolimus, Calcineurin Inhibitor, and Prednisone49
Sirolimus and Prednisone58

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Patient-reported Chronic GVHD Severity

Each patient's perception of the severity of the chronic GVHD was collected at baseline and at 6 months, 1 year, and 2 years post-randomization. Severity is categorized as none, mild, moderate, and severe. (NCT01106833)
Timeframe: Baseline, 6 months, 1 year, and 2 years post-randomization

InterventionParticipants (Count of Participants)
Baseline72115479Baseline721154786 Months721154786 Months721154791 Year721154791 Year721154782 Years721154782 Years72115479
ModerateSevereRelapsedInitiated Secondary TherapyDeadMildNone
Sirolimus, Calcineurin Inhibitor, and Prednisone21
Sirolimus and Prednisone20
Sirolimus, Calcineurin Inhibitor, and Prednisone23
Sirolimus and Prednisone32
Sirolimus and Prednisone10
Sirolimus and Prednisone0
Sirolimus and Prednisone6
Sirolimus, Calcineurin Inhibitor, and Prednisone13
Sirolimus and Prednisone25
Sirolimus, Calcineurin Inhibitor, and Prednisone15
Sirolimus, Calcineurin Inhibitor, and Prednisone3
Sirolimus and Prednisone1
Sirolimus and Prednisone14
Sirolimus, Calcineurin Inhibitor, and Prednisone6
Sirolimus and Prednisone4
Sirolimus, Calcineurin Inhibitor, and Prednisone9
Sirolimus and Prednisone2
Sirolimus and Prednisone23
Sirolimus, Calcineurin Inhibitor, and Prednisone4
Sirolimus and Prednisone3
Sirolimus, Calcineurin Inhibitor, and Prednisone5
Sirolimus and Prednisone21
Sirolimus, Calcineurin Inhibitor, and Prednisone10
Sirolimus and Prednisone13
Sirolimus, Calcineurin Inhibitor, and Prednisone2
Sirolimus, Calcineurin Inhibitor, and Prednisone0
Sirolimus, Calcineurin Inhibitor, and Prednisone8
Sirolimus and Prednisone5
Sirolimus, Calcineurin Inhibitor, and Prednisone18
Sirolimus and Prednisone28
Sirolimus, Calcineurin Inhibitor, and Prednisone7

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NIH Consensus Criteria Chronic GVHD Severity

Chronic GVHD severity was determined at baseline and at 6 months, 1 year, and 2 years post-randomization per the 2005 NIH Consensus Criteria (Filipovich et al. 2005). Severity is categorized as none, mild, moderate, and severe. (NCT01106833)
Timeframe: Baseline, 6 months, 1 year, and 2 years post-randomization

InterventionParticipants (Count of Participants)
Baseline72115478Baseline721154796 Months721154786 Months721154791 Year721154791 Year721154782 Years721154782 Years72115479
NoneMildModerateSevereRelapsedInitiated Secondary TherapyDead
Sirolimus, Calcineurin Inhibitor, and Prednisone0
Sirolimus, Calcineurin Inhibitor, and Prednisone1
Sirolimus, Calcineurin Inhibitor, and Prednisone29
Sirolimus and Prednisone23
Sirolimus, Calcineurin Inhibitor, and Prednisone33
Sirolimus and Prednisone46
Sirolimus and Prednisone0
Sirolimus, Calcineurin Inhibitor, and Prednisone25
Sirolimus and Prednisone27
Sirolimus, Calcineurin Inhibitor, and Prednisone12
Sirolimus and Prednisone17
Sirolimus, Calcineurin Inhibitor, and Prednisone3
Sirolimus and Prednisone1
Sirolimus, Calcineurin Inhibitor, and Prednisone7
Sirolimus and Prednisone14
Sirolimus, Calcineurin Inhibitor, and Prednisone6
Sirolimus and Prednisone3
Sirolimus and Prednisone5
Sirolimus, Calcineurin Inhibitor, and Prednisone16
Sirolimus and Prednisone16
Sirolimus, Calcineurin Inhibitor, and Prednisone9
Sirolimus and Prednisone10
Sirolimus, Calcineurin Inhibitor, and Prednisone5
Sirolimus, Calcineurin Inhibitor, and Prednisone15
Sirolimus and Prednisone21
Sirolimus and Prednisone4
Sirolimus and Prednisone9
Sirolimus and Prednisone12
Sirolimus, Calcineurin Inhibitor, and Prednisone8
Sirolimus and Prednisone8
Sirolimus, Calcineurin Inhibitor, and Prednisone2
Sirolimus and Prednisone2
Sirolimus, Calcineurin Inhibitor, and Prednisone18
Sirolimus and Prednisone28

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Percentage of Participants With Relapse

Relapse is defined as recurrence of the primary malignancy. Death is considered a competing risk for this endpoint. (NCT01106833)
Timeframe: 6 months and 24 months post-randomization

,
Interventionpercentage of participants (Number)
6 Months24 Months
Sirolimus and Prednisone1.410.1
Sirolimus, Calcineurin Inhibitor, and Prednisone4.814.9

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SF-36 Mental Component Summary

The Medical Outcome Study SF-36 Mental Component Summary (MCS) is a subscale of the SF-36 intended to measure mental well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being. (NCT01106833)
Timeframe: Baseline, 2 months, 6 months, 1 year, and 2 years post-randomization

,
Interventionscore on a scale (Mean)
Baseline2 Months6 Months1 Year2 Years
Sirolimus and Prednisone4850484650
Sirolimus, Calcineurin Inhibitor, and Prednisone4749505052

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Serum Creatinine Level

Creatinine level is described by treatment arm at baseline, 6 months, and 1 year post-randomization. (NCT01106833)
Timeframe: Baseline, 6 months, and 1 year post-randomization

,
Interventionmg/dL (Median)
Baseline6 Months1 Year
Sirolimus and Prednisone0.91.00.9
Sirolimus, Calcineurin Inhibitor, and Prednisone0.91.00.9

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Percentage of Participants With Secondary Immunosuppressive Therapy Initiated

The percentage of participants initiating secondary immunosuppressive therapy for chronic GVHD is described. Death is considered a competing risk for this endpoint. (NCT01106833)
Timeframe: 6 months and 24 months post-randomization

,
Interventionpercentage of participants (Number)
6 Months24 months
Sirolimus and Prednisone13.938.5
Sirolimus, Calcineurin Inhibitor, and Prednisone12.929.4

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Change in Prednisone Dose From Baseline

Change in the daily dose of prednisone from baseline, the time of randomization, is described by treatment arm at 6 months and 1 year post-randomization. (NCT01106833)
Timeframe: 6 months and 1 year post-randomization

,
Interventionmg/kg/day (Median)
6 Months1 Year
Sirolimus and Prednisone-0.6-0.7
Sirolimus, Calcineurin Inhibitor, and Prednisone-0.6-0.6

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Change in Serum Creatinine Level From Baseline

Change in creatinine level from baseline, the time of randomization, is described by treatment arm at 6 months and 1 year post-randomization. (NCT01106833)
Timeframe: 6 months and 1 year post-randomization

,
Interventionmg/dL (Median)
6 Months1 Year
Sirolimus and Prednisone0.10.0
Sirolimus, Calcineurin Inhibitor, and Prednisone0.10.0

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Percentage of Participants With Failure-free Survival

Failure-free Survival is defined as survival without malignancy progression or initiation of secondary therapy for chronic GVHD. Progression, initiation of secondary therapy for chronic GVHD, and death are considered failures for this endpoint. (NCT01106833)
Timeframe: 6 months and 24 months post-randomization

,
Interventionpercentage of participants (Number)
6 Months24 Months
Sirolimus and Prednisone73.648.6
Sirolimus, Calcineurin Inhibitor, and Prednisone74.746.2

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FACT-BMT Score

The Functional Assessment of Cancer Therapy-Bone Marrow Transplant scale (FACT-BMT) is a quality of life instrument that assesses the effects of bone marrow transplantation (BMT) on a patient's physical, social/family, emotional, and functional well-being while taking into consideration BMT-specific concerns. The assessment has 37 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-148, with higher scores indicating higher levels of overall well-being. (NCT01106833)
Timeframe: Baseline, 2 months, 6 months, 1 year, and 2 years post-randomization

,
Interventionscore on a scale (Mean)
Baseline2 Months6 Months1 Year2 Years
Sirolimus and Prednisone104110109110113
Sirolimus, Calcineurin Inhibitor, and Prednisone103105109114119

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Change in Visual Functioning Questionnaire 25 (VFQ-25) Total Score From Baseline to the Final/Early Termination Visit

"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The overall composite score ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning." (NCT01124838)
Timeframe: Baseline and Final/Early Termination Visit (up 80 weeks)

Interventionunits on a scale (Mean)
Main Study: Placebo1.24
Main Study: Adalimumab3.36
Integrated Study (Main + Japan Sub-study): Placebo1.00
Integrated Study (Main + Japan Sub-study): Adalimumab2.79

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Percent Change in Central Retinal Thickness in Each Eye From Baseline to the Final/Early Termination Visit.

Central retinal thickness was measured using OCT and assessed by a central reader. (NCT01124838)
Timeframe: Baseline and Final/Early Termination Visit (up to 80 weeks)

,,,
Interventionpercent change (Mean)
Left eye (N = 107, 114, 122, 130)Right eye (N = 108, 113, 124, 129)
Integrated Study (Main + Japan Sub-study): Adalimumab5.23.9
Integrated Study (Main + Japan Sub-study): Placebo6.39.9
Main Study: Adalimumab4.55.4
Main Study: Placebo6.47.7

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Change in Vitreous Haze (VH) Grade in Each Eye From Baseline to the Final/Early Termination Visit

"Vitreous haze was measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to National Eye Institute (NEI) and SUN criteria:~Grade 0: No evident vitreous haze;~Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized;~Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades);~Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades);~Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry;~Grade 4+: Optic nerve head is obscured." (NCT01124838)
Timeframe: Baseline and Final/Early Termination Visit (up to 80 weeks)

,,,
Interventionunits on a scale (Mean)
Left eyeRight eye
Integrated Study (Main + Japan Sub-study): Adalimumab0.180.18
Integrated Study (Main + Japan Sub-study): Placebo0.350.36
Main Study: Adalimumab0.160.18
Main Study: Placebo0.330.27

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Change In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) In Each Eye From Baseline to the Final/Early Termination Visit

Using corrective lenses based on that visit's refraction testing, participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart. On the logMAR scale, 0 is equivalent to 20/20 visual acuity, the range of normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment. (NCT01124838)
Timeframe: Baseline and Final/Early Termination Visit (up to 80 weeks)

,,,
InterventionlogMAR (Mean)
Left eyeRight eye
Integrated Study (Main + Japan Sub-study): Adalimumab0.020.00
Integrated Study (Main + Japan Sub-study): Placebo0.070.04
Main Study: Adalimumab0.01-0.01
Main Study: Placebo0.060.02

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Change in Anterior Chamber (AC) Cell Grade in Each Eye From Baseline to the Final/Early Termination Visit

"Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria:~Grade 0 = < 1 cell~Grade 0.5+ = 1 - 5 cells~Grade 1+ = 6 - 15 cells~Grade 2+ = 16 - 25 cells~Grade 3+ = 26 - 50 cells~Grade 4+ = > 50 cells." (NCT01124838)
Timeframe: Baseline and at the Final/Early Termination Visit (up to 80 weeks)

,,,
Interventionunits on a scale (Mean)
Left eyeRight eye
Integrated Study (Main + Japan Sub-study): Adalimumab0.460.44
Integrated Study (Main + Japan Sub-study): Placebo0.610.60
Main Study: Adalimumab0.410.40
Main Study: Placebo0.570.53

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Time to Treatment Failure on or After Week 2

"Treatment failure was defined by the occurrence of a uveitis flare (the inability to maintain disease control). To be considered treatment failure, ≥ 1 of these criteria had to be present in at least 1 eye at Week 2 or all other visits:~New active, inflammatory chorioretinal, and/or inflammatory retinal vascular lesions relative to Baseline~2-step increase relative to Baseline in anterior chamber cell grade or vitreous haze grade~Worsening of best corrected visual acuity by ≥ 15 letters relative to baseline.~Time to treatment failure was analyzed using the Kaplan-Meier method. Dropouts for reasons other than treatment failure at any time during the study were censored at the drop out date.~Per protocol, the primary analysis was performed in the Main Study population which included all randomized participants recruited outside Japan; for completeness results are also reported below for the Integrated dataset which includes participants recruited in Japan." (NCT01124838)
Timeframe: From Baseline until end of study (up to 80 weeks)

Interventionmonths (Median)
Main Study: Placebo8.3
Main Study: AdalimumabNA
Integrated Study (Main + Japan Sub-study): Placebo5.6
Integrated Study (Main + Japan Sub-study): AdalimumabNA

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Time to Optimal Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Week 2

"Optical coherence tomography was performed at every visit using 1 of 3 approved machines. Images were evaluated by a central reader. Macular edema was defined as cystoid macular edema.~OCT evidence of macular edema on or after Week 2 was to be counted as an event. Dropouts due to reasons other than OCT evidence of macular edema were to be considered as censored observations at the time of dropping out." (NCT01124838)
Timeframe: From Baseline until the Final Visit (up to 80 weeks)

Interventionmonths (Median)
Main Study: PlaceboNA
Main Study: AdalimumabNA
Integrated Study (Main + Japan Sub-study): PlaceboNA
Integrated Study (Main + Japan Sub-study): AdalimumabNA

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Change in VFQ-25 Subscore Ocular Pain From Baseline to the Final/Early Termination Visit

"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The ocular pain subscore is calculated form the answers to 2 eye pain questions and ranges from 0 to 100, where higher scores or increases in score indicate less pain." (NCT01124838)
Timeframe: Baseline and Final/Early Termination Visit (up 80 weeks)

Interventionunits on a scale (Mean)
Main Study: Placebo2.87
Main Study: Adalimumab3.42
Integrated Study (Main + Japan Sub-study): Placebo2.60
Integrated Study (Main + Japan Sub-study): Adalimumab2.15

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Change in VFQ-25 Subscore Near Vision From Baseline to the Final/Early Termination Visit

"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The near vision subscore is calculated from the answers to 3 near vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning." (NCT01124838)
Timeframe: Baseline and Final/Early Termination Visit (up 80 weeks)

Interventionunits on a scale (Mean)
Main Study: Placebo3.98
Main Study: Adalimumab3.88
Integrated Study (Main + Japan Sub-study): Placebo3.73
Integrated Study (Main + Japan Sub-study): Adalimumab2.89

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Change in VFQ-25 Subscore Distance Vision From Baseline to the Final/Early Termination Visit

"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The distance vision subscore is calculated from the answers to 3 distance vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning." (NCT01124838)
Timeframe: Baseline and Final/Early Termination Visit (up 80 weeks)

Interventionunits on a scale (Mean)
Main Study: Placebo0.76
Main Study: Adalimumab2.64
Integrated Study (Main + Japan Sub-study): Placebo0.60
Integrated Study (Main + Japan Sub-study): Adalimumab2.96

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36 Month Progression Free Survival Rate of Patients Receiving 4 Cycles of ABVD Versus Patients Receiving 2 Cycles of ABVD and 2 Cycles of BEACOPP and Radiation.

All patients received an initial 2-28 day cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) on Days 1 and 15. After the first 2 cycles of ABVD, PET/CT was performed and submitted for central review (cycle 2, days 23-25) and determined whether patients would receive 2 cycles of escalated BEACOPP and involved-field RT (IFRT) or an additional 2 cycles of ABVD. PFS for each patient is measured as the time from registration on trial to the first incident of death or progression. The PFS rate at 36 months is calculated as the number of patients who have a progression-free survival time greater than 36 months divided by the total number of patients that started treatment. For this endpoint, we compare the PFS rate between patients who received 4 cycles of ABVD and patients who received 2 cycles of ABVD and 2 cycles of IFRT. (NCT01132807)
Timeframe: at 36 months

Interventionproportion of participants (Number)
Treatment (ABVD:4 Cycles).91
Escalated BEACOPP and Involved Field Radiation Therapy.67

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Complete Response Rate

A Complete Response (CR) was defined as having the following conditions: 1. A complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. 2. In patients with a PET scan that was positive before therapy, a post-treatment residual mass of any size is permitted as long as it is PET-negative. A Complete Response rate was defined as the number of patients who achieved a CR divided by the number of patients that were eligible for analysis in each group. The CR rate was calculated for patients that completed 4 cycles of ABVD and for patients that completed 2 cycles of ABVD and 2 cycles of BEACOPP and IFRT. (NCT01132807)
Timeframe: Up to 5 years

Interventionproportion of participants (Number)
Treatment (ABVD: 4 Cycles).97
Escalated BEACOPP and Involved Field Radiation Therapy.85

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Progression-Free Survival (PFS) at 36-Months for Patients Who Received 4 Cycles of ABVD

The primary objective of this trial is to estimate the 3 year PFS in patients who received 4 cycles of ABVD. PFS for each patient is measured as the time from registration on trial to the first incident of death or progression. The PFS at 36 months is calculated as the number of patients who have a progression-free survival time greater than 36 months divided by the total number of patients that started treatment. For this endpoint, all patients that received 4 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) are included. (NCT01132807)
Timeframe: 36 Months

Interventionproportion of patients (Number)
Treatment (ABVD: 4 Cycles).91

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Number of Participants With Erythroid Response

The rate of erythroid response to treatment with the lenalidomide/prednisone combination in non-del (5q) low and int-1 risk Myelodysplastic Syndrome (MDS) with symptomatic anemia. Hematological improvement erythroid response (HI-E) according to International Working Group (IWG) 2006 criteria. (NCT01133275)
Timeframe: Up to 7 months

Interventionparticipants (Number)
Lenalidomide and Prednisone Therapy5

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The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment

"Geometric mean serum cortisol weighted mean values were calculated at baseline and after 6 weeks (42 days) of treatment. The geometric mean ratio of week 6 / baseline is reported. The primary outcome compares the BDP HFA and Placebo treatment arms. The comparison of active control (Placebo/Prednisone) and Placebo treatment arms is an other pre-specified outcome." (NCT01133626)
Timeframe: Day 0 (Baseline), Day 42

Interventionratio (Geometric Mean)
BDP HFA 320 µg/Day0.90
Placebo0.95
Placebo/Prednisone0.31

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Time to Treatment Failure on or After Week 6

"Time to treatment failure was analyzed using Kaplan-Meier methods. Treatment failures on or after Week 6 were counted as events. Dropouts for reasons other than treatment failure at any time during the study were censored at the dropout date. To be considered a treatment failure, ≥ 1 of these criteria had to be present in at least 1 eye:~New active, inflammatory chorioretinal or retinal vascular lesions relative to Baseline~Inability to achieve ≤ 0.5+ at Week 6 or a 2-step increase relative to best state achieved at all visits after Week 6 in anterior chamber cell grade or vitreous haze grade~Worsening of best corrected visual acuity by ≥ 15 letters relative to best state achieved.~Per protocol, the primary analysis was performed in the Main Study population which included all randomized participants recruited outside Japan; for completeness results are also reported below for the Integrated dataset which includes participants recruited in Japan." (NCT01138657)
Timeframe: From Baseline until end of study (up to 80 weeks)

Interventionmonths (Median)
Main Study: Placebo3.0
Main Study: Adalimumab5.6
Integrated Study (Main + Japan Sub-study): Placebo3.0
Integrated Study (Main + Japan Sub-study): Adalimumab4.8

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Change in Anterior Chamber (AC) Cell Grade in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit

"Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria:~Grade 0 = < 1 cell;~Grade 0.5+ = 1-5 cells;~Grade 1+ = 6-15 cells;~Grade 2+ = 16-25 cells;~Grade 3+ = 26-50 cells;~Grade 4+ = > 50 cells." (NCT01138657)
Timeframe: From Baseline to Week 6 and at the Final/Early Termination Visit (up to 80 weeks)

,,,
Interventionunits on a scale (Mean)
Left EyeRight Eye
Integrated Study (Main + Japan Sub-study): Adalimumab0.350.36
Integrated Study (Main + Japan Sub-study): Placebo0.560.65
Main Study: Adalimumab0.350.36
Main Study: Placebo0.590.69

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Change In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) In Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit

Using corrective lenses based on that visit's refraction testing, participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart. (NCT01138657)
Timeframe: From Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks)

,,,
InterventionlogMAR (Mean)
Left EyeRight Eye
Integrated Study (Main + Japan Sub-study): Adalimumab0.070.05
Integrated Study (Main + Japan Sub-study): Placebo0.110.13
Main Study: Adalimumab0.070.04
Main Study: Placebo0.120.13

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Change in Vitreous Haze (VH) Grade in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit

"Vitreous haze was measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to National Eye Institute (NEI) and SUN criteria:~Grade 0: No evident vitreous haze;~Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized;~Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades);~Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades);~Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry;~Grade 4+: Optic nerve head is obscured." (NCT01138657)
Timeframe: From Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks)

,,,
Interventionunits on a scale (Mean)
Left EyeRight Eye
Integrated Study (Main + Japan Sub-study): Adalimumab0.110.16
Integrated Study (Main + Japan Sub-study): Placebo0.340.49
Main Study: Adalimumab0.110.13
Main Study: Placebo0.330.45

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Percent Change in Central Retinal Thickness in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit

Central retinal thickness was measured using optical coherence tomography and assessed by a central reader. (NCT01138657)
Timeframe: Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks)

,,,
Interventionpercent change (Mean)
Left eye (n=100, 100, 107, 108)Right eye (n=102, 101, 108, 109)
Integrated Study (Main + Japan Sub-study): Adalimumab13.914.5
Integrated Study (Main + Japan Sub-study): Placebo19.021.7
Main Study: Adalimumab9.68.2
Main Study: Placebo20.222.0

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Time to Optical Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Week 6

"Optical coherence tomography was performed at every visit using 1 of 3 approved machines. Images were evaluated by a central reader. Macular edema was defined as cystoid macular edema.~OCT evidence of macular edema on or after Week 6 was to be counted as an event. Dropouts due to reasons other than OCT evidence of macular edema were to be considered as censored observations at the time of dropping out." (NCT01138657)
Timeframe: From Baseline until the Final Visit (up to 80 weeks)

Interventionmonths (Median)
Main Study: Placebo6.2
Main Study: Adalimumab11.1
Integrated Study (Main + Japan Sub-study): Placebo3.7
Integrated Study (Main + Japan Sub-study): Adalimumab9.2

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Change in VFQ-25 Distance Vision Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit

"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question.~The distance vision subscore is calculated from the answers to 3 distance vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning." (NCT01138657)
Timeframe: Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)

Interventionunits on a scale (Mean)
Main Study: Placebo-5.64
Main Study: Adalimumab-3.77
Integrated Study (Main + Japan Sub-study): Placebo-5.72
Integrated Study (Main + Japan Sub-study): Adalimumab-4.42

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Change in VFQ-25 Near Vision Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit

"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question.~The distance vision subscore is calculated from the answers to 3 near vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning." (NCT01138657)
Timeframe: Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)

Interventionunits on a scale (Mean)
Main Study: Placebo-8.09
Main Study: Adalimumab-2.97
Integrated Study (Main + Japan Sub-study): Placebo-7.65
Integrated Study (Main + Japan Sub-study): Adalimumab-3.52

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Change in VFQ-25 Ocular Pain Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit

"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question.~The ocular pain subscore is calculated from the answers to 2 ocular pain-related questions and ranges from 0 to 100, where higher scores or increases in score indicate less pain." (NCT01138657)
Timeframe: Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)

Interventionunits on a scale (Mean)
Main Study: Placebo-12.62
Main Study: Adalimumab-2.60
Integrated Study (Main + Japan Sub-study): Placebo-12.39
Integrated Study (Main + Japan Sub-study): Adalimumab-3.56

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Change in Visual Functioning Questionnaire 25 (VFQ-25) Composite Score From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit

"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The overall composite score ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning." (NCT01138657)
Timeframe: Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)

Interventionunits on a scale (Mean)
Main Study: Placebo-5.50
Main Study: Adalimumab-1.30
Integrated Study (Main + Japan Sub-study): Placebo-5.34
Integrated Study (Main + Japan Sub-study): Adalimumab-1.68

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Overall Survival

Overall survival is defined as the time from randomization to death or the date of last known alive. (NCT01145508)
Timeframe: Assessed every 3 months for 2 years, and then every 6 months for 3 years

InterventionMonths (Median)
Arm A (Vaccine and Chemotherapy)20.8
Arm B (Chemotherapy)NA

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Remission According to DAS28-CRP at Week 16

"Number of patients in remission according to DAS28-CRP (Disease Activity Score based on 28 joint count and C-reactive Protein) at week 16.~DAS28-CRP is calculated with the following formula : 0.56*SQRT TJC28+0.28*SQRT SJC28+0.36*ln (CRP+1)+0.014*GH+0.96 in which TJC is the tender joint count, SJC the Swollen Joint Count and GH the general health estimated by the patient on a Visual Analogue Scale (VAS).~A value below 2.6 is indicating remission, below or equal to 3.2 low disease activity, between 3.2 and 5.1 moderate disease activity and above 5.1 high disease activity." (NCT01172639)
Timeframe: week 16

InterventionParticipants (Count of Participants)
CoBRA Classic High Risk Group69
CoBRA Slim High Risk Group72
CoBRA Avant-garde High Risk Group61
CoBRA Slim Low Risk Group25
Tight Step Up Low Risk Group23

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Remission According to DAS28-CRP at Week 104

"Number of patients in remission according to DAS28-CRP (Disease Activity Score based on 28 joint count and C-reactive Protein) at week 104. (co-primary endpoints)~DAS28-CRP is calculated with the following formula : 0.56*SQRT TJC28+0.28*SQRT SJC28+0.36*ln (CRP+1)+0.014*GH+0.96 in which TJC is the tender joint count, SJC the Swollen Joint Count and GH the general health estimated by the patient on a Visual Analogue Scale (VAS).~A value below 2.6 is indicating remission, below or equal to 3.2 low disease activity, between 3.2 and 5.1 moderate disease activity and above 5.1 high disease activity." (NCT01172639)
Timeframe: week 104

InterventionParticipants (Count of Participants)
CoBRA Classic High Risk Group64
CoBRA Slim High Risk Group71
CoBRA Avant-garde High Risk Group69
CoBRA Slim Low Risk Group29
Tight Step Up Low Risk Group34

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Clinically Significant Change in HAQ Score

"Number of patients with a change of > 0.22 in the Health Assessment Questionnaire (HAQ) score over the period between baseline and week 104.~A change of > 0.22 in this score is considered as clinical relevant for rheumatoid arthritis patients." (NCT01172639)
Timeframe: Baseline-week104

InterventionParticipants (Count of Participants)
CoBRA Classic High Risk Group71
CoBRA Slim High Risk Group62
CoBRA Avant-garde High Risk Group64
CoBRA Slim Low Risk Group25
Tight Step Up Low Risk Group26

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Remission According to SDAI at Week 52

"Number of patients in remission according to SDAI (Simplified Disease Activity Index) at week 52.~SDAI is calculated with the following formula : TJC28+SJC28+GH+GA ph in which TJC is the number of tender joints, SJC the number of Swollen Joint and GH the general health assessed by the patient on a Visual Analogue Scale (VAS) and GA ph the general assessment of the physician on a VAS.~A value below 3.3 is indicating remission, between 3.4 and 11.0 low disease activity, between 11.1 and 26.0 moderate disease activity and above 26.0 high disease activity." (NCT01172639)
Timeframe: week 52

InterventionParticipants (Count of Participants)
CoBRA Classic High Risk Group36
CoBRA Slim High Risk Group27
CoBRA Avant-garde High Risk Group39
CoBRA Slim Low Risk Group20
Tight Step Up Low Risk Group15

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Remission According to SDAI at Week 104

"Number of patients in remission according to SDAI (Simplified Disease Activity Index) at week 104.~SDAI is calculated with the following formula : TJC28+SJC28+GH+GA ph in which TJC is the number of tender joints, SJC the number of Swollen Joint and GH the general health assessed by the patient on a Visual Analogue Scale (VAS) and GA ph the general assessment of the physician on a VAS.~A value below 3.3 is indicating remission, between 3.4 and 11.0 low disease activity, between 11.1 and 26.0 moderate disease activity and above 26.0 high disease activity." (NCT01172639)
Timeframe: week 104

InterventionParticipants (Count of Participants)
CoBRA Classic High Risk Group31
CoBRA Slim High Risk Group28
CoBRA Avant-garde High Risk Group41
CoBRA Slim Low Risk Group20
Tight Step Up Low Risk Group13

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Remission According to SDAI (Simple Disease Activity Index) at Week 16

"Number of patients in remission according to SDAI (Simplified Disease Activity Index) at week 16.~SDAI is calculated with the following formula : TJC28+SJC28+GH+GA ph in which TJC is the number of tender joints, SJC the number of Swollen Joint and GH the general health assessed by the patient on a Visual Analogue Scale (VAS) and GA ph the general assessment of the physician on a VAS.~A value below 3.3 is indicating remission, between 3.4 and 11.0 low disease activity, between 11.1 and 26.0 moderate disease activity and above 26.0 high disease activity." (NCT01172639)
Timeframe: week 16

InterventionParticipants (Count of Participants)
CoBRA Classic High Risk Group42
CoBRA Slim High Risk Group33
CoBRA Avant-garde High Risk Group44
CoBRA Slim Low Risk Group12
Tight Step Up Low Risk Group12

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Remission According to DAS28-CRP at Week 52

"Number of patients in remission according to DAS28-CRP (Disease Activity Score based on 28 joint count and C-reactive Protein) at week 52. (co-primary end point)~DAS28-CRP is calculated with the following formula : 0.56*SQRT TJC28+0.28*SQRT SJC28+0.36*ln (CRP+1)+0.014*GH+0.96 in which TJC is the tender joint count, SJC the Swollen Joint Count and GH the general health estimated by the patient on a Visual Analogue Scale (VAS).~A value below 2.6 is indicating remission, below or equal to 3.2 low disease activity, between 3.2 and 5.1 moderate disease activity and above 5.1 high disease activity." (NCT01172639)
Timeframe: week 52

InterventionParticipants (Count of Participants)
CoBRA Classic High Risk Group63
CoBRA Slim High Risk Group57
CoBRA Avant-garde High Risk Group57
CoBRA Slim Low Risk Group29
Tight Step Up Low Risk Group29

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Geometric Mean Fold Change From Baseline in Interleukin-1β (IL-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge

Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-1β were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants. (NCT01193049)
Timeframe: Baseline and 7 hours post-allergen challenge

,
InterventionFold Change (Geometric Mean)
SputumNasal Exudates
Placebo1.340.39
Prednisone0.800.19

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Geometric Mean Fold Change From Baseline in Eotaxin-3 From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge

Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of Eotaxin-3 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants. (NCT01193049)
Timeframe: Baseline and 7 hours post-allergen challenge

,
InterventionFold Change (Geometric Mean)
SputumNasal Exudates
Placebo2.141.35
Prednisone1.300.86

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Geometric Mean Fold Change From Baseline in Interleukin-13 (IL-13) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge

Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-13 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants. (NCT01193049)
Timeframe: Baseline and 7 hours post-allergen challenge

,
InterventionFold Change (Geometric Mean)
SputumNasal Exudate
Placebo5.863.29
Prednisone1.571.02

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Geometric Mean Fold Change From Baseline in Interleukin-17 (IL-17) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge

Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-17 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants. (NCT01193049)
Timeframe: Baseline and 7 hours post-allergen challenge

,
InterventionFold Change (Geometric Mean)
SputumNasal Exudates
Placebo0.831.23
Prednisone0.680.84

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Geometric Mean Fold Change From Baseline in Interleukin-5 (IL-5) Concentration From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge

Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, nasal exudates (NE) and sputum (SP) were collected, then the concentrations of IL-5 were determined from NE and SP collected after 7 hours and previously at baseline (BL), to derive the fold change (FC) from BL for each participant. The geometric mean (GM) was determined by averaging FC from BL for all analyzed participants. (NCT01193049)
Timeframe: Baseline and 7 hours post-allergen challenge

,
InterventionFold Change (Geometric Mean)
SputumNasal Exudate
Placebo8.608.63
Prednisone2.161.69

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Geometric Mean Fold Change From Baseline in Macrophage Inflammatory Protein-1β (MIP-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge

Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of MIP-1β were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants. (NCT01193049)
Timeframe: Baseline and 7 hours post-allergen challenge

,
InterventionFold Change (Geometric Mean)
SputumNasal Exudates
Placebo1.921.19
Prednisone1.350.73

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Geometric Mean Fold Change From Baseline in RNA Expression for Genes Encoding IL-5 and IL-13 From Sputum at 7 Hours Post-allergen Challenge

Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, SP were collected, then the RNA expression profiles of IL-5 and IL-13 genes were determined from SP collected after 7 hours and previously at baseline, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants. (NCT01193049)
Timeframe: Baseline and 7 hours post-allergen challenge

,
InterventionFold Change (Geometric Mean)
IL-5IL-13
Placebo7.373.93
Prednisone4.872.90

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Geometric Mean Fold Change From Baseline in Thymus and Activation Regulated Chemokine (TARC) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge

Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of TARC were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants. (NCT01193049)
Timeframe: Baseline and 7 hours post-allergen challenge

,
InterventionFold Change (Geometric Mean)
SputumNasal Exudates
Placebo2.041.22
Prednisone1.631.33

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Time to Deterioration in Global Health Status

Global health status deterioration is defined as a drop greater than 16 points from the baseline assessment, confirmed at least 3 weeks later, on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core Module 30 (EORTC QLQ-C30) index after the score has been linearly transformed to a 0 to 100 scale. EORTC QLQ-C30 consists of 30 questions, where question 1 to 28 can be answered with 1: Not at all, 2: A little, 3: Quite a bit, 4: Very much and question 29 to 30 with 1: Very poor to 7: Excellent. For subscales a high score from 0-100 indicates: high global quality of life, high level of functioning (physical, role, emotional, cognitive, social) or a high level of symptoms (fatigue, nausea, pain, dyspnea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties). (NCT01193244)
Timeframe: Baseline until EOT (approximately up to 4.7 years)

Interventionmonths (Median)
Placebo + Prednisone 5 mg10.7
Orteronel 400 mg + Prednisone 5 mg8.3

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Time to Docetaxel Chemotherapy

Time to docetaxel based chemotherapy is defined as the time from randomization to the start of docetaxel based chemotherapy for prostate cancer, regardless of whether the participant received concurrent orteronel or not. Deaths due to disease progression prior to Docetaxel based chemotherapy were considered as events. (NCT01193244)
Timeframe: Baseline until start of docetaxel chemotherapy (up to 4.7 years)

Interventionmonths (Median)
Placebo + Prednisone 5 mg19.0
Orteronel 400 mg + Prednisone 5 mg23.0

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Time to Pain Progression

Time to pain progression was defined as the time from participant randomization to the first assessment date of pain progression. Pain progression was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: The brief pain inventory-short form (BPI-SF) worst pain score was >=4 with a >=2 point increase over baseline in BPI-SF worst pain score with stable or increased analgesic use; The BPI-SF worst pain score was >=4 but not less than baseline with new or increased (relative to baseline) Step II or Step III analgesic use; The BPI-SF worst pain score was <=3 but not less than baseline with new or increased (relative to baseline) Step III analgesic use. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 100 with lower scores being indicative of less pain or pain interference. (NCT01193244)
Timeframe: Baseline until End of treatment (EOT) (approximately up to 4.7 years)

Interventionmonths (Median)
Placebo + Prednisone 5 mgNA
Orteronel 400 mg + Prednisone 5 mgNA

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Time to PSA Progression

Time to PSA progression was defined as time from randomization to a PSA increase of 25 percent and PSA rise of at least 2 nanogram per milliliter (ng/mL) above the lowest value observed post baseline or, if no PSA decline occurred post baseline, compared to baseline PSA. (NCT01193244)
Timeframe: Baseline until the final on treatment assessment or until end of short term follow-up following discontinuation of treatment, whichever occurred later (approximately up to 4.7 years)

Interventionmonths (Median)
Placebo + Prednisone 5 mg5.59
Orteronel 400 mg + Prednisone 5 mg8.3

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Time to SRE

Time to SRE is defined as the time from randomization to SRE, or death due to any cause, whichever comes first. SRE is defined as a fracture or spinal cord compression or the need for radiation or surgery at the site of a prostate cancer metastatic lesion that is substantiated by radiographic or pathologic evidence. (NCT01193244)
Timeframe: Baseline up to EOT (Cycle 61 Day 58)

Interventionmonths (Median)
Placebo + Prednisone 5 mg9.0
Orteronel 400 mg + Prednisone 5 mg13.9

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Overall Survival

Overall survival was calculated from the date of participant randomization to the date of participant death due to any cause. Participants without documentation of death at time of the analysis were censored as of the date the participant was last known to be alive, or the data cutoff date, whichever was earlier. (NCT01193244)
Timeframe: Baseline until death (up to 4.7 years)

Interventionmonths (Median)
Placebo + Prednisone 5 mg29.5
Orteronel 400 mg + Prednisone 5 mg29.9

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Time to Subsequent Antineoplastic Therapy

Time to subsequent antineoplastic therapy is defined as the time from randomization to the start of any alternate antineoplastic therapy for prostate cancer. Deaths due to disease progression prior to antineoplastic therapy for prostate cancer are considered as events. Otherwise, time to next therapy is censored at the date of death or the last date the participant was known to be alive or the data cutoff date, whichever is earlier. (NCT01193244)
Timeframe: Baseline until start of subsequent antineoplastic therapy (up to 4.7 years)

Interventionmonths (Median)
Placebo + Prednisone 5 mg13.9
Orteronel 400 mg + Prednisone 5 mg17.2

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Worst Change From Baseline Over Time in Cardiac Ejection Fraction

Worst change was defined as the worst overall change that occurred in cardiac ejection fraction at any measured time point. (NCT01193244)
Timeframe: Baseline up to 30 days or EOT whichever is later (approximately up to Cycle 61 Day 58)

Interventionpercent ejection fraction (Mean)
Placebo + Prednisone 5 mg-3.8
Orteronel 400 mg + Prednisone 5 mg-4.8

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Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

(NCT01193244)
Timeframe: Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)

,
Interventionparticipants (Number)
TEAESerious Adverse Events (SAE)
Orteronel 400 mg + Prednisone 5 mg769380
Placebo + Prednisone 5 mg733321

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Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings

(NCT01193244)
Timeframe: Baseline up to EOT (Cycle 61 Day 58)

Interventionparticipants (Number)
Placebo + Prednisone 5 mg130
Orteronel 400 mg + Prednisone 5 mg163

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Radiographic Progression-free Survival (rPFS)

rPFS was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause, whichever occurred first. Radiographic disease progression was evaluated by computerized tomography (CT) scan or magnetic resonance imaging (MRI) and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for soft tissue disease and Prostate Cancer Working Group (PCWG2) guidelines for bone disease. Participants who did not reach the endpoint were censored at their last assessment. (NCT01193244)
Timeframe: Baseline until radiographic disease progression or death, whichever occurred first (approximately up to 4.7 years)

Interventionmonths (Median)
Placebo + Prednisone 5 mg8.7
Orteronel 400 mg + Prednisone 5 mg13.8

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Percentage of Participants Achieving 90 Percent Reduction From Baseline in Prostate Specific Antigen (PSA90 Response) at Week 12

The PSA90 is defined as a decline of PSA by 90 percent from baseline. (NCT01193244)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Placebo + Prednisone 5 mg5.4
Orteronel 400 mg + Prednisone 5 mg16.7

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Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50) Response at Week 12

The PSA50 is defined as a decline of at least 50 percent (%) from baseline. (NCT01193244)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Placebo + Prednisone 5 mg24.6
Orteronel 400 mg + Prednisone 5 mg42.6

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Percentage of Participants With Favorable Circulating Tumor Cell Count (CTC) Levels at Week 12

A favorable CTC count was defined as less than <5 counts per 7.5 milliliter (mL) in whole blood. An unfavorable CTC count was defined as greater than or equal to (>=) 5 counts/7.5 mL in whole blood. (NCT01193244)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Placebo + Prednisone 5 mg9.1
Orteronel 400 mg + Prednisone 5 mg15.4

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Percentage of Participants With Objective Response

Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1. A CR was defined as the disappearance of all target lesions determined by computerized tomography (CT) or MRI. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 millimetre (mm). A PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of longest diameters of non-lymph node lesions and of the short diameter or short axis of lymph nodes. (NCT01193244)
Timeframe: Baseline until disease progression or death, whichever occurred first (approximately up to 4.7 years)

Interventionpercentage of participants (Number)
Placebo + Prednisone 5 mg15.2
Orteronel 400 mg + Prednisone 5 mg34.7

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Percentage of Participants Achieving PSA50 Response at Any Time During the Study

The PSA50 is defined as a decline of PSA by 50 percent from baseline. (NCT01193244)
Timeframe: Cycle: 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 and 37

,
Interventionpercentage of participants (Number)
Cycle 4 (n= 687, 672)Cycle 7 (n= 541, 540)Cycle 10 (n= 438, 450)Cycle 13 (n= 344, 382)Cycle 16 (n= 286, 303)Cycle 19 (n= 228, 272)Cycle 22 (n= 184, 211)Cycle 25 (n= 109, 119)Cycle 28 (n= 67, 77)Cycle 31 (n= 35, 39)Cycle 34 (n= 22, 18)Cycle 37 (n= 7, 5)
Orteronel 400 mg + Prednisone 5 mg49.7054.8156.0053.1454.1352.9454.0346.2248.0548.7238.8940.00
Placebo + Prednisone 5 mg28.0934.9436.9937.2134.2737.7233.1535.7844.7834.2936.3671.43

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Percentage of Participants Achieving PSA90 Response at Any Time During the Study

The PSA90 is defined as a decline of PSA by 90 percent from baseline. (NCT01193244)
Timeframe: Cycle: 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 and 37

,
Interventionpercentage of participants (Number)
Cycle 4 (n= 687, 672)Cycle 7 (n= 541, 540)Cycle 10 (n= 438, 450)Cycle 13 (n= 344, 382)Cycle 16 (n= 286, 303)Cycle 19 (n= 228, 272)Cycle 22 (n= 184, 211)Cycle 25 (n= 109, 119)Cycle 28 (n= 67, 77)Cycle 31 (n= 35, 39)Cycle 34 (n= 22, 18)Cycle 37 (n= 7, 5)
Orteronel 400 mg + Prednisone 5 mg16.6722.2226.4426.1825.7426.1028.4421.0127.2712.8222.2220.00
Placebo + Prednisone 5 mg5.398.6911.6412.7912.2412.7210.8711.0116.428.574.5514.29

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Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to (>=) Grade 3

Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE. (NCT01193244)
Timeframe: Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)

,
Interventionparticipants (Number)
Grade 3 or higher TEAEGrade 5 (Death)
Orteronel 400 mg + Prednisone 5 mg53777
Placebo + Prednisone 5 mg40578

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Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status

ECOG assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (>50 percent of waking hours [hrs]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50 percent of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. Worst change was defined as the worst overall change that occurred in ECOG status at any measured time point during the treatment period. (NCT01193244)
Timeframe: Baseline until EOT (approximately up to 4.7 years)

,
Interventionparticipants (Number)
Baseline: 0; Overall: 0Baseline: 0; Overall: 1Baseline: 0; Overall: 2Baseline: 0; Overall: 3Baseline: 0; Overall: 4Baseline: 1; Overall: 0Baseline: 1; Overall: 1Baseline: 1; Overall: 2Baseline: 1; Overall: 3Baseline: 1; Overall: 4Baseline: 2; Overall: 2
Orteronel 400 mg + Prednisone 5 mg200237661576147602661
Placebo + Prednisone 5 mg251177472276162572821

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Time to Pain Progression

Time to pain progression was defined as the time from participant randomization to the first assessment date of pain progression. Pain progression was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: The brief pain inventory-short form (BPI-SF) worst pain score was >= 4 with a >= 2 point increase over baseline in BPI-SF worst pain score with stable or increased analgesic use; The BPI-SF worst pain score was >= 4 but not less than baseline with new or increased (relative to baseline) Step II or Step III analgesic use; The BPI-SF worst pain score was <= 3 but not less than baseline with new or increased (relative to baseline) Step III analgesic use. (NCT01193257)
Timeframe: Baseline until EOT visit or until end of short term follow-up, whichever occurred later (approximately up to 4.5 years)

Interventionmonths (Median)
Placebo + Prednisone22.0
Orteronel + Prednisone24.2

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Radiographic Progression-free Survival (rPFS)

rPFS was defined as the time from randomization until radiographic disease progression or death due to any cause, whichever occurred first. Radiographic disease progression was defined as the occurrence of 1 or more of the following: The appearance of 2 or more new lesions on radionuclide bone scan as defined by prostate cancer working group (PCWG)2; Should 2 or more new bone lesions be evident at the first assessment (8-week assessment) on treatment, 2 or more additional new lesions must have been evident on a confirmatory assessment at least 6 weeks later; One or more new soft tissue/visceral organ lesions identified by computed tomography (CT)/magnetic resonance imaging (MRI); Progression as defined by response evaluation criteria in solid tumors (RECIST) 1.1 criteria. (NCT01193257)
Timeframe: Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)

Interventionmonths (Median)
Placebo + Prednisone5.7
Orteronel + Prednisone8.3

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Time to Pain Response

Time to pain response was defined as the time from randomization until first pain response. Pain response was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: A >= 2 point reduction from baseline in BPI-SF worst pain score without an increase in analgesic use, or a 25% or more reduction in analgesic use from baseline without an increase in worst pain score from baseline. The analysis was performed by Kaplan-Meier method. (NCT01193257)
Timeframe: Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)

Interventionmonths (Median)
Placebo + PrednisoneNA
Orteronel + PrednisoneNA

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Time to PSA Progression

Time to PSA progression was defined as time from randomization to a PSA increase of 25% and PSA rise of at least 2 nanogram per milliliter (ng/mL) above the lowest value observed post baseline or, if no PSA decline occurred post baseline, above the baseline PSA. (NCT01193257)
Timeframe: Baseline until the final on treatment assessment or until end of short term follow-up following discontinuation of treatment, whichever occurred later (approximately up to 4.5 years)

Interventionmonths (Median)
Placebo + Prednisone2.9
Orteronel + Prednisone5.5

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Percentage of Participants With Pain Response at Week 12

Pain response was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: A greater than or equal to (>=) 2 point reduction from baseline in BPI-SF worst pain score without an increase in analgesic use; or a 25 percent (%) or more reduction in analgesic use from baseline without an increase in worst pain score from baseline. (NCT01193257)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Placebo + Prednisone9.0
Orteronel + Prednisone12.1

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Number of Participants With Shifts From Baseline Between Favorable and Unfavorable Categories in Circulating Tumor Cell Count (CTC)

A favorable CTC count was defined as less than (<) 5 counts per (/) 7.5 mililiter (mL) in whole blood. An unfavorable CTC count was defined as >=5 counts/7.5 mL in whole blood. (NCT01193257)
Timeframe: Baseline and EOT (Cycle 59 Day 58)

,
Interventionparticipants (Number)
Baseline: Favorable; EOT: FavorableBaseline: Favorable; EOT: UnfavorableBaseline: Unfavorable; EOT: FavorableBaseline: Unfavorable; EOT: Unfavorable
Orteronel + Prednisone634023141
Placebo + Prednisone2730892

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Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings

(NCT01193257)
Timeframe: Cycle 59 Day 58

Interventionparticipants (Number)
Placebo + Prednisone1
Orteronel + Prednisone3

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Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)

(NCT01193257)
Timeframe: Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)

Interventionparticipants (Number)
Placebo + Prednisone345
Orteronel + Prednisone719

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Percentage of Participants With Objective Response

Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1. The overall objective response was defined as a complete response (CR) or partial response (PR). A complete response (CR) was defined as the disappearance of all target lesions determined by computerized tomography (CT) or MRI. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 millimetre (mm). A PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of longest diameters of non-lymph node lesions and of the short diameter(s) or short axis of lymph nodes. (NCT01193257)
Timeframe: Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)

Interventionpercentage of participants (Number)
Placebo + Prednisone2.7
Orteronel + Prednisone17.1

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Percentage of Participants Achieving 90 Percent Reduction From Baseline in Prostate Specific Antigen (PSA90 Response) at Week 12

The PSA90 was defined as the percentage of participants who had a PSA decline of at least 90% from baseline. (NCT01193257)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Placebo + Prednisone2.83
Orteronel + Prednisone9.66

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Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status

ECOG assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (>50% of waking hours [hrs]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. Worst change was defined as the worst overall change that occurred in ECOG status at any measured time point during the treatment period. (NCT01193257)
Timeframe: Baseline up to End-of-treatment (EOT) (Cycle 59 Day 58)

,
Interventionparticipants (Number)
Baseline: 0; Overall: 0Baseline: 0; Overall: 1Baseline: 0; Overall: 2Baseline: 0; Overall: 3Baseline: 0; Overall: 4Baseline: 1; Overall: 0Baseline: 1; Overall: 1Baseline: 1; Overall: 2Baseline: 1; Overall: 3Baseline: 1; Overall: 4Baseline: 2; Overall: 1Baseline: 2; Overall: 2Baseline: 2; Overall: 3Baseline: 2; Overall: 4
Orteronel + Prednisone11212147183101791133911625183
Placebo + Prednisone56701351310353227010100

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Number of Participants With Abnormal Physical Examination Findings

(NCT01193257)
Timeframe: Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)

Interventionparticipants (Number)
Placebo + Prednisone0
Orteronel + Prednisone1

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Overall Survival

Overall survival was calculated from the date of participant randomization to the date of participant death due to any cause. Participants without documentation of death at time of the analysis were censored as of the date the participant was last known to be alive, or the data cutoff date, whichever was earlier. (NCT01193257)
Timeframe: Baseline until death (approximately up to 4.5 years)

Interventionmonths (Median)
Placebo + Prednisone15.3
Orteronel + Prednisone17.1

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Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50 Response) at Week 12

The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50 percent (%) from baseline. (NCT01193257)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Placebo + Prednisone9.9
Orteronel + Prednisone24.9

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Percentage of Participants Achieving PSA50 Response at Any Time During the Study

The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50% from baseline. (NCT01193257)
Timeframe: Cycle: 4, 7, 10, 13, 16, 19, 22, and 25

,
Interventionparticipants (Number)
Cycle 4 (n= 283; 559)Cycle 7 (n= 163; 403)Cycle 10 (n= 102; 267)Cycle 13 (n= 55; 171)Cycle 16 (n= 34; 107)Cycle 19 (n= 24; 68)Cycle 22 (n= 14; 36)Cycle 25 (n= 8; 16)
Orteronel + Prednisone32.7438.2136.7040.9444.8642.6552.7862.50
Placebo + Prednisone12.7218.4022.5523.6423.5320.8328.5725.00

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Percentage of Participants Achieving PSA90 Response at Any Time During the Study

The PSA90 was defined as the percentage of participants who had a PSA decline of at least 90% from baseline. (NCT01193257)
Timeframe: Cycle: 7, 10, 13, 16, 19, 22, and 25

,
Interventionpercentage of participants (Number)
Cycle 7 (n=163; 403)Cycle 10 (n=102; 267)Cycle 13 (n=55; 171)Cycle 16 (n=34; 107)Cycle 19 (n=24; 68)Cycle 22 (n=14; 36)Cycle 25 (n=8; 16)
Orteronel + Prednisone14.8914.2315.2019.6323.5327.7843.75
Placebo + Prednisone4.916.867.275.884.170.000.00

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Number of Participants With Best Pain Response

Best pain response was evaluated in participants who had a pain response across the entire study were summarized by treatment group. The pain response was defined as a >=2-point reduction from baseline in BPI-SF worst pain score without an increase in analgesic use, or a 25% or more reduction in analgesic use from baseline without an increase in worst pain score from baseline. (NCT01193257)
Timeframe: Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years)

Interventionparticipants (Number)
Placebo + Prednisone72
Orteronel + Prednisone166

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Tumor Response (Phase I)

The percentage of participants whose best tumor response is complete response (CR) or partial response (PR). Based on clinical, radiologic (CT), and pathologic criteria, CR requires 1) complete disappearance of all detectable disease and disease-related symptoms if present before therapy, 2) bone marrow aspirate and biopsy to confirm a CR if initially positive or if clinically indicated by new abnormalities in the peripheral blood counts or blood smear, 3) negative PET results, depending on typically, variably, or unknown pre-treatment FDG status, and 4) spleen and/or liver, if considered to be enlarged before therapy on physical examination or CT scan, not being palpable on physical examination and considered normal size by imaging studies, and nodules related to lymphoma disappeared. PR includes 1) ≥50% decrease in sum of product of diameters (SPD), 2) no increase in size of nodes, liver, or spleen, 3) splenic/hepatic nodules regressed by ≥ 50% SPD, 4) no new sites of disease (NCT01193842)
Timeframe: Up to 2 years post treatment

,,
Interventionpercentage of participants (Number)
Complete responsePartial Response
Phase I: Arm C (VR-CHOP) Dose Level 11000
Phase I: VR-DA-EPOCH, Dose Level 183.316.7
Phase I: VR-DA-EPOCH, Dose Level 283.316.7

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Pharmacokinetic Clearance (Phase I)

Serial plasma samples for pharmacokinetic analysis were collected at 24-48, 48-72, and 72-96 hours after the start of the first chemotherapy infusion. Doxorubicin, etoposide, and vincristine concentrations were determined using a validated liquid chromatography-tandem mass spectrometry method. The clearance was determined by dividing the drug-infusion rate by the steady-state concentrations, which was the average of the three time points. (NCT01193842)
Timeframe: 24-48, 48-72, and 72-96 hours after the start of the first chemotherapy infusion

,
InterventionLiter/hour (Mean)
DoxorubicinEtoposideVincristine
Phase I: VR-DA-EPOCH, Dose Level 178.63.022.4
Phase I: VR-DA-EPOCH, Dose Level 276.02.416.8

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Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II)

The percentage of participants with AEs and their worst severity will be tabulated for each treatment arm. If a participant has more than one AE, the most severe AE is analyzed. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any serious AE (SAE) that the investigator considers related to protocol therapy. (NCT01193842)
Timeframe: Up to 5 years

,
Interventionpercentage of participants (Number)
DeathLife-threateningSevereModerateMild
Phase II: DA-R-EPOCH20.028.931.117.80
Phase II: VR-DA-EPOCH28.937.820.08.92.2

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Changes in Human Immunodeficiency Virus (HIV) Viral Load

Differences from baseline (specified follow-up assessment minus baseline) in HIV viral load. Undetectable viral load results were treated as 0 values. (NCT01193842)
Timeframe: Baseline up to 12 months

,
Interventionmedian change in copies per mL (Median)
End of Cycle 2At treatment discontinuation6-month follow-up12-month follow-up
Phase II: DA-R-EPOCH-25-22.5-18-20
Phase II: VR-DA-EPOCH-20-87-200

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Changes in Absolute CD4 Cell Counts (Phase I)

Differences from baseline (specified follow-up assessment minus baseline) in absolute CD4 counts. (NCT01193842)
Timeframe: Baseline up to 12 months

,,
Interventioncell/mm^3 (Median)
End of cycle 2Treatment discontinuation6-month follow-up12-month follow-up
Phase I: VR-CHOP, Dose Level 1-218-190-175-84
Phase I: VR-DA-EPOCH, Dose Level 192-3976169
Phase I: VR-DA-EPOCH, Dose Level 2-9-293131

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Change in Plasma Associated Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (Phase I)

Differences from baseline (specified follow-up assessment minus baseline) in HIV viral load. Undetectable viral load results were treated as 0 values. (NCT01193842)
Timeframe: Baseline up to 12 months

,,
Interventioncopies per milliliter (Median)
End of cycle 2Treatment discontinuation6-month follow-up12-month follow-up
Phase I: VR-CHOP, Dose Level 128000
Phase I: VR-DA-EPOCH, Dose Level 1-14518-4517-551160
Phase I: VR-DA-EPOCH, Dose Level 2-12.5000

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Change in CD8 Cell Counts (Phase I)

Differences from baseline (specified follow-up assessment minus baseline) in absolute CD8 counts. (NCT01193842)
Timeframe: Baseline up to 12 months

,,
Interventioncells/mm^3 (Median)
End of cycle 2Treatment discontinuation6-month follow-up12-month follow-up
Phase I: VR-CHOP, Dose Level 1-172-81-16128
Phase I: VR-DA-EPOCH, Dose Level 135.5-164.5-56604
Phase I: VR-DA-EPOCH, Dose Level 2-115211275154

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Event-free Survival (EFS) (Phase II)

The percentage of participants surviving without events (relapse or death) one year after starting treatment. (NCT01193842)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Phase II: VR-DA-EPOCH75.6
Phase II: DA-R-EPOCH82.2

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Overall Survival (OS) (Phase II)

The percentage of participants surviving one year after starting treatment. (NCT01193842)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Phase II: VR-DA-EPOCH77.6
Phase II: DA-R-EPOCH86.7

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Percentage of Participants With Complete Response (CR) as Assessed by Response Evaluation Criteria in Solid Tumors (Phase II)

"Percentage of participants with complete response as assessed by Response Evaluation Criteria in Solid Tumors (Phase II) according to treatment arm. Participants are planned to be treated for a total of 6 cycles (21 day cycle length). Participants with CR after Cycle 4 will receive two additional cycles of chemotherapy and complete 6 cycles of chemotherapy. Participants who achieve a partial response (PR) only after Cycle 4 may continue on protocol therapy or they may be removed from the study at the AMC discretion of the physician (local Principal Investigator). Participants with stable disease after 4 cycles (i.e., who did not achieve at least a PR) or progressive disease at any time will be removed from study.~In phase II, there are two arms: Vorinostat RPTD+rituximab-DA-EPOCH arm (VR-DA-EPOCH) and Rituximab-DA-EPOCH arm (DA-R-EPOCH)." (NCT01193842)
Timeframe: Up to 6 months

Interventionpercentage of participants (Number)
Phase II: VR-DA-EPOCH67.5
Phase II: DA-R-EPOCH76.2

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Changes in Human Herpes Virus (HHV)-8 Viral Load

Differences from baseline (specified follow-up assessment minus baseline) in (HHV)-8 viral load. (NCT01193842)
Timeframe: Baseline up to 12 months

Interventioncopies per 100uL (Median)
At treatment discontinuation6-month follow-up12-month follow-up
Phase II: DA-R-EPOCH000

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Changes in Human Herpes Virus (HHV)-8 Viral Load

Differences from baseline (specified follow-up assessment minus baseline) in (HHV)-8 viral load. (NCT01193842)
Timeframe: Baseline up to 12 months

Interventioncopies per 100uL (Median)
12-month follow-up
Phase II: VR-DA-EPOCH0

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Changes in Epstein-Barr Virus (EBV) Viral Load

Differences from baseline (specified follow-up assessment minus baseline) in EBV viral load. (NCT01193842)
Timeframe: Baseline up to 12 months

,,,
InterventionIU/mL (Median)
End of Cycle 2At treatment discontinuation6-month follow-up12-month follow-up
Phase I: VR-DA-EPOCH, Dose Level 10000
Phase I: VR-DA-EPOCH, Dose Level 2-2436.1-1.92-1.92-1.15
Phase II, DA-R-EPOCH0-0.280-2.7
Phase II, VR-DA-EPOCH-0.61-2.9-1.55-0.56

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Stage I and II (Pooled): Event-Free Survival Assessed Using International Working Group Response Criteria for NHL

Event-free survival was defined as the time from randomization to disease progression/relapse, death or initiation of new NHL therapy. If the specified event (progression/relapse, death or new anti-lymphoma treatment) did not occur, event-free survival was censored at the last tumor assessment date either during treatment or follow up. Event-free survival analysis was performed using Kaplan-Meier curves. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 31 Oct 2017 [up to 6 years]) (NCT01200758)
Timeframe: Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)

Interventiondays (Median)
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)NA
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)NA

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Percentage of Participants Who Died

(NCT01200758)
Timeframe: Baseline up to death (up to data cutoff of 31 Oct 2017 [up to 6 years])

Interventionpercentage of participants (Number)
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)12.7
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)8.8

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Stage I and II (Pooled): Percentage of Participants With Disease Progression/Relapse or Death

Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node >1 cm in its short axis or in the SPD of more than one node. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to median of 27 months; up to data cutoff of 31 Oct 2017 [up to 6 years]) (NCT01200758)
Timeframe: Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)

Interventionpercentage of participants (Number)
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)34.6
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)31.7

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Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL

Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper. (NCT01200758)
Timeframe: Stage I and II: Baseline up to 57 days after last maintenance dose (last maintenance dose: maintenance Cy12/Study Cy20 [30 months]) (up to data cutoff of 31 Oct 2017 [up to 6 years]) (1 Cy=8 weeks)

Interventionpercentage of participants (Number)
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)57.9
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)50.6

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Stage I and II (Pooled): Percentage of Participants With Disease Progression/Relapse, New Anti-Lymphoma Treatment or Death Assessed Using International Working Group Response Criteria for NHL

Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node >1 cm in its short axis or in the SPD of more than one node. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 31 Oct 2017 [up to 6 years]) (NCT01200758)
Timeframe: Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)

Interventionpercentage of participants (Number)
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)36.1
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)35.1

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Overall Survival (OS)

OS was defined as the time from randomization to death due to any cause. Participants without event were censored at the time of last follow-up information for survival, ie, at the last time known to be alive. (NCT01200758)
Timeframe: Baseline up to death (up to data cutoff of 31 Oct 2017 [up to 6 years])

Interventiondays (Median)
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)NA
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)NA

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Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL

Overall Response comprised of CR, CRu, or PR . A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper. (NCT01200758)
Timeframe: Stage I and II: Baseline up to 57 days after last maintenance dose (last maintenance dose: maintenance Cy12/Study Cy20 [30 months]) (up to data cutoff of 31 Oct 2017 [up to 6 years]) (1 Cy=8 weeks)

Interventionpercentage of participants (Number)
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)78.1
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)77.9

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Percentage of Responses Who Showed Rituximab SC Formulation Convenient as Compared to Rituximab IV Formulation as Assessed by Physician/Nurse Opinion

"All investigator physicians and nurses involved in this study were asked to complete question i.e. Which formulation of rituximab (SC or IV) do you think is more convenient? based on their experience with the rituximab SC and IV formulations across all participants and presented as rituximab SC is much more convenient; rituximab SC is a little more convenient; both formulations are equally convenient; rituximab IV is a little more convenient; and rituximab IV is much more convenient." (NCT01200758)
Timeframe: After Cycle 8 of induction treatment (24 weeks) and during the maintenance part of the study after 12 months (i.e., Cycle 15), and after the end of the maintenance treatment, (i.e., Cycle 20) (1 Cycle=4 weeks for Cycle 8 and 8 weeks for Cycles 15 and 20)

Interventionpercentage of responses (Number)
Cy8: Rituximab SC much more convenient (n=166)Cy8: Rituximab SC little more convenient (n=166)Cy8: Both formulations equally convenient (n=166)Cy8: Rituximab IV little more convenient (n=166)Cy8: Rituximab IV much more convenient (n=166)Cy15: Rituximab SC much more convenient (n=130)Cy15: Rituximab SC little more convenient (n=130)Cy15: Both formulations equally convenient (n=130)Cy15: Rituximab IV little more convenient (n=130)Cy15: Rituximab IV much more convenient (n=130)Cy20: Rituximab SC much more convenient (n=126)Cy20: Rituximab SC little more convenient (n=126)Cy20: Both formulations equally convenient (n=126)Cy20: Rituximab IV little more convenient (n=126)Cy20: Rituximab IV much more convenient (n=126)
All Participants8113240887500889210

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Percentage of Participants With B-Cell Depletion by Cycle for Maintenance Phase

Depletion is defined as a CD19 value <80 cells/mm^3. (NCT01200758)
Timeframe: Stage I and II (maintenance): D1 of Cy 9 to 20 (1 Cy=8 weeks) (up to data cutoff of 11 Jan 2016 [up to 6 years])

,
Interventionpercentage of participants (Number)
Cycle 9 Day 1 (n=170, 161)Cycle 10 Day 1 (n=165, 164)Cycle 11 Day 1 (n=158, 158)Cycle 12 Day 1 (n=151, 146)Cycle 13 Day 1 (n=149, 143)Cycle 14 Day 1 (n=152, 143)Cycle 15 Day 1 (n=149, 140)Cycle 16 Day 1 (n=142, 141)Cycle 17 Day 1 (n=145, 142)Cycle 18 Day 1 (n=141, 140)Cycle 19 Day 1 (n=140, 138)Cycle 20 Day 1 (n=139, 134)
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)99.499.499.4100.0100.0100.0100.0100.0100.0100.0100.0100.0
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)100.0100.0100.0100.0100.0100.0100.0100.0100.0100.0100.0100.0

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Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL

Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper. (NCT01200758)
Timeframe: Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)

Interventionpercentage of participants (Number)
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)31.7
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)32.2

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Percentage of Participants With B-Cell Depletion by Cycle for Induction Phase

Depletion is defined as a cluster of differentiation (CD) 19 value <80 cells per cubic millimeter (cells/mm^3). (NCT01200758)
Timeframe: Stage I and II (induction): for rituximab IV - D1 of Cy 1 to 8 (1 Cy=3 weeks); for rituximab SC - D1 of Cy 1 and Cy 3 to 8, D0 of Cy 2

,
Interventionpercentage of participants (Number)
Cycle 1 Day 1 - Baseline (n=188, 168)Cycle 2 Day 0 (n=183, 180)Cycle 3 Day 1 (n=175, 175)Cycle 4 Day 1 (n=178, 180)Cycle 5 Day 1 (n=179, 176)Cycle 6 Day 1 (n=173, 175)Cycle 7 Day 1 (n=178, 173)Cycle 8 Day 1 (n=175, 174)
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)51.695.199.499.4100.0100.0100.0100.0
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)54.895.099.4100.0100.0100.0100.0100.0

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Stage II: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for Non-Hodgkin Lymphoma (NHL)

Overall Response comprised complete response (CR), CR unconfirmed (CRu), or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and computed tomography (CT) scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by more than (>) 75% in the sum of the products of greatest diameters (SPD); PR: Greater than or equal to (≥) 50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI was estimated for one sample binomial using Pearson-Clopper. (NCT01200758)
Timeframe: Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)

Interventionpercentage of participants (Number)
Stage II: Rituximab IV + Chemotherapy (CHOP/CVP)85.1
Stage II: Rituximab SC + Chemotherapy (CHOP/CVP)80.3

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Stage II: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL

Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper. (NCT01200758)
Timeframe: Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)

Interventionpercentage of participants (Number)
Stage II: Rituximab IV + Chemotherapy (CHOP/CVP)34.8
Stage II: Rituximab SC + Chemotherapy (CHOP/CVP)28.2

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Stage I: Observed Area Under the Serum Concentration-Time Curve (AUC) of Rituximab

AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Predose (within 2 hr) and 24 hrs postdose on Cy 7 (D1,3,7,15), predose (0 hr) on Cy 8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion (infusion duration=30 minutes) on Cy 7 D1 for rituximab IV (up to data cutoff of 11 Apr 2012 [up to 26 months]) (NCT01200758)
Timeframe: Stage I (Induction): Predose (within 2 hour [hr]) up to data cutoff of 11 Apr 2012 [up to 26 months]) (See detailed timeframe in Outcome Measure description)

Interventionmcg*day/mL (Geometric Mean)
Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)2734.21
Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)3778.93

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Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL

Overall Response comprised of CR, CRu, or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumour response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD; PR: ≥50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper. (NCT01200758)
Timeframe: Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)

Interventionpercentage of participants (Number)
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)84.9
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)84.4

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Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab

(NCT01200758)
Timeframe: Stage I: Cycle (Cy) 7 Day (D) 21 (within 2 hours predose on Cy8) of induction treatment (1 Cy=3 weeks)

Interventionmicrograms per milliliter (mcg/mL) (Geometric Mean)
Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)83.1
Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)134.6

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Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Human Antibodies (HAHAs) to Rituximab

Levels of HAHA in serum were detected at Day 1 of each cycle up to Cycle 8 and at follow-up visit. Stage I and II: Baseline: pre-dose (72 hours prior) D1 of Cy1, Cy 3-20, D0 of Cy2 (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), post-baseline: every 12 weeks after last rituximab administration until 96 weeks (a median of 27 months; up to data cutoff of 11 Jan 2016 [up to 6 years]) (NCT01200758)
Timeframe: Stage I and II: Baseline, post-baseline (See detailed timeframe in Outcome Measure description)

,
Interventionpercentage of participants (Number)
Baseline (n=68, 188)Post-Baseline (n=66, 197)
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)10.37.6
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)11.213.2

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Stage I and II (Pooled): Ctrough of Rituximab at Each Induction Treatment Cycle

Stage I and II (Induction): Rituximab IV: Predose (within 2 hr) on D1 of Cy1-8 (1 Cy=3 weeks & 4 weeks for Cy8); Rituximab SC: Predose (within 2 hr) on D1 of Cy1 & Cy3-8 (1 Cy=3 weeks and 4 weeks for Cy8), predose (within 2 hr) on D0 of Cy2 (up to data cutoff of 31 Oct 2013 [up to 32 months]) (NCT01200758)
Timeframe: Stage I and II (Pooled): Predose (within 2hr) up to data cutoff of 31 Oct 2013 [up to 32 months]) (See detailed timeframe in Outcome Measure description)

,
Interventionmcg/mL (Geometric Mean)
Cycle 1 (n = 198, 193)Cycle 2 (n = 197, 190)Cycle 3 (n = 192, 190)Cycle 4 (n = 186, 185)Cycle 5 (n = 185, 185)Cycle 6 (n = 187, 180)Cycle 7 (n = 183, 172)Cycle 8 (n = 52, 54)
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)14.0030.1345.2554.0664.6871.0278.3177.60
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)12.8840.0063.8381.7198.00109.56120.75131.48

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Stage I: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL

Complete Response was comprised CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper. (NCT01200758)
Timeframe: Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)

Interventionpercentage of participants (Number)
Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)25.0
Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)42.9

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Stage I: Maximum Serum Concentrations (Cmax) of IV and SC Rituximab

Predose (within 2 hr) and 24 hrs postdose on Cy7 (D1,3,7,15), predose (0 hr) on Cy8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion (infusion duration=30 minutes) on Cy7 D1 for rituximab IV (up to data cutoff of 11 Apr 2012 [up to 26 months]) (NCT01200758)
Timeframe: Stage I (Induction): Predose (within 2hr) up to data cutoff of 11 Apr 2012 [up to 26 months]) (See detailed timeframe in Outcome Measure description)

Interventionmcg/mL (Geometric Mean)
Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)250.63
Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)236.82

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Stage I and II (Pooled): Progression-Free Survival (PFS) Assessed Using International Working Group Response Criteria for NHL

PFS was defined as the time from randomization to disease progression/relapse or death due to any cause. If the specified event (disease progression/relapse, death) did not occur, PFS was censored at the last tumor assessment date showing no disease progression, either during treatment or follow-up. Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node >1 cm in its short axis or in the SPD of more than one node. PFS analysis was performed using Kaplan - Meier curves. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to median of 27 months; up to data cutoff of 31 Oct 2017 [up to 6 years]) (NCT01200758)
Timeframe: Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)

Interventiondays (Median)
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)NA
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)NA

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Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL

Overall Response comprised CR, CRu, or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in the SPD; PR: ≥50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI was estimated for one sample binomial using Pearson-Clopper. (NCT01200758)
Timeframe: Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)

Interventionpercentage of participants (Number)
Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)82.8
Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)90.5

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Stage I and II (Pooled): Rituximab Levels 12 Weeks, 24 Weeks, and 36 Weeks After the Last Rituximab Administration

(NCT01200758)
Timeframe: 12 weeks, 24 weeks, and 36 weeks after the last rituximab administration (up to data cutoff of 11 Jan 2016 [up to 6 years])

,
Interventionmcg/mL (Median)
Week 12: Follow-up Visit 1 (n = 117, 118)Week 24: Follow-up Visit 2 (n = 88, 96)Week 36: Follow-up Visit 3 (n = 38, 53)
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)15.602.891.08
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)22.355.192.02

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Stage I and II (Pooled): Percentage of Responses Showing Time Saved of Staff as Per Physician/Nurse Opinions With Each Administration of Rituximab SC as Compared to Rituximab IV at the End of Cy 8, 15 and 20

All investigator physicians and nurses involved in this study were asked to provide the staff time that could be saved with each administration of rituximab SC as compared with rituximab IV to participants in routine practice afetr Cy 8, 15, 20 and categorized as less than (<) 1 hr, at least 1 hr but <2 hrs, at least 2 hrs but <3 hrs, at least 3 hrs but <4 hrs, >/=4 hrs. Staff were asked not to consider the time needed for the first IV administration. Analysis was done in all participants to show a comparison on the time saved by staffs when administered via SC and IV. (NCT01200758)
Timeframe: After Cycle 8 of induction treatment (24 weeks) and during the maintenance part of the study after 12 months (i.e., Cycle 15), and after the end of the maintenance treatment, (i.e., Cycle 20) (1 Cycle=4 weeks for Cycle 8 and 8 weeks for Cycles 15 and 20)

Interventionpercentage of responses (Number)
After Cy8: <1 hour (n=166)After Cy8: ≥1 to <2 hours (n=166)After Cy8: ≥2 to <3 hours (n=166)After Cy8: ≥3 to <4 hours (n=166)After Cy8: ≥4 hours (n=166)After Cy15: <1 hour (n=130)After Cy15: ≥1 to <2 hours (n=130)After Cy15: ≥2 to <3 hours (n=126)After Cy15: ≥3 to <4 hours (n=130)After Cy15: ≥4 hours (n=130)After Cy20: <1 hour (n=126)After Cy20: ≥1 to <2 hours (n=126)After Cy20: ≥2 to <3 hours (n=126)After Cy20: ≥3 to <4 hours (n=126)After Cy20: ≥4 hours (n=126)
All Participants112035181613173414221432211319

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Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Chimeric Antibodies (HACAs) to Rituximab

Levels of HACA in serum were detected at Day 1 of each cycle up to Cycle 8 and at follow-up visit. Stage I and II: Baseline: pre-dose (72 hours prior) D1 of Cy1, Cy 3-20, D0 of Cy2 (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), post-baseline: every 12 weeks after last rituximab administration until 96 weeks (a median of 27 months; up to data cutoff of 11 Jan 2016 [up to 6 years]) (NCT01200758)
Timeframe: Stage I and II: Baseline, post-baseline (See detailed timeframe in Outcome Measure description)

,
Interventionpercentage of participants (Number)
Baseline (n=208, 191)Post-Baseline (n=206, 197)
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)5.81.5
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)2.62.0

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Stage I and II (Pooled): Ctrough of Rituximab at Each Maintenance Treatment Cycle

Stage I and II (maintenance): D29 of Cy8 (induction; 1 Cy=4 weeks), predose (within 2 hr) on D1 of Cy9 to 19 (maintenance Cy1 to 12 [1 Cy=8 weeks]; up to data cutoff of 11 Jan 2016 [up to 6 years]) (NCT01200758)
Timeframe: Stage I and II (maintenance): Predose (within 2hr) up to data cutoff of 11 Jan 2016 [up to 6 years]) (See detailed timeframe in Outcome Measure description)

,
Interventionmcg/mL (Geometric Mean)
Cycle 8 (n = 174, 170)Cycle 9 (n = 171, 168)Cycle 10 (n = 164, 160)Cycle 11 (n = 164, 157)Cycle 12 (n = 160, 150)Cycle 13 (n = 157, 150)Cycle 14 (n = 153, 147)Cycle 15 (n = 148, 143)Cycle 16 (n = 150, 145)Cycle 17 (n = 149, 143)Cycle 18 (n = 143, 132)Cycle 19 (n = 138, 131)
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)37.6930.3528.4428.7728.8028.8428.0928.1928.0528.2428.5927.75
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)61.3149.4747.2746.7044.7244.3243.3244.1142.9642.8244.7943.69

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OS Based on Baseline CTC Counts

HE of CTC was defined as having CTC counts ≥5 cells/7.5 mL and LE of CTC was defined as having CTC counts <5 cells/7.5 mL. OS was defined as the time from the date of randomization to the date of death from any cause. (NCT01204710)
Timeframe: Randomization to Death Due to Any Cause Up to 36 Months

Interventionmonths (Median)
Olaratumab + Mitoxantrone (HE)12.85
Mitoxantrone (HE)8.10
Olaratumab + Mitoxantrone (LE)16.49
Mitoxantrone (LE)23.00

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Progression-Free Survival (PFS)

PFS is measured from randomization to the earliest date of the following events: PD according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version (v) 1.1, is a ≥20% increase in the sum of diameter of the target lesions taking as reference the smallest sum on study and an absolute increase in the sum diameter of ≥5 millimeter (mm), the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions, unequivocal evidence of progression by bone scan, clinical progression or death from any cause. For participants who had no documented PD or death or had started new anti-cancer therapy or were lost to follow-up, PFS was censored at their last tumor assessment. (NCT01204710)
Timeframe: Randomization to Measured PD or Death Due to Any Cause Up to 23 Months

Interventionmonths (Median)
Olaratumab + Mitoxantrone2.3
Mitoxantrone2.4

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Number of Participants Who Died During Study

(NCT01204710)
Timeframe: From Start of Treatment through Study Completion up to 36 Months

,,
Interventionparticipants (Number)
Due to PDDue to AEsDue to Other reasons
Mitoxantrone2732
Mitoxantrone: Optional Olaratumab Monotherapy1211
Olaratumab + Mitoxantrone4343

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Number of Participants With Negative Platelet-Derived Growth Factor Receptor Alpha (PDGFRα) Protein Expression by Immunohistochemistry (IHC)

"PDGFRα protein expression (pretreatment) by IHC was assessed in tumor cells, and was provided as a dichotomous variable with positive and negative expression. Positive corresponds to weak intensity membranous staining comprising greater than 30% of the tumor and/or moderate to strong intensity membranous staining comprising greater than 5% of the tumor. Negative corresponds to staining that does not meet these requirements." (NCT01204710)
Timeframe: Baseline

Interventionparticipants (Number)
Olaratumab + Mitoxantrone14
Mitoxantrone9

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Summary Listing of Participants Reporting Treatment-Emergent Adverse Events (TEAE)

Data presented are the number of participants who experienced serious adverse events (SAEs) and other nonserious adverse events (AEs). For participants in mitoxantrone group who had PD and chose optional IMC-3G3 follow-on treatment, the baseline was defined as the last assessment prior to the start of the olaratumab treatment. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section. (NCT01204710)
Timeframe: From Start of Treatment Through Study Completion Up to 36 months

,,
Interventionparticipants (Number)
SAEsAEs
Mitoxantrone2151
Mitoxantrone: Optional Olaratumab Monotherapy615
Olaratumab + Mitoxantrone2652

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Overall Survival (OS)

OS was defined as the time from the date of randomization to the date of death from any cause. If the participants were alive at the end of the follow-up period or were lost to follow-up, OS time was censored on the last date the participant was known to be alive. (NCT01204710)
Timeframe: Randomization to Death Due to Any Cause Up to 36 Months

Interventionmonths (Median)
Olaratumab + Mitoxantrone14.2
Mitoxantrone12.8

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Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]

Best response is categorized using the RECIST v1.1 guidelines. CR is the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm. PR is a ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the pretreatment sum diameter. Percentage of participants = (number of participants who had CR or PR) / (number of participants treated) * 100. (NCT01204710)
Timeframe: Randomization to Objective PD or Death Up to 23 Months

Interventionpercentage of participants (Number)
Olaratumab + Mitoxantrone10.0
Mitoxantrone3.1

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Percentage of Participants With Anti-Olaratumab Antibody Assessment (Immunogenicity)

Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20. (NCT01204710)
Timeframe: From Start of Treatment up to 9 Months

Interventionpercent of participants (Number)
Olaratumab + Mitoxantrone3.8
Mitoxantrone0

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PFS Based on Baseline Circulating Tumor Cells (CTC) Counts

High expression (HE) of CTC was defined as having CTC counts ≥5 cells/7.5 milliliter (mL) and low expression (LE) of CTC was defined as having CTC counts <5 cells/7.5 mL. PFS is measured from randomization to the earliest date of the following events: PD according to RECIST criteria v. 1.1, is a ≥20% increase in the sum diameter of the target lesions taking as reference the smallest sum on study and an absolute increase in the sum diameter of ≥5 mm, the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions, unequivocal evidence of progression by bone scan, clinical progression or death from any cause. (NCT01204710)
Timeframe: Randomization to Measured PD or Death Due to Any Cause Up to 23 Months

Interventionmonths (Median)
Olaratumab + Mitoxantrone (HE)2.32
Mitoxantrone (HE)2.23
Olaratumab + Mitoxantrone (LE)2.38
Mitoxantrone (LE)4.91

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Percentage of Participants With a ≥30% Decrease in PSA From Pretreatment to Week 12

Percentage of participants = (number of participants who had ≥30% decrease in PSA at Week 12) / (number of participants treated) * 100. (NCT01204710)
Timeframe: Pretreatment through Week 12

Interventionpercentage of participants (Number)
Olaratumab + Mitoxantrone22.6
Mitoxantrone16.9

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Percentage of Participants With a ≥50% Decrease in Prostate Specific Androgen (PSA) From Pretreatment to Any Time

Decrease in PSA ≥50% from pretreatment required confirmation no less than 3 weeks after the initial suggestion of response and occurring prior to documentation of PD. Percentage of participants = (number of participants who had ≥50% decrease in PSA at any time) / (number of participants treated) * 100. (NCT01204710)
Timeframe: Pretreatment to PD Up to 23 Months

Interventionpercentage of participants (Number)
Olaratumab + Mitoxantrone22.6
Mitoxantrone18.6

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Inflammatory Cytokine Response to Ablation Procedure

Measure inflammatory marker levels, including IL-1, IL-6, IL-8, and TNF-α, immediately post-ablation in keeping with prior studies on the anti-inflammatory effects of steroids following cardiac surgery. (NCT01206452)
Timeframe: Immediately Post-Ablation Procedure

,
Interventionpg/ml (Mean)
IL-1 levelIL-8 levelTNF-α levelIL-6 level
Ablation Plus Placebo1115.37.915.78
Ablation Plus Prednisone7.9410.545.459.03

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Number of Participants With Atrial Fibrillation Recurrence From 6 Months up to 12 Months

Number of AF recurrences between the two study groups as assessed by 1-month event monitor placed at 6 and 12 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence. (NCT01206452)
Timeframe: From 6 months up to 12 months post-procedure

InterventionParticipants with AF recurrence (Number)
Ablation Plus Placebo4
Ablation Plus Prednisone6

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Number of Participants With Atrial Fibrillation Recurrence From 0 Months up to 3 Months

Number of AF recurrences between the two study groups as assessed by inpatient telemetry in the immediate post-procedure period until discharge and 1-month event monitor placed at 3 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence. (NCT01206452)
Timeframe: From 0 months up to 3 months post procedure

InterventionParticipants with AF recurrence (Number)
Ablation Plus Placebo6
Ablation Plus Prednisone8

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Number of Participants With Atrial Fibrillation Recurrence From 3 Months up to 6 Months

Number of AF recurrences between the two study groups as assessed by 1-month event monitor placed at 3 and 6 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence. (NCT01206452)
Timeframe: From 3 months up to 6 months post-procedure

InterventionParticipants with AF recurrence (Number)
Ablation Plus Placebo5
Ablation Plus Prednisone9

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Inflammatory Cytokine Response to Ablation Procedure

Measure inflammatory marker levels, including IL-1, IL-6, IL-8, and TNF-α, 24 hours post-ablation to assess interval response to steroid administration. (NCT01206452)
Timeframe: 24 Hours after Ablation Procedure

,
Interventionpg/ml (Mean)
IL-1 levelIL-8 levelTNF-α levelIL-6 level
Ablation Plus Placebo11.759.69.740.9
Ablation Plus Prednisone8.563.97.540.2

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Percentage of Participants With Endoscopic Response 48 Weeks After Randomization

"Endoscopic response was defined as a decrease CDEIS > 5 points. CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing values 48 weeks after Randomization were counted as non-responders." (NCT01235689)
Timeframe: 48 weeks after Randomization

Interventionpercentage of participants (Number)
Clinically Driven Management40.2
Tight Control Management50.8

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Change From Baseline in CDAI Over Time

The Crohn's Disease Activity Index (CDAI) is a research tool used to quantify the symptoms of patients with Crohn's disease. Participants were asked to record the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI: presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. The CDAI is the sum of the products of each item multiplied by a weighting factor and generally ranges from 0 up to 600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. A negative change from Baseline indicates improvement. (NCT01235689)
Timeframe: Baseline and 4 and 8 weeks during the prednisone run-in, and 2, 6, 11, 14, 18, 23, 26, 30, 35, 38, 42, and 48 weeks after Randomization.

,
Interventionunits on a scale (Mean)
Week 4 of Prednisone Run-inWeek 8 of Prednisone Run-in2 Weeks After Randomization6 Weeks After Randomization11 Weeks After Randomization14 Weeks After Randomization18 Weeks After Randomization23 Weeks After Randomization26 Weeks After Randomization30 Weeks After Randomization35 Weeks After Randomization38 Weeks After Randomization42 Weeks After Randomization48 Weeks After Randomization
Clinically Driven Management-78.3-64.2-80.2-93.1-103.5-71.1-69.9-143.3-71.8-47.9-140.4-60.8-76.8-146.2
Tight Control Management-90.9-105.5-110.1-130.8-141.0-101.2-112.0-154.1-135.7-143.8-166.4-132.8-107.4-175.8

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Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Over Time

High sensitivity C-reactive protein was analyzed by a central laboratory. (NCT01235689)
Timeframe: Baseline and 8 weeks during the prednisone run-in, and 11, 23, 35, and 48 weeks after Randomization.

,
Interventionmg/L (Mean)
Week 8 of Prednisone Run-in11 Weeks After Randomization23 Weeks After Randomization35 Weeks After Randomization48 Weeks After Randomization
Clinically Driven Management-10.3-14.6-15.1-11.0-12.3
Tight Control Management-9.2-15.9-14.7-14.0-13.2

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Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores

"The Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2 is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).~The physical component summary (PCS) score summarizes the subscales physical functioning, role-physical, bodily pain, and general health. The mental component summary (MCS) score summarizes the subscales vitality, social functioning, role-emotional, and mental health. Each score ranges from 0 to 100 where higher scores indicate a better quality of life. A positive change from Baseline score indicates an improvement." (NCT01235689)
Timeframe: Baseline and 48 weeks after Randomization

,
Interventionunits on a scale (Mean)
Physical Component Summary ScoreMental Component Summary Score
Clinically Driven Management6.35.8
Tight Control Management9.29.3

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Change From Baseline in Work Productivity Activity Index - Crohn's Disease (WPAI:CD)

"The WPAI:CD questionnaire was used to assess impairments in both paid work and unpaid work due to symptoms of Crohn's Disease. The self-administered questionnaire consisted of 6 questions.~Work time missed was defined as the percentage of time absent from work due to Crohn's disease in the past week.~Impairment while working is the participant's assessment of the degree to which Crohn's disease affected productivity while working in the past 7 days.~Total work productivity impairment takes into account both hours missed due to Crohn's disease symptoms and the patient's assessment of the degree to which Crohn's disease affected their productivity while working.~Total activity impairment is the percent impairment of non-work related activities due to Crohn's disease.~WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. A negative change from Baseline indicates improvement." (NCT01235689)
Timeframe: Baseline and 48 weeks after Randomization

,
Interventionpercent impairment (Mean)
Work time missedImpairment while workingOverall work impairmentActivity impairment
Clinically Driven Management-12.8-17.5-21.7-19.2
Tight Control Management-17.6-25.8-29.2-27.7

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Percentage of Participants in Clinical Remission Over Time

"Clinical remission was defined as CDAI < 150. CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease.~Participants with missing data at each time point were counted as non-responders." (NCT01235689)
Timeframe: Baseline and 4 and 8 weeks during the prednisone run-in, and 2, 6, 11, 14, 18, 23, 26, 30, 35, 38, 42, and 48 weeks after Randomization.

,
Interventionpercentage of participants (Number)
Week 4 of Prednisone Run-inWeek 8 of Prednisone Run-in2 Weeks After Randomization6 Weeks After Randomization11 Weeks After Randomization14 Weeks After Randomization18 Weeks After Randomization23 Weeks After Randomization26 Weeks After Randomization30 Weeks After Randomization35 Weeks After Randomization38 Weeks After Randomization42 Weeks After Randomization48 Weeks After Randomization
Clinically Driven Management24.614.823.832.841.88.29.050.84.13.345.14.14.143.4
Tight Control Management30.322.141.047.562.36.68.265.620.523.059.89.07.459.8

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Percentage of Participants in Steroid-free Remission Over Time

"Steroid-free remission was defined as CDAI < 150 and discontinuation from steroids for at least 8 weeks. CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease.~Participants with missing data at each time point were counted as non-responders." (NCT01235689)
Timeframe: 11, 14, 18, 23, 26, 30, 35, 38, 42, and 48 weeks after Randomization.

,
Interventionpercentage of participants (Number)
11 Weeks After Randomization14 Weeks After Randomization18 Weeks After Randomization23 Weeks After Randomization26 Weeks After Randomization30 Weeks After Randomization35 Weeks After Randomization38 Weeks After Randomization42 Weeks After Randomization48 Weeks After Randomization
Clinically Driven Management23.84.13.345.12.50.842.64.14.139.3
Tight Control Management39.34.97.463.118.921.359.09.07.459.8

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Percentage of Participants With Complete Mucosal Healing 48 Weeks After Randomization

"Complete mucosal healing was defined as CDEIS = 0. CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing values 48 weeks after randomization were counted as non-responders." (NCT01235689)
Timeframe: 48 weeks after Randomization

Interventionpercentage of participants (Number)
Clinically Driven Management16.4
Tight Control Management18.0

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Percentage of Participants in Deep Remission 48 Weeks After Randomization

"Deep remission was defined as CDAI < 150, discontinuation from steroids for at least 8 weeks, absence of draining fistula, CDEIS < 4 and no deep ulcerations.~CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease.~CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing data 48 weeks after randomization were counted as non-responders." (NCT01235689)
Timeframe: 48 weeks after Randomization

Interventionpercentage of participants (Number)
Clinically Driven Management23.0
Tight Control Management36.9

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Percentage of Participants in Biologic Remission 48 Weeks After Randomization

"Biologic remission was defined as high sensitivity C-reactive protein (hs-CRP) < 5 mg/L, fecal Calprotectin < 250 μg/g, and CDEIS < 4 at 48 weeks after randomization.~CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing values 48 weeks after Randomization were counted as non-responders." (NCT01235689)
Timeframe: 48 weeks after Randomization

Interventionpercentage of participants (Number)
Clinically Driven Management15.6
Tight Control Management29.5

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Percentage of Participants With Mucosal Healing 48 Weeks After Randomization

"Percentage of participants with mucosal healing (defined as a CDEIS < 4) at 48 weeks after randomization (48 weeks after the 1st Key visit). The ileocolonoscopies were evaluated by the site.~CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing values 48 weeks after Randomization were counted as non-responders." (NCT01235689)
Timeframe: 48 weeks after Randomization

Interventionpercentage of participants (Number)
Clinically Driven Management30.3
Tight Control Management45.9

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Percentage of Participants With Mucosal Healing and CDEIS < 4 in Every Segment 48 Weeks After Randomization

"Percentage of participants with mucosal healing (defined as CDEIS < 4) and CDEIS < 4 in every segment on ileocolonoscopy at 48 weeks after randomization. The ileocolonoscopies were evaluated by the site.~CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing values 48 weeks after randomization were counted as non-responders." (NCT01235689)
Timeframe: 48 weeks after Randomization

Interventionpercentage of participants (Number)
Clinically Driven Management23.8
Tight Control Management29.5

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Percentage of Participants With Mucosal Healing and No Deep Ulcerations

"Percentage of participants with mucosal healing (defined as Crohn's disease endoscopy Index of severity [CDEIS] < 4) and no deep ulcerations on ileocolonoscopy (defined as the absence of all deep ulcerations in all segments explored in CDEIS) at 48 weeks after randomization (48 weeks after the 1st Key visit). The ileocolonoscopies were evaluated by the site.~CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing data 48 weeks after Randomization were counted as non-responders." (NCT01235689)
Timeframe: 48 weeks after Randomization

Interventionpercentage of participants (Number)
Clinically Driven Management30.3
Tight Control Management45.9

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Number of All-cause Hospitalizations After Randomization

Hospitalization was defined as a visit to hospital/clinic resulting in admission and overnight stay in hospital/clinic. (NCT01235689)
Timeframe: From Randomization through 48 weeks after Randomization

Interventionhospitalizations (Number)
Clinically Driven Management37
Tight Control Management25

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Change From Baseline in Quality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score

The IBDQ measures the effects of inflammatory bowel disease on daily function and quality of life. The IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease, feeling in general, and mood. Each question is answered on a scale from 1 (all of the time) to 7 ( none of the time); the total score ranges from 7 (worst) to 224 (best). A positive change from baseline indicates improvement. (NCT01235689)
Timeframe: Baseline and 48 weeks after Randomization

Interventionunits on a scale (Mean)
Clinically Driven Management31.2
Tight Control Management41.9

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Change From Baseline in Patient Health Questionnaire - 9 (PHQ9)

The PHQ-9 is a 9-item questionnaire for assessing the severity of depression. Each question is answered on a scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, where higher scores indicate more severe depression. A negative change from Baseline score indicates improvement. (NCT01235689)
Timeframe: Baseline and 48 weeks after Randomization

Interventionunits on a scale (Mean)
Clinically Driven Management-3.6
Tight Control Management-5.6

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Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score

"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, from 0 (not at all) to 4 (very much). The FACIT-Fatigue score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from Baseline score indicates an improvement.~." (NCT01235689)
Timeframe: Baseline and 48 weeks after Randomization

Interventionunits on a scale (Mean)
Clinically Driven Management7.6
Tight Control Management13.0

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Change From Baseline in CDEIS at 48 Weeks After Randomization

CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe endoscopic activity. A negative change from Baseline indicates improvement. (NCT01235689)
Timeframe: Baseline and 48 weeks after Randomization

Interventionunits on a scale (Mean)
Clinically Driven Management-6.4
Tight Control Management-7.7

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Time to All-cause Hospitalization

Hospitalization was defined as a visit to hospital/clinic resulting in admission and overnight stay in hospital/clinic. (NCT01235689)
Timeframe: From Randomization through 48 weeks after Randomization

Interventiondays (Median)
Clinically Driven ManagementNA
Tight Control ManagementNA

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Time to Clinical Remission

Clinical remission was defined as CDAI < 150. CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI scores generally range from 0 to 600 where higher scores indicate more severe disease. (NCT01235689)
Timeframe: From Randomization through 48 weeks after Randomization

Interventiondays (Median)
Clinically Driven Management78
Tight Control Management43

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Time to Crohn's Disease Flare

Time to Crohn's disease flare, where flare is defined as an increase in CDAI ≥ 70 points compared to Week 8 or Early Randomization CDAI, and a CDAI > 220. (NCT01235689)
Timeframe: From Randomization to 48 weeks after Randomization

Interventiondays (Median)
Clinically Driven ManagementNA
Tight Control ManagementNA

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Time to Steroid-free Remission

Steroid-free remission was defined as CDAI < 150 and discontinuation from steroids for at least 8 weeks. CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease. (NCT01235689)
Timeframe: From Randomization through 48 weeks after Randomization

Interventiondays (Median)
Clinically Driven Management162
Tight Control Management159

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Total Dose of Prednisone

The total dose of prednisone each participant received during both the run-in phase and post-randomization treatment phase. (NCT01235689)
Timeframe: From Baseline through 48 weeks after Randomization

Interventionmg (Mean)
Clinically Driven Management1505.7
Tight Control Management1369.8

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Total Length of Stay in Hospital for All-cause Hospitalizations

(NCT01235689)
Timeframe: From Randomization through 48 weeks after Randomization

Interventiondays (Mean)
Clinically Driven Management40.2
Tight Control Management50.1

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Duration of Response (DOR), Investigator-Assessed

DOR: time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with CT/MRI. CR: disappearance of all target lesions. PR: >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodule regression >/= 50%. Progression/relapse: at least 50% increase in nodal lesions or >/=50% increase in any node > 1 cm or >/= 50% increase in other target lesions (e.g., splenic or hepatic nodules) and/or any new bone marrow involvement and/or any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. A participant in the Rituximab+CHOP arm with the longest follow-up, 53 months, had an event. The criterion for median was the minimum time when survival went below 50%. (NCT01287741)
Timeframe: Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018)

Interventionmonths (Median)
Rituximab+Chemotherapy71.9
Obinutuzumab+ChemotherapyNA

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Median Time to Overall Survival (OS)

Kaplan Meier estimate of median OS was defined as the time at which half of the participants had died, regardless of the cause of death. Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause. (NCT01287741)
Timeframe: Baseline up to approximately 6.5 years (up to 31 January 2018)

Interventionmonths (Median)
Rituximab+ChemotherapyNA
Obinutuzumab+ChemotherapyNA

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Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)

Serum samples for assessment of obinutuzumab serum concentrations were collected only from a subset of Japanese participants following administration of 1000 mg obinutuzumab. (NCT01287741)
Timeframe: C1: D1 post-infusion and 20-28 and 66-80 hours after end of infusion, D8 and D15 pre-and post-infusion; C2: D1 pre- and post-infusion; C4: D1 pre- and post-infusion; C6: D1 pre- and post-infusion; C8: D1 pre- and post-infusion (cycle length = 21 days)

Interventionmicrograms per milliliter (μg/mL) (Geometric Mean)
Cycle 1, Day 8 pre-infusionCycle 1, Day 15 pre-infusionCycle 2, Day 1 pre-infusionCycle 4, Day 1 pre-infusionCycle 6, Day 1 pre-infusionCycle 8, Day 1 pre-infusionCycle 1, Day 1 post-infusionCycle 1, Day 1 20-28 hours after end of infusionCycle 1, Day 1 66-80 hours after end of infusionCycle 1, Day 8 post-infusionCycle 1, Day 15 post-infusionCycle 2, Day 1 post-infusionCycle 4, Day 1 post-infusionCycle 6, Day 1 post-infusionCycle 8, Day 1 post-infusion
Obinutuzumab+Chemotherapy174320431352378478435259219578718938817813881

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Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab

The presence of HAHAs to obinutuzumab was assessed in the first 100 randomized participants. (NCT01287741)
Timeframe: Pre-dose (Hour 0) on Cycle (C) 4 Day (D) 1, at end of treatment/early termination (up to Month 6), every 6 months thereafter for 30 months (cycle length = 21 days)

Interventionpercentage of participants (Number)
ScreeningCycle 4 Day 1Study Completion / Early DiscontinuationFollow-Up Month 6Follow-Up Month 12Follow-Up Month 18Follow-Up Month 24Follow-Up Month 30Follow-Up Completion/ Early DiscontinuationUnscheduled
Obinutuzumab+Chemotherapy2.0000000000

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Overall Response Rate (ORR), IRC-Assessed

Overall response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites. This outcome measure used data from primary analysis which included all 1418 participants. (NCT01287741)
Timeframe: Baseline up to approximately 4 years and 9 months (up to 29 April 2016)

,
Interventionpercentage of participants (Number)
Without PETWith PET
Obinutuzumab+Chemotherapy82.382.1
Rituximab+Chemotherapy80.281.1

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Median Time to Progression-Free Survival (PFS), Investigator-Assessed

Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease [PD]). Progression-free survival was defined as the time from randomization until the first documented day of disease progression or relapse, using a modified version of the Revised Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurred first, on the basis of investigator assessments. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI). (NCT01287741)
Timeframe: Baseline up to approximately 6.5 years (up to 31 January 2018)

Interventionmonths (Median)
Rituximab+Chemotherapy74.5
Obinutuzumab+Chemotherapy68.3

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Percentage of Participants With Adverse Events (AEs)

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. (NCT01287741)
Timeframe: Baseline up to approximately 6.5 years (up to 31 January 2018)

Interventionpercentage of participants (Number)
Rituximab+Chemotherapy95.3
Obinutuzumab+Chemotherapy98.1

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Median Time to Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed

Kaplan Meier estimate of median PFS was defined as time at which half of participants have progressed (progressive disease [PD]). Progression-free survival was defined as time from randomization until first documented day of disease progression or relapse, using a modified version of Revised Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurred first, on basis of IRC assessments. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 cm or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with diameter 1.5 cm. Tumor measurements were obtained by CT or MRI. This outcome measure used data from primary analysis which included all 1418 participants. (NCT01287741)
Timeframe: Baseline up to approximately 4 years and 9 months (up to 29 April 2016)

Interventionmonths (Median)
Rituximab+ChemotherapyNA
Obinutuzumab+ChemotherapyNA

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Overall Response Rate (ORR), Investigator-Assessed

Overall response was determined on the basis of investigator assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites. (NCT01287741)
Timeframe: Baseline up to approximately 6.5 years (up to 31 January 2018)

,
Interventionpercentage of participants (Number)
Without PETWith PET
Obinutuzumab+Chemotherapy81.477.1
Rituximab+Chemotherapy80.177.6

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Complete Response (CR) at the End of Treatment, IRC-Assessed

Percentage of participants with complete response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease. This outcome measure used data from primary analysis which included all 1418 participants. (NCT01287741)
Timeframe: Baseline up to approximately 4 years and 9 months (up to 29 April 2016)

,
Interventionpercentage of participants (Number)
Without PETWith PET
Obinutuzumab+Chemotherapy39.166.7
Rituximab+Chemotherapy34.465.3

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Complete Response (CR) at the End of Treatment, Investigator-Assessed

Percentage of participants with complete response was determined on the basis of investigator assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease. (NCT01287741)
Timeframe: Baseline up to approximately 6.5 years (up to 31 January 2018)

,
Interventionpercentage of participants (Number)
Without PETWith PET
Obinutuzumab+Chemotherapy35.456.5
Rituximab+Chemotherapy33.959.1

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Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score

The FACT-Lym subscale was developed to assess health-related quality of life in participants with non-Hodgkin lymphoma. The score range is 0-60, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement. (NCT01287741)
Timeframe: Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to approximately 6.5 years, (cycle length = 21 days)

Interventionscore on a scale (Mean)
BaselineScore Change, Cycle 3 Day 1Score Change, Study Compl./Discont.Score Change, Follow-Up Month 12Score Change, Follow-Up Month 24Score Change, Follow-Up Month 30Score Change, Follow-Up Month 36Score Change, Follow-Up Month 48Score Change, Follow-Up Term./Compl.
Obinutuzumab+Chemotherapy45.183.704.356.186.6625.007.317.375.55

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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores

The EORTC QLQ-C30 is a health-related quality of life questionnaire. A higher score indicates better quality of life, with changes of 5 to 10 points considered to be a minimally important difference to participants. (NCT01287741)
Timeframe: Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to data cut-off, up to approximately 6.5 years, (cycle length = 21 days)

Interventionscore on a scale (Mean)
BaselineChange Baseline, Cycle 3 Day 1Change Baseline, Study CompletionChange Baseline, Follow-Up Month 12Change Baseline, Follow-Up Month 24Change Baseline, Follow-Up Month 30Change Baseline, Follow-Up Month 36Change Baseline, Follow-Up Month 48Change Baseline, Follow-Up Completion
Obinutuzumab+Chemotherapy58.557.5110.2213.8415.8158.3317.9917.538.46

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Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score

The FACT-Lym subscale was developed to assess health-related quality of life in participants with non-Hodgkin lymphoma. The score range is 0-60, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement. (NCT01287741)
Timeframe: Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to approximately 6.5 years, (cycle length = 21 days)

Interventionscore on a scale (Mean)
BaselineScore Change, Cycle 3 Day 1Score Change, Study Compl./Discont.Score Change, Follow-Up Month 12Score Change, Follow-Up Month 24Score Change, Follow-Up Month 36Score Change, Follow-Up Month 48Score Change, Follow-Up Term./Compl.
Rituximab+Chemotherapy45.343.835.036.377.077.578.225.51

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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores

The EORTC QLQ-C30 is a health-related quality of life questionnaire. A higher score indicates better quality of life, with changes of 5 to 10 points considered to be a minimally important difference to participants. (NCT01287741)
Timeframe: Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to data cut-off, up to approximately 6.5 years, (cycle length = 21 days)

Interventionscore on a scale (Mean)
BaselineChange Baseline, Cycle 3 Day 1Change Baseline, Study CompletionChange Baseline, Follow-Up Month 12Change Baseline, Follow-Up Month 24Change Baseline, Follow-Up Month 36Change Baseline, Follow-Up Month 48Change Baseline, Follow-Up Completion
Rituximab+Chemotherapy59.816.379.8412.6714.7415.0116.628.74

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Median Time to Event-Free Survival (EFS), Investigator-Assessed

Kaplan Meier estimate of median EFS is the time at which half of the participants have progressed. Event-free survival was defined as the time from the date of randomization until the date of disease progression, relapse, initiation of a new non-protocol-specified anti-lymphoma treatment, or death from any cause on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. Tumor measurements were obtained by CT/MRI. (NCT01287741)
Timeframe: Baseline up to death or disease progression, or initiation of new anti-lymphoma treatment (NALT), whichever occurred first, approximately 6.5 years (up to 31 January 2018)

Interventionmonths (Mean)
Rituximab+Chemotherapy74.5
Obinutuzumab+Chemotherapy68.3

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Median Time to Disease-Free Survival (DFS), Investigator-Assessed

Kaplan Meier estimate of median DFS was defined as time at which half of participants have disease progression/relapse or death from any cause. Disease-free survival was defined as time from date of the first occurrence of a documented CR to date of disease progression/relapse or death from any cause on basis of investigator assessments with use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. (NCT01287741)
Timeframe: Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018)

Interventionmonths (Median)
Rituximab+ChemotherapyNA
Obinutuzumab+Chemotherapy65.4

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Time to Prostate Serum Antigen Progression Free Survival (PSA-PFS)

Time to PSA-PFS: time interval between date of randomization & first occurrence of PSA progression/ death, whichever was earlier. PSA progression:1) In PSA responders(≥50% decline from baseline PSA of ≥10 ng/mL):increase of ≥25%(at least 2 ng/mL)over nadir value, confirmed by second PSA value at least 3 weeks later;2)In PSA non-responders(not achieved ≥50% decline from baseline PSA ≥10 ng/mL):increase of ≥25% (at least 2 ng/mL) over baseline value, confirmed by second PSA value at least 3 weeks later;3)In participants not eligible for PSA response(baseline PSA <10 ng/mL):(a)in participants with baseline PSA>0 ng/mL&<10 ng/mL: increase in PSA by 25% (at least 2 ng/mL) above baseline level, confirmed by second PSA value at least 3weeks apart;(b)in participants with baseline value=0ng/mL: a post baseline PSA value ≥2ng/mL.Early rise in PSA only indicated progression if it was associated with another sign of DP or if it continued beyond 12 weeks. Analysis performed by Kaplan-Meier method. (NCT01308567)
Timeframe: Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)

Interventionmonths (Median)
Docetaxel 75 mg/m^28.3
Cabazitaxel 20 mg/m^28.2
Cabazitaxel 25 mg/m^29.2

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Time to Tumor Progression Free Survival

Time to tumor progression free survival was defined as the time interval between randomization and the date of first occurrence of tumor progression (assessed using RECIST version 1.1) or death, whichever was earlier. Analysis was performed by Kaplan-Meier method. (NCT01308567)
Timeframe: Baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)

Interventionmonths (Median)
Docetaxel 75 mg/m^212.1
Cabazitaxel 20 mg/m^213.4
Cabazitaxel 25 mg/m^213.1

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Percentage of Participants With PSA Response

PSA response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later in participants with baseline PSA value ≥10 ng/mL. (NCT01308567)
Timeframe: Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)

Interventionpercentage of participants (Number)
Docetaxel 75 mg/m^268.4
Cabazitaxel 20 mg/m^260.7
Cabazitaxel 25 mg/m^268.7

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Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of HRQoL

FACT-P was a 39-item participant rated questionnaire that measures the concerns of participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). Physical well being, functional well being, and prostate-specific concerns sub-scales of the FACT-P questionnaire were combined to calculate TOI. Total TOI score ranges from 0 to 104, with higher scores representing a better quality of life with fewer symptoms. (NCT01308567)
Timeframe: Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks)

,,
Interventionunits on a scale (Least Squares Mean)
Change at Cycle 1Change at Cycle 2Change at Cycle 3Change at Cycle 4Change at Cycle 5Change at Cycle 6Change at Cycle 7Change at Cycle 8Change at Cycle 9Change at Cycle 10Change at Cycle 11Change at Cycle 12Change at Cycle 13Change at Cycle 14Change at Cycle 15Change at Cycle 16Change at Follow-up 1Change at Follow-up 2Change at Follow-up 3Change at Follow-up 4Change at Follow-up 5Change at Follow-up 6
Cabazitaxel 20 mg/m^26.095.965.284.14.053.153.142.262.151.562.723.081.781.591.291.23-1.26-1.12-1.67-2.54-5.36-5.32
Cabazitaxel 25 mg/m^25.764.263.653.23.12.882.941.491.731.622.190.750.82-0.071.491.44-1.62-1.05-1.98-1.03-0.82-2.76
Docetaxel 75 mg/m^23.314.374.313.393.412.762.291.671.751.520.351.042.13-0.13-2.1-2.26-0.96-0.07-0.32-0.91-2.15-1.77

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Time to Pain Progression Free Survival (Pain PFS)

Time to pain PFS was defined as the time interval between date of randomization and the date of the first occurrence of pain progression or death, whichever was earlier. Pain progression was defined as an increase of ≥1 point in the median present pain intensity (PPI) score from the nadir confirmed by a second assessment at least 3 weeks later or ≥25 % increase in the mean analgesic score from baseline, due to cancer related pain confirmed by a second assessment at least 3 weeks later or requirement for local palliative radiotherapy. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. Analgesic score was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points. Analysis was performed by Kaplan-Meier method. (NCT01308567)
Timeframe: Baseline until disease progression, death or study cut-off date (maximum duration: 51 months)

Interventionmonths (Median)
Docetaxel 75 mg/m^210.1
Cabazitaxel 20 mg/m^28.0
Cabazitaxel 25 mg/m^27.3

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Percentage of Participants With Pain Response

Pain response was defined as either a ≥2-point decrease from baseline median PPI score without increase in analgesic score, or a ≥50% decrease in analgesic use from baseline mean analgesic score (only in participants with baseline mean analgesic score≥10) without increase in the pain. Either criterion was maintained for 2 consecutive evaluations at least 3 weeks apart. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. Analgesic score was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points. (NCT01308567)
Timeframe: Baseline until pain progression, death or study cut-off date (maximum duration: 51 months)

Interventionpercentage of participants (Number)
Docetaxel 75 mg/m^240.7
Cabazitaxel 20 mg/m^242.4
Cabazitaxel 25 mg/m^239.4

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Percentage of Participants With Overall Objective Tumor Response

Overall objective tumor response was defined as having a partial response (PR) or complete response (CR) according to the RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (NCT01308567)
Timeframe: Baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)

Interventionpercentage of participants (Number)
Docetaxel 75 mg/m^230.9
Cabazitaxel 20 mg/m^232.4
Cabazitaxel 25 mg/m^241.6

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Overall Survival (OS)

OS was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date participant was known to be alive, or at the cut-off date if the participant's last contact was after the cut-off date. The study cut-off date for the final analysis of OS was the date when the 774th death had been observed. Analysis was performed by Kaplan-Meier method. (NCT01308567)
Timeframe: Baseline up to death or study cut-off date, whichever was earlier (maximum duration: 51 months )

Interventionmonths (Median)
Docetaxel 75 mg/m^224.3
Cabazitaxel 20 mg/m^224.5
Cabazitaxel 25 mg/m^225.2

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Progression Free Survival (PFS)

PFS: time interval between date of randomization to date of first occurrence of any of following events: tumor progression according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1; Prostate Specific Antigen (PSA) progression; pain progression or death due to any cause. Analysis was performed by Kaplan-Meier method. (NCT01308567)
Timeframe: Baseline up to tumor progression, PSA progression, pain progression or death (maximum duration: 51 months)

Interventionmonths (Median)
Docetaxel 75 mg/m^25.3
Cabazitaxel 20 mg/m^24.4
Cabazitaxel 25 mg/m^25.1

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Percentage of Participants With FACT-P Total Score Response

FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL. Responder of FACT-P was defined as at least one occurrence of 7-point improvement from baseline in FACT-P total score during treatment period. (NCT01308580)
Timeframe: From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)

Interventionpercentage of participants (Number)
Cabazitaxel 20 mg/m^257.2
Cabazitaxel 25 mg/m^259.4

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Plasma Clearance (CL) for Cabazitaxel

Blood samples for pharmacokinetic (PK) analysis were obtained from a subset of the study participants (approximately 150 participants/group, by protocol) according to a sparse sampling strategy. (NCT01308580)
Timeframe: Day 1 of Cycle 1: 5 minutes before the end of infusion (EOI), 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI

InterventionLitre/hour (Mean)
Cabazitaxel 20 mg/m^244.832
Cabazitaxel 25 mg/m^249.662

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Plasma Steady State Volume of Distribution (Vss) for Cabazitaxel

Blood samples for PK analysis were obtained from a subset of the study participants (approximately 150 participants/group, by protocol) according to a sparse sampling strategy. (NCT01308580)
Timeframe: Day 1 of Cycle 1: 5 minutes before the EOI, 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI

Interventionlitre (Mean)
Cabazitaxel 20 mg/m^27381.46
Cabazitaxel 25 mg/m^27040.10

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Progression Free Survival (PFS)

PFS was evaluated from date of randomization to date of first documentation of any of the events: 1) Radiological tumor progression: as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of ≥5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target lesions, 2) Prostate Specific Antigen (PSA) progression: ≥25% increase over baseline/nadir value if baseline PSA ≥10 ng/mL; or 25% increase above the baseline level if baseline PSA >0 ng/mL & <10 ng/mL; or post-baseline value of >=2 ng/mL, if baseline PSA=0 ng/mL, 3) Pain progression: increase of ≥1 point in median Present Pain Intensity (PPI) from nadir or ≥25% increase in mean analgesic score (AS) from baseline score or requirement of local palliative radiotherapy, 4) Death. Analysis was performed by Kaplan-Meier method. (NCT01308580)
Timeframe: From baseline up to tumor progression, PSA progression, pain progression, death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)

Interventionmonths (Median)
Cabazitaxel 20 mg/m^22.9
Cabazitaxel 25 mg/m^23.5

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Time to Definitive Deterioration of ECOG PS Score From Baseline

The ECOG PS was used to evaluate participant's DP and the effect of the disease on the participant's activities of daily living. It ranges on the scale from 0-5 (0= normal activity; 1= symptoms but ambulatory; 2= in bed for < 50 % of the time; 3= in bed for > 50% of the time; 4= 100% bedridden; 5= dead). Time to definitive deterioration in ECOG PS score from baseline was defined as a change from 0, 1 to ≥2, or from 2 to ≥3. Analysis was performed by Kaplan-Meier method. (NCT01308580)
Timeframe: From baseline until death or study cut-off date (maximum duration: 48 months)

Interventionmonths (Median)
Cabazitaxel 20 mg/m^214.9
Cabazitaxel 25 mg/m^214.1

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Time to First Definitive Consumption of Narcotic Medication

Concomitant medications used were recorded for all participants, and time of first definitive consumption of narcotic medication (if it occurred) was determined. This measure summarizes the time from baseline to first definitive consumption of narcotic medication. Analysis was performed by Kaplan-Meier method. (NCT01308580)
Timeframe: From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)

Interventionmonths (Median)
Cabazitaxel 20 mg/m^22.2
Cabazitaxel 25 mg/m^20.8

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Time to Pain Progression

Pain Progression was defined as an increase of ≥1 point in the median PPI from its nadir confirmed by a second assessment at least 3 weeks later or ≥25 % increase in the mean AS compared with the baseline score confirmed by a second assessment at least 3 weeks later or requirement for local palliative radiotherapy. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. AS was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points. Analysis was performed by Kaplan-Meier method. (NCT01308580)
Timeframe: From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)

Interventionmonths (Median)
Cabazitaxel 20 mg/m^26.2
Cabazitaxel 25 mg/m^26.4

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Time to PSA Progression

Time to PSA progression was time interval between randomization & first occurrence of PSA progression. PSA progression defined as: 1) PSA responders (>50% decline from baseline PSA ≥10 ng/mL): increase of ≥25% (≥2 ng/mL) over nadir value, confirmed by second PSA ≥3 weeks later; 2) PSA non-responders (did not achieve >50% decline from baseline PSA ≥10 ng/mL): increase of ≥25% (≥2 ng/mL) over baseline value, confirmed by second PSA ≥3 weeks later; 3) In participants not eligible for PSA response (baseline PSA <10 ng/mL): (a) participants with baseline PSA >0 ng/mL & <10 ng/mL: increase in PSA by 25% (≥2 ng/mL) above baseline level, confirmed by second PSA value ≥3 weeks apart; (b) participants with baseline value=0 ng/mL: post-baseline PSA value ≥2 ng/mL. Note (for 1-3): Rise in PSA in first 12 weeks was progression only if met definition above and was associated with other sign of DP or if it continued beyond 12 weeks. Analysis was performed by Kaplan-Meier method. (NCT01308580)
Timeframe: From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)

Interventionmonths (Median)
Cabazitaxel 20 mg/m^25.7
Cabazitaxel 25 mg/m^26.8

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Time to Tumor Progression

Time to Tumor progression was defined as the first occurrence of radiological tumor progression according to RECIST 1.1. Radiological tumor progression was defined at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of ≥5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target-lesions. Analysis was performed by Kaplan-Meier method. (NCT01308580)
Timeframe: From baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)

Interventionmonths (Median)
Cabazitaxel 20 mg/m^29.0
Cabazitaxel 25 mg/m^29.3

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Percentage of Participants With Pain Response

Pain response was defined as either a ≥2-point decrease from baseline median PPI score without increase in AS, or a ≥50% decrease from baseline mean AS without increase in the PPI score, maintained for 2 consecutive evaluations at least 3 weeks apart. Increases in pain during the first 12 weeks were ignored in determining pain response. (NCT01308580)
Timeframe: From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)

Interventionpercentage of participants (Number)
Cabazitaxel 20 mg/m^234.7
Cabazitaxel 25 mg/m^237.3

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Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed or worsened or became serious during on-treatment period. On-treatment period: The time from the first dose of treatment to 30 days after the last dose of treatment (either Cabazitaxel or Prednisone). A serious adverse event: Any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) version 4.03 (Grade 3 [severe] and Grade 4 [life-threatening]) was used in this study to grade clinical AEs. (NCT01308580)
Timeframe: From first administration of study treatment until 30 days after the last administration of study treatment (Maximum duration: 48 months)

,
Interventionpercentage of participants (Number)
Any Grade TEAEAny Grade 3-4 TEAEGrade 3-4 TEAE excluding laboratory TEAEGrade 3-4 TEAE excluding DP TEAEsGrade 3-4 TEAE excluding laboratory and DP TEAEsAny Serious TEAEAny TEAE leading to permanent discontinuation
Cabazitaxel 20 mg/m^291.239.735.739.035.030.516.4
Cabazitaxel 25 mg/m^293.954.548.153.947.443.219.5

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Time to Definitive Weight Loss by 5% and 10% From Baseline

Time to definitive weight loss was defined as the time to first occurrence of ≥5% or ≥10% decrease in body weight from baseline. Analysis was performed by Kaplan-Meier method. (NCT01308580)
Timeframe: From baseline until death or study cut-off date (maximum duration: 48 months)

,
Interventionmonths (Median)
Weight Loss by 5%Weight Loss by 10%
Cabazitaxel 20 mg/m^210.6NA
Cabazitaxel 25 mg/m^211.120.3

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Time to Definitive Deterioration of Score by 10% From Baseline on FACT-P Sub-Scales

The time to definitive deterioration (10% decrease in score from baseline) was assessed for the individual sub-scales (Physical Well-Being; Social/Family Well-Being; Emotional Well-Being; Functional Well-Being; Prostate-Specific Concerns). Analysis was performed by Kaplan-Meier method. (NCT01308580)
Timeframe: From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)

,
Interventionmonths (Median)
Physical well-beingSocial/family well-beingEmotional well-beingFunctional well-beingProstate specific concern
Cabazitaxel 20 mg/m^26.610.89.76.68.7
Cabazitaxel 25 mg/m^28.312.49.96.79.7

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Overall Survival (OS)

OS was defined as the time interval from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earlier of the last date the participant was known to be alive or the study cut-off date. The cut-off date for the final analysis of OS was the date when the 988th death had been observed. Analysis was performed by Kaplan-Meier method. (NCT01308580)
Timeframe: From baseline up to death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)

Interventionmonths (Median)
Cabazitaxel 20 mg/m^213.4
Cabazitaxel 25 mg/m^214.5

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Change From Baseline in FACT-P:Total Score as a Measure of HRQoL

FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL. (NCT01308580)
Timeframe: Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks)

,
Interventionunits on a scale (Least Squares Mean)
Change from baseline at cycle 1 (n =521, 495)Change from baseline at cycle 2 (n = 502, 492)Change from baseline at cycle 3 (n = 459, 452)Change from baseline at cycle 4 (n = 421, 415)Change from baseline at cycle 5 (n = 339, 365)Change from baseline at cycle 6 (n = 275, 320)Change from baseline at cycle 7 (n = 229, 267)Change from baseline at cycle 8 (n = 196, 226)Change from baseline at cycle 9 (n = 164, 172)Change from baseline at cycle 10 (n = 137, 141)Change from baseline at Follow-up 1 (n = 137, 153)
Cabazitaxel 20 mg/m^25.65.394.392.941.792.572.621.351.10.02-3.1
Cabazitaxel 25 mg/m^25.756.236.094.23.332.352.721.9811.33-2.09

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Percentage of Participants With PSA Response

PSA response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later in participants with baseline PSA value ≥10 ng/mL. (NCT01308580)
Timeframe: From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)

Interventionpercentage of participants (Number)
Cabazitaxel 20 mg/m^229.5
Cabazitaxel 25 mg/m^242.9

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Percentage of Participants With Overall Objective Tumor Response

Overall objective tumor response was defined as either a partial response (PR) or complete response (CR) according to the RECIST 1.1 criteria, as assessed by the investigator. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (NCT01308580)
Timeframe: From baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)

Interventionpercentage of participants (Number)
Cabazitaxel 20 mg/m^218.5
Cabazitaxel 25 mg/m^223.4

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Overall Survival

(NCT01309672)
Timeframe: 3 years

Interventionmonths (Median)
Abiraterone Acetate + Prednisone25.8

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Number of Patients With Toxicity of Abiraterone Acetate

Only adverse events that are possibly, probably or definitely related to study drug are reported. (NCT01309672)
Timeframe: Up to 3 years

InterventionParticipants (Number)
Alanine aminotransferase increasedAnorexiaAspartate aminotransferase increasedHyperglycemiaHypertensionHypokalemiaINR increasedLeukocytosisLung infectionNauseaRectal hemorrhageThromboembolic eventVomitingWeight gain
Abiraterone Acetate + Prednisone21222211121121

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Number of Patients With PSA Partial Response

PSA reduction to < 4 ng/ml, but >0.2 ng/ml (NCT01309672)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Abiraterone Acetate + Prednisone13

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Number of Patients With Undetectable PSA

undetectable PSA defined as <= 0.2 ng/mL. Patients not responding in the first year were deemed non-responders. (NCT01309672)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Abiraterone Acetate + Prednisone5

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Objective Progression-free Survival

Progression defined as unequivocal progression of disease, progressive disease as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), progressive disease as defined by the Prostate Cancer Clinical Trials Working Group bone scan progression criteria, or death due to disease. (NCT01309672)
Timeframe: 3 years

Interventionmonths (Median)
Abiraterone Acetate + Prednisone17.5

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Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) Levels After 3 Cycles of Treatment

Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed. Decrease in PSA levels represented improvement. (NCT01314118)
Timeframe: End of Cycle 3 (Approximately Month 3)

InterventionPercentage of Participants (Number)
Abiraterone Acetate and Prednisone85.2

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Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) During the Core Study

Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed. (NCT01314118)
Timeframe: End of core study visit (Approximately at Month 6)

InterventionPercentage of participants (Number)
Abiraterone Acetate and Prednisone86.9

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Time to Radiographic Evidence of Disease Progression (TTRP)

Time to radiographic evidence of disease progression is defined as the time interval from the date of enrollment (Day 1) to the date of disease progression. A participant was considered as progressed by bone scan if: 1) The appearance of greater than or equal to (>=) 2 new lesions, and, following the first assessment, a confirmatory scan performed 6 or more weeks later that shows a minimum of 2 or more additional new lesions, 2) If >=2 new lesions are seen on scans following the first assessment, the confirmation is still required after 6 weeks; however, 2 addition lesions are not required to confirm progression, and 3) The date of progression is the date of the first scan that shows the changes. (NCT01314118)
Timeframe: Maximum up to Month 30.5

InterventionMonths (Median)
Abiraterone Acetate and PrednisoneNA

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Time to Prostate-Specific Antigen (PSA) Progression

Time to PSA progression is defined as the time interval from the date of enrollment (Day 1) to the date of first evidence of PSA progression. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase and an absolute increase of 2 nanogram (ng)/milliliter (mL) or more, which is confirmed by a second value obtained in 3 or more weeks. (NCT01314118)
Timeframe: Maximum up to Month 30.5

InterventionMonths (Median)
Abiraterone Acetate and Prednisone28.7

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Rolling Average Improvement From Day 1 to Day 29 Using the EXACT-PRO 14 Point Patient Reported Outcome Measure: EXACT-PRO

EXAcerbations of Chronic pulmonary disease tool patient reported outcome (EXACT-PRO) Rolling Average Improvement from Day 1 to Day 29. EXACT-PRO is a 14 point patient reported daily diary used to quantify and measure exacerbations of chronic obstructive pulmonary disease (COPD). Minimum score is 0 and Maximum score is 14 (higher scores indicate worsening indicative of an exacerbation). Reported value is LS mean improvement from at Day 29 compared to D1 of the study. (NCT01332097)
Timeframe: Up to Day 29

Interventionscore on a scale (Least Squares Mean)
Treatment A5.72
Treatment B, E, G & I8.89
Treatment C5.19
Treatment D5.83
Treatment F7.89
Treatment H8.35

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Change in FEV1 From Baseline to Day 5 or Baseline to Day 10 Measure: FEV1 Change in Forced Expiry Volume in 1 Second

"Change in FEV1 from baseline to Day 5 or baseline to Day 10 measured in mL~Measure: FEV1~Change in Forced Expiry Volume in 1 second" (NCT01332097)
Timeframe: Day 5, Day 10

,,,,,
InterventionmL (Least Squares Mean)
Day 5Day 10
Treatment A155.1164.6
Treatment B, E, G & I100.8126.9
Treatment C48.954.9
Treatment D106.354.6
Treatment F134.4109.0
Treatment H200.6250.5

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Overall Survival (Follicular Lymphoma Population)

Overall survival in the follicular lymphoma population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event. (NCT01332968)
Timeframe: Baseline up to 10 years

Interventionpercentage of participants with event (Number)
Rituximab+Chemotherapy14.3
Obinutuzumab+Chemotherapy12.6

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Event-Free Survival (Overall Study Population)

Event-free survival in the overall study population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. Tumor measurements were obtained by CT/MRI. Reported is the percentage of participants with event. (NCT01332968)
Timeframe: Baseline up to data cut-off (up to approximately 5 years and 2 months)

Interventionpercentage of participants with event (Number)
Rituximab+Chemotherapy30.6
Obinutuzumab+Chemotherapy22.6

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Overall Survival (Overall Study Population)

Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event. (NCT01332968)
Timeframe: Baseline up to data cut-off (up to approximately 5 years and 2 months)

Interventionpercentage of participants with event (Number)
Rituximab+Chemotherapy10.2
Obinutuzumab+Chemotherapy8.4

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Disease-Free Survival (Follicular Lymphoma Population)

Disease-free survival in the follicular lymphoma population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma (RRCML). Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. Reported is the percentage of participants with event. (NCT01332968)
Timeframe: From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months)

Interventionpercentage of participants with event (Number)
Rituximab+Chemotherapy27.9
Obinutuzumab+Chemotherapy26.3

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Percentage of Participants With Adverse Events

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. (NCT01332968)
Timeframe: Baseline up to 10 years

Interventionpercentage of participants (Number)
Rituximab+Chemotherapy99.6
Obinutuzumab+Chemotherapy99.9

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Overall Response (Overall Study Population), IRC-Assessed

Overall response in the overall study population was defined as percentage of participants with PR or CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%; Overall Response (OR) = CR + PR. (NCT01332968)
Timeframe: Baseline up to end of induction period (up to approximately 7 months)

,
Interventionpercentage of participants with event (Number)
Without PETWith PET
Obinutuzumab+Chemotherapy89.987.2
Rituximab+Chemotherapy86.783.3

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Overall Response (Overall Study Population), Investigator-Assessed

Overall response in the overall study population was defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without positron emission tomography (PET). CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%; Overall Response (OR) = CR + PR. (NCT01332968)
Timeframe: Baseline up to end of induction period (up to approximately 7 months)

,
Interventionpercentage of participants with event (Number)
Without PETWith PET
Obinutuzumab+Chemotherapy87.385.4
Rituximab+Chemotherapy85.781.8

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Overall Response (Follicular Lymphoma Population), IRC-Assessed

Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Overall Response (OR) = CR + PR. (NCT01332968)
Timeframe: Baseline up to end of induction period (up to approximately 7 months)

,
Interventionpercentage of participants with event (Number)
Without PETWith PET
Obinutuzumab+Chemotherapy91.388.6
Rituximab+Chemotherapy88.085.2

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Overall Response (Follicular Lymphoma Population), Investigator-Assessed

Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with and without PET. CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Overall Response (OR) = CR + PR. (NCT01332968)
Timeframe: Baseline up to end of induction period (up to approximately 7 months)

,
Interventionpercentage of participants with event (Number)
Without PETWith PET
Obinutuzumab+Chemotherapy88.285.5
Rituximab+Chemotherapy86.481.2

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Complete Response (Overall Study Population), IRC-Assessed

Percentage of participants with complete response in the overall study population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions. (NCT01332968)
Timeframe: Baseline up to end of induction period (up to approximately 7 months)]

,
Interventionpercentage of participants with event (Number)
Without PETWith PET
Obinutuzumab+Chemotherapy27.169.5
Rituximab+Chemotherapy26.359.4

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Complete Response (Overall Study Population), Investigator-Assessed

Percentage of participants with complete response in the overall study population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions. (NCT01332968)
Timeframe: Baseline up to end of induction period (up to approximately 7 months)

,
Interventionpercentage of participants with event (Number)
Without PETWith PET
Obinutuzumab+Chemotherapy18.461.1
Rituximab+Chemotherapy23.357.0

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Complete Response (Follicular Lymphoma Population), IRC-Assessed

Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions. (NCT01332968)
Timeframe: Baseline up to end of induction period (up to approximately 7 months)

,
Interventionpercentage of participants with event (Number)
Without PETWith PET
Obinutuzumab+Chemotherapy28.571.4
Rituximab+Chemotherapy26.859.7

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Complete Response (Follicular Lymphoma Population), Investigator-Assessed

Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions. (NCT01332968)
Timeframe: Baseline up to end of induction period (up to approximately 7 months)

,
Interventionpercentage of participants with event (Number)
Without PETWith PET
Obinutuzumab+Chemotherapy18.662.0
Rituximab+Chemotherapy24.156.7

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Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population)

The FACT-Lym Total Score for the follicular lymphoma population was derived from the following 5 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24),Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym Total Score is the sum of all 5 individual subscales (range 0-168). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. (NCT01332968)
Timeframe: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)

,
Interventionunits on a scale (Mean)
Total Score, BaselineTotal Score Change, Cycle 3 Day 1Total Score Change, End InductionTotal Score Change, Maint Month 2Total Score Change, Maint Month 12Total Score Change, End Maint
Obinutuzumab+Chemotherapy128.423.215.108.137.908.80
Rituximab+Chemotherapy127.401.984.188.408.877.43

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Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population)

The FACT-Lym TOI Score for the follicular lymphoma population was derived from the following 3 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym TOI Score is the sum of the 3 individual subscales (range 0-116). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. (NCT01332968)
Timeframe: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)

,
Interventionunits on a scale (Mean)
TOI Score, BaselineTOI Score Change, Cycle 3 Day 1TOI Score Change, End InductionTOI Score Change, Maint M2TOI Score Change, Maint M12TOI Score Change, End Maint
Obinutuzumab+Chemotherapy86.942.184.577.177.207.44
Rituximab+Chemotherapy86.610.462.916.227.616.23

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Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population)

The FACT-Lym Individual Subscale Lymphoma Score for the follicular lymphoma population was derived from the Lymphoma subscale questionnaire (range: 0-60). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. (NCT01332968)
Timeframe: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)

,
Interventionunits on a scale (Mean)
Lymphoma, BaselineLymphoma Change, Cycle 3 Day 1Lymphoma Change, End InductionLymphoma Change, Maint Month 2Lymphoma Change, Maint Month 12Lymphoma Change, End Maint
Obinutuzumab+Chemotherapy45.542.713.014.524.274.57
Rituximab+Chemotherapy45.012.042.994.804.934.31

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Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase

The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1 Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs. Completion includes completion visit and early termination visit. (NCT01332968)
Timeframe: Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months)

,
Interventionunits on a scale (Mean)
Change Baseline, Maint/Obs Month 2Change Baseline, Maint/Obs Month 12Change Baseline, Maint/Obs Completion
Obinutuzumab+Chemotherapy0.040.060.05
Rituximab+Chemotherapy0.040.060.03

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Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase

The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Completion (Compl) includes completion visit and early termination visit. Maintenance/Observation is indicated as Maint/Obs. (NCT01332968)
Timeframe: Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months)

Interventionunits on a scale (Mean)
Baseline InductionChange Baseline, Cycle 3 Day 1Change Baseline, Induction ComplChange Baseline, Maint/Obs Month 2Change from Baseline, Maint/Obs Month 12Change Baseline, Maint/Obs Completion
Obinutuzumab+Chemotherapy0.810.030.030.06-0.20-0.10

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Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase

The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Completion (Compl) includes completion visit and early termination visit. Maintenance/Observation is indicated as Maint/Obs. (NCT01332968)
Timeframe: Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months)

Interventionunits on a scale (Mean)
Baseline InductionChange Baseline, Cycle 3 Day 1Change Baseline, Induction ComplChange Baseline, Maint/Obs Month 2Change from Baseline, Maint/Obs Month 12
Rituximab+Chemotherapy0.800.030.040.050.00

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Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Follow Up Phase

The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs in data categories. Completion includes completion visit and early termination visit. (NCT01332968)
Timeframe: Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 after Day 1 of last induction cycle, Follow-up: every year for up to data cut-off (up to 5 years and 2 months)

,
Interventionunits on a scale (Mean)
Change Baseline, Follow-Up Month 36Change Baseline, Follow-Up Month 48
Obinutuzumab+Chemotherapy0.060.06
Rituximab+Chemotherapy0.050.05

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Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population)

FACT-G consists of the following 4 FACT-Lym sub-questionnaires: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24) and Functional Well-being (range: 0-28). Higher scores indicate better outcomes. A positive change from baseline indicates improvement. Maint = Maintenance period. (NCT01332968)
Timeframe: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)

,
Interventionunits on a scale (Mean)
Physical Well-being (PW), BaselinePW Change, Cycle 3, Day 1PW Change, End InductionPW Change, Maint Month 2PW Change, Maint Month 12PW Change, End MaintSocial/Family Well-being , BaselineS/FW Change, Cycle 3 Day 1S/FW Change, End InductionS/FW Change, Maint Month 2S/FW Change, Maint Month 12S/FW Change, End MaintEmotional Well-being (EW), BaselineEW Change, Cycle 3 Day 1EW Change, End InductionEW Change, Maint Month 2EW Change, Maint Month 12EW Change, End MaintFunctional Well-being (FW), BaselineFW Change, Cycle 3 Day 1FW Change, End InductionFW Change, Maint Month 2FW Change, Maint Month 12FW Change, End Maint
Obinutuzumab+Chemotherapy23.14-0.210.561.421.341.3323.28-0.67-0.56-0.67-0.97-0.7117.871.351.141.491.461.4918.76-0.070.931.251.651.72
Rituximab+Chemotherapy23.36-0.91-0.060.831.140.8822.84-0.52-0.46-0.39-0.61-0.9317.641.491.161.771.451.4318.66-0.300.441.041.841.40

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Progression-Free Survival in the Overall Study Population, Investigator-Assessed

Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. Tumor measurements were obtained by CT/MRI. (NCT01332968)
Timeframe: Baseline up to data cut-off (up to approximately 5 years and 2 months)

Interventionpercentage of participants with event (Number)
Rituximab+Chemotherapy41.5
Obinutuzumab+Chemotherapy34.8

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Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed

Progression-free survival in the participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. Tumor measurements were obtained by CT/MRI. In the first 170 patients with follicular lymphoma, an FDG-PET was mandatory where a PET scanner was available. (NCT01332968)
Timeframe: Baseline up to data cut-off (up to approximately 5 years and 2 months)

Interventionpercentage of participants with event (Number)
Rituximab+Chemotherapy23.5
Obinutuzumab+Chemotherapy18.0

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Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC)

Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. Tumor measurements were obtained by CT/MRI. (NCT01332968)
Timeframe: Baseline up to data cut-off (up to approximately 5 years and 2 months)

Interventionpercentage of participants with event (Number)
Rituximab+Chemotherapy24.6
Obinutuzumab+Chemotherapy18.4

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Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed

Progression-free survival in participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI). (NCT01332968)
Timeframe: Baseline up to data cut-off (up to approximately 4 years and 7 months)

Interventionpercentage of participants with event (Number)
Rituximab+Chemotherapy24.0
Obinutuzumab+Chemotherapy16.8

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Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed

Progression-free survival in participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI). (NCT01332968)
Timeframe: Baseline up to final analysis (up to 10 years)

Interventionpercentage of participants with event (Number)
Rituximab+Chemotherapy40.6
Obinutuzumab+Chemotherapy34.3

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Duration of Response (DOR) (Follicular Lymphoma Population), Investigator-Assessed

DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. PR was defined as >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. (NCT01332968)
Timeframe: From first occurrence of documented CR or PR to data cut-off (up to approximately 5 years and 2 months)

Interventionpercentage of participants with event (Number)
Rituximab+Chemotherapy39.3
Obinutuzumab+Chemotherapy33.3

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Duration of Response (DOR) (Overall Study Population), Investigator-Assessed

DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. PR was defined as >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. (NCT01332968)
Timeframe: From first occurrence of documented CR or PR to data cut-off (up to approximately 4 years and 7 months)

Interventionpercentage of participants with event (Number)
Rituximab+Chemotherapy25.5
Obinutuzumab+Chemotherapy18.7

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Event-Free Survival (Follicular Lymphoma Population)

Event-free survival in the follicular lymphoma population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. Tumor measurements were obtained by CT/MRI. Reported is the percentage of participants with an event. (NCT01332968)
Timeframe: Baseline up to 10 years

Interventionpercentage of participants with event (Number)
Rituximab+Chemotherapy42.9
Obinutuzumab+Chemotherapy35.8

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Disease-Free Survival (Overall Study Population)

Disease-free survival in the overall study population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter 1.5 cm. Reported is the percentage of participants with event. (NCT01332968)
Timeframe: From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months)

Interventionpercentage of participants with event (Number)
Rituximab+Chemotherapy14.9
Obinutuzumab+Chemotherapy11.2

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Overall Response Rate (ORR)

ORR is defined as percentage of participants with overall response including CR, VGPR, and partial response (PR). Per IMWG criteria, CR:1)Negative immunofixation on serum and urine, 2)Disappearance of any soft tissue plasmacytomas, 3)< 5% plasma cells in bone marrow. VGPR: Serum+urine M-protein detectable by immunofixation but not on electrophoresis/ 90% or >reduction in serum M-protein + urine M-protein level < 100 mg/ 24-hour. PR:1)≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24-hour. If serum+urine M-protein are unmeasurable, ≥50% decrease in difference between involved and uninvolved FLC levels is required. If serum+urine M-protein are unmeasurable and serum free light assay is also unmeasurable, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%. In addition, if present at baseline, a ≥50% reduction in size of soft tissue plasmacytomas is required. (NCT01335685)
Timeframe: Day 1 of every other cycle from Day 1 of Cycle 2 (each cycle of 28 days) up to 61 cycles, at end of treatment (Up to 5.5 years)

Interventionpercentage of participants (Number)
Arm A: Ixazomib 3.0 mg86
Arm A: Ixazomib 3.7 mg67
Arm B: Ixazomib 3.0 mg100
Arm B: Ixazomib 4.0 mg65
Arm B: Ixazomib 5.5 mg60
Arm C: Ixazomib 3.0 mg40
Arm C: Ixazomib 4.0 mg67
Arm D: Ixazomib 4.0 mg50

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Overall Survival (Phase 2)

Overall Survival is the time in months from start of study treatment to date of death due to any cause. (NCT01335685)
Timeframe: From date of enrollment to date of death, approximately 5.5 years (Approximate median follow-up: 43.6 months)

Interventionmonths (Median)
Arm B: Ixazomib 4.0 mg (RP2D)NA

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Progression Free Survival (Phase 2)

Progression Free Survival is defined as time in months from start of study treatment to first documentation of objective tumor progression per investigator assessment or up to death due to any cause, whichever occurs first. Per IMWG criteria, progressive disease requires any 1 or more of following: Increase of ≥25% from nadir in serum M-component and/or (absolute increase must be ≥0.5 g/dL), urine M-component and/or (absolute increase must be ≥200 mg/24 hour. Participants without measurable serum+urine M-protein levels: difference between involved and uninvolved FLC levels. The absolute increase must be >10 mg/dL. Bone marrow plasma cell percentage: absolute % must be ≥10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.85 mmol/L) that can be attributed solely to plasma cell proliferative disorder. (NCT01335685)
Timeframe: From the date of enrollment to the date of the first documented disease progression or death due to any cause for up to 5.5 years

Interventionmonths (Median)
Arm B: Ixazomib 4.0 mg (RP2D)18.4

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Time to First Response (Phase 2)

Response is defined as CR, VGPR and PR. Per IMWG criteria, CR:1)Negative immunofixation on serum+urine, 2)Disappearance of any soft tissue plasmacytomas, 3)< 5% plasma cells in bone marrow. VGPR: Serum+urine M-protein detectable by immunofixation but not on electrophoresis/ 90% or >reduction in serum M-protein + urine M-protein level < 100 mg/ 24-hour. PR:1)≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24-hour. If serum+urine M-protein are unmeasurable, ≥50% decrease in difference between involved and uninvolved FLC levels is required. Else, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%. In addition, if present at baseline, a ≥50% reduction in size of soft tissue plasmacytomas is required. (NCT01335685)
Timeframe: From the date of enrollment to the date of the first documented response for up to 5.5 years

Interventionmonths (Median)
Arm B: Ixazomib 4.0 mg (RP2D)1.9

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Time to Progression (TTP) (Phase 2)

TTP is defined as time from date of enrollment to date of first documented disease progression (PD). Per IMWG criteria, progressive disease requires any 1 or more of following: Increase of ≥25% from nadir in serum M-component and/or (absolute increase must be ≥0.5 g/dL), urine M-component and/or (absolute increase must be ≥200 mg/24 hour. Participants without measurable serum+urine M-protein levels: difference between involved and uninvolved FLC levels. The absolute increase must be >10 mg/dL. Bone marrow plasma cell percentage: absolute % must be ≥10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.85 mmol/L) that can be attributed solely to plasma cell proliferative disorder. (NCT01335685)
Timeframe: From the date of enrollment to the date of the first documented disease progression for up to 5.5 years

Interventionmonths (Median)
Arm B: Ixazomib 4.0 mg (RP2D)22.1

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Very Good Partial Response (VGPR) or Better Response Rate (Phase 2)

VGPR or better response rate is defined as percentage of participants with a complete response (CR) and very good partial response (VGPR). Per International Myeloma Working Group Uniform Response Criteria (IMWG), CR: 1) Negative immunofixation on the serum and urine, 2) Disappearance of any soft tissue plasmacytomas and 3) < 5% plasma cells in bone marrow. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hour. (NCT01335685)
Timeframe: Day 1 of every other cycle from Day 1 of Cycle 2 (each cycle of 28 days) until death (Up to 5.5 years)

Interventionpercentage of participants (Number)
Arm B: Ixazomib 4.0 mg (RP2D)48

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AUCtau: Area Under the Plasma Concentration-time Curve Over the Dosing Interval for Ixazomib (Phase 1)

(NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D

,
Interventionhr*ng/mL (Mean)
Cycle 1, Day 1Cycle 1, Day 11
Arm A: Ixazomib 3.0 mg319.7141227.143
Arm A: Ixazomib 3.7 mg287.0001180.000

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AUCtau: Area Under the Plasma Concentration-time Curve Over the Dosing Interval for Ixazomib (Phase 1)

(NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D

,,
Interventionhr*ng/mL (Mean)
Cycle 1, Day 1Cycle 1, Day 29
Arm C: Ixazomib 3.0 mg662.8331527.800
Arm C: Ixazomib 4.0 mg1037.5002680.000
Arm D: Ixazomib 4.0 mg934.8002435.000

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Cmax: Maximum Observed Plasma Concentration for Ixazomib (Phase 1)

(NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D

,
Interventionng/mL (Mean)
Cycle 1, Day 1Cycle 1, Day 11
Arm A: Ixazomib 3.0 mg26.79169.214
Arm A: Ixazomib 3.7 mg39.30022.000

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Cmax: Maximum Observed Plasma Concentration for Ixazomib (Phase 1)

(NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D

,,
Interventionng/mL (Mean)
Cycle 1, Day 1Cycle 1, Day 15
Arm B: Ixazomib 3.0 mg22.95030.267
Arm B: Ixazomib 4.0 mg53.27885.636
Arm B: Ixazomib 5.5 mg104.225285.000

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Cmax: Maximum Observed Plasma Concentration for Ixazomib (Phase 1)

(NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D

,,
Interventionng/mL (Mean)
Cycle 1, Day 1Cycle 1, Day 29
Arm C: Ixazomib 3.0 mg55.36759.560
Arm C: Ixazomib 4.0 mg50.875109.000
Arm D: Ixazomib 4.0 mg72.080146.400

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Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. (NCT01335685)
Timeframe: From first dose of study drug through 30 days after last dose of study drug or until the start of subsequent antineoplastic therapy for up to 5.6 years

,,,,,,,
Interventionparticipants (Number)
During Entire Study Any Adverse EventGrade 3 or Higher Adverse EventSerious Adverse EventAdverse Event With Any Study Drug DiscontinuationAdverse Event With Any Study Drug Reduction
Arm A: Ixazomib 3.0 mg77204
Arm A: Ixazomib 3.7 mg44402
Arm B: Ixazomib 3.0 mg33301
Arm B: Ixazomib 4.0 mg262112813
Arm B: Ixazomib 5.5 mg55323
Arm C: Ixazomib 3.0 mg65423
Arm C: Ixazomib 4.0 mg44212
Arm D: Ixazomib 4.0 mg65124

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Observed Accumulation Ratio for AUCtau (Rac) (Phase 1)

Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1. (NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D

,
Interventionratio (Mean)
Cycle 1, Day 11
Arm A: Ixazomib 3.0 mg4.019
Arm A: Ixazomib 3.7 mg4.120

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Observed Accumulation Ratio for AUCtau (Rac) (Phase 1)

Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1. (NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D

,,
Interventionratio (Mean)
Cycle 1, Day 15
Arm B: Ixazomib 3.0 mg1.700
Arm B: Ixazomib 4.0 mg2.288
Arm B: Ixazomib 5.5 mg1.970

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Observed Accumulation Ratio for AUCtau (Rac) (Phase 1)

Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1. (NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D

,,
Interventionratio (Mean)
Cycle 1, Day 29
Arm C: Ixazomib 3.0 mg2.632
Arm C: Ixazomib 4.0 mg2.560
Arm D: Ixazomib 4.0 mg2.540

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Terminal Elimination Rate Constant (λz) for Ixazomib (Phase 1)

Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase. (NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D

,,
Intervention1/hour (Mean)
Cycle 1, Day 15
Arm B: Ixazomib 3.0 mg0.004
Arm B: Ixazomib 4.0 mg0.006
Arm B: Ixazomib 5.5 mg0.007

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Terminal Elimination Rate Constant (λz) for Ixazomib (Phase 1)

Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase. (NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D

,
Intervention1/hour (Mean)
Cycle 1, Day 29
Arm C: Ixazomib 4.0 mg0.005
Arm D: Ixazomib 4.0 mg0.006

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Terminal Elimination Rate Constant (λz) for Ixazomib (Phase 1)

Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase. (NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D

Intervention1/hour (Mean)
Cycle 1, Day 15Cycle 1, Day 29
Arm C: Ixazomib 3.0 mgNA0.005

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Terminal Phase Elimination Half-life (T1/2) for Ixazomib (Phase 1)

Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. (NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D

,,
Interventionhours (Mean)
Cycle 1, Day 15
Arm B: Ixazomib 3.0 mg167.000
Arm B: Ixazomib 4.0 mg130.362
Arm B: Ixazomib 5.5 mg98.900

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Terminal Phase Elimination Half-life (T1/2) for Ixazomib (Phase 1)

Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. (NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D

,
Interventionhours (Mean)
Cycle 1, Day 29
Arm C: Ixazomib 4.0 mg163.500
Arm D: Ixazomib 4.0 mg120.050

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Terminal Phase Elimination Half-life (T1/2) for Ixazomib (Phase 1)

Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. (NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D

Interventionhours (Mean)
Cycle 1, Day 15Cycle 1, Day 29
Arm C: Ixazomib 3.0 mgNA140.575

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Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib (Phase 1)

(NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D

,,
Interventionhours (Median)
Cycle 1, Day 1Cycle 1, Day 15
Arm B: Ixazomib 3.0 mg1.7500.833
Arm B: Ixazomib 4.0 mg1.0001.000
Arm B: Ixazomib 5.5 mg1.3020.500

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Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib (Phase 1)

(NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D

,,
Interventionhours (Median)
Cycle 1, Day 1Cycle 1, Day 29
Arm C: Ixazomib 3.0 mg1.5601.500
Arm C: Ixazomib 4.0 mg1.2821.275
Arm D: Ixazomib 4.0 mg0.5670.760

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AUCtau: Area Under the Plasma Concentration-time Curve Over the Dosing Interval for Ixazomib (Phase 1)

(NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D

,,
Interventionhr*ng/mL (Mean)
Cycle 1, Day 1Cycle 1, Day 15
Arm B: Ixazomib 3.0 mg450.000705.667
Arm B: Ixazomib 4.0 mg806.8241610.500
Arm B: Ixazomib 5.5 mg1612.2501680.000

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Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib (Phase 1)

(NCT01335685)
Timeframe: Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D

,
Interventionhours (Median)
Cycle 1, Day 1Cycle 1, Day 11
Arm A: Ixazomib 3.0 mg1.0201.050
Arm A: Ixazomib 3.7 mg0.5178.000

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Duration of Response (DOR) (Phase 2)

DOR is defined as time of first documentation of a confirmed PR or better response to first documented PD or start of alternative therapy. DOR was presented for those achieving CR+VGPR+PR. Per IMWG criteria, CR:1)Negative immunofixation on serum+urine, 2)Disappearance of any soft tissue plasmacytomas, 3)< 5% plasma cells in bone marrow. VGPR: Serum+urine M-protein detectable by immunofixation but not on electrophoresis/ 90% or >reduction in serum M-protein + urine M-protein level < 100 mg/ 24-hour. PR:1)≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24-hour. If serum+urine M-protein are unmeasurable, ≥50% decrease in difference between involved and uninvolved FLC levels is required. Else, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%. In addition, if present at baseline, a ≥50% reduction in size of soft tissue plasmacytomas is required. (NCT01335685)
Timeframe: From the time from the date of first documentation of PR or better to the date of first documented disease progression for up to 5.5 years

Interventionmonths (Median)
Arm B: Ixazomib 4.0 mg (RP2D)25.2

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Complete Response Rate of Cyclophosphamide, Etoposide, Vincristine and Prednisone (CEOP) and Pralatrexate (P) Treatment

"Complete Response Rate (CR) was reported at the end of the CEOP-P (6 courses for patients not receiving transplant and 4-6 courses for patients receiving transplant). Response assessment was performed by computerized tomography (CT) or positron emission tomography (PET)/CT based on the investigator's preference after cycles 2, 4 and 6. Response was assessed by the treating physician according to the Cheson Revised response criteria (Cheson et al,, 2007) or International Harmonization Project criteria (Cheson, 2007), based on imaging modality used.~Complete Response Definition: Disappearance of all evidence of disease Nodal Masses: (a) [18F]fluorodeoxyglucose(FDG)-avid or PET positive prior to therapy; mass of any size permitted if PETnegative (b) Variably FDG-avid or PET negative; regression to normal size on CT Spleen, Liver: Not palpable, nodules disappeared Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative" (NCT01336933)
Timeframe: 168 days - 252 days (4-6 courses; 42 days per course)

Interventionpercentage of participants analyzed (Number)
Treatment (Chemotherapy and Enzyme Inhibitor Therapy)52

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Event Free Survival (EFS)

Estimated 2-year Event Free Survival (EFS), as well as plots of EFS, will be produced using the method of Kaplan-Meier, along with 95% confidence intervals for EFS. Event-free survival is defined as time from therapy until relapse, progression, or death from any cause. (NCT01336933)
Timeframe: 2 years

Interventionpercentage of participants analyzed (Number)
Treatment (Chemotherapy and Enzyme Inhibitor Therapy)39

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Overall Response Rates (ORR)= (Complete Response Rates (CR) + Partial Response Rates (PR))

"Every patient who fulfills all aspects of patient eligibility who receives at least 2 complete courses of chemotherapy will be evaluable for the response endpoint. Response rates will be descriptively summarized using percentages and 95% confidence intervals.~Complete Response Definition: Defined in Primary Objective Partial Response Definition: Regression of measurable disease and no new sites, Nodal Masses: > 50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes~FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site~Variably FDG-avid or PET negative; regression on CT Spleen, Liver:> 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified" (NCT01336933)
Timeframe: 2 years

Interventionpercentage of participants analyzed (Number)
Treatment (Chemotherapy and Enzyme Inhibitor Therapy)70

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To Evaluate the Safety and Tolerability of the Regimen by the Percent of Participants With Indicated Adverse Events

Adverse events will be summarized using patient level incidence rates so that a patient contributes once to any adverse event. The number and percentage of patients with any adverse event will be summarized for each course. Serious adverse events will be analyzed similarly. (NCT01336933)
Timeframe: 22 months

Interventionpercentage of participants (Number)
Grade 3-4 anaemiaGrade 3-4 thrombocoytopeniaGrade 3-4 febrile neutropeniaGrade 3-4 mucositisGrade 3-4 sepsisGrade 3-4 increased creatinineGrade 3-4 liver transaminases
Treatment (Chemotherapy and Enzyme Inhibitor Therapy)27121818151212

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Percent of Patients Who Proceeded With Transplant

Percentage of patients who received consolidation with high dose therapy and autologous stem cell rescue (HDT/SCR). (NCT01336933)
Timeframe: 168-252 days (4 courses up to 6 courses of treatment)

InterventionParticipants (Count of Participants)
Treatment15

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Overall Survival (OS)

Estimated 2-year Overall Survival (OS), as well as plots of OS, will be produced using the method of Kaplan-Meier, along with 95% confidence intervals for OS. Overall survival is defined as time from the first chemotherapy administered on trial until death from any cause. (NCT01336933)
Timeframe: 2 years

Interventionpercentage of participants analyzed (Number)
Treatment (Chemotherapy and Enzyme Inhibitor Therapy)60

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Overall Survival of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL)

Measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. (NCT01359592)
Timeframe: up to 5 years

Interventionpercentage of participants (Number)
R-CHOP x 3 Followed by PET-directed Therapy89

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Five-year Progression-free Survival (PFS) Rate in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma (DLBCL)

"Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive without report of progression or relapse are censored at date of last contact.~Progressions is defined using the 2007 revised Cheson et. Al. criteria, as ≥50% increase in the sum of the products of diameters (SPD) of target measurable lesions, appearance of any new bone marrow involvement, or appearance of any new lesion >1.5 cm in the longest axis." (NCT01359592)
Timeframe: up to 5 years

Interventionpercentage of participants (Number)
R-CHOP x 3 Followed by PET-directed Therapy87

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Progression-free Survival (PFS) Within the PET+ and PET- Subgroups of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL)

Measured from date of interim positron emission tomography (PET)/computed tomography scan to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive without report of progression or relapse are censored at date of last contact. (NCT01359592)
Timeframe: up to 5 years

Interventionpercentage of participants (Number)
Interim PET-negative89
Interim PET-positive86

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Polymyalgia Rheumatica Activity Score (PMR-AS)

The efficacy of a single dose of AIN457 and ACZ885 (canakinumab) was measured by the polymyalgia rheumatica activity score. A composite PMR-AS was developed from the following components: measure of C-reactive protein (CRP), measure of Erythrocyte Sedimentation Rate (ESR), assessment of early morning stiffness, assessment of the patient's elevation on upper limbs, patient's assessment of pain, and physician's global assessment of disease activity. Treatment effect was measured by the percent reduction in PMR-AS. N=3 for the ACZ885 arm because CRP values at Day 15 were missing for 2 participants. (NCT01364389)
Timeframe: Baseline, Day 15

InterventionPercent reduction (Least Squares Mean)
ACZ88564.5
AIN45751.7
Prednisone91.9

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Mean Steroid Dose Over a 6 Month Period

This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure. (NCT01364389)
Timeframe: 6 months

InterventionNumber of doses (Mean)
ACZ885276.8
AIN457256.7
Prednisone428.9

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Number of Flares Over a 6 Month Period

This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure. (NCT01364389)
Timeframe: 6 months

InterventionParticipant (Number)
AIN4571

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Pharmacokinetics of AIN457 and ACZ885 - CL

(NCT01364389)
Timeframe: Day 15

InterventionL/day (Mean)
ACZ8850.171
AIN4570.157

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Time to Complete Clinical Response

The time to complete clinical response was assessed in patients who received a single dose of AIN457 or ACZ885 (canakinumab). Daily monitoring (home-based) of CRP was performed. This outcome shows the percentage of patients who achieved a complete clinical response at Day 15. A participant was defined as a complete responder if the participant had: >70% reduction in patient global assessment VAS compared with baseline, morning stiffness < 30 min, CRP < 1.0 mg/dL and/or ESR < 30 mm/1st hr. (NCT01364389)
Timeframe: Day 15

InterventionPercentage of participants (Number)
ACZ8850.0
AIN4570.0
Prednisone25.0

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Pharmacokinetics of AIN457 and ACZ885 - T1/2

(NCT01364389)
Timeframe: Day 15

InterventionDay (Mean)
ACZ88526.6
AIN45740.2

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Pharmacokinetics of AIN457 and ACZ885 - Tmax

(NCT01364389)
Timeframe: Day 15

Interventiondays (Median)
ACZ8850.0868
AIN4570.107

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Pharmacokinetics of AIN457 and ACZ885 - AUCinf and AUClast

(NCT01364389)
Timeframe: Day 15

,
Interventionmicrog/day/mL (Mean)
AUCinf (microg/day/mL)AUClast (microg/day/mL)
ACZ88515701560
AIN45712601200

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Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Deaths

(NCT01364389)
Timeframe: 6 months

,,
InterventionParticipants (Number)
Adverse Events (serious and non-serious)Serious Adverse EventsDeaths
ACZ885300
AIN457200
Prednisone500

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Pharmacokinetics of AIN457 and ACZ885 - Vz

(NCT01364389)
Timeframe: Day 15

InterventionL (Mean)
ACZ8856.49
AIN4579.85

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Time to First Flare

This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. Only 1 participant experienced a flare, in the AIN457 treatment group. The flare for this one participant occurred on study day 44 (NCT01364389)
Timeframe: 6 months

InterventionDays (Number)
AIN45744

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Time to Partial Clinical Response

"The time to partial clinical response was assessed in patients who received a single dose of AIN457 or ACZ885 (canakinumab). Daily monitoring (home-based) of CRP was performed. This outcome shows the percentage of patients who achieved a partial clinical response at Day 15. A participant was defined as a partial responder if the participant had:~>50% reduction in patient global assessment visual analogue scale (VAS) compared with baseline and morning stiffness < 60 minutes." (NCT01364389)
Timeframe: Day 15

InterventionPercentage of participants (Number)
ACZ88520.0
AIN45716.7
Prednisone75.0

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Pharmacokinetics of AIN457 and ACZ885 - Cmax

(NCT01364389)
Timeframe: Day 15

Interventionmicrogram/mL (Mean)
ACZ88569.9
AIN45746.8

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Change From Baseline in DAS28-CRP at 12 Weeks

"The primary efficacy endpoint was the mean change in Disease Activity Score 28 using C-reactive protein (DAS28-CRP) from baseline to Week 12.~The DAS28-CRP is a composite measure of inflammation in Rheumatoid Arthritis and incorporates a tender and swollen joint count, CRP and Patient Global Assessment of Disease Activity expressed in a Gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of <3.2 suggests a low level of disease activity, while a score of >5.1 suggests a high level of disease activity. Using the DAS-CRP as a continuous scale allows investigators (and clinicians) to measure a clinically meaningful endpoint following institution of a therapeutic intervention. In RA, clinical remission would therefore be graded as a DAS28 score of ≤3.2 with disease flare accompanying scores of ≥5.1; well-controlled disease is best characterized as fitting in between these two scores." (NCT01369745)
Timeframe: baseline to week 12

Interventionunits on a scale (Mean)
Prednisolone-1.147
Dipyridamole-0.813
Prednisone-1.237
Z102-0.907
Placebo-0.538

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Participants With Objective Response

To determine the efficacy of the combination of Ruxolitinib + Lenalidomide in patients with Myelofibrosis (MF). Objective response rate equals Complete and Partial Response, and Clinical Improvement as defined by International Working Group for Myelofibrosis Research and Treatment (IWG-MRT). Objective response rate (ORR), defined as a clinical improvement (CI), partial remission (PR), and complete remission (CR) according to the International Working Group (IWG) Criteria. Complete remission (CR): bone marrow blasts <5%, hemoglobin >/= 10, absolute neutrophil count (ANC) >/= 1000, platelets >/= 100, <2% immature myeloid cell, spleen and liver not palpable. Partial Response (PR): CR plus one or more of the following: ANC >/= 1000, decreased platelets by 50%, hemoglobin >/= 8.5 but < 10, <2% immature myeloid cells. Clinical improvement (CI): hemoglobin increase of 2g/dl, transfusion independence or reduction splenomegaly and/or hepatomegaly >/= 50%, >/=50% reduction in MPN-SAF TSS (NCT01375140)
Timeframe: 3 cycles (28 days each) up to 3 months

InterventionParticipants (Count of Participants)
Ruxolitinib + Lenalidomide7

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Change From Baseline in Serum Endocrine Biomarkers (Estradiol and Estrone) at End of Treatment

Change from baseline in serum endocrine biomarkers (estradiol and estrone) was summarized by treatment at end of treatment. (NCT01381874)
Timeframe: Baseline and End of treatment (approximately 2 years)

,,
InterventionPicomoles Per Liter (Pmol/L) (Mean)
EstradiolEstrone
Abiraterone Acetate + Exemestane + Prednisone-1.04-30.60
Abiraterone Acetate + Prednisone-3.35-28.09
Exemestane1.53-34.20

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Progression-Free Survival (PFS)

Progression-free survival was defined as the time from randomization to first occurrence of disease progression (either radiographic or clinical), or death from any cause. PFS was determined using radiographic progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) on measurable lesions captured by computed tomography (CT) or magnetic resonance imaging (MRI). Clinical disease progression was considered only when disease progression could not be confirmed by CT or MRI, such as when the disease site is skin, bone marrow, or central nervous system. (NCT01381874)
Timeframe: Approximately 2 years

InterventionMonths (Median)
Exemestane3.68
Abiraterone Acetate + Prednisone3.65
Abiraterone Acetate + Exemestane + Prednisone4.47

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Overall Survival (OS)

OS was calculated as the time from randomization to death from any cause. (NCT01381874)
Timeframe: Approximately 3 years

InterventionMonths (Median)
ExemestaneNA
Abiraterone Acetate + Prednisone26.41
Abiraterone Acetate + Exemestane + PrednisoneNA

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Overall Response Rate (ORR)

Overall response rate was defined as the percentage of participants with measurable disease achieving a best overall response of either complete response (CR) or partial response (PR) based on RECIST. CR: disappearance of all target lesions and non-target lesions. PR: at least a 30 percent (%) decrease in the sum of longest diameter (LD) of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. (NCT01381874)
Timeframe: Approximately 2 years

InterventionPercentage of participants (Number)
Exemestane6.3
Abiraterone Acetate + Prednisone5.8
Abiraterone Acetate + Exemestane + Prednisone12.1

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Duration of Response

Duration of objective response was measured from the first time that the CR or PR was achieved to the first observation of disease progression (either radiographic or clinical) based on the RECIST criteria. (NCT01381874)
Timeframe: Approximately 2 years

Interventionmonths (Median)
Exemestane6.47
Abiraterone Acetate + Prednisone4.86
Abiraterone Acetate + Exemestane + Prednisone6.93

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Clinical Benefit Rate

Clinical benefit rate was defined as the percentage of participants with measurable disease achieving a best overall response of a CR, PR, or stable disease (SD) for at least 6 months based on RECIST. Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study and persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits. (NCT01381874)
Timeframe: Approximately 2 years

InterventionPercentage of participants (Number)
Exemestane12.7
Abiraterone Acetate + Prednisone9.6
Abiraterone Acetate + Exemestane + Prednisone22.7

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Change From Baseline in Serum Endocrine Biomarkers (Progesterone and Testosterone) at End of Treatment

Change from baseline in serum endocrine biomarkers (Progesterone and Testosterone) was summarized by treatment at end of treatment. (NCT01381874)
Timeframe: Baseline and End of treatment (approximately 2 years)

,,
InterventionNanomoles Per Liter (nmol/L) (Mean)
ProgesteroneTestosterone
Abiraterone Acetate + Exemestane + Prednisone12.34-0.48
Abiraterone Acetate + Prednisone8.98-0.51
Exemestane-4.80-0.09

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Progression-free Survival Rate

Progression-free survival is defined as the time from study entry to lymphoma progression or death from any cause. Proportion of patients who are progression-free and alive at 36 months will be reported. Progression is defined as appearance of any new lesions more than 1.5 cm in any axis, at least a 50% increase from nadir in sum of the product of the diameters (SPD) of any previously involved nodes or extranodal masses or the size of other lesions, or at least 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis. (NCT01390584)
Timeframe: Assessed at 36 months

Interventionproportion of participants (Number)
ABVD + INRTNA
ABVD + BEACOPP + INRTNA

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Overall Survival

Overall survival is defined as the time from study entry to death or date last known alive. (NCT01390584)
Timeframe: Assessed at 36 months

Interventionmonths (Median)
ABVD + INRTNA
ABVD + BEACOPP + INRTNA

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Proportion of Patients Who Are PET Negative After Induction Treatment

(NCT01390584)
Timeframe: Assessed at end of Cycle 2

Interventionproportion of participants (Number)
Step 1: Induction Tx0.8

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Progression-free Survival at 36 Months Among Patients Who Are PET Positive After Induction Treatment

Progression-free survival is defined as the time from study entry to lymphoma progression or death from any cause. Proportion of patients who are progression-free and alive at 36 months will be reported. Progression is defined as appearance of any new lesions more than 1.5 cm in any axis, at least a 50% increase from nadir in sum of the product of the diameters (SPD) of any previously involved nodes or extranodal masses or the size of other lesions, or at least 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis. (NCT01390584)
Timeframe: Assessed at 36 months

Interventionproportion of participants (Number)
ABVD + BEACOPP + INRTNA

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Complete Response (CR) Rate After Induction Treatment

Complete response (CR) is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy. (NCT01390584)
Timeframe: Assessed at end of Cycle 2

Interventionproportion of participants (Number)
Step 1: Induction Tx1.0

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Best Overall Response

Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. (NCT01393730)
Timeframe: Disease was evaluated radiologically at baseline and every 12 weeks cycles on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.

InterventionParticipants (Count of Participants)
Abiraterone + Prednisone + Dutasteride6

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Change in Serum Androgen Levels

Serum androgen levels measured based on established methods. The change from baseline to progression was calculated for each participant. (NCT01393730)
Timeframe: Pairs of patients' samples for androgen analyses were obtained at baseline and at time of progression. In this study cohort, participants were followed up to 48 months for this endpoint.

Interventionng/dl (Median)
Abiraterone + Prednisone + Dutasteride1.2

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Change in Serum Levels of Testosterone

Serum testosterone levels were estimated based on established methods. The change from baseline to progression was calculated for each participant. (NCT01393730)
Timeframe: Samples for testosterone analyses were obtained at baseline and at time of progression. In this study cohort, participants were followed up to 48 months for this endpoint.

Interventionng/dL (Median)
Abiraterone + Prednisone + Dutasteride0.25

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Presence of AR Amplification

Presence of AR amplification was measured by established methods. (NCT01393730)
Timeframe: Patients' samples were evaluated at baseline and every 12 weeks on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.

InterventionParticipants (Count of Participants)
Abiraterone + Prednisone + Dutasteride10

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Prostate-Specific Antigen (PSA) Response

PSA response was defined as decline of 50% from baseline confirmed by a PSA at least 4 weeks later based on Prostate-specific Antigen Working Group-2 (PSAWG-2) (2008) criteria. (NCT01393730)
Timeframe: PSA was measured at baseline and day 1 of every cycle on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.

InterventionParticipants (Count of Participants)
Abiraterone + Prednisone + Dutasteride34

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Time to Progression (TTP)

TTP based on the Kaplan-Meier method is defined as the duration of time from study entry to documented first observation of progressive disease (PD). Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. (NCT01393730)
Timeframe: Disease evaluation occurred every 12 weeks while patients were receiving treatment. In this study cohort, participants were followed up to 48 months for this endpoint.

InterventionMonths (Median)
Abiraterone + Prednisone + Dutasteride11

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Time to PSA Progression

Time to PSA progression based on the Kaplan-Meier method was defined as the time between registration and documented PSA progression. PSA progression based on Prostate-Specific Antigen Working Group-2 (PSAWG-2) (2008) criteria was an increase of >/=25% and >/= 2 ng/ml after 12 weeks for patients without a PSA decline from baseline and an increase of >/=25% and >/= 2 ng/ml above the nadir, confirmed by a 2nd value 3 weeks or later for patients with a PSA decline from baseline. PSA progression was reported not duration of response. (NCT01393730)
Timeframe: PSA was measured at baseline and day 1 of every cycle on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.

Interventionmonths (Median)
Abiraterone + Prednisone + Dutasteride5

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Pharmacokinetics: Terminal Half-Life (t1/2) for Obinutuzumab

T1/2 is the time required for the concentration of the drug to reach half of its original value. Blood was collected for PK Parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in days (NCT01414855)
Timeframe: Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12

Interventiondays (Mean)
Cycle 1 (n = 37)Cycle 8 (n = 21)
Obinutuzumab + CHOP6.0423

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Pharmacokinetics: Volume of Distribution (V) for Obinutuzumab

V is the apparent volume in which a drug is distributed in the body. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in milliliters (mL). (NCT01414855)
Timeframe: Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12

InterventionmL (Mean)
Cycle 1 (n = 54)Cycle 8 (n = 37)
Obinutuzumab + CHOP45809210

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Complete Response (CR) Rate as Assessed by the Investigator at the End of Treatment

Complete response rate is defined as the percentage of participants with Complete Response (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the investigator using regular clinical and laboratory examinations, fluorodeoxyglucose-positron emission tomography (FDG-PET) and computed tomography (CT). CR is the disappearance of all evidence of disease. (NCT01414855)
Timeframe: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)

Interventionpercentage of participants (Number)
Obinutuzumab + CHOP55.0

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Complete Response (CR) Rate as Assessed by the Independent Review Facility (IRF) at the End of Treatment

Complete response rate is defined as the percentage of participants with Complete Response (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the IRF using CT scans, PET scans and pertinent clinical information. CR is the disappearance of all evidence of disease. (NCT01414855)
Timeframe: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)

Interventionpercentage of participants (Number)
Obinutuzumab + CHOP58.0

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Duration of Response (DOR)

DOR is defined as first occurrence of documented response (CR or PR) until the first occurrence of relapse or progression or death of any cause. CR: disappearance of all evidence of disease. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites. (NCT01414855)
Timeframe: From the response assessment to relapse, progression, or death (up to 64 months)

Interventionmonths (Median)
Obinutuzumab + CHOP45.6

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Overall Response Rate (ORR) as Assessed by the Investigator at the End of Treatment

Overall response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the investigator using regular clinical and laboratory examinations, FDG-PET and computed tomography (CT). CR is the disappearance of all evidence of disease. PR is at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites. (NCT01414855)
Timeframe: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)

Interventionpercentage of participants (Number)
Obinutuzumab + CHOP82.0

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Overall Response Rate (ORR) as Assessed by the IRF at the End of Treatment

Overall response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the IRF using CT scans, PET scans and pertinent clinical information. CR is the disappearance of all evidence of disease. PR is at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites. (NCT01414855)
Timeframe: From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)

Interventionpercentage of participants (Number)
Obinutuzumab + CHOP75.0

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Percentage of Participants With Adverse Events as a Measure of Safety

An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug or other protocol-imposed intervention. Preexisting conditions that worsened during the study were reported as adverse events. (NCT01414855)
Timeframe: From the first dose of study treatment to end of study (up to 5 years 4 months)

Interventionpercentage of participants (Number)
Obinutuzumab + CHOP100.0

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Progression-Free Survival (PFS) as Assessed by the Investigator

PFS was defined as the time from the date of the first dose of study treatment until the date of disease progression, relapse, or death from any cause. (NCT01414855)
Timeframe: From the first dose of study treatment to PFS assessment (up to 64 months)

Interventionmonths (Median)
Obinutuzumab + CHOP48.3

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Pharmacokinetics (PK): Maximum Concentration Observed (Cmax) for Obinutuzumab

Blood was collected for PK Parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in micrograms per milliliter (μg/mL). (NCT01414855)
Timeframe: Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12

Interventionμg/mL (Mean)
Cycle 1Cycle 8 (n = 85)
Obinutuzumab + CHOP297574

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Pharmacokinetics: Area Under the Concentration-Time Curve 7 Day (AUC7day)

Blood was collected for PK parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in in day times micrograms per milliliter (day*μg/mL). (NCT01414855)
Timeframe: Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12

Interventionday*μg/mL (Mean)
Cycle 1 (n = 59)Cycle 8 (n = 74)
Obinutuzumab + CHOP13203300

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Pharmacokinetics: Clearance (Cl) for Obinutuzumab

Cl is the volume of serum cleared of the drug per unit of time. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in milliliters/day (mL/day). (NCT01414855)
Timeframe: Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12

InterventionmL/day (Mean)
Cycle 1 (n = 54)Cycle 8 (n = 37)
Obinutuzumab + CHOP456143

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Number of Participants With Grade 3 or Higher Adverse Events (AEs) of Special Interest or Grade 3 or Higher Serious AEs Due to Study Medication

AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events. (NCT01424930)
Timeframe: Postdose on Cycle 1 Day 8 to predose on Cycle 2 Day 1

InterventionParticipants (Number)
Abiraterone+Prednisone (Low-fat Meal)0
Abiraterone+Prednisone (High-fat Meal)0

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Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)

The table below shows mean AUC24h. The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. (NCT01424930)
Timeframe: Day 7 and Day 14

,
Interventionng*h/mL (Geometric Mean)
Day 7Day 14
Abiraterone+Prednisone (High-fat Meal)9731992
Abiraterone+Prednisone (Low-fat Meal)12711264

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Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone

The table below shows median Tmax of Abiraterone. The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. (NCT01424930)
Timeframe: Day 7 and Day 14

,
Interventionhours (Median)
Day 7Day 14
Abiraterone+Prednisone (High-fat Meal)24.0
Abiraterone+Prednisone (Low-fat Meal)22.5

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Maximum Observed Plasma Concentration (Cmax) of Abiraterone

The table below shows mean Cmax of Abiraterone. The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. (NCT01424930)
Timeframe: Day 7 and Day 14

,
Interventionng/mL (Geometric Mean)
Day 7Day 14
Abiraterone+Prednisone (High-fat Meal)196342
Abiraterone+Prednisone (Low-fat Meal)218265

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Overall Progression Free Survival (PFS)

Progression was assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. Progression is defined as ≥50% increase from nadir in the sum of the products of the perpendicular diameters (SPD) of any previously identified abnormal nodes for Partial Response's or non-responders. Progression-free survival (PFS) was determined from the on-study date until date of progression or last follow-up. The probability of PFS as a function of time was estimated by the Kaplan-Meier method. (NCT01445535)
Timeframe: On-study date until date of progression or last follow up, approximately 7 months.

InterventionMonths (Median)
All Participants6.8

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Number of Participants With Serious and Non-serious Adverse Events

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01445535)
Timeframe: Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.

InterventionParticipants (Count of Participants)
Cohort 1 - 3.4 mg/kg3
Cohort 2 - 4.8 mg/kg3
Cohort 3 - 8.5 mg/kg3
Cohort 4 - 15 mg/kg5

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Number of Dose-Limiting Toxicities (DLT)

DLTs for siplizumab was defined as infusional grade 3 non-hematologic toxicity lasting longer than 6 hours after the infusion, any grade 4 non-hematologic toxicity, or the development of an EBV-related lymphoproliferative disorder (LPD). Expected toxicities of dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) and grade 3 laboratory AEs were not considered to be DLTs. (NCT01445535)
Timeframe: First 30 days after treatment initiation.

InterventionDose Limiting Toxicities (Number)
Cohort 1 - 3.4 mg/kg0
Cohort 2 - 4.8 mg/kg0
Cohort 3 - 8.5 mg/kg0
Cohort 4 - 15 mg/kg0

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Number of Participants With a Response to Therapy

Response was assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. Complete Remission was defined as the disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease related symptoms if present before therapy, and normalization of those biochemical abnormalities (for example lactate dehydrogenase (LDH)) definitely assignable to the lymphoma. Complete response unconfirmed was defined as a residual node greater than 1.5 cm, with a decrease by greater than 75 percent in the sum of the products of the perpendicular diameters (SPD) of all measured lymph nodes. Partial Response was defined as a ≥ 50% decreased in SPD of 6 largest dominant nodes or nodal masses. Relapsed disease was defined as the appearance of any new lesion or increase by ≥50% in the size of the previously identified sites. Progressive disease was defined as a ≥50% increase from nadir in the SPD. (NCT01445535)
Timeframe: Response assessments were performed after the fourth and sixth cycle of therapy, at therapy completion, and every 3 months for year 1, four months for year 2, 6 months for years 3-5, and annually thereafter, up to 5 years.

,,,
InterventionParticipants (Count of Participants)
Complete RemissionComplete Response UnconfirmedPartial ResponseRelapsed DiseaseProgressive DiseaseStable DiseaseNot Evaluable
Cohort 1 - 3.4 mg/kg1010100
Cohort 2 - 4.8 mg/kg2010000
Cohort 3 - 8.5 mg/kg1010100
Cohort 4 - 15 mg/kg4000002

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Maximum Tolerated Dose (MTD) of Siplizumab

A classic 3+3 dose-escalation design was used to assess the MTD of siplizumab in combination with dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R). If 2 of 6 patients experienced a dose-limiting toxicity (DLT) at a particular dose level, the MTD has been exceeded. The preceding dose level will be the MTD, provided 6 patients have been entered at this level and no more than one has experienced a DLT. DLTs for siplizumab was defined as infusional grade 3 non-hematologic toxicity lasting longer than 6 hours after the infusion, any grade 4 non-hematologic toxicity, or the development of an Epstein Barr Virus (EBV)-related lymphoproliferative disorder (LPD). Expected toxicities of dose-adjusted EPOCH-R and grade 3 laboratory adverse events (AEs) were not considered to be DLTs. (NCT01445535)
Timeframe: First 30 days after treatment initiation.

Interventionmg/kg (Number)
All Participants15

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Overall Survival (OS)

Overall survival was determined from the on-study date until date of progression or last follow up. The probability of OS as a function of time was estimated by the Kaplan-Meier method. (NCT01445535)
Timeframe: On study date until date of death or last follow up, approximately 12 months.

InterventionMonths (Median)
All Participants12.1

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Probability of Event-free Survival (EFS)

"For EFS, relapse and second malignancies are considered as failures in addition to death in complete remission. The time to EFS will be set to 0 for patients who fail to achieve complete remission. Kaplan-Meier estimates of the OS and EFS curves are computed, along with estimates of standard errors by Peto's method.~Please note the unit of measurement of probabilities are percentages." (NCT01451515)
Timeframe: Two years post therapy.

Interventionpercentage of event-free patients (Number)
Stratum 191.7
Stratum 271.4
Stratum 3100
All Enrollments86.96

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Probability of Overall Survival (OS)

"For OS, only deaths are considered failures for OS. Kaplan-Meier estimates of the OS curves are computed along with estimates of standard errors by Peto's method.~Please note the unit of measurement of probabilities are percentages." (NCT01451515)
Timeframe: Two years post therapy.

Interventionpercentage of patients alive (Number)
Stratum 191.7
Stratum 271.4
Stratum 3100
All Enrollments86.96

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Minimal Residual Disease (MRD)

Detectable disease in bone marrow or blood: A binary measure, positive (detectable), negative (non-detectable) (NCT01451515)
Timeframe: Day 8

,,
Interventionparticipants (Number)
NegativePositive
Stratum 180
Stratum 241
Stratum 304

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Minimal Disseminated Disease (MDD)

Detectable disease in bone marrow or blood: A binary measure, positive (detectable), negative (non-detectable) (NCT01451515)
Timeframe: At Diagnosis

,,
Interventionparticipants (Number)
NegativePositive
Stratum 141
Stratum 223
Stratum 304

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Number of Participants With Complete Response and Partial Response

Complete response is transfusion independence with hemoglobin >9 gm/dl; partial response is transfusion dependence with hemoglobin < 9gm/dl with an increase in reticulocyte count over baseline (NCT01464164)
Timeframe: 9 months

InterventionParticipants (Count of Participants)
Sotatercept Cohort 10
Sotatercept Cohort 20
Sotatercept Cohort 30
Sotatercept With Prednisone Boost Cohort 4a0
Sotatercept Cohort 4b0
Sotatercept With Prednisone Boost Cohort 5a0
Sotatercept Cohort 5b0

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Severe Adverse Events Attributable to Study Drug

Assess severity of adverse events and relationship to sotatercept according to the currently active minor version of the NCI Common Terminology for Adverse Events version 4.0 (NCT01464164)
Timeframe: 9 months

InterventionParticipants (Count of Participants)
Sotatercept Cohort 10
Sotatercept Cohort 20
Sotatercept Cohort 30
Sotatercept With Prednisone Boost Cohort 4a0
Sotatercept Cohort 4b0
Sotatercept With Prednisone Boost Cohort 5a0
Sotatercept Cohort 5b0

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Maximum Tolerated Dose (MTD) of Pasireotide in Combination With Docetaxel and Prednisone by the Occurrence of Adverse Events and the Associated Grade Per NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

To identify the maximum tolerated dose (MTD) of pasireotide, The occurrence rate of binary endpoints (eg, specific types of toxicity at a certain dose level and severity grade, response, etc) will be described by point estimates and exact 90% confidence intervals (CIs) for proportions using Wilson's method. (NCT01468532)
Timeframe: Up to day 57

Interventionmg (Number)
Treatment (Chemotherapy, Receptor Agonist)60

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The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0

The count of patients who experience a given type and grade of toxicity as assessed via NCI CTCAE version 4.0 (NCT01468532)
Timeframe: On days 1, 8, 15, 22, 29, 36 43, 50 and 57

InterventionParticipants (Count of Participants)
Abdominal pain grade 1Agitation grade 1Alkaline phosphatase increased grade 3Allergic reaction grade 1Alopecia grade 1Alopecia grade 2Anemia grade 1Anemia grade 3Anorexia grade 1Anorexia grade 2Arthritis grade 1Aspartate aminotransferase increased grade 2Aspartate aminotransferase increased grade 3Back pain grade 1Back pain grade 2Bladder infection grade 2Blood and lymphatic system disorders-Other grade 1Bruising grade 1Cardiac disorders - Other, specify grade 1Cataract grade 1Chills grade 1Cholesterol high grade 1Conjunctivitis grade 2Constipation grade 1Cough grade 1Cough grade 2Creatinine increased grade 1Dehydration grade 2Dehydration grade 3Depression grade 1Diarrhea grade 1Diarrhea grade 2Diarrhea grade 3Dizziness grade 1Dry mouth grade 1Dry skin grade 1Dysgeusia grade 1Dysgeusia grade 2Dyspnea grade 1Ear and labyrinth disorders-Other, specify grade 1Edema limbs grade 1Edema limbs grade 2EKG QT corrected interval prolong grade 1EKG QT corrected interval prolong grade 2EKG QT corrected interval prolong grade 3Eye disorders - Other, specify grade 1Fatigue grade 1Fatigue grade 2Fatigue grade 3Fever grade 1Flank pain grade 1Flu like symptoms grade 1Flushing grade 1Gastroesophageal reflux disease grade 1Gastroesophageal reflux disease grade 2Gastrointestinal disorders -Other, specify grade 1Generalized muscle weakness grade 1Generalized muscle weakness grade 2Headache grade 1Hearing impaired grade 1Heart failure grade 1Hematuria grade 1Hematuria grade 2Hoarseness grade 1Hot flashes grade 1Hyperglycemia grade 1Hyperglycemia grade 2Hyperglycemia grade 3Hyperkalemia grade 2Hypertension grade 2Hypertension grade 3Hypertriglyceridemia grade 1Hypertriglyceridemia grade 3Hypoalbuminemia grade 3Hypocalcemia grade 1Hypocalcemia grade 3Hypokalemia grade 2Hypomagnesemia grade 1Hypomagnesemia grade 2Hyponatremia grade 3Hypophosphatemia grade 3Hypotension grade 3Hypothyroidism grade 1Infusion related reaction grade 2Infusion site extravasation grade 2Injection site reaction grade 1Insomnia grade 1Localized edema grade 1Lymphedema grade 1Lymphocyte count decreased grade 1Lymphocyte count decreased grade 3Lymphocyte count decreased grade 4Mucositis oral grade 2Muscle weakness lower limb grade 1Musculoskeletal and connective tissue dis. grade 1Myalgia grade 1Nail discoloration grade 1Nail discoloration grade 2Nail loss grade 1Nail ridging grade 1Nasal congestion grade 1Nausea grade 1Nausea grade 2Nervous system disorders - Other grade 1Neutrophil count decreased grade 3Neutrophil count decreased grade 4Otitis externa grade 2Pain grade 1Pain in extremity grade 2Pelvic pain grade 1Penile infection grade 1Penile pain grade 1Peripheral sensory neuropathy grade 1Peripheral sensory neuropathy grade 2Platelet count decreased grade 1Rash acneiform grade 1Rash acneiform grade 2Rectal pain grade 1Renal and urinary disorders - Other grade 1Renal and urinary disorders - Other grade 2Respiratory, thoracic and mediastinal dis. grade 3Serum amylase increased grade 4Sinus disorder grade 1Sinusitis grade 2Skin and subcutaneous tissue disorders grade 1Skin and subcutaneous tissue disorders grade 2Skin infection grade 4Sore throat grade 1Thromboembolic event grade 3Toothache grade 1Tremor grade 1Upper respiratory infection grade 1Upper respiratory infection grade 2Upper respiratory infection grade 3Urinary frequency grade 1Urinary tract infection grade 2Urinary tract infection grade 3Urinary tract obstruction grade 2Vomiting grade 1Watering eyes grade 1Weight loss grade 1Weight loss grade 2Weight loss grade 3Wheezing grade 1White blood cell decreased grade 3White blood cell decreased grade 4
Treatment (Chemotherapy, Receptor Agonist)1131114461211311111145142112121021822146111111267111223175211121133110155311112114311111111171125121121101110612111174161212111191131112114411411611113

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Pharmacokinetics (PK) of SOM230

Pharmacokinetics (PK) of SOM230 measured in the bloodstream (in ng/ml) at days 29, 57, and 85. (NCT01468532)
Timeframe: Predosing/end of infusion/2, 3, 4 ,7, 24 and 48 hours after start of docetaxel; Day 43; predosing for docetaxel and pasireotide/end of infusion/2, 3, 4, 7, 24 hours day 44/48 hours day 45 after start of infusion; days 29, 57, and 85 prior to pasireotide

Interventionng/ml (Median)
Level at day 29Level at day 57Level at day 85
Treatment (Chemotherapy, Receptor Agonist)15.414.914.5

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Percentage Prostate-specific Antigen (PSA) Change Noted

Percentage change of prostate-specific antigen (PSA) decline or increase noted (NCT01468532)
Timeframe: On days 1, 22, 43

Interventionpercentage change of PSA from day 1 (Median)
from day 1 to day 22from day 1 to day 43
Treatment (Chemotherapy, Receptor Agonist)-18.52-31.49

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Measurements of CTC Counts, the Change Between Time-points Pre-therapy, Post-therapy

Measurements of CTC counts, the change between time-points (day 22 and day 43) from day 1 as measured in percent change. (NCT01468532)
Timeframe: Baseline and days 22 and 43

Interventionpercent change of CTC from day 1 (Median)
CTC from day 1 to day 22CTC from day 1 to day 43
Treatment (Chemotherapy, Receptor Agonist)-5.50-29.50

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Measurement of Levels of IGF-1, Serum Chromogranin A (SCA), and Neuron Specific Enolase (NSE), the Change Between Time Points Pre-therapy, Post-therapy

Measurement of levels of IGF-1, serum chromogranin A (SCA), and neuron specific enolase (NSE), the change between time points (day 22 and day 43) from day 1 as measured in percent change. (NCT01468532)
Timeframe: Baseline and days 22 and 43

Interventionpercent change of biomarker from day 1 (Median)
IGF-1 day 1 to day 22IGF-1 day 1 to day 43SCA day 1 to day 22SCA day 1 to day 43NSE day 1 to day 22NSE day 1 to day 43
Treatment (Chemotherapy, Receptor Agonist)-47.74-65.64-25.36-21.43-17.008.00

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Time to Progression (TTP)

Time from Treatment start date to Progression (TTP) Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT01468532)
Timeframe: Every 3 months for the first 9 months on study then every 4 months after the first 9 months on study, up to 2 years

Interventionmonths (Median)
Treatment (Chemotherapy, Receptor Agonist)7.2

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Overall Survival (OS)

Time from Treatment start date to date of death or last follow-up. (NCT01468532)
Timeframe: Every 3 months for the first 9 months on study then every 4 months after the first 9 months on study

Interventionmonths (Median)
Treatment (Chemotherapy, Receptor Agonist)18.3

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Measurements of Tumor Using Response Evaluation Criteria In Solid Tumors (RECIST) Criteria Before and After Treatment With the Combination of Pasireotide in Combination With Docetaxel

Percentage of participants responding to treatment by measurements of tumor using Response Evaluation Criteria In Solid Tumors (RECISTv1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR, before and after treatment with the combination of pasireotide in combination with docetaxel (NCT01468532)
Timeframe: Every 12 weeks for the first 36 weeks and then every 16 weeks thereafter up to 100 weeks

Interventionpercentage of participants (Number)
Treatment (Chemotherapy, Receptor Agonist)44.4

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Time-to-First Severe Asthma Exacerbation (SAEX): Number of First SAEX in the MF/F vs MF Arms

The key secondary efficacy outcome was time-to-first protocol-defined asthma exacerbation (SAEX). The SAEX were deteriorations of asthma requiring: use of systemic corticosteroids (tablets, suspension, or injection) for >= 3 consecutive days, in-patient hospitalization >= 24 hours, or an emergency department (ED) visit < 24 hours that required systemic corticosteroids in the MF/F MDI BID arm versus the MF MDI BID arm. The number of first SAEX occurred from initiation of study treatment to 7 days after the last treatment (modified intention-to-treat). This outcome was measured as the HR and 95% CI for the number of first SAEX in the MF/F MDI BID arm versus the number of first SAEX in the MF MDI BID arm. Given insufficient data for SAEX events, it was not informative to report the time-to-first SAEX in the overall population. Therefore, the number of first SAEXs in either arm is reported as a descriptive measure. For each participant, first SAEX denotes first event per participant. (NCT01471340)
Timeframe: 26 weeks, plus 7 days after the last treatment

InterventionAsthma exacerbations (Number)
MF/F MDI BID708
MF MDI BID779

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Number of SAO Components in MF/F Participants vs MF Participants

To further examine the primary safety outcome, each adjudicated component of the SAO composite endpoint (asthma-related hospitalization, asthma-related intubation and asthma-related death), was tabulated for descriptive purposes only to show the relative contribution of each component to the SAO composite. Hospitalizations were defined as an in-patient stay of >= 24 hour in a hospital, emergency department or equivalent healthcare facility. Intubation was defined as endotracheal intubation only. (NCT01471340)
Timeframe: 26 weeks, or 7 days after the last treatment dose, whichever occurred later

,
InterventionSAO components (Number)
First SAOAsthma-related hospitalizationsAsthma-related intubationsAsthma-related deaths
MF MDI BID323200
MF/F MDI BID393900

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Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms

The primary safety outcome was the time-to-first SAO (a composite endpoint of adjudicated asthma-related hospitalizations, adjudicated asthma-related intubations, and adjudicated asthma-related deaths). To accomplish this, the number of participants experiencing a first SAO was collected for 26 weeks following initiation of study treatment (or 7 days after the last treatment dose, whichever occurred later). Data generated by this methodology were used to compute a hazard ratio (HR) and 95% confidence interval (CI), modeling the likelihood of a first SAO occurring at any given time in the MF/F arm relative to the MF arm. Although data were sufficient to generate a HR and 95% CI, time-to-first SAO in the overall population could not be accurately reported due to insufficient SAO occurrence. Therefore, the number of first SAO in either arm is reported as a descriptive measure. For each participant, first SAO denotes first event per participant. (NCT01471340)
Timeframe: 26 weeks, or 7 days after the last treatment dose, whichever occurred later

InterventionSerious asthma outcomes (Number)
MF/F MDI BID39
MF MDI BID32

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Phase II: Duration of Tumor Response in Participants With ICR PTEN Loss

Duration of tumor response: time period from 1st documentation of objective response (CR/PR) (whichever status was recorded first) to date of 1st occurrence of investigator documented disease progression or death. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR: at least 30% decrease in sum of diameters of target lesions (taking as reference baseline sum diameters), no progression in non-target lesions, and no new lesions. Progression: increase by at least 20% in sum of longest diameters of each target lesion, taking as reference smallest sum of longest diameters or appearance of one or more new lesions. Duration of tumor response was estimated using Kaplan Meier method. (NCT01485861)
Timeframe: Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)

Interventionmonths (Median)
Phase II: Ipatasertib 400 mg + Abiraterone8.77
Phase II: Ipatasertib 200 mg + AbirateroneNA
Phase II: Placebo + AbirateroneNA

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Phase II: Overall Survival (ITT Population)

Overall survival was defined as the interval between the date of screening and death due to any cause. Overall survival was estimated using Kaplan Meier method. (NCT01485861)
Timeframe: Screening up to death (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 8.9 years overall]) (cycle length = 28 days)

InterventionMonths (Median)
Phase II: Ipatasertib 400 mg + Abiraterone18.27
Phase II: Ipatasertib 200 mg + Abiraterone17.31
Phase II: Placebo + Abiraterone18.37

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Phase II: Overall Survival in Participants With ICR IHC PTEN Loss

"Overall survival was defined as the interval between the date of randomization and death from any cause. Overall survival was estimated using Kaplan Meier method. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as ICR PTEN loss." (NCT01485861)
Timeframe: Screening up to death (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 8.9 years overall]) (cycle length = 28 days)

Interventionmonths (Median)
Phase II: Ipatasertib 400 mg + Abiraterone17.12
Phase II: Ipatasertib 200 mg + Abiraterone28.45
Phase II: Placebo + Abiraterone17.28

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Phase II: Percentage of Participants With Adverse Events (AEs)

An Adverse Event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. (NCT01485861)
Timeframe: Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 8.9 years)

Interventionpercentage of participants (Number)
Phase II: Ipatasertib 400 mg + Abiraterone98.8
Phase II: Ipatasertib 200 mg + Abiraterone96.6
Phase II: Placebo + Abiraterone93.8

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Phase II: Percentage of Participants With Circulating Tumor Cells (CTC) Reduction Response (ITT Population)

CTC reduction response was defined as participants with a reduction in CTCs of ≥ 30% compared to baseline. (NCT01485861)
Timeframe: Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)

Interventionpercentage of participants (Number)
Phase II: Ipatasertib 400 mg + Abiraterone67.2
Phase II: Ipatasertib 200 mg + Abiraterone71.0
Phase II: Placebo + Abiraterone63.5

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Phase II: Percentage of Participants With CTC Conversion (ITT Population)

CTC conversion was defined as a decline to < 5 cells/7.5 milliliter (mL) post baseline among participants with CTC ≥ 5 cells/7.5 mL at baseline. (NCT01485861)
Timeframe: Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)

Interventionpercentage of participants (Number)
Phase II: Ipatasertib 400 mg + Abiraterone43.9
Phase II: Ipatasertib 200 mg + Abiraterone46.8
Phase II: Placebo + Abiraterone41.7

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Phase II: Percentage of Participants With CTC Conversion in Participants With ICR PTEN Loss

"CTC conversion was defined as a decline to < 5 cells/7.5 milliliter (mL) post baseline among participants with CTC ≥ 5 cells/7.5 mL at baseline. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as ICR PTEN loss." (NCT01485861)
Timeframe: Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)

Interventionpercentage of participants (Number)
Phase II: Ipatasertib 400 mg + Abiraterone66.7
Phase II: Ipatasertib 200 mg + Abiraterone22.2
Phase II: Placebo + Abiraterone31.8

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Phase II: Percentage of Participants With CTC Reduction Response in Participants With ICR PTEN Loss

"CTC reduction response was defined as participants with a reduction in CTCs of ≥ 30% compared to baseline. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as ICR PTEN loss." (NCT01485861)
Timeframe: Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)

Interventionpercentage of participants (Number)
Phase II: Ipatasertib 400 mg + Abiraterone75.0
Phase II: Ipatasertib 200 mg + Abiraterone75.0
Phase II: Placebo + Abiraterone70.6

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Phase II: Percentage of Participants With Objective Response (ITT Population)

Objective response was defined as having a confirm response (CR) or partial response (PR) according to a RECIST 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. (NCT01485861)
Timeframe: Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)

Interventionpercentage of participants (Number)
Phase II: Ipatasertib 400 mg + Abiraterone32.4
Phase II: Ipatasertib 200 mg + Abiraterone23.1
Phase II: Placebo + Abiraterone22.9

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Phase II: Percentage of Participants With Objective Response in Participants With ICR PTEN Loss

"Objective response was defined as having a CR or PR according to a RECIST 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as ICR PTEN loss. Number of participants analyzed=participants with PTEN loss and evaluable for this endpoint." (NCT01485861)
Timeframe: Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)

Interventionpercentage of participants (Number)
Phase II: Ipatasertib 400 mg + Abiraterone11.1
Phase II: Ipatasertib 200 mg + Abiraterone26.7
Phase II: Placebo + Abiraterone14.3

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Phase II: Percentage of Participants With Pain Progression (ITT Population)

Pain progression was defined as ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of four questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10). (NCT01485861)
Timeframe: Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)

Interventionpercentage of participants (Number)
Phase II: Ipatasertib 400 mg + Abiraterone33.3
Phase II: Ipatasertib 200 mg + Abiraterone34.9
Phase II: Placebo + Abiraterone34.9

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Phase II: Percentage of Participants With Pain Progression in Participants With ICR PTEN Loss

"Pain progression was defined as ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of four questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10). PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as ICR PTEN loss." (NCT01485861)
Timeframe: Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)

Interventionpercentage of participants (Number)
Phase II: Ipatasertib 400 mg + Abiraterone40.0
Phase II: Ipatasertib 200 mg + Abiraterone28.0
Phase II: Placebo + Abiraterone33.3

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Phase II: Percentage of Participants With PSA Progression (ITT Population)

PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 nanogram per milliliter (ng/mL) from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later. (NCT01485861)
Timeframe: Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)

Interventionpercentage of participants (Number)
Phase II: Ipatasertib 400 mg + Abiraterone57.1
Phase II: Ipatasertib 200 mg + Abiraterone69.8
Phase II: Placebo + Abiraterone72.3

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Phase II: Percentage of Participants With PSA Progression in Participants With ICR PTEN Loss

"PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as ICR PTEN loss." (NCT01485861)
Timeframe: Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)

Interventionpercentage of participants (Number)
Phase II: Ipatasertib 400 mg + Abiraterone72.0
Phase II: Ipatasertib 200 mg + Abiraterone64.0
Phase II: Placebo + Abiraterone66.7

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Phase II: Percentage of Participants With PSA Response (ITT Population)

PSA response was defined as a > 50% decrease in PSA from baseline, which was to be confirmed after ≥ 4 weeks by a confirmatory PSA measurement. (NCT01485861)
Timeframe: Baseline up to 30 days after last dose (assessed at baseline, Day 1 of every cycle [starting from Cycle 2] till 30 days after last dose [up to overall 3.6 years]) (cycle length = 28 days)

InterventionPercentage of Participants (Number)
Phase II: Ipatasertib 400 mg + Abiraterone36.9
Phase II: Ipatasertib 200 mg + Abiraterone33.7
Phase II: Placebo + Abiraterone34.9

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Phase II: Percentage of Participants With PSA Response in Participants With ICR PTEN Loss

"PSA response was defined as a > 50% decrease in PSA from baseline, which was to be confirmed after ≥ 4 weeks by a confirmatory PSA measurement. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as ICR PTEN loss." (NCT01485861)
Timeframe: Baseline up to 30 days after last dose (assessed at baseline, Day 1 of every cycle [starting from Cycle 2] till 30 days after last dose [up to overall 3.6 years]) (cycle length = 28 days)

Interventionpercentage of participants (Number)
Phase II: Ipatasertib 400 mg + Abiraterone40.0
Phase II: Ipatasertib 200 mg + Abiraterone44.0
Phase II: Placebo + Abiraterone28.6

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Phase II: Radiographic Progression Free Survival (rPFS) (Intent-To-Treat [ITT] Population)

rPFS: Time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments via CT scan and bone scans, or death on study from any cause, whichever occurred first. Progression was defined as follows: Soft tissue mass (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1): at least 20% increase in sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Bone: ≥ 2 new bone lesions plus 2 additional at confirmation on a second bone scan ≥ 4 weeks later (< 12 weeks after randomization). ≥ 2 new bone lesions consistent with progression, without need for confirmatory bone scan (≥ 12 weeks after randomization). (NCT01485861)
Timeframe: Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)

Interventionmonths (Median)
Phase II: Ipatasertib 400 mg + Abiraterone8.18
Phase II: Ipatasertib 200 mg + Abiraterone8.31
Phase II: Placebo + Abiraterone6.37

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Phase II: rPFS in Participants With Institute of Cancer Research (ICR) Phosphatase and Tensin Homolog (PTEN) Loss

"rPFS: Time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments via CT scan and bone scans, or death on study from any cause, whichever occurred first. Progression was defined as follows: Soft tissue mass (RECIST 1.1): at least 20% increase in sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Bone: ≥ 2 new bone lesions plus 2 additional at confirmation on 2nd bone scan ≥ 4 weeks later (< 12 weeks after randomization). ≥ 2 new bone lesions consistent with progression, without need for confirmatory bone scan (≥ 12 weeks after randomization). PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as ICR PTEN loss. Number of participants analyzed=participants with PTEN loss." (NCT01485861)
Timeframe: Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)

Interventionmonths (Median)
Phase II: Ipatasertib 400 mg + Abiraterone11.53
Phase II: Ipatasertib 200 mg + Abiraterone11.10
Phase II: Placebo + Abiraterone4.60

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Phase II: Time to Pain Progression (ITT Population)

Time to pain progression was defined as the time from screening till first occurrence of pain progression. Pain progression was defined as ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of four questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10). (NCT01485861)
Timeframe: Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)

Interventionmonths (Median)
Phase II: Ipatasertib 400 mg + Abiraterone13.90
Phase II: Ipatasertib 200 mg + Abiraterone16.16
Phase II: Placebo + Abiraterone15.15

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Phase II: Time to Pain Progression in Participants With ICR PTEN Loss

"Time to pain progression was defined as the time from screening till first occurrence of pain progression. Pain progression: ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of 4questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10). PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as ICR PTEN loss." (NCT01485861)
Timeframe: Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)

Interventionmonths (Median)
Phase II: Ipatasertib 400 mg + Abiraterone16.49
Phase II: Ipatasertib 200 mg + AbirateroneNA
Phase II: Placebo + Abiraterone6.93

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Phase II: Time to PSA Progression (ITT Population)

Time to PSA progression: Time from screening to the first occurrence of PSA progression, as determined by investigator. PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression is defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later. (NCT01485861)
Timeframe: Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)

Interventionmonths (Median)
Phase II: Ipatasertib 400 mg + Abiraterone5.55
Phase II: Ipatasertib 200 mg + Abiraterone3.78
Phase II: Placebo + Abiraterone3.71

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Phase II: Time to PSA Progression in Participants With ICR PTEN Loss

"Time to PSA progression: Time from screening to the first occurrence of PSA progression, as determined by investigator. PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as ICR PTEN loss." (NCT01485861)
Timeframe: Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)

InterventionMonths (Median)
Phase II: Ipatasertib 400 mg + Abiraterone3.71
Phase II: Ipatasertib 200 mg + Abiraterone2.92
Phase II: Placebo + Abiraterone2.79

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Phase Ib: Area Under The Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of Ipatasertib When Co-Administered With Abiraterone

(NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Interventionng/mL*hours (Geometric Mean)
Cycle 1, Day 1Cycle 1, Day 15
Phase Ib: Ipatasertib 400 mg17103290

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Phase Ib: AUC0-24 of Abiraterone When Co-Administered With Ipatasertib or Apitolisib

(NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

,
Interventionng/mL*hr (Geometric Mean)
Cycle 1, Day 1Cycle 1, Day 15
Phase Ib: Apitolisib 30 mg475220
Phase Ib: Ipatasertib 400 mg749961

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Phase Ib: AUC0-24 of Apitolisib When Co-Administered With Abiraterone

(NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Interventionng/mL*hours (Geometric Mean)
Cycle 1, Day 1Cycle 1, Day 15
Phase Ib: Apitolisib 30 mg16001640

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Phase Ib: AUC0-24 of G-037720 (Metabolite of Ipatasertib)

G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation. (NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Interventionng/mL*hour (Geometric Mean)
Cycle 1, Day 1Cycle 1, Day 15
Phase Ib: Ipatasertib 400 mg8392850

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Phase Ib: Cmax of Abiraterone When Co-Administered With Ipatasertib or Apitolisib

(NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

,
Interventionng/mL (Geometric Mean)
Cycle 1, Day 1Cycle 1, Day 15
Phase Ib: Apitolisib 30 mg88.252.7
Phase Ib: Ipatasertib 400 mg151140

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Phase Ib: Cmax of Apitolisib When Co-Administered With Abiraterone

(NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Interventionng/mL (Geometric Mean)
Cycle 1, Day 1Cycle 1, Day 15
Phase Ib: Apitolisib 30 mg190193

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Phase Ib: Cmax of G-037720 (Metabolite of Ipatasertib)

G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation. (NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Interventionng/mL (Geometric Mean)
Cycle 1, Day 1Cycle 1, Day 15
Phase Ib: Ipatasertib 400 mg117326

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Phase Ib: Maximum Plasma Concentration (Cmax) of Ipatasertib When Co-Administered With Abiraterone

(NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Interventionng/mL (Geometric Mean)
Cycle 1, Day 1Cycle 1, Day 15
Phase Ib: Ipatasertib 400 mg269466

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Phase Ib: Plasma Half-Life of Abiraterone When Co-Administered With Ipatasertib or Apitolisib

(NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

,
Interventionhours (Geometric Mean)
Cycle 1, Day 1Cycle 1, Day 15
Phase Ib: Apitolisib 30 mg7.6814.70
Phase Ib: Ipatasertib 400 mg5.256.92

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Phase Ib: Time to Cmax (Tmax) of Ipatasertib When Co-Administered With Abiraterone

(NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Interventionhours (Median)
Cycle 1, Day 1Cycle 1, Day 15
Phase Ib: Ipatasertib 400 mg2.002.02

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Phase Ib: Tmax of Abiraterone When Co-Administered With Ipatasertib or Apitolisib

(NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

,
Interventionhours (Median)
Cycle 1, Day 1Cycle 1, Day 15
Phase Ib: Apitolisib 30 mg2.013.04
Phase Ib: Ipatasertib 400 mg2.052.17

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Phase Ib: Tmax of Apitolisib When Co-Administered With Abiraterone

(NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Interventionhours (Median)
Cycle 1, Day 1Cycle 1, Day 15
Phase Ib: Apitolisib 30 mg2.022.04

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Phase Ib: Tmax of G-037720 (Metabolite of Ipatasertib)

G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation. (NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Interventionhours (Median)
Cycle 1, Day 1Cycle 1, Day 15
Phase Ib: Ipatasertib 400 mg2.002.10

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Phase II: G-037720 (Metabolite of Ipatasertib) Plasma Concentrations

G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation. (NCT01485861)
Timeframe: Phase II: Cycle 1, Day 1: 1, 4 hours postdose; Cycle 1, Day 15: predose, 2, 4 hours postdose; Cycle 2, Day 1: predose, 1-4 hours postdose (cycle length = 28 days)

,
Interventionng/mL (Geometric Mean)
Cycle 1, Day 1: 1 hour postdoseCycle 1, Day 1: 4 hours postdoseCycle 1, Day 15: predoseCycle 1, Day 15: 2 hours postdoseCycle 1, Day 15: 4 hours postdose
Phase II: Ipatasertib 200 mg + Abiraterone13.942.920.478.0101
Phase II: Ipatasertib 400 mg + Abiraterone34.710144.1121178

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Phase II: Ipatasertib Plasma Concentrations When Co-Administered With Abiraterone

(NCT01485861)
Timeframe: Phase II: Cycle 1, Day 1: 1, 4 hours postdose; Cycle 1, Day 15: predose, 2, 4 hours postdose; Cycle 2, Day 1: predose, 1-4 hours postdose (cycle length = 28 days)

,
Interventionng/mL (Geometric Mean)
Cycle 1, Day 1: 1 hour postdoseCycle 1, Day 1: 4 hours postdoseCycle 1, Day 15: predoseCycle 1, Day 15: 2 hours postdoseCycle 1, Day 15: 4 hours postdoseCycle 2, Day 1: predoseCycle 2, Day 1: 1-4 hours postdose
Phase II: Ipatasertib 200 mg + Abiraterone63.487.024.514013925.3145
Phase II: Ipatasertib 400 mg + Abiraterone10118053.121327246.7243

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Phase Ib: Percentage of Participants With Dose-Limiting Toxicities (DLTs)

DLT: 1 of the following toxicities, at least possibly related to ipatasertib or apitolisib. 1) Grade ≥ 3 non-hematologic, non-hepatic major organ AE; 2) Grade ≥ 3 febrile neutropenia; 3) Grade ≥ 4 neutropenia (absolute neutrophils less than [<] 500 per microliter) lasting greater than (>) 7 days; 4) Grade ≥3 thrombocytopenia associated with acute hemorrhage; 5) Grade ≥4 thrombocytopenia; 6) Grade ≥4 anemia; 7) 1 episode of fasting Grade ≥4 hyperglycemia or 3 episodes of fasting Grade 3 hyperglycemia on separate days within 7 days, as determined by laboratory blood glucose evaluation; 8) Grade ≥3 elevation lasting for > 48 hours for hepatic transaminase or liver-specific alkaline phosphatase or total bilirubin. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0. (NCT01485861)
Timeframe: Days 1 to 28 of Cycle 1 (Cycle length = 28 days)

Interventionpercentage of participants (Number)
Phase Ib: Ipatasertib 400 mg0
Phase Ib: Apitolisib 30 mg0

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Phase Ib: Total Body Clearance (CL/F) of Ipatasertib When Co-Administered With Abiraterone

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. (NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 15 of Cycle 1 (cycle length = 28 days)

Interventionmilliliter per hour (mL/h) (Geometric Mean)
Phase Ib: Ipatasertib 400 mg99600

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Phase II: Duration of Tumor Response (ITT Population)

Duration of tumor response: time period from 1st documentation of objective response (CR/PR) (whichever status was recorded first) to date of 1st occurrence of investigator documented disease progression or death. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR: at least 30% decrease in sum of diameters of target lesions (taking as reference baseline sum diameters), no progression in non-target lesions, and no new lesions. Progression: increase by at least 20% in sum of longest diameters of each target lesion, taking as reference smallest sum of longest diameters or appearance of one or more new lesions. Duration of tumor response was estimated using Kaplan Meier method. (NCT01485861)
Timeframe: Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)

Interventionmonths (Median)
Phase II: Ipatasertib 400 mg + Abiraterone8.77
Phase II: Ipatasertib 200 mg + AbirateroneNA
Phase II: Placebo + AbirateroneNA

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Phase Ib: Accumulation Ratio of Abiraterone When Co-Administered With Ipatasertib or Apitolisib

Accumulation Ratio was caculated as AUC0-24 (Cycle 1 Day 15) divided by AUC0-24 (Cycle 1 Day 1). (NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Interventionratio (Geometric Mean)
Phase Ib: Ipatasertib 400 mg0.823
Phase Ib: Apitolisib 30 mg0.882

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Phase Ib: Accumulation Ratio of G-037720 (Metabolite of Ipatasertib)

G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation. Accumulation Ratio was calculated as AUC0-24 (Cycle 1 Day 15) divided by AUC0-24 (Cycle 1 Day 1). (NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Interventionratio (Geometric Mean)
Phase Ib: Ipatasertib 400 mg2.79

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Phase Ib: Accumulation Ratio of Ipatasertib When Co-Administered With Abiraterone

Accumulation Ratio was calculated as AUC0-24 (Cycle 1 Day 15) divided by AUC0-24 (Cycle 1 Day 1). (NCT01485861)
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Interventionratio (Geometric Mean)
Phase Ib: Ipatasertib 400 mg1.82

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Phase Ib: Percentage of Participants With Adverse Events (AEs)

An Adverse Event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. (NCT01485861)
Timeframe: Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurs first (up to approximately 10 months).

Interventionpercentage of participants (Number)
Phase Ib: Ipatasertib 400 mg100.0
Phase Ib: Apitolisib 30 mg100.0

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Change in Tissue Testosterone and Dihydrotestosterone

Tissue testosterone will be measured in biopsy tissues (NCT01503229)
Timeframe: From baseline to week 4

Interventionpg/mg (Median)
Treatment (Abiraterone Acetate and Prednisone)0.156

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Phase 2: PSA Progression Free Survival

"Prostate-specific antigen progression-free survival was defined as the time interval between the date of treatment start and the date of either first documented PSA progression or death due to any cause, whichever was earlier. PSA was to be measured at baseline, every 3 weeks, throughout study period, until progression. PSA progression was defined as: -An increase of 25% above the nadir (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have achieved a ≥50% decline of PSA. -An increase in PSA by 25 % above the baseline level (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have not achieved a ≥50% decline of PSA.~Analysis was performed by Kaplan Meire method." (NCT01511536)
Timeframe: Baseline, every 3 weeks up to PSA progression (maximum duration: 603 days)

Interventionmonths (Median)
Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg6.93

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Phase 1: Maximally Tolerated Dose (MTD) of Cabazitaxel in Combination With Abiraterone Acetate

MTD was defined as highest dose level of cabazitaxel in combination with abiraterone acetate at which no more than 1 participant experienced dose limiting toxicities (DLT). DLT was defined as any of the following events related to study treatment: 1) Grade 3 or 4 non-hematological related adverse event with exception of Grade 3 fever without documented infection; Grade 3 nausea, vomiting, or diarrhea in the absence of effective maximal therapy; and Grade 3 hypersensitivity reaction in the absence of required premedication. 2) Hematological toxicity: Febrile neutropenia (fever of unknown origin ≥38.5°C with neutropenia Grade 3 or 4); Neutropenia Grade 4 lasting >7 days; Thrombocytopenia Grade 4 or Grade 3 complicated by hemorrhage. 3) Re-treatment delay of more than 2 weeks due to delayed recovery from a toxicity related to study treatment to baseline or ≤ Grade 1 (except for alopecia). Grades were based on National Cancer Institute CommonTerminology Criteria for Adverse Events v4.03. (NCT01511536)
Timeframe: Up to Cycle 2 of Phase 1 (up to 42 days)

Interventionmg/m^2 (Number)
Phase 1: Overall Population25

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Phase 2: Objective Progression Free Survival (PFS)

"Objective PFS was defined as the time interval between the date of enrollment and the first occurrence of any of the events:~1) Radiological tumor progression (assessed using Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) was defined as at least a 20 percent increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. in case of progressive disease (PD) diagnosed only on non target bone lesions on bone scan, PD was to be considered only in case of appearance of at least 2 new lesions on bone scan confirmed 6 weeks later by another bone scan, and at least the appearance of 2 new additional lesions. 2) Death due to any cause.~Analysis was performed by Kaplan-Meier method." (NCT01511536)
Timeframe: From baseline until radiological tumor or disease progression or death due to any cause, assessed up to Month 5

Interventionmonths (Median)
Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mgNA

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Phase 2: Overall Survival

Overall survival was defined as the time interval from the date of treatment start to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earlier of the last date the participant was known to be alive and the study cut-off date. Analysis was performed by Kaplan-Meier method. (NCT01511536)
Timeframe: From baseline up to death or study cut-off (maximum duration: 603 days)

Interventionmonths (Median)
Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mgNA

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Phase 2: Percentage of Participants With Objective Response

Objective response was defined as having complete response (CR) or Partial Response (PR) assessed by RECIST 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters). (NCT01511536)
Timeframe: Baseline, every 12 weeks there after until disease progression (maximum duration: 603 days)

Interventionpercentage of participants (Number)
Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg21.4

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Phase 2: Percentage of Participants With Prostate Specific Antigen (PSA) Response

Prostate specific antigen (PSA) response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed at least 3 weeks later. Increases of any magnitude during the first 12 weeks were ignored in determining PSA response. PSA was to be measured at baseline, every 3 weeks, throughout study period, until progression. PSA progression was defined as: -An increase of 25% above the nadir (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have achieved a ≥50% decline of PSA. -An increase in PSA by 25 % above the baseline level (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have not achieved a ≥50% decline of PSA. (NCT01511536)
Timeframe: Baseline, every 3 weeks up to PSA progression (maximum duration: 603 days)

Interventionpercentage of participants (Number)
Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg46.2

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Phase 2: Pharmacokinetic of Abiraterone : Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC 0-24)

Area under the plasma concentration-time curve calculated using the trapezoidal method from time zero to 24 hours corresponding to abiraterone acetate dosing interval. (NCT01511536)
Timeframe: 0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1

Interventionng*h/mL (Mean)
Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg928

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Phase 2: Pharmacokinetic of Abiraterone : Concentration Observed Just Before Treatment Administration During Repeated Dosing at Steady State (Ctrough ss)

(NCT01511536)
Timeframe: Pre abiraterone dose on Day 1 of Cycle 1

Interventionng/mL (Mean)
Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg9.99

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Phase 2: Pharmacokinetic of Abiraterone : First Time to Reach Cmax (Tmax)

(NCT01511536)
Timeframe: 0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1

Interventionhour (Median)
Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg2.00

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Phase 2: Pharmacokinetic of Abiraterone : Maximum Plasma Concentration Observed (Cmax)

(NCT01511536)
Timeframe: 0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1

Interventionng/mL (Mean)
Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg216

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Phase 2: Pharmacokinetic of Cabazitaxel : Area Under the Plasma Concentration Versus Time Curve (AUC)

Area under the concentration-time curve calculated using the following equation: AUC = Plasma clearance (CL)/dose (NCT01511536)
Timeframe: 5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1

Interventionng*h/mL (Mean)
Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg817

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Phase 2: Pharmacokinetic of Cabazitaxel : Maximum Plasma Concentration Observed (Cmax)

(NCT01511536)
Timeframe: 5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1

Interventionng/mL (Mean)
Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg330

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Phase 2: Pharmacokinetic of Cabazitaxel : Terminal Half-life (t 1/2z)

(NCT01511536)
Timeframe: 5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1

Interventionhour (Mean)
Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg91.6

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Phase 2: Pharmacokinetic of Cabazitaxel : Total Plasma Clearance (CL)

(NCT01511536)
Timeframe: 5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1

InterventionL/h/m^2 (Mean)
Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg31.4

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Phase 2: Pharmacokinetic of Cabazitaxel : Volume of Distribution at Steady State (Vss)

(NCT01511536)
Timeframe: 5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1

InterventionL/m^2 (Mean)
Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg2711

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Number of Participants With Serious Adverse Events (SAEs)

An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, or is an important medical event. (NCT01517802)
Timeframe: Up to 9 years

InterventionParticipants (Count of Participants)
Abiraterone Acetate + Prednisone/Prednisolone16

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Percentage of Participants With New Donor Specific Antibodies (DSAs)

Donor specific antibodies are antibodies that are directed against antigens expressed on donor organs. These antibodies can result in an immune attack on the transplanted organ, increasing risk of graft loss and/or rejection. (NCT01517984)
Timeframe: 6 to 18 months post-randomization

Interventionpercentage of participants (Number)
Randomized to Tacrolimus Withdrawal36
Randomized to Control Group14

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Estimated GFR Using the Chronic Kidney Disease Epidemiology (CKD-EPI) Equation

Estimated glomerular filtration rate (eGFR) is a test to measure the level of kidney function. In this measure, the effects of tacrolimus withdrawal on long-term kidney function was assessed by comparing absolute 24 month eGFR (18 months post-randomization) and change in eGFR from 6 to 24 months (randomization to 18 months randomization). Lower numbers indicate poorer kidney function (NCT01517984)
Timeframe: 6 months post-transplantation, 24 months post-transplantation

,
InterventionmL/min (Mean)
6 Month eGFR24 Month eGFRChange in eGFR from 6 to 24 months
Randomized to Control Group62.368.66.3
Randomized to Tacrolimus Withdrawal56.261.75.5

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Incidence of Acute Rejection

Acute renal allograft rejection is defined as histological reading of borderline or greater determined by the local pathology laboratory. Participants suspected of having a rejection episode on the basis of clinical signs, symptoms, or on the basis of laboratory tests, had a renal ultrasound and underwent a renal transplant biopsy. Any detection of acute cellular rejection or acute humoral rejection resulted in participants in the 'Randomized to Tacrolimus Withdrawal' group to be restarted on tacrolimus and followed per the reduced follow-up schedule of events. (NCT01517984)
Timeframe: 6 to 18 months post-randomization

Interventionparticipants (Number)
Randomized to Tacrolimus Withdrawal6
Randomized to Control Group0

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Percentage of Participants in the Experimental Arm Off Tacrolimus

Participants in the 'Randomized to Tacrolimus Withdrawal' group were considered fully withdrawn once they no longer received any doses of tacrolimus. Participants met this endpoint if they did not resume taking tacrolimus as of 18 months post randomization with stable allograft function and without rejection of donor-specific antibodies. (NCT01517984)
Timeframe: 18 months post-randomization

Interventionpercentage of participants (Number)
Randomized to Tacrolimus Withdrawal43

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Participant Survival Rate

Number of participants who did not die within the course of this study. (NCT01517984)
Timeframe: 6 to 18 months post-transplantation

Interventionparticipants (Number)
Randomized to Tacrolimus Withdrawal14
Randomized to Control Group7

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Allograft Survival Rate

Allograft survival is defined as participants who did not need to be re-transplanted or placed on dialysis due to the failure of their allograft transplantation during the course of this study. (NCT01517984)
Timeframe: 6 to 18 months post-randomization

Interventionparticipants (Number)
Randomized to Tacrolimus Withdrawal14
Randomized to Control Group7

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Bone Scan Response (BSR)

BSR is defined as >=30% in the bone scan lesion area (BSLA) compared with baseline. Bones scans were evaluated by an independent radiology facility (IRF) for response. (NCT01522443)
Timeframe: BSR was measured at the end of Week 12 as determined by the IRF

Interventionpercentage of responders (Number)
Cabozantinib31
Mitoxantrone/Prednisone5.2

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Overall Survival (OS)

OS was defined as the time from randomization to the date of death (due to any cause). Participants that had not died were censored at last known date alive. The analyses for OS occurred after 78/196 deaths (40% of the total required for the pre-specified primary analysis of OS). The data cut-off date was 06 October 2014. Median OS was calculated using Kaplan-Meier estimates. (NCT01522443)
Timeframe: OS was measured at the time of randomization until 78 deaths

Interventionmonths (Median)
Cabozantinib9.0
Mitoxantrone/Prednisone7.9

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Pain Response at Week 6 Confirmed at Week 12, Week 12 Reported

The pre-specified primary analysis of Pain Response at Week 6 confirmed at Week 12 was defined as ≥ 30% from baseline in the average daily worst pain intensity score during a 7-day reporting period, with neither a concomitant increase in average daily use of any opioid narcotic type, nor addition of any new opioid narcotic type, relative to baseline. Pain Progression at a given time point is defined as ≥ 30% increase compared with baseline in the average daily worst pain intensity score during a 7-day reporting period or either an increase in the average daily use of any type of opioid narcotic or addition of a new opioid narcotic type compared with baseline. (NCT01522443)
Timeframe: Pain response was measured at Week 6 and Week 12 by self-reports of subjects

Interventionpercentage of responders (Number)
Cabozantinib15
Mitoxantrone/Prednisone17

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Participants With Glucocorticoid Responsiveness - Cardiac Involvement

Cardiac involvement in participants with hypereosinophilic syndromes (HES) (NCT01524536)
Timeframe: Baseline (Day 1)

InterventionParticipants (Count of Participants)
Steroid Challenge - Glucocorticoid Responsiveness1
Steroid Challenge - Glucocorticoid Suboptimal Responsiveness0
Steroid Challenge - Glucocorticoid Unresponsiveness4

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Participants With Glucocorticoid Responsiveness - LHES Variant

Participants with lymphoid hypereosinophilic syndromes (LHES) that achieved glucocorticoid responsiveness, suboptimal responsiveness, or without response. (NCT01524536)
Timeframe: Baseline (Day 1)

InterventionParticipants (Count of Participants)
Steroid Challenge - Glucocorticoid Responsiveness2
Steroid Challenge - Glucocorticoid Suboptimal Responsiveness1
Steroid Challenge - Glucocorticoid Unresponsiveness2

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Participants With Glucocorticoid Responsiveness - Overlap HES Subtypes

Participants with overlap hypereosinophilic syndromes that achieved glucocorticoid responsiveness, suboptimal responsiveness, or without response. (NCT01524536)
Timeframe: Baseline (Day 1)

InterventionParticipants (Count of Participants)
Steroid Challenge - Glucocorticoid Responsiveness3
Steroid Challenge - Glucocorticoid Suboptimal Responsiveness2
Steroid Challenge - Glucocorticoid Unresponsiveness1

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Participants With Glucocorticoid Responsiveness - Pulmonary Involvement

Pulmonary involvement in participants with hypereosinophilic syndromes (HES) (NCT01524536)
Timeframe: Baseline (Day 1)

InterventionParticipants (Count of Participants)
Steroid Challenge - Glucocorticoid Responsiveness4
Steroid Challenge - Glucocorticoid Suboptimal Responsiveness3
Steroid Challenge - Glucocorticoid Unresponsiveness3

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Participants With Glucocorticoid Responsiveness - MHES Variant

Participants with myeloid hypereosinophilic syndromes (MHES) that achieved glucocorticoid responsiveness, suboptimal responsiveness, or without response. (NCT01524536)
Timeframe: Baseline (Day 1)

InterventionParticipants (Count of Participants)
Steroid Challenge - Glucocorticoid Responsiveness0
Steroid Challenge - Glucocorticoid Suboptimal Responsiveness0
Steroid Challenge - Glucocorticoid Unresponsiveness1

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Mean Baseline Absolute Eosinophil Count

Mean baseline absolute eosinophil count in participants prior to initiation of glucocorticoids (NCT01524536)
Timeframe: Baseline (Day 1)

Intervention10^3 cells per microliter (Geometric Mean)
Steroid Challenge - Glucocorticoid Responsiveness2.81
Steroid Challenge - Glucocorticoid Suboptimal Responsiveness3.85
Steroid Challenge - Glucocorticoid Unresponsiveness5.90

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Participants With Glucocorticoid Responsiveness - IHES Variant

Participants with idiopathic hypereosinophilic syndromes (IHES) that achieved glucocorticoid responsiveness, suboptimal responsiveness, or without response. (NCT01524536)
Timeframe: Baseline (Day 1)

InterventionParticipants (Count of Participants)
Steroid Challenge - Glucocorticoid Responsiveness6
Steroid Challenge - Glucocorticoid Suboptimal Responsiveness2
Steroid Challenge - Glucocorticoid Unresponsiveness2

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Mean Percent Change in Eosinophil Count After Glucocorticoid Challenge

"Response to glucocorticoid challenge as assessed by the percentage of the eosinophil count 24 hours post-glucocorticoid challenge relative to the Baseline AEC for each participant.~Measure Description (%): Percent of baseline AEC is defined as the Absolute Eosinophil Count at 24 hours divided by the Absolute Eosinophil Count at Baseline *100." (NCT01524536)
Timeframe: 24 hours

Interventionpercentage of eosinophil count (Mean)
Steroid Challenge - Responders-69.6
Steroid Challenge - Non-responders-13.6

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Mean Baseline IgE Level

Mean baseline immunoglobulin E (IgE) level in participants prior to initiation of glucocorticoid (NCT01524536)
Timeframe: Baseline (Day 1)

InterventionIU/mL (Geometric Mean)
Steroid Challenge - Glucocorticoid Responsiveness285.2
Steroid Challenge - Glucocorticoid Suboptimal Responsiveness1171.5
Steroid Challenge - Glucocorticoid Unresponsiveness434.8

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Number of Participants Who Needed Additional Therapy or Colectomy

Number of participants who needed additional therapy or colectomy. Additional therapy included Anti-Tumour Necrosis Factor alpha (TNFα), Calcineurin inhibitor, Immunomodulator (NCT01536535)
Timeframe: Within 52 weeks

InterventionParticipants (Count of Participants)
Mild UC Disease46
Moderate to Severe UC151

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Number of Participants With Corticosteroid Free Remission (SFR)

"Week 52 CS-free remission: Number of participants with a PUCAI < 10 and no corticosteroids (CS) for 28 days without additional therapy or colectomy. Participants in both groups received corticosteroids, biologics, or colectomies, if symptomatic.~The Pediatric Ulcerative Colitis Activity Index (PUCAI) is a non-invasive disease activity index. The index measures include abdominal pain, rectal bleeding, stool consistency, number of stools per 24 hours, nocturnal stools, and activity level. A total score less than 10 indicates remission, Mild disease activity is 10-30, Moderate 35-60, Severe disease activity 65-85." (NCT01536535)
Timeframe: 52 weeks

InterventionParticipants (Count of Participants)
Mild UC80
Moderate to Severe UC70

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Number of Participants Receiving a Colectomy

Number of participants who received a colectomy within 52 weeks (NCT01536535)
Timeframe: Within 52 weeks

InterventionParticipants (Count of Participants)
Mild UC Disease2
Moderate to Severe UC23

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Number of Participants Reporting Change From Baseline in ECG Morphology

Participants with incidence of ECG morphology abnormalities were observed. Types of abnormalities included appearance of abnormal U waves, T waves inversion, elevation of ST segment, depression of ST segment, second or third degree heart block, right or left bundle branch block, atrial fibrillation/flutter, and myocardial infarction. New morphological changes were observed in abnormal U waves, depression of ST segment, and T waves inversion. Here, 'new' refers to change not present at baseline, ie, at any evaluation predose, and only seen postbaseline. Results of change in ECG morphology analyzed from 12-lead ECGs at each time point were averaged for analysis and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing. (NCT01549951)
Timeframe: Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose

Interventionparticipant (Number)
Abnormal U wavesST segment depressionT-wave inversion
Orteronel + Prednisone183

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Number of Participants Reporting One or More Treatment-emergent Adverse Events

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. (NCT01549951)
Timeframe: Baseline up to 30 days after last dose of study drug (Day 86)

Interventionparticipants (Number)
Orteronel + Prednisone48

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AUC(0-6): Area Under the Plasma Concentration-Time Curve From Time 0 to 6 Hours Postdose for Orteronel and M-I Metabolite

AUC(0-6) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval - 6 hours in this study). Average results at each time point were analyzed and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing. (NCT01549951)
Timeframe: Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose

Interventionnanogram hours per milliliter (ng*hr/mL) (Mean)
Cycle 1 Day 1 (n=50)Cycle 2 Day 1 (n=44)
Orteronel + Prednisone7570.412971.6

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Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite

Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Average results at each time point were analyzed and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing. (NCT01549951)
Timeframe: Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose

Interventionnanogram per milliliter (ng/mL) (Mean)
Orteronel: Cycle 1 Day 1 (n=50)Orteronel: Cycle 2 Day 1 (n=44)M-I metabolite: Cycle 1 Day 1 (n=50)M-I metabolite: Cycle 2 Day 1 (n=44)
Orteronel + Prednisone1904.03017.9263.5597.5

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Maximum Change From Baseline in QTc Based on the Bazett Correction (QTcB) Method, PR, QRS and Uncorrected QT Interval

Triplicate 12-lead ECG measurements (each recording separated by approximately 1 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Bazette's formula (QTcB = QT divided by square root of RR). Results of change in QTcB, PR, QRS and uncorrected QT analyzed from 12-lead ECGs performed at each time point were averaged for analysis and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing. (NCT01549951)
Timeframe: Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose

Interventionmsec (Mean)
QTcB Interval (N=43)PR Interval (N=48)QRS Interval (N=48)Uncorrected QT Interval (N=48)
Orteronel + Prednisone9.7-4.2-1.0-12.5

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Number of Participants Reporting Clinically Significant Abnormalities in ECG

The number of participants who reported clinically significant abnormalities in ECG were measured throughout study. ECGs were performed after the participant had been supine for at least 10 minutes. (NCT01549951)
Timeframe: Baseline up to 30 days after last dose of study drug (Day 86)

Interventionparticipants (Number)
Orteronel + Prednisone0

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Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite

Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Average results at each time point were analyzed and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing. (NCT01549951)
Timeframe: Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose

Interventionhours (Median)
Orteronel: Cycle 1 Day 1 (n=50)Orteronel: Cycle 2 Day 1 (n=44)M-I metabolite: Cycle 1 Day 1 (n=50)M-I metabolite: Cycle 2 Day 1 (n=44)
Orteronel + Prednisone2.01.64.53.0

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Maximum Change From Baseline in QTc Interval Based on the Fridericia Correction (QTcF) Method

Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 1 minute) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Results of change in QTcF analyzed from 12-lead ECGs performed at each time point were averaged for analysis and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing. (NCT01549951)
Timeframe: Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose

Interventionmillisecond (msec) (Mean)
Orteronel + Prednisone-1.4

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Number of Participants Reporting Clinically Significant Abnormalities in Physical Findings

Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10). (NCT01549951)
Timeframe: Baseline up to 30 days after last dose of study drug (Day 86)

Interventionparticipants (Number)
Orteronel + Prednisone0

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Number of Participants Reporting Clinically Significant Abnormalities in Vital Signs

The number of participants with any clinically significant abnormalities in vital signs collected throughout study. Vital signs included body temperature (oral), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm). (NCT01549951)
Timeframe: Baseline up to 30 days after last dose of study drug (Day 86)

Interventionparticipants (Number)
Orteronel + Prednisone0

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Number of Participants Reporting Clinically Significant Abnormalities in Laboratory Values

The number of participants with any clinically significant abnormalities in safety laboratory values collected throughout study. (NCT01549951)
Timeframe: Baseline up to 30 days after last dose of study drug (Day 86)

Interventionparticipants (Number)
Orteronel + Prednisone5

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Correlation Between the QTcF Change From Baseline and Plasma Concentrations of Orteronel

Coefficient of correlation was measured using linear mixed effects model for the association between two variables; change from baseline versus the plasma concentration. Participant's effects on the intercept and plasma concentration slope were included in the model as random effects terms. Plasma concentrations were re scaled for model convergence. Average results at each time point were analyzed and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing. (NCT01549951)
Timeframe: Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose

Interventioncorrelation coefficient (Least Squares Mean)
Orteronel + Prednisone-0.002603

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Changes From Baseline in Heart Rate

Triplicate 12-lead Electrocardiogram (ECG) measurements were performed and average was calculated. Supine heart rate was measured as beats per minute (bpm). Results of change in heart rate analyzed from 12-lead ECGs performed at each time point were averaged for analysis and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing. (NCT01549951)
Timeframe: Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose

Interventionbpm (Mean)
Orteronel + Prednisone5.7

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Radiographic Progression Free Survival

Radiographic progression free survival is defined as the duration of time from start of treatment to time of radiographic progression by computed tomography (CT) scan (or magnetic resonance imaging (MRI)) or bone scan. Progression is a minimum of two new lesions observed on bone scan. The minimum size for a measurable lesion on CY and MRI should be twice the slice thickness based on the assumption that CT slice thickness is 500 or less. (NCT01553188)
Timeframe: Median potential follow-up of 50.3 months

InterventionMonths (Median)
DL 1 Run in - 15mg/kg2.7
DL 2 Run in - 30mg/kg9.0
Abiraterone, Prednisone and AMG13.7
Abiraterone and Prednisone Only10.6

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Progression Free Survival (PFS)

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. Clinical progression is assessed by the Response Criteria in Solid Tumors (RECIST) and is at least a 20% increase in the sum of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). (NCT01553188)
Timeframe: Median potential follow-up of 50.3 months

InterventionMonths (Median)
DL 1 Run in - 15mg/kg2.8
DL 2 Run in - 30mg/kg9.0
Abiraterone, Prednisone and AMG11.5
Abiraterone and Prednisone Only10.1

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Overall Survival

Overall Survival is the time between the first day of treatment to the day of death. (NCT01553188)
Timeframe: Time between the first day of treatment to the day of death, approximately 50.3 months.

InterventionMonths (Median)
DL 1 Run in - 15mg/kg11.1
DL 2 Run in - 30mg/kg27.9
Abiraterone, Prednisone and AMG31.1
Abiraterone and Prednisone Only25.5

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Dose Limiting Toxicity (DLT)

DLTs are defined as any grade 3 or higher hematologic (excluding anemia) or non-hematologic toxicity considered to be possible related to AMG 386. Any treatment related adverse events that lead tor reduction of dose exposure of either agent (duration or dose) by >50% in cycle 1 will be considered a DLT. (NCT01553188)
Timeframe: First 28 days of treatment

InterventionParticipants (Count of Participants)
DL 1 Run in - 15mg/kg0
DL 2 Run in - 30mg/kg1

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Count of Participants With Serious and Non-serious Adverse Events

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01553188)
Timeframe: Date treatment consent signed to date off study, approximately 65 months and 7 days

InterventionParticipants (Count of Participants)
DL 1 Run in - 15mg/kg3
DL 2 Run in - 30mg/kg6
Abiraterone, Prednisone and AMG16
Abiraterone and Prednisone Only11

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Maximum Tolerated Dose (MTD)

The MTD is defined as the highest dose studied for which the incidence of dose limiting toxicity was less than 33%. (NCT01553188)
Timeframe: First 28 days of treatment

Interventionmg/kg (Number)
All Participants30

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Rates of PSA Decline

Change in PSA from baseline to 12 weeks (NCT01576172)
Timeframe: 12 weeks

Interventionng/ml (Mean)
Arm I (Abiraterone Acetate and Prednisone)-41.1
Arm II (Abiraterone Acetate, Prednisone, and Veliparib)-52.9

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Progression-free Survival (PFS)

Time from randomization to disease progression or death. (NCT01576172)
Timeframe: Up to 42 months

Interventionmonths (Median)
Arm I (Abiraterone Acetate and Prednisone)10.1
Arm II (Abiraterone Acetate, Prednisone, and Veliparib)11.0

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Objective Response Rates in Patients With Measurable Disease.

Overall response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT01576172)
Timeframe: Up to 3 years

InterventionParticipants (Count of Participants)
Arm I (Abiraterone Acetate and Prednisone)18
Arm II (Abiraterone Acetate, Prednisone, and Veliparib)24

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Confirmed Prostate-specific Antigen (PSA) Response Rate

50% or greater decline in PSA from baseline. (NCT01576172)
Timeframe: Up to 3 years

InterventionParticipants (Count of Participants)
Arm I (Abiraterone Acetate and Prednisone)46
Arm II (Abiraterone Acetate, Prednisone, and Veliparib)55

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Grade 4 or 5 Adverse Events

Grade 4 or greater toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 at least possibly related to treatment. (NCT01576172)
Timeframe: 30 days after completion of study treatment

InterventionParticipants (Count of Participants)
Arm I (Abiraterone Acetate and Prednisone)1
Arm II (Abiraterone Acetate, Prednisone, and Veliparib)3

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Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction With Treatment Score

The TSQM Global Satisfaction with Treatment is a 14-item questionnaire that ranges from 0 - 100 with higher scores indicating better outcomes. (NCT01603407)
Timeframe: Average of Months 3, 6, 12, 18, 24, 30 and 36 visits

Interventionscore on a scale (Least Squares Mean)
Daily Prednisone71.2
Daily Deflazacort67.8
Intermittent Prednisone65.1

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Rise From the Floor Velocity

Reciprocal of time to rise from the floor (NCT01603407)
Timeframe: Average of Months 3, 6, 12, 18, 24, 30 and 36 visits

Interventionrise/sec (Least Squares Mean)
Daily Prednisone0.24
Daily Deflazacort0.24
Intermittent Prednisone0.18

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Range of Motion (Goniometry) of Right Ankle

Range of motion at the ankle joint in dorsiflexion measured in degrees from plantigrade averaged over all post-baseline visits. (NCT01603407)
Timeframe: Average of Months 3, 6, 12, 18, 24, 30 and 36 visits

Interventiondegrees (Mean)
Daily Prednisone4.05
Daily Deflazacort2.81
Intermittent Prednisone2.29

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Range of Motion (Goniometry) of Left Ankle

Range of motion at the ankle joint in dorsiflexion measured in degrees from plantigrade averaged over all post-baseline visits. (NCT01603407)
Timeframe: Average of Months 3, 6, 12, 18, 24, 30 and 36 visits

Interventiondegrees (Mean)
Daily Prednisone4.39
Daily Deflazacort3.29
Intermittent Prednisone2.67

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Quality of Life- Child

Quality of life was measured by child self-report in children age 5 and older utilizing the PEDSQL measurement tool. This is a 23-question tool. Scores can range from 0 to 100, with higher scores indicating better quality of life. (NCT01603407)
Timeframe: Average of Months 12, 24, and 36 visits

Interventionscore on a scale (Least Squares Mean)
Daily Prednisone67.39
Daily Deflazacort64.96
Intermittent Prednisone65.07

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Quality of Life - Parent

Quality of life was measured by parent/guardian self-report for all children utilizing the PEDSQL measurement tool. This is a 23-question tool. Scores can range from 0 to 100, with higher scores indicating better quality of life for the child. (NCT01603407)
Timeframe: Average of Months 12, 24, and 36 visits

Interventionscore on a scale (Least Squares Mean)
Daily Prednisone64.88
Daily Deflazacort63.71
Intermittent Prednisone61.33

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PR Interval

Measured by trans-thoracic echocardiogram and 12-lead ECG. (NCT01603407)
Timeframe: 36 months

Interventionmilliseconds (Least Squares Mean)
Daily Prednisone115.59
Daily Deflazacort116.87
Intermittent Prednisone117.90

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Participant Weight

(NCT01603407)
Timeframe: 36 months

Interventionkilograms (Least Squares Mean)
Daily Prednisone26.3
Daily Deflazacort24.9
Intermittent Prednisone26.3

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Participant Height

(NCT01603407)
Timeframe: 36 months

Interventioncentimeters (Least Squares Mean)
Daily Prednisone116.8
Daily Deflazacort115.3
Intermittent Prednisone119.9

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Participant Body Mass Index

(NCT01603407)
Timeframe: 36 months

Interventionkilograms/square meter (Least Squares Mean)
Daily Prednisone18.9
Daily Deflazacort18.3
Intermittent Prednisone18.1

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Number of Participants Who Tolerated the Regimen

The number of participants who completed 36 months of follow-up on the originally assigned dosage (for weight) of study medication. (NCT01603407)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
Daily Prednisone36
Daily Deflazacort36
Intermittent Prednisone37

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North Star Ambulatory Assessment (NSAA) Score

"The North Star Ambulatory Assessment (NSAA) is a 17-item rating scale that is used to measure functional motor abilities in ambulant children with Duchenne Muscular Dystrophy (DMD). It is usually used to monitor the progression of the disease and treatment effects.~The activities are graded as follows:~2 - Normal - no obvious modification of activity~1 - Modified method but achieves goal independent of physical assistance from another 0 - Unable to achieve independently This scale is ordinal with 34 as the maximum score indicating fully-independent function." (NCT01603407)
Timeframe: Average of Months 3, 6, 12, 18, 24, 30 and 36 visits

Interventionscore on a scale (Least Squares Mean)
Daily Prednisone23.7
Daily Deflazacort24.0
Intermittent Prednisone20.7

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Left Ventricular Ejection Fraction Percent

Measured by trans-thoracic echocardiogram and 12-lead ECG. (NCT01603407)
Timeframe: 36 months

Interventionpercentage of ejection fraction (Least Squares Mean)
Daily Prednisone61.88
Daily Deflazacort62.65
Intermittent Prednisone62.45

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Heart Rate

Measured by trans-thoracic echocardiogram and 12-lead ECG. (NCT01603407)
Timeframe: 36 months

Interventionbpm (Least Squares Mean)
Daily Prednisone94.10
Daily Deflazacort93.52
Intermittent Prednisone91.65

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Forced Vital Capacity

Forced vital capacity was measured during a spirometry test. Forced expiratory volume (FEV) measures how much air a person can exhale during a forced breath. Forced vital capacity (FVC) is the total amount of air exhaled during the FEV test. (NCT01603407)
Timeframe: Average of Months 3, 6, 12, 18, 24, 30 and 36 visits

Interventionliters (Least Squares Mean)
Daily Prednisone1.4
Daily Deflazacort1.4
Intermittent Prednisone1.5

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6 Minute Walk Test

Measures the total distance walked in 6 minutes averaged over all post-baseline follow-up visits through Month 36. (NCT01603407)
Timeframe: Average of Months 3, 6, 12, 18, 24, 30 and 36 visits

Interventionmeters (Least Squares Mean)
Daily Prednisone384.95
Daily Deflazacort384.17
Intermittent Prednisone346.81

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Fractional Shortening Percent

Measured by trans-thoracic echocardiogram and 12-lead ECG. (NCT01603407)
Timeframe: 36 months

Interventionpercentage of fractional shortening (Least Squares Mean)
Daily Prednisone33.74
Daily Deflazacort34.01
Intermittent Prednisone34.33

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Progression-free Survival (PFS)

The exploratory analysis of PFS is the time from randomization to date of first documented radiographic progression (bone and/or soft tissue) according to the investigator's assessment or death. PFS was defined per mRECIST 1.1 and included evaluation of measurable, nonmeasurable, target and nontarget lesions. A Kaplan-Meier analysis was performed to estimate the median duration. (NCT01605227)
Timeframe: Duration of PFS was defined as time from the date of randomization to earlier of date of radiographic progression (bone/andor soft tissue) according to the investigator's assessment or death, assessed for up to approximately 24 months

Interventionmonths (Median)
Cabozantinib5.6
Prednisone2.8

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Bone Scan Response (BSR)

BSR is defined as >=30% reduction in the bone scan lesion area (BSLA) compared with baseline. Confirmation of bone scan was not required for response or progression. Bone scans were evaluated by an independent radiology facility (IRF) for response. (NCT01605227)
Timeframe: BSR was measured at the end of Week 12 as determined by the IRF

Interventionpercentage of participants (Number)
Cabozantinib42
Prednisone3

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Overall Survival (OS)

The primary analysis of OS is defined as the time from randomization to death due to any cause. Participants that had not died or were permanently lost to follow-up were censored at the last known date alive. Median OS was calculated using Kaplan-Meier estimates. Analysis for OS was performed after 614 events had occurred. (NCT01605227)
Timeframe: OS was measured from the time of randomization until 614 events, approximately 24 months after study start

Interventionmonths (Median)
Cabozantinib11.0
Prednisone9.8

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Comparison of Circulating Androstenedione Levels Between Primary-Resistant Patients and Responders

The distribution of the baseline androstenedione levels and the change in hormone level at 12 weeks will be compared between patients experiencing a PSA decline >30% (responders) and patients without such a PSA decline (primary-resistant) using a two group t statistic. Measurements will be obtained at an earlier time point if the patient comes off study for disease progression before week 12. (NCT01637402)
Timeframe: Baseline and Week 12

Interventionng/dL (Mean)
Androstenedione in Primary Resistant (STD)NA
Androstenedione in Responders (STD)NA

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Comparison of Circulating DHEA-S Levels Between Primary-Resistant Patients and Responders

The distribution of the baseline DHEA-S levels and the change in hormone level at 12 weeks will be compared between patients experiencing a PSA decline >30% (responders) and patients without such a PSA decline (primary-resistant) using a two group t statistic. Measurements will be obtained at an earlier time point if the patient comes off study for disease progression before week 12. (NCT01637402)
Timeframe: Baseline and Week 12

Interventionmicrogram per deciliter (µg/dL) (Mean)
DHEA-S in Primary Resistant (STD)NA
DHEA-S in Responders (STD)NA

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Comparison of Circulating Testosterone Levels Between Primary-Resistant Patients and Responders

The distribution of the baseline testosterone levels and the change in hormone level at 12 weeks will be compared between patients experiencing a PSA decline >30% (responders) and patients without such a PSA decline (primary-resistant) using a two group t statistic. Measurements will be obtained at an earlier time point if the patient comes off study for disease progression before week 12. (NCT01637402)
Timeframe: Baseline and Week 12

InterventionNanograms per decilitre (ng/dL) (Mean)
Testosterone in Primary Resistant (STD)NA
Testosterone in Responders (STD)NA

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Correlation of Circulating Dehydroepiandrosterone (DHEA) Levels From Baseline to Week 12

"Pearson's correlation coefficients (r) will be calculated to summarize the relationship between DHEA values at baseline and at 12 weeks. DHEA labs will be obtained at an earlier time point if the patient comes off study for disease progression before week 12. Coefficients are on a continuous scale ranging from -1 to +1 with a value of -1 indicating a perfect negative linear association of DHEA levels between the 2 time points, a value of 0 indicating no association between DHEA levels between the two time points, and a value of +1 indicating a positive linear association of DHEA levels between the two time points." (NCT01637402)
Timeframe: Baseline and Week 12

Interventioncorrelation coefficient (r) (Number)
Standard Dose0

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Number of Patients With PSA Response From Dose Escalation

A PSA response for the dose escalation group is defined as a participant with a documented PSA decline after 12 weeks of therapy with standard-dose, then had disease progression, and then achieved a ≥30% PSA decline after 12 weeks from the start of dose escalation therapy. (NCT01637402)
Timeframe: Up to 12 weeks from start of dose escalation

InterventionParticipants (Count of Participants)
Dose Escalation0

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Serum Concentration Levels of Abiraterone Acetate Over Time

Pharmacokinetic assessment at the initiation of standard dose therapy, at the time of initial disease progression, at the time of a response to increased dose of abiraterone acetate and at the time of disease progression on increased-dose therapy. (NCT01637402)
Timeframe: Up to 24 months

Interventionnanograms per millilitre (ng/mL) (Median)
Concentration at First Draw on Standard Dose Therapy (4 Weeks)5.5
Concentration at Time of Disease Progression on Standard Dose14.2
Concentration at Time of Disease Progression on Increased Dose31.5

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Time to PSA Progression for Dose Escalation Cohort

Time to PSA progression as defined by RECIST criteria or by the Prostate Cancer Working Group 2 (PCWG) criteria for patients whom were treated with increased dose Abiraterone Acetate. (NCT01637402)
Timeframe: up to 24 months

Interventionmonths (Median)
Dose Escalation12

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Comparison of Circulating DHEA Levels Between Primary-Resistant and Responders

The distribution of the baseline DHEA levels and the change in hormone level at 12 weeks will be compared between patients experiencing a PSA decline >30% (responders) and patients without such a PSA decline (primary-resistant) using a two group t statistic. Measurements will be obtained at an earlier time point if the patient comes off study for disease progression before week 12. (NCT01637402)
Timeframe: Baseline and Week 12

,
Interventionng/dL (Mean)
Initial drawProgression / Week 12
DHEA in Primary Resistant (STD)56.228.5
DHEA in Responders (STD)79.413.5

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Change From Baseline to EoT in Bone Specific Alkaline Phosphatase

Bone metabolism marker bone specific alkaline phosphatase levels were derived from blood samples collected. (NCT01650194)
Timeframe: Baseline and EoT; the median duration of treatment was 10.1 months.

Interventionug/L (Geometric Mean)
Enzalutamide + Abiraterone + Prednisone-5.18

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Change From Baseline in Progesterone Concentration in Blood

Progesterone concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. (NCT01650194)
Timeframe: Baseline and Week 9

Interventionnmol/L (Geometric Mean)
Enzalutamide + Abiraterone + Prednisone1.43

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Change From Baseline in Pregnenolone in Bone Marrow Aspirate

Pregnenolone in bone marrow aspirate was measured by laboratory results derived from bone marrow samples. (NCT01650194)
Timeframe: Baseline and Week 9

Interventionpg/ml (Geometric Mean)
Enzalutamide + Abiraterone + Prednisone1381.44

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Change From Baseline in Pregnenolone Concentration in Blood

Pregnenolone concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. (NCT01650194)
Timeframe: Baseline and Week 9

Interventionpg/ml (Geometric Mean)
Enzalutamide + Abiraterone + Prednisone1507.42

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Percentage of Participants With Objective Response for Soft Tissue Lesions According to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST)

Objective response was based on RECIST version 1.1 for soft tissue lesion on Magnetic resonance imaging (MRI) / Computerized tomography (CT) and the PCWG2 guidelines for bone lesions on bone scans and was defined as partial response (PR) or complete response (CR) based on the investigators' assessments of target, non-target and new lesions while on study treatment. The 95% for objective response rate was based on exact binomial 95% confidence interval (Clopper-Pearson). (NCT01650194)
Timeframe: Up to 1849 days

Interventionpercentage of participants (Median)
Enzalutamide + Abiraterone + Prednisone68.8

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Progression Free Survival (PFS)

PFS was measured as the time from the date of first dose of any drug of the study combination treatment until the first evidence of documented progression (a composite endpoint consisting of radiographic progression or PSA progression by PCWG2 or clinical deterioration) or death in the absence of progression (whichever came first) or the date last known to be progression free. The Kaplan-Meier (KM) 95% CI was based on Brookmeyer and Crowley robust non-parametric method. (NCT01650194)
Timeframe: Up to 1849 days

Interventiondays (Median)
Enzalutamide + Abiraterone + Prednisone251

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Bone Scan Response at EoT

PD: ≥1 of 3 criteria: PSA progression: ≥2 rising PSA levels, interval of ≥1 week between each determination. Soft tissue disease progression: RECIST 1.1. Bone disease progression: PCWG2 criteria (≥2 or new lesions on bone scan compared with prior scan). Target lesion CR: disappearance of all target lesions, PR as ≥30% decrease in sum of longest diameter (LD) of target lesions, referencing baseline sum LD, SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing smallest sum LD since treatment start, PD ≥20% increase in sum of LD of target lesions, referencing smallest sum LD recorded since treatment start or appearance of ≥1 new lesions. Non-target lesions CR: disappearance of all non-target lesions and normalization of tumor marker level, SD: persistence of ≥1 non-target lesions and/or maintenance of tumor marker level above normal limits, PD: appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. (NCT01650194)
Timeframe: EoT; the median duration of treatment was 10.1 months.

InterventionParticipants (Count of Participants)
Complete Response (CR)Progressive Disease (PD)Non-CR/Non-PDNot Evaluable
Enzalutamide + Abiraterone + Prednisone115351

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Change From Baseline in Cortisol in Bone Marrow Aspirate

Cortisol in bone marrow aspirate was measured by laboratory results derived from bone marrow samples. (NCT01650194)
Timeframe: Baseline and Week 9

Interventionnmol/L (Geometric Mean)
Enzalutamide + Abiraterone + Prednisone-46.86

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Change From Baseline in Androstenedione Concentration in Blood

Androstenedione concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. (NCT01650194)
Timeframe: Baseline and Week 9

Interventionnmol/L (Geometric Mean)
Enzalutamide + Abiraterone + Prednisone-0.24

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Change From Baseline in Cortisol Concentration in Blood

Cortisol concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. (NCT01650194)
Timeframe: Baseline and Week 9

Interventionnmol/L (Geometric Mean)
Enzalutamide + Abiraterone + Prednisone-48.81

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Change From Baseline to End-of-Treatment (EoT) in Prostate-Specific Antigen (PSA) Levels

Prostate-specific antigen progression by Prostate Cancer Clinical Trials Working Group 2 (PCWG2) was defined as a PSA increase ≥25% and ≥2 ng/ml above the post-baseline nadir, and which was confirmed by the first subsequent value of 3 or more weeks later. (NCT01650194)
Timeframe: Baseline and EoT; the median duration of treatment was 10.1 months.

Interventionug/L (Geometric Mean)
Enzalutamide + Abiraterone + Prednisone36.35

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Change From Baseline in Progesterone in Bone Marrow Aspirate

Progesterone in bone marrow aspirate was measured by laboratory results derived from bone marrow samples. (NCT01650194)
Timeframe: Baseline and Week 9

Interventionnmol/L (Geometric Mean)
Enzalutamide + Abiraterone + Prednisone1.16

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Change From Baseline in Testosterone Concentration in Blood

Testosterone concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. (NCT01650194)
Timeframe: Baseline and Week 9

Interventionnmol/L (Geometric Mean)
Enzalutamide + Abiraterone + Prednisone-0.06

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Change From Baseline in Testosterone Concentration in Bone Marrow Aspirate

Testosterone concentration in bone marrow aspirate was measured by laboratory results derived from bone marrow samples processed through liquid chromatography mass spectrometry. (NCT01650194)
Timeframe: Baseline and Week 9

Interventionpmol/L (Geometric Mean)
Enzalutamide + Abiraterone + Prednisone-19.48

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Change From Baseline in Urine N-Telopeptide

Bone metabolism marker urine N-telopeptide levels were derived from urine samples collected. (NCT01650194)
Timeframe: Baseline and Week 9

InterventionnmolBCE/mmolcreat (Geometric Mean)
Enzalutamide + Abiraterone + Prednisone29.35

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Number of Participants With Adverse Events (AEs)

A treatment-emergent adverse event (TEAE) was defined as an adverse event occurring or worsening between the start of study treatment date and the latest date of 30 days after the last dose date or the 30-day follow-up visit date, and not later than the data cut-off date or the date of death. AEs, including abnormal clinical laboratory values, were graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) guidelines (V4.03). (NCT01650194)
Timeframe: From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.

InterventionParticipants (Count of Participants)
Any TEAEEnzalutamide-related TEAEsAbiraterone-related TEAEsPrednisone-related TEAEsDeathsSerious TEAEsEnzalutamide-related serious TEAEsAbiraterone-related serious TEAEsPrednisone-related serious TEAEsTEAEs leading to discontinuation of enzalutamideEnza-related TEAEs leading to disc. of enzaAbiraterone-related TEAEs leading to disc. of enzaPrednisone-related TEAEs leading to disc. of enzaTEAEs leading to discontinuation of abirateroneAbiraterone-related TEAEs leading to disc. of abi
Enzalutamide + Abiraterone + Prednisone60565816010020300011

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Change From Baseline in Androstenedione in Bone Marrow Aspirate

Androstenedione in bone marrow aspirate was measured by laboratory results derived from bone marrow samples. (NCT01650194)
Timeframe: Baseline and Week 9

Interventionnmol/L (Geometric Mean)
Enzalutamide + Abiraterone + Prednisone-0.32

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Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment

Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory. (NCT01666314)
Timeframe: Baseline and Week 4

Interventionpercent change (Mean)
Placebo (Japan)-87.666
Orteronel 200 mg (Japan)-97.245
Orteronel 300 mg (Japan)-96.812
Placebo (Ex-Japan)-63.702
Orteronel 200 mg (Ex-Japan)-86.268
Orteronel 400 mg (Ex-Japan)-53.954

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Percentage of Participants With Prostate-Specific Antigen Reduction ≥ 50% (PSA50) After 4 Weeks of Treatment

A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline. (NCT01666314)
Timeframe: Baseline and Week 4

Interventionpercentage of participants (Number)
Placebo (Japan)48.0
Orteronel 200 mg (Japan)50.0
Orteronel 300 mg (Japan)41.0
Placebo (Ex-Japan)17.0
Orteronel 200 mg (Ex-Japan)48.0
Orteronel 400 mg (Ex-Japan)46.0

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Absolute Values for Prostate-Specific Antigen (PSA)

Serum PSA was measured at the central laboratory. (NCT01666314)
Timeframe: Baseline and Cycle 2 Day 1

,,,,,
Interventionng/mL (Mean)
BaselineCycle 2 Day 1
Orteronel 200 mg (Ex-Japan)165.992117.257
Orteronel 200 mg (Japan)27.22718.005
Orteronel 300 mg (Japan)97.50438.892
Orteronel 400 mg (Ex-Japan)100.23756.437
Placebo (Ex-Japan)133.238152.940
Placebo (Japan)37.58824.325

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AUC(0-12): Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours Post-dose for Orteronel and M-I Metabolite

AUC(0-12) is measure of area under the curve over the dosing interval where the length of the dosing interval is time 0 to 12 hours in this study. (NCT01666314)
Timeframe: Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose

,,,
Interventionh*ng/mL (Geometric Mean)
OrteronelOrteronel Metabolite M-I
Orteronel 200 mg (Ex-Japan)78301570
Orteronel 200 mg (Japan)88102130
Orteronel 300 mg (Japan)128003290
Orteronel 400 mg (Ex-Japan)102002080

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AE (0-24) Cumulative Amount of Drug Excreted Into the Urine for Orteronel and MI-Metabolite

Cumulative amount of urine excreted time 0 to 24 hour. (NCT01666314)
Timeframe: Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose

,,,
Interventionmg (Geometric Mean)
OrteronelOrteronel Metabolite M-I
Orteronel 200 mg (Ex-Japan)95.330.0
Orteronel 200 mg (Japan)115.039.6
Orteronel 300 mg (Japan)164.062.5
Orteronel 400 mg (Ex-Japan)161.052.8

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Absolute Values for Testosterone

Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory. (NCT01666314)
Timeframe: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1

,,,,,
Interventionng/dL (Mean)
BaselineCycle 1 Day 8Cycle 2 Day 1
Orteronel 200 mg (Ex-Japan)9.2630.3450.266
Orteronel 200 mg (Japan)9.0790.2130.203
Orteronel 300 mg (Japan)10.1480.2510.270
Orteronel 400 mg (Ex-Japan)14.5886.65811.720
Placebo (Ex-Japan)9.1733.5093.095
Placebo (Japan)9.7491.9571.096

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Absolute Values for Dehydroepiandrosterone Sulfate (DHEA-S)

Serum Ultra low level quantification of DHEA-S was measured by liquid chromatography and mass spectrometry (LC/MS) at a central laboratory. (NCT01666314)
Timeframe: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1

,,,,,
Interventionnmol/L (Mean)
BaselineCycle 1 Day 8Cycle 2 Day 1
Orteronel 200 mg (Ex-Japan)1783.0116.921.5
Orteronel 200 mg (Japan)2529.063.414.5
Orteronel 300 mg (Japan)2340.971.836.3
Orteronel 400 mg (Ex-Japan)2155.7226.6180.6
Placebo (Ex-Japan)2601.7973.8815.7
Placebo (Japan)1928.0414.9268.9

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Absolute Values for Cortisol

Serum Cortisol was measured by immunometric assay at the central laboratory. (NCT01666314)
Timeframe: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1

,,,,,
Interventionnmol/L (Mean)
BaselineCycle 1 Day 8Cycle 2 Day 1
Orteronel 200 mg (Ex-Japan)449.0100.997.2
Orteronel 200 mg (Japan)371.349.549.2
Orteronel 300 mg (Japan)383.455.554.3
Orteronel 400 mg (Ex-Japan)446.8122.0109.1
Placebo (Ex-Japan)384.8175.8149.6
Placebo (Japan)366.582.353.9

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Absolute Values for Corticosterone

Serum Corticosterone was measured by high pressure liquid chromatography with mass spectrometry at the central laboratory. (NCT01666314)
Timeframe: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1

,,,,,
Interventionnmol/L (Mean)
BaselineCycle 1 Day 8Cycle 2 Day 1
Orteronel 200 mg (Ex-Japan)10.03048.66829.929
Orteronel 200 mg (Japan)6.51511.06711.108
Orteronel 300 mg (Japan)7.7689.70914.654
Orteronel 400 mg (Ex-Japan)17.97560.30147.204
Placebo (Ex-Japan)6.3175.5984.321
Placebo (Japan)5.9461.5300.758

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Percent Change From Baseline in Serum Testosterone Level After 12 Weeks of Treatment

Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory. (NCT01666314)
Timeframe: Baseline and Week 12

Interventionpercent change (Mean)
Orteronel 200 mg (Japan)-95.804
Orteronel 300 mg (Japan)-95.703
Orteronel 200 mg (Ex-Japan)-91.311
Orteronel 400 mg (Ex-Japan)-14.442

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Absolute Values for Adrenocorticotropic Hormone (ACTH)

Serum ACTH was measured by immunometric assay at the central laboratory. (NCT01666314)
Timeframe: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1

,,,,,
Interventionpmol/L (Mean)
BaselineCycle 1 Day 8Cycle 2 Day 1
Orteronel 200 mg (Ex-Japan)6.03.83.7
Orteronel 200 mg (Japan)5.52.31.7
Orteronel 300 mg (Japan)8.33.02.7
Orteronel 400 mg (Ex-Japan)6.43.23.6
Placebo (Ex-Japan)4.73.13.0
Placebo (Japan)5.03.11.7

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Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL in Ex-Japan

Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory. (NCT01666314)
Timeframe: Baseline and Week 4

Interventionpercentage of participants (Number)
Placebo (Ex-Japan)48.0
Orteronel 400 mg (Ex-Japan)79.0

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Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL After 4 Weeks of Treatment in Japan

Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory. (NCT01666314)
Timeframe: Baseline and Week 4

Interventionpercentage of participants (Number)
Placebo (Japan)86.0
Orteronel 300 mg (Japan)100.0

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Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite

Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. (NCT01666314)
Timeframe: Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose

,,,
Interventionhours (Median)
OrteronelOrteronel Metabolite M-I
Orteronel 200 mg (Ex-Japan)2.005.05
Orteronel 200 mg (Japan)2.975.00
Orteronel 300 mg (Japan)2.434.98
Orteronel 400 mg (Ex-Japan)1.924.98

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Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax), Equal to Time (Hours) to Cmax at Steady State for Orteronel and M-I Metabolite

Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax at steady state. (NCT01666314)
Timeframe: Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose

,,,
Interventionhours (Median)
OrteronelOrteronel Metabolite M-I
Orteronel 200 mg (Ex-Japan)2.003.00
Orteronel 200 mg (Japan)2.053.08
Orteronel 300 mg (Japan)2.964.78
Orteronel 400 mg (Ex-Japan)1.983.00

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Rac: Accumulation Index for Orteronel and M-I Metabolite

Rac was calculated as the ratio of AUCtau to AUC12hr. (NCT01666314)
Timeframe: Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose

,,,
Interventionratio (Geometric Mean)
OrteronelOrteronel Metabolite M-I
Orteronel 200 mg (Ex-Japan)1.622.76
Orteronel 200 mg (Japan)1.512.27
Orteronel 300 mg (Japan)1.592.26
Orteronel 400 mg (Ex-Japan)1.973.17

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Percentage of Participants With PSA50 After 12 Weeks of Treatment

A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline. (NCT01666314)
Timeframe: Baseline and Week 12

Interventionpercentage of participants (Number)
Orteronel 200 mg (Japan)55.0
Orteronel 300 mg (Japan)47.0
Orteronel 200 mg (Ex-Japan)56.0
Orteronel 400 mg (Ex-Japan)44.0

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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding),symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. (NCT01666314)
Timeframe: From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years

,,,,,
Interventionparticipants (Number)
AESAE
Orteronel 200 mg (Ex-Japan)3616
Orteronel 200 mg (Japan)338
Orteronel 300 mg (Japan)3218
Orteronel 400 mg (Ex-Japan)3612
Placebo (Ex-Japan)181
Placebo (Japan)70

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Ctrough,ss: Observed Predose Plasma Concentration at Steady State for Orteronel and M-I Metabolite

Observed predose plasma concentration at steady state. (NCT01666314)
Timeframe: Cycle 1 Day 8 Predose

,,,
Interventionng/mL (Geometric Mean)
OrteronelOrteronel Metbolite M-I
Orteronel 200 mg (Ex-Japan)807314
Orteronel 200 mg (Japan)710291
Orteronel 300 mg (Japan)1060444
Orteronel 400 mg (Ex-Japan)899417

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Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite

Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. (NCT01666314)
Timeframe: Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose

,,,
Interventionng/mL (Geometric Mean)
OrteronelOrteronel Metabolite M-I
Orteronel 200 mg (Ex-Japan)1300199
Orteronel 200 mg (Japan)1520272
Orteronel 300 mg (Japan)2210422
Orteronel 400 mg (Ex-Japan)1610261

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Cmax,ss: Maximum Observed Plasma Concentration at Steady State for Orteronel and MI-Metabolite

Maximum observed steady-state plasma concentration during a dosing interval. (NCT01666314)
Timeframe: Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose

,,,
Interventionng/mL (Geometric Mean)
OrteronelOrteronel Metabolite M-I
Orteronel 200 mg (Ex-Japan)1840485
Orteronel 200 mg (Japan)2180565
Orteronel 300 mg (Japan)3210864
Orteronel 400 mg (Ex-Japan)3100761

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AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Orteronel and M-I Metabolite

Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval. (NCT01666314)
Timeframe: Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose

,,,
Interventionh*ng/mL (Geometric Mean)
OrteronelOrteronel Metabolite M-I
Orteronel 200 mg (Ex-Japan)126004340
Orteronel 200 mg (Japan)133004840
Orteronel 300 mg (Japan)204007460
Orteronel 400 mg (Ex-Japan)200006590

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Amount of Pain Medication - Day 1 to 48 Hours

Number of times the subject needed to use pain medication between day 1 and the 48 hour follow-up (NCT01671423)
Timeframe: Assessed once during the 48 hour follow-up

Interventionmedications taken (Median)
Prednisone7
Placebo2

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Visual Analog Scale(VAS) for Pain - Day 1 to 48 Hours

The level of pain as measured by a Visual Analog Scale(VAS) measured once at day 1 and once during the 48th hour follow-up visit. Minimum value 0, maximum value 100mm, higher scores corresponds to more pain/worse outcomes. (NCT01671423)
Timeframe: Assessed once at day 1 and then once during the 48 hour follow-up

,
Interventionscore on a scale (Mean)
VAS at Day 1VAS at 48 hrs
Placebo56.4525.91
Prednisone79.6439.71

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SNOT-22 Questionnaire

"The Sino-nasal Outcome Test-22 is a validated questionnaire that measures 22 nasal and quality of life symptoms (nasal obstruction and loss of smell and taste) ranked from 0 (not a problem) to 5 (problem as bad as it can be).~Min score= 0, Max score= 110 (worst possible problem on all symptoms)~Change from baseline of the SNOT-22 score. The SNOT-22 questionnaire is a 22-item disease-specific health related quality of life instrument validated for use in chronic rhinosinusitis." (NCT01676415)
Timeframe: 4-6 weeks and 3 months after initiation of treatment

,
Interventionunits on a scale (Mean)
4-6 WEEKS3 MONTHS
Prednisone45.7549
Topical Mometasone34.434.4

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Medication Side-effect and Compliance Inventory

The medication side-effect and compliance inventory is a questionnaire to evaluate the frequency and severity of common side effects associated with the medications used in this study. (NCT01676415)
Timeframe: 4-6 weeks and 3 months after initiation of treatment

InterventionParticipants (Count of Participants)
Prednisone0
Topical Mometasone0

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Taskforce Symptom Inventory

Change from baseline in individual symptom severity. The taskforce symptom inventory is a visual analog scale of the severity of the 4 major symptoms making up the clinical diagnostic criteria of CRS. (NCT01676415)
Timeframe: 4-6 weeks and 3 months after initiation of treatment

InterventionParticipants (Count of Participants)
Prednisone0
Topical Mometasone0

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Time to Disease Progression

Compare arms to determine the time to disease progression of study patients (NCT01681433)
Timeframe: 60 days

Interventionmonths (Median)
Experimental: Arm A1.9055
Control Arm: Arm B1.0842

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PSA Response

Compare arms to determine the proportion of patients who have a PSA response (≥ 30% decline) and any PSA decline post-randomization. (NCT01681433)
Timeframe: 60 days

,
Interventionparticipants (Number)
PSA DECLINE >= 30%PSA DELCINE >=50 %ANY DECLINE
Control Arm: Arm B2111
Experimental: Arm A2213

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Objective Response

Compare arms to determine the objective response of study patients, per RECIST 1.1 (NCT01681433)
Timeframe: 60 days

,
Interventionparticipants (Number)
Partial ResponseStable DiseaseProgressive Disease
Control Arm: Arm B0525
Experimental: Arm A1626

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Circulating Tumor Cell (CTC) Counts

Compare arms to determine circulating tumor cell (CTC) counts for patients at baseline and while on study (NCT01681433)
Timeframe: Every 4 weeks

,
Interventionparticipants (Number)
Best CTC Change from Baseline >=5 to <5Best CTC Change from Baseline <5 to <5Best CTC Change from Baseline >=5 to >=5Best CTC Change from Baseline<5 to >=5
Control Arm: Arm B415101
Experimental: Arm A81671

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Progression-Free Survival

To ascertain whether Arm A has a greater proportion of patients observed to be alive without progression at Day 60 (±7 days) as compared to Arm B. (NCT01681433)
Timeframe: 60 days

Interventionparticipants (Number)
Experimental: Arm A12
Control Arm: Arm B6

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Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01683994)
Timeframe: Adverse events were assessed from the date treatment consent signed to date off study, approximately 45 months and 14 days for Arm A; 43 months and 14 days for Arm B; 9 months and 11 days for DL1; 27 months and 1 day for DL2; & 11 months & 25 days for DL3

InterventionParticipants (Count of Participants)
Ph I Dose Level 1:Cabozantinib + Docetaxel + Prednisone4
Ph I Dose Level 2:Cabozantinib + Docetaxel + Prednisone8
Ph I Dose Level 3:Cabozantinib + Docetaxel + Prednisone7
Ph II Arm A: Docetaxel + Prednisone12
Ph II Arm B: Cabozantinib + Docetaxel + Prednisone13

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Progression Free Survival (PFS) of Cabozantinib + Docetaxel + Prednisone Compared to Docetaxel + Prednisone Alone

PFS is the time interval from start of treatment to documented evidence of disease progression or death. Disease progression was assessed by the Response Criteria in Solid Tumors (RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions as referenced by the smallest sum on study. Appearance of one or more new lesions on bone scan and/or two consecutive rising prostatic-specific antigen values above the baseline at a minimum of one week intervals. A normal PSA value is 4.0 ng/ml and lower. (NCT01683994)
Timeframe: From start date of treatment until the date of first documented progression, date of death from any cause and up to 40 months, whichever occurred first.

Interventionmonths (Median)
Ph I Dose Level 1:Cabozantinib + Docetaxel + Prednisone8
Ph I Dose Level 2:Cabozantinib + Docetaxel + Prednisone13
Ph I Dose Level 3:Cabozantinib + Docetaxel + Prednisone6
Ph II Arm A: Docetaxel + Prednisone10
Ph II Arm B: Cabozantinib + Docetaxel + Prednisone6.5

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Number of Participants Achieving Prostatic-Specific Antigen (PSA) Decline of 30% or 50% From Baseline

PSA normal range is 4 ng/ml or lower. Participants with PSA decline of 30% or 50% is the measures for prostate cancer based on conventional reporting metrics. (NCT01683994)
Timeframe: up to 38 months

,,,,
InterventionParticipants (Count of Participants)
Decline in PSA>30% from baselineDecline in PSA>50% from baseline
Ph I Dose Level 1:Cabozantinib + Docetaxel + Prednisone00
Ph I Dose Level 2:Cabozantinib + Docetaxel + Prednisone55
Ph I Dose Level 3:Cabozantinib + Docetaxel + Prednisone54
Ph II Arm A Docetaxel + Prednisone53
Ph II Arm B: Cabozantinib + Docetaxel + Prednisone109

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Number of Participants With a Dose Limiting Toxicities (DLTs)

A DLT are defined as adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) occurring during the first two cycles of therapy and related to the study medications (attributions: possible, probable, and definite) while fulfilling one of the following criteria: Any Grade 3 or greater non-hematologic toxicity except asymptomatic grade 3 hypertension, hypomagnesemia, hyponatremia, hypophosphatemia, hypocalcemia, and asymptomatic grade 4 uric acid. A treatment delay of > 2 weeks due to an adverse event (delays due to dental procedures are not included). Grade 4 neutropenia (absolute neutrophil count <500/µL lasting > 5 days. Febrile neutropenia. Grade 3 thrombocytopenia lasting for 7 days or more or thrombocytopenia < 50K/µL requiring platelet transfusion for bleeding. (NCT01683994)
Timeframe: First two cycles of treatment (each cycle is 21 days), approximately 42 days.

,,
InterventionParticipants (Count of Participants)
Neutropenic feverPalmar plantar erythroderma
Ph I Dose Level 1: Cabozantinib + Docetaxel + Prednisone00
Ph I Dose Level 2: Cabozantinib + Docetaxel + Prednisone00
Ph I Dose Level 3: Cabozantinib + Docetaxel + Prednisone11

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Maximum Tolerated Dose (MTD)

MTD is defined as the dose level at which no more than 1 of 6 patients experiences a dose limiting toxicity (DLT) at the level below that which had two instances of DLT. A DLT are defined as adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) occurring during the first two cycles of therapy and related to the study medications (attributions: possible, probable, and definite) while fulfilling one of the following criteria: Any Grade 3 or greater non-hematologic toxicity except asymptomatic grade 3 hypertension, hypomagnesemia, hyponatremia, hypophosphatemia, hypocalcemia, and asymptomatic grade 4 uric acid. A treatment delay of > 2 weeks due to an adverse event (delays due to dental procedures are not included). Grade 4 neutropenia (absolute neutrophil count <500/µL lasting > 5 days. Febrile neutropenia. Grade 3 thrombocytopenia lasting for 7 days or more or thrombocytopenia < 50K/µL requiring platelet transfusion for bleeding. (NCT01683994)
Timeframe: First two cycles of treatment (each cycle is 21 days), approximately 42 days.

Interventionmg (Number)
Ph I Cabozantinib + Docetaxel + Prednisone40

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Mean Global Evaluation for Efficacy by Participant/Parent and Investigator

At Visit 3 (Day 8), participant/parent and investigator were asked to evaluate efficacy globally as very beneficial=1, beneficial=2, no effect=3 or worse=4. The global evaluation collected at the early withdrawal visit was included in the Visit 3. If participants were discontinued at Visit 2, then the global evaluation collected at the Visit 2 is also included in the Visit 3 for summary and analysis. (NCT01687296)
Timeframe: Day 8

,
InterventionScores on a scale (Mean)
Participant/parent global evaluationInvestigator global evaluation
Fluticasone Propionate1.51.5
Prednisone1.51.5

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Mean Evening PEF on Diary Card Over the Treatment Assessment Period

PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the evening (6:00-9:00 post meridiem [PM]) before taking any study drug. Only data that was drawn from Days 1/2 to 8 after randomization and before or on the end date of study drug was used for analysis. If participants started to take the study drug in the morning (early or on 12:00 PM), only then the evening PEF on the date of randomization was used. The outcome measure was considered missing if less than 2 days was recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 5 participants from prednisone group had the missing outcome measure. Analysis was performed using an ANCOVA model with effects due to gender, age, centre and treatment group. (NCT01687296)
Timeframe: Days 1/2 to 8

InterventionL/min (Least Squares Mean)
Fluticasone Propionate195.79
Prednisone194.63

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Mean Morning Peak Expiratory Flow (AM PEF) on Diary Card Over the Treatment Assessment Period in Intent-to-Treat (ITT) Population

PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants (if needed with the help of parents or guardian) recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the morning before taking any study drug. Only data that was drawn from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used for analysis. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 4 participants from prednisone group had the missing outcome measure. Analysis was performed using an analysis of covariance (ANCOVA) model with effects due to gender, age, centre and treatment group. (NCT01687296)
Timeframe: Days 2 to 8

InterventionLitres per minute (L/min) (Least Squares Mean)
Fluticasone Propionate188.77
Prednisone188.31

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Mean Morning PEF on Diary Card Over the Treatment Assessment Period in Per Protocol (PP) Population

PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants (if needed with the help of parents or guardian) recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the morning before talking any study drug. Only data that was drawn from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used for analysis. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 5 participants from prednisone group had the missing outcome measure. Analysis was performed using ANCOVA model with effects due to gender, age ,centre and treatment group. (NCT01687296)
Timeframe: Days 2 to 8

InterventionL/min (Least Squares Mean)
Fluticasone Propionate189.46
Prednisone188.96

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Median Number of Use of Rescue Medications During Day and Night Over the Treatment Assessment Period

The use of nebulized salbutamol (doses/puffs and frequency) were recorded on diary card in the morning and evening. The median numbers of times of use of rescue medication during day and night was calculated for each participant over the treatment assessment period. In each case, only data that was from Days 2 to 8 after randomization and before or on the end date of study drug was used. The outcome measure was considered missing if less than 2 days (that is., 24-hour periods) were recorded in the given treatment assessment period. The analysis only includes participants who have at least 2 days of non-missing numbers of times rescue medication (including zero) in the given treatment assessment period. (NCT01687296)
Timeframe: Days 2 to 8

InterventionNumber of use of rescue medication (Median)
Fluticasone Propionate2.0
Prednisone2.0

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Clinical Assessment of Lung Function of Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) During the Treatment Period

Spirometric assessments of FEV1 and FVC were assessed at clinic visit 1 (Screening), 2 (Day 5) and 3 (Day 8). Lung function tests were performed at the approximately same time at each visit in the morning. Participants were instructed to withhold salbutamol therapy for at least 4 hour, and the highest of three FEV1 and FVC measurements were recorded. If participants discontinued before or on Day 5, then the FEV1 and FVC collected at the early withdrawal visit is included in the Visit 2. Otherwise, the FEV1, FVC collected at the early withdrawal visit was included in the Visit 3. Analysis was performed using ANCOVA with covariates of gender, centre, age and treatment. (NCT01687296)
Timeframe: During the treatment period at Day 5, Day 8

,
InterventionLitres (Least Squares Mean)
FEV1, Day 5FEV1, Day 8FVC, Day 5FVC, Day 8
Fluticasone Propionate1.2881.4001.4761.544
Prednisone1.3311.3961.5431.582

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Mean Change From Baseline in Clinical Scoring Index at Day 5 and Day 8

The clinical scoring index was assessed at Baseline (Visit 1), Day 5 and Day 8. The score assigned represented the sum of the score for each of four signs: respiratory rate, wheezing, inspiration/expiration ratio, and accessory muscle use. Each of these parameters were scored on a 4-point scale of 0 to 3 where 0=none, 1=mild, 2=moderate and 3=severe. The total score ranged from 0 to 12, where 0 indicated absence of symptoms and 12 indicated most severe symptoms. The Baseline value was the last non-missing value prior to randomization. Change from Baseline was calculated/defined as value at the indicated visit minus value at the Baseline. A negative value of change in score from Baseline indicated improvement in severity of symptoms. If participants discontinued before or on Day 5, then the clinical scoring index collected at the early withdrawal visit was included in the Visit 2. Otherwise, the clinical scoring index collected at the early withdrawal visit was included in the Visit 3 (NCT01687296)
Timeframe: Baseline, Day 5 and Day 8

,
InterventionScores on a scale (Mean)
Day 5Day 8
Fluticasone Propionate-2.7-3.4
Prednisone-2.6-3.4

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Median Day-time and Night-time Symptom Scores Over the Treatment Assessment Period

The symptoms of cough, sputum production, wheeze and dyspnoea were assessed in morning and evening, and recorded on participant diary cards. Day-time symptoms were scored while retiring to bed on a scale of 0 (no symptoms) to 5 (severe). Night-time symptoms were scored while waking in the morning on a scale of 0 (no symptoms) to 4 (severe). For day-time score, only data that was from Days 2 to 8 after randomization and before or on the end date of study drug was used. For night-time score, only data that are from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. The analysis only includes participants with at least 2 days of non-missing symptom scores in the given treatment assessment period. (NCT01687296)
Timeframe: Days 2 to 8

,
InterventionScores on a scale (Median)
Day-time symptom scoreNight-time symptom score
Fluticasone Propionate0.50.0
Prednisone1.00.0

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Number of Participants Who Achieved a Reduction of Their Daily OCS Dose to <=5.0 mg During Weeks 20 to 24 While Maintaining Asthma Control

Maintenance (MN) dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. Number of participants who achieved a reduction of their daily OCS dose to <=5.0 mg was based on the value of the MN dose. Analysis was performed using a binary logistic regression model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose. (NCT01691508)
Timeframe: Weeks 20 to 24

,
InterventionParticipants (Number)
<=5 mg/day>5 mg/day or lack of asthma control or WD
Mepolizumab 100 mg SC3732
Placebo2145

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Median Percentage Change From Baseline in Daily OCS Dose During Weeks 20 to 24 While Maintaining Asthma Control

BL dose was the prescribed optimized prednisone/prednisolone dose following the OCS Optimization Phase. MN dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). The percent change of OCS dose during weeks 20 to 24 compared to BL dose was calculated as: 100 x (MN dose minus BL dose)/BL dose. Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. For participants who withdrew from the study prior to the Maintenance Phase, and for participants with a lack of asthma control during the Maintenance Phase, a value equal to the minimum percent reduction in OCS use across all subjects was imputed for the analysis. (NCT01691508)
Timeframe: Baseline; Weeks 20 to 24

InterventionPercentage reduction in OCS dose (Median)
Placebo0.0
Mepolizumab 100 mg SC-50.0

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Number of Participants Who Achieved a Reduction of >=50% in Their Daily Oral Corticosteroid (OCS) Dose Compared With Baseline Dose, During Weeks 20 to 24 While Maintaining Asthma Control

Baseline (BL) dose was the prescribed optimized prednisone/prednisolone dose following the OCS Optimization Phase. Maintenance (MN) dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). The percent reduction of OCS dose during weeks 20 to 24 compared to BL dose was calculated as: 100 x (BL dose minus MN dose)/BL dose. Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. Analysis was performed using a binary logistic regression model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose. (NCT01691508)
Timeframe: Baseline; Weeks 20 to 24

,
InterventionParticipants (Number)
50 to 100%<50% or no decrease/lack of asthma control/WD
Mepolizumab 100 mg SC3732
Placebo2244

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Number of Participants With the Indicated Percent Reduction From Baseline in Oral Corticosteroid (OCS) Dose During Weeks 20 to 24 While Maintaining Asthma Control

Baseline (BL) dose was the prescribed optimized prednisone/prednisolone dose following the OCS Optimization Phase. Maintenance (MN) dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). The percent reduction of OCS dose during weeks 20 to 24 compared to BL dose was calculated as: 100 x (BL dose minus MN dose)/BL dose. Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. The percent reduction of OCS was categorized as: 90 to 100%; 75 to <90%; 50 to <75%; >0 to <50%; no decrease in prednisone dose, or lack of asthma control, or withdrawal (WD) from treatment. Analysis was performed using a proportional odds model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose. (NCT01691508)
Timeframe: Baseline; Weeks 20 to 24

,
InterventionParticipants (Number)
90 to 100%75 to <90%50 to <75%>0 to <50%No decrease /lack of asthma control/early WD
Mepolizumab 100 mg SC16129725
Placebo7510737

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Number of Participants Who Achieved a Total Reduction of OCS Dose During Weeks 20 to 24 While Maintaining Asthma Control

MN dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. The number of participants who achieved a total reduction of OCS dose was based on the value of the MN dose. Total reduction implied no OCS use during the entire MN phase. Analysis was performed using a binary logistic regression model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose. (NCT01691508)
Timeframe: Weeks 20 to 24

,
InterventionParticipants (Number)
0 mg/dayOCS taken or lack of asthma control or WD
Mepolizumab 100 mg SC1059
Placebo561

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DB Phase: Objective Response Rate (ORR)

ORR was defined as the percentage of participants with measurable disease at baseline achieving a complete response (CR) or partial response (PR) according to modified response evaluation criteria in solid tumors (RECIST) criteria. RECIST criteria for CR: disappearance of all target lesions and non-target lesions and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. (NCT01695135)
Timeframe: Approximately up to 3.8 years

InterventionPercentage of Participants (Number)
Placebo + Prednisone (Double-blind)4.2
Abiraterone Acetate + Prednisone (Double-blind)17.5

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DB Phase: Overall Survival

Overall survival was defined as the time interval from the date of randomization to the date of death from any cause. (NCT01695135)
Timeframe: From randomization to the date of death due to any cause (up to approximately 3.8 years)

InterventionDays (Median)
Placebo + Prednisone (Double-blind)561.00
Abiraterone Acetate + Prednisone (Double-blind)579.00

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DB Phase: Percentage of Participants Experiencing Pain Palliation

Percentage of participants experiencing pain palliation were reported. A participant is responder if experienced >=30% reduction in Brief Pain Inventory - Short Form (BPI-SF) worst pain intensity score over 24 hours observed at 2 consecutive evaluations 4 weeks apart without any increase in analgesic usage score (best response). Analgesic usage was scored on a scale of 0 to 3 where 0=no analgesic, 1=non-opioid analgesics, 2=opioids for moderate pain and 3=opioids for severe pain. BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions. It includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Total score (average of individual questions) ranges from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. (NCT01695135)
Timeframe: Approximately up to 3.8 years

InterventionPercentage of Participants (Number)
Placebo + Prednisone (Double-blind)31.8
Abiraterone Acetate + Prednisone (Double-blind)54.5

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DB Phase: Percentage of Participants Who Achieved PSA Response

Percentage of participants who achieved PSA response (defined as >= 50% PSA decline from baseline) according to PSAWG criteria were reported. PSAWG criteria- Decline from baseline and reach response criteria: >= 50% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL (or back to the baseline), which is confirmed by a second value 4 or more weeks later; Decline from baseline but not reach response criteria: >=25% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later; and No decline from baseline: >=25% increase over the baseline and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later. (NCT01695135)
Timeframe: Approximately up to 3.8 years

InterventionPercentage of Participants (Number)
Placebo + Prednisone (Double-blind)18.3
Abiraterone Acetate + Prednisone (Double-blind)54.5

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DB Phase: Time to Pain Progression

Time to Pain progression calculated as number of days from date of randomization to date of pain progression. Pain progression- worsening of pain due to metastatic bone disease defined as increase of >=30% in worst pain over past 24 hours on BPI-SF numeric rating scale at 2 consecutive evaluations 4 weeks apart without decrease in analgesic usage score (in 2 corresponding consecutive evaluation in analgesic usage score, if there is missing visit, use existing visit only) or increase in analgesic usage score >=30% at 2 consecutive evaluations 4 weeks apart. BPI-SF is 11-item questionnaire which includes 4 questions that assess pain intensity and 7 questions that assess impact of pain on daily functions. Total score (average of individual questions) ranges from 0=No pain to 10=Pain as bad as you can imagine; Higher scores= greater pain. Analgesic usage was scored on scale of 0 to 3 where 0=no analgesic, 1=non-opioid analgesics, 2=opioids for moderate pain and 3=opioids for severe pain. (NCT01695135)
Timeframe: Approximately up to 3.8 years

InterventionDays (Median)
Placebo + Prednisone (Double-blind)169.00
Abiraterone Acetate + Prednisone (Double-blind)505.00

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DB Phase: Time to Prostate-Specific Antigen Progression (PSA)

Time to PSA progression was defined as time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the Prostate Specific Antigen Working Group (PSAWG) criteria. PSAWG criteria- Decline from baseline and reach response criteria: greater than or equal to (>=) 50 percent (%) increase over the nadir and the increase in the absolute-value by at least 5 nanogram per milliliter (ng/mL) (or back to the baseline), which is confirmed by a second value 4 or more weeks later; Decline from baseline but not reach response criteria: >=25% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later; and No decline from baseline: >=25% increase over the baseline and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later. (NCT01695135)
Timeframe: Up to 1.8 years

InterventionDays (Median)
Placebo + Prednisone (Double-blind)84.00
Abiraterone Acetate + Prednisone (Double-blind)169.00

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DB Phase: Change From Baseline in Brief Fatigue Inventory (BFI) Score at End of Treatment

"The Brief Fatigue Inventory (BFI) is a brief participant-reported questionnaire that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. BFI has nine items. Three items ask patients to rate the severity of their fatigue at its worst, usual, and now during normal waking hours, with 0 being no fatigue and 10 being fatigue as bad as you can imagine. Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, and enjoyment of life. The interference items are measured on a 0-10 scale, with 0 being does not interfere and 10 being completely interferes. BFI Total Score is the average of the nine items, ranging from 0 (no fatigue) to 10 (high fatigue)." (NCT01695135)
Timeframe: Baseline, at End of Treatment (15 and 30 days after the last dose [up to 3.8 years])

,
InterventionUnits on a scale (Mean)
Fatigue NowUsual FatigueWorst FatigueGeneral ActivityMoodWalking AbilityNormal WorkRelations with Other PeopleEnjoyment of Life
Abiraterone Acetate + Prednisone (Double-blind)1.71.51.61.71.81.82.01.61.9
Placebo + Prednisone (Double-blind)2.42.42.62.32.72.42.22.02.5

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DB Phase: Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire: Total Scores at the End of Treatment

FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS) (Range 1-156, higher scores better). The FACT-General (FACT-G) is a 28 item Quality of Life (QOL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional (0-24) Well-being. The total range was between 1-108, higher scores better. Functional Assessment of Cancer Therapy-Treatment Outcome Index (FACT-TOI) is derived from the sum of the Physical Well-Being, Functional Well-Being, and Prostate Cancer subscale scores; a sensitive measure of patient-reported health (Range 1-104, higher scores better). PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better). (NCT01695135)
Timeframe: Baseline, at End of Treatment (15 and 30 days after the last dose [up to 3.8 years])

,
InterventionUnits on a scale (Mean)
Total ScorePhysical Well-beingFunctional Well-beingEmotional Well-beingSocial Well-beingFACT-G Total ScoreProstate Cancer Subscale (PCS)Treatment Outcome Index (FACT-TOI)
Abiraterone Acetate + Prednisone (Double-blind)-16.1-4.9-2.7-2.4-1.2-11.2-4.9-12.5
Placebo + Prednisone (Double-blind)-19.9-6.7-5.1-2.1-0.8-14.6-5.3-17.1

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AUC (TAU): Area Under the Serum Concentration Time Curve Over a Dosing Interval

AUC (TAU): Area under the serum concentration time curve over a dosing interval between Days 337 to 365. (NCT01714817)
Timeframe: Days 337 to 365

Interventionug*h/mL (Geometric Mean)
Abatacept IV36480.24

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Adjusted Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 365 of the Double-blind Period in Nephrotic Participants

Adjusted Mean Change from Baseline in UPCR at Day 365 of the double-blind period in nephrotic participants (NCT01714817)
Timeframe: Baseline and Day 365

InterventionUPCR (mg/mg) (Mean)
Abatacept IV-5.01
Placebo IV-4.84

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Adjusted Mean Change From Baseline in UPCR at Day 365 of the Double-blind Period in Overall Population

Adjusted Mean Change from Baseline in Urine protein/creatinine ratio (UPCR) at Day 365 of the double-blind period in the overall population (NCT01714817)
Timeframe: Day 1 and Day 365

InterventionUPCR (mg/mg) (Mean)
Abatacept IV-2.99
Placebo IV-2.90

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Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During Year 1 of the Double-blind Period

"Adjusted mean change from baseline in British Isles Lupus Assessment Group (BILAG) score over time during Year 1 of the double-blind period based on a repeated measure mixed model and presented at each visit in the first 12-month of the double-blind period. BILAG index measures disease activity in different organs/systems separately. BILAG score is calculated for each of 9 systems depending on the clinical features present and whether they are new (4 points), worse (3 points), the same (2 points), improving (1 point) or not present (0 points) in the last 4 weeks compared with previously. BILAG A represents the presence of serious features of lupus. BILAG B represents more moderate features of the disease. BILAG C includes only mild symptomatic features. BILAG D represents prior activity with no current symptoms due to active lupus. BILAG E represents an organ that has never been involved. Overall BILAG score ranges from 0-108, with higher scores reflecting a worse outcome." (NCT01714817)
Timeframe: Day 1 to Day 365

InterventionScores on a Scale (Mean)
Abatacept IV-8.22
Placebo IV-7.60

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Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (Percentage of Blood)

"Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.~Change from Baseline = Post-baseline - Baseline value." (NCT01714817)
Timeframe: Day 729

InterventionPercentage (Mean)
Abatacept IV0.0328
Placebo IV0.0325

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Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During the Double-blind Period

"BILAG index measures and reports disease activity in different organs/systems separately. The BILAG score is calculated for each of nine systems depending on the clinical features present and whether they are new (4 points), worse (3 points), the same (2 points), improving (1 point) or not present (0 points) in the last 4 weeks compared with previously. A BILAG A represents the presence of one or more serious features of lupus. A BILAG B represents more moderate features of the disease. A BILAG C includes only mild symptomatic features. A BILAG D represents only prior activity with no current symptoms due to active lupus. A BILAG E represents an organ that has never been involved. Overall BILAG score ranges from 0-108, with higher scores reflecting a worse outcome." (NCT01714817)
Timeframe: Day 1 to Day 729; Day 365 to Day 729

,
InterventionScores on a Scale (Mean)
Day 1 to Day 729Day 365 to Day 729
Abatacept IV-9.31-0.95
Placebo IV-8.53-0.40

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Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period

"LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value HEMOGLOBIN g/L 4.0 HB >3 G/DL DECREASE FROM PRE RX HEMATOCRIT vol 6.3 HCT <0.75X PRE RX ERYTHROCYTES x10*12 c/L 5.2 RBC <0.75X PRE RX PLATELET COUNT x10*9 c/L 5.0 PLAT <0.67X LLN OR >1.5X ULN, OR IF PRE RX1.25X ULN, OR IF PRE RXULN, OR IF PRE RX>ULN THEN USE >1.2X PRE RX OR .750 X10*3 c/uL BASOPHILS (ABSOLUTE) x10*9 c/L 8.3 BASOA IF VALUE > 400/MM3 MONOCYTES (ABSOLUTE) x10*9 c/L 8.3 MONOA IF VALUE > 2000/MM3 LYMPHOCYTES (ABSOLUTE) x10*9 c/L 8.3 LYMPA IF VALUE < .750 X10*3 c/uL OR IF VALUE > 7.50 X10*3 c/uL~N = the number of participants with at least 1 on treatment lab result for each analyte" (NCT01714817)
Timeframe: Day 1 to Day 729

,
Interventionparticipants (Number)
HEMOGLOBIN, lowHEMOGLOBIN, highHEMATOCRIT, lowHEMATOCRIT, highERYTHROCYTES, lowERYTHROCYTES, highPLATELET COUNT, lowPLATELET COUNT, highLEUKOCYTES, lowLEUKOCYTES, highEOSINOPHILS (ABSOLUTE), lowEOSINOPHILS (ABSOLUTE), highBASOPHILS (ABSOLUTE), lowBASOPHILS (ABSOLUTE), highMONOCYTES (ABSOLUTE), lowMONOCYTES (ABSOLUTE), highLYMPHOCYTES (ABSOLUTE), lowLYMPHOCYTES (ABSOLUTE), high
Abatacept IV8NA6NA4NA21193NA11NA0NA0430
Placebo IV9NA2NA2NA40245NA6NA0NA0620

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Summary Statistics for Systolic Blood Pressure

Summary statistics for systolic blood pressure (NCT01714817)
Timeframe: Day 1 to Day 729

,
InterventionmmHg (Mean)
Day 1, end of observationDay 365, end of observationDay 729, end of observation
Abatacept IV122.0112.3108.6
Placebo IV122.6115.0114.2

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Summary Statistics for Heart Rate

Summary statistics for Heart Rate (NCT01714817)
Timeframe: Day 1 to Day 729

,
Interventionbeats per minute (Mean)
Day 1, end of observationDay 365, end of observationDay 729, end of observation
Abatacept IV80.678.576.2
Placebo IV81.470.076.7

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Summary Statistics for Diastolic Blood Pressure

Summary statistics for diastolic blood pressure (NCT01714817)
Timeframe: Day 1 to Day 729

,
InterventionmmHg (Mean)
Day 1, end of observationDay 365, end of observationDay 729, end of observation
Abatacept IV76.573.567.5
Placebo IV77.077.572.7

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Percentage of Participants With Ranked Outcome of Complete Renal Response, Partial Renal Response (PR), and No Renal Response (NR) During the Double-blind Period

Complete Renal Response or Complete Response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; UPCR < 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment. Partial Renal Response or Partial Response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR < 0.5 OR 50% reduced from baseline and < 1 if baseline value was < 3, OR 50% reduced from baseline and < 3 if baseline value was greater than or equal to 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment. No Renal Response or No Response (NR): defined as not meeting criteria for CR or PR or withdrawn (NCT01714817)
Timeframe: Day 365, Day 729

,
InterventionPercentage (Number)
CR - Day 365PR - Day 365NR - Day 365CR - Day 729PR - Day 729NR - Day 729
Abatacept IV35.120.844.160.725.913.4
Placebo IV33.521.744.853.622.723.6

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Percentage of Participants in Treatment Failure Over Time During the Double-blind Period

"Lupus treatment failure is defined as any of the following: Death, unless due to physical trauma or violence; Renal Flare; sustained doubling of creatinine from baseline (greater of Screening or Study Day 1 value); initiation of rescue therapy for treatment of active lupus nephritis after Study Week 20.~Overall treatment failure is defined as lupus treatment failure plus discontinuation of study drug for any reason except death due to physical trauma or violence, pregnancy or administrative decision by Sponsor." (NCT01714817)
Timeframe: Day 365, Day 729

,
InterventionPercentage (Number)
Lupus treatment failure (LTF) - Day 365Overall treatment failure (OTF) - Day 365LTF - Day 729OTF - Day 729
Abatacept IV3.54.54.55.2
Placebo IV4.44.95.38.4

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Number of Participants With Sustained Change From Higher Level of Response to no Response During the Double-blind Period

Sustained change to no response is defined as going from CR (or PR) to NR and remaining in NR for at least 2 consecutive visits; visits should be approximately 4 weeks apart. This analysis will be based on time from response CR (or PR) to the first visit in which the no response (NR) was achieved and sustained to the next visit. (NCT01714817)
Timeframe: Day 365, Day 729

,
InterventionParticipants (Number)
Day 365Day 729
Abatacept IV552
Placebo IV356

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Number of Participants With Other Marked Chemistry Laboratory Abnormalities in the Double Blind Period

"LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value CALCIUM, TOTAL mmol/L 5.2 CA <0.8X LLN OR >1.2X ULN, OR IF PRE RXULN, OR IF PRE RX>ULN THEN USE >1.25X PRE RX OR 1.25X ULN, OR IF PRE RXULN GLUCOSE, SERUM mmol/L 4.1 GLUC <65 mg/dL, OR >220 mg/dL PROTEIN, TOTAL g/L 5.0 TPRO <0.9X LLN OR >1.1X ULN, OR IF PRE RXULN, OR IF PRE RX>ULN THEN USE 1.1X PRE RX OR 2X PRE R~N = the number of participants with at least 1 on treatment lab result for each analyte" (NCT01714817)
Timeframe: Day 1 to Day 729

,
Interventionparticipants (Number)
GLUCOSE, SERUM, lowGLUCOSE, SERUM, highGLUCOSE, FASTING SERUM, lowGLUCOSE, FASTING SERUM, highPROTEIN, TOTAL, lowPROTEIN, TOTAL, highALBUMIN, lowALBUMIN, high
Abatacept IV153331024NA
Placebo IV24211735NA

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Number of Participants With Other Marked Chemistry Laboratory Abnormalities During Year 1 of the Double Blind Period

"LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value CALCIUM, TOTAL mmol/L 5.2 CA <0.8X LLN OR >1.2X ULN, OR IF PRE RXULN, OR IF PRE RX>ULN THEN USE >1.25X PRE RX OR 1.25X ULN, OR IF PRE RXULN GLUCOSE, SERUM mmol/L 4.1 GLUC <65 mg/dL, OR >220 mg/dL PROTEIN, TOTAL g/L 5.0 TPRO <0.9X LLN OR >1.1X ULN, OR IF PRE RXULN, OR IF PRE RX>ULN THEN USE 1.1X PRE RX OR 2X PRE R~N = the number of participants with at least 1 on treatment lab result for each analyte" (NCT01714817)
Timeframe: Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier

,
Interventionparticipants (Number)
GLUCOSE, SERUM, lowGLUCOSE, SERUM, highPROTEIN, TOTAL, lowPROTEIN, TOTAL, highALBUMIN, lowALBUMIN, high
Abatacept IV331044010NA
Placebo IV29526111NA

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Number of Participants With Marked Urinalysis Laboratory Abnormalities in the Double Blind Period

LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value PROTEIN, URINE Unknown UPRO IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 GLUCOSE, URINE N/A UGLU IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 BLOOD, URINE N/A UBLD IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 RBC, URINE hpf 5.0 URBC IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 WBC, URINE hpf 5.0 UWBC IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 (NCT01714817)
Timeframe: Day 1 to Day 729

,
Interventionparticipants (Number)
PROTEIN, URINE, lowPROTEIN, URINE, highGLUCOSE, URINE, lowGLUCOSE, URINE, highBLOOD, URINE, lowBLOOD, URINE, highRed blood cells (RBC), URINE, lowRed blood cells (RBC), URINE, highWhite blood cells (WBC), URINE, lowWhite blood cells (WBC), URINE, high
Abatacept IVNA0NA0NA0NA58NA46
Placebo IVNA0NA0NA0NA55NA59

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Number of Participants With Marked Urinalysis Laboratory Abnormalities During Year 1 of the Double Blind Period

LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value PROTEIN, URINE Unknown UPRO IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 GLUCOSE, URINE N/A UGLU IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 BLOOD, URINE N/A UBLD IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 RBC, URINE hpf 5.0 URBC IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 WBC, URINE hpf 5.0 UWBC IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 (NCT01714817)
Timeframe: Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier

,
Interventionparticipants (Number)
PROTEIN, URINE, lowPROTEIN, URINE, highGLUCOSE, URINE, lowGLUCOSE, URINE, highBLOOD, URINE, lowBLOOD, URINE, highRed blood cells (RBC), URINE, lowRed blood cells (RBC), URINE, highWhite blood cells (WBC), URINE, lowWhite blood cells (WBC), URINE, high
Abatacept IVNA0NA0NA0NA93NA91
Placebo IVNA0NA0NA0NA103NA98

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Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period

"LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value ALKALINE PHOSPHATASE (ALP) U/L 5.0 ALP >2X ULN, OR IF PRE RX>ULN THEN USE >3X PRE RX ASPARTATE AMINOTRANSFERASE (AST) U/L 5.0 AST >3X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX ALANINE AMINOTRANSFERASE (ALT) U/L 5.0 ALT >3X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX G-GLUTAMYL TRANSFERASE (GGT) U/L 5.0 GGT >2X ULN, OR IF PRE RX>ULN THEN USE >3X PRE RX BILIRUBIN, TOTAL umol/L 5.1 TBILI >2X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX BILIRUBIN, DIRECT umol/L 5.1 DBILI >1.5X ULN, OR IF PRE RX>ULN THEN USE >2X PRE RX BLOOD UREA NITROGEN mmol/L 5.1 BUN >2X PRE RX CREATININE umol/L 5.0 CREAT >1.5X PRE RX~N = the number of participants with at least 1 on treatment lab result for each analyte" (NCT01714817)
Timeframe: Day 1 to Day 729

,
Interventionparticipants (Number)
ALKALINE PHOSPHATASE (ALP), lowALKALINE PHOSPHATASE (ALP), highASPARTATE AMINOTRANSFERASE (AST), lowASPARTATE AMINOTRANSFERASE (AST), highALANINE AMINOTRANSFERASE (ALT), lowALANINE AMINOTRANSFERASE (ALT), highG-GLUTAMYL TRANSFERASE (GGT), lowG-GLUTAMYL TRANSFERASE (GGT), highBILIRUBIN, TOTAL, lowBILIRUBIN, TOTAL, highBILIRUBIN, DIRECT, lowBILIRUBIN, DIRECT, highBLOOD UREA NITROGEN, lowBLOOD UREA NITROGEN, highCREATININE, lowCREATININE, high
Abatacept IVNA4NA2NA4NA17NA0NA1NA10NA17
Placebo IVNA0NA3NA3NA11NA0NA0NA9NA16

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Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period

"LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value ALKALINE PHOSPHATASE (ALP) U/L 5.0 ALP >2X ULN, OR IF PRE RX>ULN THEN USE >3X PRE RX ASPARTATE AMINOTRANSFERASE (AST) U/L 5.0 AST >3X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX ALANINE AMINOTRANSFERASE (ALT) U/L 5.0 ALT >3X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX G-GLUTAMYL TRANSFERASE (GGT) U/L 5.0 GGT >2X ULN, OR IF PRE RX>ULN THEN USE >3X PRE RX BILIRUBIN, TOTAL umol/L 5.1 TBILI >2X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX BILIRUBIN, DIRECT umol/L 5.1 DBILI >1.5X ULN, OR IF PRE RX>ULN THEN USE >2X PRE RX BLOOD UREA NITROGEN mmol/L 5.1 BUN >2X PRE RX CREATININE umol/L 5.0 CREAT >1.5X PRE RX~N = the number of participants with at least 1 on treatment lab result for each analyte" (NCT01714817)
Timeframe: Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier

,
Interventionparticipants (Number)
ALKALINE PHOSPHATASE (ALP), lowALKALINE PHOSPHATASE (ALP), highASPARTATE AMINOTRANSFERASE (AST), lowASPARTATE AMINOTRANSFERASE (AST), highALANINE AMINOTRANSFERASE (ALT), lowALANINE AMINOTRANSFERASE (ALT), highG-GLUTAMYL TRANSFERASE (GGT), lowG-GLUTAMYL TRANSFERASE (GGT), highBILIRUBIN, TOTAL, lowBILIRUBIN, TOTAL, highBILIRUBIN, DIRECT, lowBILIRUBIN, DIRECT, highBLOOD UREA NITROGEN, lowBLOOD UREA NITROGEN, highCREATININE, lowCREATININE, high
Abatacept IVNA1NA5NA8NA17NA0NA0NA20NA24
Placebo IVNA1NA0NA2NA15NA0NA0NA12NA20

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Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period

"LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value HEMOGLOBIN g/L 4.0 HB >3 G/DL DECREASE FROM PRE RX HEMATOCRIT vol 6.3 HCT <0.75X PRE RX ERYTHROCYTES x10*12 c/L 5.2 RBC <0.75X PRE RX PLATELET COUNT x10*9 c/L 5.0 PLAT <0.67X LLN OR >1.5X ULN, OR IF PRE RX1.25X ULN, OR IF PRE RXULN, OR IF PRE RX>ULN THEN USE >1.2X PRE RX OR .750 X10*3 c/uL BASOPHILS (ABSOLUTE) x10*9 c/L 8.3 BASOA IF VALUE > 400/MM3 MONOCYTES (ABSOLUTE) x10*9 c/L 8.3 MONOA IF VALUE > 2000/MM3 LYMPHOCYTES (ABSOLUTE) x10*9 c/L 8.3 LYMPA IF VALUE < .750 X10*3 c/uL OR IF VALUE > 7.50 X10*3 c/uL~N = the number of participants with at least 1 on treatment lab result for each analyte" (NCT01714817)
Timeframe: Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier

,
Interventionparticipants (Number)
HEMOGLOBIN, lowHEMOGLOBIN, highHEMATOCRIT, lowHEMATOCRIT, highERYTHROCYTES, lowERYTHROCYTES, highPLATELET COUNT, lowPLATELET COUNT, highLEUKOCYTES, lowLEUKOCYTES, highEOSINOPHILS (ABSOLUTE), lowEOSINOPHILS (ABSOLUTE), highBASOPHILS (ABSOLUTE), lowBASOPHILS (ABSOLUTE), highMONOCYTES (ABSOLUTE), lowMONOCYTES (ABSOLUTE), highLYMPHOCYTES (ABSOLUTE), lowLYMPHOCYTES (ABSOLUTE), high
Abatacept IV6NA12NA7NA403529NA2NA1NA0811
Placebo IV10NA12NA10NA302125NA6NA1NA11042

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Number of Participants With Marked Electrolyte Laboratory Abnormalities in the Double Blind Period

"LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value SODIUM, SERUM mmol/L 4.0 NA <0.95X LLN OR >1.05X ULN, OR IF PRE RXULN, OR IF PRE RX>ULN THEN USE >1.05X PRE RX OR 1.1X ULN, OR IF PRE RXULN, OR IF PRE RX>ULN THEN USE >1.1X PRE RX OR 1.1X ULN, OR IF PRE RXULN, OR IF PRE RX>ULN THEN USE >1.1X PRE RX OR NCT01714817)
Timeframe: Day 1 to Day 729

,
Interventionparticipants (Number)
SODIUM, SERUM, lowSODIUM, SERUM, highPOTASSIUM, SERUM, lowPOTASSIUM, SERUM, highCHLORIDE, SERUM, lowCHLORIDE, SERUM, highCALCIUM, TOTAL, lowCALCIUM, TOTAL, highPHOSPHORUS, INORGANIC, lowPHOSPHORUS, INORGANIC, high
Abatacept IV0023000136
Placebo IV0122100043

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Number of Participants With Marked Electrolyte Laboratory Abnormalities During Year 1 of the Double Blind Period

"LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value SODIUM, SERUM mmol/L 4.0 NA <0.95X LLN OR >1.05X ULN, OR IF PRE RXULN, OR IF PRE RX>ULN THEN USE >1.05X PRE RX OR 1.1X ULN, OR IF PRE RXULN, OR IF PRE RX>ULN THEN USE >1.1X PRE RX OR 1.1X ULN, OR IF PRE RXULN, OR IF PRE RX>ULN THEN USE >1.1X PRE RX OR NCT01714817)
Timeframe: Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier

,
Interventionparticipants (Number)
SODIUM, SERUM, lowSODIUM, SERUM, highPOTASSIUM, SERUM, lowPOTASSIUM, SERUM, highCHLORIDE, SERUM, lowCHLORIDE, SERUM, highCALCIUM, TOTAL, lowCALCIUM, TOTAL, highPHOSPHORUS, INORGANIC, lowPHOSPHORUS, INORGANIC, high
Abatacept IV12370012913
Placebo IV12571010713

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Number of Participants With Any Adverse Events (AEs) During Year 2 of the Double-blind Period and Long-term Extension

All AEs were coded and grouped into preferred terms (PT) by system organ class (SOC), using the Medical Dictionary for Regulatory Activities (MedDRA, version 21.0). Investigators determined the intensity of each AE as mild, moderate, severe, or very severe and assessed the relationship to study drug. (NCT01714817)
Timeframe: From the first dose in Year 2 of the double-blind period up to 56 days post last dose

,
InterventionParticipants (Number)
Participants with Adverse EventsParticipants with Serious Adverse EventsParticipants with infection Adverse EventsParticipants with malignanciesParticipants with autoimmune events
Abatacept IV1271510007
Placebo IV13725107111

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Number of Participants With Any Adverse Events (AEs) During Year 1 of the Double-blind Period

All AEs were coded and grouped into preferred terms (PT) by system organ class (SOC), using the Medical Dictionary for Regulatory Activities (MedDRA, version 21.0). Investigators determined the intensity of each AE as mild, moderate, severe, or very severe and assessed the relationship to study drug. (NCT01714817)
Timeframe: From Day 1 up to 56 days post last dose in Year 1 of the double-blind period

,
InterventionParticipants (Number)
Participants with Adverse EventsParticipants with Serious Adverse EventsParticipants with infection Adverse EventsParticipants with malignanciesParticipants with autoimmune eventsParticipants with peri-infusional Adverse EventsParticipants with acute infusional Adverse Events
Abatacept IV1884915021072
Placebo IV194391471994

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Number of Participants With Abatacept Induced Antibody Response Over Time in the Double-blind Period

Participants who experienced a positive antibody response relative to baseline (ECL Assay) (NCT01714817)
Timeframe: Day 365, Day 729

,
InterventionParticipants (Number)
Day 365, overall
Abatacept IV7
Placebo IV9

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Median Time to Partial Renal Response During the Double-blind Period in Nephrotic Participants

The estimate of median time to Partial Response (PR) in nephrotic participants is based on Kaplan-Meier analysis. Partial renal response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR < 0.5 OR 50% reduced from baseline and < 1 if baseline value was < 3, OR 50% reduced from baseline and < 3 if baseline value was 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment (NCT01714817)
Timeframe: Day 365, Day 729

,
InterventionDays (Median)
Day 365Day 729
Abatacept IV225.058.5
Placebo IV196.056.0

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Median Time to Partial Renal Response During the Double-blind Period in All Participants

The estimate of median time to Partial Response (PR) is based on Kaplan-Meier analysis. Partial renal response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR < 0.5 OR 50% reduced from baseline and < 1 if baseline value was < 3, OR 50% reduced from baseline and < 3 if baseline value was 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment (NCT01714817)
Timeframe: Day 365, Day 729

,
InterventionDays (Median)
Day 365Day 729
Abatacept IV226.059.0
Placebo IV253.058.0

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Median Time to First Treatment Failure and Overall Treatment Failure During the Double-blind Period

"First treatment failure (or Lupus treatment failure) is defined as any of the following: Death, unless due to physical trauma or violence; Renal Flare; sustained doubling of creatinine from baseline (greater of Screening or Study Day 1 value); initiation of rescue therapy for treatment of active lupus nephritis after Study Week 20.~Overall treatment failure is defined as lupus treatment failure plus discontinuation of study drug for any reason except death due to physical trauma or violence, pregnancy or administrative decision by Sponsor.~The hazard ratio is estimated using the Cox proportional hazards model which includes treatment group, stratification variables (baseline ACEis/ARBs use, RACE) and baseline UPCR.~The estimate of median time is based on Kaplan-Meier analysis" (NCT01714817)
Timeframe: Day 365, Day 729

,
InterventionDays (Median)
First treatment failure (FTF) - Day 365Overall treatment failure (OTF) - Day 365FTF - Day 729OTF - Day 729
Abatacept IVNANANANA
Placebo IVNANANANA

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Median Time to First Sustained Change to No Response During the Double-blind Period

"Sustained response defined as response present at 2 consecutive visits approximately 4 weeks apart. No renal response (NR): defined as not meeting criteria for CR or PR or withdrawn~The estimate of median time is based on Kaplan-Meier analysis" (NCT01714817)
Timeframe: Day 365, Day 729

,
InterventionDays (Median)
Day 365Day 729
Abatacept IVNANA
Placebo IVNANA

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Median Time to Complete Renal Response During the Double-blind Period in Nephrotic Participants

The estimate of median time to Complete Renal Response in nephrotic participants is based on Kaplan-Meier analysis. Complete renal response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; Urine protein/creatinine ratio (UPCR) < 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment. (NCT01714817)
Timeframe: Day 365, Day 729

,
InterventionDays (Median)
Day 365Day 729
Abatacept IV366.0365.0
Placebo IV368.0368.0

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Median Time to Complete Renal Response During the Double-blind Period in All Participants

The estimate of median time to Complete Renal Response is based on Kaplan-Meier analysis. Complete renal response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; Urine protein/creatinine ratio (UPCR) < 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment. (NCT01714817)
Timeframe: Day 365, Day 729

,
InterventionDays (Median)
Day 365Day 729
Abatacept IV280.0170.0
Placebo IV309.0282.0

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Median Percent Change From Baseline in UPCR Over Time

"A repeated measure mixed model that included the baseline UPCR value, randomization stratification factors, time, and time by treatment interaction as fixed effects and subject as a random effect was used.~% Change from Baseline = (post baseline - baseline value) / baseline value x 100" (NCT01714817)
Timeframe: Day 365, Day 729

,
InterventionPercent (Median)
Day 365Day 729
Abatacept IV-83.77-89.83
Placebo IV-84.12-87.28

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Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (x10^9 Cells/L)

"Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.~Change from Baseline = Post-baseline - Baseline value." (NCT01714817)
Timeframe: Day 729

,
Interventionx10^9 cells/L (Mean)
EOSINOPHILS (ABSOLUTE) (x10^9 cells/L)LYMPHOCYTES (ABSOLUTE) (x10^9 cells/L)MONOCYTES (ABSOLUTE) (x10^9 cells/L)NEUTROPHILS (ABSOLUTE) (x10^9 cells/L)PLATELET COUNT (x10^9 cells/L)
Abatacept IV0.0340.141-0.018-2.259-4.9
Placebo IV0.010-0.149-0.050-2.289-9.1

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Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (Umol/L)

"Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.~Change from Baseline = Post-baseline - Baseline value." (NCT01714817)
Timeframe: Day 729

,
Interventionumol/L (Mean)
BILIRUBIN, TOTAL (umol/L)CREATININE (umol/L)
Abatacept IV1.77-5.6
Placebo IV1.00-6.2

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Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (mmol/L)

"Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.~Change from Baseline = Post-baseline - Baseline value." (NCT01714817)
Timeframe: Day 729

,
Interventionmmol/L (Mean)
BLOOD UREA NITROGEN (mmol/L)CALCIUM, TOTAL (mmol/L)CHLORIDE, SERUM (mmol/L)GLUCOSE, SERUM (mmol/L)PHOSPHORUS, INORGANIC (mmol/L)POTASSIUM, SERUM (mmol/L)SODIUM, SERUM (mmol/L)
Abatacept IV-2.310.097-1.1-0.23-0.077-0.02-0.2
Placebo IV-2.250.108-0.5-0.58-0.037-0.10-0.5

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Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (g/L)

"Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.~Change from Baseline = Post-baseline - Baseline value." (NCT01714817)
Timeframe: Day 729

,
Interventiong/L (Mean)
ALBUMIN (g/L)HEMOGLOBIN (g/L)PROTEIN, TOTAL (g/L)
Abatacept IV9.28.89.9
Placebo IV8.19.010.1

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Cmin (ug/mL): Trough Level Serum Concentration of Abatacept Prior to the Administration of the IV Infusion

Trough level serum concentration of abatacept prior to the administration of the IV infusion on Days 1 to 365 (NCT01714817)
Timeframe: Days 1 to 365

Interventionug/mL (Geometric Mean)
Day 15Day 29Day 57Day 85Day 113Day 169Day 281Day 337Day 365
Abatacept IV69.9790.4636.4334.4616.4213.9814.4414.9913.62

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Cmax: Maximum Observed Serum Concentration Following Participants Receiving Active Abatacept IV

Cmax: Maximum observed serum concentration following participants receiving active abatacept IV (NCT01714817)
Timeframe: at 1 hour post Day 1 dose and 30 minutes post Day 337 dose

Interventionug/mL (Geometric Mean)
Day 1Day 337
Abatacept IV527.43203.51

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Adjusted Mean Change From Baseline in UPCR Over Time

A repeated measure mixed model that included the baseline UPCR value, randomization stratification factors, time, and time by treatment interaction as fixed effects and subject as a random effect was used. (NCT01714817)
Timeframe: Day 365; Day 729, includes data up to July 1st 2017 when double-blind therapy ended

,
InterventionUPCR (mg/mg) (Mean)
Day 365Day 729
Abatacept IV-2.95-3.13
Placebo IV-2.68-2.72

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Adjusted Mean Change From Baseline in eGFR Over Time

Estimated glomerular filtration rate(eGFR), will be calculated by the CKD-EPI formula shown below.50 eGFR is expressed as mL/min per 1.73m2. For the purpose of this study lower limit of normal eGFR is defined as 90mL/min per 1.73m2 eGFR = 141 X min (Scr/k, 1)α X max (Scr/k, 1)-1.209 X 0.993Age X (1.018 [if female]) X (1.159 [if black]) Where Scr is serum creatinine (mg/dL), k is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/k or 1, and max indicates the maximum of Scr/k or 1, age in years. (NCT01714817)
Timeframe: Day 365, Day 729

,
InterventionmL/min per 1.73m2 (Mean)
Day 365Day 729
Abatacept IV6.857.20
Placebo IV5.857.91

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Percentage of Participants in Overall Population in Complete Renal Response of Lupus Glomerulonephritis at Day 729 of the Double-blind Period

Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no <85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no >10 mg prednisone or equivalent for at least 28 days prior. Subjects with >10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable. (NCT01714817)
Timeframe: Day 729

InterventionPercentage (Number)
Abatacept IV61.9
Placebo IV52.7

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Percentage of Participants in Complete Renal Response (CR) of Lupus Glomerulonephritis at Day 365 of the Double-blind Period

Number of participants achieving CR was divided by the total number of participants in that arm and expressed as a percentage. CR defined as: eGFR is normal or no <85% of the baseline; eGFR based on mean creatinine value from day 358 and 365. Proteinuria: UPCR<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no >10 mg prednisone or equiv. for at least 28 days prior to assessment. Participants with >10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as having achieved CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use (Yes/No), race (Asian/ Black/Caucasian/Other) and baseline UPCR as a continuous variable. (NCT01714817)
Timeframe: Day 365

InterventionPercentage (Number)
Abatacept IV35.1
Placebo IV33.5

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Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 729 of the Double-blind Period

Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no <85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no >10 mg prednisone or equivalent for at least 28 days prior. Subjects with >10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable. (NCT01714817)
Timeframe: Day 729

InterventionPercentage (Number)
Abatacept IV50.0
Placebo IV49.0

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Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 365 of the Double-blind Period

Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no <85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no >10 mg prednisone or equivalent for at least 28 days prior. Subjects with >10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable. (NCT01714817)
Timeframe: Day 365

InterventionPercentage (Number)
Abatacept IV27
Placebo IV29.5

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Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (U/L)

"Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.~Change from Baseline = Post-baseline - Baseline value." (NCT01714817)
Timeframe: Day 729

,
InterventionU/L (Mean)
ALANINE AMINOTRANSFERASE (ALT) (U/L)ALKALINE PHOSPHATASE (ALP) (U/L)ASPARTATE AMINOTRANSFERASE (AST) (U/L)G-GLUTAMYL TRANSFERASE (GGT) (U/L)
Abatacept IV-2.28.20.3-5.3
Placebo IV-3.411.70.3-4.1

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Time to Prostate-Specific Antigen (PSA) Progression

Time to PSA progression was defined as the time (in months) interval from the date of randomization to the date of PSA progression, according to PCWG2 criteria. PCWG2 defines PSA progression as the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanogram per milliliter (ng/mL) or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later. (NCT01715285)
Timeframe: Up to 66 months

InterventionMonths (Median)
Abiraterone Acetate+Prednisone+ADT33.31
Placebo + ADT7.43

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Time to Subsequent Therapy for Prostate Cancer

Time to subsequent therapy was defined as the time (in months) interval from the date of randomization to the date of initiation of subsequent therapy for prostate cancer. (NCT01715285)
Timeframe: Up to 66 months

InterventionMonths (Median)
Abiraterone Acetate+Prednisone+ADT54.87
Placebo + ADT21.22

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Time to Pain Progression

"Time to pain progression was defined as the time (in months) interval from randomization to the first date a participant experienced a greater than or equal to (>=) 30 percent (%) increase in Brief Pain Inventory-Short Form (BPI-SF) from baseline in the BPI-SF worst pain intensity (Item 3) observed at 2 consecutive evaluations (>=4) weeks apart. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 10 with 0 representing no pain and 10 representing pain as bad as you can imagine." (NCT01715285)
Timeframe: Up to 66 months

InterventionMonths (Median)
Abiraterone Acetate+Prednisone+ADT47.41
Placebo + ADT16.62

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Overall Survival (OS)

Overall survival was defined as the time from randomization to date of death from any cause. (NCT01715285)
Timeframe: Up to 66 months

Interventionmonths (Median)
Abiraterone Acetate+Prednisone+ADT53.32
Placebo + ADT36.53

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Radiographic Progression-Free Survival (PFS)

Radiographic PFS was defined as the time (in months) interval from randomization to the first date of radiographic progression or death. Radiographic progression included progression by bone scan (according to modified Prostate Cancer Working Group 2 [PCWG2] criteria), defined as at least 2 new lesions on bone scan and progression of soft tissue lesions by computed tomography (CT) or magnetic resonance imaging (MRI) (according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria). As per the RECIST 1.1 guideline, progression requires a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum as compared to nadir sum of diameter. (NCT01715285)
Timeframe: Up to 44 months

InterventionMonths (Median)
Abiraterone Acetate+Prednisone+ADT33.02
Placebo + ADT14.78

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Time to Initiation of Chemotherapy

Time to initiation of chemotherapy was defined as the time (in months) interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer. (NCT01715285)
Timeframe: Up to 66 months

Interventionmonths (Median)
Abiraterone Acetate+Prednisone+ADTNA
Placebo + ADT57.59

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Metastasis or Systemic Therapy

Time to either imaging indicating metastasis or beginning a new systemic therapy. This is a distinctly different measure from number 4 above. The two outcomes use different measures (biochemical as measured by PSA increase vs radiographic as measured by imaging), yielding different results in this case. (NCT01717053)
Timeframe: up to 5 years (60 months)

Interventionmonths (Mean)
Abiraterone Acetate60

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Safety and Tolerability

The number of patients experiencing an adverse event of at least grade 3 that is possibly, probably, or definitely related to study therapy per CTCAE version 4.0. (NCT01717053)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Abiraterone+Radiotherapy+ADT12

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Percentage of Patients With Undetectable PSA (Prostate-Specific Antigen) at 1 Year

The percentage of patients with undetectable PSA after 1 year will be calculated. Undetectable PSA is defined as a measurement of <0.1 ng/mL. (NCT01717053)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Abiraterone+Radiotherapy+ADT54.54

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Testosterone Recovery

Time to testosterone recovery (NCT01717053)
Timeframe: up to 5 years

Interventionmonths (Median)
Abiraterone Acetate9.2

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Time to PSA Nadir

The median time in months to the lowest PSA value from the start of study therapy. (NCT01717053)
Timeframe: 1 year

Interventionmonths (Median)
Abiraterone+Radiotherapy+ADT8.9

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Percentage of Participants With Biochemical Progression-free Survival (BPFS)

Disease progression defined as Phoenix RTOG definition of nadir PSA + 2ng/ml or initiation of salvage therapy not imaging. The two outcomes use different measures (biochemical as measured by PSA increase vs radiographic as measured by imaging), yielding different results in this case. (NCT01717053)
Timeframe: 36 and 48 months

Interventionpercentage of participants (Number)
36 months48 months
Abiraterone Acetate96.9696.96

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PSA < 1.5ng/ml in Setting of Non-castrate Testosterone

Percentage of men with 1, 2, 3, 4 and 5 year PSA < 1.5ng/ml in setting of non-castrate testosterone. (NCT01717053)
Timeframe: 1 year, 2 years, 3 years, 4 years, 5 years

Interventionpercentage of patients (Number)
1 year2 years3 years4 years5 years
Abiraterone+Radiotherapy+ADT10010090.9190.9190.91

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PSA Nadir Value

The lowest PSA value from the start of study therapy. (NCT01717053)
Timeframe: 1 year, 2 years

Interventionng/mL (Median)
Year 1Year 2
Abiraterone+Radiotherapy+ADT0.030.03

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Number of Reported Dose Limiting Toxicities When Combining BEZ235 With Abiraterone Acetate (Phase I).

(NCT01717898)
Timeframe: Beginning of study up to 15 months

InterventionParticipants (Count of Participants)
Phase I: BEZ235 200 mg3
Phase I: BEZ235 300 mg0
Phase I: BEZ235 400 mg0
Phase II0

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Maximum Tolerated Dose for BEZ235 + Abiraterone Acetate (Phase I).

Maximum Tolerated Dose (MTD) for BEZ235 + Abiraterone Acetate (to be determined during Phase I). The MTD of BEZ235 will be the dose when given in combination results in less than 33% dose limiting toxicities (DLT). (NCT01717898)
Timeframe: Beginning of study up to 15 months

InterventionParticipants (Count of Participants)
Phase I: BEZ235 200 mg0
Phase I: BEZ235 300 mg0
Phase I: BEZ235 400 mg0
Phase II0

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Anti-tumor Responses as Defined by a Decline in PSA of > 50%

Anti-tumor responses as defined by a decline in PSA of > 50% following 12 weeks of therapy to the combination of Abiraterone Acetate plus BEZ-235 occur in a cohort of patients who have received prior therapy with Abiraterone Acetate therapy (NCT01717898)
Timeframe: From day 1 of therapy initiation up to 12 weeks

InterventionParticipants (Count of Participants)
Phase I: BEZ235 200 mg0
Phase I: BEZ235 300 mg0
Phase I: BEZ235 400 mg0
Phase II0

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Radiographic Progression-free Survival (rPFS)

(NCT01718353)
Timeframe: From baseline, every 12 weeks until radiological tumor progression or study cut-off, whichever was earlier (Maximum duration: 60 weeks)

Interventionmonths (Median)
Overall Population (Treatment A or Treatment B)NA

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Clinical Progression-free Survival (cPFS)

cPFS was assessed before switch and during the study including skeletal-related events (SRE), increasing pain requiring escalation of narcotic analgesics, urinary obstruction, etc. SRE included pathological fractures and/or spinal cord compression, need for bone irradiation (including radioisotopes or bone surgery), change of antineoplastic therapy (including introduction of bisphosphonates or denosumab in the face of increase in pain) to treat bone pain. Pain was assessed using present pain intensity (PPI) scale (0=no pain, up to 5=excruciating pain) and analgesics used for cancer pain (1 point for non-narcotic medications and 4 points for narcotic medications). (NCT01718353)
Timeframe: Baseline, Pre-dose every 3 weeks, EOT, every 3 months (for 1 year) until first SRE occurrence or death or study cut-off, whichever was earlier (Maximum duration: 60 weeks)

Interventionmonths (Median)
Before switchWhole treatment continuum
Overall Population (Treatment A or Treatment B)NANA

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Drug-target Engagement in Circulating Tumor Cells (CTCs): Change From Baseline at Cycle 1 Day 8 in Percent Androgen Receptor Nuclear Localization (%ARNL) by Categories of PSA Decrease From Baseline (≥50%, Not ≥50%) After Cycle 4

Analysis of CTCs is a co-primary endpoint. Growth of prostate cancer cells is dependent on sustained androgen receptor (AR) nuclear signaling. Taxanes (e.g., docetaxel and cabazitaxel) may mediate some of their activity in prostate cancer by impairing AR trafficking along the microtubules from the tumor cell cytoplasm into the nucleus, as a result of taxane-induced microtubule bundling (MTB). Blood samples were collected at baseline and post-treatment to allow isolation of CTCs, which were evaluated for tumor cell biomarker measures %ARNL and MTB score. %ARNL was assessed by quantitative analysis of images of CTCs captured by geometrically enhanced differential immunocapture (GEDI). Reduction from baseline in %ARNL (percentage of total cellular AR that is located in the nucleus) may indicate inhibition of AR signaling. Change from baseline in %ARNL at Cycle 1 Day 8 is summarized by categories of participants with PSA decrease from baseline (≥50%, Not ≥50%) after Cycle 4. (NCT01718353)
Timeframe: Baseline and Cycle 1 Day 8, Cycle 4

Interventionpercentage ARNL (Mean)
PSA decreased ≥50% at Cycle 4PSA not decreased ≥50% at Cycle 4
Overall Population (Treatment A or Treatment B)-17.582.30

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Drug-target Engagement in CTCs: Change From Baseline at Cycle 1 Day 8 in MTB by Categories of PSA Decrease From Baseline (≥30%, Not ≥30%) After Cycle 4

Analysis of CTCs is a co-primary endpoint. Growth of prostate cancer cells is dependent on sustained AR nuclear signaling. Taxanes (e.g., docetaxel and cabazitaxel) may mediate some of their activity in prostate cancer by impairing AR trafficking along the microtubules from the tumor cell cytoplasm into the nucleus, as a result of taxane-induced MTB. Blood samples were collected at baseline and post-treatment to allow isolation of CTCs, which were evaluated for tumor cell biomarker measures %ARNL and MTB score. MTB in images of CTCs captured by GEDI was qualitatively assessed by three independent operators for increase compared with baseline on a scale of 0 to 3 from no to most MTB increase. Increase from baseline in MTB may indicate inhibition of AR signaling. Change from baseline in MTB at Cycle 1 Day 8 is summarized by categories of participants with PSA decrease from baseline (≥30%, Not ≥30%) after Cycle 4. (NCT01718353)
Timeframe: Baseline and Cycle 1 Day 8, Cycle 4

Interventionunits on a scale (Mean)
PSA decreased ≥30% at Cycle 4PSA not decreased ≥30% at Cycle 4
Overall Population (Treatment A or Treatment B)0.690.09

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Overall Survival

Overall survival before switch and overall survival during the study was defined as the time interval from the date of random allocation to the date of death due to any cause until study cut-off date. (NCT01718353)
Timeframe: From baseline until death due to any cause or study cut-off, whichever was earlier (Maximum duration: 60 weeks)

InterventionMonths (Median)
Before switchwhole treatment continuum
Overall Population (Treatment A or Treatment B)8.8NA

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Percentage of Participants With ≥30% and ≥50% Reduction in PSA Response

Participants with ≥30% and ≥50% reduction in PSA response from base line were evaluated in participants who were previously treated with a high potency androgen receptor (AR)-targeted agent (AR signaling inhibitor or cytochrome P450 17 alphahydroxylase/17,20lyase [CYP 17] inhibitor). (NCT01718353)
Timeframe: From baseline until DP or study cut-off, whichever was earlier (Maximum duration: 60 weeks)

,
Interventionpercentage of participants (Number)
≥30% reduction≥50% reduction
Overall Population (AR-target Agent Treated)52.044.0
Overall Population (Non AR-target Agent Treated)74.368.6

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Percentage of Participants With PSA Response

PSA response was defined as ≥50% decrease in PSA levels in both treatment arms from baseline, during the whole treatment, before treatment switch and after treatment switch. PSA progression was defined as decline of PSA from baseline (an increase of ≥25% [at least 2ng/ml] over the nadir value, confirmed by a second PSA value at least 3 weeks apart) and no decline of PSA from baseline (an increase of ≥25% [at least 2ng/ml] over the baseline value after 12 weeks of treatment, confirmed by a second PSA value at least 3 weeks apart). Because the purpose of this study is to explore the benefit of a regimen in which participants are switched to a different taxane if PSA does not decrease ≥30% after 4 cycles, irrespective of which agent (docetaxel or cabazitaxel) is administered initially, the data for participants who began treatment with docetaxel and for those who began treatment with cabazitaxel were combined for the efficacy analyses. (NCT01718353)
Timeframe: Baseline, Pre-dose every 3 weeks, 30 days after last treatment administration (End of treatment [EOT]), every 3 months (for 1 year) then every 6 months until PSA progression or study cut-off, whichever was earlier (Maximum duration: 60 weeks)

Interventionpercentage of participants (Number)
PSA response before switchPSA response after switchOverall PSA response
Overall Population (Treatment A or Treatment B)39.715.955.6

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Progression Free Survival (PFS)

PFS was defined as the time interval between the date of random allocation of the treatment and the date of first documentation of any of the following: radiographic tumor progression (using Modified Response Evaluation Criteria in Solid Tumors [RECIST1.1] before any switch and during the study), clinical progression (including skeletal-related events, increasing pain requiring escalation of narcotic analgesics, urinary obstruction), PSA progression or death from any cause. Analysis was performed by Kaplan Meier method. (NCT01718353)
Timeframe: From Baseline until DP or death due to any cause or study cut off, whichever was earlier (Maximum duration: 60 weeks)

Interventionmonths (Median)
Before switchWhole treatment continuum
Overall Population (Treatment A or Treatment B)4.19.1

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PSA Progression Free Survival

PSA progression-free survival before any switch and PSA progression free survival during the study was defined as the time interval between the date of Day 1 of Cycle 1 to the date of either first PSA progression or death due to any cause whichever came first. PSA progression was defined as decline of PSA from baseline (an increase of ≥25% [at least 2ng/mL] over the nadir value, confirmed by a second PSA value at least 3 weeks apart) and no decline of PSA from baseline (an increase of ≥25% [at least 2ng/mL] over the baseline value after 12 weeks of treatment, confirmed by a second PSA value at least 3 weeks apart). (NCT01718353)
Timeframe: From Baseline until DP or death due to any cause or study cut off date, whichever was earlier (Maximum duration: 60 weeks)

Interventionmonths (Median)
Before switchwhole treatment continuum
Overall Population (Treatment A or Treatment B)NA12.4

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Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV])

Administration time was defined as the time from start to end of the SC injection or from start to end of the IV infusion (NCT01724021)
Timeframe: Cycle 1-4, Cycle 5-8 for both SC and IV (Up to 32 weeks)

Interventionminutes (Median)
Rituximab Intravenous (IV)840
Rituximab Subcutaneous (SC)22

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Cancer Therapy Satisfaction Questionnaire (CTSQ) Score

CTSQ is a validated 16-item questionnaire that measures three domains related to participants' satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants. (NCT01724021)
Timeframe: During Cycle 4, 8 of treatment (Up to 32 weeks)

,
Interventionunits on a scale (Mean)
Expectations of therapy domainFeelings about side effects domainSatisfaction with therapy domain
Rituximab Intravenous (IV)80.8860.6384.59
Rituximab Subcutaneous (SC)82.0761.6485.42

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Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time

(NCT01724021)
Timeframe: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)

,
Interventionpercentage of participants (Number)
Cycle 1Cycle 2Cycle 3Cycle 4Interim stagingCycle 5Cycle 6Cycle 7Cycle 8Final stagingFollow-up, 6 monthsFollow-up, 12 monthsEnd of study/early treatment termination
Arm A11.47.07.17.09.012.516.023.813.310.06.57.73.5
Arm B15.618.223.514.79.710.211.610.911.012.613.48.76.3

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Percentage of Participants With Anti-Rituximab Antibodies Over Time

(NCT01724021)
Timeframe: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)

,
Interventionpercentage of participants (Number)
Cycle 1Cycle 2Cycle 3Cycle 4Interim stagingCycle 5Cycle 6Cycle 7Cycle 8Final stagingFollow-up, 6 monthsFollow-up, 12 monthsEnd of study/early treatment termination
Arm A2.02.10.300000001.82.10.6
Arm B3.02.20.90.300000000.60.6

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Rituximab Administration Satisfaction Questionnaire (RASQ) Score

The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants. (NCT01724021)
Timeframe: During Cycle 4, 8 of treatment (Up to 32 weeks)

,
Interventionunits on a scale (Mean)
Physical impact domainPsychological Impact domainImpact on activitiesf daily livingConvenience domainSatisfaction domain
Rituximab Intravenous (IV)82.1477.7359.4959.0574.88
Rituximab Subcutaneous (SC)82.0884.0081.8681.0587.26

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Summary of Observed Serum Rituximab Concentration

(NCT01724021)
Timeframe: Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)

,
Interventionmicrogram per milliter (Mean)
Cycle 1Cycle 2Cycle 3Cycle 4Interim stagingCycle 5Cycle 6Cycle 7Cycle 8Final stagingFollow-up, 6 monthsFollow-up, 12 monthsEnd of study/early treatment termination
Arm A3355.925053.162977.087956.6117273.6108030.9100927.795614.0104873.086806.67802.92380.19302.0
Arm B970.124541.146093.959485.577665.370387.398679.7117172.0137048.1120995.78042.91685.39553.9

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Number of Participants With Treatment Emergent Adverse Events (AEs)

An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. (NCT01724021)
Timeframe: Randomization of first participant to clinical cutoff date (Up to 4 years)

Interventionparticipants (Number)
Arm A352
Arm B347

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Event-free Survival (EFS)

EFS was defined as the time from randomization to first occurrence of progression or relapse according to IWG response criteria. IWG criteria is defined using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; partial response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; stable disease (SD): participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease (PD); PD: Lymph nodes considered abnormal if the long axis is more than 1.5 centimeter (cm) regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes less than or equal to (<=) 1.0 × <= 1.0 cm would not be considered as abnormal for PD. (NCT01724021)
Timeframe: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)

Interventionmonths (Median)
Arm ANA
Arm BNA

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Disease-free Survival (DFS)

DFS was defined as the period from the data of the initial CR/CRu until the date of relapse or death from any cause, whichever occurred first. (NCT01724021)
Timeframe: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)

Interventionmonths (Median)
Arm ANA
Arm BNA

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Complete Response (CR) Rate

CR rate was assessed according to the International Working Group (IWG) Response Criteria (CHESON ET AL. 1999) and included CR and CR unconfirmed (CRu). CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by > 75 % but still >1.5 cm in size, and indeterminate bone marrow assessment. Tumor assessments were based on computed tomography (CT) scans with contrast of the neck, chest, and abdomen (if detectable by these techniques) or other diagnostic means, if applicable. Other methods (e.g., MRI) were acceptable for participants in whom contrast CT scans were contraindicated. Due to the limited availability of FDG-PET scanners, an FDG-PET scan was not mandated in the study. (NCT01724021)
Timeframe: 28 days (± 3 days) after Day 1 of the last dose of induction treatment

Interventionpercentage of participants (Number)
Arm A49.2
Arm B52.7

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Overall Survival (OS)

OS was defined as the time from randomization to death from any cause. (NCT01724021)
Timeframe: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)

Interventionmonths (Median)
Arm ANA
Arm BNA

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Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6

Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing cycle 6. (NCT01724021)
Timeframe: Cycle 6 (Up to 24 weeks)

Interventionpercentage of participants (Number)
Arm A79.1
Arm B80.6

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Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8

Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing Cycle 8. (NCT01724021)
Timeframe: Cycle 8 (Up to 32 weeks)

Interventionpercentage of participants (Number)
Arm A77.1
Arm B84.2

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Progression-free Survival (PFS)

PFS was defined as the time from randomization to the first occurrence of progression or relapse, according to the IWG response criteria. IWG criteria is defined criteria using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; PR: At least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses; SD: participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD; PD: Lymph nodes considered abnormal if the long axis is more than 1.5 cm regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes <= 1.0 × <= 1.0 cm would not be considered as abnormal for PD. (NCT01724021)
Timeframe: From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)

Interventionmonths (Median)
Arm ANA
Arm BNA

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Steroid Therapy

Number of patients on treatment with corticosteroids at 2 years (NCT01729494)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Group A16
Group B14
Group C9

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eGFR (MRDRD) < 45 ml/Min/1.73m2

Patients with reduced Renal function measured by estimated GFR MDRD < 45 ml/min at 24 months (NCT01729494)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Group A9
Group B8
Group C20

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New Onset Diabetes After Transplantation (NODAT)

Number of patients developing New Onset Diabetes Mellitus after Transplant by one of 5 definitions; only patients without preexisting diabetes were included (NCT01729494)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Group A11
Group B5
Group C12

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Delayed Graft Function

Number of patients experiencing Delayed graft function (DGF) within first week after transplant. DGF is defined as need for dialysis within the first week after transplant. (NCT01729494)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Group A3
Group B1
Group C5

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Discontinuation of Mycophenolate

Number of patients who were discontinued from mycophenolate treatment at 2 years (NCT01729494)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Group A11
Group B9
Group C13

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Requirement of T-cell Depleting Therapy for Biopsy Proven Acute Rejection (BPAR)

Number of patients requiring anti-lymphocyte therapy for the treatment of BPAR rejection (NCT01729494)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Group A8
Group B15
Group C0

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Time to First BPAR

Mean Time to first episode of BPAR (days) (NCT01729494)
Timeframe: 24 months

Interventiondays (Mean)
Group A229
Group B131.6
Group C159.6

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Mean eGFR (MDRD) (ml/Min/1.73m2)

Mean eGFR (MDRD) (ml/min/1.73m2) measured for all patients reaching 2 year endpoint (NCT01729494)
Timeframe: 24 months

Interventionml/min/1.73m2 (Mean)
Group A65.5
Group B65.3
Group C63.4

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Discontinuation of Study Treatment (Belatacept or Tacrolimus)

Number of patients who had to Discontinue study treatment (belatacept or tacrolimus) at 2 years (NCT01729494)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Group A11
Group B9
Group C5

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Leukopenia (WBC < 2000/mm3)

Number of patients developing leukopenia defined as WBC < 2000/mm3 (NCT01729494)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Group A22
Group B14
Group C15

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Proteinuria UPC Ratio > 0.8

Number of Patients with a Urine protein/creatinine (UPC) ratio > 0.8 (NCT01729494)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Group A11
Group B5
Group C21

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Patient Death

Number of Patients who experienced death, all causes (NCT01729494)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Group A2
Group B4
Group C1

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Biopsy Proven Mixed Acute Rejection

Incidence of patients experiencing a Biopsy proven acute cellular rejection with either DSA positive or C4d staining positive indicating antibody rejection (NCT01729494)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Group A4
Group B2
Group C2

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Biopsy Proven Acute Rejection

Incidence of all biopsy proven acute rejection whether clinically relevant or clinically silent. (NCT01729494)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Group A20
Group B26
Group C7

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# of Patients Developing Denovo Donor Specific Antibody (DSA) Post-transplant

Number of patients (%) with development of denovo DSA after transplant (NCT01729494)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Group A5
Group B1
Group C5

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# Patients Experiencing a First Biopsy-proven ACR With Severity Banff > or = 2a Grade

Number of patients with their First BPACR with a Banff grade >= Banff 2a using the Banff 2007 classification system for biopsy grading. Banff grade 2a and above is considered severe cellular rejection and includes grades of Banff 2a, Banff 2b, and Banff 3. (NCT01729494)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Group A5
Group B12
Group C0

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# Patients Experiencing a Graft Loss But Not Including Patients Who Died With Functioning Graft (Death-censored Graft Loss)

Number of patient who experienced Graft loss, not including (censored) patients who lost graft due to death (NCT01729494)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Group A0
Group B1
Group C1

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# Patients With Composite Endpoint of Either Experiencing Death, Graft Loss, or eGFR < 45ml/Min at 24 Months

Composite Endpoint of number of patients who experienced either patient death, allograft loss, or had an eGFR < 45 ml/min/1.73m2 (NCT01729494)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Group A11
Group B13
Group C21

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# Patients With Composite Endpoint of Experiencing Either Death, Graft Loss, or eGFR < 45ml/Min

Number of Patients that experienced patient Death or Graft Loss or had an estimated GFR (eGFR) (MDRD) < 45 mL/min (NCT01729494)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Group A9
Group B15
Group C14

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Biopsy Proven Acute Antibody Mediated Rejection

Incidence of patients experiencing a Biopsy proven acute antibody mediated rejection (BPAMR) (NCT01729494)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Group A2
Group B2
Group C3

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Biopsy Proven Acute Cellular Rejection

Biopsy proven acute cellular rejection (BPACR) (NCT01729494)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Group A14
Group B22
Group C2

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Induction Response

Induction response is the defined as the proportion of patients who achieve complete remission (CR) or partial remission (PR) during 6 cycles of induction therapy. Response was assessed was using a combination of CT scans and PET scans. Partial and complete response were categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007). Given the cycle length of 3 weeks, induction duration per protocol was 18 weeks. (NCT01746173)
Timeframe: Disease was re-staged at cycles 3 and 6 during induction. Median duration of induction therapy in this study cohort was 6 cycles/18 weeks (range 2-6 cycles).

Interventionproportion of patients (Number)
CHOEP + High Dose Therapy + Auto SCT.60

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24-month Progression-Free Survival Rate

24-month progression-free survival rate is defined as the proportion of patients remaining alive and progression-free at 24 months from start of induction therapy. Disease progression was assessed using a combination of CT scans and PET scans. Progression was categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007). (NCT01746173)
Timeframe: Disease was re-staged at cycles 3 and 6 during induction, at day 100 post-ASCT, and in long-term follow-up at months 12, 18, 24 and 36. All patients were evaluable up to month 24.

Interventionproportion of patients (Number)
CHOEP + High Dose Therapy + Auto SCT0.0

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Mean Score on the Mental Component Scale (MCS) of the Short Form 36 Health Status Questionnaire (SF-36) Within 8 Weeks

The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Higher scores indicate improvement. (NCT01753401)
Timeframe: at Baseline, Week 4 and Week 8 (within 8 weeks)

,
Interventionscore on a scale (Mean)
at Baselineat Week 4at Week 8
Acthar38.40640.28040.408
Placebo41.30438.74439.256

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Krupp Fatigue Severity Score (FSS) Within 8 Weeks

"The Krupp FSS is a scale to rate disability-related fatigue. Respondents use a scale ranging from 1 (completely disagree) to 7 (completely agree) to indicate their agreement with nine statements about fatigue. A visual analogue scale is also included with the scale; respondents are asked to denote the severity of their fatigue over the past 2 weeks by placing a mark on a line extending from no fatigue to fatigue as bad as could be. Higher scores on the scale are indicative of more severe fatigue.~This validated fatigue severity scale measures impact of fatigue with a 9-item questionnaire, with a 7-point Likert scale for each question. Total score ranges from 0 (best possible outcome) to 63 (worst possible fatigue).~Rows: at Baseline, at Week 4, at Week 8" (NCT01753401)
Timeframe: at Baseline, Week 4 and Week 8 (within 8 weeks)

,
Interventionscore on a scale (Mean)
at Baselineat Week 4at Week 8
Acthar5.6485.2985.152
Placebo5.3745.3795.404

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Number of Participants Who Meet the Definition of a Responder Within 4 Weeks

"Participants are counted as responders based on two SLE indices: the Systemic Lupus Erythematosus Disease Activity Index amended by the SELENA group (SELENA-SLEDAI) and the British Isles Lupus Assessment Group (BILAG) Index.~decrease in SELENA-SLEDAI score from 4 to 0 for the arthritis descriptor (highest possible score is 4) and no worsening in other organ systems based on BILAG~OR~decrease in SELENA-SLEDAI score from 2 to 0 for rash (highest possible score is 2) and no worsening in other organ systems based on BILAG~The BILAG is a transitional index that captures changing severity of clinical manifestations. It has an ordinal scale scoring system by design that produces an overview of disease activity across eight systems. The individual system scores were not intended to be summated into a global score." (NCT01753401)
Timeframe: within 4 weeks

InterventionParticipants (Count of Participants)
Placebo3
Acthar4

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Number of Participants Who Meet the Definition of a Responder Within 8 Weeks

"Participants are counted as responders based on:~decrease in SELENA-SLEDAI score from 4 to 0 for arthritis and no worsening in other organ systems based on BILAG~OR~decrease in SELENA-SLEDAI score from 2 to 0 for rash and no worsening in other organ systems based on BILAG" (NCT01753401)
Timeframe: within 8 weeks

InterventionParticipants (Count of Participants)
Placebo3
Acthar11

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Cutaneous Lupus Activity as Measured by the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Within 8 Weeks

"The CLASI consists of two scores the first summarizes the activity of the disease while the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI score ranges from 0 to 70, with higher scores indicating more severe skin disease.~Rows: at Baseline, at Week 4, at Week 8" (NCT01753401)
Timeframe: at Baseline, Week 4 and Week 8 (within 8 weeks)

,
Interventionscore on a scale (Mean)
at Baselineat Week 4at Week 8
Acthar6.44.83.7
Placebo6.16.35.7

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Number of Participants With a Relapse Within 52 Weeks

(NCT01753401)
Timeframe: within 52 weeks

InterventionParticipants (Count of Participants)
Placebo/Acthar1
Acthar/Acthar6

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Number of Tender or Swollen Joints at Week 52

The doctor counted the number of tender or swollen joints at Week 52. (NCT01753401)
Timeframe: at Week 52

InterventionTender or Swollen Joints (Mean)
Placebo/Acthar1.1
Acthar/Acthar0.7

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Score on the SELENA-SLEDAI at Week 52

"SLEDAI was modeled on the basis of clinician global judgment. A participant's SELENA-SLEDAI total score is the sum of all marked SLE-related descriptors on a checklist developed by the SELENA Group (also referred to as hybrid SLEDAI).~The scores of the descriptors range from 0 to 8. A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity." (NCT01753401)
Timeframe: at Week 52

Interventionscore on a scale (Median)
Placebo/Acthar3
Acthar/Acthar4

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Mean Score on the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) at Week 52

The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Higher scores indicate improvement. (NCT01753401)
Timeframe: at Week 52

Interventionscore on a scale (Mean)
Placebo/Acthar43.618
Acthar/Acthar39.710

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Mean Score on the Mental Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) at Week 52

The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Higher scores indicate improvement. (NCT01753401)
Timeframe: at Week 52

Interventionscore on a scale (Mean)
Placebo/Acthar45.272
Acthar/Acthar39.700

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BILAG Total Score Within 8 Weeks

"The BILAG is a transitional index that captures changing severity of clinical manifestations that produces an overview of disease activity across eight systems.~The 8 systems are scored on a scale from 0=not present to 4=worse, for the 4 week period before the assessment. The lowest possible score is 0, and the highest possible score is 32. A higher score means the symptoms are worse.~Rows: Baseline, Week 4, Week 8" (NCT01753401)
Timeframe: within 8 weeks

,
Interventionscore on a scale (Mean)
at Baselineat Week 4at Week 8
Acthar15.79.26.8
Placebo15.410.313.5

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Krupp Fatigue Severity Score (FSS) at Week 52

"The Krupp FSS is a scale to rate disability-related fatigue. Respondents use a scale ranging from 1 (completely disagree) to 7 (completely agree) to indicate their agreement with nine statements about fatigue. A visual analogue scale is also included with the scale; respondents are asked to denote the severity of their fatigue over the past 2 weeks by placing a mark on a line extending from no fatigue to fatigue as bad as could be. Higher scores on the scale are indicative of more severe fatigue.~This validated fatigue severity scale measures impact of fatigue with a 9-item questionnaire, with a 7-point Likert scale for each question. Total score ranges from 0 (best possible outcome) to 63 (worst possible fatigue)." (NCT01753401)
Timeframe: at Week 52

Interventionscore on a scale (Mean)
Placebo/Acthar4.523
Acthar/Acthar4.743

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Cutaneous Lupus Activity as Measured by the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) at Week 52

The CLASI consists of two scores the first summarizes the activity of the disease while the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI score ranges from 0 to 70, with higher scores indicating more severe skin disease. (NCT01753401)
Timeframe: at Week 52

Interventionscore on a scale (Mean)
Placebo/Acthar0.4
Acthar/Acthar1.3

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Number of Participants Who Meet the Definition of a Responder at Week 52

"Participants are counted as responders based on:~decrease in SELENA-SLEDAI score from 4 to 0 for arthritis and no worsening in other organ systems based on BILAG~OR~decrease in SELENA-SLEDAI score from 2 to 0 for rash and no worsening in other organ systems based on BILAG" (NCT01753401)
Timeframe: at Week 52

InterventionParticipants (Count of Participants)
Placebo/Acthar4
Acthar/Acthar3

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Number of Tender or Swollen Joints Within 8 Weeks

The doctor counted the number of tender or swollen joints at Baseline, at Week 4, and at Week 8 (NCT01753401)
Timeframe: at Baseline, Week 4, and Week 8 (within 8 weeks)

,
InterventionTender or Swollen Joints (Mean)
at Baselineat Week 4at Week 8
Acthar9.64.53.5
Placebo6.23.84.0

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Mean Score on the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) Within 8 Weeks

"The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Higher scores indicate improvement.~Rows: at Baseline, at Week 4, at Week 8" (NCT01753401)
Timeframe: at Baseline, Week 4 and Week 8 (within 8 weeks)

,
Interventionscore on a scale (Mean)
at Baselineat Week 4at Week 8
Acthar31.52635.31835.701
Placebo32.92732.83133.310

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Score on the SELENA-SLEDAI Within 8 Weeks

"SLEDAI was modeled on the basis of clinician global judgment. A participant's SELENA-SLEDAI total score is the sum of all marked SLE-related descriptors on a checklist developed by the SELENA Group (also referred to as hybrid SLEDAI).~The scores of the descriptors range from 0 to 8. A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity.~Rows: Week 2, Week 4, Week 6, Week 8" (NCT01753401)
Timeframe: within 8 weeks

,
Interventionscore on a scale (Median)
Week 2Week 4Week 6Week 8
Acthar8.08.06.06.0
Placebo10.09.08.09.0

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Change in Absolute CD4 Count From Baseline to Post-treatment

Change in absolute CD4 count from baseline to post-treatment (visit 6) (NCT01775475)
Timeframe: From baseline to 18 weeks

Interventioncells per mm^3 (Mean)
Arm I (CHOP)-41.3
Arm II (Oral Chemotherapy)203.3

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Participants Who Experienced an Adverse Event

Number of participants who experienced an adverse event (NCT01775475)
Timeframe: Up to 24 months

InterventionParticipants (Count of Participants)
Arm I (CHOP)4
Arm II (Oral Chemotherapy)3

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Progression-free Survival

Proportion of participants who survived without disease progression at 2 years (NCT01775475)
Timeframe: Up to 24 months

Interventionproportion (Number)
Arm I (CHOP)0
Arm II (Oral Chemotherapy)0

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Proportion of Patients Who Are Adherent to Chemotherapy

Patients who did not miss any doses of chemotherapy (NCT01775475)
Timeframe: Up to 18 weeks

InterventionParticipants (Count of Participants)
Arm I (CHOP)4
Arm II (Oral Chemotherapy)3

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Proportion of Patients Who Are Adherent to Antiretroviral Therapy

Number of patients who did not miss any of their doses of antiretroviral therapy (NCT01775475)
Timeframe: Up to 24 months

InterventionParticipants (Count of Participants)
Arm I (CHOP)3
Arm II (Oral Chemotherapy)3

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Overall Response Rate

Overall response is complete or partial response as defined by response definitions of the 2014 International Conference on Malignant Lymphoma Imaging Working Group (i.e. Lugano classification). Complete response is the disappearance of all lesions with no new lesions detected. Partial response is >=50% decrease in the sum of the perpendicular diameters of up to 6 target measurable nodes and extranodal sites and no new sites of disease. (NCT01775475)
Timeframe: Up to 24 months

InterventionParticipants (Count of Participants)
Arm I (CHOP)3
Arm II (Oral Chemotherapy)1

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Overall Survival

Proportion of participants who survived 2 years (NCT01775475)
Timeframe: Up to 24 months

InterventionProportion of participants (Number)
Arm I (CHOP)0
Arm II (Oral Chemotherapy)0

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Number of Patients Who Complete Treatment

Number of patients who complete chemotherapy treatment. (NCT01775475)
Timeframe: Up to 18 weeks

InterventionParticipants (Count of Participants)
Arm I (CHOP)3
Arm II (Oral Chemotherapy)1

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Objective Response Rate (ORR) Per IRF at End of Treatment

The count of participants with CR or partial response (PR) per IRF following the completion of study treatment (at end of treatment or the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma. (NCT01777152)
Timeframe: Up to 8.34 months

InterventionParticipants (Count of Participants)
A+CHP188
CHOP163

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Complete Remission (CR) Rate Per IRF at End of Treatment (EOT)

The count of participants with CR per IRF following the completion of study treatment (at end of treatment or at the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma. (NCT01777152)
Timeframe: Up to 8.34 months

InterventionParticipants (Count of Participants)
A+CHP153
CHOP126

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Overall Survival (OS)

The time from randomization to death due to any cause. (NCT01777152)
Timeframe: Up to 90 months

InterventionMonths (Median)
A+CHPNA
CHOPNA

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Progression-free Survival Per Independent Review Facility (IRF)

The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first. (NCT01777152)
Timeframe: Up to 60 months

Interventionmonths (Median)
A+CHP48.20
CHOP20.80

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Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)

The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first. (NCT01777152)
Timeframe: Up to 60 months

Interventionmonths (Median)
A+CHP55.66
CHOP32.03

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Incidence of Adverse Events (AEs)

Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment. (NCT01777152)
Timeframe: Up to 8.28 months

,
InterventionParticipants (Count of Participants)
Any treatment-emergent AEBlinded study treatment-related AECHP treatment-related AEAny serious adverse event (SAE)Blinded study treatment-related SAECHP treatment-related SAETreatment discontinuations due to AETreatment discontinuations due to blinded study treatment-related AETreatment discontinuations due to CHP treatment-related AE
A+CHP22120119887586214108
CHOP22119320587455315107

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Incidence of Laboratory Abnormalities

Number of participants who experienced a Grade 3 or higher laboratory toxicity. (NCT01777152)
Timeframe: Up to 8.28 months

,
InterventionParticipants (Count of Participants)
Any Chemistry TestAlanine Aminotransferase HighAlbumin LowAlkaline Phosphatase HighCalcium LowGlucose HighPhosphate LowPotassium HighPotassium LowSodium HighSodium LowUrate HighAny Hematology TestAbsolute Neutrophil Count LowHemoglobin HighHemoglobin LowLeukocytes LowLymphocytes HighLymphocytes LowNeutrophils LowPlatelets Low
A+CHP253211840314568171912052171
CHOP2313016322062781901321161191

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Serum Prothrombin Fragment 1 and 2 (PF 1.2)

(NCT01782859)
Timeframe: First 24 hours after surgery

,
Interventionpmol/mL (Mean)
BaselineWound Closure4 hours postoperatively6 hours postoperatively24 hours postoperatively
Placebo334.15778.331306.761175.71356.79
Prednisone/Hydrocortisone298.12619.211138.651032.52422.61

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Plasmin-a 2 Antiplasmin Complex (PAP)

(NCT01782859)
Timeframe: First 24 hours after surgery

,
Interventionmcg/L (Mean)
BaselineWound Closure4 hours postoperatively6 hours postoperatively24 hours postoperatively
Placebo924.671361.232251.332283.18996.39
Prednisone/Hydrocortisone1011.172251.332455.712379.57914.16

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Pain at 3 Months Post-op

At 3 months postoperatively, patients were asked to rate their pain on a scale of 0-10, with 0 being no pain and 10 being worst pain. (NCT01782859)
Timeframe: 3 months postoperatively

Interventionunits on a scale (Mean)
Placebo0.92
Prednisone/Hydrocortisone0.54

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Interleukin (IL)-6 Cytokine Release (Inflammatory Marker)

The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital. (NCT01782859)
Timeframe: Participants will be followed from the time of surgery until discharge, expected average of 3-5 days

,
Interventionpicograms/milliliter (Mean)
BaselineWound closure4 hours postoperatively6 hours postoperatively24 hours postoperatively
Placebo2.984.4689.21115.17176.79
Prednisone/Hydrocortisone5.694.4756.7264.468.51

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Minimum Serum Concentration at Steady State (Cmin,ss) of Tocilizumab

Cmin,ss is minimum model-predicted serum steady state concentration of tocilizumab measured in mcg/mL. (NCT01791153)
Timeframe: Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0])

Interventionmcg/mL (Mean)
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper68.1
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper11.1

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Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 26 Weeks Prednisone Taper)

Remission was defined as the absence of flare and normalization of the C-reactive protein (CRP) (less than [<] 1 milligram per deciliter [mg/dL]). Sustained remission was defined as the absence of flare following induction of remission within 12 weeks of randomization and maintained up to Week 52. Flare was determined by the investigator and was defined as the recurrence of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (>/=) 30 millimeters per hour (mm/hr) attributable to GCA. A single CRP elevation (>/=1 mg/dL) was not considered as a sign of flare, unless the CRP remained elevated (>/=1 mg/dL) at the next study visit. (NCT01791153)
Timeframe: Week 52

Interventionpercentage of participants (Number)
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper56.0
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper53.1
Part 1: Placebo + 26 Weeks Prednisone Taper14.0

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Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 52 Weeks Prednisone Taper)

Remission was defined as the absence of flare and normalization of the CRP (<1 mg/dL). Sustained remission was defined as the absence of flare following induction of remission within 12 weeks of randomization and maintained up to Week 52. Flare was determined by the investigator and was defined as the recurrence of signs or symptoms of GCA and/or ESR >/=30 mm/hr attributable to GCA. A single CRP elevation (>/=1 mg/dL) was not considered as a sign of flare, unless the CRP remained elevated (>/=1 mg/dL) at the next study visit. (NCT01791153)
Timeframe: Week 52

Interventionpercentage of participants (Number)
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper56.0
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper53.1
Part 1: Placebo + 52 Weeks Prednisone Taper17.6

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Percentage of Participants With Anti-Tocilizumab Antibodies

All samples were tested by screening assay, and those samples that were positive were further analyzed by a confirmation assay to confirm specificity. Percentage of participants who has a positive confirmation assay result any time after the initial drug administration with a negative confirmation assay result at baseline was reported. (NCT01791153)
Timeframe: Baseline up to Week 52

Interventionpercentage of participants (Number)
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper1.1
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper6.5
Part 1: Placebo + 26 Weeks Prednisone Taper2.0
Part 1: Placebo + 52 Weeks Prednisone Taper2.1

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Serum Interleukin-6 (IL-6) Level

(NCT01791153)
Timeframe: Baseline and Week 52

,,,
Interventionpicograms per milliliter (pg/mL) (Mean)
Baseline (n=91,44,50,47)Week 52 (n=69,32,28,30)
Part 1: Placebo + 26 Weeks Prednisone Taper12.7335.96
Part 1: Placebo + 52 Weeks Prednisone Taper8.3110.85
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper16.2952.70
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper8.7965.99

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Serum Soluble IL-6 Receptor (sIL-6R) Level

(NCT01791153)
Timeframe: Baseline and Week 52

,,,
Interventionnanograms per milliliter (ng/mL) (Mean)
Baseline (n=99,48,50,50)Week 52 (n=73,33,33,31)
Part 1: Placebo + 26 Weeks Prednisone Taper42.0776.44
Part 1: Placebo + 52 Weeks Prednisone Taper40.3764.80
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper50.82464.30
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper51.34600.53

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Minimum Observed Serum Concentration (Ctrough) of Tocilizumab

Ctrough is minimum observed serum concentration of tocilizumab measured in mcg/mL. (NCT01791153)
Timeframe: Predose (Hour 0) at Baseline and Week 52

,
Interventionmcg/mL (Mean)
Baseline (n= 99, 48)Week 52 (n= 72, 33)
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper0.0012.22
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper0.0767.93

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Erythrocyte Sedimentation Rate (ESR)

ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation. (NCT01791153)
Timeframe: Baseline and Week 52

,,,
Interventionmm/hr (Median)
Baseline (n=99,49,50,51)Week 52 (n=76,35,35,33)
Part 1: Placebo + 26 Weeks Prednisone Taper23.0020.00
Part 1: Placebo + 52 Weeks Prednisone Taper20.0024.00
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper15.005.00
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper19.003.00

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Change From Baseline in Short Form (SF)-36 Questionnaire Score at Week 52

The SF-36 is a standardized questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical Component Score (PCS) and Mental Component Score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A positive change from baseline indicates improvement. No imputation was used for missing data. Data was set to missing for participants who received escape therapy. (NCT01791153)
Timeframe: Baseline, Week 52

,,,
Interventionunits on a scale (Mean)
PCS: Baseline (n=97,49,48,49)PCS: Change at Week 52 (n=59,26,9,18)MCS: Baseline (n=97,49,48,49)MCS: Change at Week 52 (n=59,26,9,18)
Part 1: Placebo + 26 Weeks Prednisone Taper42.652.0842.734.99
Part 1: Placebo + 52 Weeks Prednisone Taper41.12-2.8040.452.60
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper40.622.7147.671.98
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper43.105.3742.778.21

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Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Assessed Using Visual Analogue Scale (VAS) at Week 52

Participants assessed their current disease activity on a 0-100 millimeter (mm) VAS, where 0 mm = no disease activity and 100 mm = maximum disease activity. A negative change from baseline indicates improvement. (NCT01791153)
Timeframe: Baseline, Week 52

,,,
Interventionmm (Mean)
Baseline (n=100,49,49,51)Change at Week 52 (n=60,26,11,18)
Part 1: Placebo + 26 Weeks Prednisone Taper35.73-8.45
Part 1: Placebo + 52 Weeks Prednisone Taper47.78-10.00
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper46.65-22.69
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper43.61-19.68

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C-Reactive Protein (CRP) Level

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. (NCT01791153)
Timeframe: Baseline and Week 52

,,,
Interventionmilligrams per liter (mg/L) (Median)
Baseline (n=100,49,50,51)Week 52 (n=76,35,35,33)
Part 1: Placebo + 26 Weeks Prednisone Taper3.644.90
Part 1: Placebo + 52 Weeks Prednisone Taper3.568.12
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper4.520.33
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper3.670.30

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Total Cumulative Prednisone Dose

The median total cumulative prednisone dose over the 52 weeks for each treatment group and the corresponding 95% confidence intervals are presented. (NCT01791153)
Timeframe: Up to 52 weeks

Interventionmilligrams (mg) (Median)
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper1862.00
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper1862.00
Part 1: Placebo + 26 Weeks Prednisone Taper3296.00
Part 1: Placebo + 52 Weeks Prednisone Taper3817.50

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Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Steady State of Tocilizumab

AUCtau is the model-predicted area under the tocilizumab serum concentration versus time curve from time zero to the end of dosing interval. AUCtau is measured in microgram*day per milliliter (mcg*day/mL). (NCT01791153)
Timeframe: Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0])

Interventionmcg*day/mL (Mean)
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper499.2
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper227.2

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Maximum Serum Concentration at Steady State (Cmax,ss) of Tocilizumab

Cmax,ss is maximum model-predicted serum steady state concentration of tocilizumab measured in micrograms per milliliter (mcg/mL). (NCT01791153)
Timeframe: Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0])

Interventionmcg/mL (Mean)
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper73
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper19.3

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Time to First GCA Disease Flare

Flare was determined by the investigator and was defined as the recurrence of signs or symptoms of GCA and/or ESR >/=30 mm/hr attributable to GCA. Participants who withdrew from the study prior to Week 52 were censored from the time of withdrawal. (NCT01791153)
Timeframe: Up to 52 weeks

Interventiondays (Median)
Part 1: Tocilizumab qw + 26 Weeks Prednisone TaperNA
Part 1: Tocilizumab q2w + 26 Weeks Prednisone TaperNA
Part 1: Placebo + 26 Weeks Prednisone Taper165.0
Part 1: Placebo + 52 Weeks Prednisone Taper295.0

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Overall Survival (OS)

"Overall survival (OS) was defined as the time from randomization to the date of death (whatever the cause). Participants who were alive or lost to follow-up as of the data analysis cut-off date were censored on the date the patient was last known to be alive.~Median overall survival was estimated using the Kaplan-Meier method." (NCT01818752)
Timeframe: From randomization until the data cut-off date of 15 July 2016; median follow-up time for OS was 22.2 and 22.5 months in the bortezomib and carfilzomib arms respectively.

Interventionmonths (Median)
Bortezomib, Melphalan, PrednisoneNA
Carfilzomib, Melphalan, PrednisoneNA

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Complete Response Rate

"Complete response rate was defined as the percentage of participants in each treatment group who achieved a sCR or CR per the IMWG-URC as their best response.~sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).~CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM biopsy." (NCT01818752)
Timeframe: Disease response was assessed every 3 weeks during the first 54 weeks and every 6 weeks thereafter until PD or the data cut-off date of 15 July 2016; median follow-up time was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.

Interventionpercentage of participants (Number)
Bortezomib, Melphalan, Prednisone23.1
Carfilzomib, Melphalan, Prednisone25.9

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Overall Response Rate

"Disease response was evaluated according to the IMWG-URC using a validated computer algorithm. Overall response was defined as the percentage of participants with a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).~sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).~CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM biopsy; VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein <100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.~PR: ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to < 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline." (NCT01818752)
Timeframe: Disease response was assessed every 3 weeks during the first 54 weeks and every 6 weeks thereafter until PD or the data cut-off date of 15 July 2016; median follow-up time was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.

Interventionpercentage of participants (Number)
Bortezomib, Melphalan, Prednisone78.8
Carfilzomib, Melphalan, Prednisone84.3

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Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy

"Neuropathy events were defined as Grade 2 or higher peripheral neuropathy as specified by peripheral neuropathy Standardised Medical Dictionary for Regulatory Activities (MedDRA) Query, narrow (scope) (SMQN) terms.~Peripheral neuropathy was assessed by neurologic exam and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03:~Grade 1: Asymptomatic; Grade 2: Moderate symptoms, limiting instrumental activities of daily living (ADL) Grade 3: Severe symptoms; limiting self-care ADL; Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death." (NCT01818752)
Timeframe: From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups.

Interventionpercentage of participants (Number)
Bortezomib, Melphalan, Prednisone35.1
Carfilzomib, Melphalan, Prednisone2.5

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Progression-Free Survival (PFS)

"Progression-free survival was defined as the time from randomization to the earlier of documented disease progression or death due to any cause. PFS was analyzed using Kaplan-Meier methods. The duration of PFS was censored for participants with no baseline and/or post-baseline disease assessments, who started a new anti-cancer therapy before documentation of disease progression or death, death or disease progression after missed disease assessment of 100 consecutive days or longer, or who were alive without documentation of disease progression before the data cutoff date, including lost to follow-up prior to disease progression.~Participants were evaluated for disease response and progression according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC), determined centrally using a validated computer algorithm in a blinded manner." (NCT01818752)
Timeframe: From randomization until the data cut-off date of 15 July 2016; median follow-up time for PFS was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.

Interventionmonths (Median)
Bortezomib, Melphalan, Prednisone22.1
Carfilzomib, Melphalan, Prednisone22.3

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European Organisation for Research and Treatment of Cancer Quality of Life Core Module (EORTC QLQ-C30) Global Health Status/Quality of Life (QOL) Scores

"The EORTC QLQ-C30 is a validated self-rating questionnaire including 30 items used to assess the overall quality of life in cancer patients.~It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Global Health Status/QOL scale was scored between 0 and 100, with higher scores indicating better Global Health Status/QOL." (NCT01818752)
Timeframe: Baseline, weeks 6, 12, 18, 24, 30, 36, 42 and 48

,
Interventionunits on a scale (Mean)
Baseline (n = 425, 425)Week 6 (n = 412, 407)Week 12 (n = 376, 389)Week 18 (n = 341, 369)Week 24 (n = 320, 345)Week 30 (n = 298, 317)Week 36 (n = 285, 308)Week 42 (n = 275, 288)Week 48 (n = 261, 265)
Bortezomib, Melphalan, Prednisone53.356.255.355.757.361.661.963.362.9
Carfilzomib, Melphalan, Prednisone53.961.162.463.263.363.064.065.065.1

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Number of Participants With Adverse Events

"Adverse events (AEs)were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.03, where GRADE 1 = Mild; GRADE 2 = Moderate; GRADE 3 = Severe; GRADE 4 = Life-threatening; GRADE 5 = Fatal.~A serious adverse event is an adverse event that met 1 or more of the following criteria:~Death~Life-threatening~Required inpatient hospitalization or prolongation of an existing hospitalization~Resulted in persistent or significant disability/incapacity~Congenital anomaly/birth defect~Important medical event that jeopardized the participant and may have required medical or surgical intervention to prevent 1 of the outcomes listed above.~Treatment-related adverse events are adverse events considered related to at least 1 investigational product by the investigator, including those with unknown relationship." (NCT01818752)
Timeframe: From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups.

,
Interventionparticipants (Number)
All adverse eventsAEs ≥ grade 3Serious adverse eventsLeading to discontinuation of study drugFatal adverse eventsTreatment-related adverse events (TRAEs)TRAEs ≥ grade 3Treatment-related serious adverse eventsTRAE leading to discontinuation of study drugTreatment-related fatal adverse events
Bortezomib, Melphalan, Prednisone4543581987320431285102515
Carfilzomib, Melphalan, Prednisone46035423583314082681365410

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Number of Participants Achieving Treatment Success at 6 Months (Phase I, 0-6 Months)

Controlled ocular inflammation (≤ 0.5+ anterior chamber cells, ≤ 0.5+ vitreous haze, no active retinal/choroidal lesions in both eyes) with 7.5 mg/day of oral prednisone and ≤ 2 drops/day of topical 1% prednisolone acetate. (NCT01829295)
Timeframe: 6 Months

InterventionParticipants (Count of Participants)
Methotrexate64
Mycophenolate Mofetil56

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Number of Participants Achieving Treatment Success at 12 Months on Same Medication (Phase I, 6-12 Months)

Controlled ocular inflammation (≤ 0.5+ anterior chamber cells, ≤ 0.5+ vitreous haze, no active retinal/choroidal lesions in both eyes) with 7.5 mg/day of oral prednisone and ≤ 2 drops/day of topical 1% prednisolone acetate in patients who were a treatment success at the primary outcome of 6 months. (NCT01829295)
Timeframe: 12 Months

InterventionParticipants (Count of Participants)
Methotrexate48
Mycophenolate Mofetil40

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Number of Participants Achieving Treatment Success After Switching to Other Medication (Phase II, 0-6 Months)

Controlled ocular inflammation (≤ 0.5+ anterior chamber cells, ≤ 0.5+ vitreous haze, no active retinal/choroidal lesions in both eyes) with 7.5 mg/day of oral prednisone and ≤ 2 drops/day of topical 1% prednisolone acetate for patients who crossed over to other medication following treatment failure at 6 months (or earlier). (NCT01829295)
Timeframe: 6 Months

InterventionParticipants (Count of Participants)
Switched Over to Methotrexate20
Switched Over to Mycophenolate Mofetil7

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Number of Participants With a PSA Value Equal to or Greater Than 25%

Compared between the two patient subsets using the nonparametric Mann-Whitney test. A comparison of CTC counts between baseline and at progression for those who have progressed will be carried out using either a paired t test or the nonparameteric Wilcoxon matched pairs test. (NCT01848067)
Timeframe: Baseline up to 3 months

InterventionParticipants (Count of Participants)
Treatment (Alisertib, Abiraterone Acetate, Prednisone)3

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Phase I: Frequency of Dose Limiting Toxicities of Alisertib, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.1

Summarized with descriptive statistics. (NCT01848067)
Timeframe: Up to 21 days

InterventionParticipants (Count of Participants)
Treatment (Alisertib, Abiraterone Acetate, Prednisone)2

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Event-Free Survival (EFS) - Intent-to-Treat (ITT) Population

EFS: duration from randomization date to disease progression(PD) date, relapse from complete response(CR) assessed by investigator, initiation of subsequent systemic antilymphoma therapy for either positron emission tomography(PET)-positive/ biopsy-proven residual disease upon completion of >=6 cycles of R-CHOP therapy/death, whichever occurred first. Responses were based on Revised Response Criteria for Malignant Lymphoma. PD: any new lesion or increase by 50% of previously involved sites from nadir; PD criteria: Appearance of new nodal lesion 1.5 cm in any axis, 50% increase in sum of product of diameters(SPD) of >1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. CR: disappearance of all evidence of disease; CR criteria: nodal masses PET positive prior to therapy; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy. (NCT01855750)
Timeframe: Up to 5.5 years

InterventionMonths (Median)
Treatment Arm B: Ibrutinib+R-CHOP49.64
Treatment Arm A: Placebo+R-CHOP54.77

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Event-Free Survival (EFS) - Activated B-Cell (ABC) Population

EFS: duration from randomization date to PD date, relapse from CR assessed by investigator, initiation of subsequent systemic antilymphoma therapy for either PET-positive/ biopsy-proven residual disease upon completion of >=6 cycles of R-CHOP therapy/death, whichever occurred first. Responses were based on Revised Response Criteria for Malignant Lymphoma. PD: any new lesion or increase by 50% of previously involved sites from nadir; PD criteria: Appearance of new nodal lesion 1.5 cm in any axis, 50% increase in SPD of >1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. CR: disappearance of all evidence of disease; CR criteria: nodal masses PET positive prior to therapy; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy. (NCT01855750)
Timeframe: Up to approximately 4.5 years

InterventionMonths (Median)
Treatment Arm B: Ibrutinib+R-CHOP48.56
Treatment Arm A: Placebo+R-CHOP48.16

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Time to Worsening in the Lymphoma Subscale of Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)

Time to worsening in the Lymphoma subscale of the FACT-Lym, defined as the interval from the date of randomization to the start date of worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (higher the worse). Lymphoma subscale score is the total of reverse scores, range 0 to 60. Higher scores indicate a better quality of life. (NCT01855750)
Timeframe: Up to approximately 4.5 years

InterventionMonths (Median)
Treatment Arm B: Ibrutinib+R-CHOP11.7
Treatment Arm A: Placebo+R-CHOP35.0

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Progression-Free Survival (PFS)

PFS was defined as the duration from the date of randomization to the date of progression, relapse from CR, or death, whichever occurred first. Responses were based on Revised Response Criteria for Malignant Lymphoma. Progressive Disease (PD): any new lesion or increase by 50% of previously involved sites from nadir; PD criteria: Appearance of new nodal lesion 1.5 centimeter (cm) in any axis, 50% increase in SPD of >1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. CR: disappearance of all evidence of disease; CR criteria: nodal masses PET positive prior to therapy; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy. (NCT01855750)
Timeframe: Up to approximately 4.5 years

InterventionMonths (Median)
Treatment Arm B: Ibrutinib+R-CHOP48.56
Treatment Arm A: Placebo+R-CHOPNA

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Percentage of Participants Who Achieved Complete Response (CR)

Percentage of participants with measurable disease who achieved CR were reported. CR: disappearance of all evidence of disease. CR Criteria: Complete disappearance of all disease-related symptoms; all lymph nodes and nodal masses regressed to normal size (less than or equal to [<=]1.5 cm in greatest transverse diameter [GTD] for nodes greater than [>]1.5 cm before therapy). Previous nodes of 1.1 to 1.5 cm in long axis and greater than (>)1.0 cm in short axis before treatment decreased to <=1.0 cm in short axis after treatment. Disappearance of all splenic and hepatic nodules and other extranodal disease; a negative positron emission tomography (PET) scan. A posttreatment residual mass of any size but PET-negative; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy. (NCT01855750)
Timeframe: Up to approximately 4.5 years

InterventionPercentage of participants (Number)
Treatment Arm B: Ibrutinib+R-CHOP67.3
Treatment Arm A: Placebo+R-CHOP68.0

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Overall Survival

Overall survival was defined as the duration from the date of randomization to the date of the participant's death. Median Overall Survival was estimated by using the Kaplan-Meier method. (NCT01855750)
Timeframe: Up to 5.5 years

InterventionMonths (Median)
Treatment Arm B: Ibrutinib+R-CHOPNA
Treatment Arm A: Placebo+R-CHOPNA

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Proportion of Patients With Complete Response

Complete response is defined as complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy. (NCT01856192)
Timeframe: Assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10

Interventionproportion of participants (Number)
Arm A (R2CHOP)0.73
Arm B (RCHOP)0.68

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Overall Survival Rate at 3 Years

Overall survival is defined as time from randomization to death or date last known alive. Overall survival rate at 3 years was calculated using the method of Kaplan Meier. (NCT01856192)
Timeframe: Assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10

Interventionproportion of participants (Number)
Arm A (R2CHOP)0.826
Arm B (RCHOP)0.751

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3-year Progression-free Survival Rate

"Progression-free survival is defined as the time from randomization to disease progression, new primary of the same type or death, whichever occurs first. Progressive disease is defined as:~Appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size.~>= 50% increase from nadir in the sum of the product of the diameters of any previously involved nodes or extranodal masses, or in a single involved node or extranodal mass, or the size of other lesions.~>= 50% increase in the longest diameter of any single previously identified node or extranodal mass > 1 cm in its short axis.~Lesions should be PET positive unless the lesion is too small to be detected with current PET systems.~Measurable extranodal disease should be assessed in a manner similar to that for nodal disease.~3-year progression-free survival rate was calculated using Kaplan-Meier method." (NCT01856192)
Timeframe: Assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10, 3-year PFS rate reported

Interventionproportion of participants (Number)
Arm A (R2CHOP)0.727
Arm B (RCHOP)0.615

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Proportion of Patients With Response

"Response is defined as complete response (CR) or partial response (PR) CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms~PR:~>=50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses~No increase in the size of other nodes, liver or spleen~Bone marrow assessment is irrelevant for determination of a PR if the sample was positive prior to treatment. However, if positive, the cell type should be specified~No new sites of disease~The post-treatment PET should be positive at any previously involved sites~For variably FDG-avid lymphomas/FDG-avidity unknown, without a pretreatment PET scan, or if a pretreatment PET scan was negative, CT scan criteria should be used~Patients with a CR and persistent morphologic bone marrow involvement~Patients with bone marrow involved before therapy and a clinical CR but no bone marrow assessment after treatment" (NCT01856192)
Timeframe: Assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10

Interventionproportion of participants (Number)
Arm A (R2CHOP)0.97
Arm B (RCHOP)0.92

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Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Interference Subscale

BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions (pain interference). It includes 4 questions that assess pain intensity/severity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-SF scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Interference Index is the mean of the scores for the 7 items of the BPI-SF; range is 0=Does not interfere to 10=Completely interferes. LOCF approach used for endpoint analysis. Last observation is defined as last visit with non-missing data for parameter analyzed. (NCT01867710)
Timeframe: Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)

InterventionUnits on a scale (Mean)
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID0.89
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD1.76
Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID1.52
Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD1.12

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Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Worst Pain

"BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions (pain interference). It includes 4 questions that assess pain intensity/severity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-SF scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Worst pain item has a scale of 0 to 10 with 0 indicating No pain and 10 indicating Pain as bad as you can imagine. Last observation carried forward (LOCF) approach used for endpoint analysis. Last observation defined as last visit with non-missing data for parameter analyzed." (NCT01867710)
Timeframe: Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of main study treatment period [MSTP])

InterventionUnits on a scale (Mean)
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID1.6
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD2.2
Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID2.5
Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD1.3

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Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): EQ-VAS

EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). LOCF approach used for endpoint analysis. Last observation is defined as last visit with non-missing data for parameter analyzed. (NCT01867710)
Timeframe: Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)

InterventionUnits on a scale (Mean)
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID-4.5
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD-5.0
Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID-6.6
Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD-3.1

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Percentage of Participants Experiencing Neither of the 2 Mineralocorticoid Excess Toxicity During the First 24 Weeks of Treatment

No mineralocorticoid excess is defined as experiencing neither of the 2 mineralocorticoid excess toxicities, that is, neither hypokalemia nor hypertension. (NCT01867710)
Timeframe: Week 24

InterventionPercentage of Participants (Number)
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID70.6
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD36.8
Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID60.0
Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD70.3

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Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by 1 Point

Time to deterioration in ECOG Performance Status, the time interval from the date of randomization to the first date in which at least one point change (worsening) in the ECOG is observed during the main study treatment period. The ECOG performance status is a grade scale to measure quality of life (QoL). Scores run from 0 to 5, with 0 denoting perfect health and 5 denoting death. (NCT01867710)
Timeframe: Up to 156 weeks

InterventionMonths (Median)
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BIDNA
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QDNA
Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BIDNA
Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QDNA

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Progression-Free Survival (PFS)

PFS: Time from randomization to one of following: radiographic progression (RP), clinical progression (CP) or death. RP- per PCWG2 criteria and modified RECIST as time from randomization to one of following: 1) considered to have progressed by bone scan if: a) first scan with >=2 new lesions compared to baseline at <12 weeks from randomization and confirmed by second scan >=6 weeks later with >=2 additional new lesions, b) first scan with >=2 new lesions compared to baseline at >=12 weeks from randomization and new lesions on next bone scan >=6 weeks later; 2) Progression of soft tissue lesions per modified RECIST; CP: cancer pain requiring initiation of chronic use of opiate analgesia (oral use for >=3 weeks; parenteral use for >=7 days), Or immediate need to initiate cytotoxic chemotherapy or either radiation therapy or surgical intervention for complications due to tumor progression, even in absence of RP, Or deterioration in ECOG performance status to grade 3 or above. (NCT01867710)
Timeframe: Up to 4.9 years

InterventionMonths (Median)
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID16.16
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD12.68
Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID8.51
Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD21.22

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Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response Rate [Greater Than or Equal to (>=) 50 Percent (%) Decline From Baseline] at Week 12

The PSA response is defined as a >= 50% decline from baseline according to the adapted Prostate Cancer Working Group 2 (PCWG2) criteria. For a PSA response to be confirmed, an additional PSA measurement obtained 4 or more weeks later has to show >=50% decline from baseline. (NCT01867710)
Timeframe: Week 12

InterventionPercentage of Participants (Number)
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID57.1
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD70.6
Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID47.2
Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD79.5

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Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score

FACT-P is a 39-item participant rated questionnaire which consists of 5 subscales assessing physical well-being (7 items; score range 0-28), social/family well-being (7 items; score range 0-28), emotional well-being (6 items; score range 0-24), functional well-being (7 items; score range 0-28), prostate-specific concerns (12 items; score range 0-48). Each item rated on 0 to 4 Likert type scale, then combined to produce subscale scores for each domain, as well as global quality of life (QoL) score that ranges from 0 to 156. Higher scores represent better QoL. Additional Concerns subscale has 12 items, each with a score 0-6 making a total subscale range 0-72 (higher scores are better). Missing data imputed as per FACT-P Ver4 scoring system (sum of item scores*number of items in subscale/number of items answered). (NCT01867710)
Timeframe: Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)

,,,
InterventionUnits on a scale (Mean)
Physical Well-BeingSocial/Family Well-BeingEmotional Well-BeingFunctional Well-BeingGlobal ScoreAdditional Concerns
Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD-1.04-1.97-0.02-2.95-5.77-0.72
Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID-2.46-0.78-1.66-2.67-10.39-3.96
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID-0.98-0.01-1.46-1.13-4.73-1.29
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD-2.200.61-0.89-2.19-6.62-2.35

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Time to Prostate-Specific Antigen (PSA) Progression

Time to PSA progression was defined as time interval from the date of randomization to the date of the first prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group 2 (PSAWG2) criteria during the main study treatment period. PCWG2 defines PSA progression as the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanogram per milliliter (ng/mL) or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later. (NCT01867710)
Timeframe: Up to 156 weeks

InterventionMonths (Median)
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID10.38
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD10.22
Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID4.83
Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD18.56

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Overall Survival

Overall survival was defined as the time interval from the date of randomization to the date of death from any cause. (NCT01867710)
Timeframe: Up to 156 weeks

InterventionMonths (Median)
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID34.07
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD48.43
Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID27.96
Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD42.81

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Objective Response Rate (ORR)

ORR was defined as the percentage of participants with measurable disease at baseline achieving a complete response (CR) or partial response (PR) according to modified response evaluation criteria in solid tumors (RECIST) criteria. RECIST criteria for CR: disappearance of all target lesions and non-target lesions , any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 millimetre [mm] short axis). PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. (NCT01867710)
Timeframe: Up to 4.9 years

InterventionPercentage of participants (Number)
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID42.1
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD38.9
Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID60.0
Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD56.3

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Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): Index Score

"EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). The descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each has 5 levels (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health). LOCF approach used for endpoint analysis. Last observation is defined as last visit with non-missing data for parameter analyzed." (NCT01867710)
Timeframe: Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)

InterventionUnits on a scale (Mean)
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID-0.0694
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD-0.0638
Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID-0.0728
Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD-0.0359

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Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Intensity Subscale

BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions (pain interference). It includes 4 questions that assess pain intensity/severity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-SF scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-SF; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. LOCF approach used for endpoint analysis. Last observation is defined as last visit with non-missing data for parameter analyzed. (NCT01867710)
Timeframe: Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)

InterventionUnits on a scale (Mean)
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID1.31
Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD1.37
Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID1.80
Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD0.97

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Mean Rate of Change in Grip Strength Treatment Compared to Pre-Treatment

Hand grip was measured using a study approved dynamometer to test the maximum isometric strength of the hand and forearm muscles. The grip strength of the left and right hands were analyzed together. Grip strength was measured during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. Grip strength is a measurement of muscle strength and declines as ALS progresses. A positive value means that scores during treatment were higher than pre-treatment scores, indicating an increase in grip strength over time. (NCT01884571)
Timeframe: Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)

Interventionpounds change per month (Mean)
Immunosuppression Regimen1.38

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Mean Rate of Change of ALSFRS-R Scores During Treatment Compared to Pre-Treatment

The ALS Functional Rating Scale - Revised (ALSFRS-R) is an ordinal rating scale (0 through 4) used to determine the ALS patient's self assessment of their ability and need for assistance in 12 activities or functions. This is a validated scale, both in person and by phone, which provides a total score from four sub-scores which assess speech and swallowing, (bulbar function), use of upper extremities (cervical function), gait and turning in bed (lumbar function), and breathing (respiratory function). Total scores range from 0 (most impaired) to 48 (normal ability). ALSFRS-R was measured during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. A negative value means that scores during treatment were lower than pre-treatment scores, indicating a decline in ability over time. (NCT01884571)
Timeframe: Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)

Interventionunits on a scale change per month (Mean)
Immunosuppression Regimen-0.24

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Collection of Cerebrospinal Fluid for Future Analysis of Cytokine Levels

Lumbar punctures (LPs) were performed to collect cerebrospinal fluid (CSF). CSF is banked for future use to characterize immune system markers and to further the understanding of the immune factors that contribute to disease progression in ALS. Cytokines are markers of neuroinflammation and can be categorized as neurotoxic or neuroprotective. The role that cytokines play in in ALS progression is still not yet fully understood. (NCT01884571)
Timeframe: Pre-Treatment Period (two months prior to the start of treatment), Treatment Period (Months 2 and 6), Post-Treatment Period (Month 12)

InterventionParticipants (Count of Participants)
Immunosuppression Regimen29

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Mean Rate of Change of Hand-Held Dynamometry (HHD) During Treatment Compared to Pre-Treatment

Hand held dynamometry (HHD) is a measure of muscle strength and scores decrease as ALS progresses. Six proximal muscle groups were examined bilaterally in both upper and lower extremities. Mean and standard deviation for each muscle group are established from the initial values for each participant. Strength determinations were converted to Z scores and averaged to provide an HHD megascore. The Z-score indicates the number of standard deviations away from the mean of 0. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. HHD was measured during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. A negative value means that scores during treatment were lower than pre-treatment scores, indicating a decline in strength over time. (NCT01884571)
Timeframe: Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)

Interventionz-score change per month (Mean)
Immunosuppression Regimen-0.05

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Mean Rate of Change of Slow Vital Capacity (SVC) During Treatment Compared to Pre-Treatment

Vital capacity (VC), percent of predicted normal, was determined using the slow VC method. SVC measures the amount of air exhaled following a deep breath. For this test, participants hold a mouthpiece in their mouth, breathe in deeply, and breathe out as much air as they can. The test was done seated in a chair and then repeated while lying on an exam table at the Screening Visit. For all other visits, this test was done while seated in a chair. This test takes 15-20 minutes. SVC was measured during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. SVC is a way to measure respiratory insufficiency in persons with ALS and SVC decreases as ALS progresses. A negative value means that scores during treatment were lower than pre-treatment scores, indicating a decline over time. (NCT01884571)
Timeframe: Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)

Interventionpercent predicted change per month (Mean)
Immunosuppression Regimen-0.18

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Mean Rate of Change of T-cell Subsets in Blood Treatment Compared to Pre-Treatment

Blood was collected for ribonucleic acid (RNA) and the mean rate of decline of T-cells during the 6 month treatment period compared to the pre-treatment period was assessed (blood was collected twice during the 3-month long lead in period). The precise role that T-cells have in ALS is unknown and this study aims to further the understanding of how T-cells operate in persons with ALS. T-cell measurement is a ratio where the relative expression levels of FOXP3 messenger ribonucleic acid (mRNA) was calculated using the Comparative CT Method (ΔΔCT Method), normalizing to β-actin. Samples were obtained during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. A negative value means that scores during treatment were lower than pre-treatment scores, indicating a decline in T-cells over time. (NCT01884571)
Timeframe: Pre-Treatment Period (2 months prior to the start of treatment), Treatment Period (Day 1 and Months 1, 2, 4, 6)

Interventionfold change per month (Mean)
Immunosuppression Regimen-0.04

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Number of Participants With an Average Increase in ALSFRS-R Score of One Point Per Month

The ALS Functional Rating Scale - Revised (ALSFRS-R) is an ordinal rating scale (0 through 4) used to determine the ALS patient's self assessment of their ability and need for assistance in 12 activities or functions. This is a validated scale, both in person and by phone, which provides a total score (best of 48) from four sub-scores which assess speech and swallowing, (bulbar function), use of upper extremities (cervical function), gait and turning in bed (lumbar function), and breathing (respiratory function). A clinical response is defined as a rate of change of ALSFRS-R of +6 points over 6 months (mean of +1 point per month), where typically patients with ALS have a decline in ALSFRS-R by an average of -1/month. (NCT01884571)
Timeframe: Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)

InterventionParticipants (Count of Participants)
Immunosuppression Regimen0

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Collection of Blood for Future Analysis of Peripheral Blood Mononuclear Cells (PBMCs)

Blood was drawn and banked for future use in order to characterize immune system markers and further the understanding of the immune factors that contribute to disease progression in ALS. (NCT01884571)
Timeframe: Pre-Treatment Period (2 months prior to the start of treatment), Treatment Period (Day 1 and Months 1, 2, 4, 6), Post-Treatment Period (Months 8 and 12)

InterventionParticipants (Count of Participants)
Immunosuppression Regimen31

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Total Number of Adverse Events.

Adverse events were listed using CTCAE Version 4.03 (Common Terminology Criteria for Adverse Events) toxicity grade. (NCT01888952)
Timeframe: Average of 21 days.

InterventionAdverse events (Number)
Roflumilast and Prednisone2

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DLBCL: Plasma Concentrations During Different Scheduling of Rituximab SC R-CHOP-14 or R-CHOP-21

Plasma concentrations of rituximab in participants with DLBCL by chemotherapy regimen cyclophosphamide, oncovine (vincristine), doxorubicin, prednisone/prednisolone given every 14 days (R-CHOP-14) or cyclophosphamide, oncovine (vincristine), doxorubicin, prednisone/prednisolone given every 21 days (R-CHOP-21) in the PK) population.DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 Predose on Day 1

Interventionmicrograms per millilitre (ug/mL) (Mean)
Cycle 2 PredoseCycle 3 PredoseCycle 4 PredoseCycle 5 PredoseBaselineCycle 7 PredoseCycle 7 Day 7Cycle 7 Day 14Cycle 8 Predose
Diffuse Large B-Cell Lymphoma (DLBCL) R-CHOP-2128.3788.92110.5094.0074.25150.13398.76272.50123.76

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DLBCL: Plasma Concentrations During Different Scheduling of Rituximab SC R-CHOP-14 or R-CHOP-21

Plasma concentrations of rituximab in participants with DLBCL by chemotherapy regimen cyclophosphamide, oncovine (vincristine), doxorubicin, prednisone/prednisolone given every 14 days (R-CHOP-14) or cyclophosphamide, oncovine (vincristine), doxorubicin, prednisone/prednisolone given every 21 days (R-CHOP-21) in the PK) population.DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 Predose on Day 1

Interventionmicrograms per millilitre (ug/mL) (Mean)
Cycle 2 PredoseCycle 5 PredoseBaselineCycle 7 PredoseCycle 7 Day 7Cycle 7 Day 14Cycle 8 Predose
Diffuse Large B-Cell Lymphoma (DLBCL) R-CHOP-14170.00125.00214.2593.5071.5542.0078.50

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Percentage of Participants With Progression-Free Survival (PFS) According to IWG Response Criteria

PFS was defined as the time from first dose of rituximab to the first occurrence of disease progression or relapse, according to the International Working Group (IWG) response criteria or other country standards, or death from any cause, whichever occurred first. (NCT01889069)
Timeframe: Day 1 up to first occurrence of progression or relapse, or death, whichever occurs first (up to maximum 54 months)

InterventionPercentage of Participants (Number)
Diffuse Large B-Cell Lymphoma (DLBCL)29.2
Follicular Lymphoma (FL)22.1
Subcutaneous (SC) Rituximab25.3

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Percentage of Participants With Overall Survival (OS)

OS was defined as the time from first dose of rituximab to death from any cause. (NCT01889069)
Timeframe: Day 1 until death (up to maximum 54 months)

InterventionPercentage of Participants (Number)
Diffuse Large B-Cell Lymphoma (DLBCL)19.4
Follicular Lymphoma (FL)4.7
Subcutaneous (SC) Rituximab11.4

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Percentage of Participants With Event-Free Survival (EFS) According to IWG Response Criteria

EFS was defined as the time from first dose of rituximab to first occurrence of progression or relapse, according to the International Working Group (IWG) response criteria or other country standards, or initiation of a non-protocol-specified anti-lymphoma therapy or death, whichever occurred first. (NCT01889069)
Timeframe: Day 1 up to first occurrence of progression or relapse, or initiation of a non-protocol-specified anti-lymphoma therapy or death, whichever occurs first (up to maximum 54 months)

InterventionPercentage of Participants (Number)
Diffuse Large B-Cell Lymphoma (DLBCL)29.2
Follicular Lymphoma (FL)22.1
Subcutaneous (SC) Rituximab25.3

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Percentage of Participants With Disease-Free Survival (DFS) According to IWG Response Criteria

DFS assessed in participants achieving complete response (CR) including complete response unconfirmed (Cru) and was defined as the period from 4 to 8 weeks after end of Induction period up to relapse or death from any cause, whichever occured first. (NCT01889069)
Timeframe: From 4 to 8 weeks after end of Induction period up to relapse or death from any cause, whichever occurs first (up to maximum 54 months) (end of Induction period = up to 8 months)

InterventionPercentage of Participants (Number)
Diffuse Large B-Cell Lymphoma (DLBCL)21.7
Follicular Lymphoma (FL)25.6
Subcutaneous (SC) Rituximab23.5

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Percentage of Participants With Complete Response (CR) According to IWG Response Criteria

Complete response required: 1) the complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities, 2) all lymph nodes and nodal masses had regressed to normal size, 3) the spleen, if considered to be enlarged before therapy on the basis of a CT scan, must have regressed in size and not be palpable on physical examination and 4) if the bone marrow was involved by lymphoma before treatment, the infiltrate was cleared on repeat bone marrow aspirate and biopsy of the same site. CR/unconfirmed (CRu) included those patients who fulfilled criteria 1 and 3 above as well as 1) a residual lymph node mass greater than 1.5 cm in greatest transverse diameter that regressed by more than 75% in the SPD and 2) indeterminate bone marrow. Response was assessed according to the IWG response criteria. (NCT01889069)
Timeframe: At 4 to 8 weeks after end of Induction period (end of Induction period = up to 8 months)

InterventionPercentage of Participants (Number)
Diffuse Large B-Cell Lymphoma (DLBCL)65.2
Follicular Lymphoma (FL)67.9
Subcutaneous (SC) Rituximab66.4

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Percentage of Participants With At Least One Treatment-Emergent Serious Adverse Events

SAE was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/ birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here. (NCT01889069)
Timeframe: Baseline up to 54 months

InterventionPercentage of Participants (Number)
Diffuse Large B-Cell Lymphoma (DLBCL)36.1
Follicular Lymphoma (FL)26.7
Subcutaneous (SC) Rituximab31.0

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Percentage of Participants With At Least One Grade ≥ 3 Treatment-Emergent Adverse Events (TEAEs)

An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with the treatment. An adverse event was therefore any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsened during the study were also considered as adverse events. Grading was completed according to the CTCAE, version 4.0. (NCT01889069)
Timeframe: Baseline up to 54 months

InterventionPercentage of Participants (Number)
Diffuse Large B-Cell Lymphoma (DLBCL)51.4
Follicular Lymphoma (FL)43.0
Subcutaneous (SC) Rituximab46.8

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FL: Overall Geometric Least Square (LS) Mean Plasma Trough Concentrations of Rituximab

FL participants could be enrolled during induction or maintenance phase and they should have received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC if enrolled during induction or 4 cycles of rituximab SC if enrolled during maintenance. PK data only collected for participants enrolled during Induction. During the induction phase each Cycle is 21 days. (NCT01889069)
Timeframe: Induction collection: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, and Cycle 8 Predose on Day 1

Interventionmicrograms per millilitre (ug/mL) (Geometric Least Squares Mean)
Follicular Lymphoma (FL)61.01

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DLBCL: Maximum Plasma Concentration (Cmax) of Rituximab

DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 Predose on Day 1

Interventionmicrograms per millilitre (ug/mL) (Mean)
Diffuse Large B-Cell Lymphoma (DLBCL)NA

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DLBCL: Apparent Total Clearance (CL/F) of Rituximab

DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 Predose on Day 1

Interventionliter per hour (L/h) (Mean)
Diffuse Large B-Cell Lymphoma (DLBCL)NA

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DLBCL: Area Under the Plasma Concentration-Time Curve (AUC) of Rituximab

DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 Predose on Day 1

Interventionmcg*hr/mL (Mean)
Diffuse Large B-Cell Lymphoma (DLBCL)NA

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Rituximab Administration Satisfaction Questionnaire (RASQ) Convenience and Satisfaction Domain Scores

Patient-assessed satisfaction was evaluated using RASQ. Participants were asked questions regarding convenience and satisfaction for rituximab SC. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants. DLBCL participants could be enrolled at cycle 2, cycle 3, or cycle 4. FL participants could be enrolled during induction or maintenance phase and they should have received at least 1 infusion of rituximab and must be able to receive at least 4 cycles of rituximab SC if enrolled during induction or 4 cycles of rituximab SC if enrolled during maintenance. Each Cycle is 21 days for DLBCL. Each Cycle 21 days during the Induction phase and 2 months during Maintenance phase for FL. (NCT01889069)
Timeframe: DLBCL: Cycle (C) 2, C3, C4, C5, C6, End of C8; FL: Induction: C3, C4, C5, C6, C8, Maintenance: C2, C3, C4, C5, C6, C7, C8, C10, C12, End of treatment (4-8 weeks after last dose)

InterventionUnits on a Scale (Mean)
Convenience domain Cycle 3 InductionConvenience domain Cycle 4 InductionConvenience domain Cycle 5 InductionConvenience domain Cycle 6 InductionConvenience domain Cycle 8 InductionConvenience domain Cycle 2 MaintenanceConvenience domain Cycle 3 MaintenanceConvenience domain Cycle 4 MaintenanceConvenience domain Cycle 5 MaintenanceConvenience domain Cycle 6 MaintenanceConvenience domain Cycle 7 MaintenanceConvenience domain Cycle 8 MaintenanceConvenience domain Cycle 10 MaintenanceConvenience domain Cycle 12 MaintenanceConvenience domain End of TreatmentSatisfaction domain Cycle 3 InductionSatisfaction domain Cycle 4 InductionSatisfaction domain Cycle 5 InductionSatisfaction domain Cycle 6 InductionSatisfaction domain Cycle 8 InductionSatisfaction domain Cycle 2 MaintenanceSatisfaction domain Cycle 3 MaintenanceSatisfaction domain Cycle 4 MaintenanceSatisfaction domain Cycle 5 MaintenanceSatisfaction domain Cycle 6 MaintenanceSatisfaction domain Cycle 7 MaintenanceSatisfaction domain Cycle 8 MaintenanceSatisfaction domain Cycle 10 MaintenanceSatisfaction domain Cycle 12 MaintenanceSatisfaction domain End of Treatment
Follicular Lymphoma (FL)81.876.579.695.883.183.687.5100.080.283.382.793.891.786.375.089.484.191.793.891.392.079.2100.079.787.594.293.850.091.075.0

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DLBCL: Overall Geometric Least Square (LS) Mean Plasma Trough Concentrations of Rituximab

DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 Predose on Day 1

Interventionmicrograms per millilitre (ug/mL) (Geometric Least Squares Mean)
Diffuse Large B-Cell Lymphoma (DLBCL)70.50

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FL: Plasma Trough Concentrations of Rituximab

FL participants could be enrolled during induction or maintenance phase and they should have received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC if enrolled during induction or 4 cycles of rituximab SC if enrolled during maintenance. Pharmacokinetic (PK) data only collected for participants enrolled during Induction. During the induction phase each Cycle is 21 days. (NCT01889069)
Timeframe: Induction collection: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, and Cycle 8 Predose on Day 1

Interventionmicrograms per millilitre (ug/mL) (Mean)
Cycle 2 PredoseCycle 3 PredoseCycle 4 PredoseCycle 5 PredoseBaselineCycle 8 Predose
Follicular Lymphoma (FL)55.49119.50157.257.6090.88201.56

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Rituximab Administration Satisfaction Questionnaire (RASQ) Convenience and Satisfaction Domain Scores

Patient-assessed satisfaction was evaluated using RASQ. Participants were asked questions regarding convenience and satisfaction for rituximab SC. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants. DLBCL participants could be enrolled at cycle 2, cycle 3, or cycle 4. FL participants could be enrolled during induction or maintenance phase and they should have received at least 1 infusion of rituximab and must be able to receive at least 4 cycles of rituximab SC if enrolled during induction or 4 cycles of rituximab SC if enrolled during maintenance. Each Cycle is 21 days for DLBCL. Each Cycle 21 days during the Induction phase and 2 months during Maintenance phase for FL. (NCT01889069)
Timeframe: DLBCL: Cycle (C) 2, C3, C4, C5, C6, End of C8; FL: Induction: C3, C4, C5, C6, C8, Maintenance: C2, C3, C4, C5, C6, C7, C8, C10, C12, End of treatment (4-8 weeks after last dose)

InterventionUnits on a Scale (Mean)
Convenience domain Cycle 2 TreatmentConvenience domain Cycle 3 TreatmentConvenience domain Cycle 4 TreatmentConvenience domain Cycle 5 TreatmentConvenience domain Cycle 6 TreatmentConvenience domain Cycle 8 TreatmentSatisfaction domain Cycle 2 TreatmentSatisfaction domain Cycle 3 TreatmentSatisfaction domain Cycle 4 TreatmentSatisfaction domain Cycle 5 TreatmentSatisfaction domain Cycle 6 TreatmentSatisfaction domain Cycle 8 Treatment
Diffuse Large B-Cell Lymphoma (DLBCL)75.081.982.183.380.883.887.583.385.683.384.691.2

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Percentage of Participants With Administration-Associated Reactions (AAR)

AARs were defined as all adverse events (AEs) occurring within 24 hours of rituximab administration and which were considered related to study drug. AARs included infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof. Grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. (NCT01889069)
Timeframe: Baseline up to 54 months

,,
InterventionPercentage of Participants (Number)
At least One AARAt Least One AAR Grade ≥3Cutaneous and Soft Tissue AARs (Localized)Cutaneous and Soft Tissue AARs (Non-Localized)
Diffuse Large B-Cell Lymphoma (DLBCL)4.201.42.8
Follicular Lymphoma (FL)8.108.10
Subcutaneous (SC) Rituximab6.305.11.3

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FL: Plasma Trough Concentrations of Rituximab in Participants With Complete Response/Complete Response Unconfirmed (CR/CRu)

FL participants could be enrolled during induction or maintenance phase and they should have received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC if enrolled during induction or 4 cycles of rituximab SC if enrolled during maintenance. PK data only collected for participants enrolled during Induction. During the induction phase each Cycle is 21 days. (NCT01889069)
Timeframe: Induction collection: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, and Cycle 8 Predose on Day 1

Interventionmicrograms per millilitre (ug/mL) (Mean)
Cycle 2 PredoseCycle 3 PredoseCycle 4 PredoseCycle 5 PredoseBaselineCycle 8 Predose
Follicular Lymphoma (FL)48.86156.33200.337.6097.90284.08

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DLBCL: Plasma Trough Concentrations of Rituximab in Participants With Complete Response/Complete Response Unconfirmed (CR/CRu)

DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 Predose on Day 1

Interventionmicrograms per millilitre (ug/mL) (Mean)
Cycle 2 PredoseCycle 3 PredoseCycle 4 PredoseCycle 5 PredoseBaselineCycle 7 PredoseCycle 8 Predose
Diffuse Large B-Cell Lymphoma (DLBCL)53.97101.79110.50121.67109.40157.93132.57

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DLBCL: Plasma Trough Concentrations of Rituximab

DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 pre-dose on Day 1

Interventionmicrograms per millilitre (ug/mL) (Mean)
Cycle 2 PredoseCycle 3 PredoseCycle 4 PredoseCycle 5 PredoseBaselineCycle 7 PredoseCycle 8 Predose
Diffuse Large B-Cell Lymphoma (DLBCL)42.5388.92110.50100.2092.92141.44117.61

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DLBCL: Plasma Concentrations of Rituximab

DLBCL participants received at least 1 infusion of rituximab and must have been able to receive at least 4 cycles of rituximab SC; therefore DLBCL participants could be enrolled at Cycle 2, Cycle 3, Cycle 4, or Cycle 5 and as a result the baseline PK sample could be collected at Cycle 2, Cycle 3, Cycle 4, or Cycle 5. Each Cycle is 21 days. (NCT01889069)
Timeframe: Cycle 2 Predose, Cycle 3 Predose, Cycle 4 Predose, Cycle 5 Predose, Baseline Predose, Cycle 7 Predose on Day 1, Cycle 7 Day 7, Cycle 7 Day 14, Cycle 8 Predose on Day 1

Interventionmicrograms per millilitre (ug/mL) (Mean)
Cycle 2 PredoseCycle 3 PredoseCycle 4 PredoseCycle 5 PredoseBaselineCycle 7 PredoseCycle 7 Day 7Cycle 7 Day 14Cycle 8 Predose
Diffuse Large B-Cell Lymphoma (DLBCL)42.5388.92110.50100.2092.92141.44348.81226.40117.61

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Change From Baseline in Central Retinal Thickness (CRT) At Week 16

CRT was measured by spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. All images were transmitted to the central reading center. SD-OCT was performed in the study eye after pupil dilation. LS mean was calculated using MMRM model with treatment groups, randomization strata of VH level (<4, >=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT. (NCT01900431)
Timeframe: Baseline to Week 16

Interventionµm (microns) (Least Squares Mean)
Placebo (Part A)-8.9
Sarilumab 200 mg q2w (Part A)-35.4

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Percentage of Participants With Anterior Chamber (AC) Cell Score = 0 or At Least 2-step Reduction in Score at Week 16

Participants with AC cell score = 0 or with ≥2 step reduction from baseline at Week 16 were evaluated. Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria: grade 0 = no cells; grade +0.5 = 1 - 5 cells; grade +1 = 6 - 25 cells; grade +2= 26 - 50 cells; grade +3 = too many to count. (NCT01900431)
Timeframe: Week 16

InterventionPercentage of participants (Number)
Placebo (Part A)86.7
Sarilumab 200 mg q2w (Part A)86.2

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Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 16

BCVA score is based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters, and then at 1 meter. The range of ETDRS is 0 to 100 letters. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. LS mean was calculated using MMRM model with treatment groups, randomization strata of VH level (<4, >=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline BCVA. (NCT01900431)
Timeframe: Baseline to Week 16

Interventionunits on a scale (Least Squares Mean)
Placebo (Part A)3.5
Sarilumab 200 mg q2w (Part A)9.3

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Percentage of Participants With at Least 2-step Reduction in Vitreous Haze (VH) or Prednisone Dose <10 mg/Day at Week 16

At least 2-step reduction in VH per central review from baseline was evaluated on Miami 9-step scale. VH is the obscuration of fundus by vitreous cells and protein exudation. Each of the 9-step scale (from grade 0 [low opacity] to 8 [more opacity]) images (in increasing order of opacity) are equivalent to approximately 0.3 log units of degradation in visual acuity based on the Bangerter calibration. Participants with prednisone dose <10 mg/day (or equivalent oral corticosteroid) were also evaluated. (NCT01900431)
Timeframe: Week 16

InterventionPercentage of participants (Number)
Placebo (Part A)30.0
Sarilumab 200 mg q2w (Part A)46.1

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Percentage of Participants With Prednisone Dose of ≤5 mg/Day (or Equivalent Oral Corticosteroid) at Week 16

Participants with prednisone dose ≤5 mg/day (or equivalent oral corticosteroid) at Week 16 were evaluated. (NCT01900431)
Timeframe: Week 16

InterventionPercentage of participants (Number)
Placebo (Part A)40.0
Sarilumab 200 mg q2w (Part A)41.4

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Percent Change From Baseline in CRT at Week 16

CRT was measured by SD-OCT, a non-invasive diagnostic system providing high-resolution imaging sections of the retina. All images were transmitted to the central reading center. SD-OCT was performed in the study eye after pupil dilation. LS mean was calculated using MMRM model with treatment groups, randomization strata of VH level (<4, >=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT. (NCT01900431)
Timeframe: Baseline to Week 16

Interventionpercent change (Least Squares Mean)
Placebo (Part A)0.0
Sarilumab 200 mg q2w (Part A)-6.4

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Change From Baseline in VH Scale at Week 16

Change from baseline in VH scale was evaluated on Miami 9-step scale. VH is the obscuration of fundus by vitreous cells and protein exudation. Each of the 9-step scale (from grade 0 [low opacity] to 8 [more opacity]) images (in increasing order of opacity) were equivalent to approximately 0.3 log units of degradation in visual acuity based on the Bangerter calibration. Least squares (LS) mean was calculated using mixed model for repeated measurements (MMRM) model with treatment groups, visits and visit-by-treatment groups interaction as fixed categorical effects as well as fixed continuous covariate of baseline adjudicated VH. (NCT01900431)
Timeframe: Baseline to Week 16

Interventionunits on a scale (Least Squares Mean)
Placebo (Part A)-0.1
Sarilumab 200 mg q2w (Part A)-0.9

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Pharmacokinetics (PK) Assessment: Serum Functional Sarilumab Concentration

Serum functional (unbound) sarilumab concentrations were determined using an enzyme-linked immunosorbent assay (ELISA) method with a lower limit of quantification (LLOQ) of 294 ng/mL. Concentrations below LLOQ were set to zero for samples at predose. Post-treatment concentrations below LLOQ were replaced by LLOQ/2. The samples were considered non-eligible for the analysis if the previous dosing time was <11 days or >17 days before the sampling time for every other week regimens. (NCT01900431)
Timeframe: Predose on Day 1 (Baseline), Week 2, 4, 8, 12, 16, 24, 36, 52, and end of study (EOS) (Week 56)

Interventionng/mL (Mean)
At BaselineAt Week 2At Week 4At Week 8At Week 12At Week 16At Week 24At Week 36At Week 52EOS (Week 56)
Sarilumab 200 mg q2w (Part A + Part B)0.07383.39876.615958.919705.219598.422406.824375.425046.01730.0

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Descriptive of Hematological Adverse Events

To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. (NCT01920932)
Timeframe: From enrollment to end of therapy (approximately 8 months)

,,,,,,,,,,,
InterventionParticipants (Count of Participants)
LeukopeniaNeutropeniaLymphopeniaAnemiaThrombocytopenia
Cycle 1 - Grade 215515233
Cycle 1 - Grade 3-4496236123
Cycle 2 - Grade 2281318282
Cycle 2 - Grade 3-423511551
Cycle 3 - Grade 287960
Cycle 3 - Grade 3-4410712
Cycle 4 - Grade 2551660
Cycle 4 - Grade 3-4531501
Cycle 5 - Grade 2741340
Cycle 5 - Grade 3-4232211
Cycle 6 - Grade 21482021
Cycle 6 - Grade 3-4563112

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Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control

To determine the efficacy of 2 cycles of AEPA chemotherapy, the response rate for the first 32 evaluable participants enrolled was evaluated. If it shown efficacy (detect 20% increase complete rate with 80% power and 5% type I error compared with the proportion of historical control of HOD99 unfavorable risk patients had complete rate at week 8 of 17% (24/141), the response results will be reported in a national/international meeting and the study will continue to enroll for a total of 77 patients. (NCT01920932)
Timeframe: After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)

Interventionpercentage of participants (Number)
AEPA Chemotherapy31.25

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Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control

To determine the efficacy of 2 cycles of AEPA chemotherapy, the response rate for the first 32 evaluable participants enrolled was evaluated. If it shown efficacy (detect 20% increase complete rate with 80% power and 5% type I error compared with the proportion of historical control of HOD99 (NCT00145600) unfavorable risk patients had complete rate at week 8 of 17% (24/141), the response results will be reported in a national/international meeting and the study will continue to enroll for a total of 77 patients. (NCT01920932)
Timeframe: After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)

Interventionpercentage of participants (Number)
AEPA Chemotherapy31.25

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Local Failure Rate in High Risk HL Patients Treated With AEPA/CAPDac.

The local failure rate within the high-risk HL participants treated with AEPA/CAPDac will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks). (NCT01920932)
Timeframe: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment)

InterventionProbability (Number)
AEPA/CAPDac0.013

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Descriptive of Infectious Adverse Events

To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. (NCT01920932)
Timeframe: From enrollment to end of therapy (approximately 8 months)

,,,,,,,,,,,
InterventionParticipants (Count of Participants)
Febrile neutropeniaMucositisUpper respiratory infectionGenitourinary infection
Cycle 1 - Grade 201051
Cycle 1 - Grade 3-46220
Cycle 2 - Grade 20631
Cycle 2 - Grade 3-43400
Cycle 3 - Grade 20002
Cycle 3 - Grade 3-40000
Cycle 4 - Grade 20101
Cycle 4 - Grade 3-42020
Cycle 5 - Grade 20102
Cycle 5 - Grade 3-41000
Cycle 6 - Grade 20100
Cycle 6 - Grade 3-40000

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Complete Response Rate Estimate for All Evaluable Participants

To evaluate the safety of AEPA/CAPDac, as well as the efficacy (early complete response) after 2 cycles of AEPA chemotherapy in high-risk patients with Hodgkin Lymphoma (HL). (NCT01920932)
Timeframe: After the first 2 cycles of chemotherapy (at 2 months from enrollment for each participant)

Interventionpercentage of participants (Number)
AEPA/CAPDac35

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Comparison of the Event-free (EFS) Survival in High Risk HL Patients Treated With AEPA/CAPDac to the Historical Control HOD99 Unfavorable Risk 2 Arm (UR2).

Event-free survival (EFS) is defined as the probability of survival between the date of study enrollment to the date of first event (relapsed or progressive disease, second malignancy, or death from any cause) or to last follow-up for patients without events. Under the proportional hazard model assumption, the two-sample log-rank test used to compare the EFS between HLHR13 and historical control of HOD99 unfavorable risk 2 arm (UR2). (NCT01920932)
Timeframe: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment)

Interventionprobability (Number)
AEPA/CAPDac0.974

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Descriptive of Neuropathic Adverse Events

To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. (NCT01920932)
Timeframe: From enrollment to end of therapy (approximately 8 months)

,,,,,,,,,,,
InterventionParticipants (Count of Participants)
Peripheral sensory neuropathyPain in extremityNeuralgiaPain NOS
Cycle 1 - Grade 20311
Cycle 1 - Grade 3-40100
Cycle 2 - Grade 21401
Cycle 2 - Grade 3-40000
Cycle 3 - Grade 22100
Cycle 3 - Grade 3-40000
Cycle 4 - Grade 23100
Cycle 4 - Grade 3-40000
Cycle 5 - Grade 21210
Cycle 5 - Grade 3-40000
Cycle 6 - Grade 21001
Cycle 6 - Grade 3-40001

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Number of Infectious Complications

The number of infections complications occurring among study participants is presented here. (NCT01921218)
Timeframe: Baseline up to Month 36

Interventioncomplications (Number)
Belatacept Treatment Group12
Control Group18

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Number of Participants With Donor-specific Antibody Formation

The number of participants in each group with donor-specific antibody formation at 36 months following randomization. (NCT01921218)
Timeframe: Month 36

InterventionParticipants (Count of Participants)
Belatacept Treatment Group3
Control Group4

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Glomerular Filtration Rate (GFR)

The glomerular filtration rate (GFR) assesses kidney function. GFR uses values for serum creatinine (SCr) measured in mg/dL, age in years, blood urea nitrogen (BUN) measures in mg/dL, and serum albumin (Alb) measured in g/dL. GFR is calculated as 170 x (SCr/0.95)^(-0.999) x (Age)^(-0.176) x (0.762 if the patient is female) x (1.180 if the patient is black) x (BUN)^(-0.170) x (Alb)^(0.318). A value of 90 or above is considered normal while values between 15 and 29 indicate severely decreased kidney function and values below 15 indicate kidney failure. The GFR in participants who do not require dialysis will be followed for two years. (NCT01921218)
Timeframe: Baseline up to Month 24

InterventionmL/min/1.73 m^2 (Mean)
BaselineMonth 1Month 2Month 3Month 6Month 9Month 12
Control Group14.51110.516.514.513.520

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Glomerular Filtration Rate (GFR)

The glomerular filtration rate (GFR) assesses kidney function. GFR uses values for serum creatinine (SCr) measured in mg/dL, age in years, blood urea nitrogen (BUN) measures in mg/dL, and serum albumin (Alb) measured in g/dL. GFR is calculated as 170 x (SCr/0.95)^(-0.999) x (Age)^(-0.176) x (0.762 if the patient is female) x (1.180 if the patient is black) x (BUN)^(-0.170) x (Alb)^(0.318). A value of 90 or above is considered normal while values between 15 and 29 indicate severely decreased kidney function and values below 15 indicate kidney failure. The GFR in participants who do not require dialysis will be followed for two years. (NCT01921218)
Timeframe: Baseline up to Month 24

InterventionmL/min/1.73 m^2 (Mean)
BaselineMonth 1Month 2Month 3Month 6Month 9Month 12Month 18
Belatacept Treatment Group14.2514.2519.3316.3314.6714.6713.677

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Time to Initiation of Dialysis

Time to dialysis is measured as the time of randomization to initiation of dialysis. Participants already requiring dialysis at the time of enrollment were excluded from this endpoint analysis. (NCT01921218)
Timeframe: Up to Year 2

Interventionmonths (Mean)
Belatacept Treatment Group11.75
Control Group10.5

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Number of Participants With Anti-human Leukocyte Antigen (HLA) Alloantibodies

The presence of anti-HLA Class I and Class II alloantibodies is categorized as being negative (absent for both classes of alloantibodies), positive for Class I, positive for Class II, and positive for both Class I and Class II alloantibodies. (NCT01921218)
Timeframe: Baseline up to Month 36

,
InterventionParticipants (Count of Participants)
Baseline - NegativeBaseline - Positive Class IBaseline - Positive Class IIBaseline - Positive Class I and IIMonth 12 - NegativeMonth 12 - Positive Class IMonth 12 - Positive Class IIMonth 12 - Positive Class I and IIMonth 24 - NegativeMonth 24 - Positive Class IMonth 24 - Positive Class IIMonth 24 - Positive Class I and IIMonth 36 - NegativeMonth 36 - Positive Class IMonth 36 - Positive Class IIMonth 36 - Positive Class I and II
Belatacept Treatment Group6000410010201020
Control Group5200243312111211

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MTD of Inotuzumab Ozogamicin With CVP for Patients With Relapsed or Refractory CD22+ Acute Leukemia

To determine the maximum tolerated dose (MTD) of inotuzumab ozogamicin in this regimen for patients with relapsed or refractory CD22+ acute leukemia (B-cell acute lymphoblastic leukemia [B-ALL], mixed phenotype, and Burkitt's). The MTD is defined as the highest dose studied in which the incidence of dose-limiting toxicities is < 33% using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. (NCT01925131)
Timeframe: 28 days

Interventionmg/m^2 (Number)
Day 1 DoseDay 8 DoseDay 15 Dose
CVP + Inotuzumab0.80.50.5

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Frequency and Severity of Toxicities

Number of participants with Grade 3-5 adverse events that are possibly, probably or definitely related to study drug are reported by given type of adverse event. (NCT01925131)
Timeframe: Up to 3 years

,,,,,
InterventionParticipants (Number)
AnemiaAscitesDysphagiaEncephalopathyEnterocolitisFatigueFebrile neutropeniaFeverGastric hemorrhageGastrointestinal disorders - Other, specifyHeadacheHyperglycemiaHypertensionHypoalbuminemiaHypocalcemiaHypokalemiaInfections and infestations - Other, specifyIntracranial hemorrhageLipase increasedLung infectionLymphocyte count decreasedMucositis oralNeutrophil count decreasedPlatelet count decreasedRenal and urinary disorders - Other, specifySepsisSkin infectionWhite blood cell decreased
CVP + Inotuzumab Dose Level 12000000120000000010020320003
CVP + Inotuzumab Dose Level 22000002101100000000010320004
CVP + Inotuzumab Dose Level 370110121000411100000319700110
CVP + Inotuzumab Dose Level 43000003000041001000230440005
CVP + Inotuzumab Dose Level 55100101000020000100060850007
CVP + Inotuzumab MTD51000171000010004010618101209

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Response Rate (CR+CRi) Among Expansion Cohort

The response rate (CR + CRi) is defined as the rate of complete remission (CR) + complete remission with incomplete count recovery (CRi). Complete remission (CR) is defined as < 5% marrow aspirate blasts, neutrophils ≥ 1000/uL, platelets > 100,000/uL, no blasts in peripheral blood, and C1 Extramedullary disease status. C1 Extramedullary disease status is characterized by complete disappearance of all measurable and non-measurable extramedullary disease with the exception of lesions for which the following must be true: for participants with at least one measurable lesion, all lesions must have reduced by 75% in sum of products of greatest diameters (SPD), have no new lesions, and the spleen and other previously enlarged organs must have regressed in size. Complete remission with incomplete platelet recovery (CRi) is defined the same as CR, except absolute neutrophil count may be <1000/uL and/or platelet count may be ≤ 100,000/uL. (NCT01925131)
Timeframe: Up to 3 years

Interventionpercentage of participants (Number)
CVP + Inotuzumab MTD83.33

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Complete Remission Rate

Number (count) of participants that achieved remission according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007). (NCT01925612)
Timeframe: Up to 6 months

InterventionParticipants (Count of Participants)
Part 1: BV(1.2 mg/kg) + RCHOP20
Part 1: BV(1.8 mg/kg) + RCHOP16
Part 2: BV(1.8 mg/kg) + RCHP9
Part 3: BV(1.8 mg/kg) + RCHP6
Part 3: RCHOP8

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Incidence of Adverse Events

Number (count) of participants that experienced at least 1 adverse event. (NCT01925612)
Timeframe: Up to 6 months

InterventionParticipants (Count of Participants)
Part 1: BV(1.2 mg/kg) + RCHOP29
Part 1: BV(1.8 mg/kg) + RCHOP22
Part 2: BV(1.8 mg/kg) + RCHP11
Part 3: BV(1.8 mg/kg) + RCHP11
Part 3: RCHOP12

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Objective Response Rate

Number (count) of participants that achieved complete or partial remission at the end of treatment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007) (NCT01925612)
Timeframe: Up to 6 months

InterventionParticipants (Count of Participants)
Part 1: BV(1.2 mg/kg) + RCHOP23
Part 1: BV(1.8 mg/kg) + RCHOP19
Part 2: BV(1.8 mg/kg) + RCHP10
Part 3: BV(1.8 mg/kg) + RCHP10
Part 3: RCHOP9

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Incidence of Laboratory Abnormalities

Number (count) of participants that experienced a Grade 3 or higher maximum post-baseline laboratory toxicity (hematology and chemistry). Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event. (NCT01925612)
Timeframe: Up to 6 months

,,,,
InterventionParticipants (Count of Participants)
Any Hematology TestLymphocytes (x10^3/uL)Absolute Neutrophil Count (x10^3/uL)Neutrophils (x10^3/uL)Leukocytes (x10^3/uL)Hemoglobin (x10^3/uL)Platelets (x10^3/uL)Any Chemistry TestGlucose (mg/dL)Potassium (mEq)/LCalcium (mg/dL)Sodium (mEq/L)Alanine Aminotransferase (IU/L)
Part 1: BV(1.2 mg/kg) + RCHOP10844301430100
Part 1: BV(1.8 mg/kg) + RCHOP161544211752120
Part 2: BV(1.8 mg/kg) + RCHP4311100201001
Part 3: BV(1.8 mg/kg) + RCHP6422110101000
Part 3: RCHOP4400100312000

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Progression-free Survival

Median progression-free survival (in months) and observed minimum-maximum range. (NCT01925612)
Timeframe: Up to approximately 4 years

InterventionMonths (Median)
Part 1: BV(1.2 mg/kg) + RCHOPNA
Part 1: BV(1.8 mg/kg) + RCHOPNA
Part 2: BV(1.8 mg/kg) + RCHPNA
Part 3: BV(1.8 mg/kg) + RCHPNA
Part 3: RCHOPNA

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Overall Survival

Median overall survival (in months) and observed minimum-maximum range. (NCT01925612)
Timeframe: Up to approximately 4 years

InterventionMonths (Median)
Part 1: BV(1.2 mg/kg) + RCHOPNA
Part 1: BV(1.8 mg/kg) + RCHOPNA
Part 2: BV(1.8 mg/kg) + RCHPNA
Part 3: BV(1.8 mg/kg) + RCHPNA
Part 3: RCHOPNA

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Change in PSA Response

Percent of men with Prostate Specific Antigen (PSA) declines > 30%, > 50% and > 90% (NCT01940276)
Timeframe: Baseline and up to 2 years

,
Interventionpercentage of participants (Number)
Percent of men with PSA declines > 30%Percent of men with PSA declines > 50%Percent of men with PSA declines > 90%
Abiraterone Acetate and Prednisone: African American Men827448
Abiraterone Acetate and Prednisone: White Men786638

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Overall Survival

Length of patient's life after starting study (NCT01940276)
Timeframe: up to 3 years

Interventionmonths (Median)
Abiraterone Acetate and Prednisone: White Men35.7
Abiraterone Acetate and Prednisone: African American Men35.9

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Median Radiographic Progression Free Survival (PFS)

Time in months from the start of study treatment to the date of first progression according to Prostate Cancer Working Group 2 criteria, or to death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median rPFS was estimated using a Kaplan-Meier curve. (NCT01940276)
Timeframe: up to 2 years

Interventionmonths (Median)
Abiraterone Acetate and Prednisone: White Men16.8
Abiraterone Acetate and Prednisone: African American Men16.6

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Median Time to PSA Progression

Time to PSA progression as defined by PCWG 2 criteria is the date that a 25% or greater increase and an absolute increase of 2 ng/mL or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later. (NCT01940276)
Timeframe: up to 2 years

Interventionmonths (Median)
Abiraterone Acetate and Prednisone: White Men11.5
Abiraterone Acetate and Prednisone: African American Men16.6

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Number of Men With PSA Decline to < 0.1 and < 0.2 ng/ml

Number of men who achieve a PSA decline to < 0.1 and < 0.2 ng/ml (NCT01940276)
Timeframe: up to 2 years

,
InterventionParticipants (Count of Participants)
PSA decline to < 0.1PSA decline to < 0.2
Abiraterone Acetate and Prednisone: African American Men913
Abiraterone Acetate and Prednisone: White Men45

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Percent of Subjects Experiencing Hypertension

Incidence and grade of hypertension in the two populations. (Grade 1: Systolic BP 120 to 139 mmHg or diastolic BP 80 to 89 mmHg, Grade 2: Systolic BP 140 to 159 mmHg or diastolic BP 90 to 99 mmHg, Grade 3: Systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg, Grade 4: Life-threatening consequences, urgent intervention indicated) (NCT01940276)
Timeframe: up to 2 years

,
InterventionParticipants (Count of Participants)
All gradesGrades 3 and 4
Abiraterone Acetate and Prednisone: African American Men2312
Abiraterone Acetate and Prednisone: White Men208

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Proportion of Participants With Pathologic Stage Less Than or Equal to ypT2N0

The proportion of participants with pathologic stage less than or equal to ypT2N0 will be descriptively summarized and compared between the two treatment arms. The proportion will be calculated as the number of patients with less than or equal to ypT2N0 in each treatment arm divided by the total number of patients who underwent surgery in the same arm. (NCT01946165)
Timeframe: For all participants who underwent surgery, from start of treatment until surgery is completed

InterventionParticipants (Count of Participants)
Group A: Abiraterone + Enzalutamide + LHRHa + Prednisone.13
Group B: Abiraterone + LHRHa + Prednisone11

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Proportion of Participants With Positive Surgical Margins

The difference in the rate of positive surgical margins between the two groups will be descriptively summarized. (NCT01946165)
Timeframe: For both groups, tumor samples collected at baseline and during surgery.

InterventionParticipants (Count of Participants)
Group A: Abiraterone + Enzalutamide + LHRHa + Prednisone9
Group B: Abiraterone + LHRHa + Prednisone2

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Number of Grade 3, 4, or 5 Hematological Adverse Events (AEs).

The number of Grade 3, 4, or 5 hematological AEs. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

,
InterventionAdverse Events (Number)
Grade 3Grade 4Grade 5
MMF Maintenance300
MMF Withdrawal000

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Number of Grade 3, 4, or 5 Adverse Events (AEs)

The number of Grade 3, 4, or 5 AEs. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

,
InterventionAdverse Events (Number)
Grade 3Grade 4Grade 5
MMF Maintenance1820
MMF Withdrawal1500

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Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Disease Damage Index for Systemic Lupus Erythematosus (SLICC/DI): Total Score

The SLICC/DI measures accumulated damage that has occurred since the onset of systemic lupus erythematosus (SLE), regardless of cause, in 12 organ systems. SLE damage is defined as an irreversible change in an organ or system that has been present for at least 6 months. The SLICC/DI includes 39 areas of damage in 12 domains, where each item is rated as present or absent; if evidence of damage is present for a particular item, it is given a score of 1. Some items are scored with 2 or 3 points in the case of recurring events or end stage renal disease. The SLICC/DI total score will be computed as the sum of all scores for items indicated as present; scores can range from 0 to 45. Higher scores indicate more damage. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 24, Week 48, and Week 60

,
InterventionScores on a Scale (Mean)
Week 24Week 48Week 60
MMF Maintenance0.00.00.0
MMF Withdrawal0.00.00.0

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Change From Baseline in the Short Form Health Survey (SF-36) Physical Functioning (PF) Score

The SF-36 is a 36-item, patient-reported survey of patient health. Higher scores indicate better outcomes while lower scores indicate more disability. The PF score is used to assess changes in physical functioning. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 24, Week 48, and Week 60

,
InterventionScores on a Scale (Mean)
Week 24Week 48Week 60
MMF Maintenance-0.33-0.49-0.19
MMF Withdrawal0.220.951.79

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Change From Baseline in the Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score

The SF-36 is a 36-item, patient-reported survey of patient health. Higher scores indicate better outcomes while lower scores indicate more disability. The Physical Component Score is comprised of the Physical Functioning Scale, the Role-Physical Scale, the Bodily Pain Scale, and the General Health Scale. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 24, Week 48, and Week 60

,
InterventionScores on a Scale (Mean)
Week 24Week 48Week 60
MMF Maintenance-0.75-1.92-1.51
MMF Withdrawal0.900.251.51

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Change From Baseline in the Lupus Quality of Life (QoL)Score

The Lupus QoL assessment is a 34 item questionnaire across 8 domains that is designed to find out how systemic lupus erythematosus (SLE) affects a participant's life over the preceding 4 weeks. Scores range from 0 (worst QoL) to 100 (best QoL). Domains include physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 24, Week 48, and Week 60

,
InterventionScores on a Scale (Mean)
Change in Physical Health at Week 24Change in Physical Health at Week 48Change in Physical Health at Week 60Change in Pain at Week 24Change in Pain at Week 48Change in Pain at Week 60Change in Planning at Week 24Change in Planning at Week 48Change in Planning at Week 60Change in Intimate Relationships at Week 24Change in Intimate Relationships at Week 48Change in Intimate Relationships at Week 60Change in Burden to Others at Week 24Change in Burden to Others at Week 48Change in Burden to Others at Week 60Change in Emotional Health at Week 24Change in Emotional Health at Week 48Change in Emotional Health at Week 60Change in Body Image at Week 24Change in Body Image at Week 48Change in Body Image at Week 60Change in Fatigue at Week 24Change in Fatigue at Week 48Change in Fatigue at Week 60
MMF Maintenance-1.11-2.830.00-0.17-3.10-0.190.35-5.43-3.03-1.47-0.81-2.081.56-0.58-1.33-0.87-2.03-1.522.94-0.173.223.78-2.18-0.57
MMF Withdrawal1.040.461.561.771.601.423.90-0.180.184.29-1.102.860.18-4.43-3.550.09-1.22-0.87-1.09-0.56-4.45-1.17-1.56-1.95

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Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT-F) Fatigue Scale (FS): Total Score

FACIT-Fatigue scale (FS) is a 13-item questionnaire completed by the patient (participant), that provides a measure of fatigue/quality of life, with a 7-day recall period. The participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status. A decrease in the FACIT-FS score reflects worse fatigue/quality of life. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 24, Week 48, and Week 60

,
Interventionunits on a scale (Mean)
Week 24Week 48Week 60
MMF Maintenance-2.41-3.39-3.13
MMF Withdrawal-0.81-0.850.42

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Time to First Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare

The time to first severe SELENA-SLEDAI flare was defined as the time from Baseline/Day 0 to the date of the first severe SELENA-SLEDAI flare. Time to severe SELENA-SLEDAI flare was defined in study weeks as: date of SELENA-SLEDAI flare minus (-) baseline date. The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

InterventionWeeks (Mean)
MMF Maintenance43.5
MMF Withdrawal41.5

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Time to First Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare

The time to first mild/moderate or severe SELENA-SLEDAI flare was defined as the time from Baseline/Day 0 to the date of the first mild/moderate or severe SELENA-SLEDAI flare. Time to SELENA-SLEDAI flare was defined in study weeks as: date of SELENA-SLEDAI flare minus (-) baseline date. The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

InterventionWeeks (Mean)
MMF Maintenance20.5
MMF Withdrawal27.5

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Time to Clinically Significant Disease Reactivation

The time to clinically significant disease reactivation was defined as the time from Baseline/Day 0 to the date of the first Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) assessment that met (or went on to meet) the criteria for clinically significant disease reactivation. Time to clinically significant disease reactivation was defined in study weeks as: date of SELENA-SLEDAI assessment that met reactivation criteria minus (-) baseline date. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

InterventionWeeks (Mean)
MMF Maintenance38.0
MMF Withdrawal38.5

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Time From Clinically Significant Disease Reactivation to Return to Pre-Flare Steroid Dose

For each participant who experienced disease reactivation, time from clinically significant disease reactivation to recovery to pre-flare steroid dose was calculated in study days as: date of clinically significant disease reactivation minus (-) date of return to pre-flare steroid dose. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

InterventionDays (Mean)
MMF MaintenanceNA
MMF Withdrawal37

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Time From Clinically Significant Disease Reactivation to Recovery to Baseline British Isles Lupus Assessment Group (BILAG) Score or BILAG C

For each participant who experienced disease reactivation, time from clinically significant disease reactivation to recovery to baseline BILAG scores or BILAG C, whichever is worse, was calculated in study days as: date of clinically significant disease reactivation minus (-) date of BILAG recovery. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

InterventionDays (Mean)
MMF Maintenance114.5
MMF Withdrawal77.7

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Time From Clinically Significant Disease Reactivation to Improvement in British Isles Lupus Assessment Group (BILAG) From Maximum Level During Flare

For each participant who experienced disease reactivation, time from clinically significant disease reactivation to improvement in BILAG from maximum level (at least an A or B) during the flare was calculated in study days as: date of clinically significant disease reactivation minus (-) date of BILAG improvement. If multiple body systems had a BILAG flare at the visit, then the body system with the most severe score was tracked for improvement; if multiple body systems had the same score (at least an A or B), then just one needed to show improvement. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

InterventionDays (Mean)
MMF Maintenance114.5
MMF Withdrawal40.5

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The Addition of Aggressive Adjunctive Therapy to Mycophenolate Mofetil (MMF) or Change in MMF Therapy to Cytotoxic Drug Due to Flare by Week 60

The addition of aggressive adjunctive therapy could include intravenous (IV) immunoglobulin or rituximab at any point during the participant's study participation. A change in therapy to cytotoxic drug due to flare could include drugs such as cyclophosphamide, etc. A blinded list of study medications was reviewed to identify the addition of aggressive adjunctive therapy or cytotoxic drugs. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

InterventionParticipants (Count of Participants)
MMF Maintenance0
MMF Withdrawal1

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Number of Serious Adverse Events (SAEs).

The number of SAEs. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

InterventionSerious Adverse Events (Number)
MMF Maintenance12
MMF Withdrawal6

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Number of Participants in the Lupus Nephritis Subgroup Experiencing a British Isles Lupus Assessment Group (BILAG) A Renal Flare by Week 60

The BILAG assesses participants on a variety of disease activity criteria in nine body system categories (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, and hematological). Each category is scored as an A, B, C, or D/E, where A indicates most severe disease activity and D/E indicates inactive/no disease activity. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

InterventionParticipants (Count of Participants)
MMF Maintenance0
MMF Withdrawal2

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Number of Participants Experiencing Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF <2000 mg/Day Subgroup

"The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.~MMF: mycophenolate mofetil" (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

InterventionParticipants (Count of Participants)
MMF Maintenance3
MMF Withdrawal6

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Number of Participants Experiencing Clinically Significant Disease Reactivation by Week 60

Disease reactivation requires:1) SELENA-SLEDAI mild/moderate or severe flare,and 2) Increased immunosuppressive therapy on a sustained basis,defined by one of the following criteria:a) Sustained activity:Significant prolonged SLE flare requiring steroid increase/burst to ≥15 mg/day prednisone (or equivalent) for >4 weeks.b) Frequent relapsing/remitting:Participant flares requiring an increase/burst of steroids and is successfully tapered to <15 mg/day within 4 weeks, but this occurs on >2 occasions, or IA, IM or IV steroids on more than1 occasion.c)Clinical activity of sufficient severity to warrant resumption of/increased dose of MMF or addition of other major immunosuppressive including AZA or MTX.Regardless of steroid use, if the investigator observes disease activity of sufficient severity to warrant resumption, addition or increase in dosage of major immunosuppressant in the setting of a SELENA-SLEDAI flare, participant has met the primary endpoint.Risk difference also included (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

InterventionParticipants (Count of Participants)
MMF Maintenance5
MMF Withdrawal9

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Number of Participants Experiencing Any British Isles Lupus Assessment Group (BILAG) A Flare by Week 60

The BILAG assesses participants on a variety of disease activity criteria in nine body system categories (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, and hematological). Each category is scored as an A, B, C, or D/E, where A indicates most severe disease activity and D/E indicates inactive/no disease activity. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

InterventionParticipants (Count of Participants)
MMF Maintenance1
MMF Withdrawal4

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Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Non-Lupus Nephritis Subgroup

The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

InterventionParticipants (Count of Participants)
MMF Maintenance1
MMF Withdrawal1

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Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Lupus Nephritis Subgroup

The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

InterventionParticipants (Count of Participants)
MMF Maintenance3
MMF Withdrawal7

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Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60

The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

InterventionParticipants (Count of Participants)
MMF Maintenance4
MMF Withdrawal8

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Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Non-Lupus Nephritis Subgroup

The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

InterventionParticipants (Count of Participants)
MMF Maintenance5
MMF Withdrawal6

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Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF ≥ 2000 mg/Day Subgroup

"The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.~MMF: mycophenolate mofetil" (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

InterventionParticipants (Count of Participants)
MMF Maintenance9
MMF Withdrawal12

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Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60

The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

InterventionParticipants (Count of Participants)
MMF Maintenance20
MMF Withdrawal25

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Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Lupus Nephritis Subgroup

The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

InterventionParticipants (Count of Participants)
MMF Maintenance15
MMF Withdrawal19

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Number of Malignancies Reported as Adverse Events (AEs).

The number of malignancies reported as AEs. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

InterventionAdverse Events (Number)
MMF Maintenance2
MMF Withdrawal3

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Cumulative Systemic Steroid Dose by Week 60

"Steroids include medications that code to a medication class which includes the terms glucocorticoid or corticosteroid. Systemic steroids will include any of these steroids that are taken by mouth (PO), intravenous (IV), or intramuscular (IM). Total cumulative systemic steroid dose, in milligrams, was summarized over the 60 week study period, or until early study termination, for each participant." (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

Interventionsteroid dose (mg) (Mean)
MMF Maintenance851
MMF Withdrawal912

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Cumulative Excess Systemic Steroid Dose From Time of Clinically Significant Disease Reactivation to Return to Pre-Flare Dose or End of Trial Participation

"For each participant who experienced disease reactivation, excess systemic steroid dose was summed from the time of clinically significant disease reactivation until the dose returns to pre-flare levels or the end of study participation, whichever occurred first. Excess systemic steroid dose was defined as the total dose given for the flare minus (-) a participant's pre-flare steroid dose. Participants who do not have an increase in their steroid use due to the flare had their excess dose set to zero. Steroids include medications that code to a medication class which includes the terms glucocorticoid or corticosteroid. Systemic steroids will include any of these steroids that are taken by mouth (PO), intravenous (IV), or intramuscular (IM)." (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

InterventionSteroid dose (mg) (Mean)
MMF Maintenance812.8
MMF Withdrawal1750.7

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All-Cause Mortality

All-cause mortality is defined as death from any cause occurring after randomization. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0. (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

InterventionParticipants (Count of Participants)
MMF Maintenance0
MMF Withdrawal0

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Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF<2000 mg/Day Subgroup

"The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.~MMF: mycophenolate mofetil" (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

InterventionParticipants (Count of Participants)
MMF Maintenance11
MMF Withdrawal13

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Number of Participants Experiencing Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF ≥ 2000 mg/Day Subgroup

"The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.~MMF: mycophenolate mofetil" (NCT01946880)
Timeframe: Baseline (Treatment Randomization) to Week 60

InterventionParticipants (Count of Participants)
MMF Maintenance1
MMF Withdrawal2

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Overall Survival (OS)

Overall survival is defined as the time from study registration to death due to any cause. (NCT01949337)
Timeframe: Up to 5 years post treatment

Interventionmonths (Median)
Arm A: (Enzalutamide)32.5
Arm B: (Enzalutamide, Abiraterone, Prednisone)34.2

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Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported

Mean Renal function as used in clinical practice, using different formula for calculation of renal function than MDRD4 (our primary efficacy parameter), and other alternate formulae (e.g. CKD-EPI). Analysis is done without considering missing values for analysis. (NCT01950819)
Timeframe: Month 12 and 24

,
InterventionmL/min/1.73m2 (Mean)
eGFR (Hoek) baseline (mL/min/1.73m2)eGFR (Hoek) month 12 (mL/min/1.73m2)eGFR (Hoek) month 24 (mL/min/1.73m2)eGFR (MDRD4) baseline (mL/min/1.73m2)eGFR (MDRD4) month 12 (mL/min/1.73m2)eGFR (MDRD4) month 24 (mL/min/1.73m2)eGFR-CKDEPI baseline (mL/min/1.73m2)eGFR-CKDEPI month 12(mL/min/1.73m2)eGFR-CKDEPI month 24 (mL/min/1.73m2)
EVR+rCNI21.3850.0849.8611.7957.5958.0711.2958.8359.39
MPA+sCNI20.1052.0052.7511.5657.5858.6811.0558.7559.95

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Evolution of Renal Function, as eGFR, Over Time by Slope Analysis.

Rate of change of renal function, as eGFR, calculated using MDRD4 formula (Coresh, 2003) and adjusted by covariates. (NCT01950819)
Timeframe: Month 12 and 24

InterventionmL / min / 1.73m2 / day (Mean)
EVR+rCNI0.0001
MPA+sCNI0.0047

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Incidence of Adverse Events, Serious Adverse Events and Adverse Events Leading to Study Regimen Discontinuation.

Incidence of adverse events, serious adverse events and adverse events leading to study regimen discontinuation. (NCT01950819)
Timeframe: Month 24

InterventionParticipants (Count of Participants)
EVR+rCNI276
MPA+sCNI152

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Incidence of Major Cardiovascular Events.

Incidence of major cardiovascular events by Preferred Term (NCT01950819)
Timeframe: Month 24

InterventionParticipants (Count of Participants)
EVR+rCNI66
MPA+sCNI86

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Incidence of Malignancies.

Incidence of malignancies. (NCT01950819)
Timeframe: Month 24

InterventionParticipants (Count of Participants)
EVR+rCNI41
MPA+sCNI39

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Incidence of Composite of tBPAR (Treated Biopsy-proven Acute Rejection)or eGRF<50 mL/Min/1.73m2 by Subgroup

Incidence of composite of tBPAR or eGRF<50 mL/min/1.73m2 by subgroup (NCT01950819)
Timeframe: Month 12 and 24

,
InterventionParticipants (Count of Participants)
month 12month 24
EVR+rCNI489489
MPA+sCNI456443

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Incidence of Cytomegalovirus and BK Virus, New Onset Diabetes Mellitus, Chronic Kidney Disease With Associated Proteinuria and Calcineurin Inhibitor Associated Adverse Events.

Incidence of cytomegalovirus and BK virus, new onset diabetes mellitus, chronic kidney disease with associated proteinuria and calcineurin inhibitor associated adverse events. (NCT01950819)
Timeframe: Month 24

,
InterventionParticipants (Count of Participants)
clinical signs of CMV infectionany BKV infectionnew onset of diabetes mellitusat least one event of interest
EVR+rCNI53103144871
MPA+sCNI132154138764

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Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection

Incidence of death, graft loss, tBPAR (treated biopsy proven acute rejection), BPAR (biopsy proven acute rejection), tAR (treated acute rejection), AR (acute rejection) and humoral rejection (aAMR : active antibody mediated rejection and cAMR: chronic antibody mediated rejection) (NCT01950819)
Timeframe: Month 12 and 24

,
InterventionParticipants (Count of Participants)
deaths month 12deaths month 24graft loss month 12graft loss month 24tBPAR month 12tBPAR month 24BPAR month 12BPAR month 24tAR month 12tAR month 24AR month 12AR month 24aAMR month 12aAMR month 24cAMR month 12cAMR month 24
EVR+rCNI203233371071181141271291451471677384913
MPA+sCNI2836283291989510411712613314461691418

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Incidence of Failure on the Composite Endpoint of Graft Loss or Death.

Incidence of failure on the composite endpoint of graft loss or death. (NCT01950819)
Timeframe: Month 12 and 24

,
InterventionParticipants (Count of Participants)
month 12month 24
EVR+rCNI5167
MPA+sCNI5465

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Incidence of eGFR < 50 mL/Min/1.73m2

Incidence of eGFR < 50 mL/min/1.73m2 (NCT01950819)
Timeframe: Month 12 and 24

,
InterventionParticipants (Count of Participants)
month 12month 24
EVR+rCNI456474
MPA+sCNI424423

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Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios.

Mean urinary protein and albumin excretion by treatment estimated by mean urinary protein/creatinine and urinary albumin/creatinine ratios. (NCT01950819)
Timeframe: Baseline, Month 12 and 24

,
Interventionmg/g (Mean)
albumine /creatinine ratio baselinealbumine /creatinine ratio month 12albumine /creatinine ratio month 24protein /creatinine ratio baselineprotein /creatinine ratio month 12protein /creatinine ratio month 24
EVR+rCNI1019.75150.061149.0491648.10298.557290.242
MPA+sCNI646.111111.322116.6181142.59234.698233.009

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Incidence of Failure on the Composite Endpoint of tBPAR, Graft Loss, Death or eGFR < 50 mL/Min/1.73m2

Incidence of failure on the composite endpoint of tBPAR, graft loss, death or eGFR < 50 mL/min/1.73m2 (NCT01950819)
Timeframe: Month 12 and 24

,
InterventionParticipants (Count of Participants)
month 12month 24
EVR+rCNI497497
MPA+sCNI466457

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Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death

Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death (NCT01950819)
Timeframe: Month 12 and 24

,
InterventionParticipants (Count of Participants)
month 12month 24
EVR+rCNI146169
MPA+sCNI131147

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Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2.

Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2. (NCT01950819)
Timeframe: Month 12 is Primary, Month 24 secondary

,
InterventionParticipants (Count of Participants)
month 12month 24
EVR+rCNI489489
MPA+sCNI456443

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Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death or Loss to Follow-up

Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death or loss to follow-up (NCT01950819)
Timeframe: Month 12 and 24

,
InterventionParticipants (Count of Participants)
month 12month 24
EVR+rCNI181218
MPA+sCNI170201

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Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2 Among Compliant Subjects.

Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2 among compliant subjects. (NCT01950819)
Timeframe: Month 12 and 24

,
InterventionParticipants (Count of Participants)
month 12month 24
EVR+rCNI6062
MPA+sCNI106102

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Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants)

"Incidence tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), by severity (grade IA, IB, IIA, IIB, III) and time to event. Grades for T-cell mediated rejection, with increasing severity:~Type IA - Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).~Type IB - Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).~Type IIA - Mild to moderate intimal arteritis~Type IIB - Severe intimal arteritis comprising > 25% of the lumenal area~Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)" (NCT01950819)
Timeframe: Month 12 and 24

,
InterventionParticipants (Count of Participants)
Patient's maximum tBPAR grade : no grade (missing)Patient's maximum tBPAR grade : grade IAPatient's maximum tBPAR grade : grade IBPatient's maximum tBPAR grade : grade IIAPatient's maximum tBPAR grade : grade IIBPatient's maximum tBPAR grade : grade III
EVR+rCNI2534232196
MPA+sCNI1836172430

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Incidence of tBPAR (Excluding Grade IA Rejections) or GFR<50 mL/Min/1.73m2

Incidence of tBPAR (excluding grade IA rejections) or GFR<50 mL/min/1.73m2 (NCT01950819)
Timeframe: Month 12 and 24

,
InterventionParticipants (Count of Participants)
month 12month 24
EVR+rCNI475475
MPA+sCNI441426

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Incidence of tBPAR (Treated Biopsy-proven Acute Rejection) Excluding Grade IA Rejections

"Incidence of tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), excluding grade IA rejections. Grades for T-cell mediated rejection, with increasing severity:~Type IA - Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).~Type IB - Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).~Type IIA - Mild to moderate intimal arteritis~Type IIB - Severe intimal arteritis comprising > 25% of the lumenal area~Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)" (NCT01950819)
Timeframe: Month 12 and 24

,
InterventionParticipants (Count of Participants)
month 12month 24
EVR+rCNI6674
MPA+sCNI5355

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Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events)

"Incidence tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), by severity (grade IA, IB, IIA, IIB, III) and time to event. Grades for T-cell mediated rejection, with increasing severity:~Type IA - Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).~Type IB - Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).~Type IIA - Mild to moderate intimal arteritis~Type IIB - Severe intimal arteritis comprising > 25% of the lumenal area~Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)" (NCT01950819)
Timeframe: Month 12 and 24

,
Interventionevents (Number)
overall number of tBPAR regardless of gradenumber of tBPAR regardless of grade days 1-90number of tBPAR regardless of grade days 91-180number of tBPAR regardless of grade days 181-360number of tBPAR regardless of grade days 361-540number of tBPAR regardless of grade days 541-720number of tBPAR regardless of grade days 721-810
EVR+rCNI14672242512112
MPA+sCNI1166314201522

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Renal Allograft Function : Mean Estimated Glomerular Filtration Rate, eGFR

Renal allograft function : mean estimated glomerular filtration rate, eGFR (NCT01950819)
Timeframe: Baseline (week 4), Month 12 and 24

,
InterventionmL/min/1.73m2 (Mean)
baseline (week 4)month 12month 24
EVR+rCNI53.1353.2952.63
MPA+sCNI52.2554.4954.91

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Renal Function Assessed by Creatinine Lab Values

Mean Renal function as assessed in clinical practice, by ceatinine values. Analysis is done without considering missing values for analysis. (NCT01950819)
Timeframe: Month 12 and 24

,
Interventionmicromol/L (Mean)
screening baseline (creatinine, micromol/L)month 12 (creatinine, micromol/L)month 24 (creatinine, micromol/L)
EVR+rCNI590.1129.8130.1
MPA+sCNI601.8128.6127.6

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Part A: Percentage of Patients Experiencing Adverse Events (AEs)

"The safety and tolerability of olaparib in combination with abiraterone was assessed during Part A of the study. The percentage of patients experiencing AEs, including information on seriousness, severity, study treatment relationship and those leading to discontinuation for all doses of olaparib and for abiraterone are presented.~Severity of AEs was assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse events (CTCAE) v4.0. AEs were assigned to a Grade from 1 through 5 as follows:~Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening requiring hospitalisation; Grade 4: Life-threatening consequences; Grade 5: Death related to AE.~'c-r' = causally related 'discont' = discontinuation." (NCT01972217)
Timeframe: Cohort 1 and 2: From baseline in Part A (Day 1 for each cohort) up to 30 days following last dose of study treatment.

,
InterventionPercentage of patients (Number)
Any AE c-r to olaparib + abirateroneAny AE c-r to olaparib onlyAny AE c-r to abiraterone onlyAny AE CTCAE Grade 3 or higherAny AE CTCAE Grade 3 or higher c-r to olaparibAny AE CTCAE Grade 3 or higher c-r to abirateroneAny AE with outcome = deathAny serious AE (SAE)Any SAE c-r to olaparibAny SAE c-r to abirateroneAny AE causing discont of olaparibAny AE causing discont of olaparib c-r to olaparibAny AE causing discont olaparib c-r to abiraterone
Part A Cohort 1: Olaparib 200 mg + Abiraterone66.733.3066.700066.700000
Part A Cohort 2: Olaparib 300 mg + Abiraterone46.27.715.423.17.77.7023.1007.700

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Part A PK: Abiraterone Tmax,ss

"Following multiple dosing to steady state of abiraterone 1000 mg once daily, the Cohort 2 abiraterone tmax,ss is presented for abiraterone monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.

InterventionHours (Median)
Abiraterone aloneOlaparib + abiraterone
Part A Cohort 2 Group 2: Abiraterone, Olaparib + Abiraterone2.5252.500

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Part A PK: Abiraterone Tmax,ss

"Following multiple dosing to steady state of abiraterone 1000 mg once daily, the Cohort 2 abiraterone tmax,ss is presented for abiraterone monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.

InterventionHours (Median)
Olaparib + abiraterone
Part A Cohort 2 Group 1: Olaparib, Olaparib + Abiraterone3.000

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Part A PK: Abiraterone Cmin,ss

"Following multiple dosing to steady state of abiraterone 1000 mg once daily, the Cohort 2 abiraterone Cmin,ss is presented for abiraterone monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.

Interventionng/mL (Geometric Mean)
Abiraterone aloneOlaparib + abiraterone
Part A Cohort 2 Group 2: Abiraterone, Olaparib + Abiraterone8.3766.358

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Part A PK: Abiraterone Cmin,ss

"Following multiple dosing to steady state of abiraterone 1000 mg once daily, the Cohort 2 abiraterone Cmin,ss is presented for abiraterone monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.

Interventionng/mL (Geometric Mean)
Olaparib + abiraterone
Part A Cohort 2 Group 1: Olaparib, Olaparib + Abiraterone7.983

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Part A PK: Abiraterone Cmax,ss

"Following multiple dosing to steady state of abiraterone 1000 mg once daily, the Cohort 2 abiraterone Cmax,ss is presented for abiraterone monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.

Interventionnanograms per millilitre (ng/mL) (Geometric Mean)
Abiraterone aloneOlaparib + abiraterone
Part A Cohort 2 Group 2: Abiraterone, Olaparib + Abiraterone145.886.12

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Part A PK: Abiraterone Cmax,ss

"Following multiple dosing to steady state of abiraterone 1000 mg once daily, the Cohort 2 abiraterone Cmax,ss is presented for abiraterone monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.

Interventionnanograms per millilitre (ng/mL) (Geometric Mean)
Olaparib + abiraterone
Part A Cohort 2 Group 1: Olaparib, Olaparib + Abiraterone130.7

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Part A PK: Abiraterone AUCss

"Following multiple dosing to steady state of abiraterone 1000 mg once daily, the Cohort 2 abiraterone AUCss is presented for abiraterone monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.

Interventionng*h/mL (Geometric Mean)
Abiraterone aloneOlaparib + abiraterone
Part A Cohort 2 Group 2: Abiraterone, Olaparib + Abiraterone825.5524.6

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Part A PK Analysis: Olaparib Time to Reach Maximum Plasma Concentration at Steady State (Tmax,ss)

"Following multiple dosing to steady state of olaparib 300 mg bid, the Cohort 2 olaparib tmax,ss is presented for olaparib monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.

InterventionHours (h) (Median)
Olaparib aloneOlaparib + abiraterone
Part A Cohort 2 Group 1: Olaparib, Olaparib + Abiraterone2.0002.080

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Part A PK Analysis: Olaparib Time to Reach Maximum Plasma Concentration at Steady State (Tmax,ss)

"Following multiple dosing to steady state of olaparib 300 mg bid, the Cohort 2 olaparib tmax,ss is presented for olaparib monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.

InterventionHours (h) (Median)
Olaparib + abiraterone
Part A Cohort 2 Group 2: Abiraterone, Olaparib + Abiraterone2.000

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Part A PK Analysis: Olaparib Minimum Plasma Concentration at Steady State (Cmin,ss)

"Following multiple dosing to steady state of olaparib 300 mg bid, the Cohort 2 olaparib Cmin,ss is presented for olaparib monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.

Interventionmcg/mL (Geometric Mean)
Olaparib aloneOlaparib + abiraterone
Part A Cohort 2 Group 1: Olaparib, Olaparib + Abiraterone1.2640.9170

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Part A PK Analysis: Olaparib Minimum Plasma Concentration at Steady State (Cmin,ss)

"Following multiple dosing to steady state of olaparib 300 mg bid, the Cohort 2 olaparib Cmin,ss is presented for olaparib monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.

Interventionmcg/mL (Geometric Mean)
Olaparib + abiraterone
Part A Cohort 2 Group 2: Abiraterone, Olaparib + Abiraterone1.279

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Part A PK Analysis: Olaparib Area Under the Plasma Concentration-Time Curve at Steady State (AUCss)

"Following multiple dosing to steady state of olaparib 300 mg bid, the Cohort 2 olaparib AUCss is presented for olaparib monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.

Interventionmcg*h/mL (Geometric Mean)
Olaparib aloneOlaparib + abiraterone
Part A Cohort 2 Group 1: Olaparib, Olaparib + Abiraterone45.2740.83

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Part A PK Analysis: Olaparib Area Under the Plasma Concentration-Time Curve at Steady State (AUCss)

"Following multiple dosing to steady state of olaparib 300 mg bid, the Cohort 2 olaparib AUCss is presented for olaparib monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.

Interventionmcg*h/mL (Geometric Mean)
Olaparib + abiraterone
Part A Cohort 2 Group 2: Abiraterone, Olaparib + Abiraterone49.51

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Part A Pharmacokinetics (PK): Olaparib Maximum Plasma Concentration at Steady State (Cmax,ss)

"Following multiple dosing to steady state of olaparib 300 mg bid, the Cohort 2 olaparib Cmax,ss is presented for olaparib monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.

Interventionmicrograms per millilitre (mcg/mL) (Geometric Mean)
Olaparib aloneOlaparib + abiraterone
Part A Cohort 2 Group 1: Olaparib, Olaparib + Abiraterone7.7816.504

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Part A Pharmacokinetics (PK): Olaparib Maximum Plasma Concentration at Steady State (Cmax,ss)

"Following multiple dosing to steady state of olaparib 300 mg bid, the Cohort 2 olaparib Cmax,ss is presented for olaparib monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.

Interventionmicrograms per millilitre (mcg/mL) (Geometric Mean)
Olaparib + abiraterone
Part A Cohort 2 Group 2: Abiraterone, Olaparib + Abiraterone7.724

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Part B: Median Overall Survival (OS)

"OS was determined to assess the efficacy of olaparib when given in addition to abiraterone, compared with placebo given in addition to abiraterone.~OS was performed at the time of the analysis of rPFS, and the median OS, calculated using the Kaplan-Meier technique, is presented." (NCT01972217)
Timeframe: From baseline, every 12 weeks up to Week 72, then every 24 weeks up to 24 months.

InterventionMonths (Median)
Part B: Olaparib + Abiraterone22.7
Part B: Placebo + Abiraterone20.9

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Part B: Percentage of Patients With Progression Events or Death (rPFS)

"The efficacy of olaparib when given in combination with abiraterone was assessed by rPFS, defined as the time from randomisation to disease progression using RECIST version 1.1 (for soft tissue disease) and PCWG-2 (for bone disease) criteria, or death.~Progression using RECIST 1.1 criteria was defined as at least 20% increase from baseline in the sum of diameters of target lesions, progression of existing non-target lesions, or the appearance of at least 1 new lesion.~Progression using PCWG-2 criteria was determined if 2 or more new metastatic bone lesions were observed (with a total of at least 4 new lesions since baseline assessment if observed at the 12 week scan, or persistence of or increase in number of lesions if observed after the 12 week scan as determined by a confirmatory scan at least 6 weeks later or at next scheduled visit).~The percentage of patients with progression events is presented overall and according to RECIST 1.1 and/or PCWG-2 criteria, or death." (NCT01972217)
Timeframe: From baseline, every 12 weeks up to Week 72, then every 24 weeks up to 24 months.

InterventionPercentage of patients (Number)
Part B: Olaparib + Abiraterone64.8
Part B: Placebo + Abiraterone76.1

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Part A PK: Abiraterone AUCss

"Following multiple dosing to steady state of abiraterone 1000 mg once daily, the Cohort 2 abiraterone AUCss is presented for abiraterone monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.

Interventionng*h/mL (Geometric Mean)
Olaparib + abiraterone
Part A Cohort 2 Group 1: Olaparib, Olaparib + Abiraterone718.9

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Part B: Percentage of Patients With PSA Responses

"The percentages of patients with single visit responses and with confirmed responses are presented to assess the anti-tumour activity of olaparib when given in addition to abiraterone, compared with placebo given in addition to abiraterone.~A single visit response was defined as any post-dose visit PSA level reduced by 50% or more compared with baseline.~A confirmed response was defined as a reduction in PSA level of 50% or more on 2 consecutive occasions at least 4 weeks apart compared with baseline.~Patients may have had more than 1 single visit response or confirmed response but were counted once." (NCT01972217)
Timeframe: From baseline, then every 4 weeks up to Week 24, and then every 12 weeks.

,
InterventionPercentage of patients (Number)
Single visit responseConfirmed response
Part B: Olaparib + Abiraterone50.747.9
Part B: Placebo + Abiraterone47.942.3

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Part B: Percentage of Patients Experiencing AEs

"The safety and tolerability of olaparib when given in combination with abiraterone was assessed during Part B of the study. The percentage of patients experiencing AEs, including information on seriousness, severity, study treatment relationship and those leading to discontinuation for all doses of olaparib and for abiraterone are presented.~Severity of AEs was assessed using the NCI Common Terminology CTCAE v4.0. AEs were assigned to a Grade from 1 through 5 as follows:~Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening requiring hospitalisation; Grade 4: Life-threatening consequences; Grade 5: Death related to AE.~'c-r' = causally related. 'discont' = discontinuation. 'ola/pla' = olaparib/placebo." (NCT01972217)
Timeframe: From first dose of study treatment following randomisation in Part B up to 30 days following last dose of study treatment (up to approximately 3 years).

,
InterventionPercentage of patients (Number)
Any AE c-r to ola/pla + abirateroneAny AE c-r to ola/pla onlyAny AE c-r to abiraterone onlyAny AE CTCAE Grade 3 or higherAny AE CTCAE Grade 3 or higher c-r to ola/plaAny AE CTCAE Grade 3 or higher c-r to abirateroneAny AE with outcome = deathAny AE with outcome = death c-r to ola/plaAny AE with outcome = death c-r to abirateroneAny SAEAny SAE c-r to ola/plaAny SAE c-r to abirateroneAny AE causing discont of ola/plaAny AE causing discont of treatment c-r to ola/plaAny AE causing discont treatment c-r abiraterone
Part B: Olaparib + Abiraterone45.118.31.453.523.916.95.61.4035.29.95.629.616.98.5
Part B: Placebo + Abiraterone12.79.97.028.25.61.41.40019.71.409.95.61.4

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Part B: Median Radiological Progression-Free Survival (rPFS) Time

"The efficacy of olaparib when given in combination with abiraterone was assessed by rPFS, defined as the time from randomisation to disease progression using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 (for soft tissue disease) and Prostate Cancer Working Group 2 (PCWG-2) (for bone disease) criteria, or death.~Progression using RECIST 1.1 criteria was defined as at least 20% increase from baseline in the sum of diameters of target lesions, progression of existing non-target lesions, or the appearance of at least 1 new lesion.~Progression using PCWG-2 criteria was determined if 2 or more new metastatic bone lesions were observed (with a total of at least 4 new lesions since baseline assessment if observed at the 12 week scan, or persistence of or increase in number of lesions if observed after the 12 week scan as determined by a confirmatory scan at least 6 weeks later or at next scheduled visit)." (NCT01972217)
Timeframe: From baseline, every 12 weeks up to Week 72, then every 24 weeks up to 24 months.

InterventionMonths (Median)
Part B: Olaparib + Abiraterone13.8
Part B: Placebo + Abiraterone8.2

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Part B: Percentage of Patients With at Least One Objective Response (Objective Response Rate [ORR])

"The overall radiological ORR was calculated to assess the anti-tumour activity of olaparib in combination with abiraterone, compared with placebo in combination with abiraterone.~The best overall ORR was defined as the percentage of patients with at least 1 visit response of complete response (CR) or partial response (PR) in soft tissue disease assessed by RECIST 1.1 and also bone scan status of non-progressive disease or non-evaluable for their bone scans assessed by PCWG-2.~CR: Disappearance of all target lesions. Reduction of pathological lymph nodes to <10 millimetres.~PR: At least a 30% decrease in the sum of diameters of target lesions from baseline.~The percentage of patients with a response is presented." (NCT01972217)
Timeframe: From baseline, then every 4 weeks up to Week 52, and then every 12 weeks.

InterventionPercentage of patients (Number)
Part B: Olaparib + Abiraterone27.3
Part B: Placebo + Abiraterone31.6

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Part B: Median Time to Second Progression or Death (PFS2)

The efficacy of olaparib when given in combination with abiraterone was assessed by PFS2, defined by local standard clinical practice and included objective radiological progression by RECIST 1.1 (soft tissue), symptomatic progression, rise in PSA level or death in the absence of overall progression. (NCT01972217)
Timeframe: From randomisation until analysis cut-off date (up to approximately 3 years).

InterventionMonths (Median)
Part B: Olaparib + Abiraterone23.3
Part B: Placebo + Abiraterone18.5

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Part B: Median Best Percentage Change From Baseline in Prostate Specific Antigen (PSA) Levels

"The best percentage change from baseline in PSA levels was determined to assess the anti-tumour activity of olaparib when given in addition to abiraterone, compared with placebo given in addition to abiraterone.~The best percentage change was defined as the biggest reduction in PSA level compared with baseline or smallest increase in the absence of a decrease." (NCT01972217)
Timeframe: From baseline, then every 4 weeks up to Week 52, and then every 12 weeks.

InterventionPercentage change in PSA level (Median)
Part B: Olaparib + Abiraterone-54.16
Part B: Placebo + Abiraterone-49.85

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Part B: Median Best Percentage Change From Baseline in Circulating Tumour Cell (CTC) Level

"The median best percentage change from baseline in CTC levels was determined to assess the anti-tumour activity of olaparib when given in combination with abiraterone, compared with placebo given in addition to abiraterone.~The best percentage change was defined as the biggest CTC level reduction compared with baseline or smallest increase in the absence of a decrease." (NCT01972217)
Timeframe: From baseline, then every 4 weeks up to Week 24, and then every 12 weeks.

InterventionPercentage change in CTC level (Median)
Part B: Olaparib + Abiraterone-1.0
Part B: Placebo + Abiraterone-1.0

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Part A: Number of Patients With Dose Limiting Toxicities (DLTs)

"DLTs were assessed by a Safety Review Committee (SRC) after a minimum of 3 patients had received at least 14 days of treatment in Part A.~A DLT was defined as any toxicity which was not a recognised AE of abiraterone or prednisolone, and was not attributable to the disease or disease-related processes under investigation, which occurred during a minimum period of 14 days treatment and which included: 1. haematological toxicity CTCAE v4.0 Grade 4 or higher present for more than 4 days (except anaemia); 2. non-haematological toxicity CTCAE v4.0 Grade 3 or higher including infection, corrected QT interval prolongation; 3. any other toxicity that was greater than that at baseline, was clinically significant and/or unacceptable, did not respond to supportive care, resulted in a disruption of dosing schedule of 7 days or more, or was judged to be a DLT by the SRC.~A DLT excluded alopecia and isolated laboratory changes of any grade without clinical sequelae or clinical significance." (NCT01972217)
Timeframe: From Day 1 for Cohort 1 and from Day 4 for Cohort 2 up to 14 days treatment with olaparib + abiraterone for 3 patients.

InterventionPatients (Number)
Part A Cohort 1: Olaparib 200 mg + Abiraterone2
Part A Cohort 2: Olaparib 300 mg + Abiraterone4

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Median Time to First Subsequent Therapy (TFST) and Median Time to Second Subsequent Therapy (TSST)

"The TFST and TSST were determined to assess the anti-tumour activity of olaparib when given in combination with abiraterone, compared with placebo given in addition to abiraterone.~TFST was defined as the time from randomisation to the earlier of first subsequent anti-cancer therapy start date following study treatment discontinuation, or death.~TSST was defined as the time from randomisation to the earlier of the second subsequent anti-cancer therapy start date following study treatment discontinuation, or death." (NCT01972217)
Timeframe: From randomisation until analysis cut-off date (up to approximately 3 years).

,
InterventionMonths (Median)
TFSTTSST
Part B: Olaparib + Abiraterone13.519.6
Part B: Placebo + Abiraterone9.718.0

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Primary Analysis: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Number of participants with TEAEs were reported. Adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment up to and including 30 days after date of last dose of study medication. (NCT01974440)
Timeframe: Up to 8 years

InterventionParticipants (Count of Participants)
Placebo + Chemoimmunotherapy (CIT)197
Ibrutinib + CIT199

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Primary Analysis: Overall Response Rate (ORR): Stratified Analysis

ORR was defined as the percentage of participants who achieved a CR or partial response (PR). Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. (NCT01974440)
Timeframe: Up to 8 years

Interventionpercentage of participants (Number)
Placebo + Chemoimmunotherapy (CIT)90.5
Ibrutinib + CIT91.6

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Primary Analysis: Overall Survival (OS): Stratified Analysis

OS was defined as the interval (in months) between the date of randomization and the date of the participant's death due to any cause. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. (NCT01974440)
Timeframe: Up to 8 years

Interventionmonths (Median)
Placebo + Chemoimmunotherapy (CIT)NA
Ibrutinib + CITNA

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Primary Analysis: Progression Free Survival (PFS): Stratified Analysis

PFS was defined as duration (in months) from the date of randomization to the date of disease progression or relapse from complete response (CR) or death, whichever was first reported. PFS was assessed by the investigator based on the 2007 Revised Response Criteria for Malignant Lymphoma. Disease progression was defined as any new lesion or increase by greater than or equal to (>=) 50 percent (%) of previously involved sites from nadir disease progression criteria: Appearance of new nodal lesion 1.5 centimeters (cm) in any axis, 50% increase in sum of product of diameters (SPD) of greater than (>) 1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. Participants who were progression-free and alive or had unknown status were censored at the last tumor assessment. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. (NCT01974440)
Timeframe: Up to 8 years

Interventionmonths (Median)
Placebo + Chemoimmunotherapy (CIT)23.75
Ibrutinib + CIT40.51

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Supplementary Analysis: Duration of Response: Unstratified Analysis - Participants With MZL

DOR in MZL participants was defined as the interval (in months) between the date of initial documentation of response (CR or PR) and the date of first documented evidence of progressive disease (or relapse for participants who experienced CR during the study) or death, whichever occurred first. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. (NCT01974440)
Timeframe: Up to 8 years

Interventionmonths (Median)
Placebo + Chemoimmunotherapy (CIT)89.17
Ibrutinib + CITNA

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Primary Analysis: Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Questionnaire

Time-to-worsening in the Lymphoma subscale of the FACT-Lym was defined as the time (in months) from the date of randomization to the start date of the worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline in participant symptoms. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (0 = not at all, 1 = a little bit, 2 = some what, 3 = quite a bit and 4 = very much, where the higher score indicated worse condition). Lymphoma subscale score is the total of reverse scores, range 0 to 60. Higher scores indicate a better quality of life. (NCT01974440)
Timeframe: Up to 8 years

Interventionmonths (Median)
Placebo + Chemoimmunotherapy (CIT)37.03
Ibrutinib + CIT24.84

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Supplementary Analysis: Number of Participants With TEAEs: Participants With MZL

Number of MZL participants with TEAEs were reported. AE was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment up to and including 30 days after date of last dose of study medication. (NCT01974440)
Timeframe: Up to 8 years

InterventionParticipants (Count of Participants)
Placebo + Chemoimmunotherapy (CIT)28
Ibrutinib + CIT28

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Supplementary Analysis: Overall Response Rate: Unstratified Analysis - Participants With MZL

ORR in MZL participants was defined as the percentage of participants who achieved a CR or PR. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. (NCT01974440)
Timeframe: Up to 8 years

Interventionpercentage of participants (Number)
Placebo + Chemoimmunotherapy (CIT)82.1
Ibrutinib + CIT89.3

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Primary Analysis: Complete Response Rate (CRR): Stratified Analysis

CRR was defined as the percentage of participants who achieved a complete response (CR); (based on investigator assessment) on or prior to the initiation of subsequent antilymphoma therapy. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if positron emission tomography (PET) negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. (NCT01974440)
Timeframe: Up to 8 years

Interventionpercentage of participants (Number)
Placebo + Chemoimmunotherapy (CIT)50.2
Ibrutinib + CIT55

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Supplementary Analysis: Progression Free Survival: Unstratified Analysis - Participants With Marginal Zone Lymphoma (MZL)

PFS in MZL participants was defined as duration (in months) from the date of randomization to the date of disease progression or relapse from CR or death, whichever was first reported. PFS was assessed by the investigator based on the 2007 Revised Response Criteria for Malignant Lymphoma. Disease progression was defined as any new lesion or increase by >=50% of previously involved sites from nadir disease progression criteria: Appearance of new nodal lesion 1.5 cm in any axis, 50% increase in SPD of >1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. Participants who were progression-free and alive or had unknown status were censored at the last tumor assessment. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. (NCT01974440)
Timeframe: Up to 8 years

Interventionmonths (Median)
Placebo + Chemoimmunotherapy (CIT)91.63
Ibrutinib + CITNA

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Supplementary Analysis: Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Questionnaire: Participants With MZL

TTW in MZL participants in the Lymphoma subscale of the FACT-Lym was defined as the time (in months) from the date of randomization to the start date of the worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline in participant symptoms. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (0 = not at all, 1 = a little bit, 2 = some what, 3 = quite a bit and 4 = very much, where the higher score indicated worse condition). Lymphoma subscale score is the total of reverse scores, range 0 to 60. Higher scores indicate a better quality of life. (NCT01974440)
Timeframe: Up to 8 years

Interventionmonths (Median)
Placebo + Chemoimmunotherapy (CIT)36.83
Ibrutinib + CIT58.91

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Primary Analysis: Duration of Response (DOR): Stratified Analysis

DOR was defined as the interval (in months) between the date of initial documentation of response (CR or PR) and the date of first documented evidence of progressive disease (or relapse for participants who experienced CR during the study) or death, whichever occurred first. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis. (NCT01974440)
Timeframe: Up to 8 years

Interventionmonths (Median)
Placebo + Chemoimmunotherapy (CIT)21.68
Ibrutinib + CIT44.32

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Supplementary Analysis: Complete Response Rate: Unstratified Analysis - Participants With MZL

CRR in MZL participants was defined as the percentage of participants who achieved a CR (based on investigator assessment) on or prior to the initiation of subsequent antilymphoma therapy. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. (NCT01974440)
Timeframe: Up to 8 years

Interventionpercentage of participants (Number)
Placebo + Chemoimmunotherapy (CIT)60.7
Ibrutinib + CIT64.3

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Supplementary Analysis: Overall Survival: Unstratified Analysis - Participants With MZL

OS in MZL participants was defined as the interval (in months) between the date of randomization and the date of the participant's death due to any cause. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL. (NCT01974440)
Timeframe: Up to 8 years

Interventionmonths (Median)
Placebo + Chemoimmunotherapy (CIT)NA
Ibrutinib + CITNA

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Number of Participants With DLTs in Non-DLBCL Population

All dose-escalation cohorts will consist of at least 3 participants. If a DLT is observed in 1 participant at a given dose level during the DLT observation period before dose escalation, additional participants will be enrolled at that dose level for a total of at least 6 participants. DLT assessment forms part of determining the Maximum Tolerated Dose (MTD). The highest dose level resulting in DLTs in less than one-third of a minimum of 6 participants will be declared the MTD. (NCT01992653)
Timeframe: Cycle (Cy) 1 Day 1 (D1) to Cy 2 D1 (cycle length=21 days)

InterventionParticipants (Count of Participants)
Polatuzumab Vedotin (1.0mg) + R-CHP0
Polatuzumab Vedotin (1.4mg) + R-CHP0
Polatuzumab Vedotin (1.8mg) + R-CHP0
Polatuzumab Vedotin (2.4mg) + R-CHP0
Polatuzumab Vedotin (1.4mg) + G-CHP0
Polatuzumab Vedotin (1.8mg) + G-CHP0
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP0
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP0

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Number of Participants With Anti-Polatuzumab Vedotin Antibodies

The Anti-Drug Antibody (ADA) screening assay was optimized to tolerate drug interference and was able to detect 90 and 500 ng/mL of the positive control sample in the presence of 20 μg/mL of polatuzumab vedotin. Polatuzumab vedotin total antibody concentrations were determined for each ADA sample. Out of a total of 186 ADA samples that were measured for polatuzumab vedotin total antibody, 184 samples had levels less than 20 μg/mL. Polatuzumab vedotin total antibody concentrations ranged from <0.050 μg/mL to 52.1 μg/mL with a median concentration of 3.38 μg/mL. (NCT01992653)
Timeframe: Baseline up to Month 9 (assessed prior to polatuzumab vedotin infusion [0 hour; Hr] on Day 2 [D2] of Cy 1 and 2, D1 of Cy 4, treatment completion/early termination [Month 6], and at 3 months post-treatment [Month 9]; cycle length=21 days)

InterventionParticipants (Count of Participants)
Polatuzumab Vedotin (1.0mg) + R-CHP0
Polatuzumab Vedotin (1.4mg) + R-CHP0
Polatuzumab Vedotin (1.8mg) + R-CHP0
Polatuzumab Vedotin (2.4mg) + R-CHP0
Polatuzumab Vedotin (1.4mg) + G-CHP0
Polatuzumab Vedotin (1.8mg) + G-CHP0
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP0
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP0

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Number of Participants With Anti-Obinutuzumab Antibodies

The ADA screening assay was optimized to tolerate drug interference and was able to detect 500 ng/mL of the ADA-positive control sample in the presence of 50 micrograms/mL of obinutuzumab. Obinutuzumab concentrations were determined for each ADA sample. Out of a total of 48 ADA samples that were measured for obinutuzumab, 9 samples had levels less than 50 micrograms/mL of obinutuzumab. Obinutuzumab concentrations in ADA samples ranged from 0.282 micrograms/mL to 522 micrograms/mL with a median concentration of 210 micrograms/mL. Therefore, it is possible that samples with obinutuzumab concentrations greater than 50 micrograms/mL might be false negative for ADA. (NCT01992653)
Timeframe: Baseline up to Month 9 (assessed prior to obinutuzumab infusion [0 Hr] on D1 of Cy 1, 2, 4 and at 3 months post-treatment [Month 9]; cycle length=21 days)

InterventionParticipants (Count of Participants)
Polatuzumab Vedotin (1.0mg) + R-CHP0
Polatuzumab Vedotin (1.4mg) + R-CHP0
Polatuzumab Vedotin (1.8mg) + R-CHP0
Polatuzumab Vedotin (2.4mg) + R-CHP0
Polatuzumab Vedotin (1.4mg) + G-CHP0
Polatuzumab Vedotin (1.8mg) + G-CHP0
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP0
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP0

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Number of Participants With Adverse Events in Non-DLBCL Population

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs). (NCT01992653)
Timeframe: Baseline up to 5 years

InterventionParticipants (Count of Participants)
Polatuzumab Vedotin (1.0mg) + R-CHP1
Polatuzumab Vedotin (1.4mg) + R-CHP0
Polatuzumab Vedotin (1.8mg) + R-CHP1
Polatuzumab Vedotin (2.4mg) + R-CHP1
Polatuzumab Vedotin (1.4mg) + G-CHP2
Polatuzumab Vedotin (1.8mg) + G-CHP2
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP0
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP0

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Number of Participants With Adverse Events in Diffuse Large B-Cell Lymphoma (DLBCL) Population

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs). (NCT01992653)
Timeframe: Baseline up to 5 years

InterventionParticipants (Count of Participants)
Polatuzumab Vedotin (1.0mg) + R-CHP2
Polatuzumab Vedotin (1.4mg) + R-CHP3
Polatuzumab Vedotin (1.8mg) + R-CHP5
Polatuzumab Vedotin (2.4mg) + R-CHP0
Polatuzumab Vedotin (1.4mg) + G-CHP4
Polatuzumab Vedotin (1.8mg) + G-CHP4
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP40
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP17

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Maximum Concentration (Cmax) of Polatuzumab Vedotin

Cmax for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis. (NCT01992653)
Timeframe: Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)

Interventionng/mL (Mean)
Polatuzumab Vedotin (1.0mg) + R-CHP373
Polatuzumab Vedotin (1.4mg) + R-CHP537
Polatuzumab Vedotin (1.8mg) + R-CHP781
Polatuzumab Vedotin (2.4mg) + R-CHP1400
Polatuzumab Vedotin (1.4mg) + G-CHP537
Polatuzumab Vedotin (1.8mg) + G-CHP557
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP532
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP530

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Event Free Survival, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population

Time from randomization to disease progression or relapse, as assessed by the investigator, death from any cause, or initiation of any new anti-lymphoma therapy (NALT). If the specified event (disease progression or relapse, death, initiation of a NALT) did not occur, EFS was censored at the date of last tumor assessment. For participants without an event who did not have post-baseline tumor assessments, EFS was censored at the time of randomization. (NCT01992653)
Timeframe: Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)

InterventionMonths (Median)
Polatuzumab Vedotin (1.0mg) + R-CHPNA
Polatuzumab Vedotin (1.8mg) + R-CHP6.87
Polatuzumab Vedotin (2.4mg) + R-CHP6.70
Polatuzumab Vedotin (1.4mg) + G-CHPNA
Polatuzumab Vedotin (1.8mg) + G-CHPNA

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Event Free Survival, as Assessed by Investigator Using Cheson Criteria for DLBCL Population

Time from randomization to disease progression or relapse, as assessed by the investigator, death from any cause, or initiation of any new anti-lymphoma therapy (NALT). If the specified event (disease progression or relapse, death, initiation of a NALT) did not occur, EFS was censored at the date of last tumor assessment. For participants without an event who did not have post-baseline tumor assessments, EFS was censored at the time of randomization. (NCT01992653)
Timeframe: Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)

InterventionMonths (Median)
Polatuzumab Vedotin (1.0mg) + R-CHPNA
Polatuzumab Vedotin (1.4mg) + R-CHPNA
Polatuzumab Vedotin (1.8mg) + R-CHPNA
Polatuzumab Vedotin (1.4mg) + G-CHPNA
Polatuzumab Vedotin (1.8mg) + G-CHPNA
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP35.45
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHPNA

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Duration of Response, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population

Time from the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse or death from any cause (PFS), as assessed by the investigator for the subgroup of participants with a best overall response of CR or PR. For participants achieving a response who did not experience disease progression, relapse, or died prior to the time of the analysis, the DOR was censored on the date of last disease assessment. (NCT01992653)
Timeframe: Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)

InterventionMonths (Median)
Polatuzumab Vedotin (1.0mg) + R-CHPNA
Polatuzumab Vedotin (1.8mg) + R-CHP4.11
Polatuzumab Vedotin (2.4mg) + R-CHPNA
Polatuzumab Vedotin (1.4mg) + G-CHPNA
Polatuzumab Vedotin (1.8mg) + G-CHPNA

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Duration of Response, as Assessed by Investigator Using Cheson Criteria for DLBCL Population

Time from the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse or death from any cause (PFS), as assessed by the investigator for the subgroup of participants with a best overall response of CR or PR. For participants achieving a response who did not experience disease progression, relapse, or died prior to the time of the analysis, the DOR was censored on the date of last disease assessment. (NCT01992653)
Timeframe: Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)

InterventionMonths (Median)
Polatuzumab Vedotin (1.0mg) + R-CHPNA
Polatuzumab Vedotin (1.4mg) + R-CHPNA
Polatuzumab Vedotin (1.8mg) + R-CHPNA
Polatuzumab Vedotin (1.4mg) + G-CHPNA
Polatuzumab Vedotin (1.8mg) + G-CHPNA
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHPNA
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHPNA

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Clearance (CL) of Polatuzumab Vedotin

CL for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis. (NCT01992653)
Timeframe: Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)

InterventionmL/day/kg (Mean)
Polatuzumab Vedotin (1.0mg) + R-CHP14.0
Polatuzumab Vedotin (1.4mg) + R-CHP17.3
Polatuzumab Vedotin (1.8mg) + R-CHP12.8
Polatuzumab Vedotin (2.4mg) + R-CHP10.5
Polatuzumab Vedotin (1.4mg) + G-CHP13.2
Polatuzumab Vedotin (1.8mg) + G-CHP18.7
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP18.9
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP17.7

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Area Under the Concentration-Time Curve (AUC) of Polatuzumab Vedotin

AUC information for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis. (NCT01992653)
Timeframe: Pre-polatuzumab vedotin infusion (Hr 0), 30 minutes (min) post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)

Interventionng day/mL (Mean)
Polatuzumab Vedotin (1.0mg) + R-CHP1300
Polatuzumab Vedotin (1.4mg) + R-CHP1510
Polatuzumab Vedotin (1.8mg) + R-CHP2600
Polatuzumab Vedotin (2.4mg) + R-CHP4090
Polatuzumab Vedotin (1.4mg) + G-CHP1940
Polatuzumab Vedotin (1.8mg) + G-CHP1850
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP1870
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP1940

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Plasma Levels of Cyclophosphamide

Plasma levels of cyclophosphamide will be assessed and compared at the same timepoints of Cycle 1 (in the absence of polatuzumab vedotin) and Cycle 3 (in the presence of polatuzumab vedotin), and compared with historical data to evaluate potential PK interactions with polatuzumab vedotin. (NCT01992653)
Timeframe: End of cyclophosphamide infusion (infusion time=1-24 Hr), 3 and 23 hours post end of cyclophosphamide infusion on D1 of Cy 1 and 3 (cycle length=21 days)

,
Interventionug/mL (Mean)
C1D1 0.5hr POSTDOSEC1D1 3.5hr POSTDOSEC1D1 23.5hr POSTDOSEC3D1 0.5hr POSTDOSEC3D1 3.5hr POSTDOSEC3D1 23.5hr POSTDOSE
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP32.322.53.3235.222.53.16
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP37.523.22.9834.824.23.17

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Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score

The TINAS is an 11-item questionnaire scored on a 0 to 10 scale, with 0 being the symptom is not present to 10 being the symptom is as bad as the participant can imagine. The questionnaire will be analyzed for the individual neuropathy symptoms experienced by a participant as well as the calculation of an overall neuropathy severity score. The TINAS scale will be completed daily over the course of study treatment. Additionally, to collect information about the reversibility of peripheral neuropathy, the TINAS will be completed once a week for the first 2 months, then once a month for the next 10 months following treatment completion. Results are only being reported here up until the End of Treatment visit (duration of Study treatment). (NCT01992653)
Timeframe: Weekly up to Month 6 (22 weeks). TINAS data were collected daily, though for the analysis purpose for each participant, only the first record of each week was selected.

InterventionScore of a Questionnaire (Mean)
BaselineWeek 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12Week 13Week 14Week 15Week 16Week 17Week 18Week 19Week 22
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP0.320.910.070.220.260.170.250.350.310.380.530.390.650.780.620.701.120.910.640.450.09

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Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score

The TINAS is an 11-item questionnaire scored on a 0 to 10 scale, with 0 being the symptom is not present to 10 being the symptom is as bad as the participant can imagine. The questionnaire will be analyzed for the individual neuropathy symptoms experienced by a participant as well as the calculation of an overall neuropathy severity score. The TINAS scale will be completed daily over the course of study treatment. Additionally, to collect information about the reversibility of peripheral neuropathy, the TINAS will be completed once a week for the first 2 months, then once a month for the next 10 months following treatment completion. Results are only being reported here up until the End of Treatment visit (duration of Study treatment). (NCT01992653)
Timeframe: Weekly up to Month 6 (22 weeks). TINAS data were collected daily, though for the analysis purpose for each participant, only the first record of each week was selected.

InterventionScore of a Questionnaire (Mean)
BaselineWeek 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12Week 13Week 14Week 15Week 16Week 17
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP000.020.060.180.160.160.140.170.250.300.260.300.250.490.480.660.25

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Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score

The TINAS is an 11-item questionnaire scored on a 0 to 10 scale, with 0 being the symptom is not present to 10 being the symptom is as bad as the patient can imagine. The questionnaire will be analyzed for the individual neuropathy symptoms experienced by a participant as well as the calculation of an overall neuropathy severity score. The TINAS scale will be completed daily over the course of study treatment. Additionally, to collect information about the reversibility of peripheral neuropathy, the TINAS will be completed once a week for the first 2 months, then once a month for the next 10 months following treatment completion. Additionally, a single item that asks patients to rate when numbness and tingling was at the worst will be used to predict the onset of peripheral neuropathy. The measure takes less than 5 minutes to complete. Results are only being reported here up until the End of Treatment visit (duration of Study treatment). (NCT01992653)
Timeframe: Weekly up to Month 6 (22 weeks). TINAS data were collected daily, though for the analysis purpose for each participant, only the first record of each week was selected.

InterventionScore of a Questionnaire (Mean)
BaselineWeek 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12Week 13Week 14Week 15Week 16Week 17Week 18Week 19Week 22
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP0100.400.500.170.400.600.250.501.140.570.711.120.880.751.501.14221

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Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score

The TINAS is an 11-item questionnaire scored on a 0 to 10 scale, with 0 being the symptom is not present to 10 being the symptom is as bad as the patient can imagine. The questionnaire will be analyzed for the individual neuropathy symptoms experienced by a participant as well as the calculation of an overall neuropathy severity score. The TINAS scale will be completed daily over the course of study treatment. Additionally, to collect information about the reversibility of peripheral neuropathy, the TINAS will be completed once a week for the first 2 months, then once a month for the next 10 months following treatment completion. Additionally, a single item that asks patients to rate when numbness and tingling was at the worst will be used to predict the onset of peripheral neuropathy. The measure takes less than 5 minutes to complete. Results are only being reported here up until the End of Treatment visit (duration of Study treatment). (NCT01992653)
Timeframe: Weekly up to Month 6 (22 weeks). TINAS data were collected daily, though for the analysis purpose for each participant, only the first record of each week was selected.

InterventionScore of a Questionnaire (Mean)
BaselineWeek 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12Week 13Week 14Week 15Week 16Week 17
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP000.250.330.400.400.400.290.330.400.860.861.140.861.121.121.560.40

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Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population

Complete Response (CR) rate was defined as the percentage of participants with CR at the end of treatment, as assessed by the investigator, with and without FDG-PET. The overall response rate was defined as the percentage of participants with CR or PR at the end of treatment, as assessed by the investigator, with and without FDG-PET. (NCT01992653)
Timeframe: At the end of treatment (Month 6)

,,,,
InterventionPercentage of Participants (Number)
Complete Response (CR)Partial Response (PR)
Polatuzumab Vedotin (1.0mg) + R-CHP100.00
Polatuzumab Vedotin (1.4mg) + G-CHP100.00
Polatuzumab Vedotin (1.8mg) + G-CHP100.00
Polatuzumab Vedotin (1.8mg) + R-CHP100.00
Polatuzumab Vedotin (2.4mg) + R-CHP100.00

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Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for DLBCL Population

Complete Response (CR) rate was defined as the percentage of participants with CR at the end of treatment, as assessed by the investigator, with and without FDG-PET. The overall response rate was defined as the percentage of participants with CR or PR at the end of treatment, as assessed by the investigator, with and without FDG-PET. (NCT01992653)
Timeframe: At the end of treatment (Month 6)

,,,,,,
InterventionPercentage of Participants (Number)
Complete Response (CR)Partial Response (PR)
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP76.511.8
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP75.015.0
Polatuzumab Vedotin (1.0mg) + R-CHP50.050.0
Polatuzumab Vedotin (1.4mg) + G-CHP75.00
Polatuzumab Vedotin (1.4mg) + R-CHP100.00
Polatuzumab Vedotin (1.8mg) + G-CHP100.00
Polatuzumab Vedotin (1.8mg) + R-CHP100.00

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Terminal Half-Life (t1/2) of Polatuzumab Vedotin

t1/2 for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis. (NCT01992653)
Timeframe: Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)

Interventiondays (Mean)
Polatuzumab Vedotin (1.0mg) + R-CHP5.03
Polatuzumab Vedotin (1.4mg) + R-CHP4.85
Polatuzumab Vedotin (1.8mg) + R-CHP4.79
Polatuzumab Vedotin (2.4mg) + R-CHP4.42
Polatuzumab Vedotin (1.4mg) + G-CHP5.19
Polatuzumab Vedotin (1.8mg) + G-CHP4.89
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP5.03
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP5.50

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Steady-State Volume of Distribution (Vss) of Polatuzumab Vedotin

Vss for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis. (NCT01992653)
Timeframe: Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)

InterventionmL/kg (Mean)
Polatuzumab Vedotin (1.0mg) + R-CHP58.2
Polatuzumab Vedotin (1.4mg) + R-CHP80.0
Polatuzumab Vedotin (1.8mg) + R-CHP57.7
Polatuzumab Vedotin (2.4mg) + R-CHP41.9
Polatuzumab Vedotin (1.4mg) + G-CHP67.9
Polatuzumab Vedotin (1.8mg) + G-CHP87.5
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP96.5
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP99.3

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Relative Dose Intensity of Polatuzumab Vedotin (Ratio of the Amount of Drug Actually Administered to the Amount Planned) for Non-DLBCL Population

Relative dose intensity (DI) was defined as the ratio of the amount of a drug actually administered (actual DI) to the amount planned (planned DI) for a fixed time period, expressed as a percentage. (NCT01992653)
Timeframe: 6 months

InterventionPercentage (Mean)
Polatuzumab Vedotin (1.0mg) + R-CHP100.00
Polatuzumab Vedotin (1.8mg) + R-CHP100.94
Polatuzumab Vedotin (2.4mg) + R-CHP132.22
Polatuzumab Vedotin (1.4mg) + G-CHP99.72
Polatuzumab Vedotin (1.8mg) + G-CHP100.17

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Relative Dose Intensity of Polatuzumab Vedotin (Ratio of the Amount of Drug Actually Administered to the Amount Planned) for DLBCL Population

Relative dose intensity (DI) was defined as the ratio of the amount of a drug actually administered (actual DI) to the amount planned (planned DI) for a fixed time period, expressed as a percentage. (NCT01992653)
Timeframe: 6 months

InterventionPercentage (Mean)
Polatuzumab Vedotin (1.0mg) + R-CHP100.70
Polatuzumab Vedotin (1.4mg) + R-CHP99.97
Polatuzumab Vedotin (1.8mg) + R-CHP96.04
Polatuzumab Vedotin (1.4mg) + G-CHP99.35
Polatuzumab Vedotin (1.8mg) + G-CHP99.95
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP96.71
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP98.92

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Progression Free Survival, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population

Time from date of first dose of study drug (Day 1) to the first occurrence of progression or relapse, or death from any cause while in the study, as assessed by the investigator. If a participant did not experience progressive disease or death, PFS was censored on the day of the last tumor assessment. If a post-baseline assessment was not available, PFS was censored on Day 1. (NCT01992653)
Timeframe: Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)

InterventionMonths (Median)
Polatuzumab Vedotin (1.0mg) + R-CHPNA
Polatuzumab Vedotin (1.8mg) + R-CHP6.87
Polatuzumab Vedotin (2.4mg) + R-CHPNA
Polatuzumab Vedotin (1.4mg) + G-CHPNA
Polatuzumab Vedotin (1.8mg) + G-CHPNA

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Progression Free Survival, as Assessed by Investigator Using Cheson Criteria for DLBCL Population

Time from date of first dose of study drug (Day 1) to the first occurrence of progression or relapse, or death from any cause while in the study, as assessed by the investigator. If a participant did not experience progressive disease or death, PFS was censored on the day of the last tumor assessment. If a post-baseline assessment was not available, PFS was censored on Day 1. (NCT01992653)
Timeframe: Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)

InterventionMonths (Median)
Polatuzumab Vedotin (1.0mg) + R-CHPNA
Polatuzumab Vedotin (1.4mg) + R-CHPNA
Polatuzumab Vedotin (1.8mg) + R-CHPNA
Polatuzumab Vedotin (1.4mg) + G-CHPNA
Polatuzumab Vedotin (1.8mg) + G-CHPNA
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHPNA
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHPNA

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Overall Survival for Non-DLBCL Population

The time from the date of randomization to the date of death from any cause. For participants who did not die at the time of the analyses, OS was censored on the last date when the participants were known to be alive. (NCT01992653)
Timeframe: Screening up to death due to any cause (up to approximately 6 years)

InterventionMonths (Median)
Polatuzumab Vedotin (1.0mg) + R-CHPNA
Polatuzumab Vedotin (1.8mg) + R-CHP15.24
Polatuzumab Vedotin (2.4mg) + R-CHPNA
Polatuzumab Vedotin (1.4mg) + G-CHPNA
Polatuzumab Vedotin (1.8mg) + G-CHPNA

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Overall Survival for DLBCL Population

The time from the date of randomization to the date of death from any cause. For participants who did not die at the time of the analyses, OS was censored on the last date when the participants were known to be alive. (NCT01992653)
Timeframe: Screening up to death due to any cause (up to approximately 6 years)

InterventionMonths (Median)
Polatuzumab Vedotin (1.0mg) + R-CHPNA
Polatuzumab Vedotin (1.4mg) + R-CHPNA
Polatuzumab Vedotin (1.8mg) + R-CHPNA
Polatuzumab Vedotin (1.4mg) + G-CHPNA
Polatuzumab Vedotin (1.8mg) + G-CHPNA
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHPNA
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHPNA

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Number of Participants With Dose Limiting Toxicities (DLTs) in DLBCL Population

All dose-escalation cohorts will consist of at least 3 participants. If a DLT is observed in 1 participant at a given dose level during the DLT observation period before dose escalation, additional participants will be enrolled at that dose level for a total of at least 6 participants. DLT assessment forms part of determining the Maximum Tolerated Dose (MTD). The highest dose level resulting in DLTs in less than one-third of a minimum of 6 participants will be declared the MTD. (NCT01992653)
Timeframe: Cycle (Cy) 1 Day 1 (D1) to Cy 2 D1 (cycle length=21 days)

InterventionParticipants (Count of Participants)
Polatuzumab Vedotin (1.0mg) + R-CHP0
Polatuzumab Vedotin (1.4mg) + R-CHP0
Polatuzumab Vedotin (1.8mg) + R-CHP1
Polatuzumab Vedotin (2.4mg) + R-CHP0
Polatuzumab Vedotin (1.4mg) + G-CHP1
Polatuzumab Vedotin (1.8mg) + G-CHP0
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP0
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP0

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Plasma Levels of Doxorubicin

Plasma levels of doxorubicin will be assessed and compared at the same timepoints of Cycle 1 (in the absence of polatuzumab vedotin) and Cycle 3 (in the presence of polatuzumab vedotin), and compared with historical data to evaluate potential PK interactions with polatuzumab vedotin. (NCT01992653)
Timeframe: 2, 24 hours post end of doxorubicin infusion (infusion time=15 min) on D1 of Cy 1 and 3 (cycle length=21 days)

,
Interventionug/mL (Mean)
C1D1 2hr POSTDOSEC1D1 24hr POSTDOSEC3D1 2hr POSTDOSEC3D1 24hr POSTDOSE
Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP30.211.729.69.14
Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP35.49.1329.38.68

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Safety and Tolerability

Number of Participants with Adverse Events (NCT01994590)
Timeframe: Participants are followed while actively taking study drug and for at least 30 days post last dose.

InterventionParticipants (Count of Participants)
All Patients4

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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores

The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for prostate cancer domain is from 0 (worst response) to 48 (best response), where higher score indicated better quality of life with fewer symptoms. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89

Interventionunits on a scale (Mean)
BaselineChange at Week 9Change at Week 13Change at Week 17Change at Week 21Change at Week 25Change at Week 29Change at Week 33Change at Week 37Change at Week 41Change at Week 45Change at Week 49Change at Week 53Change at Week 57Change at Week 61Change at Week 65Change at Week 69Change at Week 73Change at Week 77Change at Week 81Change at Week 85Change at Week 89
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg33.2-0.7-1.9-1.0-0.4-0.8-1.3-1.4-1.5-1.0-0.8-0.8-1.1-0.5-2.1-2.0-1.5-0.2-1.03.1-0.50.0

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Percentage of Participants With Adverse Events (AEs) Leading to Death

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'. (NCT01995513)
Timeframe: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)

Interventionpercentage of participants (Number)
Enzalutamide 160 mg5.9
Enzalutamide Crossing Over to Abiraterone + Prednisone0
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg3.2
Placebo+Abiraterone 1000mg+ Prednisone 10mg2.4

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Progression Free Survival (PFS)

PFS = time from randomization to first documentation of radiographic progression (RP),unequivocal clinical progression or death due to any cause (death within 112 days of treatment discontinuation without objective evidence of RP),whichever occurred first as per investigator. Unequivocal disease progression was pain requiring chronic administration of analgesics, decline of prostate cancer of Eastern Cooperative Oncology Group (ECOG) performance status score to 3 or higher or initiation of new anticancer therapy/radiation therapy or surgical intervention due to tumor progression. ECOG score range= 0(no severity) to 5(maximum severity).RP for bone disease was evaluated by appearance of 2 or more new bone lesions as per Prostate Cancer Clinical Trials Working Group 2 (PCWG2) or for soft tissue disease according to Response Evaluation Criteria in Solid Tumor version 1.1. Participants with no PFS event at analysis date were censored at last tumor assessment date prior to data cutoff date. (NCT01995513)
Timeframe: From randomization until disease progression, last tumor assessment without disease progression or death due to any cause, whichever occurred first (maximum up to 20.3 months)

Interventionmonths (Median)
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg5.7
Placebo+Abiraterone 1000mg+ Prednisone 10mg5.6

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Rate of Pain Progression

Rate of pain progression was defined as percentage of participants with an increase of >=30% from baseline in the mean Brief Pain Inventory-Short Form (BPI-SF) pain intensity item scores of 4 items assessing average, worst, least, and intermediate pain severity. BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. BPI-sf includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-sf score range for each item was from 0=no pain to 10=worst possible pain. Total score was reported as average of individual questions ranges from 0 to 10, where lower scores indicated less pain or less pain interference. (NCT01995513)
Timeframe: Month 6

Interventionpercentage of participants (Number)
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg36.2
Placebo+Abiraterone 1000mg+ Prednisone 10mg27.1

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Time to Degradation of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score

Time to degradation of FACT-P was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the global FACT-P score for each participant. The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, and functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 with higher scores representing better quality of life. Participants with no score degradation at the time of analysis data cutoff were censored at the date of last assessment showing no degradation. (NCT01995513)
Timeframe: From randomization up to maximum of 18.4 months

Interventionmonths (Median)
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg4.6
Placebo+Abiraterone 1000mg+ Prednisone 10mg6.4

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Time to First Use of New Antineoplastic Therapy for Prostate Cancer

It was defined as time from randomization to the date of first use of subsequent antineoplastic therapy for prostate cancer. For participants who had not started subsequent antineoplastic therapy as of data analysis cutoff date, the time to first use of subsequent antineoplastic therapy was censored at the date of last assessment. (NCT01995513)
Timeframe: From randomization until date of first use of any antineoplastic therapy (after last dose date of Period 2, maximum up to 22.3 months

Interventionmonths (Median)
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg10.3
Placebo+Abiraterone 1000mg+ Prednisone 10mg8.6

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Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent are events between first dose of study drug and up to 30 days after last dose of study drug that were absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious. (NCT01995513)
Timeframe: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)

,,,
Interventionpercentage of participants (Number)
AEsSAEs
Enzalutamide 160 mg93.532.0
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg91.237.6
Enzalutamide Crossing Over to Abiraterone + Prednisone10030.8
Placebo+Abiraterone 1000mg+ Prednisone 10mg92.729.8

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Prostate Specific Antigen (PSA) Response Rate

PSA response rate was defined as percentage of participants with >=30% and >=50% decrease in PSA from baseline at randomization to the maximal PSA response with a threshold of 30% and 50% respectively. PSA response was confirmed if another assessment measured at least 3 weeks later met the criterion as well. (NCT01995513)
Timeframe: From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months)

,
Interventionpercentage of participants (Number)
>= 50%>= 30%
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg0.82.4
Placebo+Abiraterone 1000mg+ Prednisone 10mg2.52.5

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Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'. (NCT01995513)
Timeframe: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)

Interventionpercentage of participants (Number)
Drug Discontinuation with AbirateroneDrug Discontinuation with Prednisone
Enzalutamide Crossing Over to Abiraterone + Prednisone7.77.7

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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores

The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for prostate cancer domain is from 0 (worst response) to 48 (best response), where higher score indicated better quality of life with fewer symptoms. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89

Interventionunits on a scale (Mean)
BaselineChange at Week 9Change at Week 13Change at Week 17Change at Week 21Change at Week 25Change at Week 29Change at Week 33Change at Week 37Change at Week 41Change at Week 45Change at Week 49Change at Week 53Change at Week 57Change at Week 61Change at Week 65Change at Week 69Change at Week 73Change at Week 77
Placebo+Abiraterone 1000mg+ Prednisone 10mg34.2-0.9-0.1-1.4-0.6-0.8-0.3-0.6-0.8-0.7-1.7-0.9-1.8-3.3-3.1-2.61.1-6.4-1.5

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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores

The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for functional well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89

Interventionunits on a scale (Mean)
BaselineChange at Week 9Change at Week 13Change at Week 17Change at Week 21Change at Week 25Change at Week 29Change at Week 33Change at Week 37Change at Week 41Change at Week 45Change at Week 49Change at Week 53Change at Week 57Change at Week 61Change at Week 65Change at Week 69Change at Week 73Change at Week 77
Placebo+Abiraterone 1000mg+ Prednisone 10mg20.3-0.7-0.4-0.5-0.7-0.3-0.2-0.70.20.8-0.31.51.32.02.91.72.34.02.5

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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores

The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for physical well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89

Interventionunits on a scale (Mean)
BaselineChange at Week 9Change at Week 13Change at Week 17Change at Week 21Change at Week 25Change at Week 29Change at Week 33Change at Week 37Change at Week 41Change at Week 45Change at Week 49Change at Week 53Change at Week 57Change at Week 61Change at Week 65Change at Week 69Change at Week 73Change at Week 77Change at Week 81Change at Week 85Change at Week 89
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg22.9-0.8-1.0-1.1-0.8-1.7-2.5-2.5-1.8-1.5-2.0-0.9-0.2-0.4-0.8-1.9-0.3-0.3-0.71.5-1.00.0

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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores

The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for physical well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89

Interventionunits on a scale (Mean)
BaselineChange at Week 9Change at Week 13Change at Week 17Change at Week 21Change at Week 25Change at Week 29Change at Week 33Change at Week 37Change at Week 41Change at Week 45Change at Week 49Change at Week 53Change at Week 57Change at Week 61Change at Week 65Change at Week 69Change at Week 73Change at Week 77
Placebo+Abiraterone 1000mg+ Prednisone 10mg23.60.10.0-0.3-0.8-0.40.30.10.40.4-0.40.60.70.40.40.4-0.5-3.04.0

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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score

The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 where higher scores represent better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89

Interventionunits on a scale (Mean)
BaselineChange at Week 9Change at Week 13Change at Week 17Change at Week 21Change at Week 25Change at Week 29Change at Week 33Change at Week 37Change at Week 41Change at Week 45Change at Week 49Change at Week 53Change at Week 57 (n =17, 13)Change at Week 61Change at Week 65Change at Week 69Change at Week 73Change at Week 77Change at Week 81Change at Week 85Change at Week 89
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg116.4-3.3-4.4-3.7-2.5-3.1-6.8-5.9-6.1-5.7-6.0-4.2-4.8-4.3-5.5-7.0-3.5-0.7-4.010.8-5.5-2.0

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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores

The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for social/family well-being domain is from 0 (worst response) to 32 (best response), where higher score indicate better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89

Interventionunits on a scale (Mean)
BaselineChange at Week 9Change at Week 13Change at Week 17Change at Week 21Change at Week 25Change at Week 29Change at Week 33Change at Week 37Change at Week 41Change at Week 45Change at Week 49Change at Week 53Change at Week 57Change at Week 61Change at Week 65Change at Week 69Change at Week 73Change at Week 77
Placebo+Abiraterone 1000mg+ Prednisone 10mg22.4-0.8-0.4-0.6-1.2-1.0-0.20.00.8-0.1-0.80.00.40.2-0.2-0.5-0.5-1.0-0.5

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Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'. (NCT01995513)
Timeframe: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)

,
Interventionpercentage of participants (Number)
Drug Discontinuation with Enzalutamide or PlaceboDrug Discontinuation with AbirateroneDrug Discontinuation with Prednisone
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg23.223.216.0
Placebo+Abiraterone 1000mg+ Prednisone 10mg11.312.912.1

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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores

The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for emotional well-being domain is from 0 (worst response) to 24 (best response), where higher score indicate better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89

Interventionunits on a scale (Mean)
BaselineChange at Week 9Change at Week 13Change at Week 17Change at Week 21Change at Week 25Change at Week 29Change at Week 33Change at Week 37Change at Week 41Change at Week 45Change at Week 49Change at Week 53Change at Week 57Change at Week 61Change at Week 65Change at Week 69Change at Week 73Change at Week 77
Placebo+Abiraterone 1000mg+ Prednisone 10mg18.50.10.20.40.10.30.30.90.91.41.21.31.21.61.12.91.5-5.02.0

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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores

The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for emotional well-being domain is from 0 (worst response) to 24 (best response), where higher score indicate better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89

Interventionunits on a scale (Mean)
BaselineChange at Week 9Change at Week 13Change at Week 17Change at Week 21Change at Week 25Change at Week 29Change at Week 33Change at Week 37Change at Week 41Change at Week 45Change at Week 49Change at Week 53Change at Week 57Change at Week 61Change at Week 65Change at Week 69Change at Week 73Change at Week 77Change at Week 81Change at Week 85Change at Week 89
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg18.1-0.1-0.1-0.20.30.3-0.50.1-0.70.1-0.50.00.1-0.4-0.3-0.9-0.51.00.11.5-1.5-3.0

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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score

The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 where higher scores represent better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89

Interventionunits on a scale (Mean)
BaselineChange at Week 9Change at Week 13Change at Week 17Change at Week 21Change at Week 25Change at Week 29Change at Week 33Change at Week 37Change at Week 41Change at Week 45Change at Week 49Change at Week 53Change at Week 57 (n =17, 13)Change at Week 61Change at Week 65Change at Week 69Change at Week 73Change at Week 77
Placebo+Abiraterone 1000mg+ Prednisone 10mg119.0-2.2-0.5-2.3-2.7-2.10.3-0.20.91.3-2.61.81.80.10.61.94.4-35.06.5

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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores

The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for social/family well-being domain is from 0 (worst response) to 32 (best response), where higher score indicate better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89

Interventionunits on a scale (Mean)
BaselineChange at Week 9Change at Week 13Change at Week 17Change at Week 21Change at Week 25Change at Week 29Change at Week 33Change at Week 37Change at Week 41Change at Week 45Change at Week 49Change at Week 53Change at Week 57Change at Week 61Change at Week 65Change at Week 69Change at Week 73Change at Week 77Change at Week 81Change at Week 85Change at Week 89
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg22.1-0.5-0.4-0.1-0.50.1-0.1-0.2-0.8-1.4-0.9-0.6-1.0-2.0-1.5-1.5-1.4-0.6-0.96.2-1.00.0

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Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores

The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for functional well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89

Interventionunits on a scale (Mean)
BaselineChange at Week 9Change at Week 13Change at Week 17Change at Week 21Change at Week 25Change at Week 29Change at Week 33Change at Week 37Change at Week 41Change at Week 45Change at Week 49Change at Week 53Change at Week 57Change at Week 61Change at Week 65Change at Week 69Change at Week 73Change at Week 77Change at Week 81Change at Week 85Change at Week 89
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg20.2-1.0-1.2-1.3-1.2-1.0-2.4-2.0-1.5-2.1-2.0-2.1-1.6-1.4-0.8-1.20.2-0.6-1.6-1.5-1.51.0

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Objective Response Rate (ORR)

Objective response rate as assessed by the investigator according to Response Evaluation Criteria in Solid Tumor version 1.1 (RECIST v1.1) was defined as 1) Percentage of participants with confirmed best overall complete response (CR) and partial response (PR); 2) Percentage of participants with CR, PR and stable disease (SD) for target lesions or non-progressive disease for non-target lesions. CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to <10 millimeter (mm) in short axis. No new lesions and disappearance of all non-target lesions. PR: >= 30% decrease in sum of diameters of target lesions, compared to the sum at baseline. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. (NCT01995513)
Timeframe: From randomization until CR or PR, whichever occurred first (maximum up to 21.3 months)

,
Interventionpercentage of participants (Number)
CR + PRCR + PR + SD
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg0.068.4
Placebo+Abiraterone 1000mg+ Prednisone 10mg5.057.5

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Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'. (NCT01995513)
Timeframe: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)

Interventionpercentage of participants (Number)
Drug Discontinuation with Enzalutamide or Placebo
Enzalutamide 160 mg11.8

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Time to Prostate Specific Antigen (PSA) Progression

Time from date of randomization to the date of first confirmed PSA progression as per Prostate Cancer Clinical Trials Working Group 2 (PCWG2). For participant's whose PSA decreased at Week 13 after randomization, progression was defined as 25 percent (%) PSA increase relative to nadir or absolute increase of >=2 nanogram/milliliter (ng/mL) above nadir. Progression was confirmed if another assessment measured at least 3 weeks later met the criterion as well. For participant's whose PSA did not decrease at Week 13 after randomization, progression was defined as 25% PSA increase relative to baseline assessed 12 weeks after baseline. Participants who were not known to have had a PFS event at the analysis date were censored at last PSA assessment date prior to data cutoff date. (NCT01995513)
Timeframe: From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months)

Interventionmonths (Median)
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg2.8
Placebo+Abiraterone 1000mg+ Prednisone 10mg2.8

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Number of Days Post-Transplant to the First Episode of Acute Rejection Requiring Treatment

Number of days post-transplant to the first episode of acute rejection that required treatment. This includes acute rejection episodes requiring treatment that were not biopsy proven. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)

InterventionDays (Mean)
Enrolled, Transplanted23

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Number of Days From Transplant to Platelet Count Recovery

Time (in days) from transplant to the first day of a platelet count of ≥20,000 per μL without a prior platelet transfusion in the preceding seven days. Low platelet numbers is associated with increased risk of bleeding and bruising. A healthy person has a platelet count ranging from 150,000 to 450,000 platelets per microliter of blood. (NCT02029638)
Timeframe: Transplant to Platelet Count Recovery

InterventionDays (Mean)
Enrolled, Transplanted36

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Number of Days From Neutrophil Nadir to Absolute Neutrophil Recovery

Time (in days) from neutrophil nadir, the first day post-transplant on which the absolute neutrophil count (ANC) is below 500 per µL, to the first day after three consecutive daily ANCs ≥ 500 per µL. ANC is a measure of the number of neutrophils present in the blood. Neutrophils are a type of white blood cell that fight against infection. A healthy person has an ANC between 2,500 and 6,000 per µL. A value below 500 per µL means the risk of infection is higher. (NCT02029638)
Timeframe: Post-Transplant Neutrophil Nadir to Neutrophil Recover

InterventionDays (Mean)
Enrolled, Transplanted15

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Duration in Days of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy

AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy. Time (in days) from the start date of the AE until the end date of the AE. Two events contributed to this calculation. (NCT02029638)
Timeframe: First Dose of Study Medication to End of Study (Up to 25 Months After Enrollment)

InterventionDays (Mean)
Enrolled, Transplanted9.5

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Percent of Participants Who Achieved Operational Tolerance

Operational tolerance is defined as remaining off all immunosuppression 52 weeks after completion of immunosuppression withdrawal, with no evidence of biopsy-proven allograft rejection and, with acceptable renal function defined as a serum creatinine that has increased no more than 25% above baseline at the primary endpoint visit. Baseline creatinine is defined as the average of the lowest three creatinine values during 2 to 4 weeks post-transplant, excluding days on dialysis. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval. (NCT02029638)
Timeframe: Transplantation through 52 Weeks after Discontinuation of All Immunosuppression

InterventionPercent of participants (Number)
Enrolled, Transplanted0

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Duration in Days of Graft-versus-Host Disease in Transplanted Participants

Graft-versus-host disease (GVHD) is a medical complication that can occur after a person receives transplanted tissue, most commonly occurring after a bone marrow transplant. The white blood cells from the donated tissue recognize the tissue recipient's cells as foreign. These donor cells then attack the recipient's cells. Duration (in days) is measured as the time from the start of the GVHD event to the end of the GVHD event. (NCT02029638)
Timeframe: Transplant to Two Years Post-Transplant

InterventionDays (Mean)
Enrolled, Transplanted7

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Histological Severity of Biopsies Demonstrating Acute Rejection as Defined by Banff 2007 Classification Renal Allograft Pathology

This outcome includes results from biopsies with proven acute renal allograft rejection according to the 2007 Banff Classification Renal Allograft Pathology. A Banff result of indeterminate is not classified as rejection. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)

Interventionparticipants (Number)
Acute Cellular Rejection Banff Grade IAAcute Cellular Rejection Banff Grade IBAcute Cellular Rejection Banff Grade IIAAcute Cellular Rejection Banff Grade IIBAcute Cellular Rejection Banff Grade IIIAcute Antibody Mediated Rejection
Enrolled, Transplanted000000

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Number of Adverse Events (AEs) by Severity- Including Infection, Wound Complications, Post-Transplant Diabetes, Hemorrhagic Cystitis and Malignancy

AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy. Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0. (NCT02029638)
Timeframe: First Dose of Study Medication to End of Study (Up to 25 Months After Enrollment)

,
InterventionEvents (Number)
Grade 1Grade 2Grade 3Grade 4Grade 5
Enrolled, Not Transplanted00000
Enrolled, Transplanted00200

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Number of Transplanted Participants Who Developed Donor-Specific Antibody During Study Participation

Donor-specific antibodies are directed against antigens expressed on donor organs. These antibodies can result in an immune attack on the transplanted organ, increasing risk of graft loss and/or rejection. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months)

InterventionParticipants (Count of Participants)
Enrolled, Transplanted0

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Number of Transplanted Participants Who Developed Donor- Specific Antibody After Initiation of Immunosuppression Withdrawal

Donor-specific antibodies are directed against antigens expressed on donor organs. These antibodies can result in an immune attack on the transplanted organ, increasing risk of graft loss and/or rejection. (NCT02029638)
Timeframe: Initiation of Immunosuppression Withdrawal to End of Study (to 25 months)

InterventionParticipants (Count of Participants)
Enrolled, Transplanted0

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Number of Participants Free From Return to Immunosuppression for the Duration of the Study

Participants who were able to withdrawal successfully from all immunosuppression medication and remained off all immunosuppression medication for the remainder of the study. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 Months)

InterventionParticipants (Count of Participants)
Enrolled, Transplanted0

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Number of Participants Experiencing an Incidence of Graft-versus-Host Disease Post-Transplant

Graft-versus-host disease (GVHD) is a medical complication that can occur after a person receives transplanted tissue, most commonly occurring after a bone marrow transplant. The white blood cells from the donated tissue recognize the tissue recipient's cells as foreign. These donor cells then attack the recipient's cells. (NCT02029638)
Timeframe: Transplant to Two Years Post-Transplant

InterventionParticipants (Count of Participants)
Enrolled, Transplanted1

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Number of Transplanted Participants With Engraftment Syndrome

Engraftment syndrome is a complication that can occur following bone marrow transplant. The presence of engraftment syndrome is diagnosed by monitoring the common symptoms, which include: fever, rash, fluid in the lungs, and serum creatinine values above 4 mg/dL occurring within a week of absolute neutrophil recovery (e.g., first day after three consecutive daily absolute neutrophil counts ≥ 500 per µL), without apparent other cause. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)

InterventionParticipants (Count of Participants)
Enrolled, Transplanted0

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Number of Transplanted Participants With Chronic T Cell-Mediated or Antibody-Mediated Rejection

Outcome includes participants who experienced chronic T cell-mediated rejection, antibody-mediated rejection and progressive interstitial fibrosis/tubular atrophy (IF/TA), transplant glomerulopathy or chronic obliterative arteriopathy, without an alternative, non-rejection related cause. Reference: Banff 2007 Classification Renal Allograft Pathology definition of terms. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)

InterventionParticipants (Count of Participants)
Enrolled, Transplanted1

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Number of Transplanted Participants With Acute Renal Allograft Rejection

Acute renal allograft rejection demonstrated either by biopsy or clinically (when a biopsy could not be performed). This measure includes participants with biopsy proven acute renal allograft rejection and those that have creatinine values 25% or greater relative to baseline for over 72 hours. Baseline serum creatinine is defined as the average of the lowest three serum creatinine values during 2 to 4 weeks post-transplant, excluding days on dialysis. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)

InterventionParticipants (Count of Participants)
Enrolled, Transplanted1

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Number of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy

AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy. (NCT02029638)
Timeframe: First Dose of Study Medication to End of Study (Up to 25 Months After Enrollment)

,
InterventionEvents (Number)
InfectionWound complicationsPost-transplant diabetesHemorrhagic cystitisMalignancy
Enrolled, Not Transplanted00000
Enrolled, Transplanted20000

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Number of Transplanted Participants Who Died

Number of participant deaths after receiving a transplant per protocol. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)

InterventionParticipants (Count of Participants)
Enrolled, Transplanted1

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Number of Transplanted Participants Who Remained Off Immunosuppression for at Least 52 Weeks, Including Those in Whom the 52 Week Biopsy Was Not Performed

Number of transplanted participants who remained off immunosuppression for ≥52 weeks, including those in whom the 52 week biopsy was not performed. This outcome included participants who were able to withdrawal successfully from all immunosuppression medication and remain off all immunosuppression for 52 weeks after the completion of withdrawal. (NCT02029638)
Timeframe: Transplant to 52 Weeks after Discontinuation of All Immunosuppression

InterventionParticipants (Count of Participants)
Enrolled, Transplanted0

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Time to Radiological Progression

(NCT02034552)
Timeframe: From the randomization date to the date of radiological disease progression (about 30.82months)

InterventionMonths (Median)
Radium-223 Dichloride (Xofigo, BAY88-8223)4.40
Radium-223 With Abiraterone & PrednisionNA
Radium-223 With EnzalutamideNA

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Time to Radiological Bone Progression

(NCT02034552)
Timeframe: From the randomization date to the date of radiological bone progression (about 30.82 months)

InterventionMonths (Median)
Radium-223 Dichloride (Xofigo, BAY88-8223)11.5
Radium-223 With Abiraterone & PrednisionNA
Radium-223 With EnzalutamideNA

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Time to First Symptomatic Skeletal Event

(NCT02034552)
Timeframe: From the randomization date to the first SSE on or following the randomization date (about 30.82 months)

InterventionMonths (Median)
Radium-223 Dichloride (Xofigo, BAY88-8223)NA
Radium-223 With Abiraterone & PrednisionNA
Radium-223 With EnzalutamideNA

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Symptomatic Skeletal Event-free Survival

(NCT02034552)
Timeframe: From the randomization date to the first SSE on or following the randomization date or death, whichever occurred first (about 32.39 months)

InterventionMonths (Median)
Radium-223 Dichloride (Xofigo, BAY88-8223)11.93
Radium-223 With Abiraterone & PrednisionNA
Radium-223 With Enzalutamide19.91

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Radiological Progression Free Survival

(NCT02034552)
Timeframe: From randomization to radiological disease progression or death from any cause (about 30.82 months )

InterventionMonths (Median)
Radium-223 Dichloride (Xofigo, BAY88-8223)4.40
Radium-223 With Abiraterone & PrednisionNA
Radium-223 With EnzalutamideNA

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Overall Survival

(NCT02034552)
Timeframe: From the randomization date to the date of death due to any cause (about 42.94 months)

InterventionMonths (Median)
Radium-223 Dichloride (Xofigo, BAY88-8223)35.81
Radium-223 With Abiraterone & Prednision37.55
Radium-223 With Enzalutamide29.86

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Bone Scan Lesion Area

Bone scan lesion area was defined as the sum of the pixel areas (cm2) of the set of the whole body technetium-99 bone scan imaging pixels identified as bone lesion. (NCT02034552)
Timeframe: At 24 weeks

Interventioncm^2 (Mean)
Radium-223 Dichloride (Xofigo, BAY88-8223)30227.13
Radium-223 With Abiraterone & Prednision10185.58
Radium-223 With Enzalutamide17321.45

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Patient Bone Scan Response Rate

Radiological bone scan response based on change from baseline of digitized technetium-99 bone scans using computer-aided detection software. Responder (R): 30% or greater resolution of the BSLA compared to baseline. Stable Disease (SD): Not meeting the criteria for R, PD, or UE. Progressive Disease (PD): Two or more new areas of radiotracer uptake attributable to metastatic disease in regions of bone that had not previously shown radiotracer uptake or greater than 30% increase from baseline in BSLA attributable to metastatic disease. Unable to Evaluate (UE): Assigned if bone scan results cannot be interpreted due to inconsistent image acquisition parameters compared to the reference scan, incomplete imaging, or other similar technical deficiencies. (NCT02034552)
Timeframe: At 24 weeks

,,
InterventionPercentage (Number)
Responder (R)Stable Disease (SD)Progressive Disease (PD)Missing
Radium-223 Dichloride (Xofigo, BAY88-8223)22.2027.850.0
Radium-223 With Abiraterone & Prednision57.921.15.315.8
Radium-223 With Enzalutamide50.018.812.518.8

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Stricture Formation

Primary outcome measure is the rate of symptomatic esophageal stricture formation. (NCT02039115)
Timeframe: 98 weeks

InterventionParticipants (Count of Participants)
Prednisone1
Placebo0

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Number of Participants With Treatment-emergent Bone Fractures

Treatment-emergent fractures were adverse events identified as fractures that occurred after start of study treatment until the end of the treatment period. All bone fractures and bone-associated events (e.g., osteoporosis) were reported as either AEs, or SAEs if the criteria of SAE were met, regardless of the investigator's causality assessment. (NCT02043678)
Timeframe: From start of study treatment until 4 weeks after last study treatment, up to 65 months

InterventionParticipants (Count of Participants)
Radium-223 Dichloride + Abi/Pred107
Placebo + Abi/Pred49

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Number of Participants With Any Study Drug-related Post-treatment Adverse Events Per Maximum Intensity

"An adverse event (AE) was any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a participant in the study. Any bleeding event occurring during the study was not documented as an AE because this event was planned to be captured in the assessment of efficacy. AEs that started after the treatment period were defined as post-treatment AEs. Drug-related AEs were those with reasonable causal relationship to the study treatment decided by the investigators." (NCT02043678)
Timeframe: After the treatment period, up to 46 months

,
InterventionParticipants (Count of Participants)
Grade 1Grade 2Grade 3Grade 4
Placebo + Abi/Pred3330
Radium-223 Dichloride + Abi/Pred3951

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Time to Pain Progression

Time to pain progression was defined as the interval from randomization to the first date a subject experienced pain progression, assessed by BPI-SF (see Baseline Characteristics) and defined as: an increase of 2 or more points in the average worst pain score (WPS) from baseline observed at 2 consecutive evaluations >= 4 weeks apart or initiation of short- or long-acting opioid use for pain for subjects with WPS 0 at baseline; an increase of 2 or more points in the average WPS from baseline observed at 2 consecutive evaluations ≥ 4 weeks apart and an average WPS of ≥ 4 OR initiation of short- or long-acting opioid use for pain for subjects with WPS 1 to 3 at baseline. Subjects without pain progression at the end of study are censored at the last date known to have not progressed: the last evaluation date for pain scores or last visit when recorded opiate use, whichever is last. Subjects with no on-study assessment or no baseline assessment are censored at the date of randomization. (NCT02043678)
Timeframe: From randomization until the date of pain progression based on pain score, up to 47 months

InterventionMonths (Median)
Radium-223 Dichloride + Abi/Pred14.4
Placebo + Abi/Pred18.7

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Time to Opiate Use for Cancer Pain

Time to opiate use for cancer pain was defined as the interval from the date of randomization to the date of opiate use. (NCT02043678)
Timeframe: From randomization until the date of opiate use, up to 47 months

InterventionMonths (Median)
Radium-223 Dichloride + Abi/Pred19.0
Placebo + Abi/Pred22.6

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Symptomatic Skeletal Event Free Survival (SSE-FS)

SSE-FS was defined as time (months) from randomization to the earliest of onset date of skeletal symptoms treated with external beam radiotherapy (EBRT), onset date of pathological bone fracture, onset date of spinal cord compression, procedure date of tumor-related orthopedic surgery, or death from any cause. Subjects who died without prior SSE and ≥ 13 weeks after the last SSE assessment are censored at the last SSE assessment date. Subjects alive at the survival cut-off date are censored at the last date known to be alive. Subjects with multiple events are only counted for the category in which the first event occurred. If multiple SSE (component events) occur on the same date for 1 subject, the subject is only counted into 1 category in the order of: spinal cord compression > bone fracture > orthopedic surgery > EBRT. (NCT02043678)
Timeframe: From randomization until first onset of on-study symptomatic skeletal event (SSE) or death, up to 47 months

InterventionMonths (Median)
Radium-223 Dichloride + Abi/Pred22.3
Placebo + Abi/Pred26.0

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Radiological Progression Free Survival (rPFS)

rPFS was defined as the time (months) from the date of randomization to the date of confirmed radiological progression or death (if death occurred before progression) based on independent assessment. (NCT02043678)
Timeframe: From randomization until the date of confirmed radiological progression or death, up to 47 months

InterventionMonths (Median)
Radium-223 Dichloride + Abi/Pred11.2
Placebo + Abi/Pred12.4

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Overall Survival (OS)

OS was defined as the time (months) from the date of randomization to the date of death due to any cause. Subjects alive at the survival cut-off date were censored at the last date known to be alive. (NCT02043678)
Timeframe: From randomization until death from any cause, up to 67 months

InterventionMonths (Median)
Radium-223 Dichloride + Abi/Pred30.1
Placebo + Abi/Pred34.8

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Number of Participants With Any Treatment-emergent Additional Primary Malignancies

Treatment-emergent additional primary malignancies were adverse events identified as additional primary malignancies that occurred after start of study treatment until the end of the treatment period. (NCT02043678)
Timeframe: From start of study treatment until 4 weeks after last study treatment, up to 65 months

InterventionParticipants (Count of Participants)
Radium-223 Dichloride + Abi/Pred26
Placebo + Abi/Pred25

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Time to Cytotoxic Chemotherapy

Time to cytotoxic chemotherapy is time (months) from randomization to the earliest date of the first cytotoxic chemotherapy. Participants who have not started cytotoxic chemotherapy during the study were censored at the last assessment date. (NCT02043678)
Timeframe: From randomization until the date of first cytotoxic chemotherapy, up to 47 months

InterventionMonths (Median)
Radium-223 Dichloride + Abi/Pred29.5
Placebo + Abi/Pred28.5

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Number of Participants With Post-treatment Adverse Events

"An adverse event (AE) was any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a participant in the study. Any bleeding event occurring during the study was not documented as an AE because this event was planned to be captured in the assessment of efficacy. AEs that started after the treatment period were defined as post-treatment AEs. Drug-related AEs were those with reasonable causal relationship to the study treatment decided by the investigators." (NCT02043678)
Timeframe: After the treatment period, up to 46 months

,
InterventionParticipants (Count of Participants)
Any eventsAny drug-related eventsAny chemotherapy-related eventsAny additional primary malignancies
Placebo + Abi/Pred1339347
Radium-223 Dichloride + Abi/Pred13818316

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Number of Participants With Treatment-emergent Adverse Events

"An adverse event (AE) was any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a participant in the study. A serious adverse event (SAE) was any untoward medical occurrence that at any dose was resulting in death, was lifethreatening, requires hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity. AEs or SAEs occurring after start of study treatment until the end of the treatment period were defined as treatment-emergent AEs (TEAEs) or serious TEAEs. Drug-related TEAEs or serious TEAEs were those with reasonable causal relationship to the study treatment decided by the investigators." (NCT02043678)
Timeframe: From start of study treatment until the end of the treatment period, up to 65 months

,
InterventionParticipants (Count of Participants)
Any TEAEAny drug-related TEAERadium-223/Placebo-related TEAEAny serious TEAEAny drug-related serious TEAERadium-223/Placebo-related serious TEAE
Placebo + Abi/Pred38727192172297
Radium-223 Dichloride + Abi/Pred382265921753211

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Number of Participants With Post-treatment Chemotherapy-related Blood and Lymphatic System Disorders

Post-treatment blood and lymphatic system disorders were adverse events identified as blood and lymphatic system disorders that occurred after the end of the treatment period until participant died, was lost to follow-up, withdrew informed consent, actively objected to collection of further data, or was transitioned to the extended safety follow-up study. (NCT02043678)
Timeframe: After the treatment period, up to 46 months

,
InterventionParticipants (Count of Participants)
AnaemiaBone marrow failureFebrile neutropeniaLeukopeniaNeutropeniaPancytopeniaThrombocytopenia
Placebo + Abi/Pred4080312
Radium-223 Dichloride + Abi/Pred5151802

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Number of Participants With Post-treatment Bone Fractures

Post-treatment fractures were adverse events identified as fractures that occured after the end of the treatment period until participant died, was lost to follow-up, withdrew informed consent, actively objected to collection of further data, or was transitioned to the extended safety follow-up study. All bone fractures and bone-associated events (e.g., osteoporosis), were reported as either AEs, or SAEs if the criteria of SAE were met, regardless of the investigator's causality assessment. (NCT02043678)
Timeframe: After the treatment period, up to 46 months

,
InterventionParticipants (Count of Participants)
Lumbar vertebral fractureRib fractureSpinal compression fractureThoracic vertebral fractureTraumatic fractureOsteoporotic fracturePathological fracture
Placebo + Abi/Pred11112013
Radium-223 Dichloride + Abi/Pred00006612

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Cyclophosphamide PK: Cmax

Cmax was determined using the post-dose Cyclophosphamide plasma concentrations on Cycle 1 Day 1. (NCT02055820)
Timeframe: End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)

Interventionmcg/mL (Mean)
Venetoclax PK Popluation32.1

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Doxorubicin PK: Cmax

Cmax was determined using the post-dose Doxorubicin plasma concentrations. (NCT02055820)
Timeframe: End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)

Interventionmcg/mL (Mean)
Venetoclax PK Popluation1260

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Prednisone Plasma PK: Cmax

Cmax was determined based on measurement of Predisone concentrations in plasma over time. (NCT02055820)
Timeframe: Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)

InterventionNg/ML (Mean)
Cycle 1, Day 1Cycle 2, Day 1
Venetoclax PK Popluation49.943.2

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Safety: Percentage of Participants Maintaining Relative Dose Intensity of CHOP Chemotherapy

Maintenance of relative dose intensity was defined as a dose intensity of >/= 90%. (NCT02055820)
Timeframe: Baseline up to Cycle 6 (cycle length = 21 days)

,
InterventionPercentage of participants (Number)
CyclophosphamideDoxorubicinVincristinePrednisone
Venetoclax + R-CHOP Arm89.588.686.687.4
Venetoclax 600mg + G-CHOP77.477.478.181.3

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Relative Dose Intensity of Venetoclax

Dose intensity was categorized as < 80%, 80% to < 85%, 85% to < 90%, or >/= 90%. (NCT02055820)
Timeframe: Baseline up to Cycle 6 (cycle length = 21 days)

,,,,,,,,,
InterventionPercentage of Partcipants (Number)
<80%80-<85%85-<90%>=90%
Venetoclax + G-CHOP 800 mg83.30.0016.70.00
Venetoclax + G-CHOP 800mg B100.00.000.000.00
Venetoclax + R-CHOP 800 mg Phase II26.03.42.967.6
Venetoclax 200 mg + R-CHOP71.40.000.0028.6
Venetoclax 200mg + G-CHOP100.000.000.000.00
Venetoclax 400 mg + R-CHOP0.000.000.00100.00
Venetoclax 400mg + G-CHOP14.314.30.0071.4
Venetoclax 600 mg + R-CHOP12.512.512.562.5
Venetoclax 600mg + G-CHOP50.016.70.0033.3
Venetoclax 800mg + R-CHOP0.000.000.00100.00

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Prednisone Plasma PK: Tmax

Tmax was determined based on measurement of Predisone concentrations in plasma over time. (NCT02055820)
Timeframe: Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)

InterventionHour (Mean)
Cycle 1, Day 1Cycle 2, Day 1
Venetoclax PK Popluation2.193.80

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Prednisone Plasma PK: AUC

AUC was determined based on measurement of Predisone concentrations in plasma over time. (NCT02055820)
Timeframe: Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)

Interventionhr*mcg/mL (Mean)
Cycle 1, Day 1Cycle 2, Day 1
Venetoclax PK Popluation195184

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Vincristine PK: Cmax

Cmax was determined using the post-dose Vincristine plasma concentrations. (NCT02055820)
Timeframe: End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)

Interventionmcg/mL (Mean)
Venetoclax PK Popluation54.0

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Venetoclax Plasma PK: Time to Maximum Observed Plasma Concentration (Tmax)

Tmax was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts. (NCT02055820)
Timeframe: Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)

InterventionHour (Mean)
Venetoclax + R-CHOP 100 mg4.0
Venetoclax 200 mg + R-CHOP4.59
Venetoclax 400 mg + R-CHOP6.50
Venetoclax 600 mg + R-CHOP5.52
Venetoclax 800mg + R-CHOP5.53
Venetoclax 200mg + G-CHOP5.72
Venetoclax 400mg + G-CHOP6.56
Venetoclax 600mg + G-CHOP5.30
Venetoclax + G-CHOP 800 mg5.79

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Venetoclax Plasma PK: Minimum Plasma Concentration (Cmin) Within the Dosing Interval

Cmin was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts. (NCT02055820)
Timeframe: Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)

Interventionmcg/mL (Mean)
Venetoclax + R-CHOP 100 mg0.0714
Venetoclax 200 mg + R-CHOP0.522
Venetoclax 400 mg + R-CHOP0.253
Venetoclax 600 mg + R-CHOP0.387
Venetoclax 800mg + R-CHOP0.640
Venetoclax 200mg + G-CHOP0.134
Venetoclax 400mg + G-CHOP0.395
Venetoclax 600mg + G-CHOP0.612
Venetoclax + G-CHOP 800 mg0.628

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Venetoclax Plasma PK: Maximum Observed Plasma Concentration (Cmax)

"Cmax was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.~Data are reported as micrograms per milliliter" (NCT02055820)
Timeframe: Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)

InterventionUg/ML (Mean)
Venetoclax + R-CHOP 100 mg.09
Venetoclax 200 mg + R-CHOP.58
Venetoclax 400 mg + R-CHOP.92
Venetoclax 600 mg + R-CHOP.85
Venetoclax 800mg + R-CHOP1.15
Venetoclax 200mg + G-CHOP.52
Venetoclax 400mg + G-CHOP1.26
Venetoclax 600mg + G-CHOP1.00
Venetoclax + G-CHOP 800 mg1.54

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Venetoclax Plasma PK: Area Under the Plasma Concentration-Time Curve (AUC)

"AUC was calculated based on measurement of venetoclax concentration in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.~Data are reported as hour*micrograms per milliliter (hr*mcg/mL)" (NCT02055820)
Timeframe: Predose (within 30 minutes) & 2, 4, 6, 8 hours (Hr) postdose on Cycle 1 Day 4 (cycle length = 21 days)

Interventionhr*mcg/mL (Mean)
Venetoclax 800mg + R-CHOP.66
Venetoclax 200 mg + R-CHOP2.51
Venetoclax 400 mg + R-CHOP3.87
Venetoclax 600 mg + R-CHOP3.70
Venetoclax + R-CHOP 800 mg4.51
Venetoclax 200mg + G-CHOP2.55
Venetoclax 400mg + G-CHOP4.33
Venetoclax 600mg + G-CHOP5.13
Venetoclax + G-CHOP 800mg6.20

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Safety: Percentage of Participants With Adverse Events

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. (NCT02055820)
Timeframe: Baseline up to approximately 36 months

InterventionPercentage of Participants (Number)
Venetoclax 200 mg + R-CHOP100.00
Venetoclax 400 mg + R-CHOP100.00
Venetoclax 600 mg + R-CHOP100.00
Venetoclax 800mg + R-CHOP100.00
Venetoclax + R-CHOP 800 mg Phase II99.0
Venetoclax 200mg + G-CHOP100.00
Venetoclax 400mg + G-CHOP100.00
Venetoclax 600mg + G-CHOP100.00
Venetoclax 800 mg + G-CHOP A100.00
Venetoclax 800 mg + G-CHOP B100.00

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Safety: Number of Participants With Dose-Limiting Toxicities (DLTs)

DLTs were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0). Decrease in B cells, lymphopenia, and leukopenia caused by lymphopenia were not considered DLTs but instead were expected outcomes of study treatment. Any Grade >/= 3 adverse event, that was attributed to having a reasonable possibility of being related to the combined administration of venetoclax plus R-CHOP or G-CHOP, that could not be attributed by the investigator to an alternative, clearly identifiable cause such as tumor progression, concurrent illness or medical condition, or concomitant medication and that occurred during the DLT observation period (start of venetoclax treatment through end of Cycle 2) was considered a DLT for dose-escalation purposes. Grade 3 or 4 neutropenia or thrombocytopenia identified on Day 1 of Cycle 2 or 3, resulting in dose delay were considered DLTs. (NCT02055820)
Timeframe: Start of venetoclax administration (Cycle 1 Day 4 or 3 days after first CHOP dose) up to end of Cycle 2 (cycle length = 21 days)

InterventionParticipants (Number)
Venetoclax 200 mg + R-CHOP1
Venetoclax 400 mg + R-CHOP0
Venetoclax 600 mg + R-CHOP1
Venetoclax 800mg + R-CHOP0
Venetoclax 200mg + G-CHOP2
Venetoclax 400mg + G-CHOP1
Venetoclax 600mg + G-CHOP1
Venetoclax 800 mg + G-CHOP A0
Venetoclax 800 mg + G-CHOP B0

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Rituximab PK: Cmin Within the Dosing Interval

Cmin was determined using the pre-dose rituximab plasma concentrations at the 800 mg Venetoclax Dose on Day 1 of Cycle 2. (NCT02055820)
Timeframe: Pre-dose on Cycle 2 Day 1 (cycle length = 21 days)

Interventionmcg/mL (Mean)
Venetoclax 800 mg26.1

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Rituximab PK: Cmax

Cmax was determined using the post-dose rituximab plasma concentrations at the 800 mg Venetoclax Dose using the end of infusion time point on Cycle 1 Day 1. (NCT02055820)
Timeframe: End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)

Interventionmcg/mL (Mean)
Venetoclax 800 mg173

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Percentage of Previously Untreated DLBCL Participants With Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Scan Using the Modified Lugano Classification Assessed by Independent Review Committee (IRC)

CR was defined as follows according to modified Lugano classification for PET/CT-based response: Lymph nodes and extra-lymphatic sites with score 1, 2, or 3 with or without a residual mass on 5-point scale with 1) no uptake above background; 2) uptake NCT02055820)
Timeframe: Baseline up to end of treatment (up to approximately 6 months)

InterventionPercentage of participants (Number)
Venetoclax + R-CHOP 800 mg Phase II68.2

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Percentage of Participants With Objective Response Defined as Partial Response (PR) or Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Using the Modified Lugano Classification Assessed by IRC

"Objective Response defined as PR (partial response) or CR (complete response) at end of treatment.~CR: Lymph nodes and extra-lymphatic sites with score 1, 2 or 3 on a 5-point scale (with a higher score being a worse outcome). No evidence of fluorodeoxyglucose (FDG)-uptake disease in marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy.~PR: Lymph nodes and extralymphatic sites with score of 4 or 5 on the 5-point scale with reduced uptake compared with baseline and residual mass(es) of any size. CT-based response criteria for PR must also be met. No new lesions. In bone marrow residual uptake could be higher than in normal marrow but must be reduced compared with baseline; persistent focal changes in the marrow to be considered for further evaluation with magnetic resonance imaging (MRI) or biopsy or an interval scan. OR=PR+CR" (NCT02055820)
Timeframe: Baseline to end of treatment (up to approximately 6 months)

InterventionPercentage of Participants (Number)
Venetoclax + R-CHOP 800 mg Phase II81.5

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Percentage of Participants With CR Defined by PET/CT Scan in Previously Untreated DLBCL Co-Expressing Both Bcl-2 and c-Myc Proteins (DE-DLBCL) Participants Assessed by IRC

CR was defined as follows according to modified Lugano classification for PET/CT-based response: Lymph nodes and extra-lymphatic sites with score 1, 2, or 3 with or without a residual mass on 5-point scale with 1) no uptake above background; 2) uptake NCT02055820)
Timeframe: Baseline up to end of treatment (up to approximately 6 months)

InterventionPercentage of participants (Number)
Venetoclax + R-CHOP 800 mg Phase II66.7

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Percentage of Participants With CR Defined by Computed Tomography (CT) Scan Using the Modified Lugano Classification

CR was defined as follows according to modified Lugano classification for CT-based response: Target nodes/nodal masses must have regressed to NCT02055820)
Timeframe: Baseline up to end of treatment (approx. 6 months)

InterventionPercentage of Participants (Number)
Venetoclax + R-CHOP 800 mg Phase II37.4

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Percentage of Participants Who Are Alive and Without Disease Progression at Month 12

Progressive disease (PD) was determined using the modified Lugano classification criteria. For PET-CT-based PD: Score 4 (uptake moderately > liver) or 5 (uptake markedly higher than liver and/or new lesions) with an increase in intensity of uptake from baseline in target nodes and nodal lesions, new FDG-uptake foci of extranodal lesions consistent with lymphoma at interim or end-of-treatment assessment, no non-measured lesions, new FDG-uptake foci consistent with lymphoma, new or recurrent FDG-uptake foci in bone marrow. For CT-based PD: >/= 50% decrease in SPD of up to 6 target measureable nodes and extranodal sites; non-measured lesion should be absent/normal, have regressed, but not increased; no new lesions. (NCT02055820)
Timeframe: Month 12

InterventionPercentage of Participants (Number)
Venetoclax 200 mg + R-CHOP85.71
Venetoclax 400 mg + R-CHOP100.00
Venetoclax 600 mg + R-CHOP87.50
Venetoclax 800mg + R-CHOP66.67
Venetoclax + R-CHOP 800 mg Phase II88.99
Venetoclax 200mg + G-CHOP100.00
Venetoclax 400mg + G-CHOP75.00
Venetoclax 600mg + G-CHOP100.00
Venetoclax 800 mg + G-CHOP A100.00
Venetoclax 800 mg + G-CHOP B100.00

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Obinutuzumab PK: Cmax

Cmax was determined using the post-dose obinutuzumab plasma concentrations at the 800 mg Venetoclax Dose using the end of infusion time point on Cycle 1 Day 1. (NCT02055820)
Timeframe: End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)

Interventionmcg/mL (Mean)
Venetoclax 800 mg326

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Change From Baseline in Morning Stiffness Duration at Week 12 as Assessed by Patient Diary

"Data for the duration of morning stiffness will be obtained from patient diaries. Duration of morning stiffness will be from wake-up time to time of resolution of morning stiffness.~Relative reduction rate of the morning stiffness duration from baseline to Week 12 of the study drug treatment was calculated for this outcome measure." (NCT02072200)
Timeframe: Baseline and 12 weeks

Interventionminutes (Mean)
Modified Release Prednisone-16.76

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Change of Baseline Severity of Morning Stiffness at Week 12 Using Visual Analog Scale (VAS) Scale

The VAS is a 100 mm line ranging from 0 mm (no pain) on the left end and 100 mm (worst pain) on the right end. Subjects marked on the line to indicate their pain severity. The distance in mm was measured from the left end to the subject's marking. (NCT02072200)
Timeframe: Baseline and 12 weeks

Interventionmm (Mean)
Modified Release Prednisone-25.70

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Change of Functional Disability Index of the Korea Health Assessment Questionnaire (KHAQ) From Baseline to Week 12

Change in KHAQ score from baseline to Week 12 post-treatment: KHAQ is composed of 8 functional disability indices. The scale for each index is from 0 (without any difficulty) to 3 (unable to do). Scores for each disability index were summed to obtain the total score for each subject, ranging between 0 to 24, with higher scores reflecting higher functional disability. The scores were then averaged across all subjects. (NCT02072200)
Timeframe: 12 weeks

Interventionscores on a scale (Mean)
Modified Release Prednisone-4.76

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Alkaline Phosphatase (ALP) and Prostate Specific Antigen (PSA) Levels Before and After Treatment

[Not specified] (NCT02097303)
Timeframe: Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline

Interventionng/dL (Mean)
ALP (Baseline)ALP (EOT)PSA (Baseline)PSA (EOT)
Radium 223 With Concomitant Abiraterone Acetate and Prednisone26111087137

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Safety Data Was Analyzed and Summarized in Subjects Who Receive at Least One Infusion of Radium Ra 223 Dichloride. Number of Adverse Events Are Being Reported.

All adverse events relevant to advanced mCRPC subjects as well as adverse events of interest for both Abiraterone Acetate plus Prednisone and Radium Ra 223 dichloride will be reported. (NCT02097303)
Timeframe: Subjects were evaluated at the screening visit, monthly during the study, and 30 days after the last dose of Radium Ra 223 dichloride, which will be approximately 32 weeks after the screening visit of evaluable subjects.

InterventionAdverse Events (Number)
Overall Adverse EventsGrade I or II Adverse EventsTreatment Related Adverse Events
Radium 223 With Concomitant Abiraterone Acetate and Prednisone18617970

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Radiologic Assessment Mean Number of Bone Lesions Before and After the Treatment

[Not Specified] (NCT02097303)
Timeframe: Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline

InterventionLesions (Mean)
BaselineEOT
Radium 223 With Concomitant Abiraterone Acetate and Prednisone11.65.6

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Overall Response Rate

Determination of measurable disease progression or response was based on modified RECIST criteria. Reported is the number of participants with either a partial or complete response, and who had radiological extraskeletal progression. (NCT02097303)
Timeframe: Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline

InterventionParticipants (Count of Participants)
Partial or complete responseProgression
Radium 223 With Concomitant Abiraterone Acetate and Prednisone48

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Number and Percentage of Participants With Clinically Meaningful Improvement (CMI) in Pain (Between Baseline and End of Treatment)

"Improvement in Bone Pain was assessed using the Bone Pain Inventory (BPI)~Pain Severity: Pain severity is the composite of scores of worst pain, least pain, average pain, and pain now. CMI criteria: Decrease >30% at two consecutive visits in Pain Severity Score in 24 hours without an increase in analgesic use.~Pain interference: Pain interference is the composite scores on general activity, mood, walking ability, normal work, relationships with others, sleep and enjoyment of life. CMI criteria: Decrease by 1.25 points or more compared with baseline at two consecutive visits.~Transient Pain Flare: Based on the work of Atkinson et al, a transient pain flare was assessed by pain at its worst in 24 hours. CMI criteria: > 2 points on the BPI-SF Worst Pain scale and subsequent reduction after initiation of Ra-223 and during the first 3 cycles." (NCT02097303)
Timeframe: Subjects were evaluated at the screening visit, monthly during the study, and 30 days after the last dose of Radium Ra 223 dichloride, which will be approximately 32 weeks after the screening visit of evaluable subjects.

InterventionParticipants (Count of Participants)
Pain SeverityPain InterferenceTransient Pain Flare
Radium 223 With Concomitant Abiraterone Acetate and Prednisone18122

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Number and Percentage of Participants With Clinically Meaningful Improvement (Between Baseline and End of Treatment) in Quality-of-Life Determined by the Minimum Increase From Baseline in Scores as Per the QOL CMI Criteria

"Following Quality of Life questionnaires were given at each visit:~FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the PCS (Range 1-156, higher scores better).~The FACT-General (FACT-G) is a 28 item QOL measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), Emotional (0-24) Well-being, and Satisfaction with Treatment was not assessed for this study (The total range was between 1-108, higher scores better)~FACT-TOI is derived from the sum of the Physical Well-Being, Functional Well-Being, and Prostate Cancer subscale scores; a sensitive measure of patient-reported health (Range 1-104, higher scores better)~PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better)." (NCT02097303)
Timeframe: Subjects were evaluated at the screening visit, monthly during the study, and 30 days after the last dose of Radium Ra 223 dichloride, which will be approximately 32 weeks after the screening visit of evaluable subjects.

InterventionParticipants (Count of Participants)
FACT-P Total ScaleFACT-G Total ScaleTreatment Outcome Index (FACT-TOI)Prostate Cancer Subscale (PCS)Physical Well-beingFunctional Well-beingEmotional Well-beingSocial Well-being
Radium 223 With Concomitant Abiraterone Acetate and Prednisone2018182519171815

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Bone Imaging Response (Number of Participants With Progression and Stable Disease)

Bone imaging response was assessed at baseline and at EOT visit. Progression was defined as two or more additional lesions in comparison to the baseline. (NCT02097303)
Timeframe: Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline

InterventionParticipants (Count of Participants)
Stable DiseaseProgression
Radium 223 With Concomitant Abiraterone Acetate and Prednisone292

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Time to Discontinuation of Steroid Therapy

Time in days to discontinuation of steroid therapy. (NCT02133924)
Timeframe: up to 365 days

Interventiondays (Median)
Participants With High Risk Acute Graft-Versus-Host Disease108

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Number of Participants With Non-Relapse Mortality (NRM)

Number of participants with Non-Relapse Mortality (NRM) at 6 months and 1 year (NCT02133924)
Timeframe: 6 months and 1 year

InterventionParticipants (Count of Participants)
6 months1 year
Participants With High Risk Acute Graft-Versus-Host Disease2528

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Number of Participants Who Received Additional GVHD Therapies

Number of participants who received additional GVHD therapies (defined as the initiation of a new acute GVHD therapy, regardless of duration) (NCT02133924)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Participants With High Risk Acute Graft-Versus-Host Disease33

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Number of Participants With Complete Response (CR)

The primary endpoint for this clinical study is the proportion of complete response, CR (that is, the percent of patients with skin, liver, and GI GVHD - all stage 0) at day 28 of study treatment. Stage 0 = no rash, total bilirubin <2 mg/dl, diarrhea <500 ml/d (NCT02133924)
Timeframe: Day 28

InterventionParticipants (Count of Participants)
Participants With High Risk Acute Graft-Versus-Host Disease34

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Number of Participants With Overall Response Rate (CR + PR)

Overall response rate (CR + PR) at day 28. Partial Response (PR) is defined as improvement in one or more organs involved with GVHD symptoms without progression in others. For a response to be scored as PR on day 28, the patient must be in PR on day 28 and have had no intervening non-study therapy for acute GVHD. (NCT02133924)
Timeframe: Day 28

InterventionParticipants (Count of Participants)
Participants With High Risk Acute Graft-Versus-Host Disease45

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Number of Participants With Overall Survival (OS)

Number of participants with overall survival at 1 year (NCT02133924)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Participants With High Risk Acute Graft-Versus-Host Disease37

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Number of Participants With SR GVHD

Number of participants with steroid-refractory (SR) GVHD to express cumulative incidence of treatment-refractory GVHD (defined as absence of CR or PR on day 28 of treatment or who receive additional immunosuppression prior to day 28) (NCT02133924)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Participants With High Risk Acute Graft-Versus-Host Disease30

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Number of Serious Infections

Number of serious infections (defined as score 3 by the Blood and Marrow Transplant Clinical Trials Network) (NCT02133924)
Timeframe: 6 months

Interventionevents (Number)
Participants With High Risk Acute Graft-Versus-Host Disease52

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Absolute Calculated Glomerular Filtration Rate (cGFR): Mean

Absolute (mean and median) cGFR values at 3, 6, 12 and 24 months post-transplant, as determined from the 4-variable Modification of Diet in Renal Disease (MDRD) formula (NCT02137239)
Timeframe: Up 24 Months post-transplant

,
InterventionmL/min/1.73 m^2 (Mean)
At 3 MonthsAt 6 MonthsAt 12 MonthsAt 24 Months
Treatment A69.266.066.271.8
Treatment B62.263.962.068.7

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Time to Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR).

Time to Clinically suspected biopsy proven acute rejection (NCT02137239)
Timeframe: Up to 24 Months

InterventionMonths (Mean)
Treatment ANA
Treatment BNA

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Treatment Differences in Therapeutic Modalities

Treatment Received for Biopsy Proven Acute Rejection (Banff Grade IA or Higher), or Humoral (Antibody Mediated) Rejection Treatment regimen: Categorical analysis of CSBPAR episodes by treatment received. (NCT02137239)
Timeframe: at 6, 12 and 24 Months

,
InterventionPercentage of participants with CSBPARs (Number)
Corticosteroids (6 months)Lymphocyte depleting agent (6 months)Plasmapheresis (6 months)IVIG (6 months)Rituximab (6 months)Corticosteroids (12 months)Lymphocyte depleting agent (12 months)Plasmapheresis (12 months)IVIG (12 months)Rituximab (12 months)Corticosteroids (24 months)Lymphocyte depleting agent (24 months)Plasmapheresis (24 months)IVIG (24 months)Rituximab (24 months)
Treatment A7.7000015.43.800019.23.8000
Treatment B9.46.303.1012.56.303.1012.56.303.10

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Number of Participants Who Experience Graft Loss Post Transplant

Number of all participants who experience graft loss at 6, 12 and 24 months post transplant (NCT02137239)
Timeframe: At 6, 12 and 24 months

,
InterventionParticipants (Count of Participants)
At 6 MonthsAt 12 MonthsAt 24 Months
Treatment A111
Treatment B111

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Percentage of Participants With Serious Adverse Events (SAEs)

Percentage of participants with SAEs up to 24 months post-transplant (NCT02137239)
Timeframe: Up to 24 months Post-Transplant

InterventionPercentage of participants with SAEs (Number)
Treatment A52.0
Treatment B60.6

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Number of Participants Who Survive With a Functioning Graft

Number of all participants who survive with a functioning graft at 6, 12 and 24 months post transplant (NCT02137239)
Timeframe: At 6, 12 and 24 months

,
InterventionParticipants (Count of Participants)
At 6 MonthsAt 12 MonthsAt 24 Months
Treatment A252525
Treatment B313131

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Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection

"Treatment differences in the severity grades to treat all episodes of CSBPAR at 6, 12, and 24 months post-transplant.~Type 1A - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/Tubular cross section or group of 10 Tubular cell). Type 1B - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/Tubular cross section or group of 10 Tubular cell).Type 2A - Cases with mild to moderate intimal arteritis.Type 2B - Cases with severe intimal arteritis comprising >25% of the luminal area. Type 3 - Cases with transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (v3 with accompanying lymphocytic inflammation)" (NCT02137239)
Timeframe: At 6, 12 and 24 Months

,
InterventionPercentage of Participants (Number)
6 Months: Mild Acute (1A)6 Months: Mild Acute (1B)6 Months: Moderate Acute (2A)6 Months: Moderate Acute (2B)6 Months: Severe Acute12 Months: Mild Acute (1A)12 Months: Mild Acute (1B)12 Months: Moderate Acute (2A)12 Months: Moderate Acute (2B)12 Months: Severe Acute24 Months: Mild Acute (1A)24 Months: Mild Acute (1B)24 Months: Moderate Acute (2A)24 Months: Moderate Acute (2B)24 Months: Severe Acute
Treatment A3.807.7007.707.70011.507.700
Treatment B03.16.3003.13.16.3003.13.16.300

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Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA)

Characterization of any de novo DSA detected by IgM and IgG subclasses, and by the presence or absence of complement fixing properties. (NCT02137239)
Timeframe: Up to 24 Months

,
InterventionPercentage (Number)
Baseline Class 1 DSABaseline Class 2 DSABaseline Both Class 1 and 2 DSADe Novo 12 Month Class 1 DSADe Novo 12 Month Class 2 DSADe Novo 12 Month Both Class 1 and 2 DSADe Novo 24 Month Class 1 DSADe Novo 24 Month Class 2 DSADe Novo 24 Month Both Class 1 and 2 DSA
Treatment A1000000000
Treatment B0000003.4500

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Absolute Values of Blood Pressure: Mean

Absolute (mean and median) values for SBP and DBP at 3, 6, 12 and 24 months posttransplant; (NCT02137239)
Timeframe: Up to 24 Months

,
InterventionmmHg (Mean)
Diastolic Month 3Systolic Month 3Diastolic Month 6Systolic Month 6Diastolic Month 12Systolic Month 12Diastolic Month 24Systolic Month 24
Treatment A78.7134.277.4128.178.7131.078.1130.9
Treatment B77.7131.079.4133.080.1131.078.5131.7

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Absolute Values of Blood Pressure: Median

Absolute (mean and median) values for SBP and DBP at 3, 6, 12 and 24 months posttransplant; (NCT02137239)
Timeframe: Up to 24 Months

,
InterventionmmHg (Median)
Diastolic Month 3Systolic Month 3Diastolic Month 6Systolic Month 6Diastolic Month 12Systolic Month 12Diastolic Month 24Systolic Month 24
Treatment A78.5135.575.5127.077.0130.078.0130.0
Treatment B80.0131.080.0131.081.0126.079.0130.0

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Absolute Values of Fasting Lipid Values: Mean

"Absolute (mean and median) values at 3, 6, 12 and 24 months post-transplant for the following:~Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG)" (NCT02137239)
Timeframe: Up to 24 Months

,
Interventionmg/dL (Mean)
TC Month 3TC Month 6TC Month 12TC Month 24HDL Month 3HDL Month 6HDL Month 12HDL Month 24LDL Month 3LDL Month 6LDL Month 12LDL Month 24TG Month 3TG Month 6TG Month 12TG Month 24
Treatment A181.2197.7189.0193.250.646.449.450.196.9115.2107.597.9171.6180.0162.4263.4
Treatment B174.4175169.9168.250.453.949.651.396.593.788.091.5137.8138.3161.3145.0

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Absolute Values of Fasting Lipid Values: Median

"Absolute (mean and median) values at 3, 6, 12 and 24 months post-transplant for the following:~Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG)" (NCT02137239)
Timeframe: Up to 24 Months

,
Interventionmg/dL (Median)
TC Month 3TC Month 6TC Month 12TC Month 24HDL Month 3HDL Month 6HDL Month 12HDL Month 24LDL Month 3LDL Month 6LDL Month 12LDL Month 24TG Month 3TG Month 6TG Month 12TG Month 24
Treatment A167.0187.0184.0193.045.045.550.049.089.099.5104.0103.5147.0157.5154.0159.0
Treatment B173.0178.0171.5166.049.049.047.049.095.0100.091.586.0128.0126.0130.0114.0

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Mean and Mean Change From Baseline in Blood Glucose

Mean fasting blood glucose levels, and mean changes from baseline values at Months 6, 12 and 24 months post- transplant (NCT02137239)
Timeframe: Up to 24 months

,
Interventionmg/dL (Mean)
Mean Value at 6 monthsChange from baseline at 6 monthsMean Value at 12 monthsChange from baseline at 12 monthsMean Value at 24 monthsChange from baseline at 24 months
Treatment A107.24.9101.1-1.3127.522.3
Treatment B107.24.8127.520.6111.815.0

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Mean and Mean Change From Baseline in Whole Blood HbA1c

Mean whole blood HbA1C concentrations, and mean changes from baseline values at Months 6, 12 and 24 months post-transplant. (NCT02137239)
Timeframe: Up to 24 months

,
Interventionmg/dL (Mean)
Mean Value at 6 monthsChange from baseline at 6 monthsMean Value at 12 monthsChange from baseline at 12 monthsMean Value at 24 monthsChange from baseline at 24 months
Treatment A6.110.346.180.476.240.66
Treatment B6.130.486.210.326.290.41

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Mean Change From Month 3 in cGFR

The mean change from Month 3 cGFR at 3, 6, 12 and 24 months post-transplant (NCT02137239)
Timeframe: Up 24 Months post-transplant

,
InterventionmL/min/1.73 m^2 (Mean)
At 3 MonthsAt 6 MonthsAt 12 MonthsAt 24 Months
Treatment A0-3.2-3.13.1
Treatment B02.81.46.3

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Mean Changes From Baseline Values for Blood Pressure

Mean changes from baseline values for SBP and DBP at 6, 12 and 24 months post-transplant (NCT02137239)
Timeframe: Up to 24 Months

,
InterventionmmHg (Mean)
Diastolic Month 6Systolic Month 6Diastolic Month 12Systolic Month 12Diastolic Month 24Systolic Month 24
Treatment A1.0-4.02.3-1.10.9-2.3
Treatment B4.8-0.75.4-3.22.1-4.2

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Mean Changes From Baseline Values of Lipid Values

"Mean changes from baseline values in the following:~Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG)" (NCT02137239)
Timeframe: at months 12 and 24

,
Interventionmg/dL (Mean)
TC Month 12TC Month 24HDL Month 12HDL Month 24LDL Month 12LDL Month 24TG Month 12TG Month 24
Treatment A25.726.65.46.225.717.43.3106.8
Treatment B-2.810.01.94.810.815.7-86.1-13.6

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Median Calculated Glomerular Filtration Rate (cGFR)

Median cGFR values at 3, 6, 12 and 24 months post-transplant, as determined from the 4-variable Modification of Diet in Renal Disease (MDRD) formula (NCT02137239)
Timeframe: Up 24 Months post-transplant

,
InterventionmL/min/1.73 m^2 (Median)
At 3 MonthsAt 6 MonthsAt 12 MonthsAt 24 Months
Treatment A64.064.066.073.5
Treatment B62.067.062.568.0

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Percentage of Participants With Adverse Events (AEs)

Percentage of participants with AEs up to 24 months post-transplant (NCT02137239)
Timeframe: Up to 24 months Post-Transplant

InterventionPercentage of participants with AEs (Number)
Treatment A100.0
Treatment B97.0

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Percentage of Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6 Months

Number of Participants with Clinically-suspected biopsy-proven acute rejection (CSBPAR) at 6 Months (NCT02137239)
Timeframe: 6 Months

InterventionPercentage of participants (Number)
Treatment A7.7
Treatment B9.4

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Number of Participants Deaths Post Transplant

Number of participant deaths at 6, 12 and 24 months post transplant (NCT02137239)
Timeframe: up to 24 months

,
InterventionParticipants (Count of Participants)
At 6 MonthsAt 12 MonthsAt 24 Months
Treatment A000
Treatment B000

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Time to Event: Graft Loss and Death

The Number of days to participant Graft Loss and death for any reason (NCT02137239)
Timeframe: Up to 728 Days

,
InterventionDays (Number)
Graft Loss
Treatment A107
Treatment B2

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Urine Protein Creatinine Ratio (UPr/Cr)

Urine protein to creatinine ratio (UPr/Cr) at 3, 6, 12 and 24 months post-transplant. (NCT02137239)
Timeframe: Up 24 Months post-transplant

,
Interventionmg Protein/mg Creatinine (Mean)
At 3 MonthsAt 6 MonthsAt 12 MonthsAt 24 Months
Treatment A0.31460.38960.28350.3940
Treatment B0.14120.14610.18490.1685

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Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA)

Percentage of participants with, and titers of pre-existing (pre-transplant) DSA on Day 1 (pre-transplant, pre-dose), and at Months 12 and 24 posttransplant (NCT02137239)
Timeframe: Up to 24 Months

,
InterventionPercentage of Participants (Number)
Baseline Class 1 DSABaseline Class 2 DSABaseline Both Class 1 and 2 DSA12 Month Class 1 DSA12 Month Class 2 DSA12 Month Both Class 1 and 2 DSA24 Month Class 1 DSA24 Month Class 2 DSA24 Month Both Class 1 and 2 DSA
Treatment A10008.00008.0000
Treatment B00003.0303.033.030

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Percentage of Participants With Events of Special Interest (ESIs)

"Percentage of participants which have one of the following events of special interest:~Serious Infections Post-Transplant Lymphoproliferative Disorder (PTLD) Progressive multifocal leukoencephalopathy (PML) Malignancies (Other than PTLD) including non-melanoma skin carcinomas (Malignancies) Tuberculosis Infections Central Nervous System (CNS) Infections Viral Infections Infusion Related reactions within 24 hours since belatacept infusion" (NCT02137239)
Timeframe: Up to 24 Months

,
InterventionPercentage of participants with ESIs (Number)
Serious InfectionsPTLDPMLMalignanciesTBCNS InfectionsViral InfectionsInfusion Related Reactions
Treatment A164.004.00001
Treatment B15.23.003.00000

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Percentage of Participants With New Onset Diabetes After Transplant

Percentage of participants with New Onset Diabetes After Transplantation (NODAT) at 6, 12, and 24 months post-transplant. (NCT02137239)
Timeframe: up to 24 months

,
InterventionPercentage of participants (Number)
Up to 6 MonthsUp to 12 MonthsUp to 24 Months
Treatment A11.511.515.4
Treatment B6.36.312.5

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Percentage of Particpants With Laboratory Test Abnormalities (LTAs)

Percentage of participants with laboratory tests with marked laboratory abnormalities (NCT02137239)
Timeframe: At 24 Months

,
InterventionPercentage of participants (Number)
Hemoglobin (Low)Leukocytes (low)Lymphocyte (Absolute) (low)Neutrophils (Absolute) (low)Aspartate Aminotransferase (High)Creatinine (High)Inorganic Phosphorus (low)Potassium (high)Sodium (low)Albumin (low)Glucose (high)Triglycerides (high)Uric Acid (high)
Treatment A12.0084.004.016.024.04.04.008.012.08.0
Treatment B6.13.069.73.003.012.1003.012.100

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Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6, 12 and 24 Months

"Clinically-suspected biopsy-proven acute rejection (CSBPAR) at 6, 12 and 24 Months~Change in the incidence of CSBPAR at 6, 12 and 24 months post transplant, in the belatacept + EVL(Treatment A) as compared to TAC + MMF (Treatment B)." (NCT02137239)
Timeframe: Up to 24 Months

,
InterventionPercentage of CSBPAR (Number)
CSBPAR at 6 MonthsCSBPAR at 12 monthsCSBPAR at 24 Months
Treatment A7.711.515.4
Treatment B9.412.512.5

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Disease-free Survival (Cohort II)

An estimate of disease free survival in Ph-positive ALL and Ph-like DSMKF ALL (Cohort II). Disease free survival is measured by the number of years between the date the patient first achieves complete remission (CR) or complete remission with incomplete platelet recovery (CRi) until relapse from CR/CRi or death from any cause. CR is defined as having <5% marrow aspirate blasts, ANC >1,000/mcL, platelets > 100,000/mcL, no blasts in peripheral blood, and C1 extramedullary disease status. CRi is the same as CR but platelet count may be <= 100,000/mcL and/or ANC <=1,000/mcL. (NCT02143414)
Timeframe: Duration of treatment and follow up until death or date of primary analysis (about 7.5 years)

Interventionyears (Median)
Cohort II (Ph+/Ph-like)5.3

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Overall Survival Rate (Cohort I)

To evaluate the 3-year overall survival rate in elderly participants with newly diagnosed Ph-negative ALL treated with blinatumomab followed by POMP maintenance. Overall (NCT02143414)
Timeframe: From the day of registration on study until death from any cause, assessed at 3 years

Interventionpercentage of participants (Number)
Cohort I (Ph-)34

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Complete Response Rate (Cohort I)

Complete response rate is measured by the number of participants achieving complete remission (CR) or complete remission with incomplete platelet recovery (CRi) rate. CR is defined as having <5% marrow aspirate blasts, ANC >1,000/mcL, platelets > 100,000/mcL, no blasts in peripheral blood, and C1 extramedullary disease status. CRi is the same as CR but platelet count may be <= 100,000/mcL and/or ANC <=1,000/mcL. (NCT02143414)
Timeframe: Participants are assessed after induction treatment and again after re-induction treatment, if re-induction treatment is received (i.e. up to 85 days after registration)

InterventionParticipants (Count of Participants)
CR or CRiNo CR or CRi
Cohort I (Ph-)1910

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Incidence of Dose-limiting Toxicity (Cohort II)

Defined as any grade 4 or higher treatment-related, non-hematologic toxicity in the first cycle of post-remission therapy (blinatumomab/dasatinib) graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Only participants with Ph-positive ALL or Ph-like DSMKF ALL were evaluated. (NCT02143414)
Timeframe: Up to day 42 of post-remission therapy

InterventionParticipants (Count of Participants)
Cohort II (Ph+/Ph-like)0

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Minimal Residual Disease Negativity

To estimate in each cohort the rate of minimal residual disease (MRD) negativity. (NCT02143414)
Timeframe: Participants are assessed after induction treatment and again after re-induction treatment, if re-induction treatment is received (i.e. up to 85 days after registration)

,
InterventionParticipants (Count of Participants)
MRD-MRD+
Cohort I (Ph-)121
Cohort II (Ph+/Ph-like)79

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B-cell Kinetics (B-cell Depletion and Recovery)

B-cell kinetics were demonstrated by median values of B-cell counts (Lower limit of quantification was 20 cells/uL). (NCT02162771)
Timeframe: Cycles 1 to 8 during the Core Study Period

,
Interventioncells/uL (Median)
Core Cycle 1 (Predose)Core Cycle 1 (1 hour after the end of infusion)Core Cycle 2 (Predose)Core Cycle 3 (Predose)Core Cycle 4 (Predose)Core Cycle 5 (Predose)Core Cycle 6 (Predose)Core Cycle 7 (Predose)Core Cycle 8 (Predose)
CT-P1092.520.020.020.020.020.020.020.020.0
Rituxan62.020.020.020.020.020.020.020.020.0

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Overall Response Rate (ORR) According to the 1999 International Working Group (IWG) Criteria

"ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed complete response (CRu), or partial response (PR) by central review.~Per 1999 IWG criteria, the disease status was assessed by using contrasted CT, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: >=75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: >=50% decrease in SPD of target lesions and no evidence of disease progression." (NCT02162771)
Timeframe: During the Core Study Period (up to 8 cycles; Week 24)

InterventionParticipants (Count of Participants)
CT-P1064
Rituxan63

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Maximum Serum Concentration at Steady State (Cmax,ss)

"Cmax,ss: Maximum concentration of drug in plasma at steady state on administering a fixed dose at equal dosing intervals.~PK sampling was done at pre-dose and 1 hour after the end of infusion (EOI) at Core Cycles 1-3 and 5-8. At Core Cycle 4 (i.e. steady state), intensive PK samplings were done as follows: predose, EOI, 1 hour after EOI, 24 hour after EOI, 168 hour after EOI, 336 hour after EOI, 504 hour after EOI. Lastly, one sample at any time of the end of treatment (EOT) 1 visit was obtained." (NCT02162771)
Timeframe: Core Cycle 4 (Week 12)

Interventionug/mL (Geometric Mean)
CT-P10256.19
Rituxan254.49

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Area Under the Serum Concentration-time Curve at Steady State (AUCtau)

"AUCtau: Area under the plasma drug concentration-time curve within a dosing interval at steady state.~PK sampling was done at pre-dose and 1 hour after the end of infusion (EOI) at Core Cycles 1-3 and 5-8. At Core Cycle 4 (i.e. steady state), intensive PK samplings were done as follows: predose, EOI, 1 hour after EOI, 24 hour after EOI, 168 hour after EOI, 336 hour after EOI, 504 hour after EOI. Lastly, one sample at any time of the end of treatment (EOT) 1 visit was obtained." (NCT02162771)
Timeframe: Core Cycle 4 (Week 12)

Interventionh*ug/mL (Geometric Mean)
CT-P1041002.43
Rituxan40099.08

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Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death

Primary analysis will be based 1-sided log rank test comparison of EFS curves between the 2 randomized arms per intention-to-treat principle. Progression is defined as an ≥50% increase of in the product of the perpendicular diameters of any of the involved nodes or nodal masses or focal organ lesions in sites that were persistently PET positive; or recurrent PET positive lesions (Deauville 4, 5) in sites that had previously been PET negative regardless of change of size, as was the development of new PET avid measurable lesion(s) >1.5cm in any axis, or new sites of assessable disease. Relapse is defined in patients who achieved a prior CR but subsequently has an increase of ≥50% of the PPD in prior nodal or extranodal sites in a recurrently PET positive lesion(s), or the development of new measurable lesion(s) >1.5cm in any axis, or new sites of assessable disease. Second malignancy is defined based on report of a cancer that is not considered to be classic Hodgkin Lymphoma. (NCT02166463)
Timeframe: Up to 48 months after the last enrollment

Interventionpercentage of participants (Number)
Arm I (ABVE-PC)82.5
ARM II (Bv-AVEPC)92.1

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Percentages of Patients With Early Response Defined as no Slow Responding Lesions (SRL) and no Progressive Disease (PD) at Any Disease Sites Determined by Positron Emission Tomography (PET) Per Deauville Criteria Through Central Review

The percentages of patients (with available PET scan) with no SRL and no PD will be compared between the two randomized arms to see if brentuximab vedotin in the chemotherapy backbone of doxorubicin hydrochloride, vincristine sulfate, etoposide, prednisone and cyclophosphamide (Bv-AVEPC) arm has a higher rate of early response compared to doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide (ABVE-PC) arm. Two-sample Z test of proportions at 1-sided alpha level of 0.05 will be used for these comparisons. (NCT02166463)
Timeframe: After 42 days of chemotherapy

InterventionPercentage of patients (Number)
Arm I (ABVE-PC)80.7
ARM II (Bv-AVEPC)81.2

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Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale

"The percentages of patients experiencing grade 3+ peripheral neuropathy assessed by the treating clinician using the modified Balis scale. The Modified Balis scale of Pediatric Neuropathy allows clinicians to assign a score for sensory or motor neuropathy symptoms separately. Scores range from 1 to 4 with 1 being the least symptomatic state and 4 indicating a severe debility. The percentages of patients (with a score >/=3) will be compared between the 2 arms by two-sample Z test at 1-sided alpha level of 0.05." (NCT02166463)
Timeframe: From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years.

InterventionPercentage of patients (Number)
Arm I (ABVE-PC)5.5
ARM II (Bv-AVEPC)6.7

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Vasculitis Damage Index (VDI)

The Vasculitis Damage Index (VDI) is a single-page catalog of damage items separated into 11 groupings of items by organ system. There are a total of 60 items. Each item is recorded if it occurred since the onset of vasculitis, has been present for at least 3 months, or occurred at least 3 months ago. Each item of damage is scored as present (1) or absent (0), yielding a maximum score of 60. (NCT02169219)
Timeframe: 24 months

Interventionunits on a scale (Mean)
Baseline VDI score24 month VDI score
Glucocorticoids and Rituximab00.5

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Sustained Complete Remission

Number of patients entering sustained remission defined as BVAS/WG = 0, prednisone dose = 0 and no disease flares during the study period. (NCT02169219)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Glucocorticoids and Rituximab14

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Severe Flares

Number of severe flares defined as flare with BVAS/WG > 3 or experiencing one of the major BVAS/WG items (NCT02169219)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Glucocorticoids and Rituximab5

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Partial Remission

Number of patients entering partial remission, defined as no new disease manifestations, no worsening of existing disease and BVAS/WG < 3. (NCT02169219)
Timeframe: 8 weeks

InterventionParticipants (Count of Participants)
Glucocorticoids and Rituximab20

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Limited Flares

Number of limited flares defined as a new occurrence or worsening of one or more minor BVAS/WG items and a total BVAS/WG ≤ 3 (NCT02169219)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Glucocorticoids and Rituximab2

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Early Treatment Failures

Number of early treatment failures defined as patients who have new or worsening disease manifestations assessed at 4 weeks after study entry (NCT02169219)
Timeframe: 4 weeks

InterventionParticipants (Count of Participants)
Glucocorticoids and Rituximab0

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Disease Response

Number of patients achieving disease response defined as, no new disease manifestations; no worsening of existing disease; stable or improved BVAS/WG score at 4 weeks. (NCT02169219)
Timeframe: 4 weeks

InterventionParticipants (Count of Participants)
Rituximab and Glucocorticoids20

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Complete Remission

We examined whether an 8-week glucocorticoid course in combination with rituximab (RTX) would induce disease remission in patients with AAV. The primary outcome was disease remission off steroids at 6 months. (NCT02169219)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Glucocorticoids and Rituximab14

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Percent of Participants With Grade 3 or Higher Wound Complication(s) Adverse Event(s)

"The severity of adverse events (AEs) was classified into grades using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 (4/28/2009):~Grade 3 wound complications are defined as Hernia without evidence of strangulation; fascial disruption/dehiscence; primary wound closure or revision by operative intervention indicated~Grade 4 complications are defined as Hernia with evidence of strangulation; major reconstruction flap, grafting, resection, or amputation indicated" (NCT02188719)
Timeframe: Transplantation to 40 Weeks Post Transplantation

InterventionPercent of Participants (Number)
Cohort 10
Cohort 20

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Percent of Participants With Biopsy-Proven Acute and/or Chronic Rejection

"Biopsy-proven acute rejection graded as Mild, Moderate or Severe, per 1997 Banff classification. Chronic Rejection graded using Banff 2000 classification.~References: 1.) Banff Schema for Grading Liver Allograft Rejection: An International Consensus Document developed by an international panel of experts in liver transplantation pathology, hepatology, and surgery (Hepatology 1997; 25(3): 658-663). 2.) Update of the International Banff Schema for Liver Allograft Rejection: Working Recommendations for the Histopathologic Staging and Reporting of Chronic Rejection (Hepatology 2000; 31(3): 792-799)." (NCT02188719)
Timeframe: Transplantation to 40 Weeks Post Transplantation

,
InterventionPercent of Participants (Number)
Mild Acute RejectionModerate Acute RejectionSevere Acute RejectionChronic Rejection
Cohort 10000
Cohort 211.1000

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Percent of Participants With Grade 2 or Higher Hematologic Adverse Events (AEs) of Anemia, Neutropenia, and/or Thrombocytopenia

"The severity of adverse events (AEs) was classified into grades using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 (4/28/2009):~Grade 1 = mild AE~Grade 2 = moderate AE~Grade 3 = severe and undesirable AE~Grade 4 = life-threatening or disabling AE~Grade 5 = death" (NCT02188719)
Timeframe: Transplantation to 40 Weeks Post Transplantation

,
InterventionPercent of Participants (Number)
AnemiaNeutropeniaThrombocytopenia
Cohort 166.716.716.7
Cohort 222.200

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Percent of Participants With Adverse Events (AEs) Attributable to the Donor Alloantigen Reactive Tregs (darTregs) Infusion

"AEs classified by the site investigator/clinician as possibly or definitely related to the study treatment, the Donor Alloantigen Reactive Tregs (darTregs) infusion. These AEs include:~infusion reaction~Grade 3 or higher cytokine release syndrome (Reference: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 (4/28/2009) grading criteria~malignant cellular transformation." (NCT02188719)
Timeframe: Transplantation to 40 Weeks Post Transplantation

InterventionPercent of Participants (Number)
Cohort 20

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Percent of Participants With Grade 3 or Higher Infectious Adverse Event(s)

"The severity of infectious adverse events (AEs) was classified into grades as follows:~Grade 1 = asymptomatic; clinical or diagnostic observation only; intervention with oral antibiotic, antifungal, or antiviral agent only; no invasive intervention required~Grade 2 = symptomatic; intervention with intravenous antibiotic, antifungal, or antiviral agent; invasive intervention may be required~Grade 3 = any infection associated with hemodynamic compromise requiring pressors; any infection necessitating intensive care unit level of care; any infection necessitating operative intervention; any infection involving the central nervous system; any infection with a positive fungal blood culture; any proven or probable aspergillus infection; any tissue invasive fungal infection; any pneumocystis jiroveci infection~Grade 4 = life-threatening infection~Grade 5 = death resulting from infection" (NCT02188719)
Timeframe: Transplantation to 40 Weeks Post Transplantation

InterventionPercent of Participants (Number)
Cohort 10
Cohort 211.1

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Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30: Emotional Functioning Score

"The EORTC QLQ-C30 is a 30 items self-reporting questionnaire, with a 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The questionnaire includes 28 items with 4-point Likert type responses from 1-not at all to 4-very much to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall QoL. Scores are transformed to a 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values indicate deterioration in quality of life or functioning and positive values indicate improvement." (NCT02195479)
Timeframe: Baseline, Months 3, 6, 9, 12 and 18

,
InterventionUnits on a scale (Least Squares Mean)
Month 3Month 6Month 9Month 12Month 18
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)8.810.611.112.611.4
Velcade, Melphalan and Prednisone (VMP)9.410.511.91112.7

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Time to Response

Time to response, defined as the time between the date of randomization and the first efficacy evaluation that the participant has met all criteria for PR or better. PR: >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours; If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow PCs is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. (NCT02195479)
Timeframe: From randomization to first documented PR or better (up to 2.4 years)

InterventionMonths (Median)
Velcade, Melphalan and Prednisone (VMP)0.82
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)0.79

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Time to Disease Progression (TTP)

TTP: Time from date of randomization to date of first documented evidence of PD or death due to PD, whichever occurs first. PD per IMWG criteria- Increase of 25 % from lowest response value in one of following: Serum and urine M-component (absolute increase >=0.5 gram per deciliter [g/dL] and >=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase >10 milligram per deciliter [mg/dL]); Only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cells (PC)% (absolute % >=10%); Bone marrow PC %: absolute % >10%; Definite development of new bone lesions/soft tissue plasmacytomas or definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to the PC proliferative disorder. (NCT02195479)
Timeframe: From randomization to either disease progression or death due to PD whichever occurs first (up to 2.4 years)

InterventionMonths (Median)
Velcade, Melphalan and Prednisone (VMP)19.35
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)NA

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Progression Free Survival (PFS)

PFS- duration from date of randomization to Progressive disease (PD)/death, whichever occurs first. PD per IMWG criteria-Increase of 25% from lowest response value in one of following: Serum and urine M-component (absolute increase >=0.5 gram per deciliter [g/dL] and >=200 milligram [mg]/24 hours respectively); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase>10 mg/dL); Only participants without measurable serum and urine M-protein levels,without measurable disease by FLC levels,bone marrow Plasma cells (PC) %(absolute % >=10%);Bone marrow PC%: absolute% >10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to the PC proliferative disorder. (NCT02195479)
Timeframe: From randomization to either disease progression or death whichever occurs first (up to 2.4 years)

InterventionMonths (Median)
Velcade, Melphalan and Prednisone (VMP)18.14
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)NA

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Percentage of Participants With Very Good Partial Response (VGPR) or Better

VGPR or better rate was defined as the percentage of participants who achieved VGPR or complete response (CR) (including stringent complete response[sCR]) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or >= 90% reduction in serum M-protein plus urine M-protein level less than (<) 100 milligram (mg) per 24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and < 5% plasms cells (PCs) in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by immunohistochemistry, immunofluorescence, 2-4 color flow cytometry. (NCT02195479)
Timeframe: From randomization to disease progression (up to 2.4 years)

InterventionPercentage of participants (Number)
Velcade, Melphalan and Prednisone (VMP)49.7
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)71.1

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Percentage of Participants With Stringent Complete Response (sCR)

sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry. CR: Negative immunofixation on the serum and urine; Disappearance of any soft tissue plasmacytomas; <5% plasma cells (PCs) in bone marrow. (NCT02195479)
Timeframe: From randomization to disease progression (up to 2.4 years)

InterventionPercentage of participants (Number)
Velcade, Melphalan and Prednisone (VMP)9.3
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)20.3

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Percentage of Participants With Negative Minimal Residual Disease (MRD)

The Minimal Residual Disease negativity rate was defined as the percentage of participants who had negative MRD (detection of less than 1 malignant cell among 100,000 normal cells) assessment at any timepoint after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood at 10^-5 threshold. MRD was evaluated by using Deoxyribonucleic acid (DNA) sequencing of immunoglobulin genes. MRD was assessed in participants who achieved complete response or stringent complete response (CR/sCR). (NCT02195479)
Timeframe: From randomization to disease progression (up to 2.4 years)

InterventionPercentage of participants (Number)
Velcade, Melphalan and Prednisone (VMP)6.2
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)22.3

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Percentage of Participants With Complete Response (CR) or Better

CR or better rate was defined as the percentage of participants with a CR or better (i.e. CR and sCR) as per IMWG criteria. CR: as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (<) 5 percent plasma cells in bone marrow; sCR: CR plus normal free light chain (FLC) ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry. (NCT02195479)
Timeframe: From randomization to disease progression (up to 2.4 years)

InterventionPercentage of participants (Number)
Velcade, Melphalan and Prednisone (VMP)24.4
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)42.6

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Overall Response Rate (ORR)

The Overall response rate was defined as the percentage of participants who achieved a partial response (PR) or better, according to the International Myeloma Working Group (IMWG) criteria, during the study or during follow up. IMWG criteria for PR: greater than or equal to (>=) 50 percentage(%) reduction of serum M-protein and reduction in 24 hour urinary M-protein by >=90% or to <200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required. (NCT02195479)
Timeframe: From randomization to disease progression (up to 2.4 years)

InterventionPercentage of participants (Number)
Velcade, Melphalan and Prednisone (VMP)73.9
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)90.9

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Duration of Response (DOR)

DOR: participants with a confirmed response (PR or better) as time between first documentation of response and disease progression, IMWG response criteria, or death due to PD, whichever occurs first. PD: Increase of 25% from lowest response value in any one of following: Serum M-component (absolute increase>=0.5 g/dL); Urine M-component (absolute increase>=200 mg/24 hours); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase >10 mg/dL); Only participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC%(absolute%>=10%); Bone marrow PC's %: absolute%>10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in the size of existing bone lesions or soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder. (NCT02195479)
Timeframe: Up to 2.4 years

InterventionMonths (Median)
Velcade, Melphalan and Prednisone (VMP)21.3
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)NA

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Overall Survival (OS)

Overall Survival (OS) was defined as the number of days the date of randomization to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method. (NCT02195479)
Timeframe: From randomization to death (up to approximately 2.4 years)

InterventionMonths (Median)
Velcade, Melphalan and Prednisone (VMP)NA
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)NA

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Percentage of Participants With Best M-protein Response

Percentage of participants with Best M- protein response of 100% reduction and >=90% to < 100% reduction were assessed. Best M-protein response was defined as the maximal percent reduction or the lowest percent increase from baseline in serum M-protein for participants with measurable heavy chain at baseline or urine M-protein for participants without measurable heavy chain, but with measurable light chain disease at baseline. For participants without measurable heavy chain and light chain disease at baseline, best response in serum free light chain (FLC) was defined as the maximal percent reduction or the lowest percent increase from baseline in the difference between involved and uninvolved serum FLC level (dFLC). (NCT02195479)
Timeframe: Approximately up to 2.4 years

,
InterventionPercentage of participants (Number)
Best M-protein response in serum: 100% reductionBest M-protein response in serum:>= 90 to < 100%Best M-protein response in urine:100% reductionBest M-protein response in urine:>=90 to < 100%Best response in dFLC:100% reductionBest response in dFLC: >=90% to < 100% reduction
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)58.515.290.57.10100.0
Velcade, Melphalan and Prednisone (VMP)38.714.669.413.9077.8

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Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L): Visual Analogue Scale (VAS)

EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. (NCT02195479)
Timeframe: Baseline, Months 3, 6, 9, 12 and 18

,
InterventionUnits on a scale (Mean)
BaselineMonth 3Month 6Month 9Month 12Month 18
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)57.909.2810.8312.5010.7912.04
Velcade, Melphalan and Prednisone (VMP)60.334.207.409.8910.807.65

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Change From Baseline in EuroQol 5 Dimensions-5 Level (EQ-5D-5L) Utility Score

EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The EQ-5D-5L descriptive system provides a profile of the participant's health state 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score 0 (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of the individual based on the UK scoring algorithm. (NCT02195479)
Timeframe: Baseline, Months 3, 6, 9, 12 and 18

,
InterventionUnits on a scale (Mean)
BaselineMonth 3Month 6Month 9Month 12Month 18
Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)0.570.120.130.160.170.13
Velcade, Melphalan and Prednisone (VMP)0.590.090.120.160.150.13

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Overall Survival

Overall survival was defined as the time from date of the first dose of abiraterone acetate to the date of death due to any cause. For participants who did not die until the time of analysis, survival time was censored at the time of last contact alive. (NCT02217566)
Timeframe: Up to 4 years

InterventionMonths (Median)
Abiraterone Acetate29.6

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Percentage of Participants Who Achieved Prostate-Specific Antigen (PSA) Response

The PSA response according to Prostate Specific Antigen Working Group 3 criteria was defined as at least 50% decrease in PSA level from Baseline. (NCT02217566)
Timeframe: Week 12 to any time up to 2 years

InterventionPercentage of participants (Number)
Abiraterone Acetate57.50

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Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Severity Score

The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain severity score is a mean value for BPI-SF questions 3, 4, 5 and 6 (questions inquiring about the extent of pain, where the extent is ranked from 0 [no pain] to 10 [pain as bad as you can imagine]). Pain severity progression was defined as an increase in score of 30% or greater from baseline without decrease in analgesic use. (NCT02217566)
Timeframe: Up to 2 years

InterventionPercentage of participants (Number)
Abiraterone Acetate19.44

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Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Interference Score

The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain interference score is mean value for the 7 BPI-SF questions (questions inquiring about the extent of interference with activities by pain) where the extent is ranked from 0 (does not interfere) to 10 (completely interferes). Pain interference progression was defined as an increase in score of 50% or greater from baseline without decrease in analgesic use. (NCT02217566)
Timeframe: Up to 2 years

InterventionPercentage of participants (Number)
Abiraterone Acetate15.15

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Time to Prostate-specific Antigen (PSA) Progression

Time to PSA progression was calculated from date of enrollment to the date of first documentation of PSA progression. As per Prostate Cancer Clinical Trials Working Group (PCWG2) criteria, PSA progression was defined as greater than or equal to (>=) 25 percent (%) and >=2 nanogram/milliliter (ng/mL) after 12 weeks (in case of no decline in PSA from Baseline), or first PSA increase that is >=25% and >=2 ng/mL above the nadir, and which was confirmed by a second value 3 or more weeks later (in case of decline of PSA from Baseline). (NCT02217566)
Timeframe: Up to 2 years

InterventionMonths (Median)
Abiraterone Acetate7.3

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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE is any untoward medical occurrence in a participant who will receive study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly. (NCT02217566)
Timeframe: Up to 4 years

InterventionParticipants (Count of Participants)
Participants with AEsParticipants with SAEs
Abiraterone Acetate4511

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Radiographic Progression-free Survival (rPFS)

The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (>=) 2 new lesions compared to baseline was observed in less than (<) 12 weeks from randomization and was confirmed by a second bone scan taken >=6 weeks later showing >=2 additional new lesions (a total of >=4 new lesions compared to baseline), b) the first bone scan with >=2 new lesions compared to baseline was observed in >=12 weeks from randomization and the new lesions were verified on the next bone scan >=6 weeks later (a total of >=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. (NCT02257736)
Timeframe: Up to 3 years and 4 months

Interventionmonths (Median)
Placebo+ Abiraterone Acetate - Prednisolone16.59
Apalutamide + Abiraterone Acetate - Prednisolone23.98

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Overall Survival (OS)

The OS was defined as the time from randomization to date of death from any cause. (NCT02257736)
Timeframe: Up to 5 years and 10 months

Interventionmonths (Median)
Placebo+ Abiraterone Acetate - Prednisolone33.71
Apalutamide + Abiraterone Acetate - Prednisolone36.17

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Time to Chronic Opioid Use

Time to chronic opioid use was defined as the time from date of randomization to the first date of opioid use. (NCT02257736)
Timeframe: Up to 5 years and 10 months

Interventionmonths (Median)
Placebo+ Abiraterone Acetate - Prednisolone53.26
Apalutamide + Abiraterone Acetate - Prednisolone46.98

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Time to Initiation of Cytotoxic Chemotherapy

Time to initiation of cytotoxic chemotherapy was defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy. (NCT02257736)
Timeframe: Up to 5 years and 10 months

Interventionmonths (Median)
Placebo+ Abiraterone Acetate - Prednisolone34.23
Apalutamide + Abiraterone Acetate - Prednisolone36.11

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Time to Pain Progression

"Time to pain progression: time from randomization to first date that participant either experienced an increase by 2 points from baseline in Brief Pain Inventory Short Form (BPI-SF) worst pain intensity item (item 3) or Case Report Form (CRF) pain, observed at 2 consecutive evaluations >=4 wks apart, or initiation of chronic opioids as defined in time to chronic opioid use, whichever occurred first. BPI-SF is a self-administered questionnaire developed to assess severity of pain and impact of pain on daily functions. Item 3(worst pain intensity) asks participants to rate worst pain in prior 7-days on a 0-10 numeric rating scale, where 0 indicates No pain and 10 indicates Pain as bad as you can imagine. A lower score is better.CRF pain refers to participant's response to global pain assessment How would you rate your pain over the past 7 days?with a scale of 0(No pain) to 10(Pain as bad as you can imagine),that is systematically reported and recorded on the eCRF." (NCT02257736)
Timeframe: Up to 5 years and 10 months

Interventionmonths (Median)
Placebo+ Abiraterone Acetate - Prednisolone26.51
Apalutamide + Abiraterone Acetate - Prednisolone21.82

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Percentage of Participants With an Negative Anti-dsDNA Result at Week 24, Week 48, and Week 96

"The percentage of participants who were anti-double stranded DNA (anti-dsDNA) negative, defined as having anti-dsDNA levels <30 IU/mL.~Anti-dsDNA levels are associated with systemic lupus erythematosus disease activity." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)14.320.00.0
Rituximab/Cyclophosphamide/Belimumab (RCB)15.830.027.8

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Percentage of Participants With At Least One Grade 3 or Higher Infectious Adverse Event By Week 24, Week 48 and Week 96

"The percentage of participants who experienced at least one Grade 3 or higher treatment-emergent infectious adverse event. The severity of adverse events (AEs) was classified into grades using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010). Treatment-emergent AEs are those:~with an onset date on or after the first dose of study medication,~with onset before first dose but that worsened in severity after first dose, and~for which the start of the AE in relation to the start of study medication could not be established.~AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0. Grade 3 or higher AEs were classified infectious based on the study team's review of the MedDRA body systems and preferred terms of the AEs." (NCT02260934)
Timeframe: Week 0 to Week 96

,
Interventionpercentage of participants (Number)
Week 0 to Week 24Week 0 to Week 48Week 0 to Week 96
Rituximab/Cyclophosphamide (RC)9.122.727.3
Rituximab/Cyclophosphamide/Belimumab (RCB)4.89.59.5

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Percentage of Participants With B Cell Reconstitution at Week 24, Week 48 and Week 96

"The percentage of participants who achieved B cell reconstitution, defined as a peripheral blood total B cell count ≥ to the baseline count or the lower limit of normal, whichever was lower. Note: B cell depletion was expected to occur in this study between Weeks 0 and 4, after initiation of rituximab and cyclophosphamide.~Normal peripheral blood B Cell count: 107 to 698 cells/µL." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
InterventionPercentage of Participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)31.335.740.0
Rituximab/Cyclophosphamide/Belimumab (RCB)6.311.830.8

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Percentage of Participants With Grade 4 Hypogammaglobulinemia by Week 24, Week 48, and Week 96

The percentage of participants who experienced Grade 4 hypogammaglobulinemia, defined as having a serum Immunoglobulin G (IgG) level < 300 mg/dL. Severity of adverse events (AEs) was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010). (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 0 to Week 24Week 0 to Week 48Week 0 to Week 96
Rituximab/Cyclophosphamide (RC)000
Rituximab/Cyclophosphamide/Belimumab (RCB)000

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Frequency of Specific Adverse Events of Interest By Event by Week 96

"Number of ≥ Grade 2 specific treatment-emergent adverse events (AEs) of interest. Grade 2 or higher AEs were classified according to the listed categories of interest based on the study team's review of the AEs.~Treatment-emergent AEs are those:~with an onset date on or after the first dose of study medication,~with onset before first dose but that worsened in severity after first dose, and~for which the start of the AE in relation to the start of study medication could not be established.~The severity of AEs was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03: June 14, 2010). AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0." (NCT02260934)
Timeframe: Week 96

,
InterventionEvents (Number)
Any event leading to death≥Grade 2 leukopenia or thrombocytopeniaPremature ovarian failureMalignancyVenous thromboembolic event
Rituximab/Cyclophosphamide (RC)013003
Rituximab/Cyclophosphamide/Belimumab (RCB)016000

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Frequency of Specific Adverse Events of Interest By Participant, By Week 96

"Number of participants who experienced ≥Grade 2 specific treatment-emergent adverse events (AEs) of interest. Grade 2 or higher AEs were classified according to the listed categories of interest based on the study team's review of the AEs.~Treatment-emergent AEs are those:~with an onset date on or after the first dose of study medication,~with onset before first dose but that worsened in severity after first dose, and~for which the start of the AE in relation to the start of study medication could not be established.~The severity of AEs was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03: June 14, 2010). AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0." (NCT02260934)
Timeframe: Week 96

,
InterventionParticipants (Count of Participants)
Any event leading to death≥Grade 2 leukopenia or thrombocytopeniaPremature ovarian failureMalignancyVenous thromboembolic event
Rituximab/Cyclophosphamide (RC)06002
Rituximab/Cyclophosphamide/Belimumab (RCB)06000

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Percentage of Participants With an Overall Response at Week 24, Week 48, and Week 96

"The percentage of participants who achieved an overall response, defined as meeting all of the following criteria:~>50% improvement in the urine protein-to-creatinine ratio (UPCR) from study entry, based on a 24-hour collection;~Estimated glomerular filtration rate (eGFR) ≥120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and~Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)46.760.053.3
Rituximab/Cyclophosphamide/Belimumab (RCB)55.073.771.4

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Percentage of Participants With Treatment Failure by Week 24, Week 48, and Week 96

The percentage of participants who met the criteria for treatment failure, defined by withdrawal from the protocol treatment regimen due to worsening nephritis, infection, or study medication toxicity. (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 0 to Week 24Week 0 to Week 48Week 0 to Week 96
Rituximab/Cyclophosphamide (RC)18.245.563.6
Rituximab/Cyclophosphamide/Belimumab (RCB)14.328.647.6

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Count of Participants: Frequency of Non-renal Flares by Week 96

"Count of participants who experienced non-renal flares, defined as any new A finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG A finding represents a significant increase in, or a new manifestation of, disease activity." (NCT02260934)
Timeframe: Week 96

,
InterventionParticipants (Count of Participants)
0 Non-renal flares1 Non-renal flare2 Non-renal flares
Rituximab/Cyclophosphamide (RC)1840
Rituximab/Cyclophosphamide/Belimumab (RCB)1911

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Count of Participants: Frequency of Non-renal Flares by Week 48

"Count of participants who experienced non-renal flares, defined as any new A finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG A finding represents a significant increase in, or a new manifestation of, disease activity." (NCT02260934)
Timeframe: Week 48

,
InterventionParticipants (Count of Participants)
0 Non-renal flares1 Non-renal flares2 Non-renal flare
Rituximab/Cyclophosphamide (RC)2020
Rituximab/Cyclophosphamide/Belimumab (RCB)2001

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Count of Participants: Frequency of Non-renal Flares by Week 24

"Count of participants who experienced non-renal flares, defined as any new A finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG A finding represents a significant increase in, or a new manifestation of, disease activity." (NCT02260934)
Timeframe: Week 24

,
InterventionParticipants (Count of Participants)
0 Non-renal flares1 Non-renal flare2 Non-renal flares
Rituximab/Cyclophosphamide (RC)2110
Rituximab/Cyclophosphamide/Belimumab (RCB)2001

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Percentage of Participants With a Sustained Complete Response

"The percentage of participants who achieved a sustained complete response, defined as a complete response achieved at Week 48 and Week 96.~Complete response was defined as meeting all of the following criteria:~Urine protein-to-creatinine ratio (UPCR) < 0.5, based on a 24-hour collection;~Estimated glomerular filtration rate (eGFR) ≥120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and~Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions." (NCT02260934)
Timeframe: Week 48, Week 96

Interventionpercentage of participants (Number)
Rituximab/Cyclophosphamide (RC)26.7
Rituximab/Cyclophosphamide/Belimumab (RCB)28.6

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Percentage of Participants With a Complete Response at Week 24, Week 48, and Week 96

"The percentage of participants who achieved a complete response, defined as meeting all of the following criteria:~Urine protein-to-creatinine ratio (UPCR) < 0.5, based on a 24-hour collection;~Estimated glomerular filtration rate (eGFR) ≥ 120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and~Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)23.835.033.3
Rituximab/Cyclophosphamide/Belimumab (RCB)30.042.142.9

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Percentage of Participants Hypocomplementemic for Complement Component C4 at Week 24, Week 48, and Week 96

"The percentage of participants who were hypocomplementemic for complemen component C4, defined as a C4 level <10 mg/dL.~Serum C4 complement is a protein which can be measured in the blood. Low blood levels of C4 are common in those with active lupus." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)19.015.016.7
Rituximab/Cyclophosphamide/Belimumab (RCB)5.015.011.1

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Percentage of Participants Hypocomplementemic for Complement Component C3 at Week 24, Week 48, and Week 96

"The percentage of participants who were hypocomplementemic for complement component, C3, defined as a C3 level <90 mg/dL.~Serum C3 complement is a protein which can be measured in the blood. Low blood levels of C3 are common in those with active lupus." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)57.155.061.1
Rituximab/Cyclophosphamide/Belimumab (RCB)30.030.027.8

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Post Bronchodilator FEV1

The change in post bronchodilator FEV1 from baseline to 48 weeks (NCT02261727)
Timeframe: Change at 48 weeks

InterventionL/sec (Mean)
Placebo-0.02
Low-dose Theophylline Arm-0.01
Theophylline and Prednisone Arm-0.02

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Change in COPD Assessment Test (CAT) Score

The COPD Assessment Test (CAT) is a patient-completed questionnaire assessing globally the impact of COPD (cough, sputum, dysnea, chest tighteness) on health status. The range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. The outcome measure is assessing the change in score from baseline to 48 weeks. A negative change denotes an improvement in health status. (NCT02261727)
Timeframe: 48 weeks

InterventionScore on a scale (Mean)
Placebo-2.29
Low-dose Theophylline Arm-2.77
Theophylline and Prednisone Arm-2.57

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Quality of Life Measured by St. George's Respiratory Questionnaire (SGRQ)

THe St. George's Respiratory Questionnaire (SGRQ) is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations. (NCT02261727)
Timeframe: Change over 48 week study duration

InterventionScores on a scale (Mean)
Placebo-4.95
Low-dose Theophylline Arm-6.85
Theophylline and Prednisone Arm-6.48

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Total COPD Exacerbation Rate

The total number of COPD exacerbations reported within 48 weeks (NCT02261727)
Timeframe: 48 weeks observation; rate annualised

InterventionExacerbations per participant year (Number)
Placebo1.00
Low-dose Theophylline Arm0.86
Theophylline and Prednisone Arm0.89

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Time to First COPD Exacerbation

The median time (days) from randomisation to first exacerbation per participant (NCT02261727)
Timeframe: Median time (days) from randomisation to first exacerbation over a 48 week period per participant

InterventionDays (Median)
Placebo137
Low-dose Theophylline Arm150
Theophylline and Prednisone Arm151

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Hospitalisations

The total number of hospitalisation events within 48 weeks (NCT02261727)
Timeframe: 48 weeks

InterventionNumber of hospitalisation events (Number)
Placebo120
Low-dose Theophylline Arm101
Theophylline and Prednisone Arm122

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Median Prostate Specific Antigen (PSA) Nadir

PSA nadir is the lowest PSA level recorded during neoadjuvant therapy. (NCT02268175)
Timeframe: PSA was assessed at baseline and every cycle during neoadjuvant therapy (up to 24 weeks).

Interventionng/mL (Median)
ARM 10.03
ARM 20.02

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Participants With Pathologic Complete Response (pCR)

pCR is defined as the absence of morphologically identifiable carcinoma in the radical prostatectomy (RP) specimen. (NCT02268175)
Timeframe: after RP approximately 24 weeks from study entry

InterventionParticipants (Count of Participants)
ARM 15
ARM 22

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Percentage of Participants With Pathologic Complete Response (pCR) or Minimal Residual Disease (MRD)

pCR is defined as the absence of morphologically identifiable carcinoma in the radical prostatectomy (RP) specimen. MRD is defined as the largest cross-sectional dimension of residual tumor measuring NCT02268175)
Timeframe: after RP approximately 24 weeks from study entry

Interventionpercentage of participants (Number)
ARM 130
ARM 216

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Residual Cancer Burden (RCB)

RCB was analyzed using radical prostatectomy (RP) tissue. The largest area of tumor was measured by ruler and the longest tumor dimension in this area was used as the dimension for calculation. (NCT02268175)
Timeframe: after RP approximately 24 weeks from study entry

Interventioncm (Median)
ARM 10.03
ARM 20.05

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Renal Function

Renal function after kidney transplant in both groups at 24 months measured according to the proteinuria (mg/24 h) concentrations (NCT02284464)
Timeframe: 24 months

Interventionmg/24h (Mean)
Steroids, Tacrolimus and Mycophenolate209
Tacrolimus and Mycophenolate148

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Assess the Adherence to Immunosuppressive Therapy in the Two Treatment Groups

The Basle scale was used to assess adherence (BAASIS questionnaire) to immunosuppressive therapy. (NCT02284464)
Timeframe: At 24 months

,
InterventionParticipants (Count of Participants)
Forgot at least one dose during last 4 weeksDose taken 2 hours or more before or after time
Steroids, Tacrolimus and Mycophenolate03
Tacrolimus and Mycophenolate111

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Number of Participants With Acute Rejection Lesions

Patients with acute rejection lesions (including subclinical rejection) at 24 months according to Banff classification (NCT02284464)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Steroids, Tacrolimus and Mycophenolate2
Tacrolimus and Mycophenolate3

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Mean Score on the Protocol Biopsies in the Two Treatment Groups

Measurement at 24 months according to the Banff classification. The Banff Classification of Allograft Pathology is an international consensus classification for the reporting of biopsies from solid organ transplant. The scale ranges from 0 to 3, 3 being the worst. (NCT02284464)
Timeframe: 24 months

,
Interventionscore on a scale (Mean)
Interstitial fibrosis and tubular atrophyChronic graft lesionGlomerulitisPeritubular capillaritisTubulitisInterstitial inflammationArteritisInterstitial fibrosisTubular atrophyGraft glomerulopathyChronic vascular lesionsArteriolar hyalinosis
Steroids, Tacrolimus and Mycophenolate1.181.960.170.240.50.8200.60.60.140.580.53
Tacrolimus and Mycophenolate1.832.60.080.200.560.6800.880.8800.640.69

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Patient Survival

Patient survival after kidney transplant in both groups (NCT02284464)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Steroids, Tacrolimus and Mycophenolate39
Tacrolimus and Mycophenolate36

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Graft Survival

Graft survival after kidney transplant in both groups (NCT02284464)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Steroids, Tacrolimus and Mycophenolate39
Tacrolimus and Mycophenolate36

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Cases of Kidney Transplant Patients With DSA

Measurements of DSA at baseline, and at 3, 6, 12, 18 and 24 months (NCT02284464)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Steroids, Tacrolimus and Mycophenolate0
Tacrolimus and Mycophenolate0

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Lipid Profile

Lipid profile after kidney transplant in both groups at 24 months (NCT02284464)
Timeframe: 24 months

,
Interventionmg/dl (Mean)
CholesterolHDLLDLTriglycerides
Steroids, Tacrolimus and Mycophenolate1645186140
Tacrolimus and Mycophenolate16144.792127

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Blood Pressure

Blood pressure after kidney transplant in both groups at 24 months (NCT02284464)
Timeframe: 24 months

,
InterventionmmHg (Mean)
Systolic BPDiastolic BP
Steroids, Tacrolimus and Mycophenolate13374.9
Tacrolimus and Mycophenolate12576

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Renal Function

Renal function after kidney transplant in both groups at 24 months measured according to the creatinine (mg/dL) concentrations (NCT02284464)
Timeframe: 24 months

Interventionmg/dl (Mean)
Steroids, Tacrolimus and Mycophenolate1.34
Tacrolimus and Mycophenolate1.4

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Incidence of Diabetes Mellitus

Incidence of diabetes mellitus after kidney transplant in both groups at 1, 2, 3, 4, 6, 9, 12, 18 and 24 months (NCT02284464)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Steroids, Tacrolimus and Mycophenolate10
Tacrolimus and Mycophenolate6

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Kaplan-Meier (K-M) Estimate of Event Free Survival (EFS)

EFS was defined as the time (months) from randomization until occurrence of one of the following events, whichever occurred first: • Disease progression • Initiation of subsequent systemic anti-lymphoma therapy • Death due to any cause The assessment of EFS was conducted by the IRAC using the International Working Group (IWG) criteria for NHL. Pre-specified optional therapies such as the extra 2 doses of single agent rituximab after Cycle 6 or consolidation radiotherapy did not count as an EFS event (initiation of subsequent systemic anti-lymphoma therapy) if the decision to treat and the location to be treated was determined prior to randomization. Participants who did not experience any of the events defined in the categories above before the clinical data cutoff date were censored at date last known alive. (NCT02285062)
Timeframe: From the date of randomization up to the data cut off date of 15 March 2019; median follow-up was 24.5 months

InterventionMonths (Median)
Lenalidomide Plus R-CHOP (R2-CHOP)NA
Placebo Plus R-CHOPNA

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Kaplan-Meier Estimate of Progression Free Survival (PFS)

Progression free survival was defined as the time (months) from the date of randomization to the date of disease progression or death (any cause), whichever occurred earlier and was assessed by the Independent Response Adjudication Committee (IRAC). Relapse from complete response (CR) was considered as disease progression throughout the study. Disease progression was determined based on the Revised Response Criteria for Malignant Lymphoma. The PFS analysis was based on the censoring rules using the Food and Drug Administration (FDA) Guidance. Participants who did not experience disease progression and who did not die before the clinical data cutoff date were censored at the date of last adequate response assessment. (NCT02285062)
Timeframe: From the date of randomization up to the data cut off date of 15 March 2019; median follow-up of 24.5 months

Interventionmonths (Median)
Lenalidomide Plus R-CHOP (R2-CHOP)NA
Placebo Plus R-CHOPNA

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Percentage of Participants Who Achieved a Complete Response (CR)

The percentage of participants who achieved a CR after initiation of the study treatment and prior to initiation of subsequent systemic antilymphoma therapy as assessed by the IRAC. A CR = complete metabolic response; target nodes/nodal masses regressed on computed tomography to (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy. Regressed to normal size by imaging, and absence of nodules related to lymphoma. If bone marrow was involved prior to therapy, no evidence of fluorodeoxyglucose avid disease in marrow per International Working Group (IWG) 2014 for Non-Hodgkin's Lymphoma (NHL). Participants who did not have any adequate response assessments during this period were not considered as responders. (NCT02285062)
Timeframe: From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months

InterventionPercentage of Participants (Number)
Lenalidomide Plus R-CHOP (R2-CHOP)69.1
Placebo Plus R-CHOP64.9

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Mean Change From Baseline in the EQ-5D-3L Visual Analogue Scale (VAS)

"The EQ-5D-3L questionnaire includes a visual analogue scale which records the respondent's self-rated health on a vertical, 0-100 scale where 100 = Best imaginable health state and 0 = Worst imaginable health state. Higher scores again indicate better HRQoL and positive change scores indicate that post screening values were higher than those observed at screening. The EQ-5D-3L is a generic, self-reported preference-based measure of health across five dimensions: mobility, self-care, pain, usual activities, and anxiety/depression. Each dimension has three levels of 'severity' corresponding to no problems, some problems and extreme problems." (NCT02285062)
Timeframe: Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34

,
InterventionUnits on a Scale (Mean)
MidcycleC6 D1EoT = 3-4 weeks after C6Follow-Up Period: Week 34
Lenalidomide Plus R-CHOP (R2-CHOP)4.06.08.012.0
Placebo Plus R-CHOP3.09.06.09

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Mean Change From Baseline in the Euroqol 5-Dimension 3-Level (EQ-5D-3L) Index Score

"The EQ-5D-3L is a generic, self-reported preference-based measure of health across five dimensions: mobility, self-care, pain, usual activities, and anxiety/depression. Each dimension has three levels of 'severity' corresponding to no problems, some problems and extreme problems. The instrument is scored as a single summary index using one of the available EQ-5D-3L value sets; in this study the UK scoring weights 9 were used. The UK index ranges from -0.594 to 1, where 0 equates to death and 1 equates to full health (-0.594 is considered 'worse than death')." (NCT02285062)
Timeframe: Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34

,
InterventionUnits on a Scale (Mean)
MidcycleC6 D1EoT = 3-4 weeks after C6Follow-Up Period: Week 34
Lenalidomide Plus R-CHOP (R2-CHOP)0.080.100.100.15
Placebo Plus R-CHOP0.080.140.060.09

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Mean Change From Baseline in the FACT-Lym Additional Concerns Subscale

"The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on HRQL and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess NHL-related symptoms such as pain, itching, night sweats,trouble sleeping, fatigue and trouble concentrating and concerns regarding lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment. All questions are answered on a 5-point scale ranging from not at all (0) to very much (4). The Additional Concerns subscale ranges from 0 to 60, where higher scores reflect better HRQoL." (NCT02285062)
Timeframe: Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34

,
InterventionUnits on a Scale (Mean)
MidcycleC6 D1EoT = 3-4 weeks after C6Follow-Up Period: Week 34
Lenalidomide Plus R-CHOP (R2-CHOP)3.85.86.68.3
Placebo Plus R-CHOP4.15.24.56.5

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Mean Change From Baseline in the FACT-Lym Functional Well-Being Subscale

"The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on HRQL and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from not at all (0) to very much (4). The functional well-being subscale ranges from 0 to 28, where higher scores reflect better HRQoL." (NCT02285062)
Timeframe: Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34

,
InterventionUnits on a Scale (Mean)
MidcycleC6 D1EoT = 3-4 weeks after C6Follow-Up Period: Week 34
Lenalidomide Plus R-CHOP (R2-CHOP)-0.50.01.02.3
Placebo Plus R-CHOP0.51.40.73.1

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Percentage of Participants Who Achieved an Objective Response

An objective response = percentage of participants who achieved a complete response or partial response after initiation of the treatment and prior to initiation of subsequent systemic anti-lymphoma therapy. A CR = complete metabolic response; Target nodes/nodal masses regressed on computed tomography to (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy. Regressed to normal size by imaging, and absence of nodules related to lymphoma. If bone marrow was involved prior to therapy, no evidence of fluorodeoxyglucose avid disease in marrow. PR = ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. No increase in other nodes, liver, or spleen. Splenic nodules regressed by ≥ 50% in their SPD or for single nodules, in the greatest transverse diameter; no new lesions. Participants who did not have any adequate response assessments during this period were not considered as responders. (NCT02285062)
Timeframe: From randomization date up to the data cut off date of 15 March 2019; median total treatment duration was 18.10 weeks for both treatment arms; range = 1.6 to 29.0 weeks for R2-CHOP arm and 0.3 to 22.9 weeks for placebo-R-CHOP arm

InterventionPercentage of Participants (Number)
Lenalidomide Plus R-CHOP (R2-CHOP)90.9
Placebo Plus R-CHOP90.9

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K-M Estimate of Overall Survival (OS)

Overall survival was assessed by the Independent Response Adjudication Committee (IRAC) and defined as time from randomization until death due to any cause. Participants who withdrew consent were censored at the time of withdrawal. Participants who were still alive before the clinical data cutoff date and participants who were lost to follow-up were censored at date last known alive. (NCT02285062)
Timeframe: From randomization until death due to any cause (up to approximately 86 months)

InterventionMonths (Median)
Lenalidomide Plus R-CHOP (R2-CHOP)NA
Placebo Plus R-CHOPNA

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Mean Change From Baseline in the FACT-Lym Trial Outcome Index (TOI)

"The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on HRQL and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from not at all (0) to very much (4). The FACT-Lym TOI is calculated by summing the Physical Well-being, Functional Well-being and Additional Concerns scores and has a range of 0 to 116. Higher scores reflect better HRQoL or fewer symptoms." (NCT02285062)
Timeframe: Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34

,
InterventionUnits on a Scale (Mean)
MidcycleC6 D1EoT = 3-4 weeks after C6Follow-Up Period: Week 34
Lenalidomide Plus R-CHOP (R2-CHOP)2.65.99.113.5
Placebo Plus R-CHOP4.67.55.812.2

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Percentage of Participants Who Completed the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Questionnaire

The completion rate for FACT-Lym assessments was judged by looking at the number of completed FACT-Lym assessments at each time point. The FACT-Lym was considered completed if at least 1 calculable score was present. Completion rates were calculated as the number and percentage of participants out of the total number of patients in the ITT population and summarized by visit/cycle and treatment group. The FACT-Lym is a health related quality of life (HRQoL) questionnaire targeted to the management of chronic illness, predominantly within oncology and is considered an extension of the FACT-General questionnaire. (NCT02285062)
Timeframe: Screening, Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34

,
InterventionPercentage of Participants (Number)
ScreeningMidcycle = After Cycle 3, but before Cycle 4End of Treatment (EoT) = 3-4 weeks after C6Follow-Up Period: Week 34
Lenalidomide Plus R-CHOP (R2-CHOP)98.687.076.167.7
Placebo Plus R-CHOP98.286.379.669.5

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Mean Change From Baseline in the FACT-Lym Physical Well-Being Subscale

"The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on HRQL and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from not at all (0) to very much (4). The physical well-being subscale ranges from 0 to 28, where higher scores reflect better HRQoL." (NCT02285062)
Timeframe: Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34

,
InterventionUnits on a Scale (Mean)
MidcycleC6 D1EoT = 3-4 weeks after C6Follow-Up Period: Week 34
Lenalidomide Plus R-CHOP (R2-CHOP)-0.7-0.01.52.8
Placebo Plus R-CHOP0.20.90.72.6

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K-M Estimate of Duration of Complete Response

Duration of complete response was calculated for complete responders only and was defined as the time from documented initial complete response prior to initiation of subsequent systemic antilymphoma therapy until documented disease progression or death, whichever occurred earlier. Participants who had not progressed or died at the time of the analysis were censored at the date of last response assessment demonstrating no disease progression. Participants who changed treatment without evidence of disease progression were censored at the last assessment showing no progression prior to treatment change. (NCT02285062)
Timeframe: From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months.

InterventionMonths (Median)
Lenalidomide Plus R-CHOP (R2-CHOP)NA
Placebo Plus R-CHOPNA

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Change in Multidimensional Health Assessment Questionnaire (MDHAQ) the Rheumatoid Arthritis Disease Activity Index (RADAI) Patient Self-report Joint Count (PTJT) Component From Baseline to Final Visit (Final Follow-up Visit)

"For the Change in Multidimensional Health Assessment Questionnaire (MDHAQ) - the Rheumatoid Arthritis disease Activity Index (RADAI) patient self-report joint count (PTJT), participants were asked to score the amount of pain they were experiencing in each of 16 joints (left joint, left wrist, right shoulder etc.) as None (score of 0), Mild (score of 1), Moderate (score of 2) or Severe (score of 3). The raw 0-48 score is adjusted to 0-10 using a scoring template. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in PTJT was only calculated for participants that had measurements at both baseline and final follow-up." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

Interventionunits on a scale (Mean)
Delayed-release Prednisone (RAYOS)-0.29

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Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Review of Symptoms (ROS) Component From Baseline to Final Visit (Final Follow-up Visit)

Multidimensional Health Assessment Questionnaire (MDHAQ) - review of symptoms (ROS) was gathered using a symptom checklist and was calculated by summing the total number of items checked (0 to 60 symptoms could be checked). A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in MDHAQ ROS was only calculated for participants that had measurements at both baseline and final follow-up. (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

Interventionnumber of symptoms (Mean)
Delayed-release Prednisone (RAYOS)-0.3

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Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Recent Medical History Component From Baseline to Final Visit (Final Follow-up Visit)

"Multidimensional Health Assessment Questionnaire (MDHAQ) - recent medical history was gathered using a medical history checklist and was calculated by summing the total number of items checked Yes (0 to 12 items could be checked). A negative change from baseline indicates fewer items were checked at the follow-up visit. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in MDHAQ recent medical history was only calculated for participants that had measurements at both baseline and final follow-up." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

Interventionnumber of items checked (Mean)
Delayed-release Prednisone (RAYOS)-0.2

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Mean Change in Severity of Morning Stiffness (Using 100mm VAS) From Baseline (Week 0) to Final Follow-Up Visit

"Mean change in severity of morning stiffness was assessed using a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to Not Severe at All and 100 to Extremely Severe. This measure was collected at baseline and at the last follow-up visit. As this study was a non-interventional research initiative and no assessments or visits were mandated, the mean change was only calculated for participants that had measurements at both baseline and final follow-up." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

Interventionunits on a scale (Mean)
Delayed-release Prednisone (RAYOS)-5.2

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Percentage of Participants With American College of Rheumatology 20% Improvement (ACR20) Response From Baseline to Final Visit (Final Follow-up Visit)

American College of Rheumatology (ACR) 20, a patient must demonstrate a >= 20% improvement in tender and swollen joints (each scored 0-28 with higher scores indicating higher disease activity) as well as a 20% improvement in at least 3 of the following 5 parameters: patient global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10 scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein). (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

Interventionpercentage of participants (Number)
Delayed-release Prednisone (RAYOS)5.4

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Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Psychological Status (PS) Component From Baseline to Final Visit (Final Follow-up Visit)

"The change in Multidimensional Health Assessment Questionnaire (MDHAQ) - Psychological status (PS) was assessed by asking participants to score how they were sleeping, dealing with anxiety/nervousness, and dealing with depression as without any difficulty (score of 0), with some difficulty (score of 1.1), with much difficulty (score of 2.2) or unable to do (score of 3.3). The results were summed to give a score ranging from 0 to 9.9. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in psychological status was only calculated for participants that had measurements at both baseline and final follow-up." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

Interventionunits on a scale (Mean)
Delayed-release Prednisone (RAYOS)0.17

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Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Patient Global Assessment (PTGL) Component From Baseline to Final Visit (Final Follow-up Visit)

Multidimensional Health Assessment Questionnaire (MDHAQ) - patient global assessment (PTGL) was measured by asking the participant to rate on a 0 to 10 scale how they were doing considering all of the ways in which their illness and health conditions affected them: 0 - Very Well, 10 - Very Poor. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in PTGL was only calculated for participants that had measurements at both baseline and final follow-up. (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

Interventionunits on a scale (Mean)
Delayed-release Prednisone (RAYOS)-0.53

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Percentage of Participants With European League Against Rheumatism (EULAR) Response From Baseline to Final Visit (Final Follow-up Visit)

"European League Against Rheumatism (EULAR) response is based on change (improvement) in Disease Activity Score in 28 Joints score from baseline to last follow-up visit. DAS28 scores were broken into 3 categories: ≤3.2 at last follow-up (low disease activity), >3.2 and ≤ 5.1 at last follow-up (moderate or high disease activity), and DAS28 >5.1 at last follow-up (high disease activity). Then based on the category and magnitude of the change in DAS28 from baseline, the EULAR response of Good, Moderate or No Response was determined.~DAS28 is an index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response determined as erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), and patient global assessment (PGA) on a visual analogue scale (higher scores indicate higher disease activity)." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

Interventionpercentage of participants (Number)
Good responseModerate responseNo responseMissingNo follow-up visit/unable to calculate
Delayed-release Prednisone (RAYOS)3.614.328.644.68.9

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Percentage of Participants With American College of Rheumatology 50% Improvement (ACR50) Response From Baseline to Final Visit (Final Follow-up Visit)

American College of Rheumatology (ACR) 50, a patient must demonstrate a >= 50% improvement in tender and swollen joints (each scored 0-28 with higher scores indicating higher disease activity) as well as a 50% improvement in at least 3 of the following 5 parameters: patient global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10 scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein). (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

Interventionpercentage of participants (Number)
Delayed-release Prednisone (RAYOS)1.8

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Percentage of Participants With American College of Rheumatology 70% Improvement (ACR70) Response From Baseline to Final Visit (Final Follow-up Visit)

American College of Rheumatology (ACR) 70 a patient must demonstrate a >= 70% improvement in tender and swollen joints (each scored 0-28 with higher scores indicating higher disease activity) as well as a 70% improvement in at least 3 of the following 5 parameters: patient global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10 scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein). (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

Interventionpercentage of particpants (Number)
Delayed-release Prednisone (RAYOS)1.8

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ACR-N From Baseline to Final Visit (Final Follow-up Visit)

ACR-N is the index of improvement in rheumatoid arthritis, and is defined as the lowest of 3 values: percent change in the number of swollen joints (scored 0-28 with higher scores indicating higher disease activity), percent change in the number of tender joints (scored 0-28 with higher scores indicating higher disease activity), and the median of the other 5 measures in the American College of Rheumatology core data set-Patient's global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician's global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein). Positive percent change indicates improvement. Negative percent change indicates worsening. (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

Interventionpercent change (Mean)
Delayed-release Prednisone (RAYOS)-15.4

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Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Pain (PN) Component From Baseline to Final Visit (Final Follow-up Visit)

"Multidimensional Health Assessment Questionnaire (MDHAQ) - pain (PN) scoring was gathered using a 0-10 scale where 0 corresponded to No Pain and 10 to Pain as bad as it could be because of the condition (over the past week). A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in pain was only calculated for participants that had measurements at both baseline and final follow-up." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

Interventionunits on a scale (Mean)
Delayed-release Prednisone (RAYOS)-0.62

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Change in Physician's Overall Assessment in Disease Activity From Baseline to Final Visit (Final Follow-up Visit)

"Physician's Overall Assessment in Disease Activity was measured with a 10-cm visual analogue scale (VAS) where 0 corresponded to Very Well' and 10 to Very Poor. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in Physician's Overall Assessment in Disease Activity was only calculated for participants that had measurements at both baseline and final follow-up." (NCT02287610)
Timeframe: Baseline to Last Follow-up visit (up to 18.7 weeks)

Interventionunits on a scale (Mean)
Delayed-release Prednisone (RAYOS)-0.86

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Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Neck and Back (NB) Component From Baseline to Final Visit (Final Follow-up Visit)

"For the Multidimensional Health Assessment Questionnaire (MDHAQ) - neck and back (NB), participants were asked to score the amount of pain they were experiencing in their neck and back as None (score of 0), Mild (score of 1), Moderate (score of 2) or Severe (score of 3). The raw 0-6 score was adjusted to 0-10. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in NB measure was only calculated for participants that had measurements at both baseline and final follow-up." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

Interventionunits on a scale (Mean)
Delayed-release Prednisone (RAYOS)-0.35

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Change in Routine Assessment of Patient Index Data (RAPID3) From Baseline to Final Visit (Final Follow-up Visit)

"Routine Assessment of Patient Index Data (RAPID3) was calculated by summing three measures: physical function (0 to 10 with higher scores indicating less function), pain (0 to 10 with higher scores indicating higher pain), and patient global assessment (0 to 10 with higher scores indicating the participant was doing very poorly considering the ways in which the illness was affecting them). As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in RAPID3 was only calculated for participants that had measurements at both baseline and final follow-up.~RAPID3 scores range from 0 to 30 with higher scores meaning worse condition. A negative change from baseline indicates improvement in condition." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

Interventionunits on a scale (Mean)
Delayed-release Prednisone (RAYOS)-2.06

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"Change in Multidimensional Health Assessment Questionnaire (MDHAQ) How do You Feel Today (Compared to One Week Ago) Component From Baseline to Final Visit (Final Follow-up Visit)"

"The Multidimensional Health Assessment Questionnaire (MDHAQ) - how do you feel today compared to one week ago question was scored as follows: 1: Much Better, 2: Better, 3: The Same, 4: Worse, 5: Much Worse. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in How do you feel measure was only calculated for participants that had measurements at both baseline and final follow-up." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

Interventionunits on a scale (Mean)
Delayed-release Prednisone (RAYOS)-0.2

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Change in Patient's Overall Assessment in Disease Activity From Baseline to Final Visit (Final Follow-up Visit)

Patient's Overall Assessment in Disease Activity was measured by asking the participant to rate on a 10-cm visual analogue scale (VAS) how well they were doing considering all of the ways their arthritis affected them: 0 - Very Well, 10 - Very Poor. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in Patient's Overall Assessment in Disease Activity was only calculated for participants that had measurements at both baseline and final follow-up. (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

Interventionunits on a scale (Mean)
Delayed-release Prednisone (RAYOS)-0.47

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Corticosteroid Sparing Effect - Change in Total Daily Prednisone Dose From Baseline to Final Visit (Final Follow-up Visit)

The change in total daily prednisone from baseline to follow-up (whether the patient was taking RAYOS or returned to conventional prednisone) was calculated for all participants. (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

Interventionmilligrams (Mean)
Delayed-release Prednisone (RAYOS)-0.96

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Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Morning Stiffness Component From Baseline to Final Visit (Final Follow-up Visit)

The duration of morning stiffness was the amount of time participants experienced stiffness after waking up in the morning (over the last week). This measure was collected at baseline and at the last follow-up visit. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in duration of morning stiffness was only calculated for participants that had measurements at both baseline and final follow-up. (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

Interventionminutes (Mean)
Delayed-release Prednisone (RAYOS)-2.5

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Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Function (FN) Component From Baseline to Final Visit (Final Follow-up Visit)

"The change in Multidimensional Health Assessment Questionnaire (MDHAQ) - function (FN) was assessed by asking participants to score the performance of multiple activities as without any difficulty (score of 0), with some difficulty (score of 1), with much difficulty (score of 2) or unable to do (score of 3). The results were summed and divided by 3 to give a score from 0 to10. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in function was only calculated for participants that had measurements at both baseline and final follow-up." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

Interventionunits on a scale (Mean)
Delayed-release Prednisone (RAYOS)-0.05

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Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Fatigue (FAT) Component From Baseline to Final Visit (Final Follow-up Visit)

"Multidimensional Health Assessment Questionnaire (MDHAQ) - fatigue (FAT) scoring was gathered using a 0-10 scale where 0 corresponded to Fatigue is no problem and 10 to Fatigue is a major problem over the past week. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in fatigue was only calculated for participants that had measurements at both baseline and final follow-up." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

Interventionunits on a scale (Mean)
Delayed-release Prednisone (RAYOS)-0.12

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Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Exercise (EX) Component From Baseline to Final Visit (Final Follow-up Visit)

"The exercise aerobically for at least one-half hour (30 minutes) measure of the multidimensional health assessment questionnaire (MDHAQ) was scored as follows: 3 or more times a week (3), 1-2 times per week (2), 1-2 times per month (1), Do not exercise regularly (0), Cannot exercise due to disability/handicap (-1). As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in MDHAQ exercise measure was only calculated for participants that had measurements at both baseline and final follow-up." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

Interventionunits on a scale (Mean)
Delayed-release Prednisone (RAYOS)-0.1

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Change in Duration of Morning Stiffness (Minutes) From Baseline to Final Visit (Final Follow-Up Visit)

The duration of morning stiffness was the amount of time participants experienced stiffness after getting up in the morning. This measure was collected at baseline and at the last follow-up visit. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in duration of morning stiffness was only calculated for participants that had measurements at both baseline and final follow-up. (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

Interventionminutes (Mean)
Delayed-release Prednisone (RAYOS)-18.9

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Change in Simple Disease Activity Index (SDAI) From Baseline to Final Visit (Final Follow-up Visit)

Simple Disease Activity Index (SDAI) is the sum of the following 5 components to assess rheumatoid arthritis severity: Swollen Joint Count 28 (SJC28, scored 0-28 with higher scores indicating higher disease activity) + Tender Joint Count 28 (TJC28, scored 0-28 with higher scores indicating higher disease activity) + Patient Global Assessment (PGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity) + Physician Global Assessment (PhGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity) + C-reactive Protein (CRP). SDAI scores indicate whether a participant is in remission or low, moderate or high activity. A negative change in SDAI indicates improvement. (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

Interventionunits on a scale (Mean)
Delayed-release Prednisone (RAYOS)-6.28

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Change in Disease Activity Score in 28 Joints Calculated With Erythrocyte Sedimentation Rate (DAS28-ESR) From Baseline to Final Visit (Final Follow-up Visit)

"The DAS28 is an index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response determined by erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), and patient global assessment (PGA) on a visual analogue scale (higher scores indicate higher disease activity).~DAS28-ESR was calculated according to the following formula: DAS28-ESR equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + [0.70 * the natural logarithm (ln) ESR in millimeters per hour (mm/h)] + [0.014 * PGA in mm]. A negative change from baseline indicates improvement.~As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in DAS28-ESR was only calculated for participants that had measurements at both baseline and final follow-up." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

Interventionunits on a scale (Mean)
Delayed-release Prednisone (RAYOS)-0.39

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Change in Disease Activity Score in 28 Joints Calculated With C-reactive Protein (DAS28-CRP) From Baseline to Final Visit (Final Follow-up Visit)

"The DAS28 is an index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response determined by erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), and patient global assessment (PGA) on a visual analogue scale (higher scores indicate higher disease activity).~DAS28-CRP was calculated according to the following formula: DAS28-CRP equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + [0.36 * the natural logarithm (ln) of (CRP + 1)] + [0.014 * PGA in mm] + 0.96. A negative change from baseline indicated improvement.~As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in DAS28-CRP was only calculated for participants that had measurements at both baseline and final follow-up." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

Interventionunits on a scale (Mean)
Delayed-release Prednisone (RAYOS)-0.62

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Change in Clinical Disease Activity Index (CDAI) From Baseline to Final Visit (Final Follow-up Visit)

"Clinical Disease Activity Index (CDAI) is the sum of 4 parameters: Swollen Joint Count 28 (SJC28, scored 0-28 with higher scores indicating higher disease activity) + Tender Joint Count 28 (TJC28, scored 0-28 with higher scores indicating higher disease activity) + Patient Global Assessment (PGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity) + Physician Global Assessment (PhGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity). CDAI scores range from 0 to 76 and indicate whether a participant is in remission or low, moderate or high activity; higher scores indicate higher disease activity. A negative change from baseline indicates improvement in condition.~As this study was a non-interventional research initiative and no assessments/visits were mandated, the change in CDAI was only calculated for participants that had both baseline and final follow-up measurements." (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

Interventionunits on a scale (Mean)
Delayed-release Prednisone (RAYOS)-5.59

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Assessment of Unsolicited Serious Adverse Events

Please refer to the safety section for further details. (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

InterventionParticipants (Count of Participants)
Delayed-release Prednisone (RAYOS)1

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Assessment of Unsolicited Adverse Events

Please refer to the safety section for further details. (NCT02287610)
Timeframe: Baseline to Last Follow up visit (up to 18.7 weeks)

InterventionParticipants (Count of Participants)
Delayed-release Prednisone (RAYOS)11

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Crohn's Disease Activity Index (CDAI)

Clinical remission, defined as CDAI < 150, in group with steroid co-induction vs. placebo co-induction. The purpose of this crohn's disease activity index (CDAI) calculator is to gauge the progress or lack of progress for people with crohn's disease. CDAI scores below 150 indicate a better prognosis than higher scores (NCT02324699)
Timeframe: baseline, week 6, week 10

Interventionscore on a scale (Number)
BaselineWeek 6Week 10
Prednisone Co-inductive Therapy263112.6137.5

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Change in Simple Endoscopic Score for Crohn's Disease (SES-CD)

The SES-CD tool is used to quantify and compare inflammatory load. The Simple Endoscopic Score for Crohn Disease (SES-CD) assesses the size of mucosal ulcers, the ulcerated surface, the endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity. (NCT02324699)
Timeframe: baseline and week 10

Interventionscore on a scale (Number)
BaselineWeek 10
Prednisone Co-inductive Therapy2418

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Change in C-Reactive Protein (CRP)

Comparison of absolute change in CRP from baseline to week 10. C-reactive protein is produced by the liver. The level of CRP rises when there is inflammation throughout the body. (NCT02324699)
Timeframe: baseline and week 10

Interventionmg/L (Number)
baselineweek 10
Prednisone Co-inductive Therapy11.043.0

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Remission Duration

Percentage of patients in ongoing remission at 6 months (NCT02334813)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Arm A: Daily Prednisone3
Arm B: Pulsed Dexamethasone11

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Number of Participants With Response or Remission at End of 4 Weeks

Number of participants with Harvey-Bradshaw Index <5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 4 weeks (NCT02392286)
Timeframe: 4 weeks

InterventionParticipants (Count of Participants)
Weight-based5
Fixed Dose5

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Number of Participants With Response at End of 2 Weeks

Number of participants with at least a 3-point drop in Harvey-Bradshaw Index at end of 2 weeks (NCT02392286)
Timeframe: 2 weeks

InterventionParticipants (Count of Participants)
Weight-based4
Fixed Dose6

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Number of Participants With Response or Remission at End of 1 Week

Number of participants with Harvey-Bradshaw Index <5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 1 week (NCT02392286)
Timeframe: 1 week

InterventionParticipants (Count of Participants)
Weight-based5
Fixed Dose5

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Number of Participants in Remission at End of 2 Weeks

Number of participants with Harvey Bradshaw Index < 5 at end of 2 weeks. The minimum score obtainable is 0, suggesting absence of disease or remission, while the maximum score obtainable goes beyond 18 points, depending on the number of stools the patient identifies per day (because 1 point is given for each stool in a day, there is no specific maximum score. A higher score represents more severe disease. <5 is determined to be remission. (NCT02392286)
Timeframe: 2 weeks

InterventionParticipants (Count of Participants)
Weight-based2
Fixed Dose3

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Number of Participants With Corticosteroid-associated Side Effects

Number of participants with side effects that may be associated with use of corticosteroids such as mood swings, sleep disturbance, edema, acne, bruising, myalgias. (NCT02392286)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Weight-based5
Fixed Dose7

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Number of Participants With Response or Remission at End of 12 Weeks

Number of participants with Harvey-Bradshaw Index <5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 12 weeks (NCT02392286)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Weight-based5
Fixed Dose7

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Event Free Survival (EFS)

Event free survival defined as the time from treatment to relapse of leukemia or death for any reason or lost to follow-up. Study regimen considered successful if it exhibits a 3-year EFS rate greater than 65% and response rate no less than 90% with Grade III-IV infectious toxicity rate in induction no more than 33%. (NCT02419469)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
Ofatumumab Plus ChemotherapyNA

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Maximal Tolerated Dose (MTD) of Ruxolitinib in Combination With Chemotherapy Defined as the Highest Dose Level at Which no More Than 1 Out of 6 Patients Experience a Dose Limiting Toxicity (Phase I)

The method of Thall, Simon and Estey will be used for toxicity monitoring for this study. The severity of the toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 whenever possible. Safety data will be summarized by category, severity and frequency. (NCT02420717)
Timeframe: 42 days

InterventionMilligrams (mg) (Number)
Phase I Ruxolitinib 15mg25

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Overall Survival

Time from date of treatment start until date of death due to any cause or last Follow-up. (NCT02420717)
Timeframe: Up to 4 years 7 months

InterventionMonths (Median)
Phase I Ruxolitinib 15mg4.8
Phase I Ruxolitinib 20mg5.4
Phase I Ruxolitinib 25mg38.5

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Participants With Complete Response (Complete Response [CR]/CR With Incomplete Marrow Recovery [CRi]) (Phase II)

Complete Response (CR) is disappearance of all clinical and/or radiologic evidence of disease, Neutrophil count ≥ 1.0 x 10^9/L, Platelet count ≥ 100 x 10^9/L, Normal bone marrow differential (≤ 5% blasts), No extra-medullary leukemia. Complete Remission with Incomplete Blood Count Recovery (CRi) is CR except for ANC < 1.0 x 10^9/L and/or platelets < 100 x 10^9/L. (NCT02420717)
Timeframe: 42 days

InterventionParticipants (Count of Participants)
Phase I Ruxolitinib 15mg0
Phase I Ruxolitinib 20mg1
Phase I Ruxolitinib 25mg0

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Progression-free Survival

Time from date of treatment start until the date of first objective documentation of disease-relapse. (NCT02420717)
Timeframe: Up to 4 years 7 months

InterventionMonths (Median)
Phase I Ruxolitinib 15mg2.3
Phase I Ruxolitinib 20mg1.8
Phase I Ruxolitinib 25mg1.9

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Histopathological Response to Therapy

Histopathological response is achieved when there is minimal or no inflammation in hepatic tissue, as assessed by liver biopsy. (NCT02463331)
Timeframe: liver biopsy was was performed to evaluate histopathological response after 18 months of biochemical response

InterventionParticipants (Count of Participants)
Chloroquine Plus Prednisone4
Azathioprine Plus Prednisone10

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Biochemical Response to Therapy

The biochemical response is defined when there is normalization of hepatic enzymes, mainly AST and ALT. (NCT02463331)
Timeframe: six months

InterventionParticipants (Count of Participants)
Chloroquine Plus Prednisone14
Azathioprine Plus Prednisone21

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12-month PFS (Progression Free Survival) of Treatment With Ixazomib in Combination With DA-EPOCH-R (Phase II)

12-month PFS will be defined as the percentage of patients alive and progression free 12 months from start of therapy. Patients lost to follow up will be censored from last point of contact. PFS was calculated using a Kplan-meier estimation with the probability of patients being progression free at 12 months, presented as the percentage based on this probability. (NCT02481310)
Timeframe: Up to 12 months from initiation of treatment

Interventionprobability (%) of patients alive (Number)
Treatment (Combination Chemotherapy, Rituximab, Ixazomib)75.84

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Radiographic Progression-Free Survival (rPFS)

Radiographic progression-free survival: time (in months) from randomization to occurrence of any one of following: radiological tumor progressions using response evaluation criteria in solid tumors (RECIST 1.1), progression of bone lesions using Prostate Cancer Working Group 2 (PCWG2) criteria or occurrence of death due to any cause. Progression as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Progression of bone lesions (PCWG2 criteria): first bone scan with >= 2 new lesions compared to Baseline observed less than (<) 12 weeks from randomization and confirmed by a second bone scan performed >=6 weeks; first bone scan with >=2 new lesions compared to Baseline observed >=12 weeks from randomization. In accordance with protocol, data cut-off date for final analysis of this endpoint was the date when 196 rPFS events had occurred. Analysis done by Kaplan-Meier method. (NCT02485691)
Timeframe: From randomization until tumor progression or bone lesion progression, death due to any cause, or data cut-off date whichever comes first (maximum duration: up to 141 weeks)

Interventionmonths (Median)
Cabazitaxel8.0
Abiraterone Acetate or Enzalutamide3.7

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Time to Pain Progression

Time to pain progression was defined as the time duration (in months) between the date of randomization and the date of first documented pain progression. Pain progression, in participants with no pain or stable pain at Baseline was defined as increase of >=30% from baseline in the BPI-SF pain intensity score observed at 2 consecutive evaluations >=3 weeks apart without decrease in analgesic usage score or increase in analgesic usage score (calculated from analgesic use data, with non-narcotic medications assigned value of 1 point and narcotic medications assigned 4 points) >=30%. The BPI-SF is a self-administered questionnaire developed to assess the severity of pain on a 0-10 categorical scale where 0=no pain, 10=pain as bad as you can imagine. Higher scores indicated worst outcomes. Analysis was performed by Kaplan-Meier method. (NCT02485691)
Timeframe: Baseline until pain progression or data cut-off whichever comes first (maximum duration: up to 141 weeks)

Interventionmonths (Median)
CabazitaxelNA
Abiraterone Acetate or Enzalutamide8.5

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Time to PSA Progression (TTPP)

TTPP was defined as the time duration (in months) between the date of randomization and the date of first documented PSA progression. PSA progression (as per PCWG 2) was defined as: 1) If decline from Baseline value: an increase of >=25% (at least 2 ng/mL) over the nadir value, confirmed by a second PSA value at least 3 weeks apart; 2) If no decline from Baseline value: an increase of >=25% (at least 2 ng/mL) over the baseline value after 12 weeks of treatment, confirmed by a second PSA value at least 3 weeks apart. Analysis performed by Kaplan-Meier method. (NCT02485691)
Timeframe: From time from randomization until PSA progression, death due to any cause or data cut-off whichever comes first (maximum duration: up to 141 weeks)

Interventionmonths (Median)
Cabazitaxel6.3
Abiraterone Acetate or Enzalutamide2.1

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Time to Symptomatic Skeletal Event

Time to SSE was defined as the time duration (in months) between the date of randomization and the date of occurrence of the first SSE. Analysis was performed by Kaplan-Meier method. (NCT02485691)
Timeframe: From date of randomization until first SSE, or data cut-off whichever comes first (maximum duration: up to 141 weeks)

Interventionmonths (Median)
CabazitaxelNA
Abiraterone Acetate or Enzalutamide16.7

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Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Utility Single Index and Visual Analogue Scale (VAS) Scores at Cycle 2, 3, 4, 5, 6, 7, 8 and End of Treatment

EQ-5D was a standardized HRQOL questionnaire consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). EQ-5D descriptive system comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression measured on 3 levels (no problem, some problems & severe problems) within a particular EQ-5D dimension. 5 dimensional 3-level system was converted into single index utility score. Possible values for single index utility score ranged from -0.594 (severe problems in all dimensions) to 1.0 (no problem in all dimensions) on scale where 1 represented best possible health state. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS scale ranging from 0-100, where 0=worst imaginable health state and 100=best imaginable health state, where higher states indicated better outcomes. Baseline corresponded to last evaluable assessment before treatment administration. (NCT02485691)
Timeframe: Baseline, Day 1 of each Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6, Cycle 7, Cycle 8 and at End of Treatment (any time up to: 141 weeks)

,
Interventionscore on a scale (Mean)
Cycle 2: VASCycle 3: VASCycle 4: VASCycle 5: VASCycle 6: VASCycle 7: VASCycle 8: VASEnd of treatment: VASCycle 2: Utility Index ScoreCycle 3: Utility Index ScoreCycle 4: Utility Index ScoreCycle 5: Utility Index ScoreCycle 6: Utility Index ScoreCycle 7: Utility Index ScoreCycle 8: Utility Index ScoreEnd of treatment: Utility Index Score
Abiraterone Acetate or Enzalutamide0.91.5-1.13.2-1.5-0.21.2-5.9-0.010-0.011-0.002-0.035-0.0000.024-0.014-0.079
Cabazitaxel3.64.54.60.6-1.32.92.8-3.30.0260.0410.0510.0270.0150.0290.008-0.048

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Radiographic Progression-Free Survival (rPFS) in Participants With Presence and Absence of Biomarker

Circulating tumor cell (CTC) counts were considered as biomarker in a liquid biopsy. rPFS in participants with presence and absence of subtypes of CTC biomarker i.e. chromosomal instability (CIN) and neuroendocrine (NE) was reported in this outcome measure. rPFS was defined as: time (in months) from randomization to the first occurrence of any one of following: radiological tumor progressions (RECIST1.1), progression of bone lesions (PCWG2 criteria) or death due to any cause. Progression (RECIST1.1): at least a 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Progression of bone lesions (PCWG2 criteria): first bone scan with >= 2 new lesions compared to Baseline observed <12 weeks from randomization and confirmed by a second bone scan performed >=6 weeks later; first bone scan with >=2 new lesions compared to Baseline observed >=12 weeks from randomization and new lesions were verified on next bone scan >= 6 weeks later. (NCT02485691)
Timeframe: From randomization until tumor progression or bone lesion progression, death due to any cause, or data cut-off date whichever comes first (maximum duration: up to 141 weeks)

,
Interventionmonths (Median)
Presence of CINAbsence of CINPresence of NEAbsence of NE
Abiraterone Acetate or Enzalutamide4.23.43.93.5
Cabazitaxel4.28.53.08.2

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Percentage of Participants With Prostate Specific Antigen (PSA) Response

PSA response was defined as >= 50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later. (NCT02485691)
Timeframe: Baseline up to PSA response, death due to any cause or data cut-off date whichever comes first (maximum duration: up to 141 weeks)

Interventionpercentage of participants (Number)
Cabazitaxel36.3
Abiraterone Acetate or Enzalutamide14.3

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Progression Free Survival (PFS)

PFS:time duration (in months) from date of randomization to date of first occurrence of any of following events: radiological tumor progression (RECIST 1.1); progression of bone lesions (PCWG2); symptomatic progression (developing urinary or bowel symptoms; need to change anti-cancer therapy), pain progression or death due to any cause. Tumor Progression(RECIST 1.1): at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Progression of bone lesion (PCWG2 criteria): first bone scan with >=2 new lesions compared to Baseline and confirmed by second bone scan performed >=6 weeks later; pain progression: increase by >=30% from Baseline in pain intensity score (calculated using scale ranged from 0=no pain to 5=extreme pain) or increase in analgesic usage score >=30% (calculated from analgesic use data, non-narcotic medications assigned value of 1 point and narcotic medications assigned 4 points). Analyzed by Kaplan-Meier method. (NCT02485691)
Timeframe: From randomization until tumor progression or bone lesion progression, pain progression, death due to any cause, or data cut-off date whichever comes first (maximum duration: up to 141 weeks)

Interventionmonths (Median)
Cabazitaxel4.4
Abiraterone Acetate or Enzalutamide2.7

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Percentage of Participants With Overall Objective Tumor Response

Overall objective tumor response was defined as having a partial response (PR) or complete response (CR) according to the RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (NCT02485691)
Timeframe: From randomization until disease progression, death due to any cause or data cut-off date whichever comes first (maximum duration: up to 141 weeks)

Interventionpercentage of participants (Number)
Cabazitaxel36.5
Abiraterone Acetate or Enzalutamide11.5

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Duration of Tumor Response

Duration of tumor response was defined as the time (in months) from date of first response (CR or PR) until date of first documentation of tumor progression or death, whichever occurs first. As per RECIST 1.1 CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progression was defined as at least a 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method. (NCT02485691)
Timeframe: From the date of the first response to the date of first documented tumor progression, or death due to any cause or data cut-off date whichever comes first (maximum duration: up to 141 weeks)

Interventionmonths (Median)
Cabazitaxel6.5
Abiraterone Acetate or Enzalutamide8.0

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Number of Symptomatic Skeletal Events (SSE)

SSE was defined as occurrence of a new symptomatic pathological fracture, use of external beam radiation to relieve bone pain, occurrence of spinal cord compression or tumor- related orthopedic surgical intervention. (NCT02485691)
Timeframe: Baseline until occurrence of first SSE or data cut-off, whichever comes first (maximum duration: up to 141 weeks)

Interventionevents (Number)
Cabazitaxel24
Abiraterone Acetate or Enzalutamide35

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Overall Survival (OS)

Overall survival was defined as the time interval (in months) from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date participant was known to be alive, or at the cut-off date whichever comes first. Analysis was performed by Kaplan-Meier method. (NCT02485691)
Timeframe: From randomization to death due to any cause, or data cut-off date whichever comes first (maximum duration: up to 141 weeks)

Interventionmonths (Median)
Cabazitaxel13.6
Abiraterone Acetate or Enzalutamide11.0

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Percentage of Participants Achieving Pain Response Assessed Using Brief Pain Inventory-Short Form (BPI-SF) Pain Intensity Score

Pain response as per BPI-SF was defined as a decrease of at least 30% from Baseline in the average of BPI-SF pain intensity score observed at 2 consecutive evaluations >=3 weeks apart without increase in analgesic usage score (calculated from analgesic use data, with non-narcotic medications assigned value of 1 point and narcotic medications assigned 4 points). The BPI-SF is a self-administered questionnaire developed to assess the severity of pain on a 0-10 categorical scale where 0=no pain, 10=pain as bad as you can imagine. Higher scores indicated worst outcomes. Percentage of Participants Achieving Pain Response assessed using BPI-SF Pain Intensity Score were reported. (NCT02485691)
Timeframe: Baseline until pain progression, first further anticancer therapy, or data cut-off whichever comes first (maximum duration: up to 141 weeks)

Interventionpercentage of participants (Number)
Cabazitaxel45.9
Abiraterone Acetate or Enzalutamide19.3

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Probability of Event Free Survival (EFS)

EFS was calculated as the time from randomization to the date of first reported event. Events were defined as disease progression or relapse, institution of a new anticancer treatment, or death from any cause without progression. (NCT02486952)
Timeframe: Up to 41 months

Interventionprobability of EFS (Number)
Diffuse Large B-Cell Lymphoma0.695

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Percentage of Participants Who Were Alive

Percentage of participants with survival was calculated 41 months after the first dose of study treatment. (NCT02486952)
Timeframe: Up to 41 months

Interventionpercentage of participants (Number)
Diffuse Large B-Cell Lymphoma74.4

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Objective Response Rate (ORR) (Phase1b/2 RP2D)

ORR will be assessed using RECIST version 1.1 criteria, and defined as participants who were determined to have demonstrated a complete response (CR) and/or partial response (PR). Participants must have measurable disease at baseline with at least one restaging scan on treatment to be included in the analysis. (NCT02494921)
Timeframe: Up to 2 years

Interventionpercentage of participants (Number)
Treatment (Phase 1b/2 RP2D)23.1

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RP2D of Docetaxel (Phase 1b)

The RP2D of docetaxel will be reported when used in combination with ribociclib and prednisone based upon evaluation of dose-limiting toxicities (DLTs) and adverse events for all participants in the Phase Ib group. Per Investigator discretion, the RP2D schedule of docetaxel and ribociclib may be established in the absence of reaching MTD, based on the cumulative safety data of the treatment regimen. (NCT02494921)
Timeframe: Up to 2 years

Interventionmg/m^2 (Number)
Treatment (Phase 1b)60

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Prostate-Specific Antigen (PSA) Response Rate (Phase 1b/2 RP2D)

PSA progression occurs when the PSA value has increased 25% or greater above nadir and an absolute increase of 2 ng/mL or more from the nadir is documented. Where no decline is observed, PSA progression similarly occurs when a 25% increase from baseline value along with an increase in absolute value of 2 ng/mL or more per the Prostate Cancer Working Group 2 (PCWG2) Criteria. (NCT02494921)
Timeframe: Up to 2 years

Interventionpercentage of participants (Number)
Treatment (Phase 1b/2 RP2D)32

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Percentage of Participants With Radiographic Progression-free Survival at 6 Months (Phase 1b/2 RP2D)

Radiographic progression-free survival will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percent of participants has been estimated using the Kaplan-Meier product limit method. Duration will be measured from day 1 of study treatment to first date of radiographic progression or death, whichever occurs first, for all Phase 1b or Phase 2 participants receiving the RP2D. Participants who discontinue study therapy for toxicity, withdrawal from study, or prostate-specific antigen (PSA)-only progression, will be censored at the date of last radiographic tumor assessment for this analysis. Patients who discontinue therapy for evidence of clinical progression/clinical deterioration will be included in this analysis. (NCT02494921)
Timeframe: Up to 6 months

Interventionpercentage of participants (Number)
Treatment (Phase 1b/2 RP2D)65.8

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Maximally Tolerated Dose (MTD) (Phase 1b)

Maximally tolerated dose (MTD) of ribociclib in combination with docetaxel and prednisone is based upon evaluation of dose-limiting toxicities (DLTs) and adverse events for all participants who received treatment in Phase Ib. If 1 of 3 participants in a cohort experiences a DLT, then the cohort will be expanded to treat an additional 3 participants. If only 1 of 6 participants experiences a DLT, the next cohort of participants will be treated at the next higher dose level. If 2 or more participants in a cohort experience a DLT, then MTD has been exceeded and the previous dose level will be considered the MTD. If more than 1 of 6 patients experience a DLT at dose level IA then the study will be terminated, as the MTD cannot be determined and de-escalation from dose level IA is not planned. Per Investigator discretion the Recommended Phase 2 Dose (RP2D) schedule of ribociclib and docetaxel may be established in the absence of reaching MTD. (NCT02494921)
Timeframe: Up to 2 years

Interventionmg/m^2 (Number)
Treatment (Phase 1b)NA

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Mean Maximum Serum Concentration of Ribociclib (Cmax) (Phase 1b)

The maximum concentration (Cmax) is shown to reflect not only the rate but also the extent of absorption. The mean Cmax for serum concentration of ribociclib will be reported using descriptive statistics for all participants in Phase 1b who received at least one dose of study treatment and completed a serum blood draw. (NCT02494921)
Timeframe: Pre-dose on day 1, and 1, 2, 4, and 24 hours post-dose

Interventionng/mL (Mean)
200 mg Ribociclib300 mg Ribociclib
Treatment (Phase 1b, Non-RP2D)207.5289.8

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Mean Maximum Serum Concentration of Ribociclib (Cmax) (Phase 1b)

The maximum concentration (Cmax) is shown to reflect not only the rate but also the extent of absorption. The mean Cmax for serum concentration of ribociclib will be reported using descriptive statistics for all participants in Phase 1b who received at least one dose of study treatment and completed a serum blood draw. (NCT02494921)
Timeframe: Pre-dose on day 1, and 1, 2, 4, and 24 hours post-dose

Interventionng/mL (Mean)
400 mg Ribociclib
Treatment (Phase 1b, RP2D)393.6

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Mean Area Under Curve (AUC) 0-24 Hour (Phase 1b)

The estimated AUC for serum concentration of ribociclib for a 24 hour interval after dose will be reported using descriptive statistics for all participants in Phase 1b who received at least one dose of study treatment and completed a serum blood draw. (NCT02494921)
Timeframe: Pre-dose on day 1, and 1, 2, 4, and 24 hours post-dose

Interventionng*hrs/mL (Mean)
200 mg ribociclib300 mg ribociclib
Treatment (Phase 1b, Non-RP2D)29093340.3

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Median Duration of Response (Phase1b/2 RP2D)

For participants with both measurable disease at baseline and at least one restaging scan on treatment, duration of response will be defined as the time criteria are met for CR or PR until recurrent or progressive disease is objectively documented. (NCT02494921)
Timeframe: Up to 2 years

Interventiondays (Median)
Treatment (Phase 1b/2)141.5

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Median PSA Progression-Free Survival (Phase 1b/2 RP2D)

The PSA response duration commences on the date of the first 50% decline in PSA. The response duration ends when the PSA value increases by 25% above the nadir, provided that the increase in the absolute-value PSA level is at least 5 ng/mL or back to baseline, whichever is lower. The probability distribution of the median time to PSA progression will be estimated using the Kaplan-Meier product limit method. (NCT02494921)
Timeframe: Up to 2 years

Interventionmonths (Median)
Treatment (Phase 1b/2 RP2D)7.15

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Median Radiographic Progression-free Survival (Phase1b/2 RP2D)

Radiographic progression-free survival will be assessed using RECIST version 1.1. Median duration will be Estimated using the Kaplan-Meier product limit method. Duration will be measured from day 1 of study treatment to first date of radiographic progression or death, whichever occurs sooner for participants in Phase 1b and Phase 2 who receive the RP2D. Participants who discontinue study therapy for toxicity, withdrawal from study, or prostate-specific antigen (PSA)-only progression, will be censored at the date of last radiographic tumor assessment for this analysis. Participants who discontinue therapy for evidence of clinical progression/clinical deterioration will be included in this analysis. (NCT02494921)
Timeframe: Up to 2 years

Interventionmonths (Median)
Treatment (Phase 1b/2 RP2D)8.09

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Mean Area Under Curve (AUC) 0-24 Hour (Phase 1b)

The estimated AUC for serum concentration of ribociclib for a 24 hour interval after dose will be reported using descriptive statistics for all participants in Phase 1b who received at least one dose of study treatment and completed a serum blood draw. (NCT02494921)
Timeframe: Pre-dose on day 1, and 1, 2, 4, and 24 hours post-dose

Interventionng*hrs/mL (Mean)
400 mg ribociclib
Treatment (Phase 1b, RP2D)6531.6

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Percent of Participants With Death or Graft Failure.

Participants who died or experienced graft failure were considered to have met this endpoint. Graft failure was defined as the need for post-transplant dialysis for more than 56 days. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental5.3
Control7.1

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Percent of Participants With Impaired Wound Healing Manifested by Wound Dehiscence, Wound Infection, or Hernia at the Site of the Transplant Incision

Participants were considered to have met this endpoint if they had a reported case of impaired wound healing at the site of the transplant incision manifested by one wound dehiscence, wound infection, or hernia. (NCT02495077)
Timeframe: 24 months post-transplantation

InterventionPercent of participants (Number)
Experimental7.9
Control11.6

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Percent of Participants With Locally Treated Rejection, Defined as Treatment Administered for Rejection Based on Clinical Signs or Biopsy Findings.

Biopsies were read by the local pathologist at the hospital where the participant was a patient. These local reads informed clinical care for the participant, which may or may not include prescribing/administering medication to the participant to help with clinical concerns or findings noted on a biopsy. Participants were considered to have met this endpoint if they have a report of receiving treatment for clinical or biopsy-proven rejection during the 24 month post-transplant follow-up. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental16.2
Control27

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Percent of Participants With Locally Treated Rejection, Defined as Treatment Administered for Rejection Based on Clinical Signs or Biopsy Findings.

Biopsies were read by the local pathologist at the hospital where the participant was a patient. These local reads informed clinical care for the participant, which may or may not include prescribing/administering medication to the participant to help with clinical concerns or findings noted on a biopsy. Participants were considered to have met this endpoint if they have a report of receiving treatment for clinical or biopsy-proven rejection during the first 6 months post-transplant. (NCT02495077)
Timeframe: 6 months post-transplantation

Interventionpercentage of participants (Number)
Experimental12.6
Control20.5

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Percent of Participants With Malignancy.

Participants were considered to have met this endpoint if they had a reported case of malignancy. (NCT02495077)
Timeframe: 24 months post-transplantation

InterventionPercent of Participants (Number)
Experimental1.8
Control0.9

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Percent of Participants With Mycobacterial or Fungal Infections

Participants were considered to have met this endpoint if they had at least one mycobacterial of fungal infection. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental6.1
Control6.3

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Percent of Participants With Only Graft Failure.

Participants who experienced graft failure were considered to have met this endpoint. Graft failure was defined as the need for post-transplant dialysis for more than 56 days. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental2.7
Control2.7

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Percent of Participants With Primary Non-Function (PNF), Defined as Dialysis-dependency for More Than 3 Months.

Post-transplant dialysis is sometimes required in the setting of kidney transplant. If such dialysis continues for more than 3 months, the participant is considered to have PNF and, as such, meets this endpoint definition. (NCT02495077)
Timeframe: Transplantation through at least month 3 up to month 24

InterventionPercent of Participants (Number)
Experimental2.8
Control0.9

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The Difference Between the Mean eGFR (Modified MDRD) in the Experimental vs. Control Groups.

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the month 24 eGFR for each treatment group. (NCT02495077)
Timeframe: 24-Month post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental52.45
Control57.35

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The Percent of Participants Who Need Dialysis After Week 1.

Participants who needed dialysis after the first week post-transplant were considered to have met this endpoint. (NCT02495077)
Timeframe: 1 week to 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental9.0
Control2.8

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The Percent of Participants Whose Day 2 Serum CRR Was Less Than 30%.

Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 2 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function. A participant was considered to have met this endpoint if their day 2 serum CRR was less than 30%. (NCT02495077)
Timeframe: Day 2 post-transplantation

Interventionpercentage of participants (Number)
Experimental57.1
Control68.6

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The Percent of Participants Whose Day 5 Serum CRR Was Less Than 70%.

Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 5 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function. A participant was considered to have met this endpoint if their day 5 serum CRR was less than 70%. (NCT02495077)
Timeframe: Day 5 post-transplantation

Interventionpercentage of participants (Number)
Experimental74.4
Control88.4

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The Percent of Participants With a Serum Creatinine of More Than 3 mg/dL.

Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. This endpoint is ascertaining slow graft function in the immediate days post-transplant. A participant was considered to have met this endpoint if their day 5 serum creatinine was greater than 3 mg/dL. (NCT02495077)
Timeframe: Day 5 post-transplantation

Interventionpercentage of participants (Number)
Experimental47.4
Control42.9

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Change From Baseline (Immediately After Surgery) in Serum Creatinine.

Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. eGFR values from 24, 48, and 72 hours post-transplant (i.e., days 1, 2, and 3) were used to generate an estimate of the serum creatinine at each time point of interest for each treatment group. (NCT02495077)
Timeframe: 24, 48 and 72 hours post-transplantation

,
Interventionmg/dL (Mean)
24 Hours48 Hours72 Hours
Control6.855.875.21
Experimental7.356.245.77

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eGFR Values as Measured by CKD-EPI

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group. (NCT02495077)
Timeframe: Days 30, 90, and 180 post-transplantation

,
InterventionmL/min/1.73m2 (Mean)
Day 30Day 90Day 180
Control50.6351.4452.65
Experimental49.2949.8050.56

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eGFR Values as Measured by MDRD

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group. (NCT02495077)
Timeframe: Days 30, 60, and 180 post-transplantation

,
InterventionmL/min/1.73m2 (Mean)
Day 30Day 90Day 180
Control48.2048.9950.16
Experimental46.6447.1447.89

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BANFF Grades of First AMR.

Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR within 6 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, or C4d staining positive. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes. (NCT02495077)
Timeframe: 6 months post-transplantation

InterventionParticipants (Count of Participants)
Experimental0
Control0

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Change in eGFR Between 3 Months and 24 Months as Measured by CKD-EPI

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 3 and 24 was calculated as the month 24 eGFR minus the month 3 eGFR for each participant. A window of +/- 14 days was used for month 3 and +/- 1 month was used for month 24. (NCT02495077)
Timeframe: 3 months and 24 months post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental2.7
Control4.4

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Change in eGFR Between 3 Months and 24 Months as Measured by MDRD

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 3 and 24 was calculated as the month 24 eGFR minus the month 3 eGFR for each participant. A window of +/- 14 days was used for month 3 and +/- 1 month was used for month 24. (NCT02495077)
Timeframe: 3 months and 24 months post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental2.8
Control4.8

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Change in eGFR Between 6 Months and 24 Months as Measured by CKD-EPI

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 6 and 24 was calculated as the month 24 eGFR minus the month 6 eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24. (NCT02495077)
Timeframe: 6 months and 24 months post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental0.8
Control4.8

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Change in eGFR Between 6 Months and 24 Months as Measured by MDRD

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 6 and 24 was calculated as the month 24 eGFR minus the month 6 eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24. (NCT02495077)
Timeframe: 6 months and 24 months post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental1.0
Control5.2

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Change in eGFR Between Post-transplant Nadir and 24 Months as Measured by CKD-EPI

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. Post-transplant nadir was defined as the lowest value of eGFR from the first 6 months post-transplant. The change in eGFR between nadir and month 24 was calculated as the month 24 eGFR minus the nadir eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24. (NCT02495077)
Timeframe: 6 months and 24 months post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental8.5
Control12.0

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Change in eGFR Between Post-transplant Nadir and 24 Months as Measured by MDRD

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. Post-transplant nadir was defined as the lowest value of eGFR from the first 6 months post-transplant. The change in eGFR between nadir and month 24 was calculated as the month 24 eGFR minus the nadir eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24. (NCT02495077)
Timeframe: 6 months and 24 months post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental8.1
Control11.6

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Percent of Participants That Required at Least One Dialysis Treatment.

Dialysis within the first week post-transplant is used in the setting of delayed graft function (DGF). Participants are considered to have had DGF if they had at least one dialysis treatment in the first week post-transplant. (NCT02495077)
Timeframe: 1 week post-transplantation

Interventionpercentage of participants (Number)
Experimental31.0
Control35.7

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Creatinine Reduction Ratio (CRR), Defined as the First Creatinine on Day 2 Divided by he First Creatinine After Surgery

Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 2 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function. (NCT02495077)
Timeframe: Day 2 post-transplantation

InterventionPercentage (Mean)
Experimental24.28
Control20.97

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Creatinine Reduction Ratio (CRR), Defined as the First Creatinine on Day 5 Divided by the First Creatinine After Surgery.

Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 5 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function. (NCT02495077)
Timeframe: Day 5 post-transplantation

InterventionPercentage (Mean)
Experimental47.06
Control43.37

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Days From Transplantation Until Event (ACR, AMR, or Hospitalization for Infection and/or Malignancy)

Participants are considered to have met this endpoint if they experienced biopsy-proven T-cell mediated rejection (ACR) or antibody mediated rejection (AMR) based on central pathology reading or were hospitalized for infection and/or malignancy. For participants who met one or more of these three components, the earliest event date of the three components was used as the time of meeting the endpoint. Participants who did not meet any of the three components were censored at their last date of follow-up. Event (or censor) day was calculated as event (or censor) date minus transplant date. (NCT02495077)
Timeframe: 24 months post-transplantation

InterventionDays to event (Median)
Experimental642
Control613

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Duration of Delayed Graft Function (DGF), Defined as Time From Transplantation to the Last Required Dialysis Treatment.

Participants are considered to have had DGF if they had at least one dialysis treatment in the first week post-transplant. For this endpoint, duration was calculated as the date of last post-transplant dialysis treatment minus the date of the first post-transplant dialysis treatment. (NCT02495077)
Timeframe: First post-transplant dialysis treatment to last post-transplant dialysis treatment

InterventionDays (Mean)
Experimental13.27
Control15.74

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eGFR Values as Measured by CKD-EPI

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group. (NCT02495077)
Timeframe: Day 7 post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental41.01
Control41.85

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eGFR Values as Measured by MDRD

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group. (NCT02495077)
Timeframe: Day 7 post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental38.93
Control39.96

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Number of Dialysis Sessions.

The number of dialysis sessions a person had during their first 8 weeks post-transplant was used for this endpoint. (NCT02495077)
Timeframe: 8 weeks post-transplantation

InterventionDialysis sessions (Mean)
Experimental0.14
Control0.26

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Percent of Participants With Any Infection Requiring Hospitalization or Resulting in Death.

Participants were considered to have met this endpoint if they had an infection that required hospitalization or resulted in death. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental43.0
Control39.3

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Percent of Participants With BANFF Chronicity Scores > or Equal 2 on the 24 Month Biopsy.

The Banff 2013 classification involves scoring numerous characteristics of renal biopsy specimens. The ci (interstitial fibrosis) and ct (tubular atrophy) scores are two such characteristics. The scores can take values of 0, 1, 2, or 3 for each characteristic (ci and ct), indicating increasing severity of disease as the scores increase. Participants are considered to have met this endpoint if their ci + ct score on the 24 month biopsy summed to be > or equal to 2. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental73.1
Control36.4

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Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection (AMR)

Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR within 6 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, or C4d staining positive.Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes. (NCT02495077)
Timeframe: 6 months post-transplantation

InterventionParticipants (Count of Participants)
Experimental0.0
Control0.0

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Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection (AMR).

Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR within 24 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, or C4d staining positive. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participant (Number)
Experimental1.3
Control0.0

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Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection AMR or Suspicious for AMR

Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR or suspicious for AMR within 6 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, C4d staining positive, or suspicious. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes; suspicious-when 2 of 3 factors for acute/active are present. (NCT02495077)
Timeframe: 6 months post-transplantation

Interventionpercentage of participants (Number)
Experimental2.8
Control0.0

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Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection AMR or Suspicious for AMR.

Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR or suspicious for AMR within 24 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, C4d staining positive, or suspicious. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes; suspicious-when 2 of 3 factors for acute/active are present (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental3.8
Control1.4

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Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR)

Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of greater than or equal to IA with or without clinical symptoms within 6 months of transplant were determined to have met the endpoint. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe form of cellular rejection.Criteria include: IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation. (NCT02495077)
Timeframe: 6 month post-transplantation

Interventionpercentage of participants (Number)
Experimental4.2
Control3.0

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Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR) or Borderline Rejection

Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of borderline or greater than or equal to IA with or without clinical symptoms within 24 months of transplant were determined to have met the endpoint. Severity is graded as Borderline, IA, IB, IIA, IIB, or III, with borderline representing possible cellular rejection, IA being the mildest form of cellular rejection, and III being the most severe form of cellular rejection. Criteria include: Borderline-no intimal arteritis is present but foci of mild tubulitis; IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental12.8
Control7

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Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR) or Borderline Rejection.

Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of borderline or greater than or equal to IA with or without clinical symptoms within 6 months of transplant were determined to have met the endpoint. Severity is graded as Borderline, IA, IB, IIA, IIB, or III, with borderline representing possible cellular rejection, IA being the mildest form of cellular rejection, and III being the most severe form of cellular rejection.Criteria include: Borderline-no intimal arteritis is present but foci of mild tubulitis; IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation. (NCT02495077)
Timeframe: 6 months post-transplantation

Interventionpercentage of participants (Number)
Experimental8.5
Control6.1

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Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR).

Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of greater than or equal to IA with or without clinical symptoms within 24 months of transplant were determined to have met the endpoint. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe form of cellular rejection. Criteria include: IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental5.1
Control4.2

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Percent of Participants With BK Viremia That Require a Change in Immunosuppression or Anti-viral Treatment as Per Standard of Care at the Site.

Participants were considered to have met this endpoint if they had a reported case of BK viremia that required a change in their existing immunosuppression or the use of anti-viral therapy. (NCT02495077)
Timeframe: 24 months post-transplantation

InterventionPercent of participants (Number)
Experimental28.9
Control13.4

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Percent of Participants With CMV Viremia That Require a Change in Immunosuppression or Anti-viral Treatment as Per Standard of Care at the Site

Participants were considered to have met this endpoint if they had a reported case of CMV viremia that required a change in their existing immunosuppression or the use of anti-viral therapy. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental18.4
Control11.6

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Percent of Participants With de Novo DSA.

Donor specific antibody (DSA) can be formed post-transplant as part of the recipient's alloimmune response to the transplanted organ. DSA was determined by a central laboratory. Participants with newly developed DSA (i.e., de novo) following transplant were considered to have met this endpoint. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental8.0
Control3.6

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Change From Baseline of Veterans RAND 36-Item Health Survey Mental Component Summary Score (MCS) Scores at 8 and 16 Weeks

"SF-36V MCS is a measure of HRQOL with respect to mental functioning. The SF-36V is a modification of the well-established Medical Outcomes Study Short Form Health Survey (SF-36). It surveys eight concepts of health: physical functioning, role limitations because of physical problems, bodily pain, general health perceptions, energy/vitality, social functioning, role limitations due to emotional problems and mental health. From these concepts, two summary component scores are derived: a Physical Component Summary (PCS) and a Mental Component Summary (MCS).~To calculate MCS, scales are standardized with a scoring algorithm or by the scoring software. Scores are standardized and range from 0 to 100, with a US population mean of 50 points and a SD of 10 points. The PCS and the MCS have been demonstrated to have excellent psychometric properties. SF-36V MCS is a measure of HRQOL with respect to mental functioning and symptoms. Higher scores indicate better health status," (NCT02506192)
Timeframe: 0, 8, and 16 weeks

,
Interventionunits on a scale (Mean)
baseline8 weeks16 weeks
Modified-Release Prednisone40.842.440.1
Placebo40.443.142.7

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Change From Baseline of Veterans RAND 36-Item Health Survey Physical Component Summary Score (PCS) Scores at 8 and 16 Weeks

"The SF-36V is a modification of the well-established Medical Outcomes Study Short Form Health Survey (SF-36). It surveys eight concepts of health: physical functioning, role limitations because of physical problems, bodily pain, general health perceptions, energy/vitality, social functioning, role limitations due to emotional problems and mental health. From these concepts, two summary component scores are derived: a Physical Component Summary (PCS) and a Mental Component Summary (MCS).~To calculate PCS, scales are standardized with a scoring algorithm or by the scoring software. Scores are standardized and range from 0 to 100, with a US population mean of 50 points and a SD of 10 points. The PCS and the MCS have been demonstrated to have excellent psychometric properties. SF-36V PCS is a measure of HRQOL with respect to physical functioning and symptoms. Higher scores indicate better health status," (NCT02506192)
Timeframe: 0, 8, and 16 weeks

,
Interventionunits on a scale (Mean)
baseline8 weeks16 weeks
Modified-Release Prednisone40.843.540.8
Placebo41.543.441.4

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Percentage of Participants With Dose Limiting ToxicitiesGgraded by National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (Phase I)

The percentage of participants will be reported with 95% confidence interval using exact method. (NCT02522715)
Timeframe: Up to 42 days

Interventionpercentage of participants (Number)
Phase I - Treatment (Cabazitaxel, Enzalutamide)0.0

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PSA Response 1, Defined as >= 90% PSA Decline From Baseline

The percentage of participants with a >= 90% PSA decline from baseline will be reported with 95% confidence interval using exact method. 'PSA response' is based on Prostate Cancer Working Group 2's (PCWG2) recommendations, which do not offer a specific definition as no single degree of decline has been established. (NCT02522715)
Timeframe: Baseline to time of >= 90% PSA decline, assessed up to 68 weeks

Interventionpercentage of subjects (Number)
Phase I and Phase II - Treatment (Cabazitaxel, Enzalutamide)55.6

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PSA Response 2, Defined as >= 50% PSA Decline From Baseline

The percentage of participants with a >= 50% PSA decline from baseline will be reported with 95% confidence interval using exact method. 'PSA response' is based on Prostate Cancer Working Group 2's (PCWG2) recommendations, which do not offer a specific definition as no single degree of decline has been established. (NCT02522715)
Timeframe: Baseline to time of >= 50% PSA decline, assessed up to 68 weeks

Interventionpercentage of subjects (Number)
Phase I and Phase II - Treatment (Cabazitaxel, Enzalutamide)77.8

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PSA Response 3, Defined as >= 30% PSA Decline From Baseline

The percentage of participants with a >= 30% PSA decline from baseline will be reported with 95% confidence interval using exact method. 'PSA response' is based on Prostate Cancer Working Group 2's (PCWG2) recommendations, which do not offer a specific definition as no single degree of decline has been established. (NCT02522715)
Timeframe: Baseline to time of >= 30% PSA decline, assessed up to 68 weeks

Interventionpercentage of subjects (Number)
Phase I and Phase II - Treatment (Cabazitaxel, Enzalutamide)80.6

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Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 12 and Week 24

The HADS is a general scale to detect states of anxiety and depression already used and validated in asthma, which includes HADS-A and HADS-D subscales. The instrument is comprised of 14 items: 7 related to anxiety (HADS-A) and 7 to depression (HADS-D). Each item on the questionnaire is scored from 0-3. And, the total score is the sum of the scores of the 14 items ranging from 0 (no symptoms) to 42 (severe symptoms), with higher scores indicating higher anxiety/depression complains. (NCT02528214)
Timeframe: Baseline, Week 12 and Week 24

,
Interventionscore on a scale (Mean)
Change at Week 12Change at Week 24
Dupilumab 300 mg q2w-2.13-2.53
Placebo q2w-0.75-0.99

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Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Weeks 12 and 24

FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. (NCT02528214)
Timeframe: Baseline, Week 12 and Week 24

,
Interventionliter (Mean)
BaselineWeek 12Change at Week 12Week 24Change at Week 24
Dupilumab 300 mg q2w1.531.820.291.840.29
Placebo q2w1.631.680.061.630.00

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Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Score at Week 12 and Week 24

AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that were most important to participants with asthma. AQLQ comprised of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item was scored on a 7-point likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire were averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life. (NCT02528214)
Timeframe: Baseline, Week 12 and Week 24

,
Interventionscore on a scale (Mean)
Change at Week 12Change at Week 24
Dupilumab 300 mg q2w0.780.94
Placebo q2w0.560.56

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Change From Baseline in Sino Nasal Outcome Test-22 (SNOT-22) Global Score at Week 12 and Week 24

The SNOT-22 is a validated measure of health related quality of life in sino nasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease), lower scores represent better health related quality of life. (NCT02528214)
Timeframe: Baseline, Week 12 and Week 24

,
Interventionscore on a scale (Mean)
Change at Week 12Change at Week 24
Dupilumab 300 mg q2w-12.45-14.56
Placebo q2w-3.79-2.46

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Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Week 12 and Week 24

EQ-5D-5L is a standardized health-related quality of life questionnaire developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state. EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable). (NCT02528214)
Timeframe: Baseline, Week 12 and Week 24

,
Interventionscore on a scale (Median)
Single Index: Change at Week 12Single Index: Change at Week 24VAS Score: Change at Week 12VAS Score: Change at Week 24
Dupilumab 300 mg q2w0.030.059.3411.06
Placebo q2w0.040.055.994.16

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Annualized Rate of Severe Exacerbation Events During The 24-Week Treatment Period

A severe asthma exacerbation event was defined as a deterioration of asthma during the 24-week treatment period requiring: use of systemic corticosteroids for >=3 days (at least double the dose currently used); and/or hospitalization related to asthma symptoms or emergency room visit because of asthma requiring intervention with a systemic corticosteroid treatment. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated. (NCT02528214)
Timeframe: Baseline to Week 24

InterventionExacerbation per participant-year (Number)
Placebo q2w1.597
Dupilumab 300 mg q2w0.649

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Percentage of Participants Achieving >= 50% Reduction in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control

Participants were classified according to the binary status of whether or not the 50% OCS dose reduction criterion was achieved at week 24. (NCT02528214)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Placebo q2w53.3
Dupilumab 300 mg q2w79.6

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Percentage of Participants Achieving a Reduction in Oral Corticosteroids Dose to <5 mg/Day at Week 24 While Maintaining Asthma Control

Participants were classified according to the binary status of whether or not the reduction of OCS dose to <5 mg/day was achieved at Week 24. (NCT02528214)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Placebo q2w37.4
Dupilumab 300 mg q2w71.8

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Percentage of Participants Achieving Maximum Possible Reduction in Oral Corticosteroids Dose Per Protocol at Week 24 While Maintaining Asthma Control

For all participants except those with baseline OCS dose at 35 mg/day, the maximum possible reduction corresponds to reduction to 0 mg/day (no longer requiring OCS). For participants starting with 35 mg/day at baseline, the maximum possible reduction is 32.5 mg/day (i.e. minimum dose per protocol is 2.5 mg). (NCT02528214)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Placebo q2w29.9
Dupilumab 300 mg q2w52.4

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Percentage of Participants Who No Longer Required Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control

Participants were classified according to the binary status of whether or not the participant still required OCS at Week 24 while maintaining asthma control. (NCT02528214)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Placebo q2w29.2
Dupilumab 300 mg q2w52.4

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Percentage Reduction From Baseline in Oral Corticosteroids (OCS) Dose at Week 24 While Maintaining Asthma Control

Percentage reduction of OCS dose was calculated as (optimized OCS dose [mg/day] at baseline - final OCS dose at Week 24)/optimized OCS dose at baseline x 100. Result is presented as Least Squares Mean (Standard Error) percentage reduction from baseline derived from ANCOVA model with missing data multiply imputed. (NCT02528214)
Timeframe: Baseline, Week 24

InterventionPercentage reduction from baseline (Least Squares Mean)
Placebo q2w41.85
Dupilumab 300 mg q2w70.09

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Supplementary Presentation of Primary Outcome Measure Data: Median Percentage Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control

The Primary Outcome Measure (Percentage Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control) is summarized above, as LS Mean (SE). Table below provides a supplementary presentation of the Primary Outcome Measure data; result is presented as median (inter-quartile range). Percentage reduction of OCS dose was calculated as (optimized OCS dose [mg/day] at baseline - final OCS dose at Week 24)/optimized OCS dose at baseline x 100. (NCT02528214)
Timeframe: Baseline, Week 24

Interventionpercentage reduction from baseline (Median)
Placebo q2w50.0
Dupilumab 300 mg q2w100.0

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Absolute Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control

Absolute reduction was calculated by subtracting Week 24 value from baseline value. (NCT02528214)
Timeframe: Baseline and Week 24

,
Interventionmg/day (Mean)
BaselineWeek 24Absolute reduction at Week 24
Dupilumab 300 mg q2w10.753.137.66
Placebo q2w11.756.325.45

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Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Score at Weeks 2, 4, 8, 12, 16, 20, and 24

The ACQ-5 has 5 questions, reflecting top-scoring 5 asthma symptoms: woken at night by symptoms, wake in mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during previous week and to respond to each of 5 symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control. (NCT02528214)
Timeframe: Baseline and at Weeks 2, 4, 8, 12, 16, 20, and 24

,
Interventionscore on a scale (Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24
Dupilumab 300 mg q2w-0.49-0.61-0.68-0.92-0.87-0.83-0.94
Placebo q2w-0.18-0.36-0.39-0.54-0.57-0.53-0.57

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Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionGiga cells per liter (Mean)
Eosinophils,Week 2,n=1,1,0,1,2Eosinophils,Week 4,n=2,1,1,2,2Eosinophils,Week 8,n=2,1,1,2,1Eosinophils,Week 12,n=2,0,1,1,0Eosinophils,Week 16,n=2,0,0,1,0Eosinophils,Week 24,n=2,0,0,0,0Eosinophils,Week 36,n=2,0,0,0,0Eosinophils,Week 38,n=1,0,0,0,0Eosinophils,Week 40,n=1,0,0,0,0Leukocytes,Week 2,n=1,1,0,1,2Leukocytes,Week 4,n=2,1,1,2,2Leukocytes,Week 8,n=2,1,1,2,1Leukocytes,Week 12,n=2,0,1,1,0Leukocytes,Week 16,n=2,0,0,1,0Leukocytes,Week 24,n=2,0,0,0,0Leukocytes,Week 36,n=2,0,0,0,0Leukocytes,Week 38,n=1,0,0,0,0Leukocytes,Week 40,n=1,0,0,0,0Lymphocytes,Week 2,n=1,1,0,1,2Lymphocytes,Week 4,n=2,1,1,2,2Lymphocytes,Week 8,n=2,1,1,2,1Lymphocytes,Week 12,n=2,0,1,1,0Lymphocytes,Week 16,n=2,0,0,1,0Lymphocytes,Week 24,n=2,0,0,0,0Lymphocytes,Week 36,n=2,0,0,0,0LymphocytesWeek 38,n=1,0,0,0,0Lymphocytes,Week 40,n=1,0,0,0,0Neutrophils ,Week 2,n=1,1,0,1,2Neutrophils ,Week 4,n=2,1,1,2,2Neutrophils ,Week 8,n=2,1,1,2,2Neutrophils ,Week 12,n=2,0,1,1,0Neutrophils ,Week 16,n=2,0,0,1,0Neutrophils ,Week 24,n=2,0,0,0,0Neutrophils ,Week 36,n=2,0,0,0,0Neutrophils ,Week 38,n=1,0,0,0,0Neutrophils,Week 40,n=1,0,0,0,0Platelets ,Week 2,n=1,1,0,1,2Platelets,Week 4,n=2,1,1,2,2Platelets,Week 8,n=2,1,1,2,1Platelets,Week 12,n=2,0,1,1,0Platelets,Week 16,n=2,0,0,1,0Platelets,Week 24,n=2,0,0,0,0Platelets,Week 36,n=2,0,0,0,0Platelets,Week 38,n=1,0,0,0,0Platelets,Week 40,n=1,0,0,0,0
PartB:SIR 100 mg SC q2w+6 Month Prednisone-0.010-0.015-0.010-0.0300.030-0.015-0.0100.020-0.030-0.200.25-0.25-0.10-0.45-0.200.65-0.50-1.30-0.1700.110-0.120-0.030-0.230-0.3200.1950.010-0.160-0.0400.205-0.2650.020-0.2350.0850.540-0.460-0.7705.0-1.07.07.02.0-18.510.0-15.0-6.0

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Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionGrams per liter (Mean)
MCHC,Week 4,n=3,3,2,1,2MCHC,Week 8,n=0,1,2,0,2MCHC,Week 12,n=0,1,1,1,1MCHC,Week 16,n=0,1,1,1,0MCHC,Week 24,n=0,1,0,0,0MCHC,Week 36,n=0,1,0,0,0Hemoglobin,Week 4,n=3,3,2,1,2Hemoglobin,Week 8,n=2,1,2,0,2Hemoglobin,Week 12,n=1,1,1,1,1Hemoglobin,Week 16,n=0,1,1,1,0Hemoglobin,Week 24,n=0,1,0,0,0Hemoglobin,Week 36,n=0,1,0,0,0
PartB:SIR 100 mg SC q2w+3 Month Prednisone-14.0-8.0-10.0-9.0-17.0-15.0-6.3-4.0-1.0-2.0-4.02.0

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Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionGrams per liter (Mean)
MCHC,Week 4,n=3,3,2,1,2Hemoglobin,Week 4,n=3,3,2,1,2Hemoglobin,Week 8,n=2,1,2,0,2Hemoglobin,Week 12,n=1,1,1,1,1
PartB:SIR 100 mg SC q2w+6 Month Prednisone-18.0-4.0-6.0-5.0

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Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionGrams per liter (Mean)
MCHC,Week 4,n=3,3,2,1,2MCHC,Week 12,n=0,1,1,1,1MCHC,Week 16,n=0,1,1,1,0Hemoglobin,Week 4,n=3,3,2,1,2Hemoglobin,Week 12,n=1,1,1,1,1Hemoglobin,Week 16,n=0,1,1,1,0
PartB:Placebo SC q2w + 6 Month Prednisone0.021.08.0-2.08.02.0

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Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionGrams per liter (Mean)
MCHC,Week 4,n=3,3,2,1,2MCHC,Week 8,n=0,1,2,0,2MCHC,Week 12,n=0,1,1,1,1Hemoglobin,Week 4,n=3,3,2,1,2Hemoglobin,Week 8,n=2,1,2,0,2Hemoglobin,Week 12,n=1,1,1,1,1
PartB:Placebo SC q2w + 12 Month Prednisone-7.08.011.0-5.5-1.55.0

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Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionGrams per liter (Mean)
MCHC,Week 4,n=3,3,2,1,2MCHC,Week 8,n=0,1,2,0,2MCHC,Week 12,n=0,1,1,1,1MCHC,Week 16,n=0,1,1,1,0Hemoglobin,Week 4,n=3,3,2,1,2Hemoglobin,Week 8,n=2,1,2,0,2Hemoglobin,Week 12,n=1,1,1,1,1Hemoglobin,Week 16,n=0,1,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone-3.0-0.511.0-1.02.04.020.019.0

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Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionGrams per liter (Mean)
MCHC,Week 2,n=1,1,0,1,1MCHC,Week 4,n=2,1,0,2,1MCHC,Week 8,n=2,1,0,2,1MCHC,Week 12,n=2,0,0,1,0MCHC,Week 14,n=0,0,0,1,0MCHC,Week 16,n=2,0,0,1,0Hemoglobin,Week 2,n=1,1,0,1,2Hemoglobin,Week 4,n=2,1,1,2,2Hemoglobin,Week 8,n=2,1,1,2,1Hemoglobin,Week 12,n=2,0,1,1,0Hemoglobin,Week 14,n=0,0,0,1,0Hemoglobin,Week 16,n=2,0,0,1,0
PartB:Placebo SC q2w + 6 Month Prednisone-3.03.53.519.05.011.07.0-0.5-0.5-6.00.08.0

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Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionGrams per liter (Mean)
MCHC,Week 2,n=1,1,0,1,1MCHC,Week 4,n=2,1,0,2,1MCHC,Week 8,n=2,1,0,2,1MCHC,Week 12,n=2,0,0,1,0MCHC,Week 16,n=2,0,0,1,0MCHC,Week 24,n=2,0,0,0,0MCHC,Week 36,n=2,0,0,0,0MCHC,Week 38,n=1,0,0,0,0MCHC,Week 40,n=1,0,0,0,0Hemoglobin,Week 2,n=1,1,0,1,2Hemoglobin,Week 4,n=2,1,1,2,2Hemoglobin,Week 8,n=2,1,1,2,1Hemoglobin,Week 12,n=2,0,1,1,0Hemoglobin,Week 16,n=2,0,0,1,0Hemoglobin,Week 24,n=2,0,0,0,0Hemoglobin,Week 36,n=2,0,0,0,0Hemoglobin,Week 38,n=1,0,0,0,0Hemoglobin,Week 40,n=1,0,0,0,0
PartB:SIR 100 mg SC q2w+6 Month Prednisone-3.0-1.50.0-5.50.0-3.0-4.0-3.04.0-4.00.54.01.50.0-0.5-1.5-3.0-3.0

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Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionGrams per liter (Mean)
Hemoglobin,Week 4,n=2,1,1,2,2Hemoglobin,Week 8,n=2,1,1,2,1Hemoglobin,Week 12,n=2,0,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone-9.00.00.0

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Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

,
InterventionGrams per liter (Mean)
MCHC,Week 2,n=1,1,0,1,1MCHC,Week 4,n=2,1,0,2,1MCHC,Week 8,n=2,1,0,2,1Hemoglobin,Week 2,n=1,1,0,1,2Hemoglobin,Week 4,n=2,1,1,2,2Hemoglobin,Week 8,n=2,1,1,2,1
PartB:Placebo SC q2w + 12 Month Prednisone20.023.09.010.08.09.0
PartB:SIR 100 mg SC q2w+3 Month Prednisone-1.01.016.0-2.0-2.03.0

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Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B

"The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain now on an 11-point numeric rating scale ranging from 0, no pain to 10, the worst pain imaginable. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported." (NCT02531633)
Timeframe: Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24

,,,,
InterventionScores on scale (Number)
Par 1, Day 30Par 2, Day 29Par 3, Day 23Par 4, Week 4Par 4, Week 8Par 4, Week 12Par 4, Day 113Par 5, Week 4Par 5, Week 8Par 5, Day 85Par 6, Week 4Par 6, Day 65Par 7, Week 4Par 7, Week 8Par 7, Week 12Par 7, Day 373Par 8, Week 4Par 8, Day 64Par 9, Day 29Par 10, Week 4Par 10, Day 57Par 11, Week 4Par 11, Week 8Par 11, Week 12Par 11, Day 163Par 12, Week 4Par 12, Week 8Par 12, Day 85Par 13, Week 4Par 13, Day 59Par 14, Week 4Par 14, Day 57Par 16, Day 169Par 17, Week 4Par 17, Week 12Par 17, Day 112Par 18, Week 8Par 18, Day 85
PartB:Placebo SC q2w + 12 Month PrednisoneNANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA-2-2-210
PartB:Placebo SC q2w + 6 Month PrednisoneNANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA0-1-3NANANANANA
PartB:SIR 100 mg SC q2w+3 Month PrednisoneNANANANANANANANANANANANA10000-100-1NANANANANANANANANANANANANANANANANA
PartB:SIR 100 mg SC q2w+6 Month Prednisone00-1000000200NANANANANANANANANANANANANANANANANANANANANANANANANANA
PartB:SIR 50 mg SC q4w+6 Month PrednisoneNANANANANANANANANANANANANANANANANANANANANA00110-1000NANANANANANANANA

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Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B

"The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain now on an 11-point numeric rating scale ranging from 0, no pain to 10, the worst pain imaginable. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value." (NCT02531633)
Timeframe: Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24

,,,,
InterventionScores on scale (Number)
Par 1, Week 2Par 1, Week 4Par 1, Week 8Par 1, Week 12Par 1, Week 24Par 1, Day 339Par 2, Week 4Par 2, Week 8Par 2, Week 12Par 2, Week 24Par 2, Week 38Par 2, Week 40Par 2, Day 344Par 3, Day 113Par 4, Week 4Par 4, Week 8Par 4, Week 12Par 5, Week 4Par 5, Week 8Par 5, Week 12Par 5, Week 14Par 5, Week 16Par 5, Day 162Par 6, Week 2Par 6, Week 4Par 6, Week 8Par 6, Day 91Par 7, Week 2Par 7, Week 4Par 7, Week 8Par 7, Day 85Par 8, Week 2Par 8, Week 4Par 8, Day 87
PartB:Placebo SC q2w + 12 Month PrednisoneNANANANANANANANANANANANANANANANANANANANANANANANANANANA-1010200
PartB:Placebo SC q2w + 6 Month PrednisoneNANANANANANANANANANANANANANANANANA0101012-2-2-1NANANANANANANA
PartB:SIR 100 mg SC q2w+3 Month PrednisoneNANANANANANANANA0NANANANA-2NANANANANANANANANANANANANANANANANANANANA
PartB:SIR 100 mg SC q2w+6 Month Prednisone4-1-140-20010110NANANANANANANANANANANANANANANANANANANANANA
PartB:SIR 50 mg SC q4w+6 Month PrednisoneNANANANANANANANANANANANANANA-20-3NANANANANANANANANANANANANANANANANA

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Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B

"In PhGA was based on What is physician's assessment of the participant's current disease activity. PhGA used a 10 cm VAS ranging from 0 (none) to 10 (extremely active). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported." (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 4, 8, 12, 16, 36; Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169 and 373

,,,,
InterventionScores on scale (Number)
Par 1, Day 30Par 2, Day 29Par 3, Day 23Par 3, Week 12Par 4, Day 113Par 5, Week 4Par 5, Day 85Par 6, Week 4Par 6, Day 65Par 7, Week 4Par 7, Week 8Par 7, Week 12Par 7, Week 16Par 7, Week 36Par 7, Day 373Par 8, Week 4Par 8, Day 64Par 9, Day 29Par 10, Week 4Par 10, Day 57Par 11, Week 12Par 11, Week 16Par 11, Day 163Par 12, Week 4Par 12, Week 8Par 12, Day 85Par 13, Week 4Par 13, Day 59Par 14, Week 4Par 14, Day 57Par 15, Day 169Par 16, Week 4Par 16, Week 12Par 16, Day 112Par 17, Week 8Par 17, Day 85
PartB:Placebo SC q2w + 12 Month PrednisoneNANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA-0.10.00.40.10.2
PartB:Placebo SC q2w + 6 Month PrednisoneNANANANANANANANANANANANANANANANANANANANANANANANANANANANA-0.30.3-0.5NANANANANA
PartB:SIR 100 mg SC q2w+3 Month PrednisoneNANANANANANANANANA0.20.00.20.40.20.00.40.10.20.00.1NANANANANANANANANANANANANANANANA
PartB:SIR 100 mg SC q2w+6 Month Prednisone0.00.10.00.70.0-0.30.3-0.2-0.3NANANANANANANANANANANANANANANANANANANANANANANANANANANA
PartB:SIR 50 mg SC q4w+6 Month PrednisoneNANANANANANANANANANANANANANANANANANANANA0.90.90.4-0.10.1-0.1-0.6-0.3NANANANANANANANA

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Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B

"In PhGA was based on What is physician's assessment of the participant's current disease activity. PhGA used a 10 cm VAS ranging from 0 (none) to 10 (extremely active). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value." (NCT02531633)
Timeframe: Baseline (Day 0) and Day 85, Day 113, Day 162, Day 203, Day 339, Day 344, Week 2, Week 4, Week 8, Week 12, Week 14, Week 16, Week 24, Week 36, Week 38, Week 40

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InterventionScores on scale (Number)
Par 1, Week 2Par 1, Week 4Par 1, Week 8Par 1, Week 12Par 1, Week 16Par 1, Week 24Par 1, Week 36Par 1, Day 339Par 2, Week 4Par 2, Week 8Par 2, Week 12Par 2, Week 16Par 2, Week 24Par 2, Week 36Par 2, Week 38Par 2, Week 40Par 2, Day 344Par 3, Day 113Par 4, Week 4Par 4, Week 12Par 5, Week 4Par 5, Week 8Par 5, Week 12Par 5, Week 14Par 5, Week 16Par 5, Day 162Par 6, Day 203Par 7, Week 2Par 7, Week 4Par 7, Week 8Par 7, Day 85Par 8, Week 2Par 8, Week 4
PartB:Placebo SC q2w + 12 Month PrednisoneNANANANANANANANANANANANANANANANANANANANANANANANANANANA0.00.10.00.0-6.0-6.3
PartB:Placebo SC q2w + 6 Month PrednisoneNANANANANANANANANANANANANANANANANANANANA1.8-1.1-0.71.5-1.1-0.47.6NANANANANANA
PartB:SIR 100 mg SC q2w+3 Month PrednisoneNANANANANANANANANANANANANANANANANA-0.2NANANANANANANANANANANANANANANA
PartB:SIR 100 mg SC q2w+6 Month Prednisone0.0-0.5-1.2-0.6-0.9-0.6-1.1-1.20.00.10.40.10.00.10.70.40.2NANANANANANANANANANANANANANANANA
PartB:SIR 50 mg SC q4w+6 Month PrednisoneNANANANANANANANANANANANANANANANANANA-0.20.1NANANANANANANANANANANANANA

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Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B

"The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS). of 10 centimeter (cm) ranging from 0 (very well) to 10 (very poor). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported." (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 16, 36; Days 23, 29, 30, 57, 59, 64, 65, 85,112, 113, 115, 163, 169 and 373

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InterventionScores on scale (Number)
Par 1, Day 30Par 2, Day 29Par 3, Day 23Par 4, Week 4Par 4, Week 8Par 4, Week 12Par 4, Day 113Par 5, Week 4Par 5, Week 8Par 5, Day 85Par 6, Week 4Par 6, Day 65Par 7, Week 4Par 7, Week 8Par 7, Week 12Par 7, Week 16Par 7, Week 36Par 7, Day 373Par 8, Week 4Par 8, Day 64Par 9, Day 29Par 10, Week 4Par 10, Day 57Par 11, Week 4Par 11, Week 8Par 11, Week 12Par 11, Week 16Par 11, Day 163Par 12, Week 4Par 12, Week 8Par 12, Day 85Par 13, Week 4Par 13, Day 59Par 14, Week 4Par 14, Day 57Par 15, Day 169Par 16, Week 4Par 16, Week 12Par 16, Day 112Par 17, Week 8Par 17, Day 85
PartB:Placebo SC q2w + 12 Month PrednisoneNANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA-0.3-0.3-0.10.2-0.1
PartB:Placebo SC q2w + 6 Month PrednisoneNANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA-0.4-0.9-1.1NANANANANA
PartB:SIR 100 mg SC q2w+3 Month PrednisoneNANANANANANANANANANANANA1.00.00.00.20.20.9-0.2-0.40.10.0-0.3NANANANANANANANANANANANANANANANANANA
PartB:SIR 100 mg SC q2w+6 Month Prednisone0.2-0.10.0-0.20.10.00.00.10.42.3-1.00.5NANANANANANANANANANANANANANANANANANANANANANANANANANANANANA
PartB:SIR 50 mg SC q4w+6 Month PrednisoneNANANANANANANANANANANANANANANANANANANANANANANA-0.10.20.21.20.3-0.8-0.70.9-0.71.0NANANANANANANANA

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Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B

"The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS). of 10 centimeter (cm) ranging from 0 (very well) to 10 (very poor). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value." (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38, 40; Days 85, 87, 91, , 113, 162, 339, and 344

,,,,
InterventionScores on scale (Number)
Par 1, Week 2Par 1, Week 4Par 1, Week 8Par 1, Week 12Par 1, Week 16Par 1, Week 24Par 1, Week 36Par 1, Day 339Par 2, Week 4Par 2, Week 8Par 2, Week 12Par 2, Week 16Par 2, Week 24Par 2, Week 36Par 2, Week 38Par 2, Week 40Par 2, Day 344Par 3,Par 3,, Day 113Par 4, Week 4Par 4, Week 8Par 4, Week 12Par 5, Week 4Par 5, Week 8Par 5, Week 12Par 5, Week 14Par 5, Week 16Par 5, Day 162Par 6, Week 4Par 6, Week 8Par 6, Day 91Par 7, Week 2Par 7, Week 4Par 7, Week 8Par 7, Day 85Par 8, Week 2Par 8, Week 4Par 8, Day 87Par 6, Week 2
PartB:Placebo SC q2w + 12 Month PrednisoneNANANANANANANANANANANANANANANANANANANANANANA0.4NANANANANANANA-0.70.70.8-0.4-0.1-3.7-3.1NA
PartB:Placebo SC q2w + 6 Month PrednisoneNANANANANANANANANANANANANANANANANANANANANA2.0NA0.21.01.00.8-3.1-3.2-3.5NANANANANANANA-0.1
PartB:SIR 100 mg SC q2w+3 Month PrednisoneNANANANANANANANANANANANANANANANANA2.1NANANANANANANANANANANANANANANANANANANANA
PartB:SIR 100 mg SC q2w+6 Month Prednisone4.32.3-0.24.04.72.20.4-0.7-1.0-0.3-0.6-0.70.5-0.60.9-0.3-0.7NANANANANANANANANANANANANANANANANANANANANA
PartB:SIR 50 mg SC q4w+6 Month PrednisoneNANANANANANANANANANANANANANANANANANA-1.04.90.4NANANANANANANANANANANANANANANANANA

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Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)

Interventionbeats per minute (Mean)
Week 4,n=3,3,3,1,2Week 12,n=1,1,1,1,1Week 16,n=0,1,1,1,0Week follow up,n=5,4,2,3,2
PartB:Placebo SC q2w + 6 Month Prednisone-29.06.06.0-7.7

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Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)

,
Interventionbeats per minute (Mean)
Week 4,n=3,3,3,1,2Week 8,n=2,1,2,0,2Week 12,n=1,1,1,1,1Week follow up,n=5,4,2,3,2
PartB:Placebo SC q2w + 12 Month Prednisone-1.5-0.56.07.5
PartB:SIR 100 mg SC q2w+6 Month Prednisone3.78.011.01.4

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Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)

Interventionbeats per minute (Mean)
Week 4,n=3,3,3,1,2Week 8,n=2,1,2,0,2Week 12,n=1,1,1,1,1Week 16,n=0,1,1,1,0Week follow up,n=5,4,2,3,2
PartB:SIR 50 mg SC q4w+6 Month Prednisone-14.7-5.54.0-4.0-1.5

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Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)

Interventionbeats per minute (Mean)
Week 4,n=3,3,3,1,2Week 8,n=2,1,2,0,2Week 12,n=1,1,1,1,1Week 16,n=0,1,1,1,0Week 24,n=0,1,0,0,0Week 36,n=0,1,0,0,0Week follow up,n=5,4,2,3,2
PartB:SIR 100 mg SC q2w+3 Month Prednisone0.34.0-4.0-4.00.00.04.0

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Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)

Interventionbeats per minute (Mean)
Week 2,n=1,1,0,1,2Week 4,n=2,1,1,2,2Week 8,n=2,1,1,2,1Week 12,n=2,1,1,1,0Week 16,n=2,0,0,1,0Week 24,n=2,0,0,0,0Week 36,n=2,0,0,0,0Week 38,n=1,0,0,0,0Week 40,n=1,0,0,0,0Week follow up,n=2,1,0,1,1
PartB:SIR 100 mg SC q2w+6 Month Prednisone4.0-2.00.0-2.02.05.0-2.00.00.05.0

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Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)

Interventionbeats per minute (Mean)
Week 4,n=2,1,1,2,2Week 8,n=2,1,1,2,1Week 12,n=2,1,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone-10.04.04.0

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Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)

Interventionbeats per minute (Mean)
Week 2,n=1,1,0,1,2Week 4,n=2,1,1,2,2Week 8,n=2,1,1,2,1Week follow up,n=2,1,0,1,1
PartB:Placebo SC q2w + 12 Month Prednisone4.0-5.5-4.06.0

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Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)

Interventionbeats per minute (Mean)
Week 2,n=1,1,0,1,2Week 4,n=2,1,1,2,2Week 8,n=2,1,1,2,1Week 12,n=2,1,1,1,0Week follow up,n=2,1,0,1,1
PartB:SIR 100 mg SC q2w+3 Month Prednisone7.06.03.02.0-3.0

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Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)

Interventionbeats per minute (Mean)
Week 2,n=1,1,0,1,2Week 4,n=2,1,1,2,2Week 8,n=2,1,1,2,1Week 12,n=2,1,1,1,0Week 14,n=0,0,0,1,0Week 16,n=2,0,0,1,0Week follow up,n=2,1,0,1,1
PartB:Placebo SC q2w + 6 Month Prednisone0.0-17.0-12.5-12.0-24.0-14.0-22.0

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Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)

InterventionMillimeters of mercury (Mean)
SBP,Week 4,n=3,3,3,1,2SBP,Week 8,n=2,1,2,0,2SBP,Week 12,n=1,1,1,1,1SBP,Week 16,n=0,1,1,1,0SBP,Week follow up,n=5,4,2,3,2DBP,Week 4,n=3,3,3,1,2DBP,Week 8,n=2,1,2,0,2DBP,Week 12,n=1,1,1,1,1DBP,Week 16,n=0,1,1,1,0DBP,Week follow up,n=5,4,2,3,2
PartB:SIR 50 mg SC q4w+6 Month Prednisone7.0-7.515.025.0-17.57.716.515.015.012.5

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Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)

InterventionMillimeters of mercury (Mean)
SBP,Week 4,n=3,3,3,1,2SBP,Week 8,n=2,1,2,0,2SBP,Week 12,n=1,1,1,1,1SBP,Week 16,n=0,1,1,1,0SBP,Week 24,n=0,1,0,0,0SBP,Week 36,n=0,1,0,0,0SBP,Week follow up,n=5,4,2,3,2DBP,Week 4,n=3,3,3,1,2DBP,Week 8,n=2,1,2,0,2DBP,Week 12,n=1,1,1,1,1DBP,Week 16,n=0,1,1,1,0DBP,Week 24,n=0,1,0,0,0DBP,Week 36,n=0,1,0,0,0DBP,Week follow up,n=5,4,2,3,2
PartB:SIR 100 mg SC q2w+3 Month Prednisone-6.3-6.0-4.0-8.04.0-26.0-3.30.3-10.0-6.00.0-10.0-10.0-2.8

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Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)

InterventionMillimeters of mercury (Mean)
SBP,Week 4,n=3,3,3,1,2SBP,Week 12,n=1,1,1,1,1SBP,Week 16,n=0,1,1,1,0SBP,Week follow up,n=5,4,2,3,2DBP,Week 4,n=3,3,3,1,2DBP,Week 12,n=1,1,1,1,1DBP,Week 16,n=0,1,1,1,0DBP,Week follow up,n=5,4,2,3,2
PartB:Placebo SC q2w + 6 Month Prednisone10.013.0-8.010.7-4.08.0-17.06.0

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Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)

,
InterventionMillimeters of mercury (Mean)
SBP,Week 4,n=3,3,3,1,2SBP,Week 8,n=2,1,2,0,2SBP,Week 12,n=1,1,1,1,1SBP,Week follow up,n=5,4,2,3,2DBP,Week 4,n=3,3,3,1,2DBP,Week 8,n=2,1,2,0,2DBP,Week 12,n=1,1,1,1,1DBP,Week follow up,n=5,4,2,3,2
PartB:SIR 100 mg SC q2w+6 Month Prednisone-23.7-32.5-59.0-7.4-8.3-9.0-22.03.4
PartB:Placebo SC q2w + 12 Month Prednisone-2.0-1.5-2.05.0-11.0-6.0-9.0-2.0

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Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)

InterventionMillimeters of mercury (Mean)
SBP,Week 2,n=1,1,0,1,2SBP,Week 4,n=2,1,1,2,2SBP,Week 8,n=2,1,1,2,1SBP,Week 12,n=2,1,1,1,0SBP,Week follow up,n=2,1,0,1,1DBP,Week 2,n=1,1,0,1,2DBP,Week 4,n=2,1,1,2,2DBP,Week 8,n=2,1,1,2,1DBP,Week 12,n=2,1,1,1,0DBP,Week follow up,n=2,1,0,1,1
PartB:SIR 100 mg SC q2w+3 Month Prednisone15.00.018.014.0-1.0-8.0-15.0-5.0-5.0-7.0

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Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)

InterventionMillimeters of mercury (Mean)
SBP,Week 2,n=1,1,0,1,2SBP,Week 4,n=2,1,1,2,2SBP,Week 8,n=2,1,1,2,1SBP,Week 12,n=2,1,1,1,0SBP,Week 14,n=0,0,0,1,0SBP,Week 16,n=2,0,0,1,0SBP,Week follow up,n=2,1,0,1,1DBP,Week 2,n=1,1,0,1,2DBP,Week 4,n=2,1,1,2,2DBP,Week 8,n=2,1,1,2,1DBP,Week 12,n=2,1,1,1,0DBP,Week 14,n=0,0,0,1,0DBP,Week 16,n=2,0,0,1,0DBP,Week follow up,n=2,1,0,1,1
PartB:Placebo SC q2w + 6 Month Prednisone0.0-1.5-11.52.09.011.022.00.02.04.04.07.015.021.0

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Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)

InterventionMillimeters of mercury (Mean)
SBP,Week 2,n=1,1,0,1,2SBP,Week 4,n=2,1,1,2,2SBP,Week 8,n=2,1,1,2,1SBP,Week 12,n=2,1,1,1,0SBP,Week 16,n=2,0,0,1,0SBP,Week 24,n=2,0,0,0,0SBP,Week 36,n=2,0,0,0,0SBP,Week 38,n=1,0,0,0,0SBP,Week 40,n=1,0,0,0,0SBP,Week follow up,n=2,1,0,1,1DBP,Week 2,n=1,1,0,1,2DBP,Week 4,n=2,1,1,2,2DBP,Week 8,n=2,1,1,2,1DBP,Week 12,n=2,1,1,1,0DBP,Week 16,n=2,0,0,1,0DBP,Week 24,n=2,0,0,0,0DBP,Week 36,n=2,0,0,0,0DBP,Week 38,n=1,0,0,0,0DBP,Week 40,n=1,0,0,0,0DBP,Week follow up,n=2,1,0,1,1
PartB:SIR 100 mg SC q2w+6 Month Prednisone2.05.014.07.00.08.011.0-6.0-10.03.0-10.0-3.03.0-5.0-5.01.0-2.0-8.0-10.0-2.0

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Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)

InterventionMillimeters of mercury (Mean)
SBP,Week 4,n=2,1,1,2,2SBP,Week 8,n=2,1,1,2,1SBP,Week 12,n=2,1,1,1,0DBP,Week 4,n=2,1,1,2,2DBP,Week 8,n=2,1,1,2,1DBP,Week 12,n=2,1,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone6.0-12.08.06.0-4.01.0

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Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)

InterventionMillimeters of mercury (Mean)
SBP,Week 2,n=1,1,0,1,2SBP,Week 4,n=2,1,1,2,2SBP,Week 8,n=2,1,1,2,1SBP,Week follow up,n=2,1,0,1,1DBP,Week 2,n=1,1,0,1,2DBP,Week 4,n=2,1,1,2,2DBP,Week 8,n=2,1,1,2,1DBP,Week follow up,n=2,1,0,1,1
PartB:Placebo SC q2w + 12 Month Prednisone6.51.55.012.07.04.5-1.03.0

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Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)

InterventionCelsius (Mean)
Week 4,n=3,3,3,1,2Week 12,n=1,1,1,1,1Week 16,n=0,1,1,1,0Week follow up,n=5,4,2,3,2
PartB:Placebo SC q2w + 6 Month Prednisone-0.200.00-0.10-0.13

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Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)

,
InterventionCelsius (Mean)
Week 4,n=3,3,3,1,2Week 8,n=2,1,2,0,2Week 12,n=1,1,1,1,1Week follow up,n=5,4,2,3,2
PartB:Placebo SC q2w + 12 Month Prednisone0.100.05-0.500.20
PartB:SIR 100 mg SC q2w+6 Month Prednisone0.10-0.10-0.300.06

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Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)

InterventionCelsius (Mean)
Week 4,n=3,3,3,1,2Week 8,n=2,1,2,0,2Week 12,n=1,1,1,1,1Week 16,n=0,1,1,1,0Week follow up,n=5,4,2,3,2
PartB:SIR 50 mg SC q4w+6 Month Prednisone0.00-0.100.000.000.00

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Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)

InterventionCelsius (Mean)
Week 4,n=3,3,3,1,2Week 8,n=2,1,2,0,2Week 12,n=1,1,1,1,1Week 16,n=0,1,1,1,0Week 24,n=0,1,0,0,0Week 36,n=0,1,0,0,0Week follow up,n=5,4,2,3,2
PartB:SIR 100 mg SC q2w+3 Month Prednisone0.070.000.400.200.000.000.15

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Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)

InterventionCelsius (Mean)
Week 2,n=1,1,0,1,2Week 4,n=2,1,1,2,2Week 8,n=2,1,1,2,1Week 12,n=2,1,1,1,0Week 16,n=2,0,0,1,0Week 24,n=2,0,0,0,0Week 36,n=2,0,0,0,0Week 38,n=1,0,0,0,0Week 40,n=1,0,0,0,0Week follow up,n=2,1,0,1,1
PartB:SIR 100 mg SC q2w+6 Month Prednisone0.200.15-0.15-0.25-0.05-0.42-0.250.000.000.15

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Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)

InterventionCelsius (Mean)
Week 4,n=2,1,1,2,2Week 8,n=2,1,1,2,1Week 12,n=2,1,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone-0.300.100.50

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Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)

InterventionCelsius (Mean)
Week 2,n=1,1,0,1,2Week 4,n=2,1,1,2,2Week 8,n=2,1,1,2,1Week follow up,n=2,1,0,1,1
PartB:Placebo SC q2w + 12 Month Prednisone-0.650.30-0.50-0.60

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Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)

InterventionCelsius (Mean)
Week 2,n=1,1,0,1,2Week 4,n=2,1,1,2,2Week 8,n=2,1,1,2,1Week 12,n=2,1,1,1,0Week follow up,n=2,1,0,1,1
PartB:SIR 100 mg SC q2w+3 Month Prednisone0.50-0.500.000.900.00

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Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)

InterventionCelsius (Mean)
Week 2,n=1,1,0,1,2Week 4,n=2,1,1,2,2Week 8,n=2,1,1,2,1Week 12,n=2,1,1,1,0Week 14,n=0,0,0,1,0Week 16,n=2,0,0,1,0Week follow up,n=2,1,0,1,1
PartB:Placebo SC q2w + 6 Month Prednisone-0.40-0.10-0.200.00-0.20-0.100.50

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Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Cumulative prednisone dose is the cumulative doses taken from start of Part B. The cumulative prednisone dose at each visit was calculated based on the number of participants who attended that visit. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38

InterventionMilligrams (Mean)
Week 4,n=0,0,0,1,1Week 8,n=0,0,0,1,1Week 24,n=0,0,0,1,0
PartBPlacebo SC q2w + 6 Month Prednisone203.750357.500397.500

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Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Cumulative prednisone dose is the cumulative doses taken from start of Part B. The cumulative prednisone dose at each visit was calculated based on the number of participants who attended that visit. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38

InterventionMilligrams (Mean)
Week 4,n=0,0,0,1,1Week 8,n=0,0,0,1,1Week 12,n=0,0,0,0,1Week 16,n=0,0,0,0,1Week 32,n=0,0,0,0,1
PartBPlacebo SC q2w + 12 Month Prednisone325.000596.250830.0001020.0001211.250

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Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Cumulative prednisone dose is the cumulative doses taken from start of Part B. The cumulative prednisone dose at each visit was calculated based on the number of participants who attended that visit. Data for participants who received at least one dose of 100mg open label Sirukumab was presented. (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38

InterventionMilligrams (Mean)
Week 2, n=0,0,0,1,1Week 4,n=0,0,0,2,1Week 12,n=0,0,0,2,1Week 32,n=0,0,0,0,1
PartB:Placebo SC q2w + 12 Month Prednisone550.000775.0001600.0001600.000

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Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Cumulative prednisone dose is the cumulative doses taken from start of Part B. The cumulative prednisone dose at each visit was calculated based on the number of participants who attended that visit. Data for participants who received at least one dose of 100mg open label Sirukumab was presented. (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38

InterventionMilligrams (Mean)
Week 2, n=0,0,0,1,1Week 4,n=0,0,0,2,1Week 8,n=0,0,0,2,0Week 12,n=0,0,0,2,1Week 14,n=0,0,0,1,0Week 16,n=0,0,0,1,0Week 24,n=0,0,0,1,0Week 28,n=0,0,0,1,0Week 38,n=0,0,0,1,0
PartB:Placebo SC q2w + 6 Month Prednisone561.000596.125956.1251201.125843.7501233.7501853.7501908.5002153.750

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Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B

"Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing no difficulty (0), some difficulty (1), much difficulty (2), and unable to do (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability" (NCT02531633)
Timeframe: Day 29, 64, 65, 85, 112, 113, 169, 373 and Week 12

,,,,
InterventionScores on scale (Number)
Par 1, Day 29, Able to Do ChoresPar 1, Day 29, Get In and Out of a carPar 1, Day 29, Run Errands and ShopPar 1, Day 29, Get In and Out of BedPar 1, Day 29, Stand Up From a Straight ChairPar 1, Day 29, Dress yourselfPar 1, Day 29, Shampoo your hairPar 1, Day 29, Cut your meatPar 1, Day 29, Lift a Full Cup or Glass to MouthPar 1, Day 29, Open a New Milk CartonPar 1, Day 29, Open car doorsPar 1, Day 29, Open Jars Previously OpenedPar 1, Day 29, Turn Faucets On And OffPar 1, Day 29, Get On and Off The ToiletPar 1, Day 29, Take a Tub BathPar 1, Day 29, Wash and Dry Your BodyPar 1, Day 29, Bend Down Pick Up Clothing- FloorPar 1, Day 29, Reach-Get Down 5 Lb Obj Above HeadPar 1, Day 29, Climb Up Five StepsPar 1, Day 29, Walk Outdoors on Flat GroundPar 2, Week 12, Able to Do ChoresPar 2, Week 12, Get In and Out of a carPar 2, Week 12, Run Errands and ShopPar 2, Week 12, Get In and Out of BedPar 2, Week 12, Stand Up From a Straight ChairPar 2, Week 12, Dress yourselfPar 2, Week 12, Shampoo your hairPar 2, Week 12, Cut your meatPar 2, Week 12, Lift a Full Cup or Glass to MouthPar 2, Week 12, Open a New Milk CartonPar 2, Week 12, Open r car doorsPar 2, Week 12, Open Jars Previously OpenedPar 2, Week 12, Turn Faucets On And OffPar 2, Week 12, Get On and Off The ToiletPar 2, Week 12, Take a Tub BathPar 2, Week 12, Wash and Dry Your BodyPar 2, Week 12, Bend Down Pick Up Clothing- FloorPar 2, Week 12, Reach-Get Down 5 Lb Obj Above HeadPar 2, Week 12, Climb Up Five StepsPar 2, Week 12, Walk Outdoors on Flat GroundPar 2, Day 113, Able to Do ChoresPar 2, Day 113, Get In and Out of a carPar 2, Day 113, Run Errands and ShopPar 2, Day 113, Get In and Out of BedPar 2, Day 113, Stand Up From a Straight ChairPar 2, Day 113, Dress yourselfPar 2, Day 113, Shampoo your hairPar 2, Day 113, Cut your meatPar 2, Day 113, Lift a Full Cup or Glass to MouthPar 2, Day 113, Open a New Milk CartonPar 2, Day 113, Open car doorsPar 2, Day 113, Open Jars Previously OpenedPar 2, Day 113, Turn Faucets On And OffPar 2, Day 113, Get On and Off The ToiletPar 2, Day 113, Take a Tub BathPar 2, Day 113, Wash and Dry Your BodyPar 2, Day 113, Bend Down Pick Up Clothing- FloorPar 2, Day 113, Reach-Get Down 5 Lb Obj Above HeadPar 2, Day 113, Climb Up Five StepsPar 2, Day 113, Walk Outdoors on Flat GroundPar 3, Day 65, Able to Do ChoresPar 3, Day 65, Get In and Out of a carPar 3, Day 65, Run Errands and ShopPar 3, Day 65, Get In and Out of BedPar 3, Day 65, Stand Up From a Straight ChairPar 3, Day 65, Dress yourselfPar 3, Day 65, Shampoo your hairPar 3, Day 65, Cut your meatPar 3, Day 65, Lift a Full Cup or Glass to MouthPar 3, Day 65, Open a New Milk CartonPar 3, Day 65, Open car doorsPar 3, Day 65, Open Jars Previously OpenedPar 3, Day 65, Turn Faucets On And OffPar 3, Day 65, Get On and Off The ToiletPar 3, Day 65, Take a Tub BathPar 3, Day 65, Wash and Dry Your BodyPar 3, Day 65, Bend Down Pick Up Clothing- FloorPar 3, Day 65, Reach-Get Down 5 Lb Obj Above HeadPar 3, Day 65, Climb Up Five StepsPar 3, Day 65, Walk Outdoors on Flat GroundPar 4, Week 12, Able to Do ChoresPar 4, Week 12, Get In and Out of a carPar 4, Week 12, Run Errands and ShopPar 4, Week 12, Get In and Out of BedPar 4, Week 12, Stand Up From a Straight ChairPar 4, Week 12, Dress yourselfPar 4, Week 12, Shampoo your hairPar 4, Week 12, Cut your meatPar 4, Week 12, Lift a Full Cup or Glass to MouthPar 4, Week 12, Open a New Milk CartonPar 4, Week 12, Open car doorsPar 4, Week 12, Open Jars Previously OpenedPar 4, Week 12, Turn Faucets On And OffPar 4, Week 12, Get On and Off The ToiletPar 4, Week 12,Take a Tub BathPar 4, Week 12, Wash and Dry Your BodyPar 4, Week 12, Bend Down Pick Up Clothing- FloorPar 4, Week 12, Reach-Get Down 5 Lb Obj Above HeadPar 4, Week 12, Climb Up Five StepsPar 4, Week 12, Walk Outdoors on Flat GroundPar 4, Day 373, Able to Do ChoresPar 4, Day 373, Get In and Out of a carPar 4, Day 373, Run Errands and ShopPar 4, Day 373, Get In and Out of BedPar 4, Day 373, Stand Up From a Straight ChairPar 4, Day 373, Dress yourselfPar 4, Day 373, Shampoo your hairPar 4, Day 373, Cut your meatPar 4, Day 373, Lift a Full Cup or Glass to MouthPar 4, Day 373, Open a New Milk CartonPar 4, Day 373, Open car doorsPar 4, Day 373, Open Jars Previously OpenedPar 4, Day 373, Turn Faucets On And OffPar 4, Day 373, Get On and Off The ToiletPar 4, Day 373,Take a Tub BathPar 4, Day 373, Wash and Dry Your BodyPar 4, Day 373, Bend Down Pick Up Clothing- FloorPar 4, Day 373, Reach-Get Down 5 Lb Obj Above HeadPar 4, Day 373, Climb Up Five StepsPar 4, Day 373, Walk Outdoors on Flat GroundPar 5, Day 64, Able to Do ChoresPar 5, Day 64, Get In and Out of a carPar 5, Day 64, Run Errands and ShopPar 5, Day 64, Get In and Out of BedPar 5, Day 64, Stand Up From a Straight ChairPar 5, Day 64, Dress yourselfPar 5, Day 64, Shampoo your hairPar 5, Day 64, Cut your meatPar 5, Day 64, Lift a Full Cup or Glass to MouthPar 5, Day 64, Open a New Milk CartonPar 5, Day 64, Open car doorsPar 5, Day 64, Open Jars Previously OpenedPar 5, Day 64, Turn Faucets On And OffPar 5, Day 64, Get On and Off The ToiletPar 5, Day 64,Take a Tub BathPar 5, Day 64, Wash and Dry Your BodyPar 5, Day 64, Bend Down Pick Up Clothing- FloorPar 5, Day 64, Reach-Get Down 5 Lb Obj Above HeadPar 5, Day 64, Climb Up Five StepsPar 5, Day 64, Walk Outdoors on Flat GroundPar 6, Day 85 Able to Do ChoresPar 6, Day 85, Get In and Out of a carPar 6, Day 85, Run Errands and ShopPar 6, Day 85, Get In and Out of BedPar 6, Day 85, Stand Up From a Straight ChairPar 6, Day 85, Dress yourselfPar 6, Day 85,Shampoo your hairPar 6, Day 85, Cut your meatPar 6, Day 85, Lift a Full Cup or Glass to MouthPar 6, Day 85, Open a New Milk CartonPar 6, Day 85, Open car doorsPar 6, Day 85, Open Jars Previously OpenedPar 6, Day 85, Turn Faucets On And OffPar 6, Day 85, Get On and Off The ToiletPar 6, Day 85,Take a Tub BathPar 6, Day 85, Wash and Dry Your BodyPar 6, Day 85, Bend Down Pick Up Clothing- FloorPar 6, Day 85, Reach-Get Down 5 Lb Obj Above HeadPar 6, Day 85, Climb Up Five StepsPar 6, Day 85, Walk Outdoors on Flat GroundPar 7, Day 169, Able to Do ChoresPar 7, Day 169, Get In and Out of a carPar 7, Day 169, Run Errands and ShopPar 7, Day 169, Get In and Out of BedPar 7, Day 169, Stand Up From a Straight ChairPar 7, Day 169, Dress yourselfPar 7, Day 169,Shampoo your hairPar 7, Day 169, Cut your meatPar 7, Day 169, Lift a Full Cup or Glass to MouthPar 7, Day 169, Open a New Milk CartonPar 7, Day 169, Open car doorsPar 7, Day 169, Open Jars Previously OpenedPar 7, Day 169, Turn Faucets On And OffPar 7, Day 169, Get On and Off The ToiletPar 7, Day 169,Take a Tub BathPar 7, Day 169, Wash and Dry Your BodyPar 7, Day 169, Bend Down Pick Up Clothing- FloorPar 7, Day 169, Reach-Get Down 5 Lb Obj Above HeadPar 7, Day 169, Climb Up Five StepsPar 7, Day 169, Walk Outdoors on Flat GroundPar 8, Week 12, Able to Do ChoresPar 8, Week 12, Get In and Out of a carPar 8, Week 12, Run Errands and ShopPar 8, Week 12, Get In and Out of BedPar 8, Week 12, Stand Up From a Straight ChairPar 8, Week 12, Dress yourselfPar 8, Week 12,Shampoo your hairPar 8, Week 12, Cut your meatPar 8, Week 12, Lift a Full Cup or Glass to MouthPar 8, Week 12, Open a New Milk CartonPar 8, Week 12, Open car doorsPar 8, Week 12, Open Jars Previously OpenedPar 8, Week 12, Turn Faucets On And OffPar 8, Week 12, Get On and Off The ToiletPar 8, Week 12,Take a Tub BathPar 8, Week 12, Wash and Dry Your BodyPar 8, Week 12, Bend Down Pick Up Clothing- FloorPar 8, Week 12 Reach-Get Down 5 Lb Obj Above HeadPar 8, Week 12, Climb Up Five StepsPar 8, Week 12, Walk Outdoors on Flat GroundPar 8, Day 112, Able to Do ChoresPar 8, Day 112, Get In and Out of a carPar 8, Day 112, Run Errands and ShopPar 8, Day 112, Get In and Out of BedPar 8, Day 112, Stand Up From a Straight ChairPar 8, Day 112, Dress yourselfPar 8, Day 112, Shampoo your hairPar 8, Day 112, Cut your meatPar 8, Day 112, Lift a Full Cup or Glass to MoutPar 8, Day 112, Open a New Milk CartonPar 8, Day 112, Open car doorsPar 8, Day 112, Open Jars Previously OpenedPar 8, Day 112, Turn Faucets On And OffPar 8, Day 112, Get On and Off The ToiletPar 8, Day 112, Take a Tub BathPar 8, Day 112, Wash and Dry Your BodyPar 8, Day 112, Bend Down Pick Up Clothing- FloorPar 8, Day 112, Reach-Get Down 5 Lb Obj Above HeadPar 8, Day 112, Climb Up Five StepsPar 8, Day 112, Walk Outdoors on Flat Ground
PartB:Placebo SC q2w + 12 Month PrednisoneNANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA0000000000000000000000000000000000000000
PartB:Placebo SC q2w + 6 Month PrednisoneNANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA00000000000000000000NANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA
PartB:SIR 100 mg SC q2w+3 Month PrednisoneNANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA000000000000000000000000000000000000000000000100000000001111NANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA
PartB:SIR 100 mg SC q2w+6 Month Prednisone00000000000000000000000000000000000011000100100000000000010000011000000000000100NANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA
PartB:SIR 50 mg SC q4w+6 Month PrednisoneNANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA10000000000100100000NANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA

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Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B

"Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing no difficulty (0), some difficulty (1), much difficulty (2), and unable to do (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability" (NCT02531633)
Timeframe: Day 87, 339, 344, Week 12, 24

,,
InterventionScores on scale (Number)
Par 1, Week 12, Able to Do ChoresPar 1, Week 12, Get In and Out of a carPar 1, Week 12, Run Errands and ShopPar 1, Week 12, Get In and Out of BedPar 1, Week 12, Stand Up From a StraightPar 1, Week 12, Dress yourselfPar 1, Week 12, Shampoo your hairPar 1, Week 12, Cut your meatPar 1, Week 12, Lift a Full Cup/Glass to mouthPar 1, Week 12, Open a New Milk CartonPar 1, Week 12, Open car doorsPar 1, Week 12, Open Jars Previously OpenedPar 1, Week 12, Turn Faucets On And OffPar 1, Week 12, Get On and Off The ToiletPar 1, Week 12, Take a Tub BathPar 1, Week 12, Wash and Dry Your BodyPar 1, Week 12, Bend Down Pick Up Clothing-FloorPar 1, Week 12, Reach-Get Down 5 Lb Obj Above HeadPar 1, Week 12, Climb Up Five StepsPar 1, Week 12, Walk Outdoors on Flat GroundPar 1, Week 24, Able to Do ChoresPar 1, Week 24, Get In and Out of a carPar 1, Week 24, Run Errands and ShopPar 1, Week 24, Get In and Out of BedPar 1, Week 24, Stand Up From a StraightPar 1, Week 24, Dress yourselfPar 1, Week 24, Shampoo your hairPar 1, Week 24, Cut your meatPar 1, Week 24, Lift a Full Cup/Glass to mouthPar 1, Week 24, Open a New Milk CartonPar 1, Week 24, Open car doorsPar 1, Week 24, Open Jars Previously OpenedPar 1, Week 24, Turn Faucets On And OffPar 1, Week 24, Get On and Off The ToiletPar 1, Week 24, Take a Tub BathPar 1, Week 24, Wash and Dry Your BodyPar 1, Week 24, Bend Down Pick Up Clothing-FloorPar 1, Week 24, Reach-Get Down 5 Lb Obj Above HeadPar 1, Week 24, Climb Up Five StepsPar 1, Week 24, Walk Outdoors on Flat GroundPar 1, Day 339, Able to Do ChoresPar 1, Day 339, Get In and Out of a carPar 1, Day 339, Run Errands and ShopPar 1, Day 339, Get In and Out of BedPar 1, Day 339, Stand Up From a StraightPar 1, Day 339, Dress yourselfPar 1, Day 339, Shampoo your hairPar 1, Day 339, Cut your meatPar 1, Day 339, Lift a Full Cup/Glass to mouthPar 1, Day 339, Open a New Milk CartonPar 1, Day 339, Open car doorsPar 1, Day 339, Open Jars Previously OpenedPar 1, Day 339, Turn Faucets On And OffPar 1, Day 339, Get On and Off The ToiletPar 1, Day 339, Take a Tub BathPar 1, Day 339, Wash and Dry Your BodyPar 1, Day 339, Bend Down Pick Up Clothing-FloorPar 1, Day 339, Reach-Get Down 5 Lb Obj Above HeadPar 1, Day 339, Climb Up Five StepsPar 1, Day 339, Walk Outdoors on Flat GroundPar 2, Week 12, Able to Do ChoresPar 2, Week 12, Get In and Out of a carPar 2, Week 12, Run Errands and ShopPar 2, Week 12, Get In and Out of BedPar 2, Week 12, Stand Up From a StraightPar 2, Week 12, Dress yourselfPar 2, Week 12, Shampoo your hairPar 2, Week 12, Cut your meatPar 2, Week 12, Lift a Full Cup/Glass to mouthPar 2, Week 12, Open a New Milk CartonPar 2, Week 12, Open car doorsPar 2, Week 12, Open Jars Previously OpenedPar 2, Week 12, Turn Faucets On And OffPar 2, Week 12, Get On and Off The ToiletPar 2, Week 12, Take a Tub BathPar 2, Week 12, Wash and Dry Your BodyPar 2, Week 12, Bend Down Pick Up Clothing-FloorPar 2, Week 12, Reach-Get Down 5 Lb Obj Above HeadPar 2, Week 12, Climb Up Five StepsPar 2, Week 12, Walk Outdoors on Flat GroundPar 2, Week 24, Able to Do ChoresPar 2, Week 24, Get In and Out of a carPar 2, Week 24, Run Errands and ShopPar 2, Week 24, Get In and Out of BedPar 2, Week 24, Stand Up From a StraightPar 2, Week 24, Dress yourselfPar 2, Week 24, Shampoo your hairPar 2, Week 24, Cut your meatPar 2, Week 24, Lift a Full Cup/Glass to mouthPar 2, Week 24, Open a New Milk CartonPar 2, Week 24, Open car doorsPar 2, Week 24, Open Jars Previously OpenedPar 2, Week 24, Turn Faucets On And OffPar 2, Week 24, Get On and Off The ToiletPar 2, Week 24, Take a Tub BathPar 2, Week 24, Wash and Dry Your BodyPar 2, Week 24, Bend Down Pick Up Clothing-FloorPar 2, Week 24, Reach-Get Down 5 Lb Obj Above HeadPar 2, Week 24, Climb Up Five StepsPar 2, Week 24, Walk Outdoors on Flat GroundPar 2, Day 344, Able to Do ChoresPar 2, Day 344, Get In and Out of a carPar 2, Day 344, Run Errands and ShopPar 2, Day 344, Get In and Out of BedPar 2, Day 344, Stand Up From a StraightPar 2, Day 344, Dress yourselfPar 2, Day 344, Shampoo your hairPar 2, Day 344, Cut your meatPar 2, Day 344, Lift a Full Cup/Glass to mouthPar 2, Day 344, Open a New Milk CartonPar 2, Day 344, Open car doorsPar 2, Day 344,Open Jars Previously OpenedPar 2, Day 344, Turn Faucets On And OffPar 2, Day 344, Get On and Off The ToiletPar 2, Day 344, Take a Tub BathPar 2, Day 344, Wash and Dry Your BodyPar 2, Day 344, Bend Down Pick Up Clothing-FloorPar 2, Day 344, Reach-Get Down 5 Lb Obj Above HeadPar 2, Day 344, Climb Up Five StepsPar 2, Day 344, Walk Outdoors on Flat GroundPar 3, Week 12, Able to Do ChoresPar 3, Week 12, Get In and Out of a carPar 3, Week 12, Run Errands and ShopPar 3, Week 12, Get In and Out of BedPar 3, Week 12, Stand Up From a StraightPar 3, Week 12, Dress yourselfPar 3, Week 12, Shampoo your hairPar 3, Week 12, Cut your meatPar 3, Week 12, Lift a Full Cup/Glass to mouthPar 3, Week 12, Open a New Milk CartonPar 3, Week 12, Open car doorsPar 3, Week 12, Open Jars Previously OpenedPar 3, Week 12, Turn Faucets On And OffPar 3, Week 12, Get On and Off The ToiletPar 3, Week 12, Take a Tub BathPar 3, Week 12, Wash and Dry Your BodyPar 3, Week 12, Bend Down Pick Up Clothing-FloorPar 3, Week 12, Reach-Get Down 5 Lb Obj Above HeadPar 3, Week 12, Climb Up Five StepsPar 3, Week 12, Walk Outdoors on Flat GroundPar 4, Day 87, Able to Do ChoresPar 4, Day 87, Get In and Out of a carPar 4, Day 87, Run Errands and ShopPar 4, Day 87, Get In and Out of BedPar 4, Day 87, Stand Up From a StraightPar 4, Day 87, Dress yourselfPar 4, Day 87, Shampoo your hairPar 4, Day 87, Cut your meatPar 4, Day 87, Lift a Full Cup/Glass to mouthPar 4, Day 87, Open a New Milk CartonPar 4, Day 87, Open Jars Previously OpenedPar 4, Day 87, Turn Faucets On And OffPar 4, Day 87, Get On and Off The ToiletPar 4, Day 87, Take a Tub BathPar 4, Day 87, Wash and Dry Your BodyPar 4, Day 87, Bend Down Pick Up Clothing-FloorPar 4, Day 87, Reach-Get Down 5 Lb Obj Above HeadPar 4, Day 87, Climb Up Five StepsPar 4, Day 87, Walk Outdoors on Flat Ground
PartB:Placebo SC q2w + 12 Month PrednisoneNANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA1000000000000010100
PartB:SIR 100 mg SC q2w+6 Month Prednisone100011000101103011000000000000011030000000000000010000300000100000000100003012000000000000000000010010000000010000300100NANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA
PartB:SIR 50 mg SC q4w+6 Month PrednisoneNANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA00000000000000000000NANANANANANANANANANANANANANANANANANANA

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Part B: Number of Disease Flares Over Time

This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants. Data for number of disease flares per participant over time for part B were presented. (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionDisease flares (Number)
Week 2, n=1,1,0,1,2Week 4, n=5,4,4,3,4Week 8, n=4,2,3,2,3Week 12, n=3,2,2,2,1
PartB:Placebo SC q2w + 12 Month Prednisone0000

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Part B: Number of Disease Flares Over Time

This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants. Data for number of disease flares per participant over time for part B were presented. (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionDisease flares (Number)
Week 4, n=5,4,4,3,4Week 8, n=4,2,3,2,3Week 12, n=3,2,2,2,1Week 16, n=2,1,1,2,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone0110

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Part B: Number of Disease Flares Over Time

This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants. Data for number of disease flares per participant over time for part B were presented. (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionDisease flares (Number)
Week 2, n=1,1,0,1,2Week 4, n=5,4,4,3,4Week 8, n=4,2,3,2,3Week 12, n=3,2,2,2,1Week 14, n=0,0,0,1,0Week 16, n=2,1,1,2,0
PartB:Placebo SC q2w + 6 Month Prednisone000011

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Part B: Number of Disease Flares Over Time

This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants. Data for number of disease flares per participant over time for part B were presented. (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionDisease flares (Number)
Week 2, n=1,1,0,1,2Week 4, n=5,4,4,3,4Week 8, n=4,2,3,2,3Week 12, n=3,2,2,2,1Week 16, n=2,1,1,2,0Week 24, n=2,1,0,0,0Week 36, n=2,1,0,0,0
PartB:SIR 100 mg SC q2w+3 Month Prednisone0000000

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Part B: Number of Disease Flares Over Time

This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants. Data for number of disease flares per participant over time for part B were presented. (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionDisease flares (Number)
Week 2, n=1,1,0,1,2Week 4, n=5,4,4,3,4Week 8, n=4,2,3,2,3Week 12, n=3,2,2,2,1Week 16, n=2,1,1,2,0Week 24, n=2,1,0,0,0Week 36, n=2,1,0,0,0Week 38, n=1,0,0,0,0Week 40, n=1,0,0,0,0
PartB:SIR 100 mg SC q2w+6 Month Prednisone000000022

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Part B: Number of Participants in Sustained Remission Over Time

Sustained remission was defined as having achieved all of the following: 1) remission at Week 12 (absence of signs and symptoms of GCA and normalization of ESR and CRP), 2) absence of disease flare Week 12 through Week 52 with or without elevations in ESR and/or CRP, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR [<30millimeters per hour] and CRP [<1milligram/deciliter]) and Flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission over time for Part B is presented. Only participants who were in sustained remission at Week 52 of Part A, who Completed the Week X Visit of Part B or who Withdraw before 10th of October 2017 were included in the analysis. (NCT02531633)
Timeframe: Weeks 4, 8 and 12

InterventionParticipants (Count of Participants)
Week 4,n=1,1,1,0,0
PartB:SIR 100 mg SC q2w+3 Month Prednisone1

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Part B: Number of Participants in Sustained Remission Over Time

Sustained remission was defined as having achieved all of the following: 1) remission at Week 12 (absence of signs and symptoms of GCA and normalization of ESR and CRP), 2) absence of disease flare Week 12 through Week 52 with or without elevations in ESR and/or CRP, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR [<30millimeters per hour] and CRP [<1milligram/deciliter]) and Flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission over time for Part B is presented. Only participants who were in sustained remission at Week 52 of Part A, who Completed the Week X Visit of Part B or who Withdraw before 10th of October 2017 were included in the analysis. (NCT02531633)
Timeframe: Weeks 4, 8 and 12

InterventionParticipants (Count of Participants)
Week 4,n=1,1,1,0,0Week 8,n=1,0,1,0,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone11

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Part B: Number of Participants in Sustained Remission Over Time

Sustained remission was defined as having achieved all of the following: 1) remission at Week 12 (absence of signs and symptoms of GCA and normalization of ESR and CRP), 2) absence of disease flare Week 12 through Week 52 with or without elevations in ESR and/or CRP, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR [<30millimeters per hour] and CRP [<1milligram/deciliter]) and Flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission over time for Part B is presented. Only participants who were in sustained remission at Week 52 of Part A, who Completed the Week X Visit of Part B or who Withdraw before 10th of October 2017 were included in the analysis. (NCT02531633)
Timeframe: Weeks 4, 8 and 12

InterventionParticipants (Count of Participants)
Week 4,n=1,1,1,0,0Week 8,n=1,0,1,0,0Week 12,n=1,0,0,0,0
PartB:SIR 100 mg SC q2w+6 Month Prednisone111

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Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B

Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category. (NCT02531633)
Timeframe: Baseline (Day 1)

,,,,
InterventionParticipants (Number)
Par 1, Day 1: No changePar 2, Day 1: Much BetterPar 3, Day 1: Much BetterPar 4, Day 1: Much BetterPar 5, Day 1: BetterPar 6, Day 1: Much BetterPar 7, Day 1: Much BetterPar 8, Day 1: BetterPar 9, Day 1: Much BetterPar 10, Day 1: BetterPar 11, Day 1: Much BetterPar 12, Day 1: Much BetterPar 13, Day 1: BetterPar 14, Day 1: BetterPar 15, Day 1: Much BetterPar 16, Day 1: Much BetterPar 17, Day 1: Much BetterPar 18, Day 1: Much Better
PartB:Placebo SC q2w + 12 Month PrednisoneNANANANANANANANANANANANANANANANA11
PartB:Placebo SC q2w + 6 Month PrednisoneNANANANANANANANANANANANANA111NANA
PartB:SIR 100 mg SC q2w+3 Month PrednisoneNANANANANANA1111NANANANANANANANA
PartB:SIR 100 mg SC q2w+6 Month Prednisone111111NANANANANANANANANANANANA
PartB:SIR 50 mg SC q4w+6 Month PrednisoneNANANANANANANANANANA111NANANANANA

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Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B

Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category. (NCT02531633)
Timeframe: Baseline (Day 1), Days 103 and 271

,,,,
InterventionParticipants (Number)
Par 1, Day 1: Much BetterPar 2, Day 1: Much BetterPar 2, Day 271: WorsePar 3, Day 1: Much BetterPar 4, Day 1: Much BetterPar 5,Day 1: Slightly BetterPar 5, Day 103: No changePar 6, Day 1: BetterPar 7, Day 1: Much BetterPar 8, Day 1: Slightly Better
PartB:Placebo SC q2w + 12 Month PrednisoneNANANANANANANANA11
PartB:Placebo SC q2w + 6 Month PrednisoneNANANANANA111NANA
PartB:SIR 100 mg SC q2w+3 Month PrednisoneNANANA1NANANANANANA
PartB:SIR 100 mg SC q2w+6 Month Prednisone111NANANANANANANA
PartB:SIR 50 mg SC q4w+6 Month PrednisoneNANANANA1NANANANANA

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Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B

Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionMilligram per liter (mg/L) (Mean)
Week 2, n=1,1,0,1,2Week 4, n=2,1,1,2,2Week 8, n=2,1,1,2,1Week 12, n=2,1,1,1,0Week 16, n=2,0,0,1,0Week 24, n=2,0,0,0,0Week 36, n=2,0,0,0,0Week 38, n=1,0,0,0,0Week 40, n=1,0,0,0,0
PartB:SIR 100 mg SC q2w+6 Month Prednisone0.000.100.100.100.401.900.80-0.100.00

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Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B

Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionMilligram per liter (mg/L) (Mean)
Week 2, n=1,1,0,1,2Week 4, n=2,1,1,2,2Week 8, n=2,1,1,2,1Week 12, n=2,1,1,1,0Week 14, n=0,0,0,1,0Week 16, n=2,0,0,1,0
PartB:Placebo SC q2w + 6 Month Prednisone-3.70-2.350.553.90-30.20-30.70

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Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B

Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionMilligram per liter (mg/L) (Mean)
Week 2, n=1,1,0,1,2Week 4, n=2,1,1,2,2Week 8, n=2,1,1,2,1Week 12, n=2,1,1,1,0
PartB:SIR 100 mg SC q2w+3 Month Prednisone-0.200.10-0.10-0.10

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Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B

Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionMilligram per liter (mg/L) (Mean)
Week 4, n=2,1,1,2,2Week 8, n=2,1,1,2,1Week 12, n=2,1,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone0.100.300.10

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Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B

Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionMilligram per liter (mg/L) (Mean)
Week 2, n=1,1,0,1,2Week 4, n=2,1,1,2,2Week 8, n=2,1,1,2,1
PartB:Placebo SC q2w + 12 Month Prednisone-4.20-4.20-2.10

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Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B

Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36

Interventionmg/L (Mean)
Week 4, n=3,3,2,1,2Week 8, n=2,1,2,0,2Week 12, n=1,1,1,1,1Week 16, n=0,1,1,1,0Week 24, n=0,1,0,0,0Week 36, n=0,1,0,0,0
PartB:SIR 100 mg SC q2w+3 Month Prednisone-0.230.000.000.000.000.00

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Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B

EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score). Baseline was last measurement done up to and including Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0) and Day 29, 30, 57, 59, 64, 65, 85, 112, 113,163,169 and 373, Week 12

,,,,
InterventionScores on scale (Number)
Par 1, Day 30Par 2, Day 29Par 3, Day 29Par 4, Week 12Par 4, Day 113Par 5, Day 85Par 6, Day 65Par 7, Week 12Par 7, Day 373Par 8, Day 64Par 9, Day 29Par 10, Day 57Par 11, Week 12Par 11, Day 163Par 12, Day 85Par 13, Day 59Par 14, Day 57Par 16, Day 169Par 17,Week 12Par 17, Day 112Par 18, Day 85
PartB:Placebo SC q2w + 12 Month PrednisoneNANANANANANANANANANANANANANANANANANA0.1630.163-0.042
PartB:Placebo SC q2w + 6 Month PrednisoneNANANANANANANANANANANANANANANANA0.0000.232NANANA
PartB:SIR 100 mg SC q2w+3 Month PrednisoneNANANANANANANA0.1630.163-0.0160.2120.000NANANANANANANANANA
PartB:SIR 100 mg SC q2w+6 Month Prednisone-0.2480.0000.2330.0000.000-0.0150.163NANANANANANANANANANANANANANA
PartB:SIR 50 mg SC q4w+6 Month PrednisoneNANANANANANANANANANANANA-0.0690.042-0.0590.000NANANANANA

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Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B

Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36

Interventionmm/h (Mean)
Week 4, n=3,3,3,1,2Week 12, n=1,1,1,1,1Week 16, n=0,1,1,1,0
PartB:Placebo SC q2w + 6 Month Prednisone8.0-6.0-4.0

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Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B

Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36

,
Interventionmm/h (Mean)
Week 4, n=3,3,3,1,2Week 8, n=2,1,3,0,2Week 12, n=1,1,1,1,1
PartB:Placebo SC q2w + 12 Month Prednisone-2.00.012.0
PartB:SIR 100 mg SC q2w+6 Month Prednisone-1.7-1.0-6.0

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Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B

Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36

Interventionmm/h (Mean)
Week 4, n=3,3,3,1,2Week 8, n=2,1,3,0,2Week 12, n=1,1,1,1,1Week 16, n=0,1,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone-1.0-2.00.01.0

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Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B

Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36

Interventionmm/h (Mean)
Week 4, n=3,3,3,1,2Week 8, n=2,1,3,0,2Week 12, n=1,1,1,1,1Week 16, n=0,1,1,1,0Week 24, n=0,1,0,0,0Week 36, n=0,1,0,0,0
PartB:SIR 100 mg SC q2w+3 Month Prednisone1.32.01.03.01.01.0

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Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B

Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionMillimeter per hour (mm/h) (Mean)
Week 4, n=2,1,1,2,2Week 12, n=2,1,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone4.04.0

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Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B

Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionMillimeter per hour (mm/h) (Mean)
Week 2, n=1,1,0,1,1Week 4, n=2,1,1,2,2Week 8, n=2,1,0,2,1
PartB:Placebo SC q2w + 12 Month Prednisone-7.0-29.5-7.0

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Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B

Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionMillimeter per hour (mm/h) (Mean)
Week 2, n=1,1,0,1,1Week 4, n=2,1,1,2,2Week 8, n=2,1,0,2,1Week 12, n=2,1,1,1,0
PartB:SIR 100 mg SC q2w+3 Month Prednisone4.04.02.02.0

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Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B

Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionMillimeter per hour (mm/h) (Mean)
Week 2, n=1,1,0,1,1Week 4, n=2,1,1,2,2Week 8, n=2,1,0,2,1Week 12, n=2,1,1,1,0Week 14, n=0,0,0,1,0Week 16, n=2,0,0,1,0
PartB:Placebo SC q2w + 6 Month Prednisone-14.0-5.0-6.010.0-19.0-18.0

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Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B

Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionMillimeter per hour (mm/h) (Mean)
Week 2, n=1,1,0,1,1Week 4, n=2,1,1,2,2Week 8, n=2,1,0,2,1Week 12, n=2,1,1,1,0Week 16, n=2,0,0,1,0Week 24, n=2,0,0,0,0Week 36, n=2,0,0,0,0Week 38, n=1,0,0,0,0Week 40, n=1,0,0,0,0
PartB:SIR 100 mg SC q2w+6 Month Prednisone-1.00.53.00.0-0.5-1.56.0-1.01.0

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Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B

The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported. (NCT02531633)
Timeframe: Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24

,,,,
InterventionScores on scale (Number)
Par 1, Day 30, I Feel FatiguedPar 2, Day 29, I Feel FatiguedPar 3, Day 23, I Feel FatiguedPar 4, Week 12, I Feel FatiguedPar 4, Day 113, I Feel FatiguedPar 5, Week 8, I Feel FatiguedPar 5, Day 85, I Feel FatiguedPar 6, Day 65, I Feel FatiguedPar 7, Week 12, I Feel FatiguedPar 7, Day 373, I Feel FatiguedPar 8, Day 64, I Feel FatiguedPar 9, Day 29, I Feel FatiguedPar 10, Day 57, I Feel FatiguedPar 11, Week 12, I Feel FatiguedPar 11, Day 163, I Feel FatiguedPar 12, Day 85, I Feel FatiguedPar 13, Day 59, I Feel FatiguedPar 14, Day 57, I Feel FatiguedPar 16, Day 169, I Feel FatiguedPar 17, Week 12, I Feel FatiguedPar 17, Day112, I Feel FatiguedPar 18, Day 85, I Feel Fatigued
PartB:Placebo SC q2w + 12 Month PrednisoneNANANANANANANANANANANANANANANANANANANA66-1
PartB:Placebo SC q2w + 6 Month PrednisoneNANANANANANANANANANANANANANANANANA-110NANANA
PartB:SIR 100 mg SC q2w+3 Month PrednisoneNANANANANANANANA05-3013NANANANANANANANANA
PartB:SIR 100 mg SC q2w+6 Month Prednisone-3-102-16-1-3-1NANANANANANANANANANANANANANA
PartB:SIR 50 mg SC q4w+6 Month PrednisoneNANANANANANANANANANANANANA56-17NANANANANA

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Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B

The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0) and Day 85,87,91,113,162, 344,339,Week 12, 24

,,,,
InterventionScores on scale (Number)
Par 1, Week 12, I Feel FatiguedPar 1, Week 24, I Feel FatiguedPar 1, Day 339, I Feel FatiguedPar 2, Week 12, I Feel FatiguedPar 2, Week 24, I Feel FatiguedPar 2, Day 344, I Feel FatiguedPar 3, Day 113, I Feel FatiguedPar 4, Week 12, I Feel FatiguedPar 5, Week 12, I Feel FatiguedPar 5, Day 162, I Feel FatiguedPar 6, Day 91, I Feel FatiguedPar 7, Day 85, I Feel FatiguedPar 8, Day 87, I Feel Fatigued
PartB:Placebo SC q2w + 12 Month PrednisoneNANANANANANANANANANANA-7-10
PartB:Placebo SC q2w + 6 Month PrednisoneNANANANANANANANA-5-4-12NANA
PartB:SIR 100 mg SC q2w+3 Month PrednisoneNANANANANANA2NANANANANANA
PartB:SIR 100 mg SC q2w+6 Month Prednisone-3-43826NANANANANANANA
PartB:SIR 50 mg SC q4w+6 Month PrednisoneNANANANANANANA2NANANANANA

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Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionFemtoliter (Mean)
Week 4,n=3,3,2,1,2Week 12,n=1,1,1,1,1Week 16,n=0,1,1,1,0
PartB:Placebo SC q2w + 6 Month Prednisone-3.01.02.0

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Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

,
InterventionFemtoliter (Mean)
Week 4,n=3,3,2,1,2Week 8,n=2,1,2,0,2Week 12,n=1,1,1,1,1
PartB:Placebo SC q2w + 12 Month Prednisone2.01.52.0
PartB:SIR 100 mg SC q2w+6 Month Prednisone0.7-0.50.0

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Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time

Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category. (NCT02531633)
Timeframe: Weeks 12, 24 and 52

,,,,
InterventionParticipants (Count of Participants)
Week 12,Much Better, n=31,28,24,22,22Week 12,Better, n=31,28,24,22,22Week 12, Slightly Better, n=31,28,24,22,22Week 12,No Change, n=31,28,24,22,22Week 12,Slightly Worse, n=31,28,24,22,22Week 12,Worse, n=31,28,24,22,22Week 12,Much Worse, n=31,28,24,22,22Week 24,Much Better, n=23,20,15,17,16Week 24,Better, n=23,20,15,17,16Week 24, Slightly Better,n=23,20,15,17,16Week 24,No Change, n=23,20,15,17,16Week 24,Slightly Worse, n=23,20,15,17,16Week 24, Worse,n=23,20,15,17,16Week 24, Much Worse,n=23,20,15,17,16Week 52,Much Better, n=9,5,5,5,4Week 52,Better, n=9,5,5,5,4Week 52,Slightly Better, n=9,5,5,5,4Week 52,No Change, n=9,5,5,5,4Week 52,Slightly Worse, n=9,5,5,5,4Week 52,Worse, n=9,5,5,5,4Week 52,Much Worse, n=9,5,5,5,4
PartA:Placebo SC q2w + 12 Month Prednisone5113300066111103010000
PartA:Placebo SC q2w + 6 Month Prednisone548041056411002210000
PartA:SIR 100 mg SC q2w+3 Month Prednisone7105312068221103200000
PartA:SIR 100 mg SC q2w+6 Month Prednisone111133120117212006201000
PartA:SIR 50 mg SC q4w+6 Month Prednisone2114421064022103110000

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Part B: Number of Participants Who Remained in Sustained Remission Without Requirement for Rescue Therapy or Treatment Change at Week 24

Participants who remained in sustained remission without requirement for rescue therapy or treatment change at each scheduled visit of Part B were defined as participants having achieved all of the following criteria: 1. Participants in sustained remission at the Week 52 visit of Part A, 2. Absence of disease flare, 3. No requirement for rescue therapy at any time through Week 24 of Part B, 4. No requirement for treatment change at any time through Week 24 of Part B. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR [<30 millimeters per hour] and CRP [<1 milligram/deciliter]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. (NCT02531633)
Timeframe: Week 24

InterventionParticipants (Count of Participants)
PartB:SIR 100 mg SC q2w+6 Month PrednisoneNA
Part B:SIR 100 mg SC q2w+3 Month PrednisoneNA
PartB:SIR 50 mg SC q4w+6 Month PrednisoneNA

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Part B: Number of Participants Requiring at Least One Hospitalization for Disease Flare

"Number of participants with at least one flare at a given visit was the number of participants with at least one flare between first SC IP intake and the day of the given visit. The hospitalizations for disease flare were planned to be identified through the adjudication of adverse events of special interest, and include events from the category: Severe Flare including Hospitalizations. Data for participants requiring hospitalizations for disease flare for part B was not available due to early termination of study." (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionParticipants (Count of Participants)
PartB:SIR 100 mg SC q2w+6 Month Prednisone0
PartB:SIR 100 mg SC q2w+3 Month Prednisone0
PartB:SIR 50 mg SC q4w+6 Month Prednisone0
PartB:Placebo SC q2w + 6 Month Prednisone0
PartB:Placebo SC q2w + 12 Month Prednisone0

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Part B: Number of Hospitalizations for Disease Flare Over Time

"Number of participants with at least one flare at a given visit was the number of participants with at least one flare between first SC IP intake and the day of the given visit. The hospitalizations for disease flare were planned to be identified through the adjudication of adverse events of special interest, and include events from the category: Severe Flare including Hospitalizations. Data for participants requiring hospitalizations for disease flare for part B was not available due to early termination of study." (NCT02531633)
Timeframe: Up to Week 104

InterventionNumber of hospitalizations (Number)
PartB:SIR 100 mg SC q2w+6 Month Prednisone0
PartB:SIR 100 mg SC q2w+3 Month Prednisone0
PartB:SIR 50 mg SC q4w+6 Month Prednisone0
PartB:Placebo SC q2w + 6 Month Prednisone0
PartB:Placebo SC q2w + 12 Month Prednisone0

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Part A: Time to First Disease Flare After Clinical Remission

Clinical remission was defined as absence of clinical signs and symptoms of GCA, which was determined by a lack of flare for the participant. If a participant had a flare, they had one or more signs and symptoms, and therefore are not considered as being in clinical remission. Time to first disease flare (days) was calculated as (Date of First Flare - Date of Clinical Remission + 1 day). Data for Time to first disease flare after clinical remission for part A is presented. (NCT02531633)
Timeframe: Week 52

InterventionDays (Median)
PartA:SIR 100 mg SC q2w+6 Month PrednisoneNA
PartA:SIR 100 mg SC q2w+3 Month PrednisoneNA
PartA:SIR 50 mg SC q4w+6 Month PrednisoneNA
PartA:Placebo SC q2w + 6 Month PrednisoneNA
PartA:Placebo SC q2w + 12 Month PrednisoneNA

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Part B: Time to First Disease Flare for Participants in Sustained Remission

Clinical remission was defined as absence of clinical signs and symptoms of GCA. If a participant had a flare, they had one or more signs and symptoms, and therefore are not considered as being in clinical remission. Time to event (days) is defined as the duration in days from the date of the Week 52 visit of Part A to the start date of Event (Date of First Flare - Date of Week 52 visit of Part A + 1). Data for Time to first disease flare after clinical remission for part B is presented. (NCT02531633)
Timeframe: Week 52

InterventionDays (Median)
PartB:SIR 100 mg SC q2w+6 Month PrednisoneNA
PartB:SIR 100 mg SC q2w+3 Month PrednisoneNA
PartB:SIR 50 mg SC q4w+6 Month PrednisoneNA

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Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

SBP and DBP were measured in semi-supine position after 5 minutes rest at indicated time points. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Week 0), Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,,,
InterventionMillimeters of mercury (Mean)
SBP,Week 2,n=37,39,26,24,27SBP,Week 4,n=37,37,25,23,27SBP,Week 8,n=34,32,24,22,23SBP,Week 12,n=32,29,24,22,22SBP,Week 16,n=28,26,22,19,19SBP,Week 20,n=26,23,19,18,16SBP,Week 24,n=23,21,16,17,16SBP,Week 28,n=19,18,12,14,14SBP,Week 32,n=19,15,10,12,13SBP,Week 36,n=15,13,10,12,13SBP,Week 40,n=15,11,9,10,10SBP,Week 44,n=11,11,6,8,9SBP,Week 48,n=9,8,5,8,5SBP,Week 52,n=9,5,5,5,4DBP,Week 2,n=37,39,26,24,27DBP,Week 4,n=37,37,25,23,27DBP,Week 8,n=34,32,24,22,23DBP,Week 12,n=32,29,24,22,22DBP,Week 16,n=28,26,22,19,19DBP,Week 20,n=26,23,19,18,16DBP,Week 24,n=23,21,16,17,16DBP,Week 28,n=19,18,12,14,14DBP,Week 32,n=19,15,10,12,13DBP,Week 36,n=15,13,10,12,13DBP,Week 40,n=15,11,9,10,10DBP,Week 44,n=11,11,6,8,9DBP,Week 48,n=9,8,5,8,5DBP,Week 52,n=9,5,5,5,4
PartA:Placebo SC q2w + 12 Month Prednisone-0.9-3.4-8.3-6.1-6.4-9.4-8.6-2.6-8.8-2.5-7.41.84.8-3.8-2.2-3.0-5.6-2.5-3.4-2.1-3.1-1.9-5.8-2.7-6.11.30.60.5
PartA:Placebo SC q2w + 6 Month Prednisone5.7-2.2-0.81.41.9-1.7-2.66.43.4-0.62.12.98.82.22.40.12.61.3-1.3-2.0-3.30.1-1.2-1.2-2.0-1.5-3.41.4
PartA:SIR 100 mg SC q2w+3 Month Prednisone3.50.2-3.9-2.4-5.1-0.7-2.5-4.2-3.7-8.00.9-4.2-0.41.21.21.5-1.32.0-2.51.4-0.6-2.2-2.3-5.12.6-6.5-2.31.8
PartA:SIR 100 mg SC q2w+6 Month Prednisone-0.9-0.90.3-2.3-6.0-6.7-5.2-8.8-10.7-6.2-11.9-12.7-13.6-8.10.31.82.11.00.2-0.91.3-3.1-4.2-0.6-6.9-2.7-5.60.2
PartA:SIR 50 mg SC q4w+6 Month Prednisone-2.1-4.7-3.5-6.2-3.0-3.4-5.6-0.1-7.4-6.8-4.82.7-3.62.2-2.3-4.1-4.0-4.7-3.1-3.2-2.7-4.3-6.9-5.6-8.0-2.5-2.02.2

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Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea

Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea . Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,,,
InterventionMillimoles per liter (Mean)
calcium,Week 2,n=38,39,26,24,26calcium,Week 4,n=37,38,25,23,27calcium,Week 8,n=34,31,24,22,23calcium,Week 12,n=32,28,24,22,21calcium,Week 16,n=28,26,22,19,18calcium,Week 20,n=25,23,19,18,16calcium,Week 24,n=22,21,16,17,16calcium,Week 28,n=19,18,12,13,14calcium,Week 32,n=19,15,10,12,13calcium,Week 36,n=15,12,10,12,13calcium,Week 40,n=15,11,9,10,10calcium,Week 44,n=11,11,6,8,9calcium,Week 48,n=9,8,5,8,5calcium,Week 52,n=9,5,5,5,4Carbon Dioxide,Week 2,n=38,39,26,24,26Carbon Dioxide,Week 4,n=37,38,25,23,27Carbon Dioxide,Week 8,n=34,31,24,22,23Carbon Dioxide,Week 12,n=32,28,24,22,21Carbon Dioxide,Week 16,n=28,26,22,19,18Carbon Dioxide,Week 20,n=25,23,19,18,16Carbon Dioxide,Week 24,n=22,21,16,17,16Carbon Dioxide,Week 28,n=19,18,12,13,14Carbon Dioxide,Week 32,n=19,15,10,12,13Carbon Dioxide,Week 36,n=15,12,10,12,13Carbon Dioxide,Week 40,n=15,11,6,10,10Carbon Dioxide,Week 44,n=11,11,6,8,9Carbon Dioxide,Week 48,n=9,8,5,8,5Carbon Dioxide,Week 52,n=9,5,5,5,4Chloride,Week 2,n=38,39,26,24,26Chloride,Week 4,n=37,38,25,23,27Chloride,Week 8,n=34,31,24,22,23Chloride,Week 12,n=32,28,24,22,21Chloride,Week 16,n=28,26,22,19,18Chloride,Week 20,n=25,23,19,18,16Chloride,Week 24,n=22,21,16,17,16Chloride,Week 28,n=19,18,12,13,14Chloride,Week 32,n=19,15,10,12,13Chloride,Week 36,n=15,12,10,12,13Chloride,Week 40,n=15,11,9,10,10Chloride,Week 44,n=11,11,6,8,9Chloride,Week 48,n=9,8,5,8,5Chloride,Week 52,n=9,5,5,5,4Glucose,Week 2,n=38,39,26,24,26Glucose,Week 4,n=37,38,25,23,27Glucose,Week 8,n=34,31,24,22,23Glucose,Week 12,n=32,28,24,22,21Glucose,Week 16,n=28,26,22,19,18Glucose,Week 20,n=25,23,19,18,16Glucose,Week 24,n=22,21,16,17,16Glucose,Week 28,n=19,18,12,13,14Glucose,Week 32,n=19,15,10,12,13Glucose,Week 36,n=15,12,10,12,13Glucose,Week 40,n=15,11,9,10,10Glucose,Week 44,n=11,11,6,8,9Glucose,Week 48,n=9,8,5,8,5Glucose,Week 52,n=9,5,5,5,4Phosphate,Week 2,n=38,39,26,24,26Phosphate,Week 4,n=37,38,25,23,27Phosphate,Week 8,n=34,31,24,22,23Phosphate,Week 12,n=32,28,24,22,21Phosphate,Week 16,n=28,26,22,19,18Phosphate,Week 20,n=25,23,19,18,16Phosphate,Week 24,n=22,21,16,17,16Phosphate,Week 28,n=19,18,12,13,14Phosphate,Week 32,n=19,15,10,12,13Phosphate,Week 36,n=15,12,10,12,13Phosphate,Week 40,n=15,11,6,10,10Phosphate,Week 44,n=11,11,6,8,9Phosphate,Week 48,n=9,8,5,8,5Phosphate,Week 52,n=9,5,5,5,4Potassium,Week 2,n=38,39,26,24,26Potassium,Week 4,n=37,38,25,23,27Potassium,Week 8,n=34,31,24,22,23Potassium,Week 12,n=32,28,24,22,21Potassium,Week 16,n=28,26,22,19,18Potassium,Week 20,n=25,23,19,18,16Potassium,Week 24,n=22,21,16,17,16Potassium,Week 28,n=19,18,12,13,14Potassium,Week 32,n=19,15,10,12,13Potassium,Week 36,n=15,12,10,12,13Potassium,Week 40,n=15,11,9,10,10Potassium,Week 44,n=11,11,6,8,9Potassium,Week 48,n=9,8,5,8,5Potassium,Week 52,n=9,5,5,5,4Sodium,Week 2,n=38,39,26,24,26Sodium,Week 4,n=37,38,25,23,27Sodium,Week 8,n=34,31,24,22,23Sodium,Week 12,n=32,28,24,22,21Sodium,Week 16,n=28,26,22,19,18Sodium,Week 20,n=25,23,19,18,16Sodium,Week 24,n=22,21,16,17,16Sodium,Week 28,n=19,18,12,13,14Sodium,Week 32,n=19,15,10,12,13Sodium,Week 36,n=15,12,10,12,13Sodium,Week 40,n=15,11,9,10,10Sodium,Week 44,n=11,11,6,8,9Sodium,Week 48,n=9,8,5,8,5Sodium,Week 52,n=9,5,5,5,4Urea,Week 2,n=38,39,26,24,26Urea,Week 4,n=37,38,25,23,27Urea,Week 8,n=34,31,24,22,23Urea,Week 12,n=32,28,24,22,21Urea,Week 16,n=28,26,22,19,18Urea,Week 20,n=25,23,19,18,16Urea,Week 24,n=22,21,16,17,16Urea,Week 28,n=19,18,12,13,14Urea,Week 32,n=19,15,10,12,13Urea,Week 36,n=15,12,10,12,13Urea,Week 40,n=15,11,9,10,10Urea,Week 44,n=11,11,6,8,9Urea,Week 48,n=9,8,5,8,5Urea,Week 52,n=9,5,5,5,4
PartA:Placebo SC q2w + 12 Month Prednisone0.013-0.0010.0130.0160.0440.0120.0090.0760.0750.0530.0370.0540.1420.0830.70.11.11.20.50.5-0.20.40.21.00.4-0.1-0.21.80.81.42.12.02.42.52.32.93.42.83.92.22.83.8-0.44-0.03-1.15-1.76-1.15-1.96-2.08-2.05-3.12-2.98-0.94-0.23-0.360.450.0050.0080.0550.0790.0390.0600.1010.1900.1550.1510.2060.2180.1320.1150.08-0.030.060.040.150.160.160.230.250.210.280.160.520.200.90.61.72.12.32.31.92.43.22.82.91.81.63.5-0.32-0.27-0.34-0.35-0.07-0.77-0.64-0.310.17-0.220.32-1.090.44-0.45
PartA:Placebo SC q2w + 6 Month Prednisone0.008-0.0160.0200.011-0.0080.000-0.0020.018-0.008-0.038-0.042-0.035-0.035-0.056-0.30.20.00.0-0.1-0.30.5-0.4-0.6-0.3-0.8-1.60.0-0.41.00.71.00.61.11.31.00.2-0.11.11.91.11.83.60.290.310.10-0.25-0.12-0.33-0.38-0.25-0.05-0.50-0.220.30-0.88-0.72-0.0250.0060.0450.0670.0250.0430.0550.0730.0480.0980.073-0.065-0.0150.0360.180.060.100.060.150.100.150.080.190.180.030.150.160.06-0.20.00.50.5-0.3-0.60.4-0.8-0.8-0.20.5-0.80.31.6-0.31-0.22-0.91-1.12-0.40-0.31-0.650.23-0.76-0.01-0.76-0.76-0.51-0.82
PartA:SIR 100 mg SC q2w+3 Month Prednisone0.0060.0080.0490.0720.0500.0700.0640.0660.0440.0550.0160.0250.0280.0760.60.20.30.60.5-0.10.40.40.80.30.91.60.51.20.61.62.41.82.32.02.72.81.92.43.63.42.12.2-0.46-0.35-0.58-0.630.33-0.46-0.44-0.32-0.48-0.35-0.33-0.05-0.93-0.94-0.004-0.0110.0910.1540.1390.1600.1630.0900.1010.068-0.0070.025-0.054-0.036-0.03-0.040.050.150.030.07-0.010.070.01-0.07-0.03-0.130.06-0.160.00.40.90.50.60.61.01.2-0.30.61.20.40.80.4-0.16-0.61-0.99-1.20-0.52-0.70-0.22-0.42-0.64-1.43-0.78-1.05-1.58-1.22
PartA:SIR 100 mg SC q2w+6 Month Prednisone0.0020.0090.0320.0190.0090.0180.0080.0060.0290.0160.0770.042-0.0070.0130.70.10.10.10.10.10.4-1.6-1.0-1.1-1.5-1.7-2.6-1.11.11.82.52.93.03.33.43.93.43.83.33.84.64.8-0.03-0.10-0.29-0.64-0.71-0.66-0.72-0.91-0.74-1.14-0.99-1.39-1.39-1.510.0560.0710.0880.1220.1130.0700.1320.1560.1640.1110.2210.1420.0290.0490.03-0.130.01-0.120.010.040.050.120.160.160.240.160.210.220.30.71.11.81.01.00.90.90.70.50.10.5-0.30.70.05-0.09-0.36-0.65-0.56-0.30-0.48-0.45-0.160.06-0.17-0.46-0.18-0.26
PartA:SIR 50 mg SC q4w+6 Month Prednisone-0.0080.0130.005-0.0010.0180.0320.0320.0540.0590.0750.008-0.002-0.0180.0260.50.40.0-0.40.8-0.1-0.8-1.0-1.4-0.9-1.70.0-1.0-1.20.71.42.02.42.22.11.62.82.01.91.40.22.00.20.010.38-0.12-0.33-0.290.46-0.230.580.720.050.22-0.27-0.62-0.260.0170.0930.1120.1900.1460.1410.1810.1910.2140.3040.1040.0900.0280.208-0.02-0.10-0.11-0.10-0.020.02-0.130.170.170.180.01-0.13-0.04-0.10-0.80.20.10.6-0.2-0.3-0.40.5-0.2-0.4-1.2-2.0-0.6-0.80.28-0.06-0.40-0.62-0.72-0.70-0.80-0.73-0.83-0.93-0.98-0.63-0.06-0.76

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Part A: Number of Participants in Sustained Remission at Week 52

Sustained remission was defined as having achieved all of the following: 1) remission at Week 12, 2) absence of disease flare Week 12 through Week 52, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of erythrocyte sedimentation rate (ESR) [<30 millimeters per hour] and C-reactive Protein (CRP) [<1 milligram/deciliter]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission at Week 52 is presented. Only those participants who completed Week 52 visit or withdrew before 10 Oct 2017 were included in the analysis. (NCT02531633)
Timeframe: Week 52

InterventionParticipants (Count of Participants)
PartA:SIR 100 mg SC q2w+6 Month Prednisone3
PartA:SIR 100 mg SC q2w+3 Month Prednisone2
PartA:SIR 50 mg SC q4w+6 Month Prednisone1
PartA:Placebo SC q2w + 6 Month Prednisone0
PartA:Placebo SC q2w + 12 Month Prednisone0

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Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)

Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,,,
InterventionInternational units per liter (Mean)
ALT,Week 2,n=38,39,26,24,26ALT,Week 4,n=37,38,25,23,27ALT,Week 8,n=34,31,24,22,23ALT,Week 12,n=32,28,24,22,21ALT,Week 16,n=28,26,22,19,18ALT,Week 20,n=25,23,19,18,16ALT,Week 24,n=22,21,16,17,16ALT,Week 28,n=19,18,12,13,14ALT,Week 32,n=19,15,10,12,13ALT,Week 36,n=15,12,10,12,13ALT,Week 40,n=15,11,9,10,10ALT,Week 44,n=11,11,6,8,9ALT,Week 48,n=9,8,5,8,5ALT,Week 52,n=9,5,5,5,4ALP,Week 2,n=38,39,26,24,26ALP,Week 4,n=37,38,25,23,27ALP,Week 8,n=34,31,24,22,23ALP,Week 12,n=32,28,24,22,21ALP,Week 16,n=28,26,22,19,18ALP,Week 20,n=25,23,19,18,16ALP,Week 24,n=22,21,16,17,16ALP,Week 28,n=19,18,12,13,14ALP,Week 32,n=19,15,10,12,13ALP,Week 36,n=15,12,10,12,13ALP,Week 40,n=15,11,9,10,10ALP,Week 44,n=11,11,6,8,9ALP,Week 48,n=9,8,5,8,5ALP,Week 52,n=9,5,5,5,4AST,Week 2,n=38,39,26,24,26AST,Week 4,n=37,38,25,23,27AST,Week 8,n=34,31,24,22,23AST,Week 12,n=32,28,24,22,21AST,Week 16,n=28,26,22,19,18AST,Week 20,n=25,23,19,18,16AST,Week 24,n=22,21,16,17,16AST,Week 28,n=19,18,12,13,14AST,Week 32,n=19,15,10,12,13AST,Week 36,n=15,12,10,12,13AST,Week 40,n=15,11,9,10,10AST,Week 44,n=11,11,6,8,9AST,Week 48,n=9,8,5,8,5AST,Week 52,n=9,5,5,5,4
PartA:Placebo SC q2w + 12 Month Prednisone1.8-3.1-6.8-7.0-6.6-8.1-9.4-8.9-10.0-10.0-2.1-7.00.25.3-2.65.31.6-5.3-0.3-1.0-1.82.95.27.312.311.97.2-1.50.4-0.7-1.60.11.01.4-1.3-0.11.20.26.72.36.44.3
PartA:Placebo SC q2w + 6 Month Prednisone-0.6-1.2-2.8-3.3-3.52.3-2.8-1.9-2.0-2.80.1-0.4-3.5-4.4-3.0-2.22.96.61.15.96.91.6-2.3-1.8-0.22.81.51.0-0.3-1.00.10.50.24.30.61.10.61.34.73.51.3-0.2
PartA:SIR 100 mg SC q2w+3 Month Prednisone5.36.69.54.42.24.92.52.95.06.07.35.54.51.6-11.4-13.4-10.4-7.0-8.0-4.4-6.2-4.3-6.1-7.3-7.4-6.2-6.5-8.03.75.910.69.07.07.77.68.19.210.88.79.211.89.2
PartA:SIR 100 mg SC q2w+6 Month Prednisone8.26.66.04.74.116.18.36.76.68.75.31.82.31.3-9.3-15.5-16.8-19.2-18.2-14.4-16.3-17.6-15.9-20.3-14.5-19.4-24.4-26.06.15.46.47.68.514.69.89.08.810.68.98.18.17.1
PartA:SIR 50 mg SC q4w+6 Month Prednisone10.15.24.74.05.28.616.412.15.14.55.42.73.68.8-11.4-14.2-15.3-15.0-14.6-13.3-12.5-17.5-12.6-9.6-9.9-4.0-4.4-3.64.55.06.76.58.09.010.59.48.07.69.18.39.811.6

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Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B

EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score). Baseline was last measurement done up to and including Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0) and Day 85, Day 87, Day 91, Day 113, Day 162, Day 339, Day 344, Week 12 and Week24

,,,,
InterventionScores on scale (Number)
Par 1, Week 12Par 1, Week 24Par 1, Day 339Par 2, Week 12Par 2, Week 24Par 2, Day 344Par 3, Day 113Par 4, Week 12Par 5, Week 12Par 5, Day 162Par 6, Day 91Par 7, Day 85Par 8, Day 87
PartB:Placebo SC q2w + 12 Month PrednisoneNANANANANANANANANANANA0.0000.012
PartB:Placebo SC q2w + 6 Month PrednisoneNANANANANANANANA0.0280.0280.000NANA
PartB:SIR 100 mg SC q2w+3 Month PrednisoneNANANANANANA0.000NANANANANANA
PartB:SIR 100 mg SC q2w+6 Month Prednisone-0.127-0.098-0.0700.2040.0410.110NANANANANANANA
PartB:SIR 50 mg SC q4w+6 Month PrednisoneNANANANANANANA0.097NANANANANA

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Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B

EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 6 dimensions: 1.Mobility, 2.Self, 3.Usual Activities, 4.Pain/Discomfort, 5.Anxiety/Depression; 6.How good or or bad your health is today. Each of these 6 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 100 (Best imaginable health state) and 0 (Worst imaginable health state). Answers to 'How good or bad your health is today' were measured on a 100 point VAS scale. Baseline for Part B is the last non-missing measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0) and Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169, 344 and 373 and Week 12

,,,,
InterventionScores on scale (Number)
Par 1, Day 30Par 2, Day 29Par 3, Day 23Par 4, Week 12Par 4, Day 113Par 5, Day 85Par 6, Day 65Par 7, Week 12Par 7, Day 373Par 8, Day 64Par 9, Day 29Par 10, Day 57Par 11, Week 12Par 11, Day 163Par 12, Day 85Par 13, Day 59Par 14, Day 57Par 16, Day 169Par 17, Week 12Par 17, Day 112Par 18, Day 85
PartB:Placebo SC q2w + 12 Month PrednisoneNANANANANANANANANANANANANANANANANANA97-4
PartB:Placebo SC q2w + 6 Month PrednisoneNANANANANANANANANANANANANANANANA-4262NANANA
PartB:SIR 100 mg SC q2w+3 Month PrednisoneNANANANANANANA48-2-15NANANANANANANANANA
PartB:SIR 100 mg SC q2w+6 Month Prednisone201-2-47-120NANANANANANANANANANANANANANA
PartB:SIR 50 mg SC q4w+6 Month PrednisoneNANANANANANANANANANANANA-10-12-810NANANANANA

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Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B

EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 6 dimensions: 1.Mobility, 2.Self, 3.Usual Activities, 4.Pain/Discomfort, 5.Anxiety/Depression; 6.How good or or bad your health is today. Each of these 6 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 'Best imaginable health state' and 'Worst imaginable health state'. Answers to 'How good or bad your health is today' were measured on a 100 point VAS scale. Baseline for Part B is the last non-missing measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0) and Days 85, 87, 91, 113, 162, 339 and 344 and Weeks 12 and 24

,,,,
InterventionScores on scale (Number)
Par 1, Week 12Par 1, Week 24Par 1, Day 339Par 2, Week 12Par 2, Week 24Par 2, Day 344Par 3, Day 113Par 4, Week 12Par 5, Week 12Par 5, Day 162Par 6, Day 91Par 7, Day 85Par 8, Day 87
PartB:Placebo SC q2w + 12 Month PrednisoneNANANANANANANANANANANA421
PartB:Placebo SC q2w + 6 Month PrednisoneNANANANANANANANA9-1520NANA
PartB:SIR 100 mg SC q2w+3 Month PrednisoneNANANANANANA1NANANANANANA
PartB:SIR 100 mg SC q2w+6 Month Prednisone-1218314-1NANANANANANANA
PartB:SIR 50 mg SC q4w+6 Month PrednisoneNANANANANANANA-4NANANANANA

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Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionProportion of red blood cells in blood (Mean)
Hematocrit,Week 4,n=3,3,2,1,2Hematocrit,Week 12,n=1,1,1,1,1Hematocrit,Week 16,n=0,1,1,1,0
PartB:Placebo SC q2w + 6 Month Prednisone-0.0040-0.0010-0.0030

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Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

,
InterventionProportion of red blood cells in blood (Mean)
Hematocrit,Week 4,n=3,3,2,1,2Hematocrit,Week 8,n=2,1,2,0,2Hematocrit,Week 12,n=1,1,1,1,1
PartB:Placebo SC q2w + 12 Month Prednisone-0.0070-0.01200.0030
PartB:SIR 100 mg SC q2w+6 Month Prednisone-0.0047-0.0185-0.0120

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Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionProportion of red blood cells in blood (Mean)
Hematocrit,Week 4,n=3,3,2,1,2Hematocrit,Week 8,n=2,1,2,0,2Hematocrit,Week 12,n=1,1,1,1,1Hematocrit,Week 16,n=0,1,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone0.01150.01350.04700.0610

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Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionProportion of red blood cells in blood (Mean)
Hematocrit,Week 4,n=3,3,2,1,2Hematocrit,Week 8,n=2,1,2,0,2Hematocrit,Week 12,n=1,1,1,1,1Hematocrit,Week 16,n=0,1,1,1,0Hematocrit,Week 24,n=0,1,0,0,0Hematocrit,Week 36,n=0,1,0,0,0
PartB:SIR 100 mg SC q2w+3 Month Prednisone-0.00570.00000.00800.00600.01000.0280

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Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

,
InterventionProportion of red blood cells in blood (Mean)
Hematocrit,Week 2,n=1,1,0,1,2Hematocrit,Week 4,n=2,1,1,2,2Hematocrit,Week 8,n=2,1,1,2,2
PartB:Placebo SC q2w + 12 Month Prednisone0.02350.01050.0260
PartB:SIR 100 mg SC q2w+3 Month Prednisone-0.0060-0.0080-0.0110

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Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionProportion of red blood cells in blood (Mean)
Hematocrit,Week 4,n=2,1,1,2,2Hematocrit,Week 8,n=2,1,1,2,2Hematocrit,Week 12,n=2,0,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone-0.0250-0.0030-0.0060

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Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein

Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,,,
InterventionGrams per liter (Mean)
Albumin,Week 2,n=38,39,26,24,26Albumin,Week 4,n=37,38,25,23,27Albumin,Week 8,n=34,31,24,22,23Albumin,Week 12,n=32,28,24,22,21Albumin,Week 16,n=28,26,22,19,18Albumin,Week 20,n=25,23,19,18,16Albumin,Week 24,n=22,21,16,17,16Albumin,Week 28,n=19,18,12,13,14Albumin,Week 32,n=19,15,10,12,13Albumin,Week 36,n=15,12,10,12,13Albumin,Week 40,n=15,11,9,10,10Albumin,Week 44,n=11,11,6,8,9Albumin,Week 48,n=9,8,5,8,5Albumin,Week 52,n=9,5,5,5,4Protein,Week 2,n=38,39,26,24,26Protein,Week 4,n=37,38,25,23,27Protein,Week 8,n=34,31,24,22,23Protein,Week 12,n=32,28,24,22,21Protein,Week 16,n=28,26,22,19,18Protein,Week 20,n=25,23,19,18,16Protein,Week 24,n=22,21,16,17,16Protein,Week 28,n=19,18,12,13,14Protein,Week 32,n=19,15,10,12,13Protein,Week 36,n=15,12,10,12,13Protein,Week 40,n=15,11,9,10,10Protein,Week 44,n=11,11,6,8,9Protein,Week 48,n=9,8,5,8,5Protein,Week 52,n=9,5,5,5,4
PartA:Placebo SC q2w + 12 Month Prednisone-0.7-0.9-0.60.20.60.30.30.41.10.2-0.50.62.01.5-1.7-2.0-0.70.91.00.40.81.62.61.81.41.73.21.8
PartA:Placebo SC q2w + 6 Month Prednisone-0.9-1.4-1.1-0.5-1.2-0.90.0-0.5-0.7-1.3-1.10.4-0.8-1.2-1.7-2.0-0.71.00.20.61.5-0.2-0.3-0.3-0.42.31.4-1.0
PartA:SIR 100 mg SC q2w+3 Month Prednisone0.92.03.13.42.83.93.83.53.64.33.94.14.45.2-2.4-2.4-1.6-1.3-2.0-0.4-0.9-0.8-1.5-0.8-1.5-0.4-0.11.0
PartA:SIR 100 mg SC q2w+6 Month Prednisone0.30.91.92.01.71.81.61.52.23.13.23.23.43.7-2.6-2.5-1.9-1.7-2.3-1.9-1.1-2.4-1.4-0.3-0.50.30.3-0.4
PartA:SIR 50 mg SC q4w+6 Month Prednisone0.81.62.13.12.82.83.72.42.22.92.42.21.64.0-1.9-1.8-2.2-0.8-1.9-1.30.0-2.7-2.1-0.5-2.1-2.0-1.80.6

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Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin

Blood samples were collected to analyze the chemistry parameters including bilirubin, creatinine, direct bilirubin and indirect bilirubin. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,,,
InterventionMicromoles per liter (Mean)
Bilirubin,Week 2,n=38,39,26,24,26Bilirubin,Week 4,n=37,38,25,23,27Bilirubin,Week 8,n=34,31,24,22,23Bilirubin,Week 12,n=32,28,24,22,21Bilirubin,Week 16,n=28,26,22,19,18Bilirubin,Week 20,n=25,23,19,18,16Bilirubin,Week 24,n=22,21,16,17,16Bilirubin,Week 28,n=19,18,12,13,14Bilirubin,Week 32,n=19,15,10,12,13Bilirubin,Week 36,n=15,12,10,12,13Bilirubin,Week 40,n=15,11,6,10,10Bilirubin,Week 44,n=11,11,6,8,9Bilirubin,Week 48,n=9,8,5,8,5Bilirubin,Week 52,n=9,5,5,5,4Direct Bilirubin,Week 2,n=38,39,26,24,26Direct Bilirubin,Week 4,n=37,38,25,23,27Direct Bilirubin,Week 8,n=34,31,24,22,23Direct Bilirubin,Week 12,n=32,28,24,22,21Direct Bilirubin,Week 16,n=28,26,22,19,18Direct Bilirubin,Week 20,n=25,23,19,18,16Direct Bilirubin,Week 24,n=22,21,16,17,16Direct Bilirubin,Week 28,n=19,18,12,13,14Direct Bilirubin,Week 32,n=19,15,10,12,13Direct Bilirubin,Week 36,n=15,12,10,12,13Direct Bilirubin,Week 40,n=15,11,6,10,10Direct Bilirubin,Week 44,n=11,11,6,8,9Direct Bilirubin,Week 48,n=9,8,5,8,5Direct Bilirubin,Week 52,n=9,5,5,5,4Indirect Bilirubin,Week 2,n=38,39,26,24,26Indirect Bilirubin,Week 4,n=37,38,25,23,27Indirect Bilirubin,Week 8,n=34,31,24,22,23Indirect Bilirubin,Week 12,n=32,28,24,22,21Indirect Bilirubin,Week 16,n=28,26,22,19,18Indirect Bilirubin,Week 20,n=25,23,19,18,16Indirect Bilirubin,Week 24,n=22,21,16,17,16Indirect Bilirubin,Week 28,n=19,18,12,13,14Indirect Bilirubin,Week 32,n=19,15,10,12,13Indirect Bilirubin,Week 36,n=15,12,10,12,13Indirect Bilirubin,Week 40,n=15,11,6,10,10Indirect Bilirubin,Week 44,n=11,11,6,8,9Indirect Bilirubin,Week 48,n=9,8,5,8,5Indirect Bilirubin,Week 52,n=9,5,5,5,4Creatinine,Week 2,n=38,39,26,24,26Creatinine,,Week 4,n=37,38,25,23,27Creatinine,Week 8,n=34,31,24,22,23Creatinine,,Week 12,n=32,28,24,22,21Creatinine,,Week 16,n=28,26,22,19,18Creatinine,,Week 20,n=25,23,19,18,16Creatinine,Week 24,n=22,21,16,17,16Creatinine,,Week 28,n=19,18,12,13,14Creatinine, Week 32,n=19,15,10,12,13Creatinine,,Week 36,n=15,12,10,12,13Creatinine,,Week 40,n=15,11,6,10,10Creatinine, Week 44,n=11,11,6,8,9Creatinine,,Week 48,n=9,8,5,8,5Creatinine,,Week 52,n=9,5,5,5,4
PartA:Placebo SC q2w + 12 Month Prednisone-1.0-1.5-3.2-2.9-3.3-3.1-1.7-3.2-3.0-2.1-1.9-1.2-1.81.8-0.3-0.6-0.8-0.6-0.8-0.9-0.8-1.0-1.2-1.2-1.4-0.7-1.2-0.5-0.7-0.9-2.4-2.3-2.5-2.2-0.9-2.2-1.8-0.8-0.5-0.6-0.62.30.280.482.431.463.374.732.634.074.103.621.553.965.7212.23
PartA:Placebo SC q2w + 6 Month Prednisone-1.1-1.8-2.3-1.0-0.9-1.4-1.1-0.8-0.8-0.9-1.1-0.1-1.1-1.00.0-0.2-0.1-0.1-0.1-0.2-0.4-0.5-0.2-0.20.00.00.0-0.4-1.1-1.6-2.2-1.0-0.8-1.2-0.8-0.3-0.6-0.8-1.1-0.1-1.1-0.6-1.65-0.64-2.93-3.09-0.14-0.18-1.14-0.280.594.561.670.231.431.78
PartA:SIR 100 mg SC q2w+3 Month Prednisone1.51.92.82.84.44.33.03.74.05.32.91.83.81.6-0.10.10.10.10.40.10.0-0.10.30.3-0.4-0.4-0.3-0.81.61.92.72.74.04.23.03.83.75.03.32.24.02.44.103.031.48-0.841.160.33-0.450.46-2.52-3.82-1.45-7.06-7.15-5.10
PartA:SIR 100 mg SC q2w+6 Month Prednisone1.82.43.04.32.74.74.94.44.25.25.14.46.74.80.10.30.20.30.31.41.00.70.50.70.60.81.21.01.72.12.84.02.43.34.03.73.74.54.53.55.43.84.964.003.262.883.87-0.871.585.003.881.094.870.037.213.56
PartA:SIR 50 mg SC q4w+6 Month Prednisone1.91.80.92.73.93.64.83.12.72.32.62.52.25.00.10.10.00.20.30.40.40.10.1-0.1-0.30.2-0.6-0.21.81.80.92.53.63.24.43.02.62.42.92.32.85.20.712.560.953.281.27-0.091.86-1.33-1.330.88-0.88-2.382.804.20

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Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time

Blood samples were collected for analysis of ESR. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for Change from Baseline in ESR over time for part A was reported. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

,,,,
InterventionMillimeters per hour (Mean)
Week 2,n=37,39,26,24,26Week 4,n=36,38,25,22,27Week 8,n=33,31,24,22,23Week 12,n=32,28,24,22,22Week 16,n=28,26,22,19,19Week 20,n=26,23,18,18,16Week 24,n=23,19,16,17,16Week 28,n=19,18,11,14,14Week 32,n=19,15,10,12,13Week 36,n=15,12,10,12, 13Week 40,n=15,11,9,10,10Week 44,n=11,11,6,8,8Week 48,n=9,8,5,8,5Week 52,n=9,5,5,5,4
PartA:Placebo SC q2w + 12 Month Prednisone-9.96-5.301.78-2.55-2.53-5.81-3.06-1.71-2.850.92-2.602.888.601.25
PartA:Placebo SC q2w + 6 Month Prednisone-1.337.596.4120.3614.2110.007.591.50-2.420.679.804.884.50-4.60
PartA:SIR 100 mg SC q2w+3 Month Prednisone-12.78-17.41-18.76-17.89-17.17-17.07-16.84-19.94-19.80-21.25-22.27-22.18-25.63-24.60
PartA:SIR 100 mg SC q2w+6 Month Prednisone-13.05-12.83-14.21-14.97-12.50-13.19-13.63-15.26-13.26-14.47-14.40-12.64-15.33-14.78
PartA:SIR 50 mg SC q4w+6 Month Prednisone-14.62-14.13-15.05-14.30-15.37-14.33-14.89-16.84-14.52-14.42-11.24-12.00-14.00-12.80

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Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume

Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,,,
InterventionFemtoliter (Mean)
Week 2,n=38,39,24,24,25Week 4,n=36,37,24,22,27Week 8,n=34,29,23,22,21Week 12,n=31,28,23,22,22Week 16,n=27,26,21,19,19Week 20,n=25,23,18,18,16Week 24,n=22,21,16,16,16Week 28,n=18,18,12,14,13Week 32,n=19,15,10,12,13Week 36,n=15,12,10,12,12Week 40,n=14,11,8,10,10Week 44,n=11,10,6,8,9Week 48,n=9,8,4,8,5Week 52,n=8,5,5,5,4
PartA:Placebo SC q2w + 12 Month Prednisone0.40.6-0.20.3-0.30.1-1.6-0.5-0.5-0.2-2.1-0.72.01.0
PartA:Placebo SC q2w + 6 Month Prednisone0.60.61.70.90.4-0.5-1.0-0.40.3-0.50.4-0.7-1.13.2
PartA:SIR 100 mg SC q2w+3 Month Prednisone0.51.11.82.02.21.81.11.42.01.61.82.53.33.2
PartA:SIR 100 mg SC q2w+6 Month Prednisone0.50.91.20.81.01.21.10.60.91.80.6-0.5-0.4-0.6
PartA:SIR 50 mg SC q4w+6 Month Prednisone0.51.01.92.63.12.12.62.01.30.92.01.72.31.4

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Part A: Change From Baseline in Hematology Parameter-Hematocrit

Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,,,
InterventionProportion of red blood cells in blood (Mean)
Week 2,n=38,39,24,24,25Week 4,n=36,37,24,22,27Week 8,n=34,29,23,22,21Week 12,n=31,28,23,22,22Week 16,n=27,26,21,19,19Week 20,n=25,23,18,18,16Week 24,n=22,21,16,16,16Week 28,n=18,18,12,14,13Week 32,n=19,15,10,12,13Week 36,n=15,12,10,12,12Week 40,n=14,11,8,10,10Week 44,n=11,10,6,7,9Week 48,n=9,8,4,8,5Week 52,n=8,5,5,5,4
PartA:Placebo SC q2w + 12 Month Prednisone-0.0030-0.0087-0.0159-0.0095-0.0095-0.0062-0.0077-0.00350.00250.0018-0.0160-0.00370.01440.0025
PartA:Placebo SC q2w + 6 Month Prednisone-0.0063-0.0035-0.0054-0.0118-0.0135-0.0184-0.0133-0.0186-0.0176-0.0198-0.0193-0.0126-0.0216-0.0006
PartA:SIR 100 mg SC q2w+3 Month Prednisone0.00600.00480.00540.01480.00490.00660.00100.00390.00270.0036-0.00520.0054-0.00250.0016
PartA:SIR 100 mg SC q2w+6 Month Prednisone0.00400.00590.01010.0087-0.0037-0.0063-0.0017-0.0089-0.00760.0012-0.0115-0.0185-0.0136-0.0135
PartA:SIR 50 mg SC q4w+6 Month Prednisone0.00080.00400.00190.00590.0008-0.00150.0089-0.0046-0.0060-0.0054-0.0009-0.0097-0.00530.0058

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Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets

Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,,,
InterventionGiga cells per liter (Mean)
Eosinophils,Week 2,n=37,36,24,23,25Eosinophils,Week 4,n=36,37,24,22,26Eosinophils,Week 8,n=34,29,22,22,21Eosinophils,Week 12,n=31,28,23,22,22Eosinophils,Week 16,n=27,26,20,19,19Eosinophils,Week 20,n=25,22,18,17,16Eosinophils,Week 24,n=22,21,16,16,16Eosinophils,Week 28,n=18,18,11,14,13Eosinophils,Week 32,n=19,15,10,12,13Eosinophils,Week 36,n=15,12,10,12,12Eosinophils,Week 40,n=14,11,8,10,10Eosinophils,Week 44,n=11,10,6,7,9Eosinophils,Week 48,n=9,8,4,8,5Eosinophils,Week 52,n=8,5,5,5,4Leukocytes,Week 2,n=37,38,24,24,25Leukocytes,Week 4,n=36,37,24,22,26Leukocytes,Week 8,n=34,29,23,22,21Leukocytes,Week 12,n=31,28,23,22,22Leukocytes,Week 16,n=27,26,20,19,19Leukocytes,Week 20,n=25,23,18,18,16Leukocytes,Week 24,n=22,21,16,16,16Leukocytes,Week 28,n=18,18,12,14,13Leukocytes,Week 32,n=19,15,10,12,13Leukocytes,Week 36,n=15,12,10,12,12Leukocytes,Week 40,n=14,11,8,10,10Leukocytes,Week 44,n=11,10,6,7,9Leukocytes,Week 48,n=9,8,4,8,5Leukocytes,Week 52,n=8,5,5,5,4Lymphocytes,Week 2,n=37,36,24,23,25Lymphocytes,Week 4,n=36,37,24,22,26Lymphocytes,Week 8,n=34,29,22,22,21Lymphocytes,Week 12,n=31,28,23,22,22Lymphocytes,Week 16,n=27,26,20,19,19Lymphocytes,Week 20,n=25,22,18,17,16Lymphocytes,Week 24,n=22,21,16,16,16Lymphocytes,Week 28,n=18,18,11,14,13Lymphocytes,Week 32,n=19,15,10,12,13Lymphocytes,Week 36,n=15,12,10,12,12Lymphocytes,Week 40,n=14,11,8,10,10Lymphocytes,Week 44,n=11,10,6,7,9Lymphocytes,Week 48,n=9,8,4,8,5Lymphocytes,Week 52,n=8,5,5,5,4Neutrophils,Week 2,n=37,36,24,23,25Neutrophils,Week 4,n=36,37,24,22,26Neutrophils,Week 8,n=34,29,22,22,21Neutrophils,Week 12,n=31,28,23,22,22Neutrophils,Week 16,n=27,26,20,19,19Neutrophils,Week 20,n=25,22,18,17,16Neutrophils,Week 24,n=22,21,16,16,16Neutrophils,Week 28,n=18,18,11,14,13Neutrophils,Week 32,n=19,15,10,12,13Neutrophils,Week 36,n=15,12,10,12,12Neutrophils,Week 40,n=14,11,8,10,10Neutrophils,Week 44,n=11,10,6,7,9Neutrophils,Week 48,n=9,8,4,8,5Neutrophils,Week 52,n=8,5,5,5,4Platelets,Week 2,n=37,38,24,23,25Platelets,Week 4,n=36,37,24,22,26Platelets,Week 8,n=34,29,22,22,21Platelets,Week 12,n=31,28,23,22,22Platelets,Week 16,n=27,26,20,19,19Platelets,Week 20,n=25,22,18,17,16Platelets,Week 24,n=22,21,16,16,16Platelets,Week 28,n=18,18,11,14,13Platelets,Week 32,n=19,15,10,12,13Platelets,Week 36,n=15,12,10,12,12Platelets,Week 40,n=14,11,8,10,10Platelets,Week 44,n=11,10,6,7,9Platelets,Week 48,n=9,8,4,8,5Platelets,Week 52,n=8,5,5,5,4
PartA:Placebo SC q2w + 12 Month Prednisone0.0620.0300.0100.0300.0670.0570.0510.0510.0560.0590.0710.0660.0300.0130.34-0.16-0.26-1.28-0.79-1.71-1.52-1.97-2.33-2.95-2.23-3.08-3.00-3.10-0.209-0.382-0.516-0.344-0.635-0.533-0.386-0.565-0.492-0.078-0.681-0.343-0.510-0.1280.3870.0890.192-1.019-0.263-1.355-1.342-1.503-2.018-3.018-1.663-2.883-2.650-2.990-4.3-5.715.74.313.8-0.120.113.110.720.05.3-3.30.4-17.5
PartA:Placebo SC q2w + 6 Month Prednisone0.0150.0230.0480.0900.0670.0940.0890.0460.0380.0490.0650.0240.0280.108-0.76-1.64-1.79-2.66-2.98-3.24-2.89-3.01-3.43-3.36-3.18-2.83-2.69-3.84-0.159-0.002-0.049-0.128-0.327-0.385-0.401-0.258-0.402-0.417-0.519-1.029-0.5760.194-0.748-1.673-1.869-2.678-2.766-2.856-2.570-2.764-3.006-3.023-2.705-1.807-2.160-4.214-1.92.114.217.812.414.86.315.4-1.513.45.611.114.4-18.6
PartA:SIR 100 mg SC q2w+3 Month Prednisone0.0010.0350.1020.1550.1620.1140.1090.0680.0690.0760.0750.0450.0590.192-3.63-4.76-5.65-5.67-5.61-5.20-6.39-6.04-5.61-6.82-7.10-6.95-7.35-7.360.002-0.255-0.411-0.437-0.704-0.313-0.179-0.273-0.407-0.672-0.845-1.047-0.923-0.754-3.454-4.476-5.271-5.340-4.929-4.997-6.257-5.729-5.153-6.079-6.179-5.799-6.396-6.774-49.2-64.3-72.2-74.0-69.9-69.5-72.4-61.3-65.5-70.6-66.9-76.7-71.4-51.6
PartA:SIR 100 mg SC q2w+6 Month Prednisone0.0190.0430.0560.0770.0970.1660.2100.1630.2440.2820.1910.1440.0910.151-3.12-3.66-4.04-4.68-5.21-5.24-5.14-5.46-5.71-5.76-6.14-6.25-6.88-6.660.0150.027-0.191-0.215-0.450-0.616-0.399-0.614-0.602-0.625-0.929-0.915-1.258-1.253-3.208-3.791-3.949-4.590-4.933-4.867-4.985-5.076-5.357-5.444-5.416-5.432-5.628-5.520-39.0-45.9-37.3-51.2-53.8-52.2-58.0-70.2-57.6-74.1-77.4-69.5-68.3-81.9
PartA:SIR 50 mg SC q4w+6 Month Prednisone0.0100.0120.0540.0900.1170.1360.1090.1200.0920.1530.1040.1650.2330.172-3.32-4.07-4.42-5.23-5.36-5.40-5.01-4.58-5.27-5.58-6.46-6.17-6.48-6.38-0.0410.057-0.067-0.081-0.153-0.439-0.073-0.192-0.476-0.430-0.570-0.1980.118-0.286-3.367-4.106-4.354-5.250-5.358-5.168-5.030-4.469-4.840-5.265-5.916-6.185-6.790-6.256-41.1-49.0-53.3-55.4-54.8-53.5-57.5-50.6-50.8-48.6-42.0-58.2-80.8-58.6

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Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin

Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,,,
InterventionGrams per liter (Mean)
MCHC,Week 2,n=32,33,18,22,23MCHC,Week 4,n=31,31,19,20,25MCHC,Week 8,n=28,24,18,20,20MCHC,Week 12,n=25,23,18,20,20MCHC,Week 16,n=22,21,17,17,17MCHC,Week 20,n=19,18,14,16,14MCHC,Week 24,n=16,16,13,15,14MCHC,Week 28,n=13,14,10,12,11MCHC,Week 32,n=13,11,8,10,11MCHC,Week 36,n=10,10,8,10,10MCHC,Week 40,n=10,9,7,8,9MCHC,Week 44,n=8,8,4,5,8MCHC,Week 48,n=6,7,2,6,4MCHC,Week 52,n=6,4,3,4,3Hemoglobin,Week 2,n=38,39,24,24,25Hemoglobin,Week 4,n=36,37,24,22,27Hemoglobin,Week 8,n=34,29,23,22,21Hemoglobin,Week 12,n=31,28,23,22,22Hemoglobin,Week 16,n=27,26,21,19,19Hemoglobin,Week 20,n=25,23,18,18,16Hemoglobin,Week 24,n=22,21,16,16,16Hemoglobin,Week 28,n=18,18,12,14,13Hemoglobin,Week 32,n=19,15,10,12,13Hemoglobin,Week 36,n=15,12,10,12,12Hemoglobin,Week 40,n=14,11,8,10,10Hemoglobin,Week 44,n=11,10,6,8,9Hemoglobin,Week 48,n=9,8,4,8,5Hemoglobin,Week 52,n=8,5,5,5,4
PartA:Placebo SC q2w + 12 Month Prednisone1.22.46.74.94.54.64.9-0.41.44.213.912.19.35.0-0.9-2.1-2.8-1.4-1.7-0.6-0.9-1.50.81.3-0.42.87.62.8
PartA:Placebo SC q2w + 6 Month Prednisone-1.10.10.61.30.93.43.02.86.77.95.15.23.811.3-2.4-1.0-1.4-3.2-3.8-4.6-3.1-4.4-3.0-2.6-3.4-0.3-4.64.4
PartA:SIR 100 mg SC q2w+3 Month Prednisone0.12.36.76.78.910.814.69.28.46.711.39.911.918.82.52.84.78.45.87.47.05.85.14.83.86.74.88.6
PartA:SIR 100 mg SC q2w+6 Month Prednisone-0.51.66.16.58.37.74.74.56.96.911.512.513.316.51.23.05.95.82.62.02.20.30.94.41.30.02.42.9
PartA:SIR 50 mg SC q4w+6 Month Prednisone1.92.66.45.910.29.04.98.98.813.514.413.510.524.01.32.53.14.74.23.35.42.82.04.06.32.32.810.4

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Part A: Change From Baseline in Pulse Rate

Pulse rate was measured in semi-supine position after 5 minutes rest at Baseline and up to 52 weeks. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,,,
InterventionBeats per minute (Mean)
Week 2, ,n=37,39,25,24,27Week 4,n=37,37,25,22,27Week 8,n=34,32,24,22,23Week 12,n=32,29,23,22,22Week 16,n=28,26,22,19,19Week 20,n=26,23,19,18,16Week 24,n=23,21,16,17,16Week 28,n=19,18,12,14,14Week 32,n=19,15,10,12,13Week 36,n=15,13,10,12,13Week 40,n=15,11,9,10,10Week 44,n=11,11,6,8,9Week 48,n=9,8,5,8,5Week 52,n=9,5,5,5,4
PartA:Placebo SC q2w + 12 Month Prednisone-1.6-1.90.5-2.7-2.2-4.02.70.5-0.6-3.2-3.8-3.40.0-5.3
PartA:Placebo SC q2w + 6 Month Prednisone-0.42.24.34.50.31.00.10.1-0.8-0.53.34.3-1.96.8
PartA:SIR 100 mg SC q2w+3 Month Prednisone-2.1-1.4-3.2-1.20.30.2-3.5-1.2-4.7-5.1-3.0-3.4-9.3-11.0
PartA:SIR 100 mg SC q2w+6 Month Prednisone-1.90.2-1.1-3.8-3.4-3.0-2.1-1.4-1.3-5.9-3.9-7.1-8.2-5.0
PartA:SIR 50 mg SC q4w+6 Month Prednisone1.8-2.4-3.1-0.8-5.3-0.70.7-3.5-2.2-4.5-3.4-8.3-7.2-4.0

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Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time

Blood samples were collected for analysis of CRP. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for Change from Baseline in serum CRP over time for part A was reported. The Safety set comprised of all randomized participants who received at least 1 dose of SC IP. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

,,,,
InterventionMilligrams per liter (Mean)
Week 2,n=38,39,26,24,26Week 4,n=37,38,25,23,27Week 8,n=34,31,24,22,23Week 12,n=32,28,24,21,21Week 16,n=28,26,22,19,18Week 20,n=26,23,19,18,16Week 24,n=23,20,16,17,16Week 28,n=19,18,12,14,14Week 32,n=19,15,10,12,13Week 36,n=15,12,10,12,13Week 40,n=15,11,8,10,10Week 44,n=11,11,6,8,9Week 48,n=9,7,5,8,5Week 52,n=9,5,5,5,4
PartA:Placebo SC q2w + 12 Month Prednisone1.070.767.864.046.992.356.540.224.371.642.775.138.10-1.65
PartA:Placebo SC q2w + 6 Month Prednisone1.274.9110.0014.8110.535.325.071.872.615.736.272.806.310.64
PartA:SIR 100 mg SC q2w+3 Month Prednisone-8.81-9.01-9.94-9.96-10.43-11.67-13.19-13.42-14.47-16.28-17.67-17.47-23.39-7.26
PartA:SIR 100 mg SC q2w+6 Month Prednisone-5.07-4.39-4.98-5.08-4.35-4.50-4.38-5.28-4.85-4.72-4.72-5.35-5.91-6.00
PartA:SIR 50 mg SC q4w+6 Month Prednisone-5.15-4.09-4.19-4.22-4.48-4.78-5.14-6.33-7.15-7.08-4.69-1.90-2.20-2.20

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Part A: Change From Baseline in Temperature

Temperature was measured in semi-supine position after 5 minutes rest at Baseline and up to 52 weeks. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,,,
InterventionCelsius (Mean)
Week 2, ,n=37,39,26,24,27Week 4,n=37,37,25,23,27Week 8,n=34,32,23,22,23Week 12,n=32,29,24,22,22Week 16,n=28,26,22,19,19Week 20,n=26,23,19,18,16Week 24,n=23,21,16,17,16Week 28,n=19,18,12,13,14Week 32,n=19,15,10,12,13Week 36,n=15,13,9,12,13Week 40,n=15,11,9,10,10Week 44,n=11,11,6,8,9Week 48,n=9,8,5,8,5Week 52,n=9,5,5,5,4
PartA:Placebo SC q2w + 12 Month Prednisone0.100.110.190.090.090.050.04-0.060.01-0.08-0.05-0.08-0.08-0.08
PartA:Placebo SC q2w + 6 Month Prednisone-0.16-0.100.04-0.15-0.21-0.07-0.26-0.16-0.13-0.09-0.050.00-0.010.02
PartA:SIR 100 mg SC q2w+3 Month Prednisone-0.040.01-0.09-0.11-0.05-0.05-0.11-0.07-0.07-0.11-0.03-0.06-0.05-0.32
PartA:SIR 100 mg SC q2w+6 Month Prednisone-0.11-0.12-0.04-0.08-0.080.030.030.03-0.01-0.090.08-0.14-0.22-0.08
PartA:SIR 50 mg SC q4w+6 Month Prednisone0.030.04-0.070.010.04-0.12-0.11-0.090.28-0.100.18-0.03-0.140.14

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Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionProportion of red blood cells in blood (Mean)
Hematocrit,Week 2,n=1,1,0,1,2Hematocrit,Week 4,n=2,1,1,2,2Hematocrit,Week 8,n=2,1,1,2,2Hematocrit,Week 12,n=2,0,1,1,0Hematocrit,Week 14,n=0,0,0,1,0Hematocrit,Week 16,n=2,0,0,1,0
PartB:Placebo SC q2w + 6 Month Prednisone0.0250-0.0060-0.0040-0.0420-0.00800.0080

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Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B

Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36

Interventionmg/L (Mean)
Week 4, n=3,3,2,1,2Week 8, n=2,1,2,0,2Week 12, n=1,1,1,1,1Week 16, n=0,1,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone0.050.000.000.00

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Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B

Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36

,
Interventionmg/L (Mean)
Week 4, n=3,3,2,1,2Week 8, n=2,1,2,0,2Week 12, n=1,1,1,1,1
PartB:Placebo SC q2w + 12 Month Prednisone-0.550.950.70
PartB:SIR 100 mg SC q2w+6 Month Prednisone-0.30-0.05-0.90

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Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B

Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36

Interventionmg/L (Mean)
Week 4, n=3,3,2,1,2Week 12, n=1,1,1,1,1Week 16, n=0,1,1,1,0
PartB:Placebo SC q2w + 6 Month Prednisone6.10-0.80-0.70

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Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionMicromoles per liter (Mean)
Bilirubin,Week 2,n=1,1,0,1,2Bilirubin,Week 4,n=2,1,1,2,2Bilirubin,Week 8,n=2,1,1,2,2Bilirubin,Week 12,n=2,0,1,1,0Bilirubin,Week 16,n=2,0,0,1,0Bilirubin,Week 24,n=2,0,0,0,0Bilirubin,Week 36,n=2,0,0,0,0Bilirubin,Week 38,n=1,0,0,0,0Bilirubin,Week 40,n=1,0,0,0,0Direct Bilirubin,Week 2,n=1,1,0,1,2Direct Bilirubin,Week 4,n=2,1,1,2,2Direct Bilirubin,Week 8,n=2,1,1,2,1Direct Bilirubin,Week 12,n=2,0,1,1,0Direct Bilirubin,Week 16,n=2,0,0,1,0Direct Bilirubin,Week 24,n=2,0,0,0,0Direct Bilirubin,Week 36,n=2,0,0,0,0Direct Bilirubin,Week 38,n=1,0,0,0,0Direct Bilirubin,Week 40,n=1,0,0,0,0Indirect Bilirubin,Week 2,n=1,1,0,1,2Indirect Bilirubin,Week 4,n=2,1,1,2,2Indirect Bilirubin,Week 8,n=2,1,1,2,1Indirect Bilirubin,Week 12,n=2,0,1,1,0Indirect Bilirubin,Week 16,n=2,0,0,1,0Indirect Bilirubin,Week 24,n=2,0,0,0,0Indirect Bilirubin,Week 36,n=2,0,0,0,0Indirect Bilirubin,Week 38,n=1,0,0,0,0Indirect Bilirubin,Week 40,n=1,0,0,0,0Creatinine,Week 2,n=1,1,0,1,2Creatinine,Week 4,n=2,1,1,2,2Creatinine,Week 8,n=2,1,1,2,1Creatinine,Week 12,n=2,0,1,1,0Creatinine,Week 16,n=2,0,0,1,0Creatinine,Week 24,n=2,0,0,0,0Creatinine,Week 36,n=2,0,0,0,0Creatinine,Week 38,n=1,0,0,0,0Creatinine,Week 40,n=1,0,0,0,0
PartB:SIR 100 mg SC q2w+6 Month Prednisone0.05.0-1.00.05.0-2.01.00.02.00.01.00.00.01.00.0-1.00.00.00.04.0-1.00.04.0-2.02.00.02.0-3.50-11.05-8.40-11.90-12.80-9.75-15.05-19.40-20.30

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Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionMicromoles per liter (Mean)
Bilirubin,Week 2,n=1,1,0,1,2Bilirubin,Week 4,n=2,1,1,2,2Bilirubin,Week 8,n=2,1,1,2,2Bilirubin,Week 12,n=2,0,1,1,0Bilirubin,Week 14,n=0,0,0,1,0Bilirubin,Week 16,n=2,0,0,1,0Direct Bilirubin,Week 2,n=1,1,0,1,2Direct Bilirubin,Week 4,n=2,1,1,2,2Direct Bilirubin,Week 8,n=2,1,1,2,1Direct Bilirubin,Week 12,n=2,0,1,1,0Direct Bilirubin,Week 14,n=0,0,0,1,0Direct Bilirubin,Week 16,n=2,0,0,1,0Indirect Bilirubin,Week 2,n=1,1,0,1,2Indirect Bilirubin,Week 4,n=2,1,1,2,2Indirect Bilirubin,Week 8,n=2,1,1,2,1Indirect Bilirubin,Week 12,n=2,0,1,1,0Indirect Bilirubin,Week 14,n=0,0,0,1,0Indirect Bilirubin,Week 16,n=2,0,0,1,0Creatinine,Week 2,n=1,1,0,1,2Creatinine,Week 4,n=2,1,1,2,2Creatinine,Week 8,n=2,1,1,2,1Creatinine,Week 12,n=2,0,1,1,0Creatinine,Week 14,n=0,0,0,1,0Creatinine,Week 16,n=2,0,0,1,0
PartB:Placebo SC q2w + 6 Month Prednisone2.01.01.0-2.00.02.02.01.01.00.00.00.00.00.00.0-2.00.02.01.80-1.300.45-0.900.804.40

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Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionMicromoles per liter (Mean)
Bilirubin,Week 4,n=2,1,1,2,2Bilirubin,Week 8,n=2,1,1,2,2Bilirubin,Week 12,n=2,0,1,1,0Direct Bilirubin,Week 4,n=2,1,1,2,2Direct Bilirubin,Week 8,n=2,1,1,2,1Direct Bilirubin,Week 12,n=2,0,1,1,0Indirect Bilirubin,Week 4,n=2,1,1,2,2Indirect Bilirubin,Week 8,n=2,1,1,2,1Indirect Bilirubin,Week 12,n=2,0,1,1,0Creatinine,Week 4,n=2,1,1,2,2Creatinine,Week 8,n=2,1,1,2,1Creatinine,Week 12,n=2,0,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone0.02.00.00.00.00.00.02.00.02.709.704.40

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Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

,
InterventionMicromoles per liter (Mean)
Bilirubin,Week 2,n=1,1,0,1,2Bilirubin,Week 4,n=2,1,1,2,2Bilirubin,Week 8,n=2,1,1,2,2Direct Bilirubin,Week 2,n=1,1,0,1,2Direct Bilirubin,Week 4,n=2,1,1,2,2Direct Bilirubin,Week 8,n=2,1,1,2,1Indirect Bilirubin,Week 2,n=1,1,0,1,2Indirect Bilirubin,Week 4,n=2,1,1,2,2Indirect Bilirubin,Week 8,n=2,1,1,2,1Creatinine,Week 2,n=1,1,0,1,2Creatinine,Week 4,n=2,1,1,2,2Creatinine,Week 8,n=2,1,1,2,1
PartB:Placebo SC q2w + 12 Month Prednisone-1.01.02.00.00.00.0-1.01.02.03.102.200.00
PartB:SIR 100 mg SC q2w+3 Month Prednisone0.0-2.00.00.00.00.00.0-2.00.0-6.20-12.40-8.00

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Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B

SF-36v2 acute health survey questionnaire was developed as part of the Rand Health Insurance Experiment and consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for participants (Par) who never received 100 mg OL Sirukumab has been presented. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0) and Day 23, Day 29, Day 30, Day 57, Day 59, Day 64, Day 65 , Day 85, Day 112, Day 113, Day 163, Day 169, Day 373, Week 8 and Week 12

,,,,
InterventionScores on scale (Number)
Par 1, Day 30, Physical FunctioningPar 1, Day 30, Role PhysicalPar 1, Day 30, Bodily PainPar 1, Day 30, General healthPar 1, Day 30, VitalityPar 1, Day 30, Social FunctioningPar 1, Day 30, Role emotionalPar 1, Day 30, Mental healthPar 1, Day 30, Physical Component SummaryPar 1, Day 30, Mental Component SummaryPar 2, Day 29, Physical FunctioningPar 2, Day 29, Role PhysicalPar 2, Day 29, Bodily PainPar 2, Day 29, General healthPar 2, Day 29, VitalityPar 2, Day 29, Social FunctioningPar 2, Day 29, Role emotionalPar 2, Day 29, Mental healthPar 2, Day 29, Physical Component SummaryPar 2, Day 29, Mental Component SummaryPar 3, Day 23, Physical FunctioningPar 3, Day 23, Role PhysicalPar 3, Day 23, Bodily PainPar 3, Day 23, General healthPar 3, Day 23, VitalityPar 3, Day 23, Social FunctioningPar 3, Day 23, Role emotionalPar 3, Day 23, Mental healthPar 3, Day 23, Physical Component SummaryPar 3, Day 23, Mental Component SummaryPar 4, Week 12, Physical FunctioningPar 4, Week 12, Role PhysicalPar 4, Week 12, Bodily PainPar 4, Week 12, General healthPar 4, Week 12, VitalityPar 4, Week 12, Social FunctioningPar 4, Week 12, Role emotionalPar 4, Week 12, Mental healthPar 4, Week 12, Physical Component SummaryPar 4, Week 12, Mental Component SummaryPar 4, Day 113, Physical FunctioningPar 4, Day 113, Role PhysicalPar 4, Day 113, Bodily PainPar 4, Day 113, General healthPar 4, Day 113, VitalityPar 4, Day 113, Social FunctioningPar 4, Day 113, Role emotionalPar 4, Day 113, Mental healthPar 4, Day 113, Physical Component SummaryPar 4, Day 113, Mental Component SummaryPar 5, Week 8, Physical FunctioningPar 5, Week 8, Role PhysicalPar 5, Week 8, Bodily PainPar 5, Week 8, General healthPar 5, Week 8, VitalityPar 5, Week 8, Social FunctioningPar 5, Week 8, Role emotionalPar 5, Week 8, Mental healthPar 5, Week 8, Physical Component SummaryPar 5, Week 8, Mental Component SummaryPar 5, Day 85, Physical FunctioningPar 5, Day 85, Role PhysicalPar 5, Day 85, Bodily PainPar 5, Day 85, General healthPar 5, Day 85, VitalityPar 5, Day 85, Social FunctioningPar 5, Day 85, Role emotionalPar 5, Day 85, Mental healthPar 5, Day 85, Physical Component SummaryPar 5, Day 85, Mental Component SummaryPar 6, Day 65, Physical FunctioningPar 6, Day 65, Role PhysicalPar 6, Day 65, Bodily PainPar 6, Day 65, General healthPar 6, Day 65, VitalityPar 6, Day 65, Social FunctioningPar 6, Day 65, Role emotionalPar 6, Day 65, Mental healthPar 6, Day 65, Physical Component SummaryPar 6, Day 65, Mental Component SummaryPar 7, Week 12, Physical FunctioningPar 7, Week 12, Role PhysicalPar 7, Week 12, Bodily PainPar 7, Week 12, General healthPar 7, Week 12, VitalityPar 7, Week 12, Social FunctioningPar 7, Week 12, Role emotionalPar 7, Week 12, Mental healthPar 7, Week 12, Physical Component SummaryPar 7, Week 12, Mental Component SummaryPar 7, Day 373, Physical FunctioningPar 7, Day 373, Role PhysicalPar 7, Day 373, Bodily PainPar 7, Day 373, General healthPar 7, Day 373, VitalityPar 7, Day 373, Social FunctioningPar 7, Day 373, Role emotionalPar 7, Day 373, Mental healthPar 7, Day 373, Physical Component SummaryPar 7, Day 373, Mental Component SummaryPar 8, Day 64, Physical FunctioningPar 8, Day 64, Role PhysicalPar 8, Day 64, Bodily PainPar 8, Day 64, General healthPar 8, Day 64, VitalityPar 8, Day 64, Social FunctioningPar 8, Day 64, Role emotionalPar 8, Day 64, Mental healthPar 8, Day 64, Physical Component SummaryPar 8, Day 64, Mental Component SummaryPar 9, Day 29, Physical FunctioningPar 9, Day 29, Role PhysicalPar 9, Day 29, Bodily PainPar 9, Day 29, General healthPar 9, Day 29, VitalityPar 9, Day 29, Social FunctioningPar 9, Day 29, Role emotionalPar 9, Day 29, Mental healthPar 9, Day 29, Physical Component SummaryPar 9, Day 29, Mental Component SummaryPar 10, Day 57, Physical FunctioningPar 10, Day 57, Role PhysicalPar 10, Day 57, Bodily PainPar 10, Day 57, General healthPar 10, Day 57, VitalityPar 10, Day 57, Social FunctioningPar 10, Day 57, Role emotionalPar 10, Day 57, Mental healthPar 10, Day 57, Physical Component SummaryPar 10, Day 57, Mental Component SummaryPar 11, Week 12, Physical FunctioningPar 11, Week 12, Role PhysicalPar 11, Week 12, Bodily PainPar 11, Week 12, General healthPar 11, Week 12, VitalityPar 11, Week 12, Social FunctioningPar 11, Week 12, Role emotionalPar 11, Week 12, Mental healthPar 11, Week 12, Physical Component SummaryPar 11, Week 12, Mental Component SummaryPar 11, Day 163, Physical FunctioningPar 11, Day 163, Role PhysicalPar 11, Day 163, Bodily PainPar 11, Day 163, General healthPar 11, Day 163, VitalityPar 11, Day 163, Social FunctioningPar 11, Day 163, Role emotionalPar 11, Day 163, Mental healthPar 11, Day 163, Physical Component SummaryPar 11, Day 163, Mental Component SummaryPar 12, Day 85, Physical FunctioningPar 12, Day 85, Role PhysicalPar 12, Day 85, Bodily PainPar 12, Day 85, General healthPar 12, Day 85, VitalityPar 12, Day 85, Social FunctioningPar 12, Day 85, Role emotionalPar 12, Day 85, Mental healthPar 12, Day 85, Physical Component SummaryPar 12, Day 85, Mental Component SummaryPar 13, Day 59, Physical FunctioningPar 13, Day 59, Role PhysicalPar 13, Day 59, Bodily PainPar 13, Day 59, General healthPar 13, Day 59, VitalityPar 13, Day 59, Social FunctioningPar 13, Day 59, Role emotionalPar 13, Day 59, Mental healthPar 13, Day 59, Physical Component SummaryPar 13, Day 59, Mental Component SummaryPar 14, Day 57, Physical FunctioningPar 14, Day 57, Role PhysicalPar 14, Day 57, Bodily PainPar 14, Day 57, General healthPar 14, Day 57, VitalityPar 14, Day 57, Social FunctioningPar 14, Day 57, Role emotionalPar 14, Day 57, Mental healthPar 14, Day 57, Physical Component SummaryPar 14, Day 57, Mental Component SummaryPar 15, Day 169, Physical FunctioningPar 15, Day 169, Role PhysicalPar 15, Day 169, Bodily PainPar 15, Day 169, General healthPar 15, Day 169, VitalityPar 15, Day 169, Social FunctioningPar 15, Day 169, Role emotionalPar 15, Day 169, Mental healthPar 15, Day 169, Physical Component SummaryPar 15, Day 169, Mental Component SummaryPar 16, Week 12, Physical FunctioningPar 16, Week 12, Role PhysicalPar 16, Week 12, Bodily PainPar 16, Week 12, General healthPar 16, Week 12, VitalityPar 16, Week 12, Social FunctioningPar 16, Week 12, Role emotionalPar 16, Week 12, Mental healthPar 16, Week 12, Physical Component SummaryPar 16, Week 12, Mental Component SummaryPar 16, Day 112, Physical FunctioningPar 16, Day 112, Role PhysicalPar 16, Day 112, Bodily PainPar 16, Day 112, General healthPar 16, Day 112, VitalityPar 16, Day 112, Social FunctioningPar 16, Day 112, Role emotionalPar 16, Day 112, Mental healthPar 16, Day 112, Physical Component SummaryPar 16, Day 112, Mental Component SummaryPar 17, Day 85, Physical FunctioningPar 17, Day 85, Role PhysicalPar 17, Day 85, Bodily PainPar 17, Day 85, General healthPar 17, Day 85, VitalityPar 17, Day 85, Social FunctioningPar 17, Day 85, Role emotionalPar 17, Day 85, Mental healthPar 17, Day 85, Physical Component SummaryPar 17, Day 85, Mental Component Summary
PartB:Placebo SC q2w + 12 Month PrednisoneNANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA56.25280-6.250005.1-2.52012.528-20-6.250002.71-2.21-10-25-1006.25-12.505-6.513.01
PartB:Placebo SC q2w + 6 Month PrednisoneNANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA-5.01-18.75-321012.5-37.5015-7.543.624.99503356.25255007.938.48NANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA
PartB:SIR 100 mg SC q2w+3 Month PrednisoneNANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA06.25160-6.2500-5-3.33-2.88156.25168000-157.95-6.15-6.25-220-12.5025-15-3.240.02106.250-3000-103.22-3.68012.50-5012.5000.950.83NANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA
PartB:SIR 100 mg SC q2w+6 Month Prednisone-50-16100005-2.262.2600086.250010-0.123.18256.254910000-512.88-5.751518.75006.250004.88-1.451500100-12.50250.773.61-5010-10-6.25-12.516.670-2.11.15-6.2510-22-6.25-12.58.3310-3.171.6206.2500-6.2512.58.330-0.011.88NANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA
PartB:SIR 50 mg SC q4w+6 Month PrednisoneNANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA-29.99-18.750-13-6.25-2505-9.371.44-15.016.250-80-37.5910-3.64-0.4-5-6.25-11-56.250-16.675-2.760.135-12.5000-12.50-252.16-7.59NANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA

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Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B

SF-36v2 acute health survey questionnaire was developed as part of the Rand Health Insurance Experiment and consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for participants (Par) who received at least one dose of 100 mg OL Sirukumab has been presented. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Day 0), Day 85, Day 87, Day 91, Day 113, Day 162, Day 339, Day 344, Week 12 and Week 24

,,,,
InterventionScores on scale (Number)
Par 1, Week 12, Physical FunctioningPar 1, Week 12, Role PhysicalPar 1, Week 12, Bodily PainPar 1, Week 12, General HealthPar 1, Week 12, VitalityPar 1, Week 12, Social FunctioningPar 1, Week 12, Role EmotionalPar 1, Week 12, Mental HealthPar 1, Week 12, Physical Component SummaryPar 1, Week 12, Mental Component SummaryPar 1, Week 24, Physical FunctioningPar 1, Week 24, Role PhysicalPar 1, Week 24, Bodily PainPar 1, Week 24, General HealthPar 1, Week 24, VitalityPar 1, Week 24, Social FunctioningPar 1, Week 24, Role EmotionalPar 1, Week 24, Mental HealthPar 1, Week 24, Physical Component SummaryPar 1, Week 24, Mental Component SummaryPar 1, Day 339, Physical FunctioningPar 1, Day 339, Role PhysicalPar 1, Day 339, Bodily PainPar 1, Day 339, General HealthPar 1, Day 339, VitalityPar 1, Day 339, Social FunctioningPar 1, Day 339, Role EmotionalPar 1, Day 339, Mental HealthPar 1, Day 339, Physical Component SummaryPar 1, Day 339, Mental Component SummaryPar 2, Week 12, Physical FunctioningPar 2, Week 12, Role PhysicalPar 2, Week 12, Bodily PainPar 2, Week 12, General HealthPar 2, Week 12, VitalityPar 2, Week 12, Social FunctioningPar 2, Week 12, Role EmotionalPar 2, Week 12, Mental HealthPar 2, Week 12, Physical Component SummaryPar 2, Week 12, Mental Component SummaryPar 2, Week 24, Physical FunctioningPar 2, Week 24, Role PhysicalPar 2, Week 24, Bodily PainPar 2, Week 24, General HealthPar 2, Week 24, VitalityPar 2, Week 24, Social FunctioningPar 2, Week 24, Role EmotionalPar 2, Week 24, Mental HealthPar 2, Week 24, Physical Component SummaryPar 2, Week 24, Mental Component SummaryPar 2, Day 344, Physical FunctioningPar 2, Day 344, Role PhysicalPar 2, Day 344, Bodily PainPar 2, Day 344, General HealthPar 2, Day 344, VitalityPar 2, Day 344, Social FunctioningPar 2, Day 344, Role EmotionalPar 2, Day 344, Mental HealthPar 2, Day 344, Physical Component SummaryPar 2, Day 344, Mental Component SummaryPar 3, Day 113, Physical FunctioningPar 3, Day 113, Role PhysicalPar 3, Day 113, Bodily PainPar 3, Day 113, General HealthPar 3, Day 113, VitalityPar 3, Day 113, Social FunctioningPar 3, Day 113, Role EmotionalPar 3, Day 113, Mental HealthPar 3, Day 113, Physical Component SummaryPar 3, Day 113, Mental Component SummaryPar 4, Week 12, Physical FunctioningPar 4, Week 12, Role PhysicalPar 4, Week 12, Bodily PainPar 4, Week 12, General HealthPar 4, Week 12, VitalityPar 4, Week 12, Social FunctioningPar 4, Week 12, Role EmotionalPar 4, Week 12, Mental HealthPar 4, Week 12, Physical Component SummaryPar 4, Week 12, Mental Component SummaryPar 5, Week 12, Physical FunctioningPar 5, Week 12, Role PhysicalPar 5, Week 12, Bodily PainPar 5, Week 12, General HealthPar 5, Week 12, VitalityPar 5, Week 12, Social FunctioningPar 5, Week 12, Role EmotionalPar 5, Week 12, Mental HealthPar 5, Week 12, Physical Component SummaryPar 5, Week 12, Mental Component SummaryPar 5, Day 162, Physical FunctioningPar 5, Day 162, Role PhysicalPar 5, Day 162, Bodily PainPar 5, Day 162, General HealthPar 5, Day 162, VitalityPar 5, Day 162, Social FunctioningPar 5, Day 162, Role EmotionalPar 5, Day 162, Mental HealthPar 5, Day 162, Physical Component SummaryPar 5, Day 162, Mental Component SummaryPar 6, Day 91, Physical FunctioningPar 6, Day 91, Role PhysicalPar 6, Day 91, Bodily PainPar 6, Day 91, General HealthPar 6, Day 91, VitalityPar 6, Day 91, Social FunctioningPar 6, Day 91, Role EmotionalPar 6, Day 91, Mental HealthPar 6, Day 91, Physical Component SummaryPar 6, Day 91, Mental Component SummaryPar 7, Day 85, Physical FunctioningPar 7, Day 85, Role PhysicalPar 7, Day 85, Bodily PainPar 7, Day 85, General HealthPar 7, Day 85, VitalityPar 7, Day 85, Social FunctioningPar 7, Day 85, Role EmotionalPar 7, Day 85, Mental HealthPar 7, Day 85, Physical Component SummaryPar 7, Day 85, Mental Component SummaryPar 8, Day 87, Physical FunctioningPar 8, Day 87, Role PhysicalPar 8, Day 87, Bodily PainPar 8, Day 87, General HealthPar 8, Day 87, VitalityPar 8, Day 87, Social FunctioningPar 8, Day 87, Role EmotionalPar 8, Day 87, Mental HealthPar 8, Day 87, Physical Component SummaryPar 8, Day 87, Mental Component Summary
PartB:Placebo SC q2w + 12 Month PrednisoneNANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA10NANANANANANANANANANANANANANANANANANANANANANANANANANA-10.01-6.25-2210-12.5NANA5-4.791.8206.25210012.516.6651.524.54
PartB:Placebo SC q2w + 6 Month PrednisoneNANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA5-18.75-16106.25-25-16.66-5-0.34-5.3510.01-18.75-16-7-12.5-25-33.335-1.62-8.24-15-25220-6.250020-5.175.95NANANANANANANANANANANANANANANANANANANANA
PartB:SIR 100 mg SC q2w+3 Month PrednisoneNANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA-1000-5-6.25NA0-5-1.72-1.05NANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA
PartB:SIR 100 mg SC q2w+6 Month Prednisone-10-12.5-390-6.250-8.3310-8.763.29-4.99-12.51-500-16.675-2.09-0.769.9937.52356.250009.98-2.784.99504910012.5NA-1015.7-5.8424.9950335-6.2512.50-2017.37-10.18-5.0137.51110-6.2512.50-158.12-4.89NANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA168NANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA
PartB:SIR 50 mg SC q4w+6 Month PrednisoneNANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA156.2533-500056.28-1.59NANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANANA

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Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionMillimoles per liter (Mean)
Calcium,Week 4,n=3,3,2,1,2Calcium,Week 12,n=1,1,1,1,1Calcium,Week 16,n=0,1,1,1,0Carbon Dioxide,Week 4,n=3,3,2,1,2Carbon Dioxide,Week 12,n=1,1,1,1,1Carbon Dioxide,Week 16,n=0,1,1,1,0Chloride,Week 4,n=3,3,2,1,2Chloride,Week 12,n=1,1,1,1,1Chloride,Week 16,n=0,1,1,1,0Glucose,Week 4,n=3,3,2,1,2Glucose,Week 12,n=1,1,1,1,1Glucose,Week 16,n=0,1,1,1,0Phosphate,Week 4,n=3,3,2,1,2Phosphate,Week 12,n=1,1,1,1,1Phosphate,Week 16,n=0,1,1,1,0Potassium,Week 4,n=3,3,2,1,2Potassium,Week 12,n=1,1,1,1,1Potassium,Week 16,n=0,1,1,1,0Sodium,Week 4,n=3,3,2,1,2Sodium,Week 12,n=1,1,1,1,1Sodium,Week 16,n=0,1,1,1,0Urea,Week 4,n=3,3,2,1,2Urea,Week 12,n=1,1,1,1,1Urea,Week 16,n=0,1,1,1,0
PartB:Placebo SC q2w + 6 Month Prednisone0.1200.0000.060-1.00.00.0-4.0-2.0-1.00.70-0.502.100.0500.2500.0000.400.00-0.20-3.00.00.00.00-1.000.50

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Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionProportion of red blood cells in blood (Mean)
Hematocrit,Week 2,n=1,1,0,1,2Hematocrit,Week 4,n=2,1,1,2,2Hematocrit,Week 8,n=2,1,1,2,2Hematocrit,Week 12,n=2,0,1,1,0Hematocrit,Week 16,n=2,0,0,1,0Hematocrit,Week 24,n=2,0,0,0,0Hematocrit,Week 36,n=2,0,0,0,0Hematocrit,Week 38,n=1,0,0,0,0Hematocrit,Week 40,n=1,0,0,0,0
PartB:SIR 100 mg SC q2w+6 Month Prednisone-0.00800.00300.01150.01250.00000.00400.0005-0.0050-0.0140

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Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionGiga cells per liter (Mean)
Eosinophils,Week 4,n=3,3,2,1,2Eosinophils,Week 12,n=1,1,1,1,1Eosinophils,Week 16,n=0,1,1,1,0Leukocytes,Week 4,n=3,3,2,1,2Leukocytes,Week 12,n=1,1,1,1,1Leukocytes,Week 16,n=0,1,1,1,0Lymphocytes,Week 4,n=3,3,2,1,2Lymphocytes,Week 12,n=1,1,1,1,1Lymphocytes,Week 16,n=0,1,1,1,0Neutrophils ,Week 4,n=3,3,2,1,2Neutrophils ,Week 12,n=1,1,1,1,1Neutrophils ,Week 16,n=0,1,1,1,0Platelets,Week 4,n=3,3,2,1,2Platelets,Week 12,n=1,1,1,1,1Platelets,Week 16,n=0,1,1,1,0
PartB:Placebo SC q2w + 6 Month Prednisone-0.0300.070-0.050-0.40-1.50-1.30-0.9600.380-0.5200.390-1.770-0.21026.0-8.0-19.0

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Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

,
InterventionGiga cells per liter (Mean)
Eosinophils,Week 4,n=3,3,2,1,2Eosinophils,Week 8,n=2,1,2,0,2Eosinophils,Week 12,n=1,1,1,1,1Leukocytes,Week 4,n=3,3,2,1,2Leukocytes,Week 8,n=2,1,2,0,2Leukocytes,Week 12,n=1,1,1,1,1Lymphocytes,Week 4,n=3,3,2,1,2Lymphocytes,Week 8,n=2,1,2,0,2Lymphocytes,Week 12,n=1,1,1,1,1Neutrophils ,Week 4,n=3,3,2,1,2Neutrophils ,Week 8,n=2,1,2,0,2Neutrophils ,Week 12,n=1,1,1,1,1Platelets,Week 4,n=3,3,2,1,2Platelets,Week 8,n=2,1,2,0,2Platelets,Week 12,n=1,1,1,1,1
PartB:Placebo SC q2w + 12 Month Prednisone0.4150.3300.0301.300.65-0.700.015-0.180-0.6100.8150.500-0.140-14.031.514.0
PartB:SIR 100 mg SC q2w+6 Month Prednisone-0.110-0.070-0.1200.400.25-1.300.2930.470-0.2100.183-0.205-0.75015.017.527.0

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Part A: Cumulative Prednisone Dose Over Time

Cumulative prednisone is the dose from the taper (both open-label and blinded) as well as from the corticosteroid rescue therapies. Cumulative dose at the specified Week was derived as the sum of all the doses from Baseline to the specified Week at each visit was calculated based on the number of participants who attended that visit. For the main analysis of cumulative prednisone dose over time. Data for Prednisone Dose- Study Drug and Prednisone Equivalent Concomitant Therapy for part A is presented. ITT population and the number of participants included at specific time points were based on the participants who attended a scheduled or unscheduled visit mapped to that time point and received a total prednisone dose greater than 0 mg. (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

,,,,
InterventionMilligrams (Mean)
Week 2, n= 40,39,26,27,26Week 4,n=40,39,26,25,27Week 8,n=37, 37,26,23,26Week 12,n=34,32,24,22,24Week 16,n=32,30,24,22,22Week 20,n=29,27,21,24,19Week 24,n=30,25,19,18,17Week 28,n=24,23,15,17,15Week 32,n=19,21,13,15,18Week 36,n=19,17,14,13,14Week 40,n=18,15,11,13,12Week 44,n=17,13,10,12,13Week 48,n=10,16,9,8,11Week 52,n=11,10,6,7,6
PartA:Placebo SC q2w + 12 Month Prednisone430.846751.4071129.0771462.9171729.9772041.6322299.4712387.8002404.5002717.6962963.8652954.7603167.8983603.229
PartA:Placebo SC q2w + 6 Month Prednisone432.815705.4801161.3911379.4091672.7951646.1771917.4442141.2942531.4172617.8172960.1442783.5422859.2083157.054
PartA:SIR 100 mg SC q2w+3 Month Prednisone464.923741.115987.7301063.7731182.2881339.5461495.0151575.5491716.8631803.9192023.3421481.1151601.6562418.213
PartA:SIR 100 mg SC q2w+6 Month Prednisone439.575701.1001086.6761344.4411545.6021690.3021878.4582000.8132216.0002321.7112003.2642051.6031821.3252974.295
PartA:SIR 50 mg SC q4w+6 Month Prednisone424.577701.1921014.7311208.1671348.7501475.7861626.3421797.5331859.3461705.2141842.5001980.7331562.3332556.222

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Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time

SF-36v2 acute health survey questionnaire consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for Physical Component Summary (PCS), Mental Component Summary (MCS) scores was presented. (NCT02531633)
Timeframe: Baseline (Week 0), Weeks 12, 24, 36, 52

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InterventionScores on scale (Mean)
PCS,Baseline, n=42,38,25,23,27PCS,Week 12, n=31,28,24,22,22PCS,Week 24, n=23,20,15,17,16PCS,Week 36, n=15,13,10,12,13PCS,Week 52, n=9,5,5,5,4MCS,Week 12, n=31,28,24,22,22MCS,Week 24, n=23,20,15,17,16MCS,Week 36, n=15,13,10,12,13MCS,Week 52, n=9,5,5,5,4
PartA:Placebo SC q2w + 12 Month Prednisone45.47047.00744.28044.94653.14343.18245.52646.75542.125
PartA:Placebo SC q2w + 6 Month Prednisone49.24048.55246.91148.33652.02643.74645.37242.95942.258
PartA:SIR 100 mg SC q2w+3 Month Prednisone43.27143.12845.67747.06953.69045.26445.95445.54045.008
PartA:SIR 100 mg SC q2w+6 Month Prednisone49.25851.51950.02351.98950.26943.95544.53845.25844.810
PartA:SIR 50 mg SC q4w+6 Month Prednisone42.91943.65545.09746.00553.60846.39344.87744.55042.004

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Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time

EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of the 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. The index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for the conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1 (best score). The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 'Best imaginable health state' and 'Worst imaginable health state'. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 12, 24, 36, 52

,,,,
InterventionScores on scale (Mean)
Baseline, n=42,38,25,23,27Week 12, n=31,28,24,22,22Week 24, n=23,20,15,17,16Week 36, n=15,13,10,12,13Week 52, n=9,5,5,5,4
PartA:Placebo SC q2w + 12 Month Prednisone65.165.561.561.670.0
PartA:Placebo SC q2w + 6 Month Prednisone62.163.364.968.360.2
PartA:SIR 100 mg SC q2w+3 Month Prednisone65.664.270.673.980.6
PartA:SIR 100 mg SC q2w+6 Month Prednisone67.074.374.679.579.9
PartA:SIR 50 mg SC q4w+6 Month Prednisone57.068.465.166.978.4

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Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionGiga cells per liter (Mean)
Eosinophils,Week 4,n=3,3,2,1,2Eosinophils,Week 8,n=2,1,2,0,2Eosinophils,Week 12,n=1,1,1,1,1Eosinophils,Week 16,n=0,1,1,1,0Leukocytes,Week 4,n=3,3,2,1,2Leukocytes,Week 8,n=2,1,2,0,2Leukocytes,Week 12,n=1,1,1,1,1Leukocytes,Week 16,n=0,1,1,1,0Lymphocytes,Week 4,n=3,3,2,1,2Lymphocytes,Week 8,n=2,1,2,0,2Lymphocytes,Week 12,n=1,1,1,1,1Lymphocytes,Week 16,n=0,1,1,1,0Neutrophils ,Week 4,n=3,3,2,1,2Neutrophils ,Week 8,n=2,1,2,0,2Neutrophils ,Week 12,n=1,1,1,1,1Neutrophils ,Week 16,n=0,1,1,1,0Platelets,Week 4,n=3,3,2,1,2Platelets,Week 8,n=2,1,2,0,2Platelets,Week 12,n=1,1,1,1,1Platelets,Week 16,n=0,1,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone-0.0500.020-0.190-0.1800.500.900.800.300.3700.2050.1900.3400.1800.6000.8200.23010.510.014.015.0

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Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionGiga cells per liter (Mean)
Eosinophils,Week 4,n=3,3,2,1,2Eosinophils,Week 8,n=2,1,2,0,2Eosinophils,Week 12,n=1,1,1,1,1Eosinophils,Week 16,n=0,1,1,1,0Eosinophils,Week 24,n=0,1,0,0,0Eosinophils,Week 36,n=0,1,0,0,0Leukocytes,Week 4,n=3,3,2,1,2Leukocytes,Week 8,n=2,1,2,0,2Leukocytes,Week 12,n=1,1,1,1,1Leukocytes,Week 16,n=0,1,1,1,0Leukocytes,Week 24,n=0,1,0,0,0Leukocytes,Week 36,n=0,1,0,0,0Lymphocytes,Week 4,n=3,3,2,1,2Lymphocytes,Week 8,n=2,1,2,0,2Lymphocytes,Week 12,n=1,1,1,1,1Lymphocytes,Week 16,n=0,1,1,1,0Lymphocytes,Week 24,n=0,1,0,0,0Lymphocytes,Week 36,n=0,1,0,0,0Neutrophils ,Week 4,n=3,3,2,1,2Neutrophils ,Week 8,n=2,1,2,0,2Neutrophils ,Week 12,n=1,1,1,1,1Neutrophils ,Week 16,n=0,1,1,1,0Neutrophils ,Week 24,n=0,1,0,0,0Neutrophils ,Week 36,n=0,1,0,0,0Platelets,Week 4,n=3,3,2,1,2Platelets,Week 8,n=2,1,2,0,2Platelets,Week 12,n=1,1,1,1,1Platelets,Week 16,n=0,1,1,1,0Platelets,Week 24,n=0,1,0,0,0Platelets,Week 36,n=0,1,0,0,0
PartB:SIR 100 mg SC q2w+3 Month Prednisone-0.0130.020-0.120-0.200-0.100-0.2400.300.10-1.60-0.50-0.60-1.100.0770.0900.140-0.0400.000-0.2400.3330.010-1.440-0.220-0.350-0.420-6.0-25.0-20.0-4.0-20.0-16.0

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Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

,
InterventionGiga cells per liter (Mean)
Eosinophils,Week 2,n=1,1,0,1,2Eosinophils,Week 4,n=2,1,1,2,2Eosinophils,Week 8,n=2,1,1,2,1Leukocytes,Week 2,n=1,1,0,1,2Leukocytes,Week 4,n=2,1,1,2,2Leukocytes,Week 8,n=2,1,1,2,1Lymphocytes,Week 2,n=1,1,0,1,2Lymphocytes,Week 4,n=2,1,1,2,2Lymphocytes,Week 8,n=2,1,1,2,1Neutrophils ,Week 2,n=1,1,0,1,2Neutrophils ,Week 4,n=2,1,1,2,2Neutrophils ,Week 8,n=2,1,1,2,2Platelets ,Week 2,n=1,1,0,1,2Platelets,Week 4,n=2,1,1,2,2Platelets,Week 8,n=2,1,1,2,1
PartB:Placebo SC q2w + 12 Month Prednisone-0.0100.0350.045-2.30-1.45-0.95-0.160-0.115-0.275-2.210-1.420-0.790-20.5-42.0-40.0
PartB:SIR 100 mg SC q2w+3 Month Prednisone-0.110-0.210-0.1800.30-0.300.000.000-0.3400.1600.5100.4000.0604.06.0-6.0

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Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionGiga cells per liter (Mean)
Eosinophils,Week 4,n=2,1,1,2,2Eosinophils,Week 8,n=2,1,1,2,1Eosinophils,Week 12,n=2,0,1,1,0Leukocytes,Week 4,n=2,1,1,2,2Leukocytes,Week 8,n=2,1,1,2,1Leukocytes,Week 12,n=2,0,1,1,0Lymphocytes,Week 4,n=2,1,1,2,2Lymphocytes,Week 8,n=2,1,1,2,1Lymphocytes,Week 12,n=2,0,1,1,0Neutrophils ,Week 4,n=2,1,1,2,2Neutrophils ,Week 8,n=2,1,1,2,2Neutrophils ,Week 12,n=2,0,1,1,0Platelets,Week 4,n=2,1,1,2,2Platelets,Week 8,n=2,1,1,2,1Platelets,Week 12,n=2,0,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone-0.0100.0400.0300.200.600.90-0.0100.0500.3000.2300.6200.630-1.02.052.0

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Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time

EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score). (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 12, 24, 36, 52

,,,,
InterventionScores on scale (Mean)
Baseline, n=42,38,25,23,27Week 12, n=31,28,24,22,22Week 24, n=23,20,15,17,16Week 36, n=15,13,10,12,13Week 52, n=9,5,5,5,4
PartA:Placebo SC q2w + 12 Month Prednisone0.75540.70690.73010.75060.8068
PartA:Placebo SC q2w + 6 Month Prednisone0.74290.72280.73230.69500.7864
PartA:SIR 100 mg SC q2w+3 Month Prednisone0.66810.70240.72170.74540.7628
PartA:SIR 100 mg SC q2w+6 Month Prednisone0.79180.78660.74850.80110.8210
PartA:SIR 50 mg SC q4w+6 Month Prednisone0.69120.74520.71350.77740.8092

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Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time

The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Each negatively-worded item response was recoded so that 0 is a bad response and 4 is good response. All responses were added with equal weight to obtain the total score. The total score was calculated as the sum of all the individual items after recoding some of the items. (NCT02531633)
Timeframe: Baseline (Week 0), Weeks 12, 24, 36, 52

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InterventionScores on scale (Mean)
Baseline, n=42,38,25,23,27Week 12, n=31,28,24,22,22Week 24, n=23,20,15,17,16Week 36, n=15,13,10,12,13Week 52, n=9,5,5,5,4
PartA:Placebo SC q2w + 12 Month Prednisone34.135.536.037.541.0
PartA:Placebo SC q2w + 6 Month Prednisone38.038.536.240.944.0
PartA:SIR 100 mg SC q2w+3 Month Prednisone34.232.736.538.443.0
PartA:SIR 100 mg SC q2w+6 Month Prednisone38.740.238.141.442.1
PartA:SIR 50 mg SC q4w+6 Month Prednisone31.134.331.236.940.4

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Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time

"Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing no difficulty (0), some difficulty (1), much difficulty (2), and unable to do (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability." (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 12, 24, 36 and 52

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InterventionScores on scale (Mean)
Baseline, n=19,14,13,9,12Week 12, n=12,8,12,9,9Week 24, n=10, 7,7,7,9Week 36, n=6,5,4,4,7Week 52, n=5,2,3,1,2
PartA:Placebo SC q2w + 12 Month Prednisone0.86460.93060.95831.00000.1875
PartA:Placebo SC q2w + 6 Month Prednisone0.88890.56940.91070.56250.0000
PartA:SIR 100 mg SC q2w+3 Month Prednisone1.12501.09380.87500.82500.3125
PartA:SIR 100 mg SC q2w+6 Month Prednisone0.67760.32290.58750.52080.3000
PartA:SIR 50 mg SC q4w+6 Month Prednisone0.96150.72920.98210.62500.1667

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Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time

"The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain on a 11-point numeric rating scale ranging from 0, no pain to 10, the worst pain imaginable. Data for NRS scores over time for part A is reported." (NCT02531633)
Timeframe: Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

,,,,
InterventionScores on scale (Mean)
Baseline, n=42,38,25,23,27Week 2, n=38,38,25,21,27Week 4, n=36,37,24,22,27Week 8, n=34,30,24,21,23Week 12, n=31,28,24,22,22Week 16, n=27,25,22,19,19Week 20, n=26,23,19,18,15Week 24, n=23,20,15,17,16Week 28, n=18,17,11,13,14Week 32, n=19,14,9,12,12Week 36, n=15,13,10,12,13Week 40, n=15,11,9,10,10Week 44, n=11,11,6,8,8Week 48, n=9,8,5,7,5Week 52, n=9,5,5,5,4
PartA:Placebo SC q2w + 12 Month Prednisone2.62.61.83.32.02.72.73.52.93.11.92.63.04.01.0
PartA:Placebo SC q2w + 6 Month Prednisone2.62.62.42.12.32.41.42.42.32.62.31.91.31.62.2
PartA:SIR 100 mg SC q2w+3 Month Prednisone2.52.83.12.93.63.32.92.52.81.92.02.01.90.80.8
PartA:SIR 100 mg SC q2w+6 Month Prednisone1.81.31.71.81.71.41.72.42.62.11.62.02.11.91.3
PartA:SIR 50 mg SC q4w+6 Month Prednisone3.12.83.33.03.33.03.63.33.62.92.93.12.22.62.8

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Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time

"The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS) of 10 centimeter (cm) ranging from 0 (very well) to 10 (very poor)." (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

,,,,
InterventionScores on scale (Mean)
Baseline, n=42,39,25,26,27Week 2, n=38,38,25,21,27Week 4, n=36,37,24,22,27Week 8, n=34,30,24,21,23Week 12, n=31,28,24,22,22Week 16, n=27,25,22,19,19Week 20, n=26,23,19,18,15Week 24, n=23,20,15,17,16Week 28, n=18,17,11,13,14Week 32, n=19,14,9,12,12Week 36, n=15,13,10,12,13Week 40, n=15,11,9,10,10Week 44, n=11,11,6,8,8Week 48, n=9,8,5,7,5Week 52, n=9,5,5,5,4
PartA:Placebo SC q2w + 12 Month Prednisone3.643.522.622.902.752.762.903.342.742.882.623.003.494.482.13
PartA:Placebo SC q2w + 6 Month Prednisone3.603.453.012.853.202.862.452.852.682.432.682.242.181.862.44
PartA:SIR 100 mg SC q2w+3 Month Prednisone3.723.513.753.873.803.823.202.333.092.222.662.352.191.030.46
PartA:SIR 100 mg SC q2w+6 Month Prednisone2.962.592.431.971.971.952.602.632.442.011.462.052.281.811.10
PartA:SIR 50 mg SC q4w+6 Month Prednisone4.243.733.813.443.953.394.173.834.183.022.793.202.172.302.76

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Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time

"The Physician's Global Assessments of Disease Activity was recorded on a VAS of 10 cm ranging from 0 (none) to 10 (extremely active)." (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

,,,,
InterventionScores on scale (Mean)
Baseline, n=42,39,25,26,27Week 2, n=36,35,25,20,26Week 4, n=33,32,23,21,25Week 8, n=33,28,23,20,21Week 12, n=29,25,23,18,21Week 16, n=26,23,21,16,19Week 20, n=25,23,18,17,15Week 24, n=20,20,15,15,15Week 28, n=17,17,11,12,13Week 32, n=19,14,8,11,12Week 36, n=13,11,10,11,13Week 40, n=13,9,8,9,10Week 44, n=10,9,6,8,7Week 48, n=7,7,5,6,5Week 52, n=9,5,5,4,4
PartA:Placebo SC q2w + 12 Month Prednisone3.251.761.021.141.470.671.271.370.850.890.750.570.871.601.80
PartA:Placebo SC q2w + 6 Month Prednisone3.051.850.920.791.281.390.831.480.881.260.560.520.580.781.35
PartA:SIR 100 mg SC q2w+3 Month Prednisone2.951.521.441.301.811.541.420.681.430.671.120.771.070.310.10
PartA:SIR 100 mg SC q2w+6 Month Prednisone2.331.090.811.091.080.740.710.820.760.830.480.380.310.270.31
PartA:SIR 50 mg SC q4w+6 Month Prednisone2.941.831.551.351.641.871.161.501.181.400.610.360.430.300.32

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Part A: Number of Disease Flares Over Time

This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants; participants who did not reach Week 2 were not included in this analysis. Data for number of disease flares per participant over time for part A were presented. (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

,,,,
InterventionDisease flares (Number)
Week 2, n=38, 39,26,25,27Week 4, n=37,37,25,23,27Week 8, n=34,32,24,23,23Week 12, n=32,29,24,22,22Week 16, n=28,26,22,19,19Week 20, n=26,23,19,18,16Week 24, n=23,21,16,17,16Week 28, n=19,18,12,14,14Week 32, n=19,15,10,12,13Week 36, n=15,13,10,12,13Week 40, n=15,11,9,10,10Week 44, n=11,11,6,8,9Week 48, n=9,8,5,8,5Week 52, n=9,5,5,5,4
PartA:Placebo SC q2w + 12 Month Prednisone22544355665734
PartA:Placebo SC q2w + 6 Month Prednisone0014910111110108677
PartA:SIR 100 mg SC q2w+3 Month Prednisone24699998887842
PartA:SIR 100 mg SC q2w+6 Month Prednisone13244465532111
PartA:SIR 50 mg SC q4w+6 Month Prednisone23345688555311

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Part A: Number of Hospitalizations for Disease Flare Over Time

Number of hospitalizations for disease flare at given visit is the number of hospitalizations for disease flare between first SC IP intake and the day of the of the given visit.. Data for number of hospitalizations for disease flare over time for part A was presented. (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

,,,,
InterventionNumber of Hospitalizations (Number)
Week 2, n=38, 39,26,25,27Week 4, n=37,37,25,23,27Week 8, n=34,32,24,23,23Week 12, n=32,29,24,22,22Week 16, n=28,26,22,19,19Week 20, n=26,23,19,18,16Week 24, n=23,21,16,17,16Week 28, n=19,18,12,14,14Week 32, n=19,15,10,12,13Week 36, n=15,13,10,12,13Week 40, n=15,11,9,10,10Week 44, n=11,11,6,8,9Week 48, n=9,8,5,8,5Week 52, n=9,5,5,5,4
PartA:Placebo SC q2w + 12 Month Prednisone00000000000000
PartA:Placebo SC q2w + 6 Month Prednisone00000000000000
PartA:SIR 100 mg SC q2w+3 Month Prednisone00000000000000
PartA:SIR 100 mg SC q2w+6 Month Prednisone00022220000000
PartA:SIR 50 mg SC q4w+6 Month Prednisone00000111000000

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Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

,
InterventionMillimoles per liter (Mean)
Calcium,Week 4,n=3,3,2,1,2Calcium,Week 8,n=2,1,2,0,2Calcium,Week 12,n=1,1,1,1,1Carbon Dioxide,Week 4,n=3,3,2,1,2Carbon Dioxide,Week 8,n=2,1,2,0,2Carbon Dioxide,Week 12,n=1,1,1,1,1Chloride,Week 4,n=3,3,2,1,2Chloride,Week 8,n=2,1,2,0,2Chloride,Week 12,n=1,1,1,1,1Glucose,Week 4,n=3,3,2,1,2Glucose,Week 8,n=2,1,2,0,2Glucose,Week 12,n=1,1,1,1,1Phosphate,Week 4,n=3,3,2,1,2Phosphate,Week 8,n=2,1,2,0,2Phosphate,Week 12,n=1,1,1,1,1Potassium,Week 4,n=3,3,2,1,2Potassium,Week 8,n=2,1,2,0,2Potassium,Week 12,n=1,1,1,1,1Sodium,Week 4,n=3,3,2,1,2Sodium,Week 8,n=2,1,2,0,2Sodium,Week 12,n=1,1,1,1,1Urea,Week 4,n=3,3,2,1,2Urea,Week 8,n=2,1,2,0,2Urea,Week 12,n=1,1,1,1,1
PartB:Placebo SC q2w + 12 Month Prednisone-0.0400.0200.000-3.0-1.5-3.00.50.5-2.0-0.400.550.20-0.025-0.075-0.100-0.10-0.10-0.40-1.0-1.0-4.0-0.250.50-2.50
PartB:SIR 100 mg SC q2w+6 Month Prednisone0.0670.0100.0200.0-0.51.00.7-2.0-2.0-0.100.150.000.0500.1500.050-0.27-0.25-0.200.3-2.5-2.0-0.83-0.50-0.50

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Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionMillimoles per liter (Mean)
Calcium,Week 4,n=3,3,2,1,2Calcium,Week 8,n=2,1,2,0,2Calcium,Week 12,n=1,1,1,1,1Calcium,Week 16,n=0,1,1,1,0Carbon Dioxide,Week 4,n=3,3,2,1,2Carbon Dioxide,Week 8,n=2,1,2,0,2Carbon Dioxide,Week 12,n=1,1,1,1,1Carbon Dioxide,Week 16,n=0,1,1,1,0Chloride,Week 4,n=3,3,2,1,2Chloride,Week 8,n=2,1,2,0,2Chloride,Week 12,n=1,1,1,1,1Chloride,Week 16,n=0,1,1,1,0Glucose,Week 4,n=3,3,2,1,2Glucose,Week 8,n=2,1,2,0,2Glucose,Week 12,n=1,1,1,1,1Glucose,Week 16,n=0,1,1,1,0Phosphate,Week 4,n=3,3,2,1,2Phosphate,Week 8,n=2,1,2,0,2Phosphate,Week 12,n=1,1,1,1,1Phosphate,Week 16,n=0,1,1,1,0Potassium,Week 4,n=3,3,2,1,2Potassium,Week 8,n=2,1,2,0,2Potassium,Week 12,n=1,1,1,1,1Potassium,Week 16,n=0,1,1,1,0Sodium,Week 4,n=3,3,2,1,2Sodium,Week 8,n=2,1,2,0,2Sodium,Week 12,n=1,1,1,1,1Sodium,Week 16,n=0,1,1,1,0Urea,Week 4,n=3,3,2,1,2Urea,Week 8,n=2,1,2,0,2Urea,Week 12,n=1,1,1,1,1Urea,Week 16,n=0,1,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone0.0600.0500.1600.1800.00.50.01.0-2.5-2.5-4.0-5.0-0.80-0.850.300.30-0.125-0.2500.0000.0000.100.000.40-0.10-3.0-3.5-4.0-4.0-0.50-0.750.00-0.50

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Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionMillimoles per liter (Mean)
Calcium,Week 4,n=3,3,2,1,2Calcium,Week 8,n=2,1,2,0,2Calcium,Week 12,n=1,1,1,1,1Calcium,Week 16,n=0,1,1,1,0Calcium,Week 24,n=0,1,0,0,0Calcium,Week 36,n=0,1,0,0,0Carbon Dioxide,Week 4,n=3,3,2,1,2Carbon Dioxide,Week 8,n=2,1,2,0,2Carbon Dioxide,Week 12,n=1,1,1,1,1Carbon Dioxide,Week 16,n=0,1,1,1,0Carbon Dioxide,Week 24,n=0,1,0,0,0Carbon Dioxide,Week 36,n=0,1,0,0,0Chloride,Week 4,n=3,3,2,1,2Chloride,Week 8,n=2,1,2,0,2Chloride,Week 12,n=1,1,1,1,1Chloride,Week 16,n=0,1,1,1,0Chloride,Week 24,n=0,1,0,0,0Chloride,Week 36,n=0,1,0,0,0Glucose,Week 4,n=3,3,2,1,2Glucose,Week 8,n=2,1,2,0,2Glucose,Week 12,n=1,1,1,1,1Glucose,Week 16,n=0,1,1,1,0Glucose,Week 24,n=0,1,0,0,0Glucose,Week 36,n=0,1,0,0,0Phosphate,Week 4,n=3,3,2,1,2Phosphate,Week 8,n=2,1,2,0,2Phosphate,Week 12,n=1,1,1,1,1Phosphate,Week 16,n=0,1,1,1,0Phosphate,Week 24,n=0,1,0,0,0Phosphate,Week 36,n=0,1,0,0,0Potassium,Week 4,n=3,3,2,1,2Potassium,Week 8,n=2,1,2,0,2Potassium,Week 12,n=1,1,1,1,1Potassium,Week 16,n=0,1,1,1,0Potassium,Week 24,n=0,1,0,0,0Potassium,Week 36,n=0,1,0,0,0Sodium,Week 4,n=3,3,2,1,2Sodium,Week 8,n=2,1,2,0,2Sodium,Week 12,n=1,1,1,1,1Sodium,Week 16,n=0,1,1,1,0Sodium,Week 24,n=0,1,0,0,0Sodium,Week 36,n=0,1,0,0,0Urea,Week 4,n=3,3,2,1,2Urea,Week 8,n=2,1,2,0,2Urea,Week 12,n=1,1,1,1,1Urea,Week 16,n=0,1,1,1,0Urea,Week 24,n=0,1,0,0,0Urea,Week 36,n=0,1,0,0,0
PartB:SIR 100 mg SC q2w+3 Month Prednisone-0.093-0.0600.0400.040-0.040-0.020-2.7-4.0-2.00.01.0-2.00.3-1.00.01.01.00.00.330.602.801.401.102.10-0.033-0.100-0.2500.1000.050-0.1500.03-0.30-0.20-0.10-0.10-0.20-1.02.01.00.03.01.0-0.500.00-1.500.00-0.50-1.00

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Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionMillimoles per liter (Mean)
Calcium,Week 2,n=1,1,0,1,2Calcium,Week 4,n=2,1,1,2,2Calcium,Week 8,n=2,1,1,2,1Carbon Dioxide,Week 2,n=1,1,0,1,2Carbon Dioxide,Week 4,n=2,1,1,2,2Carbon Dioxide,Week 8,n=2,1,1,2,1Chloride,Week 2,n=1,1,0,1,2Chloride,Week 4,n=2,1,1,2,2Chloride,Week 8,n=2,1,1,2,1Glucose,Week 2,n=1,1,0,1,2Glucose,Week 4,n=2,1,1,2,2Glucose,Week 8,n=2,1,1,2,1Phosphate,Week 2,n=1,1,0,1,2Phosphate,Week 4,n=2,1,1,2,2Phosphate,Week 8,n=2,1,1,2,1Potassium,Week 2,n=1,1,0,1,2Potassium,Week 4,n=2,1,1,2,2Potassium,Week 8,n=2,1,1,2,1Sodium,Week 2,n=1,1,0,1,2Sodium,Week 4,n=2,1,1,2,2Sodium,Week 8,n=2,1,1,2,1Urea,Week 2,n=1,1,0,1,2Urea,Week 4,n=2,1,1,2,2Urea,Week 8,n=2,1,1,2,1
PartB:Placebo SC q2w + 12 Month Prednisone0.0400.0000.020-1.0-3.5-1.01.01.53.01.25-0.050.200.000-0.050-0.0500.100.000.101.00.52.00.750.250.50

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Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionMillimoles per liter (Mean)
Calcium,Week 4,n=2,1,1,2,2Calcium,Week 8,n=2,1,1,2,1Calcium,Week 12,n=2,1,1,1,0Carbon Dioxide,Week 4,n=2,1,1,2,2Carbon Dioxide,Week 8,n=2,1,1,2,1Carbon Dioxide,Week 12,n=2,1,1,1,0Chloride,Week 4,n=2,1,1,2,2Chloride,Week 8,n=2,1,1,2,1Chloride,Week 12,n=2,1,1,1,0Glucose,Week 4,n=2,1,1,2,2Glucose,Week 8,n=2,1,1,2,1Glucose,Week 12,n=2,1,1,1,0Phosphate,Week 4,n=2,1,1,2,2Phosphate,Week 8,n=2,1,1,2,1Phosphate,Week 12,n=2,1,1,1,0Potassium,Week 4,n=2,1,1,2,2Potassium,Week 8,n=2,1,1,2,1Potassium,Week 12,n=2,1,1,1,0Sodium,Week 4,n=2,1,1,2,2Sodium,Week 8,n=2,1,1,2,1Sodium,Week 12,n=2,1,1,1,0Urea,Week 4,n=2,1,1,2,2Urea,Week 8,n=2,1,1,2,1Urea,Week 12,n=2,1,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone-0.0800.0000.0002.01.02.06.02.0-1.0-0.700.100.000.0000.1500.0500.200.500.303.00.0-2.01.503.001.50

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Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionMillimoles per liter (Mean)
Calcium,Week 2,n=1,1,0,1,2Calcium,Week 4,n=2,1,1,2,2Calcium,Week 8,n=2,1,1,2,1Calcium,Week 12,n=2,1,1,1,0Carbon Dioxide,Week 2,n=1,1,0,1,2Carbon Dioxide,Week 4,n=2,1,1,2,2Carbon Dioxide,Week 8,n=2,1,1,2,1Carbon Dioxide,Week 12,n=2,1,1,1,0Chloride,Week 2,n=1,1,0,1,2Chloride,Week 4,n=2,1,1,2,2Chloride,Week 8,n=2,1,1,2,1Chloride,Week 12,n=2,1,1,1,0Glucose,Week 2,n=1,1,0,1,2Glucose,Week 4,n=2,1,1,2,2Glucose,Week 8,n=2,1,1,2,1Glucose,Week 12,n=2,1,1,1,0Phosphate,Week 2,n=1,1,0,1,2Phosphate,Week 4,n=2,1,1,2,2Phosphate,Week 8,n=2,1,1,2,1Phosphate,Week 12,n=2,1,1,1,0Potassium,Week 2,n=1,1,0,1,2Potassium,Week 4,n=2,1,1,2,2Potassium,Week 8,n=2,1,1,2,1Potassium,Week 12,n=2,1,1,1,0Sodium,Week 2,n=1,1,0,1,2Sodium,Week 4,n=2,1,1,2,2Sodium,Week 8,n=2,1,1,2,1Sodium,Week 12,n=2,1,1,1,0Urea,Week 2,n=1,1,0,1,2Urea,Week 4,n=2,1,1,2,2Urea,Week 8,n=2,1,1,2,1Urea,Week 12,n=2,1,1,1,0
PartB:SIR 100 mg SC q2w+3 Month Prednisone0.000-0.100-0.140NA-5.0-3.0-4.0NA2.01.00.0NA0.200.400.000.00-0.100-0.250-0.200NA-0.20-0.200.00NA-2.0-1.0-1.0NA-2.50-1.00-2.00NA

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Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionMillimoles per liter (Mean)
Calcium,Week 2,n=1,1,0,1,2Calcium,Week 4,n=2,1,1,2,2Calcium,Week 8,n=2,1,1,2,1Calcium,Week 12,n=2,1,1,1,0Calcium,Week 14,n=0,0,0,1,0Calcium,Week 16,n=2,0,0,1,0Carbon Dioxide,Week 2,n=1,1,0,1,2Carbon Dioxide,Week 4,n=2,1,1,2,2Carbon Dioxide,Week 8,n=2,1,1,2,1Carbon Dioxide,Week 12,n=2,1,1,1,0Carbon Dioxide,Week 14,n=0,0,0,1,0Carbon Dioxide,Week 16,n=2,0,0,1,0Chloride,Week 2,n=1,1,0,1,2Chloride,Week 4,n=2,1,1,2,2Chloride,Week 8,n=2,1,1,2,1Chloride,Week 12,n=2,1,1,1,0Chloride,Week 14,n=0,0,0,1,0Chloride,Week 16,n=2,0,0,1,0Glucose,Week 2,n=1,1,0,1,2Glucose,Week 4,n=2,1,1,2,2Glucose,Week 8,n=2,1,1,2,1Glucose,Week 12,n=2,1,1,1,0Glucose,Week 14,n=0,0,0,1,0Glucose,Week 16,n=2,0,0,1,0Phosphate,Week 2,n=1,1,0,1,2Phosphate,Week 4,n=2,1,1,2,2Phosphate,Week 8,n=2,1,1,2,1Phosphate,Week 12,n=2,1,1,1,0Phosphate,Week 14,n=0,0,0,1,0Phosphate,Week 16,n=2,0,0,1,0Potassium,Week 2,n=1,1,0,1,2Potassium,Week 4,n=2,1,1,2,2Potassium,Week 8,n=2,1,1,2,1Potassium,Week 12,n=2,1,1,1,0Potassium,Week 14,n=0,0,0,1,0Potassium,Week 16,n=2,0,0,1,0Sodium,Week 2,n=1,1,0,1,2Sodium,Week 4,n=2,1,1,2,2Sodium,Week 8,n=2,1,1,2,1Sodium,Week 12,n=2,1,1,1,0Sodium,Week 14,n=0,0,0,1,0Sodium,Week 16,n=2,0,0,1,0Urea,Week 2,n=1,1,0,1,2Urea,Week 4,n=2,1,1,2,2Urea,Week 8,n=2,1,1,2,1Urea,Week 12,n=2,1,1,1,0Urea,Week 14,n=0,0,0,1,0Urea,Week 16,n=2,0,0,1,0
PartB:Placebo SC q2w + 6 Month Prednisone0.1000.050-0.020-0.0400.0000.140-2.0-1.5-1.0-3.01.0-1.00.00.51.01.01.00.01.30-0.050.30-0.10-0.10-0.20-0.3000.050-0.0750.2000.2500.3000.00-0.30-0.300.100.00-0.10-2.00.5-0.52.02.00.00.501.50-0.250.001.001.50

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Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionMillimoles per liter (Mean)
Calcium,Week 2,n=1,1,0,1,2Calcium,Week 4,n=2,1,1,2,2Calcium,Week 8,n=2,1,1,2,1Calcium,Week 12,n=2,1,1,1,0Calcium,Week 16,n=2,0,0,1,0Calcium,Week 24,n=2,0,0,0,0Calcium,Week 36,n=2,0,0,0,0Calcium,Week 38,n=1,0,0,0,0Calcium,Week 40,n=1,0,0,0,0Carbon Dioxide,Week 2,n=1,1,0,1,2Carbon Dioxide,Week 4,n=2,1,1,2,2Carbon Dioxide,Week 8,n=2,1,1,2,1Carbon Dioxide,Week 12,n=2,1,1,1,0Carbon Dioxide,Week 16,n=2,0,0,1,0Carbon Dioxide,Week 24,n=2,0,0,0,0Carbon Dioxide,Week 36,n=2,0,0,0,0Carbon Dioxide,Week 38,n=1,0,0,0,0Carbon Dioxide,Week 40,n=1,0,0,0,0Chloride,Week 2,n=1,1,0,1,2Chloride,Week 4,n=2,1,1,2,2Chloride,Week 8,n=2,1,1,2,1Chloride,Week 12,n=2,1,1,1,0Chloride,Week 16,n=2,0,0,1,0Chloride,Week 24,n=2,0,0,0,0Chloride,Week 36,n=2,0,0,0,0Chloride,Week 38,n=1,0,0,0,0Chloride,Week 40,n=1,0,0,0,0Glucose,Week 2,n=1,1,0,1,2Glucose,Week 4,n=2,1,1,2,2Glucose,Week 8,n=2,1,1,2,1Glucose,Week 12,n=2,1,1,1,0Glucose,Week 16,n=2,0,0,1,0Glucose,Week 24,n=2,0,0,0,0Glucose,Week 36,n=2,0,0,0,0Glucose,Week 38,n=1,0,0,0,0Glucose,Week 40,n=1,0,0,0,0Phosphate,Week 2,n=1,1,0,1,2Phosphate,Week 4,n=2,1,1,2,2Phosphate,Week 8,n=2,1,1,2,1Phosphate,Week 12,n=2,1,1,1,0Phosphate,Week 16,n=2,0,0,1,0Phosphate,Week 24,n=2,0,0,0,0Phosphate,Week 36,n=2,0,0,0,0Phosphate,Week 38,n=1,0,0,0,0Phosphate,Week 40,n=1,0,0,0,0Potassium,Week 2,n=1,1,0,1,2Potassium,Week 4,n=2,1,1,2,2Potassium,Week 8,n=2,1,1,2,1Potassium,Week 12,n=2,1,1,1,0Potassium,Week 16,n=2,0,0,1,0Potassium,Week 24,n=2,0,0,0,0Potassium,Week 36,n=2,0,0,0,0Potassium,Week 38,n=1,0,0,0,0Potassium,Week 40,n=1,0,0,0,0Sodium,Week 2,n=1,1,0,1,2Sodium,Week 4,n=2,1,1,2,2Sodium,Week 8,n=2,1,1,2,1Sodium,Week 12,n=2,1,1,1,0Sodium,Week 16,n=2,0,0,1,0Sodium,Week 24,n=2,0,0,0,0Sodium,Week 36,n=2,0,0,0,0Sodium,Week 38,n=1,0,0,0,0Sodium,Week 40,n=1,0,0,0,0Urea,Week 2,n=1,1,0,1,2Urea,Week 4,n=2,1,1,2,2Urea,Week 8,n=2,1,1,2,1Urea,Week 12,n=2,1,1,1,0Urea,Week 16,n=2,0,0,1,0Urea,Week 24,n=2,0,0,0,0Urea,Week 36,n=2,0,0,0,0Urea,Week 38,n=1,0,0,0,0Urea,Week 40,n=1,0,0,0,0
PartB:SIR 100 mg SC q2w+6 Month Prednisone0.0600.0700.1200.1100.0000.040-0.050-0.020-0.0203.03.52.53.50.53.01.51.0-2.0-1.0-2.5-3.0-2.5-1.0-2.00.5-1.00.00.800.950.700.600.550.650.350.503.600.050-0.1250.025-0.025-0.0500.050-0.0250.0000.0000.100.200.100.250.000.400.200.00-0.300.0-0.5-2.0-1.0-1.5-0.52.0-1.02.0-1.001.252.00-0.501.250.000.001.501.50

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Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionMicromoles per liter (Mean)
Bilirubin,Week 4,n=3,3,2,1,2Bilirubin,Week 8,n=2,1,2,0,2Bilirubin,Week 12,n=1,1,1,1,1Bilirubin,Week 16,n=0,1,1,1,0Bilirubin,Week 24,n=0,1,0,0,0Bilirubin,Week 36,n=0,1,0,0,0Direct Bilirubin,Week 4,n=3,3,2,1,2Direct Bilirubin,Week 8,n=2,1,2,0,2Direct Bilirubin,Week 12,n=1,1,1,1,1Direct Bilirubin,Week 16,n=0,1,1,1,0Direct Bilirubin,Week 24,n=0,1,0,0,0Direct Bilirubin,Week 36,n=0,1,0,0,0Indirect Bilirubin,Week 4,n=3,3,2,1,2Indirect Bilirubin,Week 8,n=2,1,2,0,2Indirect Bilirubin,Week 12,n=1,1,1,1,1Indirect Bilirubin,Week 16,n=0,1,1,1,0Indirect Bilirubin,Week 24,n=0,1,0,0,0Indirect Bilirubin,Week 36,n=0,1,0,0,0Creatinine,Week 4,n=3,3,2,1,2Creatinine,Week 8,n=2,1,2,0,2Creatinine,Week 12,n=1,1,1,1,1Creatinine,Week 16,n=0,1,1,1,0Creatinine,Week 24,n=0,1,0,0,0Creatinine,Week 36,n=0,1,0,0,0
PartBSIR 100 mg SC q2w+3 Month Prednisone1.32.0-2.0-2.0-2.0-4.00.02.02.00.00.00.01.30.0-4.0-2.0-2.0-4.0-0.63-18.60-27.40-19.50-27.40-21.20

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Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionMicromoles per liter (Mean)
Bilirubin,Week 4,n=3,3,2,1,2Bilirubin,Week 8,n=2,1,2,0,2Bilirubin,Week 12,n=1,1,1,1,1Bilirubin,Week 16,n=0,1,1,1,0Direct Bilirubin,Week 4,n=3,3,2,1,2Direct Bilirubin,Week 8,n=2,1,2,0,2Direct Bilirubin,Week 12,n=1,1,1,1,1Direct Bilirubin,Week 16,n=0,1,1,1,0Indirect Bilirubin,Week 4,n=3,3,2,1,2Indirect Bilirubin,Week 8,n=2,1,2,0,2Indirect Bilirubin,Week 12,n=1,1,1,1,1Indirect Bilirubin,Week 16,n=0,1,1,1,0Creatinine,Week 4,n=3,3,2,1,2Creatinine,Week 8,n=2,1,2,0,2Creatinine,Week 12,n=1,1,1,1,1Creatinine,Week 16,n=0,1,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone-5.0-4.02.0-2.00.00.00.00.0-5.0-4.02.0-2.0-1.30-5.255.305.30

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Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

,
InterventionMicromoles per liter (Mean)
Bilirubin,Week 4,n=3,3,2,1,2Bilirubin,Week 8,n=2,1,2,0,2Bilirubin,Week 12,n=1,1,1,1,1Direct Bilirubin,Week 4,n=3,3,2,1,2Direct Bilirubin,Week 8,n=2,1,2,0,2Direct Bilirubin,Week 12,n=1,1,1,1,1Indirect Bilirubin,Week 4,n=3,3,2,1,2Indirect Bilirubin,Week 8,n=2,1,2,0,2Indirect Bilirubin,Week 12,n=1,1,1,1,1Creatinine,Week 4,n=3,3,2,1,2Creatinine,Week 8,n=2,1,2,0,2Creatinine,Week 12,n=1,1,1,1,1
PartBPlacebo SC q2w + 12 Month Prednisone-8.0-6.0-8.0-2.0-2.0-2.0-6.0-4.0-6.03.95-5.75-19.50
PartBSIR 100 mg SC q2w+6 Month Prednisone0.73.04.00.01.02.00.72.02.0-7.07-8.40-6.20

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Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionMicromoles per liter (Mean)
Bilirubin,Week 4,n=3,3,2,1,2Bilirubin,Week 12,n=1,1,1,1,1Bilirubin,Week 16,n=0,1,1,1,0Direct Bilirubin,Week 4,n=3,3,2,1,2Direct Bilirubin,Week 12,n=1,1,1,1,1Direct Bilirubin,Week 16,n=0,1,1,1,0Indirect Bilirubin,Week 4,n=3,3,2,1,2Indirect Bilirubin,Week 12,n=1,1,1,1,1Indirect Bilirubin,Week 16,n=0,1,1,1,0Creatinine,Week 4,n=3,3,2,1,2Creatinine,Week 12,n=1,1,1,1,1Creatinine,Week 16,n=0,1,1,1,0
PartBPlacebo SC q2w + 6 Month Prednisone0.04.04.00.00.00.00.04.04.0-0.909.705.30

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Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionGrams per liter (Mean)
Albumin,Week 4,n=3,3,2,1,2Albumin,Week 8,n=2,1,2,0,2Albumin,Week 12,n=1,1,1,1,1Albumin,Week 16,n=0,1,1,1,0Albumin,Week 24,n=0,1,0,0,0Albumin,Week 36,n=0,1,0,0,0Protein,Week 4,n=3,3,2,1,2Protein,Week 8,n=2,1,2,0,2Protein,Week 12,n=1,1,1,1,1Protein,Week 16,n=0,1,1,1,0Protein,Week 24,n=0,1,0,0,0Protein,Week 36,n=0,1,0,0,0
PartB:SIR 100 mg SC q2w+3 Month Prednisone-1.3-2.0-1.0-2.0-1.0-2.0-2.7-2.0-2.0-2.0-1.0-2.0

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Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionGrams per liter (Mean)
Albumin,Week 4,n=3,3,2,1,2Albumin,Week 12,n=1,1,1,1,1Albumin,Week 16,n=0,1,1,1,0Protein,Week 4,n=3,3,2,1,2Protein,Week 12,n=1,1,1,1,1Protein,Week 16,n=0,1,1,1,0
PartB:Placebo SC q2w + 6 Month Prednisone0.03.00.00.01.0-1.0

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Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

,
InterventionGrams per liter (Mean)
Albumin,Week 4,n=3,3,2,1,2Albumin,Week 8,n=2,1,2,0,2Albumin,Week 12,n=1,1,1,1,1Protein,Week 4,n=3,3,2,1,2Protein,Week 8,n=2,1,2,0,2Protein,Week 12,n=1,1,1,1,1
PartB:Placebo SC q2w + 12 Month Prednisone-2.5-1.50.0-5.0-1.52.0
PartB:SIR 100 mg SC q2w+6 Month Prednisone-0.31.53.0-0.31.53.0

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Part A: Number of Participants With at Least One Hospitalization for Disease Flare

Number of participants with at least one hospitalization for disease flare at a given visit is the number of participants with at least one hospitalization for disease flare between first SC IP intake and the day of the given visit. Data for participants requiring at least one hospitalization for disease flare for part A is presented. (NCT02531633)
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

,,,,
InterventionParticipants (Count of Participants)
Week 2, n=38, 39,26,25,27Week 4, n=37,37,25,23,27Week 8, n=34,32,24,23,23Week 12, n=32,29,24,22,22Week 16, n=28,26,22,19,19Week 20, n=26,23,19,18,16Week 24, n=23,21,16,17,16Week 28, n=19,18,12,14,14Week 32, n=19,15,10,12,13Week 36, n=15,13,10,12,13Week 40, n=15,11,9,10,10Week 44, n=11,11,6,8,9Week 48, n=9,8,5,8,5Week 52, n=9,5,5,5,4
PartA:Placebo SC q2w + 12 Month Prednisone00000000000000
PartA:Placebo SC q2w + 6 Month Prednisone00000000000000
PartA:SIR 100 mg SC q2w+3 Month Prednisone00000000000000
PartA:SIR 100 mg SC q2w+6 Month Prednisone00011110000000
PartA:SIR 50 mg SC q4w+6 Month Prednisone00000111000000

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Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionGiga cells per liter (Mean)
Eosinophils,Week 2,n=1,1,0,1,2Eosinophils,Week 4,n=2,1,1,2,2Eosinophils,Week 8,n=2,1,1,2,1Eosinophils,Week 12,n=2,0,1,1,0Eosinophils,Week 14,n=0,0,0,1,0Eosinophils,Week 16,n=2,0,0,1,0Leukocytes,Week 2,n=1,1,0,1,2Leukocytes,Week 4,n=2,1,1,2,2Leukocytes,Week 8,n=2,1,1,2,1Leukocytes,Week 12,n=2,0,1,1,0Leukocytes,Week 14,n=0,0,0,1,0Leukocytes,Week 16,n=2,0,0,1,0Lymphocytes,Week 2,n=1,1,0,1,2Lymphocytes,Week 4,n=2,1,1,2,2Lymphocytes,Week 8,n=2,1,1,2,1Lymphocytes,Week 12,n=2,0,1,1,0Lymphocytes,Week 14,n=0,0,0,1,0Lymphocytes,Week 16,n=2,0,0,1,0Neutrophils ,Week 2,n=1,1,0,1,2Neutrophils ,Week 4,n=2,1,1,2,2Neutrophils ,Week 8,n=2,1,1,2,2Neutrophils ,Week 12,n=2,0,1,1,0Neutrophils ,Week 14,n=0,0,0,1,0Neutrophils ,Week 16,n=2,0,0,1,0Platelets ,Week 2,n=1,1,0,1,2Platelets,Week 4,n=2,1,1,2,2Platelets,Week 8,n=2,1,1,2,1Platelets,Week 12,n=2,0,1,1,0Platelets,Week 14,n=0,0,0,1,0Platelets,Week 16,n=2,0,0,1,0
PartB:Placebo SC q2w + 6 Month Prednisone0.000-0.030-0.120-0.160-0.290-0.2702.600.600.10-0.600.40-0.30-0.400-0.035-0.185-0.1900.4900.5403.0100.7400.485-0.3200.590-0.050-27.0-33.5-20.512.0-31.0-97.0

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Part A:Change From Baseline in Hematology Parameter- Erythrocytes

Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,,,
Interventiontrillion cells per liter (Mean)
Week 2,n=38,39,24,24,25Week 4,n=36,37,24,22,27Week 8,n=34,29,23,22,21Week 12,n=31,28,23,22,22Week 16,n=27,26,21,19,19Week 20,n=25,23,18,18,16Week 24,n=22,21,16,16,16Week 28,n=18,18,12,14,13Week 32,n=19,15,10,12,13Week 36,n=15,12,10,12,12Week 40,n=14,11,8,10,10Week 44,n=11,10,6,7,9Week 48,n=9,8,4,8,5Week 52,n=8,5,5,5,4
PartA:Placebo SC q2w + 12 Month Prednisone-0.07-0.14-0.17-0.11-0.11-0.08-0.01-0.020.040.03-0.10-0.030.04-0.05
PartA:Placebo SC q2w + 6 Month Prednisone-0.10-0.09-0.16-0.20-0.19-0.20-0.11-0.18-0.22-0.21-0.22-0.10-0.20-0.18
PartA:SIR 100 mg SC q2w+3 Month Prednisone0.02-0.01-0.040.05-0.07-0.03-0.06-0.04-0.09-0.04-0.16-0.10-0.23-0.18
PartA:SIR 100 mg SC q2w+6 Month Prednisone0.010.010.040.03-0.09-0.13-0.09-0.14-0.13-0.08-0.16-0.18-0.14-0.16
PartA:SIR 50 mg SC q4w+6 Month Prednisone-0.01-0.01-0.08-0.07-0.14-0.12-0.04-0.16-0.13-0.10-0.09-0.17-0.18-0.02

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Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin

Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

,,,,
InterventionPicograms (Mean)
Week 2,n=38,39,24,24,25Week 4,n=36,37,24,22,27Week 8,n=34,29,23,22,21Week 12,n=31,28,23,22,22Week 16,n=27,26,21,19,19Week 20,n=25,23,18,18,16Week 24,n=22,21,16,16,16Week 28,n=18,18,12,14,13Week 32,n=19,15,10,12,13Week 36,n=15,12,10,12,12Week 40,n=14,11,8,10,10Week 44,n=11,10,6,8,9Week 48,n=9,8,4,8,5Week 52,n=8,5,5,5,4
PartA:Placebo SC q2w + 12 Month Prednisone0.220.360.490.470.220.39-0.08-0.20-0.140.150.440.771.320.80
PartA:Placebo SC q2w + 6 Month Prednisone0.120.250.600.440.240.14-0.040.210.680.680.710.300.141.84
PartA:SIR 100 mg SC q2w+3 Month Prednisone0.290.581.201.431.591.691.801.481.571.291.751.832.252.70
PartA:SIR 100 mg SC q2w+6 Month Prednisone0.130.530.960.941.161.240.970.911.011.421.301.161.361.44
PartA:SIR 50 mg SC q4w+6 Month Prednisone0.420.551.161.381.831.481.341.471.271.391.911.631.732.24

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Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionFemtoliter (Mean)
Week 4,n=3,3,2,1,2Week 8,n=2,1,2,0,2Week 12,n=1,1,1,1,1Week 16,n=0,1,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone0.00.0-1.00.0

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Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionFemtoliter (Mean)
Week 4,n=3,3,2,1,2Week 8,n=2,1,2,0,2Week 12,n=1,1,1,1,1Week 16,n=0,1,1,1,0Week 24,n=0,1,0,0,0Week 36,n=0,1,0,0,0
PartB:SIR 100 mg SC q2w+3 Month Prednisone1.31.02.01.03.04.0

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Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

,
InterventionFemtoliter (Mean)
Week 2,n=1,1,0,1,2Week 4,n=2,1,1,2,2Week 8,n=2,1,1,2,1
PartB:Placebo SC q2w + 12 Month Prednisone0.50.52.0
PartB:SIR 100 mg SC q2w+3 Month Prednisone1.01.0-1.0

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Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionFemtoliter (Mean)
Week 4,n=2,1,1,2,2Week 8,n=2,1,1,2,1Week 12,n=2,0,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone1.00.00.0

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Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionFemtoliter (Mean)
Week 2,n=1,1,0,1,2Week 4,n=2,1,1,2,2Week 8,n=2,1,1,2,1Week 12,n=2,0,1,1,0Week 14,n=0,0,0,1,0Week 16,n=2,0,0,1,0
PartB:Placebo SC q2w + 6 Month Prednisone0.0-1.5-2.5-6.0-5.0-4.0

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Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionFemtoliter (Mean)
Week 2,n=1,1,0,1,2Week 4,n=2,1,1,2,2Week 8,n=2,1,1,2,1Week 12,n=2,0,1,1,0Week 16,n=2,0,0,1,0Week 24,n=2,0,0,0,0Week 36,n=2,0,0,0,0Week 38,n=1,0,0,0,0Week 40,n=1,0,0,0,0
PartB:SIR 100 mg SC q2w+6 Month Prednisone-2.01.51.52.50.51.52.50.0-2.0

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Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionTrillion cells per liter (Mean)
Week 4,n=3,3,2,1,2Week 12,n=1,1,1,1,1Week 16,n=0,1,1,1,0
PartB:Placebo SC q2w + 6 Month Prednisone0.100.00-0.10

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Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

,
InterventionTrillion cells per liter (Mean)
Week 4,n=3,3,2,1,2Week 8,n=2,1,2,0,2Week 12,n=1,1,1,1,1
PartB:Placebo SC q2w + 12 Month Prednisone-0.20-0.20-0.10
PartB:SIR 100 mg SC q2w+6 Month Prednisone-0.03-0.15-0.10

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Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionTrillion cells per liter (Mean)
Week 4,n=3,3,2,1,2Week 8,n=2,1,2,0,2Week 12,n=1,1,1,1,1Week 16,n=0,1,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone0.100.100.600.70

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Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionTrillion cells per liter (Mean)
Week 4,n=3,3,2,1,2Week 8,n=2,1,2,0,2Week 12,n=1,1,1,1,1Week 16,n=0,1,1,1,0Week 24,n=0,1,0,0,0Week 36,n=0,1,0,0,0
PartB:SIR 100 mg SC q2w+3 Month Prednisone-0.100.000.100.100.000.10

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Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionTrillion cells per liter (Mean)
Week 2,n=1,1,0,1,2Week 4,n=2,1,1,2,2Week 8,n=2,1,1,2,2
PartB:Placebo SC q2w + 12 Month Prednisone0.250.100.15

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Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionTrillion cells per liter (Mean)
Week 4,n=2,1,1,2,2Week 8,n=2,1,1,2,2Week 12,n=2,1,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone-0.300.000.00

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Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionTrillion cells per liter (Mean)
Week 2,n=1,1,0,1,2Week 4,n=2,1,1,2,2Week 8,n=2,1,1,2,2Week 12,n=2,1,1,1,0
PartB:SIR 100 mg SC q2w+3 Month Prednisone-0.10-0.100.00NA

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Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionTrillion cells per liter (Mean)
Week 2,n=1,1,0,1,2Week 4,n=2,1,1,2,2Week 8,n=2,1,1,2,2Week 12,n=2,1,1,1,0Week 14,n=0,0,0,1,0Week 16,n=2,0,0,1,0
PartB:Placebo SC q2w + 6 Month Prednisone0.300.000.05-0.200.10-0.20

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Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionTrillion cells per liter (Mean)
Week 2,n=1,1,0,1,2Week 4,n=2,1,1,2,2Week 8,n=2,1,1,2,2Week 12,n=2,1,1,1,0Week 16,n=2,0,0,1,0Week 24,n=2,0,0,0,0Week 36,n=2,0,0,0,0Week 38,n=1,0,0,0,0Week 40,n=1,0,0,0,0
PartB:SIR 100 mg SC q2w+6 Month Prednisone0.000.000.100.100.000.00-0.050.000.00

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Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionPicograms (Mean)
Week 4,n=3,3,2,1,2Week 12,n=1,1,1,1,1Week 16,n=0,1,1,1,0
PartB:Placebo SC q2w + 6 Month Prednisone-1.002.201.30

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Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

,
InterventionPicograms (Mean)
Week 4,n=3,3,2,1,2Week 8,n=2,1,2,0,2Week 12,n=1,1,1,1,1
PartB:Placebo SC q2w + 12 Month Prednisone0.001.101.80
PartB:SIR 100 mg SC q2w+6 Month Prednisone-0.33-0.15-0.10

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Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionPicograms (Mean)
Week 4,n=3,3,2,1,2Week 8,n=2,1,2,0,2Week 12,n=1,1,1,1,1Week 16,n=0,1,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone-0.250.000.70-0.20

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Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionPicograms (Mean)
Week 4,n=3,3,2,1,2Week 8,n=2,1,2,0,2Week 12,n=1,1,1,1,1Week 16,n=0,1,1,1,0Week 24,n=0,1,0,0,0Week 36,n=0,1,0,0,0
PartB:SIR 100 mg SC q2w+3 Month Prednisone-0.47-0.60-0.50-0.80-0.80-0.20

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Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionPicograms (Mean)
Week 2,n=1,1,0,1,2Week 4,n=2,1,1,2,2Week 8,n=2,1,1,2,2
PartB:Placebo SC q2w + 12 Month Prednisone0.601.000.70

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Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionPicograms (Mean)
Week 4,n=2,1,1,2,2Week 8,n=2,1,1,2,2Week 12,n=2,1,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone0.200.300.30

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Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionPicograms (Mean)
Week 2,n=1,1,0,1,2Week 4,n=2,1,1,2,2Week 8,n=2,1,1,2,2Week 12,n=2,1,1,1,0
PartB:SIR 100 mg SC q2w+3 Month Prednisone0.200.601.30NA

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Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionPicograms (Mean)
Week 2,n=1,1,0,1,2Week 4,n=2,1,1,2,2Week 8,n=2,1,1,2,2Week 12,n=2,1,1,1,0Week 14,n=0,0,0,1,0Week 16,n=2,0,0,1,0
PartB:Placebo SC q2w + 6 Month Prednisone-0.20-0.05-0.450.00-0.90-0.10

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Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionPicograms (Mean)
Week 2,n=1,1,0,1,2Week 4,n=2,1,1,2,2Week 8,n=2,1,1,2,2Week 12,n=2,1,1,1,0Week 16,n=2,0,0,1,0Week 24,n=2,0,0,0,0Week 36,n=2,0,0,0,0Week 38,n=1,0,0,0,0Week 40,n=1,0,0,0,0
PartB:SIR 100 mg SC q2w+6 Month Prednisone-1.100.300.300.250.000.100.25-0.400.40

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Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionInternational units per liter (Mean)
ALT,Week 4,n=2,1,1,2,2ALT,Week 8,n=2,1,1,2,2ALT,Week 12,n=2,0,1,1,0ALP,Week 4,n=2,1,1,2,2ALP,Week 8,n=2,1,1,2,2ALP,Week 12,n=2,0,1,1,0AST,Week 4,n=2,1,1,2,2AST,Week 8,n=2,1,1,2,2AST,Week 12,n=2,0,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone0.01.04.0-4.0-3.02.00.0-3.0-1.0

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Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

,
InterventionInternational units per liter (Mean)
ALT,Week 2,n=1,1,0,1,2ALT,Week 4,n=2,1,1,2,2ALT,Week 8,n=2,1,1,2,2ALP,Week 2,n=1,1,0,1,2ALP,Week 4,n=2,1,1,2,2ALP,Week 8,n=2,1,1,2,2AST,Week 2,n=1,1,0,1,2AST,Week 4,n=2,1,1,2,2AST,Week 8,n=2,1,1,2,2
PartB:SIR 100 mg SC q2w+3 Month Prednisone4.04.02.0-2.0-9.0-16.00.00.0-2.0
PartB:Placebo SC q2w + 12 Month Prednisone72.551.531.5-5.0-7.0-12.044.523.014.0

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Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionInternational units per liter (Mean)
ALT,Week 2,n=1,1,0,1,2ALT,Week 4,n=2,1,1,2,2ALT,Week 8,n=2,1,1,2,2ALT,Week 12,n=2,0,1,1,0ALT,Week 16,n=2,0,0,1,0ALT,Week 24,n=2,0,0,0,0ALT,Week 36,n=2,0,0,0,0ALT,Week 38,n=1,0,0,0,0ALT,Week 40,n=1,0,0,0,0ALP,Week 2,n=1,1,0,1,2ALP,Week 4,n=2,1,1,2,2ALP,Week 8,n=2,1,1,2,2ALP,Week 12,n=2,0,1,1,0ALP,Week 16,n=2,0,0,1,0ALP,Week 24,n=2,0,0,0,0ALP,Week 36,n=2,0,0,0,0ALP,Week 38,n=1,0,0,0,0ALP,Week 40,n=1,0,0,0,0AST,Week 2,n=1,1,0,1,2AST,Week 4,n=2,1,1,2,2AST,Week 8,n=2,1,1,2,2AST,Week 12,n=2,0,1,1,0AST,Week 16,n=2,0,0,1,0AST,Week 24,n=2,0,0,0,0AST,Week 36,n=2,0,0,0,0AST,Week 38,n=1,0,0,0,0AST,Week 40,n=1,0,0,0,0
PartB:SIR 100 mg SC q2w+6 Month Prednisone1.0-1.52.5-3.0-1.0-2.5-4.5-9.0-9.07.05.57.05.0-0.52.52.07.018.00.0-4.51.5-4.0-3.0-3.5-4.5-7.0-7.0

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Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionInternational units per liter (Mean)
ALT,Week 2,n=1,1,0,1,2ALT,Week 4,n=2,1,1,2,2ALT,Week 8,n=2,1,1,2,2ALT,Week 12,n=2,0,1,1,0ALT,Week 14,n=0,0,0,1,0ALT,Week 16,n=2,0,0,1,0ALP,Week 2,n=1,1,0,1,2ALP,Week 4,n=2,1,1,2,2ALP,Week 8,n=2,1,1,2,2ALP,Week 12,n=2,0,1,1,0ALP,Week 14,n=0,0,0,1,0ALP,Week 16,n=2,0,0,1,0AST,Week 2,n=1,1,0,1,2AST,Week 4,n=2,1,1,2,2AST,Week 8,n=2,1,1,2,2AST,Week 12,n=2,0,1,1,0AST,Week 14,n=0,0,0,1,0AST,Week 16,n=2,0,0,1,0
PartB:Placebo SC q2w + 6 Month Prednisone3.04.04.5-3.02.02.0-17.0-9.0-4.58.0-15.0-9.03.0-0.52.0-2.00.01.0

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Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

,
InterventionInternational units per liter (Mean)
ALT,Week 4,n=3,3,2,1,2ALT,Week 8,n=2,1,2,0,2ALT,Week 12,n=1,1,1,1,1ALP,Week 4,n=3,3,2,1,2ALP,Week 8,n=2,1,2,0,2ALP,Week 12,n=1,1,1,1,1AST,Week 4,n=3,3,2,1,2AST,Week 8,n=2,1,2,0,2AST,Week 12,n=1,1,1,1,1
PartB:Placebo SC q2w + 12 Month Prednisone1.0-1.52.00.0-3.0-10.0-1.50.02.0
PartB:SIR 100 mg SC q2w+6 Month Prednisone2.39.03.0-0.71.5-1.00.710.51.0

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Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionInternational units per liter (Mean)
ALT,Week 4,n=3,3,2,1,2ALT,Week 12,n=1,1,1,1,1ALT,Week 16,n=0,1,1,1,0ALP,Week 4,n=3,3,2,1,2ALP,Week 12,n=1,1,1,1,1ALP,Week 16,n=0,1,1,1,0AST,Week 4,n=3,3,2,1,2AST,Week 12,n=1,1,1,1,1AST,Week 16,n=0,1,1,1,0
PartB:Placebo SC q2w + 6 Month Prednisone103.00.01.081.0-11.0-10.024.00.02.0

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Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionInternational units per liter (Mean)
ALT,Week 4,n=3,3,2,1,2ALT,Week 8,n=2,1,2,0,2ALT,Week 12,n=1,1,1,1,1ALT,Week 16,n=0,1,1,1,0ALT,Week 24,n=0,1,0,0,0ALT,Week 36,n=0,1,0,0,0ALP,Week 4,n=3,3,2,1,2ALP,Week 8,n=2,1,2,0,2ALP,Week 12,n=1,1,1,1,1ALP,Week 16,n=0,1,1,1,0ALP,Week 24,n=0,1,0,0,0ALP,Week 36,n=0,1,0,0,0AST,Week 4,n=3,3,2,1,2AST,Week 8,n=2,1,2,0,2AST,Week 12,n=1,1,1,1,1AST,Week 16,n=0,1,1,1,0AST,Week 24,n=0,1,0,0,0AST,Week 36,n=0,1,0,0,0
PartB:SIR 100 mg SC q2w+3 Month Prednisone2.713.08.0-5.00.0-4.00.0-1.00.04.02.04.02.07.0-1.0-4.0-1.0-3.0

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Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionInternational units per liter (Mean)
ALT,Week 4,n=3,3,2,1,2ALT,Week 8,n=2,1,2,0,2ALT,Week 12,n=1,1,1,1,1ALT,Week 16,n=0,1,1,1,0ALP,Week 4,n=3,3,2,1,2ALP,Week 8,n=2,1,2,0,2ALP,Week 12,n=1,1,1,1,1ALP,Week 16,n=0,1,1,1,0AST,Week 4,n=3,3,2,1,2AST,Week 8,n=2,1,2,0,2AST,Week 12,n=1,1,1,1,1AST,Week 16,n=0,1,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone-8.0-9.5-4.0-6.00.5-1.017.03.0-5.0-6.02.00.0

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Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionGrams per liter (Mean)
Albumin,Week 4,n=2,1,1,2,2Albumin,Week 8,n=2,1,1,2,1Albumin,Week 12,n=2,0,1,1,0Protein,Week 4,n=2,1,1,2,2Protein,Week 8,n=2,1,1,2,1Protein,Week 12,n=2,0,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone-1.00.01.0-2.02.02.0

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Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

,
InterventionGrams per liter (Mean)
Albumin,Week 2,n=1,1,0,1,2Albumin,Week 4,n=2,1,1,2,2Albumin,Week 8,n=2,1,1,2,1Protein,Week 2,n=1,1,0,1,2Protein,Week 4,n=2,1,1,2,2Protein,Week 8,n=2,1,1,2,1
PartB:Placebo SC q2w + 12 Month Prednisone3.53.02.01.5-0.50.0
PartB:SIR 100 mg SC q2w+3 Month Prednisone-1.00.00.0-1.00.00.0

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Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionGrams per liter (Mean)
Albumin,Week 2,n=1,1,0,1,2Albumin,Week 4,n=2,1,1,2,2Albumin,Week 8,n=2,1,1,2,1Albumin,Week 12,n=2,0,1,1,0Albumin,Week 16,n=2,0,0,1,0Albumin,Week 24,n=2,0,0,0,0Albumin,Week 36,n=2,0,0,0,0Albumin,Week 38,n=1,0,0,0,0Albumin,Week 40,n=1,0,0,0,0Protein,Week 2,n=1,1,0,1,2Protein,Week 4,n=2,1,1,2,2Protein,Week 8,n=2,1,1,2,1Protein,Week 12,n=2,0,1,1,0Protein,Week 16,n=2,0,0,1,0Protein,Week 24,n=2,0,0,0,0Protein,Week 36,n=2,0,0,0,0Protein,Week 38,n=1,0,0,0,0Protein,Week 40,n=1,0,0,0,0
PartB:SIR 100 mg SC q2w+6 Month Prednisone-1.00.01.01.0-0.5-0.5-1.0-2.0-2.00.01.03.02.51.00.51.51.00.0

[back to top]

Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40

InterventionGrams per liter (Mean)
Albumin,Week 2,n=1,1,0,1,2Albumin,Week 4,n=2,1,1,2,2Albumin,Week 8,n=2,1,1,2,1Albumin,Week 12,n=2,0,1,1,0Albumin,Week 14,n=0,0,0,1,0Albumin,Week 16,n=2,0,0,1,0Protein,Week 2,n=1,1,0,1,2Protein,Week 4,n=2,1,1,2,2Protein,Week 8,n=2,1,1,2,1Protein,Week 12,n=2,0,1,1,0Protein,Week 14,n=0,0,0,1,0Protein,Week 16,n=2,0,0,1,0
PartB:Placebo SC q2w + 6 Month Prednisone5.00.0-2.0-4.00.02.08.0-0.5-2.5-4.0-5.0-2.0

[back to top]

Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B

Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. (NCT02531633)
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36

InterventionGrams per liter (Mean)
Albumin,Week 4,n=3,3,2,1,2Albumin,Week 8,n=2,1,2,0,2Albumin,Week 12,n=1,1,1,1,1Albumin,Week 16,n=0,1,1,1,0Protein,Week 4,n=3,3,2,1,2Protein,Week 8,n=2,1,2,0,2Protein,Week 12,n=1,1,1,1,1Protein,Week 16,n=0,1,1,1,0
PartB:SIR 50 mg SC q4w+6 Month Prednisone1.01.05.05.01.02.59.012.0

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Number of Participants With a Grade 3 or Higher Toxicity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

The Primary Outcome measures toxicity, with particular attention to Events of Clinical Interest when adding MK-3475 to standard RCHOP therapy. The sample size of 30 patients will permit the estimation of a 40% incidence of grade 3-5 clinically relevant toxicity. (NCT02541565)
Timeframe: Up to 90 days after completion of study treatment

InterventionParticipants (Count of Participants)
Treatment (Pembrolizumab, Combination Chemotherapy)13

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Terminal Plasma Half-Life (t1/2) of Obinutuzumab

(NCT02550652)
Timeframe: Day 0, Week 24, Week 52

Interventionday (Mean)
Day 0Week 24Week 52
OBINUTUZUMAB 1000MG and MMF13.120.522.1

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Volume of Distribution Under Steady State (Vss) of Obinutuzumab

(NCT02550652)
Timeframe: Day 0, Week 24, Week 52

InterventionL (Mean)
Day 0Week 24Week 52
OBINUTUZUMAB 1000MG and MMF3.673.673.67

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Change From Baseline in Anti-Double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Antibody Levels at Week 52

Anti-dsDNA antibodies are a group of anti-nuclear antibodies targeting double stranded DNA. (NCT02550652)
Timeframe: Baseline and Week 52

Interventionlog IU/mL (Mean)
OBINUTUZUMAB 1000MG and MMF-0.810
PLACEBO and MMF-0.080

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Change From Baseline in C4 Levels at Week 52

Complement C4 is a blood test that reflects activation of complement pathway associated with immune deposition in certain autoimmune diseases. (NCT02550652)
Timeframe: Baseline, Week 52

Interventiong/L (Mean)
OBINUTUZUMAB 1000MG and MMF0.101
PLACEBO and MMF0.003

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Change From Baseline in Complement Component 3 (C3) Levels at Week 52

Complement C3 is a blood test that reflects activation of complement pathway associated with immune deposition in certain autoimmune diseases. (NCT02550652)
Timeframe: Baseline and Week 52

Interventiong/L (Mean)
OBINUTUZUMAB 1000MG and MMF0.311
PLACEBO and MMF0.108

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Percentage of Participants Who Achieve Protocol Defined Complete Renal Response (CRR) at Week 52

Percentage of participants with normalization of serum creatinine, inactive urinary sediment (as evidenced by < 10 red blood cells (RBCs)/high-power field (HPF) and the absence of red cell casts) and urinary protein to creatinine ratio < 0.5. Normalization of serum creatinine is defined as serum creatinine ≤ the upper limit of normal (ULN) range of central laboratory values if baseline (Day 1) serum creatinine is above the ULN or serum creatinine ≤ 15% above baseline and ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is ≤ the ULN range of central laboratory values. (NCT02550652)
Timeframe: From baseline to Week 52

Interventionpercentage of participants (Number)
OBINUTUZUMAB 1000MG and MMF34.9
PLACEBO and MMF22.6

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Percentage of Participants Who Achieve Protocol Defined CRR at Week 24

CRR defined as normalization of serum creatinine, inactive urinary sediment (as evidenced by < 10 red blood cells (RBCs)/high-power field (HPF) and the absence of red cell casts) and urinary protein to creatinine ratio < 0.5. Normalization of serum creatinine is defined as serum creatinine ≤ the upper limit of normal (ULN) range of central laboratory values if baseline (Day 1) serum creatinine is above the ULN or serum creatinine ≤ 15% above baseline and ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is ≤ the ULN range of central laboratory values. (NCT02550652)
Timeframe: Week 24

Interventionpercentage of participants (Number)
OBINUTUZUMAB 1000MG and MMF23.8
PLACEBO and MMF24.2

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Percentage of Participants Who Achieve Protocol Defined Modified CRR (mCRR1) at Week 52

mCRR1 has got two components only, i.e. serum Creatinine and urinary protein to creatinine ratio. mCRR1 is defined by attainment of normalization of serum creatinine as evidenced by 1.) serum creatinine ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is above the ULN or serum creatinine ≤15% above baseline and ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine ≤ the ULN range of central laboratory values and 2.) Urinary protein to creatinine ratio <0.5. (NCT02550652)
Timeframe: Week 52

Interventionpercentage of participants (Number)
OBINUTUZUMAB 1000MG and MMF39.7
PLACEBO and MMF25.8

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Percentage of Participants Who Achieve Protocol Defined Overall Response (OR) at Week 52

OR includes both CRR and partial renal response (PRR). CRR as defined in the primary outcome measure above. PRR defined as 50% improvement in urine protein:creatinine ratio, with one of following conditions met: 1. If baseline urine protein:creatinine ratio is ≤ 3.0, then urine protein:creatinine ratio of <1.0. 2. If baseline protein:creatinine ratio is > 3.0, then urine protein:creatinine ratio of <3.0, serum creatinine ≤15% above baseline value, and no urinary red cell casts and either RBCs/HPF ≤50% above baseline or <10 RBCs/HPF. (NCT02550652)
Timeframe: From baseline to Week 52

Interventionpercentage of participants (Number)
OBINUTUZUMAB 1000MG and MMF55.6
PLACEBO and MMF35.5

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Percentage of Participants Who Achieve Protocol Defined Partial Renal Response (PRR) at Week 52

PRR defined as serum creatinine ≤15% above baseline value, no urinary red cell casts and either RBCs/HPF ≤ 50% above baseline or < 10 RBCs/HPF, 50% improvement in urine protein:creatinine ratio, with one of following conditions met: 1. If baseline urine protein:creatinine ratio is ≤ 3.0, then a urine protein:creatinine ratio of < 1.0. 2. If baseline protein:creatinine ratio is > 3.0, then a urine protein:creatinine ratio of < 3.0. (NCT02550652)
Timeframe: From baseline to Week 52

Interventionpercentage of participants (Number)
OBINUTUZUMAB 1000MG and MMF55.6
PLACEBO and MMF33.9

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Percentage of Participants Who Achieve Protocol Defined Second mCRR (mCRR2) at Week 52

mCRR2 is defined by normalization of serum creatinine, inactive urinary sediment (as evidenced by < 10 RBCs/HPF and the absence of red cell casts), and urinary protein to creatinine ratio <0.5. Normalization of serum creatinine as evidenced by the following: Serum creatinine ≤15% above baseline if baseline (Day 1) serum creatinine is above the normal range of the central laboratory values or ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is ≤ the ULN range of central laboratory values. (NCT02550652)
Timeframe: Week 52

Interventionpercentage of participants (Number)
OBINUTUZUMAB 1000MG and MMF44.4
PLACEBO and MMF33.9

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Percentage of Participants Who Achieve Protocol Defined Third mCRR (mCRR3) at Week 52

mCRR3 is defined by normalization of serum creatine as evidenced by serum creatinine ≤ the ULN range of central laboratory values and urinary protein to creatinine ratio < 0.5. (NCT02550652)
Timeframe: Week 52

Interventionpercentage of participants (Number)
OBINUTUZUMAB 1000MG and MMF46.0
PLACEBO and MMF38.7

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Percentage of Participants With Anti-Drug Antibody (ADA) to Obinutuzumab

Antibodies are a blood protein produced in response to and counteracting a specific antigen. (NCT02550652)
Timeframe: From baseline up to Week 104

Interventionpercentage of participants (Number)
OBINUTUZUMAB 1000MG and MMF9.38

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Area Under the Plasma Concentration Versus Time Curve (AUC) of Obinutuzumab

(NCT02550652)
Timeframe: Week 0, Week 24, Week 52

Interventionug/mL*day (Mean)
Week 0-24Week 24-52Week 0-52
OBINUTUZUMAB 1000MG and MMF105951581126406

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Change From Baseline of Participant's Global Assessment of Disease Activity Visual Analog Scale (VAS) Score

Each VAS had a range from 0-100 with higher scores indicating greater symptom impact on global health status. (NCT02550652)
Timeframe: Baseline (Day 1), Weeks 4, 12, 24, 36, 52

,
Interventionscore on scale (Mean)
BaselineWeek 4Week 12Week 24Week 36Week 52
OBINUTUZUMAB 1000MG and MMF41.3-14.4-19.9-25.0-24.8-25.4
PLACEBO and MMF39.4-8.7-11.6-20.8-19.6-23.3

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Maximum Observed Plasma Concentration (Cmax) of Obinutuzumab

(NCT02550652)
Timeframe: Week 0, Week 24, Week 52

Interventionug/mL (Mean)
Week 0-24Week 24-52Week 0-52
OBINUTUZUMAB 1000MG and MMF559605605

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Percent Change From Baseline in Circulating CD19-Positive B-Cell Levels

CD19+ B cell is a B-lymphocyte with a transmembrane protein that is encoded by the gene CD19. (NCT02550652)
Timeframe: Baseline, Week 2, Week 4, Week 12, Week 24, Week 52

,
InterventionPercent change of cells/uL (Mean)
Week 2Week 4Week 12Week 24Week 52
OBINUTUZUMAB 1000MG and MMF-97.469-98.777-97.045-96.628-98.620
PLACEBO and MMF39.293-5.1860.661-11.44637.695

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Percentage of Participants With Adverse Events (AEs)

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs, including AEs of Special Interest were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs), Infections and Serious infections. (NCT02550652)
Timeframe: From Baseline up to Week 104

,
Interventionpercentage of participants (Number)
Adverse EventsGrade 3 AEsGrade 4 AEsGrade 5 AEsSerious Adverse EventsInfectionsSerious infections
OBINUTUZUMAB 1000MG and MMF90.629.710.91.625.075.07.8
PLACEBO and MMF88.524.613.16.629.562.318.0

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Percentage of Participants With First Protocol Defined CRR Over the Course of 52 Weeks

CRR included normalization of serum creatinine, inactive urinary sediment (as evidenced by < 10 RBCs/HPF and the absence of red cell casts) and urinary protein to creatinine ratio < 0.5. Normalization of serum creatinine is defined as serum creatinine ≤ the ULN range of central laboratory values if baseline serum creatinine is above the ULN or serum creatinine ≤ 15% above baseline and ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is ≤ the ULN range of central laboratory values. Percentage of participants with response at various time points were measured using Kaplan Meier method. (NCT02550652)
Timeframe: From Baseline to Week 52

,
Interventionpercentage of participants (Number)
Week 12Week 24Week 36Week 52
OBINUTUZUMAB 1000MG and MMF10263650
PLACEBO and MMF10283540

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Percentage of Participants With First Protocol Defined Overall Response Over the Course of 52 Weeks

OR includes both CRR and partial renal response(PRR). CRR as defined in the primary outcome measure above. PRR defined as 50% improvement in upcr, with one of these conditions met: 1. If baseline upcr is ≤3.0, then upcr of <1.0. 2. If baseline pcr is > 3.0, then upcr of <3.0, serum creatinine ≤15% above baseline value, and no urinary red cell casts and either RBCs/HPF ≤50% above baseline or <10 RBCs/HPF. Percentage of participants with response at various time points were measured using Kaplan Meier method. (NCT02550652)
Timeframe: From baseline to Week 52

,
Interventionpercentage of participants (Number)
Week 12Week 24Week 36Week 52
OBINUTUZUMAB 1000MG and MMF26576375
PLACEBO and MMF19415158

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Systemic Clearance of Obinutuzumab

(NCT02550652)
Timeframe: Day 0, Week 24, Week 52

InterventionL/day (Mean)
Day 0Week 24Week 52
OBINUTUZUMAB 1000MG and MMF0.2550.1470.137

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Number of Participants With Adverse Events Graded According to CTC (Phase II)

"The toxicity profile will be further assessed based on phase II patients. Overall toxicity incidence of maximum tolerated dose level of the Intent to treat (ITT) group of subjects is summarized.~39 subjects were dosed with 10 mg dose of Lenalidamide as the ITT group." (NCT02561273)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
grade 3,4 neutropeniagrade 3, 4 leukopeniagrade 3, 4 anemiagrade 3, 4 thrombocytopeniagrade 3, 4 lymphopeniagrade 3, 4 febrile neutropeniagrade 3, 4 diarrheagrade 3, 4 Peripheral sensory neuropathygrade 3, 4 fatiguegrade 3, 4 nauseagrade 3, 4 anorexiagrade 3, 4 vomitinggrade 3, 4 mucositis oralgrade 3, 4 Rash maculo-papulargrade 3, 4 hypotensiongrade 3, 4 back pain
Treatment (Combination Chemotherapy, Lenalidomide)2725171718153211111111

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Complete Response Rate (Phase II)

A success is defined to be an objective status of CR after completion of 6 cycles of treatment. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. A 95% confidence interval for the true overall CR rate will be calculated according to the method of Duffy and Santner. (NCT02561273)
Timeframe: Up to the completion of course 6 (18 weeks)

Interventionpercentage of participants (Number)
Treatment (Combination Chemotherapy, Lenalidomide)49

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Maximum Tolerated Dose (MTD) of Lenalidomide and CHOEP

MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients) (Phase I) within the first cycle of study treatment. (NCT02561273)
Timeframe: 21 days

Interventionmilligrams (Number)
Treatment (Combination Chemotherapy, Lenalidomide)10

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Overall Response Rate

The ORR will be estimated by the total number of patients who achieve a PR or CR at the end of six cycles of treatment divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true ORR will be calculated. (NCT02561273)
Timeframe: Up to the completion of course 6 (18 weeks)

Interventionpercentage of participants (Number)
Treatment (Combination Chemotherapy, Lenalidomide)69

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Overall Survival

The distribution of overall survival will be estimated using the method of Kaplan-Meier. (NCT02561273)
Timeframe: Time from registration to death due to any cause, assessed up to 1 year

Interventionpercentage of participants (Number)
Treatment (Combination Chemotherapy, Lenalidomide)89

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Progression-free Survival

The distribution of PFS will be estimated using the method of Kaplan-Meier. The PFS rate at 2 years will be estimated. A 2-year PFS rate of 60% will be considered of interest. (NCT02561273)
Timeframe: Time from registration to progression or death due to any cause, assessed up to 2 years

Interventionpercentage of participants (Number)
Treatment (Combination Chemotherapy, Lenalidomide)55

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Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I)

Non-hematologic toxicities will be evaluated via the ordinal CTC standard toxicity grading. Hematologic toxicity measures of thrombocytopenia, neutropenia, and leukopenia will be assessed using continuous variables as the outcome measures (primarily nadir) as well as categorization via CTC standard toxicity grading. Overall toxicity incidence as well as toxicity profiles by dose level and patient will be explored and summarized. (NCT02561273)
Timeframe: Up to 6 cycles of treatment (approximately 5 months)

,
InterventionParticipants (Count of Participants)
grade 3,4 neutropeniagrade 3, 4 anemiagrade 3, 4 thrombocytopeniagrade 3,4 neutropenia fevergrade 3, 4 diarrheagrade 3, 4 hyperglycemiagrade 3, 4 hypokalemiagrade 3, 4 hypotensiongrade 3, 4 hyperbilirubinemiagrade 3, 4 mucositisgrade 3,4 nauseagrade 3,4 vomiting
10 mg Lenalidomide Participants532400000000
15 mg Lenalidomide Participants433022111221

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Change in Lund-Kennedy Endoscopic Scores

"Characteristics of each sinonasal cavity are assessed endoscopically to provide a score based on polyp disease, mucosal edema/crusting/scarring and nasal secretions. A score is provided for the left and right. The scores are totaled to provide a number between 0 and 20.~Polyps: 0 = absence of polyp; 1 = polyps in middle meatus only; 2 = polyps beyond middle meatus Edema: 0 = absent; 1 = mild; 2 = severe Discharge: 0 = no discharge; 1 = clear, thin discharge; 2 = thick, purulent discharge Scarring: 0 = absent; 1 = mild; 2 = severe Crusting: 0 = absent; 1 = mild; 2 = severe~This scoring system has since been the instrument of choice to endoscopically evaluate outcomes of interventions in non-neoplastic sinonasal disease prospectively over time in research and clinical practice. The higher the score, the worse the outcome. Endoscopy scores from the 3 study groups are compared for the average unit change between baseline and day 119." (NCT02562924)
Timeframe: 119 days

Interventionscore on a scale (Mean)
Budesonide Rinse Group-8.0
MEDIHONEY® Rinse Alone Group-1.5
MEDIHONEY® and Budesonide Rinse Group-6.9

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Change in SNOT-22 Nasal Symptom Scores

"The SNOT-22 consists of 22 questions; items 1 to 12 represent the physical problems associated with rhinosinusitis, items 13 to 18 represent the functional limitations, and items 20 to 22 represent the emotional consequences. Each question is scored by the patient from 0 (no problem) to 5 (the problem is as bad as it can be).~The first seven questions relate to nasal symptoms. The nasal symptoms score is calculated by summing the scores for these first seven questions. The range is 0 to 35. Higher scores reflect more severe quality of life impairment as subjectively reported by the patient. The nasal symptom scores from the 3 study groups are compared for the average change in score from baseline to day 119." (NCT02562924)
Timeframe: 119 days

Interventionscore on a scale (Mean)
Budesonide Rinse Group-10.0
MEDIHONEY® Rinse Alone Group-5.3
MEDIHONEY® and Budesonide Rinse Group-11.7

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Change in Sinonasal Outcome Test (SNOT-22) Questionnaire Score

The SNOT-22 consists of 22 questions; items 1 to 12 represent the physical problems associated with rhinosinusitis, items 13 to 18 represent the functional limitations, and items 20 to 22 represent the emotional consequences. Each question is scored by the patient from 0 (no problem) to 5 (the problem is as bad as it can be). The overall score can theoretically range from 0 to 110, with higher scores reflecting more severe quality of life impairment as subjectively reported by the patient. Overall SNOT-22 scores from the 3 study groups are compared for the average change in score from baseline to day 119. (NCT02562924)
Timeframe: 119 days

Interventionscore on a scale (Mean)
Budesonide Rinse Group-22.8
MEDIHONEY® Rinse Alone Group-15.3
MEDIHONEY® and Budesonide Rinse Group-25.6

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Treatment Success

Treatment success was defined as the percentage of participants with stable low disease activity (LDA) (DAS28-ESR score ≤ 3.2) at Week 24 post-randomization, who did not suffer a flare due to RA and who showed no confirmed adrenal insufficiency that required replacement therapy. DAS28 has the following standardized cut-offs for disease activity and remission: DAS28 > 5.1 = high disease activity; DAS28 between 3.2 and 5.1 = moderate disease activity; DAS28 ≤ 3.2 = low disease activity; DAS28 ≤ 2.6 = remission. (NCT02573012)
Timeframe: Week 24

InterventionPercentage of Participants (Number)
Tocilizumab+Prednisone (Tapering Dose)64.9
Tocilizumab+Prednisone (Constant Dose)77.3

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Changes From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) Score

The WPAI:SHP is a 6-item questionnaire to measure performance impairment of work and regular daily activity and yields 4 types of scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (WI) (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). Total score and each score range from 0 (not affected/no impairment) to 100 (completely affected/impaired). Higher scores indicate greater impairment and less productivity. A positive change in score indicates impairment, and a negative change indicates improvement. (NCT02573012)
Timeframe: Baseline and Week 24

,
InterventionScore on a scale (Mean)
Percent work time missed due to problemPercent impairment while working due to problemPercent overall work impairment due to problemPercent activity impairment due to problem
Tocilizumab+Prednisone (Constant Dose)0.572-5.584-6.191-4.190
Tocilizumab+Prednisone (Tapering Dose)4.535-0.8516.2193.398

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Cumulative Prednisone Exposure (Dose)

"In Post-randomization prednisone arm, Cumulative dose = (number of capsules taken during week 1 to 4 * 1 mg) + (3/4 * number of capsules taken during week 5 to 8 * 1 mg) + (1/2 * number of capsules taken during week 9 to 12 * 1 mg) + (1/4 * number of capsules taken during week 13 to 16 * 1 mg). In continued arm, cumulative dose = (1/4 * number of capsule taken * 5 mg).~Cumulative prednisone dose is defined as cumulative blinded prednisone + cumulative flare rescue prednisone." (NCT02573012)
Timeframe: Randomization to 24 weeks

,
Interventionmg (Mean)
Cumulative blinded prednisone doseCumulative flare rescue prednisone doseCumulative prednisone dose
Tocilizumab+Prednisone (Constant Dose)769.459121.875777.136
Tocilizumab+Prednisone (Tapering Dose)267.09998.519287.405

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Number of Administrations of Flare Rescue Medication

Proportion of participants who received courses of RA flare rescue medication by number of courses received. (NCT02573012)
Timeframe: Randomization to 24 weeks

,
InterventionPercentage of Participants (Number)
0 courses1 course2 courses3 courses>3 courses
Tocilizumab+Prednisone (Constant Dose)93.83.91.60.80
Tocilizumab+Prednisone (Tapering Dose)79.415.34.600.8

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Percentage of Participants Who Maintain LDA (DAS28 ESR Score <=3.2) or Remission (DAS28 ESR Score <2.6) and the Percentage of Participants Who Maintain the Baseline Disease Activity Level

"The proportion of participants who maintained LDA and the proportion of participants who maintained the baseline disease activity level at Week 24.~LDA was defined as DAS28 ESR score <= 3.2. Remission was defined as DAS28 ESR score <= 2.6. Participants who maintained the baseline activity was defined as DAS28-ESR at Week 24 <= DAS28-ESR at baseline." (NCT02573012)
Timeframe: Randomization to Week 24

,
InterventionPercentage of Participants (Number)
LDA at baselineLDA at Week 24Baseline DAS28-ESR ≤ 2.6Remission at Week 24Maintained baseline activity at Week 24
Tocilizumab+Prednisone (Constant Dose)96.983.176.681.654.7
Tocilizumab+Prednisone (Tapering Dose)97.773.478.661.236.6

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Time to First RA Flare

The mean time of onset for the first RA flare since randomization. (NCT02573012)
Timeframe: Randomization to 24 weeks

InterventionWeeks (Mean)
Tocilizumab+Prednisone (Tapering Dose)15.64
Tocilizumab+Prednisone (Constant Dose)12.11

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Percentage of Participants With >=1 Flare

Percentage of participants with >=1 flare (NCT02573012)
Timeframe: 24 weeks

InterventionPercentage of Participants (Number)
Tocilizumab+Prednisone (Tapering Dose)26.0
Tocilizumab+Prednisone (Constant Dose)10.9

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Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Tender 68 Joint Counts

Count of tender joints based on 68 assessed joints. (NCT02573012)
Timeframe: Baseline to Week 24

InterventionTender joints (Mean)
Tocilizumab+Prednisone (Tapering Dose)0.793
Tocilizumab+Prednisone (Constant Dose)-0.330

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Changes From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Final Score

The RAID is a participant-completed questionnaire specific for RA consisting of a 0-10 rating for pain, functional disability, fatigue, sleep, physical well-being, emotional well-being and coping. Scores are weighted to produce a final numerical result. A positive change in score indicates worsening, and a negative change indicates improvement. (NCT02573012)
Timeframe: Baseline and Week 24

InterventionScore on a scale (Mean)
Tocilizumab+Prednisone (Tapering Dose)0.469
Tocilizumab+Prednisone (Constant Dose)-0.220

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Percentage of Participants Who Permanently Discontinue Study Treatment Due to Insufficient Flare Control

Percentage of participants who permanently discontinue study treatment due to insufficient flare control (NCT02573012)
Timeframe: 24 weeks

InterventionPercentage of Participants (Number)
Tocilizumab+Prednisone (Tapering Dose)0
Tocilizumab+Prednisone (Constant Dose)0.8

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Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24

Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index is calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter (cm) visual analog scale (VAS) + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 100 mm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores range from 0 to 76, with higher scores indicating increased disease activity. A positive change in score indicates worsening, and a negative change indicates improvement. (NCT02573012)
Timeframe: Baseline and Week 24

InterventionScore on a scale (Least Squares Mean)
Tocilizumab+Prednisone (Tapering Dose)2.663
Tocilizumab+Prednisone (Constant Dose)0.321

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Time to First Administration of Flare Rescue Medication

Time of onset of first administration of RA flare rescue medication since randomization date (NCT02573012)
Timeframe: Randomization to 24 weeks

InterventionWeeks (Mean)
Tocilizumab+Prednisone (Tapering Dose)13.59
Tocilizumab+Prednisone (Constant Dose)8.76

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Change From Baseline in Disease Activity Score in 28 Joints - Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 24 Post-randomization

The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint count, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100-millimeter (mm) visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A positive change in score indicates worsening, and a negative change indicates improvement. (NCT02573012)
Timeframe: Baseline to Week 24

InterventionScore on a scale (Least Squares Mean)
Tocilizumab+Prednisone (Tapering Dose)0.538
Tocilizumab+Prednisone (Constant Dose)-0.075

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Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 24

The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count based on a 28-joint assessment, patient and physician global assessment of disease activity according to 100-mm visual analog scale (VAS) and level of C-reactive protein in milligrams per deciliter (mg/dL, normal <1 mg/dl). The total SDAI score range is 0-86, where higher scores indicate increased disease activity. A positive change in score indicates worsening, and a negative change indicates improvement. (NCT02573012)
Timeframe: Randomization to Week 24

InterventionScore on a scale (Least Squares Mean)
Tocilizumab+Prednisone (Tapering Dose)2.511
Tocilizumab+Prednisone (Constant Dose)0.248

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Percentage of Participants With >=1 Administration of Flare Rescue Medication

The proportion of participants with at least one administration of RA flare rescue medication. (NCT02573012)
Timeframe: Randomization to 24 weeks

InterventionPercentage of Participants (Number)
Tocilizumab+Prednisone (Tapering Dose)20.6
Tocilizumab+Prednisone (Constant Dose)6.3

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Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Patient's Global Assessment of Disease Activity

The ACR patient's global assessment of disease activity is scored on a visual analog scale (VAS) from 0 (symptom-free and no arthritis symptoms) to 100 mm (maximum arthritis disease activity). A positive change in score indicates worsening, and a negative change indicates improvement. (NCT02573012)
Timeframe: Baseline to Week 24

Interventioncm (Mean)
Tocilizumab+Prednisone (Tapering Dose)0.280
Tocilizumab+Prednisone (Constant Dose)-0.153

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Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Patient's Assessment of Pain

The ACR patient's assessment of pain is scored on a visual analog scale (VAS) from 0 (no pain) to 100 mm (unbearable pain). A positive change in score indicates worsening, and a negative change indicates improvement. (NCT02573012)
Timeframe: Baseline to Week 24

Interventionmm (Mean)
Tocilizumab+Prednisone (Tapering Dose)4.648
Tocilizumab+Prednisone (Constant Dose)-8.010

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Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: High Sensitivity C-Reactive Protein (hsCRP)

Change from baseline in the acute phase reactant hsCRP (NCT02573012)
Timeframe: Baseline to Week 24

Interventionmg/dL (Mean)
Tocilizumab+Prednisone (Tapering Dose)-0.135
Tocilizumab+Prednisone (Constant Dose)-0.040

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Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Health Assessment Questionnaire-Disability Index (HAQ-DI)

A measure of self-perceived disability containing 20 questions in eight categories and including additional section about aid from other people and devices needed to correct the disabilities. Scores range from 0 to 3, with higher scores indicating worse disability. (NCT02573012)
Timeframe: Baseline to Week 24

InterventionScore on a scale (Mean)
Tocilizumab+Prednisone (Tapering Dose)0.167
Tocilizumab+Prednisone (Constant Dose)-0.087

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Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Erythrocyte Sedimentation Rate (ESR)

Change from baseline in the acute phase reactant ESR (NCT02573012)
Timeframe: Baseline to Week 24

Interventionmm/hr (Mean)
Tocilizumab+Prednisone (Tapering Dose)1.517
Tocilizumab+Prednisone (Constant Dose)-0.679

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Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Physician's Global Assessment of Disease Activity

The ACR physician's global assessment of disease activity is scored on a visual analog scale (VAS) from 0 (symptom-free and no arthritis symptoms) to 100 mm (maximum arthritis disease activity). A positive change in score indicates worsening, and a negative change indicates improvement. (NCT02573012)
Timeframe: Baseline to Week 24

Interventioncm (Mean)
Tocilizumab+Prednisone (Tapering Dose)0.345
Tocilizumab+Prednisone (Constant Dose)-0.248

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Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Swollen 66 Joint Counts

Count of swollen joints based upon 66 assessed joints. (NCT02573012)
Timeframe: Baseline to Week 24

InterventionSwollen joints (Mean)
Tocilizumab+Prednisone (Tapering Dose)0.129
Tocilizumab+Prednisone (Constant Dose)-0.107

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Percentage of Visits With RA Flares

(NCT02573012)
Timeframe: Randomization to 24 weeks

,
InterventionPercentage of visits with flares (Number)
1 Visit2 Visits3 Visits>3 Visits
Tocilizumab+Prednisone (Constant Dose)7.03.900
Tocilizumab+Prednisone (Tapering Dose)16.06.92.30.8

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Observed Serum Rituximab Concentration

"Predose time point was any time prior to dose for Cycle 1 and within 5 hour prior to dose for other cycles (Cycles 2,5,8) during induction phase and for Months 1 to 24 during maintenance phase. Infusion duration for administration of first infusion should begin at an initial rate of 50 mg/hour. If no infusion-related or hypersensitivity reaction occurs, increase the infusion rate in 50 mg/hour increments every 30 minutes to a maximum of 400 mg/hour. If no reaction occurs, increase the infusion rate in 100 mg/hour increments every 30 minutes to a maximum of 400 mg/hour." (NCT02596971)
Timeframe: Predose, 0.5h postinfusion on D1 of Cy1,2,5,8 (1Cy: 21 days); at 120 days and 1 year after last rituximab dose or at treatment discontinuation (up to 4 years)

Interventionug/mL (Median)
C1 - Cmax after dosing C1C1 - Ctrough after dosing C1C8 - Cmax after dosing C8C8 - Ctrough after dosing C8
Atezo-R-CHOP Cohort (Expansion Phase)15926.1229105.5

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Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab

"Atezo-G-CHOP: Induction: Predose on D1 of Cy2,3,5,6 (1 Cy: 21 days); Maintenance: Predose on D1 of Month 1,2,4,7,15,23; at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years); Atezo-R-CHOP: Predose on D1 of Cy 2,3,5,8,16,25 (1 Cy: 21 days); at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years). Predose time point was any time prior to dose for Cycles 2,3,5,6,8 during induction phase, for Cycles 16,25 during consolidation treatment, and for Months 1 to 24 during maintenance phase. Atezo-G-Benda: Induction: Predose on D1 of Cy2,3,5,6 (1Cy: 28 days), Cy3D15: Predose; ; Maintenance: Predose on D1 of Month 1,4,7,15,23; at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years). The percentage of participants with positive results for ATAs to atezolizumab at baseline and at post-baseline time points are reported." (NCT02596971)
Timeframe: Baseline up to approximately 4 years

,
Interventionpercentage of participants (Number)
BaselineInduction Cycle 2 Day 1Atezolizumab Day 120 Follow upAtezo PK and Immunogenicity Follow Up (1YR)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)2.4000
Atezo-G-CHOP Cohort (Safety Run-In Phase)0000

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Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab

"Atezo-G-CHOP: Induction: Predose on D1 of Cy2,3,5,6 (1 Cy: 21 days); Maintenance: Predose on D1 of Month 1,2,4,7,15,23; at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years); Atezo-R-CHOP: Predose on D1 of Cy 2,3,5,8,16,25 (1 Cy: 21 days); at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years). Predose time point was any time prior to dose for Cycles 2,3,5,6,8 during induction phase, for Cycles 16,25 during consolidation treatment, and for Months 1 to 24 during maintenance phase. Atezo-G-Benda: Induction: Predose on D1 of Cy2,3,5,6 (1Cy: 28 days), Cy3D15: Predose; ; Maintenance: Predose on D1 of Month 1,4,7,15,23; at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years). The percentage of participants with positive results for ATAs to atezolizumab at baseline and at post-baseline time points are reported." (NCT02596971)
Timeframe: Baseline up to approximately 4 years

Interventionpercentage of participants (Number)
BaselineInduction Cycle 2 Day 1Consolidation Cycle 16Atezolizumab Day 120 Follow upAtezo PK and Immunogenicity Follow Up (1YR)
Atezo-R-CHOP Cohort (Expansion Phase)14.32.65.99.15.6

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Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab

Induction: Predose (any time prior to dose) on D1 of Cy1,5,8 (1Cy: 21 days); Maintenance: at 120 days and 1 year of last rituximab dose or at treatment discontinuation (up to 4 years) (NCT02596971)
Timeframe: Baseline up to approximately 4 years

Interventionpercentage of participants (Number)
BaselineInduction Cycle 1 Day 1Induction Cycle 5 Day 1Induction Cycle 8 Day 1Rituximab Day 120 Follow upRituximab 1 Year Follow upStudy Drug Completion or Early Discontinuation
Atezo-R-CHOP Cohort (Expansion Phase)14.3000000

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Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab

Induction: Predose (any time prior to dose) on D1 of Cy1,5,6 (1Cy: 21/28 days); Maintenance: Predose (any time prior to dose) on D1 of Month 1; at 120 days and 1 year of last obinutuzumab dose or at treatment discontinuation (up to 4 years) (NCT02596971)
Timeframe: Baseline up to approximately 4 years

Interventionpercentage of participants (Number)
Induction Cycle 1 Day 1Induction Cycle 5 Day 1Induction Cycle 6 Day 1Maintenance Month 1Study Drug Completion or Early DiscontinuationObinutuzumab Day 120 Follow up
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)2.400000

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Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Lugano 2014 Criteria

Tumor response assessment was performed by IRC according to modified Lugano classification using PET/CT scan. OR defined as a response of CR or PR. CR: a score of 1 (no uptake above background), 2 (uptake ] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. (NCT02596971)
Timeframe: Up to approximately 6 months

Interventionpercentage of participants (Number)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)90.0
Atezo-R-CHOP Cohort (Expansion Phase)87.5

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Percentage of Participants With Adverse Events

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. (NCT02596971)
Timeframe: Baseline up to approximately 4 years

Interventionpercentage of participants (Number)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)100
Atezo-G-CHOP Cohort (Safety Run-In Phase)100
Atezo-R-CHOP Cohort (Expansion Phase)100

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Percentage of Participants With Best Response of CR or PR During Study, as Determined by Investigator Using Modified Cheson 2007 Criteria

CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. (NCT02596971)
Timeframe: Baseline up to approximately 4 years (assessed at Baseline, 6 to 8 weeks after Day [D] 1 of Cycle [Cy] 6 or 8 (1Cy: 21 or 28 days), then every 2 months up to 24 months, at 35 days of last dose, and at every 3 months post-treatment follow-up [up 4 years])

Interventionpercentage of participants (Number)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)80.0
Atezo-R-CHOP Cohort (Expansion Phase)75.0

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Percentage of Participants With Complete Response (CR) at End of Induction (EOI), as Determined by the Independent Review Committee (IRC) Using Modified Lugano 2014 Criteria

Primary end point was positron emission tomography (PET) CR at EOI by IRC according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake less than or equal to [NCT02596971)
Timeframe: Up to approximately 6 months

Interventionpercentage of participants (Number)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)75
Atezo-R-CHOP Cohort (Expansion Phase)77.5

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Percentage of Participants With CR at EOI, as Determined by the Investigator Using Lugano 2014 Criteria

Tumor response assessment was performed by the investigator according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake NCT02596971)
Timeframe: Up to approximately 6 months

Interventionpercentage of participants (Number)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)87.5
Atezo-R-CHOP Cohort (Expansion Phase)77.5

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Percentage of Participants With CR at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria

Complete response according to modified Cheson 2007 criteria using PET/CT scan: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If bone marrow was involved by lymphoma prior to treatment, infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. (NCT02596971)
Timeframe: Up to approximately 6 months

Interventionpercentage of participants (Number)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)80.0
Atezo-R-CHOP Cohort (Expansion Phase)75.0

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Percentage of Participants With CR at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria

Complete response according to the modified Cheson 2007 criteria using PET/CT scan: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. Partial Response (PR): at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. (NCT02596971)
Timeframe: Up to approximately 6 months

Interventionpercentage of participants (Number)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)75.0
Atezo-R-CHOP Cohort (Expansion Phase)77.5

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Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Lugano 2014 Criteria

Tumor response assessment was performed by investigator according to modified Lugano classification using PET/CT scan. OR: a response of CR or PR. CR: a score of 1 (no uptake above background), 2 (uptake ] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. (NCT02596971)
Timeframe: Up to approximately 6 months

Interventionpercentage of participants (Number)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)95.0
Atezo-R-CHOP Cohort (Expansion Phase)87.5

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Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria

Objective response: having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. (NCT02596971)
Timeframe: Up to approximately 6 months

Interventionpercentage of participants (Number)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)95.0
Atezo-R-CHOP Cohort (Expansion Phase)87.5

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Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria

Objective response: having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. (NCT02596971)
Timeframe: Up to approximately 6 months

Interventionpercentage of participants (Number)
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)90.0
Atezo-R-CHOP Cohort (Expansion Phase)90.0

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Observed Serum Atezolizumab Concentration

"Atezo-G-Benda: Induction:Predose on D1 of Cy5,6 & D1,15 of Cy2,3 (1Cy:21/28 days), Cy2D1:0.5h postinfusion; Maintenance:Predose on D1 of Month 1,2,4,7,15,23, Month 2 D1: 0.5h postinfusion; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years); Atezo-G-CHOP: Induction:Predose on D1 of Cy2,3,5,6 (1Cy:21 days), Cy2D1:0.5h postinfusion; Maintenance:Predose on D1 of Month 1,2,3,4,7,15,23, Month 2 D1: 0.5h postinfusion; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years). Predose time point was within 5 hour prior to dose for Cy2,3,5,6 during induction phase and for Months 1 to 24 during maintenance phase. infusion length: 30-60 minutes." (NCT02596971)
Timeframe: Atezo-R-CHOP: Predose on D1 of Cy2,3,5,8,9,10,11,12,16,20,25 (1Cy:21 days), 0.5h postinfusion of D1 of Cy2,9; at 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years)

,
Interventionug/mL (Median)
Cycle 2 - Cmax after 1st infusionC2 - Cmin before 2nd infusionC6 - Cmin after 6th infusion
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)27583256
Atezo-G-CHOP Cohort (Safety Run-In Phase)42494195

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Observed Serum Atezolizumab Concentration

"Atezo-G-Benda: Induction:Predose on D1 of Cy5,6 & D1,15 of Cy2,3 (1Cy:21/28 days), Cy2D1:0.5h postinfusion; Maintenance:Predose on D1 of Month 1,2,4,7,15,23, Month 2 D1: 0.5h postinfusion; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years); Atezo-G-CHOP: Induction:Predose on D1 of Cy2,3,5,6 (1Cy:21 days), Cy2D1:0.5h postinfusion; Maintenance:Predose on D1 of Month 1,2,3,4,7,15,23, Month 2 D1: 0.5h postinfusion; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years). Predose time point was within 5 hour prior to dose for Cy2,3,5,6 during induction phase and for Months 1 to 24 during maintenance phase. infusion length: 30-60 minutes." (NCT02596971)
Timeframe: Atezo-R-CHOP: Predose on D1 of Cy2,3,5,8,9,10,11,12,16,20,25 (1Cy:21 days), 0.5h postinfusion of D1 of Cy2,9; at 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years)

Interventionug/mL (Median)
Cycle 2 - Cmax after 1st infusionC2 - Cmin before 2nd infusionC8 - Cmax after 7th infusionC8 - Cmin before 8th infusion
Atezo-R-CHOP Cohort (Expansion Phase)33282.1486.5184

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Observed Serum Obinutuzumab Concentration

"Predose time point was any time prior to dose for Cycle (Cy) 1 and within 5 hour prior to dose for other cycles (Cy 2,5,6) and for Months 1 to 24 during maintenance phase. Infusion duration for administration of first infusion should begin at an initial rate of 50 milligrams per hour (mg/hour). If no reaction occurs, increase the infusion rate in 100 mg/hour increments every 30 minutes to a maximum of 400 mg/hour." (NCT02596971)
Timeframe: Induction: Predose, 0.5 hour (h) postinfusion on Day (D) 1 of Cy1,2,5,6 (1Cy: 21/28 days); Maintenance: Predose, 0.5h postinfusion on Day 1 of Month 1,3,7,15,23; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years)

,
Interventionug/mL (Median)
C1 Cmax after 1st infusionC1 Cmin after the last infusion on C1C6 - Cmax after last dosing of inductionC6 - Cmin after last dosing of induction
Atezo-G-Benda Cohort (Safety Run-In and Expansion Phases)329322544203
Atezo-G-CHOP Cohort (Safety Run-In Phase)400399659245

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Number of Participants With Serious Adverse Events (SAEs) and AEs of Special Interest (AESI)

Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention, events associated with liver injury and impaired liver function were to be categorized as SAE. AEs of special interest included any opportunistic infections, serious post injection systemic reactions, progressive multifocal leukoencephalopathy (PML), hepatitis B virus infection or reactivation, severe mucocutaneous reactions (e.g., toxic epidermal necrolysis and stevens-johnson syndrome), cytopenias and cardiovascular events. Participants with SAEs and AESI were to be summarized. No serious adverse events (SAEs) or adverse events of special interest (AESI) reported. (NCT02613910)
Timeframe: Up to Week 156

InterventionParticipants (Number)
Any SAEAny AESI
Ofatumumab00

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Number of Participants With Adverse Events(AEs) and AEs Leading to Permanent Discontinuation of Ofatumumab SC (AELD)

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs and those with AEs leading to permanent discontinuation of ofatumumab SC (AELD) were to be summarized. Safety Population consists of all participants enrolled in the study. No safety events were reported for the one participant enrolled. (NCT02613910)
Timeframe: Up to Week 60

InterventionParticipants (Number)
Ofatumumab0

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Number of Participants With Clinically-significant Electrocardiogram (ECG) Abnormalities

12-lead ECG was planned to be taken on Baseline (Week 0) and at Follow-up visit (Week 60). No clinically significant ECG abnormalities were noted for the one participant. (NCT02613910)
Timeframe: Up to Week 60

InterventionParticipants (Number)
Ofatumumab0

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Number of Participants With Injection Site Reactions

Number of participants with injection site reactions were planned to be summarized. No cases of injection site reaction were reported for the one participant. (NCT02613910)
Timeframe: Up to Week 60

InterventionParticipants (Number)
Ofatumumab0

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Number of Participants With Vital Signs of Clinical Concern

Participants with vitals signs of clinical concern were planned to be summarized. No vital signs of clinical concerns were present for the one participant. (NCT02613910)
Timeframe: Up to Week 60

InterventionParticipants (Number)
Ofatumumab0

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Number of Participants With Severe Adverse Events

Severity is a category utilized for rating the intensity of an adverse event. Participants with severe AEs were to be summarized. No serious adverse events (SAEs) were reported for the one participant enrolled. (NCT02613910)
Timeframe: Up to Week 60

InterventionParticipants (Number)
Ofatumumab0

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Number of Participants With Post-injection Systemic Reactions

All serious post-injection systemic reactions were planned to be monitored closely throughout the study and number of participants with post-injection systemic reactions was to be summarized. No cases of post-injection systemic reactions were reported for the one participant. (NCT02613910)
Timeframe: Up to Week 60

InterventionParticipants (Number)
Ofatumumab0

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Number of Participants With Laboratory Results of Potential Clinical Concern

Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156 for evaluation of clinical chemistry parameters; and at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156 for evaluation of hematology parameters. No laboratory values of potential clinical concern were identified for this one participant. (NCT02613910)
Timeframe: Up to Week 156

InterventionParticipants (Number)
Ofatumumab0

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Number of Participants With Infections

All infections were planned to be monitored closely throughout the study and participants with infections were to be summarized. No cases of infection were reported for the one participant. (NCT02613910)
Timeframe: Up to Week 60

InterventionParticipants (Number)
Ofatumumab0

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Area Under the Serum Concentration-time Curve From Day 1 to Week 4 (AUC[1-4])

Area under the serum concentration-time curve from time zero (Day 1) to final time point measured after the first administration (Week 1) until Week 4 (AUC(W1-W4)). PK blood samples for this endpoint were drawn at Day 1 (before and after the first infusion), Day 8 ± 1 (7 days after first infusion), Day 15 ± 1 (14 days after first infusion), Day 22 ± 2 (before and after completion of the second infusion). (NCT02617485)
Timeframe: Baseline to Week 4

Intervention(μg*day)/mL (Mean)
MabionCD201559.51
MabThera1509.79

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Area Under the Serum Concentration-time Curve From Week 13 to Week 26 (AUC[W13-W26])

Area under the serum concentration-time curve from time zero to final time point measured from Week 13 until Week 26 (AUC[W13-W26]). PK blood samples for this endpoint were drawn at Day 85 ± 4 (before and after completion of the fifth infusion), Day 106 ± 4 (before and after completion of sixth infusion), Day 127 ± 4 (before and after completion of the seventh infusion), Day 148 ± 4 (before and after completion of the eight infusion), Day 155 ± 4 (one week after last infusion) and Day 176 ± 4 (one month after last infusion). (NCT02617485)
Timeframe: Week 13 to Week 26

Intervention(μg*day)/mL (Mean)
MabionCD2016498.9
MabThera15647.4

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AUC (W1-W26)

Area under the serum concentration-time curve measured after the first administration (Week 1) until Week 26 (AUC(1-26)) (NCT02617485)
Timeframe: Week 1 until Week 26

Intervention(μg*day)/mL (Mean)
MabionCD2028413.6
MabThera26955.3

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AUC (W1-W26) B-cell

Area under the serum concentration-time curve of CD19+ B cell counts, measured from the first administration to the final time point at Week 26 (AUC(1-26) B-cell). (NCT02617485)
Timeframe: baseline to Week 26

Interventioncells*days/mL blood (Mean)
MabionCD203395.82
MabThera10476.2

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Ctrough (Before 8th Infusion)

Trough serum concentration measured at the end of a dosing interval at steady state, taken directly before eighth infusion. (NCT02617485)
Timeframe: Week 22

Interventionμg/mL (Mean)
MabionCD20102.246
MabThera90.61

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Adverse Events

Percentage of patients with at least one AE in a given category. Data from the entire follow-up are included (Period 1 and Period 2). (NCT02617485)
Timeframe: from baseline to Week 46

,
Interventionpercent (Number)
all AEsTEAEsTESAEssevere TEAEsrelated TEAEsrelated severe TEAEsrelated TESAEsTEAEs leading to deathrelated TEAEs leading to death
MabionCD2071.071.019.040.053.029.013.08.02.0
MabThera67.565.012.522.542.522.55.000

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Efficacy Assessment at Week 26

An efficacy assessment was made after 8 treatment cycles (at Week 26) based on tumour responses classified according to the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (Cheson et al. 1999). Response was assessed based on clinical, radiologic (CT scan) and pathologic (bone marrow) criteria. Possible efficacy responses were: complete response, partial response, stable disease, and progressive disease. Efficacy reported here includes all patients included in the ITT set. (NCT02617485)
Timeframe: Week 26

,
InterventionParticipants (Count of Participants)
CompletePartialStable diseaseProgressive diseaseMissing
MabionCD20344210104
MabThera1418422

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Cmax (Post 5th and 8th Infusion)

Maximum serum drug concentration (Cmax) at steady state after the 5th and 8th infusions. (NCT02617485)
Timeframe: Week 13 (5th infusion) and Week 22 (8th infusion)

,
Interventionμg/mL (Mean)
5th infusion8th infusion
MabionCD20273.356296.784
MabThera266.439296.462

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T1/2 (Post 5th and 8th Infusions)

Elimination half-life at steady state after the 5th and 8th infusions. (NCT02617485)
Timeframe: Week 13 to Week 16 and Week 22 to Week 26

,
Interventiondays (Mean)
5th infusion8th infusion
MabionCD2014.80118.301
MabThera15.21716.997

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Kel (Post 5th and 8th Infusions)

Elimination Rate Constant at steady stade after the 5th and 8th infusions. (NCT02617485)
Timeframe: Week 13 (5th infusion) and Week 22 (8th infusion)

,
Intervention1/day (Mean)
5th infusion8th infusion
MabionCD200.056630.04335
MabThera0.054180.04379

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CLss (Post 5th and 8th Infusions)

Clearance at steady state after the 5th and 8th infusions. (NCT02617485)
Timeframe: Week 13 to Week 16 and Week 22 to Week 26

,
InterventionmL/day (Mean)
5th infusion8th infusion
MabionCD20198.701179.168
MabThera206.905191.272

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Immunogenicity

Percentage of patients with positive ADA or NAb results in a given category. Data pertain to the entire follow-up period (from Baseline to Week 46). (NCT02617485)
Timeframe: from baseline to Week 46

,
Interventionparticipants (Number)
Treatment-induced ADAPersistent ADATransient ADATreatment-boosted ADANAb positive
MabionCD2064200
MabThera11000

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PSA Response in the Standard Treatment Arm and Experimental Treatment Arm

"PSA response measured according to Prostate Cancer Working Group 2 (PCWG2).~The study was terminated after only 9 patients enrolled, 5 to the standard of care docetaxel/prednisone arm and 4 to experimental docetaxel/prednisone/enzalutamide arm." (NCT02685267)
Timeframe: Baseline, Day 84 (C4D1), Day 147 (C7D1), Day 210 (C10D1), Day 231, and every 21 days through study completion (an average of 1 year)

InterventionParticipants (Count of Participants)
Docetaxel/Prednisone2
Docetaxel/Prednisone + Enzalutamide3

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Overall Survival

(NCT02685267)
Timeframe: At both 1 year and 2 years from treatment start

InterventionParticipants (Count of Participants)
Docetaxel/Prednisone2
Docetaxel/Prednisone + Enzalutamide4

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Progression-free Survival (Radiographic or Per PCWG2 Criteria)

The primary endpoint of the study is progression-free survival (PFS), defined as the time from randomization to disease progression. Progression will be evaluated using a combination of RECIST and Prostate Cancer Working Group 2 guidelines. (NCT02685267)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Docetaxel/Prednisone0
Docetaxel/Prednisone + Enzalutamide0

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Change From Baseline to 24 Weeks of the Mean of the 24-hour Standard Deviation Score (SDS) Profile for 17-OHP

Change from baseline to 24 weeks of the mean of the 24-hour standard deviation score (SDS) - also referred to as a z-score - profile for 17-OHP (17-Hydroxyprogesterone). The primary efficacy variable was the natural logarithm of the mean of the 24-hour SDS for the natural logarithm of 17-OHP. The mean of the 24-hour SDS profile for each visit was the arithmetic mean of all the SDSs with the first and last (13th) weighted one half relative to the intermediate SDSs. For each of the 13 log-transformed 17-OHP values at each visit, an SDS was calculated by counting the number of SDs that were above or below the mean of the log-transformed range. A negative z-score indicated greater control of 17-OHP when compared to baseline (0). (NCT02716818)
Timeframe: 24 weeks

InterventionZ-score (Mean)
Chronocort®-0.403
Standard Glucocorticoid Therapy-0.172

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Number of Participants With 17-OHP and A4 Levels in the Optimal Range at 9:00 at Week 24 Visit

"17-OHP and A4 levels at 09:00 at the week 24 visit, as a responder analysis (i.e. the number of participants achieving results in the optimal range).~Optimal range for 17-OHP (male) = 1.2* - 6.7 nmol/L (female) = 1.2* - 8.6 Optimal range for A4 (male) = 1.4 - 5.2 nmol/L (female) = 1.0 - 7.0 nmol/L~* = There is no lower reference range available for 17-OHP, hence the lower limit of the optimal range was used in the derivation of the average Standard Deviation Score. This enabled calculation of an 'unsigned' SDS score which was used to assess potential over-treatment as well as under-treatment." (NCT02716818)
Timeframe: 24 weeks

InterventionParticipants (Count of Participants)
Chronocort - 09:00h Response - 17-OHP30
Chronocort - 09:00h Response - A425
Standard Glucocorticoid Therapy - 09:00h Response - 17-OHP30
Standard Glucocorticoid Therapy - 09:00h Response - A430

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Changes Relative to Standard Glucocorticoid Therapy in Body Composition (DEXA - Fat Mass and Lean Mass)

Changes relative to Standard glucocorticoid therapy in body composition (DEXA) (fat mass and lean mass) - measured at all sites except Germany. (NCT02716818)
Timeframe: Baseline and 24 weeks

Interventionkilograms (Mean)
Chronocort - DEXA - Fat Mass-0.575
Standard Glucocorticoid Therapy - DEXA - Fat Mass0.445
Chronocort - DEXA - Lean Mass0.640
Standard Glucocorticoid Therapy - DEXA - Lean Mass0.234

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Changes Relative to Standard Glucocorticoid Therapy in Body Composition (DEXA - Bone Mineral Density) - Measured at All Sites Except Germany.

Changes relative to Standard glucocorticoid therapy in body composition (DEXA - bone mineral density only) - measured at all sites except Germany. (NCT02716818)
Timeframe: Baseline and 24 weeks

Interventiong/cm^2 (Mean)
Chronocort - DEXA - Bone Mineral Density-0.001
Standard Glucocorticoid Therapy - DEXA - Bone Mineral Density-0.008

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17-OHP and A4 by Individual Baseline Treatment Strata.

17-OHP and A4 by individual baseline treatment strata presented in the same manner as the primary endpoint (using 24-hour SDS profile at 24 weeks). Change from baseline to 24 weeks of the mean of the 24-hour standard deviation score (SDS) - also referred to as a z-score - profile for 17-OHP and A4. This secondary efficacy variable was calculated as follows: the natural logarithm of the mean of the 24-hour SDS for the natural logarithm of 17-OHP and A4. The mean of the 24-hour SDS profile for each visit was the arithmetic mean of all the SDSs with the first and last (13th) weighted one half relative to the intermediate SDSs. For each of the 13 log-transformed 17-OHP and A4 values at each visit, an SDS was calculated by counting the number of SDs that were above or below the mean of the log-transformed range. A negative z-score indicated greater control of 17-OHP and A4 when compared to baseline (0). (NCT02716818)
Timeframe: 24 weeks

InterventionZ-score (Mean)
Pre-Baseline - Hydrocortisone - 17-OHP-0.248
Pre-Baseline - Prednisone/Prednisolone - 17-OHP-0.061
Pre-Baseline - Dexamethasone - 17-OHP-0.245
Pre-Baseline - Chronocort vs. Hydrocortisone - 17-OHP-0.431
Pre-Baseline - Chronocort vs. Prednisone/Prednisolone - 17-OHP-0.320
Pre-Baseline - Chronocort vs. Dexamethasone - 17-OHP-0.565
Pre-Baseline - Hydrocortisone - A4-0.211
Pre-Baseline - Prednisone/Prednisolone - A40.100
Pre-Baseline - Dexamethasone - A40.368
Pre-Baseline - Chronocort vs. Hydrocortisone - A40.015
Pre-Baseline - Chronocort vs. Prednisone/Prednisolone - A40.328
Pre-Baseline - Chronocort vs. Dexamethasone - A4-0.092

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Change From Baseline to 24 Weeks of the Mean of the 24-hour Standard Deviation Score (SDS) Profile for A4

Change from baseline to 24 weeks of the mean of the 24-hour standard deviation score (SDS) - also referred to as a z-score - profile for A4 (androstenedione). This secondary efficacy variable was calculated as follows: the natural logarithm of the mean of the 24-hour SDS for the natural logarithm of A4. The mean of the 24-hour SDS profile for each visit was the arithmetic mean of all the SDSs with the first and last (13th) weighted one half relative to the intermediate SDSs. For each of the 13 log-transformed A4 values at each visit, an SDS was calculated by counting the number of SDs that were above or below the mean of the log-transformed range. A negative z-score indicated greater control of A4 when compared to baseline (0). (NCT02716818)
Timeframe: 24 weeks

InterventionZ-score (Mean)
Chronocort®0.113
Standard Glucocorticoid Therapy-0.041

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Time to Maximum Plasma Concentration (Tmax) of Mometsone Furoate

Blood samples were collected predose, and 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12 in a subset of participants who consented to take part in a PK sub-trial. Per protocol, descriptive MF pharmacokinetics were summarized without regard to treatment assignment. (NCT02741271)
Timeframe: Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12

Interventionhr (Median)
Pooled MF/F 100/10 mcg and MF 100 mcg1.47

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Mean Change From Baseline in Total Daily Use of Short-Acting Beta-Agonist (SABA) Rescue Medication With MF/F MDI 100/10 mcg BID or MF MDI 100 mcg BID Over the First 12 Weeks of Treatment

To evaluate the efficacy of MF/F MDI 100/10 mcg BID compared with MF MDI 100 mcg BID, the change from baseline in total daily short-acting beta-agonist (SABA) use (puffs per day) was averaged and assessed. All participants received SABA MDIs (albuterol 90 mcg or salbutamol 100 mcg) for as-needed relief of asthma symptoms. This secondary analysis of the change from baseline used the cLDA method without multiple imputation.A model-based MAR approach was used for missing data. (NCT02741271)
Timeframe: Baseline and Weeks 1-12 (Averaged)

,
InterventionPuffs per day (Mean)
BaselineChange from Baseline Over Weeks 1-12 (Average)
MF MDI 100 mcg BID0.13-0.02
MF/F MDI 100/10 mcg BID0.25-0.12

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Change From Baseline AM Post-Dose Percent Predicted FEV1 on Day 1 of Treatment

The key secondary objective was to determine the onset of action for the efficacy of MF/F MDI 100/10 mcg BID, compared with MF MDI 100 mcg BID. The post-dose AM % predicted FEV1 was averaged sequentially, and the change from baseline on Day 1 was assessed. This key secondary endpoint was controlled for multiplicity in a step-down fashion, based on trial success defined as a statistically significant improvement in the primary endpoint for MF/F vs MF. Missing data were imputed using control-based multiple imputations with the cLDA model. (NCT02741271)
Timeframe: Baseline and Day 1, measured at 4 hr, 2 hr and 60, 30, 15, and 5 min, post-dose time points

,
InterventionPercent predicted FEV1 (Mean)
BaselineChange from Baseline (4 hr post-dose on Day 1)Change from Baseline (2 hr post-dose on Day 1)Change from Baseline (60 min post-dose on Day 1)Change from Baseline (30 min post-dose on Day 1)Change from Baseline (15 min post-dose on Day 1)Change from Baseline (5 min post-dose on Day 1)
MF MDI 100 mcg BID78.485.685.874.923.051.380.95
MF/F MDI 100/10 mcg BID79.2111.6112.7111.059.568.005.20

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Participants Using SABA Rescue Medication Across Weeks 1-12 of the Treatment Period

To evaluate the efficacy of MF/F MDI 100/10 mcg BID compared with MF MDI 100 mcg BID, the number of participants using SABA rescue medication in Weeks 1-12 (individually) of the double-blind treatment period was assessed. All participants received SABA MDIs (albuterol 90 mcg or salbutamol 100 mcg) for as-needed relief of asthma symptoms. (NCT02741271)
Timeframe: Baseline and Weeks 1-12 (Averaged)

,
InterventionParticipants (Number)
BaselineWeeks 1-12
MF MDI 100 mcg BID1745
MF/F MDI 100/10 mcg BID2341

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Area Under the Plasma Concentration-Time Curve of Mometasone Furoate From Time 0 to Time of Last Measurable Concentration (AUC0-last)

Blood samples were collected predose, and 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12 in a subset of participants who consented to take part in a PK sub-trial. Per protocol, descriptive MF pharmacokinetics were summarized without regard to treatment assignment. (NCT02741271)
Timeframe: Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12

Interventionhr*pg/mL (Geometric Mean)
Pooled MF/F 100/10 mcg and MF 100 mcg106

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Count (Percentage) of Participants Discontinuing From Study Medication Due to An AE

An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition temporally associated with the use of the Sponsor's product, is also an AE. (NCT02741271)
Timeframe: Up to 24 weeks

InterventionParticipants (Count of Participants)
MF/F MDI 100/10 mcg BID0
MF MDI 100 mcg BID3
Total3

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Count (Percentage) of Participants Experiencing At Least One Adverse Event (AE)

An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition temporally associated with the use of the Sponsor's product, is also an AE. (NCT02741271)
Timeframe: Up to 26 weeks

InterventionParticipants (Count of Participants)
MF/F MDI 100/10 mcg BID37
MF MDI 100 mcg BID52
Total89

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Change From Baseline AM Post-Dose % Predicted FEV1 AUC 0-4 Hours on Day 1 and Week 12 of Treatment

This endpoint reflects changes in lung function data (forced expiratory volume in 1 second) measured across 0 to 4 hours post-dose on Day 1 and Week 12 compared to Baseline. Baseline was the average of 30 and 0 minutes pre-dose % predicted FEV1 values. The AUC was calculated over the scheduled timepoints of 0 min, 5 min, 15 min, 30 min, 60 min, 2 hr and 4 hr post-dose. Units are standardized to percent predicted FEV1 by dividing the AUC calculation by the duration of the observed AUC. (NCT02741271)
Timeframe: Baseline, Day 1 and Week 12

,
InterventionPercent predicted FEV1 (Mean)
BaselineChange from Baseline on Day 1Change from Baseline at Week 12
MF MDI 100 mcg BID78.482.704.87
MF/F MDI 100/10 mcg BID79.217.137.56

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Change From Baseline in Morning (AM) Post-Dose % Predicted Forced Expiratory Volume in One Second (FEV1) in the Area Under the Curve (AUC)0-60

This endpoint reflects changes in lung function data (forced expiratory volume in 1 second) measured across 0 to 60 minutes post-dose (at 0, 5, 15, 30 and 60 minutes) and averaged across study visits in the Treatment Period (Day 1, Week 1, Week 4, Week 8 and Week 12) compared to Baseline. Baseline was the average of % predicted FEV1 values at 30 min and 0 min pre-dose. At each visit, the area under the curve is calculated over the post-dose timepoints. Units are standardized to percent predicted FEV1 by dividing the AUC calculation by the duration of the observed AUC. (NCT02741271)
Timeframe: Baseline, and average of Day 1, Weeks 1, 4, 8, and 12

,
InterventionPercent predicted FEV1 (Mean)
BaselineChange from Baseline
MF MDI 100 mcg BID78.483.96
MF/F MDI 100/10 mcg BID79.218.99

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Change From Baseline in AM Pre-Dose % Predicted FEV1 With MF/F MDI 100/10 mcg BID or MF MDI 100 mcg BID Over the First 12 Weeks of Treatment

The change from baseline in AM pre-dose % predicted FEV1 with MF/F MDI 100/10 mcg BID vs MF MDI 100 mcg BID averaged over 12 weeks treatment was assessed. This secondary analysis of the change from baseline used the cLDA method without multiple imputation. A model-based MAR approach was used for missing data. (NCT02741271)
Timeframe: Baseline and Weeks 4, 8, and 12 (Averaged)

,
InterventionPercent predicted FEV1 (Mean)
BaselineChange from Baseline (Weeks 4, 8, and 12)
MF MDI 100 mcg BID78.220.44
MF/F MDI 100/10 mcg BID79.211.51

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Area Under the Plasma Concentration-Time Curve of Mometasone Furoate From Time 0 to 12 Hours (AUC0-12)

Blood samples were collected predose, and 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12 in a subset of participants who consented to take part in a PK sub-trial. Per protocol, descriptive MF pharmacokinetics were summarized without regard to treatment assignment. (NCT02741271)
Timeframe: Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12

Interventionhr*pg/mL (Geometric Mean)
Pooled MF/F 100/10 mcg and MF 100 mcg109

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Participants Whose SABA Rescue Medication Use Increased Across Weeks 1-12 of the Treatment Period

To evaluate the efficacy of MF/F MDI 100/10 mcg BID compared with MF MDI 100 mcg BID, the number of participants whose use of SABA rescue medication increased in Weeks 1-12 (individually) of the double-blind treatment period was assessed. All participants received SABA MDIs (albuterol 90 mcg or salbutamol 100 mcg) for relief of asthma symptoms. (NCT02741271)
Timeframe: Weeks 1-12 (Averaged)

InterventionParticipants (Number)
MF/F MDI 100/10 mcg BID24
MF MDI 100 mcg BID34

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Maximum Plasma Concentration (Cmax) of Mometsone Furoate

Blood samples were collected predose, and 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12 in a subset of participants who consented to take part in a PK sub-trial. Per protocol, descriptive MF pharmacokinetics were summarized without regard to treatment assignment. (NCT02741271)
Timeframe: Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12

Interventionpg/mL (Geometric Mean)
Pooled MF/F 100/10 mcg and MF 100 mcg16

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Lund Kennedy Endoscopy Score Over Time

The Lund-Kennedy score is a validated scale by which clinicians grade the endoscopic appearance of the sinonasal cavity for sinusitis patients. There are 5 parameters rated on a scale of 0-2 for each side of the nose, for a maximum total score of 20 points. Higher scores represent a worse endoscopic appearance. (NCT02748070)
Timeframe: Baseline, 1, week, 1 month, 3 months, and 6 months

,
Interventionscore on a scale (Mean)
Baseline1 week1 month3 months6 months
Placebo3.85.33.82.41.8
Prednisone2.95.93.51.91.3

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Sino-nasal Outcome Test (SNOT-22) Over Time

SNOT-22 is a validated scale which measures sinonasal symptoms for sinusitis patients. The 22 questions are rated on a scale of 0-5 for a maximum total score of 110. Higher scores represent more symptomatic patients. (NCT02748070)
Timeframe: Baseline, 1, week, 1 month, 3 months, and 6 months

,
Interventionscore on a scale (Mean)
Baseline1 week1 month3 months6 months
Placebo42.938.528.620.325.2
Prednisone43.839.726.628.334.2

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Percentage of Participants With Overall Survival

Overall survival is defined as survival of death from any cause. (NCT02806947)
Timeframe: 6 and 12 Months Post-randomization

,
Interventionpercentage of participants (Number)
Overall Survival at 6 MonthsOverall Survival at 12 Months
Prednisone82.773.2
Sirolimus81.976.3

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Percentage of Participants With Complete or Partial Response (CR/PR) to Acute GVHD Treatment

"Scoring of CR/PR is in comparison to the participant's acute GVHD status at randomization. Complete response (CR) is defined as staging of 0 for in all target organs for GVHD - skin, GI tract, and liver. Partial response (PR) is defined as improvement in some target organ(s) without worsening in others. Death and initiation of systemic acute GVHD treatment beyond randomized treatment are considered failures for this endpoint. Organ staging is defined below:~Skin stage:~0: No rash~Rash <25% of body surface area (BSA)~Rash on 25-50% of BSA~Rash on >50% of BSA~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level):~0: <2 mg/dL~2-3 mg/dL~3.01-6 mg/dL~6.01-15.0 mg/dL~>15 mg/dL~GI stage:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus" (NCT02806947)
Timeframe: Days 28 and 56 Post-randomization

InterventionParticipants (Count of Participants)
CR/PR at Day 2872566668CR/PR at Day 2872566669CR/PR at Day 5672566669CR/PR at Day 5672566668
YesNo
Sirolimus35
Prednisone46
Prednisone17
Sirolimus34
Prednisone50
Sirolimus19
Prednisone13

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Percentage of Participants With Non-relapse Mortality

Non-relapse mortality is defined as death due to any cause other than relapse of the underlying malignancy. The cumulative incidence of non-relapse mortality is described, with malignancy relapse treated as a competing risk. (NCT02806947)
Timeframe: 6 and 12 Months Post-randomization

,
Interventionpercentage of participants (Number)
Non-relapse Mortality at 6 MonthsNon-relapse Mortality at 12 Months
Prednisone9.414.2
Sirolimus12.716.5

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Percentage of Participants With Malignancy Relapse

The cumulative incidence of relapse of the primary malignancy is described, with death treated as a competing risk. (NCT02806947)
Timeframe: 6 and 12 Months Post-randomization

,
Interventionpercentage of participants (Number)
Malignancy Relapse at 6 MonthsMalignancy Relapse at 12 Months
Prednisone12.515.7
Sirolimus14.521.9

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Acute GVHD Response

"Acute GVHD response is classified as CR, PR, mixed response (MR), no response (NR), and progression and scored by comparison to acute GVHD status at randomization. MR is defined as improvement in some organ(s) with worsening in another, progression as worsening in some organ(s) without improvement in others, and NR as absence of any improvement or worsening. Death and initiation of systemic acute GVHD treatment beyond randomized treatment are classified as NR. Organ staging is defined as:~Skin stage:~0: No rash~Rash <25% of body surface area (BSA)~Rash 25-50% of BSA~Rash >50% of BSA~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level in mg/dL):~0: <2~2-3~3.01-6~6.01-15.0~>15~GI stage:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus" (NCT02806947)
Timeframe: Days 28 and 56 Post-randomization

InterventionParticipants (Count of Participants)
Acute GVHD Response at Day 2872566669Acute GVHD Response at Day 2872566668Acute GVHD Response at Day 5672566669Acute GVHD Response at Day 5672566668
Complete Response (CR)Partial Response (PR)Mixed Response (MR)No Response (NR)Progression
Prednisone39
Sirolimus5
Prednisone7
Sirolimus1
Prednisone5
Sirolimus16
Prednisone11
Sirolimus2
Prednisone1
Sirolimus30
Prednisone48
Sirolimus4
Prednisone2
Sirolimus0
Prednisone0
Sirolimus19
Prednisone10
Prednisone3

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Percentage of Participants With Chronic GVHD

Chronic GVHD is classified per 2005 NIH Consensus Criteria (Filipovich et al. 2005) into categories of severity: none, mild, moderate, and severe. Occurrence of chronic GVHD is defined as the occurrence of mild, moderate, or severe chronic GVHD per this classification. The cumulative incidence of chronic GVHD is described, with death and malignancy relapse treated as competing risks. (NCT02806947)
Timeframe: 6 and 12 Months Post-randomization

,
Interventionpercentage of participants (Number)
Chronic GVHD at 6 MonthsChronic GVHD at 12 Months
Prednisone31.240.6
Sirolimus25.731.4

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Proportion of Participants With Event-free Survival

Event-free survival is defined as freedom from acute GVHD progression, chronic GVHD, malignancy relapse, and death. (NCT02806947)
Timeframe: 6 and 12 Months Post-randomization

,
Interventionpercentage of participants (Number)
Event-free Survival at 6 MonthsEvent-free Survival at 12 Months
Prednisone43.731.2
Sirolimus47.335.9

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Percentage of Participants With Treatment Failure

"Treatment failure is defined as either no response (NR) or progression and scored by comparison to acute GVHD status at randomization. Progression is defined as worsening in some target organ(s) without improvement in others and NR is defined as absence of any improvement or worsening in target organs. Death and initiation of systemic acute GVHD treatment beyond randomized treatment are classified as NR. Organ staging is defined as:~Skin stage:~0: No rash~Rash <25% of body surface area (BSA)~Rash 25-50% of BSA~Rash >50% of BSA~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level in mg/dL):~0: <2~2-3~3.01-6~6.01-15.0~>15~GI stage:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus" (NCT02806947)
Timeframe: Days 28 and 56 Post-randomization

InterventionParticipants (Count of Participants)
Treatment Failure at Day 2872566668Treatment Failure at Day 2872566669Treatment Failure at Day 5672566668Treatment Failure at Day 5672566669
NoYes
Sirolimus18
Prednisone12
Sirolimus36
Prednisone51
Sirolimus19
Prednisone13
Sirolimus34
Prednisone50

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Percentage of Participants With Serious Infections

The cumulative incidence of serious infections (Grade 2 or 3 per BMT CTN MOP) is described, with death treated as a competing risk. (NCT02806947)
Timeframe: 6 and 12 Months Post-randomization

,
Interventionpercentage of participants (Number)
Seirious Infections at 6 MonthsSeirious Infections at 12 Months
Prednisone43.851.8
Sirolimus30.439.6

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Percentage of Participants With Disease-free Survival

Disease-free survival is defined as freedom from death and relapse of the underlying malignancy. (NCT02806947)
Timeframe: 6 and 12 Months Post-randomization

,
Interventionpercentage of participants (Number)
Disease-free Survival at 6 MonthsDisease-free Survival at 12 Months
Prednisone78.170.2
Sirolimus72.861.6

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Percentage of Participants With GVHD-free Survival

GVHD-free survival is defined as freedom from acute GVHD, chronic GVHD, and death. The proportion of participants alive and free of both acute and chronic GVHD are described at 6 and 12 months post-randomization. (NCT02806947)
Timeframe: 6 and 12 Months Post-randomization

,
Interventionpercentage of participants (Number)
GVHD-free Survival at 6 MonthsGVHD-free Survival at 12 Months
Prednisone46.046.0
Sirolimus45.350.9

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Number of HES Flares Per Participant Per Year

The rate of HES flares for each participant was calculated as the number of observed HES flares divided by the time (expressed in years) between randomization and either the week 32 visit date if available, or the study withdrawal date. Negative binomial generalized linear model including Baseline OCS dose, region, treatment and observed time (offset variable). Wilcoxon test stratified by Baseline OCS (0-<=20mg/day, >20mg/day prednisone or equivalent) and region. Adjusted mean and 95% CI rate/year has been presented. (NCT02836496)
Timeframe: Up to Week 32

InterventionFlares per participant per year (Mean)
Placebo1.46
Mepolizumab 300 mg SC0.50

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Percentage of Participants Who Experienced an HES Flare or Who Withdrew From the Study During the 32-Week Study Treatment Period

Percentage of participants who experienced >=1 HES flare during the 32-Week treatment period or who withdrew from the study has been presented. A HES flare is defined as a HES related clinical manifestation based on a physician-documented change in clinical signs or symptoms which resulted in need for an increase in the maintenance Oral Corticosteroid (OCS) dose by at least 10 mg per day for 5 days or an increase in or addition of any cytotoxic or immunosuppressive HES therapy. HES flare is also defined as receipt of two or more courses of blinded active OCS during the treatment period. Intent-to-treat (ITT) Population comprises of all randomized participants. This population was based on the treatment to which the participants were randomized. Any participant who received a treatment randomization number were considered to be randomized. (NCT02836496)
Timeframe: Up to Week 32

InterventionPercentage of participants (Number)
Placebo56
Mepolizumab 300 mg SC28

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Number of Participants With Change From Baseline in Fatigue Severity Based on Brief Fatigue Inventory (BFI) in Item 3 (Worst Level of Fatigue During Past 24 Hours) at Week 32 by Category

"The change from Baseline in fatigue severity (worst level of fatigue during past 24 hours) at Week 32 was calculated using the mean of the 7 daily assessments of BFI item 3 up to and including the date of the Week 32 visit as the Week 32 assessment, and the mean of the 7 daily assessments of BFI item 3 up to but not including the date of first dose of study treatment as the Baseline assessment. Wilcoxon Rank Sum test stratified by Baseline fatigue severity (severe defined as BFI item 3>=7 and not severe defined as BFI item 3<7), Baseline OCS (0-<=20mg/day and >20mg/day prednisone or equivalent) and region. Participants with missing change from Baseline at Week 32 were included in the worst category (>=4 point increase)." (NCT02836496)
Timeframe: Baseline (Week 0) and at Week 32

,
InterventionParticipants (Count of Participants)
>=4 point increase (>=3.5)3 point increase (>=2.5 to <3.5)2 point increase (>=1.5 to <2.5)1 point increase (>=0.5 to <1.5)No change (>-0.5 to <0.5)1 point reduction (>-1.5 to <=-0.5)2 point reduction (>-2.5 to <=-1.5)3 point reduction (>-3.5 to <=-2.5)>=4 point reduction (<=-3.5)
Mepolizumab 300 mg SC5056911729
Placebo7449145353

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Time to First HES Flare

The time to first HES flare was calculated as (onset date of first HES flare minus date of first dose of study treatment) plus 1. Probability of first flare (by week 4, 8, 12, 16, 20, 24, 28, and 32) and corresponding 95% CI have been presented, calculated using the Kaplan-Meier method. (NCT02836496)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28 and 32

,
InterventionProbability expressed as percentage (Number)
Flares by Week 4Flares by Week 8Flares by Week 12Flares by Week 16Flares by Week 20Flares by Week 24Flares by Week 28Flares by Week 32
Mepolizumab 300 mg SC5.67.49.313.013.014.820.526.3
Placebo7.414.926.233.841.348.950.852.7

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Percentage of Participants Who Experienced a HES Flare or Who Withdrew From the Study During Week 20 Through Week 32

HES flare during Week 20 through Week 32 was defined as a HES flare starting or ongoing on or after the date of the Week 20 visit up to and including the date of the Week 32 visit. Percentage of participants who experienced >=1 HES flare during Week 20 through Week 32 or who withdrew from the study has been presented. (NCT02836496)
Timeframe: Week 20 to Week 32

InterventionPercentage of participants (Number)
Placebo35
Mepolizumab 300 mg SC17

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PSA Response Rate, Defined as >= 50% Decline in PSA From Baseline Maintained for at Least 3 Weeks and Measured by the Same Laboratory, and Without Evidence of Other Disease Progression Documented at Time of Confirmatory Values

The response rate will be compared to a historical response rate of 20% using the exact binomial test for a single proportion. Confidence intervals for the response rate will be calculated using Wilson's method. (NCT02844582)
Timeframe: Up to 18 months.

InterventionParticipants (Count of Participants)
Treatment (Cabazitaxel, Prednisone)0

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Incidence of Adverse Events, Serious Adverse Events, and Discontinuations, Described and Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03

Incidence of adverse events, serious adverse events, and discontinuations, described and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCT02844582)
Timeframe: Up to 28 days after discontinuation of study drug

Interventionparticipants (Number)
Back painDiarrheaFatigueHot flashesNeutrophil count decreasedNon-cardiac chest painPainRenal and urinary disorders - Other, specifyWhite blood cell decreased
Treatment (Cabazitaxel, Prednisone)112121112

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Number of Participants Without Biochemical Failure at 2 Years

Prostate-specific antigen progression (i.e. biochemical failure) will be defined per the American Urological Association guidelines (i.e. confirmed prostate-specific antigen post-radical prostatectomy >= 0.2 ng/mL). We will report the number of patients without biochemical failure at 2 years. (NCT02849990)
Timeframe: At 2 years

Interventionparticipants (Number)
Treatment (Neoadjuvant Chemotherapy)18

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Number of Patients With a Near Pathologic Complete Response After 3 Months of Treatment

The near pathologic complete response will be defined as =< 5 mm of residual tumor as assessed on prostatectomy specimens after 3 months of treatment. (NCT02849990)
Timeframe: At 3 months

InterventionParticipants (Count of Participants)
Treatment (Neoadjuvant Chemotherapy)6

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Number of Patients With Pathologic T3 Disease After 3 Months of Treatment.

The presence of T3 disease (e.g. extraprostatic tumor not invading adjacent structures) will be determine from the prostatectomy specimen after 3 months of treament. (NCT02849990)
Timeframe: At 3 months

InterventionParticipants (Count of Participants)
Treatment (Neoadjuvant Chemotherapy)18

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Overall Survival (OS)

Will will report the number of participants alive at 2-years following enrollment. (NCT02849990)
Timeframe: At 2 years

InterventionParticipants (Count of Participants)
Treatment (Neoadjuvant Chemotherapy)20

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Pathologic Complete Response Rate as Assessed From Prostatectomy Specimens Following Neoadjuvant Treatment

Pathologic complete response is defined as no evidence of cancer on fully submitted prostatectomy specimens using standard surgical pathology assessments (i.e. H&E assessment will be used for the purpose of defining pathologic complete response per protocol) at 3 months. (NCT02849990)
Timeframe: At 3 months

InterventionParticipants (Count of Participants)
Treatment (Neoadjuvant Chemotherapy)1

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The Proportion of Men Who Receive Adjuvant Radiation Therapy

Patients that received radiation following prostatetomy (NCT02849990)
Timeframe: Up to 1 year post prostatectomy

InterventionParticipants (Count of Participants)
Treatment (Neoadjuvant Chemotherapy)7

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Number of Patients With no Nodal Metastases After 3 Months of Treatment.

The presence of tumor cells within surgically excised lymph nodes will be assessed after 3 months of treament. (NCT02849990)
Timeframe: At 3 months

InterventionParticipants (Count of Participants)
No nodal metastasesNodal metastases
Treatment (Neoadjuvant Chemotherapy)137

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Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities

Part A data reported; study did not progress to Part B. Laboratory abnormalities Grade 1+ are reported. (NCT02855359)
Timeframe: Up to 183 days

,
InterventionParticipants (Count of Participants)
Alanine aminotransferase increasedHypoalbuminemiaAlkaline phosphatase increasedAspartate aminotransferase increasedBlood bilirubin increasedHypercalcemiaHypocalcemiaHyperglycemiaHypoglycemiaHypermagnesemiaHypomagnesemiaHypophosphatemiaHypokalemiaHypernatremiaHyponatremiaHyperuricemiaAnemiaLeukopeniaLymphopeniaNeutropeniaThrombocytopenia
Denintuzumab Mafodotin + RCHOP4489405114445711211213131113
Denintuzumab Mafodotin + RCHP335503581045614010109910

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Part A and Part B Outcome Measure: Incidence of Adverse Events

Part A data only; study did not progress to Part B. (NCT02855359)
Timeframe: 54.7 weeks

,
InterventionParticipants (Count of Participants)
Any Treatment-emergent adverse event (TEAE)Any Grade 3-5 TEAEAny Treatment-related Adverse Event (AE)Any DM treatment-related AEAny RCHOP/RCHP treatment-related AEAny AE with Outcome of DeathAny Serious Adverse Event (SAE)Any Treatment-Related SAEAny DM Treatment-Related SAE
Denintuzumab Mafodotin + RCHOP13121313131432
Denintuzumab Mafodotin + RCHP1111109102542

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Biochemical Progression Free Survival (bPFS) Rate at 4 Years Post RP [Part 2]

4-year bPFS rate is defined as the probability of biochemical progression free and survival at 4 years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event is considered to be biochemical progression (defined as a confirmed PSA ≥ 0.2 ng/mL), local, regional, or distant metastatic disease on CT/MRI or bone scan, or receipt of post-operative systemic therapy or radiotherapy for rising PSA, or death from any cause. Participants who are lost to follow-up before the 4-year mark are censored at date of last disease evaluation. (NCT02903368)
Timeframe: At 4 years post RP

Interventionpercentage of subjects (Number)
Arm 2A: AAPL Adjuvant Therapy (Part 2)67
Arm 2B: Observation (Part 2)61

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Rate of Freedom From Further Anti-cancer Therapy at 2-years Post RP (Part 2)

Defined as the probability of freedom from further anti-cancer therapy at 2-years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event includes initiation of anti-cancer therapy (radiation therapy, ADT, or other therapies) for rising PSAs and/or clinical progression. Participants who are lost to follow-up before the 2-year mark are censored at date of last follow-up. (NCT02903368)
Timeframe: At 2-years post RP

Interventionpercentage of subjects (Number)
Arm 2A: AAPL Adjuvant Therapy (Part 2)90
Arm 2B: Observation (Part 2)80

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Percent of Participants With Nadir PSA < 0.2 ng/mL Prior to RP (Part 1)

Prostate specific antigen (PSA) was measured on day 1 of each cycle during the neoadjuvant therapy. PSA nadir was defined as the lowest PSA value prior to Radical Prostatectomy (RP). Number and percent of participants with nadir PSA < 0.2 ng/mL were reported. (NCT02903368)
Timeframe: Assessed on day 1 of each cycle (1 cycle=28 +/- 2 days), up to 6 months from the initiation of neoadjuvant therapy.

InterventionParticipants (Count of Participants)
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)55
Arm 1B: APL Neoadjuvant Therapy (Part 1)58

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Median of Residual Cancer Burden (RCB) at RP (Part 1)

"RCB was calculated as tumor volume (cm^3) X % cellularity. RCB was analyzed as a continuous score (with median and range) instead of a categorical variable based on the percentile cutoff point, at the time of radical prostatectomy (RP)." (NCT02903368)
Timeframe: Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.

Intervention(cm^3) * % (Median)
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)0.023
Arm 1B: APL Neoadjuvant Therapy (Part 1)0.075

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Combined pCR or MRD Rate [Part 1]

Pathological response, defined as achieving either pCR or MRD at radical prostatectomy (RP). Pathological Complete Response (pCR) is defined as the absence of morphologically identifiable carcinoma in the RP specimen. MRD will be defined as residual tumor in the RP specimen measuring ≤ 5 mm. (NCT02903368)
Timeframe: Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.

InterventionParticipants (Count of Participants)
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)12
Arm 1B: APL Neoadjuvant Therapy (Part 1)12

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Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 12-months Post-RP (Part 2)

The QOL will be measured using the Expanded Prostate Cancer Index Composite 26 (EPIC-26). For part 2, the questionnaires will be administered at 6 months, 12 months, and 24 months post RP. Resulting domain scores for EPIC-26 (urinary incontinence, urinary obstruction, sexual, bowel, hormonal/vitality) is on a 0-100 scale, with higher values representing a more favorable health-related QOL. (NCT02903368)
Timeframe: At 12-months post-RP

,
Interventionscore on 0-100 scale (Mean)
Urinary IrritativeUrinary IncontinenceBowelSexualHormonal
Arm 2A: AAPL Adjuvant Therapy (Part 2)9175951668
Arm 2B: Observation (Part 2)9174942686

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Frequency of Presenting Intraductal Carcinoma at RP (Part 1)

Intraductal carcinoma was evaluated by central pathology review of specimens at Radical Prostatectomy (RP). (NCT02903368)
Timeframe: Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.

InterventionParticipants (Count of Participants)
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)15
Arm 1B: APL Neoadjuvant Therapy (Part 1)19

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Frequency of Presenting Intra-operative Complications Following RP (Part 1)

Intra-operative complications were collected via questionnaire following Radical Prostatectomy. (NCT02903368)
Timeframe: Assessed post-RP, at 6 months from the initiation of neoadjuvant therapy.

InterventionParticipants (Count of Participants)
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)1
Arm 1B: APL Neoadjuvant Therapy (Part 1)1

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Biochemical Progression Free Survival (bPFS) Rate at 2 Years Post RP [Part 2]

2-year bPFS rate is defined as the probability of biochemical progression free and survival at 2 years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event is considered to be biochemical progression (defined as a confirmed PSA ≥ 0.2 ng/mL), local, regional, or distant metastatic disease on CT/MRI or bone scan, or receipt of post-operative systemic therapy or radiotherapy for rising PSA, or death from any cause. Participants who are lost to follow-up before the 2-year mark are censored at date of last disease evaluation. (NCT02903368)
Timeframe: At 2 years post RP

Interventionpercentage of subjects (Number)
Arm 2A: AAPL Adjuvant Therapy (Part 2)90
Arm 2B: Observation (Part 2)80

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Biochemical Progression Free Survival (bPFS) Rate at 3 Years Post RP [Part 2]

3-year bPFS rate is defined as the probability of biochemical progression free and survival at 3 years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event is considered to be biochemical progression (defined as a confirmed PSA ≥ 0.2 ng/mL), local, regional, or distant metastatic disease on CT/MRI or bone scan, or receipt of post-operative systemic therapy or radiotherapy for rising PSA, or death from any cause. Participants who are lost to follow-up before the 3-year mark are censored at date last disease evaluation. (NCT02903368)
Timeframe: At 3 years post RP

Interventionpercentage of subjects (Number)
Arm 2A: AAPL Adjuvant Therapy (Part 2)81
Arm 2B: Observation (Part 2)72

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Frequency of Presenting Cribriform at RP (Part 1)

Presence or cribriform was evaluated by central pathology review of specimens at radical prostatectomy (RP). (NCT02903368)
Timeframe: Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.

InterventionParticipants (Count of Participants)
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)1
Arm 1B: APL Neoadjuvant Therapy (Part 1)0

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Frequency of Positive Surgical Margins at RP (Part 1)

Pathologic specimens were centrally reviewed and counted for positive surgical margins at the time of Radical Prostatectomy (RP). (NCT02903368)
Timeframe: Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.

InterventionParticipants (Count of Participants)
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)4
Arm 1B: APL Neoadjuvant Therapy (Part 1)7

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Rate of Freedom From Further Anti-cancer Therapy at 3-years Post RP (Part 2)

Defined as the probability of freedom from further anti-cancer therapy at 3-years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event includes initiation of anti-cancer therapy (radiation therapy, ADT, or other therapies) for rising PSAs and/or clinical progression. Participants who are lost to follow-up before the 3-year mark are censored at date of last follow-up. (NCT02903368)
Timeframe: At 3 years post RP

Interventionpercentage of subjects (Number)
Arm 2A: AAPL Adjuvant Therapy (Part 2)83
Arm 2B: Observation (Part 2)72

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Rate of Freedom From Further Anti-cancer Therapy at 4-years Post RP (Part 2)

Defined as the probability of freedom from further anti-cancer therapy at 4-years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event includes initiation of anti-cancer therapy (radiation therapy, ADT, or other therapies) for rising PSAs and/or clinical progression. Participants who are lost to follow-up before the 4-year mark are censored at date of last follow-up. (NCT02903368)
Timeframe: At 4-years post RP

Interventionpercentage of subjects (Number)
Arm 2A: AAPL Adjuvant Therapy (Part 2)78
Arm 2B: Observation (Part 2)67

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Rate of pCR at RP (Part 1)

Pathological Complete Response (pCR) is defined as the absence of morphologically identifiable carcinoma in the RP specimen at radical prostatectomy (RP). (NCT02903368)
Timeframe: Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.

InterventionParticipants (Count of Participants)
Arm 1A: AAPL Neoadjuvant Therapy (Part 1)7
Arm 1B: APL Neoadjuvant Therapy (Part 1)6

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Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 24-months Post-RP (Part 2)

The QOL will be measured using the Expanded Prostate Cancer Index Composite 26 (EPIC-26). For part 2, the questionnaires will be administered at 6 months, 12 months, and 24 months post RP. Resulting domain scores for EPIC-26 (urinary incontinence, urinary obstruction, sexual, bowel, hormonal/vitality) is on a 0-100 scale, with higher values representing a more favorable health-related QOL. (NCT02903368)
Timeframe: At 24-months post-RP

,
Interventionscore on 0-100 scale (Mean)
Urinary IrritativeUrinary IncontinenceBowelSexualHormonal
Arm 2A: AAPL Adjuvant Therapy (Part 2)9275953188
Arm 2B: Observation (Part 2)9376972690

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Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 6-months Post-RP (Part 2)

The QOL will be measured using the Expanded Prostate Cancer Index Composite 26 (EPIC-26). For part 2, the questionnaires will be administered at 6 months, 12 months, and 24 months post RP. Resulting domain scores for EPIC-26 (urinary incontinence, urinary obstruction, sexual, bowel, hormonal/vitality) is on a 0-100 scale, with higher values representing a more favorable health-related QOL. (NCT02903368)
Timeframe: At 6-months post-RP

,
InterventionScore on 0-100 (Mean)
Urinary IrritativeUrinary IncontinenceBowelSexualHormonal
Arm 2A: AAPL Adjuvant Therapy (Part 2)9063951768
Arm 2B: Observation (Part 2)9272961483

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Percentage of Participants With Recurrence of Focal Segmental Glomerulosclerosis (rFSGS) or Death or Graft Loss or Lost to Follow-up Through 3 Months Post Transplant

rFSGS was defined as nephrotic range proteinuria with a protein/creatinine ratio (≥ 3.0 g/g). Death, graft loss or lost to follow-up was imputed as rFSGS. (NCT02921789)
Timeframe: At 3 Months post transplant

InterventionPercentage of participants (Number)
SOC Regimen31.3
Bleselumab Regimen18.5

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Percentage of Participants With rFSGS or Death or Graft Loss or Lost to Follow-up Through 6 and 12 Months Post Transplant

rFSGS was defined as nephrotic range proteinuria with a protein/creatinine ratio (≥ 3.0 g/g). Death, graft loss or lost to follow-up was imputed as rFSGS. (NCT02921789)
Timeframe: At 6 and 12 Months post transplant

,
InterventionPercentage of participants (Number)
Month 6Month 12
Bleselumab Regimen18.523.1
SOC Regimen31.335.5

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Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) Through 3, 6, and 12 Months Post Transplant

All episodes of kidney dysfunction based on clinical signs and symptoms were evaluated for possible BPAR. BPAR was confirmed if participants Banff criteria >=1. (NCT02921789)
Timeframe: At 3, 6 and 12 Months post transplant

,
InterventionPercentage of participants (Number)
Month 3Month 6Month 12
Bleselumab Regimen26.926.929.2
SOC Regimen20.020.024.1

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Percentage of Participants With Biopsy Proven rFSGS Through 3, 6 and 12 Months Post-Transplant

Percentage of participants with biopsy-proven rFSGS determined by a blinded central review of images from electron microscopy (EM) and slides for light microscopy (LM) by an independent pathologist. (NCT02921789)
Timeframe: At 3, 6 and 12 Months post transplant

,
InterventionPercentage of participants (Number)
Month 3Month 6Month 12
Bleselumab Regimen31.830.429.2
SOC Regimen35.736.736.7

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Percentage of Participants With Efficacy Failure Through 12 Months Post Transplant

Efficacy failure was defined as BPAR, death, graft loss or lost to follow-up through 12 months post transplant. (NCT02921789)
Timeframe: 12 Months post transplant

InterventionPercentage of participants (Number)
SOC Regimen32.3
Bleselumab Regimen32.0

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CT Scan Changes

CT scan of the sinuses, Lund Mackay score to access severity of sinus disease on CT scan. Scored on scale 0-20 with lower score better. (NCT02927834)
Timeframe: 4 week post treatment

Interventionscore out of total 20 (Mean)
Antibiotic Only10.33
Augmentin With 6 Day Steroid11
Augmentin With 21 Day Steroid11.83

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Nasal Endoscopy

Physical exam findings of the nasal cavity. Scored 0-12. Lower score is better (NCT02927834)
Timeframe: 4 weeks post treatment

Interventionscore out of total 12 (Mean)
Antibiotic Only2.55
Augmentin With 6 Day Steroid3.00
Augmentin With 21 Day Steroid2.16

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Sinonasal Outcome Test (SNOT 20)

Sinonasal outcome test to access nasal/sinus symptoms. 20 questions, each question scored 0-5. 0 meaning no symptoms, 5 worse. 0- 100 total with lower number meaning better outcome (NCT02927834)
Timeframe: 4 weeks post treatment

InterventionScore out of total 100 (Mean)
Antibiotic Only50.33
Augmentin With 6 Day Steroid53.14
Augmentin With 21 Day Steroid37

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Nonrelapse Mortality (NRM)

Defined as the proportion of subjects who died due to causes other than malignancy relapse. (NCT02953678)
Timeframe: From baseline to Months 6, 9, 12, and 24

Interventionpercentage of participants (Number)
6 months9 months12 months24 months
Ruxolitinib in Combination With Corticosteroids44.448.252.964.8

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Relapse Rate

Defined as the percentage of participants whose underlying malignancy relapsed. (NCT02953678)
Timeframe: From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)

Interventionpercentage of participants (Number)
Ruxolitinib in Combination With Corticosteroids7.0

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Overall Response Rate (ORR) at Day 28

Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR). (NCT02953678)
Timeframe: From baseline to Day 28

InterventionParticipants (Count of Participants)
Responders - CRResponders - VGPRResponders - PR
Ruxolitinib in Combination With Corticosteroids19713

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Failure-free Survival (FFS)

Defined as the time from first dose of ruxolitinib to the earliest date that a participant died, had a relapse/progression of the underlying malignancy, required additional therapy for aGVHD, or demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD). (NCT02953678)
Timeframe: From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)

Interventiondays (Median)
Ruxolitinib in Combination With Corticosteroids85.0

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Overall Survival (OS)

Defined as the time from study enrollment (first day of ruxolitinib treatment) to death due to any cause. (NCT02953678)
Timeframe: From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)

Interventiondays (Median)
Ruxolitinib in Combination With Corticosteroids232.0

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Overall Response Rate (ORR)

Defined as the percentage of participants demonstrating a CR, VGPR, or PR. (NCT02953678)
Timeframe: From baseline to days 14, 56, and 100

Interventionpercentage of participants (Number)
Day 14Day 56Day 100
Ruxolitinib in Combination With Corticosteroids62.036.632.4

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Percentage of Participants With Six-month Duration of Response (DOR)

Defined as the time from first response until graft-versus-host disease (GVHD) progression or death. DOR was assessed when all participants who were on the study completed the Day 180 visit. (NCT02953678)
Timeframe: From Baseline up to 6 months

Interventionpercentage of participants (Number)
Ruxolitinib in Combination With Corticosteroids68.2

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Percentage of Participants With Three-month DOR

Defined as the time from first response until GVHD progression or death. DOR was assessed when all participants who were on the study completed the Day 84 visit. (NCT02953678)
Timeframe: From Baseline up to 3 months

Interventionpercentage of participants (Number)
Ruxolitinib in Combination With Corticosteroids84.5

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Number of Participants With Treatment-emergent Adverse Events (TEAES), Serious TEAEs, And Grade 3 or Higher TEAEs

AE was any unfavorable and unintended sign, symptom, or disease temporally associated with use of medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Serious AE was any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. TEAE was an AE that was reported for the first time, or worsening of a pre-existing event after the first dose of study drug (until 30 days after the last dose of study drug). Severity of AEs was described and graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03). Grade 3 and above would constitute a severe, life-threatening, or death event. (NCT02953678)
Timeframe: From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)

InterventionParticipants (Count of Participants)
TEAEsSerious TEAEsGrade 3 or Higher TEAEs
Ruxolitinib in Combination With Corticosteroids715969

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Weight-Based Dose Requirement

Weight-based dose requirements to reach therapeutic goal pre- and post-conversion (NCT02953873)
Timeframe: Baseline to 3 months post conversion

Interventionmg/kg (Median)
Pre-ConversionPost-Conversion
Conversion Arm0.110.16

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Total Daily Dose

Difference in Total Daily Dose necessary for steady state therapeutic goal (NCT02953873)
Timeframe: Baseline to 3 months post conversion

Interventionmg (Median)
Pre-Conversion Tacrolimus DosePost-Conversion Tacrolimus Dose
Conversion Arm1015

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Number of Days to Reach Therapeutic Trough Goal

Days to reach therapeutic goal after conversion (NCT02953873)
Timeframe: Baseline to 3 months post conversion

Interventionnumber of days (Median)
Homozygous CYP3A5 1 expressorsHeterozygous CYP3A5 1 expressorsCYP3A5 1 non-expressors
Conversion Arm151015

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Dose-normalized Trough

Difference in dose-normalized trough at steady state before and after conversion from tacrolimus IR to Astagraf XL® (NCT02953873)
Timeframe: Baseline to 3 months post-conversion

Interventionng/dL (Median)
Pre-Conversion Dose TroughPost-Conversion Dose Trough
Conversion Arm0.590.44

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Dose Modifications

Number of dose modifications from baseline to 3 months post-conversion. (NCT02953873)
Timeframe: Baseline to 3 months post conversion

Interventionnumber of dose modifications (Median)
Homozygous CYP3A5 1 expressorsHeterozygous CYP3A5 1 expressorsCYP3A5 1 non expressers
Conversion Arm124

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Self-reported Medication Adherence From Baseline to 6 Months.

Percent of subjects reporting high medication adherence at baseline compared to 6 months post-conversion, using the Morisky Medication Adherence scale (MMAS). The MMAS rates medication adherence on a scale of 0 to 8. 0 is high adherence, 1-2 is medium adherence, and greater than or equal to 3 is low adherence. (NCT02954198)
Timeframe: 6 months post conversion

,
Intervention% of participants (Number)
Baseline6 months post-conversion
Control: Envarsus + MMF8059
Intervention: Envarsus + Everoliumus4547

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Subject Specific Change on Medication Side Effect Scale

Examine subject specific change on a validated Medication Side Effect Scale at the time of the conversion versus six months post-conversion, compared between the two arms. Side effect burden scale is from 0 to 180. A lower score is less side effect burden, a higher score is more side effect burden. (NCT02954198)
Timeframe: Baseline to 6 months post conversion

,
Interventionunits on a scale (Mean)
Baseline6 month post-conversion
Control: Envarsus + MMF7193
Intervention: Envarsus + Everoliumus3738

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Percent of Participants Who Experienced Kidney Transplant Graft Loss

Measure and compare time-to-event analysis between the two arms graft loss (time to event analysis) (NCT02954198)
Timeframe: Baseline to 6 months post conversion

InterventionParticipants (Count of Participants)
Control: Envarsus + MMF0
Intervention: Envarsus + Everoliumus0

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Percent of Participants Experiencing Acute Allograft Rejection

Estimate the composite of treatment failure rate, defined as acute allograft rejection with a Banff grade 1A or higher, graft loss, or death at six months post-conversion, in patients converted to a once-daily immunosuppressant regimen of Envarsus®, everolimus, and prednisone versus patients converted to a twice-daily regimen of Envarsus®, MMF, and prednisone. (NCT02954198)
Timeframe: Baseline to 6 months post conversion

InterventionParticipants (Count of Participants)
Control: Envarsus + MMF0
Intervention: Envarsus + Everoliumus0

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Number of Participants With Disease Flare

Disease relapse was defined as the recurrence of signs or symptoms of GCA (e.g., cranial or PMR) that required treatment intensification, regardless of the ESR and CRP levels. (NCT02955147)
Timeframe: 52 weeks

InterventionParticipants (Count of Participants)
Ustekinumab Plus Prednisone7

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Percentage of Patients in Glucocorticoid-free Remission

The primary study endpoint, prednisone-free remission, was defined as: 1) absence of relapse from the time that remission was achieved through week 52; 2) normalization of ESR (<40 mm/hour) and CRP (<10 mg/L); and, 3) adherence to the protocol prednisone taper. (NCT02955147)
Timeframe: 52 weeks

InterventionParticipants (Count of Participants)
Ustekinumab Plus Prednisone3

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Cumulative Prednisone Dose

(NCT02955147)
Timeframe: 52 weeks

Interventionmg of prednisone (Mean)
Ustekinumab Plus Prednisone2289

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Number of Participants With at Least One Adverse Event

(NCT02955147)
Timeframe: 52 weeks

InterventionParticipants (Count of Participants)
Ustekinumab Plus Prednisone12

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Final Analysis: Percentage of Participants Who Achieved Reduction of Prednisone Dose Level to Less Than 0.15 mg/kg/Day at 24 Weeks Sustained for at Least 30 Days

(NCT02959944)
Timeframe: 24 weeks (Cumulatively up to 12 July 2021)

Interventionpercentage of participants (Number)
Ibrutinib + Prednisone41.1
Placebo + Prednisone45.9

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Final Analysis: Percentage of Participants With Improvement in Overall Score on Lee cGVHD Symptom Scale at Two Consecutive Visits

"Clinically meaningful improvement on Lee cGVHD symptom scale was defined as at least a 7-point decrease in Lee Symptom Scale overall summary score on at least 2 consecutive visits, not preceded by progressive disease, relapse of underlying disease or start of subsequent cGVHD treatment.~The Lee cGVHD Symptom Scale score has 7 subscales (Skin, Eyes and Mouth, Breathing, Eating and Digestion, Muscles and Joints, Energy, and Mental and Emotional) with ratings as follows: 0- Not at all, 1- Slightly, 2 Moderately, 3 Quite a bit, 4-Extremely, with lower values representing a better outcome. A score is calculated for each subscale by taking the mean of all items completed if more than 50% were answered and normalizing to a 0 to 100 scale. An overall score is calculated as the average of these 7 subscales if at least 4 subscales have valid scores." (NCT02959944)
Timeframe: Assessed at Weeks 5, 13, 25, 37, 49, 30 days after the last dose of study drug, and then every 12 weeks of follow-up until progressed disease. (Cumulatively up to 12 July 2021)

Interventionpercentage of participants (Number)
Ibrutinib + Prednisone43.2
Placebo + Prednisone30.6

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Final Analysis: Response Rate at 24 Weeks

"Response rate was defined as the percentage of participants who were responders. Responders were defined as participants who had a CR or PR at 24 weeks without starting any subsequent therapy for cGVHD or having evidence of relapse of their underlying disease that was indication for transplant prior to response assessment at 24 weeks.~Response was defined using the National Institutes of Health (NIH) Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR is defined as resolution of all manifestations in each organ or site. PR is defined as improvement in at least 1 organ or site without progression in any other organ or site." (NCT02959944)
Timeframe: 24 weeks (Cumulatively up to 12 July 2021)

Interventionpercentage of participants (Number)
Ibrutinib + Prednisone47.4
Placebo + Prednisone54.1

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Final Analysis: Response Rate at 48 Weeks

"Response rate was defined as the percentage of participants who were responders. Responders were defined as participants who had a complete response (CR) or a partial response (PR) at 48 weeks without starting any subsequent therapy for cGVHD or having evidence of relapse of their underlying disease that was indication for transplant prior to response assessment at 48 weeks.~Response was defined using the National Institutes of Health (NIH) Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR is defined as resolution of all manifestations in each organ or site. PR is defined as improvement in at least 1 organ or site without progression in any other organ or site." (NCT02959944)
Timeframe: 48 weeks (Cumulatively up to 12 July 2021)

Interventionpercentage of participants (Number)
Ibrutinib + Prednisone41.1
Placebo + Prednisone36.7

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Primary Analysis: Duration of Response (DOR) for Participants Who Had PR or CR at Any Time

Response was defined using the NIH Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower GI, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR was defined as resolution of all manifestations in each organ or site. PR was defined as improvement in at least 1 organ or site without progression in any other organ or site. Duration of response was estimated by Kaplan-Meier methodology. (NCT02959944)
Timeframe: Response was assessed every 4 weeks from Week 5 through Week 25, Week 37, Week 49, 30 days after the last dose of study drug, and then every 12 weeks of follow-up until progressed disease. (Cumulatively up to 30 March 2020)

Interventionmonths (Median)
Ibrutinib + Prednisone19.8
Placebo + Prednisone10.0

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Primary Analysis: Overall Survival (OS)

OS was defined as the time of randomization until the time of death due to any cause, in months. (NCT02959944)
Timeframe: Median time on study (cumulatively up to 30 March 2020) was 19.8 months and 18.4 months for the Ibrutinib + Prednisone and Placebo + Prednisone arms, respectively.

Interventionmonths (Median)
Ibrutinib + PrednisoneNA
Placebo + PrednisoneNA

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Primary Analysis: Percentage of Participants Who Achieved Reduction of Prednisone Dose Level to Less Than 0.15 mg/kg/Day at 24 Weeks Sustained for at Least 30 Days

(NCT02959944)
Timeframe: 24 weeks (Cumulatively up to 30 March 2020)

Interventionpercentage of participants (Number)
Ibrutinib + Prednisone40.0
Placebo + Prednisone45.9

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Primary Analysis: Percentage of Participants With Improvement in Overall Score on Lee cGVHD Symptom Scale at Two Consecutive Visits

"Clinically meaningful improvement on Lee cGVHD symptom scale was defined as at least a 7-point decrease in Lee Symptom Scale overall summary score on at least 2 consecutive visits, not preceded by progressive disease, relapse of underlying disease or start of subsequent cGVHD treatment.~The Lee cGVHD Symptom Scale score has 7 subscales (Skin, Eyes and Mouth, Breathing, Eating and Digestion, Muscles and Joints, Energy, and Mental and Emotional) with ratings as follows: 0- Not at all, 1- Slightly, 2 Moderately, 3 Quite a bit, 4-Extremely, with lower values representing a better outcome. A score is calculated for each subscale by taking the mean of all items completed if more than 50% were answered and normalizing to a 0 to 100 scale. An overall score is calculated as the average of these 7 subscales if at least 4 subscales have valid scores." (NCT02959944)
Timeframe: Assessed at Weeks 5, 13, 25, 37, 49, 30 days after the last dose of study drug, and then every 12 weeks of follow-up until progressed disease. (Cumulatively up to 30 March 2020)

Interventionpercentage of participants (Number)
Ibrutinib + Prednisone38.9
Placebo + Prednisone26.5

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Primary Analysis: Response Rate at 24 Weeks

"Response rate was defined as the percentage of participants who were responders. Responders were defined as participants who had a CR or PR at 24 weeks without starting any subsequent therapy for cGVHD or having evidence of relapse of their underlying disease that was indication for transplant prior to response assessment at 24 weeks.~Response was defined using the National Institutes of Health (NIH) Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR is defined as resolution of all manifestations in each organ or site. PR is defined as improvement in at least 1 organ or site without progression in any other organ or site." (NCT02959944)
Timeframe: 24 weeks (Cumulatively up to 30 March 2020)

Interventionpercentage of participants (Number)
Ibrutinib + Prednisone47.4
Placebo + Prednisone54.1

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Primary Analysis: Response Rate at 48 Weeks

"Response rate was defined as the percentage of participants who were responders. Responders were defined as participants who had a complete response (CR) or a partial response (PR) at 48 weeks without starting any subsequent therapy for cGVHD or having evidence of relapse of their underlying disease that was indication for transplant prior to response assessment at 48 weeks.~Response was defined using the National Institutes of Health (NIH) Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR is defined as resolution of all manifestations in each organ or site. PR is defined as improvement in at least 1 organ or site without progression in any other organ or site." (NCT02959944)
Timeframe: 48 weeks (Cumulatively up to 30 March 2020)

Interventionpercentage of participants (Number)
Ibrutinib + Prednisone41.1
Placebo + Prednisone36.7

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Final Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD

The cumulative incidence of withdrawal of all corticosteroids (95% confidence interval [CI]) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all corticosteroids at given time point. The time to withdrawal of corticosteroids is computed from randomization date to the first date of withdrawal of all corticosteroids for treatment of cGVHD to 0 mg daily for at least 30 days. (NCT02959944)
Timeframe: Months 3, 6, 9, 12, 15, 18, 21, 24 (Cumulatively up to 12 July 2021)

,
Interventionproportion of participants (Number)
3 Months6 Months9 Months12 Months15 Months18 Months21 Months24 Months
Ibrutinib + Prednisone0.0420.2180.3180.4060.4390.4500.4950.495
Placebo + Prednisone0.0210.2190.3260.3590.3590.3690.3910.391

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Final Analysis: Cumulative Incidence of Withdrawal of All Immunosuppressants

The cumulative incidence of withdrawal of all immunosuppressants (95% CI) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all immunosuppressants at a given time point. The time to withdrawal of all immunosuppressants is computed from randomization date to the first date of withdrawal of all immunosuppressants for treatment of cGVHD, sustained for at least 30 days. All immunosuppressants include corticosteroids but they do not include ibrutinib. (NCT02959944)
Timeframe: Months 3, 6, 9, 12, 15, 18, 21, 24 (Cumulatively up to 12 July 2021)

,
Interventionproportion of participants (Number)
3 Months6 Months9 Months12 Months15 Months18 Months21 Months24 Months
Ibrutinib + Prednisone0.0110.1430.2220.2800.3140.3490.3720.406
Placebo + Prednisone0.0000.1360.2210.2640.2740.2850.3070.307

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Final Analysis: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs Placebo in Combination With Prednisone

AE: any untoward medical occurrence, which does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization >24 hours or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. Severity was graded according to the Common Terminology Criteria for Adverse Events version 4.03 (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening, grade 5=death). Treatment-related events are those that were possibly related or related to study treatment per investigator's judgment. Treatment emergent AEs (TEAEs) occurred from the first dose of study drug up to 30 days after the last dose of study drug. (NCT02959944)
Timeframe: From first dose of study drug through the end of treatment plus 30 days. As of data cutoff (cumulatively up to 12 July 2021), median ibrutinib treatment duration was 5.4 months and the median placebo treatment duration was 6.4 months.

,
InterventionParticipants (Count of Participants)
Any TEAEAny Grade ≥ 3 TEAEAny Ibrutinib-/Placebo-Related TEAEAny Grade ≥ 3 Ibrutinib-/Placebo-Related TEAEAny Corticosteroid-Related TEAEAny Grade ≥ 3 Corticosteroid-Related TEAEAny TEAE Leading to Discontinuation (DC) of Any TreatmentAny TEAE Leading to DC of Ibrutinib/PlaceboAny TEAE Leading to DC of CorticosteroidAny Treatment Emergent SAE (TESAE)Any Grade ≥ 3 TESAEAny Treatment-Related TESAEAny Ibrutinib/Placebo Treatment-Related TESAEAny Corticosteroid Treatment-Related TESAEAny Fatal TEAE
Ibrutinib + Prednisone936467357234232210494629262612
Placebo + Prednisone9564572776352827947452718266

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Primary Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD

The cumulative incidence of withdrawal of all corticosteroids (95% confidence interval [CI]) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all corticosteroids at given time point. The time to withdrawal of corticosteroids is computed from randomization date to the first date of withdrawal of all corticosteroids for treatment of cGVHD to 0 mg daily for at least 30 days. (NCT02959944)
Timeframe: Months 3, 6, 9, 12, 15, 18, 21, 24 (Cumulatively up to 30 March 2020)

Interventionproportion of participants (Number)
3 Months6 Months9 Months12 Months15 Months18 Months
Ibrutinib + Prednisone0.0420.2290.3180.3920.4190.419

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Primary Analysis: Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD

The cumulative incidence of withdrawal of all corticosteroids (95% confidence interval [CI]) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all corticosteroids at given time point. The time to withdrawal of corticosteroids is computed from randomization date to the first date of withdrawal of all corticosteroids for treatment of cGVHD to 0 mg daily for at least 30 days. (NCT02959944)
Timeframe: Months 3, 6, 9, 12, 15, 18, 21, 24 (Cumulatively up to 30 March 2020)

Interventionproportion of participants (Number)
3 Months6 Months9 Months12 Months15 Months18 Months21 Months24 Months
Placebo + Prednisone0.0210.2160.3220.3560.3560.3560.4250.425

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Primary Analysis: Cumulative Incidence of Withdrawal of All Immunosuppressants

The cumulative incidence of withdrawal of all immunosuppressants (95% CI) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all immunosuppressants at a given time point. The time to withdrawal of all immunosuppressants is computed from randomization date to the first date of withdrawal of all immunosuppressants for treatment of cGVHD, sustained for at least 30 days. All immunosuppressants include corticosteroids but they do not include ibrutinib. (NCT02959944)
Timeframe: Months 3, 6, 9, 12, 15, 18, 21, 24 (cumulatively up to 30 March 2020)

,
Interventionproportion of participants (Number)
3 Months6 Months9 Months12 Months15 Months18 Months21 Months24 Months
Ibrutinib + Prednisone0.0110.1420.2200.2560.2850.3130.3760.421
Placebo + Prednisone0.0000.1340.2070.2410.2410.2410.2680.268

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Primary Analysis: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs Placebo in Combination With Prednisone

AE: any untoward medical occurrence, which does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization >24 hours or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. Severity was graded according to the Common Terminology Criteria for Adverse Events version 4.03 (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening, grade 5=death). Treatment-related events are those that were possibly related or related to study treatment per investigator's judgment. Treatment emergent AEs (TEAEs) occurred from the first dose of study drug up to 30 days after the last dose of study drug. (NCT02959944)
Timeframe: From first dose of study drug through the end of treatment plus 30 days. As of data cutoff (cumulatively up to 30 March 2020), median ibrutinib treatment duration was 5.4 months and the median placebo treatment duration was 6.4 months.

,
InterventionParticipants (Count of Participants)
Any TEAEAny Grade ≥ 3 TEAEAny Ibrutinib-/Placebo-Related TEAEAny Grade ≥ 3 Ibrutinib-/Placebo-Related TEAEAny Corticosteroid-Related TEAEAny Grade ≥ 3 Corticosteroid-Related TEAEAny TEAE Leading to Discontinuation (DC) of Any TreatmentAny TEAE Leading to DC of Ibrutinib/PlaceboAny TEAE Leading to DC of CorticosteroidAny Treatment Emergent SAE (TESAE)Any Grade ≥ 3 TESAEAny Treatment-Related TESAEAny Ibrutinib/Placebo Treatment-Related TESAEAny Corticosteroid Treatment-Related TESAEAny Fatal TEAE
Ibrutinib + Prednisone93606632713221218464327242410
Placebo + Prednisone9564582877362423848462819277

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Final Analysis: DOR for Participants Who Had PR or CR at Any Time

Response was defined using the NIH Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower GI, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR was defined as resolution of all manifestations in each organ or site. PR was defined as improvement in at least 1 organ or site without progression in any other organ or site. Duration of response was estimated by Kaplan-Meier methodology. (NCT02959944)
Timeframe: Response was assessed every 4 weeks from Week 5 through Week 25, Week 37, Week 49, 30 days after the last dose of study drug, and then every 12 weeks of follow-up until progressed disease. (Cumulatively up to 12 July 2021)

Interventionmonths (Median)
Ibrutinib + Prednisone19.1
Placebo + Prednisone10.2

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Final Analysis: OS

OS was defined as the time of randomization until the time of death due to any cause, in months. (NCT02959944)
Timeframe: Median time on study (cumulatively up to 12 July 2021) was 33.1 months and 32.5 months for the Ibrutinib + Prednisone and Placebo + Prednisone arms, respectively.

Interventionmonths (Median)
Ibrutinib + PrednisoneNA
Placebo + PrednisoneNA

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Objective Response Rate (ORR) Cohorts B and C Per BICR

"Objective response rate (ORR) is defined as the percent of participants who had confirmed complete or partial best overall response (BOR) per retrospective Blinded Independent Central Review (BICR) among treated participants with measurable disease at baseline. For participants without documented progression by RECIST v1.1 or subsequent therapy, all available response assessments contributed to the BOR assessment.~Partial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Tumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days).~Confidence-interval based on Clopper Pearson method." (NCT02985957)
Timeframe: From first dose to the date of objectively documented progression or the date of subsequent systemic anti-cancer therapy, whichever occurred first (assessed up to approximately 61 months)

InterventionPercent of Participants (Number)
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg12.5
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg20.0

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Objective Response Rate (ORR) Cohort D

"In Cohort D, ORR is defined as the percentage of participants who had confirmed complete or partial BOR by BICR among randomized subjects with measurable disease at baseline as entered in Interactive Response Technologies web-based system (IWRS). For participants without documented progression or subsequent therapy, all available response assessments will contribute to the BOR assessment.~Partial Response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Tumor assessments were performed every 8 weeks (± 7 days) for 6 months since treatment initiation and thereafter every 12 weeks (± 7 days).~Confidence-interval based on Clopper Pearson method." (NCT02985957)
Timeframe: From randomization to the date of objectively documented progression or the date of subsequent systemic anti-cancer therapy, whichever occurred first (assessed up to approximately 61 months)

InterventionPercent of Participants (Number)
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W8.9
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W15.2
Cohort D Arm 3: Ipilimumab 3 mg/kg4.3
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg11.1

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Overall Survival (OS) Cohorts B and C

"Overall survival (OS) is defined as the time from first treatment to the date of death from any cause. For participants who were alive, their survival time was censored at the last known alive date. Overall survival was censored for participants at the date of first treatment if they had no follow-up.~Based on Kaplan-Meier estimates." (NCT02985957)
Timeframe: From first dose to the date of death due to any cause (assessed up to approximately 61 months)

InterventionMonths (Median)
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg19.75
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg15.21

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The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D

The number of participants with an change in laboratory values from baseline Grade in Cohort D. (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)

InterventionParticipants (Number)
HemoglobinPlatelet CountLeukocytesLymphocytes (Absolute)Absolute Neutrophil CountAlkaline PhosphataseAspartate AminotransferaseAlanine AminotransferaseBilirubin, TotalCreatinineAmylase, TotalLipase, TotalHypernatremiaHyponatremiaHyperkalemiaHypokalemiaHypercalcemiaHypocalcemia
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W2396207231619318121442173211

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The Number of Participants With Changes in Laboratory Values From Baseline in Cohort D

The number of participants with an change in laboratory values from baseline Grade in Cohort D. (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)

,,
InterventionParticipants (Number)
HemoglobinPlatelet CountLeukocytesLymphocytes (Absolute)Absolute Neutrophil CountAlkaline PhosphataseAspartate AminotransferaseAlanine AminotransferaseBilirubin, TotalCreatinineAmylase, TotalLipase, TotalHypernatremiaHyponatremiaHyperkalemiaHypokalemiaHypercalcemiaHypocalcemiaHyperglycemiaHypoglycemia
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W34772171818211131515398852190
Cohort D Arm 3: Ipilimumab 3 mg/kg1322729430116160311230
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg42142336197116314373107711751

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The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C

The number of participants with a change in laboratory values from baseline Grade in Cohorts A, B and C. (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)

,
InterventionParticipants (Number)
HemoglobinPlatelet CountLeukocytesLymphocytes (Absolute)Absolute Neutrophil CountAlkaline PhosphataseAspartate AminotransferaseAlanine AminotransferaseBilirubin, TotalCreatinineAmylase, TotalLipase, TotalHypernatremiaHyponatremiaHyperkalemiaHypokalemiaHypercalcemiaHypocalcemiaHyperglycemiaHypoglycemia
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg63190795358618130400
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg238717615171408630155701220

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Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohorts B and C

The European Quality of Life 5D-3L Scale (EQ-5D-3L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Responses are: '1' = no problem, and '3' = the most serious problem. The responses are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-3L health utility index based on the UK population weights range from -0.594 to 1.0 with higher scores indicating higher health utility. Baseline evaluations or events are defined as occurring before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations. (NCT02985957)
Timeframe: At baseline and at Week 4 of Cycle 2.

InterventionScore on a scale (Mean)
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg0.0083
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg-0.0074

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The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort D

"The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units.~TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal" (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)

,,,
InterventionParticipants (Count of Participants)
TSH > ULNTSH > ULN WITH TSH <= ULN AT BASELINETSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLNTSH > ULN WITH FT3/FT4 TEST MISSINGTSH < LLNTSH = LLN AT BASELINETSH ULNTSH TSH < LLN WITH FT3/FT4 TEST MISSING
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W121084021219120
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W2016127122209112
Cohort D Arm 3: Ipilimumab 3 mg/kg1101076151
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg11635365330

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The Number of Participants With Thyroid Function Laboratory Abnormalities in Cohort A, B and C

"The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units.~TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal" (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)

,,
InterventionParticipants (Count of Participants)
TSH > ULNTSH > ULN WITH TSH <= ULN AT BASELINETSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLNTSH > ULN WITH FT3/FT4 TEST MISSINGTSH < LLNTSH = LLN AT BASELINETSH ULNTSH TSH < LLN WITH FT3/FT4 TEST MISSING
Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg0000000000
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg5341076421
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg1376431010811

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The Number of Participants With Liver Function Laboratory Abnormalities in Cohorts A, B and C

"The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units.~ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal" (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)

,,
InterventionParticipants (Count of Participants)
ALT OR AST > 3XULNALT OR AST> 5XULNALT OR AST> 10XULNALT OR AST > 20XULNTOTAL BILIRUBIN > 2XULN
Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg00000
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg22222
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg52110

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The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohort D

A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)

InterventionParticipants (Count of Participants)
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W38
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W44
Cohort D Arm 3: Ipilimumab 3 mg/kg15
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg32
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D36
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D416

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The Number of Participants With Liver Function Laboratory Abnormalities in Cohort D

"The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units.~ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal" (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)

,,,
InterventionParticipants (Count of Participants)
ALT OR AST > 3XULNALT OR AST> 5XULNALT OR AST> 10XULNALT OR AST > 20XULNTOTAL BILIRUBIN > 2XULNALP>1.5XULNCONCURR ALT/ AST ELEV>3XULN WITH TOT BILI>1.5XULN WITHIN 1 DAYCONCURR ALT/ AST ELEV>3XULN WITH TOT BILI>1.5XULN WITHIN 30 DAYSCONCURR ALT/ AST ELEV>3XULN WITH TOT BILI>2XULN WITHIN 1 DAYCONCURR ALT/ AST ELEV>3XULN WITH TOT BILI>2XULN WITHIN 30 DAYS
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W63102221111
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W85310240000
Cohort D Arm 3: Ipilimumab 3 mg/kg00000140000
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg10000170000

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The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohorts A, B and C

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)

InterventionParticipants (Count of Participants)
Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg1
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg17
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg18

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The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation in Cohort D

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)

InterventionParticipants (Count of Participants)
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W16
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W26
Cohort D Arm 3: Ipilimumab 3 mg/kg7
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg13
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D32
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D46

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The Number of Participants Experiencing Adverse Events (AEs) in Cohorts A, B and C

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation in a participant administered study treatment and that does not necessarily have a causal relationship with this treatment. (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)

InterventionParticipants (Count of Participants)
Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg2
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg45
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg45

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The Number of Participants Experiencing Adverse Events (AEs) in Cohort D

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation in a participant administered study treatment and that does not necessarily have a causal relationship with this treatment. (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 26.5 months)

InterventionParticipants (Count of Participants)
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W69
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W71
Cohort D Arm 3: Ipilimumab 3 mg/kg37
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg69
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D310
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D425

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Radiographic/Clinical Progression Free Survival (rcPFS) for Cohorts B and C

"Radiographic/clinical progression-free survival (rcPFS) is the time between first dose and first documented progression or death due to any cause, whichever occurred first.~Radiographic progression per Investigator assessment:~Bone disease progression by Prostate Cancer Working Group (PCWG2)~Non-bone soft tissue disease progression by RECIST v1.1~Clinical progression per investigator assessment:~Need for palliative radiation therapy involving more than one site, OR~Surgery of kyphoplasty to any neoplastic lesion, OR~Cancer-associated clinical deterioration determined by treating physician. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).~Based on Kaplan-Meier estimates." (NCT02985957)
Timeframe: From first dose to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)

InterventionMonths (Median)
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg4.34
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg3.71

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Radiographic/Clinical Progression Free Survival (rcPFS) for Cohort D

"Radiographic/clinical progression-free survival (rcPFS) is the time between first dose and first documented progression or death due to any cause, whichever occurred first.~Radiographic progression per Investigator assessment:~Bone disease progression by Prostate Cancer Working Group (PCWG2)~Non-bone soft tissue disease progression by RECIST v1.1~Clinical progression per investigator assessment:~Need for palliative radiation therapy involving more than one site, OR~Surgery of kyphoplasty to any neoplastic lesion, OR~Cancer-associated clinical deterioration determined by treating physician. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).~Based on Kaplan-Meier estimates." (NCT02985957)
Timeframe: From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 61 months)

InterventionMonths (Median)
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W2.53
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W3.68
Cohort D Arm 3: Ipilimumab 3 mg/kg2.66
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg5.85

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Change From Baseline in Health Status and Health Utility by 3-level EuroQol Five Dimensions (EQ-5D-3L) Questionnaire Cohort D

The European Quality of Life 5D-3L Scale (EQ-5D-3L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Responses are: '1' = no problem, and '3' = the most serious problem. The responses are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-3L health utility index based on the UK population weights range from -0.594 to 1.0 with higher scores indicating higher health utility. Baseline evaluations or events are defined as occurring before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations. (NCT02985957)
Timeframe: At baseline and 4 weeks after first dose.

InterventionScore on a scale (Mean)
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W0.0032
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W-0.0328
Cohort D Arm 3: Ipilimumab 3 mg/kg0.0113
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg0.0219

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Radiographic Progression-Free Survival (rPFS) for Cohort D

"Radiographic progression-free survival (rPFS) is defined as the time between the date of randomization and the first date of documented progression per BICR or death due to any cause, whichever occurs first.~The following progressive diseases were collected, documented and assessed as below:~Radiographic progression per BICR assessment~Bone disease progression by (Prostate Cancer Working Group) PCWG2~Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).~Based on Kaplan-Meier estimates." (NCT02985957)
Timeframe: From randomization and the first date of documented progression or death due to any cause, whichever occurs first (assessed up to approximately 61 months)

InterventionMonths (Median)
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W3.94
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W4.17
Cohort D Arm 3: Ipilimumab 3 mg/kg3.48
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg7.92

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Radiographic Progression Free Survival (rPFS) for Cohorts B and C Per BICR

"Radiographic progression-free survival (rPFS) is defined as the time between the date of first treatment and the first date of documented radiographic progression or death due to any cause, whichever occurs first.~The following progressive diseases were collected, documented and assessed as below:~Radiographic progression per retrospective Blinded Independent Central Review (BICR) assessment~Bone disease progression by Prostate Cancer Working Group (PCWG2)~Non-bone soft tissue disease progression by RECIST v1.1 Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression).~Based on Kaplan-Meier estimates." (NCT02985957)
Timeframe: From first dose to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)

InterventionMonths (Median)
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg7.59
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg5.36

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Prostate-Specific Antigen Response Rate (PSA-RR) Cohorts B and C

"The percent of participants with a 50% or greater decrease in prostate-specific antigen (PSA) from baseline to the lowest post-baseline PSA result. BBaseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.~Confidence-interval based on Clopper Pearson method." (NCT02985957)
Timeframe: From baseline to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)

InterventionPercent of Participants (Number)
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg17.6
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg10.0

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Prostate-Specific Antigen Response Rate (PSA-RR) Cohort D

"The percent of participants with a 50% or greater decrease in prostate-specific antigen (PSA) from baseline to the lowest post-baseline PSA result. Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations.~Confidence-interval based on Clopper Pearson method." (NCT02985957)
Timeframe: From baseline to the date of objectively documented progression or death due to any cause, whichever occurred first (assessed up to approximately 61 months)

InterventionPercent of Participants (Number)
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W12.3
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W16.2
Cohort D Arm 3: Ipilimumab 3 mg/kg5.3
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg23.0
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D325.0
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D416.0

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Overall Survival (OS) Cohort D

"Overall survival (OS) is defined as the time from randomization to the date of death from any cause. For participants who were alive, their survival time was censored at the last known alive date. Overall survival was censored for participants at the date of first treatment if they had no follow-up.~Based on Kaplan-Meier estimates." (NCT02985957)
Timeframe: From randomization to the date of death due to any cause (assessed up to approximately 61 months)

InterventionMonths (Median)
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W15.9
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W13.47
Cohort D Arm 3: Ipilimumab 3 mg/kg18.46
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg14.78

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The Number of Participants Experiencing Serious Adverse Events (SAEs) in Cohorts A, B and C

A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)

InterventionParticipants (Count of Participants)
Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg1
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg17
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg33

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The Number of Participants Who Died in Cohort D

Death due to any cause. (NCT02985957)
Timeframe: From first dose to 100 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 29.5 months).

InterventionParticipants (Count of Participants)
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W47
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W44
Cohort D Arm 3: Ipilimumab 3 mg/kg14
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg31
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D36
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D417

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The Number of Participants Who Died in Cohorts A, B and C

Death due to any cause. (NCT02985957)
Timeframe: From first dose to 100 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 20.7 months).

InterventionParticipants (Count of Participants)
Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg2
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg39
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg39

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The Number of Participants With Changes in Laboratory Values From Baseline in Cohorts A, B and C

The number of participants with a change in laboratory values from baseline Grade in Cohorts A, B and C. (NCT02985957)
Timeframe: From first dose to 30 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 18.2 months)

InterventionParticipants (Number)
HemoglobinPlatelet CountLeukocytesLymphocytes (Absolute)Absolute Neutrophil CountAlkaline PhosphataseAspartate AminotransferaseAlanine AminotransferaseBilirubin, TotalCreatinineAmylase, TotalLipase, TotalHypernatremiaHyponatremiaHyperkalemiaHypokalemiaHypercalcemiaHypocalcemia
Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg000000010000000000

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Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohort D

"Change between Mean BPI-SF scores at baseline and week 4 (cycle 2). The BPI-SF measures pain severity through the use of a numerical rating scale. Participants rate the severity of their pain at its ''worst,'' ''least,'' and ''average'' in the last 24 hours using an 11-point numerical rating scale with anchors of ''0 = no pain'' and ''10 = pain as bad as you can imagine.'' A higher score = a worse outcome. Pain Severity Score = Mean of items 3-6 (pain at its worst, pain at its least). Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations." (NCT02985957)
Timeframe: At baseline and 4 weeks after first dose.

,,,
InterventionScore on a scale (Mean)
Worst pain in the last 24 hours Week 4Least pain in the last 24 hours Week 4Average pain in the last 24 hours Week 4Current pain Week 4
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W-0.3-0.3-0.5-0.2
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W0.50.20.20.3
Cohort D Arm 3: Ipilimumab 3 mg/kg-0.10.2-0.3-0.4
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg-0.5-0.3-0.4-0.3

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Changes in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Scores Cohorts B and C

"Change between Mean BPI-SF scores at baseline and week 4 (cycle 2). The BPI-SF measures pain severity through the use of a numerical rating scale. Participants rate the severity of their pain at its ''worst,'' ''least,'' and ''average'' in the last 24 hours using an 11-point numerical rating scale with anchors of ''0 = no pain'' and ''10 = pain as bad as you can imagine.'' A higher score = a worse outcome. Pain Severity Score = Mean of items 3-6 (pain at its worst, pain at its least). Baseline evaluations or events are defined as evaluations or events that occur before the date and time of the first dose of study treatment. Evaluations on the same date and time of the first dose of study treatment were considered as baseline evaluations." (NCT02985957)
Timeframe: At baseline and Week 4 (Cycle 2)

,
InterventionScore on a scale (Mean)
Worst pain in the last 24 hours Week 4 (Cycle 2)Least pain in the last 24 hours Week 4 (Cycle 2)Average pain in the last 24 hours Week 4 (Cycle 2)Current pain Week 4 (Cycle 2)
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg0.0-0.5-0.2-0.1
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg-0.1-0.1-0.10

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The Number of Participants Experiencing Immune Mediated Adverse Events in Cohort D

Immune-mediated adverse events (IMAEs) are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity. (NCT02985957)
Timeframe: From first dose to 100 days after last dose of study therapy (an average of 4.83 months assessed up to approximately 29.5 months).

,,,,,
InterventionParticipants (Count of Participants)
PneumonitisDiarrhea/ColitisHepatitisAdrenal InsufficiencyHypothyroidism/ThyroiditisDiabetes MellitusNephritis and Renal DysfunctionRashHypersensitivityHyperthyroidismHypophysitis
Cohort D Arm 1: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W195261012042
Cohort D Arm 2: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Q6W4208392010055
Cohort D Arm 3: Ipilimumab 3 mg/kg05011002003
Cohort D Arm 4: Cabazitaxel 20 mg/m2 or 25 mg/m2 + Prednisone 10 mg00000000000
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D310022001001
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg Q4W After Crossover From Arm D422211103011

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The Number of Participants Experiencing Immune Mediated Adverse Events in Cohorts A, B and C

Immune-mediated adverse events (IMAEs) are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity. (NCT02985957)
Timeframe: From first dose to 100 days after last dose of study therapy (an average of 2.8 months assessed up to approximately 20.7 months)

,,
InterventionParticipants (Count of Participants)
PneumonitisDiarrhea/ColitisHepatitisAdrenal InsufficiencyHypothyroidism/ThyroiditisDiabetes MellitusNephritis and Renal DysfunctionRashHypersensitivityHyperthyroidismHypophysitis
Cohort A: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg10000000000
Cohort B: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg3154120116013
Cohort C: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg217121006011

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Certain Safety Endpoints of Interest: Infections, Hepatic System Abnormalities, WBC Count Decreases, and Hypersensitivity

"WBC=White Blood Cell~TEAE=Treatment-Emergent Adverse Event" (NCT02994927)
Timeframe: From day 1 throughout the study period (day 421/week 60)

,
InterventionParticipants (Count of Participants)
Any Treatment-Emergent InfectionAny Serious Treatment-Emergent InfectionAny Severe Treatment-Emergent InfectionAny Treatment-Emergent Infection Leading to Study WithdrawalAny Treatment-Emergent Life-threatening InfectionAny Treatment-Emergent Infection Leading to DeathAny TEAE Associated with Hepatic AbnormalitiesAny TEAE Associated with Low WBC CountsAny TEAE Associated with hypersensitivity
Avacopan Group1132212411223168
Prednisone Group1242510522193970

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Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving BVAS=0 at Any Time During the Treatment Period

"The median time to relapse was not estimable because of small number of relapsed subjects.~A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:~having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or~having achieved BVAS=0 at any time during the treatment period~The Birmingham Vasculitis Activity Score (BVAS) form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health)." (NCT02994927)
Timeframe: Week 52

Interventionpercentage of participants (Number)
Prednisone Group21.0
Avacopan Group10.1

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Percentage of Subjects Achieving Sustained Disease Remission at Week 52

"Sustained remission at Week 52 was defined as:~Disease remission at Week 26 as defined above;~Disease remission at Week 52 defined as a BVAS of 0 at Week 52 as determined by the Adjudication Committee and no administration of glucocorticoids for treatment of ANCA-associated vasculitis within 4 weeks prior to Week 52;~No disease relapse between Week 26 and Week 52 as determined by the Adjudication Committee." (NCT02994927)
Timeframe: Week 52

Interventionpercentage of participants (Number)
Prednisone Group54.9
Avacopan Group65.7

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Percentage of Subjects Achieving Disease Remission at Week 26

"Disease remission at Week 26 was defined as:~Achieving a BVAS of 0 as determined by the Adjudication Committee;~No administration of glucocorticoids given for ANCA-associated vasculitis within 4 weeks prior to Week 26;~No BVAS >0 during the 4 weeks prior to Week 26 (if collected for an unscheduled assessment)." (NCT02994927)
Timeframe: Week 26

Interventionpercentage of participants (Number)
Prednisone Group70.1
Avacopan Group72.3

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Percentage of Participants With BVAS of 0 at Week 4, Regardless of Whether the Subjects Received Glucocorticoids During This Period of Time and Based on Assessment by the Blinded AC

"AC=Adjudication Committee; BVAS=Birmingham Vasculitis Activity Score;~The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health)." (NCT02994927)
Timeframe: Week 4

Interventionpercentage of participants (Number)
Prednisone Group68.9
Avacopan Group62.7

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Number of Subjects With Clinically Significant ECG Changes From Baseline

"Clinical significance was assessed by the individual reading of the ECGs~ECG=Electrocardiogram" (NCT02994927)
Timeframe: From day 1 throughout the study period (day 421/week 60)

InterventionParticipants (Count of Participants)
Prednisone Group8
Avacopan Group12

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Number of Subjects Experiencing a Relapse After Previously Achieving BVAS=0 During the Study

"BVAS=Birmingham Vasculitis Activity Score;~A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:~having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or~having achieved BVAS=0 at any time during the treatment period~The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health)." (NCT02994927)
Timeframe: From day 1 throughout the study period (day 421/week 60)

InterventionParticipants (Count of Participants)
Prednisone Group33
Avacopan Group16

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Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission at Week 26 in the Study

"The median time to relapse was not estimable because of small number of relapsed subjects.~A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:~having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or~having achieved BVAS=0 at any time during the treatment period~ANCA=anti-neutrophil cytoplasmic autoantibody; BVAS=Birmingham Vasculitis Activity Score; The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health)." (NCT02994927)
Timeframe: Week 52

Interventionpercentage of participants (Number)
Prednisone Group12.2
Avacopan Group7.5

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Change From Baseline in Vital Signs (4/5)

(NCT02994927)
Timeframe: Baseline, Week 26 and 52

,
Interventionkilogram(s) (Mean)
Weight (Week 26)Weight (Week 52)
Avacopan Group1.932.59
Prednisone Group3.333.27

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Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs

"AEs=Adverse events~SAEs=Serious adverse events~TEAE=Treatment-emergent adverse event" (NCT02994927)
Timeframe: From day 1 throughout the study period (day 421/week 60)

,
InterventionNumber (Number)
Number of subjects with at least one TEAENumber of TEAEsNumber of subjects with SAEsNumber of SAEsSubjects with TEAE leading to discontinuation
Avacopan Group16417797011627
Prednisone Group16121397416628

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Number of Subjects Where a Relationship Between Avacopan/Placebo, Glucocorticoid Use, Cyclophosphamide, Rituximab, and Azathioprine or Mycophenolate Use to an AE Was Determined by the Investigator

AE=Adverse Event (NCT02994927)
Timeframe: From day 1 throughout the study period (day 421/week 60)

,
InterventionParticipants (Count of Participants)
Relationship of avacopan/placebo to an AERelationship of glucocorticoid use to an AERelationship of cyclophosphamide IV use to an AERelationship of oral cyclophosphamide use to an AERelationship of rituximab use to an AERelationship of azathioprine use to an AERelationship of mycophenolate use to an AE
Avacopan Group10010731850286
Prednisone Group10313130461359

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In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Percent Change in Urinary MCP-1:Creatinine Ratio From Baseline Over 52 Weeks

"BVAS=Birmingham Vasculitis Activity Score~MCP-1=monocyte chemoattractant protein-1" (NCT02994927)
Timeframe: Baseline, Week 26 and 52

,
InterventionPercentage change (Least Squares Mean)
Week 26Week 52
Avacopan Group-67-73
Prednisone Group-64-71

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In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Change in eGFR From Baseline Over 52 Weeks

"Change from baseline in kidney function, as measured by eGFR (based on the MDRD equation), was measured in subjects with renal disease based on the BVAS renal component.~eGFR=estimated glomerular filtration rate~BVAS=Birmingham Vasculitis Activity Score~MDRD=Modification of Diet in Renal Disease" (NCT02994927)
Timeframe: Baseline, Week 26 and 52

,
InterventionChange in eGFR (mL/min/1.73 m^2) (Least Squares Mean)
Week 26Week 52
Avacopan Group5.87.3
Prednisone Group2.94.1

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In Subjects With Renal Disease and Albuminuria at Baseline (Based in the BVAS Renal Component), the Percent Change in UACR From Baseline Over 52 Weeks

"BVAS=Birmingham Vasculitis Activity Score~UACR=Urinary albumin:creatinine ratio" (NCT02994927)
Timeframe: Baseline, Week 4, 26 and 52

,
InterventionPercentage change (Least Squares Mean)
Week 4Week 26Week 52
Avacopan Group-40-63-74
Prednisone Group0-70-77

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Glucocorticoid-induced Toxicity as Measured by Change From Baseline Over the First 26 Weeks in the GTI

"GTI-CWS=Glucocorticoid Toxicity Index Cumulative Worsening Score;~GTI-AIS=Glucocorticoid Toxicity Index Aggregate Improvement Score;~The Glucocorticoid Toxicity Index (GTI) was developed to score glucocorticoid toxicity. The GTI includes: the Cumulative Worsening Score (CWS) that captures cumulative toxicity, both permanent and transient, over the course of time (serves as a cumulative record of toxicity); and the Aggregate Improvement Score that captures both improvement and worsening of toxicity over time (serves as a record of both improving and worsening toxicity). Both scores range from 0 (best health) to 100 (worst health)." (NCT02994927)
Timeframe: Baseline, Week 13 and 26

,
InterventionGlucocorticoid Toxicity Index (Least Squares Mean)
GTI-CWS (Week 13)GTI-CWS (Week 26)GTI-AIS (Week 13)GTI-AIS (Week 26)
Avacopan Group25.739.79.911.2
Prednisone Group36.656.623.223.4

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Change in the VDI From Baseline Over 52 Weeks, Including the Week 26 and Week 52 Time Points

VDI=Vasculitis Damage Index; The VDI is comprised of 64 items of damage, grouped into 11 organ-based systems or categorizations. Damage is defined as the presence of non-healing scars and does not give any indication of current disease activity. Damage is also defined as having been present or currently present for at least 3 months. Completion of the form provides a numerical score, which ranges from 0 (best health) to 64 (worst health). (NCT02994927)
Timeframe: Baseline, Week 26 and 52

,
Interventionscore on a scale (Least Squares Mean)
Week 26Week 52
Avacopan Group1.061.17
Prednisone Group0.971.15

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Change From Baseline in Vital Signs (5/5)

BMI=Body Mass Index (NCT02994927)
Timeframe: Baseline, Week 26 and 52

,
Interventionkilogram(s)/ square meter (Mean)
BMI (Week 26)BMI (Week 52)
Avacopan Group0.670.94
Prednisone Group1.131.12

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Change From Baseline in Vital Signs (3/5)

(NCT02994927)
Timeframe: Baseline, Week 26 and 52

,
Interventiondegree Celsius (Mean)
Temperature (Week 26)Temperature (Week 52)
Avacopan Group-0.11-0.11
Prednisone Group-0.030.04

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Change From Baseline in Vital Signs (2/5)

(NCT02994927)
Timeframe: Baseline, Week 26 and 52

,
Interventionbeats/min (Mean)
Pulse Rate (Week 26)Pulse Rate (Week 52)
Avacopan Group0.9-0.3
Prednisone Group2.2-1.3

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Change From Baseline in Vital Signs (1/5)

(NCT02994927)
Timeframe: Baseline, Week 26 and 52

,
InterventionmmHg (Mean)
Systolic Blood Pressure (Week 26)Systolic Blood Pressure (Week 52)Diastolic Blood Pressure (Week 26)Diastolic Blood Pressure (Week 52)
Avacopan Group-2.6-1.00.51.4
Prednisone Group-2.5-2.42.71.4

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Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (2/2)

(NCT02994927)
Timeframe: Baseline, Week 26 and 52

,
Interventionmg/dL (Mean)
Creatinine (Week 26)Creatinine (Week 52)Urea Nitrogen (Week 26)Urea Nitrogen (Week 52)Protein (Week 26)Protein (Week 52)Cholesterol (Week 26)Cholesterol (Week 52)LDL Cholesterol (Week 26)LDL Cholesterol (Week 52)Bilirubin (Week 26)Bilirubin (Week 52)
Avacopan Group-0.195-0.244-11.0-11.92202507.49.312.011.90.0780.057
Prednisone Group-0.105-0.200-9.4-7.85016019.013.822.721.70.0650.053

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Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (1/2)

(NCT02994927)
Timeframe: Baseline, Week 26 and 52

,
InterventionU/L (Mean)
Lactate Dehydrogenase (Week 26)Lactate Dehydrogenase (Week 52)Alkaline Phosphatase (Week 26)Alkaline Phosphatase (Week 52)Creatine Kinase (Week 26)Creatine Kinase (Week 52)Alanine Aminotransferase (Week 26)Alanine Aminotransferase (Week 52)Aspartate Aminotransferase (Week 26)Aspartate Aminotransferase (Week 52)
Avacopan Group-6.1-10.7-3.9-4.076.876.3-6.1-7.22.52.0
Prednisone Group2.3-8.6-0.60.847.657.6-6.8-8.21.90.5

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Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (5/5)

(NCT02994927)
Timeframe: Baseline, Week 26 and 52

,
Interventionpercentage of red blood cells (Mean)
Hematocrit (Week 26)Hematocrit (Week 52)
Avacopan Group2.73.2
Prednisone Group2.63.0

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Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (4/5)

(NCT02994927)
Timeframe: Baseline, Week 26 and 52

,
Interventiong/dL (Mean)
Hemoglobin (Week 26)Hemoglobin (Week 52)
Avacopan Group1.101.27
Prednisone Group1.071.20

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Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (3/5)

(NCT02994927)
Timeframe: Baseline, Week 26 and 52

,
Intervention10^12 cells/L (Mean)
Erythrocytes (Week 26)Erythrocytes (Week 52)
Avacopan Group0.2520.279
Prednisone Group0.2260.244

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Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (2/5)

(NCT02994927)
Timeframe: Baseline, Week 26 and 52

,
Intervention10^9 cells/L (Mean)
Eosinophils (Week 26)Eosinophils (Week 52)Basophils (Week 26)Basophils (Week 52)Monocytes (Week 26)Monocytes (Week 52)Platelets (Week 26)Platelets (Week 52)
Avacopan Group0.070.07-0.00-0.01-0.04-0.01-77.1-73.8
Prednisone Group0.070.05-0.01-0.010.010.01-73.9-75.5

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Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (1/5)

(NCT02994927)
Timeframe: Baseline, Week 26 and 52

,
Intervention10^3 cells/μL (Mean)
Leukocytes (Week 26)Leukocytes (Week 52)Neutrophils (Week 26)Neutrophils (Week 52)Lymphocytes (Week 26)Lymphocytes (Week 52)
Avacopan Group-5.94-5.62-5.24-4.95-0.84-0.82
Prednisone Group-5.69-5.54-5.10-4.89-0.62-0.67

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Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for Immunohistochemistry (IHC) Programmed Death Ligand - 1 (PDL1) Total Percentage

Data in the analysis include all participants who received durvalumab, irrespective of the study arm in which they enrolled, because the selected biomarkers have been associated with response in other anti-PD1 or anti-PDL1 studies, such as durvalumab. IHC analysis was performed on the baseline tumor biopsy to quantify CD8 T-cell density. Participants with 'high' values, i.e. above the threshold defined as the median value of 774 cells/mm^2 found in commercial DLBCL samples using matched analytical methods, were predicted to be responders to treatment with durvalumab. The definition of a complete response was that used in the primary outcome. (NCT03003520)
Timeframe: Biomarker biopsies: Days -28 to Day -1. Clinical response: From first dose of study drug to end of Induction therapy (Day 1 up to Week 26 - maximum duration of Induction Period).

Interventionpercentage of participants (Number)
High Group for PDL1 % of Total Cells75
Low Group for PDL1 % of Total Cells20

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Percentage of Participants Who Responded During Induction and Continued Into Consolidation Therapy (Database Cutoff Date: 02-Aug-2018)

The percentage of participants who achieved a partial response (PR) or complete response (CR) at the end of Induction and continued into consolidation period in the efficacy evaluable population in a comparative manner against historical control. The response to treatment was assessed according to the 2014 International Working Group (IWG) Response Criteria for Non-Hodgkin's Lymphoma (NHL) (Cheson, 2014). CR was defined in outcome #1. PR was defined as a partial metabolic response and radiographic evidence showing ≥ 50% decrease in sum of perpendicular diameters (SPD) of up to 6 target measurable nodes and extranodal sites, no new lesions, spleen must have regressed > 50% in length beyond normal, and residual bone marrow involvement improved from baseline. Clopper-Pearson two-sided 95% confidence interval is reported. Null hypothesis was rejected if the lower limit of the confidence interval for the rate of subjects who continue consolidation therapy out of all subjects. (NCT03003520)
Timeframe: From first dose of study drug to completion of at least one cycle in the Consolidation Period (Day 1 up to Week 52)

Interventionpercentage of participants (Number)
DUR + R-CHOP67.6
DUR + R2-CHOP66.7

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Participants With Treatment Emergent Adverse Events (TEAE)

An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03): - Grade 1 = Mild (no limitation in activity or intervention); - Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); - Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); - Grade 4 = Life-threatening; - Grade 5 = Death. Relation to IP is determined by the investigator. (NCT03003520)
Timeframe: From the date of the first dose of study drug to within 90 days after the last dose of durvalumab or 28 days after the last dose of any investigational product (IP) whichever is greater. (Up to approximately 72 weeks)

InterventionParticipants (Count of Participants)
>= 1 Treatment-emergent adverse event (TEAE)>=1 TEAE related to durvalumab>=1 TEAE related to R-CHOP>=1 TEAE related to durvalumab or any other IP>=1 TEAE severity grade 3-4>=1 TEAE severity grade 3-4 related to durvalumab>=1 TEAE severity grade 3-4 related to R-CHOP>=1 TEAE severity grade 3-4 related to any IP>=1 TEAE severity grade 5>=1 TEAE severity grade 5 related to any IP>=1 serious TEAE>=1 serious TEAE related to durvalumab>=1 serious TEAE related to R-CHOP>=1 serious TEAE related to any IP>=1 leading to discontinuation of durvalumab>=1 leading to discontinuation of R-CHOP>=1 leading to discontinuation of any IP>=1 leading to interruption of durvalumab>=1 leading to interruption of R-CHOP>=1 leading to interruption of any IP>=1 leading to infusion interruption of durvalumab>=1 leading to dose reduction of vincristine
DUR + R-CHOP433340413718273130231010141341315121824

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Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for Immunohistochemistry (IHC) Programmed Death Ligand - 1 (PDL1) Percentage of Tumor Cells

Data in the analysis include all participants who received durvalumab, irrespective of the study arm in which they enrolled, because the selected biomarkers have been associated with response in other anti-PD1 or anti-PDL1 studies, such as durvalumab. IHC analysis was performed on the baseline tumor biopsy to quantify CD8 T-cell density. Participants with 'high' values, i.e. above the threshold defined as the median value of 774 cells/mm^2 found in commercial DLBCL samples using matched analytical methods, were predicted to be responders to treatment with durvalumab. The definition of a complete response was that used in the primary outcome. (NCT03003520)
Timeframe: Biomarker biopsies: Days -28 to Day -1. Clinical response: From first dose of study drug to end of Induction therapy (Day 1 up to Week 26 - maximum duration of Induction Period).

Interventionpercentage of participants (Number)
High Group for PDL1 % of Tumor Cells64
Low Group for PDL1 % of Tumor Cells56

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Percentage of Participants Who Achieved a Complete Response (CR) at the End of Induction Therapy

The primary efficacy analysis evaluated the complete response rate (CRR) at the end of the induction therapy in the efficacy evaluable population in a comparative manner against historical control. The response to treatment was assessed according to the 2014 International Working Group (IWG) Response Criteria for Non-Hodgkin's Lymphoma (NHL) (Cheson, 2014). CR was defined as a complete metabolic response and radiographic evidence showing target nodes/nodal masses regressed to ≤ 1.5 cm in longest diameter, no new lesions, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. Clopper-Pearson two-sided 95% confidence interval is reported. Null hypothesis for the primary endpoint was rejected if the lower limit of the confidence interval for the complete response rate at the completion of the induction therapy in the efficacy evaluable population is above 55%. (NCT03003520)
Timeframe: From first dose of study drug to end of Induction therapy (Day 1 up to Week 26 - maximum duration of Induction Period).

Interventionpercentage of participants (Number)
DUR + R-CHOP54.1
DUR + R2-CHOP66.7

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Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for the Interferon Gamma Score (IFNG-Score) From Ribonucleic Acid (RNA)-Sequencing Data

Data in the analysis include all participants who received durvalumab, irrespective of the study arm in which they enrolled, because the selected biomarkers have been associated with response in other anti-PD1 or anti-PDL1 studies, such as durvalumab. IHC analysis was performed on the baseline tumor biopsy to quantify CD8 T-cell density. Participants with 'high' values, i.e. above the threshold defined as the median value of 774 cells/mm^2 found in commercial DLBCL samples using matched analytical methods, were predicted to be responders to treatment with durvalumab. The definition of a complete response was that used in the primary outcome. (NCT03003520)
Timeframe: Biomarker biopsies: Days -28 to Day -1. Clinical response: From first dose of study drug to end of Induction therapy (Day 1 up to Week 26 - maximum duration of Induction Period).

Interventionpercentage of participants (Number)
High Group for RNA IFN Gamma Score43
Low Group for RNA IFN Gamma Score60

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Participants With Treatment Emergent Adverse Events (TEAE)

An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03): - Grade 1 = Mild (no limitation in activity or intervention); - Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); - Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); - Grade 4 = Life-threatening; - Grade 5 = Death. Relation to IP is determined by the investigator. (NCT03003520)
Timeframe: From the date of the first dose of study drug to within 90 days after the last dose of durvalumab or 28 days after the last dose of any investigational product (IP) whichever is greater. (Up to approximately 72 weeks)

InterventionParticipants (Count of Participants)
>= 1 Treatment-emergent adverse event (TEAE)>=1 TEAE related to durvalumab>=1 TEAE related to R-CHOP>=1 TEAE related to lenalidomide>=1 TEAE related to durvalumab or any other IP>=1 TEAE severity grade 3-4>=1 TEAE severity grade 3-4 related to durvalumab>=1 TEAE severity grade 3-4 related to R-CHOP>=1 TEAE severity grade 3-4 related to lenalidomid>=1 TEAE severity grade 3-4 related to any IP>=1 TEAE severity grade 5>=1 TEAE severity grade 5 related to any IP>=1 serious TEAE>=1 serious TEAE related to durvalumab>=1 serious TEAE related to R-CHOP>=1 serious TEAE related to lenalidomide>=1 serious TEAE related to any IP>=1 leading to discontinuation of durvalumab>=1 leading to discontinuation of R-CHOP>=1 leading to discontinuation of lenalidomide>=1 leading to discontinuation of any IP>=1 leading to interruption of durvalumab>=1 leading to interruption of R-CHOP>=1 leading to interruption of lenalidomide>=1 leading to interruption of any IP>=1 leading to infusion interruption of durvalumab>=1 leading to dose reduction of vincristine>=1 leading to dose reduction of lenalidomide
DUR + R2-CHOP3333331323001111100002123011

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Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for Immunohistochemistry (IHC) CD8 T-Cell Density

Data in the analysis include all participants who received durvalumab, irrespective of the study arm in which they enrolled, because the selected biomarkers have been associated with response in other anti-PD1 or anti-PDL1 studies, such as durvalumab. IHC analysis was performed on the baseline tumor biopsy to quantify CD8 T-cell density. Participants with 'high' values, i.e. above the threshold defined as the median value of 774 cells/mm^2 found in commercial DLBCL samples using matched analytical methods, were predicted to be responders to treatment with durvalumab. The definition of a complete response was that used in the primary outcome. (NCT03003520)
Timeframe: Biomarker biopsies: Days -28 to Day -1. Clinical response: From first dose of study drug to end of Induction therapy (Day 1 up to Week 26 - maximum duration of Induction Period).

Interventionpercentage of participants (Number)
High Group for CD8 Density67
Low Group for CD8 Density64

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Number of Participants With Complete Measurable Residual Disease (MRD) Response Rate

"Response was determined by having no detectable disease by multiparameter flow cytometry (MFC-). For Ph+ subjects, complete molecular response (CMR) by BCR-ABL RT-PCR was assigned when MFC was undetectable.~When no measurable residual disease was detected by MFC (MFC-) per EuroFlow criteria, high-throughput sequencing-based MRD testing (HTS; ClonoSEQ) was performed." (NCT03023046)
Timeframe: Within 4 cycles of study therapy

InterventionParticipants (Count of Participants)Participants (Count of Participants)
MFC-72545885MFC-72545886CMR72545885HTS-72545885HTS-72545886
Achieve within 4 cyclesNot achieved within 4 cycles
Ph+ Subjects20
Ph- Subjects9
Ph+ Subjects11
Ph+ Subjects17
Ph+ Subjects8
Ph- Subjects6
Ph+ Subjects16
Ph- Subjects16

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Overall Survival

Alive at 2 years after enrollment (NCT03023046)
Timeframe: Up to 2 years

InterventionPercentage of Participants (Number)
Treatment (Chemotherapy)70

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Number of Participants With Morphological Complete Response Rate

Morphological complete remission (CR) was determined by bone marrow aspirate morphology and defined as <5% blasts by morphology, absolute neutrophil count >1000/uL, and platelet count >100,000/uL. (NCT03023046)
Timeframe: Within 4 cycles of study therapy

InterventionParticipants (Count of Participants)
Ph+ Subjects27
Ph- Subjects20

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Number of Participants With Adverse Events

Grade 1 or higher non-hematologic adverse events will be assessed by Common Terminology Criteria for Adverse Events version 5.0. (NCT03023046)
Timeframe: Within 28 days of the last dose of the study drugs

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy)44

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Event-free Survival

Events were defined as any of the following: (1) unable to achieve either morphologic complete remission (CR) or MRD- by MFC, (2) relapse after CR, (3) MRD recurrence after achieving MRD-, or (4) death from any cause. (NCT03023046)
Timeframe: Up to 2 years

InterventionPercentage of Participants (Number)
Treatment (Chemotherapy)32

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Glucose Tolerance Test: Area Under the Curve (AUC) for C-peptide Levels

"AUC for C-peptide during glucose tolerance test at baseline and 4-8 hours after prednisone.~C-peptide levels were measured at 0, 10, 20, 30, 60, 90, and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration (Visit 2)" (NCT03023891)
Timeframe: baseline and 4-8 hours after drug administration

Interventionng*min/mL (Mean)
Visit 1: baselineVisit 2: 4-8 hours post prednisone
Prednisone493.89449.41

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Glucose Tolerance Test: Area Under the Curve (AUC) for Insulin Levels

"AUC for insulin levels during glucose tolerance test at baseline and 4-8 hours after prednisone.~Insulin levels were measured at 0, 10, 20, 30, 60, 90 and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration administration (Visit 2)." (NCT03023891)
Timeframe: baseline and 4-8 hours after drug administration

InterventionμU*min/mL (Mean)
Visit 1: baselineVisit 2: 4-8 hours post prednisone
Prednisone5415.875466.55

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White Blood Cell Counts

White Blood Count at baseline (Visit 1) and within 4 to 8 hours after drug administration (Visit 2) (NCT03023891)
Timeframe: baseline and within 4 and 8 hours after drug administration

Interventionx10^3 cells/mL (Mean)
Visit 1: baselineVisit 2: 4 to 8 hours post prednisone
Prednisone5.266.99

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Glucose Tolerance Test: Area Under the Curve (AUC) for Plasma Glucose

"AUC for plasma glucose during glucose tolerance test at baseline and 4-8 hours after drug administration.~Plasma glucose levels were measured at 0, 10, 20, 30, 60, 90 and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration (Visit 2)" (NCT03023891)
Timeframe: baseline and 4-8 hours after drug administration

Interventionmg*min/dL (Mean)
Visit 1: baselineVisit 2: 4-8 hours post prednisone
Prednisone13530.5620273.75

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Number of Patients With Durable Tumor and Symptomatic Response

Durable tumor and symptomatic response is complete response (CR) + partial response (PR). CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to multicentric Castleman's disease, sustained for at least 18 weeks. PR: >=50 percent decrease in sum of the product of the diameters of indicator lesion(s), with at least stable disease in all other evaluable disease in the absence of treatment failure sustained for at least 6 months. (NCT03043105)
Timeframe: From baseline to the time point when a patient achieves treatment response for 24 weeks.

InterventionParticipants (Count of Participants)
TCP Treatment Group12

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Overall Survival

Overall survival, defined as the time to patients' death, is measured. (NCT03043105)
Timeframe: From date of randomization until the date of death from any cause, assessed up to 36 months.

Interventionmonths (Mean)
TCP Treatment Group32.16

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Progression-free Survival

Progression-free survival (PFS) is defined as the time to death or treatment failure. Treatment failure is defined as: sustained increase in grade ≥2 disease-related symptoms persisting ≥12 weeks; new disease-related grade ≥3 symptoms; sustained >1 point increase in ECOG-PS persisting for ≥12 weeks; radiological progression; or initiation of another treatment for MCD. (NCT03043105)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Interventionmonths (Mean)
TCP Treatment Group23.32

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Change in SF-36 Score

SF-36 score is a self-administered scoring system which reflects a patient's general health status. SF-36 contains 8 dimensions, including physical functioning, role physical, role emotional, vitality, mental health, social functioning, bodily pain, and general health. Each dimension ranges from 0 to 100. Higher scores mean better outcome. SF-36 score at baseline was compared with SF-36 score at 24 weeks. (NCT03043105)
Timeframe: From baseline to 24 weeks after treatment.

Interventionscore on a scale (Mean)
physical functioningrole physicalrole emotionalvitalitymental healthsocial functioningbodily paingeneral health
TCP Treatment Group15.126.719.611.18.513.615.89.1

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Investigator-Assessed Radiographic Progression-Free Survival (rPFS) Per PCWG3 Criteria (Intent-To-Treat (ITT) Population)

Radiographic progression-free survival is defined as time from date of randomization to the first occurrence of documented disease progression, as assessed by the investigator with use of the Prostate Cancer Working Group 3 (PCWG3) criteria or death from any cause, whichever occurs first. Disease progression for soft tissue is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm in the sum of diameters of target lesions; progression of non target lesions; the appearance of one or more new lesions. Disease progression for bone lesions is defined as 2 or more new lesions compared to baseline followed by a confirmatory bone scan at least 6 weeks later. rPFS will be analyzed in the Intent-to-Treat (ITT) population. (NCT03072238)
Timeframe: Up to approximately 31 months

InterventionMonths (Median)
Placebo + Abiraterone16.6
Ipatasertib + Abiraterone19.2

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Plasma Concentrations of Abiraterone at Specified Timepoints

Plasma samples for pharmacokinetic characterization was collected at various timepoints in all participants. (NCT03072238)
Timeframe: Pre-dose at steady state in Cycle 1, Day 15 and Cycle 3 Day 1 (each cycle length= 28 days)

,
Interventionng/mL (Geometric Mean)
Cycle 1 Day 15Cycle 3 Day 1
Ipatasertib + Abiraterone9.409.55
Placebo + Abiraterone11.210.4

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Investigator-Assessed Radiographic Progression-Free Survival (rPFS) Per PCWG3 Criteria (PTEN Loss Population)

Radiographic progression-free survival is defined as time from date of randomization to the first occurrence of documented disease progression, as assessed by the investigator with use of the Prostate Cancer Working Group 3 (PCWG3) criteria or death from any cause, whichever occurs first. Disease progression for soft tissue is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm in the sum of diameters of target lesions; progression of non target lesions; the appearance of one or more new lesions. Disease progression for bone lesions is defined as 2 or more new lesions compared to baseline followed by a confirmatory bone scan at least 6 weeks later. rPFS will be analyzed in participants with phosphatase and tensin homolog (PTEN) - loss tumors (using the Ventana PTEN immunohistochemistry (IHC) assay). (NCT03072238)
Timeframe: Up to approximately 31 months

InterventionMonths (Median)
Placebo + Abiraterone16.5
Ipatasertib + Abiraterone18.5

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Plasma Concentrations of Ipatasertib at Specified Timepoints

Plasma samples for pharmacokinetic characterization was collected at various timepoints in all participants. (NCT03072238)
Timeframe: 1-3 hours post-dose (Cycle 1, Day 1; Cycle 1 Day 15 and Cycle 3 Day 1) and pre-dose at steady state (Cycle 1 Day 15, Cycle 3 Day 1, Cycle 6 Day 1) (each cycle length= 28 days)

Interventionng/mL (Geometric Mean)
Cycle 1 Day 1 Post-doseCycle 1 Day 15 Pre-doseCycle 1 Day 15 Post-doseCycle 3 Day 1 Pre-doseCycle 3 Day 1 Post-doseCycle 6 Day 1 Pre-dose
Ipatasertib + Abiraterone21246.824735.420746.1

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To Evaluate Progression-free Survival on the Combination of Docetaxel Plus Apalutamide

"Progression free survival (PFS) is defined as the time from treatment initiation until the occurrence of one of the following:~A participant was considered to have progressed by bone scan if~the first bone scan with greater than or equal to (≥) 2 new lesions compared to baseline was observed in less than (<) 12 weeks from study drug initiation and was confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline);~the first bone scan with ≥2 new lesions compared to baseline was observed in ≥12 weeks from study drug initiation and the new lesions were verified on the next bone scan ≥6 weeks later (a total of ≥2 new lesions compared to baseline);~Progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) by RECIST v. 1.1; or~Death from any cause." (NCT03093272)
Timeframe: Disease was evaluated radiologically at baseline and every 12 weeks on treatment; PFS follow up was up to 9.4 months

Interventionmonths (Number)
Participant 1Participant 2Participant 3Participant 4Participant 5Participant 6Participant 7Participant 8Participant 9
Apalutamide Combined With Docetaxel5.6NA5.68.11.84.85.1NA9.4

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Serum PSA Change From Baseline to 12 Weeks on Treatment

The maximum percent PSA change (rise or fall) from baseline to after 12 weeks on study. For patients who discontinue on or before the 12 week assessment or for whom the 12 week assessment is missing, the last observation prior to the week 12 assessment will be utilized. Patients with no post-baseline PSA data will be excluded from the summary. (NCT03093272)
Timeframe: PSA was measured on Cycle 1 Day 1 (Baseline) and at 12 weeks on treatment.

Interventionpercent (Median)
Apalutamide Combined With Docetaxel13.0

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Maximum Blood Concentration (Cmax) for Docetaxel Pharmacokinetic Analysis

The pharmacokinetic (PK) parameters of the first 9 patients enrolled at Dana-Farber Cancer Institute will be determined using noncompartmental methods with WinNonLin version 5.2. Maximum blood concentration (Cmax) will be determined by visual inspection. Due to the premature termination of the study, only 9 patients were evaluated. The PK samples were collected on Days 1 and 2 of the first two treatment cycles. (NCT03093272)
Timeframe: Cycle 1, 2: During infusion at pre-dose, 15 minutes and 30 minutes post-dose, end of dose, and 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours post dose.

Interventionng/mL (Mean)
Cycle 1Cycle 2
Apalutamide Combined With Docetaxel24151641

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Area Under the Curve (AUC) for Docetaxel Pharmacokinetic Analysis

The area under the blood concentration-time curve (linear trapezoidal rule) will be determined between 0-24 hours (AUC0-24). The PK samples were collected during the first two days of cycles 1 and 2. (NCT03093272)
Timeframe: Cycle 1, 2: During infusion at pre-dose, 15 minutes and 30 minutes post-dose, end of dose, and 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours post dose.

Interventionng•h/mL (Mean)
Cycle 1Cycle 2
Apalutamide Combined With Docetaxel34063095

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Overall Survival

Overall Survival (OS) is defined as the time from trial treatment start to death due to any cause, or censored at date last known alive. (NCT03093272)
Timeframe: Measured from end of study treatment to death due to any cause; OS measured as 22.4 months

Interventionmonths (Number)
Participant 1Participant 2Participant 3Participant 4Participant 5Participant 6Participant 7Participant 8Participant 9
Apalutamide Combined With Docetaxel22.44.221.216.81.89.010.15.912.2

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Complete Response (CR) Rate After Cyclophosphamide, Doxorubicin, Etoposide, Prednisone, and Brentuximab Vedotin (CHEP-BV) Induction Therapy

CR rate was estimated by the proportion of evaluable patients achieving CR after CHEP-BV induction therapy, along with the 95% exact binomial confidence interval. (NCT03113500)
Timeframe: Up to the end of the CHEP-BV treatment

Interventionpercentage of response rate (Number)
Treatment (CHEP-BV)79

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Overall Survival at 1 Year

Overall survival (OS) was measured from enrollment to death from any cause. OS was estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error. (NCT03113500)
Timeframe: The time from enrollment to death from any cause assessed up to 1 year.

Interventionpercentage of survival probability (Number)
Treatment (CHEP-BV)91

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Incidence Rate of aGVHD Flares

(NCT03139604)
Timeframe: up to day 100

Interventionparticipants (Number)
Itacitinib Plus Corticosteroids42
Placebo Plus Corticosteroids48

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Failure-free Survival

Defined as the proportion of subjects who are still alive, have not relapsed, have not required additional therapy for aGVHD, and have not demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD) (NCT03139604)
Timeframe: 6 months from randomization

Interventionproportion of participants (Number)
Itacitinib Plus Corticosteroids44.29
Placebo Plus Corticosteroids40.00

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Duration of Response

Defined as the interval from first response until GVHD progression or death. (NCT03139604)
Timeframe: Baseline through 30-35 days after end of treatment, total particpation expected to average 24 months

Interventiondays (Median)
Itacitinib Plus Corticosteroids587
Placebo Plus CorticosteroidsNA

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Time to Response

Defined as the interval from treatment initiation to first response (NCT03139604)
Timeframe: End of Study, total particpation expected to average 24 months

Interventiondays (Mean)
Itacitinib Plus Corticosteroids9.9
Placebo Plus Corticosteroids10.1

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Number of Treatment-emergent Adverse Events With INCB39110

Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study treatment (NCT03139604)
Timeframe: 30-35 days after end of treatment, approximately 24 months

Interventionparticipants (Number)
Itacitinib Plus Corticosteroids208
Placebo Plus Corticosteroids214

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Cmin of Itacitinib When Administered in Combination With Corticosteroids

Defined as minimum observed plasma concentration. (NCT03139604)
Timeframe: Protocol-defined timepoints up to Day 28

InterventionnM (Mean)
Itacitinib Plus Corticosteroids72.5

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Cmax of Itacitinib When Administered in Combination With Corticosteroids

Defined as maximum observed plasma concentration. (NCT03139604)
Timeframe: Protocol-defined timepoints up to Day 28

InterventionnM (Mean)
Itacitinib Plus Corticosteroids796

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CL/F of Itacitinib When Administered in Combination With Corticosteroids

Defined as oral dose clearance. (NCT03139604)
Timeframe: Protocol-defined timepoints up to Day 28

InterventionL/h (Mean)
Itacitinib Plus Corticosteroids104

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AUC of Itacitinib When Administered in Combination With Corticosteroids

Defined as area under the concentration-time curve. (NCT03139604)
Timeframe: Protocol-defined timepoints up to Day 28

InterventionnM*h (Mean)
Itacitinib Plus Corticosteroids6720

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Proportion of Subjects Who Discontinue Corticosteroids

Average and cumulative corticosteroid dose usage will be calculated and proportion of subjects discontinuing corticosteroids will be tabulated (NCT03139604)
Timeframe: Days 28, 56, 100, and 180

,
Interventionparticipants (Number)
Day 28Day 56Day 100Day 180
Itacitinib Plus Corticosteroids3163939
Placebo Plus Corticosteroids3114545

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Objective Response Rate

(NCT03139604)
Timeframe: Days 14, 56 and 100

,
Interventionparticipants (Number)
Day 14Day 56Day 100
Itacitinib Plus Corticosteroids17013892
Placebo Plus Corticosteroids16012496

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Nonrelapse Mortality

Defined as the percentage of participants who died due to causes other than malignancy relapse. (NCT03139604)
Timeframe: Month 6,9,12 and 24

,
Interventionparticipants (Number)
6 Months9 Months12 Months24 Months
Itacitinib Plus Corticosteroids36465156
Placebo Plus Corticosteroids37455252

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Incidence Rate of cGVHD

(NCT03139604)
Timeframe: Days 180 and 365

,
Interventionparticipants (Number)
Day 180Day 365
Itacitinib Plus Corticosteroids2543
Placebo Plus Corticosteroids3658

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Tmax of Itacitinib When Administered in Combination With Corticosteroids

Defined as time to maximum plasma concentration. (NCT03139604)
Timeframe: Protocol-defined timepoints up to Day 28

Interventionhrs (Median)
Itacitinib Plus Corticosteroids2.1

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Relapse Rate of Malignant and Nonmalignant Hematologic Disease

Defined as the proportion of subjects whose underlying hematologic disease relapses (NCT03139604)
Timeframe: Randomization through end of Study, study duration expected to average 24 months

Interventionpercentage (Number)
Itacitinib Plus Corticosteroids12.4
Placebo Plus Corticosteroids11.4

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Overall Survival (OS)

Defined as the interval from study enrollment to death due to any cause. (NCT03139604)
Timeframe: End of Study up to approximately 24 months

Interventiondays (Median)
Itacitinib Plus Corticosteroids365
Placebo Plus Corticosteroids348.5

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Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response Index

Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR). (NCT03139604)
Timeframe: Day 28

InterventionPercentage of Participants (Number)
Itacitinib Plus Corticosteroids74.0
Placebo Plus Corticosteroids66.4

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Proportion of Subjects Who Discontinue Immunosuppressive Medications

Summary statistics of subjects discontinuing immunosuppressive medications will be calculated (NCT03139604)
Timeframe: Days 56 and 100

,
Interventionparticipants (Number)
Day 56Day 100
Itacitinib Plus Corticosteroids1211
Placebo Plus Corticosteroids108

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Incidence Rate of Secondary Graft Failure

Defined as > 95% recipient cells any time after engraftment with no signs of relapse, OR retransplantation because of secondary neutropenia (< 0.5 × 109/L) and/or thrombocytopenia (< 20 × 109/L) within 2 months of transplantion (NCT03139604)
Timeframe: Randomization through end of Study, study duration expected to average 24 months

Interventionparticipants (Number)
Itacitinib Plus Corticosteroids2
Placebo Plus Corticosteroids0

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Number of Participants With AEs Leading to Any Dose Reduction or Delays Until End of the Study

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of Participants with AEs leading to any dose reduction or delays from start of the treatment until end of the study were reported. (NCT03150056)
Timeframe: Up to 3 years and 11 months

,,,,,
InterventionParticipants (Count of Participants)
Dose reductionDose delay
GSK525762 40 mg+Abiraterone 1000 mg04
GSK525762 60 mg Alternate+Abiraterone 1000 mg12
GSK525762 60 mg Alternate+Enzalutamide 160 mg712
GSK525762 60 mg+Abiraterone 1000 mg45
GSK525762 60 mg+Enzalutamide 160 mg1015
GSK525762 80 mg+Enzalutamide 160 mg78

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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)

EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included 5 functional scales (physical functioning, role functioning, cognitive functioning, emotional functioning and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhea, insomnia, dyspnea, appetite loss and financial difficulties). Response options for GHS/QoL range from 1 to 4, where 1=not at all and 4=very much. Scores were averaged and transformed to a 0 to 100 scale, with higher scores representing a high QoL. Baseline is defined as the latest non-missing assessment time-point prior to the first study treatment dose. Change from Baseline was calculated as post-Baseline visit value minus Baseline value. (NCT03150056)
Timeframe: Baseline (Week 1 Day 1, pre-dose) and on Day 1 of Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 61

InterventionScores on a scale (Mean)
Week 1 Day 1,n=1,0,0,0,2,0Week 2 Day 1,n=6,1,2,4,4,8Week 3 Day 1,n=6,0,1,4,3,7Week 4 Day 1,n=6,1,2,3,6,10Week 5 Day 1,n=3,0,1,3,5,9Week 9 Day 1,n=2,0,1,2,3,6Week 13 Day 1,n=1,1,1,1,2,3Week 17 Day 1,n=1,1,1,1,1,3Week 33 Day 1,n=0,0,1,0,1,2
GSK525762 60 mg+Enzalutamide 160 mg4.20.02.81.40.0-30.6-8.30.00.0

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Cmax of Abiraterone

Blood samples were collected at indicated time points for PK analysis of abiraterone. PK parameters were calculated using standard non-compartmental analysis. (NCT03150056)
Timeframe: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3

,,
InterventionNanogram per milliliter (Geometric Mean)
Week 1 Day 1, n=10,5,4Week 3 Day 1, n=4,4,2
GSK525762 40 mg+Abiraterone 1000 mg122.496146.924
GSK525762 60 mg Alternate+Abiraterone 1000 mg63.36987.554
GSK525762 60 mg+Abiraterone 1000 mg77.962149.673

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Ctrough of Enzalutamide

Blood samples were collected at indicated time points for PK analysis of enzalutamide. PK parameters were calculated using standard non-compartmental analysis. (NCT03150056)
Timeframe: Pre-dose on Day 1 of Weeks 1, 3, 5, 9, 17 and 25

,,
InterventionMicrogram per milliliter (Geometric Mean)
Week 1 Day 1, Pre-dose, n=9,20,18Week 3 Day 1, Pre-dose, n=9,19,13Week 5 Day 1, Pre-dose, n=10,15,18Week 9 Day 1, Pre-dose, n=6,6,13Week 17 Day 1, Pre-dose, n=4,2,4Week 25 Day 1, Pre-dose, n=2,2,2
GSK525762 60 mg Alternate+Enzalutamide 160 mg14.54611.49712.56112.05610.26713.791
GSK525762 60 mg+Enzalutamide 160 mg13.31310.9029.8148.06412.56813.069
GSK525762 80 mg+Enzalutamide 160 mg13.06610.38510.02610.0218.62110.103

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Maximum Observed Plasma Concentration (Cmax) of GSK525762 and Its Active Metabolites GSK3529246

Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK525762 and GSK3529246 (metabolite of GSK525762). PK parameters were calculated using standard non-compartmental analysis. PK Population consisted of all participants from the All Treated Safety Population for whom a PK sample was obtained and analyzed. (NCT03150056)
Timeframe: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3

,,,,,
InterventionNanogram per milliliter (Geometric Mean)
GSK525762:Week1 Day1,n=10,6,4,10,21,18GSK525762:Week3 Day1,n=4,3,3,9,17,10GSK3529246:Week1 Day1,n=10,6,4,10,21,18GSK3529246:Week3 Day1,n=4,3,3,10,17,10
GSK525762 40 mg+Abiraterone 1000 mg671.129559.711199.456364.151
GSK525762 60 mg Alternate+Abiraterone 1000 mg993.154735.171318.772444.232
GSK525762 60 mg Alternate+Enzalutamide 160 mg336.296171.527323.685356.615
GSK525762 60 mg+Abiraterone 1000 mg950.319891.302280.892447.929
GSK525762 60 mg+Enzalutamide 160 mg333.256158.409321.750328.398
GSK525762 80 mg+Enzalutamide 160 mg427.580284.298408.208449.614

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Number of Participants With AEs Leading to Any Dose Reduction or Delays

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs leading to any dose reduction or delays have been presented. (NCT03150056)
Timeframe: Up to 21.3 months

,,,,,
InterventionParticipants (Count of Participants)
Dose reductionDose delay
GSK525762 40 mg+Abiraterone 1000 mg04
GSK525762 60 mg Alternate+Abiraterone 1000 mg12
GSK525762 60 mg Alternate+Enzalutamide 160 mg712
GSK525762 60 mg+Abiraterone 1000 mg45
GSK525762 60 mg+Enzalutamide 160 mg1015
GSK525762 80 mg+Enzalutamide 160 mg78

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Number of Participants Who Withdrew Due to Toxicity and Changes in Safety Assessment Until End of the Study

Number of participants who withdrew due to toxicity and changes in safety assessment including laboratory parameters and vital signs from start of the treatment until end of the study were reported. (NCT03150056)
Timeframe: Up to 3 years and 11 months

InterventionParticipants (Count of Participants)
GSK525762 60 mg+Abiraterone 1000 mg6
GSK525762 60 mg Alternate+Abiraterone 1000 mg2
GSK525762 40 mg+Abiraterone 1000 mg2
GSK525762 80 mg+Enzalutamide 160 mg3
GSK525762 60 mg+Enzalutamide 160 mg8
GSK525762 60 mg Alternate+Enzalutamide 160 mg4

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Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Until End of the Study

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgement, or is associated with liver injury and impaired liver function. Number of Participants With any AEs and SAEs collected from start of the treatment until end of the study were reported. (NCT03150056)
Timeframe: Up to 3 years and 11 months

,,,,,
InterventionParticipants (Count of Participants)
Any AEsAny SAEs
GSK525762 40 mg+Abiraterone 1000 mg40
GSK525762 60 mg Alternate+Abiraterone 1000 mg62
GSK525762 60 mg Alternate+Enzalutamide 160 mg217
GSK525762 60 mg+Abiraterone 1000 mg104
GSK525762 60 mg+Enzalutamide 160 mg226
GSK525762 80 mg+Enzalutamide 160 mg101

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Number of Participants With Worst-Case Post Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status

Performance status assessments were based on 6-point ECOG scale (from 0 to 5), where 0=fully active, able to carry on all pre-disease performance without restriction; 1=restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (e.g., light house work, office work); 2=ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3=capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed or chair; and 5=dead. Data for worst case post-Baseline is presented. (NCT03150056)
Timeframe: Up to 21.3 months

,,,,,
InterventionParticipants (Count of Participants)
012345
GSK525762 40 mg+Abiraterone 1000 mg030100
GSK525762 60 mg Alternate+Abiraterone 1000 mg042000
GSK525762 60 mg Alternate+Enzalutamide 160 mg1136100
GSK525762 60 mg+Abiraterone 1000 mg271000
GSK525762 60 mg+Enzalutamide 160 mg1163100
GSK525762 80 mg+Enzalutamide 160 mg253000

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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)

EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included 5 functional scales (physical functioning, role functioning, cognitive functioning, emotional functioning and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhea, insomnia, dyspnea, appetite loss and financial difficulties). Response options for GHS/QoL range from 1 to 4, where 1=not at all and 4=very much. Scores were averaged and transformed to a 0 to 100 scale, with higher scores representing a high QoL. Baseline is defined as the latest non-missing assessment time-point prior to the first study treatment dose. Change from Baseline was calculated as post-Baseline visit value minus Baseline value. (NCT03150056)
Timeframe: Baseline (Week 1 Day 1, pre-dose) and on Day 1 of Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 61

InterventionScores on a scale (Mean)
Week 2 Day 1,n=6,1,2,4,4,8Week 3 Day 1,n=6,0,1,4,3,7Week 4 Day 1,n=6,1,2,3,6,10Week 5 Day 1,n=3,0,1,3,5,9Week 9 Day 1,n=2,0,1,2,3,6Week 13 Day 1,n=1,1,1,1,2,3Week 17 Day 1,n=1,1,1,1,1,3Week 21 Day 1,n=0,0,1,1,0,2
GSK525762 80 mg+Enzalutamide 160 mg-2.1-4.25.6-5.6-20.80.00.00.0

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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)

EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included 5 functional scales (physical functioning, role functioning, cognitive functioning, emotional functioning and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhea, insomnia, dyspnea, appetite loss and financial difficulties). Response options for GHS/QoL range from 1 to 4, where 1=not at all and 4=very much. Scores were averaged and transformed to a 0 to 100 scale, with higher scores representing a high QoL. Baseline is defined as the latest non-missing assessment time-point prior to the first study treatment dose. Change from Baseline was calculated as post-Baseline visit value minus Baseline value. (NCT03150056)
Timeframe: Baseline (Week 1 Day 1, pre-dose) and on Day 1 of Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 61

InterventionScores on a scale (Mean)
Week 1 Day 1,n=1,0,0,0,2,0Week 2 Day 1,n=6,1,2,4,4,8Week 3 Day 1,n=6,0,1,4,3,7Week 4 Day 1,n=6,1,2,3,6,10Week 5 Day 1,n=3,0,1,3,5,9Week 9 Day 1,n=2,0,1,2,3,6Week 13 Day 1,n=1,1,1,1,2,3Week 17 Day 1,n=1,1,1,1,1,3
GSK525762 60 mg+Abiraterone 1000 mg8.3-8.3-8.3-8.3-8.3-12.5-25.0-25.0

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Cmax of Enzalutamide

Blood samples were collected at indicated time points for PK analysis of enzalutamide. PK parameters were calculated using standard non-compartmental analysis. (NCT03150056)
Timeframe: Pre-dose on Day 1 of Weeks 1, 3, 5, 9, 17 and 25

InterventionMicrogram per milliliter (Geometric Mean)
GSK525762 80 mg+Enzalutamide 160 mgNA
GSK525762 60 mg+Enzalutamide 160 mgNA
GSK525762 60 mg Alternate+Enzalutamide 160 mgNA

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Circulating Tumor Cells (CTC) Response Rate

CTC response rate is defined as the percentage of participants with a CTC conversion to <5/7.5 mL blood at nadir (confirmed by a second consecutive value obtained four or more weeks later) for participants with unfavourable CTC (>=5/7.5 mL) at Baseline. CI was computed using exact two sided 95% CI. (NCT03150056)
Timeframe: Up to 21.3 months

InterventionPercentage of participants (Number)
GSK525762 60 mg+Abiraterone 1000 mg0
GSK525762 60 mg Alternate+Abiraterone 1000 mg0
GSK525762 80 mg+Enzalutamide 160 mg33
GSK525762 60 mg+Enzalutamide 160 mg8
GSK525762 60 mg Alternate+Enzalutamide 160 mg0

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AUC(0-tau) of Enzalutamide

Blood samples were collected at indicated time points for PK analysis of enzalutamide. PK parameters were calculated using standard non-compartmental analysis. (NCT03150056)
Timeframe: Pre-dose on Day 1 of Weeks 1, 3, 5, 9, 17 and 25

InterventionHours*microgram per milliliter (Geometric Mean)
GSK525762 80 mg+Enzalutamide 160 mgNA
GSK525762 60 mg+Enzalutamide 160 mgNA
GSK525762 60 mg Alternate+Enzalutamide 160 mgNA

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Ctrough of Abiraterone

Blood samples were collected at indicated time points for PK analysis of abiraterone. PK parameters were calculated using standard non-compartmental analysis. (NCT03150056)
Timeframe: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3

,,
InterventionNanogram per milliliter (Geometric Mean)
Week 1 Day 1, n=9,2,3Week 3 Day 1, n=2,4,1
GSK525762 40 mg+Abiraterone 1000 mg11.26321.800
GSK525762 60 mg Alternate+Abiraterone 1000 mg4.6367.697
GSK525762 60 mg+Abiraterone 1000 mg7.60315.114

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Prostate-specific Antigen (PSA) Response Rate at Week 4

PSA Response Rate is defined as percentage of participants achieving >=30% decrease from Baseline PSA after 4 weeks of study treatment. The CI was calculated using exact two sided 95% CI for the percentage of participants with Baseline PSA values who show >=30% reduction in PSA at >=4 weeks post-Baseline. (NCT03150056)
Timeframe: Week 4

InterventionPercentage of participants (Number)
GSK525762 60 mg+Abiraterone 1000 mg0
GSK525762 60 mg Alternate+Abiraterone 1000 mg17
GSK525762 40 mg+Abiraterone 1000 mg0
GSK525762 80 mg+Enzalutamide 160 mg0
GSK525762 60 mg+Enzalutamide 160 mg0
GSK525762 60 mg Alternate+Enzalutamide 160 mg0

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Radiographic Progression-free Survival (rPFS)

rPFS is defined as the time from study treatment start until the first date of either disease progression or death due to any cause. The date of disease progression is defined as the earliest date of disease progression as assessed by the investigator using PCWG3-modified RECIST, version 1.1 or progression on bone scan. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. (NCT03150056)
Timeframe: Up to 21.3 montths

InterventionDays (Median)
GSK525762 60 mg+Abiraterone 1000 mg53.0
GSK525762 60 mg Alternate+Abiraterone 1000 mgNA
GSK525762 40 mg+Abiraterone 1000 mgNA
GSK525762 80 mg+Enzalutamide 160 mg416.0
GSK525762 60 mg+Enzalutamide 160 mg141.0
GSK525762 60 mg Alternate+Enzalutamide 160 mg330.0

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Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgement, or is associated with liver injury and impaired liver function. (NCT03150056)
Timeframe: Up to 21.3 months

,,,,,
InterventionParticipants (Count of Participants)
Any AEsAny SAEs
GSK525762 40 mg+Abiraterone 1000 mg40
GSK525762 60 mg Alternate+Abiraterone 1000 mg62
GSK525762 60 mg Alternate+Enzalutamide 160 mg217
GSK525762 60 mg+Abiraterone 1000 mg104
GSK525762 60 mg+Enzalutamide 160 mg226
GSK525762 80 mg+Enzalutamide 160 mg101

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Number of Participants Who Withdrew Due to Toxicity and Changes in Safety Assessment

Number of participants who withdrew due to toxicity and changes in safety assessment including laboratory parameters and vital signs have been presented. (NCT03150056)
Timeframe: Up to 21.3 months

InterventionParticipants (Count of Participants)
GSK525762 60 mg+Abiraterone 1000 mg6
GSK525762 60 mg Alternate+Abiraterone 1000 mg2
GSK525762 40 mg+Abiraterone 1000 mg2
GSK525762 80 mg+Enzalutamide 160 mg3
GSK525762 60 mg+Enzalutamide 160 mg8
GSK525762 60 mg Alternate+Enzalutamide 160 mg4

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Tmax of Enzalutamide

Blood samples were collected at indicated time points for PK analysis of enzalutamide. PK parameters were calculated using standard non-compartmental analysis. (NCT03150056)
Timeframe: Pre-dose on Day 1 of Weeks 1, 3, 5, 9, 17 and 25

InterventionHours (Median)
GSK525762 80 mg+Enzalutamide 160 mgNA
GSK525762 60 mg+Enzalutamide 160 mgNA
GSK525762 60 mg Alternate+Enzalutamide 160 mgNA

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Time to Cmax (Tmax) of GSK525762 and Its Active Metabolites GSK3529246

Blood samples were collected at indicated time points for PK analysis of GSK525762 and GSK3529246 (metabolite of GSK525762). PK parameters were calculated using standard non-compartmental analysis. (NCT03150056)
Timeframe: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3

,,,,,
InterventionHours (Median)
GSK525762:Week1 Day1,n=10,6,4,10,21,18GSK525762:Week3 Day1,n=4,3,3,9,17,10GSK3529246:Week1 Day1,n=10,6,4,10,21,18GSK3529246:Week3 Day1,n=4,3,3,10,17,10
GSK525762 40 mg+Abiraterone 1000 mg1.0000.9502.0423.000
GSK525762 60 mg Alternate+Abiraterone 1000 mg0.5581.0003.0003.000
GSK525762 60 mg Alternate+Enzalutamide 160 mg0.7420.5171.8171.875
GSK525762 60 mg+Abiraterone 1000 mg0.8000.5003.0001.000
GSK525762 60 mg+Enzalutamide 160 mg1.0000.9332.9171.017
GSK525762 80 mg+Enzalutamide 160 mg0.5080.5832.0671.042

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Tmax of Abiraterone

Blood samples were collected at indicated time points for PK analysis of abiraterone. PK parameters were calculated using standard non-compartmental analysis. (NCT03150056)
Timeframe: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3

,,
InterventionHours (Median)
Week 1 Day 1, n=10,5,4Week 3 Day 1, n=4,4,2
GSK525762 40 mg+Abiraterone 1000 mg0.7503.017
GSK525762 60 mg Alternate+Abiraterone 1000 mg1.0832.000
GSK525762 60 mg+Abiraterone 1000 mg1.1331.000

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Trough Concentration (Ctrough) of GSK525762 and Its Active Metabolites GSK3529246

Blood samples were collected at indicated time points for PK analysis of GSK525762 and GSK3529246 (metabolite of GSK525762). PK parameters were calculated using standard non-compartmental analysis. (NCT03150056)
Timeframe: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3

,
InterventionNanogram per milliliter (Geometric Mean)
GSK525762:Week1 Day1,n=8,2,3,1,3,4GSK3529246:Week1 Day1,n=8,3,3,9,20,17GSK3529246:Week3 Day1,n=3,3,2,7,13,8
GSK525762 60 mg Alternate+Enzalutamide 160 mg1.66038.20026.165
GSK525762 60 mg+Enzalutamide 160 mg5.05337.76532.299

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Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUC[0-tau]) of GSK525762 and Its Active Metabolites GSK3529246

Blood samples were collected at indicated time points for PK analysis of GSK525762 and GSK3529246 (metabolite of GSK525762). PK parameters were calculated using standard non-compartmental analysis. (NCT03150056)
Timeframe: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3

InterventionHours*nanogram per milliliter (Geometric Mean)
GSK525762:Week1 Day1,n=8,2,2,6,9,8GSK525762:Week3 Day1,n=4,1,3,5,6,6GSK3529246:Week3 Day1,n=2,2,2,4,12,7
GSK525762 40 mg+Abiraterone 1000 mg4172.2821561.9084598.235

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Disease Control Rate at Week 24

Disease control rate (DCR) is defined as the percentage of participants with >=1 post-Baseline disease assessment who showed either a confirmed complete response (CR), partial response (PR) or stable disease (SD) observed at >=24 weeks per prostate cancer working group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; where CR: disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeter in the short axis; PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive diseases. Confidence interval (CI) was computed using exact two sided 95% CI. (NCT03150056)
Timeframe: Week 24

InterventionPercentage of participants (Number)
GSK525762 60 mg+Abiraterone 1000 mg0
GSK525762 60 mg Alternate+Abiraterone 1000 mg40
GSK525762 40 mg+Abiraterone 1000 mg50
GSK525762 80 mg+Enzalutamide 160 mg40
GSK525762 60 mg+Enzalutamide 160 mg11
GSK525762 60 mg Alternate+Enzalutamide 160 mg29

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Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUC[0-tau]) of GSK525762 and Its Active Metabolites GSK3529246

Blood samples were collected at indicated time points for PK analysis of GSK525762 and GSK3529246 (metabolite of GSK525762). PK parameters were calculated using standard non-compartmental analysis. (NCT03150056)
Timeframe: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3

,,,,
InterventionHours*nanogram per milliliter (Geometric Mean)
GSK525762:Week1 Day1,n=8,2,2,6,9,8GSK525762:Week3 Day1,n=4,1,3,5,6,6GSK3529246:Week1 Day1,n=2,1,0,5,9,10GSK3529246:Week3 Day1,n=2,2,2,4,12,7
GSK525762 60 mg Alternate+Abiraterone 1000 mg4677.4112580.8774918.5495146.749
GSK525762 60 mg Alternate+Enzalutamide 160 mg959.452386.9503306.0183082.516
GSK525762 60 mg+Abiraterone 1000 mg4927.8342697.9233765.1964170.516
GSK525762 60 mg+Enzalutamide 160 mg1261.529660.6073373.9903386.702
GSK525762 80 mg+Enzalutamide 160 mg1139.481674.4374379.3423816.407

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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)

EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included 5 functional scales (physical functioning, role functioning, cognitive functioning, emotional functioning and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhea, insomnia, dyspnea, appetite loss and financial difficulties). Response options for GHS/QoL range from 1 to 4, where 1=not at all and 4=very much. Scores were averaged and transformed to a 0 to 100 scale, with higher scores representing a high QoL. Baseline is defined as the latest non-missing assessment time-point prior to the first study treatment dose. Change from Baseline was calculated as post-Baseline visit value minus Baseline value. (NCT03150056)
Timeframe: Baseline (Week 1 Day 1, pre-dose) and on Day 1 of Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 61

InterventionScores on a scale (Mean)
Week 2 Day 1,n=6,1,2,4,4,8Week 4 Day 1,n=6,1,2,3,6,10Week 13 Day 1,n=1,1,1,1,2,3Week 17 Day 1,n=1,1,1,1,1,3
GSK525762 60 mg Alternate+Abiraterone 1000 mg16.716.78.3-16.7

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Time to Disease Progression

Time to disease progression is defined as the time from date of first dose of study treatment to date of disease progression defined as one or more of the following criteria: 1. Radiographic progression by PCWG3-modified RECIST version 1.1 for participants with measurable disease, 2. Bone progression on bone scan according to the PCGW3 criteria, 3. PSA progression according to the PCWG3 criteria accompanied by any one of the following: investigator-defined clinical progression or either of the above RECIST version 1.1 radiographic progression or bone progression. (NCT03150056)
Timeframe: Up to 21.3 months

InterventionDays (Median)
GSK525762 60 mg+Abiraterone 1000 mg88.0
GSK525762 60 mg Alternate+Abiraterone 1000 mgNA
GSK525762 40 mg+Abiraterone 1000 mgNA
GSK525762 80 mg+Enzalutamide 160 mg87.0
GSK525762 60 mg+Enzalutamide 160 mg86.0
GSK525762 60 mg Alternate+Enzalutamide 160 mg84.0

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Objective Response Rate

Objective response rate (ORR) is defined as the percentage of participants with a confirmed CR or PR at any time as per PCWG3-modified RECIST version 1.1; where CR: Disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeter (mm) in the short axis and PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. (NCT03150056)
Timeframe: Up to 21.3 months

InterventionPercentage of participants (Number)
GSK525762 60 mg+Abiraterone 1000 mg0
GSK525762 60 mg Alternate+Abiraterone 1000 mg0
GSK525762 40 mg+Abiraterone 1000 mg0
GSK525762 80 mg+Enzalutamide 160 mg0
GSK525762 60 mg+Enzalutamide 160 mg0
GSK525762 60 mg Alternate+Enzalutamide 160 mg0

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Trough Concentration (Ctrough) of GSK525762 and Its Active Metabolites GSK3529246

Blood samples were collected at indicated time points for PK analysis of GSK525762 and GSK3529246 (metabolite of GSK525762). PK parameters were calculated using standard non-compartmental analysis. (NCT03150056)
Timeframe: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3

,,,
InterventionNanogram per milliliter (Geometric Mean)
GSK525762:Week1 Day1,n=8,2,3,1,3,4GSK525762:Week3 Day1,n=2,2,2,1,0,0GSK3529246:Week1 Day1,n=8,3,3,9,20,17GSK3529246:Week3 Day1,n=3,3,2,7,13,8
GSK525762 40 mg+Abiraterone 1000 mg13.6641.41042.10763.526
GSK525762 60 mg Alternate+Abiraterone 1000 mg8.6964.55568.37948.291
GSK525762 60 mg+Abiraterone 1000 mg22.4188.96658.99548.223
GSK525762 80 mg+Enzalutamide 160 mg2.1003.54046.01150.882

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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)

EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included 5 functional scales (physical functioning, role functioning, cognitive functioning, emotional functioning and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhea, insomnia, dyspnea, appetite loss and financial difficulties). Response options for GHS/QoL range from 1 to 4, where 1=not at all and 4=very much. Scores were averaged and transformed to a 0 to 100 scale, with higher scores representing a high QoL. Baseline is defined as the latest non-missing assessment time-point prior to the first study treatment dose. Change from Baseline was calculated as post-Baseline visit value minus Baseline value. (NCT03150056)
Timeframe: Baseline (Week 1 Day 1, pre-dose) and on Day 1 of Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 61

InterventionScores on a scale (Mean)
Week 2 Day 1,n=6,1,2,4,4,8Week 3 Day 1,n=6,0,1,4,3,7Week 4 Day 1,n=6,1,2,3,6,10Week 5 Day 1,n=3,0,1,3,5,9Week 9 Day 1,n=2,0,1,2,3,6Week 13 Day 1,n=1,1,1,1,2,3Week 17 Day 1,n=1,1,1,1,1,3Week 21 Day 1,n=0,0,1,1,0,2Week 25 Day 1,n=0,0,1,0,0,1Week 33 Day 1,n=0,0,1,0,1,2Week 37 Day 1,n=0,0,1,0,0,3Week 41 Day 1,n=0,0,1,0,0,0Week 45 Day 1,n=0,0,1,0,0,1Week 49 Day 1,n=0,0,1,0,0,2Week 61 Day 1,n=0,0,1,0,0,1
GSK525762 40 mg+Abiraterone 1000 mg-12.5-16.70.08.3-8.30.016.716.70.08.30.08.3-8.316.716.7

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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): Global Health Status (GHS)

EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included 5 functional scales (physical functioning, role functioning, cognitive functioning, emotional functioning and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhea, insomnia, dyspnea, appetite loss and financial difficulties). Response options for GHS/QoL range from 1 to 4, where 1=not at all and 4=very much. Scores were averaged and transformed to a 0 to 100 scale, with higher scores representing a high QoL. Baseline is defined as the latest non-missing assessment time-point prior to the first study treatment dose. Change from Baseline was calculated as post-Baseline visit value minus Baseline value. (NCT03150056)
Timeframe: Baseline (Week 1 Day 1, pre-dose) and on Day 1 of Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 61

InterventionScores on a scale (Mean)
Week 2 Day 1,n=6,1,2,4,4,8Week 3 Day 1,n=6,0,1,4,3,7Week 4 Day 1,n=6,1,2,3,6,10Week 5 Day 1,n=3,0,1,3,5,9Week 9 Day 1,n=2,0,1,2,3,6Week 13 Day 1,n=1,1,1,1,2,3Week 17 Day 1,n=1,1,1,1,1,3Week 21 Day 1,n=0,0,1,1,0,2Week 25 Day 1,n=0,0,1,0,0,1Week 29 Day 1,n=0,0,0,0,0,2Week 33 Day 1,n=0,0,1,0,1,2Week 37 Day 1,n=0,0,1,0,0,3Week 45 Day 1,n=0,0,1,0,0,1Week 49 Day 1,n=0,0,1,0,0,2Week 61 Day 1,n=0,0,1,0,0,1
GSK525762 60 mg Alternate+Enzalutamide 160 mg-1.0-1.22.5-0.0-12.50.0-11.1-4.2-8.3-8.3-8.3-2.80.0-8.3-16.7

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Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours

BPI-SF is 9-item self-administered questionnaire. Pain intensity score was calculated from the four items (items 3, 4, 5 and 6) for worst pain, least pain, average pain and current pain. Worst pain in last 24 hours was rated from 0 (no pain) to 10 (pain as bad as you can imagine). Baseline is defined as the latest non-missing assessment time-point prior to the first study treatment dose (latest up to Week 1 Day 1). Change from Baseline was calculated as post-Baseline visit value minus Baseline value. (NCT03150056)
Timeframe: Baseline (Pre-dose on Week 1 Day 1) and on Day 1 of Weeks 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 61, 73, 85, 97

,
InterventionScores on a scale (Mean)
Week 2 Day 1,n=9,5,4,9,14,13Week 3 Day 1,n=8,3,4,10,16,15Week 4 Day 1,n=8,4,3,8,16,15Week 5 Day 1,n=6,4,4,10,19,17Week 9 Day 1,n=3,4,3,8,10,13Week 13 Day 1,n=2,3,1,5,7,7Week 17 Day 1,n=2,4,2,5,3,8Week 21 Day 1,n=1,2,2,5,3,6
GSK525762 60 mg Alternate+Abiraterone 1000 mg0.8-1.70.5-0.31.32.03.50.5
GSK525762 60 mg+Abiraterone 1000 mg0.10.50.4-0.81.30.52.52.0

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Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours

BPI-SF is 9-item self-administered questionnaire. Pain intensity score was calculated from the four items (items 3, 4, 5 and 6) for worst pain, least pain, average pain and current pain. Worst pain in last 24 hours was rated from 0 (no pain) to 10 (pain as bad as you can imagine). Baseline is defined as the latest non-missing assessment time-point prior to the first study treatment dose (latest up to Week 1 Day 1). Change from Baseline was calculated as post-Baseline visit value minus Baseline value. (NCT03150056)
Timeframe: Baseline (Pre-dose on Week 1 Day 1) and on Day 1 of Weeks 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 61, 73, 85, 97

InterventionScores on a scale (Mean)
Week 2 Day 1,n=9,5,4,9,14,13Week 3 Day 1,n=8,3,4,10,16,15Week 4 Day 1,n=8,4,3,8,16,15Week 5 Day 1,n=6,4,4,10,19,17Week 9 Day 1,n=3,4,3,8,10,13Week 13 Day 1,n=2,3,1,5,7,7Week 17 Day 1,n=2,4,2,5,3,8Week 21 Day 1,n=1,2,2,5,3,6Week 25 Day 1,n=0,0,1,2,3,4Week 29 Day 1,n=0,0,1,3,2,4Week 33 Day 1,n=0,0,1,3,2,2Week 41 Day 1,n=0,0,1,3,1,1Week 45 Day 1,n=0,0,1,2,1,3Week 49 Day 1,n=0,0,1,3,1,3Week 61 Day 1,n=0,0,1,1,1,1Week 73 Day 1,n=0,0,0,1,1,0Week 85 Day 1,n=0,0,0,1,1,0Week 97 Day 1,n=0,0,0,0,1,0
GSK525762 60 mg+Enzalutamide 160 mg0.00.30.20.70.2-1.7-1.3-2.3-1.3-3.5-1.5-3.0-1.0-3.0-3.0-2.0-3.0-3.0

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Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours

BPI-SF is 9-item self-administered questionnaire. Pain intensity score was calculated from the four items (items 3, 4, 5 and 6) for worst pain, least pain, average pain and current pain. Worst pain in last 24 hours was rated from 0 (no pain) to 10 (pain as bad as you can imagine). Baseline is defined as the latest non-missing assessment time-point prior to the first study treatment dose (latest up to Week 1 Day 1). Change from Baseline was calculated as post-Baseline visit value minus Baseline value. (NCT03150056)
Timeframe: Baseline (Pre-dose on Week 1 Day 1) and on Day 1 of Weeks 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 61, 73, 85, 97

InterventionScores on a scale (Mean)
Week 2 Day 1,n=9,5,4,9,14,13Week 3 Day 1,n=8,3,4,10,16,15Week 4 Day 1,n=8,4,3,8,16,15Week 5 Day 1,n=6,4,4,10,19,17Week 9 Day 1,n=3,4,3,8,10,13Week 13 Day 1,n=2,3,1,5,7,7Week 17 Day 1,n=2,4,2,5,3,8Week 21 Day 1,n=1,2,2,5,3,6Week 25 Day 1,n=0,0,1,2,3,4Week 29 Day 1,n=0,0,1,3,2,4Week 33 Day 1,n=0,0,1,3,2,2Week 37 Day 1,n=0,0,1,3,0,4Week 41 Day 1,n=0,0,1,3,1,1Week 45 Day 1,n=0,0,1,2,1,3Week 49 Day 1,n=0,0,1,3,1,3Week 61 Day 1,n=0,0,1,1,1,1Week 73 Day 1,n=0,0,0,1,1,0Week 85 Day 1,n=0,0,0,1,1,0
GSK525762 80 mg+Enzalutamide 160 mg0.0-1.0-0.8-0.9-0.50.2-0.8-0.20.0-0.70.71.71.32.50.30.00.03.0

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Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF): Pain Intensity- Pain at Worst in Last 24 Hours

BPI-SF is 9-item self-administered questionnaire. Pain intensity score was calculated from the four items (items 3, 4, 5 and 6) for worst pain, least pain, average pain and current pain. Worst pain in last 24 hours was rated from 0 (no pain) to 10 (pain as bad as you can imagine). Baseline is defined as the latest non-missing assessment time-point prior to the first study treatment dose (latest up to Week 1 Day 1). Change from Baseline was calculated as post-Baseline visit value minus Baseline value. (NCT03150056)
Timeframe: Baseline (Pre-dose on Week 1 Day 1) and on Day 1 of Weeks 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 61, 73, 85, 97

,
InterventionScores on a scale (Mean)
Week 2 Day 1,n=9,5,4,9,14,13Week 3 Day 1,n=8,3,4,10,16,15Week 4 Day 1,n=8,4,3,8,16,15Week 5 Day 1,n=6,4,4,10,19,17Week 9 Day 1,n=3,4,3,8,10,13Week 13 Day 1,n=2,3,1,5,7,7Week 17 Day 1,n=2,4,2,5,3,8Week 21 Day 1,n=1,2,2,5,3,6Week 25 Day 1,n=0,0,1,2,3,4Week 29 Day 1,n=0,0,1,3,2,4Week 33 Day 1,n=0,0,1,3,2,2Week 37 Day 1,n=0,0,1,3,0,4Week 41 Day 1,n=0,0,1,3,1,1Week 45 Day 1,n=0,0,1,2,1,3Week 49 Day 1,n=0,0,1,3,1,3Week 61 Day 1,n=0,0,1,1,1,1
GSK525762 40 mg+Abiraterone 1000 mg-2.3-1.8-1.3-1.0-0.32.0-0.5-2.53.0-3.01.00.0-1.01.02.0-2.0
GSK525762 60 mg Alternate+Enzalutamide 160 mg0.20.00.4-0.2-0.4-0.4-0.51.0-1.00.8-1.00.0-1.01.72.73.0

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AUC(0-tau) of Abiraterone

Blood samples were collected at indicated time points for PK analysis of abiraterone. PK parameters were calculated using standard non-compartmental analysis. (NCT03150056)
Timeframe: Pre-dose, 30 minutes, 1, 3, 6 to 12, 24 hours post-dose on Day 1 of Weeks 1 and 3

,,
InterventionHours*nanogram per milliliter (Geometric Mean)
Week 1 Day 1, n=5,1,1Week 3 Day 1, n=1,2,1
GSK525762 40 mg+Abiraterone 1000 mg1405.8092185.039
GSK525762 60 mg Alternate+Abiraterone 1000 mg148.871595.686
GSK525762 60 mg+Abiraterone 1000 mg432.3681361.627

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Percentage of Participants With Greater Than or Equals to (>=)50 Percent (%) Decrease in Prostate-specific Antigen From Baseline (PSA50)

PSA50 response rate is defined as percentage of participants with a decrease of >=50% in the PSA concentration from the Baseline PSA value determined at least 12 weeks after start of treatment and confirmed >=4 weeks later by an additional PSA evaluation. (NCT03150056)
Timeframe: Up to 21.3 months

InterventionPercentage of participants (Number)
GSK525762 60 mg+Abiraterone 1000 mg0
GSK525762 60 mg Alternate+Abiraterone 1000 mg0
GSK525762 40 mg+Abiraterone 1000 mg0
GSK525762 80 mg+Enzalutamide 160 mg0
GSK525762 60 mg+Enzalutamide 160 mg0
GSK525762 60 mg Alternate+Enzalutamide 160 mg0

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Composite Response Rate

Composite response rate was defined as the percentage of participants with one of the following: a) Response based on PCWG3-modified RECIST version 1.1, b) PSA decrease of >=50% from Baseline at Week 12 and thereafter, or c) Circulating Tumor-cell Count Conversion from unfavorable (>=5/7.5 milliliter [mL]) at Baseline to favorable (<5/7.5 mL) confirmed by a second assessment at least 4 weeks later. If a participant met at least one of the above requirements, then that participant was considered a composite responder. CI was computed using exact two sided 95% CI. (NCT03150056)
Timeframe: Up to 21.3 months

InterventionPercentage of participants (Number)
GSK525762 60 mg+Abiraterone 1000 mg0
GSK525762 60 mg Alternate+Abiraterone 1000 mg0
GSK525762 40 mg+Abiraterone 1000 mg0
GSK525762 80 mg+Enzalutamide 160 mg10
GSK525762 60 mg+Enzalutamide 160 mg5
GSK525762 60 mg Alternate+Enzalutamide 160 mg0

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Percentage of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24

Treatment failure was a participant meeting at least 1 of these criteria in at least 1 eye: New active, inflammatory lesions relative to Day 1/Baseline (all visits starting Week (Wk) 6); Inability to achieve ≤Grade 0.5+ (at Wk 6) or 2-step increase (change of Grade 0 to Grade 2+/Grade 0.5+ to Grade 3+) (all visits after Wk 6) relative to best state (RBS) achieved in Anterior Chamber (AC) cell grade (Standardization of Uveitis Nomenclature [SUN] criteria)[AC cell grades range from 0 (0 cells) to 4+ (>50 cells), higher scores=severe uveitis]; Inability to achieve ≤Grade 0.5+ (at Wk 6) or 2-step increase (all visits after Wk 6) RBS achieved in Vitreous Haze (VH) grade (National Eye Institute [NEI]/SUN criteria)[VH grades range from 0 (no evident VH) to 4+ (optic nerve head is obscured), higher scores=severe uveitis]; Worsening of best corrected visual acuity (BCVA) by ≥15 letters RBS achieved (all visits starting Wk 6), measured by an eye chart, fewer correct letters=severe uveitis. (NCT03207815)
Timeframe: Week 6 through Week 24

Interventionpercentage of participants (Number)
Filgotinib37.5
Placebo67.6

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Time to Development of Macular Edema in At Least One Eye on or After Week 6

Time in weeks until the development of Macular edema or Week 52 or EOT or ET. Macular edema is determined by OCT and is defined as central retinal thickness ≥ 300 microns if using Cirrus machine, or ≥ 315 microns if using Spectralis machine. (NCT03207815)
Timeframe: Week 6 through Week 52

Interventionweeks (Median)
Filgotinib7.8
Placebo12.3

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Change in Anterior Chamber (AC) Cell Grade in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET

The number of AC cells observed within a 1 mm × 1 mm slit beam were recorded for each eye. The reported number was used to determine the grade according to the SUN criteria. AC cell grades range from 0 (0 cells in field) to 4+ (>50 cells in field), with higher scores indicating more cells visible in the AC and greater severity of uveitis. A negative change from best state value obtained prior to Week 6 indicates improvement. (NCT03207815)
Timeframe: Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)

,
Interventionscore (Mean)
Left Eye: Best State Prior to Week 6Right Eye: Best State Prior to Week 6Left Eye: Change From Best State at Week 52/EOT/ETRight Eye: Change From Best State at Week 52/EOT/ET
Filgotinib0.00.00.20.2
Placebo0.10.10.60.7

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Change in Logarithm of the Minimal Angle of Resolution (logMAR) Best Corrected Visual Acuity (BCVA) in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET

BCVA is the best possible vision that an eye can achieve with the set of glasses or contact lenses. A refraction test was performed to measure the appropriate lens strength to focus light on the retina. Using the appropriate corrective lenses based on that visit's refraction, participant's BCVA was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. In the ETDRS system, 15 letters is equal to a change in 3 lines of visual acuity. If the participant is unable to read letters on a testing chart, visual acuity is described as ranging from ability to count fingers, recognize hand movements, or light perception. The smaller BVCA score indicates greater severity of uveitis. A positive change from best state value obtained prior to Week 6 indicates improvement. (NCT03207815)
Timeframe: Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)

,
InterventionlogMAR (Mean)
Left Eye: Best State Prior to Week 6Right Eye: Best State Prior to Week 6Left Eye: Change From Best State at Week 52/EOT/ETRight Eye: Change From Best State at Week 52/EOT/ET
Filgotinib0.090.090.03-0.01
Placebo0.070.120.050.07

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Change in Vitreous Haze (VH) Grade in Each Eye (NEI/SUN Criteria), From Best State Achieved Prior to Week 6 to Week 52 or End of Treatment (EOT) Visit or Early Termination (ET)

Grading of VH was based on the publication from the NEI which has also been adapted by the SUN working group. VH grades range from 0 (no evident VH) to 4+ (optic nerve head is obscured), with higher scores indicating greater severity of uveitis. A negative change from best state value obtained prior to Week 6 indicates improvement. (NCT03207815)
Timeframe: Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)

,
Interventionscore (Mean)
Left Eye: Best State Prior to Week 6Right Eye: Best State Prior to Week 6Left Eye: Change From Best State at Week 52/EOT/ETRight Eye: Change From Best State at Week 52/EOT/ET
Filgotinib0.30.30.10.1
Placebo0.20.30.30.2

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Log Change in Central Retinal Thickness in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET

Central retinal thickness is measured by optical coherence tomography (OCT). Central retinal thickness is defined as the thickness of the retina in the center of the foveal pit (1 mm subfield). The larger central retinal thickness value indicates greater severity of uveitis. A negative change from best state value obtained prior to Week 6 indicates improvement. (NCT03207815)
Timeframe: Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)

,
Interventionlog microns (Mean)
Left Eye: Best State Prior to Week 6Right Eye: Best State Prior to Week 6Left Eye: Change From Best State at Week 52/EOT/ETRight Eye: Change From Best State at Week 52/EOT/ET
Filgotinib2.452.470.010.01
Placebo2.462.440.040.03

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Plasma Concentration of Filgotinib

(NCT03207815)
Timeframe: Day 1 post dose, Weeks 4 and 6 predose, Week 12 post dose, Weeks 24, 36, 52 (EOT), ET at any time

Interventionnanograms per millilitre (ng/ml) (Mean)
Day 1 PostdoseWeek 4 PredoseWeek 6 PredoseWeek 12 PostdoseWeek 24 Single AnytimeWeek 36 Single AnytimeWeek 52 Single AnytimeEarly Termination Single Anytime
Filgotinib748.5173.3133.91088.7397.5295.7195.2434.8

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Plasma Concentration of Metabolite, GS-829845

(NCT03207815)
Timeframe: Day 1 post dose, Weeks 4 and 6 predose, Week 12 post dose, Weeks 24, 36, 52 (EOT), ET at any time

Interventionng/ml (Mean)
Day 1 PostdoseWeek 4 PredoseWeek 6 PredoseWeek 12 PostdoseWeek 24 Single AnytimeWeek 36 Single AnytimeWeek 52 Single AnytimeEarly Termination Single Anytime
Filgotinib230.82085.62107.73237.03478.12944.32510.72171.0

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Time to Treatment Failure on or After Week 6

Treatment failure was a participant meeting at least 1 of these criteria in at least 1 eye: New active, inflammatory lesions relative to Day 1/Baseline (all visits starting Wk 6); Inability to achieve ≤Grade 0.5+ (at Wk 6) or 2-step increase (change of Grade 0 to Grade 2+/Grade 0.5+ to Grade 3+) (all visits after Wk 6) relative to best state (RBS) achieved in AC cell grade (SUN criteria) [AC cell grades range from 0 (0 cells) to 4+ (>50 cells), higher scores=severe uveitis]; Inability to achieve ≤Grade 0.5+ (at Wk 6) or 2-step increase (all visits after Wk 6) RBS achieved in VH grade (NEI/SUN criteria) [VH grades range from 0 (no evident VH) to 4+ (optic nerve head is obscured), higher scores=severe uveitis]; Worsening of BCVA by ≥15 letters RBS achieved (all visits starting Wk 6), measured by an eye chart, fewer correct letters=severe uveitis. (NCT03207815)
Timeframe: Week 6 through Week 52

Interventionweeks (Median)
FilgotinibNA
Placebo22.0

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The Number of Participants With Rate of Pathologic Stage =< pT2N0 at Prostatectomy

The study will provide a point estimate and 95% confidence interval of the proportion of patients with pathologic stage =< pT2N0 at prostatectomy for each arm. Patient characteristics will be summarized using descriptive statistics for each arm. (NCT03279250)
Timeframe: At the time of radical prostatectomy

InterventionParticipants (Count of Participants)
Arm A (LHRHa, Apalutamide)13
Arm B (LHRHa, Apalutamide, Abiraterone Acetate)12

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Number of Participants With Incidence of Adverse Events

Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Incidence of serious adverse events and 95% confidence interval will be provided overall as well as for each major affected organ category. (NCT03279250)
Timeframe: From screening up to 4 weeks post-surgery, an average of 7 months

,
InterventionParticipants (Count of Participants)
SeriousNon Serious
Arm A (LHRHa, Apalutamide)134
Arm B (LHRHa, Apalutamide, Abiraterone Acetate)234

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Number of Participants With Acute Cellular Rejection Between Study and Control Groups

Acute Cellular Rejection of liver graft was determined by liver biopsy using Banff criteria. The decision to perform liver biopsy was as per treating physician based on patient's clinical course and blood chemisteries. Protocol bioopsies were not performed. (NCT03304626)
Timeframe: Post-Transplant day 4 to week 24

InterventionParticipants (Count of Participants)
Study Group1
Control Group1

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Rate of New Onset Diabetes After Transplant

Rates of new onset diabetes in patients who did not have diabetes prior to liver transplant (NCT03304626)
Timeframe: Post-Transplant day 4 to week 24

InterventionParticipants (Count of Participants)
Study Group0
Control Group3

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Number of Participants With Adrenal Suppression

"This outcomes was measured in Budesonide group only. Serum cortisol levels after 12 weeks of Budesonide use were checked to see if they fall below the adrenal suppression threshold of 3microgram/dl. If these were below 3 microgram/dl then patient is considered to have developed adrenal suppression.~Second measure used to check for adrenal suppression was Cosyntorpin stimulation test. One-time, low-dose, cosyntropin stimulation test at week 12 was performed by administering cosyntropin at a dose of 0.5 µg/1.73 m2 of the body surface area and checking the serum cortisol levels at baseline and at 30 minutes after cosyntropin injection. A serum cortisol value of <11 µg/dL after cosyntropin stimulation was used to define adrenal suppression. Participant meeting any of these criteria was said to have developed adrenal suppression" (NCT03304626)
Timeframe: Post-Transplant week 12

InterventionParticipants (Count of Participants)
Study Group2

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Number of Participants With Adverse Events

"Rates of adverse events~All cause mortality~Graft failure~Acute cellular rejection~New Onset Diabetes after Transplant~Rates of bacterial, fungal or viral infections~Other adverse events including ascites, pleural effusion, kidney injury, biliary stricture" (NCT03304626)
Timeframe: Post-Transplant day 4 to week 24

InterventionParticipants (Count of Participants)
Study Group10
Control Group6

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Number of Participants With Laboratory Values Change From Baseline

Number of participants changed from baseline in laboratory values of worst toxicity grade (grade 0= wnl, grade 1= mild, grade 2= moderate, grade 3= severe) based on US conventional units by cohort (NCT03338790)
Timeframe: From first dose to up to 30 days post last dose (Up to 34 months)

InterventionParticipants (Number)
Hemoglobin Grade 0Hemoglobin Grade 1Hemoglobin Grade 2Platelet Grade 0Platelet Grade 1Leukocytes Grade 0Leukocytes Grade 1Leukocytes Grade 2Lymphocytes Grade 0Lymphocytes Grade 1Lymphocytes Grade 2Lymphocytes Grade 3Neutrophil Grade 0Neutrophil Grade 1Neutrophil Grade 2Alkaline Phosphatase Grade 0Alkaline Phosphatase Grade 1Alkaline Phosphatase Grade 2Alkaline Phosphatase Grade 3Aspartate Aminotransferase Grade 0Aspartate Aminotransferase Grade 1Alanine Aminotransferase Grade 0Alanine Aminotransferase Grade 1Bilirubin Grade 0Bilirubin Grade 1Creatinine Grade 0Creatinine Grade 1
Arm A12338835438101241031353125139152547441307

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Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3)

Objective response rate per prostate cancer clinical trials working group 3 (ORR-PCWG3) for target lesions and assessed by MRI is the percentage of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among treated participants who have measurable disease (NCT03338790)
Timeframe: Up to approximately 36 months

,,,
InterventionPercentage of participants (Number)
OverallHomologous Recombination Deficiency (HRD+)
Arm A110.317.2
Arm A215.425.0
Arm B40.036.8
Arm C11.120.0

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Prostate-Specific Antigen Response Rate (RR-PSA)

Prostate-specific antigen response rate (RR-PSA) is the percentage of treated participants with a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result (NCT03338790)
Timeframe: Up to approximately 36 months

,,,
InterventionPercentage of participants (Number)
OverallHomologous Recombination Deficiency (HRD+)
Arm A111.918.2
Arm A227.341.9
Arm B46.950.0
Arm C34.150.0

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Number of Deaths

Number of deaths in all treated participants (NCT03338790)
Timeframe: Up to 36 months

InterventionDeaths (Number)
Arm A159
Arm A242
Arm B44
Arm C28

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Number of Participants With Adverse Events (AEs)

Number of Participants with any grade adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and immune-mediated AEs using the Common Toxicity Criteria Grade for Adverse Events (CTCAE V4) (NCT03338790)
Timeframe: From first dose to up to 30 days post last dose (Up to 34 months)

,,,
InterventionParticipants (Number)
Adverse Events (AEs)Serious Adverse Events (SAEs)AEs leading to discontinuationImmune-mediated AEs (Pneumonitis)Immune-mediated AEs (Diarrhea/Colitis)Immune-mediated AEs (Hepatitis)Immune-mediated AEs (Nephritis/Renal Dysfunction)Immune-mediated AEs (Rash)Immune-mediated AEs (Hypersensitivity/Infusion Reactions)
Arm A1884739148250
Arm A2713726247351
Arm B834133813091
Arm C4920180020103

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Number of Participants With Laboratory Abnormalities in Specific Liver Tests

"Number of participants with laboratory abnormalities in specific liver tests based on SI conventional units to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:~ALT or AST > 3 x ULN, > 5 x ULN, > 10 x ULN and > 20 x ULN~Total bilirubin > 2 x ULN~ALP > 1.5 x ULN~Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN~Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN~Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN~Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN" (NCT03338790)
Timeframe: From first dose to up to 30 days post last dose (up to 34 months)

,,,
InterventionParticipants (Number)
ALT or AST > 3xULNALT or AST > 5xULNALT or AST > 10xULNALT or AST > 20xULNTOTAL BILIRUBIN > 2xULNALP > 1.5xULNConcurrent ALT or AST elevation > 3xULN with total Bilirubin > 1.5xULN within one dayConcurrent ALT or AST elevation > 3xULN with total Bilirubin > 1.5xULN within 30 daysConcurrent ALT or AST elevation > 3xULN with total Bilirubin > 2xULN within one dayConcurrent ALT or AST elevation > 3xULN with total Bilirubin > 2xULN within 30 days
Arm A11911203493422
Arm A22314511341111
Arm B63111340000
Arm C43000211100

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Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests

"Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:~TSH value > ULN and~with baseline TSH value <= ULN~with at least one FT3/FT4 test value < LLN within 2-week window after the abnormal TSH test~with all FT3/FT4 test values >= LLN within 2-week window after the abnormal TSH test~with FT3/FT4 missing within 2-week window after the abnormal TSH test.~TSH < LLN and~with baseline TSH value >= LLN~with at least one FT3/FT4 test value > ULN within 2-week window after the abnormal TSH test~with all FT3/FT4 test values <= ULN within 2-week window after the abnormal TSH test~with FT3/FT4 missing within 2-week window after the abnormal TSH test" (NCT03338790)
Timeframe: From first dose to up to 30 days post last dose (Up to 34 months)

,,,
InterventionParticipants (Number)
TSH > ULNTSH > ULN with TSH <= ULN at baselineTSH > ULN with at least one FT3/FT4 test value < LLNTSH > ULN with all other FT3/FT4 test values >= LLNTSH > ULN with FT3/FT4 test missingTSH < LLNTSH < LLN with TSH >= LLN at baselineTSH < LLN with at least one FT3/FT4 test value > ULNTSH < LLN with all other FT3/FT4 test values <= ULNTSH < LLN with FT3/FT4 test missing
Arm A12217101021613583
Arm A217126921211543
Arm B127732251921112
Arm C1712510288701

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Number of Participants With Laboratory Values Change From Baseline

Number of participants changed from baseline in laboratory values of worst toxicity grade (grade 0= wnl, grade 1= mild, grade 2= moderate, grade 3= severe) based on US conventional units by cohort (NCT03338790)
Timeframe: From first dose to up to 30 days post last dose (Up to 34 months)

InterventionParticipants (Number)
Hemoglobin Grade 0Hemoglobin Grade 1Hemoglobin Grade 2Platelet Grade 0Platelet Grade 1Leukocytes Grade 0Leukocytes Grade 1Lymphocytes Grade 0Lymphocytes Grade 1Lymphocytes Grade 2Neutrophil Grade 0Neutrophil Grade 2Alkaline Phosphatase Grade 0Alkaline Phosphatase Grade 1Alkaline Phosphatase Grade 2Alkaline Phosphatase Grade 3Aspartate Aminotransferase Grade 0Aspartate Aminotransferase Grade 1Alanine Aminotransferase Grade 0Alanine Aminotransferase Grade 1Bilirubin Grade 0Bilirubin Grade 1Creatinine Grade 0Creatinine Grade 1
Arm C8122130132142371860094413032

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Number of Participants With Laboratory Values Change From Baseline

Number of participants changed from baseline in laboratory values of worst toxicity grade (grade 0= wnl, grade 1= mild, grade 2= moderate, grade 3= severe) based on US conventional units by cohort (NCT03338790)
Timeframe: From first dose to up to 30 days post last dose (Up to 34 months)

,
InterventionParticipants (Number)
Hemoglobin Grade 0Hemoglobin Grade 1Hemoglobin Grade 2Platelet Grade 0Platelet Grade 1Leukocytes Grade 0Leukocytes Grade 1Leukocytes Grade 2Lymphocytes Grade 0Lymphocytes Grade 1Lymphocytes Grade 2Lymphocytes Grade 3Neutrophil Grade 0Neutrophil Grade 1Alkaline Phosphatase Grade 0Alkaline Phosphatase Grade 1Alkaline Phosphatase Grade 2Alkaline Phosphatase Grade 3Aspartate Aminotransferase Grade 0Aspartate Aminotransferase Grade 1Alanine Aminotransferase Grade 0Alanine Aminotransferase Grade 1Bilirubin Grade 0Creatinine Grade 0Creatinine Grade 1
Arm A2212833213460308302643341349448312305
Arm B302021002841280503711313202861332135

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Cohort 1: Percentage of Participants With Complete Response (CR) for B-cell Acute Lymphoblastic Leukemia (ALL)

Complete response based on the modified National Comprehensive Cancer Network (NCCN) criteria was defined as: less than 5 percent (%) blasts in the bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets greater than (>)100*10^9 cells/liter (L) and absolute neutrophil count (ANC) >1.0*10^9 cells/L. This outcome measure was planned to be analyzed for specified arm only. (NCT03384654)
Timeframe: Up to 2 cycles, that is, up to 56 days (each cycle of 28-days)

InterventionPercentage of participants (Number)
Cohort 1: B-cell ALL (1-17 Years)0

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Overall Response Rate (ORR)

For ALL participants, ORR was defined as percentage of participants who achieved CR or CR with only partial hematological recovery(CRi) as per NCCN criteria. CR for ALL: less than 5% blasts in bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets >100*10^9 cells/L and ANC >1.0*10^9 cells/L. CRi for ALL: less than 5% blasts in bone marrow; no evidence of circulating blasts or extramedullary disease; partial recovery of peripheral blood counts not meeting criteria for CR. For LL participants, ORR was defined as percentage of participants who had CR or PR during or after treatment administration but prior to start of subsequent anti-cancer therapy or allogeneic hematopoietic stem cell transplant(HSCT). CR for LL: disappearance of all evidence of disease from all sites. PR for LL: decrease of >=50% in sum of products of diameter of lesions of up to 6 of largest dominant nodes or nodal masses with no new lesions. (NCT03384654)
Timeframe: Up to 4 years 4 months

InterventionPercentage of participants (Number)
Cohort 1: B-cell ALL (1-17 Years)14.3
Cohort 2: T-Cell ALL (1-17 Years)83.3
Cohort 2: T-Cell ALL (18-30 Years)80.0
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)50.0

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Concentration of Daratumumab in Cerebrospinal Fluid (CSF)

Concentration of daratumumab in CSF was reported. '0' in the number analyzed field signifies that none of the participants were available for the analysis at the specified time points. (NCT03384654)
Timeframe: Pre-dose on Cohort 1: Cycles 1 and 2: Day 1; Cohort 2: Cycle 1 Day 1 and Day 15 and Cycle 2 Day 2 and Day 15

Interventionmcg/mL (Mean)
Cycle 1 Day 1 predoseCycle 2 Day 1 predose
Cohort 1: B-cell ALL (1-17 Years)NA0.573

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Concentration of Daratumumab in Cerebrospinal Fluid (CSF)

Concentration of daratumumab in CSF was reported. '0' in the number analyzed field signifies that none of the participants were available for the analysis at the specified time points. (NCT03384654)
Timeframe: Pre-dose on Cohort 1: Cycles 1 and 2: Day 1; Cohort 2: Cycle 1 Day 1 and Day 15 and Cycle 2 Day 2 and Day 15

,,
Interventionmcg/mL (Mean)
Cycle 1 Day 1 predoseCycle 1 Day 15 predoseCycle 2 Day 2 predoseCycle 2 Day 15 predose
Cohort 2: T-Cell ALL (1-17 Years)NA0.9070.9150.934
Cohort 2: T-Cell ALL (18-30 Years)NA0.3190.2960.163
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)NA0.4561.231.06

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Minimum Observed Serum Concentration (Cmin) of Daratumumab

Cmin was defined as minimum observed serum concentration of daratumumab. (NCT03384654)
Timeframe: Cohort 1: B-cell ALL: Predose on Day 1 of Cycle 2; Cohort 2: T-cell ALL (1-17 years): Predose on Day 22 of Cycle 2; Cohort 2: T-cell ALL (18-30 years): Predose on Day 1 of Cycle 2; Cohort 2: T-cell LL (1-30 years): Predose on Day 22 of Cycle 2

Interventionmcg/mL (Mean)
Cohort 1: B-cell ALL (1-17 Years)172
Cohort 2: T-Cell ALL (1-17 Years)369
Cohort 2: T-Cell ALL (18-30 Years)172
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)365

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Cohort 2: Percentage of Participants With Complete Response (CR) for T-cell ALL

Complete response based on the modified NCCN criteria was defined as: less than 5% blasts in the bone marrow; no evidence of circulating blasts or extramedullary disease; full recovery of peripheral blood counts: platelets >100*10^9 cells/L and ANC >1.0*10^9 cells/L. This outcome measure was planned to be analyzed for specified arms only. (NCT03384654)
Timeframe: End of Cycle 1 (that is, up to 28 days)

InterventionPercentage of participants (Number)
Cohort 2: T-Cell ALL (1-17 Years)41.7
Cohort 2: T-Cell ALL (18-30 Years)60.0
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)30.0

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Event-free Survival (EFS)

EFS was defined as the time (in months) from the date of first treatment to the first documented treatment failure (that is [ie], disease progression) or date of relapse from CR or death due to any cause, whichever occurred first. Per NCCN criteria, relapse from CR is defined as: reappearance of leukemia blasts in the peripheral blood or >5% blasts in the bone marrow; reappearance of extramedullary disease or new extramedullary disease. Progressive disease: increase of at least 25% in the absolute number of circulating peripheral or bone marrow blasts, or development of new extramedullary disease. Kaplan-Meier method was used for the analysis. (NCT03384654)
Timeframe: Up to 4 years 4 months

InterventionMonths (Median)
Cohort 1: B-cell ALL (1-17 Years)1.1
Cohort 2: T-Cell ALL (1-17 Years)8.9
Cohort 2: T-Cell ALL (18-30 Years)10.3
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)2.9

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Maximum Observed Serum Concentration (Cmax) of Daratumumab

Cmax was defined as maximum observed serum concentration of daratumumab. (NCT03384654)
Timeframe: Cohort 1: B-cell ALL: End of infusion (EOI) on Day 1 of Cycle 2; Cohort 2: T-cell ALL (1-17 years): EOI on Day 22 of Cycle 2; Cohort 2: T-cell ALL (18-30 years): EOI on Day 1 of Cycle 2; Cohort 2: T-cell LL (1-30 years): EOI on Day 22 of Cycle 2

InterventionMicrograms per milliliter (mcg/mL) (Mean)
Cohort 1: B-cell ALL (1-17 Years)494
Cohort 2: T-Cell ALL (1-17 Years)763
Cohort 2: T-Cell ALL (18-30 Years)501
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)758

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Minimal Residual Disease (MRD) Negative Rate

MRD negative rate was defined as the percentage of participants who were considered MRD negative after MRD testing by bone marrow aspirate at any timepoint after first study treatment administration and before disease progression or starting subsequent anti-cancer therapy or allogeneic hematopoietic stem cell transplant (HSCT). MRD negative was defined as less than (<) 0.01% abnormal population counts to nucleated mononuclear cells when measured by flow cytometry. (NCT03384654)
Timeframe: Up to 4 years 4 months

InterventionPercentage of participants (Number)
Cohort 1: B-cell ALL (1-17 Years)0
Cohort 2: T-Cell ALL (1-17 Years)45.8
Cohort 2: T-Cell ALL (18-30 Years)20.0
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)50.0

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Overall Survival (OS)

OS was defined as the time (in months) from the date of first study drug administration to the date of death due to any cause. Kaplan-Meier method was used for the analysis. Participants who died after consent withdrawal were considered as having an OS event. (NCT03384654)
Timeframe: Up to 4 years 4 months

InterventionMonths (Median)
Cohort 1: B-cell ALL (1-17 Years)3.2
Cohort 2: T-Cell ALL (1-17 Years)10.9
Cohort 2: T-Cell ALL (18-30 Years)12.0
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)4.2

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Number of Participants With Anti-daratumumab Antibodies

Number of participants with anti-daratumumab antibodies was reported. (NCT03384654)
Timeframe: Up to 4 years 4 months

InterventionParticipants (Count of Participants)
Cohort 1: B-cell ALL (1-17 Years)0
Cohort 2: T-Cell ALL (1-17 Years)0
Cohort 2: T-Cell ALL (18-30 Years)0
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)0

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Relapse-free Survival (RFS)

RFS was defined as the time (in months) from CR to relapse from CR, or disease progression or death due to any cause, whichever occurred first. For ALL, as per NCCN criteria, relapse from CR is defined as: reappearance of leukemia blasts in the peripheral blood or >5% blasts in the bone marrow, or reappearance of extramedullary disease or new extramedullary disease. Progressive disease: increase of at least 25% in absolute number of circulating peripheral or bone marrow blasts, or development of new extramedullary disease. Kaplan-Meier method was used for analysis. (NCT03384654)
Timeframe: Up to 4 years 4 months

InterventionMonths (Median)
Cohort 2: T-Cell ALL (1-17 Years)19.4
Cohort 2: T-Cell ALL (18-30 Years)9.4
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)NA

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Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT)

Percentage of participants who received an allogeneic HSCT after treatment with daratumumab were reported. (NCT03384654)
Timeframe: Up to 4 years 4 months

InterventionPercentage of participants (Number)
Cohort 1: B-cell ALL (1-17 Years)14.3
Cohort 2: T-Cell ALL (1-17 Years)75.0
Cohort 2: T-Cell ALL (18-30 Years)60.0
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)30.0

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Donor-specific HLA Antibodies, Re-transplantation, or Death

The Outcome Measure is a composite primary endpoint of the development of donor-specific HLA antibodies, re-transplantation, or death. Testing for donor-specifc HLA antibodies was performed at study-specified time points using the single antigen bead assay at the study core lab. Donor-specific HLA antibodies were defined as reactivity with a mean fluorescence intensity (MFI) ≥ 2,000. (NCT03388008)
Timeframe: 365 days

,
Interventionparticipants (Number)
DeathDonor-specific HLA antibodiesRe-transplantation
Belatacept-based Immunosuppression530
Standard of Care030

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Maximum Observed Serum Concentration (Cmax) of Daratumumab

Cmax was defined as maximum serum concentration observed following daratumumab administration. Each cycle for: D-VRd cohort is of 21 days, D-VMP cohort is of 42 days and D-Rd and D-Kd cohorts is of 28 days. Each cohort have a treatment period of 84 days. (NCT03412565)
Timeframe: D-VRd: Day 4 of Cycles 1 and 4 and post treatment at Week 8; D-VMP: Day 4 of Cycles 1 and 2 and post treatment at Week 8; D-Rd and D-Kd: Day 4 of Cycles 1 and 3 and post treatment at Week 8

Interventionmicrograms per milliliter (mcg/mL) (Mean)
Cycle 1 Day 4Cycle 3 Day 4
Daratumumab + Lenalidomide + Dexamethasone (D-Rd)108648

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Maximum Observed Serum Concentration (Cmax) of Daratumumab

Cmax was defined as maximum serum concentration observed following daratumumab administration. Each cycle for: D-VRd cohort is of 21 days, D-VMP cohort is of 42 days and D-Rd and D-Kd cohorts is of 28 days. Each cohort have a treatment period of 84 days. (NCT03412565)
Timeframe: D-VRd: Day 4 of Cycles 1 and 4 and post treatment at Week 8; D-VMP: Day 4 of Cycles 1 and 2 and post treatment at Week 8; D-Rd and D-Kd: Day 4 of Cycles 1 and 3 and post treatment at Week 8

Interventionmicrograms per milliliter (mcg/mL) (Mean)
Cycle 1 Day 4Cycle 2 Day 4Post-treatment Phase Week 8
D + Bortezomib + Melphalan + Prednisone (D-VMP)98.6612162

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Maximum Observed Serum Concentration (Cmax) of Daratumumab

Cmax was defined as maximum serum concentration observed following daratumumab administration. Each cycle for: D-VRd cohort is of 21 days, D-VMP cohort is of 42 days and D-Rd and D-Kd cohorts is of 28 days. Each cohort have a treatment period of 84 days. (NCT03412565)
Timeframe: D-VRd: Day 4 of Cycles 1 and 4 and post treatment at Week 8; D-VMP: Day 4 of Cycles 1 and 2 and post treatment at Week 8; D-Rd and D-Kd: Day 4 of Cycles 1 and 3 and post treatment at Week 8

Interventionmicrograms per milliliter (mcg/mL) (Mean)
Cycle 1 Day 4Cycle 3 Day 4Post-treatment Phase Week 8
Daratumumab + Carfilzomib + Dexamethasone (D-Kd)13786949.3

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Maximum Observed Serum Concentration (Cmax) of Daratumumab

Cmax was defined as maximum serum concentration observed following daratumumab administration. Each cycle for: D-VRd cohort is of 21 days, D-VMP cohort is of 42 days and D-Rd and D-Kd cohorts is of 28 days. Each cohort have a treatment period of 84 days. (NCT03412565)
Timeframe: D-VRd: Day 4 of Cycles 1 and 4 and post treatment at Week 8; D-VMP: Day 4 of Cycles 1 and 2 and post treatment at Week 8; D-Rd and D-Kd: Day 4 of Cycles 1 and 3 and post treatment at Week 8

Interventionmicrograms per milliliter (mcg/mL) (Mean)
Cycle 1 Day 4Cycle 4 Day 4Post-treatment Phase Week 8
Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)100746263

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D-VRd Cohort: Overall Response Rate (ORR)

ORR was defined as the percentage of participants who achieved a PR or better, IMWG criteria, during the study or during follow up. IMWG criteria for PR >= 50% reduction of serum M-protein and reduction in 24 hour urinary M-protein by >=90% or to <200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow PCs is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required. (NCT03412565)
Timeframe: Up to 2 years and 3 months

Interventionpercentage of participants (Number)
Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)97.0

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D-VMP, D-Rd, and D-Kd Cohorts: Percentage of Participants With VGPR or Better Response

VGPR or better rate was defined as the percentage of participants who achieved VGPR or CR (including sCR) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or >= 90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and <5% PCs in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by immunohistochemistry, immunofluorescence, 2-4 color flow cytometry. (NCT03412565)
Timeframe: From baseline up to 2 years 7 months

Interventionpercentage of participants (Number)
D + Bortezomib + Melphalan + Prednisone (D-VMP)77.6
Daratumumab + Lenalidomide + Dexamethasone (D-Rd)80.0
Daratumumab + Carfilzomib + Dexamethasone (D-Kd)77.3

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D-VMP, D-Rd, and D-Kd Cohorts: Percentage of Participants With Minimal Residual Disease (MRD) Negative Rate

MRD negativity rate was defined as the percentage of participants who were considered MRD negative after MRD testing at any timepoint after the first dose by bone marrow aspirate. MRD negativity rate was assessed by next-generation sequencing at a threshold of <10^5. (NCT03412565)
Timeframe: Up to 2 years and 3 months

Interventionpercentage of participants (Number)
D + Bortezomib + Melphalan + Prednisone (D-VMP)25.4
Daratumumab + Lenalidomide + Dexamethasone (D-Rd)21.5
Daratumumab + Carfilzomib + Dexamethasone (D-Kd)27.3

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D-VMP, D-Rd, and D-Kd Cohorts: Overall Response Rate (ORR)

ORR was defined as the percentage of participants who achieved partial response (PR) or better according to international myeloma working group (IMWG) criteria. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 milligrams (mg) per 24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required. (NCT03412565)
Timeframe: Up to 2 years 3 months

Interventionpercentage of participants (Number)
D + Bortezomib + Melphalan + Prednisone (D-VMP)88.1
Daratumumab + Lenalidomide + Dexamethasone (D-Rd)90.8
Daratumumab + Carfilzomib + Dexamethasone (D-Kd)84.8

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D-VMP, D-Rd and D-Kd Cohorts: Duration of Response (DOR)

DOR was defined as the time from the date of initial documented response (PR or better response) to the date of first documented evidence of progressive disease (PD) or death due to PD. PD is defined as an increase of 25% from the lowest response value in one of the following: serum and urine M-component (absolute increase must be >=0.5 gram per deciliter [g/dL] and >=200 mg/24 hours respectively); only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be >10 mg/dL); definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder. (NCT03412565)
Timeframe: From baseline up to 2 years 7 months

Interventionmonths (Median)
D + Bortezomib + Melphalan + Prednisone (D-VMP)NA
Daratumumab + Lenalidomide + Dexamethasone (D-Rd)NA
Daratumumab + Carfilzomib + Dexamethasone (D-Kd)NA

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D-VRd Cohort: Percentage of Participants With Very Good Partial Response (VGPR) or Better Response

VGPR or better rate was defined as the percentage of participants who achieved VGPR or complete response (CR) (including stringent complete response [sCR]) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or >= 90% reduction in serum M-protein plus urine M-protein level <100 mg/24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and <5% PCs in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by immunohistochemistry, immunofluorescence, 2-4 color flow cytometry. (NCT03412565)
Timeframe: Up to 2 years and 3 months

Interventionpercentage of participants (Number)
Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)71.6

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Percentage of Participants With CR or Better Response

CR or better rate was defined as the percentage of participants with a CR or better response (that is, CR and sCR) as per IMWG criteria. CR: as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (<) 5 percent plasma cells in bone marrow; sCR: CR plus normal FLC ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry. (NCT03412565)
Timeframe: For D-VRD Arm: Baseline up to 2 years 3 months; For D-VMP, D-Rd and D-Kd Arms: Baseline up to 2 years 7 months

Interventionpercentage of participants (Number)
Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)16.4
D + Bortezomib + Melphalan + Prednisone (D-VMP)55.2
Daratumumab + Lenalidomide + Dexamethasone (D-Rd)50.8
Daratumumab + Carfilzomib + Dexamethasone (D-Kd)42.4

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Percentage of Participants With Anti-rHuPH20 Antibodies

Percentage of participants with antibodies to rHuPH20 were reported. (NCT03412565)
Timeframe: For D-VRD Arm: Baseline up to 2 years 3 months; For D-VMP, D-Rd and D-Kd Arms: Baseline up to 2 years 7 months

Interventionpercentage of participants (Number)
Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)6.1
D + Bortezomib + Melphalan + Prednisone (D-VMP)3.1
Daratumumab + Lenalidomide + Dexamethasone (D-Rd)4.8
Daratumumab + Carfilzomib + Dexamethasone (D-Kd)4.7

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Percentage of Participants With Anti-Daratumumab Antibodies

Percentage of participants with antibodies to daratumumab were reported. (NCT03412565)
Timeframe: For D-VRD Arm: Baseline up to 2 years 3 months; For D-VMP, D-Rd and D-Kd Arms: Baseline up to 2 years 7 months

Interventionpercentage of participants (Number)
Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)0
D + Bortezomib + Melphalan + Prednisone (D-VMP)0
Daratumumab + Lenalidomide + Dexamethasone (D-Rd)0
Daratumumab + Carfilzomib + Dexamethasone (D-Kd)0

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Combination 3: Area Under the Plasma Concentration-Time Curve From Time Zero to 168 Hours (AUC [0-168hr]) of Niraparib Administered With AA After a Single Dose

AUC(0-168 hours) was defined as area under the plasma concentration-time curve from time zero to 168 hours of Niraparib administered with AA After a single dose. (NCT03431350)
Timeframe: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1

InterventionNanograms*hour per milliliter (ng*h/mL) (Mean)
Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA14672
Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010)11862
Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012)13321

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Combination 1: Part 2: Objective Response Rate (ORR)

ORR of soft tissue (visceral or nodal disease) was defined as percentage of participants with measurable disease who achieved a best response of either complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with no evidence of bone progression according to prostate cancer working group 3 (PCWG3) criteria. (NCT03431350)
Timeframe: Up to 37 months

InterventionPercentage of participants (Number)
Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg23.8
Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg9.1

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Combination 2: Number of Participants With Adverse Events (AEs) of Grade >=3 Severity

AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An assessment of severity grade was made using the NCI-CTCAE as Grade 1 (mild): awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with everyday activities; Grade 2 (moderate): sufficient discomfort is present to cause interference with normal activity; Grade 3 (severe): extreme distress, causing significant impairment of functioning or incapacitation, prevents normal everyday activities; Grade 4 (Life-threatening): urgent intervention indicated; and Grade 5 (death). (NCT03431350)
Timeframe: Up to 31 months

InterventionParticipants (Count of Participants)
Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone6
Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone7
Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone4
Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone1

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Combination 1: Part 2: Number of Participants With Adverse Events (AEs) of Grade >=3 Severity

AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An assessment of severity grade was made using the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) as Grade 1 (mild): awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with everyday activities; Grade 2 (moderate): sufficient discomfort is present to cause interference with normal activity; Grade 3 (severe): extreme distress, causing significant impairment of functioning or incapacitation, prevents normal everyday activities; Grade 4 (Life-threatening): urgent intervention indicated; and Grade 5 (death). (NCT03431350)
Timeframe: Up to 37 months

InterventionParticipants (Count of Participants)
Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg14
Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg8

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Combination 1: Part 2: Number of Participants With Adverse Events (AEs)

AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. (NCT03431350)
Timeframe: Up to 37 months

InterventionParticipants (Count of Participants)
Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg21
Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg11

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Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib and Abiraterone Acetate After a Single Dose

Cmax is defined as maximum observed plasma concentration of niraparib and abiraterone acetate (AA) after a single dose. (NCT03431350)
Timeframe: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1

InterventionNanograms per milliliter (ng/mL) (Mean)
Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA428
Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010)398
Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012)417

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Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib Normalized by the Dose(Niraparib) (Cmax/Dose) of Niraparib Administered With AA After a Single Dose

Cmax/dose of niraparib was defined as maximum observed plasma concentration of niraparib Cmax normalized by the dose of niraparib administered with AA after a single dose. (NCT03431350)
Timeframe: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1

Interventionnanograms per milliliter per milligram (Mean)
Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA2.14
Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010)1.99
Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012)2.09

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Combination 2: Composite Response Rate (RR)

Composite response rate was defined as the percentage of participants who had a composite response which is defined as one of the following PCWG3 criteria: Objective response (percentage of participants with measurable disease who achieved a best response of either CR or PR as assessed by RECIST 1.1 with no evidence of bone progression according to PCWG3 criteria) (confirmed per RECIST 1.1), or; circulating tumor cells (CTC) response: defined as CTC=0 per 7.5 milliliters (mL) of blood at 8 weeks for participants who had CTC greater than or equal to (>=) 1 at baseline or CTC less than (<) 5 per 7.5 mL with CTC >=5 at baseline, confirmed by a second consecutive value obtained 4 or more weeks later, or prostate-specific antigen (PSA) declined of >=50 percentage (%), measured twice 3 to 4 weeks apart. This outcome measure was analyzed for specified arms only as pre-planned in the protocol. (NCT03431350)
Timeframe: Up to 31 months

InterventionPercentage of participants (Number)
Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone75.0
Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone55.6
Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone33.3

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Combination 3: Area Under the Plasma Concentration-Time Curve for Niraparib From Time Zero to 168 Hours (AUC [0-168 Hours]/Dose) of Niraparib Administered With AA After a Single Dose

AUC0(168 hours)/dose was defined as area under the plasma concentration-time curve for niraparib from time 0 to 168 hours of niraparib administered with AA after a single dose. (NCT03431350)
Timeframe: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1

Interventionnanogram*hour/milliliter/milligram (Mean)
Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA73.36
Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010)59.31
Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012)66.61

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Combination 2: Number of Participants With Adverse Events (AEs)

AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. (NCT03431350)
Timeframe: Up to 31 months

InterventionParticipants (Count of Participants)
Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone8
Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone9
Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone5
Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone1

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Combination 1: Part 1: Number of Participants With Specified Toxicity

Number of participants with specified toxicity during Cycle 1 was reported. Only toxicities that occurred during safety evaluation period(defined as first 28 days of treatment-Cycle 1 of Part 1) was used for analysis of specified toxicities and for dose reduction decisions. Toxicities were graded for severity as per NCI-CTCAE, version 4.03. Safety evaluation criteria were: Any Grade(G) >=3 non-hematological toxicity without anorexia, or constipation, fatigue improved to G<=2 in <7 days, vomiting and diarrhea resolved in <=3 days, laboratory abnormalities with hospitalization, tumor flare improved to G<=2 in <=7 days, elevation in AST/ALT for <=7 days and G3 hypertension controlled by medical therapy; any treatment-related(TR)G4 or G>=3 thrombocytopenia required platelet transfusion; Any TR G4 neutropenia >=7 days or G3 or 4 neutropenia with infection/fever >38.5 degrees Celsius; Any TR SAE or intolerable toxicity. (NCT03431350)
Timeframe: Cycle 1 (28 days)

InterventionParticipants (Count of Participants)
Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg0
Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg0

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Efficacy Measured by Time to Stand Test (TTSTAND) Velocity in Rises/Second Change From Baseline

Vamorolone at 6.0mg/kg/day vs. placebo group in change from baseline to the Week 24 assessment (NCT03439670)
Timeframe: 24 weeks

InterventionRises/Seconds (Mean)
Treatment Group 1-.007
Treatment Group 20.054

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Number of Participants With Minimal Residual Disease (MRD) Negativity

MRD levels continuously assessed during induction and consolidation therapy by 6-color multiparameter flow. MRD negativity defined by a value of at least 10-4 and confirmed on a second bone marrow aspiration/biopsy performed after a subsequent cycle. (NCT03488225)
Timeframe: Start of treatment up to 2 years

InterventionParticipants (Count of Participants)
Treatment (Hyper-CVAD, Inotuzumab Ozogamicin)4

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Overall Survival

Time from date of treatment start until date of death due to any cause or last Follow-up. (NCT03488225)
Timeframe: Start of treatment up to 2 years

InterventionMonths (Median)
Treatment (Hyper-CVAD, Inotuzumab Ozogamicin)24

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Event-Free Survival

Event-free survival defined as the time interval from date of treatment start until the date of death, disease progression or relapse. (NCT03488225)
Timeframe: Start of treatment up to 2 years

InterventionMonths (Median)
Treatment (Hyper-CVAD, Inotuzumab Ozogamicin)24

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Participants to Achieve Complete Remission (CR):

Complete Remission (CR) is defined as - Normalization of the peripheral blood and bone marrow blasts /= 100X10^9/L and complete resolution of all sites of extramedullary disease. (NCT03488225)
Timeframe: Start of treatment up to 2 years

InterventionParticipants (Count of Participants)
Treatment (Hyper-CVAD, Inotuzumab Ozogamicin)4

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Number of Participants With Adverse Events

For the purpose of toxicity monitoring, toxicities are defined as any treatment -related grade 3 or 4 non-hematologic AEs occurred any time during the trial.NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 utilized for adverse event reporting. (NCT03488225)
Timeframe: Start of treatment up to 30 days after last dose received.

InterventionParticipants (Count of Participants)
Neutropenic FeverPeripheral Sensory NeuropathyAllergic ReactionMuscle Weakness
Treatment (Hyper-CVAD, Inotuzumab Ozogamicin)2111

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Number of Participants With Minimal Residual Disease (MRD)-Negative Complete Remission (CR) at The End of Induction Phase

MRD-negative CR was achieved when a participant met the criteria for both MRD negativity and CR. MRD-negativity: ≤0.01 % breakpoint cluster region-Abelson (BCR-ABL1/ABL1), or undetectable BCR-ABL1 transcripts in complementary deoxyribonucleic acid (cDNA) with ≥ 10,000 ABL1 transcripts. CR: meeting all the following for at least 4 weeks (that is no recurrence):1. No circulating blasts and less than (<) 5% blasts in the bone marrow (BM). 2. Normal maturation of all cellular components in the BM. 3. No extramedullary disease (central nervous system [CNS] involvement, lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass). 4. Absolute neutrophil count (ANC) > 1000 per microliter (/mcL) (or >1.0*10^9/L). 5. Platelets >100,000/mcL (or >100*10^9/L). (NCT03589326)
Timeframe: From Cycle 1 through Cycle 3 (approximately 3 months) (Cycle length = 28 days)

InterventionParticipants (Count of Participants)
Cohort A: Ponatinib 30 mg53
Cohort B: Imatinib 600 mg13

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Number of Participants With Absence of Disease Flare From Week 12 Through Week 24: ITT Population

Disease flare was defined as either recurrence of signs and symptoms attributable to active GCA plus an increase in CS dose due to GCA, or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA. Number of participants with absence of disease flare from Week 12 through Week 24 were reported. (NCT03600805)
Timeframe: From Week 12 through Week 24

InterventionParticipants (Count of Participants)
Placebo+52 Week Taper21
Placebo+26 Week Taper7
Sarilumab 150mg q2w+26 Week Taper10
Sarilumab 200mg q2w+26 Week Taper15

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Pharmacodynamics: Change From Baseline in Interleukin-6 (IL-6) at Weeks 2, 12, 24, and 52

Interleukin-6 is a protein produced in the body. Levels of IL-6 often increase when there is inflammation (redness, warmth, swelling, and pain as a result of infection, irritation, or injury), either acute or chronic. (NCT03600805)
Timeframe: Baseline, Weeks 2, 12, 24, and 52

,,,
Interventionnanograms per Liter (Mean)
BaselineWeek 2Week 12Week 24Week 52
Placebo+26 Week Taper8.743.475.565.572.82
Placebo+52 Week Taper10.912.90-0.88-1.030.43
Sarilumab 150mg q2w+26 Week Taper11.0331.7452.3853.6042.14
Sarilumab 200mg q2w+26 Week Taper7.71117.3381.8269.2033.28

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Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab

Ctrough was pre dose concentration of drug. Data for this outcome measure was not planned to be collected and analyzed for placebo arms (Placebo+52 Week Taper and Placebo+26 Week Taper) as pre-specified in the protocol. (NCT03600805)
Timeframe: Pre-dose on Week 0 (Baseline), Weeks 2, 4, 12, 16, 24 and 52

,
Interventionnanograms per milliliter (Mean)
BaselineWeek 2Week 4Week 12Week 16Week 24Week 52
Sarilumab 150mg q2w+26 Week Taper0.002099.294644.718371.338111.0812926.6719780.00
Sarilumab 200mg q2w+26 Week Taper0.005400.8211640.9827586.0028911.8835451.7446766.67

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Pharmacodynamics: Change From Baseline in Soluble Interleukin-6 Receptor (sIL-6R) Level at Weeks 2, 12, 24, and 52

Interleukin-6 is a protein produced in the body. Levels of IL-6 often increase when there is inflammation (redness, warmth, swelling, and pain as a result of infection, irritation, or injury), either acute or chronic. sIL-6R is one of the receptors that bind IL-6. (NCT03600805)
Timeframe: Baseline, Weeks 2, 12, 24, and 52

,
Interventionnanograms per milliliter (Mean)
BaselineWeek 2Week 12Week 24Week 52
Sarilumab 150mg q2w+26 Week Taper50.05212.19336.30311.88377.23
Sarilumab 200mg q2w+26 Week Taper61.37224.87427.40456.09471.16

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Pharmacodynamics: Change From Baseline in Soluble Interleukin-6 Receptor (sIL-6R) Level at Weeks 2, 12, 24, and 52

Interleukin-6 is a protein produced in the body. Levels of IL-6 often increase when there is inflammation (redness, warmth, swelling, and pain as a result of infection, irritation, or injury), either acute or chronic. sIL-6R is one of the receptors that bind IL-6. (NCT03600805)
Timeframe: Baseline, Weeks 2, 12, 24, and 52

Interventionnanograms per milliliter (Mean)
BaselineWeek 12Week 24Week 52
Placebo+52 Week Taper136.6317.67-12.72-131.47

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Pharmacodynamics: Change From Baseline in Soluble Interleukin-6 Receptor (sIL-6R) Level at Weeks 2, 12, 24, and 52

Interleukin-6 is a protein produced in the body. Levels of IL-6 often increase when there is inflammation (redness, warmth, swelling, and pain as a result of infection, irritation, or injury), either acute or chronic. sIL-6R is one of the receptors that bind IL-6. (NCT03600805)
Timeframe: Baseline, Weeks 2, 12, 24, and 52

Interventionnanograms per milliliter (Mean)
BaselineWeek 52
Placebo+26 Week Taper54.80-9.69

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Pharmacodynamics: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52

ESR is a laboratory test to provide non-specific measure of inflammation in the body. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeters per hour. (NCT03600805)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52

,,,
Interventionmillimeters per hour (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24Week 32Week 40Week 52
Placebo+26 Week Taper21.90.75.210.29.89.88.813.96.64.0-1.4
Placebo+52 Week Taper29.3-1.1-4.2-2.0-1.5-4.1-6.6-4.2-7.0-1.5-1.0
Sarilumab 150mg q2w+26 Week Taper24.9-10.4-13.3-11.9-14.7-13.5-18.2-16.4-9.4-10.1-15.2
Sarilumab 200mg q2w+26 Week Taper18.2-8.8-9.4-8.7-11.0-10.4-10.9-9.3-7.9-7.9-7.0

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Pharmacodynamics: Change From Baseline in C-reactive Protein (CRP) Level at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52

CRP is a protein made by the liver. CRP levels increase in blood when inflammation occurs in the body. (NCT03600805)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 52

,,,
Interventionmilligrams per liter (Mean)
BaselineWeek 2Week 4Week 8Week 12Week 16Week 20Week 24Week 32Week 40Week 52
Placebo+26 Week Taper9.7-1.0-2.2-0.94.45.00.60.31.1-9.2-13.8
Placebo+52 Week Taper10.90.4-3.6-4.0-4.4-4.5-4.5-4.1-5.2-1.98.2
Sarilumab 150mg q2w+26 Week Taper10.1-3.5-2.6-3.5-3.3-5.0-4.9-3.1-5.8-2.2-4.5
Sarilumab 200mg q2w+26 Week Taper3.7-2.0-1.9-1.7-1.1-1.8-1.6-1.0-0.4-2.8-4.6

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Percentage of Participants With Treatment-emergent Antidrug Antibodies (ADA) Response

ADA response categories: 1) Treatment-boosted ADA positive participant: Participant with a positive ADA assay response at Baseline and with at least a 4-fold increase in titer compared to Baseline during TEAE period. 2) Treatment-emergent ADA positive participant: Participant with non-positive assay (meaning negative or missing) response at Baseline but with a positive assay response during the TEAE period (defined as the time from the first dose of the IMP to the last dose of the SC IMP + 60 days). Titer values were categorized as low (titer <1,000); moderate (1,000<= titer <=10,000) and high (titer >10,000). (NCT03600805)
Timeframe: From Day 1 (Baseline) up to last dose date of study drug + 60 days (i.e., up to Week 60)

,,,
Interventionpercentage of participants (Number)
Treatment-boosted ADA positive participantsTreatment-emergent ADA positive participants
Placebo+26 Week Taper00
Placebo+52 Week Taper03.8
Sarilumab 150mg q2w+26 Week Taper07.1
Sarilumab 200mg q2w+26 Week Taper00

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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. Serious AEs (SAEs) were any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were the AEs that developed or worsened or became serious during the TEAE period (defined as the time from the first dose of the investigational medicinal product (IMP) to the last dose of the SC IMP +60 days). (NCT03600805)
Timeframe: From first dose (i.e., Day 1) up to 60 days after last dose (i.e., up to Week 60)

,,,
InterventionParticipants (Count of Participants)
Any TEAEAny treatment emergent SAE
Placebo+26 Week Taper143
Placebo+52 Week Taper242
Sarilumab 150mg q2w+26 Week Taper132
Sarilumab 200mg q2w+26 Week Taper227

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Composite Glucocorticoid Toxicity Index: Cumulative Worsening Score and Aggregate Improvement Score at Week 52

GTI assessed glucocorticoid (GC) related morbidity and GC-sparing ability of other therapies; composed of 2 components: Composite GTI and Specific List. Composite GTI contained 9 domains and Specific List contained of 23 items (11 domains), used as complementary tool to C-GTI. Composite GTI score was the sum of 9 domain-specific scores at each visit and Cumulative GTI score was the sum of composite GTI scores across each visit. Two cumulative GTI scores: CWS and AIS at Week 52 are reported in this OM. CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects or was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. For CWS, composite score ranged from 0 to 439 and for AIS, composite score ranged from -346 to 439. For both CWS and AIS, the minimum score implies the least toxicity and the maximum score implies the most toxicity. (NCT03600805)
Timeframe: At Week 52

,,,
Interventionunits on a scale (Mean)
Cumulative worsening scoreAggregate improvement score
Placebo+26 Week Taper84.731.2
Placebo+52 Week Taper73.0-19.5
Sarilumab 150mg q2w+26 Week Taper77.223.7
Sarilumab 200mg q2w+26 Week Taper52.8-0.5

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Composite Glucocorticoid Toxicity Index (C-GTI): Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 24: ITT Population

GTI assessed glucocorticoid (GC) related morbidity and GC-sparing ability of other therapies; composed of 2 components: Composite GTI and Specific List. Composite GTI contained 9 domains and Specific List contained of 23 items (11 domains), used as complementary tool to C-GTI. Composite GTI score was the sum of 9 domain-specific scores at each visit and Cumulative GTI score was the sum of composite GTI scores across each visit. Two cumulative GTI scores: CWS and AIS at Week 24 are reported in this outcome measure (OM). CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects or was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. For CWS, composite score ranged from 0 to 439 and for AIS, composite score ranged from -346 to 439. For both CWS and AIS, the minimum score implies the least toxicity and the maximum score implies the most toxicity. (NCT03600805)
Timeframe: At Week 24

,,,
Interventionunits on a scale (Mean)
Cumulative worsening scoreAggregate improvement score
Placebo+26 Week Taper30.7-13.4
Placebo+52 Week Taper29.2-21.6
Sarilumab 150mg q2w+26 Week Taper55.114.2
Sarilumab 200mg q2w+26 Week Taper31.0-3.3

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Total Cumulative Corticosteroid (Including Prednisone) Dose

Cumulative dose of CS used for GCA disease was defined as the dose taken up to the end of treatment, including expected prednisone in tapering regimen per protocol, CS used in rescue therapy and the use of commercial prednisone (an excess of <=100 mg of prednisone during the study treatment period employed to manage AE not related to GCA). The total cumulative CS dose was based on the total number of days with complete or partial intake, no imputation was done on missed tablets. (NCT03600805)
Timeframe: Up to Week 52

Interventionmilligrams (Mean)
Placebo+52 Week Taper2577.3
Placebo+26 Week Taper2270.7
Sarilumab 150mg q2w+26 Week Taper2177.1
Sarilumab 200mg q2w+26 Week Taper1643.1

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Time to First Giant Cell Arteritis Disease Flare

Time to first GCA flare was defined as the duration (in days) from randomization to first GCA flare after clinical remission (defined as resolution of signs and symptoms and normalization of CRP [<10 mg/L]) and up to 52 weeks. Disease flare was defined as either the recurrence of signs or symptoms attributable to active plus an increase in CS dose due to GCA or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA. Kaplan-Meier method was used for the analysis. Participants who never achieved remission were censored at randomization day; and those who achieved clinical remission and never flared were censored at the end of treatment assessment date up to Week 52. (NCT03600805)
Timeframe: Up to Week 52

Interventiondays (Median)
Placebo+52 Week TaperNA
Placebo+26 Week Taper170.00
Sarilumab 150mg q2w+26 Week TaperNA
Sarilumab 200mg q2w+26 Week TaperNA

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Pharmacokinetics: Serum Drug Concentration of Sarilumab Post-dose at Week 24

Serum concentrations of functional sarilumab were analyzed using validated enzyme linked immunosorbent assay. (NCT03600805)
Timeframe: post-dose at Week 24

Interventionnanograms per milliliter (Mean)
Sarilumab 150mg q2w+26 Week Taper25255.45
Sarilumab 200mg q2w+26 Week Taper44551.54

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Percentage of Participants Who Achieved Sustained Disease Remission at Week 52

Disease remission was defined as resolution of signs and symptoms of giant cell arteries (GCA), and normalization of C-reactive protein (CRP) (<10 mg/L). Sustained remission was defined as meeting all of the following parameters: achievement of disease remission not later than Week 12, absence of disease flare (defined as recurrence of signs and symptoms attributable to active GCA plus an increase in corticosteroid [CS] dose due to GCA or elevation of erythrocyte sedimentation rate [ESR] attributable to active GCA plus an increase in CS dose due to GCA) from Week 12 through Week 52, normalization of CRP (to <10 mg/L, with absence of successive elevations to >=10 mg/L) from Week 12 through Week 52, and successful adherence to prednisone taper from Week 12 through Week 52. (NCT03600805)
Timeframe: At Week 52

Interventionpercentage of participants (Number)
Placebo+52 Week Taper30.0
Placebo+26 Week Taper0
Sarilumab 150mg q2w+26 Week Taper42.9
Sarilumab 200mg q2w+26 Week Taper46.2

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Percentage of Participants Who Achieved Sustained Disease Remission at Week 24

Disease remission was defined as resolution of signs and symptoms of GCA, and normalization of CRP <10 mg/L. Sustained remission was defined as meeting all of the following parameters: achievement of disease remission not later than Week 12, absence of disease flare (defined as recurrence of signs and symptoms attributable to active GCA plus an increase in CS dose due to GCA, or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA) from Week 12 through Week 24, normalization of CRP (to <10 mg/L, with an absence of successive elevations to >=10 mg/L) from Week 12 through Week 24, and successful adherence to the prednisone taper from Week 12 through Week 24. (NCT03600805)
Timeframe: At Week 24

Interventionpercentage of participants (Number)
Placebo+52 Week Taper39.3
Placebo+26 Week Taper7.1
Sarilumab 150mg q2w+26 Week Taper42.9
Sarilumab 200mg q2w+26 Week Taper48.1

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Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 52: Week 52 Analysis Set

Successful adherence to the prednisone taper from Week 12 through Week 52 was defined as participants who did not take rescue therapy from Week 12 through Week 52 and might include the use of any excess prednisone (beyond the per protocol CS tapering regimen) with a cumulative dose of <=100 mg (or equivalent), such as those employed to manage adverse event (AE) not related to GCA. (NCT03600805)
Timeframe: From Week 12 through Week 52

InterventionParticipants (Count of Participants)
Placebo+52 Week Taper6
Placebo+26 Week Taper2
Sarilumab 150mg q2w+26 Week Taper3
Sarilumab 200mg q2w+26 Week Taper6

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Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 24: ITT Population

Successful adherence to the prednisone taper from Week 12 through Week 24 was defined as participants who did not take rescue therapy from Week 12 through Week 24 and might include the use of any excess prednisone (beyond the per protocol CS tapering regimen) with a cumulative dose of <=100 mg (or equivalent), such as those employed to manage AE not related to GCA. (NCT03600805)
Timeframe: From Week 12 through Week 24

InterventionParticipants (Count of Participants)
Placebo+52 Week Taper18
Placebo+26 Week Taper5
Sarilumab 150mg q2w+26 Week Taper7
Sarilumab 200mg q2w+26 Week Taper13

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Number of Participants With Normalization of C-Reactive Protein From Week 12 Through Week 52: Week 52 Analysis Set

Normalization of CRP was defined as CRP levels <10 mg/L. If there were two or more consecutive visits with CRP >=10 mg/L, then it was categorized as no normalization of CRP. (NCT03600805)
Timeframe: From Week 12 through Week 52

InterventionParticipants (Count of Participants)
Placebo+52 Week Taper6
Placebo+26 Week Taper3
Sarilumab 150mg q2w+26 Week Taper5
Sarilumab 200mg q2w+26 Week Taper8

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Number of Participants With Normalization of C-Reactive Protein (CRP) From Week 12 Through Week 24: ITT Population

Normalization of CRP was defined as CRP levels <10 mg/L. If there were two or more consecutive visits with CRP >=10 mg/L, then it was categorized as no normalization of CRP. (NCT03600805)
Timeframe: From Week 12 through Week 24

InterventionParticipants (Count of Participants)
Placebo+52 Week Taper20
Placebo+26 Week Taper4
Sarilumab 150mg q2w+26 Week Taper11
Sarilumab 200mg q2w+26 Week Taper17

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Number of Participants With Achievement of Disease Remission up to Week 12: Week 52 Analysis Set

Disease remission was defined as resolution of signs and symptoms of GCA, and normalization of CRP (< 10 mg/L). The status of normalization of CRP (<10 mg/L) was determined based on the last two non-missing post-baseline CRP values measured up to Week 12. If at least one of the value was <10 mg/L, then it was considered as normalization of CRP. Participants who took rescue corticosteroid (CS) due to active GCA prior to Week 12 or who permanently withdrew from the study treatment prior to Week 12 were considered as not achieved disease remission by Week 12. (NCT03600805)
Timeframe: Up to Week 12

InterventionParticipants (Count of Participants)
Placebo+52 Week Taper7
Placebo+26 Week Taper3
Sarilumab 150mg q2w+26 Week Taper4
Sarilumab 200mg q2w+26 Week Taper7

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Number of Participants With Achievement of Disease Remission up to Week 12: Intent-to-treat (ITT) Population

Disease remission was defined as resolution of signs and symptoms of GCA, and normalization of CRP (< 10 mg/L). The status of normalization of CRP (<10 mg/L) was determined based on the last two non-missing post-baseline CRP values measured up to Week 12. If at least one of the value was <10 mg/L, then it was considered as normalization of CRP. Participants who took rescue CS due to active GCA prior to Week 12 or who permanently withdrew from the study treatment prior to Week 12 were considered as not achieved disease remission by Week 12. (NCT03600805)
Timeframe: Up to Week 12

InterventionParticipants (Count of Participants)
Placebo+52 Week Taper16
Placebo+26 Week Taper6
Sarilumab 150mg q2w+26 Week Taper9
Sarilumab 200mg q2w+26 Week Taper15

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Number of Participants With Absence of Disease Flare From Week 12 Through Week 52: Week 52 Analysis Set

Disease flare was defined as either recurrence of signs and symptoms attributable to active GCA plus an increase in CS dose due to GCA, or elevation of ESR attributable to active GCA plus an increase in CS dose due to GCA. Number of participants with absence of disease flare from Week 12 through Week 52 were reported. (NCT03600805)
Timeframe: From Week 12 through Week 52

InterventionParticipants (Count of Participants)
Placebo+52 Week Taper7
Placebo+26 Week Taper3
Sarilumab 150mg q2w+26 Week Taper4
Sarilumab 200mg q2w+26 Week Taper7

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Number of Participants With Absence of Disease Flare From Week 12 Through Week 52

Disease flare was defined as either recurrence of signs and symptoms attributable to active PMR plus an increase in CS dose due to PMR, or elevation of ESR attributable to active PMR plus an increase in CS dose due to PMR. (NCT03600818)
Timeframe: From Week 12 Through Week 52

InterventionParticipants (Count of Participants)
Placebo+52 Week Taper19
Sarilumab 200mg q2w+14 Week Taper33

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Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During TEAE Period

"Criteria for potentially clinically significant vital sign abnormalities:~Systolic Blood Pressure (SBP): <= 95 mmHg and decrease from baseline (DFB) more than or equal to (>=) 20 mmHg; >= 160 mmHg and increase from baseline (IFB) >= 20 mmHg~Diastolic blood pressure (DBP): <=45 mmHg and DFB >=10 mmHg; >=110 mmHg and IFB >=10 mmHg.~Heart Rate (HR): <= 50 beats per min (bpm) and DFB >=20 bpm; >=120 bpm and IFB >= 20 bpm~Weight: >=5% DFB; >=5% IFB.~TEAE period was defined as the time from the first dose of the IMP to the last dose of the IMP + 60 days." (NCT03600818)
Timeframe: From first dose (i.e., Day 1) up to 60 days after last dose date of study drug (i.e., up to Week 60)

,
InterventionParticipants (Count of Participants)
SBP <=95 mmHg and DFB >=20 mmHgSBP >=160 mmHg and IFB >=20 mmHgDBP <=45 mmHg and DFB >=10 mmHgDBP >=110 mmHg and IFB >=10 mmHgHR <=50 bpm and DFB >= 20 bpmHR >=120 bpm and IFB >=20 bpmWeight >=5% DFBWeight >=5% IFB
Placebo+52 Week Taper04111129
Sarilumab 200mg q2w+14 Week Taper250100512

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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. Serious AEs (SAEs) were any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were the AEs that developed or worsened or became serious during the TEAE period (defined as the time from the first dose of the investigational medicinal product (IMP) to the last dose of the IMP +60 days). (NCT03600818)
Timeframe: From first dose (i.e. Day 1) up to 60 days after last dose date of study drug (i.e. up to Week 60)

,
InterventionParticipants (Count of Participants)
Any TEAETESAE
Placebo+52 Week Taper4912
Sarilumab 200mg q2w+14 Week Taper568

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Number of Participants With Treatment-emergent Antidrug Antibodies (ADA) Response

ADA response categories: 1) Treatment-boosted ADA positive participant: Participant with a positive ADA assay response at Baseline and with at least a 4-fold increase in titer compared to Baseline during TEAE period. 2) Treatment-emergent ADA positive participant: Participant with non-positive assay (meaning negative or missing) response at Baseline but with a positive assay response during the TEAE period (defined as the time from the first dose of the IMP to the last dose of the IMP +60 days). (NCT03600818)
Timeframe: From first dose (i.e., Day 1) up to 60 days after last dose date of study drug (i.e., up to Week 60)

,
InterventionParticipants (Count of Participants)
Treatment-boosted ADATreatment-emergent ADA
Placebo+52 Week Taper01
Sarilumab 200mg q2w+14 Week Taper02

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Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function

"Criteria for potentially clinically significant abnormalities:~Albumin: <= 25 g/L.~Alanine Aminotransferase (ALT): >3 ULN; >5 ULN; >10 ULN.~Aspartate Aminotransferase (AST): >3 ULN; >5 ULN; >10 ULN; >20 ULN.~Alkaline Phosphatase: >1.5 ULN.~Bilirubin: >1.5 ULN; >2 ULN.~ALT and Total Bilirubin: ALT > 3 ULN and Bilirubin > 2 ULN" (NCT03600818)
Timeframe: From first dose (i.e., Day 1) up to 60 days after last dose date of study drug (i.e., up to Week 60)

,
InterventionParticipants (Count of Participants)
Albumin: <= 25 g/LALT: >3 ULNALT: >5 ULNALT: >10 ULNAST: >3 ULNAST: >5 ULNAST: >10 ULNAST: >20 ULNAlkaline Phosphatase: >1.5 ULNBilirubin: >1.5 ULNBilirubin: >2 ULNALT > 3 ULN and Bilirubin > 2 ULN
Placebo+52 Week Taper021011101100
Sarilumab 200mg q2w+14 Week Taper000000000100

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Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameter

"Criteria for potentially clinically significant laboratory abnormalities included:~Hemoglobin (Hb): <= 115 grams per liter (g/L) (Male [M]), <= 95 g/L (Female [F]); >= 185 g/L (M), >= 165 g/L (F); DFB >= 20 g/L .~Hematocrit: <= 0.37 volume/volume (v/v) (M); <= 0.32 v/v (F); >= 0.55 v/v (M); >= 0.5 v/v (F).~Erythrocytes: >=6 Tera/ liter (L).~Platelets: < 100 Giga/L, >= 700 Giga/L.~Leukocytes: < 3.0 Giga/L (Non-Black [NB]); < 2.0 Giga/L (Black [B]), >= 16.0 Giga/L.~Neutrophils: < 1.5 Giga/L (NB); < 1.0 Giga/L (B).~Lymphocytes: > 4.0 Giga/L.~Monocytes: > 0.7 Giga/L.~Basophils: > 0.1 Giga/L.~Eosinophils: > 0.5 Giga/L or > upper limit of normal (ULN) (if ULN >= 0.5 Giga/L)." (NCT03600818)
Timeframe: From first dose (i.e., Day 1) up to 60 days after last dose date of study drug (i.e., up to Week 60)

,
InterventionParticipants (Count of Participants)
Hb: <= 115 g/L (M), <= 95 g/L (F)Hb: >=185 g/L(M), >=165 g/L(F)Hb: DFB >=20 g/LHematocrit: <= 0.37 v/v(M); <=0.32 v/v(F)Hematocrit: >=0.55 v/v(M); >=0.5 v/v(F)Erythrocytes: >=6 Tera/LPlatelets: < 100 Giga/LPlatelets: >= 700 Giga/LLeukocytes:<3.0Giga/L(NB);<2.0Giga/L(B)Leukocytes: >= 16.0 Giga/L.Neutrophils: < 1.5 Giga/L (NB); < 1.0 Giga/L (B).Lymphocytes: > 4.0 Giga/LMonocytes: > 0.7 Giga/LBasophils: > 0.1 Giga/L.Eosinophils:>0.5 Giga/L; >ULN (if ULN>=0.5Giga/L)
Placebo+52 Week Taper10310000010412162
Sarilumab 200mg q2w+14 Week Taper112100201111828132

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Total Cumulative Corticosteroid Dose

Cumulative dose of CS used for PMR disease was defined as the dose taken up to the end of treatment, including expected prednisone in tapering regimen per protocol, add-on prednisone, CS used in rescue therapy and the use of commercial prednisone (an excess of <=100 mg of prednisone during the study treatment period). The total cumulative CS dose was based on the total number of days with complete or partial intake, no imputation was done on missed tablets. (NCT03600818)
Timeframe: Up to Week 52

Interventionmilligrams (Mean)
Placebo+52 Week Taper2235.8
Sarilumab 200mg q2w+14 Week Taper1039.5

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Number of Participants Who Achieved Disease Remission up to Week 12

Disease remission was defined as resolution of signs and symptoms of PMR, and normalization of CRP (< 10 mg/L). The status of normalization of CRP (<10 mg/L) was determined based on the last two non-missing post-baseline CRP values measured up to Week 12. If at least one of the value was <10 mg/L, then it was considered as normalization of CRP. Participants who took rescue CS due to active PMR prior to Week 12 or who permanently withdrew from the study treatment prior to Week 12 were considered as not achieved disease remission by Week 12. During the initial 12 weeks of prednisone taper, treatment for one flare before Week 12 was permitted if it was successfully treated with a low dose (<=5 mg/day) prednisone add-on taper regimen (completed prior to Week 12) and provided that all other sustained remission parameters were met. (NCT03600818)
Timeframe: Up to Week 12

InterventionParticipants (Count of Participants)
Placebo+52 Week Taper22
Sarilumab 200mg q2w+14 Week Taper28

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Pharmacokinetics (PK): Serum Trough Concentration (Ctrough) of Sarilumab

Ctrough was pre dose concentration of drug. Data for this outcome measure was not planned to be collected and analyzed for placebo arm (Placebo+52 Week Taper) as pre-specified in the protocol. (NCT03600818)
Timeframe: Pre-dose on Week 0 (Baseline), Week 2, 4, 12, 16, 24, and 52

Interventionnanograms per milliliter (ng/mL) (Mean)
BaselineWeek 2Week 4Week 12Week 16Week 24Week 52
Sarilumab 200mg q2w+14 Week Taper0.005209.029259.2517494.2023082.8627289.7527604.95

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Number of Participants With Successful Adherence to the Prednisone Taper From Week 12 Through Week 52

Successful adherence to the prednisone taper from Week 12 through Week 52 was defined as participants who did not take rescue therapy from Week 12 through Week 52 and any excess prednisone (beyond the per protocol CS tapering regimen) with a cumulative dose of <=100 mg (or equivalent), such as those employed to manage adverse event (AE) not related to PMR. (NCT03600818)
Timeframe: From Week 12 through Week 52

InterventionParticipants (Count of Participants)
Placebo+52 Week Taper14
Sarilumab 200mg q2w+14 Week Taper30

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Number of Participants With Sustained Reduction of CRP From Week 12 Through Week 52

Normalization (sustained reduction) of CRP was defined as CRP levels <10 mg/L. If there were two or more consecutive visits with CRP >=10 mg/L, then it was categorized as no normalization of CRP. (NCT03600818)
Timeframe: From Week 12 through Week 52

InterventionParticipants (Count of Participants)
Placebo+52 Week Taper26
Sarilumab 200mg q2w+14 Week Taper40

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Percentage of Participants Achieving Sustained Remission at Week 52

Sustained remission was defined as meeting all of the following parameters: achievement of disease remission (defined as resolution of signs and symptoms of polymyalgia rheumatica [PMR], and normalization of C-reactive protein [CRP] {less than [<]10 milligrams per liter [mg/L]}) not later than Week 12, absence of disease flare (defined as recurrence of signs and symptoms attributable to active PMR plus an increase in corticosteroid [CS] dose due to PMR or elevation of erythrocyte sedimentation rate [ESR] attributable to active PMR plus an increase in CS dose due to PMR) from Week 12 through Week 52, sustained reduction of CRP (to <10 mg/L, with absence of successive elevations to greater than or equal to [>=]10 mg/L) from Week 12 through Week 52, and successful adherence to prednisone taper from Week 12 through Week 52. (NCT03600818)
Timeframe: At Week 52

Interventionpercentage of participants (Number)
Placebo+52 Week Taper10.3
Sarilumab 200mg q2w+14 Week Taper28.3

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Pharmacokinetics: Serum Drug Concentration of Sarilumab Post-dose at Week 24

Serum concentrations of functional sarilumab were analyzed using validated enzyme linked immunosorbent assay. (NCT03600818)
Timeframe: Post-dose at Week 24

Interventionng/mL (Mean)
Sarilumab 200mg q2w+14 Week Taper35757.69

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Time to First Polymyalgia Rheumatica Flare After Clinical Remission up to Week 52

Time to first PMR flare was defined as the duration (in days) from randomization to first PMR flare after clinical remission (defined as resolution of signs and symptoms and normalization of CRP [<10 mg/L]) and up to 52 weeks. Disease flare was defined as either the recurrence of signs or symptoms attributable to active plus an increase in CS dose due to PMR or elevation of ESR attributable to active PMR plus an increase in CS dose due to PMR. Kaplan-Meier method was used for the analysis. Participants who never achieved remission were censored at randomization day; and those who achieved clinical remission and never flared were censored at the end of treatment assessment date up to Week 52. (NCT03600818)
Timeframe: Up to Week 52

Interventiondays (Median)
Placebo+52 Week Taper99.00
Sarilumab 200mg q2w+14 Week TaperNA

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Composite Glucocorticoid Toxicity Index (C-GTI): Cumulative Worsening Score (CWS) and Aggregate Improvement Score (AIS) at Week 52

GTI assessed glucocorticoid (GC) related morbidity and GC-sparing ability of other therapies; composed of 2 components: C-GTI and Specific List. C-GTI contained 9 domains and Specific List contained of 23 items (11 domains), used as complementary tool to C-GTI. C-GTI score was sum of 9 domain-specific scores at each visit and Cumulative GTI score was sum of C-GTI scores across each visit. Two cumulative GTI scores: CWS and AIS at Week 52 are reported in this outcome measure. CWS assessed cumulative GC toxicity regardless of whether toxicity had lasting effects or was transient. AIS assessed new therapy effectiveness in decreasing any Baseline GC toxicity over time. Negative scores reflect improvement in CS toxicities present from Baseline. For CWS, composite score ranged from 0 to 439 and for AIS, composite score ranged from -346 to 439. For both CWS and AIS, minimum score implies least toxicity and maximum score implies most toxicity. (NCT03600818)
Timeframe: At Week 52

,
Interventionunits on a scale (Least Squares Mean)
CWSAIS
Placebo+52 Week Taper57.222.57
Sarilumab 200mg q2w+14 Week Taper52.32-4.02

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Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters

"Criteria for potentially clinically significant abnormalities:~Glucose: <=3.9 millimoles (mmol)/L and < lower limit of normal (LLN); >=11.1 mmol/L (unfasted [unfas]); >=7 mmol/L (fasted [fas]).~HbA1c: >8%.~Cholesterol: >=7.74 mmol/L.~Triglycerides: >=4.6 mmol/L.~C Reactive Protein (CRP): >2 ULN or >10 mg/L (if ULN not provided)." (NCT03600818)
Timeframe: From first dose (i.e., Day 1) up to 60 days after last dose date of study drug (i.e., up to Week 60)

,
InterventionParticipants (Count of Participants)
Glucose: <=3.9 mmol/L and < LLNGlucose: >=11.1 mmol/L (unfas); >=7 mmol/L (fas)HbA1c: >8%Cholesterol: >=7.74 mmol/LTriglycerides: >=4.6 mmol/LCRP: >2 ULN or >10 mg/L (if ULN not provided)
Placebo+52 Week Taper11444137
Sarilumab 200mg q2w+14 Week Taper2528313

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Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function

"Criteria for potentially clinically significant abnormalities:~Creatinine: >=150 micromol/L (adults); >=30% change from baseline, >=100% change from baseline.~Creatinine clearance: >=60 to <90 milliliters per minute (mL/min); >=30 to <60 mL/min ; >=15 to <30 mL/min; <15 mL/min.~Blood urea nitrogen: >=17 mmol/L.~Urate: <120 micromol/L; >408 micromol/L." (NCT03600818)
Timeframe: From first dose (i.e., Day 1) up to 60 days after last dose date of study drug (i.e., up to Week 60)

,
InterventionParticipants (Count of Participants)
Creatinine: >=150 micromol/L (adults)Creatinine: >=30% change from baselineCreatinine: >=100% change from baselineCreatinine clearance: >=60 to <90 mL/minCreatinine clearance: >=30 to <60 mL/minCreatinine clearance: >=15 to <30 mL/minCreatinine clearance: <15 mL/minBlood urea nitrogen: >=17 mmol/LUrate: <120 micromol/LUrate: >408 micromol/L
Placebo+52 Week Taper2303013000016
Sarilumab 200mg q2w+14 Week Taper21412917100016

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Rate of Undetectable Prostate Specific Antigen (PSA) (< 0.2)

The number of patients with undetectable PSA at 6-months will be summarized by each arm and all combined. (NCT03649841)
Timeframe: At 6 months after start of abiraterone acetate

InterventionParticipants (Count of Participants)
Arm I (ADT, Abiraterone, Prednisone)1
Arm II (ADT, Abiraterone, Prednisone, Radiation Therapy)1

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Incidence of Adverse Events

Will be assessed per Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Safety and tolerability as evaluated by the incidence, severity, duration, causality, seriousness of adverse events. Toxicities will be summarized as the number of patients with grade 3 or higher toxicities per CTCAE v4.0, in addition to total number of toxicities (allowing for multiple toxicities within a patient) among all patients, and per treatment arm. (NCT03649841)
Timeframe: Up to 6 months

InterventionParticipants (Count of Participants)
Arm I (ADT, Abiraterone, Prednisone)2
Arm II (ADT, Abiraterone, Prednisone, Radiation Therapy)0

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Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

A TEAE was defined as an AE that began or worsened from Baseline after the first administration of study drug. (NCT03721965)
Timeframe: up to 45 days

InterventionParticipants (Count of Participants)
Cohort 1 : Itacitinib + Corticosteroids2

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Adverse Events

Number and percentage of participants with at least one adverse event by week 52 (NCT03726749)
Timeframe: 52 weeks

InterventionParticipants (Count of Participants)
Tocilizumab Plus Prednisone Treatment30

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Cumulative Prednisone Dose

Cumulative prednisone dose (mg) by week 52 (NCT03726749)
Timeframe: 52 Weeks

Interventionmg (Mean)
Tocilizumab and Prednisone1187

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Disease Flares

Total number of disease flares by week 52. Flare was defined as the re-appearance of clinical manifestations of GCA with or without elevation of the inflammatory makers erythrocyte sedimentation rate (ESR) and/or C-reactive protein (CRP) (NCT03726749)
Timeframe: 52 Weeks

InterventionTotal number of flares (Number)
Tocilizumab and Prednisone9

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Serious Adverse Events

Number and percentage of participants with at least one serious adverse event by week 52 (NCT03726749)
Timeframe: 52 weeks

InterventionParticipants (Count of Participants)
Tocilizumab and Prednisone4

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Sustained Remission

Number and percentage of patients in sustained remission by week 52. Sustained remission was defined as the absence of disease flare between baseline and week 52. Flare was defined as the re-appearance of clinical manifestations of GCA with or without elevation of the inflammatory makers erythrocyte sedimentation rate (ESR) and/or C-reactive protein (CRP) (NCT03726749)
Timeframe: 52 weeks

InterventionParticipants (Count of Participants)
Tocilizumab and Prednisone23

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Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)

As per BICR, rPFS is time interval from the date of randomization to radiographic progression or death, whichever occurs first. Radiographic progression was determined by: 1) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per response evaluation criteria in solid tumors (RECIST) 1.1; 2) Progression of bone lesions observed by bone scan based on prostate cancer working group 3 (PCWG3) criteria. PCWG3 criteria: bone progression was confirmed by subsequent scan greater than or equal to (>=) 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. Confirmatory scan >=2 new lesions indicate progression; scan does not show >= 2 new lesions means no progression. If Week 8 scan less than (<) 2 new bone lesions compared to baseline, the initial scan >=2 new lesions compared to Week 8 scan indicates progression if confirmed by subsequent scan >=6 weeks later. (NCT03748641)
Timeframe: Up to 32 months

InterventionMonths (Median)
Cohort 1: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg16.46
Cohort 1: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg13.70

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Number of Participants With Significantly Decreased Expression of STAT1 Mediated Genes as Determined by RNA Sequencing

Peripheral blood RNA sequencing performed before and after 16 weeks of tofacitinib treatment. Significant changes are defined as at least 1.5 fold change in the expression of STAT1-mediated genes, with a false discover rate p value of < 0.05. (NCT03793439)
Timeframe: 16 weeks

InterventionParticipants (Count of Participants)
Open Label0

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Number of Participants With 50% Reduction in Corticosteroid Requirement

50% reduction in corticosteroid requirement by week 16, without significant decline in their pulmonary function-defined as a >15% decline in forced vital capacity (FVC), forced expiratory volume at 1 second (FEV1), or diffusing capacity of lung for carbon monoxide (DLCO) relative to the baseline value (NCT03793439)
Timeframe: 16 weeks

InterventionParticipants (Count of Participants)
Open Label3

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Duration of Overall Survival After Receiving Nivolumab, Tacrolimus, and Prednisone

The time from the participant's first dose of nivolumab to the date of death from any cause. (NCT03816332)
Timeframe: Up to 3 years

Interventionmonths (Median)
Nivolumab, Tacrolimus, and Prednisone9.1

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Duration of Progression-free Survival After Receiving Nivolumab, Tacrolimus, and Prednisone

From the first dose of nivolumab to the date of the first documented tumor progression or death due to any cause, whichever occurs first. (NCT03816332)
Timeframe: Up to 4 months

Interventiondays (Mean)
Nivolumab, Tacrolimus, and Prednisone59

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Rate of Allograft Loss After Receiving Ipilimumab, Nivolumab, Tacrolimus, and Prednisone

Number of patients who experienced allograft loss after receiving nivolumab, ipilimumab, tacrolimus, and prednisone. (NCT03816332)
Timeframe: Up to 3 years

InterventionParticipants (Count of Participants)
Experienced allograft lossDid not experience allograft loss
Ipilimumab, Nivolumab, Tacrolimus, and Prednisone33

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Number (and Percentage) of Outcome Responses After Receiving Nivolumab, Tacrolimus, and Prednisone

Percentage of kidney transplant recipients who experienced complete response (CR), partial response (PR) or stable disease (SD) without allograft loss. (NCT03816332)
Timeframe: At 16 weeks

InterventionParticipants (Count of Participants)
Complete response (CR), partial response (PR) or stable disease (SD) without allograft lossProgressive Disease (PD) without allograft loss
Nivolumab, Tacrolimus, and Prednisone08

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Objective Response Rate (ORR) at the End of Induction (EOI) Therapy

ORR at EOI therapy was defined as the percentage of particpants with either a CR, CR unconfirmed or PR at the EOI visit, as determined by the investigator and according to the guidelines used at the site. (NCT03817853)
Timeframe: Baseline up to end of induction therapy (up to approximately 6 months)

InterventionPercentage of Participants (Number)
Complete ResponsePartial Response
All Participants72.119.1

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Duration (In Minutes) of Obinutuzumab Administration by Cycle

The duration of obinutuzumab administration (in minutes) by cycle was defined as the difference between the end time and the start time of obinutuzumab administration. (NCT03817853)
Timeframe: All cycles including maintenance (1 cycle: 21 or 28 days depending on the chemotherapy selected; up to approximately 2.5 years)

InterventionMinutes (Mean)
Cycle(C) 1 Day(D) 1C1D8C1D15C2C3C4C5C6C7C8Maintenance Week 1Maintenance Week 9Maintenance Week 17Maintenance Week 25Maintenance Week 33Maintenance Week 41
All Participants295.96215.97207.52101.48102.9798.3398.2699.4999.5694.54101.4897.2197.6493.8392.5090.00

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Time to IRR From Infusion to Onset of the IRR During Cycle 2

Time to IRR (of any grade) in Cycle 2 was defined as the time from the start of infusion (i.e., start date/time of infusion of the first component of study treatment) in Cycle 2 to the onset of the IRR (of any grade) during Cycle 2. (NCT03817853)
Timeframe: From infusion to onset of IRR during Cycle 2 (1 cycle: 21 or 28 days depending on the chemotherapy selected)

InterventionHours (Mean)
All Participants11.800

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Percentage of Participants With Adverse Events (AEs)

An AE was defined as any untoward medical occurrence in a clinical investigation participant who was administered a pharmaceutical product, regardless of causal attribution. An AE was therefore any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsened during the study, recurrence of an intermittent medical condition, deterioration in a laboratory value or other clinical test or were related to a protocol-mandated intervention were also considered AEs. Grading was completed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. (NCT03817853)
Timeframe: Baseline up to clinical cut off date (up to approximately 1.5 years)

InterventionPercentage of Participants (Number)
All Participants99.1
Maintenance: Obinutuzumab41.1
Follow-up35.3

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Duration of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle

The duration, in minutes, of IRRs during all cycles, where obinutuzumab was administered as an SDI. (NCT03817853)
Timeframe: All cycles including maintenance (1 cycle: 21 or 28 days depending on the chemotherapy selected; up to approximately 2.5 years)

InterventionMinutes (Mean)
All Participants165.0

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Percentage of IRRs Regardless of Grade by Cycle

IRRs were defined as all adverse events (AEs) that occurred during or within 24 hours from the end of study treatment infusion and were judged as related to infusion of study treatment components by the investigator. (NCT03817853)
Timeframe: Within 24 hours from the end of study treatment infusion in all cycles, including maintenance ((1 cycle: 21 or 28 days depending on the chemotherapy selected); up to approximately 2.5 years)

InterventionPercentage of Participants (Number)
Cycle 1 Day 1Cycle 1 Day 2Cycle 1 Day 8Cycle 1 Day 15Cycle 2Cycle 3Cycle 4Cycle 5Cycle 6Cycle 7
All Participants49.67.84.54.511.88.34.96.23.64.4

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Type of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle

(NCT03817853)
Timeframe: All cycles including maintenance (1 cycle: 21 or 28 days depending on the chemotherapy selected; up to approximately 2.5 years)

InterventionPercentage of Participants (Number)
Cycle (C) 5- HypertensionC5 - Renal failureC5 - Weight increased
All Participants33.333.333.3

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Time to Signs/Symptoms of Giant Cell Arteritis (GCA) or New or Worsening Vasculitis on Imaging by Week 26

Kaplan-Meier method used to estimate the survival functions for each treatment arm. (NCT03827018)
Timeframe: Week 26

Interventionweeks (Median)
MavrilimumabNA
Placebo25.1

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Time to Elevated Erythrocyte Sedimentation Rate (ESR) by Week 26

Elevated ESR is defined as first occurrence of ESR value ≥ 30 mm/hr. Participants with elevated ESR within 3 days of first dose are excluded from the analysis. Kaplan-Meier method used to estimate the survival functions for each treatment arm. (NCT03827018)
Timeframe: Week 26

Interventionweeks (Median)
Mavrilimumab26.1
Placebo12.1

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Time to Elevated C-Reactive Protein (CRP) by Week 26

Elevated CRP is defined as first occurrence of CRP value ≥ 1.0 mg/dL. Participants with elevated CRP within 3 days of first dose are excluded from the analysis. Kaplan-Meier method used to estimate the survival functions for each treatment arm. (NCT03827018)
Timeframe: Week 26

Interventionweeks (Median)
MavrilimumabNA
Placebo12.3

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Cumulative Corticosteroid Dose at the End of the Washout Safety Follow-up Period

(NCT03827018)
Timeframe: Final Safety Follow-up visit (Week 38)

Interventionmg (Mean)
Mavrilimumab2464.93
Placebo2845.45

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Cumulative Corticosteroid Dose at Week 26

(NCT03827018)
Timeframe: Week 26

Interventionmg (Mean)
Mavrilimumab2074.15
Placebo2402.98

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Percentage of Participants Who Completed the 26-Week Corticosteroid Taper and Who Had a Normal CRP Level

Participants were considered to have completed the corticosteroid taper if by week 26 receiving 1 mg/day for those who start with 60 mg/day, or 0 mg/day for those who start with doses < 60 mg/day. 95% CI calculated using Clopper-Pearson confidence intervals. (NCT03827018)
Timeframe: Week 26

Interventionpercentage of participants (Number)
Mavrilimumab23.8
Placebo14.3

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Percentage of Participants Who Completed the 26-Week Corticosteroid Taper and Who Had a Normal ESR

Participants were considered to have completed the corticosteroid taper if by week 26 receiving 1 mg/day for those who start with 60 mg/day, or 0 mg/day for those who start with doses < 60 mg/day. 95% CI calculated using Clopper-Pearson confidence intervals. (NCT03827018)
Timeframe: Week 26

Interventionpercentage of participants (Number)
Mavrilimumab45.2
Placebo14.3

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Percentage of Participants Who Completed the 26-week Corticosteroid Taper and Who Had No Signs or Symptoms of GCA Nor New or Worsening Vasculitis by Imaging by Week 26

Participants were considered to have completed the corticosteroid taper if by week 26 receiving 1 mg/day for those who start with 60 mg/day, or 0 mg/day for those who start with doses < 60 mg/day. 95% CI calculated using Clopper-Pearson confidence intervals. (NCT03827018)
Timeframe: Week 26

Interventionpercentage of participants (Number)
Mavrilimumab71.4
Placebo32.1

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Sustained Remission Rate at Week 26

The sustained remission rate at Week 26 is defined as the percentage of participants with sustained remission, as assessed by independent adjudication, at Week 26, derived from the time to flare curve. Kaplan-Meier Survival Estimates with standard error and 95% CI for each arm. Participants who completed the treatment period without a flare by Week 26 were considered to have sustained remission. (NCT03827018)
Timeframe: Week 26

Interventionpercentage of participants (Number)
Mavrilimumab83.2
Placebo49.9

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Time to Flare by Week 26

"Time to flare by Week 26 was defined as time from randomization to the date of first flare occurring within the 26-week period, as assessed by independent adjudication. Kaplan-Meier method used to estimate the survival functions for each treatment arm.~Flare/relapse was defined as a C-reactive protein (CRP) of 1 mg/dL or greater and/or erythrocyte sedimentation rate (ESR) of 30 mm/h or greater AND at least one of the following signs or symptoms attributed to GCA: Cranial symptoms (new-onset localized headache; scalp or temporal artery tenderness; ischemic-related vision loss; unexplained mouth or jaw pain upon mastication; transient ischemic attack or stroke related to GCA); Extracranial symptoms (claudication of the extremities; symptoms of polymyalgia rheumatica); New or worsening angiographic abnormalities detected via MRI, CT/CTA, or PET-CT of the aorta or other great vessels or via ultrasound of the temporal arteries." (NCT03827018)
Timeframe: Week 26

Interventionweeks (Median)
MavrilimumabNA
Placebo25.1

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Prostate Specific Antigen Progression Free Survival (PSA-PFS)

Prostate Specific Antigen (PSA) will be measured every three months while on study. PSA Progression Free Survival (PSA-PSF) will be reported as the number of participants who have not demonstrated PSA progression by the end of the follow-up period. PSA progression is defined by meeting the following criteria: 1) an increase in PSA of greater than or equal to 25% from baseline or nadir, AND 2) an increase in PSA of at least 2 ng/dL, AND 3) the increase is confirmed at least 3 weeks later. This analysis was planned for up to 18 months following study enrollment, but the only participant enrolled on the study was only followed for 3 months. (NCT03827473)
Timeframe: Planned up to 18 months, but actual was 3 months

InterventionParticipants (Count of Participants)
Arm A (ADT, Docetaxel)1

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Prostate-specific Antigen (PSA) Response

PSA evaluations will occur every 3 months while on study. PSA response is defined as a reduction in PSA value of greater than or equal to 90% from baseline, reported as a count of participants who had a PSA response on the study. (NCT03827473)
Timeframe: Planned for up to 18 months, but actual was 3 months

InterventionParticipants (Count of Participants)
Arm A (ADT, Docetaxel)1

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Change in Quality of Life - FACT-P

The impact of abiraterone acetate and docetaxel on health related quality of life will be assessed every 3 months from screening to month 12 of treatment or follow-up. The scale used will be the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale. The total score ranges from 0 to 156, with higher scores indicating a higher quality of life. The primary endpoint was intended to be quality of life at 12 months, but since no participants completed 12 months of treatment/follow-up, scores at baseline and 3 months are reported instead. (NCT03827473)
Timeframe: Planned for up to one year, but actual was 3 months

Interventionscore on a scale (Number)
Baseline ScoreMonth 3 Score
Arm A (ADT, Docetaxel)139.83127

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Change in Quality of Life - FACT/GOG-NTX

Quality of Life questionnaires will be done every 3 months while participants are on treatment. The scale used will be the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG)-Neurotoxicity (NTX) (FACT/GOG-NTX) scale (version 4). FACT/GOG-NTX total score ranges from 0 to 152, with higher scores indicating a higher quality of life. (NCT03827473)
Timeframe: Planned for up to 18 months, but actual was 3 months

Interventionscore on a scale (Number)
Baseline ScoreMonth 3 Score
Arm A (ADT, Docetaxel)131.83126

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Change in Quality of Life - PROMIS Fatigue

Quality of Life questionnaires will be done every 3 months while participants are on treatment. The scale used will be the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue scale. Total raw scores range from 7 to 35, with higher scores indicating a higher level of fatigue. (NCT03827473)
Timeframe: Planned for up to 18 months, but actual was 3 months

Interventionscore on a scale (Number)
Baseline ScoreMonth 3 Score
Arm A (ADT, Docetaxel)1016

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Time to Radiographic Soft Tissue Progression Per Soft Tissue Rules of Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

The time to radiographic soft tissue progression was defined as the time from randomization to radiographic soft tissue progression per soft tissue rules of PCWG-modified RECIST 1.1 as assessed by BICR. Progression was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered progression. Time to radiographic soft tissue progression was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without radiographic soft tissue progression were censored at the last evaluable assessment. (NCT03834506)
Timeframe: Up to 36.5 months

InterventionMonths (Median)
Pembrolizumab + Docetaxel12.4
Placebo + Docetaxel11.2

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Time to Prostate-specific Antigen (PSA) Progression

"The time to PSA progression was the time from randomization to PSA progression. The PSA progression date was defined as the date of:~≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there was PSA decline from baseline; OR~≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there was no PSA decline from baseline~Time to PSA progression was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without PSA progression were censored at the last evaluable assessment." (NCT03834506)
Timeframe: Up to 36.5 months

InterventionMonths (Median)
Pembrolizumab + Docetaxel6.9
Placebo + Docetaxel7.0

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Time to Initiation of the First Subsequent Anti-cancer Therapy (TFST)

TFST was defined as the time from randomization to initiation of the first subsequent anti-cancer therapy or death; whichever occurred first. The TFST was calculated using the product-limit (Kaplan-Meier) method for censored data. Any participant not known to have further subsequent therapy or death was censored at the last known time that no subsequent new anti-cancer therapy was received. (NCT03834506)
Timeframe: Up to approximately 28 months

InterventionMonths (Median)
Pembrolizumab + Docetaxel10.7
Placebo + Docetaxel10.4

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Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE is presented. (NCT03834506)
Timeframe: Up to approximately 27 months

InterventionParticipants (Count of Participants)
Pembrolizumab + Docetaxel150
Placebo + Docetaxel115

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Duration of Response (DOR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review

DOR was defined as the time from first documented evidence of complete response (CR) or partial response (PR) per PCWG and RECIST 1.1 criteria until progressive disease (PD) or death. PD per RECIST 1.1 was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PD per PCWG was the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and were persistent for ≥6 weeks. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data. If a participant had not progressed, the participant was censored at the date of last disease assessment. (NCT03834506)
Timeframe: Up to 36.5 months

InterventionMonths (Median)
Pembrolizumab + Docetaxel6.3
Placebo + Docetaxel6.2

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"Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 (Worst Pain in 24 Hours) and Opiate Analgesic Use Assessed by the Analgesic Quantification Algorithm [AQA] Score"

"TTPP was defined as the time from randomization to pain progression as determined by Item 3 of the BPI-SF and by the AQA score. Pain progression was defined as:~For participants asymptomatic at baseline: a ≥2-point change from baseline in the average (4-7 days) BPI-SF item 3 score at 2 consecutive visits OR initiation of opioid use for pain~For participants symptomatic at baseline (average BPI-SF Item 3 score >0 and/or currently taking opioids:, a ≥2-point change from baseline in the average BPI-SF Item 3 score and an average worst pain score ≥4 and no decrease in average opioid use (≥1-point decrease in AQA score from a starting value of 2 or higher) OR any increase in opioid use at 2 consecutive follow-up visits.~TTPP was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants who had > 2 consecutive visits that were not evaluable for pain progression were censored at the last evaluable assessment." (NCT03834506)
Timeframe: Up to 36.5 months

InterventionMonths (Median)
Pembrolizumab + Docetaxel21.1
Placebo + DocetaxelNA

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Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

rPFS was defined as the time from randomization to occurrence of: radiological tumor progression using RECIST 1.1 as assessed by BICR; progression of bone lesions using PCWG criteria; or death due to any cause. Progression as per RECIST 1.1 was ≥20% increase in sum of diameters of target lesions and progression of existing non-target lesions. Progression of bone lesions by PCWG criteria was the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and was persistent for ≥6 weeks. The rPFS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without a rPFS event were censored at the date of last disease assessment. (NCT03834506)
Timeframe: Up to approximately 28 months

InterventionMonths (Median)
Pembrolizumab + Docetaxel8.6
Placebo + Docetaxel8.3

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Overall Survival (OS)

OS was defined as the time from randomization to death due to any cause. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. (NCT03834506)
Timeframe: Up to 36.5 months

InterventionMonths (Median)
Pembrolizumab + Docetaxel19.6
Placebo + Docetaxel19.0

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Objective Response Rate (ORR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review

ORR was defined as the percentage of participants with complete response (CR: disappearance of all target lesions per RECIST 1.1; and no evidence of disease (NED) on bone scan per PCWG) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1; and non-progressive disease, non-evaluable [NE], or NED on bone scan or CR with non-progressive disease or NE bone scan per PCWG). (NCT03834506)
Timeframe: Up to 36.5 months

InterventionPercentage of participants (Number)
Pembrolizumab + Docetaxel33.5
Placebo + Docetaxel35.3

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Number of Participants Who Experienced an Adverse Event (AE)

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE is presented. (NCT03834506)
Timeframe: Up to approximately 30 months

InterventionParticipants (Count of Participants)
Pembrolizumab + Docetaxel508
Placebo + Docetaxel505

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Prostate-specific Antigen (PSA) Response Rate

The Prostate-specific Antigen (PSA) response rate was the percentage of participants who had PSA response defined as a reduction in the PSA level from baseline by ≥50%. The reduction in PSA level was confirmed by an additional PSA evaluation performed ≥3 weeks from the original response. The analysis was performed on participants who had baseline PSA measurements. (NCT03834506)
Timeframe: Up to 36.5 months

InterventionPercentage of participants (Number)
Pembrolizumab + Docetaxel44.5
Placebo + Docetaxel45.7

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Radiographic Progression-Free Survival (rPFS)

rPFS is defined as the time from randomization to the first documented progressive disease (PD) per PCWG-modified RECIST 1.1 based on BICR or death due to any cause, whichever occurred first. Per PCWG-modified RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions or ≥2 new bone lesions was also considered PD. PCWG-modified RECIST is similar to RECIST 1.1 with the exception that a confirmation assessment of PD (>4 weeks after the initial PD) is required for participants who remain on treatment following a documented PD per RECIST 1.1 and PCWG rules include new bone lesions. The rPFS per PCWG-modified RECIST as assessed by BICR for all participants is presented. The nonparametric Kaplan-Meier method was used to estimate the survival curves. (NCT03834519)
Timeframe: Up to ~31 months

InterventionMonths (Median)
Pembrolizumab + Olaparib4.4
Next-generation Hormonal Agent Monotherapy (NHA)4.2

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Overall Survival (OS)

Overall survival (OS) is defined as the time from randomization to death due to any cause. The nonparametric Kaplan-Meier method was used to estimate the survival curves. (NCT03834519)
Timeframe: Up to ~31 months

InterventionMonths (Median)
Pembrolizumab + Olaparib15.8
Next-generation Hormonal Agent Monotherapy (NHA)14.6

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IFX-1 Blocking Activity 10 nM

Pharmacodynamics endpoint: IFX-1 blocking activity 10 nM (NCT03895801)
Timeframe: Week 16

Interventionpercentage of IFX-1 blocking activity (Mean)
IFX-1 + Placebo-GC100.571
IFX-1 + Reduced Dose GC100.508

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Vasculitis Damage Index (VDI)

Efficacy endpoint: Absolute values of VDI; The VDI total score ranges from 0 to 64 with higher scores indicating more organ damage since the onset of vasculitis. The total score is the number of present damage items. (NCT03895801)
Timeframe: Week 16

Interventionscore on a scale (Mean)
IFX-1 + Placebo-GC1.0
Placebo-IFX-1 + Standard Dose GC1.5
IFX-1 + Reduced Dose GC1.9

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Change From Baseline in BVASv3 Total Score

Efficacy endpoint: Absolute Change from baseline (= screening assessment) in Birmingham Vasculitis Activity Score version 3 (BVASv3) total score; The BVASv3 score ranges from 0 to 63 with higher values representing higher disease activity. The total score is derived by summing up item scores according to the scoring manual for the BVASv3. (NCT03895801)
Timeframe: Baseline, Week 16

Interventionscore on a scale (Mean)
IFX-1 + Placebo-GC-13.8
Placebo-IFX-1 + Standard Dose GC-14.7
IFX-1 + Reduced Dose GC-16.6

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Plasma Concentrations of C5a

Pharmacodynamics endpoint: Plasma concentrations of C5a (NCT03895801)
Timeframe: Week 16

Interventionng/mL (Mean)
IFX-1 + Placebo-GC10.6816
Placebo-IFX-1 + Standard Dose GC39.2822
IFX-1 + Reduced Dose GC13.6320

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Physician Global Assessment (PGA)

Efficacy endpoint: Absolute values in PGA; Physician global assessment scale: 0 = Remission to 10 = Maximum activity; (NCT03895801)
Timeframe: Week 16

Interventionscore on a scale (Mean)
IFX-1 + Placebo-GC0.4
Placebo-IFX-1 + Standard Dose GC0.1
IFX-1 + Reduced Dose GC0.7

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IFX-1 Plasma Concentrations (Pre-dose)

Pharmacokinetics endpoint: IFX-1 plasma concentrations assessed prior to study drug administration at corresponding visit. (NCT03895801)
Timeframe: Week 16 (pre-dose)

Interventionng/mL (Geometric Mean)
IFX-1 + Placebo-GC67077.19
Placebo-IFX-1 + Standard Dose GC47.80
IFX-1 + Reduced Dose GC52597.85

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IFX-1 Blocking Activity 2.5 nM

Pharmacodynamics endpoint: IFX-1 blocking activity 2.5 nM (NCT03895801)
Timeframe: Week 16

Interventionpercentage of IFX-1 blocking activity (Mean)
IFX-1 + Placebo-GC98.260
IFX-1 + Reduced Dose GC121.881

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Glucocorticoid Toxicity Index (GTI)

"Safety endpoint: The GTI total score ranges from -35 to 410 (because the bone domain is excluded in this study) with higher score indicating greater Glucocorticoid toxicity. Scoring was performed in the electronic case report form according to the corresponding scoring manual in Development of a Glucocorticoid Toxicity Index (GTI) using multicriteria decision analysis. by Miloslavsky EM, Naden RP, Bijlsma JW, Brogan PA, Brown ES, Brunetta P, et al." (NCT03895801)
Timeframe: Week 16

Interventionscore on a scale (Mean)
IFX-1 + Placebo-GC0.8
Placebo-IFX-1 + Standard Dose GC44.9
IFX-1 + Reduced Dose GC26.1

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Percentage of Subjects With Clinical Remission

Efficacy endpoint: Percentage of subjects with clinical remission, defined as having a BVASv3 = 0. Subjects who received rescue therapy after Day 1 or discontinued due to related adverse event, lack of efficacy or progressive disease are considered as non-responders at all subsequent visits. The BVASv3 score ranges from 0 to 63 with higher values representing higher disease activity. (NCT03895801)
Timeframe: Week 16

InterventionParticipants (Count of Participants)
IFX-1 + Placebo-GC14
Placebo-IFX-1 + Standard Dose GC20
IFX-1 + Reduced Dose GC10

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Percentage of Subjects Achieving Clinical Response

Efficacy Endpoint: Percentage of subjects achieving clinical response (reduction in Birmingham Vasculitis Activity Score version 3 [BVASv3] of ≥50% compared to baseline and no worsening in any body system). Subjects who received rescue therapy after Day 1 or discontinued due to related adverse event, lack of efficacy or progressive disease are considered as non-responders at all subsequent visits. The BVASv3 score ranges from 0 to 63 with higher values representing higher disease activity. (NCT03895801)
Timeframe: Baseline, Week 16

InterventionParticipants (Count of Participants)
IFX-1 + Placebo-GC16
Placebo-IFX-1 + Standard Dose GC22
IFX-1 + Reduced Dose GC10

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Number and Percentage of Subjects Who Had a Treatment-emergent Adverse Event (TEAE)

Safety endpoint: Number and percentage of subjects who had a treatment-emergent adverse event (TEAE) (NCT03895801)
Timeframe: Week 24

InterventionParticipants (Count of Participants)
IFX-1 + Placebo-GC16
Placebo-IFX-1 + Standard Dose GC24
IFX-1 + Reduced Dose GC15

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Estimated Glomerular Filtration Rate

"Efficacy endpoint: Absolute values of estimated glomerular filtration rate (eGFR) in mL/min/1.73 m²; The eGFR was calculated by the central laboratory according to the Modified Diet in Renal Disease equation:~eGFR = 175 x (serum creatinine, mg/dL)-1.154 x (age, years)-0.203 x (0.742 if female) x (1.212 if black)" (NCT03895801)
Timeframe: Week 16

InterventionmL/min/1.73 m² (Mean)
IFX-1 + Placebo-GC50.2
Placebo-IFX-1 + Standard Dose GC57.0
IFX-1 + Reduced Dose GC51.2

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Fasting Glucose

mg/dL, 0-unlimited, higher score indicates worse outcome (NCT04054375)
Timeframe: Baseline and 6 months (Final Visit)

Interventionmg/dL (Mean)
BaselineEnd
Weekly Steroid93102

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Fasting Lipid Profile

cholesterol levels - mg/dL, higher levels indicate worse outcomes (NCT04054375)
Timeframe: Baseline and 6 months (Final Visit)

Interventionmg/dL (Mean)
BaselineEnd
Weekly Steroid182185

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Muscle Strength Test

Manual motor testing of the right knee flexion muscle group. (NCT04054375)
Timeframe: baseline, 6 months

InterventionUnits on scale (Mean)
Baseline6 months
Weekly Steroid33

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Functional Assessments - Upper Limb Strength

"Grip strength of the total force (Newtons) in both hands.~Participants attempted 3 trials in the right hand that was then averaged to create a right-hand average force score.~Then, the participants attempted 3 trials in the left hand that was then averaged to create a left-hand average force score.~The right-hand average force score was added to the left-hand average force score to create a total grip strength score." (NCT04054375)
Timeframe: Baseline and 6 months

InterventionForce (Newtons) (Mean)
Baseline6 months
Weekly Steroid3941

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Respiratory Changes

Force Vital Capacity (% of predicted value), decrease in FVC indicates declining respiratory function. (NCT04054375)
Timeframe: Baseline, 6 months

Intervention% Expected (Mean)
BaselineEnd
Weekly Steroid8079

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Creatine Kinase

units/L, 0-unlimited, higher scores indicate worse outcome (NCT04054375)
Timeframe: Baseline and 6 months (Final Visit)

InterventionU/L (Mean)
BaselineEnd
Weekly Steroid15741047

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Brooke Scale Score

upper extremity assessment, scoring between 1- 6, lower score indicates more upper extremity function (NCT04054375)
Timeframe: Baseline, Month 6

Interventionscores on a scale (Mean)
baseline6 months
Weekly Steroid33

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Bone Density

"whole dexa body scan to assess bone density with Z scores (more negative z score indicates increased risk for fractures).~Z-score of 0 represents the population mean, and is the average bone density. Positive scores indicate greater bone density and negative scores indicate decreased bone density, which could be clinically correlated with osteoporosis." (NCT04054375)
Timeframe: Baseline, 6 months

Interventionz-score (Mean)
baseline6 months
Weekly Steroid-1.64-1.65

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Vignos Scale Score

Lower extremity assessment, score from 1-10, lower score indicates more function. (NCT04054375)
Timeframe: Baseline, Month 6

Interventionscores on a scale (Mean)
baseline6 months
Steroid Treatment Group55

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HbgA1c

% , 0-100, higher score indicates worse outcome (NCT04054375)
Timeframe: Baseline and 6 months (Final Visit)

Intervention% A1c (Mean)
BaselineEnd
Weekly Steroid5.25.3

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6 Minute Walk Test

number of meters walked in 6 minute period. Higher values indicate more motor function. (NCT04054375)
Timeframe: Baseline, Month 6

Interventionmeters (Mean)
Baseline6 months
Steroid Group386410

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10 Meter Run Timed

time in seconds to walk/run 10 meters , less time to run indicates greater motor function (NCT04054375)
Timeframe: Baseline, Month 6

Interventionseconds (Mean)
Baseline6 months
Steroid Treatment7.326.67

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Muscle Imaging

MRI of leg muscles to measure changes in muscle fat percentage. The data point was collected by taking fat percentage at 6 months minus fat percentage at baseline with the following equation: (([final fat percentage - initial fat percentage]/initial fat percentage) * 100%)). All participants were included, both ambulatory and nonambulatory, with all genetic subtypes included. Five participants didn't have an MRI scan at 6 months and therefore were not included. Muscles imaged were analyzed for muscle fat changes from baseline to 6 months. Data is limited in interpretation due to various muscle groups in both ambulatory and non-ambulatory patients. (NCT04054375)
Timeframe: Baseline, 6 months

Interventionpercent of change from baseline (Mean)
Weekly Steroid-14

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Lean Mass %

whole body dexa scans to assess lean mass % (0- 100 %). Increase lean mass % is the desired outcome. (NCT04054375)
Timeframe: Baseline, 6 months

Interventionpercentage (Mean)
baseline6 months
Weekly Steroid37.538.1

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Functional Assessments - NSAD Change

"Northstar Assessment for Dysferlinopathy~- score out of 58, range from 0 to 58, higher score indicates greater functional ability." (NCT04054375)
Timeframe: Baseline, Month 6

Interventionscore on a scale (Mean)
baseline6 months
Weekly Steroid18.418.6

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Number of Participants With AKI (Acute Kidney Injury)

"Increase in creatinine of 50% above baseline over a period of 7 days~Increase in creatinine of 0.3 mg/dl within a period of 48 hrs~Onset of renal failure requiring dialysis" (NCT04072822)
Timeframe: 7, 30, and 90 days

,
InterventionParticipants (Number)
Day 7Day 30Day 90
Anakinra and Zinc17205
Prednisone465

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Number of Participants With Changes in Sequential Organ Failure Assessment (SOFA) Scores and Proportions Requiring Hemodynamic Support for MAP < 65 mm Hg and Lactate > 2 mmol/l, Renal Replacement Therapy or Mechanical Ventilation.

"The SOFA score will be calculated at the following website https://www.mdcalc.com/sequential-organ-failure-assessment-sofa-score~Scores can be from 0 - >14 (favorable to less favorable)" (NCT04072822)
Timeframe: 180 days

,
InterventionParticipants (Number)
Increase in SOFA > 2 pointsNeed for hemodynamic supportRenal replacement therapy
Anakinra and Zinc31110
Prednisone397

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Number of Participants Requiring Transfer to ICU for Care, Intubation for Airway Control, Need for Ventilator Support or RRT.

(NCT04072822)
Timeframe: 180 days

InterventionParticipant counts (Number)
Prednisone6
Anakinra and Zinc15

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Number of Participants With Infections

(NCT04072822)
Timeframe: 180 days

Interventionparticipants (Number)
Prednisone20
Anakinra and Zinc23

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Percentage of Participants With Renal Dysfunction

Defined by a creatinine > 2 mg/dl (NCT04072822)
Timeframe: 180 days

InterventionPercentage of Participants (Number)
Prednisone21.9
Anakinra and Zinc47.3

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Survival at 90 Days

The primary analysis will be comparisons of 90-day mortality of Prednisone and Anakinra plus zinc vs Prednisone. (NCT04072822)
Timeframe: 90 days

Interventionpercentage of participants (Number)
Prednisone90
Anakinra and Zinc70

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To Measure the Changes in Lille Score

"Change in Lille score is represented as the percentage of participants who achieved a Lille score < 0.45 on day 7.~The Lille score will be calculated using the following website: https://www.mdcalc.com/lille-model-alcoholic-hepatitis Lille score = (exp(-R))/(1 + exp(-R)) where the variables are as follows: R = 3.19 - 0.101*(age, years) + 0.147*(albumin day 0, g/L) + 0.0165* (evolution in bilirubin level, µmol/L) - 0.206*(renal insufficiency) - 0.0065*(bilirubin day 0, µmol/L) - 0.0096*(prothrombin time, sec) Renal insufficiency = 1 (if creatinine >1.3 mg/dL (115 µmol/L)) or 0 (if ≤1.3 mg/dL (115 µmol/L)) The Lille score was developed to provide early recognition of patients with severe alcoholic hepatitis not responding to corticosteroids. Lower scores indicate more improvement in response to corticosteroids. A Lille score > 0.45 predicts worse 6-month survival. A Lille score < 0.45 predicts better 6-month survival." (NCT04072822)
Timeframe: Day 7

Interventionpercentage of participants (Number)
Prednisone67.8
Anakinra and Zinc65.6

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Transplant Free Survival Rate

(NCT04072822)
Timeframe: 90 Days

InterventionPercentage of Participants (Number)
Prednisone88
Anakinra and Zinc64

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Changes in Liver Function

"Changes in liver function were evaluated by changes in the Child Pugh Score at days 7, 30, and 90. The Child Pugh Score is a scoring system used to assess the severity of chronic liver disease. Scores range from 5 to 15, with higher scores indicating more severe disease. Points are assigned as follows:~Hepatic encephalopathy: None = 1 point, Grade 1 and 2 = 2 points, Grade 3 and 4 = 3 points Ascites: None = 1 point, mild = 2 points, moderate to severe = 3 points Total Bilirubin: under 2 mg/dl = 1 point, 2 to 3 mg/dl = 2 points, over 3 mg/dl = 3 points Albumin: greater than 3.5g/dl = 1 point, 2.8 to 3.5g/dl = 2 points, less than 2.8g/dl = 3 points International normalised ratio (INR): under 1.7 = 1 point, 1.7 to 2.3 = 2 points, above 2.3 = 3 points~Assigned points for each category are summed to calculate the Child Pugh Score." (NCT04072822)
Timeframe: 7, 30, and 90 days

,
Interventionscore on a scale (Mean)
Day 0Day 7Day 30Day 90
Anakinra and Zinc10.19.79.28.0
Prednisone10.39.48.57.2

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Number of Participants With Progression of Sepsis

"Life-threatening organ dysfunction caused by a dysregulated host response to infection~An increase in SOFA score of 2 points of more~Note: most participants with severe AH have 4 points based on bilirubin only" (NCT04072822)
Timeframe: 180 days

,
InterventionParticipants (Number)
SepsisSepsis shock
Anakinra and Zinc05
Prednisone32

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Number of Transfers to ICU

Recording the change of hospital word from regular floor to ICU floor as a marker for worsening illness and care escalation (NCT04072822)
Timeframe: 7, 30, and 90 days

,
InterventionTransfers (Number)
Day 7Day 30Day 90
Anakinra and Zinc590
Prednisone222

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Survival

(NCT04072822)
Timeframe: 30 days and 180 days

,
InterventionPercentage of Participants (Number)
Day 30Day 180
Anakinra and Zinc8568
Prednisone9781

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Changes in MELD Score

The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill), used for liver transplant candidates age 12 and older. It gives each person a 'score' (number) based on how urgently he or she needs a liver transplant within the next three months. (NCT04072822)
Timeframe: 7, 30, and 90 days

,
Interventionscores on a scale (Mean)
Day 7Day 30Day 90
Anakinra and Zinc0.2-1.6-8.1
Prednisone-2.8-6.9-10.3

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Development of Multi-organ Failure

Defined as failure ≥2 organs (NCT04072822)
Timeframe: 7, 30, and 90 days

,
InterventionNumber of Subjects (Number)
Day 7Day 30Day 90
Anakinra and Zinc241
Prednisone311

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Development of SIRS (Systemic Inflammatory Response Syndrome)

Defined as two or more abnormalities in temperature, increased heart rate, respiration, or white blood cell count with increase in SOFA score ≥2 points (NCT04072822)
Timeframe: 7, 30, and 90 days

,
InterventionEvents (Number)
Day 7Day 30Day 90
Anakinra and Zinc200
Prednisone021

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Incidence of Acute Rejection

Biopsy-proven according to Banff 2017 criteria (NCT04177095)
Timeframe: Enrollment through 12 months

InterventionParticipants (Count of Participants)
Belatacept Treated Patients0

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Incidence of Acute Rejection

Biopsy-proven according to Banff 2017 criteria (NCT04177095)
Timeframe: Through study completion, 1 year

InterventionParticipants (Count of Participants)
Belatacept Treated Patients0

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Incidence of de Novo Donor Specific Antibodies

Screened for using Luminex platform (NCT04177095)
Timeframe: At 12 months

InterventionParticipants (Count of Participants)
Belatacept Treated Patients0

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Increase in eGFR

Calculated using CKD-EPI formula (NCT04177095)
Timeframe: From baseline to 12 months

InterventionParticipants (Count of Participants)
Belatacept Treated Patients6

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Survival

Overall and death-censored graft survival (NCT04177095)
Timeframe: At 12 months

InterventionParticipants (Count of Participants)
Belatacept Treated Patients12

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Rate of New-onset Proteinuria

Defined as g/g creatinine, measured on random urine sample (NCT04177095)
Timeframe: At 12 months

InterventionParticipants (Count of Participants)
Belatacept Treated Patients1

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Percent Change From Baseline Mean in Autoantibody Levels

Autoantibodies that may be positive include: Thyroglobulin Antibody [TgAb], Thyroid peroxidase antibody [TPO], Thyroid Stimulating Ig antibody [TSI], and/or Thyrotropin Receptor antibody [TRAb]. Any that were positive pre-op will be measured at each time point. Baseline level will be 1. (NCT04542278)
Timeframe: baseline measure day of surgery (up to 4 weeks), up to 6 weeks (2 weeks post-op), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op)

,
Interventionpercent change from baseline mean (Mean)
surgery to 2 weeks post opsurgery to 6 weeks post-opsurgery to 6 months post-op
No Steroids0.780.540.24
Steroids0.810.430.12

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Change in Thyroid-specific Quality of Life Patient-reported Outcome Measure for Benign Thyroid Disorders (ThyPRO) Score

The ThyPRO survey is a quality of life measure designed to evaluate how thyroid disease has affected the participant's life. It is a 39-item survey that was scored from 0-4, higher scores indicate worse quality of life. (NCT04542278)
Timeframe: baseline (2-4 weeks prior to surgery), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op)

,
Interventionscore on a scale (Mean)
Baseline6 weeks post-op6 months post-op
No Steroids1.951.050.99
Steroids2.031.471.29

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Change in Short Form Health Survey (SF-12) Physical Component Score (PCS)

The SF-12 is a 12-item quality of life survey to understand how the participant feels and how well they are able to do their normal activities, it is composed of the mental component score and the physical component score. Each is scored on a scale of 0-100, with higher numbers indicating higher quality of life. (NCT04542278)
Timeframe: baseline (2-4 weeks prior to surgery), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op)

,
Interventionscore on a scale (Mean)
baseline6 weeks post-op6 months post-op
No Steroids43.242.744.2
Steroids41.547.450.2

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Change in Short Form Health Survey (SF-12) Mental Component Score (MCS)

The SF-12 is a 12-item quality of life survey to understand how the participant feels and how well they are able to do their normal activities, it is composed of the mental component score and the physical component score. Each is scored on a scale of 0-100, with higher numbers indicating higher quality of life. (NCT04542278)
Timeframe: baseline (2-4 weeks prior to surgery), up to 10 weeks (6 weeks post-op), up to 30 weeks (6 months post-op)

,
Interventionscore on a scale (Mean)
baseline6 weeks post-op6 months post-op
No Steroids35.338.640.3
Steroids39.446.743.4

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Thyroid Difficulty Scale Score

"The surgeon will fill out the Thyroid Difficulty Scale at the conclusion of the operation. This is a 4-item survey to rate the vascularity, friability, mobility, and glandular size of the thyroid. The total possible range of scores from 4-20, higher scores indicate increased difficulty in thyroid surgery" (NCT04542278)
Timeframe: surgery occurs up to 4 weeks, data collected a conclusion of operation

Interventionscore on a scale (Mean)
Steroids9.8
No Steroids9.75

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Surgical Complications: Parathyroid Hormone (PTH) Level

PTH is measured right after surgery to determine whether the nearby parathyroid glands were injured during surgery. Low PTH levels immediately after surgery are concerning for symptomatic low calcium levels, either temporarily or permanent, after thyroidectomy. Normal PTH is typically between 20-70. (NCT04542278)
Timeframe: immediately after surgery (baseline for all participants)

Interventionpg/mL (Mean)
Steroids52
No Steroids38

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Number of Participants With Surgical Complications: Recurrent Laryngeal Nerve (RLN) Injury

(NCT04542278)
Timeframe: up to 4 weeks (Post Operative Day 1)

InterventionParticipants (Count of Participants)
Steroids2
No Steroids2

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Observed SC and IV Rituximab Area Under the Curve (AUCsc and AUCiv)

The area under the curve (AUC) for serum rituximab concentration versus time after dosage was measured for SC and IV administrations during Cycle 7. Geometric mean ratio and 90% confidence interval were estimated based on an ANCOVA model adjusted for tumor load at baseline and are reported in the statistical analysis. (NCT04660799)
Timeframe: During Cycle 7 (one cycle=21 days): pre-dose, within 15 minutes of end of infusion, 24 hours post-dose, Days 3, 7, 15, 21, up to 21 weeks

Interventionday*mcg/mL (Geometric Mean)
Rituximab IV+CHOP3050.7
Rituximab SC+CHOP3806.7

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Subcutaneous Serum Rituximab Trough Concentration (Ctrough SC) and Intravenous Serum Rituximab Trough Concentration (Ctrough IV)

For this pharmacokinetics (PK) primary outcome measure the serum rituximab Ctrough for SC and IV administrations were measured at Cycle 7, 21 days after study treatment administration for Cycle 7 (pre-dose of Cycle 8). Geometric mean ratio and 90% confidence interval were estimated based on an ANCOVA model adjusted for tumor load at baseline and are reported in the statistical analysis. (NCT04660799)
Timeframe: At Cycle 7 (one cycle=21 days), 21 days after study treatment administration, up to 21 weeks

Interventionmicrograms/milliliter (mcg/mL) (Geometric Mean)
Rituximab IV+CHOP90.7
Rituximab SC+CHOP137.4

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Area Under the Curve (AUC) of Rituximab

AUC is the area under the serum concentration curve over the dosing interval of 21 days during Cycle 2 and Cycle 7. (NCT04660799)
Timeframe: During Cycles 2 and 7 (one cycle=21 days): pre-dose, within 15 minutes of end of infusion, 24 hours post-dose, Days 3, 7, 15, 21, up to 21 weeks

,
Interventionday*mcg/mL (Geometric Mean)
Cycle 2Cycle 7
Rituximab IV+CHOP17303050
Rituximab SC+CHOP21303810

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Maximum Observed Serum Concentration (Cmax) of Rituximab

(NCT04660799)
Timeframe: At Cycles 2 and 7 (one cycle=21 days): pre-dose, within 15 minutes of end of infusion, 24 hours post-dose, Days 3, 7, 15, 21, up to 21 weeks

,
Interventionmicrograms per milliliter (mcg/mL) (Geometric Mean)
Cycle 2Cycle 7
Rituximab IV+CHOP200255
Rituximab SC+CHOP144228

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Number of Participants Positive for Anti-drug Antibodies (ADAs) to Rituximab

Reported here is the number of participants who had a positive ADA assay result at baseline or post-baseline. The post-baseline results are divided in treatment-enhanced ADAs and treatment-induced ADAs. Treatment-enhanced ADAs are participants with a positive ADA result at baseline who had one or more post-baseline titer results that was at least 0.60 titer unit greater than the baseline titer result. Treatment-induced ADAs include participants with negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. (NCT04660799)
Timeframe: From baseline up to 6 months after the last dose of study treatment (up to approximately 1 year)

,
InterventionParticipants (Count of Participants)
BaselinePost-baseline: Treatment-enhancedPost-baseline: Treatment-induced
Rituximab IV+CHOP211
Rituximab SC+CHOP101

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Number of Participants Positive for Anti-rHuPH20 Antibodies

Reported here is the number of participants who had a positive anti-rHuPH20 antibody assay result at baseline or post-baseline. The post-baseline results are divided in treatment-enhanced anti-rHuPH20 antibodies and treatment-induced anti-rHuPH20 antibodies. Treatment-enhanced anti-rHuPH20 antibodies are participants with a positive anti-rHuPH20 antibody result at baseline who had one or more post-baseline titer results that was at least 0.60 titer unit greater than the baseline titer result. Treatment-induced anti-rHuPH20 antibodies include participants with negative or missing baseline anti-rHuPH20 antibody result(s) and at least one positive post-baseline anti-rHuPH20 antibody result. (NCT04660799)
Timeframe: From baseline up to 6 months after the last dose of study treatment (up to approximately 1 year)

InterventionParticipants (Count of Participants)
BaselinePost-baseline: Treatment-enhancedPost-baseline: Treatment-induced
Rituximab SC+CHOP211

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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

AE: any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of causal attribution. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. New disease, exacerbation of existing disease, recurrence of an intermittent medical condition not present at baseline, any deterioration in a laboratory value or other clinical test associated with symptoms or leading to a change in study/concomitant treatment or discontinuation from study drug as well as events related to protocol-mandated interventions are considered AEs. SAEs: any event that met any of these criteria: fatal, life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, medically significant or required intervention to prevent any of the outcomes listed here. (NCT04660799)
Timeframe: AEs were reported up to 28 days after the last dose (up to approximately 7 months), and SAEs were reported up to 6 months after the last dose of study treatment (up to approximately 1 year)

,
InterventionParticipants (Count of Participants)
AEsSAEs
Rituximab IV+CHOP2411
Rituximab SC+CHOP268

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Objective Response Rate (ORR), Complete Response (CR) or Partial Response (PR), as Determined by Investigator and IRC Using Lugano Response Criteria (LRC) for Malignant Lymphoma

ORR=CR+PR. Per LRC: CR by PET-CT: complete MR in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass; no new lesions, no FDG-avid disease in bone marrow; CR by CT: complete radiologic response in lymph nodes and extralymphatic sites with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi, no extralymphatic disease; absence of non-measured lesion; organ enlargement regressing to normal; no new lesions; normal bone marrow; PR by PET-CT: partial MR in lymph nodes and extralymphatic sites with a score of 4 or 5 with reduced uptake compared with baseline + residual masses of any size; no new lesions, residual uptake higher than in normal bone marrow but reduced compared with baseline; PR by CT: ≥ 50% decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 target nodes and extranodal sites; non-measured lesion absent/normal, regressed, but no increase; spleen regressed by >50 % in length beyond normal; no new lesions. (NCT04660799)
Timeframe: 6-8 weeks after the last dose of study treatment or 4-8 weeks after last dose of study treatment for early discontinuation (up to approximately 32 weeks)

,
Interventionpercentage of participants (Number)
InvestigatorIRC
Rituximab IV+CHOP70.866.7
Rituximab SC+CHOP88.580.8

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Time to Cmax (Tmax) of Rituximab

(NCT04660799)
Timeframe: At Cycles 2 and 7 (one cycle=21 days): pre-dose, within 15 minutes of end of infusion, 24 hours post-dose, Days 3, 7, 15, 21, up to 21 weeks

,
Interventionday (Median)
Cycle 2Cycle 7
Rituximab IV+CHOP0.140.16
Rituximab SC+CHOP5.421.99

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Trough Serum Concentration (Ctrough) of Rituximab

Ctrough was measured at Cycle 2 and Cycle 7, 21 days after study treatment administration for each cycle (pre-dose of Cycle 3 and Cycle 8, respectively). (NCT04660799)
Timeframe: At Cycles 2 and 7 (one cycle=21 days), 21 days after study treatment administration, up to 21 weeks

,
Interventionmcg/mL (Geometric Mean)
Cycle 2Cycle 7
Rituximab IV+CHOP43.290.7
Rituximab SC+CHOP63.5137

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Complete Response Rate (CRR) as Determined by the Independent Review Committee (IRC) Using Lugano Response Criteria (LRC) for Malignant Lymphoma

Per LRC, CR based on positron emission tomography- computed tomography (PET-CT) was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass, on 5-point scale (5PS), where, 1= no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake > mediastinum but ≤ liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Per LRC, CR based on CT was defined as complete radiologic response in lymph nodes and extralymphatic sites with target nodes/nodal masses regressing to ≤ 1.5 centimeters (cm) in longest transverse diameter (LDi) and no extralymphatic sites of disease; absence of non-measured lesion; organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, immunohistochemistry (IHC) negative. (NCT04660799)
Timeframe: 6-8 weeks after the last dose of study treatment or 4-8 weeks after last dose of study treatment for early discontinuation (up to approximately 32 weeks)

Interventionpercentage of participants (Number)
Rituximab IV+CHOP62.5
Rituximab SC+CHOP80.8

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CRR, as Determined by IRC Using International Working Group (IWG) Response Criteria for Non-Hodgkin's Lymphoma (NHL) 1999 Guidelines

CRR was assessed according to the IWG Response Criteria for NHL 1999 guidelines and included CR and CR unconfirmed (CRu). CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by > 75 % but still >1.5 cm in size, and indeterminate bone marrow assessment. (NCT04660799)
Timeframe: 6-8 weeks after the last dose of study treatment or 4-8 weeks after last dose of study treatment for early discontinuation (up to approximately 32 weeks)

Interventionpercentage of participants (Number)
Rituximab IV+CHOP58.3
Rituximab SC+CHOP65.4

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CRR, as Determined by the Investigator Using Lugano Response Criteria for Malignant Lymphoma

Per LRC, CR based on PET-CT was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass, on 5-point scale (5PS), where, 1= no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake > mediastinum but ≤ liver; 4 = uptake moderately > liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of FDG-avid disease in bone marrow. Per LRC, CR based on CT was defined as complete radiologic response in lymph nodes and extralymphatic sites with target nodes/nodal masses regressing to ≤ 1.5 centimeters (cm) in longest transverse diameter (LDi) and no extralymphatic sites of disease; absence of non-measured lesion; organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. (NCT04660799)
Timeframe: 6-8 weeks after the last dose of study treatment or 4-8 weeks after last dose of study treatment for early discontinuation (up to approximately 32 weeks)

Interventionpercentage of participants (Number)
Rituximab IV+CHOP58.3
Rituximab SC+CHOP76.9

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Number of SAEs (Zandelisib When Combined With Rituximab)

Measured by the number of SAEs (NCT04745832)
Timeframe: 1 year 7 months

InterventionParticipants (Count of Participants)
Rituximab Plus Zandelisib12
Rituximab Plus Chemotherapy8

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Number of Treatment Emergent AEs (Zandelisib When Combined With Rituximab)

Measured by the number of Treatment Emergent AEs (NCT04745832)
Timeframe: 1 year 7 months

InterventionParticipants (Count of Participants)
Rituximab Plus Zandelisib38
Rituximab Plus Chemotherapy37

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Nebraska Interprofessional Education Attitude Scale (NIPEAS) Score for Professional Staff Arm

The Nebraska Interprofessional Education Attitude Scale (NIPEAS) was developed to measure the attitudes of pre-clinical learners to practicing health professionals. The NIPEAS is a 19-item questionnaire assessing attitudes related to interprofessional collaboration. Responses were given using a 5-point Likert scale where 1 = Strongly Disagree to 5 = Strongly Agree. The total score is the average of the average scores for each item and ranges from 1 to 5. A higher total score indicates increased positive perceptions toward interprofessional collaboration. (NCT04766996)
Timeframe: Prior to protocol implementation (baseline), halfway through the recruitment period (2 months) and after the last participant has been discharged from the hospital (4 months)

Interventionscore on a scale (Mean)
Baseline
Professional Staff4.35

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Total Post-operative Opioid Requirements With Non-opioid Drug Regimen

Total post-operative opioid requirements (opioid dose) were calculated for participants receiving the non-opioid drug regimen, among participants who required post-operative opioid medication. (NCT04766996)
Timeframe: Up to 5 weeks

Interventionmilligrams (Mean)
Prospective Cases Undergoing Non-opioid Drug Regimen400

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Time to Initiation of the First Subsequent Anti-cancer Therapy (TFST)

TFST was defined as the time from randomization to initiation of the first subsequent anti-cancer therapy or death; whichever occurred first. The TFST was calculated using the product-limit (Kaplan-Meier) method for censored data. Any participant not known to have further subsequent therapy or death was censored at the last known time that no subsequent new anti-cancer therapy was received. The TFST results are based on data from the primary completion data cut-off date. (NCT04907227)
Timeframe: Up to 19.8 months

InterventionMonths (Median)
Pembrolizumab + Docetaxel9.4
Placebo + Docetaxel8.3

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Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

rPFS was defined as the time from randomization to occurrence of: radiological tumor progression using RECIST 1.1 as assessed by BICR; progression of bone lesions using PCWG criteria; or death due to any cause. Progression as per RECIST 1.1 was ≥20% increase in sum of diameters of target lesions and progression of existing non-target lesions. Progression of bone lesions by PCWG criteria was the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and was persistent for ≥6 weeks. The rPFS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without a rPFS event were censored at the date of last disease assessment. The rPFS results are based on data from the primary completion data cut-off date. (NCT04907227)
Timeframe: Up to 19.8 months

InterventionMonths (Median)
Pembrolizumab + Docetaxel6.4
Placebo + Docetaxel11.2

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Prostate-specific Antigen (PSA) Response Rate

The Prostate-specific Antigen (PSA) response rate was the percentage of participants who had PSA response defined as a reduction in the PSA level from baseline by ≥50%. The reduction in PSA level was confirmed by an additional PSA evaluation performed ≥3 weeks from the original response. The analysis was performed on participants who had baseline PSA measurements. The PSA response rate results are based on data from the primary completion data cut-off date. (NCT04907227)
Timeframe: Up to 19.8 months

InterventionPercentage of participants (Number)
Pembrolizumab + Docetaxel24.4
Placebo + Docetaxel22.5

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Objective Response Rate (ORR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review

ORR was defined as the percentage of participants with complete response (CR: disappearance of all target lesions per RECIST 1.1; and no evidence of disease (NED) on bone scan per PCWG) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1; and non-progressive disease, non-evaluable [NE], or NED on bone scan or CR with non-progressive disease or NE bone scan per PCWG). The ORR results are based on data from the primary completion data cut-off date. (NCT04907227)
Timeframe: Up to 19.8 months

InterventionPercentage of participants (Number)
Pembrolizumab + Docetaxel17.6
Placebo + Docetaxel13.3

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Number of Participants Who Experienced an Adverse Event (AE)

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE is presented. (NCT04907227)
Timeframe: Up to 17 months

InterventionParticipants (Count of Participants)
Pembrolizumab + Docetaxel37
Placebo + Docetaxel34

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Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE is presented. (NCT04907227)
Timeframe: Up to 14 months

InterventionParticipants (Count of Participants)
Pembrolizumab + Docetaxel3
Placebo + Docetaxel6

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"Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 (Worst Pain in 24 Hours) and Opiate Analgesic Use Assessed by the Analgesic Quantification Algorithm [AQA] Score"

TTPP=the time from randomization to pain progression determined by BPI-SF Item 3 and the AQA score. Pain progression was defined as: 1. For participants asymptomatic at baseline: a ≥2-point change from baseline in the average (4-7 days) BPI-SF item 3 score at 2 consecutive visits OR initiation of opioid use for pain 2. For participants symptomatic at baseline (average BPI-SF Item 3 score >0 and/or currently taking opioids:, a ≥2-point change from baseline in the average BPI-SF Item 3 score and an average worst pain score ≥4 and no decrease in average opioid use (≥1-point decrease in AQA score from a starting value of ≥2) OR any increase in opioid use at 2 consecutive follow-up visits. TTPP was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants who had >2 consecutive visits that were not evaluable for pain progression were censored at the last evaluable assessment. The TTPP results are based on data from the primary completion data cut-off date. (NCT04907227)
Timeframe: Up to 19.8 months

InterventionMonths (Median)
Pembrolizumab + DocetaxelNA
Placebo + DocetaxelNA

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Overall Survival (OS)

OS was defined as the time from randomization to death due to any cause. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. The OS results are based on data from the primary completion data cut-off date. (NCT04907227)
Timeframe: Up to 19.8 months

InterventionMonths (Median)
Pembrolizumab + Docetaxel16.3
Placebo + Docetaxel13.9

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Time to Radiographic Soft Tissue Progression Per Soft Tissue Rules of Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

The time to radiographic soft tissue progression was defined as the time from randomization to radiographic soft tissue progression per soft tissue rules of PCWG-modified RECIST 1.1 as assessed by BICR. Progression was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered progression. Time to radiographic soft tissue progression was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without radiographic soft tissue progression were censored at the last evaluable assessment. The time to radiographic soft tissue progression results are based on data from the primary completion data cut-off date. (NCT04907227)
Timeframe: Up to 19.8 months

InterventionMonths (Median)
Pembrolizumab + DocetaxelNA
Placebo + Docetaxel11.2

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Time to Prostate-specific Antigen (PSA) Progression

The time to PSA progression was the time from randomization to PSA progression. The PSA progression date was defined as the date of: 1. ≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there was PSA decline from baseline; OR 2. ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there was no PSA decline from baseline Time to PSA progression was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without PSA progression were censored at the last evaluable assessment. The time to PSA progression results are based on data from the primary completion data cut-off date. (NCT04907227)
Timeframe: Up to 19.8 months

InterventionMonths (Median)
Pembrolizumab + Docetaxel5.0
Placebo + Docetaxel3.7

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Duration of Response (DOR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review

DOR was defined as the time from first documented evidence of complete response (CR) or partial response (PR) per PCWG and RECIST 1.1 criteria until progressive disease (PD) or death. PD per RECIST 1.1 was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PD per PCWG was the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and were persistent for ≥6 weeks. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data. If a participant had not progressed, the participant was censored at the date of last disease assessment. The DOR results are based on data from the primary completion data cut-off date. (NCT04907227)
Timeframe: Up to 19.8 months

InterventionMonths (Median)
Pembrolizumab + DocetaxelNA
Placebo + DocetaxelNA

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