Page last updated: 2024-12-05

prednisolone

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Description

Prednisolone: A glucocorticoid with the general properties of the corticosteroids. It is the drug of choice for all conditions in which routine systemic corticosteroid therapy is indicated, except adrenal deficiency states. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

prednisolone : A glucocorticoid that is prednisone in which the oxo group at position 11 has been reduced to the corresponding beta-hydroxy group. It is a drug metabolite of prednisone. [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 CID5755
CHEMBL ID131
CHEBI ID8378
SCHEMBL ID3233
MeSH IDM0017460

Synonyms (308)

Synonym
MLS002207037
MLS002154250
BRD-K98039984-001-03-0
delta.1-cortisol
gtpl2866
prelone
PRESTWICK2_000274
1,4-pregnadiene-11-beta,17-alpha,21-triol-3,20-dione
predniretard
1,4-pregnadien-11-beta,17-alpha,21-triol-3,20-dione
decaprednil
solone
prednisolona [inn-spanish]
einecs 200-021-7
delta(1)-cortisol
pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-
11-beta,17,21-trihydroxypregna-1,4-diene-3,20-dione
1,4-pregnadiene-3,20-dione-11-beta,17-alpha,21-triol
pregna-1,4-diene-3,20-dione, 11beta,17,21-trihydroxy-
delta(sup 1)-hydrocortisone
delta(sup 1)-dehydrocortisol
fernisolone-p
hsdb 3385
nsc 9120
ccris 980
prednisolone [inn:ban:jan]
brn 1354103
prednisolonum [inn-latin]
delta(sup 1)-cortisol
delta(sup 1)-dehydrohydrocortisone
.delta.-stab
delta-stab
hydeltrone
fernisolone p
hostacortin h
pregna-1,20-dione, 11.beta.,17,21-trihydroxy-
derpo pd
prdl
lentosone
dydeltrone
nsc-9900
precortancyl
ultracortene-hydrogen
dexa-cortidelt hostacortin h
deltacortenol
component of k-predne-dome
paracortol
co-hydeltra
.delta.1-dehydrohydrocortisone
hydeltra
sterolone
cortalone
predonine
donisolone
delta-cortef
dicortol
delcortol
ulacort
eazolin d
cotogesic
prenolone
delta f
ultracortene-h
metacortandralone
sterane
meticortelone
hydrodeltisone
ultracorten h
k 1557
cordrol
erbasona
deltisilone
scherisolon
delta-ef-cortelan
deltahydrocortisone
.delta.1-cortisol
1-dehydrohydrocortisone
predonin
precortilon
paracotol
nsc9900
precortisyl
nsc9120
component of ataraxoid
hydrodeltalone
fernisolone
.delta.1-dehydrocortisol
meti-derm
pregna-1,20-dione, 11,17,21-trihydroxy-, (11.beta.)-
deltacortril
steran
decortin h
erbacort
di-adreson f
predne-dome
estilsona
codelcortone
.delta.-cortef
.delta.1-hydrocortisone
predniliderm
hydroretrocortin
prednicen
rolisone
1,2-dehydrohydrocortisone
nsc-9120
prednis
prednelan
PRESTWICK_404
BSPBIO_000148
PRESTWICK3_000274
NCGC00179649-01
BPBIO1_000164
prednisolone
C07369
50-24-8
prednisolone, >=99%
delta(1)-dehydrohydrocortisone
prednisolonum
hydroretrocortine
11beta,17,21-trihydroxypregna-1,4-diene-3,20-dione
prednisolona
1,4-pregnadiene-11beta,17alpha,21-triol-3,20-dione
1,4-pregnadiene-3,20-dione-11beta,17alpha,21-triol
delta(1)-dehydrocortisol
CHEBI:8378 ,
delta(1)-hydrocortisone
(11beta)-11,17,21-trihydroxypregna-1,4-diene-3,20-dione
3,20-dioxo-11beta,17alpha,21-trihydroxy-1,4-pregnadiene
delta-hydrocortisone
delta-dehydrocortisol
DB00860
delta-dehydrohydrocortisone
delta-cortef (tn)
D00472
prednisolone (jp17/usp/inn)
NCGC00094764-01
neo-delta-cortef
SPBIO_002367
PRESTWICK0_000274
PRESTWICK1_000274
smr000718761
MLS001304083
bdbm19190
chembl131 ,
(1s,2r,10s,11s,14r,15s,17s)-14,17-dihydroxy-14-(2-hydroxyacetyl)-2,15-dimethyltetracyclo[8.7.0.0;{2,7}.0;{11,15}]heptadeca-3,6-dien-5-one
AC-1773
HMS2090J05
delta1-hydrocortisone
11beta,17alpha,21-trihydroxypregna-1,4-diene-3,20-dione
P0637
HMS1568H10
(8s,9s,10r,11s,13s,14s,17r)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-7,8,9,11,12,14,15,16-octahydro-6h-cyclopenta[a]phenanthren-3-one
LMST02030179
NCGC00179649-04
NCGC00179649-02
NCGC00179649-03
HMS2095H10
HMS3259E09
(1r,3as,3bs,9ar,9bs,10s,11as)-1,10-dihydroxy-1-(2-hydroxyacetyl)-9a,11a-dimethyl-1h,2h,3h,3ah,3bh,4h,5h,7h,9ah,9bh,10h,11h,11ah-cyclopenta[a]phenanthren-7-one
EN300-53017
dtxsid9021184 ,
dtxcid301184
NCGC00256577-01
tox21_302987
tox21_201673
NCGC00259222-01
MLS002548883
tox21_111327
HMS2230P10
panafcortelone
klismacort
deltasolone
predisolone sodium phosphate
supercortisol
ec 200-021-7
unii-9phq9y1olm
bubbli-pred
4-08-00-03467 (beilstein handbook reference)
cotolone
9phq9y1olm ,
equisolon
prednisolone [mi]
prednisolone [usp monograph]
8056-11-9
prednisolone [ep monograph]
prednisolone component of chloroptic-p s.o.p.
prednisolone (ema epar: veterinary)
prednisolone [who-ip]
chloroptic-p s.o.p. component prednisolone
methylprednisolone impurity k [ep impurity]
prednisolone [inn]
prednisolone anhydrous
prednisolonum [who-ip latin]
prednisolone [mart.]
prednisone impurity b [ep]
prednisolone [hsdb]
prednisolone [green book]
prednisolone [vandf]
(+)-prednisolone
hydrocortisone impurity a [ep impurity]
prednisolone [jan]
prednisolone [who-dd]
prednisolone [ep]
prednicarbate impurity a [ep impurity]
11.beta.,17,21-trihydroxypregna-1,4-diene-3,20-dione.
prednisolone [orange book]
pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-, (11.beta)-
prednisolone acetate impurity b [ep impurity]
prednisolone [usp-rs]
vetsolone
aprednislon
S1737
AKOS015894935
CCG-220274
HY-17463
NC00473
SCHEMBL3233
tox21_111327_1
NCGC00179649-06
prednisolon
11beta,17,21-trihydroxy-1,4-pregnadiene-3,20-dione
Q-201616
11-.beta.,17-.alpha.,21-trihydroxypregna-1,4-diene-3,20-dione
pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-, (11.beta.)-
pregna-1,4-diene-3,20-dione, 11.beta.,17,21-trihydroxy-
.delta.(sup 1)-dehydrocortisol
.delta.(sup 1)-cortisol
1,4-pregnadiene-11-.beta.,17-.alpha.,21-triol-3,20-dione
11-.beta.,17,21-trihydroxypregna-1,4-diene-3,20-dione
11.beta.,17.alpha.,21-trihydroxypregna-1,4-diene-3,20-dione
.delta.(sup 1)-hydrocortisone
1,4-pregnadiene-3,20-dione-11-.beta.,17-.alpha.,21-triol
k-predne-dome (salt/mix)
preflam
11-.beta.,17-.alpha.,21-trihydroxy-1,4-pregnadiene-3,20-dione
11,17,21-trihydroxypregna-1,4-diene-3,20-dione, (11.beta.)-
.delta.(sup 1)-dehydrohydrocortisone
t-pred (salt/mix)
1,4-pregnadien-11-.beta.,17-.alpha.,21-triol-3,20-dione
pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-, (11b)-
(8s,9s,10r,11s,13s,14s,17r)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3h-cyclopenta[a]phenanthren-3-one
mfcd00003649
SR-01000837502-2
sr-01000837502
prednisolone, vetranal(tm), analytical standard
prednisolone, united states pharmacopeia (usp) reference standard
prednisolone for peak identification, european pharmacopoeia (ep) reference standard
prednisolone, pharmaceutical secondary standard; certified reference material
prednisolone for system suitability, european pharmacopoeia (ep) reference standard
prednisolone, european pharmacopoeia (ep) reference standard
HMS3712H10
prednisolone, british pharmacopoeia (bp) assay standard
A929791
delta-1-cortisol; prednicarbate ep imp a; supercortisol
AS-13665
BCP09053
Q11426176
BRD-K98039984-001-06-3
'(11alpha)-11,17,21-trihydroxypregna-1,4-diene-3,20-dione'
D91990
TUA ,
(8s,9s,10r,11s,13s,14s,17r)-11,17-dihydroxy-8,10,13-trimethyl-3-oxo-6,7,9,11,12,14,15,16-octahydrocyclopenta[a]phenanthrene-17-carboxylic acid;prednisolone
prednisolone powder
HY-17463R
CS-0695025
prednisolone (standard)
Z778141968
meti derm
opredsone
lenisolone
fisopred
gupisone
prednicortelone
prednisolone anhydrous micronized
dontisolon d
prednisolone (usp-rs)
prenilone
delta-phoricol
kuhlprednon
linola-h-fett n
adnisolone
delta1-dehydro-hydrocortisone
predni-coelin
delta(1)hydrocortisone
prednisolone (ep monograph)
dhasolone
dacortin h
delta-diona
prednicarbate impurity a (ep impurity)
hydrocortisone impurity a (ep impurity)
prednisolone oral
prednistab
delta-f
frisolona
longiprednil
linola-h n
prednisolona (inn-spanish)
methylprednisolone impurity k (ep impurity)
predni-helvacort
prednisolonum (inn-latin)
predeltilone
capsoid
pred-clysma
lepi-cortinolo
prednisolone (mart.)
prednisolone (usp monograph)
prednisone impurity b
deltidrosol

Research Excerpts

Overview

Prednisolone (PRD) is an immunosuppressant and anti-inflammatory drug, although it may cause peptic ulcers as a side effect. It is a corticosteroid and one of the most important agents in the treatment of ALL.

ExcerptReferenceRelevance
"Prednisolone (PRD) is an immunosuppressant and anti-inflammatory drug, although it may cause peptic ulcers as a side effect. "( Multivariate Model Update Chemometric Methods for Determination of Prednisolone and Esomeprazole in Spiked Human Plasma: A Comparative Study.
Abdelhamid, NS; Anwar, BH; Farid, NF; Magdy, MA, 2022
)
2.4
"Prednisolone is a new treatment method for such patients."( Prednisolone Treatment Is Effective for an Idiopathic Penile Abscess: A Case Report and Review.
Konno, T; Kurokawa, M; Nishida, H; Tsuchiya, N; Yamagishi, A, 2021
)
2.79
"Prednisolone is a widely used immunosuppressive and anti-inflammatory drug type that suffers from low aqueous solubility and bioavailability. "( Orally Fast Disintegrating Cyclodextrin/Prednisolone Inclusion-Complex Nanofibrous Webs for Potential Steroid Medications.
Celebioglu, A; Durgun, E; Kilic, ME; Uyar, T; Wang, N, 2021
)
2.33
"Prednisolone (PN) is a glucocorticoid (GC) analog that is clinically used to treat allergic inflammation and autoimmune diseases. "( Prednisolone induces sleep disorders via inhibition of melatonin secretion by the circadian rhythm in zebrafish.
Feng, N; Gen, N; Jiang, Y; Lu, X; Wang, P, 2022
)
3.61
"Prednisolone is a corticosteroid and one of the most important agents in the treatment of ALL."( Early and Very Early GRIM19 and MCL1 Expression Are Correlated to Late Acquired Prednisolone Effects in a T-Cell Acute Leukemia Cell Line.
Adamaki, M; G, L; Geronikolou, SA; Hatziagapiou, K; Tsartsalis, AN; Vlahopoulos, S, 2021
)
1.57
"Prednisolone is an effective and well-tolerated medication for treating infantile spasms in Down syndrome. "( Response to treatment and outcomes of infantile spasms in Down syndrome.
Allen, NM; Gorman, KM; Harvey, S; King, MD; Lynch, B; Lynch, SA; O'Regan, M; O'Rourke, D; Shahwan, A; Webb, D, 2022
)
2.16
"Prednisolone is a reported predisposing factor in humans with lipomatosis."( Spinal epidural and synovial lipomatosis in a 3-year-old Eurasian dog receiving sustained steroid therapy.
Cauzinille, L; Dally, C; Dumont, R; Gros, L; Le Boedec, K; Signoret, M, 2022
)
1.44
"Prednisolone is a synthetic glucocorticoid used clinically for treating allergies, inflammation, and autoimmune diseases. "( Effects of prednisolone on behavior and hypothalamic-pituitary-interrenal axis activity in zebrafish.
Cheng, Y; Jiang, Y; Liu, S; Xin, N; Zhou, Y, 2020
)
2.39
"Prednisolone acetate (PDN) is a corticosteroid anti-inflammatory liable to degradation under different conditions and used with antibiotics in eye drops. "( Selective and Sensitive Chromatographic Methods for Determination of a Co-Formulated Binary Mixture in Antibacterial Eye Drops and Aqueous Humor in the Presence of Their Degradation Products and Potential Impurities.
Abbas, SS; Abdelwahab, MH; Hegazy, MA; Hendawy, HAM; Weshahy, SA, 2019
)
1.96
"Prednisolone is a corticosteroid and one of the most important agents in the treatment of acute lymphoblastic leukemia."( Gene Expression and Resistance to Glucocorticoid-Induced Apoptosis in Acute Lymphoblastic Leukemia: A Brief Review and Update.
Adamaki, M; Hatziagapiou, K; Lambrou, GI; Vlahopoulos, S, 2020
)
1.28
"Prednisolone is a commonly used drug in cats and potential adverse effects include hyperglycaemia and diabetes mellitus. "( Prednisolone-induced diabetes mellitus in the cat: a historical cohort.
Boge, GS; Glanemann, B; Moberg, HL; Nerhagen, S, 2021
)
3.51
"Prednisolone (PL) is a standard component of most immunosuppressive protocols after solid organ transplantation (Tx). "( 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
)
3.51
"Prednisolone is an anti‑inflammatory drug used to treat a number of conditions, including liver disease and cancer. "( γ‑irradiated prednisolone promotes apoptosis of liver cancer cells via activation of intrinsic apoptosis signaling pathway.
Bai, HW; Chung, BY; Kang, BS; Kang, SH; Kawala, RA; Ramadhani, FJ, 2021
)
2.43
"Prednisolone is a GC proven to be very effective in the treatment of nasal congestions and allergic rhinitis and its therapeutic use is allowed."( Investigation of the urinary excretion of prednisolone and metabolites after nasal administration: Relevance to doping control.
Deventer, K; Hooghe, F; Polet, M; Van Eenoo, P; Van Gansbeke, W; Van Hoecke, H, 2021
)
1.61
"Prednisolone is a standard component of immunosuppressive protocols in renal transplantation (Tx) and despite standardized treatment regimens, adverse side effects are still frequent. "( Prednisolone and Prednisone Pharmacokinetics in Pediatric Renal Transplant Recipients-A Prospective Study.
Bergan, S; Bjerre, A; Bremer, S; Skauby, RH; Svarstad, A; Sæves, I; Vethe, NT, 2017
)
3.34
"Prednisolone is a synthetic corticosteroid acting on both hydrosaline balance and metabolism that is liable to fraudulent administration to meat-producing animals for growth-promoting purposes. "( Determination of prednisolone metabolites in beef cattle.
Biolatti, B; Cannizzo, FT; Capra, P; Leporati, M; Nebbia, C; Vincenti, M, 2013
)
2.17
"Prednisolone is a steroid belonging to the corticosteroid group. "( Investigation on the origin of prednisolone in urine and adrenal glands of cows.
Arioli, F; Bertocchi, L; Casati, A; Dusi, G; Fidani, M; Ghidelli, V; Hathaway, T; Nassuato, C; Pompa, G, 2013
)
2.12
"Prednisolone (PLN) is a widely used corticosteroid in a variety of immune-mediated diseases. "( 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
)
2.22
"Prednisolone is a major risk factor for hyperglycaemia and new-onset diabetes after transplantation. "( Divided dosing reduces prednisolone-induced hyperglycaemia and glycaemic variability: a randomized trial after kidney transplantation.
Cohney, SJ; Colman, PG; Fourlanos, S; Yates, CJ, 2014
)
2.16
"Prednisolone is a member of synthetic glucocorticoids which are widely used to treat chronic inflammatory diseases. "( Prednisolone induces microglial activation in the subnucleus caudalis of the rat trigeminal sensory complex.
Endo, Y; Ichikawa, H; Iikubo, M; Kasahara, E; Sasano, T; Sato, T; Shimada, Y; Shoji, N, 2014
)
3.29
"Prednisolone is a corticosteroid that has been used to treat inflammatory liver diseases such as autoimmune hepatitis and alcoholic hepatitis. "( Opposing effects of prednisolone treatment on T/NKT cell- and hepatotoxin-mediated hepatitis in mice.
Feng, D; Gao, B; Kwon, HJ; Park, O; Won, YS, 2014
)
2.17
"Prednisolone is a potent anti-inflammatory glucocorticoid (GC) but chronic use is hampered by metabolic side effects. "( Identification of gene signatures for prednisolone-induced metabolic dysfunction in collagen-induced arthritic mice.
Bauerschmidt, S; Dokter, WH; Ellero-Simatos, S; Fleuren, WW; Toonen, EJ, 2014
)
2.12
"Prednisolone (Prd) is a polymorphous synthetic corticosteroid that has three crystalline forms mediated by different solvents. "( Solid-state NMR investigation of effect of fluorination and methylation on prednisolone conformation.
Arco, S; Carillo, KD; Tzou, DL; Wang, CC, 2015
)
2.09
"Prednisolone is a safe, effective first-line option for treatment of acute gout."( Oral Prednisolone in the Treatment of Acute Gout: A Pragmatic, Multicenter, Double-Blind, Randomized Trial.
Cheng, CH; Choi, YF; Graham, CA; Janssens, HJ; Lee, KH; Man, CY; Rainer, TH; Tam, LS; Yau, WH, 2016
)
1.67
"Prednisolone is a commonly prescribed synthetic glucocorticoid which has been repeatedly detected in the environment."( Physiological and Behavioral Effects of Exposure to Environmentally Relevant Concentrations of Prednisolone During Zebrafish (Danio rerio) Embryogenesis.
McNeil, PL; Nebot, C; Sloman, KA, 2016
)
1.37
"Prednisolone is an immunosuppressant shown to have anti-inflammatory and antiproliferative effects on PASMC."( Prednisolone inhibits PDGF-induced nuclear translocation of NF-kappaB in human pulmonary artery smooth muscle cells.
Firth, AL; Ogawa, A; Rubin, LJ; Yao, W; Yuan, JX, 2008
)
2.51
"Oral prednisolone is a very effective medicine and symptoms and clinical findings disappear soon after the start of steroid therapy."( [Autoimmune pancreatitis].
Shimosegawa, T, 2008
)
0.8
"(1) Prednisolone monotherapy is a successful immunosuppressive modality in the treatment of SRMA; (2) protein markers are useful in identifying the potential for relapse."( Steroid responsive meningitis-arteritis: a prospective study of potential disease markers, prednisolone treatment, and long-term outcome in 20 dogs (2006-2008).
Anderson, TJ; Eckersall, PD; Lowrie, M; McLaughlin, M; Penderis, J,
)
0.91
"Prednisolone is a glucocorticoid (GC) commonly used in the treatment of canine mast cell tumours (MCTs); however, resistance to GCs develops in many MCTs following repeated treatment. "( Overexpression of P-glycoprotein, STAT3, phospho-STAT3 and KIT in spontaneous canine cutaneous mast cell tumours before and after prednisolone treatment.
Chang, SC; Chiu, CY; Hsu, WL; Teng, SP; Wong, ML, 2012
)
2.03
"Prednisolone is a synthetic glucocorticoid widely employed in bovine clinical practice that may also be used illegally as a growth promoter. "( A field survey on the presence of prednisolone and prednisone in urine samples from untreated cows.
Attucci, A; Barbarino, G; Capra, P; Gatto, S; Leporati, M; Nebbia, C; Vincenti, M, 2012
)
2.1
"Prednisolone testing is an unreliable predictor of the benefit from inhaled fluticasone propionate in individual patients."( Prednisolone response in patients with chronic obstructive pulmonary disease: results from the ISOLDE study.
Anderson, JA; Burge, PS; Calverley, PM; Jones, PW; Spencer, S, 2003
)
2.48
"Prednisolone is an analgesic and anti-inflammatory drug. "( Investigations of anti-inflammatory and analgesic activities of prednisolone solid dispersion prepared with skimmed milk.
Librowski, T; Sahin, NO,
)
1.81
"Prednisolone is a commonly prescribed corticosteroid used in the treatment of many diseases. "( Prednisolone measurement in human serum using liquid chromatography tandem mass spectrometry.
Gillingwater, S; Keevil, BG; Owen, LJ, 2005
)
3.21
"Prednisolone is a safe antiinflammatory agent for the treatment of inflammatory diseases. "( Inclusion complex of prednisolone with skimmed milk. Part I: Physicochemical characterization.
Arslan, H; Sahin, NO, 2007
)
2.1
"Prednisolone proved to be a strong drug-metabolizing enzyme inducer but it was less potent than PCN."( Actions of prednisolone acetate, pregnenolone-16alpha-carbonitrile, and triamcinolone upon drug resistance and metabolism: a comparative study.
Kourounakis, P; Selye, H, 1977
)
1.37

Effects

Prednisolone has been used frequently in the treatment of acute lymphoblastic leukemia. It has been suggested as a treatment for olfactory disorders after COVID-19, but evidence is scarce. Prednislone has become the principal agent for treating patients with severe AH.

ExcerptReferenceRelevance
"Prednisolone has been used frequently in the treatment of acute lymphoblastic leukemia. "( Antileukemic Effects of Anti-miR-146a, Anti-miR-155, Anti-miR-181a, and Prednisolone on Childhood Acute Lymphoblastic Leukemia.
Aksoylar, S; Alpay, A; Bagca, BG; Cogulu, O; Durmaz, B; Gunduz, C; Susluer, SY, 2021
)
2.3
"Prednisolone has been suggested as a treatment for olfactory disorders after COVID-19, but evidence is scarce. "( Prednisolone does not improve olfactory function after COVID-19: a randomized, double-blind, placebo-controlled trial.
Blijleven, EE; Boek, WM; Boesveldt, S; Kamalski, DMA; Schepens, EJA; Stegeman, I; Stokroos, RJ, 2022
)
3.61
"Prednisolone therapy has shown modest survival benefits over placebo at 28 but not 90 days."( Fecal microbiota transplantation compared with prednisolone in severe alcoholic hepatitis patients: a randomized trial.
Arora, V; Dore, J; Jagdish, R; Khillan, V; Kumar, G; Kumar, M; Mondot, S; Pande, A; Rastogi, A; Sarin, SK; Sharma, S; Shasthry, SM; Vijayaraghavan, R, 2023
)
1.89
"Prednisolone has been recommended rather than hydrocortisone for glucocorticoid replacement in adrenal insufficiency due its longer duration of action and lower cost."( Mortality Risk in Patients With Adrenal Insufficiency Using Prednisolone or Hydrocortisone: A Retrospective Cohort Study.
Cox, J; Godsland, IF; Johnston, DG; Majeed, A; Ngaosuwan, K; Oliver, N; Quint, JK; Robinson, S, 2021
)
2.31
"Oral prednisolone has more favourable pharmacokinetics in cats than prednisone; therefore, lower doses of prednisolone may be effective in treating feline PF."( Use of prednisolone as monotherapy in the treatment of feline pemphigus foliaceus: a retrospective study of 37 cats.
Burton, GG; Simpson, DL, 2013
)
1.3
"Prednisolone has been gradually reduced."( Florid urticarial vasculitis heralding a flare up of ulcerative colitis.
Boules, E; Lyon, C, 2014
)
1.12
"Prednisolone has become the principal agent for treating patients with severe AH."( Acute Alcoholic Hepatitis: Therapy.
Lucey, MR; Phillips, PK, 2016
)
1.16
"Prednisolone (PSL) has been suggested to be useful for the treatment of Kawasaki disease (KD) resistant to i.v. "( Targeted use of prednisolone with the second IVIG dose for refractory Kawasaki disease.
Akiyama, N; Asakura, I; Fukuoka, T; Harazaki, M; Iwashima, S; Kamimaki, T; Kimura, M; Meguro, T; Morishita, H; Ohkawara, I; Sakai, H; Seto, S; Shimomura, M; Tsurui, S, 2017
)
2.24
"Prednisolone monotherapy has been the standard systemic treatment in many patients with androgen- independent prostate cancer and should today be compared to treatment with Taxotere plus prednisolone. "( A randomized phase II trial comparing weekly taxotere plus prednisolone versus prednisolone alone in androgen-independent prostate cancer.
Fosså, SD, 2008
)
2.03
"Prednisolone has been widely used due to its relatively short pituitary inhibition and its moderate potency. "( Sub-maximal exercise altered the prednisolone absorption pattern.
Chen, TT; Chien, KY; Hsu, J; Hsu, MC; Kuo, CH; Li, JH; Pan, RN, 2010
)
2.08
"Prednisolone has no significant effect on reducing the prevalence of post-bronchiolitis wheezing and on improving the acute course of illness in hospitalized infants with bronchiolitis."( Long and short-term effect of prednisolone in hospitalized infants with acute bronchiolitis.
Auler, MI; Bonfanti, T; Costa, MM; D'avila, NE; Faria, CS; Ferruzzi, E; Zhang, L,
)
1.86
"Prednisolone has unknown growth-suppressing effects relative to other steroids. "( Prednisolone in the treatment of adrenal insufficiency: a re-evaluation of relative potency.
Legault, L; Polychronakos, C; Punthakee, Z, 2003
)
3.2
"Prednisolone has been shown to reduce the rate of hand joint destruction as seen on radiography but has not been shown to reduce the rate of hand bone loss."( Reduced loss of hand bone density with prednisolone in early rheumatoid arthritis: results from a randomized placebo-controlled trial.
Haugeberg, G; Kirwan, JR; Kvien, TK; Strand, A, 2005
)
1.32
"Prednisolone has similar pharmacokinetic properties and has a significant advantage in that it is commercially available in liquid preparations."( Prednisolone versus dexamethasone in croup: a randomised equivalence trial.
Geelhoed, G; Sparrow, A, 2006
)
2.5
"Prednisolone has no effect on withdrawal headache in unselected patients with chronic daily headache and medication overuse."( Prednisolone does not reduce withdrawal headache: a randomized, double-blind study.
Bøe, MG; Mygland, A; Salvesen, R, 2007
)
3.23
"Prednisolone has stable oral pharmaceutical formulations commercially available, with the advantage of a single daily dose."( [Comparative study of prednisolone versus hydrocortisone acetate for treatment of patients with the classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency].
Borghi, M; Calliari, LE; Faria, CD; Kochi, C; Leite, FM; Longui, CA; Monte, O, 2008
)
1.38
"Prednisolone suppositories have been used successfully for the treatment of ulcerative colitis in hospital settings. "( [Controlled release of prednisolone from suppository prepared using powder of pulverized tablet].
Hamaguchi, T; Kadobayashi, M; Kobayashi, Y; Muraoka, R; Nakamoto, T; Oda, S; Shikata, T; Tagawa, N; Takahashi, Y; Tanaka, K; Tatsumi, A; Tatsumi, S, 2008
)
2.1
"The prednisolone has got a devastating effect on the creatine content of muscle when it is tenotomised. "( Creatine of tenotomised muscle under influence of prednisolone treatment.
Dastidar, AG; Mandal, SK,
)
0.94
"Prednisolone serum levels have been measured by radio-immunoassay in 12 steroid-dependent asthmatic patients. "( Prednisolone pharmacokinetics in asthmatic patients.
Bochner, F; Caffin, JA; Halliday, JW; May, CS, 1980
)
3.15
"Prednisolone has been shown to improve strength in Duchenne dystrophy, the improvement starting within 10 days of treatment and reaching a maximum by 3 months, and then plateauing. "( Steroids in Duchenne muscular dystrophy; pilot study of a new low-dosage schedule.
Dubowitz, V; Royston, P; Sansome, A,
)
1.57
"Prednisolone priming has been found to be beneficial over treatment with interferon alone in these subjects."( Treatment of hepatitis B surface antigen carriers in the early stage of the infection using recombinant alpha-interferon with steroid priming.
Guan, R; Ho, KY; Kang, JY; Ng, C; Smith, R; Tan, CC; Wee, A; Yap, I, 1995
)
1.01
"Prednisolone has not been previously used to treat patients with hyperthyroidism who have not responded to thionamide drugs."( Treatment of thyrotoxicosis resistant to carbimazole with corticosteroids.
Dale, J; Dodson, PM; Jude, EB; Kumar, S, 1996
)
1.02
"Prednisolone has no effect on a neuromuscular block caused by choline, decamethonium, physostigmine, d-tubocurarine, and a high or low calcium ion concentration."( Effect of corticosteroids on the phrenic nerve-diaphragm of preparation treated with hemicholinium. A possible model of myasthenia gravis.
Leeuwin, RS; Wolters, MJ, 1976
)
0.98
"Prednisolone has no effect on the reaction after this phase."( Effect of prednisolone on cell-mediated cytotoxicity in vitro. Demonstration of a short sensitive induction phase.
Franks, D; Sanderson, CJ, 1975
)
1.38
"Low prednisolone doses have been quite effective in therapy of this condition."( [Clinical variants of Wegener's granulomatosis].
Batishchev, EV; Rodionov, AN; Samtsov, AV, 1989
)
0.76

Actions

Pradnisolone displays significant pharmacokinetic variability and exposure-outcome relationships in renal transplant recipients. Prednisolones can suppress ischemia-reperfusion injury of the rat liver.

ExcerptReferenceRelevance
"Prednisolone displays significant pharmacokinetic variability and exposure-outcome relationships in renal transplant recipients, suggesting a role for drug monitoring in some scenarios. "( Prednisolone Concentrations in Plasma (Total and Unbound) and Saliva of Adult Kidney Transplant Recipients.
Brooks, E; Isbel, NM; McWhinney, B; Staatz, CE; Tett, SE, 2019
)
3.4
"Prednisolone can suppress ischemia-reperfusion injury of the rat liver. "( Protective effect of prednisolone on ischemia-induced liver injury in rats.
Chen, X; Li, XF; Shen, F; Shi, LH; Wang, M; Wu, MC; Xi, T, 2008
)
2.11
"Prednisolone may cause hyperglycemia after organ transplantation. "( Role of prednisolone pharmacokinetics in postchallenge glycemia after renal transplantation.
Bergrem, H; Bergrem, HA; Hartmann, A; Hjelmesaeth, J; Jenssen, T, 2008
)
2.22
"Prednisolone did not inhibit either of these responses."( The suppressive effects of YM-58483/BTP-2, a store-operated Ca2+ entry blocker, on inflammatory mediator release in vitro and airway responses in vivo.
Ishikawa, J; Ohga, K; Shimizu, Y; Takezawa, R; Yamada, T; Yoshino, T, 2008
)
1.07
"Prednisolone was found to suppress the development of arthritis which, in turn, decreased the increased activity of collagenase and lysosomal enzymes cathepsin B1 and D in tissues and serum of arthritic rats."( Effect of adjuvant arthritis on collagenase and certain lysosomal enzymes in relation to the catabolism of collagen.
Bose, SM; Kuberasampath, T, 1980
)
0.98
"Prednisolone may enhance the degree of mucosal protection afforded by this mechanism."( Influence of prednisolone on ethanol-induced gastric injury in the rat.
Derelanko, MJ; Long, JF, 1982
)
1.35
"Prednisolone could cause dramatic increase in activity of ALP, but no change in ALP isozyme spectrum and concomitant increase in lactic dehydrogenase activity were found after prednisolone treatment."( [Expression of placental alkaline phosphatase in esophageal cancer cell line Eca109].
Yan, X; Zhang, F; Zhang, M, 1996
)
1.02
"Prednisolone could not inhibit PGE2 synthesis in these cells in our experimental conditions."( PGE2 synthesis by corneal endothelial cells: effect of glucocorticoids and NSAIDs.
Bellot, JL; García-Cabanes, C; Orts, A; Palmero, M, 1999
)
1.02

Treatment

Prednisolone treatment decreased collagen type-II degradation in immature cartilage, whereas glucocorticoids did not affect collagentype-II in mature cartilage. Prednisolones were gradually withdrawn and was completely stopped at 9 months post-KTX.

ExcerptReferenceRelevance
"Prednisolone is a new treatment method for such patients."( Prednisolone Treatment Is Effective for an Idiopathic Penile Abscess: A Case Report and Review.
Konno, T; Kurokawa, M; Nishida, H; Tsuchiya, N; Yamagishi, A, 2021
)
2.79
"Six prednisolone and six fMSC treatment cats completed the study. "( Comparing adipose-derived mesenchymal stem cells with prednisolone for the treatment of feline inflammatory bowel disease.
Webb, CB; Webb, TL, 2022
)
1.53
"Prednisolone, a routine treatment, is intolerable in almost one-third of children, requiring repeated dosing, which may prolong length of stay (LOS)."( Reducing oral steroid intolerability and drug costs for acute wheezers: A retrospective evaluation of a clinical management algorithm in a Pediatric Emergency Department.
Bartholome, B; Davison, G; Kennedy, B; McCann, J; McDonald, R; Mullen, S; O'Neill, V; Ruddell, J; Shields, MD; Steen, H; Trouton, M, 2023
)
1.63
"The prednisolone treatment duration was significantly longer in the PIO patient group than in the non-PIO patient group."( Analysis of Prednisolone-Induced Osteoporosis Using the Japanese Adverse Drug Event Report Database.
Hasegawa, S; Inoue, M; Iwata, M; Maezawa, M; Masuta, M; Matsumoto, K; Nakamura, M; Oura, K; Satake, R; Suzuki, T; Tanaka, M; Uranishi, H; Wakabayashi, W; Yoshida, Y, 2022
)
1.58
"Oral prednisolone was added to treatment 5 days after antiviral therapy."( Human Adenovirus: An Unusual Causative Agent for Acute Retinal Necrosis Presented with Central Retinal Vascular Occlusion.
Özdal, PÇ; Özdemir, HB, 2020
)
1.01
"Prednisolone treatment significantly improved her myositis."( Drop Head Syndrome as a Rare Complication in Mixed Connective Tissue Disease.
Akagi, M; Endo, Y; Fukui, S; Hara, K; Hashisako, M; Ichinose, K; Igawa, T; Iwamoto, N; Kawakami, A; Kawashiri, SY; Koga, T; Nakamura, H; Niino, D; Origuchi, T; Shimizu, T; Takatani, A; Tamai, M; Tsuji, S; Umeda, M, 2020
)
1.28
"Prednisolone as preemptive treatment did not lead to an increase in relapse (20.2% in the placebo and 14.0% in the prednisolone group (P = 0.46))."( A multicenter prospective, randomized, placebo-controlled phase II/III trial for preemptive acute graft-versus-host disease therapy.
Baurmann, H; Bethge, W; Beutel, G; Bunjes, DW; Ehrlich, S; Ganser, A; Hambach, L; Hamwi, I; Heidenreich, D; Holler, E; Jonigk, D; Klein, S; Krauter, J; Kreipe, HH; Messinger, D; Metzger, J; Papkalla, A; Raad, J; Rank, A; Schäfer-Eckart, K; Schetelig, J; Schleuning, M; Schmid, C; Stadler, M; Stolzl, F; Türüchanow, I; von der Leyen, H; von Harsdorf, S; Wagner-Drouet, EM; Weissinger, EM; Westphal, K, 2021
)
1.34
"No prednisolone treatment (control group) and B."( Prednisolone treatment in acute interstitial nephritis (PRAISE) - protocol for the randomized controlled trial.
Bech, JN; Birn, H; Hoffmann-Petersen, N; Mose, FH, 2021
)
2.58
"Prednisolone treatment successfully induced clinical remission and mucosal healing."( A case of nivolumab-associated colitis, which relapsed after mucosal healing and was then successfully treated with mesalazine.
Akemoto, Y; Asari, T; Chinda, D; Fukuda, S; Fukutoku, Y; Hasui, K; Hiraga, H; Kikuchi, H; Mikami, T; Murai, Y; Sakuraba, H; Sawaya, M; Tanaka, M; Tatsuta, T, 2019
)
1.24
"Prednisolone treatment increased the chance of Lille response if the NLR was  ≥ 5 (56.5% cf."( Baseline neutrophil-to-lymphocyte ratio predicts response to corticosteroids and is associated with infection and renal dysfunction in alcoholic hepatitis.
Allison, M; Atkinson, SR; Austin, A; Dhanda, A; Forrest, EH; Fraser, A; Hayes, PC; Katarey, D; Masson, S; McCune, A; Parker, R; Potts, J; Richardson, P; Ryder, S; Sinha, R; Storey, N; Thursz, MR; Vergis, N; Verma, S, 2019
)
1.24
"Each prednisolone-treated cat was matched to a healthy control cat on the basis of sex, neuter status, age (± 1 year), and body weight (± 10%)."( Clinicopathologic, hemodynamic, and echocardiographic effects of short-term oral administration of anti-inflammatory doses of prednisolone to systemically normal cats.
Berger, DJ; Khelik, IA; Mochel, JP; Palerme, JS; Seo, YJ; Ward, JL; Ware, WA, 2019
)
1.18
"Prednisolone-treated cats had expected clinicopathologic alterations (mild increases in neutrophil and monocyte counts and serum concentrations of albumin, cholesterol, and triglycerides) but systolic arterial blood pressure; blood glucose, serum potassium, and cardiac biomarker concentrations; urinary sodium excretion; and echocardiographic variables did not differ significantly from baseline at any time. "( Clinicopathologic, hemodynamic, and echocardiographic effects of short-term oral administration of anti-inflammatory doses of prednisolone to systemically normal cats.
Berger, DJ; Khelik, IA; Mochel, JP; Palerme, JS; Seo, YJ; Ward, JL; Ware, WA, 2019
)
2.16
"Oral prednisolone treatment provided temporary remission."( Spinal dural ossification causing neurological signs in a cat.
Antila, JM; Anttila, M; Cizinauskas, S; Jeserevics, J; Rakauskas, M, 2013
)
0.84
"Prednisolone treatment further impedes regeneration through a shift in the time profiles of osteoblast and osteoclast genes that commensurates with an osteoporosis-like imbalance in bone formation."( Prednisolone induces osteoporosis-like phenotype in regenerating zebrafish scales.
de Vrieze, E; Flik, G; Metz, JR; Peters, HM; Spanings, FA; van Kessel, MA, 2014
)
2.57
"Prednisolone treatment was well tolerated; none of the participants left the study."( Glucocorticoid treatment impairs microvascular function in healthy men in association with its adverse effects on glucose metabolism and blood pressure: a randomised controlled trial.
Diamant, M; Eringa, EC; Guigas, B; Ijzerman, RG; Linssen, MM; Ouwens, DM; Serné, EH; van Raalte, DH, 2013
)
1.11
"Prednisolone treatment normalized coagulopathies associated with chronic idiopathic hepatitis within one week in all 10 dogs that had coagulopathies at initial diagnosis."( A retrospective study of oral prednisolone treatment in canine chronic hepatitis.
Favier, RP; Penning, LC; Poldervaart, JH; Rothuizen, J; van den Ingh, TS, 2013
)
1.4
"Prednisolone treatment prevents T/NKT cell hepatitis but exacerbates hepatotoxin-induced liver injury by inhibiting macrophage- and neutrophil-mediated phagocytic and hepatic regenerative functions. "( Opposing effects of prednisolone treatment on T/NKT cell- and hepatotoxin-mediated hepatitis in mice.
Feng, D; Gao, B; Kwon, HJ; Park, O; Won, YS, 2014
)
2.17
"Prednisolone treatment further upregulated urea synthesis, which increases the hepatic loss of nitrogen and promotes body catabolism. "( Prednisolone but not infliximab aggravates the upregulated hepatic nitrogen elimination in patients with active inflammatory bowel disease.
Aagaard, NK; Agnholt, J; Christensen, LA; Dahlerup, JF; Frystyk, J; Grønbæk, H; Thomsen, KL; Vilstrup, H, 2014
)
3.29
"Prednisolone-treated patients presented with more advanced disease compared to controls (Class IIB or greater, 42 [60.0%] versus 7 [11.3%], respectively; P < 0.001). "( Efficacy of perioperative high-dose prednisolone therapy during thymectomy in myasthenia gravis patients.
Iwata, T; Kawaguchi, N; Mizobuchi, T; Suzuki, H; Tagawa, T; Yamada, Y; Yoshida, S; Yoshino, I, 2013
)
2.11
"Prednisolone treatment reduced circulating IL-6 and creatinine plasma levels but not serum AST, ALT or LDH. "( Prednisolone has a positive effect on the kidney but not on the liver of brain dead rats: a potencial role in complement activation.
Akhtar, MZ; Leuvenink, HG; Liu, B; Ottens, PJ; Ploeg, RJ; Rebolledo, R; Zhang, JN, 2014
)
3.29
"Prednisolone treatment caused an appreciable decrease in calcium levels both in the bone and serum and also in bone dry weight, BMC, and BMD in rats."( Moderate zinc supplementation during prolonged steroid therapy exacerbates bone loss in rats.
Bansal, SC; Dhawan, DK; Kamal, R; Khandelwal, N; Rai, DV, 2014
)
1.12
"The prednisolone co-treatment may improve the clinical pregnancy rate and reduce the miscarriage rate after IVF in women affected by thyroid autoimmunity."( In women with thyroid autoimmunity, does low-dose prednisolone administration, compared with no adjuvant therapy, improve in vitro fertilization clinical results?
Arrivi, C; Greco, E; Litwicka, K; Mencacci, C; Varricchio, MT, 2015
)
1.15
"In prednisolone-treated eyes, corneal epithelial thickness was decreased, and apoptosis of corneal epithelial cells was increased."( Comparison of Topical Application of TSG-6, Cyclosporine, and Prednisolone for Treating Dry Eye.
Kim, MK; Kim, YJ; Ko, JH; Lee, HJ; Oh, JY; Park, SY; Ryu, JS; Wee, WR, 2016
)
1.19
"Prednisolone treatment of patients with subacute thyroiditis was superior to nonsteroidal anti-inflammation drugs with regard to resolution of symptoms."( Comparison of the therapeutic effects of prednisolone and nonsteroidal anti-inflammatory drugs in patients with subacute thyroiditis.
Goto, H; Himuro, M; Honda, A; Komiya, K; Sato, J; Suzuki, R; Takeno, K; Uchida, T; Watada, H, 2017
)
1.44
"Prednisolone treatment ameliorated diarrhea and hypoproteinemia."( A unique case of collagenous colitis presenting as protein-losing enteropathy successfully treated with prednisolone.
Inoue, T; Kubo, Y; Nakamura, T; Nishio, M; Okawa, K; Sano, S; Tanaka, A; Ueda, W; Yamagami, K; Yoshioka, K, 2008
)
1.28
"In prednisolone treated rats Ipamorelin reduced CUNS by 20% (p<0.05), decreased the expression of urea cycle enzymes, neutralised N-balance, and normalized or improved organ N-contents."( Growth hormone and growth hormone secretagogue effects on nitrogen balance and urea synthesis in steroid treated rats.
Aagaard, NK; Greisen, J; Grøfte, T; Grønbaek, H; Johansen, PB; Malmlöf, K; Tygstrup, N; Vilstrup, H; Ørskov, H, 2009
)
0.87
"Prednisolone treatment ablated eosinophilia and MuSC in adult Scnn1b-Tg mice, but did not decrease mucus plugging or neutrophilia."( Airway and lung pathology due to mucosal surface dehydration in {beta}-epithelial Na+ channel-overexpressing mice: role of TNF-{alpha} and IL-4R{alpha} signaling, influence of neonatal development, and limited efficacy of glucocorticoid treatment.
Boucher, RC; Grubb, BR; Hudson, EJ; Livraghi, A; Mall, MA; O'Neal, WK; Randell, SH; Sheehan, JK; Wilkinson, KJ, 2009
)
1.07
"Prednisolone treatment in patients with inflammatory bowel disease is associated with a delayed onset and a shorter duration of action of rocuronium. "( Attenuation of a rocuronium-induced neuromuscular block in patients receiving prednisolone.
Diefenbach, C; Mencke, T; Molter, GP; Soltész, S; Stunz, M; Ziegeler, S, 2009
)
2.02
"Prednisolone pre-treatment did not alter the summed or peak immediate headache responses to GTN significantly (P = 0.08, P = 0.07), whereas the peak headache scores during the following 12 h were significantly lower after prednisolone pre-treatment (median peak score = 1, range 0-8) compared with placebo (median = 4, range 0-8) (P < 0.01)."( Prednisolone reduces nitric oxide-induced migraine.
Daugaard, D; Iversen, HK; Lassen, LH; Olesen, J; Tfelt-Hansen, P, 2009
)
2.52
"Prednisolone treatment did not affect force loss during eccentric contractions or recovery of force following injury."( Effects of prednisolone on skeletal muscle contractility in mdx mice.
Baltgalvis, KA; Call, JA; Lowe, DA; Nikas, JB, 2009
)
1.46
"Prednisolone treatment increased fasting blood glucose and plasma insulin concentrations, but this apparently reduced insulin sensitivity could not be confirmed in hyperinsulinemic euglycemic clamp studies."( Chronic prednisolone treatment reduces hepatic insulin sensitivity while perturbing the fed-to-fasting transition in mice.
Bloks, VW; Dokter, WH; Grefhorst, A; Groen, AK; Kuipers, F; Laskewitz, AJ; Reijngoud, DJ; van Dijk, TH; van Lierop, MJ, 2010
)
1.52
"Prednisolone treatment resulted in reduction (P < 0.05) and indomethacin treatment produced raise (P < 0.01) in synovial tissue kallikrein levels."( Modifications in tissue kallikrein activity with indomethacin and prednisolone treatment in arthritic rats.
Sharma, JN, 2010
)
1.32
"Prednisolone treatment was strongly associated with negative TST, adjusted odds ratio (AOR) 0.22 (0.1-0.8; P = 0.018), and with an increased risk of indeterminate QFT-IT results AOR 16.1 (4.1-63.2; P < 0.001), whereas no negative effect was found for long-acting corticosteroids."( Prednisolone treatment affects the performance of the QuantiFERON gold in-tube test and the tuberculin skin test in patients with autoimmune disorders screened for latent tuberculosis infection.
Bélard, E; Brylov, A; Hetland, ML; Jensen, FK; Nordgaard-Lassen, I; Ravn, P; Ruhwald, M; Semb, S; Soborg, B; Thomsen, H; Werlinrud, AM, 2011
)
2.53
"Prednisolone treatment provided relief of pain within 2 days."( [Atypical presentation of subacute thyroiditis].
Janssen, OE, 2011
)
1.09
"The prednisolone-treated patients were assigned to one of five regimens: 0.5 mg/kg/day given for the first 10 days of every month (n = 6), 0.75 mg/kg/day given for the first 10 days of every month (n = 3), 0.5 mg/kg on alternate days (n = 1), 0.75 mg/kg on alternate days (n = 1), or 5 mg/kg twice a week (n = 3)."( [Prednisolone treatment for Duchenne muscular dystrophy].
Fujii, T; Kimura, N; Kumada, T; Miyajima, T; Oda, N; Saito, K; Shimomura, H, 2011
)
1.76
"Prednisolone treatment was gradually withdrawn and was completely stopped at 9 months post-KTX."( Pediatric kidney transplantation followed by de novo therapy with everolimus, low-dose cyclosporine A, and steroid elimination: 3-year data.
Ahlenstiel, T; Blume, C; Lehner, F; Pape, L, 2011
)
1.09
"Prednisolone treatment decreased collagen type-II degradation in immature cartilage, whereas glucocorticoids did not affect collagen type-II in mature cartilage. "( Glucocorticoids exert context-dependent effects on cells of the joint in vitro.
Andreassen, KV; Bay-Jensen, AC; Christensen, ST; Henriksen, K; Karsdal, MA; Madsen, SH; Sverdrup, FM, 2011
)
1.81
"Prednisolone treatment reduces endometrial vascular maturation and angiogenic growth factor expression in women with RM with increased uNK cells."( Prednisolone treatment reduces endometrial spiral artery development in women with recurrent miscarriage.
Bulmer, JN; Drury, JA; Innes, BA; Lash, GE; Quenby, S; Robson, SC, 2011
)
3.25
"Prednisolone treatment showed significant lower osteocalcin levels and lower Z-scores for lumbar spine and femoral neck compared to PAI patients on hydrocortisone."( Bone mineral density is not significantly reduced in adult patients on low-dose glucocorticoid replacement therapy.
Diederich, S; Koetz, KR; Quinkler, M; Ventz, M, 2012
)
1.1
"The prednisolone-treated group showed significantly greater improvements in all nasal symptoms, nasal flow and polyp size than the placebo-treated group (p < 0.001, all). "( Clinical efficacy of a short course of systemic steroids in nasal polyposis.
Kirtsreesakul, V; Ruttanaphol, S; Wongsritrang, K, 2011
)
0.93
"Prednisolone treatment that caused a marked reduction in tumour volume was correlated with reduced pSTAT3 expression."( Overexpression of P-glycoprotein, STAT3, phospho-STAT3 and KIT in spontaneous canine cutaneous mast cell tumours before and after prednisolone treatment.
Chang, SC; Chiu, CY; Hsu, WL; Teng, SP; Wong, ML, 2012
)
1.31
"Prednisolone treatment delayed the half-emptying time (184 ± 45 min) compared with that of controls (137 ± 19 min), and coadministration of mosapride improved this gastric-emptying delay (143 ± 29 min)."( Effect of mosapride on prednisolone-induced gastric mucosal injury and gastric-emptying disorder in dog.
Fujino, Y; Fukushima, K; Hori, M; Maeda, S; Nakashima, K; Ohno, K; Tsujimoto, H; Tsukamoto, A, 2012
)
1.41
"Prednisolone treatment, by contrast, resulted in decreased BW, decreased feed efficiency, increased FHS index, and elevated blood lipid levels."( Effects of high fat diets or prednisolone treatment on femoral head separation in chickens.
Clark, FD; Coon, CC; Durairaj, V; Huff, GR; Huff, WE; Okimoto, R; Rath, NC, 2012
)
1.39
"Prednisolone treatment aggravated fasting hyperglycemia and hyperinsulinemia caused by high-fat feeding, resulting in a higher homeostatic assessment model of insulin resistance."( Chronic prednisolone treatment aggravates hyperglycemia in mice fed a high-fat diet but does not worsen dietary fat-induced insulin resistance.
Bloks, VW; Dokter, WH; Grefhorst, A; Groen, AK; Kuipers, F; Laskewitz, AJ; Reijngoud, DJ; Schreurs, M; van Dijk, TH; van Lierop, MJ, 2012
)
1.53
"Prednisolone treatment resulted in higher complete recovery rates, regardless of severity at baseline. "( Bell's palsy - the effect of prednisolone and/or valaciclovir versus placebo in relation to baseline severity in a randomised controlled trial.
Axelsson, S; Berg, T; Engström, M; Jonsson, L; Kanerva, M; Stjernquist-Desatnik, A, 2012
)
2.11
"Prednisolone treatment resulted in a statistically longer survival time compared to UDCA."( Retrospective comparison of prednisolone and ursodeoxycholic acid for the treatment of feline lymphocytic cholangitis.
Favier, RP; Otte, CM; Penning, LC; Rothuizen, J, 2013
)
1.41
"Prednisolone treatment reduced IGF1 bioactivity by 12.6% from 2.22±0.18 to 1.94±0.15 μg/l (P=0.01) compared with placebo. "( Prednisolone reduces the ability of serum to activate the IGF1 receptor in vitro without affecting circulating total or free IGF1.
Flyvbjerg, A; Frystyk, J; Heuck, C; Lyngholm, M; Schou, AJ; Vorum, H; Wolthers, OD, 2013
)
3.28
"Oral prednisolone treatment was initiated at 60 mg daily together with oral cyclosporin A (100-150 mg daily)."( [A case of nonspecific interstitial pneumonia associated with amyopathic dermatomyositis efficiently treated with a combination of cyclosporin A and prednisolone].
Abe, S; Harada, H; Hiraga, Y; Inoue, N; Morikawa, Y; Ohmichi, M; Sasaki-Date, H; Shijubo, N; Takahashi, H, 2002
)
0.97
"Oral prednisolone treatment markedly reduced the tumor and improved not only abnormal laboratory data such as C-reactive protein, but also the hoarseness."( [A case of fibrosing mediastinitis manifesting recurrent nerve palsy].
Asai, M; Iwahori, K; Kido, T; Komuta, K; Minami, S; Utsumi, T, 2002
)
0.77
"Prednisolone treatment was associated with decreases in the total thickness of the cutis and subcutis in the thigh (0.28 mm) and forearm (0.15 mm), and an increase in the abdomen (0.23 mm)."( Differential effects of short-term prednisolone treatment on peripheral and abdominal subcutaneous thickness in children assessed by ultrasound.
Heuck, C; Schou, AJ; Wolthers, OD, 2003
)
1.32
"In prednisolone-treated animals, 40.5% of the hypertrophic chondrocytes was apoptotic (P<0.02), with apoptotic chondrocytes also appearing higher in the hypertrophic zone."( Short-term glucocorticoid treatment of piglets causes changes in growth plate morphology and angiogenesis.
Buchholz, IM; Christis, C; de Meer, K; Hamers, N; Koedam, JA; Sakkers, RJ; Smink, JJ; van Buul-Offers, SC; van Tilburg, CM, 2003
)
0.83
"Oral prednisolone is the treatment of choice for the most severe asthma exacerbations, given together with oxygen and beta-2 agonists."( [Treatment of acute asthma attack in the emergency department].
Volovitz, B, 2003
)
0.77
"Oral prednisolone treatment initiated at 20 mg daily, combined with oral cyclophosphamide at 50 mg daily markedly improved not only the clinical symptoms, but also the mass shadows in the left upper lobe."( [A case of the limited from of Wegener's granulomatosis without c-ANCA].
Bandoh, S; Fujita, J; Horiike, A; Ishida, T; Ishii, T; Kubo, A; Tojo, Y; Yokomise, H, 2003
)
0.77
"Prednisolone treatment of sensory impairment of the ulnar and posterior tibial nerves detectable with the monofilament test, but not with the ballpen test, did not improve the long-term outcome in terms of recovery of touch sensibility, not did it reduce the risk of leprosy reactions or nerve function impairment beyond the initial 4-month treatment phase."( The prognostic importance of detecting mild sensory impairment in leprosy: a randomized controlled trial (TRIPOD 2).
Anderson, AM; Croft, RP; Nicholls, PG; Richardus, JH; Smith, WC; Van Brakel, WH; Withington, SG, 2003
)
1.04
"Prednisolone-treated mice also exhibited decreased vascular P-selectin (-82%) and ICAM-1 (-52%) expression and fewer L-selectin (-79%) and ICAM-1 (-57%) expressing mononuclear cells in quadriceps."( Prednisolone decreases cellular adhesion molecules required for inflammatory cell infiltration in dystrophin-deficient skeletal muscle.
Lee, JJ; Tidball, JG; Wehling-Henricks, M, 2004
)
2.49
"Prednisolone treatment was administered orally to patients at 30 mg for 7 days, 15 mg for 4 days, and 5 mg for 3 days."( Efficacy of steroid treatment for sensory impairment after orthognathic surgery.
Seo, K; Someya, G; Tanaka, Y; Terumitsu, M, 2004
)
1.04
"Prednisolone treated patients had an increased percentage body fat (SDS +0.46; P < 0.05) and increased body mass index (SDS 0.88; P < 0.01) compared to normal."( No difference between prednisolone and dexamethasone treatment in bone mineral density and growth in long term survivors of childhood acute lymphoblastic leukemia.
de Muinck Keizer-Schrama, SM; Hakvoort-Cammel, FG; Krenning, EP; Pieters, R; van Beek, RD; van den Heuvel-Eibrink, MM; van der Sluis, IM, 2006
)
1.37
"Prednisolone treatment significantly reduced the number of CD56 cells in the endometrium, from a median of 14% (before) to 9% (after) (P=.0004)."( Prednisolone reduces preconceptual endometrial natural killer cells in women with recurrent miscarriage.
Bates, M; Farquharson, R; Kalumbi, C; Quenby, S; Vince, G, 2005
)
2.49
"Prednisolone treatment did not influence the responses."( Influence of methotrexate, TNF blockers and prednisolone on antibody responses to pneumococcal polysaccharide vaccine in patients with rheumatoid arthritis.
Geborek, P; Jönsson, G; Kapetanovic, MC; Saxne, T; Sjöholm, A; Truedsson, L, 2006
)
1.32
"Prednisolone treatment alone was not successful."( Satoyoshi syndrome: a rare multisystemic disorder requiring systemic and symptomatic treatment.
Heger, S; Kuester, RM; Sippell, WG; Stephani, U; Volk, R, 2006
)
1.06
"Prednisolone treated patients and controls became chair bound at the mean age of 169 +/- 9 and 132 +/- 8 months respectively."( Prednisolone in Duchenne muscular dystrophy with imminent loss of ambulation.
Ghosh, D; Kumar, A; Mittal, B; Pandey, CM; Pradhan, S; Singh, U; Srivastava, NK, 2006
)
2.5
"Prednisolone treatment was associated with progressive reduction in height standard deviation score, which became statistically significant after 3 years (p<0.05)."( Follow-up of linear growth of body height in children with nephrotic syndrome.
Hung, YT; Yang, LY, 2006
)
1.06
"Prednisolone treatment of patients with reactions is associated with an upregulation of 11beta-HSD2 expression in skin."( Alteration of the cortisol-cortisone shuttle in leprosy type 1 reactions in leprosy patients in Hyderabad, India.
Andersson, AK; Atkinson, SE; Chaduvula, M; Jain, S; Khanolkar-Young, S; Lockwood, DN; Suneetha, L; Suneetha, S, 2007
)
1.06
"Prednisolone treatment increased the frequency of muscle calcification, while RAG2 genotype had no effect."( Strength and corticosteroid responsiveness of mdx mice is unchanged by RAG2 gene knockout.
Connolly, AM; Golumbek, PT; Keeling, RM, 2007
)
1.06
"Prednisolone treatment, which is known to retard bone formation activity, led to a significant decrease in PINP, whereas PTH treatment dose-dependently increased PINP."( Development of a highly sensitive, high-throughput, mass spectrometry-based assay for rat procollagen type-I N-terminal propeptide (PINP) to measure bone formation activity.
Copeland, M; Geiser, AG; Hale, JE; Hale, LV; Han, B; Harvey, A; Ma, YL; Powers, CS; Sato, M; You, J, 2007
)
1.06
"Prednisolone treatment reduced the influx of inflammatory cells into the BALF, but not significantly, had no effect on pulmonary function, and did not reduce of airway hypersensitivity."( Characterisation of the acute and reversible airway inflammation induced by cadmium chloride inhalation in healthy dogs and evaluation of the effects of salbutamol and prednisolone.
Bolognin, M; Clercx, C; De Buscher, V; Gustin, P; Kirschvink, N; Leemans, J; Peeters, D; Snaps, F, 2009
)
1.27
"Prednisolone treatment (50 mg daily) resulted in dramatic regression of recurrent mediastinal and pleural tumors, as well as improvement of pure red cell aplasia."( [Successful corticosteroid therapy of a recurrent thymoma with pure red cell aplasia].
Koshio, J; Maeda, T; Nagasawa, Y; Tsukada, H; Yokoyama, A, 2007
)
1.06
"Prednisolone treatment of infected animals did not affect the concanavalin A response, and lipopolysaccharide stimulation decreased more slowly and to a lesser extent than it did in mice treated with antilymphocyte globulin or both agents."( Immediate loss of cell-mediated immunity to murine cytomegalovirus upon treatment with immunosuppressive agents.
Balfour, HH; Howard, RJ; Mattsson, DM, 1980
)
0.98
"Prednisolone treatment did not alter the number of somatic cells in milk or reduce the inflammatory response of experimentally infected cows."( Excretion of [3H]prednisolone in clinically normal and experimentally infected bovine udders.
Geleta, JN; Mercer, HD; Shimoda, W, 1984
)
1.33
"83 prednisolone-treated and 57 control children of a previous study demonstrating benefits of antenatal steroid prophylaxis of IRDS were reexamined at the age of 6 years. "( Normal physical and mental development of 6-year-old children whose mothers were treated antenatally with prednisolone.
Adamovich, K; Arató, J; Horváth, I; Ostorharics-Horváth, G; Papp, K, 1984
)
1.1
"Prednisolone treatment also had deleterious effect on cartilage proteoglycan metabolism determined both histologically and biochemically."( Some further effects of prednisolone and triamcinolone hexacetonide on experimental arthritis in rabbits.
Hunneyball, IM, 1981
)
1.29
"Prednisolone treatment produced no important beneficial effect on any of the hepatic biochemical tests."( Double-blind controlled trial of prednisolone therapy in patients with severe acute alcoholic hepatitis and spontaneous encephalopathy.
Boyer, T; Depew, W; Omata, M; Redeker, A; Reynolds, T, 1980
)
1.26
"Prednisolone treatment did not alter fecundity in primary or secondary infections."( Effects of prednisolone on murine strongyloidiasis.
Dawkins, HJ; Grove, DI, 1981
)
1.37
"Prednisolone treatment did not increase the risk of treatment failure, nor did decreasing the total dose of melarsoprol from 12 to 9 injections for patients with > or = 100 white blood cells/mm3 of CSF."( Gambiense trypanosomiasis: frequency of, and risk factors for, failure of melarsoprol therapy.
Khonde, A; Loko, L; Milord, F; Mpia, B; Niyonsenga, T; Pépin, J,
)
0.85
"Prednisolone treatment (> or = 2 mg.kg-1 x day-1) resulted in a significant reduction in phosphofructokinase activity (expressed as microM substrate.min-1 x mg protein-1) and an increase in 3-hydroxyacyl-CoA dehydrogenase activity in the plantaris muscle."( Exercise and glucocorticoid-induced diaphragmatic myopathy.
Chen, CL; Criswell, D; Herb, RA; Lieu, FK; Martin, D; Powers, SK; Stainsby, W; Wood, C, 1993
)
1.01
"Prednisolone pretreatment resulted in decreased covalent binding of the toxic metabolite in vivo and an increased urinary excretion of glutathione-derived conjugates of acetaminophen, indicating an enhanced detoxification of the reactive metabolite by glutathione."( Prednisolone stimulates hepatic glutathione synthesis in mice. Protection by prednisolone against acetaminophen hepatotoxicity in vivo.
Lauterburg, BH; Schranz, C; Speck, RF, 1993
)
2.45
"When prednisolone- and placebo-treated groups were compared there was a decrease in airway methacholine responsiveness (p < 0.01) and an increase in FEV1 (p < 0.05) after prednisolone."( Prednisolone treatment in asthma. Reduction in the numbers of eosinophils, T cells, tryptase-only positive mast cells, and modulation of IL-4, IL-5, and interferon-gamma cytokine gene expression within the bronchial mucosa.
Assoufi, B; Bentley, AM; Durham, SR; Hamid, Q; Kay, AB; Meng, Q; Robinson, DS; Schotman, E, 1996
)
2.19
"Prednisolone treated patients had significantly fewer days with liquid stools than mesalazine patients, with a median of 0 and 1 days respectively by week 4 (p = 0.001)."( A randomised trial comparing mesalazine and prednisolone foam enemas in patients with acute distal ulcerative colitis.
Daniels, S; Grace, RH; Jewell, DP; Keighley, MR; Kingston, RD; Lee, FI; Mani, V; Patterson, J; Record, CO; Smith, K, 1996
)
1.28
"Prednisolone pre-treatment tended to be more effective in patients with higher transaminase levels and in patients with low levels of HBV DNA."( Prednisolone withdrawal therapy enhances the effect of human lymphoblastoid interferon in chronic hepatitis B. INTERPRED Trial Group.
Bassendine, M; Benhamou, JP; Berthelot, P; Bindslev, N; Enriquez, J; Krogsgaard, K; Lindberg, J; Marcellin, P; Ouzan, D; Ring-Larsen, H; Sanchez-Tapias, JM; Tran, A; Trepo, C, 1996
)
2.46
"Prednisolone pre-treatment significantly enhanced the treatment effect of lymphoblastoid interferon in terms of HBeAg clearance and seroconversion to anti-HBe. "( Prednisolone withdrawal therapy enhances the effect of human lymphoblastoid interferon in chronic hepatitis B. INTERPRED Trial Group.
Bassendine, M; Benhamou, JP; Berthelot, P; Bindslev, N; Enriquez, J; Krogsgaard, K; Lindberg, J; Marcellin, P; Ouzan, D; Ring-Larsen, H; Sanchez-Tapias, JM; Tran, A; Trepo, C, 1996
)
3.18
"Oral prednisolone treatment was started and the retinopathy was improved, but was complicated by acute interstitial pneumonia."( [A case of dermatomyositis with severe retinopathy in a patient who died of acute interstitial pneumonia].
Enoki, T; Murakami, A; Nakabayasi, I; Nakagami, T; Okisaka, S; Yoshizawa, N, 1997
)
0.75
"The prednisolone-treated patients had a median length of hospital stay (secondary end-point) of 5 days vs 6 for the placebo-treated (p < 0.01)."( Antibiotic and prednisolone therapy of erysipelas: a randomized, double blind, placebo-controlled study.
Bergkvist, PI; Sjöbeck, K, 1997
)
1.13
"Prednisolone treatment significantly prevented the increase in urinary protein and albumin excretion and glomerular cell proliferation in ATS-induced GN, indicating the beneficial effects of prednisolone on this GN."( Effects of prednisolone on glomerular signal transduction cascades in experimental glomerulonephritis.
Hamaguchi, A; Iwao, H; Kim, S; Masuda, T; Nakamura, Y; Seto, M; Yamanaka, S; Yoshifusa, H, 1998
)
1.41
"Prednisolone pre-treatment, enhances the effect of lymphoblastoid interferon in chronic hepatitis B."( [Pretreatment with prednisolone enhances the effect of human lymphoblastoid interferon in chronic hepatitis B].
Bassendine, M; Benhamou, JP; Berthelot, P; Bindslev, N; Enriquez, J; Krogsgaard, K; Lindberg, J; Marcellin, P; Ouzan, D; Ring-Larsen, H; Sanchez-Tapias, JM; Tran, A; Trepo, C, 1998
)
1.35
"Prednisolone treated patients had higher exhaled NO levels than patients only requiring inhaled corticosteroids (17.5 ppb, 95% CI 11.1 to 24.0 versus 7.2 ppb, 95% CI 4.6 to 9.8; p = 0.016), suggesting greater disease severity in this group."( Increase in exhaled nitric oxide levels in patients with difficult asthma and correlation with symptoms and disease severity despite treatment with oral and inhaled corticosteroids. Asthma and Allergy Group.
Barnes, PJ; Campbell, D; Chung, KF; Durham, SR; Kharitonov, SA; Robinson, DS; Stirling, RG, 1998
)
1.02
"Prednisolone treatment had no effect on any of the outcome measures."( Prednisolone treatment of respiratory syncytial virus infection: a randomized controlled trial of 147 infants.
Bonde-Hansen, ME; Bülow, SM; Friis, B; Holm, JC; Levin, E; Moller, T; Nielsen, HE; Nielsen, JE; Nir, M; Thomsen, LL, 1999
)
3.19
"Prednisolone treatment decreased the serum concentration of lysozyme and MPO."( Serum lysozyme: a potential marker of monocyte/macrophage activity in rheumatoid arthritis.
Arvidson, NG; Gudbjörnsson, B; Hâkansson, L; Hällgren, R; Torsteinsdóttir, I; Venge, P, 1999
)
1.02
"Prednisolone treatment induced a complete remission of both clinical and hematological findings after two months, while Coombs' tests became negative after three months."( [Autoimmune hemolytic anemia in chronic hepatitis C virus infection treated with alpha-interferon: a therapy-related event or extra-hepatic immunologic manifestation?].
Antonaci, S; Giannoccaro, F; Pace, L; Schiraldi, O, 1999
)
1.02
"Prednisolone pretreatment resulted in an increase in the proportion of mutant in patients with initially low percentages (< or = 25%) of mutant."( Olone modulates the therapeutic effect of interferon to eliminate preferentially the hepatitis B virus precore stop mutant.
Chen, TC; Chu, CM; Hsieh, SY; Liaw, YF; Sheen, IS; Yeh, CT, 2000
)
1.03
"The prednisolone treated patients were compared to 30 newly diagnosed PMR (n = 26) or TA patients (n=4) examined prior to start of prednisolone, and 70 healthy controls."( No permanent reduction in bone mineral density during treatment of polymyalgia rheumatica and temporal arteritis using low dose corticosteroids.
Dovland, H; Gran, JT; Haugeberg, G; Mikkelsen, B; Myklebust, G, 2000
)
0.79
"Prednisolone treatment had no effect on any of the outcome measures. "( [Prednisolone treatment of respiratory syncytial virus infection. A randomized, controlled trial of 147 children].
Bonde-Hansen, MB; Bülow, SL; Friis, B; Holm, JC; Levin, EF; Nielsen, HE; Nielsen, JE; Nir, M; Pedersen, TM; Thomsen, LL, 2000
)
2.66
"The prednisolone treatment led to an increase in the content of oxyproline (a marker of bone resorption), calcium, and inorganic phosphates in the urine."( [Comparative study of dimephosphon and xidiphone efficacy in steroid-induced osteoporosis in rats].
Burnasheva, ZA; Galiautdinova, AIu; Samoĭlova, NS; Valeeva, IKh; Ziganshina, LE,
)
0.61
"In prednisolone-treated patients there was no correlation between clinical synovitis and change in Larsen score (r=0.029) and only a slight and non-significant correlation with joint space narrowing (r=0.127)."( The relationship between soft tissue swelling, joint space narrowing and erosive damage in hand X-rays of patients with rheumatoid arthritis.
Byron, M; Kirwan, J; Watt, I, 2001
)
0.82
"Prednisolone treatment had little effect at day 7, but by day 28 significant decreases were found in cytokine levels."( Immunohistochemical analysis of cellular infiltrate and gamma interferon, interleukin-12, and inducible nitric oxide synthase expression in leprosy type 1 (reversal) reactions before and during prednisolone treatment.
Coulthart, A; Khanolkar-Young, S; Little, D; Lockwood, DN; Suneetha, S, 2001
)
1.22
"Oral prednisolone treatment improved the pulmonary nodular lesion, the abnormal laboratory data, and the uveitis."( [A case of pulmonary inflammatory pseudotumor with hypergammaglobulinemia, elevated ANA, and uveitis].
Gejyo, F; Kaizu, C; Kuwabara, K; Moriyama, H; Saito, Y; Suzuki, E; Takada, T; Terada, M, 2001
)
0.77
"Prednisolone or saline treatment was continued until the rabbits were killed either 6 weeks or 8 weeks after creation of the osteotomy."( Recombinant human bone morphogenetic protein-2 enhances osteotomy healing in glucocorticoid-treated rabbits.
Ammirati, KM; Blake, CA; Bouxsein, ML; Luppen, CA; Seeherman, HJ; Stevens, ML; Wozney, JM, 2002
)
1.04
"Prednisolone treatment led to insulin resistance as expected (HOMA-S; prednisolone vs placebo; 1.85 +/- 0.26 vs 1.02 +/- 0.10; p < 0.01) with exaggerated first-phase insulin secretion (3016 +/- 468 pmol/l vs 1688 +/- 207 pmol/l; p < 0.01), suggesting a stable disposition index. "( Glucocorticoid induced insulin resistance impairs basal but not glucose entrained high-frequency insulin pulsatility in humans.
Dall, R; Hollingdal, M; Juhl, CB; Pørksen, N; Schmitz, O; Sturis, J; Veldhuis, JD, 2002
)
1.76
"Prednisolone treatment caused immunosuppression in one monkey; this was accompanied by a progressive loss of humoral antibody to HVS-associated antigens, but neoplastic disease did not develop."( Infection of capuchin monkeys (Cebus albifrons) with Herpesvirus saimiri.
Cicmanec, JL; Neubauer, RH; Orr, TW; Pearson, GR; Rabin, H; Wallen, WC, 1975
)
0.98
"Prednisolone treatment of thymocytes before their injection cancelled the suppressive effect of autologous thymocytes."( [Suppressive effect of autologous thymocytes abolished by prednisolone].
Giulling, EV; Mel'nikov, OF, 1978
)
1.22
"Prednisolone treatment did not result in significantly increased P50 values."( Effect of prednisolone treatment on selected respiratory parameters and cardiac output in prematurely delivered neonatal lambs.
Culver, DH; Thompson, FN; van Kampen, M, 1978
)
1.38
"Prednisolone treatment elicited a quantitative increase in galactosamine (30.2%), uronic acid (76.2%), and sulphate (9.1%), while no difference was observed in sialic acid content between the treated and untreated groups."( Effect of prednisolone on the glycosaminoglycan components of the regenerating articular cartilage.
Kostenszky, KS; Oláh, EH, 1976
)
1.38
"Prednisolone treatment (40 mg daily) resulted in a dramatic improvement of renal function as well as other clinical abnormalities due to sarcoidosis, without any significant changes in liver function."( [An autopsy case of sarcoidosis associated with renal failure].
Ishii, A; Ito, K; Kobayashi, N; Miyamoto, T; Ohta, K; Okudaira, H; Suzuki, S; Takizawa, H, 1992
)
1
"prednisolone (PSL) treated nephrotic stage, 3."( Two-color analysis of lymphocyte subpopulations in patients with nephrotic syndrome due to membranous nephropathy.
Koide, H; Nakayama, S; Ozaki, T; Tomino, Y, 1992
)
1
"In prednisolone-treated arthritic rats, there was a sustained decrease in plasma copper starting after 2 weeks of treatment which could be correlated with an improvement of the clinical and biochemical signs of inflammation."( Effects of chronic prednisolone administration on plasma copper in rats with adjuvant arthritis.
Famaey, JP; Fontaine, J; Neve, J; Pelen, F; Peretz, A, 1991
)
1.12
"Prednisolone treatment leads to diminution of ACTH and cortisol levels, elevation of glucose, insulin and C-peptide concentrations in plasma compared to prednisolone-untreated patients, producing insignificant effect on plasma levels of STH, vasopressin, aldosterone, area and creatinine."( [Effect of glucocorticoid hormones on the status of the hypothalamo-hypophyseal-adrenal system and endocrine function of the pancreas in patients with hemorrhagic fever with renal syndrome].
Bystrovskiĭ, VF, 1990
)
1
"Prednisolone treatment is not recommended when the reliability of the treatment cannot be guaranteed, as the hazard of harm would exceed the expected benefit."( Corticosteroids in primary tuberculosis with bronchial obstruction.
Dab, I; Derde, MP; Malfroot, A; Spehl, M; Toppet, M; Toppet, V, 1990
)
1
"Prednisolone treatment reduced POMC mRNA below the levels detected in untreated animals, with no detectable response to stress.(ABSTRACT TRUNCATED AT 250 WORDS)"( Stress responsiveness of hypothalamic corticotrophin-releasing factor and pituitary pro-opiomelanocortin mRNAs following high-dose glucocorticoid treatment and withdrawal in the rat.
Gillham, B; Harbuz, MS; Lightman, SL; Nicholson, SA, 1990
)
1
"Only prednisolone-treated eyes had an extended period of virus shedding, and the rabbit mortality rate in this group was slightly higher."( Assessment of diclofenac on herpes keratitis in rabbit eyes.
Barlow, WE; McGuigan, LJ; Trousdale, MD, 1989
)
0.73
"Prednisolone treatment effected the state of neutrophils manifested in a reduced acid phosphatase activity; the production of lysozyme increased, the absorptive capacity normalized."( [The effect of prednisolone on the functional status of phagocytic cells in the peripheral blood of patients with pulmonary sarcoidosis].
Tyshko, NA, 1989
)
1.35
"Prednisolone treatment merits further assessment in primary biliary cirrhosis over a longer period, with attention to selection of patients most likely to benefit and continuing observation of bone mass to better establish the "cost/benefit" ratio."( A pilot, double-blind, controlled 1-year trial of prednisolone treatment in primary biliary cirrhosis: hepatic improvement but greater bone loss.
Bassendine, MF; James, OF; Malcolm, AJ; Mitchison, HC; Record, CO; Watson, AJ, 1989
)
1.25
"Prednisolone treatment of eleven asthmatics and beclomethasone treatment of five asthmatics did not inhibit the early response but only the late response."( Drug effects on exercise-induced late asthmatic responses.
Iikura, Y; Inui, H; Kay, AB; Lee, TH; Nagakura, T; Obata, T; Sugimoto, H,
)
0.85
"Prednisolone pretreatment (2 mg/kg, s.c.) also prolonged baclofen-induced muscle relaxation."( [Enhancement of the muscle relaxant action of baclofen by glucocorticoids].
Wakayama, K, 1987
)
0.99
"In prednisolone-treated cells, the processing of 61.5 K to the 64.5 K monomer was accelerated, and the presence of the 61.5 K precursor could only be detected by either neuraminidase or monensin treatment."( Control of placental alkaline phosphatase gene expression in HeLa cells: induction of synthesis by prednisolone and sodium butyrate.
Chou, JY; Takahashi, S, 1987
)
1
"Prednisolone treatment reduced intestinal calcium transport and increased phosphate excretion, causing a reduction in serum phosphate."( The effect of 1 alpha-hydroxyvitamin D2 on calcium metabolism in glucocorticoid-treated rats.
DeLuca, HF; Lindgren, JU; Sjödén, GO, 1985
)
0.99
"Treatment with prednisolone (PSL), mycophenolate mofetil (MMF), and tacrolimus (TAC) resulted in improved SLE activity and glucose intolerance with the reduction of anti-insulin receptor autoantibodies."( Effect of a multitarget therapy with prednisolone, mycophenolate mofetil, and tacrolimus in a patient with type B insulin resistance syndrome complicated by lupus nephritis.
Asano, T; Fujita, Y; Furuya-Yashiro, M; Kiko, Y; Kobayashi, H; Matsumoto, H; Matsuoka, N; Migita, K; Oda, A; Saito, K; Sasajima, T; Sato, S; Shimabukuro, M; Shio-Yano, K; Tanabe, H; Temmoku, J; Watanabe, H, 2022
)
1.33
"Treatment with prednisolone alone within 72 hours after onset still is the cornerstone of the treatment."( [Diagnostics and Therapy of Idiopathic Facial Palsy (Bell's Palsy)].
Guntinas-Lichius, O; Kuttenreich, AM; Thielker, J; Volk, GF, 2021
)
0.96
"Treatment with prednisolone upregulated expression of CD20 and an apoptosis-inducing protein BIM, which might augment perforin/granzyme B-mediated cell death."( Resistance to obinutuzumab-induced antibody-dependent cellular cytotoxicity caused by abnormal Fas signaling is overcome by combination therapies.
Fujimura, T; Harada, N; Kawasaki, N; Kondoh, O; Yamashita-Kashima, Y; Yoshimura, Y; Yoshiura, S, 2022
)
1.06
"Treatment with prednisolone 15 mg daily was instituted."( Remitting seronegative symmetrical synovitis with pitting edema: a case report.
Kitamoto, K; Kohchi, K; Tanaka, Y, 2022
)
1.06
"Treatment with prednisolone and furosemide was initiated, but then dialysis was initiated due to AKI."( Rehabilitation of a Patient With Minimal Change Nephrotic Syndrome and Acute Kidney Injury: A Case Report.
Hirano, Y; Kono, K; Yamauchi, K; Yasuda, H, 2022
)
1.06
"Treatment with prednisolone (PSL) reduced urinary protein from 7.8 g/gCre to approximately 1 g/gCre but did not lead to complete remission."( Complete remission of primary membranous nephropathy following hepatitis E infection.
Igarashi, H; Kitayama, Y; Koyano, A; Rachi, H; Shimasaki, M; Shiratori, K; Sugiura, T; Takanohashi, S; Togawa, A; Ueno, T, 2023
)
1.25
"Treatment by prednisolone eye drops was initiated every 30 minutes for 1 day with a gradual decrease for 6 weeks."( Preventive Inflammation Management with Steroids before Retreatment with Anti-VEGF after Severe Inflammation due to Brolucizumab.
Ambresin, A; Castro, DG; Karmy, BE, 2023
)
1.26
"Treatment with prednisolone, in combination with theophylline, curcumin or resveratrol increases SIRT1 expression, restores steroid sensitivity, and inhibits pro-inflammatory cytokine production from these cells and may reduce systemic inflammation in COPD."( Lymphocyte senescence in COPD is associated with decreased sirtuin 1 expression in steroid resistant pro-inflammatory lymphocytes.
Hodge, G; Hodge, S; Jersmann, H; Reynolds, PN; Tran, HB,
)
0.47
"Treatment with prednisolone rapidly ameliorated the symptoms, and the serum CK level normalized."( [A case of anti-titin antibody positive nivolumab-related necrotizing myopathy with myasthenia gravis].
Fujita, N; Isami, A; Kawachi, I; Shimaoka, Y; Suzuki, S; Uchiyama, A, 2019
)
0.85
"Treatment with prednisolone resolved the clinical signs and laboratory abnormalities."( Diagnosis and management of atypical hypoadrenocorticism in a variable flying fox (Pteropus hypomelanus).
Brock, AP; Cooke, KL; Emerson, JA; Hall, NH; Reese, DJ; Wellehan, JF, 2013
)
0.73
"Treatment with prednisolone, sirolimus, and regular ureteric stent revision was initiated to achieve adequate urinary tract drainage."( Erdheim-Chester disease: an uncommon cause of upper urinary tract obstruction.
Cheung, H; Lee, YW; Liu, PL; Tsu, JH; Yuen, SK, 2013
)
0.73
"Treatment with prednisolone was well tolerated."( Comparison of methods for evaluation of the suppressive effects of prednisolone on the HPA axis and bone turnover: changes in s-DHEAS are as sensitive as the ACTH test.
Gruvstad, E; Hedner, LP; Höglund, P; Luts, A; Norjavaara, E, 2014
)
0.98
"Treatment with prednisolone and MMF led to a significant drop in IgG after two weeks, reaching a nadir at eight weeks, followed by gradual normalization."( Serum immunoglobulin G level in patients with lupus nephritis and the effect of treatment with corticosteroids and mycophenolate mofetil.
Chan, GC; Chan, TM; Kwan, LP; Ma, MK; Mok, MM; Yap, DY; Yung, S, 2014
)
0.74
"Treatment with prednisolone and MMF does not result in clinically important suppression of IgG."( Serum immunoglobulin G level in patients with lupus nephritis and the effect of treatment with corticosteroids and mycophenolate mofetil.
Chan, GC; Chan, TM; Kwan, LP; Ma, MK; Mok, MM; Yap, DY; Yung, S, 2014
)
0.74
"Treatment with prednisolone and azathioprine was initiated."( Pneumomediastinum in a patient with microscopic polyangiitis preceded by interstitial pneumonia.
Hanafusa, T; Ishida, T; Isoda, K; Makino, S; Takeuchi, T, 2014
)
0.74
"Treatment with prednisolone (60 mg/d) along with WHO MDT-MB continued."( Optic nerve involvement in a borderline lepromatous leprosy patient on multidrug therapy.
Abhinav, C; Chander, B; Chauhan, PS; Khatri, G; Mahajan, VK; Mehta, KS; Prabha, N; Sharma, SK; Sharma, V; Tuli, R, 2013
)
0.73
"Treatment with prednisolone (PSL) 60 mg/day resulted in resolution of the AIHA, and the treatment was completed in November 2011."( A case of recurrent autoimmune hemolytic anemia during remission associated with acute pure red cell aplasia and hemophagocytic syndrome due to human parvovirus B19 infection successfully treated by steroid pulse therapy with a review of the literature.
Imai, H; Komatsu, N; Nakamura, N; Noguchi, M; Sawada, T; Sekiguchi, Y; Shimada, A; Sugimoto, K; Wakabayashi, M, 2014
)
0.74
"Treatment with prednisolone for 2 months resulted in a significant improvement of the skin and joint symptoms, but was discontinued due to his significant enlargement and extensive metastases of the liver carcinoma."( Erythema, papules, and arthralgia associated with liver cancer: report of a rare case of multicentric reticulohistiocytosis.
Cheng, LP; Hao, QS; Hu, L; Mei, JH; Wu, YH; Xia, J, 2015
)
0.76
"Treatment with prednisolone achieved good clinical response."( Idiopathic pulmonary hemosiderosis complicated by Down syndrome.
Abe, Y; Ayusawa, M; Chou, A; Izumi, H; Kamiyama, H; Kato, M; Komori, A; Matsumura, M; Takahashi, S; Watanabe, H, 2015
)
0.76
"Treatment with prednisolone was associated with a 3.2-fold increase in HIV viral load (p < 0.0001)."( Effects of Prednisolone on Disease Progression in Antiretroviral-Untreated HIV Infection: A 2-Year Randomized, Double-Blind Placebo-Controlled Clinical Trial.
Dölken, L; Gschmack, E; Hain, J; Hofmann, D; Horn, A; Kabyemera, R; Kalluvya, S; Kasang, C; Klinker, H; Kongola, G; Koutsilieri, E; Magambo, K; Majinge, C; Massawe, I; Mlewa, M; Müller, A; Preiser, W; Rethwilm, A; Scheller, C; Stich, A; Ulmer, A; Weissbrich, B, 2016
)
1.16
"Treatment with prednisolone at 125 μg/L to 1000 μg/L resulted in significant decline in growth, survival, and heart rate, as well as notable abnormalities in embryonic development."( Prednisolone impairs embryonic and posthatching development and shell formation of the freshwater snail, Physa acuta.
Bal, N; Du, J; Kumar, A; Nugegoda, D, 2016
)
2.22
"Treatment with prednisolone resulted in improvement of the skin and other lesions along with a decrease in IgG4 serum levels."( Immunoglobulin G4-related disease presenting with prurigo: Circulating T-helper 2 cells may be involved in the pathogenesis.
Suyama, T; Takamura, S; Teraki, Y, 2016
)
0.77
"Treatment with prednisolone resulted in an amelioration of the symptoms."( A case of systemic lupus erythematosus (SLE) following Human papillomavirus (HPV) vaccination.
Furuya, K; Hirai, K; Ito, H; Kurosaka, D; Noda, K; Ukichi, T, 2016
)
0.77
"Treatment with prednisolone followed by methotrexate resolved the cutaneous symptoms and the arthralgia completely."( [Primary cutaneous manifestation of Wegener's granulomatosis].
Bramsiepe, I; Danz, B; Fiedler, E; Heine, R; Holzhausen, HJ; Marsch, WC; Taube, KM, 2008
)
0.69
"Treatment with prednisolone combined with the NO-donor DETA-NONOate led to a greater inhibition of the eosinophilia and Cys-LT generation as compared with either drug alone."( Suppressive effects of nitric oxide-releasing prednisolone NCX-1015 on the allergic pleural eosinophil recruitment in rats.
Cordeiro, RS; de O Barreto, E; e Silva, PM; Ferreira, TP; Lagente, V; Martins, MA; Oliveira, MS; Pires, AL; Wallace, JL; Zamuner, S, 2008
)
0.94
"Treatment with prednisolone combined with valsartan effectively decreased both chymase-positive mast cells and RI, displaying a significant correlation between these biomarkers (rho=0.85, p=0.016)."( Evidence for abundant presence of chymase-positive mast cells in the kidneys of patients with immunoglobulin A nephropathy: effect of combination therapy with prednisolone and angiotensin II receptor blocker valsartan.
Imanishi, M; Kitabayashi, C; Konishi, Y; Maeda, I; Miyazaki, M; Morikawa, T; Nishiyama, A; Okada, N; Okumura, M; Takai, S; Ueda, M; Yoshioka, K, 2008
)
0.88
"Treatment of prednisolone-resistant Jurkat and Molt4 cells with 2-deoxy-D-glucose (2-DG), lonidamine (LND), or 3-bromopyruvate (3-BrPA) increased the in vitro sensitivity to glucocorticoids, while treatment of the prednisolone-sensitive cell lines Tom-1 and RS4; 11 did not influence drug cytotoxicity."( Inhibition of glycolysis modulates prednisolone resistance in acute lymphoblastic leukemia cells.
Broekhuis, MJ; Den Boer, ML; Evans, WE; Holleman, A; Hulleman, E; Kazemier, KM; Pieters, R; Rudin, CM; VanderWeele, DJ, 2009
)
0.98
"Treatment with prednisolone resulted in a rapid improvement and recovery of his hearing."( Cogan's syndrome: a rare cause of meningoencephalitis.
Ferrie, CD; Long, V; Pysden, KS, 2009
)
0.69
"Pre-treatment with prednisolone did not reduce the immediate GTN-induced headache, did not inhibit the frequency of delayed headache but significantly decreased the intensity of delayed GTN-induced headache. "( Prednisolone reduces nitric oxide-induced migraine.
Daugaard, D; Iversen, HK; Lassen, LH; Olesen, J; Tfelt-Hansen, P, 2009
)
2.12
"Treatment with prednisolone, 100 mg/day, had no significant effect. "( [Severe corticoid-refractory autoimmune thrombocytopenia associated with mixed connective tissue disease (Sharp's syndrome). Treatment with rituximab].
Hrdlicka, P; Kouba, M; Rudolph, SE, 2009
)
0.71
"Treatment with prednisolone was also associated with a 16% reduction in the night time symptom score (geometric mean ratio 0.84, 95% CI 0.70 to 1.00; P=0.050), a reduced risk of health resource use (odds ratio 0.54, 95% CI 0.34 to 0.86; P=0.010), and reduced school absenteeism (mean difference -0.4 days, 95% CI -0.8 to 0.0 days; P=0.045)."( Parent initiated prednisolone for acute asthma in children of school age: randomised controlled crossover trial.
Biscan, MI; Brennan, SL; Carlin, JB; Robertson, CF; South, M; Vuillermin, PJ, 2010
)
1.04
"Treatment with prednisolone and azathioprine resulted in complete or partial remission in majority of the patients (54.8%)."( Autoimmune hepatitis: Single-center experience of clinical presentation, response to treatment and prognosis in Saudi Arabia.
Akbar, HO; Fallatah, HI; Qari, YA,
)
0.47
"Treatment with prednisolone improves IS along with normalization of cytokine and adipokine levels and physical activity."( Insulin sensitivity and related cytokines, chemokines, and adipokines in polymyalgia rheumatica.
Galbo, H; Kreiner, F, 2010
)
0.7
"Oral treatment with prednisolone results in a reduction of effective thyroidal (131)I half-life in Graves disease, especially at higher doses."( Qualitative and quantitative impact of protective glucocorticoid therapy on the effective 131I half-life in radioiodine therapy for Graves disease.
Beu, M; Hautzel, H; Müller, HW; Pisar, E; Schott, M; Yazdan-Doust, N, 2010
)
0.68
"Treatment with prednisolone within 48 hours of onset of palsy resulted in significantly higher complete recovery rates and less synkinesis compared with no prednisolone."( Prednisolone in Bell's palsy related to treatment start and age.
Axelsson, S; Berg, T; Engström, M; Jonsson, L; Kanerva, M; Pitkäranta, A; Stjernquist-Desatnik, A, 2011
)
2.16
"Oral treatment with prednisolone (30 mg/day) resulted in rapid disappearance of the infiltrative shadow."( A case of adult onset Still's disease complicated with cryptogenic organizing pneumonia.
Haraoka, H; Kobayashi, Y; Nishio, S; Onishi, T; Sato, H; Takao, T; Yokoe, I, 2011
)
0.68
"Treatment with prednisolone and azathioprine led to fast and durable resolution of symptoms."( [Protein-losing enteropathy: a cause of hypoalbuminaemia in patients with systemic lupus erythematosus].
Briem, S; Fiehn, C; Mühleisen, H; Weis, D; Xanthouli, P, 2011
)
0.71
"Treatment with prednisolone led to improvement of both AIHA and IIP."( [Autoimmune hemolytic anemia in a patient with idiopathic interstitial pneumonia].
Chiba, S; Fukuda, K; Kamada, Y; Suzukawa, K; Taoka, K; Yokoyama, Y, 2011
)
0.71
"Treatment of prednisolone-induced hyperglycemia should be targeted at this time period."( Continuous monitoring of circadian glycemic patterns in patients receiving prednisolone for COPD.
Aguilar-Loza, NR; Burt, MG; Frith, P; Roberts, GW; Stranks, SN, 2011
)
0.95
"Treatment with prednisolone successfully prevented inflammatory infiltration over significant regions of the OE. "( The role of TNF-α in inflammatory olfactory loss.
Lane, AP; May, LA; Sultan, B, 2011
)
0.72
"Treatment with prednisolone at both dosages reduced CRP levels significantly."( Metabolic effects of high-dose prednisolone treatment in early rheumatoid arthritis: balance between diabetogenic effects and inflammation reduction.
Bijlsma, JW; den Uyl, D; Diamant, M; Dijkmans, BA; Hoes, JN; Lems, WF; Nurmohamed, MT; van Raalte, DH, 2012
)
1
"Treatment with prednisolone and vinblastin resulted in settling of fever and resolution of respiratory symptoms and signs."( Pulmonary langerhans cell histiocytosis masquerading as tuberculosis in an infant.
De Silva, MV; Mettananda, S; Senanayake, MP, 2011
)
0.71
"Treatment of prednisolone-induced hyperglycaemia should be directed at the postprandial period."( Screening for diabetes in patients with inflammatory rheumatological disease administered long-term prednisolone: a cross-sectional study.
Ahern, MJ; Burt, MG; Petersons, CJ; Smith, MD; Stranks, SN; Willenberg, VM, 2012
)
0.95
"Treatment with prednisolone does not improve short-term outcome in patients with IFP in an unselected clinical setting. "( No effect of corticosteroid treatment for idiopathic facial paralysis.
Andreassen, CS; Christensen, KF; Ovesen, T, 2012
)
0.73
"Treatment with prednisolone resulted in resolution of the lesions."( Pemphigus foliaceus in a juvenile Cashmere goat, and outcome after prednisolone and methylprednisolone therapy.
Janzen, AM; Marqués, FJ; Myers, S; Wiles, D, 2011
)
0.95
"Treatment with prednisolone and mycophenolate mofetil led to considerable clinical improvement."( Generalised lymphadenopathy as the first manifestation of lupus nephritis.
Al-Hashimi, H; Bhowmik, A, 2010
)
0.7
"Treatment with prednisolone, vinblastine and methotrexate was successful with regression of skin and CNS lesions."( Systemic juvenile xanthogranuloma with multiple central nervous system lesions.
Hamdi, A; Meshkini, A; Mirzayan, J; Shahzadi, S; Tajeddini, A; Zali, A,
)
0.47
"Treatment with prednisolone at 60 mg/day resulted in dramatic improvement of both the symptoms and the radiologic abnormalities."( Chronic eosinophilic pneumonia presenting with acute onset.
Hashimoto, S; Kobayashi, T; Koyama, D; Kumasawa, F; Mizumura, K; Nishinarita, S; Noda, A; Oki, T; Sawada, T; Shintani, Y, 2012
)
0.72
"Treatment with prednisolone induced insulin resistance (Homeostasis Model Assessment index: placebo vs. "( Preferential stimulation of abdominal subcutaneous lipolysis after prednisolone exposure in humans.
Christiansen, JS; Dall, R; Gravholt, CH; Møller, N; Schmitz, O, 2002
)
0.9
"The treatment with prednisolone and cyclophosphamide reduced his symptoms and laboratory data including serum C-ANCA."( [A case of Wegener's granulomatosis complicated with cytomegalovirus pneumonia during the treatment with immunosuppressants].
Izaki, K; Kawano, T; Kohno, S; Kondo, Y; Machida, I; Matsuse, H; Shimoda, T; Tomari, SY, 2002
)
0.63
"Treatment with prednisolone induced a prompt improvement with normalization of serum concentrations of ionized calcium and 1,25-(OH)2D3."( A patient with sarcoidosis presenting with acute renal failure: implication for granulomatous interstitial nephritis and hypercalcemia.
Fujigaki, Y; Hirano, M; Hishida, A; Kato, A; Ohashi, N; Takahashi, S; Yamamoto, T; Yonemura, K, 2002
)
0.65
"Treatment with prednisolone and azathioprine is beneficial in ameliorating the clinical course of a subset of IgAN patients with heavy proteinuria or impaired renal function. "( Prednisolone and azathioprine in IgA nephropathy - a ten-year follow-up study.
Ahuja, M; Brown, CB; Davlouros, P; El Nahas, AM; Goumenos, DS; Shortland, JR; Vlachojannis, JG, 2003
)
2.11
"Treatment with prednisolone resulted in remission of neurological symptoms and a rapidly normalization of the eosinophil count."( [A case of hypereosinophilic syndrome associated with paraplegia].
Endo, C; Miyake, S, 2003
)
0.66
"Treatment with prednisolone resulted in a reduction in pulmonary arterial pressure and CXR findings improved 2 months later, but no further effect was observed."( A case of pulmonary veno-occlusive disease associated with systemic sclerosis.
Ito, K; Oka, T; Saito, A; Takizawa, H; Yamamoto, K, 2003
)
0.66
"Treatment with prednisolone alone caused loss of bone mineral density, which could be fully prevented in groups D, K, and D + K. "( Protective effect of vitamins K2 and D3 on prednisolone-induced loss of bone mineral density in the lumbar spine.
Fujigaki, Y; Fukasawa, H; Hishida, A; Yonemura, K, 2004
)
0.94
"Treatment with prednisolone (2 mg/kg/day) for 14 days resulted in dramatic improvement of the thrombocytopenia."( Neonatal lupus erythematosus with cholestatic hepatitis.
Chuo, HT; Huang, LH; Lee, HC; Lin, SC; Shyur, SD; Wu, JY, 2004
)
0.66
"Treatment with prednisolone lowered (p < 0.001) trabecular thickness (TbTh) and number (TbN), while increasing (p < 0.001) the gap between trabeculae."( Effect of D-003, a mixture of very high molecular weight aliphatic acids, on prednisolone-induced osteoporosis in Sprague-Dawley rats.
León, F; Más, R; Mendoza, N; Mendoza, S; Noa, M, 2004
)
0.89
"Treatment with prednisolone and immunoglobulin resulted in a relative increase in the platelet count."( Immune-mediated thrombocytopenic purpura associated with Toxoplasma gondii infection in an immunocompetent patient.
Belegrati, M; Deutsch, M; Dourakis, SP; Kalmantis, T; Kountouras, D; Nezi, V, 2004
)
0.66
"Treatment with prednisolone quickly brought remission of systemic and laryngeal symptoms as well as improvement in the results of video-laryngostroboscopic tests."( Cricoarytenoid arthritis in Sjögren's syndrome.
Broussolle, C; Bui-Xuan, C; Charhon, A; Poupart, M; Sève, P, 2005
)
0.67
"Treatment with prednisolone was without effect, but 3 weeks after i.v."( Aplastic anemia successfully treated with rituximab.
Hansen, PB; Lauritzen, AM, 2005
)
0.67
"Treatment with prednisolone resulted in an increase in p-gp expression (P=0.005)."( P-glycoprotein expression in lamina propria lymphocytes of duodenal biopsy samples in dogs with chronic idiopathic enteropathies.
Allenspach, K; Bergman, PJ; Doherr, MG; Gaschen, F; Gröne, A; Sauter, S, 2006
)
0.67
"Treatment with prednisolone and azathioprine caused rapid and complete healing."( [Desmoglein 1-negative, desmoglein 3-positive pemphigus herpetiformis with involvement of oral mucous membranes].
Brod, C; Fierlbeck, G; Metzler, G; Röcken, M; Schaller, M; Sönnichsen, K, 2005
)
0.67
"Treatment with prednisolone, erythropoietin and danocrine was without effect."( [Refractory anaemia successfully treated with thalidomide].
Hansen, M; Hansen, PB, 2006
)
0.67
"Treatment with Prednisolone priming and Interferon, improved both the time and rate of seroconversion compared to no treatment or Interferon alone, suggesting that this combination of drugs might have an immunomodulatory effect."( Long-term follow-up of hepatitis B carrier children treated with interferon and prednisolone.
Ballard, AL; Boxall, EH; Davies, P; Kelly, DA; Sira, J, 2006
)
0.9
"Treatment with prednisolone and azathioprine seems to be of no long-term benefit in ameliorating the clinical course of nephrotic patients with membranous nephropathy. "( Prednisolone and azathioprine in membranous nephropathy: a 10-year follow-up study.
Ahuja, M; Brown, CB; Davlouros, P; El Nahas, AM; Goumenos, DS, 2006
)
2.13
"Treatment with prednisolone and endoscopic variceal ligation resulted in improvement of her symptoms."( A case of systemic sclerosis complicated by idiopathic portal hypertension: case report and literature review.
Akimoto, K; Kawai, S; Nishio, S; Takagi, K; Yoshino, T, 2006
)
0.67
"With treatment of prednisolone, an angiotensin-converting enzyme inhibitor, and an angiotensin II receptor-blocker, his proteinuria markedly decreased and renal function was stabilized."( Nephrotic syndrome and IgA nephropathy in polycystic kidney disease.
Gejyo, F; Hiura, T; Kawabe, S; Miyamura, S; Nishi, S; Saeki, T; Ueno, M; Yamazaki, H, 2006
)
0.66
"The treatment with prednisolone was started, which was effective on each disease."( [A case of autoimmune pancreatitis complicated with immune thrombocytopenia].
Fukushima, H; Katou, E; Nagayama, K; Sata, M; Shirachi, A, 2006
)
0.65
"Treatment with prednisolone and hydroxychloroquine followed by inhaled corticosteroids may improve survival in children with IPH."( Idiopathic pulmonary hemosiderosis: clinical profile and follow up of 26 children.
Bhargava, S; Kabra, SK; Lodha, R; Satyavani, A; Walia, M, 2007
)
0.69
"Treatment with prednisolone (1.5 mg/kg) or indomethacin (5 mg/kg) had no effect on the serum calcium level of these mice."( Association of hypercalcemia with tumors producing colony-stimulating factor(s).
Asano, S; Kondo, Y; Kosaka, K; Mori, M; Ohkawa, H; Ohsawa, N; Okabe, T; Sato, K; Sato, N; Ueyama, Y, 1983
)
0.61
"Treatment with prednisolone and clofazimine produced an excellent clinical response."( Pyoderma gangrenosum associated with selective hereditary IgA deficiency.
Bundino, S; Zina, AM, 1984
)
0.61
"Treatment with prednisolone alone or with a prednisolone/azathioprine combination resulted in an equal five-year survival (82%) and a similar overall preservation of renal function."( Renal involvement in systemic lupus erythematosus.
Atkins, RC; Boyce, NW; Holdsworth, SR; Thomson, NM, 1984
)
0.61
"Mice treated with prednisolone for 1 week had delayed clearance at 22h, and mice treated for 2 days had normal clearance."( Chronic glucocorticosteroid therapy impairs staphylococcal clearance from murine lungs.
Nugent, KM; Pesanti, EL, 1982
)
0.59
"Treatment with prednisolone gave rapid relief of pain and allowed the patient to become mobile again."( Engelmann's disease and the effect of corticosteroids. A case report.
Fitton, JM; Forsythe, WI; Hardy, GJ; Minford, AM; Rowe, VL, 1981
)
0.6
"Treatment with prednisolone was tried in some cases with excellent results."( Sinus histiocytosis with massive lymphadenopathy and epidural involvement.
Haas, RJ; Helmig, MS; Meister, P, 1981
)
0.6
"Treatment with prednisolone largely normalized the lung functions in case 2, completely in case 1, and renal functions in both."( [Sarcoidosis in monozygotic twins].
Jany, B; Kneitz, C; Kraus, MR; Tony, HP; Tschammler, A; Wilhelm, M, 1995
)
0.63
"Treatment with prednisolone resulted in an improvement in the chest X-ray findings, as well as a diminished polyclonal hypergammaglobulin level."( Lymphoid interstitial pneumonia as a pulmonary lesion of idiopathic plasmacytic lymphadenopathy with hyperimmunoglobulinemia.
Kawabata, Y; Miwa, T; Ogawa, K; Takagi, K; Torii, K; Yokoi, T, 1994
)
0.63
"Oral treatment with prednisolone and cyclosporin A of zymosan-challenged animals showed a dose-dependent reduction of IL-1 beta concentrations, but no effect of indomethacin."( Interleukin-1 (IL-1) production in a mouse tissue chamber model of inflammation. II. Identification of (tissue) macrophages as the IL-1 producing cells and the effect of anti-inflammatory drugs.
Chaplin, D; Dawson, J; Geiger, T; Kunz, S; Nguyen, H; Rordorf-Adam, C; Towbin, H; Vosbeck, K; Zingel, O, 1993
)
0.6
"Treatment with prednisolone markedly improved her symptoms."( Anticardiolipin antibody-induced sudden profound sensorineural hearing loss.
Hisashi, K; Komune, S; Sadoshima, S; Taira, T; Tsuda, H; Uemura, T,
)
0.47
"Treatment with prednisolone and melphalan resulted in improvement of clinical findings such as anemia, lymph node swelling and hypergammaglobulinemia in concurrence with decrease in serum levels of IL-6."( [Chromosomal abnormalities in Castleman's disease with high levels of serum interleukin-6].
Hashimoto, S; Ishii, A; Kawano, E; Kogure, K; Matsuura, Y; Nakamura, H; Nakaseko, C; Nishimura, M; Oh, H; Yoshida, S, 1993
)
0.63
"The treatment with prednisolone rapidly and progressively decreased serum levels of thyroglobulin, T4, and C-reactive protein and the erythrocyte sedimentation rate."( Dissociation between serum interleukin-6 rise and other parameters of disease activity in subacute thyroiditis during treatment with corticosteroid.
Aizawa, T; Sato, A; Yamada, T, 1996
)
0.61
"Treatment with prednisolone (15 mg/day), chloroquine phosphate (200 mg/ day), cyclosporine (5 mg/kg daily), and gold (10 mg/day) failed to reduce pruritic plaque formation, and pulse methylprednisolone therapy led to only a transient remission."( Widespread pruritic plaques in a patient with subacute cutaneous lupus erythematosus and hypocomplementemia: response to dapsone therapy.
Hatta, N; Imai, T; Sakai, H; Takata, M; Takehara, K; Tsutsui, K, 1996
)
0.63
"Treatment with prednisolone for DM and acetylspiramycin for toxoplasmosis was successful."( [A case of toxoplasmosis with dermatomyositis].
Fujisaki, T; Hayashi, J; Kashiwagi, S; Kawakami, Y; Tani, Y; Yamaga, S, 1995
)
0.63
"Treatment with prednisolone and cyclophosphamide."( Polyarteritis nodosa--a few unusual findings.
Bajwa, RP; Joshi, K; Kumar, L; Malik, N; Sarkar, B; Singh, S, 1996
)
0.65
"Treatment with prednisolone (7.5 mg/day) and aspirin (40 mg/day) was continued."( [A case of antiphospholipid antibody syndrome successfully treated with prednisolone and low-dose aspirin, with subsequent normal pregnancy].
Maeda, T; Maesima, E; Yamada, Y; Yamamoto, M; Yukawa, S, 1997
)
0.87
"Treatment with prednisolone, but not placebo, significantly reduced asthma symptoms (from mean +/- SEM total weekly score of 34 +/- 6.2 to 15.7 +/- 3.2, p = 0.02) and albuterol usage (from mean +/- SEM number of puffs/wk of 29.7 +/- 6.2 to 18.2 +/- 3.7, p = 0.01) and significantly increased FEV1 (from 89.8 +/- 4.4% to 99.3 +/- 4.1% of predicted, p = 0.03)."( The effect of treatment with oral corticosteroids on asthma symptoms and airway inflammation.
Djukanović, R; Gratziou, C; Holgate, S; Homeyard, S; Howarth, P; Madden, J; Montefort, S; Peroni, D; Polosa, R; Walls, A, 1997
)
0.64
"Treatment with prednisolone, a glucocorticoid hormone, prevented activation of both NF-kappa B and AP-1 in glomeruli and subsequent mRNA expression of NF-kappa B- and AP-1-regulated genes."( Suppression of NF-kappa B and AP-1 activation by glucocorticoids in experimental glomerulonephritis in rats: molecular mechanisms of anti-nephritic action.
Hisada, Y; Ishizuka, T; Kawashima, K; Sakurai, H; Shigemori, N; Sugita, T, 1997
)
0.64
"Treatment with prednisolone alone did not prevent progression to overt hepatic failure."( Recovery from life-threatening, corticosteroid-unresponsive, chemotherapy-related reactivation of hepatitis B associated with lamivudine therapy.
Chamuleau, RA; de Man, RA; Jones, EA; Rietbroek, RC; Smorenburg, S; ter Borg, F, 1998
)
0.64
"Treatment with prednisolone and melphalan for one year has stabilised the condition."( [Localized diffuse pulmonary AL-amyloidosis].
Abdulla, J; Birgens, H; Maltboek, N, 1998
)
0.64
"Treatment with prednisolone, azathioprine, heparin-warfarin, and dipyridamole early in the course of disease may prevent immunologic renal injury in children with severe IgA nephropathy."( A controlled trial of combined therapy for newly diagnosed severe childhood IgA nephropathy. The Japanese Pediatric IgA Nephropathy Treatment Study Group.
Awazu, M; Hattori, S; Honda, M; Iitaka, K; Ito, H; Ito, K; Koitabashi, Y; Matsuyama, S; Nakagawa, K; Nakamura, H; Ninomiya, M; Sakai, T; Seino, Y; Takeda, N; Takekoshi, Y; Yamaoka, K; Yoshikawa, N, 1999
)
0.64
"Treatment with prednisolone and azathioprine was initiated."( [Pyoderma gangrenosum and portal vein thrombosis in a 33-year-old female patient].
Berr, F; Halm, U; Mössner, J; Paasch, U; Pönisch, W; Schiefke, I, 1999
)
0.64
"Mice treated with prednisolone after auditory threshold elevations demonstrated significant improvement and stabilization of thresholds compared with untreated controls."( Steroid-responsive cochlear dysfunction in the MRL/lpr autoimmune mouse.
Kempton, Jb; Trune, DR; Wobig, RJ, 1999
)
0.63
"Treatment with prednisolone and cyclophosphamide resulted in the disappearance of the skin lesions and the improvement of laboratory data."( [The radiographic report of soft tissue tumor on the legs in a case of cutaneous polyarteritis nodosa].
Saegusa, J; Sinzato, I; Sugimoto, K; Yabe, H, 2000
)
0.65
"Treatment with prednisolone and cyclophosphamide induced a rapid recovery from acute renal failure."( A case with acute renal failure complicated by Waldenström's macroglobulinemia and cryoglobulinemia.
Fujigaki, Y; Hishida, A; Ikegaya, N; Sano, K; Suzuki, T; Yonemura, K, 2000
)
0.65
"Pre-treatment with prednisolone decreased the cell attracting effect of ICAM-1 in a dose-dependent manner to 72% of the basal migration (P<0.001)."( Chemotactic properties of ICAM-1 and PECAM-1 on neutrophil granulocytes in ulcerative colitis: effects of prednisolone and mesalazine.
Nielsen, OH; Vainer, B, 2000
)
0.84
"Treatment with prednisolone subsequently improved insulin secretion and glycaemic control in these patients."( Corticosteroid-responsive diabetes mellitus associated with autoimmune pancreatitis.
Hashimoto, M; Kobayashi, T; Murase, T; Nakanishi, K; Okubo, M; Takeuchi, K; Tanaka, S, 2000
)
0.65
"Treatment with prednisolone (1 mg/kg/d) began on approximately day 300."( Successful treatment of dry eye in two patients with chronic graft-versus-host disease with systemic administration of FK506 and corticosteroids.
Kuwana, M; Mashima, Y; Mori, T; Nakajima, T; Ogawa, Y; Oguchi, Y; Okamoto, S; Tsubota, K; Watanabe, R; Yamada, M, 2001
)
0.65
"Treatment with prednisolone resulted in marked improvement of biochemical, hematological and dermatological abnormalities."( Autoimmune hepatitis concomitant with hypergammaglobulinemic purpura, immune thrombocytopenia, and Sjögren's syndrome.
Kamimoto, H; Nakasho, K; Park, SY; Shintani, S; Wada, M, 2001
)
0.65
"Treatment with prednisolone largely prevents the microcirculatory alterations in the small bowel induced by extracorporeal circulation."( Influence of steroids on microvascular perfusion injury of the bowel induced by extracorporeal circulation.
Dollner, R; Gebhard, MM; Hagl, S; Reidenbach, B; Sack, FU; Schledt, A, 2001
)
0.66
"Treatment with prednisolone 10 mg tid rapid resolved nausea and vomiting, allowing discharge in 3 (range 1-6.5) days. "( Management of hyperemesis gravidarum: the importance of weight loss as a criterion for steroid therapy.
Moran, P; Taylor, R, 2002
)
0.67
"Retreatment with prednisolone and azathioprine has resulted in its improvement."( [Interstitial pneumonia associated with chronic thyroiditis].
Hashizume, T; Matsushita, K; Numata, H, 2002
)
0.64
"Treatment with prednisolone (40 mg/day) started and the bleeding tendency gradually improved."( Acquired type 3-like von Willebrand syndrome preceded full-blown systemic lupus erythematosus.
Hasegawa, H; Hayashi, Y; Kushiro, M; Niiya, K; Niiya, M; Takazawa, Y; Tanimizu, M; Tanimoto, M; Tanio, Y, 2002
)
0.65
"Treatment with prednisolone may be applied to any form of myasthenia gravis, particularly those which do not react to anticholinesterasic agents in moderate dosages."( [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,
)
0.73
"Pretreatment with prednisolone 10 mg/kg or cortisone acetate 10 mg/kg given subcutaneously significantly suppressed the aggravated ulceration in response to 20 mg/kg of indomethacin in these adrenalectomized rats."( The mechanism of aggravation of indomethacin-induced gastric ulcers by adrenalectomy in the rat.
Kasuya, Y; Okabe, S; Urushidani, T, 1979
)
0.58
"Treatment with prednisolone increased the concentrations of thiamine mono-, di- and triphosphates in both of these tissues in adrenalectomized rats, compared with unoperated control animals."( Effects of adrenalectomy and prednisolone on the absorption and phosphorylation of thiamine in rats.
Lazarov, J, 1978
)
0.89
"Treatment with prednisolone did not appear to have any effect on the length of the follicular phase or on ovulation."( Urinary oestrogen excretion, oestrous behaviour and ovulation in heifers treated with prednisolone during pro-oestrus and oestrus.
Tomasgard, G, 1976
)
0.82
"Treatment with prednisolone or dexamethasone is followed by an increase in renal excretion of p-aminohippurate (PAH) and in accumulation of PAH in renal cortical slices, particularly in 5- and 10-day-old rats with immature kidney function. "( Stimulation of renal tubular transport of p-aminohippurate in rats of different ages by treatment with adrenocortical steroids.
Bräunlich, H; Rassbach, H; Vogelsang, S, 1992
)
0.64
"Treatment with prednisolone improves the short-term survival of patients with severe biopsy-proved alcoholic hepatitis."( A randomized trial of prednisolone in patients with severe alcoholic hepatitis.
Benhamou, JP; Chaput, JC; Mathurin, P; Poynard, T; Ramond, MJ; Rueff, B; Théodore, C, 1992
)
0.95
"Treatment with prednisolone or cytostatic drugs as single therapy for up to 6 months increased the risk of improvement of the disease, and had no significant effect on deterioration."( Prognosis in glomerulonephritis. III. A longitudinal analysis of changes in serum creatinine and proteinuria during the course of disease: effect of immunosuppressive treatment. Report from Copenhagen Study Group of Renal Diseases.
Balsløv, JT; Brahm, M; Brammer, M; Brun, C; Gerstoft, J; Jørgensen, HE; Lorenzen, I; Thomsen, AC, 1992
)
0.62
"Treatment with prednisolone 60 mg daily was started."( [A case of mixed connective tissue disease (MCTD) associated with transverse myelitis responding to pulse therapy].
Obara, K; Tanaka, K, 1991
)
0.62
"was treated with prednisolone following the recommendation of Rubinstein."( [Initial therapeutic experiences in AIDS in childhood].
Eitelberger, F; Tulzer, W, 1990
)
0.61
"Pretreatment with prednisolone was started as therapy for leukemia, and 2 days later, the patient underwent surgery."( Intestinal obstruction at the onset of acute lymphoblastic leukemia in a child.
Ballati, G; Cozzi, F; Digilio, G; Iacobini, M; Lemmo, M; Multari, G; Roggini, M; Sirignano, A; Werner, B, 1990
)
0.6
"Treatment with prednisolone and acetylsalicylic acid (ASA) during pregnancy should be given to only those women who have high levels of anti-cardiolipin antibodies concomitant with high APTT values, and low values of complement C4."( The results of investigations for blocking antibody and autoantibodies help to choose between different immunological treatments for recurrent abortion.
Arfors, L; Haeger, M; Lindholm, A; Norberg, R; Siösteen, C; Stigendal, L; Unander, AM; Wenneström, H,
)
0.47
"Treatment with prednisolone resulted in striking improvement in both patients."( Allergic bronchopulmonary aspergillosis with coexistent aspergilloma: a long-term followup.
Chaturvedi, S; Jaggi, OP; Khan, ZU; Ramchandran, S; Randhawa, HS; Shah, A, 1989
)
0.62
"Treatment with prednisolone brought relief."( Endobronchial pseudolymphoma associated with Sjögren's syndrome. Report of a case.
Kajiki, A; Kido, M; Kuroiwa, A; Miyazaki, N; Yamazaki, H; Yoashihara, S, 1989
)
0.62
"Treatment with prednisolone produced marked reductions in body weight gain, adrenal weight and pituitary ACTH content, but no significant change in hypothalamic corticotrophin-releasing factor (CRF) bio- or immunoreactivity."( Recovery of the components of the hypothalamo-pituitary-adrenocortical axis in the rat after chronic treatment with prednisolone.
Campbell, EA; Gillham, B; Jones, MT; Nicholson, SA, 1987
)
0.82
"Treatment with prednisolone, cytotoxic drugs, and plasma exchange hastened the time to clearance of autoantibody and improved the outlook of patients who were not dependent on dialysis and those with lung haemorrhage."( Antiglomerular basement membrane antibody mediated disease in the British Isles 1980-4.
Bowman, C; Lockwood, CM; Pusey, CD; Rees, AJ; Savage, CO, 1986
)
0.61
"Treatment with prednisolone resulted in a marked improvement in both clinical condition and renal function."( Reversible acute renal failure due to Churg-Strauss syndrome.
Davenport, A; Goldsmith, HJ; McDicken, I, 1988
)
0.61
"Treatment with prednisolone should be given for at least two years, with adjustment of dosage according to the serum levels of aspartate transaminase; maintenance does should be 8-12 mg a day."( Treatment of chronic active hepatitis and other liver diseases with corticosteroid agents.
Mackay, IR, 1987
)
0.61
"Treatment with prednisolone hemisuccinate sodium (0.25 mumol/egg) produced an elevation in the level of LPO in the lens but that with cortisone hemisuccinate sodium or cortexolone hemisuccinate sodium did not change the level of LPO in the lens."( The alteration of lipid peroxide in glucocorticoid-induced cataract of developing chick embryos and the effect of ascorbic acid.
Iwatsuru, M; Lee, JW; Nishigori, H; Yamauchi, Y, 1986
)
0.61
"Treatment with prednisolone or with maintenance doses of carbohydrate-active steroids returned auditory detection and perception to normal in every patient tested."( Auditory detection and perception in normal man and in patients with adrenal cortical insufficiency: effect of adrenal cortical steroids.
Daly, RL; Henkin, RI, 1968
)
0.59
"Treatment with Prednisolone(R) did not change the magnitude of the initial response to 1,25-dihydroxyvitamin D(3) at 7 hr, but did decrease the response at 24 and 48 hr after a single dose of 1,25-dihydroxyvitamin D(3)."( The effect of Prednisolone upon the metabolism and action of 25-hydroxy-and 1,25-dihydroxyvitamin D3.
Ayigbedé, O; Carré, M; Miravet, L; Rasmussen, H, 1974
)
0.95

Toxicity

MMF seems safe and effective as first-line therapy in inducing and maintaining remission in treatment-naive patients with AIH. Incidence rates per 1000 person-years of potential corticosteroid-related adverse events in patients with new current use of oral prednisolone ranged from 1 to 2.

ExcerptReferenceRelevance
" No toxic effects of the drug have been found."( The therapeutic value of oral long-term treatment with terbutaline (Bricanyl) in asthma. A follow-up study of its efficacy and side effects.
Formgren, H, 1975
)
0.25
"03 mg/kg/day group, ther were no toxic signs."( [A 13-week subcutaneous toxicity study of prednisolone farnesylate (PNF) in rats].
Anabuki, K; Hoshiya, T; Okazaki, S; Tamura, K; Tanaka, G; Tanaka, H; Yamazaki, E, 1992
)
0.55
" In the groups that received less than 1 mg/kg/day of PNF gel, there were no toxic signs induced by the drug."( [A 13-week dermal toxicity study of prednisolone farnesylate (PNF) gel in rats with a recovery period of 5 weeks].
Anabuki, K; Hoshiya, T; Okazaki, S; Tamura, K; Tanaka, G; Tanaka, H; Yamazaki, E, 1992
)
0.56
"125 mg/kg/day group, there were no toxic signs induced by the drug."( [A 52-week dermal toxicity study of prednisolone farnesylate (PNF) gel in rats with a recovery period of 8 weeks].
Aikawa, T; Hatayama, K; Nishimura, S; Okazaki, S; Tamura, K; Tanaka, G; Tanaka, H, 1992
)
0.56
" Main side-effect shown was osteoporosis (n = 7), other known steroid-side effects were quite seldom (less than 5%)."( [Polymyalgia rheumatica and giant cell arteritis; diagnosis and side effects of low-dose long-term glucocorticoid therapy].
Hatz, HJ; Helmke, K,
)
0.13
" An animal model is presented to assess these adverse effects on growth."( An animal model to study toxicity of central nervous system therapy for childhood acute lymphoblastic leukemia: effects on growth and craniofacial proportion.
Howes, A; Mullenix, PJ; Schunior, A; Tarbell, NJ; Tassinari, MS; Zengel, AE, 1990
)
0.28
" From the direction and magnitude of these changes it was concluded that they did not reflect any toxic actions of the preparation."( Target animal safety test of a dexamethasone-prednisolone combination in horses.
Laczay, P; Lehel, J; Móra, Z; Simon, F, 1990
)
0.54
"Six patients with histologically proven HBsAg-negative chronic active hepatitis (CAH), who were initially treated successfully with prednisolone with or without azathioprine, developed unacceptable adverse effects due to prednisolone."( D-penicillamine therapy in patients with HBsAg-negative chronic active hepatitis and major prednisolone-induced adverse effects.
Callender, ME; McClements, BM, 1990
)
0.7
"In contrast to its importance in improving renal graft survival, nephrotoxicity is the most serious side effect of cyclosporine."( Amplification of the nephrotoxic effect of cyclosporine by preexistent chronic histological lesions in the kidney.
Bosman, FT; Kootstra, G; Leunissen, KM; Nieman, FH; Noordzij, TC; van Hooff, JP; Vromen, MA, 1989
)
0.28
"Prednisolone, given orally or intraperitoneally before challenge, protected mice against the lethal effect of a crude cell extract of Bordetella pertussis containing heat-labile toxin (HLT) as the major toxic component."( Effect of prednisolone on the toxicity of Bordetella pertussis for mice.
Parton, R, 1985
)
2.11
"Some widely used ototopical preparations are potentially toxic to the middle and inner ear."( Ototoxicity of Vasocidin drops applied to the chinchilla middle ear.
Brown, OE; Masaki, M; Meyerhoff, WL; Wright, CG, 1988
)
0.27
"A retrospective analysis of 350 treatment courses using high dose pulsed intravenous methylprednisolone for relapses of multiple sclerosis revealed a low number of adverse effects."( Methylprednisolone therapy in multiple sclerosis: a profile of adverse effects.
Lyons, PR; Newman, PK; Saunders, M, 1988
)
0.98
" These findings suggest that the action site(s) of steroidal anti-inflammatory agents is involved in the development of the toxic actions of T-2 toxin, and the implications of the results with bioamines and opioids are also discussed."( Effects of drugs and metabolic inhibitors on the acute toxicity of T-2 toxin in mice.
Ryu, JC; Shiraki, N; Ueno, Y, 1987
)
0.27
" From the above evidence, it was concluded that HBP ointment was less toxic than the other topical corticosteroids."( Comparative toxicity study of hydrocortisone 17-butyrate 21-propionate (HBP) ointment and other topical corticosteroids in rats.
Kimura, M; Nakane, S; Otomo, S; Tarumoto, Y, 1986
)
0.27
" To determine if both groups of substances act through similar biologic mechanisms, their capacity to protect macrophages from the direct toxic effects of LPS was examined in vitro."( Inhibition of LPS toxicity for macrophages by metallothionein-inducing agents.
Costa, M; Lewis, VM; Patierno, SR; Peavy, DL, 1983
)
0.27
" To evaluate the role of direct toxic action of drugs on hepatocytes, the effects of salicylate, chloroquine, prednisolone and indomethacin on LDH leakage from cultured rat hepatocytes were studied."( Hepatotoxic effects of anti-rheumatic drugs in cultured rat hepatocytes.
Akesson, A; Akesson, B, 1984
)
0.48
" Adverse effects are rarely if ever associated with short courses of steroids used for this purpose."( Safety of oral corticosteroids.
Weinberger, M, 1982
)
0.26
" In 59 patients with advanced disease who received no other treatment, a 5-year survival rate of 66% was comparable with that achieved by more toxic mustine-containing combinations."( Five years' experience with ChlVPP: effective low-toxicity combination chemotherapy for Hodgkin's disease.
Austin, DE; Barrett, A; Dady, PJ; McElwain, TJ; Peckham, MJ, 1982
)
0.26
"To determine whether intermittent rather than daily administration of D-penicillamine (D-Pen) would effectively reduce the incidence of adverse effects without significantly diminishing the clinical benefits."( Intermittent treatment with D-penicillamine is effective in lower doses and with fewer adverse effects in patients with rheumatoid arthritis.
Akahoshi, T; Hakoda, M; Kamatani, N; Kashiwazaki, S; Taniguchi, A, 1994
)
0.29
" The incidence of adverse effects was significantly lower in the intermittent group."( Intermittent treatment with D-penicillamine is effective in lower doses and with fewer adverse effects in patients with rheumatoid arthritis.
Akahoshi, T; Hakoda, M; Kamatani, N; Kashiwazaki, S; Taniguchi, A, 1994
)
0.29
" Prednisolone pretreatment resulted in decreased covalent binding of the toxic metabolite in vivo and an increased urinary excretion of glutathione-derived conjugates of acetaminophen, indicating an enhanced detoxification of the reactive metabolite by glutathione."( Prednisolone stimulates hepatic glutathione synthesis in mice. Protection by prednisolone against acetaminophen hepatotoxicity in vivo.
Lauterburg, BH; Schranz, C; Speck, RF, 1993
)
2.64
" However on multivariate analysis only the presence of bulky disease and of B symptoms were independent adverse factors for response and for survival."( EPIC: an effective low toxicity regimen for relapsing lymphoma.
Ashley, S; Catovsky, D; Cunningham, D; Gore, ME; Hickish, T; Mansi, J; Nicolson, V; Roldan, A; Smith, IE, 1993
)
0.29
"Rimexolone 1% ophthalmic suspension is safe and effective for the treatment of uveitis."( Efficacy and safety of rimexolone 1% ophthalmic suspension vs 1% prednisolone acetate in the treatment of uveitis.
Alter, G; Crabb, JL; DeBarge, LR; Feiler, LS; Foster, CS; Friedlaender, MH; Raizman, MB; Santos, CI, 1996
)
0.53
" depot bromocriptine (Parlodel-LAR, Sandoz, Basel, Switzerland), but adverse effects following the first injection may still be a significant problem."( Oral prednisolone supplement abolishes the acute adverse effects following initiation of depot bromocriptine therapy.
Besser, GM; Grossman, AB; Jain, A; Jenkins, PJ; Jones, SL, 1996
)
0.81
"Concurrent oral administration of prednisolone significantly reduces the incidence of acute adverse effects following depot bromocriptine."( Oral prednisolone supplement abolishes the acute adverse effects following initiation of depot bromocriptine therapy.
Besser, GM; Grossman, AB; Jain, A; Jenkins, PJ; Jones, SL, 1996
)
1.09
" Additionally, the toxic effect of amiodarone on the cells was depressed by pretreatment of them with docosahexaenoic acid (DHA) or alpha-tocopherol for 2 days and co-treatment with these agents for 1 day, but not with prednisolone or indomethacin co-treatment."( Toxicity of amiodarone on mouse pulmonary endothelial cells cultured with or without alveolar macrophages.
Futamura, Y, 1996
)
0.48
" There were no significant adverse effects."( Efficacy and safety of one year of growth hormone therapy in steroid-dependent nephrotic syndrome.
Chao, SM; Lee, KO; Loke, KY; Tan, SP; Yap, HK; Zhou, X, 1997
)
0.3
" However, the induction phase is toxic and a 3-weekly interval appears more appropriate."( Feasibility, toxicity, and activity of LNH84-derived chemotherapy in the management of aggressive lymphomas.
Alberto, P; Bauer, J; Iten, PA; Laurencet, FM; Mermillod, B; Zulian, GB, 1997
)
0.3
" The drop-out rate due to adverse events was surprisingly higher in the placebo group (41%) than in the auranofin group (10%) and, as expected, higher due to lack of effect (29 and 16%)."( Auranofin is safe and superior to placebo in elderly-onset rheumatoid arthritis.
Andrup, O; Brodin, U; Clarke-Jenssen, O; Glennås, A; Karstensen, B; Kvien, TK, 1997
)
0.3
"Deflazacort (DFZ) is claimed to have fewer adverse bone effects than prednisone (PDN) at doses with equivalent anti-inflammatory activity (5 mg PDN = 6 mg DFZ)."( The long-term efficacy and safety of two different corticosteroids in chronic sarcoidosis.
Imbimbo, B; Milani, S; Riboldi, A; Rizzato, G; Torresin, A, 1997
)
0.3
" Our initial studies have demonstrated a direct adverse effect of individual glucocorticoids and cytotoxic agents on the proliferative capacity of rat tibial growth-plate chondrocytes in vitro."( Glucocorticoid pretreatment reduces the cytotoxic effects of a variety of DNA-damaging agents on rat tibial growth-plate chondrocytes in vitro.
Anderson, E; Eden, O; Isaksson, O; Robson, H; Shalet, S, 1998
)
0.3
" Adverse events were similar between groups (P = ."( The efficacy and safety of diclofenac 0.1% versus prednisolone acetate 1% following trabeculectomy with adjunctive mitomycin-C.
Cate, EA; Dubiner, HB; Kent, AR; Mundorf, TK; Stewart, JA; Stewart, WC; Whitaker, R, 1998
)
0.55
"To appraise the adjunctive role of prednisolone (PN) in pulmonary tuberculosis (PTB) with toxic reactions."( Prednisolone: a beneficial and safe adjunct to antituberculosis treatment? A randomized controlled trial.
Bilaçeroğlu, S; Büyükşirin, M; Celikten, E; Perim, K, 1999
)
2.02
"Prednosolone is a beneficial and safe adjunct to 12-month antituberculosis treatment in advanced PTB causing toxic reactions, provided that close clinical, radiographic and bacillary monitoring is exercised."( Prednisolone: a beneficial and safe adjunct to antituberculosis treatment? A randomized controlled trial.
Bilaçeroğlu, S; Büyükşirin, M; Celikten, E; Perim, K, 1999
)
1.75
"To appraise the data on systemic adverse effects of inhaled corticosteroids."( Systemic adverse effects of inhaled corticosteroid therapy: A systematic review and meta-analysis.
Lipworth, BJ, 1999
)
0.3
"All inhaled corticosteroids exhibit dose-related systemic adverse effects, although these are less than with a comparable dose of oral corticosteroids."( Systemic adverse effects of inhaled corticosteroid therapy: A systematic review and meta-analysis.
Lipworth, BJ, 1999
)
0.3
" No adverse events were reported, and there were no significant changes in intraocular pressure in either group."( Comparison of the efficacy and safety of ketorolac tromethamine 0.5% and prednisolone acetate 1% after cataract surgery.
Jenkins, JE; Pendelton, RA; Simone, JN, 1999
)
0.54
" There were no toxic deaths."( Epic as an effective, low toxicity salvage therapy for patients with poor risk lymphoma prior to beam high dose chemotherapy and peripheral blood progenitor cell transplantation.
Cavenagh, JD; Eden, AG; Hughes, A; Kelsey, SM; Lamont, A; McBride, NC; Mills, MJ; Newland, AC; Ward, MC, 1999
)
0.3
"Systemic toxic effects may develop as a result of topical and local use of ophthalmic corticosteroid preparations in susceptible patients."( Systemic toxicity of topical and periocular corticosteroid therapy in an 11-year-old male with posterior uveitis.
Cheng, L; Freeman, WR; Levi, L; Ozerdem, U; Scher, C; Song, MK, 2000
)
0.31
"The adverse effects of oral corticosteroids are widely recognised but there are few quantitative data on which to base advice to patients."( Adverse effects of oral corticosteroids in relation to dose in patients with lung disease.
Cooper, S; Hubbard, R; Lewis, SA; Oborne, J; Pringle, M; Tattersfield, AE; Walsh, LJ; Wong, CA, 2001
)
0.31
"Data on oral corticosteroid use, lifestyle, fractures, and other possible adverse effects were collected by questionnaire and compared between a community based cohort of patients taking continuous or frequent intermittent oral corticosteroids for asthma, chronic obstructive pulmonary disease, or alveolitis and age and sex matched control subjects."( Adverse effects of oral corticosteroids in relation to dose in patients with lung disease.
Cooper, S; Hubbard, R; Lewis, SA; Oborne, J; Pringle, M; Tattersfield, AE; Walsh, LJ; Wong, CA, 2001
)
0.31
" The principal adverse reactions to FK 506 therapy were hyperglycaemia, renal dysfunction and hyperkalaemia."( Two-year follow-up study of the efficacy and safety of FK 506 in kidney transplant patients. Japanese FK 506 Study Group.
, 1994
)
0.29
" Oral administration of prednisolone (1 mg/kg of body weight) resulted in resolution of adverse effects in all 8 dogs."( Evaluation of the safety of an abbreviated course of injections of allergen extracts (rush immunotherapy) for the treatment of dogs with atopic dermatitis.
Bettenay, SV; Mueller, RS, 2001
)
0.62
"Rush immunotherapy performed by personnel at a veterinary hospital is a safe method for treatment of dogs with atopic dermatitis."( Evaluation of the safety of an abbreviated course of injections of allergen extracts (rush immunotherapy) for the treatment of dogs with atopic dermatitis.
Bettenay, SV; Mueller, RS, 2001
)
0.31
" We have concluded that, in selected patients with cyclosporine nephrotoxicity, CsA withdrawal with concomitant use of MMF is safe and effective in the improvement of graft function and arterial hypertension."( [Use of mycophenolate mofetil in patients with a transplanted kidney and cyclosporin nephrotoxicity].
Dimitrijević, J; Drasković-Pavlović, B; Dujić, A; Elaković, D; Hrvacević, R; Ignjatović, Lj; Kronja, G; Marić, M; Vavić, N,
)
0.13
" In this study, the PDsuc-appended alpha-CyD ester conjugate (PDsuc/alpha-CyD conjugate) was intracolonically administered to rats with 2,4,6-trinitrobenzensulfonic acid-induced colitis, and its antiinflammatory and systemic adverse effects were compared with those of prednisolone (PD) alone and the PD/2-hydroxypropyl-beta-CyD complex (PD/HP-beta-CyD complex), which is a noncovalent inclusion complex."( Prednisolone-appended alpha-cyclodextrin: alleviation of systemic adverse effect of prednisolone after intracolonic administration in 2,4,6-trinitrobenzenesulfonic acid-induced colitis rats.
Arima, H; Hirayama, F; Uekama, K; Yano, H, 2001
)
1.93
" The most significant side effect is nephrotoxicity, which may present differently at different times after transplantation."( Cyclosporine nephrotoxicity: associated allograft dysfunction at low trough concentration.
Druskis, V; Jankauskiene, A; Laurinavicius, A, 2001
)
0.31
" In this study, the anti-inflammatory effect and systemic side effect of the PD succinate/alpha-cyclodextrin (PDsuc/alpha-CyD) ester conjugate after oral administration were studied using IBD model rats."( Colon-specific delivery of prednisolone-appended alpha-cyclodextrin conjugate: alleviation of systemic side effect after oral administration.
Arima, H; Hirayama, F; Kamada, M; Uekama, K; Yano, H, 2002
)
0.61
"A major thrust of transplantation research is to find more effective and less broadly toxic immunosuppressive agents."( Long-term safety, tolerability and efficacy of daclizumab (Zenapax) in a two-dose regimen in liver transplant recipients.
Koch, M; Kuse, ER; Light, S; Nashan, B; Niemeyer, G, 2002
)
0.31
"Intravenous pulse cyclophosphamide may be a safe and effective treatment in patients with severe IBD unresponsive to steroid treatment and merits evaluation in a controlled trial."( Safety and efficacy of intravenous pulse cyclophosphamide in acute steroid refractory inflammatory bowel disease.
Duchmann, R; Fischinger, J; Moser, C; Stallmach, A; Wittig, BM; Zeitz, M, 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
" Prednisolone, dexamethasone and their photoproducts have been tested to evaluate their acute and chronic toxic effects on some freshwater chain organisms."( Toxicity of prednisolone, dexamethasone and their photochemical derivatives on aquatic organisms.
DellaGreca, M; Fiorentino, A; Isidori, M; Lavorgna, M; Previtera, L; Rubino, M; Temussi, F, 2004
)
1.61
" For this reason, one goal of research in the GC field is the development of new drugs, which show a reduced side-effect profile while maintaining the antiinflammatory and immunosuppressive properties of classical GCs."( Dissociation of transactivation from transrepression by a selective glucocorticoid receptor agonist leads to separation of therapeutic effects from side effects.
Asadullah, K; Döcke, WD; Hennekes, H; Jaroch, S; Rehwinkel, H; Schäcke, H; Schmees, N; Schottelius, A; Strehlke, P, 2004
)
0.32
" Safety concerns led to an assessment of adverse events of corticosteroids, based on data of three trials studying prevention of NFI (the TRIPOD study)."( Adverse events of standardized regimens of corticosteroids for prophylaxis and treatment of nerve function impairment in leprosy: results from the 'TRIPOD' trials.
Anderson, AM; Croft, RP; Nicholls, PG; Richardus, JH; Smith, WC; Van Brakel, WH; Withington, SG, 2003
)
0.32
" There were no significant differences between the tacrolimus groups and placebo group in the incidence of adverse events."( Efficacy and safety of tacrolimus (FK506) in treatment of rheumatoid arthritis: a randomized, double blind, placebo controlled dose-finding study.
Abe, T; Hara, M; Hashimoto, H; Irimajiri, S; Kondo, H; Sugawara, S; Uchida, S, 2004
)
0.32
" Safety of the rimexolone was evaluated by IOP values and the presence of adverse effects."( Efficacy and safety of rimexolone 1% versus prednisolone acetate 1% in the control of postoperative inflammation following phacoemulsification cataract surgery.
Ozbay, D; Ozden, S; Tatlipinar, S; Yaylali, V; Yildirim, C, 2004
)
0.58
"Rimexolone 1% ophthalmic suspension is both an effective and safe topical steroid in controlling postoperative inflammation after cataract extraction with phacoemulsification."( Efficacy and safety of rimexolone 1% versus prednisolone acetate 1% in the control of postoperative inflammation following phacoemulsification cataract surgery.
Ozbay, D; Ozden, S; Tatlipinar, S; Yaylali, V; Yildirim, C, 2004
)
0.58
" While many effects on the immune system's components can be found as a result of a drug treatment or chemical exposure, true immunotoxicity occurs when such treatment results in adverse effects or defects in the immune response."( Adequate immunotoxicity testing in drug development.
Gore, ER; Herzyk, DJ, 2004
)
0.32
"Glucocorticoid treatment for steroid-dependent nephrotic syndrome (NS) is associated with severe adverse effects, such as bone fractures and epidural lipomatosis."( Effectiveness of high trough levels of cyclosporine for 5 months in a case of steroid-dependent nephrotic syndrome with severe steroid toxicity.
Arisaka, O; Kano, K; Nishikura, K; Shimizu, A; Shiraiwa, T; Tomita, S; Ueda, Y; Yamada, Y, 2004
)
0.32
" Low doses of MMF were chosen to minimize adverse effects and to reduce levels of CNIs without the attendant risks of under-immunosuppression."( Low-dose mycophenolate mofetil is an effective and safe treatment to permit phased reduction in calcineurin inhibitors in chronic allograft nephropathy.
Afzali, B; Chowdhury, P; Goldsmith, D; O'sullivan, H; Shah, S; Taylor, J, 2005
)
0.33
" There was no significant difference between groups in terms of infection or serious adverse events."( Alemtuzumab (CAMPATH 1H) induction therapy in cadaveric kidney transplantation--efficacy and safety at five years.
Bradley, JA; Bradley, JR; Calne, R; Firth, J; Friend, PJ; Hale, G; Jamieson, NV; Smith, KG; Taylor, CJ; Thiru, S; Waldmann, H; Watson, CJ, 2005
)
0.33
" Lipid profile, oral glucose tolerance, and adverse events were monitored."( Efficacy and cardiovascular safety of daclizumab, mycophenolate mofetil, tacrolimus, and early steroid withdrawal in renal transplant recipients: a multicenter, prospective, pilot trial.
Abramowicz, D; Kuypers, D; Meurisse, M; Mourad, M; Squifflet, JP; Vanrenterghem, Y; Wissing, M, 2005
)
0.33
"Steroid administration currently plays a central role in the medical management of ulcerative colitis (UC); however, long-term steroid usage causes adverse effects, which necessitates stoppage of drug intake, leading to worsening of the disease."( Leukocytapheresis therapy for steroid-naïve patients with active ulcerative colitis: its clinical efficacy and adverse effects compared with those of conventional steroid therapy.
Abe, T; Aoyama, N; Fukagawa, M; Kasuga, M; Maekawa, S; Nakahara, T; Nishioka, C; Shirasaka, D; Tamura, T; Umezu, M, 2005
)
0.33
" As for the treatment complications, three major adverse effects were observed in the PSL group, but none were observed in the LCAP group."( Leukocytapheresis therapy for steroid-naïve patients with active ulcerative colitis: its clinical efficacy and adverse effects compared with those of conventional steroid therapy.
Abe, T; Aoyama, N; Fukagawa, M; Kasuga, M; Maekawa, S; Nakahara, T; Nishioka, C; Shirasaka, D; Tamura, T; Umezu, M, 2005
)
0.33
"The results of this study suggest that the efficacy and safety of LCAP are equivalent, and in terms of severe adverse effects, superior to those of steroid therapy."( Leukocytapheresis therapy for steroid-naïve patients with active ulcerative colitis: its clinical efficacy and adverse effects compared with those of conventional steroid therapy.
Abe, T; Aoyama, N; Fukagawa, M; Kasuga, M; Maekawa, S; Nakahara, T; Nishioka, C; Shirasaka, D; Tamura, T; Umezu, M, 2005
)
0.33
" We evaluated total Quantitative MG (Q-MG) score, anti-acetylcholine receptor (AChR) antibody titer in the blood, interleukin 2 (IL-2) production in peripheral blood mononuclear cells (PBMCs), administration dosage of prednisolone (PSL), and adverse effects of FK506."( Long-term therapeutic efficacy and safety of low-dose tacrolimus (FK506) for myasthenia gravis.
Igarashi, S; Naruse, S; Nishizawa, M; Onodera, O; Oyake, M; Shimohata, T; Tada, M; Tanaka, K; Tsuji, S, 2006
)
0.52
" Although adverse effects were observed in three patients (33."( Long-term therapeutic efficacy and safety of low-dose tacrolimus (FK506) for myasthenia gravis.
Igarashi, S; Naruse, S; Nishizawa, M; Onodera, O; Oyake, M; Shimohata, T; Tada, M; Tanaka, K; Tsuji, S, 2006
)
0.33
"Our study indicates that low-dose FK506 treatment may be efficacious not only in controlling intractable myasthenic symptoms, but also in reducing steroid dosage, and that FK506 is safe as an adjunctive drug to PSL for MG treatment for a maximum of 3 years."( Long-term therapeutic efficacy and safety of low-dose tacrolimus (FK506) for myasthenia gravis.
Igarashi, S; Naruse, S; Nishizawa, M; Onodera, O; Oyake, M; Shimohata, T; Tada, M; Tanaka, K; Tsuji, S, 2006
)
0.33
"A retrospective cohort study involving 29 Japanese patients with autoimmune hepatitis (AIH) was performed to clarify factors that predict the efficacy of prednisolone and the occurrence of various serious adverse effects."( Efficacy and safety of prednisolone in patients with autoimmune hepatitis.
Honda, E; Inawari, M; Kiuchi, Y; Kogo, M; Mitamura, K; Shibata, M; Yoneyama, K,
)
0.64
"We examined the efficacy and adverse effects of rituximab with CHOP (cyclophosphamide, doxorubicin, vincristin, prednisone) or THP-COP (pirarubicin, cyclophosphamide, vincristin, prednisone) in previously untreated old-old and extremely old patients with diffuse large B cell lymphoma (DLBCL)."( [The efficacy and adverse effects of rituximab with CHOP or THP-COP in old-old and extremely old patients with diffuse large B cell lymphoma].
Abe, S; Fujii, H; Iwamoto, T; Kanaya, K; Kikukawa, M; Kiuchi, A; Miyazaki, K; Shin, K, 2006
)
0.33
" The most frequent adverse effect was bone marrow suppression, observed in 9 patients (69."( [The efficacy and adverse effects of rituximab with CHOP or THP-COP in old-old and extremely old patients with diffuse large B cell lymphoma].
Abe, S; Fujii, H; Iwamoto, T; Kanaya, K; Kikukawa, M; Kiuchi, A; Miyazaki, K; Shin, K, 2006
)
0.33
"This result suggested that both CHOP and THP-COP combined with rituximab were safe and effective for old-old and extremely old patients."( [The efficacy and adverse effects of rituximab with CHOP or THP-COP in old-old and extremely old patients with diffuse large B cell lymphoma].
Abe, S; Fujii, H; Iwamoto, T; Kanaya, K; Kikukawa, M; Kiuchi, A; Miyazaki, K; Shin, K, 2006
)
0.33
" After the treatment, each treatment modality was evaluated by the response rate, relapse rate, and side effect profile."( A comparison of the efficacy, relapse rate and side effects among three modalities of systemic corticosteroid therapy for alopecia areata.
Aiba, S; Kawamura, M; Kurosawa, M; Mizuashi, M; Nakagawa, S; Saito, M; Sasaki, Y, 2006
)
0.33
" It had minimum adverse effects, however, MZR therapy does not sufficiently suppress the relapse of FRNS."( [Beneficial and adverse effects of high-dosage MZR therapy in the management of children with frequently relapsing nephrotic syndrome].
Goto, M; Hamasaki, Y; Hataya, H; Honda, M; Ikeda, M; Ishikura, K, 2006
)
0.33
" No other adverse effect was observed."( [Beneficial and adverse effects of high-dosage MZR therapy in the management of children with frequently relapsing nephrotic syndrome].
Goto, M; Hamasaki, Y; Hataya, H; Honda, M; Ikeda, M; Ishikura, K, 2006
)
0.33
"High-dose MZR therapy in the management for FRNS may provide more beneficial effects without significant adverse effects."( [Beneficial and adverse effects of high-dosage MZR therapy in the management of children with frequently relapsing nephrotic syndrome].
Goto, M; Hamasaki, Y; Hataya, H; Honda, M; Ikeda, M; Ishikura, K, 2006
)
0.33
" In addition, we have found that it is critical to pay attention to patient-reported adverse reactions."( Influence of methotrexate dose on its efficacy and safety in rheumatoid arthritis patients: evidence based on the variety of prescribing approaches among practicing Japanese rheumatologists in a single institute-based large observational cohort (IORRA).
Hara, M; Inoue, E; Kamatani, N; Nakajima, A; Tanaka, E; Taniguchi, A; Terai, C; Tomatsu, T; Yamanaka, H, 2007
)
0.34
" Both therapeutic agents were suspected as a possible cause of this adverse event."( Severe lung and skin toxicity during treatment with gemcitabine and erlotinib for metastatic pancreatic cancer.
Boeck, S; Hausmann, A; Heinemann, V; Reibke, R; Schulz, C, 2007
)
0.34
" The most frequently reported adverse event during the study was headache (52% in CRx-102 vs 15% in the placebo group)."( Efficacy and safety of a novel synergistic drug candidate, CRx-102, in hand osteoarthritis.
Borisy, AA; Fjeld, E; Kvien, TK; Lessem, J; Mikkelsen, K; Nichols, M; Palm, Ø; Prøven, A; Slatkowsky-Christensen, B; Zhang, Y, 2008
)
0.35
" It was demonstrated that Ch-SP-MS/EuL enhanced effectiveness of PD and reduced toxic side effects of PD greatly."( Efficacy and toxicity of Eudragit-coated chitosan-succinyl-prednisolone conjugate microspheres using rats with 2,4,6-trinitrobenzenesulfonic acid-induced colitis.
Machida, Y; Onishi, H; Oosegi, T, 2008
)
0.59
"To assess the incidence and severity of disease modifying antirheumatic drug (DMARD)-induced adverse effects (AE) in patients with rheumatoid arthritis (RA) taking/not taking glucocorticoids (GC)."( Low-dose prednisolone in rheumatoid arthritis: adverse effects of various disease modifying antirheumatic drugs.
Arnold, S; Baerwald, CG; Häntzschel, H; Malysheva, OA; Pierer, M; Wagner, U; Wahle, M, 2008
)
0.76
"Fourteen members of the Japanese Society for Pediatric Inflammatory Bowel Disease reported 35 retrospective cases that received AZA/6-MP and were evaluated for adverse drug effects."( Efficacy and safety of azathioprine and 6-mercaptopurine in Japanese pediatric patients with ulcerative colitis: a survey of the Japanese Society for Pediatric Inflammatory Bowel Disease.
Etani, Y; Kobayashi, A; Konno, M; Maisawa, S; Nakacho, M; Sasaki, M; Shimizu, T; Sumazaki, R; Tajiri, H; Tomomasa, T; Toyoda, S; Ushijima, K; Yoden, A, 2008
)
0.35
"AZA or 6-MP was safely used in 21 of 35 patients (60%) without adverse drug effects."( Efficacy and safety of azathioprine and 6-mercaptopurine in Japanese pediatric patients with ulcerative colitis: a survey of the Japanese Society for Pediatric Inflammatory Bowel Disease.
Etani, Y; Kobayashi, A; Konno, M; Maisawa, S; Nakacho, M; Sasaki, M; Shimizu, T; Sumazaki, R; Tajiri, H; Tomomasa, T; Toyoda, S; Ushijima, K; Yoden, A, 2008
)
0.35
" However, 40% experienced adverse drug effects, mainly myelosuppression."( Efficacy and safety of azathioprine and 6-mercaptopurine in Japanese pediatric patients with ulcerative colitis: a survey of the Japanese Society for Pediatric Inflammatory Bowel Disease.
Etani, Y; Kobayashi, A; Konno, M; Maisawa, S; Nakacho, M; Sasaki, M; Shimizu, T; Sumazaki, R; Tajiri, H; Tomomasa, T; Toyoda, S; Ushijima, K; Yoden, A, 2008
)
0.35
"It is safe for patients with CAN to use substitute sirolimus for CNI; the incidence of acute rejection did not increase."( Observation of efficacy and safety of converting the calcineurin inhibitor to sirolimus in renal transplant recipients with chronic allograft nephropathy.
Chen, J; Cheng, D; Cheng, Z; Ji, S; Li, L; Liu, Z; Sha, G; Sun, Q; Tang, Z; Wen, J, 2008
)
0.35
"5-month-old infant with IPP is presented, who was successfully treated with systemic retinoid therapy, which appears to be a safe and effective option for this challenging pustular eruption of childhood."( Acitretin is a safe treatment option for infantile pustular psoriasis.
Ergin, S; Ersoy-Evans, S; Ozkaya, O; Sahin, S, 2008
)
0.35
" Main Outcome Measure Severe adverse effects were defined as those judged serious enough that azathioprine therapy be discontinued in 139 patients treated with azathioprine."( Role of thiopurine methyltransferase activity in the safety and efficacy of azathioprine in the treatment of pemphigus vulgaris.
Chams-Davatchi, C; Firooz, A; Ghandi, N; Hallaji, Z; Karbakhsh Davari, M; Valikhani, M, 2008
)
0.35
" Serious adverse effects occurred in 14 patients (10."( Role of thiopurine methyltransferase activity in the safety and efficacy of azathioprine in the treatment of pemphigus vulgaris.
Chams-Davatchi, C; Firooz, A; Ghandi, N; Hallaji, Z; Karbakhsh Davari, M; Valikhani, M, 2008
)
0.35
" There seems to be a boost and extension of the glucocorticoid effect by the combination, without a clear increase of adverse effects, potentially allowing the application of lower dosages."( Innovative combination strategy to enhance effect and diminish adverse effects of glucocorticoids: another promise?
Bijlsma, JW; Jacobs, JW, 2009
)
0.35
" Toxicity was assessed by number of the patients withdrawn for adverse events (AEs), and the numbers of serious adverse events (SAEs) and AEs."( Safety of medium- to long-term glucocorticoid therapy in rheumatoid arthritis: a meta-analysis.
Choy, EH; Rachapalli, S; Ravindran, V, 2009
)
0.35
" However, long-term efficacy and adverse events are barely known."( Maintenance immunosuppression with mycophenolate mofetil: long-term efficacy and safety after heart transplantation.
Dandel, M; Hetzer, R; Jasaityte, R; Knosalla, C; Lehmkuhl, H,
)
0.13
" We analyzed the survival, number, and severity of ARE, development of coronary allograft vasculopathy (CAV), and main adverse effects (infections, tumors)."( Maintenance immunosuppression with mycophenolate mofetil: long-term efficacy and safety after heart transplantation.
Dandel, M; Hetzer, R; Jasaityte, R; Knosalla, C; Lehmkuhl, H,
)
0.13
"Initial remission targeted therapy with the FIN-RACo DMARD combination in early RA is safe for kidneys and does not induce more short- or long-term renal complications compared to traditional therapy with a single DMARD."( Renal safety of initial combination versus single DMARD therapy in patients with early rheumatoid arthritis: an 11-year experience from the FIN-RACo Trial.
Hannonen, PJ; Kaipiainen-Seppänen, OA; Karjalainen, AH; Karstila, KL; Korpela, MM; Leirisalo-Repo, M; Möttönen, TT; Mustonen, JT; Rantalaiho, VM,
)
0.13
", re-introduction of CNI), incidence of adverse events, and mortality up to one year after OLT."( A therapeutic exploratory study to determine the efficacy and safety of calcineurin-inhibitor-free de-novo immunosuppression after liver transplantation: CILT.
Goralczyk, AD; Lorf, T; Obed, A; Ramadori, G; Schnitzbauer, A; Tsui, TY, 2010
)
0.36
" When the two agents were combined, all the adverse effects of glucocorticoid excess on bone were prevented."( Intermittent parathyroid hormone administration counteracts the adverse effects of glucocorticoids on osteoblast and osteocyte viability, bone formation, and strength in mice.
Almeida, M; Jilka, RL; Manolagas, SC; Roberson, PK; Weinstein, RS, 2010
)
0.36
"Remission and complete response (primary outcome measures), frequency of uveitis attacks, visual acuity (VA), and adverse effects (secondary outcome measures)."( Safety and effectiveness of interferon alpha-2a in treatment of patients with Behçet's uveitis refractory to conventional treatments.
Bayer, A; Bayraktar, MZ; Durukan, AH; Erdem, U; Erdurman, C; Karagul, S; Köksal, S; Sobaci, G, 2010
)
0.36
"6%) developed severe adverse effects, including psoriasis, epileptic seizure, and extreme tiredness."( Safety and effectiveness of interferon alpha-2a in treatment of patients with Behçet's uveitis refractory to conventional treatments.
Bayer, A; Bayraktar, MZ; Durukan, AH; Erdem, U; Erdurman, C; Karagul, S; Köksal, S; Sobaci, G, 2010
)
0.36
" Adverse reactions responsible for discontinuation included gastrointestinal symptoms, renal dysfunction, and infection."( Efficacy and safety of tacrolimus in 101 consecutive patients with rheumatoid arthritis.
Inoue, E; Kaneko, H; Kitahama, M; Koseki, Y; Momohara, S; Okamoto, H; Taniguchi, A; Yamanaka, H, 2010
)
0.36
" Adverse events occurring immediately after the procedure and within the first month were collected."( Feasibility and safety of ultrasound-guided caudal epidural glucocorticoid injections.
Berthelot, JM; Blanchais, A; Glemarec, J; Guillot, P; Le Goff, B; Maugars, Y, 2010
)
0.36
"Mizoribine (MZR) is an immunosuppressant that inhibits nucleic acid metabolism and is a relatively safe disease-modifying anti-rheumatic drug (DMARD)."( Efficacy and safety of mizoribine by one single dose administration for patients with rheumatoid arthritis.
Aramaki, T; Arima, K; Eguchi, K; Fujikawa, K; Ichinose, K; Ida, H; Iwamoto, N; Kamachi, M; Kawakami, A; Kawashiri, SY; Nakamura, H; Origuchi, T; Tamai, M; Tsukada, T; Ueki, Y, 2010
)
0.36
" We show that MZR may be a useful and relatively safe therapy for patients in this group."( Efficacy and safety of mizoribine by one single dose administration for patients with rheumatoid arthritis.
Aramaki, T; Arima, K; Eguchi, K; Fujikawa, K; Ichinose, K; Ida, H; Iwamoto, N; Kamachi, M; Kawakami, A; Kawashiri, SY; Nakamura, H; Origuchi, T; Tamai, M; Tsukada, T; Ueki, Y, 2010
)
0.36
"Neurotoxicity is an unwanted acute side effect of aggressive chemotherapy."( Evidence for acute neurotoxicity after chemotherapy.
Cornelissen, J; Filippi, M; Giovannoni, G; Hintzen, R; Kappos, L; Kuhle, J; Lowenberg, B; Mondria, T; Petzold, A; Rocca, MA; te Boekhorst, P, 2010
)
0.36
"MMF seems safe and effective as first-line therapy in inducing and maintaining remission in treatment-naive patients with AIH, having a significant and rapid steroid sparing effect as attested by the fact that so far, 37% (22/59) of AIH patients achieved CR off prednisolone."( Mycophenolate for the treatment of autoimmune hepatitis: prospective assessment of its efficacy and safety for induction and maintenance of remission in a large cohort of treatment-naïve patients.
Dalekos, GN; Gatselis, N; Papadamou, G; Rigopoulou, EI; Zachou, K, 2011
)
0.55
" SbV has a side effect profile that requires treatment interruption in up to 28% of patients."( Glucocorticoids as a novel approach to the treatment of disabling side effects of sodium stibogluconate.
Brostoff, JM; Lockwood, DN, 2012
)
0.38
" Therapy is safe because it is limited to several months and the dosage is continually weaned as the infant gains weight."( Oral prednisolone for infantile hemangioma: efficacy and safety using a standardized treatment protocol.
Couto, RA; Greene, AK, 2011
)
0.88
"Bendamustine is a safe and useful addition to the drug arsenal against lymphoproliferative disorders."( Preliminary experience with the use of bendamustine: a peculiar skin rash as the commonest side effect.
Ganesan, P; Malipatil, B; Sagar, TG; Sundersingh, S, 2011
)
0.37
" It can be considered as a safe alternative for management of aggressive nasal polyposis refractory to traditional treatment strategies."( Examining the safety of prednisolone acetate 1% nasal spray for treatment of nasal polyposis.
Liang, J; Strong, EB,
)
0.44
" None of the patients in the study and control group experienced any adverse reaction and complications, neither after routine treatment nor after cell transplantation."( Clinical safety and primary efficacy of bone marrow mesenchymal cell transplantation in subacute spinal cord injured patients.
Eskandary, H; Karamouzian, S; Nakhaee, N; Nematollahi-Mahani, SN, 2012
)
0.38
"We conclude that transplantation of autologous BMC via LP is a feasible and safe technique, but at the moment, no clear answer can be given regarding the clinical potential, despite a potential tendency to treat SCI patients, observed through statistics."( Clinical safety and primary efficacy of bone marrow mesenchymal cell transplantation in subacute spinal cord injured patients.
Eskandary, H; Karamouzian, S; Nakhaee, N; Nematollahi-Mahani, SN, 2012
)
0.38
" Adverse event reports including elevation of intraocular pressure (IOP) were recorded."( Topical loteprednol etabonate 0.5 % for treatment of vernal keratoconjunctivitis: efficacy and safety.
Alakuş, MF; Işcan, Y; Oner, V; Taş, M; Türkcü, FM, 2012
)
0.38
" Rituximab's adverse effects generally could be controlled with an effective dosing regimen."( Efficacy and safety of rituximab therapy for systemic lupus erythematosus: a systematic review and meta-analysis.
Chen, JH; Han, F; Lan, L, 2012
)
0.38
" Vidofludimus was well tolerated, no drug-related serious adverse events were observed."( Efficacy, safety and tolerability of vidofludimus in patients with inflammatory bowel disease: the ENTRANCE study.
Ammendola, A; Diculescu, M; Dietrich, B; Fellermann, K; Hartmann, H; Hentsch, B; Herrlinger, KR; Howaldt, S; Nikolov, R; Otte, JM; Petrov, A; Reindl, W; Stange, EF; Stoynov, S; Strauch, U; Sturm, A; Voiosu, R, 2013
)
0.39
"To assess the current use of glucocorticoids (GCs) in Duchenne muscular dystrophy in the UK, and compare the benefits and the adverse events of daily versus intermittent prednisolone regimens."( Long-term benefits and adverse effects of intermittent versus daily glucocorticoids in boys with Duchenne muscular dystrophy.
Manzur, AY; Muntoni, F; Quinlivan, R; Ricotti, V; Ridout, DA; Robb, SA; Scott, E, 2013
)
0.58
" Moderate to severe side effects were more commonly reported and observed in the daily regimen, including Cushingoid features, adverse behavioural events and hypertension."( Long-term benefits and adverse effects of intermittent versus daily glucocorticoids in boys with Duchenne muscular dystrophy.
Manzur, AY; Muntoni, F; Quinlivan, R; Ricotti, V; Ridout, DA; Robb, SA; Scott, E, 2013
)
0.39
" The study also highlights the importance of collecting longitudinal natural history data on patients treated according to standardised protocols, and clearly identifies the benefits and the side-effect profile of two treatment regimens, which will help with informed choices and implementation of targeted surveillance."( Long-term benefits and adverse effects of intermittent versus daily glucocorticoids in boys with Duchenne muscular dystrophy.
Manzur, AY; Muntoni, F; Quinlivan, R; Ricotti, V; Ridout, DA; Robb, SA; Scott, E, 2013
)
0.39
"Patients with ulcerative colitis (UC) are treated with prednisolone (PSL), which causes adverse side effects."( Efficacy, safety and cost analyses in ulcerative colitis patients undergoing granulocyte and monocyte adsorption or receiving prednisolone.
Hiraishi, H; Hoshino, M; Kanke, K; Nakano, M; Tominaga, K, 2013
)
0.84
" In the GMA group, 5 transient adverse events were observed vs 10 steroid related adverse events in the PSL group (P<0."( Efficacy, safety and cost analyses in ulcerative colitis patients undergoing granulocyte and monocyte adsorption or receiving prednisolone.
Hiraishi, H; Hoshino, M; Kanke, K; Nakano, M; Tominaga, K, 2013
)
0.6
"Amiodarone pulmonary toxicity (APT) is the most serious side effect of amiodarone."( Successful treatment of severe amiodarone pulmonary toxicity with polymyxin B-immobilized fiber column direct hemoperfusion.
Goto, E; Horio, Y; Ichiyasu, H; Kohrogi, H; Kojima, K; Masunaga, A; Sato, N, 2013
)
0.39
" Here, we investigated the contribution of microvascular dysfunction to the development of these adverse effects in healthy men."( Glucocorticoid treatment impairs microvascular function in healthy men in association with its adverse effects on glucose metabolism and blood pressure: a randomised controlled trial.
Diamant, M; Eringa, EC; Guigas, B; Ijzerman, RG; Linssen, MM; Ouwens, DM; Serné, EH; van Raalte, DH, 2013
)
0.39
" We propose that GC-induced impairments of microvascular function may contribute to the adverse effects of GC treatment on glucose metabolism and blood pressure."( Glucocorticoid treatment impairs microvascular function in healthy men in association with its adverse effects on glucose metabolism and blood pressure: a randomised controlled trial.
Diamant, M; Eringa, EC; Guigas, B; Ijzerman, RG; Linssen, MM; Ouwens, DM; Serné, EH; van Raalte, DH, 2013
)
0.39
" Two cases of serious adverse events were associated with cytomegalovirus infection in the multi-target group, namely gastric ulcer and pancytopenia, both of which were successfully treated by antiviral therapy."( Efficacy and safety of multi-target therapy using a combination of tacrolimus, mycophenolate mofetil and a steroid in patients with active lupus nephritis.
Hiromura, K; Ikeuchi, H; Kaneko, Y; Kuroiwa, T; Maeshima, A; Mishima, K; Nojima, Y; Sakairi, T; Sakurai, N; Takahashi, S, 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
" The primary outcome was death and secondary outcome measures were 6 month disability, repeat MRI changes and serious adverse events (SAEs)."( Safety and efficacy of levofloxacin versus rifampicin in tuberculous meningitis: an open-label randomized controlled trial.
Bhoi, SK; Kalita, J; Misra, UK; Prasad, S, 2014
)
0.4
" Meanwhile, adherence to recommendations on standardized methodologies for registration and report of glucocorticoid adverse events is essential for improving our knowledge and competence in the best management of these important medications."( Safety of low- to medium-dose glucocorticoid treatment in rheumatoid arthritis: myths and reality over the years.
da Silva, JA; Santiago, T, 2014
)
0.4
" Adverse events (AEs) possibly related to cabazitaxel occurred in 143 (93."( Cabazitaxel for metastatic castration-resistant prostate cancer: safety data from the Spanish expanded access program.
Antón Aparicio, LM; Batista, N; Castellano, D; Esteban, E; Germà, JR; Luque, R; Maroto, P; Méndez-Vidal, MJ; Pérez-Valderrama, B; Sánchez-Hernández, A, 2014
)
0.4
" Pregnancy with SLE is associated with an increase risk of adverse maternal and fetal outcomes."( Safety of tacrolimus treatment during pregnancy and lactation in systemic lupus erythematosus: a report of two patients.
Izumi, Y; Migita, K; Miyashita, T, 2014
)
0.4
" In the present study, we have integrated this blood glucose kinetic model in the CIA model to enable quantification of both efficacy and adverse effects in one animal model."( Glucose kinetics in the collagen-induced arthritis model: an all-in-one model to assess both efficacy and metabolic side effects of glucocorticoids.
Ballak, DB; Bastiaanssen, EA; Bleeker, A; Dokter, WH; Grefhorst, A; Groen, AK; Koenders, MI; Laskewitz, AJ; Schouten, AE; Toonen, EJ; van der Vleuten, MA; van Dijk, TH; van Doorn, C; van Lierop, MJ, 2014
)
0.4
" We analyzed their biochemistries, immune parameters, liver synthetic function, and noninvasive assessments of liver fibrosis, as well as treatment efficacy and adverse effects at baseline and at 1, 3, 6, 12, 24, and 36 months."( Case-control study on prednisolone combined with ursodeoxycholic acid and azathioprine in pure primary biliary cirrhosis with high levels of immunoglobulin G and transaminases: efficacy and safety analysis.
Deng, YQ; Fang, YQ; Jia, W; Li, J; Lv, DX; Wang, GQ; Wang, Y; Yu, M, 2014
)
0.72
"The primary outcomes are: (i) effectiveness (assessor-blinded blister count at 6 weeks) and (ii) safety [proportion of patients experiencing ≥ grade 3 adverse events (i."( A randomized controlled trial to compare the safety and effectiveness of doxycycline (200 mg daily) with oral prednisolone (0.5 mg kg(-1) daily) for initial treatment of bullous pemphigoid: a protocol for the Bullous Pemphigoid Steroids and Tetracyclines
Bratton, DJ; Chalmers, JR; Foster, KA; Kirtschig, G; Mason, J; Nunn, AJ; Whitham, D; Williams, HC; Wojnarowska, F, 2015
)
0.63
"4%) treatment-related deaths due to adverse events, which were interstitial lung disease, and febrile neutropenia and bacterial pneumonia."( Efficacy and safety of docetaxel and prednisolone for castration-resistant prostate cancer: a multi-institutional retrospective study in Japan.
Adachi, H; Fukuta, F; Hirose, T; Itoh, N; Kitamura, H; Kunishima, Y; Masumori, N; Matsukawa, M; Miyake, M; Miyao, N; Shigyo, M; Taguchi, K; Takagi, S; Takahashi, A; Yanase, M, 2015
)
0.69
" Although most patients safely received docetaxel and prednisolone, we must always keep interstitial lung disease in mind as a possible lethal adverse event."( Efficacy and safety of docetaxel and prednisolone for castration-resistant prostate cancer: a multi-institutional retrospective study in Japan.
Adachi, H; Fukuta, F; Hirose, T; Itoh, N; Kitamura, H; Kunishima, Y; Masumori, N; Matsukawa, M; Miyake, M; Miyao, N; Shigyo, M; Taguchi, K; Takagi, S; Takahashi, A; Yanase, M, 2015
)
0.94
"SC MTX is a safe and effective treatment option for patients with RA."( Effectiveness, tolerability, and safety of subcutaneous methotrexate in early rheumatoid arthritis: A retrospective analysis of real-world data from the St. Gallen cohort.
Haile, SR; Müller, RB; Schiff, MH; von Kempis, J, 2015
)
0.42
" Herein, we assessed the safety of rituximab treatment and its effect in ameliorating the adverse effects of prednisolone (PRED) in a larger study sample."( Amelioration of the adverse effects of prednisolone by rituximab treatment in adults with steroid-dependent minimal-change nephrotic syndrome.
Iwabuchi, Y; Miyabe, Y; Moriyama, T; Nitta, K; Takei, T, 2016
)
0.92
" We compared the adverse effects of PRED (osteoporosis, hypertension, and diabetes mellitus) between the first rituximab infusion (baseline) and the end of the 24-month observation period."( Amelioration of the adverse effects of prednisolone by rituximab treatment in adults with steroid-dependent minimal-change nephrotic syndrome.
Iwabuchi, Y; Miyabe, Y; Moriyama, T; Nitta, K; Takei, T, 2016
)
0.7
" There were no severe adverse effects of rituximab."( Amelioration of the adverse effects of prednisolone by rituximab treatment in adults with steroid-dependent minimal-change nephrotic syndrome.
Iwabuchi, Y; Miyabe, Y; Moriyama, T; Nitta, K; Takei, T, 2016
)
0.7
"Rituximab treatment was effective and safe in patients with steroid-dependent nephrotic syndrome, allowed reduction of the PRED dose, and ameliorated the adverse effects of PRED."( Amelioration of the adverse effects of prednisolone by rituximab treatment in adults with steroid-dependent minimal-change nephrotic syndrome.
Iwabuchi, Y; Miyabe, Y; Moriyama, T; Nitta, K; Takei, T, 2016
)
0.7
"Long-term adverse effects of oral glucocorticoids are frequent and serious."( Exploratory study of total and free prednisolone plasma exposure and cushingoid appearance, quality of life and biochemical toxicity in adult male kidney transplant recipients.
Barraclough, KA; Bergmann, TK; Campbell, SB; Inder, WJ; Isbel, NM; McWhinney, BC; Ostini, R; Russell, A; Staatz, CE, 2015
)
0.69
"Male kidney transplant recipients were recruited for serial blood sampling and assessment of glucocorticoid-related adverse effects including dyslipidaemia, abnormal body fat distribution, Cushingoid appearance and impaired quality of life."( Exploratory study of total and free prednisolone plasma exposure and cushingoid appearance, quality of life and biochemical toxicity in adult male kidney transplant recipients.
Barraclough, KA; Bergmann, TK; Campbell, SB; Inder, WJ; Isbel, NM; McWhinney, BC; Ostini, R; Russell, A; Staatz, CE, 2015
)
0.69
" In this work, the effectiveness, toxic side effects (5 mg prednisolone (PD) eq/kg × 3 d, 10 mg PD eq/kg × 3 d), and pharmacokinetic characteristics (5 mg PD eq/kg) were examined using rats with colitis induced through 2,4,6-trinitrobenzenesulfonic acid."( Comparison of Simple Eudragit Microparticles Loaded with Prednisolone and Eudragit-Coated Chitosan-Succinyl-Prednisolone Conjugate Microparticles: Part II. In Vivo Evaluation of Efficacy, Toxicity, and Biodisposition Characteristics.
Kikuchi, H; Onishi, H, 2015
)
0.91
"Short term prednisolone use was generally safe and did not prevent reaccumulation of ascites in this study population."( The safety and efficacy of prednisolone in preventing reaccumulation of ascites among endomyocardial fibrosis patients in Uganda: a randomized clinical trial.
Freers, J; Josephson, RA; Kayima, J; Longenecker, CT; Nabunnya, YB, 2015
)
1.1
" None of the nine patients had local or systemic adverse events related to the vector during the 9-month follow-up period."( Efficacy and Safety of rAAV2-ND4 Treatment for Leber's Hereditary Optic Neuropathy.
Chen, C; Dong, XY; He, H; Hu, WK; Li, B; Ma, SQ; Pei, H; Wan, X; Wang, DW; Yang, S; Zhang, G; Zhao, MJ, 2016
)
0.43
" These two pilot studies compare the efficacy and side effect profile of ciclosporin plus prednisolone against prednisolone alone in the treatment of patients with either new ENL or chronic and recurrent ENL."( Comparison of Efficacy and Safety of Ciclosporin to Prednisolone in the Treatment of Erythema Nodosum Leprosum: Two Randomised, Double Blind, Controlled Pilot Studies in Ethiopia.
Alembo, DT; Idriss, MH; Lambert, SM; Lockwood, DN; Nicholls, PG; Nigusse, SD; Walker, SL; Yamuah, LK, 2016
)
0.91
" Adverse events attributable to prednisolone were more common that those attributable to ciclosporin."( Comparison of Efficacy and Safety of Ciclosporin to Prednisolone in the Treatment of Erythema Nodosum Leprosum: Two Randomised, Double Blind, Controlled Pilot Studies in Ethiopia.
Alembo, DT; Idriss, MH; Lambert, SM; Lockwood, DN; Nicholls, PG; Nigusse, SD; Walker, SL; Yamuah, LK, 2016
)
0.97
"In this study, it was aimed to investigate the toxic and teratogenic effects of cyclosporine A and tacrolimus and their combinations with prednisolone using an in vitro rat embryo culture technique."( Investigation of developmental toxicity and teratogenicity of cyclosporine A, tacrolimus and their combinations with prednisolone.
Acar, H; Fazliogullari, Z; Karabulut, AK; Unver Dogan, N; Uysal, II, 2016
)
0.85
"Intrapolyp steroid injection appears to be an effective and safe method for treatment of nasal polyps, with comparable results to oral short-term steroid treatment."( Intrapolyp steroid injection for nasal polyposis: Randomized trial of safety and efficacy.
Bercin, S; Gul, F; Kırıs, M; Muderris, T; Sevil, E; Yalçıner, G, 2016
)
0.43
" The symptoms of COPD, forced expiratory volume in one second (FEV1) and other spirometric indicators, peripheral blood oxygen saturation (SpO2), and adverse events were studied."( [Nebulized budesonide in the treatment of exacerbations of chronic obstructive pulmonary disease: Efficacy, safety, and effects on the serum levels of soluble differentiation molecules].
Czapaeva, MY; Karaulov, AV; Kazatskaya, ZA; Lazareva, ES; Makarova, EV; Menkov, NV; Novikov, VV; Varvarina, GN, 2016
)
0.43
"Nebulized budesonide is an effective and safe alternative to SGCS in treating an exacerbation of COPD."( [Nebulized budesonide in the treatment of exacerbations of chronic obstructive pulmonary disease: Efficacy, safety, and effects on the serum levels of soluble differentiation molecules].
Czapaeva, MY; Karaulov, AV; Kazatskaya, ZA; Lazareva, ES; Makarova, EV; Menkov, NV; Novikov, VV; Varvarina, GN, 2016
)
0.43
"After LT, an immunosuppressive regimen without steroids could be a safe and feasible treatment for HBVrelated HCC patients, thus resulting in the reduction of HBV recurrence."( Efficacy and Safety of a Steroid-Free Immunosuppressive Regimen after Liver Transplantation for Hepatocellular Carcinoma.
Shen, Y; Wang, C; Wang, W; Wei, Q; Wu, J; Xie, H; Xu, X; Zhang, M; Zheng, S; Zhou, L; Zhuang, L; Zhuang, R, 2016
)
0.43
" In comparison with few minor adverse events in other two cohorts, several serious adverse events were documented in the tacrolimus group."( Long-term efficacy and safety of common steroid-sparing agents in idiopathic nephrotic children.
Babu, BG; Basu, B; Mahapatra, TK, 2017
)
0.46
" Taking together the long-term efficacy and safety data observed, MMF appears as a safe and effective alternative to tacrolimus in managing pediatric FRNS/SDNS."( Long-term efficacy and safety of common steroid-sparing agents in idiopathic nephrotic children.
Babu, BG; Basu, B; Mahapatra, TK, 2017
)
0.46
"Rituximab (RTX) is regarded as a relatively safe and effective treatment for children with steroid-dependent nephrotic syndrome (SDNS)."( Late-onset adverse events after a single dose of rituximab in children with complicated steroid-dependent nephrotic syndrome.
Fujinaga, S; Ozawa, K; Sakuraya, K; Shimizu, T; Yamada, A, 2016
)
0.43
"This was a single-center retrospective analysis of adverse events during B-cell depletion periods after a single dose of RTX (375 mg/m2) in 60 patients with complicated SDNS (total 126 doses)."( Late-onset adverse events after a single dose of rituximab in children with complicated steroid-dependent nephrotic syndrome.
Fujinaga, S; Ozawa, K; Sakuraya, K; Shimizu, T; Yamada, A, 2016
)
0.43
"Although neutropenia and hypogammaglobulinemia should be kept in mind as late-onset adverse events of RTX therapy in patients with complicated SDNS, severe infections during B-cell depletion periods are infrequent when our treatment strategies are implemented."( Late-onset adverse events after a single dose of rituximab in children with complicated steroid-dependent nephrotic syndrome.
Fujinaga, S; Ozawa, K; Sakuraya, K; Shimizu, T; Yamada, A, 2016
)
0.43
" We investigated whether high-dose MZR is effective and safe for renal transplant patients in conjunction with cyclosporine (CsA), basiliximab, and corticosteroids."( Efficacy and Safety of High-Dose Mizoribine Combined With Cyclosporine, Basiliximab, and Corticosteroids in Renal Transplantation: A Japanese Multicenter Study.
Akioka, K; Fujisawa, M; Fukuda, Y; Horimi, T; Ito, SI; Nakatani, T; Nishimura, K; Sugitani, A; Uchida, K; Ushigome, H; Yoshimura, N; Yuzawa, K, 2016
)
0.43
" Safety included evaluation of adverse events."( Difluprednate versus prednisolone acetate for inflammation following cataract surgery in pediatric patients: a randomized safety and efficacy study.
Gedif, K; Lambert, SR; Markwardt, K; O'Halloran, H; Plager, DA; Roarty, J; VanderVeen, D; Wilson, ME, 2016
)
0.75
" Compared to placebo, RTX combined with prednisone may be effective and safe for treating newly-diagnosed wAIHA in adults."( A randomized and double-blind controlled trial evaluating the safety and efficacy of rituximab for warm auto-immune hemolytic anemia in adults (the RAIHA study).
Audia, S; Ebbo, M; Frenzel, L; Galicier, L; Godeau, B; Hamidou, M; Jaccard, A; Khellaf, M; Le Guenno, G; Marie Michot, J; Michel, M; Morin, AS; Roudot-Thoraval, F; Royer, B; Terriou, L, 2017
)
0.46
" The adverse events during TAS were generally tolerable, but 39 (10."( Efficacy and toxicity of the combination chemotherapy of thalidomide, alkylating agent, and steroid for relapsed/refractory myeloma patients: a report from the Korean Multiple Myeloma Working Party (KMMWP) retrospective study.
Choi, YS; Eom, HS; Han, JJ; Kang, HJ; Kim, HJ; Kim, K; Kim, MK; Kim, SH; Kwon, J; Lee, JH; Lee, JJ; Lee, JO; Lee, WS; Min, CK; Moon, JH; Yoon, DH; Yoon, SS, 2017
)
0.46
" Using data from the UK Clinical Practice Research Datalink (CPRD), we examined the risk of oral GC-related serious adverse events (SAEs) in a UK population of patients with giant cell arteritis (GCA)."( Serious adverse effects associated with glucocorticoid therapy in patients with giant cell arteritis (GCA): A nested case-control analysis.
Collinson, N; Jick, SS; Klearman, M; Meier, CR; Musselman, D; Napalkov, P; Sarsour, K; Stone, JH; Tuckwell, K; Wilson, JC, 2017
)
0.46
"Compared to lower average daily prednisolone doses, high average daily doses were associated with an increased risk of serious adverse effects."( Serious adverse effects associated with glucocorticoid therapy in patients with giant cell arteritis (GCA): A nested case-control analysis.
Collinson, N; Jick, SS; Klearman, M; Meier, CR; Musselman, D; Napalkov, P; Sarsour, K; Stone, JH; Tuckwell, K; Wilson, JC, 2017
)
0.74
" Cyclosporine-associated nephrotoxicity (CAN) is a potential side effect of long-term cyclosporine treatment."( Nephrotoxicity in children with frequently relapsing nephrotic syndrome receiving long-term cyclosporine treatment.
Ando, T; Hamada, R; Hamasaki, Y; Hataya, H; Honda, M; Ishikura, K; Komaki, F; Ogata, K; Sakai, T, 2017
)
0.46
" Secondary outcomes included the effectiveness of blister control after 6 weeks, relapses, related adverse events and quality of life."( A randomised controlled trial to compare the safety, effectiveness and cost-effectiveness of doxycycline (200 mg/day) with that of oral prednisolone (0.5 mg/kg/day) for initial treatment of bullous pemphigoid: the Bullous Pemphigoid Steroids and Tetracycl
Chalmers, JR; Chapman, A; Childs, M; Godec, TR; Harman, K; Kirtschig, G; Mason, J; Nunn, AJ; Schmidt, E; Walton, S; Whitham, D; Williams, HC; Wojnarowska, F, 2017
)
0.66
" The limitations of the trial were the wide non-inferiority margin, the moderate dropout rate and that serious adverse event collection was unblinded."( A randomised controlled trial to compare the safety, effectiveness and cost-effectiveness of doxycycline (200 mg/day) with that of oral prednisolone (0.5 mg/kg/day) for initial treatment of bullous pemphigoid: the Bullous Pemphigoid Steroids and Tetracycl
Chalmers, JR; Chapman, A; Childs, M; Godec, TR; Harman, K; Kirtschig, G; Mason, J; Nunn, AJ; Schmidt, E; Walton, S; Whitham, D; Williams, HC; Wojnarowska, F, 2017
)
0.66
" In the propranolol group, the patients were admitted, observed for adverse effects for 3 days after treatment initiation, and then released and treated as outpatients for 16 weeks (2 mg/kg/d)."( Comparison of Efficacy and Safety Between Propranolol and Steroid for Infantile Hemangioma: A Randomized Clinical Trial.
Cheon, JE; Choe, YS; Choi, TH; Choi, Y; Hong, KY; Jeong, JH; Kang, HJ; Kim, DY; Kim, KH; Lee, H; Park, JB; Park, KD; Park, YW; Shin, HY, 2017
)
0.46
" While comparing the effect of medication between the groups, we monitored the adverse effects of both drugs."( Comparison of Efficacy and Safety Between Propranolol and Steroid for Infantile Hemangioma: A Randomized Clinical Trial.
Cheon, JE; Choe, YS; Choi, TH; Choi, Y; Hong, KY; Jeong, JH; Kang, HJ; Kim, DY; Kim, KH; Lee, H; Park, JB; Park, KD; Park, YW; Shin, HY, 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
)
0.46
" And the adverse drug reactions (ADRs) of tacrolimus were monitored in each patient from the beginning of tacrolimus treatment to the end of the follow-up period."( A multicenter prospective observational study on the safety and efficacy of tacrolimus in patients with myasthenia gravis.
Ahn, SW; Cho, EB; Hong, YH; Joo, IS; Kang, SY; Kim, BJ; Min, JH; Minn, YK; Nam, TS; Oh, J; Oh, SY; Park, JS; Park, YE; Seok, HY; Seok, JI; Seok, JM; Shin, HY; Shin, JY; Suh, BC; Sung, JJ, 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
)
0.89
" Outcome measures evaluated were subsidence of patient-perceived pruritus, improvement in rash quantified by a specific score, adverse effects and relapse at 12 weeks."( Double-blind randomized placebo-controlled trial to evaluate the efficacy and safety of short-course low-dose oral prednisolone in pityriasis rosea.
Gupta, A; Kumar, A; Priya, A; Sonthalia, S; Srivastava, S; Yadav, P; Zawar, V, 2018
)
0.69
" No adverse effects reported in either group."( Double-blind randomized placebo-controlled trial to evaluate the efficacy and safety of short-course low-dose oral prednisolone in pityriasis rosea.
Gupta, A; Kumar, A; Priya, A; Sonthalia, S; Srivastava, S; Yadav, P; Zawar, V, 2018
)
0.69
"Corticosteroids (CSs), used to treat rheumatoid arthritis (RA), confer a risk of adverse events (AEs)."( Safety and efficacy of alternate-day corticosteroid treatment as adjunctive therapy for rheumatoid arthritis: a comparative study.
Kishimoto, M; Ohde, S; Okada, M; Suda, M; Tsuda, T, 2018
)
0.48
"To evaluate the adverse events profile of oral prednisolone among adult asthma patients in the UK."( Adverse events profile of oral corticosteroids among asthma patients in the UK: cohort study with a nested case-control analysis.
Bloechliger, M; Chang, SC; Heaney, LG; Jick, SS; Kuhlbusch, K; Meier, CR; Reinau, D; Spoendlin, J, 2018
)
0.74
"Using data from the UK-based Clinical Practice Research Datalink, we conducted a series of cohort studies to quantify incidence rates and incidence rate ratios, and a series of nested case-control analyses to estimate crude and adjusted odds ratios, of 11 different potential corticosteroid-related adverse events (bone-related conditions, hypertension, peptic ulcer, severe infections, herpes zoster, diabetes mellitus type 2, cataract, glaucoma, chronic kidney disease, affective disorders, and cardiovascular events)."( Adverse events profile of oral corticosteroids among asthma patients in the UK: cohort study with a nested case-control analysis.
Bloechliger, M; Chang, SC; Heaney, LG; Jick, SS; Kuhlbusch, K; Meier, CR; Reinau, D; Spoendlin, J, 2018
)
0.48
"Uveitis due to brimonidine is a rare adverse effect, but it must be known."( Hypertensive acute granulomatous anterior uveitis as a side effect of topical brimonidine.
Arciniegas-Perasso, CA; Clemente-Tomás, R; Duch-Samper, AM; García-Ibor, F; Hervás-Hernandis, JM; Ruiz-Del Río, N, 2018
)
0.48
" The toxic action of the drug may be connected with the extent and routes of its biotransformation."( Cytotoxicity of anticancer candidate salinomycin and identification of its metabolites in rat cell cultures.
Olejnik, M; Radko, L, 2018
)
0.48
" The primary outcome was safety, evaluated by the incidence and severity of adverse events."( Safety of IBI-10090 for inflammation associated with cataract surgery: Phase 3 multicenter study.
Donnenfeld, ED; Matossian, C; Solomon, KD, 2018
)
0.48
" Two serious adverse events unrelated to treatment were reported."( Safety of IBI-10090 for inflammation associated with cataract surgery: Phase 3 multicenter study.
Donnenfeld, ED; Matossian, C; Solomon, KD, 2018
)
0.48
"Intralesional steroid injection plus oral steroid administration is safe and effective in preventing stricture following esophageal ESD for esophageal epithelial neoplasms with a mucosal defect extending no less than two-thirds of the circumference in a long-term follow-up."( Long-term efficacy and safety of intralesional steroid injection plus oral steroid administration in preventing stricture after endoscopic submucosal dissection for esophageal epithelial neoplasms.
Chen, T; Chen, W; Chu, Y; Li, H; Xu, M; Yao, L; Zhang, Y; Zhong, Y; Zhou, P, 2019
)
0.51
" Although their conventional adverse effects including hyperglycemia, hypertension, hyperlipidemia, and osteoporosis are well-recognized and managed, steroid-induced cardiac arrhythmias are known to a lesser extent."( Dose-dependent bradycardia as a rare side effect of corticosteroids: a case report and review of the literature.
Bodakçi, E; Korkmaz, C; Üsküdar Cansu, D, 2018
)
0.48
" Serious adverse events were reported in 12 (1·7%) of 724 patients treated with primary IVIG plus prednisolone; two of these patients had hypertension and bacteraemia that was probably related to prednisolone."( Efficacy and safety of intravenous immunoglobulin plus prednisolone therapy in patients with Kawasaki disease (Post RAISE): a multicentre, prospective cohort study.
Chiga, M; Hori, N; Kaneko, T; Komiyama, O; Matsushima, T; Misawa, M; Miura, M; Miyata, K; Morikawa, Y; Nakazawa, M; Obonai, T; Sakakibara, H; Takahashi, T; Tamame, T; Tsuchihashi, T; Yamagishi, H; Yamashita, Y, 2018
)
0.95
"Overall, adjunctive systemic corticosteroids therapy was effective and safe for patients with severe CAP."( Efficacy and safety of adjunctive corticosteroids therapy for patients with severe community-acquired pneumonia: A systematic review and meta-analysis.
Guo, J; Huang, J; Huang, W; Li, H; Zhang, T, 2019
)
0.51
" In case 2, the only adverse event was hypokalemia, which was treated using potassium preparations."( Safety of Abiraterone Acetate Administration in Elderly Patients Receiving Peritoneal Dialysis with Castration-Resistant Prostate Cancer: Two Case Reports.
Kimata, R; Kondo, Y; Tomita, Y, 2019
)
0.51
" However, different liposomal drugs have different levels of reactogenicity, which means that the optimal protocol for each liposomal drug may differ and should be identified and evaluated to make the treatment as safe and convenient as possible."( Liposome-induced hypersensitivity reactions: Risk reduction by design of safe infusion protocols in pigs.
Fülöp, T; Kozma, GT; Mészáros, T; Metselaar, JM; Rosivall, L; Storm, G; Szebeni, J; Urbanics, R; Vashegyi, I, 2019
)
0.51
" Efficacy and rate of adverse events (AEs) were evaluated during a 24-month period after tocilizumab commencement."( Efficacy and safety of tocilizumab in a real-life observational cohort of patients with polyarticular juvenile idiopathic arthritis.
Aalto, K; Backström, M; Grönlund, MM; Kröger, L; Markula-Patjas, K; Putto-Laurila, A; Remes-Pakarinen, T; Vähäsalo, P, 2020
)
0.56
"To compare the early biochemical response and rate of adverse effects in patients who received prednisolone (PRED)/azathioprine (AZA) and those who received budesonide (BUD)/AZA as the first-line treatment for autoimmune hepatitis."( The efficacy and adverse effects of budesonide in remission induction treatment of autoimmune hepatitis: a retrospective study.
Binicier, OB; Günay, S, 2019
)
0.73
" Biochemical and hemogram data at baseline and after 6 months of treatment, and adverse effects observed in the follow-up, were compared."( The efficacy and adverse effects of budesonide in remission induction treatment of autoimmune hepatitis: a retrospective study.
Binicier, OB; Günay, S, 2019
)
0.51
"There was no difference between the groups in biochemical response (17 patients receiving PRED/AZA and 18 receiving BUD/AZA) and the rate of adverse effects (9 patients receiving PRED/AZA and 5 receiving BUD/AZA)."( The efficacy and adverse effects of budesonide in remission induction treatment of autoimmune hepatitis: a retrospective study.
Binicier, OB; Günay, S, 2019
)
0.51
" Lower, although not significantly, rate of adverse effects and lower total number of adverse effects indicate that BUD/AZA may potentially be used as the first-line treatment of choice, especially in patients with obesity, diabetes, resistant hypertension, glaucoma, or osteoporosis."( The efficacy and adverse effects of budesonide in remission induction treatment of autoimmune hepatitis: a retrospective study.
Binicier, OB; Günay, S, 2019
)
0.51
" Several immune-mediated neurological adverse events associated with ICIs have been reported to date, such as Guillain-Barré syndrome."( Ramsay-Hunt syndrome and subsequent sensory neuropathy as potential immune-related adverse events of nivolumab: a case report.
Kakumoto, T; Kanzaki, M; Kishi, K; Miyamoto, A; Mochizuki, S; Sakoh, T; Sato, K; Uesaka, Y, 2019
)
0.51
"Metronomic chemotherapy could prolong survival time of unfit AML patients, especially in the first 12 months after diagnosis without increasing treatment-associated adverse events."( Efficacy and Safety of Metronomic Chemotherapy Versus Palliative Hydroxyurea in Unfit Acute Myeloid Leukemia Patients: A Multicenter, Open-Label Randomized Controlled Trial.
Charoenprasert, K; Chinthammitr, Y; Kasyanan, H; Panoi, N; Phinyo, P; Pongudom, S; Purattanamal, J; Surawong, A; Wongyai, K, 2020
)
0.56
" There are many reports of its toxicity to animals but little is known about the potential adverse effects in humans."( Primary Human Hepatocytes, but Not HepG2 or Balb/c 3T3 Cells, Efficiently Metabolize Salinomycin and Are Resistant to Its Cytotoxicity.
Olejnik, M; Posyniak, A; Radko, L, 2020
)
0.56
" Eight serious adverse events were recorded, four events in three (16%) patients assigned rituximab (lumbar compression fracture and infection around nail of right foot [n=1], diplopia [n=1], and uterine cancer [n=1]) and four events in two (11%) people allocated to placebo (exacerbation of glaucoma and bleeding in the right eye chamber after surgery [n=1], and visual impairment and asymptomatic white matter brain lesion on MRI [n=1]); all patients recovered."( Safety and efficacy of rituximab in neuromyelitis optica spectrum disorders (RIN-1 study): a multicentre, randomised, double-blind, placebo-controlled trial.
Fukaura, H; Kiriyama, T; Maruyama, H; Misu, T; Mori, M; Nakashima, I; Nomura, K; Ochi, K; Oeda, T; Okada, K; Sawada, H; Shimizu, Y; Tahara, M; Umemura, A; Yamamoto, K, 2020
)
0.56
" SjS is a relatively rare immune-related adverse event that might sometimes be overlooked."( Sjögren's Syndrome as an Immune-related Adverse Event of Nivolumab Treatment for Gastric Cancer.
Furuta, Y; Higashi, T; Miyamoto, H; Nagaoka, K; Naito, H; Nakayama, H; Naoe, H; Tanaka, M; Yoshida, R, 2020
)
0.56
"In this population, with thorough screening and careful post-gene transfer management, replacement therapy with onasemnogene abeparvovec-xioi is safe and shows promise for early efficacy."( Gene Therapy for Spinal Muscular Atrophy: Safety and Early Outcomes.
Alfano, LN; Bass, N; Broomall, E; Connolly, AM; Ginsberg, M; Goldstein, J; Iammarino, MA; Karingada, C; Lowes, LP; Mendell, JR; Miller, NF; Mosher, KA; Noritz, G; Powers, B; Rossman, I; Storey, MA; Tsao, CY; Waldrop, MA, 2020
)
0.56
" RAI is associated with troublesome early, intermediate and late adverse effects."( Prophylactic prednisolone for the prevention of early and intermediate adverse effects of radioactive iodine therapy in patients with thyroid cancer: study protocol for a single-centre, phase II/III, randomized, double-blinded, placebo-controlled clinical
Jayarajah, U; Seneviratne, SA; Wijekoon, M, 2020
)
0.93
" Clinically significant adverse effects assessed as related to RAI as well as prednisolone therapy and the quality of life parameters will be compared between the two groups."( Prophylactic prednisolone for the prevention of early and intermediate adverse effects of radioactive iodine therapy in patients with thyroid cancer: study protocol for a single-centre, phase II/III, randomized, double-blinded, placebo-controlled clinical
Jayarajah, U; Seneviratne, SA; Wijekoon, M, 2020
)
1.16
"If proven beneficial, this intervention can be incorporated into the standard practice to reduce early and intermediate adverse effects of RAI for thyroid cancer with a potential improvement of quality of life."( Prophylactic prednisolone for the prevention of early and intermediate adverse effects of radioactive iodine therapy in patients with thyroid cancer: study protocol for a single-centre, phase II/III, randomized, double-blinded, placebo-controlled clinical
Jayarajah, U; Seneviratne, SA; Wijekoon, M, 2020
)
0.93
" The disease phenotypes, laboratory data, concomitant medication use, and adverse events were also investigated."( Efficacy and safety of apremilast for 3 months in Behçet's disease: A prospective observational study.
Hirahara, L; Kirino, Y; Mizuki, N; Nakajima, H; Soejima, Y; Takase-Minegishi, K; Takeno, M; Takeuchi, M; Yoshimi, R, 2021
)
0.62
" Rituximab (RTX) might be an effective and safe choice."( Efficacy and safety of rituximab for childhood refractory nephrotic syndrome: A meta-analysis of randomized controlled trials.
Chang, D; Gong, M; Hu, Z; Li, Z; Liu, C; Zhang, Q, 2021
)
0.62
" No significant differences between the RTX and the control group were found in total adverse events (AEs) or serious AEs."( Efficacy and safety of rituximab for childhood refractory nephrotic syndrome: A meta-analysis of randomized controlled trials.
Chang, D; Gong, M; Hu, Z; Li, Z; Liu, C; Zhang, Q, 2021
)
0.62
" 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
)
0.89
" Liver-related adverse events, laboratory data, concomitant medications, and prednisolone use were analyzed."( Hepatotoxicity following administration of onasemnogene abeparvovec (AVXS-101) for the treatment of spinal muscular atrophy.
Chand, D; Kaufmann, P; Kleyn, A; Kullak-Ublick, G; McMillan, H; Mohr, F; Montgomery, K; Sun, R; Tauscher-Wisniewski, S; Tukov, FF, 2021
)
0.85
"Based on adverse events and laboratory data, 90 of 100 patients had elevated liver function test results (alanine aminotransferase, and/or aspartate aminotransferase, and/or bilirubin concentrations)."( Hepatotoxicity following administration of onasemnogene abeparvovec (AVXS-101) for the treatment of spinal muscular atrophy.
Chand, D; Kaufmann, P; Kleyn, A; Kullak-Ublick, G; McMillan, H; Mohr, F; Montgomery, K; Sun, R; Tauscher-Wisniewski, S; Tukov, FF, 2021
)
0.62
" Most common adverse event was nasopharyngitis (15/50 patients, 30."( Efficacy and safety of abiraterone acetate plus prednisolone in patients with early metastatic castration-resistant prostate cancer who failed first-line androgen-deprivation therapy: a single-arm, phase 4 study.
Arai, G; Furukawa, J; Iinuma, M; Kamiya, N; Kikukawa, H; Kobayashi, H; Kobayashi, K; Maniwa, A; Mikami, K; Nakashima, T; Nakatsu, H; Nasu, Y; Okuno, N; Satoh, T; Tanabe, K; Uemura, H, 2021
)
0.88
" In the future, more selectively acting substances could achieve an uncoupling of desired and adverse effects."( [Safety aspects of the treatment with glucocorticoids for rheumatoid arthritis].
Keyßer, G, 2021
)
0.62
" Disease exacerbation, GC dose, IgG-IgG4 titre and adverse events were evaluated using univariate analyses, including the Kaplan-Meier method."( Effectiveness and safety of mizoribine for the treatment of IgG4-related disease: a retrospective cohort study.
Fukui, S; Ikeda, Y; Kawaai, S; Kishimoto, M; Nakai, T; Nomura, A; Ohde, S; Okada, M; Suda, M; Tamaki, H, 2021
)
0.62
" Adverse events and adverse drug reactions were evaluated for safety."( Safety and efficacy of abiraterone acetate plus prednisolone in patients with castration-resistant prostate cancer: a prospective, observational, post-marketing surveillance study.
Fujino, A; Harada, S; Imanaka, K; Koroki, Y; Yasuda, Y, 2021
)
0.88
" Adverse events were observed in 225/492 patients (45."( Safety and efficacy of abiraterone acetate plus prednisolone in patients with castration-resistant prostate cancer: a prospective, observational, post-marketing surveillance study.
Fujino, A; Harada, S; Imanaka, K; Koroki, Y; Yasuda, Y, 2021
)
0.88
"Immune checkpoint inhibitors (ICIs), particularly anti-PD-1 antibody, have dramatically changed cancer treatment; however, fatal immune-related adverse events (irAEs) can develop."( A case report on severe nivolumab-induced adverse events similar to primary sclerosing cholangitis refractory to immunosuppressive therapy.
Arai, J; Ariizumi, H; Hamada, K; Hirasawa, Y; Horiike, A; Imamura, CK; Ishida, H; Ishiguro, T; Iwamoto, S; Kiuchi, Y; Kobayashi, S; Kubota, Y; Matsui, H; Oguro, N; Ohkuma, R; Sakaki, M; Sambe, T; Shida, M; Shiozawa, E; Taniguchi, M; Tate, G; Tsunoda, T; Tsurutani, J; Uchida, N; Wada, S; Yoshimura, K, 2021
)
0.62
" Data presented are from a composite of preclinical studies, seven clinical trials, and postmarketing sources (clinical trials, n = 102 patients; postmarketing surveillance, n = 665 reported adverse event [AE] cases)."( Clinical Trial and Postmarketing Safety of Onasemnogene Abeparvovec Therapy.
Chand, DH; Day, JW; Finkel, RS; Kleyn, A; Mendell, JR; Mercuri, E; Reyna, SP; Strauss, KA; Tauscher-Wisniewski, S; Tukov, FF, 2021
)
0.62
" The benefits of glucocorticoids in terms of symptoms and structural damage were confirmed, but the proportion of patients with at least one adverse event of special interest (serious or glucocorticoids-related) was increased by 24%, mostly due to nonsevere infections."( The safety of glucocorticoids in the treatment of inflammatory rheumatic disease: new evidence.
Boers, M; Buttgereit, F; da Silva, JAP; Luís, M; Saag, K, 2022
)
0.72
"2 in DAS28-ESR for ≥ 6 months) and discontinuations due to treatment failure in the low dose group, and we compared the incidence of serious adverse events (SAEs) between LD and SD groups."( Rheumatoid arthritis patients initiating rituximab with low number of previous bDMARDs failures may effectively reduce rituximab dose and experience fewer serious adverse events than patients on full dose: a 5-year cohort study.
Avgoustidis, N; Bertsias, A; Bertsias, G; Flouri, I; Kalogiannaki, E; Kougkas, N; Papalopoulos, I; Repa, A; Sidiropoulos, P, 2022
)
0.72
" Since adverse effects of a short course of high-dose systemic corticosteroids have not been documented with good evidence, the trial will improve knowledge on possible side effects in the different treatment arms with a focus on hyperglycemia and hypertension."( Efficacy and safety of systemic, high-dose glucocorticoid therapy for idiopathic sudden sensorineural hearing loss : Study protocol for a three-armed, randomized, triple-blind, multicenter trial (HODOKORT).
Böselt, I; Girndt, M; Ludwig-Kraus, B; Meisner, C; Plontke, SK; Rahne, T; Richter, M, 2022
)
0.72
" Secondary endpoints were time to relapse, mean cumulative dose of prednisolone after rituximab infusion, mean duration of follow up, and adverse events to rituximab if any."( Long-term efficacy and safety analysis of single cycle of biosimilar rituximab in pemphigus: A retrospective study of 76 patients from India.
Mistry, D; Shah, BJ; Shah, SR, 2022
)
0.96
" The purpose of this study was to clarify the frequency of adverse events caused by drugs used in JIA treatment and characterize their safety profiles using a spontaneous reporting system database."( Adverse event profiles of drugs used for treatment of juvenile idiopathic arthritis according to spontaneous reporting system database.
Hirai, T; Hosohata, K; Iida, T; Inada, A; Kambara, H; Niinomi, I; Oyama, S; Sano, Y; Uchida, M; Wakabayashi, T, 2022
)
0.72
" The safety endpoint was the frequency of adverse events over 1 year before and after switching."( Safety and efficacy of switching immunosuppressive drugs for maintenance treatment in patients with systemic lupus erythematosus: A retrospective cohort study.
Akahoshi, M; Akashi, K; Arinobu, Y; Ayano, M; Horiuchi, T; Kimoto, Y; Mitoma, H; Niiro, H; Ono, N, 2023
)
0.91
" The frequency of adverse events was similar in the year before and after switching the drug."( Safety and efficacy of switching immunosuppressive drugs for maintenance treatment in patients with systemic lupus erythematosus: A retrospective cohort study.
Akahoshi, M; Akashi, K; Arinobu, Y; Ayano, M; Horiuchi, T; Kimoto, Y; Mitoma, H; Niiro, H; Ono, N, 2023
)
0.91
"Immunosuppressive drug switching led to reduced disease activity and decreased glucocorticoid dose without disease exacerbations and severe adverse events."( Safety and efficacy of switching immunosuppressive drugs for maintenance treatment in patients with systemic lupus erythematosus: A retrospective cohort study.
Akahoshi, M; Akashi, K; Arinobu, Y; Ayano, M; Horiuchi, T; Kimoto, Y; Mitoma, H; Niiro, H; Ono, N, 2023
)
0.91
" Any adverse events that required dose reduction or cessation of hydroxychloroquine, indicating intolerance to the drug, were recorded for up to 26 weeks after initiation of hydroxychloroquine."( Safe Introduction of Hydroxychloroquine Focusing on Early Intolerance Due to Adverse Drug Reactions in Patients with Systemic Lupus Erythematosus.
Araki, K; Hirata, S; Ishitoku, M; Kohno, H; Masuda, S; Mokuda, S; Oka, N; Sugimoto, T; Watanabe, H; Yorishima, A; Yoshida, Y, 2023
)
0.91
" Secondary outcomes include safety and tolerability of MMF and azathioprine, time to remission, changes in Model For End-Stage Liver Disease (MELD)-score, adverse events, and aspects of quality of life."( Assessing the efficacy and safety of mycophenolate mofetil versus azathioprine in patients with autoimmune hepatitis (CAMARO trial): study protocol for a randomised controlled trial.
Bakker, SF; Bartelink, M; Beuers, UHW; Biewenga, M; de Boer, YS; de Jonge, HJM; Drenth, JPH; Gevers, TJG; Gisbertz, IAM; Guichelaar, MMJ; Levens, AD; Pape, S; Pronk, MAMCB; Sebib Korkmaz, K; Sijtsma, MGM; Snijders, RJALM; Soufidi, K; Stoelinga, AEC; van den Berg, AP; van den Brand, FF; van der Meer, AJ; van Gerven, NMF; van Hoek, B; Vanwolleghem, T; Verdonk, RC; Verwer, BJ; Vrolijk, JM, 2022
)
0.72
" 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
"Glucocorticoids prescribed to limit inflammation, have significant adverse effects."( 11β-HSD1 inhibition in men mitigates prednisolone-induced adverse effects in a proof-of-concept randomised double-blind placebo-controlled trial.
Agbaje, O; Arvaniti, A; Bateman, E; Bonaventura, I; Coleman, RL; Cornfield, T; Duffy, J; Eastell, R; Gossiel, F; Hodson, L; Holman, RR; Isidori, AM; Jane Escott, K; Karpe, F; Kirik, U; Marjot, T; Milton, JE; Moolla, A; Nikolaou, N; Othonos, N; Pofi, R; Sadler, R; Scott, CAB; Stewart, PM; Stimson, RH; Tomlinson, JW; van Beek, AP; van Faassen, M; Webster, C; White, S; Whittaker, A, 2023
)
1.18
" Although he was previously treated with prednisolone (1 mg/kg/day) for immune-related adverse event (irAE) hepatitis by a previous doctor, he still had worsening liver function and was transferred to our hospital."( Immune-related adverse events in hepatitis treated with thiopurine-based immunosuppressants: A case report.
Hamaguchi, M; Horie, M; Isobe, T; Kawakado, K; Nagase, M; Nakashima, K; Okimoto, T; Tobita, H; Tsubata, Y; Yoshihara, K, 2023
)
1.18
" This suggests that withdrawal of low-dose prednisolone is feasible and safe after 2 years of administration."( Three-month tapering and discontinuation of long- term, low-dose glucocorticoids in senior patients with rheumatoid arthritis is feasible and safe: placebo-controlled double blind tapering after the GLORIA trial.
Allaart, CF; Almayali, AAH; Baudoin, P; Boers, M; Bos, R; Buttgereit, F; Cutolo, M; Da Silva, JA; Griep, E; Hartman, L; Klaasen, R; Kok, MR; Lems, W; Masaryk, P; Opris, D; Raterman, HG; Smulders, Y; Szekanecz, Z; Ter Wee, MM, 2023
)
1.17

Pharmacokinetics

The pharmacokinetic profile of a single 10 mg oral dose of prednisolone was studied in three groups of six patients with rheumatoid arthritis (RA), polymyalgia rheumatica (PMR) and bronchial asthma (BA) who were already receiving steroid therapy. Clinical factors tested for influence on pharmacokinetics parameters were weight, haemoglobin, duration and duration.

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
)
0.74
" Suppression of plasma cortisol and alterations in blood basophil and helper-T cell trafficking were used as pharmacodynamic indices."( Evaluation of dose-related pharmacokinetics and pharmacodynamics of prednisolone in man.
Jusko, WJ; Law, RM; Ludwig, EA; Middleton, E; Sloan, RR; Wald, JA, 1992
)
0.52
" Furthermore, the results of the present study confirm the presence of pharmacodynamic corticosteroid effects on blood cell count and blood glucose."( Pharmacokinetics and pharmacodynamics of prednisolone after intravenous and oral administration.
Barth, J; Brandis, KH; Damoiseaux, M; Derendorf, H; Hochhaus, G; Möllmann, H, 1992
)
0.55
" Indeed, test doses of cyclosporin followed by series of blood samples and the calculation of individual pharmacokinetic parameters are needed to assure successful immunosuppression right from the start."( Optimisation of immunosuppressive therapy using pharmacokinetic principles.
Grevel, J, 1992
)
0.28
" To estimate HC production after DEX administration a pharmacokinetic model was developed and applied to the time course of plasma HC."( Time-dependent effects of dexamethasone administration on the suppression of plasma hydrocortisone, assessed with a pharmacokinetic model.
Braat, MC; Koopmans, RP; Oosterhuis, B; van Boxtel, CJ, 1992
)
0.28
" 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
)
0.72
" 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
)
1.23
" The pharmacokinetic parameters of PSL were determined by non-compartment analysis."( Effect of oral administration of glycyrrhizin on the pharmacokinetics of prednisolone.
Chen, MF; Kanaoka, M; Kato, H; Shimada, F; Yano, S, 1991
)
0.51
" Since the pharmacokinetics of prednisolone are little altered in renal transplantation, it is concluded that lymphocyte sensitivity specific to prednisolone may be a pharmacodynamic marker characteristic of successful graft survival in patients with histo-incompatibility and/or drug resistance."( Role of altered prednisolone-specific lymphocyte sensitivity in chronic renal failure as a pharmacodynamic marker of acute allograft rejection after kidney transplantation.
Hirano, T; Kang, XX; Kozaki, M; Oka, K; Sakurai, E; Tamaki, T, 1991
)
0.91
" The 50% inhibitory concentration values derived from pharmacodynamic models developed to describe the direct suppressive effects of corticosteroids indicated no alteration in intrinsic sensitivity in the presence of ketoconazole."( Lack of pharmacokinetic and pharmacodynamic interactions between ketoconazole and prednisolone.
Jusko, WJ; Ludwig, EA; Middleton, E; Yamashita, SK, 1991
)
0.51
"The pharmacokinetic characteristics of prednisolone and of chlorambucil and its beta-oxidized metabolite, phenylacetic mustard (PAM) were studied in plasma after the oral administration of 200 mg prednimustine (Sterecyt) and a regimen consisting of 20 mg prednisolone plus 20 mg chlorambucil, respectively."( A pharmacokinetic study of prednimustine as compared with prednisolone plus chlorambucil in cancer patients.
Bastholt, L; Gunnarsson, PO; Johansson, CJ; Johansson, SA; Mouridsen, H; Pfeiffer, P; Svensson, L, 1991
)
0.79
" To ascertain which pharmacokinetic properties of these drugs explain this difference, we gave methylprednisolone and prednisolone, 5 mg/kg intravenous bolus, to 23 adult rabbits."( Methylprednisolone achieves greater concentrations in the lung than prednisolone. A pharmacokinetic analysis.
Bloedow, DC; Greos, LS; Hill, MR; Irvin, CG; Larsen, GL; Szefler, SJ; Vichyanond, P, 1991
)
0.98
" 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
)
0.56
" The absorption of each of the three compounds was rapid, as the peak concentration was attained within 20 min after injection."( Pharmacokinetics of prednisolone and its local anti-inflammatory steroid-21-oate ester derivatives. In vitro and in vivo comparative study.
al-Habet, SM; Lee, HJ; Taraporewala, IB,
)
0.45
"To determine the pharmacokinetic changes of prednisolone associated with an alternate-day regimen, 12 patients with various diseases were studied longitudinally."( The pharmacokinetics of plasma total and free prednisolone during an alternate-day regimen.
Adachi, K; Fuwa, Y; Goshima, E; Miura, K; Yamakita, N; Yasuda, K, 1991
)
0.8
" 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
)
0.81
" After the development of a data base of pharmacokinetic parameters, we examined glucocorticoid pharmacokinetics in 54 patients between 2 and 70 years of age using 70 pharmacokinetic studies after administration of intravenous methylprednisolone (n = 25), oral methylprednisolone (n = 15), intravenous prednisolone (n = 18), and oral prednisone (n = 12)."( Monitoring glucocorticoid therapy: a pharmacokinetic approach.
Ball, BD; Bartoszek, M; Brenner, AM; Hill, MR; Szefler, SJ, 1990
)
0.46
" 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
)
0.83
" The pharmacokinetic parameters of PSL were determined, using noncompartmental analysis."( Effect of glycyrrhizin on the pharmacokinetics of prednisolone following low dosage of prednisolone hemisuccinate.
Chen, MF; Kanaoka, M; Kato, H; Shimada, F; Yano, S, 1990
)
0.53
"3 h and 1160 micrograms/l, respectively), the initial and terminal elimination half-life (3."( Effects of low-dose prednisolone on cyclosporine pharmacokinetics in liver transplant recipients: radioimmunoassay with specific and non-specific monoclonal antibodies.
Arnold, JC; O'Grady, JG; Tredger, JM; Williams, R, 1990
)
0.6
" 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
)
0.78
"To determine the pharmacokinetic changes of prednisolone associated with differing therapy regimens, we studied 15 patients with various diseases who were treated with daily doses of prednisolone and were then placed on an intermittent regimen, [administration for 4 consecutive days (on-day period), followed by 3 days cessation (off-day period)]."( Changes in the pharmacokinetics of plasma total and free prednisolone during daily and intermittent regimens.
Adachi, K; Fuwa, Y; Goshima, E; Miura, K; Yamakita, N; Yasuda, K, 1990
)
0.79
" The presented methods are simple, rapid, specific, sensitive, reproducible, and economical for the pharmacokinetic study of these steroids."( Two chromatographic methods for the determination of corticosteroids in human biological fluids: pharmacokinetic applications.
al-Habet, SM; Rogers, HJ, 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
)
0.99
" The described method involves a simple organic extraction procedure and separation of steroids using a C18 reversed-phase column for pharmacokinetic study."( High-performance liquid chromatographic determination of prednisolone and its steroid 21-oate ester derivatives in rat plasma: pharmacokinetic applications.
Al-Habet, SM; Lee, HJ, 1989
)
0.52
"The pharmacokinetics and pharmacodynamic response to prednisolone were examined in dietary-induced obese rats and matched controls."( Pharmacokinetics and pharmacodynamics of prednisolone in obese rats.
D'Ambrosio, R; Jusko, WJ; Nichols, AI; Pyszczynski, NA, 1989
)
0.79
" Sulphasalazine itself is poorly absorbed (3 to 12%) and its elimination half-life of about 5 to 10 hours is probably affected by the absorption process."( Clinical pharmacokinetics of sulphasalazine, its metabolites and other prodrugs of 5-aminosalicylic acid.
Klotz, U,
)
0.13
" This different pharmacokinetic behavior might offer an explanation for the superior therapeutic effects of prednimustine demonstrated by clinical studies."( Studies on the pharmacokinetics of chlorambucil and prednimustine in patients using a new high-performance liquid chromatographic assay.
Loos, U; Malek, M; Mühlenbruch, B; Musch, E; Oppitz, MM; Rüb, HP; von Unruh, GE, 1989
)
0.28
" The purpose of this study was to investigate possible correlations between the pharmacokinetic values of prednisolone and the main clinical criteria of effectiveness and safety."( [Pharmacokinetics of prednisolone in children. Study of a correlation with tolerability and therapeutic effect in nephrosis].
Baron, S; Bensman, A; Raux Demay, MC; Vasmant, D, 1988
)
0.81
" The use of prednisolone in patients with sarcoidosis can be safely based upon pharmacokinetic data obtained from normal volunteers."( Angiotensin-converting enzyme. Investigation of diurnal variation, the effect of a large dose of prednisolone, and prednisolone pharmacokinetics in patients with sarcoidosis.
Al Habet, SM; Kemp, MW; McAllister, WA; Thompson, PJ; Turner-Warwick, ME, 1986
)
0.87
" 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,
)
0.58
" To compare clinical and pharmacokinetic variables of methylprednisolone and oral prednisolone in patients with RA, a controlled crossover study was carried out."( Comparison of methylprednisolone (1 g i.v.) with prednisolone (1 g orally) in rheumatoid arthritis: a pharmacokinetic and clinical study.
Boutagy, J; Brooks, PM; Cosh, D; Donovan, S; McCredie, M; Needs, CJ; Smith, M, 1988
)
0.84
"The effects of beta- and gamma-cyclodextrins (CyDs) on the pharmacokinetic behavior of prednisolone after intravenous or intramuscular administration in rabbits were investigated."( Effects of beta- and gamma-cyclodextrins on the pharmacokinetic behavior of prednisolone after intravenous and intramuscular administrations to rabbits.
Arimori, K; Uekama, K, 1987
)
0.73
" Cmax, Tmax and AUCp."( [Pharmacokinetics of prednisolone (PSL) during PSL treatment. I. PSL pharmacokinetics during daily PSL treatment].
Adachi, K; Fuwa, Y; Goshima, E; Minamori, Y; Miura, K; Murase, H; Murayama, M; Yamakita, N; Yasuda, K, 1986
)
0.59
"The pharmacokinetic profile of a single 10 mg oral dose of prednisolone was studied in three groups of six patients with rheumatoid arthritis (RA), polymyalgia rheumatica (PMR) and bronchial asthma (BA) who were already receiving steroid therapy."( Prednisolone pharmacokinetics in patients with rheumatoid arthritis, polymyalgia rheumatica and asthma.
Astbury, C; Bird, HA; Dixon, JS; Taggart, AJ, 1986
)
1.96
" Half-life (0."( Dose-dependent pharmacokinetics of prednisolone in normal and adrenalectomized rats.
Boudinot, FD; Jusko, WJ, 1986
)
0.55
"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,
)
0.58
" Plasma levels of the ester and prednisolone were measured and pharmacokinetic parameters were calculated."( Pharmacokinetics of prednisolone after high doses of prednisolone hemisuccinate.
Barth, J; Derendorf, H; Möllmann, H; Neveling, D; Rehder, J; Rohdewald, P,
)
0.74
" It is suggested that prednisolone pharmacodynamics may be influenced by pharmacokinetic differences, and that differences in renal function may be an important contributing factor."( Different prednisolone pharmacokinetics in Cushingoid and non-Cushingoid kidney transplant patients.
Bergrem, H; Flatmark, A; Jervell, J, 1983
)
0.98
" The results showed no significant differences between the two groups in estimates of prednisolone plasma protein binding parameters and peak time, peak concentration, mean input time, clearance/F, volume of distribution/F, or half-life (t 1/2), using total or unbound prednisolone concentrations."( The absence of effect of azathioprine on prednisolone pharmacokinetics following maintenance prednisone doses in kidney transplant patients.
Amend, WJ; Birnbaum, JL; Gambertoglio, JG; Holford, HG; Lizak, PS; Salvatierra, O, 1984
)
0.76
" After dexamethasone alcohol (IV) or dexamethasone 21-isonicotinate (IV), the half-life of elimination was similar (53 minutes) for both formulations."( Dexamethasone and prednisolone in the horse: pharmacokinetics and action on the adrenal gland.
Alvinerie, M; Baggot, JD; Brandon, RA; de Pomyers, H; Toutain, PL, 1984
)
0.6
" Along with the partial and total AUC and moment, the program generates model-independent pharmacokinetic parameters such as plasma clearance, terminal slope, half-life, volume of distribution at steady-state, mean residence time, and variance of the residence time."( LAGRAN program for area and moments in pharmacokinetic analysis.
Jusko, WJ; Rocci, ML, 1983
)
0.27
" The pharmacodynamic component of the model was a hyperbolic function in which a threshold concentration parameter had to be incorporated."( Pharmacokinetic-pharmacodynamic modeling of prednisolone-induced lymphocytopenia in man.
Endert, E; Oosterhuis, B; Sauerwein, HP; Schellekens, PT; ten Berge, RJ; van Boxtel, CJ, 1984
)
0.53
" 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
)
0.52
" The reduction in area under the time concentration curve of free, non-protein bound prednisolone was 56."( Changes in prednisolone pharmacokinetics and protein binding during treatment with rifampicin.
Bergrem, H; Refvem, OK, 1983
)
0.88
"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
)
0.71
"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
)
0.5
" 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
)
0.52
" 7 It was concluded that over the dose range investigated, non-linear pharmacokinetic behaviour had not been demonstrated in this group of normal volunteers."( Pharmacokinetics of intravenous and oral prednisolone.
Al-Habet, S; Rogers, HJ, 1980
)
0.53
"A problem in the evaluation of pharmacokinetic interactions between prednisolone and cortisol is that both steroids bind to cortisol binding globulin (CBG) and albumin."( Pharmacokinetic interaction between endogenous cortisol and exogenous corticosteroids.
Barth, J; Derendorf, H; Hochhaus, G; Möllmann, H; Rohatagi, S, 1995
)
0.53
"Due to the short pharmacokinetic half-life of its active metabolite, pharmacodynamic effects of deflazacort are of shorter duration than those of methylprednisolone and prednisolone."( Pharmacokinetic/pharmacodynamic evaluation of deflazacort in comparison to methylprednisolone and prednisolone.
Barth, J; Derendorf, H; Hochhaus, G; Möllmann, H; Rohatagi, S, 1995
)
0.72
" Estrogen replacement therapy (ERT) did not restore POM pharmacokinetic parameters to PRM values."( Menopause: pharmacodynamics and pharmacokinetics.
Benet, LZ; Gustavson, LE,
)
0.13
" This prospect was investigated using pharmacodynamic cell trafficking models."( Prednisolone pharmacodynamics: leukocyte trafficking in the rat.
Jusko, WJ; Wald, JA, 1994
)
1.73
" 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
)
0.52
"Stable isotopically labeled steroids can, without radiation hazards, be safely used as biological internal standards to perform pharmacokinetic studies of steroids in man."( [Stable isotope methodology in the pharmacokinetic study of steroids].
Kasuya, Y, 1994
)
0.29
" Serial IV pharmacokinetic studies of prednisolone (1 mg/kg) in groups of 3 patients over a 1 month period of rifampin co-treatment or after its withdrawal, revealed significant changes in the area under the curve, the total clearance, the non-renal clearance and the half-life."( Time course of the changes in prednisolone pharmacokinetics after co-administration or discontinuation of rifampin.
Chong, WS; Jang, IJ; Kim, S; Lee, JS; Lee, KH; Shin, JG; Shin, SG, 1993
)
0.85
"95) giving a mean elimination half-life (t0."( The pharmacokinetics of anti-thymocyte globulin (ATG) following intravenous infusion in man.
Bevan, DJ; Bunn, D; Hendry, BM; Higgins, RM; Lea, CK, 1996
)
0.29
"The pharmacokinetic interaction of multiple oral doses of sirolimus (rapamycin) and prednisone were evaluated in 40 stable patients with renal transplants receiving concomitant multiple doses of cyclosporine."( Pharmacokinetics of prednisolone during administration of sirolimus in patients with renal transplants.
Ferron, GM; Jusko, WJ; Kahan, BD; Mis, SM; Zimmerman, JJ, 1996
)
0.62
" 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,
)
0.38
" Samples from the arterial and venous blood catheters and from the ultradiafiltrate were collected over the next 12 hrs to calculate pharmacokinetic parameters and clearance of hemodiafiltration."( Pharmacokinetics and clearance of ganciclovir during continuous hemodiafiltration.
Gando, S; Hayakawa, T; Kameue, T; Nakanishi, Y; Nanzaki, S, 1998
)
0.3
" Synopsis of pharmacokinetic and pharmacodynamic studies, possibly explaining the improved benefit-risk ratio of prednicarbate."( Prednicarbate versus conventional topical glucocorticoids: pharmacodynamic characterization in vitro.
Bader, M; Gysler, A; Kleuser, B; Korting, HC; Lange, K; Schäfer-Korting, M, 1997
)
0.3
" Due to the complicated pharmacokinetic properties of prednisolone, it is extremely difficult to determine the dose needed to obtain a desired target concentration."( Pharmacokinetics of methylprednisolone and prednisolone after single and multiple oral administration.
Barth, J; Derendorf, H; Hochhaus, G; Möllmann, C; Möllmann, H; Rohatagi, S; Soldner, A, 1997
)
0.85
" The presence of multicompartment response variables and/or polyexponential loss complicates the response patterns and resolution of pharmacologic parameters of indirect response models and requires careful experimental and data analysis approaches in order to properly evaluate such pharmacodynamic responses."( Indirect pharmacodynamic models for responses with multicompartmental distribution or polyexponential disposition.
Jusko, WJ; Krzyzanski, W, 2001
)
0.31
" Plasma cortisol concentrations were determined as a pharmacodynamic index."( Effect of itraconazole on the pharmacokinetics of prednisolone and methylprednisolone and cortisol secretion in healthy subjects.
Archer, VC; Chosidow, O; Diquet, B; Lebrun-Vignes, B; Levron, JC; Puech, AJ; Warot, D, 2001
)
0.56
" The pharmacokinetic interaction between methylprednisolone and itraconazole is probably related to inhibition of hepatic CYP3A4 activity by itraconazole."( Effect of itraconazole on the pharmacokinetics of prednisolone and methylprednisolone and cortisol secretion in healthy subjects.
Archer, VC; Chosidow, O; Diquet, B; Lebrun-Vignes, B; Levron, JC; Puech, AJ; Warot, D, 2001
)
0.82
" Total and free plasma prednisolone concentrations were assayed by HPLC and ultrafiltration, and pharmacokinetic data were analyzed by compartmental fitting using WinNonlin."( Prednisolone pharmacokinetics and pharmacodynamics in relation to sex and race.
Blum, RA; Jusko, WJ; Lates, CD; Magee, MH, 2001
)
2.06
" 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
)
0.6
"3% for Cmax and 98."( Pharmacokinetics of two oral prednisolone tablet formulations in healthy volunteers.
Benöhr, P; Luippold, G; Marto, M; Mühlbauer, B; Schneider, S, 2001
)
0.6
" Their pharmacodynamic interactions were examined in blood from healthy adult male and female volunteers using an in vitro phytohemagglutinin (PHA)-stimulated whole-blood lymphocyte proliferation technique."( Pharmacodynamic interaction of recombinant human interleukin-10 and prednisolone using in vitro whole blood lymphocyte proliferation.
Chakraborty, A; Jusko, WJ, 2002
)
0.55
" Pharmacokinetic parameters were estimated in one-chamber model with absorption."( [Pharmacokinetic of prednisolone in patients with rheumatoid arthritis].
Chekalin, AF; Nesterov, SL; Rossokhin, VF; Shishkanov, SF, 2002
)
0.64
"In spite of the same dose of prednisolone, its serum concentration as well as pharmacokinetic parameters were individual in each patient."( [Pharmacokinetic of prednisolone in patients with rheumatoid arthritis].
Chekalin, AF; Nesterov, SL; Rossokhin, VF; Shishkanov, SF, 2002
)
0.93
" However, the potential bilateral pharmacokinetic interaction between atorvastatin and CsA in renal transplant recipients has not previously been examined."( Bilateral pharmacokinetic interaction between cyclosporine A and atorvastatin in renal transplant recipients.
Asberg, A; Bergan, S; Fjeldså, E; Hartmann, A; Holdaas, H, 2001
)
0.31
" Model simulations well captured the pharmacodynamic data once initial conditions were corrected for observed baseline values."( Integrated QSPR--pharmacodynamic model of genomic effects of several corticosteroids.
Jusko, WJ; Mager, DE; Pyszczynski, NA, 2003
)
0.32
"A two-compartment pharmacokinetic model was used to describe data from 23 children with ALL (aged 2-15 years)."( Population pharmacokinetics of prednisolone in children with acute lymphoblastic leukemia.
Jusko, WJ; Petersen, KB; Rasmussen, M; Schmiegelow, K, 2003
)
0.6
" The median unbound clearance (32 l/h per m(2)) was lower, and the half-life (3."( Population pharmacokinetics of prednisolone in children with acute lymphoblastic leukemia.
Jusko, WJ; Petersen, KB; Rasmussen, M; Schmiegelow, K, 2003
)
0.6
"The study showed complete oral bioavailability, a lower unbound clearance and a longer half-life for prednisolone than previously reported in childhood ALL."( Population pharmacokinetics of prednisolone in children with acute lymphoblastic leukemia.
Jusko, WJ; Petersen, KB; Rasmussen, M; Schmiegelow, K, 2003
)
0.82
"97, mean bias < 1%; mean precision < 10%) these pharmacokinetic parameters."( Prednisolone: limited sampling strategies for estimating pharmacokinetic parameters.
Estrela, Rde C; Salvadori, MC; Suarez-Kurtz, G, 2004
)
1.77
" 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
" 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
"The pharmacodynamic interactions between recombinant mouse interleukin-10 (IL-10) and prednisolone were examined in lipopolysaccharide (LPS)-induced experimental endotoxemia in Balb/c mice."( Pharmacodynamic interactions between recombinant mouse interleukin-10 and prednisolone using a mouse endotoxemia model.
Chakraborty, A; Jusko, WJ; Pyszczynski, NA; Yeung, S, 2005
)
0.78
"There were no statistically significant differences in the pharmacokinetic parameters calculated from plasma data in the three situations studied."( Pharmacokinetics of prednisolone in man during acute and chronic exposure to high altitude.
Arancibia, A; Chávez, J; Gai, MN; González, C; Paulos, C; Pinilla, E; Ritschel, WA; Villanueva, S, 2005
)
0.65
"A population pharmacokinetic analysis of cyclosporine (CsA) was performed, and the influence of covariates on CsA oral clearance and relative bioavailability was investigated."( Population pharmacokinetics of cyclosporine in cardiopulmonary transplant recipients.
Akhlaghi, F; Baheti, G; Rosenbaum, SE; Trull, AK, 2005
)
0.33
"), respectively, showed significant change of the pharmacokinetic parameters of Dx compared with the control rats."( Pharmacokinetic interaction with digoxin and glucocorticoids in rats detected by radio-immunoassay using a novel specific antiserum.
Fujii, Y; Higashi, Y; Ikeda, Y; Yamamoto, R; Yamashiro, M, 2005
)
0.33
"Corticosteroid therapy has been associated with bone toxicities (eg, osteonecrosis) and Cushing syndrome in HIV-infected patients; this may be partially attributable to a pharmacokinetic drug interaction between HIV protease inhibitors and corticosteroids."( Prednisolone pharmacokinetics in the presence and absence of ritonavir after oral prednisone administration to healthy volunteers.
Alfaro, RM; Formentini, E; Kovacs, J; Long, M; Natarajan, V; Penzak, SR, 2005
)
1.77
" This study compared the pharmacokinetic profiles of MPA and its major metabolite MPA glucuronide (MPAG) in combination with tacrolimus (TAC) or cyclosporine (CyA) during the maintenance period (>6 months) following renal transplantation."( Effects of calcineurin inhibitors on pharmacokinetics of mycophenolic acid and its glucuronide metabolite during the maintenance period following renal transplantation.
Hashimoto, H; Kagawa, Y; Maeda, T; Naito, T; Otsuka, A; Ozono, S; Shinno, K; Suzuki, K; Takayama, T; Ushiyama, T, 2006
)
0.33
" The pharmacokinetic properties of CyA vary widely and lipoproteins are the major complexing constituents for CyA in the plasma."( Effect of plasma lipid on pharmacokinetics of ciclosporin and its relationship with plasma prednisolone level in renal transplant patients.
Ito, Y; Kokuhu, T; Okamoto, M; Shibata, N; Sugioka, N; Takada, K; Yoshimura, N, 2006
)
0.55
" Finally, theoretical assumptions about the potential pharmacokinetic changes of glucocorticoids in pregnancy and their application to clinical settings are discussed."( Pharmacokinetics of corticosteroids during pregnancy.
Ghulmiyyah, LM; Hankins, GD; Pacheco, LD; Snodgrass, WR, 2007
)
0.34
" 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
)
0.78
" We aimed at investigating the effect of high-doses of MZ on prevention of anti-donor antibody (Ab) production and acute Ab-mediated rejection (AMR) on the basis of the pharmacokinetic profile in a pig kidney transplantation model."( Prophylactic treatment of antibody-mediated rejection with high-dose mizoribine and pharmacokinetic study.
Kobayashi, T; Kuzuya, T; Liu, D; Ma, Y; Miwa, Y; Morozumi, K; Nagasaka, T; Nakao, A; Oikawa, T; Uchida, K; Yokoyama, I, 2007
)
0.34
" However, this sensitivity was not satisfactory for corticosterone during pharmacokinetic studies involving dexamethasone due to its strong adrenosuppressive effect."( Quantification of dexamethasone and corticosterone in rat biofluids and fetal tissue using highly sensitive analytical methods: assay validation and application to a pharmacokinetic study.
Jusko, WJ; Samtani, MN, 2007
)
0.34
"We investigated the pharmacokinetic equivalency of oral and intravenous etoposide in ten patients (male, n=7; female, n=3; median age 56 years) with aggressive lymphomas."( Pharmacokinetic comparison of oral and intravenous etoposide in patients treated with the CHOEP-regimen for malignant lymphomas.
Ehninger, G; Friedrichsen, K; Haenel, M; Kroschinsky, FP; Mueller, J; Prondzinsky, R; Pursche, S; Schleyer, E, 2008
)
0.35
"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
)
0.55
" The mean dose-unadjusted and -adjusted Cmax of MPA with 30 mg lansoprazole were significantly lower than those without PPI (11."( Influence of lansoprazole and rabeprazole on mycophenolic acid pharmacokinetics one year after renal transplantation.
Habuchi, T; Inoue, K; Kagaya, H; Miura, M; Saito, M; Satoh, S; Suzuki, T, 2008
)
0.35
" AUCs of OP and IVMP were determined by the trapezoid method; pharmacokinetic parameters were obtained using noncompartmental and compartmental analysis."( Pharmacokinetic study of oral prednisolone compared with intravenous methylprednisolone in patients with juvenile dermatomyositis.
Daru, JA; Gursahaney, A; Ngai, KL; Pachman, LM; Rouster-Stevens, KA, 2008
)
0.63
" Mean peak concentration was higher for IVMP (34."( Pharmacokinetic study of oral prednisolone compared with intravenous methylprednisolone in patients with juvenile dermatomyositis.
Daru, JA; Gursahaney, A; Ngai, KL; Pachman, LM; Rouster-Stevens, KA, 2008
)
0.63
"Twenty-four patients who were enrolled in a large randomized trial of thalidomide vs no thalidomide maintenance therapy for myeloma, in which all patients also received zoledronic acid, were recruited to a pharmacokinetic and renal safety sub-study, and followed for up to 16 months."( Renal safety of zoledronic acid with thalidomide in patients with myeloma: a pharmacokinetic and safety sub-study.
Bilic, S; Copeman, M; Cremers, S; Kennedy, N; Lynch, K; Neeman, T; Ravera, C; Roberts, A; Schran, H; Spencer, A, 2008
)
0.35
" 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
" Even at comparable weight-adjusted doses, prednisolone side effects vary considerably between individuals, suggesting between-patient pharmacokinetic differences."( Role of prednisolone pharmacokinetics in postchallenge glycemia after renal transplantation.
Bergrem, H; Bergrem, HA; Hartmann, A; Hjelmesaeth, J; Jenssen, T, 2008
)
1.04
" The purpose of this study was to evaluate the presystemic extraction and pharmacodynamic action of buccal budesonide."( Pharmacokinetics and pharmacodynamic action of budesonide after buccal administration in healthy subjects and patients with oral chronic graft-versus-host disease.
Bertz, H; Dilger, K; Finke, J; Gratwohl, A; Halter, J; Lopez-Lazaro, L, 2009
)
0.35
" A population pharmacokinetic analysis was performed to estimate the effects of demographic factors, hematocrit, serum albumin concentration, prednisolone dose, TRL dose interval, polymorphisms in genes coding for ABCB1, CYP3A5, CYP3A4, and the pregnane X receptor on TRL pharmacokinetics."( Explaining variability in tacrolimus pharmacokinetics to optimize early exposure in adult kidney transplant recipients.
Danhof, M; de Fijter, JW; den Hartigh, J; Guchelaar, HJ; Ploeger, BA; Press, RR; van der Straaten, T; van Pelt, J, 2009
)
0.55
"African green monkeys (vervets) have been proposed as an alternate species that might allow improved access and provide high-quality pharmacokinetic results comparable with other primates."( Exploration of the African green monkey as a preclinical pharmacokinetic model: oral pharmacokinetic parameters and drug-drug interactions.
Bhadresa, S; Coon, DJ; Lawrence, MS; Magiera, D; Struharik, M; Ward, KW, 2009
)
0.35
" This validated method has been used successfully in clinical pharmacokinetic studies of CRx-102 in healthy volunteers."( Development and validation of a liquid chromatography-tandem mass spectrometry assay for the simultaneous quantitation of prednisolone and dipyridamole in human plasma and its application in a pharmacokinetic study.
Chen, M; Granvil, C; Ji, QC; Kansra, VV; Padval, MV; Zhang, ZY, 2009
)
0.56
" Pharmacodynamic (PD) assay for evaluating the inhibition of interleukin-2 (IL-2) production for each patient could provide a more appropriate dosing regimen."( Evaluation of interleukin-2 mRNA in whole blood as a parameter for monitoring cyclosporine pharmacodynamics.
Katayama, A; Kobayashi, T; Kuzuya, T; Miwa, Y; Nagasaka, T; Nakao, A; Uchida, K; Yamada, K, 2009
)
0.35
" The large pharmacokinetic (PK) and pharmacodynamic (PD) variability and narrow therapeutic range of MPA provide a potential for therapeutic drug monitoring."( Mycophenolate pharmacokinetics and pharmacodynamics in belatacept treated renal allograft recipients - a pilot study.
Bergan, S; Bremer, S; Holdaas, H; Jørgensen, PF; Midtvedt, K; Rootwelt, H; Stenstrøm, J; Vethe, NT, 2009
)
0.35
"There were no differences in dose (D) and body weight (BW)-adjusted pharmacokinetic parameters of tacrolimus among the three groups."( No impact of age on dose-adjusted pharmacokinetics of tacrolimus, mycophenolic acid and prednisolone 1 month after renal transplantation.
Habuchi, T; Inoue, T; Kagaya, H; Miura, M; Saito, M; Satoh, S; Suzuki, T; Tsuchiya, N, 2009
)
0.57
"021, respectively), but there were no significant differences in the half-life and T(max) of prednisolone between the two groups."( Inter-individual difference determinant of prednisolone pharmacokinetics for Japanese renal transplant recipients in the maintenance stage.
Habuchi, T; Inoue, K; Kagaya, H; Miura, M; Saito, M; Satoh, S, 2009
)
0.84
"Detailed pharmacokinetic (PK) studies in rats were performed (i)to compare the PK of prednisolone (PRN) and loteprednol etabonate (LE, a soft corticosteroid) as well as their common inactive metabolite delta1-cortienic acid (delta1-CA), (ii) to investigate the excretion of delta1-CA after PRN and LE administration, and (iii) to investigate the effect of delta1-unsaturation on the excretion of delta1-CA versus CA."( Pharmacokinetics and delta1-cortienic acid excretion after intravenous administration of prednisolone and loteprednol etabonate in rats.
Bodor, N; Buchwald, P; Tang, Y; Wu, WM, 2010
)
0.81
" The favorable pharmacokinetic profile of mapracorat supports further clinical investigation and suggests that a convenient daily dosing regimen may be efficacious for this novel ophthalmic anti-inflammatory therapy."( Ocular pharmacokinetics of mapracorat, a novel, selective glucocorticoid receptor agonist, in rabbits and monkeys.
Lowe, ER; Proksch, JW; Ward, KW, 2011
)
0.37
"To estimate the population pharmacokinetic parameters of cyclosporine in Korean adults undergoing living-donor kidney transplantation, and to identify clinical factors affecting cyclosporine pharmacokinetics."( Population pharmacokinetics of cyclosporine in Korean adults undergoing living-donor kidney transplantation.
Ji, E; Kang, W; Kim, IW; Kim, KI; Kim, MY; Kwon, KI; Lee, HS; Oh, JM; Shin, WG; Yun, HY, 2011
)
0.37
" The effects of several clinical covariates on cyclosporine pharmacokinetic parameters were evaluated over 12 months after transplantation."( Population pharmacokinetics of cyclosporine in Korean adults undergoing living-donor kidney transplantation.
Ji, E; Kang, W; Kim, IW; Kim, KI; Kim, MY; Kwon, KI; Lee, HS; Oh, JM; Shin, WG; Yun, HY, 2011
)
0.37
"This population pharmacokinetic model identified important sources of variability in cyclosporine pharmacokinetics."( Population pharmacokinetics of cyclosporine in Korean adults undergoing living-donor kidney transplantation.
Ji, E; Kang, W; Kim, IW; Kim, KI; Kim, MY; Kwon, KI; Lee, HS; Oh, JM; Shin, WG; Yun, HY, 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
)
0.92
" Dose-response data and pharmacokinetic data were used to calculate effective and safe clinical doses of paquinimod."( Pharmacokinetics, tolerability, and preliminary efficacy of paquinimod (ABR-215757), a new quinoline-3-carboxamide derivative: studies in lupus-prone mice and a multicenter, randomized, double-blind, placebo-controlled, repeat-dose, dose-ranging study in
Axelsson, B; Bengtsson, AA; Leanderson, T; Lood, C; Ohman, MW; Rönnblom, L; Sparre, B; Sturfelt, G; Tuvesson, H; van Vollenhoven, RF, 2012
)
0.38
" In patients with SLE, the pharmacokinetic properties of paquinimod were linear and well suitable for once-daily oral treatment."( Pharmacokinetics, tolerability, and preliminary efficacy of paquinimod (ABR-215757), a new quinoline-3-carboxamide derivative: studies in lupus-prone mice and a multicenter, randomized, double-blind, placebo-controlled, repeat-dose, dose-ranging study in
Axelsson, B; Bengtsson, AA; Leanderson, T; Lood, C; Ohman, MW; Rönnblom, L; Sparre, B; Sturfelt, G; Tuvesson, H; van Vollenhoven, RF, 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
)
0.63
" However, there is little information about the pharmacokinetic interaction of sorafenib."( Pharmacokinetic interaction between sorafenib and prednisolone in a patient with hepatocellular carcinoma.
Fujiyama, Y; Hira, D; Morita, SY; Noda, S; Shioya, M; Terada, T, 2013
)
0.64
" 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
)
0.78
" 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
)
0.78
"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
)
0.78
" Some pharmacokinetic studies have demonstrated increased prednisolone exposure in patients on cyclosporine therapy compared with azathioprine, whereas other studies have found no difference."( Comparison of the influence of cyclosporine and tacrolimus on the pharmacokinetics of prednisolone in adult male kidney transplant recipients.
Barraclough, KA; Bergmann, TK; Campbell, SB; Isbel, NM; McWhinney, BC; Staatz, CE, 2014
)
0.87
"Adult male kidney transplant recipients treated with prednisolone and either cyclosporine or tacrolimus were recruited for pharmacokinetic blood sampling at the outpatient clinic at the Princess Alexandra Hospital, Brisbane, Australia."( Comparison of the influence of cyclosporine and tacrolimus on the pharmacokinetics of prednisolone in adult male kidney transplant recipients.
Barraclough, KA; Bergmann, TK; Campbell, SB; Isbel, NM; McWhinney, BC; Staatz, CE, 2014
)
0.88
" 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
)
0.88
" PDC showed similar pharmacokinetic profile to PRED, but exhibited higher efficiency (1."( L-Carnitine ester of prednisolone: pharmacokinetic and pharmacodynamic evaluation of a type I prodrug.
Lim, LY; Mo, J; Zhang, ZR, 2014
)
0.72
"The aim was to develop a theory-based population pharmacokinetic model of tacrolimus in adult kidney transplant recipients and to externally evaluate this model and two previous empirical models."( Improved prediction of tacrolimus concentrations early after kidney transplantation using theory-based pharmacokinetic modelling.
Åsberg, A; Bergan, S; Bergmann, TK; Bremer, S; Hennig, S; Holford, N; Midtvedt, K; Staatz, CE; Størset, E, 2014
)
0.4
"A theory-based population pharmacokinetic model was superior to two empirical models for prediction of tacrolimus concentrations and seemed suitable for Bayesian prediction of tacrolimus doses early after kidney transplantation."( Improved prediction of tacrolimus concentrations early after kidney transplantation using theory-based pharmacokinetic modelling.
Åsberg, A; Bergan, S; Bergmann, TK; Bremer, S; Hennig, S; Holford, N; Midtvedt, K; Staatz, CE; Størset, E, 2014
)
0.4
" Comparing pharmacokinetic data with MRI data it was observed that maximal blood levels occurred before the solvent and the dispersion agent were removed from the muscle tissue."( Simultaneous magnetic resonance imaging and pharmacokinetic analysis of intramuscular depots.
Evert, K; Hadlich, S; Kühn, JP; Oswald, S; Probst, M; Scheuch, E; Seidlitz, A; Siegmund, W; Weitschies, W, 2016
)
0.43
" Pharmacokinetic parameters were analyzed in relation to relapse patterns and side effects."( Population Pharmacokinetics of Prednisolone in Relation to Clinical Outcome in Children With Nephrotic Syndrome.
Ackermans, MT; Guan, Z; Kist-van Holthe, JE; Nauta, J; Stevens, J; Teeninga, N; van der Heijden, AJ; van Gelder, T; van Schaik, RH, 2016
)
0.72
" The purpose of this study was to develop a population pharmacokinetic model and investigate the influence of clinical factors on the pharmacokinetics of tacrolimus in adult Thai kidney transplant patients from routine data monitoring."( Population pharmacokinetics of tacrolimus in Thai kidney transplant patients: comparison with similar data from other populations.
Avihingsanon, Y; Praisuwan, S; Techawathanawanna, N; Treyaprasert, W; Vadcharavivad, S, 2016
)
0.43
" Clinical factors tested for influence on pharmacokinetic parameters were weight, haemoglobin, duration of tacrolimus therapy, prednisolone dose, serum albumin and estimated glomerular filtration rate."( Population pharmacokinetics of tacrolimus in Thai kidney transplant patients: comparison with similar data from other populations.
Avihingsanon, Y; Praisuwan, S; Techawathanawanna, N; Treyaprasert, W; Vadcharavivad, S, 2016
)
0.64
" The population pharmacokinetic equation that predicted CL/F of tacrolimus was CL/F = 21·5 × exp((-0·05 () (HB) ( - 11·8)))  × (DOT/125)(-0·06) , where CL/F was tacrolimus apparent oral clearance (L/h), HB was haemoglobin levels (g/dL), and DOT was duration of tacrolimus therapy (days)."( Population pharmacokinetics of tacrolimus in Thai kidney transplant patients: comparison with similar data from other populations.
Avihingsanon, Y; Praisuwan, S; Techawathanawanna, N; Treyaprasert, W; Vadcharavivad, S, 2016
)
0.43
"The first population pharmacokinetic model of tacrolimus in Thai adult kidney transplant patients was developed and validated."( Population pharmacokinetics of tacrolimus in Thai kidney transplant patients: comparison with similar data from other populations.
Avihingsanon, Y; Praisuwan, S; Techawathanawanna, N; Treyaprasert, W; Vadcharavivad, S, 2016
)
0.43
"This report summarizes phase 1 studies that evaluated pharmacokinetic interactions between the novel triazole antifungal agent isavuconazole and the immunosuppressants cyclosporine, mycophenolic acid, prednisolone, sirolimus, and tacrolimus in healthy adults."( Pharmacokinetic Assessment of Drug-Drug Interactions of Isavuconazole With the Immunosuppressants Cyclosporine, Mycophenolic Acid, Prednisolone, Sirolimus, and Tacrolimus in Healthy Adults.
Akhtar, S; Desai, A; Groll, AH; Han, D; Howieson, C; Kato, K; Kowalski, D; Lademacher, C; Lewis, W; Mandarino, D; Pearlman, H; Townsend, R; Yamazaki, T, 2017
)
0.85
" Conventional pharmacokinetic methods for immunosuppressive drug monitoring are not cell type-specific."( Pharmacodynamic Monitoring of Tacrolimus-Based Immunosuppression in CD14+ Monocytes After Kidney Transplantation.
Baan, CC; de Graav, GN; Dieterich, M; Hesselink, DA; Kannegieter, NM; Kraaijeveld, R; Leenen, PJM; Rowshani, AT, 2017
)
0.46
" This inhibition can be determined by phospho-specific flow cytometry, which enables the assessment of the pharmacodynamic effects of immunosuppressive drugs in a cell type-specific manner."( Pharmacodynamic Monitoring of Tacrolimus-Based Immunosuppression in CD14+ Monocytes After Kidney Transplantation.
Baan, CC; de Graav, GN; Dieterich, M; Hesselink, DA; Kannegieter, NM; Kraaijeveld, R; Leenen, PJM; Rowshani, AT, 2017
)
0.46
" In this study, the validity of these strategies was verified by investigating the plasma pharmacokinetic and urinary excretion profiles of relevant glucocorticoids in bovines, subjected to exogenous prednisolone treatment or tetracosactide hexaacetate administration to induce endogenous prednisolone formation."( Pharmacokinetic and urinary profiling reveals the prednisolone/cortisol ratio as a valid biomarker for prednisolone administration.
Croubels, S; De Clercq, N; Delahaut, P; Devreese, M; Fichant, E; Van Meulebroek, L; Vanden Bussche, J; Vanhaecke, L, 2017
)
0.9
"To develop an objective, readily measurable pharmacodynamic biomarker of glucocorticoid (GC) activity."( Development of a Molecular Signature to Monitor Pharmacodynamic Responses Mediated by In Vivo Administration of Glucocorticoids.
Bandyopadhyay, S; Carman, JA; Connolly, S; Fan, L; Furie, R; Goldstine, C; Holloway, D; Hu, Y; Johnsen, A; Kansal, S; Latek, R; Lee, D; Nadler, SG; Shadick, N; Somerville, JE; Townsend, R; Weinblatt, ME, 2018
)
0.48
"The GC gene signature identified in this study represents a pharmacodynamic marker of GC exposure."( Development of a Molecular Signature to Monitor Pharmacodynamic Responses Mediated by In Vivo Administration of Glucocorticoids.
Bandyopadhyay, S; Carman, JA; Connolly, S; Fan, L; Furie, R; Goldstine, C; Holloway, D; Hu, Y; Johnsen, A; Kansal, S; Latek, R; Lee, D; Nadler, SG; Shadick, N; Somerville, JE; Townsend, R; Weinblatt, ME, 2018
)
0.48
" 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
" The influence of hyperhydration on the plasma and urinary pharmacokinetic (PK) profiles of BDS and metabolites was also examined."( Effect of hyperhydration on the pharmacokinetics and detection of orally administered budesonide in doping control analysis.
Al-Maadheed, M; Athanasiadou, I; Dokoumetzidis, A; Georgakopoulos, C; Mbeloug, M; Saleh, A; Valsami, G; Vonaparti, A, 2019
)
0.51
" The method was successfully applied to a preclinical pharmacokinetic (PK) study of the six GCs on female nude mice after a single oral dose of 1 mg/kg."( Development and validation of a LC-MS/MS method for simultaneous determination of six glucocorticoids and its application to a pharmacokinetic study in nude mice.
Guo, Y; Hao, C; Kong, D; Li, J; Tian, X; Xue, J; Yao, Q; Zhou, T, 2020
)
0.56
" A population pharmacokinetic model was developed and post hoc area under the curve (AUC) was tested against treatment outcome parameters."( Evaluation of the pharmacokinetics of prednisolone in paediatric patients with acute lymphoblastic leukaemia treated according to Dutch Childhood Oncology Group protocols and its relation to treatment response.
Bierings, MB; de Haas, V; Kaspers, GJL; Mathôt, RAA; Pieters, R; Sassen, SDT; Te Loo, DMWW; Tissing, WJE; van den Bos, C; van der Sluis, IM; Zwaan, CM, 2021
)
0.89
" This study was undertaken to characterize pharmacokinetic profiles of ipatasertib and its metabolite M1 (G-037720) and to understand the sources of variability."( Population Pharmacokinetics of Ipatasertib and Its Metabolite in Cancer Patients.
Chanu, P; Kotani, N; Sane, R; Wade, JR; Wang, N; Wilkins, J; Winkler, J; Yoshida, K, 2021
)
0.62
" Despite various review articles having suggested the presence of pharmacokinetic interactions between MPA and steroids, definitive data have not yet been demonstrated."( Clinical Evidence on the Purported Pharmacokinetic Interactions between Corticosteroids and Mycophenolic Acid.
Kiang, T; Rong, Y, 2023
)
0.91

Compound-Compound Interactions

JKB-122 as monotherapy or in combination with prednisolone may offer a viable approach to the treatment of AIH.

ExcerptReferenceRelevance
"Twenty-one patients with myasthenia gravis underwent a course of plasma exchange combined with immunosuppressive therapy."( Plasma-exchange combined with immunosuppressive therapy in myasthenia gravis.
Allan, TL; Behan, PO; Burnett, AK; Haase, G; Shakir, RA; Simpson, JA, 1979
)
0.26
"The dynamics of penicillin concentrations in the blood and lung tissue of animals with chronic experimental pneumonia after its repeated administration in combination with prednisolone was studied."( [Penicillin distribution in the body of animals with experimental chronic pneumonia when administered repeatedly in combination with prednisolone].
Sazonov, VF, 1976
)
0.65
" Using a rabbit model, the effects of trifluridine (F3TdR) on corneal edema and stromal disease were examined when combined with each of three immunosuppressive agents."( Therapeutic response of herpes simplex virus-induced corneal edema to trifluridine in combination with immunosuppressive agents.
O'Brien, WJ; Taylor, JL, 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
" The low toxicity combined with worthwhile remissions make this an attractive first-line option for elderly patients."( Phase 2 study of mitozantrone in combination with chlorambucil and prednisolone for relapsed and refractory non-Hodgkins lymphoma.
Cotter, FE; Jones, L; Lord, D; Newland, AC,
)
0.37
" The best use of FK at low doses was in combination with CyA and Pred."( Canine kidney transplantation with FK-506 alone or in combination with cyclosporine and steroids.
Casavilla, A; Cemaj, S; Demetris, AJ; Ghalab, A; Imventarza, O; Mazzaferro, V; Okuda, K; Rhoe, BS; Todo, S; Ueda, Y, 1987
)
0.27
"The dynamics of the immunological parameters was studied in 17 patients with multiple sclerosis (MS) who received prednisolone therapy in combination with plasmacytapheresis."( [The dynamics of immunological indicators in the treatment of patients with multiple sclerosis with prednisolone combined with plasmapheresis].
Gannushkina, IV; Kir'iakov, VA; Neretin, VIa; Sapfirova, VA; Zhirnova, IG, 1988
)
0.7
"A study of pirprofen (rengasil) combined with small doses of corticosteroids in 93 patients with rheumatoid arthritis during a double blind multicentre testing showed good and satisfactory therapeutic results in 60%."( [Study of pirprofen (rengasil) combined with maintenance doses of corticosteroids in rheumatoid arthritis in a double-blind multicenter trial].
Alekberova, ZS; Kobaladze, SG; Pokryshkin, VI; Taletene, IP; Trofimova, TM, 1986
)
0.27
"Fifty RA patients receiving prednisolone and prednisolone combined with retabolil were examined."( [Experimental substantiation of the treatment of patients with rheumatoid arthritis with prednisolone and its combination with retabolil (clinico-experimental study)].
Bagirova, VV; Iaglinskiĭ, VA; Kriukov, AP, 1986
)
0.79
" Hoe S 2922) in combination with the steroid prednicarbate (prednisolone 17-(ethylcarbonate)-21-propionate, Hoe 777) were used."( [Treatment of impetiginized eczema with prednicarbate in combination with a quarternary ammonium salt].
Schäfer, V; Wölbling, RH, 1987
)
0.52
" Our policy is to carry out an extended thymectomy combined with pre- and post-operative administration of prednisolone on alternate days."( Favorable results of thymectomy combined with prednisolone alternate-day administration in myasthenia gravis.
Baba, M; Obata, S; Saito, Y; Yamaguchi, Y, 1987
)
0.74
"SA96 in combination with indomethacin or prednisolone was investigated for their effects on the adjuvant arthritis in Lewis rats."( [Pharmacological studies of N-(2-mercapto-2-methylpropanoyl)-L-cysteine (SA96). V. Effects of SA96 in combination with indomethacin or prednisolone on adjuvant arthritis in rats].
Hayashi, M; Iso, T; Kasamatsu, S; Mibu, H; Nakata, K; Yamauchi, H, 1985
)
0.74
" These effects, combined with the common use of cimetidine in clinical practice, make the risk of adverse drug interactions a relatively frequent risk in the clinical setting."( Drug interactions involving cimetidine--mechanisms, documentation, implications.
Greene, W, 1984
)
0.27
" Prednisolone in combination with asathioprin (imuran) administered to CBA mice inhibited the GVHR."( [Effect of prodigiosin and its combination with immunodepressants on the graft versus host reaction in mice].
Alekhin, EK; Shigaev, NI, 1983
)
1.18
" The clinical picture was markedly mitigated by the early initiation of silybin therapy, in combination with penicillin and cortisone."( [Treatment of Amanita phalloides poisoning with silybin in combination with penicillin and cortisone].
Egermann, G; Hofer, JF; Mach, K; Sommer, K, 1983
)
0.27
"Anti-acetylcholine receptor antibody titres have been monitored in the sera of 19 myasthenic patients treated with plasma exchange combined with a three month period of immunosuppressive therapy."( Anti-acetylcholine receptor antibody titres in the sera of myasthenia patients treated with plasma exchange combined with immunosuppressive therapy.
Behan, PO; Carter, B; Harrison, R; Lunt, GG; Simpson, JA, 1980
)
0.26
"In treatment of GO, 24 Gy of radiation is a more effective dose than 10 Gy when combined with systemic corticosteroids."( Graves ophthalmopathy: MR evaluation of 10-Gy versus 24-Gy irradiation combined with systemic corticosteroids.
Futami, S; Hoshi, H; Jinnouchi, S; Morita, M; Murakami, N; Nagamachi, S; Nakahara, H; Noguchi, S; Ohnishi, T; Tamaru, M, 1995
)
0.29
"VCAP chemotherapy combined with natural interferon-alpha (HBLI) was performed on elderly patients over 65 year with multiple myeloma (MM), and its clinical effects were compared with those of VCAP chemotherapy without HLBI on elderly MM and also with those of HLBI-VCAP and VCAP combination therapy on non-elderly MM."( [VCAP chemotherapy combined with interferon-alpha (HLBI) for elderly multiple myeloma].
Katoh, M; Niitsu, N; Shikoshi, K; Takata, M; Umeda, M, 1994
)
0.29
" The type of interaction was different between patients, and depends on the drug combination and concentrations."( Drug combination testing in acute lymphoblastic leukemia using the MTT assay.
Hählen, K; Kaspers, GJ; Pieters, R; Van Wering, ER; Van Zantwijk, I; Veerman, AJ, 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
", twice a day for 5 days) alone or in combination with prednisolone (2 mg."( Suppression of renal scarring by prednisolone combined with ciprofloxacin in ascending pyelonephritis in rats.
Haraoka, M; Kubo, S; Kumazawa, J; Matsumoto, T; Takahashi, K; Tanaka, M, 1994
)
0.82
" This study examined whether AZA combined with standard prednisolone therapy improved the therapeutic outcome compared with monotherapy with prednisolone."( Azathioprine combined with prednisolone or monotherapy with prednisolone in active Crohn's disease.
Ewe, K; Hommel, G; Meyer zum Büschenfelde, KH; Press, AG; Singe, CC; Stufler, M; Ueberschaer, B, 1993
)
0.83
" These results suggest that either salt of prednisolone, when combined with ciprofloxacin, reduces ocular inflammation without affecting the antimicrobial efficacy of the antibiotic."( Prednisolone acetate or prednisolone phosphate concurrently administered with ciprofloxacin for the therapy of experimental Pseudomonas aeruginosa keratitis.
Callegan, MC; Engel, LS; Hill, JM; Hobden, JA; O'Callaghan, RJ, 1993
)
1.99
"We carried out lymphocytapheresis (LCP) in combination with the administration of immunosuppressive drugs in patients with myasthenia gravis (MG), who were resistant to conventional immunosuppressive therapy, and examined its efficacy and effects on peripheral blood lymphocyte subsets."( Lymphocytapheresis in combination with immunosuppressive drugs for refractory myasthenia gravis: two-color flow cytometric analysis of changes in peripheral blood lymphocyte subsets.
Furutama, D; Makino, S; Nakajima, H; Ohsawa, N; Shinoda, K, 1995
)
0.29
" In the present study, mature female rats were treated with prednisolone (Pred) or vehicle, in combination with ovariectomy (ovx), dietary calcium deficiency (LoCa), or right hind limb immobilization (IM)."( Prednisolone alone, or in combination with estrogen or dietary calcium deficiency or immobilization, inhibits bone formation but does not induce bone loss in mature rats.
Birchman, R; Dempster, DW; Liang, XG; Lindsay, R; Shen, V; Wu, DD, 1997
)
1.98
" We conclude that the treatment with CPM combined with PSL may be useful, when neurological manifestations of MCTD are serious and resistant to conventional therapy."( [A case of mixed connective tissue disease with lupus-like manifestations of the central nervous system, successfully treated with cyclophosphamide combined with prednisolone].
Iga, M; Kai, Y; Kuroki, M; Kuwata, G; Matsuyama, M; Murai, K; Okamoto, M; Okayama, A; Tanaka, G; Tsubouchi, H, 2000
)
0.5
" Eighty-six patients were treated in combination with high-dose or pulsed corticosteroids and irradiation."( Clinical outcomes of orbital irradiation combined with or without systemic high-dose or pulsed corticosteroids for Graves' ophthalmopathy.
Abe, M; Fukada, S; Hagiwara, M; Hirota, S; Hishikawa, Y; Kono, M; Takada, Y; Tsujino, K, 2000
)
0.31
"Orbital irradiation combined with high-dose or pulsed corticosteroids is an effective treatment for moderate to severe GO, especially in cases with major manifestations of soft-tissue signs, extraocular muscle impairment, or sight loss."( Clinical outcomes of orbital irradiation combined with or without systemic high-dose or pulsed corticosteroids for Graves' ophthalmopathy.
Abe, M; Fukada, S; Hagiwara, M; Hirota, S; Hishikawa, Y; Kono, M; Takada, Y; Tsujino, K, 2000
)
0.31
"This study evaluated the effects of azathioprine in combination with low-dose prednisolone in the management of patients with intractable autoimmune hepatitis."( Therapeutic effects of azathioprine in combination with low-dose prednisolone in patients with intractable autoimmune hepatitis type 1.
Fujiwara, A; Miyake, Y; Miyashita, M; Nishimura, M; Sakaguchi, K; Takenami, T; Terao, M; Tsuji, T, 2001
)
0.78
"Rituximab, a chimeric monoclonal antibody, produces response rates of up to 73% in patients with previously untreated indolent non-Hodgkin's lymphoma (NHL), and has high activity when combined with chemotherapy."( Rituximab in combination with CNOP chemotherapy in patients with previously untreated indolent non-Hodgkin's lymphoma.
Christodoulou, C; Dimopoulos, M; Economopoulos, T; Fountzilas, G; Hamilos, G; Kalantzis, D; Nicolaides, C; Papageorgiou, E; Pavlidis, N, 2003
)
0.32
" Considering these mechanisms of the reproductive failure generation by APLs, the application of immune suppressive therapy in combination with anti-coagulation therapy should be reconsidered as a treatment option."( Effect of sairei-to combined with aspirin and prednisolone on four recurrent reproductive failure women who are positive for anti-phospholipid antibodies.
Adachi, H; Ishii, K; Kurabayasi, T; Kurata, H; Natsume, N; Takaki, Y; Takakuwa, K; Tamura, M; Tanaka, K, 2003
)
0.58
"To compare potency and efficacy of dexamethasone (DEXA) and prednisolone (PRED) in assumed equipotent doses in combination with endogenous cortisol, using lymphocyte counts, plasma osteocalcin (OC), and eosinophilic cationic protein (ECP) as effect variables and to evaluate potential differences between healthy subjects and asthmatic patients."( Pharmacokinetic/pharmacodynamic modelling of effects of dexamethasone and prednisolone in combination with endogenous cortisol on lymphocyte counts and systemic markers of bone turn over and inflammation in healthy and asthmatic men.
Dekhuijzen, PN; Derks, MG; Dubois, EF; Schweitzer, DH; van Boxtel, CJ; Zwinderman, AH, 2004
)
0.8
"5 mg, respectively, on separate occasions, in combination with subcutaneously injected granulocyte-colony-stimulating factor (G-CSF) as a stimulant for ECP production."( Pharmacokinetic/pharmacodynamic modelling of effects of dexamethasone and prednisolone in combination with endogenous cortisol on lymphocyte counts and systemic markers of bone turn over and inflammation in healthy and asthmatic men.
Dekhuijzen, PN; Derks, MG; Dubois, EF; Schweitzer, DH; van Boxtel, CJ; Zwinderman, AH, 2004
)
0.55
"In a double-blind manner, 149 patients were randomized to a 12-week treatment with FK778 in combination with tacrolimus (Tac) and corticosteroids (S)."( The effects of FK778 in combination with tacrolimus and steroids: a phase II multicenter study in renal transplant patients.
Chang, R; Charpentier, B; Grinyó, JM; Jurewicz, A; Klinger, M; Kreis, H; Mourad, G; Neuhaus, P; Paczek, L; Paul, LC; Rostaing, L; Short, C; Squifflet, JP; van Hooff, JP; Vanrenterghem, Y; Wlodarczyk, Z, 2004
)
0.32
" We present an asthmatic patient who developed primary bacterial peritonitis while receiving a leukotriene modulator in combination with prednisolone therapy."( Leukotriene inhibitors in combination with steroids: potential role in the development of primary bacterial peritonitis.
Ammori, BJ; Farooq, A, 2005
)
0.53
"We report a case of IgA nephropathy with tuberculous pleurisy that was treated with steroid pulse therapy combined with tonsillectomy."( [Steroid pulse therapy combined with tonsillectomy in a patient with IgA nephropathy complicated with tuberculous pleurisy].
Koike, K; Okuda, S; Sugawara, K; Takeda, K; Tamaki, K; Wakasugi, D, 2005
)
0.33
"To report on visual acuity (VA) and angiographic outcomes in patients presenting with subfoveal choroidal neovascular membranes (CNV) secondary to punctate inner choroidopathy (PIC), treated with photodynamic therapy (PDT) with verteporfin combined with systemic corticosteroids."( Photodynamic therapy combined with systemic corticosteroids for choroidal neovascularisation secondary to punctate inner choroidopathy.
Amin, K; Fong, KC; Horgan, SE; Inzerillo, D; Thomas, D, 2008
)
0.35
" All patients were treated with PDT combined with oral prednisolone (1 mg/kg body weight/day) which was started 5 days before PDT."( Photodynamic therapy combined with systemic corticosteroids for choroidal neovascularisation secondary to punctate inner choroidopathy.
Amin, K; Fong, KC; Horgan, SE; Inzerillo, D; Thomas, D, 2008
)
0.59
"The vaso-occlusive effect of PDT combined with the vasostatic and anti-inflammatory effect of systemic oral prednisolone appears to be a safe and effective option in the primary treatment of subfoveal CNV in patients with PIC."( Photodynamic therapy combined with systemic corticosteroids for choroidal neovascularisation secondary to punctate inner choroidopathy.
Amin, K; Fong, KC; Horgan, SE; Inzerillo, D; Thomas, D, 2008
)
0.56
" We report a case of primary MALT lymphoma of the bladder regressed after rituximab in combination with CHOP chemotherapy (R-CHOP)."( [A case of primary mucosa-associated lymphoid tissue lymphoma of the bladder regressed after rituximab in combination with CHOP chemotherapy].
Hosomi, M; Itoh, K; Kakuta, Y; Katoh, T; Saitoh, J; Yazawa, K, 2006
)
0.33
"3HCL, a potent inhibitor of P-glycoprotein (P-gp), when administered orally alone and in combination with the CHOP regimen in patients with untreated non-Hodgkin's lymphoma and to determine whether zosuquidar."( Phase I/II trial of a P-glycoprotein inhibitor, Zosuquidar.3HCl trihydrochloride (LY335979), given orally in combination with the CHOP regimen in patients with non-Hodgkin's lymphoma.
Bouafia, F; Burgess, M; Dumontet, C; Morschhauser, F; Sloots, L; Zinzani, PL, 2007
)
0.34
"To investigate the effects of short-term prednisolone ingestion combined with intense training on exercise performance, hormonal (adrenocorticotrophic hormone (ACTH), prolactin, luteinising hormone (LH), growth hormone (GH), thyroid-stimulating hormone (TSH), dehydroepiandrosterone (DHEA), testosterone, insulin) and metabolic parameters (blood glucose, lactate, bicarbonate, pH)."( Short-term glucocorticoid intake combined with intense training on performance and hormonal responses.
Arlettaz, A; Collomp, K; De Ceaurriz, J; Le Panse, B; Lecoq, AM; Portier, H; Rieth, N, 2008
)
0.61
"To investigate the effects of vitamin K2 (Vit K2) alone or in combination with etidronate and risedronate on bone loss, osteoclast induction, and inflammation in patients with rheumatoid arthritis (RA)."( Osteoclast inhibitory effects of vitamin K2 alone or in combination with etidronate or risedronate in patients with rheumatoid arthritis: 2-year results.
Morishita, M; Nagashima, M; Takahashi, H; Takenouchi, K; Wauke, K, 2008
)
0.35
"Vit K2 alone or in combination with bisphosphonates for treatment of osteoporosis in patients with RA may inhibit osteoclast induction via decreases in levels of RANKL."( Osteoclast inhibitory effects of vitamin K2 alone or in combination with etidronate or risedronate in patients with rheumatoid arthritis: 2-year results.
Morishita, M; Nagashima, M; Takahashi, H; Takenouchi, K; Wauke, K, 2008
)
0.35
" MMF combined with prednisolone is an effective and well-tolerated induction treatment for patients with active lupus nephritis and for controlling SLE systemic activity."( A prospective multicentre study of mycophenolate mofetil combined with prednisolone as induction therapy in 213 patients with active lupus nephritis.
F, L; H, W; H, Z; L, W; X, P; Y, T; Z, H; Z, S, 2008
)
0.91
" Patients were randomly assigned to receive either 12 courses of the chemotherapy regimen CHVP (cyclophosphamide, adriamycin, etoposide, and prednisolone) plus interferon-alpha2a (CHVP+I arm) over 18 months or 6 courses of the same chemotherapy regimen combined with 6 infusions of 375 mg/m(2) rituximab and interferon for the same time period (R-CHVP+I arm)."( Rituximab combined with chemotherapy and interferon in follicular lymphoma patients: results of the GELA-GOELAMS FL2000 study.
Audhuy, B; Bouabdallah, R; Brice, P; Dartigeas, C; de Guibert, S; Doyen, C; Ferme, C; Feugier, P; Foussard, C; Haioun, C; Mahé, B; Morschhauser, F; Mounier, N; Rossi, JF; Salles, G; Sebban, C; Xerri, L, 2008
)
0.55
" To assess drug-drug interactions, co-administration experiments were conducted with ketoconazole and either propranolol or erythromycin."( Exploration of the African green monkey as a preclinical pharmacokinetic model: oral pharmacokinetic parameters and drug-drug interactions.
Bhadresa, S; Coon, DJ; Lawrence, MS; Magiera, D; Struharik, M; Ward, KW, 2009
)
0.35
" Here we delineate the in vitro metabolism and explore the potential for a drug-drug interaction between the active agents in CRx-102."( Biotransformation and in vitro assessment of metabolism-associated drug-drug interaction for CRx-102, a novel combination drug candidate.
Chen, J; Chen, M; Kansra, VV; Padval, MV; Zhang, ZY, 2009
)
0.35
" We report a case of the patient with autoimmune pancreatitis combined with extensive involvement of extrahepatic and intrahepatic bile duct, which had a favorable response to steroid therapy."( [A case of autoimmune pancreatitis combined with extensive involvement of biliary tract].
Baek, YH; Cho, JH; Choi, SR; Jung, CK; Lee, CM; Lee, SW; Roh, MH; Won, JJ, 2009
)
0.35
" However, it is unknown if higher RDI in chemotherapy when combined with rituximab leads to a better outcome in aggressive B-cell lymphoma."( Impact of relative dose intensity (RDI) in CHOP combined with rituximab (R-CHOP) on survival in diffuse large B-cell lymphoma.
Aimoto, M; Aimoto, R; Hino, M; Inoue, E; Kanashima, H; Koh, H; Koh, KR; Mugitani, A; Nakamae, H; Nakane, T; Nakao, Y; Ohsawa, M; Ohta, K; Sakamoto, E; Takeoka, Y; Terada, Y; Teshima, H; Yamane, T, 2009
)
0.35
"The objective of this study was to evaluate the efficacy and toxicity of docetaxel in combination with prednisolone in Japanese patients with hormone refractory prostate cancer."( Docetaxel in combination with prednisolone for hormone refractory prostate cancer.
Ide, H; Kikuchi, E; Kono, H; Miyajima, A; Nagata, H; Nakagawa, K; Nakashima, J; Ohigashi, T; Oya, M, 2010
)
0.86
"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
" Here we report a similar case of SLE combined with CD in a 23-year-old girl who displayed systemic symptoms, including systemic lymphadenopathy and abnormal laboratory findings indicating the active phase of SLE."( A case report of systemic lupus erythematosus combined with Castleman's disease and literature review.
Chen, XY; Wang, HY; Xia, JY; Xu, F; Xue, J; Yang, Y, 2012
)
0.38
"The effectiveness of steroid pulse therapy combined with tonsillectomy (ST) has been shown in immunoglobulin A nephropathy (IgAN) patients with moderate or severe urinary abnormalities."( Clinical effectiveness of steroid pulse therapy combined with tonsillectomy in patients with immunoglobulin A nephropathy presenting glomerular haematuria and minimal proteinuria.
Fukuhara, S; Gillespie, B; Hayashino, Y; Hotta, O; Ieiri, N; Kawaguchi, T; Miyazaki, M; Taguma, Y; Yamazaki, S, 2010
)
0.36
" Imatinib mesylate, a recently introduced specific tyrosine kinase inhibitor of BCR-ABL, in combination with chemotherapy, resulted in more than 90% hematologic CR in adult Ph-positive ALL, including molecular CR in more than 50% of patients."( Treatment of Philadelphia-chromosome-positive acute lymphoblastic leukemia with imatinib in combination with chemotherapy.
Ohno, R, 2006
)
0.33
"We compared the preventive effects of cyclosporine A combined with prednisolone and melatonin (Sigma-Aldrich) on damage to the contralateral testis after ipsilateral testicular torsion-detorsion between pubertal and adult rats."( Preventive effects of cyclosporine a combined with prednisolone and melatonin on contralateral testicular damage after ipsilateral torsion-detorsion in pubertal and adult rats.
Baek, M; Choi, H; Choi, WS; Chung, JS; Hong, SK; Jeong, SJ, 2010
)
0.85
"The preventive effects of cyclosporine A combined with prednisolone on contralateral testicular damage were noted only in pubertal rats while the preventive effects of melatonin were noted in pubertal and adult rats."( Preventive effects of cyclosporine a combined with prednisolone and melatonin on contralateral testicular damage after ipsilateral torsion-detorsion in pubertal and adult rats.
Baek, M; Choi, H; Choi, WS; Chung, JS; Hong, SK; Jeong, SJ, 2010
)
0.86
" We concluded that orbital MR imaging combined with CAS could improve the sensitivity of detection of active disease and the prediction of the response to ivGC."( Orbital magnetic resonance imaging combined with clinical activity score can improve the sensitivity of detection of disease activity and prediction of response to immunosuppressive therapy for Graves' ophthalmopathy.
Murakami, T; Nakashima, A; Noguchi, H; Noguchi, S; Noguchi, Y; Ohyabu, Y; Tachibana, S, 2010
)
0.36
" Patients with previously untreated aggressive NHL were randomized to receive either eight cycles of (R)CHOP given every 3 wk or (R)CHOP combined with gemcitabine [Gem-(R)CHOP]."( Gem-(R)CHOP versus (R)CHOP: a randomized phase II study of gemcitabine combined with (R)CHOP in untreated aggressive non-Hodgkin's lymphoma--EORTC lymphoma group protocol 20021 (EudraCT number 2004-004635-54).
Aurer, I; Baila, L; Eghbali, H; Fortpied, C; Khaled, HM; Raemaekers, J; van der Maazen, RW, 2011
)
0.37
" Here we report a phase II study of the THP-COP regimen combined with R (R-THP-COP) every 3 weeks."( Phase II study of the tetrahydropyranyl adriamycin-cyclophosphamide, vincristine, and prednisolone regimen combined with rituximab as first-line treatment for elderly patients with diffuse large B-cell lymphoma.
Fukuno, K; Goto, H; Goto, N; Hara, T; Kanemura, N; Kasahara, S; Kitagawa, J; Moriwaki, H; Sawada, M; Takahashi, T; Takami, T; Tsurumi, H; Yamada, T; Yoshikawa, T, 2011
)
0.59
"Evaluate costs and benefits of rituximab in combination with cyclophosphamide/vincristine/prednisolone chemotherapy regimen (R-CVP), in previously untreated patients with indolent non-Hodgkin lymphoma (NHL), compared to CVP alone from a Portuguese National Health System (NHS) perspective."( [Economic analysis of rituximab in combination with cyclophosphamide, vincristine and prednisolone in the treatment of patients with advanced follicular lymphoma in Portugal].
Braga, P; Carvalho, S; Gomes, M; Guerra, L; Lúcio, P; Marques, H; Negreiro, F; Pereira, C; Silva, C; Teixeira, A,
)
0.58
" In this cross-sectional study we show that MS patients treated with IFN-β alone or in combination with low-dose prednisolone displayed increased proportion of all NK cell subsets in the active phase of the cell cycle (Ki-67+)."( Increase of Ki-67+ natural killer cells in multiple sclerosis patients treated with interferon-β and interferon-β combined with low-dose oral steroids.
Aranami, T; Chihara, N; Gran, B; Lin, Y; Ogawa, M; Okamoto, T; Sanvito, L; Tomita, A; Yamamura, T, 2011
)
0.58
" Some immunosuppressive drugs also interact with one another: cyclosporine raises the level of mTOR inhibitors and lowers the level of mycophenolate."( [Drug interactions and immunosuppression in organ transplant recipients].
Amundsen, R; Asberg, A; Bergan, S; Midtvedt, K; Vethe, NT, 2011
)
0.37
" Consequently, she was diagnosed with liver cirrhosis due to autoimmune hepatitis (AIH) combined with SSc."( Liver cirrhosis due to autoimmune hepatitis combined with systemic sclerosis.
Goo, SM; Jang, JY; Jeen, YM; Jeon, CH; Jeong, SW; Kim, SG; Kim, YS; You, BC, 2012
)
0.38
"The hepatic organic anion transporting polypeptides (OATPs) influence the pharmacokinetics of several drug classes and are involved in many clinical drug-drug interactions."( Classification of inhibitors of hepatic organic anion transporting polypeptides (OATPs): influence of protein expression on drug-drug interactions.
Artursson, P; Haglund, U; Karlgren, M; Kimoto, E; Lai, Y; Norinder, U; Vildhede, A; Wisniewski, JR, 2012
)
0.38
" Drug-drug interactions (DDIs) involving OAAs pose a major concern in oncology practice due to these drugs' narrow therapeutic indices and potential for compromised efficacy and fatal adverse events."( Prevalence of the coprescription of clinically important interacting drug combinations involving oral anticancer agents in Singapore: a retrospective database study.
Chan, A; Ko, Y; Lim, SW; Ng, RC; Salim, A; Tan, SL; Wong, YP; Yong, WP, 2012
)
0.38
" This report presents the case of a large PCL that was successfully treated by emergency surgical resection combined with postoperative chemotherapy."( Successful treatment of a large primary cardiac lymphoma by surgical resection combined with chemotherapy: report of a case.
Fukushima, S; Kawamura, T; Miyagawa, S; Nishi, H; Saito, S; Sakaguchi, T; Sawa, Y; Yamauchi, T; Yoshikawa, Y, 2013
)
0.39
" Elevated serum tumor necrosis factor-α, interferon-γ, and IL-12 levels returned to normal 10 days after initiating plasma exchange combined with leukocytapheresis, with a reduction in white blood cell count."( Successful remission induced by plasma exchange combined with leukocytapheresis against refractory systemic juvenile idiopathic arthritis.
Abe, J; Fujimaru, T; Ito, S; Kamei, K; Miyazono, A; Ogura, M; Sato, M, 2014
)
0.4
" Our study suggests that the MTD of idarubicin in combination with HD-MTX, VDS, and PRED, should be 16 mg/m(2) ."( A phase 1 dose escalation study of idarubicin combined with methotrexate, vindesine, and prednisolone for untreated elderly patients with primary central nervous system lymphoma. The GOELAMS LCP 99 trial.
Brion, A; Chabin, M; Clavert, A; Colombat, P; Cumin, I; Delwail, V; Escoffre-Barbe, M; Gardembas, M; Ingrand, P; Lacotte-Thierry, L; Legouffe, E; Olivier, G; Solal-Celigny, P, 2014
)
0.62
"The aim of this study was to evaluate the effect of treatment with methotrexate (MTX), by itself or combined with other non-biological disease-modifying antirheumatic drugs (DMARDs) (methotrexate, MTX with prednisolone, MTX with leflunomide, MTX with chloroquine, and MTX with sulfasalazine) on clinimetric outcomes in a retrospective cohort with a 6-month follow-up and under a Treat to Target (T2T) approach."( Treatment of rheumatoid arthritis with methotrexate alone and in combination with other conventional DMARDs using the T2T strategy. A cohort study.
Castro, C; de la Hoz-Valle, J; Palomino, A; Sánchez, G; Santos-Moreno, PI; Villarreal, L, 2015
)
0.6
"The purpose of this study is to compare the efficacy and safety of Gefitinib versus VMP in combination with three-dimensional conformal radiotherapy (3D-CRT) for multiple brain metastases from non-small cell lung cancer (NSCLC)."( Comparison of Gefitinib versus VMP in the combination with radiotherapy for multiple brain metastases from non-small cell lung cancer.
Chen, S; Hao, Y; Li, B; Li, L; Liu, C; Ning, F; Wang, F; Yu, Z, 2015
)
0.42
" Prednisolone combined with UDCA and azathioprine showed a higher efficacy based on our new criteria."( Case-control study on prednisolone combined with ursodeoxycholic acid and azathioprine in pure primary biliary cirrhosis with high levels of immunoglobulin G and transaminases: efficacy and safety analysis.
Deng, YQ; Fang, YQ; Jia, W; Li, J; Lv, DX; Wang, GQ; Wang, Y; Yu, M, 2014
)
1.63
" Although the patient declined surgery using an external approach, treatment with systemic corticosteroids combined with antibiotics resulted in tumor regression and an endoscopic en bloc resection was possible."( Pre-operative effects of the administration of systemic corticosteroids combined with antibiotics on a lobular capillary hemangioma in the nasal cavity.
Fujikawa, A; Hanazawa, T; Nakamura, H; Okamoto, Y; Yonekura, S, 2016
)
0.43
"To investigate the clinical efficacy of L-asparginasum, ASP) combined with CHOP for treating patients with extranodal natural killer/T-cell lymphoma."( [Clinical Efficacy of L-Asparaginasum Combined with CHOP for Treating Patients with Extranodal Natural Killer/T Cell Lymphoma].
Fang, RY; Ma, DL; Zhang, DF, 2015
)
0.42
"A total of 68 patients with extranodal natural killer/T-cell lymphoma in our hospital from August 2007 to May 2009 were enrolled in this study, out of them 34 patients received CHOP regimen (CHOP group) and other 34 patients received CHOP regimen combined with L-Asparaginasum (ASP+CHOP group)."( [Clinical Efficacy of L-Asparaginasum Combined with CHOP for Treating Patients with Extranodal Natural Killer/T Cell Lymphoma].
Fang, RY; Ma, DL; Zhang, DF, 2015
)
0.42
"L-Asparaginasum combined with CHOP for treating patients with extranodal natural killer/T-cell lymphoma is effective, and may be used in clinic."( [Clinical Efficacy of L-Asparaginasum Combined with CHOP for Treating Patients with Extranodal Natural Killer/T Cell Lymphoma].
Fang, RY; Ma, DL; Zhang, DF, 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
)
0.62
" Treatment protocols were a single-course steroid pulse combined with mizoribine during a period from August 2006 to June 2010 (Group A; n = 34) and a three-course steroid pulse during a period from July 2010 to March 2013 (Group B; n = 32)."( Comparison of immunosuppressive therapies for IgA nephropathy after tonsillectomy: three-course versus one-course steroid pulse combined with mizoribine.
Arai, M; Hirama, A; Ikeda, M; Kaneko, T; Morita, M; Shimizu, A; Tsuruoka, S; Watanabe, Y, 2015
)
0.42
"Single-course steroid pulse therapy combined with mizoribine was considered to have a protective effect on the renal function in IgA nephropathy, especially accompanying renal dysfunction."( Comparison of immunosuppressive therapies for IgA nephropathy after tonsillectomy: three-course versus one-course steroid pulse combined with mizoribine.
Arai, M; Hirama, A; Ikeda, M; Kaneko, T; Morita, M; Shimizu, A; Tsuruoka, S; Watanabe, Y, 2015
)
0.42
" We compared these findings with others obtained using cyclophosphamide (CPA) combined with low-dose CS: the current standard therapy for IPF."( Cyclosporine A combined with low-dose corticosteroid treatment in patients with idiopathic pulmonary fibrosis.
Azuma, A; Inase, N; Inoue, E; Kudoh, S; Miyazaki, Y; Ogura, T; Sugiyama, Y; Takeuchi, M; Taniguchi, H; Yoshizawa, Y, 2015
)
0.42
"To analyze the effect of intensified topical steroid therapy after Descemet membrane endothelial keratoplasty combined with cataract surgery (triple-DMEK) on the incidence of postoperative cystoid macular edema (CME)."( Intensified Topical Steroids as Prophylaxis for Macular Edema After Posterior Lamellar Keratoplasty Combined With Cataract Surgery.
Bachmann, BO; Cursiefen, C; Felsch, M; Hoerster, R; Siebelmann, S; Stanzel, TP, 2016
)
0.43
"To investigate the effect of intensified postoperative topical steroid therapy after Descemet membrane endothelial keratoplasty combined with cataract surgery (Triple-DMEK) on postoperative endothelial cell density (ECD)."( Intensified Early Postoperative Topical Steroids Do Not Influence Endothelial Cell Density After Descemet Membrane Endothelial Keratoplasty Combined With Cataract Surgery (Triple-DMEK).
Bachmann, BO; Cursiefen, C; Hoerster, R; Siebelmann, S; Stanzel, TP, 2016
)
0.43
" We randomly assigned participants (1:1) to receive either oral prednisone alone, 1·0 or 1·5 mg/kg per day tapered over 12 or 18 months (prednisone alone group), or 1000 mg of intravenous rituximab on days 0 and 14, and 500 mg at months 12 and 18, combined with a short-term prednisone regimen, 0·5 or 1·0 mg/kg per day tapered over 3 or 6 months (rituximab plus short-term prednisone group)."( First-line rituximab combined with short-term prednisone versus prednisone alone for the treatment of pemphigus (Ritux 3): a prospective, multicentre, parallel-group, open-label randomised trial.
Alexandre, M; Avenel-Audran, M; Bedane, C; Bénéton, N; Benichou, J; Bernard, P; Beylot-Barry, M; Bouaziz, JD; Caillot, F; Calbo, S; Caux, F; D'Incan, M; Debarbieux, S; Delaporte, E; Dereure, O; Dupin, N; Dupuy, A; Duvert-Lehembre, S; Golinski, ML; Hebert, V; Houivet, E; Ingen-Housz-Oro, S; Joly, P; Jullien, D; Labeille, B; Machet, L; Maho-Vaillant, M; Misery, L; Musette, P; Paul, C; Picard-Dahan, C; Prost-Squarcioni, C; Quereux, G; Richard, MA; Sassolas, B; Vabres, P; Vermeulin, T, 2017
)
0.46
"The aim of this study was to compare asparaginase-related toxicities in two asparaginase preparations, namely native Escherichia coli L-asparaginase (L-ASP) and pegylated asparaginase (PEG-ASP) in combination with ifosfamide, methotrexate, etoposide, and prednisolone (IMEP) in natural killer (NK)/T-cell lymphoma (NTCL)."( Comparison of Native Escherichia coli L-Asparaginase versus Pegylated Asparaginase, in Combination with Ifosfamide, Methotrexate, Etoposide, and Prednisolone, in Extranodal NK/T-Cell Lymphoma, Nasal Type.
Cho, YS; Heo, DS; Jung, SH; Keam, B; Kim, DW; Kim, HJ; Kim, IH; Kim, M; Kim, TM; Lee, JY; Lee, SH; Ock, CY, 2018
)
0.86
" The results suggest that JKB-122 as monotherapy or in combination with prednisolone may offer a viable approach to the treatment of AIH."( JKB-122 is effective, alone or in combination with prednisolone in Con A-induced hepatitis.
Chiu, PJS; Hsu, MC; Hu, NY; Liu, SH; Shih, YC; Wang, CW; Wu, ESC, 2017
)
0.94
" To investigate the effects of these compounds on bortezomib's anti-proliferative potency and its intracellular accumulation and potency to inhibit the chymotrypsin-like proteasomal subunit, seven myeloma cell lines were investigated after exposure to bortezomib alone or either combined with adriamycin plus dexamethasone (PAD regimen) or melphalan plus prednisolone (VMP regimen), respectively."( Elucidating the beneficial effects of melphalan, adriamycin, and corticoids in combination with bortezomib against multiple myeloma in vitro.
Burhenne, J; Schäfer, J; Theile, D; Weiss, J, 2019
)
0.68
"In this study we compared the anatomic and functional outcomes of two steroid treatments on rhegmatogenous retinal detachment (RRD) combined with choroidal detachment (CD), namely treatment with oral prednisolone (1 mg/kg daily) for 3-7 days before vitrectomy or a single periocular injection of methylprednisolone (40 mg) 1-3 days before vitrectomy."( The effect of single periocular injection of methylprednisolone and drainage of suprachoroidal fluid in the treatment of rhegmatogenous retinal detachment combined with choroidal detachment.
Chen, H; Chen, X; Wang, X; Wei, Y; Zhou, R, 2019
)
0.95
" Seventy five eyes with RRD combined with CD were divided into 2 groups based on the two different treatment regimens as above."( The effect of single periocular injection of methylprednisolone and drainage of suprachoroidal fluid in the treatment of rhegmatogenous retinal detachment combined with choroidal detachment.
Chen, H; Chen, X; Wang, X; Wei, Y; Zhou, R, 2019
)
0.77
"For RRD combined with CD, eyes treated with a single periocular injection of methylprednisolone (40 mg, 1-3 days before pars plana vitrectomy) combined with the drainage of suprachoroidal fluids during the surgery had similar anatomic and functional outcomes compared to the eyes treated with oral prednisolone for 3-7 days before vitrectomy."( The effect of single periocular injection of methylprednisolone and drainage of suprachoroidal fluid in the treatment of rhegmatogenous retinal detachment combined with choroidal detachment.
Chen, H; Chen, X; Wang, X; Wei, Y; Zhou, R, 2019
)
0.99
" This study was designed to find out whether there is an augmentation of the therapeutic effectiveness of the antiinflammatory drugs like diclofenac sodium (NSAID), prednisolone (steroid) and atorvastatin (statin) when used in combination with ascorbic acid (antioxidant)."( Evaluation of the Anti-Inflammatory Activities of Diclofenac Sodium, Prednisolone and Atorvastatin in Combination with Ascorbic Acid.
Ahmed, T; Ahsan, CR; Al Shoyaib, A; Archie, SR; Chowdhury, FA; Faruk, A, 2020
)
0.99
" The inhibitions of such responses were measured after administering a drug alone and in combination with ascorbic acid."( Evaluation of the Anti-Inflammatory Activities of Diclofenac Sodium, Prednisolone and Atorvastatin in Combination with Ascorbic Acid.
Ahmed, T; Ahsan, CR; Al Shoyaib, A; Archie, SR; Chowdhury, FA; Faruk, A, 2020
)
0.79
" In stage II, Japanese patients with castration-resistant prostate cancer were administered ipatasertib 200 or 400 mg/day in combination with abiraterone and prednisolone in 28-day cycles."( Phase I study of ipatasertib as a single agent and in combination with abiraterone plus prednisolone in Japanese patients with advanced solid tumors.
Doi, T; Endo-Tsukude, C; Fujiwara, Y; Iwasa, S; Matsubara, N; Nakagawa, S; Takahashi, S; Tanaka, A; Tomomatsu, J, 2019
)
0.93
" The ipatasertib MTD was 600 mg as monotherapy and MAD was 400 mg in combination with abiraterone and prednisolone."( Phase I study of ipatasertib as a single agent and in combination with abiraterone plus prednisolone in Japanese patients with advanced solid tumors.
Doi, T; Endo-Tsukude, C; Fujiwara, Y; Iwasa, S; Matsubara, N; Nakagawa, S; Takahashi, S; Tanaka, A; Tomomatsu, J, 2019
)
0.95
"Ipatasertib, at the monotherapy MTD of 600 mg/day and MAD of 400 mg/day in combination with abiraterone and prednisolone, was safe and tolerable in Japanese patients with solid tumors."( Phase I study of ipatasertib as a single agent and in combination with abiraterone plus prednisolone in Japanese patients with advanced solid tumors.
Doi, T; Endo-Tsukude, C; Fujiwara, Y; Iwasa, S; Matsubara, N; Nakagawa, S; Takahashi, S; Tanaka, A; Tomomatsu, J, 2019
)
0.95
"To investigate the incidence and outcomes of cystoid macular edema (CME) after Descemet membrane endothelial keratoplasty (DMEK) alone and DMEK combined with cataract surgery (DMEK triple)."( Incidence and Outcomes of Cystoid Macular Edema after Descemet Membrane Endothelial Keratoplasty (DMEK) and DMEK Combined with Cataract Surgery.
Bae, SS; Ching, G; Covello, AT; Holland, S; Iovieno, A; McCarthy, M; Ritenour, R; Yeung, SN, 2021
)
0.62
"From a total of 1,174 IgAN patients in a multicenter retrospective cohort analysis in Japan, 195 patients were treated by tonsillectomy combined with corticosteroid."( Impact of the number of steroid pulses in tonsillectomy combined with steroid pulse therapy: a nationwide retrospective study in Japan.
Hirano, K; Kataoka, H; Kawamura, T; Koike, K; Maruyama, S; Matsuo, S; Matsuzaki, K; Moriyama, T; Nitta, K; Suzuki, Y; Yasuda, T; Yasuda, Y; Yokoo, T, 2021
)
0.62
" Prednisolone was tested alone and in combination with other drugs."( Biomarker-focused multi-drug combination therapy and repurposing trial in mdx mice.
Barkhouse, M; Dang, UJ; Giri, M; Gordish-Dressman, H; Hathout, Y; Hoffman, EP; Nagaraju, K; Uaesoontrachoon, K; Ziemba, M, 2021
)
1.53
"A case of intractable IgG4-related orbital disease (IgG4-ROD) was successfully treated by debulking surgery combined with low-dose prednisolone and azathioprine as maintenance therapy."( Debulking Surgery Combined with Low-Dose Oral Prednisolone and Azathioprine for Intractable IgG4-Related Orbital Disease: A Case Report.
Chen, CH; Kuo, HH; Wu, SY, 2021
)
1.08
" However, data regarding the therapeutic outcomes of oral steroid combined with oral NAC for ISSNHL are still limited."( Effects of oral N-acetylcysteine combined with oral prednisolone on idiopathic sudden sensorineural hearing loss.
Chen, SL; Chin, SC; Ho, CY, 2022
)
0.97
"This study demonstrated the effect of oral steroid combined with oral NAC for ISSNHL."( Effects of oral N-acetylcysteine combined with oral prednisolone on idiopathic sudden sensorineural hearing loss.
Chen, SL; Chin, SC; Ho, CY, 2022
)
0.97
" Seventy adults with severe SLE including lupus nephritis will be randomized 1:1 to receive either standard of care consisting of prednisolone and mycophenolate as induction and maintenance treatment, or belimumab and rituximab combined with standard of care as induction treatment, followed by prednisolone and belimumab as maintenance treatment."( Efficacy of belimumab combined with rituximab in severe systemic lupus erythematosus: study protocol for the phase 3, multicenter, randomized, open-label Synbiose 2 trial.
Arends, EJ; de Leeuw, K; Huizinga, TWJ; Limper, M; Rabelink, TJ; Rotmans, JI; Soonawala, D; Teng, YKO; Toes, REM; van Kooten, C; van Ommen, E; van Paassen, P; van Schaik, M, 2022
)
0.93
" At present, the treatment norm for ELP has not well defined, and so the aim of this study is to evaluate the effect of bronchoalveolar lavage in combination with glucocorticoids on children with ELP."( The effect of therapeutic bronchoalveolar lavage in combination with glucocorticoids on children with acute exogenous lipoid pneumonia.
Chen, D; Chen, X; Huang, Z; Lin, Y; Lu, C; Wu, S; Xu, J; Xu, Q; Yang, S, 2023
)
0.91
" Multiple bronchoalveolar lavages in combination with oral prednisolone for children who had a confirmed history of exogenous oily substances ingestion were an efficient and safe for the clearance of oily materials from the lung and the prevention of fibrosis."( The effect of therapeutic bronchoalveolar lavage in combination with glucocorticoids on children with acute exogenous lipoid pneumonia.
Chen, D; Chen, X; Huang, Z; Lin, Y; Lu, C; Wu, S; Xu, J; Xu, Q; Yang, S, 2023
)
1.15
"Management of drug-drug interactions (DDIs) for ensitrelvir, a novel 3-chymotrypsin-like protease inhibitor of SARS-CoV-2 infection is crucial."( Evaluation of the Drug-Drug Interaction Potential of Ensitrelvir Fumaric Acid with Cytochrome P450 3A Substrates in Healthy Japanese Adults.
Fukuhara, T; Kubota, R; Kuwata, A; Matsuo, Y; Matsuzaki, T; Shimizu, R; Sonoyama, T, 2023
)
0.91
" Either dexamethasone, prednisolone, or midazolam was administered alone (Day - 2) or in combination with ensitrelvir (Day 5) in each of the cohorts."( Evaluation of the Drug-Drug Interaction Potential of Ensitrelvir Fumaric Acid with Cytochrome P450 3A Substrates in Healthy Japanese Adults.
Fukuhara, T; Kubota, R; Kuwata, A; Matsuo, Y; Matsuzaki, T; Shimizu, R; Sonoyama, T, 2023
)
1.22

Bioavailability

The results are consistent with the hypothesis that CsA increases the bioavailability of prednisolone. The plasma levels of the drug were determined by radioimmunoassay in six children receiving corticosteroids for nephrotic syndrome.

ExcerptReferenceRelevance
" The decrease in ocular steroid bioavailability could not be directly equated with differences in antinflammatory effectiveness, so that the therapeutic relevance of the demonstrated drug interaction is not known."( Drug interaction in the eye. Concurrent corticosteroid-antibiotic therapy for inflammatory keratitis.
Kupferman, A; Leibowitz, HM, 1977
)
0.26
" Butanol reduced the rate of absorption of sulfapyridine but did not significantly affect the absorption rates of prednisolone or salicylic acid."( Effects of normal alcohols on intestinal absorption of salicylic acid, sulfapyridine, and prednisolone in rats.
Hayton, WL, 1975
)
0.69
" Breakfast given before prednisolone tended to reduce the rate of absorption of the drug, the effect being quantitatively most pronounced with large doses."( Variation in plasma prednisolone concentrations in renal transplant recipients given enteric-coated prednisolone.
Chakraborty, J; English, J; Henderson, RG; Marks, V; Wheatley, T, 1979
)
0.89
" 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,
)
0.35
" The median value of bioavailability (relative to oral dose) of methylprednisolone acetate based on unchanged methylprednisolone plasma levels was 14."( Rectal and oral absorption of methylprednisolone acetate.
Albert, KS; Garg, DC; Sakmar, E; Wagner, JG; Weidler, DJ, 1979
)
0.77
" The bioavailability of the CAP based preparation is similar to that of plain prednisolone."( The effect of food and tablet formulation on plasma prednisolone levels following administration of enteric-coated tablets.
James, VH; Lee, DA; Taylor, GM; Walker, JG, 1979
)
0.74
" Dissolution parameters were correlated with results obtained in three human bioavailability trials which were previously reported."( Comparison of two dissolution apparatuses with correlation of in vitro-in vivo data for prednisone and prednisolone tablets.
Ayres, JW; Mackichan, JJ; Milsap, RL; Wagner, JG,
)
0.35
" 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
)
0.83
" When premicellar concentrations of butyric, octanoic, or dodecanoic acid were present in the perfusate, the griseofulvin absorption rate decreased while that of prednisolone increased."( Effects of short and medium chain fatty acids on absorption of lipophilic drugs from perfused rat intestine.
Grisafe, JA; Hayton, WL, 1978
)
0.45
"In order to assess the bioavailability of steroids from a high-viscosity gel, rabbit cornea and aqueous humor levels were measured over 12 hr following topical instillation of a gel and reference preparation."( A bioavailability comparison in rabbits of two steroids formulated as high-viscosity gels and reference aqueous preparations.
Boltralik, JJ; Schoenwald, RD, 1979
)
0.26
" 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
" The area under the drug concentration in aqueous humor-vs-time curve (a measure of the drug's bioavailability in aqueous humor) was 88 mug min/ml, and its half-life in human aqueous humor was 28 minutes."( Penetration of topically administered prednisolone acetate into the human aqueous humor.
Alvarez, JA; Berrospi, AR; Galvis, V; Kupferman, A; Leibowitz, HM; Restropo, GV, 1977
)
0.53
" Thus, no influence of cholestyramine on the bioavailability of orally administered prednisolone could be demonstrated."( [Does cholestyramine impair the bioavailability of prednisolone?].
Audétat, V; Bircher, J; Paumgartner, G, 1977
)
0.73
" It was shown that the CPB method has considerably greater precision than the RIA method and could be employed in bioavailability and pharmacokinetic studies of both prednisolone and prednisone."( Plasma prednisolone concentrations: comparison of radioimmunoassay and competitive protein binding assay.
Ayres, JW; Hallmark, MR; Sakmar, E; Tembo, AV; Wagner, JG, 1977
)
0.91
" The bioavailability of the two preparations was similar."( Plasma prednisolone levels in man following administration in plain and enteric-coated forms.
May, CS; Paterson, JW; Wilson, CG, 1977
)
0.71
" Intersubject variability in bioavailability was noted."( Plasma prednisolone levels from enteric and non-enteric coated tablets estimated by an original technique.
Bradbrook, ID; Morrison, PJ; Rogers, HJ, 1977
)
0.71
"With a fasted dog as an animal model, the bioavailability and pharmacokinetics of prednisolone were studied following rapid intravenous injection and oral dosing of a prednisolone sodium phosphate solution and also following oral doses of prednisolone as tablets and a slurry."( Prednisolone bioavailability in the dog.
Tse, FL; Welling, PG, 1977
)
1.93
"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
)
0.25
" A comparison of each drug's corneal bioavailability with its anti-inflammatory effectiveness shows the acetate derivative of prednisolone to be a more potent anti-inflammatory agent than the phosphate derivative."( Anti-inflammatory effectiveness of topically administered corticosteroids in the cornea without epithelium.
Kupferman, A; Leibowitz, HM, 1975
)
0.46
" 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
)
0.79
" Bioavailability averaged 88."( Altered prednisolone pharmacokinetics in patients with cystic fibrosis.
Accurso, FJ; Dove, AM; Hill, MR; Jusko, WJ; Larsen, GL; Szefler, SJ, 1992
)
0.72
"The superior bioavailability and therapeutic effect of prednisolone acetate over prednisolone sodium phosphate was described about 15 years ago."( The bioavailability and therapeutic effectiveness of prednisolone acetate vs. prednisolone sodium phosphate: a 20-year review.
Sousa, FJ, 1991
)
0.78
" The mean bioavailability was 14% for chlorambucil, 21% for phenylacetic acid mustard, and 22% for prednisolone, when given as prednimustine, compared to the administration of free compounds in stoichiometrically equivalent doses."( Comparative pharmacokinetics of chlorambucil and prednimustine after oral administration.
Loos, U; Malek, M; Musch, E; Riedel, E, 1991
)
0.5
"Comparative corneal penetration studies in the literature with prednisolone sodium phosphate solution and prednisolone acetate suspension administered to rabbit eyes give conflicting results concerning the greater bioavailability of prednisolone acetate."( Comparative corneal penetration of prednisolone sodium phosphate and prednisolone acetate in NZW rabbits.
Bidgood, AM; Musson, DG; Olejnik, O, 1991
)
0.8
"Prednisolone absorption and bioavailability of 10 mg enteric-coated (EC) and plain (uncoated) tablets were investigated after fasting and heavy meals (EC only) consumed to satiety in normal healthy volunteers."( Effect of food on the absorption and pharmacokinetics of prednisolone from enteric-coated tablets.
Al-Habet, SM; Rogers, HJ, 1989
)
1.96
" Sulphasalazine itself is poorly absorbed (3 to 12%) and its elimination half-life of about 5 to 10 hours is probably affected by the absorption process."( Clinical pharmacokinetics of sulphasalazine, its metabolites and other prodrugs of 5-aminosalicylic acid.
Klotz, U,
)
0.13
"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
)
0.72
" Such a process of absorption was different of that described for prednisolone acetate suspension for which rate of absorption was slower."( [Pharmacokinetics of prednisolone administered to cows in the form of a prednisolone acetate solution in dimethyl sulfoxide in association with antibiotics].
Alvinerie, M; Oukessou, M; Toutain, PL, 1987
)
0.83
"The absolute bioavailability of prednisolone was assessed in ten asthmatic patients who responded poorly to ordinary doses of corticosteroids so-called "steroid-resistant" bronchial asthma."( Bioavailability of prednisolone in asthmatic patients with a poor response to steroid treatment.
Grettve, L; Lindström, B; Lönnerholm, G; Mortimer, O; Zetterström, O, 1987
)
0.88
", prolongation of half-life, and decreases in MCR and bioavailability on on-day of intermittent period were observed in comparison with those before treatment, respectively."( [Pharmacokinetics of prednisolone (PSL) during PSL treatment. II. PSL pharmacokinetics during intermittent treatment with PSL administration 4 consecutive days a week].
Adachi, K; Fuwa, Y; Goshima, E; Minamori, Y; Miura, K; Murase, H; Murayama, M; Yamakita, N; Yasuda, K, 1987
)
0.59
" Bioavailability of prednisolone after the oral administration of prednisone and methylprednisolone ranged from 86% to 104% during anticonvulsant therapy."( Prednisolone and methylprednisolone kinetics in children receiving anticonvulsant therapy.
Bartoszek, M; Brenner, AM; Szefler, SJ, 1987
)
2.04
" The enhanced rate of bioavailability of prednisolone after intramuscular administration in the form of a suspension may be due to the rapid dissolution of CyD complexes."( Effects of beta- and gamma-cyclodextrins on the pharmacokinetic behavior of prednisolone after intravenous and intramuscular administrations to rabbits.
Arimori, K; Uekama, K, 1987
)
0.77
" Bioavailability was calculated by the ratio of AUCp."( [Pharmacokinetics of prednisolone (PSL) during PSL treatment. I. PSL pharmacokinetics during daily PSL treatment].
Adachi, K; Fuwa, Y; Goshima, E; Minamori, Y; Miura, K; Murase, H; Murayama, M; Yamakita, N; Yasuda, K, 1986
)
0.59
" While the parent steroids are well absorbed over the entire length of the intestinal tract, variability in plasma levels is observed at higher doses."( Oral absorption of 21-corticosteroid esters: a function of aqueous stability and intestinal enzyme activity and distribution.
Amidon, GL; Fleisher, D; Johnson, KC; Stewart, BH, 1986
)
0.27
" The freely soluble succinate and phosphate esters were well absorbed in the jejunum."( Uptake of prodrugs by rat intestinal mucosal cells: mechanism and pharmaceutical implications.
Amidon, GL; Brabec, RK; Stewart, BH, 1986
)
0.27
"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
)
0.27
" This indicates that in vitro data can be useful in predicting oral bioavailability of GCS."( Effect of structural alterations on the biotransformation rate of glucocorticosteroids in rat and human liver.
Andersson, P; Lihné, M; Ryrfeldt, A; Thalén, A, 1987
)
0.27
" In view of the low plasma prednisolone concentrations obtained, there are theoretical advantages in using a poorly absorbed enema to avoid the possibility of systemic steroid effects in patients requiring long term steroid treatment."( Therapeutic benefits from a poorly absorbed prednisolone enema in distal colitis.
Berghouse, L; English, J; Lennard-Jones, JE; Macrae, FA; McIntyre, PB, 1985
)
0.83
" Thus, the concomitant administration of azathioprine does not appear to alter the bioavailability or elimination of prednisolone at these doses."( The absence of effect of azathioprine on prednisolone pharmacokinetics following maintenance prednisone doses in kidney transplant patients.
Amend, WJ; Birnbaum, JL; Gambertoglio, JG; Holford, HG; Lizak, PS; Salvatierra, O, 1984
)
0.74
" After prednisolone 21-sodium succinate (IM), absorption was rapid and bioavailability was high."( Dexamethasone and prednisolone in the horse: pharmacokinetics and action on the adrenal gland.
Alvinerie, M; Baggot, JD; Brandon, RA; de Pomyers, H; Toutain, PL, 1984
)
1.06
" 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
)
1.91
"The effect of intestinal malabsorption on the oral bioavailability of prednisolone has been studied in six patients with celiac disease and in six patients with malabsorption of various etiologies, five of whom had undergone gut resections."( Bioavailability of prednisolone in patients with intestinal malabsorption: the importance of measuring serum protein-binding.
Bergrem, H; Opedal, I, 1983
)
0.83
" The elimination half-time and the extent of bioavailability of total prednisolone tended to be lower in the patients, and the extent of free, unbound prednisolone higher, but the differences were not statistically significant."( Prednisolone pharmacokinetics and protein-binding in patients with portosystemic shunt.
Bergan, A; Bergrem, H; Opedal, I; Ritland, S, 1983
)
1.94
" There were marked differences in plasma prednisolone concentrations, clearance rates, and bioavailability of both free and total fractions at different times of the day."( Diurnal variation in prednisolone kinetics.
Dunne, M; English, J; Marks, V, 1983
)
0.85
" This may be attributable to differences in steroid bioavailability to cells."( Prednisolone levels in plasma and leukemia cells during therapy of chronic lymphocytic leukemia.
Bird, CC; Child, JA; Panesar, NS; Roberts, BE, 1984
)
1.71
" The absolute bioavailability of both corticosteroids was higher than 80% and independent of both dose levels investigated."( The pharmacokinetics of fluocortolone and prednisolone after intravenous and oral administration.
Haack, D; Kloss, G; Nieuweboer, B; Täuber, U; Vecsei, P; Wendt, H, 1984
)
0.53
" Drug glycosides are hydrophilic and, thus, poorly absorbed from the small intestine."( A colon-specific drug-delivery system based on drug glycosides and the glycosidases of colonic bacteria.
Chang, GW; Friend, DR, 1984
)
0.27
" The mean prednisolone bioavailability from oral prednisone was not different between nephrotic patients and controls."( Altered plasma protein-binding of prednisolone in patients with the nephrotic syndrome.
Frey, BM; Frey, FJ, 1984
)
0.95
" The results indicate that aluminium phosphate does not reduce the bioavailability of cimetidine and prednisolone."( Effect of aluminium phosphate on the bioavailability of cimetidine and prednisolone.
Albin, H; Bedjaoui, A; Begaud, B; Demotes-Mainard, F; Vincon, G, 1984
)
0.72
" 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
)
0.49
" These results suggest variable bioavailability of prednisolone, but do not indicate the reason."( Variation in 17 oxogenic steroid excretion following oral prednisolone in children with lymphoblastic leukaemia.
French, AJ; Lilleyman, JS; Young, IP, 1981
)
0.76
"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
)
0.76
" The bioavailability after oral administration was 84."( Pharmacokinetics and protein binding of prednisolone after oral and intravenous administration.
Bergrem, H; Grøttum, P; Rugstad, HE, 1983
)
0.53
" A crossover bioavailability study was performed using human subjects with lower doses of prednisolone tablets, where the plasma levels of the drug were determined by radioimmunoassay."( Improvement of oral bioavailability of prednisolone by beta-cyclodextrin complexation in humans.
Arimori, K; Fujinaga, T; Matsuo, N; Otagiri, M; Sugii, A; Tasaki, K; Uekama, K; Uemura, Y, 1983
)
0.76
" Because of the marked reduction in the extent of bioavailability of total, and especially free, prednisolone, dosage adjustments should be made accordingly if prednisolone and rifampicin are prescribed concomitantly."( Changes in prednisolone pharmacokinetics and protein binding during treatment with rifampicin.
Bergrem, H; Refvem, OK, 1983
)
0.87
" The maximum serum concentration of prednisolone was higher, (mean Cmax; fasting: 597 +/- 101 ng/ml, non-fasting: Cmax 489 +/- 56 ng/ml) and the rate of absorption more rapid in the fasting than in the non-fasting subjects (absorption t1/2 fasting: 15."( Immunosuppressive treatment policies. A) Glucocorticoids: absorption of prednisolone. I. The effect of fasting, food, and food combined with antacids.
Bergrem, H; Djøseland, O; Jervell, J; Rugstad, HE, 1981
)
0.77
"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
)
0.73
"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
)
0.97
"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
)
0.48
" 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
)
0.58
"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
)
0.77
" Three poorly controlled patients were studied on a high-dose alternate-day steroid regimen, and a marked decrease in pyridostigmine bioavailability on the same dose of drug was observed in all three."( Plasma pyridostigmine levels in myasthenia gravis.
De Silva, P; Havard, CW; White, MC, 1981
)
0.26
" It is suggested that prednisolone plasma levels are as good a parameter of Prednimustine absorption and bioavailability as chlorambucil levels, Prednimustine itself having never been detected in plasma."( Prednisolone plasma levels after oral administration of Prednimustine. Comparison with levels obtained after administration of an equimolar dose of prednisolone.
Hove, WV; Sayed, A; Vermeulen, A, 1981
)
2.02
" Sodium cromoglycate and nedocromil sodium, which are poorly absorbed from the gastrointestinal tract, were tested by intraperitoneal administration."( LCB 2183 inhibits the inflammation associated with oxazolone-induced contact sensitivity.
Bonhomme, Y; Brown, T; Murray, N; Zoerkler, N, 1994
)
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
)
0.8
" Budesonide is a potent, well-absorbed corticosteroid, but because of a high rate of first-pass metabolism in the liver, its systemic bioavailability is low."( A comparison of budesonide with prednisolone for active Crohn's disease.
Danielsson, A; Goebell, H; Jewell, D; Lamers, C; Löfberg, R; Lorenz-Meyer, H; Malchow, H; Olaison, G; Rutgeerts, P; Thomsen, OO, 1994
)
0.57
" The low systemic bioavailability after dermal application was also reflected in an unchanged cortisol secretion pattern."( Studies on the pharmacokinetics and metabolism of prednicarbate after cutaneous and oral administration.
Barth, J; Derendorf, H; Hochhaus, G; Höhler, T; Lehr, KH; Möllmann, HW, 1993
)
0.29
"), the bioavailability (0."( Metabolism of prednisone in kidney transplanted patients with necrosis of the femoral head.
Egfjord, M; Lausten, GS; Olgaard, K, 1993
)
0.29
" The bioavailability and volume of distribution of prednisolone were unaffected by menopausal status."( The effects of menopause and hormone replacement therapies on prednisolone and erythromycin pharmacokinetics.
Benet, LZ; Harris, RZ; Mroczkowski, P; Tsunoda, SM; Wong, H, 1996
)
0.79
"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,
)
0.39
"The freeze-dried ternary formulations of meclizine (MZ, an anti-motion sickness drug), prednisolone (PRED, an anti-inflammatory drug) and norfloxacin (NFLX, an anti-microbial drug) which are poorly water-soluble and are low bioavailability drugs, were prepared using egg albumin and olive oil."( Pharmaceutical properties of freeze-dried formulations of egg albumin, several drugs and olive oil.
Kakegawa, H; Matsumoto, H; Miyataka, H; Nishiki, M; Satoh, T; Tsuji, Y, 1996
)
0.52
" Budesonide is a topically acting corticosteroid with low systemic bioavailability and is efficacious in the treatment of inflammatory bowel disease."( Suppression of intestinal mucosal natural killer cells by corticosteroids.
Griffioen, G; Lamers, CB; Mieremet-Ooms, MA; Van der Zon, JM; Van Hogezand, RA; Van Ierssel, AJ; Verspaget, HW, 1997
)
0.3
" The lower variability of trough levels and the higher L/D ratio in the CyE group, which are related ti improved bioavailability of CyE, may explain the lower rejection rate among these patients."( Comparison of Neoral and Sandimmun for induction and maintenance immunosuppression after kidney transplantation.
Haberal, M; Karakayali, H; Moray, G; Senel, FM; Yildirim, S, 1997
)
0.3
" Budesonide is a potent corticosteroid with low systemic bioavailability due to an extensive first pass liver metabolism."( Oral budesonide is as effective as oral prednisolone in active Crohn's disease. The Global Budesonide Study Group.
Campieri, M; Doe, W; Ferguson, A; Nilsson, LG; Persson, T, 1997
)
0.56
" In April 1995, the microemulsion-based formulation of cyclosporin (Neoral) was introduced based on its increased bioavailability at 'no extra cost'."( Neoral--new cyclosporin for old?
Scott, DG; Somerville, MF, 1997
)
0.3
" Our previous study on paediatric patients showed that Neoral (a new microemulsion formulation) had better bioavailability than CsA capsules."( Clinical efficacy of cyclosporin a neoral in the treatment of paediatric lupus nephritis with heavy proteinuria.
Chen, WP; Fu, LW; Lin, CY; Yang, LY, 1998
)
0.3
"4) were prepared by the enzymatic hydrolysis of casein, and their effects on in vitro dissolution rates and oral bioavailability of drugs were evaluated."( Casein hydrolysate as a rapid and/or enteric dissolving additive for oral drugs.
Imai, T; Nishiyama, T; Otagiri, M; Shameem, M, 1998
)
0.3
"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
"The relative bioavailability of different prednisolone (CAS 50-24-8) tablet formulations (Prednisolon Ferring 2, 5, and 20 mg) was investigated in comparison to a reference formulation."( Bioequivalence of different prednisolone tablet formulations.
Benöhr, P; Luippold, G; Marto, M; Mühlbauer, B; Schneider, S, 2001
)
0.87
" 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
)
0.51
"When topical controlled delivery of ophthalmic drugs is realised via erodible inserts, drug bioavailability is maximised, if release is controlled exclusively by insert erosion, since parallel mechanisms which increase the release rate, also increases the dose fraction cleared from the precorneal area by tear fluid draining."( A study of release mechanisms of different ophthalmic drugs from erodible ocular inserts based on poly(ethylene oxide).
Di Colo, G; Zambito, Y, 2002
)
0.31
" Transdermal delivery provided equivalent to or higher bioavailability (drug distribution) to the eyeball of topical administration."( Drug delivery to the eye with a transdermal therapeutic system.
Isowaki, A; Matsuo, Y; Ohtori, A; Tojo, K, 2003
)
0.32
"Predocol is an oral preparation of a poorly absorbed salt of prednisolone that is effective in reducing inflammation over short treatment periods in patients with active ulcerative colitis."( Oral prednisolone metasulphobenzoate in the treatment of active ulcerative colitis.
Balan, K; Binnie, JA; Cameron, EA; Middleton, SJ; Skerratt, SA; Solanki, C; Swift, A, 2003
)
1.07
"Budesonide is a corticosteroid with low systemic bioavailability because of its high first-pass metabolism in the liver."( Budesonide versus prednisolone for the treatment of active Crohn's disease in children: a randomized, double-blind, controlled, multicentre trial.
Escher, JC, 2004
)
0.66
" The bioavailability is nearly 100% after oral application, and the main metabolites are 4-hydroxytrofosfamide, and 4-hydroxyifosfamide."( Hypersensitivity pneumonitis associated with the use of trofosfamide.
Hartmann, JT; Kanz, L; Kopp, HG, 2004
)
0.32
"Cyclosporine A (CsA) is characterized by high interindividual variations in oral bioavailability and a narrow therapeutic index."( MDR-1 C3435T polymorphism influences cyclosporine a dose requirement in liver-transplant recipients.
Bonhomme-Faivre, L; Chatled, S; Devocelle, A; Farinotti, R; Maccario, J; Picard, V; Saliba, F, 2004
)
0.32
" Prednisolone bioavailability was measured using a limited 6-hour area under the curve (AUC), with prednisolone measured using specific HPLC assay."( Area-under-the-curve monitoring of prednisolone for dose optimization in a stable renal transplant population.
Hickman, PE; McWhinney, BC; Potter, JM; Sampson, L, 2004
)
1.51
"The results are consistent with the hypothesis that CsA increases the bioavailability of prednisolone, most likely through inhibition of P-glycoprotein."( Area-under-the-curve monitoring of prednisolone for dose optimization in a stable renal transplant population.
Hickman, PE; McWhinney, BC; Potter, JM; Sampson, L, 2004
)
0.82
"A population pharmacokinetic analysis of cyclosporine (CsA) was performed, and the influence of covariates on CsA oral clearance and relative bioavailability was investigated."( Population pharmacokinetics of cyclosporine in cardiopulmonary transplant recipients.
Akhlaghi, F; Baheti, G; Rosenbaum, SE; Trull, AK, 2005
)
0.33
" The area under the concentration-time course of Dx was significantly lower than that using Antiserum-II and the total body clearance values were significantly higher, while an obvious change of bioavailability was not observed."( Pharmacokinetic interaction with digoxin and glucocorticoids in rats detected by radio-immunoassay using a novel specific antiserum.
Fujii, Y; Higashi, Y; Ikeda, Y; Yamamoto, R; Yamashiro, M, 2005
)
0.33
" In this study, we assessed the cutaneous bioavailability of topically applied maxacalcitol ointment in vivo by tape stripping."( In vivo assessment of the cutaneous bioavailability of topically applied maxacalcitol.
Hirata, K; Ikeda, Y; Kano, S; Kondo, K; Takahara, J; Umemura, K; Yanagihara, H, 2005
)
0.33
" The mean bioavailability of oral etoposide was 58+/-15% with an interpatient variability of 26%."( Pharmacokinetic comparison of oral and intravenous etoposide in patients treated with the CHOEP-regimen for malignant lymphomas.
Ehninger, G; Friedrichsen, K; Haenel, M; Kroschinsky, FP; Mueller, J; Prondzinsky, R; Pursche, S; Schleyer, E, 2008
)
0.35
" The effect of particle size in the micron and nano-size ranges as well as the effect of viscosity of the nanosuspension on the ocular bioavailability was studied by measuring the intraocular pressure of normotensive Albino rabbits using shiØetz tonometer."( Nanosuspension as an ophthalmic delivery system for certain glucocorticoid drugs.
Abdel Rahman, AA; Ahmed, MB; Ghorab, MM; Kassem, MA; Khalil, RM, 2007
)
0.34
"Patients with juvenile DM and ERL loss may have decreased bioavailability of OP compared with IVMP."( Pharmacokinetic study of oral prednisolone compared with intravenous methylprednisolone in patients with juvenile dermatomyositis.
Daru, JA; Gursahaney, A; Ngai, KL; Pachman, LM; Rouster-Stevens, KA, 2008
)
0.63
" Whereas systemic exposure to budesonide was markedly lower in healthy subjects after the mouthwash compared to oral dosing (mean relative bioavailability 18%-36%), the systemic concentrations thereafter in patients were as high as those after the identical dose of oral budesonide."( Pharmacokinetics and pharmacodynamic action of budesonide after buccal administration in healthy subjects and patients with oral chronic graft-versus-host disease.
Bertz, H; Dilger, K; Finke, J; Gratwohl, A; Halter, J; Lopez-Lazaro, L, 2009
)
0.35
" Selected compounds were further evaluated for their oral anti-histaminic activity in mice and bioavailability in rats."( Synthesis and structure-activity relationships of phenothiazine carboxylic acids having pyrimidine-dione as novel histamine H(1) antagonists.
Isobe, Y; Kubota, K; Kurebayashi, H; Miyachi, H; Onishi, M; Tobe, M, 2009
)
0.35
"The results support our hypothesis that CD improves bioavailability of drugs to the synovial joints."( "ChilDrive": a technique of combining regional cutaneous hypothermia with iontophoresis for the delivery of drugs to synovial fluid.
Murthy, SN; Sammeta, SM, 2009
)
0.35
"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
" Gatifloxacin showed better bioavailability and sustained action in aqueous humor and corneal tissue from the nanoparticles compared to the commercial eye drops."( Mucoadhesive nanoparticles as carrier systems for prolonged ocular delivery of gatifloxacin/prednisolone bitherapy.
El-Leithy, IS; Ibrahim, HK; Makky, AA, 2010
)
0.58
" To show the importance of physicochemical properties, the classic QSAR and CoMFA of neonicotinoids and prediction of bioavailability of pesticides in terms of membrane permeability in comparison with drugs are described."( Importance of physicochemical properties for the design of new pesticides.
Akamatsu, M, 2011
)
0.37
" In addition to their drug targeting application and their ability to improve bioavailability of drugs, nanoparticles can be designed to allow their detection with a variety of imaging methodologies."( Multifunctional nanoemulsion platform for imaging guided therapy evaluated in experimental cancer.
Calcagno, C; Dijk, WJ; Fayad, ZA; Gianella, A; Griffioen, AW; Jarzyna, PA; Kann, B; Mani, V; Mulder, WJ; Ramachandran, S; Storm, G; Tang, J; Thijssen, VL, 2011
)
0.37
" It is used frequently in children with croup and bacterial meningitis, and is well absorbed orally."( Single dose oral dexamethasone versus multi-dose prednisolone in the treatment of acute exacerbations of asthma in children who attend the emergency department: study protocol for a randomized controlled trial.
An Fhailí, SN; Crispino-O'Connell, G; Cronin, J; Hayden, J; Kennedy, U; McCoy, S; O'Sullivan, R; Wakai, A; Walsh, S, 2012
)
0.63
" 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
)
0.89
"42 h (dogs), and bioavailability of 74."( VBP15: preclinical characterization of a novel anti-inflammatory delta 9,11 steroid.
Damsker, JM; Hoffman, EP; McCall, JM; Nagaraju, K; Reeves, EKM, 2013
)
0.39
" Ocular irritation, bioavailability and anti-inflammatory effects were evaluated and compared with the conventional suspension and solution eye drops."( Preparation, characterization and evaluation of novel elastic nano-sized niosomes (ethoniosomes) for ocular delivery of prednisolone.
Abdallah, OY; Abdelkader, H; Farid, RM; Gaafar, PM, 2014
)
0.61
" In vivo data of buccal film show greater bioavailability (AUC0-α: 24."( Buccal films of prednisolone with enhanced bioavailability.
Goomber, G; Gupta, S; Kumria, R; Nair, AB, 2016
)
0.78
" Tacrolimus clearance was 30% higher (95% CI 13, 46%) and bioavailability 18% lower (95% CI 2, 29%) in CYP3A5 expressers compared with non-expressers."( Improved prediction of tacrolimus concentrations early after kidney transplantation using theory-based pharmacokinetic modelling.
Åsberg, A; Bergan, S; Bergmann, TK; Bremer, S; Hennig, S; Holford, N; Midtvedt, K; Staatz, CE; Størset, E, 2014
)
0.4
" Compound 13d, having good in vitro ADME profile and moderate oral bioavailability in mice, showed potent anti-inflammatory activity against hapten-induced contact hypersensitivity reaction in mice following topical and oral administration."( Synthesis and biological evaluation of novel orally available 1-phenyl-6-aminouracils containing dimethyldihydrobenzofuranol structure for the treatment of allergic skin diseases.
Fujiwara, N; Hasegawa, F; Inoue, Y; Isobe, M; Isobe, Y; Tobe, M; Tsuboi, K, 2016
)
0.43
"The developed SMEDDS are a feasible option to conventional eye drops for its capability to improve bioavailability via its longer precorneal residence time and its capacity to sustain the release of the drug."( Ocular Self-Microemulsifying Drug Delivery System of Prednisolone Improves Therapeutic Effectiveness in the Treatment of Experimental Uveitis.
Dubey, V; Kesavan, K; Tiwari, R, 2019
)
0.76
"We found that formulation did not influence bioavailability and that use of >20 mg prednisolone daily increased everolimus clearance."( A pharmacological rationale for improved everolimus dosing in oncology and transplant patients.
Burger, DM; de Fijter, JW; Guchelaar, HJ; Moes, DJAR; Reinders, MEJ; Ter Heine, R; van Erp, NP; van Herpen, CM, 2018
)
0.71
"Budesonide with multi-matrix technology (MMX) is an oral corticosteroid, shown to have high topical activity against ulcerative colitis (UC) while maintaining low systemic bioavailability with few adverse events."( Budesonide with multi-matrix technology as second-line treatment for ulcerative colitis: evaluation of long-term cost-effectiveness in the Netherlands.
Ghatnekar, O; Gherardi, A; Kuijvenhoven, J; Roze, S; Yip Sonderegger, YL, 2018
)
0.48
"It can be stated that the innovative PR-containing compositions are suitable for producing mucoadhesive, properly preserved aqueous ophthalmic solutions with increased bioavailability attributes."( Development of prednisolone-containing eye drop formulations by cyclodextrin complexation and antimicrobial, mucoadhesive biopolymer.
Aigner, Z; Bíró, T; Budai-Szűcs, M; Csányi, E; Csóka, I; Facskó, A; Horvát, G; Szabó-Révész, P; Urbán, E, 2018
)
0.83
" Thus, IGFBP-4 may modulate IGF bioavailability in IBD."( The IGF system in patients with inflammatory bowel disease treated with prednisolone or infliximab: potential role of the stanniocalcin-2 / PAPP-A / IGFBP-4 axis.
Agnholt, J; Frystyk, J; Hjortebjerg, R; Thomsen, KL, 2019
)
0.75
"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
"We combined PD with curcumin (CU), an effective monomer from traditional Chinese medicine, and human serum albumin (HSA) in a nanoparticulate system (N-PD/CU) to compensate for the poor bioavailability of PD and CU."( Co-Delivery of Prednisolone and Curcumin in Human Serum Albumin Nanoparticles for Effective Treatment of Rheumatoid Arthritis.
Li, C; Li, H; Lin, Y; Tang, C; Yan, F; Zhong, Z; Zhou, M, 2019
)
0.87
" Oral dexamethasone demonstrates bioavailability similar to that of oral prednisolone but has a longer half-life."( Two regimens of dexamethasone versus prednisolone for acute exacerbations in asthmatic Egyptian children.
Elazab, GA; Elkharwili, DA; Elrifaey, SM; Ibrahim, OM, 2020
)
1.06
" To overcome limitations in the bioavailability of Curcumin, the therapeutic effect of oral Nano-Curcumin was evaluated for the first time."( Comparison of oral Nano-Curcumin with oral prednisolone on oral lichen planus: a randomized double-blinded clinical trial.
Basirat, M; Kia, SJ; Moosavi, MS; Mortezaie, T, 2020
)
0.82
" In comparison with previous studies, current results clarify the importance of Nano-Curcumin bioavailability in therapeutic effects."( Comparison of oral Nano-Curcumin with oral prednisolone on oral lichen planus: a randomized double-blinded clinical trial.
Basirat, M; Kia, SJ; Moosavi, MS; Mortezaie, T, 2020
)
0.82
"The results of this work indicate a good strategy for the selection of mucoadhesive polymers for SLP-based tablets in improving the bioavailability of poorly water-soluble drugs."( Effects of Mucoadhesive Polymers on Released Particles and Drug Release in Solid Lipid Particle-Based Buccal Tablets.
Phan, TTH; Tran, PHL; Tran, TTD, 2021
)
0.62
" Ipatasertib bioavailability and M1 formation increased after multiple dosing, resulting in an increase in exposure beyond that expected from accumulation alone."( Population Pharmacokinetics of Ipatasertib and Its Metabolite in Cancer Patients.
Chanu, P; Kotani, N; Sane, R; Wade, JR; Wang, N; Wilkins, J; Winkler, J; Yoshida, K, 2021
)
0.62
" 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
)
1.01
"001), with increases in poorly bioavailable oral corticosteroids in Crohn's (pandemic 15."( Treatment adaptations and outcomes of patients experiencing inflammatory bowel disease flares during the early COVID-19 pandemic: the PREPARE-IBD multicentre cohort study.
Bhala, N; Brookes, MJ; Conley, TE; Gonzalez, HA; Hicks, LC; Kennedy, NA; Kent, AJ; Lamb, CA; Mehta, SJ; Patel, KV; Saifuddin, A; Sebastian, S; Segal, JP; Subramanian, S; Walker, GJ, 2022
)
0.72
" However, low water solubility and bioavailability have hindered its application."( Preparation of Pinocembrin-Loaded F127/MPEG-PDLLA Polymer Micelles and Anti-Osteoporotic Activity.
Adu-Frimpong, M; Cao, X; He, Q; Ji, H; Li, X; Rong, W; Shen, X; Shi, F; Toreniyazov, E; Wang, Q; Xia, X; Xu, X; Yu, J; Zhang, J, 2022
)
0.72

Dosage Studied

There was an increased risk of IFI in the lupus patients receiving high daily dosage of prednisolone therapy. No correlation was observed between the daily prednislone dosage (mg/d or mg kg d) and glucose AUC.

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
)
0.69
" The impact of the duration of the disease, of sex, age, and the dosage of corticosteroids on the postoperative development of the disease is demonstrated."( [Results of splenectomy in patients with hypoplastic and aplastic anemia].
Grosdow, DM; Sliskow, SS, 1975
)
0.25
" 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
" The substances are mesenchymosuppressive as well as immunosuppressive, but the present results show that the effective dosage is higher for mesenchymal suppression than for immunosuppression."( Experimental results to immunomesenchymal suppression.
Hauss, GM; Hauss, WH; Kramer, H; Müller, U; Wirth, W, 1975
)
0.25
"5 months of synthetic ACTH-Z medication at either of these dosage levels, the response of urinary 17-KGS was found to have decreased to about 1/2 of its level at the beginning of medication."( [A clinical study on the effect of extrinsic corticotropin on the pituitary-adrenocortical function (author's transl)].
Mori, M, 1978
)
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,
)
0.39
" Eleven patients with advanced carcinoma of the lung (5 adenocarcinoma, 3 squamous cell carcinoma, 2 small cell carcinoma and 1 large cell carcinoma) were treated at a dosage of 40 mg."( Preliminary clinical study of prednimustine in lung cancer.
Catane, H; Catane, R; Kaufman, JH; Mittelman, A; Murphy, GP; Takita, H, 1977
)
0.26
" Drug combinations incorporating niridazole at a lower dosage or for a shorter period were less effective, and azathioprine and prednisolone on their own or used together prolonged graft survival only marginally in this model."( Prolonged allograft survival with niridazole, azathioprine, and prednisolone.
Bird, M; Godfrey, AM; Jones, B; Millar, D; Miller, J; Salaman, JR, 1977
)
0.7
" To prevent recurrent pulmonary infiltrates it is probably necessary to give prednisolone in a daily dosage of at least 10 mg for an indefinite period."( Asthmatic pulmonary eosinophilia: a review of 65 cases.
Douglas, AC; Grant, IW; Middleton, WG; Paterson, IC, 1977
)
0.49
" CEA levels did not correlate with prednisolone dosage nor with number of rejection episodes, after allowing for time after transplantation and smoking habit."( Carcinoembryonic antigen in renal allograft recipients and immunosuppressed renal patients.
Coates, AS; Frost, M; Kincaid-Smith, P; Mathews, JD; Myers, JB, 1977
)
0.53
" Emphases of the description are general principles of treatment, indications and dosage in systemic and local treatment, side effects, problems of long-term treatment, application of ACTH, the cortisonoid withdrawal syndrome, prophylaxis of therapy complications and references to the reduction of the dose or to the withdrawal of the treatment with cortisonoids."( [Cortisonoids in the therapy of rheumatic diseases].
Reinicke, C, 1977
)
0.26
"Forty mg has been shown to be the optimal daily dosage of prednisone for outpatients requiring oral steroids for active proctocolitis."( A comparison of oral prednisolone given as single or multiple daily doses for active proctocolitis.
Bown, RL; Lennard-Jones, JE; Powell-Tuck, J, 1978
)
0.58
" In agreement with current literature, immunosuppression with ALG in high dosage seems to be justified."( [Evaluation of the effectiveness of ALG in clinical kidney transplantation in alternating studies].
Bunzendahl, H; Pichlmayr, R; Tidow, G; Wonigeit, K, 1979
)
0.26
" This gross day-to-day variation occurred irrespective of the dosage used."( Variation in plasma prednisolone concentrations in renal transplant recipients given enteric-coated prednisolone.
Chakraborty, J; English, J; Henderson, RG; Marks, V; Wheatley, T, 1979
)
0.58
" Dosage in such patients should be reduced in accordance with serum albumin concentration."( Corticosteroid pharmacokinetics in liver disease.
Go, VL; Uribe, M,
)
0.13
" This change coincided with the attainment of maintenance steroid dosage (usually prednisolone 10 mg."( Hyperlipidaemia following renal transplantation. A study of the prevalence, 'natural history' and dietary treatment.
Gokal, R; Mann, JI; Moore, RA; Morris, PJ, 1979
)
0.49
" Whether similar improvement could have been achieved by a different dosage regimen of corticosteroid tablets or whether it might have ocurred spontaneously was not tested."( Triamcinolone in corticosteroid-resistant asthma.
Cayton, RM; Howard, P; Peake, MD, 1979
)
0.26
" Corticosteroids reduced spleen size but reduction or withdrawal of the relatively high dosage required resulted in rebound splenomegaly within a period of three months to three years."( Splenomegaly and splenectomy in sarcoidosis.
Bradstreet, CM; Mitchell, DN; Salsbury, AJ; Webb, AK, 1979
)
0.26
" Administration of a standard premedication dosage to patients sedated for other reasons occasionally led to worsened respiratory status; pre-medication should be reduced or eliminated in sedated patients."( Bronchofiberscopy in the postoperative management of lung surgery patients.
Nakhosteen, JA, 1979
)
0.26
" These results suggest that Y-8004 may make feasible a reduction in dosage or a withdrawal of the steroid prescription."( [Pharmacological studies of 2-(5H-(1)benzopyrano[2,3-b]pyridin-7-yl)propionic acid (Y-8004). (3) Its interaction with anti-inflammatory agents].
Foto, K; Imayoshi, T; Kadobe, Y; Maruyama, Y, 1977
)
0.26
" It was concluded that the proper dosage of the prednisolone given to these children should be 1 mg/kg per day."( The effect of different doses of prednisolone in the treatment of childhood ITP.
Hathirat, P; Isarangkura, P; Uthai, K, 1979
)
0.8
"The parenteral use of triamcinolone acetonide (Kenacort A) is said to have the following advantages: to keep the effect for two weeks by one injection, to be able to reduce the total treatment dosage and to secure the dosage regardless of patients cooperation."( Parenteral treatment of sarcoidosis with triamcinolone.
Hiraga, Y; Mikami, R; Osada, H; Yotsumoto, H, 1977
)
0.26
" Sixty patients who were on corticosteroids (hereinafter their dosage is expressed as the equivalent of prednisolone) given at 10 to 40 mg initially and then on a gradually decreasing basis down to below 10 mg currently or who had already been withdrawn from such a drug regimen were involved in the study and analysed for baseline values for plasma cortisol."( [Study on suppression of the pituitary-adrenocortical function by the therapeutic use of corticosteroids and its spontaneous recovery (author's transl)].
Mori, M, 1978
)
0.47
" Monitoring prednisolone levels may be of value in identifying those children who accumulate excessively high levels on moderate dosage regimens."( Plasma levels, half-life values, and correlation with physiologic assays for growth and immunity.
Green, OC; Hart, RL; Kawahara, FS; Lewy, PR; Pachman, LM; Phillips, LS; Winter, RJ, 1978
)
0.64
"Thirty-nine patients with gynecological malignancies who had failed on conventional chemotherapeutic agents were treated with Leo 1031 to study the effective dosage and toxicity of the compound in gynecological malignancies."( Leo 1031 (NSC-134087) in gynecologic malignancies.
Barlow, JJ; Lele, SB; Murphy, GP; Piver, MS, 1978
)
0.26
" The patients were divided into three groups according to dosage and previous treatment."( Continuous treatment of non-Hodgkin's malignant lymphoma with prednimustine (Leo 1031).
Håkansson, L; Könyves, I; Lindberg, LG; Möller, T, 1978
)
0.26
" The study revealed no correlation between steroid dosage and postoperative morbidity or mortality."( Factors which influenced postoperative complications in patients with ulcerative colitis or Crohn's disease of the colon on corticosteroids.
Allsop, JR; Lee, EC, 1978
)
0.26
" 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
" A significant relation between steroid dosage and blood pressure was found in only a quarter of the hypertensive patients, and in another quarter no cause could be found."( Hypertension after renal transplantation.
Alexandre, GP; Bachy, C; van Ypersele de Strihou, C, 1976
)
0.26
" We, therefore, consider a preventive administration of biguanides to be effective in long term or high dosage administration of glucocorticoides."( [Antagonistic action of prednisolone and buformin in the carbohydrate metabolism of healthy persons (author's transl)].
Bottermann, P; Ermler, R; Schweigart, U, 1976
)
0.56
" Although under the given dosage the intensity of the immune reaction in the fluid remains uninfluenced with regard to plasma cells and an increase in gammaglobulin--a causal therapeutic effect cannot be shown--however, because of the results with regard to the condition of the fluid after the glucocorticoid it is useful for the control of therapy."( [Changes in cerebrospinal fluid findings with glucocorticoid therapy].
Olischer, RM, 1975
)
0.25
" 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
)
0.71
" Thus, at the dosage used, beclomethasone dipropionate might have minor systemic endocrinometabolic effects."( The endocrinometabolic effects of beclomethasone dipropionate in asthmatic patients.
Copinschi, G; De Coster, A; Leclercq, R; Schandevyl, W; Virasoro, E; Yernault, JC, 1977
)
0.26
" Prednisolone and indomethacin also reduced the periosteal reaction when administered from one day before injection with FCA, but they were inactive in this respect when dosing was started on day 21 when the periosteal reaction was well established."( An X-ray analysis of adjuvant arthritis in the rat. The effect of prednisolone and indomethacin.
Blackham, A; Burns, JW; Farmer, JB; Radziwonik, H; Westwick, J, 1977
)
1.4
"With a fasted dog as an animal model, the bioavailability and pharmacokinetics of prednisolone were studied following rapid intravenous injection and oral dosing of a prednisolone sodium phosphate solution and also following oral doses of prednisolone as tablets and a slurry."( Prednisolone bioavailability in the dog.
Tse, FL; Welling, PG, 1977
)
1.93
"The addition of phenobarbitone in therapeutic dosage to the drug regimen of prednisolone-treated subjects with rheumatoid arthritis produced measurable deterioration in the clinical status of the patients associated with a more rapid clearance of prednisolone from plasma."( Effects of enzyme induction on metabolism of prednisolone. Clinical and laboratory study.
Brooks, PM; Buchanan, WW; Downie, WW; Grove, M, 1976
)
0.74
" The glucocorticoid effect on motoneuron outlasts the dosing period, suggesting an underlying alteration in the neuron."( Glucocorticoids and mammalian motor nerve excitability.
Baker, T; Okamoto, M; Riker, WF, 1975
)
0.25
" Steroid therapy should not only be introduced rapidly at appropriate dosage levels as soon as the diagnosis is made but should not be reduced or discontinued prematurely."( Visual complications of polymyalgia rheumatica (polymyalgia arteritica).
Hart, FD, 1975
)
0.25
" For avoiding irreparable and dangerous defects of the cartilage a sufficiency dosed treatment with corticoids is necessary."( [Clinical-biochemical study of systemic panchondritis].
Bussler, H; Ehrig, J; Neupert, G; Rössner, B; Schramm, G, 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
)
0.85
"Infection of human foreskin cells (D-550) by the Snyder-Theilen strain of feline sarcoma virus produced small but countable foci and demonstrated "single-hit" dose-response kinetics."( Influence of glucocorticoid, estrogen, and androgen hormones on transformation of human cells in vitro by feline sarcoma virus.
Blakeslee, JR; Milo, GE; Olsen, RG; Schaller, JP; Yohn, DS, 1976
)
0.26
" Steroid was also effective but reduction of the dosage resulted in worsening of symptoms."( [A steroid-effective case with "prolonged" cerebellar ataxia].
Aso, K; Haga, Y; Kito, M; Maeda, N; Negoro, T; Okumura, A; Watanabe, K, 1992
)
0.28
"7) cyclosporin-A treatment was associated with a marked decrease in the dosage of prednisolone, from a mean of 12."( "Catch-up" growth in steroid dependent dermatomyositis treated with cyclosporin-A.
Dubowitz, V; Hamill, G; Heckmatt, J; Saunders, C; Stanhope, R, 1992
)
0.51
" This study shows that avascular necrosis occurs even when low dose steroids regimes are used and demonstrates no significant correlation between steroid dosage and the development of avn."( Avascular necrosis of the femoral head post heart-transplantation and steroid dosage.
Barry, C; Coughlan, RJ; Daly, C; Foley-Nolan, D; Neligan, M; Woods, A, 1992
)
0.28
" In order to determine the ideal form of induction regimen, combination drugs with CYA, the initial dosage of CYA and its blood trough level were retrospectively analyzed with particular reference to the possible factors relevant to the occurrence of acute rejection episode in the first three post-transplant months and graft survival."( [Study of 54 renal allograft recipients in the cyclosporin A era. What influences acute rejection episode and long-term graft survival?].
Chikaraishi, T; Hirano, T; Kanagawa, K; Koyanagi, T; Seki, T; Takeuchi, I; Tanda, K; Togashi, M; Tsubo, S, 1992
)
0.28
"Due to good therapeutic results and few side-effects so-called "low-dose glucocorticoid therapy" (ldgc) with daily glucosteroid dosage below 10 mg prednisolone-equivalent has recently been recommended in managing polymyalgia rheumatica and giant cell arteritis."( [Polymyalgia rheumatica and giant cell arteritis; diagnosis and side effects of low-dose long-term glucocorticoid therapy].
Hatz, HJ; Helmke, K,
)
0.33
" Among the many pharmacological agents presently in use, only prednisone (or methylprednisolone) and cyclosporin require dosage individualisation."( Optimisation of immunosuppressive therapy using pharmacokinetic principles.
Grevel, J, 1992
)
0.51
" Twelve potential risk factors were evaluated as covariates: recipient age, body weight after 6 months, body weight gain over 6 months, body mass index after 6 months, body mass index gain over 6 months, current cyclosporine dosage, trough level of cyclosporine in whole blood according to high-performance liquid chromatography after 6 months, cumulative cyclosporine dosage over 6 months, serum bilirubin, type of original cardiac disease, maintenance steroids, and steroid bolus treatment."( The determinants of elevated total plasma cholesterol levels in cardiac transplant recipients administered low dose cyclosporine for immunosuppression.
Grablowitz, V; Heinz, G; Laczkovics, A; Laufer, G; Miholic, J; Schreiner, W; Wolfram, J; Wollenek, G; Wolner, E, 1992
)
0.28
" CsA dosage remained unchanged in the range of 200 mg/m2/day; CsA whole blood trough level was 120 to 130 ng/mL throughout the years."( Long-term results of cyclosporin A therapy in children.
Bökenkamp, A; Brodehl, J; Hoyer, PF; Offner, G, 1992
)
0.28
" Cyclosporine A did not produce any side effects because the administered dosage was relatively low."( Alopecia universalis treated with oral cyclosporine A and prednisolone: immunologic studies.
Hori, Y; Irie, M; Nakagawa, T; Nakayama, J; Teshima, H; Urabe, A, 1992
)
0.53
") on the suppression of plasma hydrocortisone (HC) was investigated in six healthy subjects, by comparing dosage times of 8 and 20 hr."( Time-dependent effects of dexamethasone administration on the suppression of plasma hydrocortisone, assessed with a pharmacokinetic model.
Braat, MC; Koopmans, RP; Oosterhuis, B; van Boxtel, CJ, 1992
)
0.28
" The employment of a special diet favourably influenced the course of the disease and enabled the dosage of antirheumatic drugs to be reduced, thereby reducing the frequency of side-effects of the drugs."( On the medicinal efficacy of dietetic therapy in patients with rheumatoid arthritis.
Denissov, LN; Samsonov, MA; Sharafetdinov, Kh, 1992
)
0.28
"5-50 mg/kg according to the same dosing protocol."( Therapeutic activity of deoxyspergualin in comparison with cyclosporin A, and its combined use with cyclosporin A and prednisolone in highly allogeneic skin transplantation in the rat.
Abe, F; Fujii, A; Hayashi, M; Mae, T; Nemoto, K; Sugawara, Y; Takeuchi, T, 1992
)
0.49
"day-1; 136 achieved clinical remission, but 96 of them still had active endoscopic lesions and were randomized either to immediate start of steroid tapering (group A; n = 46) or to continued prednisolone treatment at the same dosage for 5 more weeks before steroid tapering was begun (group B; n = 50)."( Endoscopic monitoring of Crohn's disease treatment: a prospective, randomized clinical trial. The Groupe d'Etudes Therapeutiques des Affections Inflammatoires Digestives.
Anh, TN; Bories, P; Cortot, A; Florent, C; Gendre, JP; Landi, B; Metman, EH; Rene, E; See, A; Soule, JC, 1992
)
0.47
" Measurement of plasma peak PE or AUC could be valuable for individualizing steroid dosing in children with RD."( Use of a radioreceptor assay in the assessment of cushingoid features in patients with juvenile rheumatic diseases.
Getson, PR; Lipnick, RN; Morales, A; Soldin, SJ; White, PH, 1992
)
0.28
" Antirheumatic therapy therefore requires strict adherence to the prescribed indications and careful selection of the specific drug type and dosage regimen."( [Glucocorticoids].
Hayashi, T, 1992
)
0.28
" The addition of azathioprine therapy resulted in no appreciable reduction of steroid dosage nor improvement of yearly growth rate, although the frequency of relapse for that year was diminished."( [Growth retardation in children with frequent relapsing nephrotic syndrome on steroid--improvement of height velocity after administration of immunosuppressive agent].
Kitamura, M, 1992
)
0.28
" Through data of these cases, it is recommended that the maximum dosage is to be continued for as long as 2 to 19 weeks with average 7 weeks."( [Myasthenia gravis and steroid therapy].
Araki, Y; Kinoshita, M; Nemoto, H; Niizuma, M; Wakata, N, 1992
)
0.28
" They were compared with the dosage and trough blood levels of cyclosporin A, and, in 15 patients receiving prednisolone in addition to cyclosporin A, with steroid dosage."( Renal haemodynamics of cyclosporin A nephrotoxicity in children with juvenile dermatomyositis.
Dubowitz, V; el-Meleigy, D; Hasson, N; Heckmatt, JZ; Henderson, BL; Peters, AM; Rose, ML, 1991
)
0.49
" After 25 days in the hospital, treatment with high dosage of methylprednisolone was started for presumed ulcerative colitis."( Fatal cytomegalovirus (CMV) colitis in a patient receiving low dose prednisolone therapy.
Aukrust, P; Bjørneklett, A; Farstad, IN; Holter, E; Kremer, D; Moum, B, 1991
)
0.75
" Because neutropenia persisted despite the administration of prednisolone for 30 days, daily subcutaneous injection of human recombinant granulocyte colony-stimulating factor (rhG-CSF) at a dosage of 100 micrograms was started."( Human recombinant granulocyte colony-stimulating factor for the treatment of autoimmune neutropenia.
Akashi, K; Fujimoto, K; Harada, M; Ishibashi, H; Niho, Y; Sibuya, T; Takahashi, K; Taniguchi, S, 1991
)
0.52
" In 18/33 patients an oligoarthropathy of large joints could be observed after a significant reduction of prednisolon dosage over a period of 5 months."( [Musculoskeletal manifestations in patients after bone marrow transplantation. Initial clinical rheumatologic observations].
Kirchner, H; Link, H; Poliwoda, H; Schulte, D; Stoll, M; Wagener, P,
)
0.13
"Infarct healing delay by prednisolone is dosage dependent, and smaller infarcts may be more sensitive to its effect."( Effect of prednisolone on myocardial infarct healing: characteristics and comparison with indomethacin.
Iimura, O; Ishimoto, R; Itoya, M; Miura, T; Shizukuda, Y, 1991
)
0.99
" The eruption responded quickly to systemic steroids, with recrudescence when steroid dosage was reduced."( Sweet's panniculitis.
Cullity, J; Gebauer, K; Maguire, B, 1991
)
0.28
" Twelve healthy subjects (4 m, 8 f) were treated for 1 week at each dosage level, the graduated dosages being given in ascending order."( The assessment of the systemic effects of inhaled glucocorticosteroids. The effects of inhaled budesonide vs oral prednisolone on calcium metabolism.
Andersson, KE; Jennings, BH; Johansson, SA, 1991
)
0.49
" Late intensification consisted of a 5-day course of ARA-C and one dose of ADR which was repeated until the cumulative dosage of ADR reached 465 mg/m2."( Improved prognosis of acute nonlymphocytic leukemia in children: results of the 12th-ANLL protocol of Tokyo Children's Cancer Study Group.
Bessho, F; Kigasawa, H; Nakazawa, S; Ohkawa, Y; Sugita, K; Tsuchida, M; Tsukimoto, I; Tsunematsu, Y; Yamada, K; Yamamoto, M, 1991
)
0.28
" One study compares a tapering dosage of topical prednisolone or placebo eye drops for HSV stromal keratitis (HEDS-SKN)."( Design and organization of the herpetic eye disease study (HEDS).
Barron, BA; Dawson, CR; Hauck, WW; Jones, DB; Kaufman, HE; Wilhelmus, KR, 1991
)
0.54
" Secondary effects were observed in both therapeutic alternatives, the most notable being alterations in serum creatinine concentration and hypertension with the dosage of cyclosporine used."( Randomized, double-masked study of cyclosporine compared to prednisolone in the treatment of endogenous uveitis.
Chan, CC; Green, SB; Mellow, SD; Nussenblatt, RB; Palestine, AG; Stevens, G, 1991
)
0.52
" Steroids were found to be beneficial and safe, in the dosage that we prescribed."( Treatment of recent facial nerve damage with lagophthalmos, using a semistandardized steroid regimen.
Hogeweg, M; Kiran, KU; Suneetha, S, 1991
)
0.28
" These observations suggest that most of the patients with pemphigus respond well to the treatment of relatively small or moderate dosage of corticosteroids."( [Statistical observations of pemphigus at the Nara University Hospital from 1975 to 1989].
Matsuoka, A; Miyagawa, S; Muramatsu, T; Nakatani, C; Sakamoto, K; Shirai, T, 1991
)
0.28
" Receptor and TAT profiles were essentially superimposable for both dosing groups."( Receptor-mediated prednisolone pharmacodynamics in rats: model verification using a dose-sparing regimen.
Jusko, WJ; Nichols, AI, 1990
)
0.61
" Higher dosage of prednisolone or prednisone more than 120 mg/day has never been used."( Treatment of pemphigus.
Ophaswongse, S; Piamphongsant, T, 1991
)
0.62
" But, as many of them are young, treatment may present problems if they require high doses of steroids to control the scleral inflammation and then relapse when the dosage is reduced."( Use of cyclosporin in the management of steroid dependent non-necrotising scleritis.
Hakin, KN; Ham, J; Lightman, SL, 1991
)
0.28
" The muscle spasms worsened when the dosage of glucocorticoid was reduced, and they improved on the increased dosage."( [A case of generalized komuragaeri disease (Satoyoshi disease) treated with glucocorticoid].
Matsumoto, S; Miyao, M; Momoi, M; Yamagata, T; Yanagisawa, M, 1991
)
0.28
" But eight weeks later, after dose reduction to 10 mg daily, the nephrotic syndrome recurred so that the dosage had to be increased again to 20 mg prednisolone daily."( [Kimura disease with minimally proliferative glomerulonephritis].
Baretton, G; Sack, K; Steinhoff, J; Uthgenannt, D, 1991
)
0.48
" The incidence of thrombosis is similar to that previously found in a cohort of consecutive patients treated at our Department with a different schedule and dosage of L-ase administration, and similar to that reported in previous series."( Thrombotic complications during L-asparaginase treatment for acute lymphocytic leukemia.
Castaman, G; Dini, E; Rodeghiero, F,
)
0.13
" Patients who responded less well to treatment tended to be younger, and their disease was more severe in that a higher dosage was required for initial control."( The use of chlorambucil in the treatment of bullous pemphigoid.
Hutchinson, PE; Milligan, A, 1990
)
0.28
"0 mg prednisolone daily given in divided dosage in the morning and evening."( Short term linear growth in asthmatic children during treatment with prednisolone.
Pedersen, S; Wolthers, OD, 1990
)
1.03
" Standardised reductions in corticosteroid dosage were therefore undertaken every five weeks, unless clinically contraindicated."( Controlled trial of natamycin in the treatment of allergic bronchopulmonary aspergillosis.
Cole, PJ; Currie, DC; Darbyshire, JH; Harvey, C; Longbottom, JL; Lueck, C; Milburn, HJ; Nunn, AJ, 1990
)
0.28
" This technique can be used to individualize glucocorticoid dosing regimens."( Monitoring glucocorticoid therapy: a pharmacokinetic approach.
Ball, BD; Bartoszek, M; Brenner, AM; Hill, MR; Szefler, SJ, 1990
)
0.28
"When we perform renal biopsy in patients with lupus nephritis (LN), we use the histopathological findings in glomerulus for the choice and dosage of steroid and immunosuppressive therapy."( [Morphologic transformation of renal lesions by steroid treatment and its therapeutic implication in a patient with lupus nephritis].
Kitamoto, K; Maemura, C; Nagasawa, T; Nakabayashi, K; Saito, M, 1990
)
0.28
" All patients had previously relapsed while the dosage was being reduced or within 14 days of discontinuing prednisolone in the six months before receiving cyclophosphamide treatment (steroid dependent), and had severe steroid toxicity."( Eight and 12 week courses of cyclophosphamide in nephrotic syndrome.
Ito, S; Kuno, K; Ueda, N, 1990
)
0.49
" The results in three heart transplantation models--auricular free graft in mice, abdominal graft in rats and cervical graft in rabbits--suggested that RSM injection in an appropriate dosage prolonged the survival time of cardiac allograft."( Effect of radix Salviae miltiorrhizae extract injection on survival of allogeneic heart transplantation.
Li, J; Niu, X; Qin, Z; Zhu, H; Zhuang, H, 1990
)
0.28
" We conclude that changes in the clearance of prednisolone and altered protein binding might account for some of the variability in both therapeutic responses and the incidence of toxicity in patients treated with standard dosage regimens."( Pharmacokinetics of prednisolone in children with nephrosis.
Bowmer, CJ; Brocklebank, JT; Miller, PF; Wheeldon, J, 1990
)
0.86
" It was controlled by increasing the cyclophosphamide dosage for six months."( [Buccal lymphomatoid granulomatosis].
Auriol, M; Cabane, J; Chomette, G; Godeau, P; Raphael, M; Szpirglass, H,
)
0.13
"5 mg/kg) in descending dosage (n = 8)."( Prednisolone therapy of experimental allergic neuritis in Lewis rats does not induce relapsing or chronic disease.
Schabet, M; Schott, K; Stevens, A; Wiethölter, H, 1990
)
1.72
" Combination of radiotherapy and chemotherapy can improve the survival rate, but the optimal dosage needs to be investigated further."( Improved survival rate in primary intracranial lymphoma treated by high-dose radiation and systemic vincristine-doxorubicin-cyclophosphamide-prednisolone chemotherapy.
Abe, M; Dodo, Y; Shibamoto, Y; Shima, N; Tsutsui, K; Yamabe, H, 1990
)
0.48
" The rare clinical picture of a fatal cardiac rupture in the later phase of acute myocardial infarction and the precise dosage of prednisolone for her SLE are described."( Cardiac rupture following acute myocardial infarction in systemic lupus erythematosus: case report.
Kishimoto, M; Nakamura, Y; Ouami, H; Shibata, S; Takayanagi, K, 1990
)
0.48
" She went into hematological remission 6 weeks following 40 mg/day treatment with prednisolone, but the anemia relapsed frequently when the dosage was lessened."( [Chronic T-cell lymphoproliferative disorder associated with pure red cell aplasia].
Akihama, T; Chubachi, A; Endo, Y; Kuwayama, A; Miura, A; Yoshida, K, 1989
)
0.5
" A numerical technique to determine the efficiency of TAT induction based on area under the curve calculations is presented, which supports the hypothesis that nonlinear dose-response effects are due to dose and time-dependent receptor depletion in the cytosol."( Second generation model for prednisolone pharmacodynamics in the rat.
Boudinot, FD; Jusko, WJ; Nichols, AI, 1989
)
0.57
" AZP was orally administered to 3 dogs daily at a dosage of 1-10 mg/kg for a period from 3 days before infection until the end of the experiment."( Influence of immunosuppressants against Dirofilaria immitis infection in dogs.
Hayasaki, M; Ohishi, I, 1989
)
0.28
" This decreased response in obese animals may indicate a need for joint pharmacokinetic/dynamic considerations in dosing obese individuals with corticosteroids."( Pharmacokinetics and pharmacodynamics of prednisolone in obese rats.
D'Ambrosio, R; Jusko, WJ; Nichols, AI; Pyszczynski, NA, 1989
)
0.54
" Dosage reductions of CsA mitigate its nephrotoxic effect."( Amplification of the nephrotoxic effect of cyclosporine by preexistent chronic histological lesions in the kidney.
Bosman, FT; Kootstra, G; Leunissen, KM; Nieman, FH; Noordzij, TC; van Hooff, JP; Vromen, MA, 1989
)
0.28
" To ensure the human therapeutic dose, each drug was given twice a day per os in 3 different dosage regimes."( Impact of NSAIDS on murine antigen induced arthritis. I. Investigation of antiinflammatory and chondroprotective effects.
de Vries, BJ; van den Berg, WB, 1989
)
0.28
" Prednisolone was given in a dosage averaging 25 mg at 12 h intervals orally for up to 2 weeks to adult volunteers."( Recovery from glucocorticoid inhibition of the responses to corticotrophin-releasing hormone.
Fang, VS; Rosenfield, RL; Watson, AC, 1988
)
1.19
" For rational dosage of these xenobiotics, their pharmacokinetics should be characterized."( Marked interspecies differences between humans and pigs in cyclosporine and prednisolone disposition.
Frey, BM; Frey, FJ; Gänger, H; Mettler, D; Sieber, M,
)
0.36
" Permanent complete relief or pronounced improvement of the dyskinesias was observed at a dosage of 5 mg prednisolone/day."( Successful treatment of tardive and spontaneous dyskinesias with corticosteroids.
Benecke, R; Conrad, B; Klingelhöfer, J, 1988
)
0.49
" In patients with nephrotic syndrome no correlation was found between pharmacokinetic values and criteria of clinical effectiveness, such as the time and dosage required to obtain remissions and the duration of these remissions."( [Pharmacokinetics of prednisolone in children. Study of a correlation with tolerability and therapeutic effect in nephrosis].
Baron, S; Bensman, A; Raux Demay, MC; Vasmant, D, 1988
)
0.59
" Prednisolone therapy in 22 patients (mean dosage 8 mg/day) was associated with reductions in estrone and testosterone levels; however, DHEAS and femoral BMD were also decreased in RA patients who were not receiving corticosteroids."( Sex hormone status and osteoporosis in postmenopausal women with rheumatoid arthritis.
Champion, GD; Eisman, JA; Pocock, NA; Sambrook, PN, 1988
)
1.19
"0) at high prednisolone dosage compared to the lower incidence (CMV 54."( Cytomegalo and herpes simplex virus infections in renal transplant recipients.
Geelen, JL; Slaterus, KW; van der Noordaa, J; Wertheim, P; Wilmink, JM, 1985
)
0.66
" An analysis with dose-response curves revealed that the glucocorticoids decreased the sensitivity of the GABAA receptor in a non-competitive manner."( Glucocorticoid modulates the sensitivity of the GABAA receptor on primary afferent neurons of bullfrogs.
Akasu, T; Ariyoshi, M, 1986
)
0.27
" During gradual reduction of the steroid dosage osteocalcin returned to pretreatment values."( Serum osteocalcin in rheumatoid arthritis and other inflammatory arthritides: relation between inflammatory activity and the effect of glucocorticoids and remission inducing drugs.
Ekenstam, EA; Hällgren, R; Ljunghall, S, 1986
)
0.27
"The best systemic treatment of dysthyroid ophthalmopathy remains high dosage Prednisolone."( Systemic management of dysthyroid ophthalmopathy.
Fells, P, 1988
)
0.5
" In these 7 children prednisolone dosage could be decreased significantly or discontinued altogether (44."( Immunoregulation with levamisole in children with frequently relapsing steroid responsive nephrotic syndrome.
Alon, U; Drachman, R; Drukker, A; Etzioni, A; Mor, J; Ohali, M; Schlesinger, M; Shapira, H, 1988
)
0.59
" Long term prophylactic inhalation of beclomethasone dipropionate in 26 children in a dosage up to 600 mcg/day before puberty and 400 mcg/day during puberty was shown not to affect growth."( Growth and childhood asthma.
Balfour-Lynn, L, 1986
)
0.27
"The immunosuppressive treatment with cyclosporin A plus low-dose prednisolone in 33 children after kidney transplantation was compared with conventional treatment with azathioprine plus regular prednisolone dosage in 34 children."( Cyclosporine in pediatric kidney transplantation.
Brodehl, J; Hoyer, PF; Offner, G, 1987
)
0.51
" Buserelin (d-Ser-[TBU]6 LHRH ethylamide) was prescribed in two different dosage schedules to twenty men, and in a single dosage schedule to eight women."( Failure to preserve fertility in patients with Hodgkin's disease.
Ahmed, R; Besser, GM; Crowther, D; Gregory, W; Malpas, JS; Rees, LH; Shalet, S; Smith, D; Waxman, JH; Wrigley, PF, 1987
)
0.27
"Polylactic acid-polylipoic acid nanospheres (PLA-PLIA-NS) were prepared, and their properties as drug targeting dosage forms were evaluated."( Preparation of polylactic acid-polylipoic acid nanospheres as drug targeting carriers.
Arai, K; Machida, Y; Nagai, T; Nambu, N; Nambu, Y; Takayama, K; Ueda, H, 1987
)
0.27
" During progressive decrease of steroid dosage 5 of these 8 patients remained well (mean follow-up 7 months), 2 relapsed and one died of marasmus."( [Treatment of bullous pemphigoid by plasma exchange and prednisolone].
Guillaume, JC; Revuz, J; Roujeau, JC; Touraine, R; Touzet, C, 1985
)
0.52
" All patients received oral prednisolone in the same initial dosage (0."( Controlled study of plasma exchange in pemphigus.
Doutre, MS; Guillaume, JC; Guillot, B; Lambert, D; Lauret, P; Lorette, G; Morel, P; Prigent, F; Roujeau, JC; Triller, R, 1988
)
0.57
" To assess the influence on the course of these diseases of the clinical symptoms at initial presentation and of the starting dosage of corticosteroid (CS) treatment the data for 210 patients, who were diagnosed as having PMR or TA from 1976 to 1986 and were followed up closely, were reviewed."( Polymyalgia rheumatica and temporal arteritis: a retrospective analysis of prognostic features and different corticosteroid regimens (11 year survey of 210 patients).
Cohen de Lara, A; Delecoeuillerie, G; Joly, P; Paolaggi, JB, 1988
)
0.27
" By the fifth hospital day the patient's skin lesions and conjunctivitis had improved to the point that the prednisone dosage was tapered to 120 mg, then to 80 mg, and then to nothing over the following three days."( Sulindac-induced toxic epidermal necrolysis.
Garnett, WR; Small, RE, 1988
)
0.27
" Neither dosage nor duration of treatment influenced severity, onset or duration of this mental disorders."( [Cortisone-induced psychoses].
Bleistein, J; Bräunig, P, 1988
)
0.27
" A dose-response study, at the range of 2-40 mg/kg, showed that a significant decrease was noted at 6 mg/kg and it was maximal (45% inhibition) at 20 and 40 mg/kg."( Inhibition of prostaglandin synthesis in brain of rat by dexamethasone: lack of effect of dexamethasone phosphate ester and various hormonal steroids.
Abu-Amer, Y; Shohami, E; Weidenfeld, J, 1988
)
0.27
" 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
)
0.57
" Two patients in the azathioprine group required dosage reduction because of myelosuppression and both subsequently relapsed."( Maintenance of remission in autoimmune chronic active hepatitis with azathioprine after corticosteroid withdrawal.
Johnson, PJ; Keating, JJ; McFarlane, IG; Stellon, AJ; Williams, R,
)
0.13
" Toxicity, particularly alopecia, was appreciably lower in the VMP treated patients, but subclinical cardiotoxicity was seen within the scheduled dosage for both combinations."( Mitoxantrone versus doxorubicin in combination chemotherapy for advanced carcinoma of the breast.
Cornbleet, MA; Hutcheon, AW; Kaye, SB; Kerr, ME; Leonard, RC; Robinson, S; Smyth, JF; Soukop, M; White, G, 1987
)
0.27
" Azathioprine dosage correlated negatively with post-transplantation polycythaemia regardless of the original cause of renal failure."( Polycythaemia following renal transplantation: an association with azathioprine dosage?
Hutton, RD; Newcombe, RG; Orchard, J; Price, KA; Salaman, JR; Webb, DB, 1987
)
0.27
"8%) the oral prednisolone dosage was increased, from a mean of 10."( [Management of rejection following heart transplantation using oral steroid medication].
Fieguth, HJ; Frimpong, K; Haverich, A; Herrmann, G; Jurmann, M; Kemnitz, J; Schäfers, HJ; Wahlers, T, 1987
)
0.64
" Its implication for the dosage of steroids is opposite that in steroid-induced peptic ulcers."( Oesophageal pemphigus vulgaris.
Al Karawi, M; Coode, P; Mobacken, H; Mohamed, A, 1988
)
0.27
" The treatment with ciclosporin has been continued in all 6 patients, but the dosage has been reduced to 5 mg/kg/day."( Myasthenia gravis treated with ciclosporin.
Gjerstad, L; Nyberg-Hansen, R, 1988
)
0.27
" Prednisolone shifted the dose-response curve of the GABA current downward."( Voltage-clamp studies of the inhibition of gamma-aminobutyric acid response by glucocorticoids in bullfrog primary afferent neurons.
Akasu, T; Ariyoshi, M, 1987
)
1.18
" Such chitosan/CMC-Na mixtures are a promising basis in the design of sustained release dosage forms of water-insoluble drugs."( Sustained release tablets based on chitosan and carboxymethylcellulose sodium.
Inouye, K; Machida, Y; Nagai, T, 1987
)
0.27
"Rat recipients of renal allografts and unilaterally nephrectomized control rats were studied to evaluate the response in blood pressure to prednisolone in diverse doses, and to determine the dosage required to achieve adequate immunosuppression without undue complication of hypertension."( Prednisolone and posttransplantation hypertension in rat renal allograft recipients.
de Keijzer, MH; Molenaar, JC; Provoost, AP; Van Aken, M; Wolff, ED, 1987
)
1.92
" In vitro, the dose-response curves to MP were examined in pretransplant PHA cultures."( The impact of high lymphocyte sensitivity to glucocorticoids on kidney graft survival in patients treated with azathioprine and cyclosporine.
Ladefoged, J; Langhoff, E, 1987
)
0.27
" Although their initial dosage is subject to some controversy, corticosteroids (CS) provide currently the basis of therapy."( [Immediate treatment of bullous pemphigus with a corticosteroid-cyclophosphamide combination].
Klene, C; Maleville, J; Taïeb, A, 1986
)
0.27
" Treatment with prednisolone should be given for at least two years, with adjustment of dosage according to the serum levels of aspartate transaminase; maintenance does should be 8-12 mg a day."( Treatment of chronic active hepatitis and other liver diseases with corticosteroid agents.
Mackay, IR, 1987
)
0.62
" Prednisolone (mean dosage 8 mg/day) was not associated with significantly increased bone loss in women, whereas higher dosages in men (mean 10."( Determinants of axial bone loss in rheumatoid arthritis.
Champion, GD; Eberl, S; Eisman, JA; Pocock, NA; Sambrook, PN; Yeates, MG, 1987
)
1.18
" The initial dosage was maintained for 1 or 2 weeks in each group, tailing off with a period of several weeks of oral prednisolone."( High-dose intravenous corticosteroids in the treatment of multiple sclerosis.
Hamaguchi, K; Ohno, R; Sowa, K; Tanaka, H; Watanabe, Y, 1987
)
0.48
" Patients with CAH received a four-week regimen of prednisolone with daily dosage tapering from 40 to 10 mg (total 700 mg)."( Short-term prednisolone for inducing seroconversion from hepatitis B e antigen to antibody along with clinical improvement in patients with chronic active hepatitis type B.
Ikeda, K; Kojima, M; Kumada, H; Mayumi, M; Seto, S; Suzuki, H; Tsukada, T; Yoshida, A, 1987
)
0.91
" In view of the prominent cerebral edema associated with the intracranial lymphoma, dexamethasone was initiated at a daily dosage of 8 mg by intravenous administration."( Steroid-induced regression of primary malignant lymphoma of the brain.
Kikuchi, K; Kowada, M; Miura, S; Watanabe, K, 1986
)
0.27
" In order to better understand the effects and mechanism of action of these treatments, we treated ducks chronically infected with duck hepatitis B virus (DHBV) with different dosage regimens of the two therapies."( Effects of adenine arabinoside and corticosteroid on replication of duck hepatitis B virus DNA in the liver.
Hirota, K; Okuda, K; Omata, M; Sherker, AH; Yokosuka, O, 1986
)
0.27
" However, oral dosage of the drug is difficult and regular determinations of the trough blood concentration are indispensable."( [Cyclosporin A in acute Crohn disease: initial findings].
Gyr, K; Marbet, UA; Stalder, GA, 1986
)
0.27
" Extents of absorption are compared over a 10-fold dose range of parent steroid and with the steroid derivatives by measuring plasma levels from solid oral dosage in dogs."( Oral absorption of 21-corticosteroid esters: a function of aqueous stability and intestinal enzyme activity and distribution.
Amidon, GL; Fleisher, D; Johnson, KC; Stewart, BH, 1986
)
0.27
" Blood samples were taken over a period of 12 hr after dosing for determination of corticosteroid levels and OKT4 positive lymphocyte counts."( Prednisolone concentration-effect relations in humans and the influence of plasma hydrocortisone.
Koopmans, RP; Oosterhuis, B; Schellekens, PT; ten Berge, IJ; van Boxtel, CJ, 1986
)
1.71
" 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
)
0.27
" There were negative correlations between the receptor numbers (both whole cell and nucleus) of patients and daily dosage of prednisolone."( [Studies on the glucocorticoid receptor in human peripheral lymphocytes. II. Regulation by glucocorticoid].
Oshima, H, 1986
)
0.48
" The relative receptor number was expressed as a percentage of the receptor number to the mean of the receptor number in the group of patients stratified by every 10mg/day of the dosage of prednisolone."( [Studies on the glucocorticoid receptor in human peripheral lymphocytes. III. Correlation between receptor number and clinical response to glucocorticoid].
Oshima, H, 1986
)
0.46
" Most of the flare-ups occurred during the first year of therapy and in 55% of the patients on a prednisolone dosage of 5 mg or less."( Long-term corticosteroid treatment in giant cell arteritis.
Andersson, R; Bengtsson, BA; Malmvall, BE, 1986
)
0.49
" As a decreased degradation of prednisolone during Cys treatment may lead to increased steroid activity, we recommend that a reduction of the prednisone dosage during Cys treatment is safe."( Clinical results and cyclosporine effect on prednisolone metabolism of cadaver kidney transplanted patients.
Ladefoged, J; Langhoff, E; Madsen, S; Olgaard, K, 1985
)
0.82
" Nephrotoxicity, hepatotoxicity and other side-effects of cyclosporin A could usually be dealt with by dosage adjustments, making feasible the chronic ingestion of this agent."( Cyclosporin A effective therapy for fifty-two cadaver kidney recipients.
Asano, H; Fujita, T; Kano, T; Ohshima, S; Ono, Y; Takagi, H; Uchida, K, 1985
)
0.27
" This lack of effect can be due to an inappropriate dosage of the steroid or failure of steroid treatment to alleviate endotoxin-mediated effects."( Endotoxic shock in the awake young pig: absence of beneficial effect of prednisolone sodium succinate treatment.
Houvenaghel, AM; Schrauwen, EM, 1985
)
0.5
" These results suggested that prednisolone treatment with a smaller dosage as well as with the higher dosage resulted in a carbohydrate intolerance, the main cause of which is located in a postreceptor step (or steps) of insulin action."( Erythrocyte insulin receptor and glucose tolerance test in children treated with prednisolone.
Fujimoto, S; Kan, H; Matsuda, I, 1985
)
0.78
" Renal calcification were more pronounced after dosing with 1 alpha OHD3 than after treatment with 1 alpha OHD2."( Effects of vitamin D. A comparison of 1 alpha OHD2 and 1 alpha OHD3 in rats.
Sjödén, G, 1985
)
0.27
"5 mg/day of prednisolone on the amount of calcium deposited in the kidney of rats dosed with either 500 ng/d or 2000 ng/day of 1-alpha OHD2 or 1-alpha OHD3."( The effect of prednisolone on kidney calcification in vitamin D-treated rats.
Lindgren, U; Sjöden, G, 1985
)
1.01
" 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
)
0.8
"Of nineteen patients with RPCGN who responded promptly to initial treatment with PMP or PX, and who were subsequently maintained on oral immunosuppression with prednisolone (reducing dosage from 30mg/day) and azathioprine/cyclophosphamide (1-3 mg/kg/day), five showed progressive loss of renal function within one year of responding to treatment."( Follow-up prednisolone dosage in rapidly progressive crescentic glomerulonephritis successfully treated with pulse methylprednisolone or plasma exchange.
Bone, JM; Stevens, ME, 1985
)
0.87
" In 9 cases, prednisolone (40 mg/day) was given at a constant dosage for 4 wk before Ara-A treatment."( Combination of short-term prednisolone and adenine arabinoside in the treatment of chronic hepatitis B. A controlled study.
Hirota, K; Imazeki, F; Ito, Y; Mori, J; Okuda, K; Omata, M; Uchiumi, K; Yokosuka, O, 1985
)
0.94
"3 years) with intrinsic asthma requiring corticosteroids were treated for an average of 36 days with budesonid (Pulmicort dosage aerosol, Astra Sweden) in a dose of 3 X 400 micrograms per day."( [Results of treatment with budesonide (Pulmicort) in corticosteroid-dependent intrinsic asthma].
Petri, E, 1985
)
0.27
" No detectable change in T(4) deiodination rate was observed with these agents in the dosage ranges employed in this study."( A new method for the measurement of acute alterations in thyroxine deiodination rate in man.
Nicoloff, JT, 1970
)
0.25
" DDAVP in equivalent intravenous dosage has been found to be at least as potent and to have a more prolonged action, lasting 13-22 hours instead of 1-2 hours."( DDAVP in treatment of vasopressin-sensitive diabetes insipidus.
Fraser, TR; Ward, MK, 1974
)
0.25
"A controlled trial in 20 adult patients with the nephrotic syndrome due to proliferative glomerulonephritis compared the effects of consecutive eight-week courses of treatment with prednisolone in conventional dosage and a low-dose azathioprine-prednisolone combination."( Nephrotic syndrome due to primary renal disease in adults: II. A controlled trial of prednisolone and azathioprine.
Cameron, JS; Ogg, CS; Sharpstone, P, 1969
)
0.66
"One hundred and ninety-one cases of acute lymphoblastic leukaemia were entered in a trial in which, for five months, all received cytotoxic therapy with prednisolone, vincristine, mercaptopurine, L-asparaginase, and methotrexate (the latter in high dosage followed by folinic acid)."( Treatment of acute lymphoblastic leukaemia. Comparison of immunotherapy (B.C.G.), intermittent methotrexate, and no therapy after a five-month intensive cytotoxic regimen ((Concord trial). Preliminary report to the Medical Research Council by the Leukaemi
, 1971
)
0.45
" Five glucocorticoids, when administered daily to rats for 5-7 days at a dosage of 5mg/kg, were in the following order of effectiveness with respect to their ability to decrease the weight gain of whole animals and the vastus lateralis, vastus medialis and gluteus medius muscles: corticosterone( Relative changes in the function of muscle ribosomes and mitochondria during the early phase of steroid-induced catabolism.
Bullock, GR; Carter, EE; Elliott, P; Peters, RF; Simpson, P; White, AM, 1972
)
0.43
" In the fulminant form of the disease the highly dosed application of prednisolone with ease the highly dosed application of prednisolone with parenteral hypercaloric nutrition and the substitution of mineral, protein and blood losses are therapeutically in the first place."( [Ulcerative and granulomatous colitis].
Bosseckert, H, 1981
)
0.5
"Miniaturised methods have been used to construct dose-response curves for the effects of inhibitory drugs on prostaglandin synthesis using individual rectal biopsies obtained from patients with ulcerative colitis."( Inhibition of prostaglandin synthetase in human rectal mucosa.
Hawkey, CJ; Lo Casto, M, 1983
)
0.27
" Feed was infused continuously via a nasoduodenal tube in a dosage of 2600-3200 kcal/day."( Is tube feeding with elemental diets a primary therapy of Crohn's disease?
Egger-Schödl, M; Lochs, H; Meryn, S; Pötzi, R; Schuh, R; Westphal, G, 1984
)
0.27
" dosing was 66."( Prednisolone pharmacodynamics assessed by inhibition of the mixed lymphocyte reaction.
Benet, LZ; Frey, BM; Frey, FJ; Holford, NH; Lozada, F, 1982
)
1.71
" Immunosuppression was generally reduced in the second trimester and was temporarily increased above the maintenance dosage after delivery."( [Pregnancy after kidney transplantation. Report of 6 successful cases with multiple risk factors].
Hengst, P; May, G; Mebel, M; Schilling, H; Schmitt, E; Scholz, D, 1983
)
0.27
" Age, sex, type of original nephropathy, graft source or prednisolone dosage are not related to hypertension; body weight is greater in hypertensive patients."( Prevalence and causes of hypertension late after renal transplantation.
Alexandre, GP; Kinnaert, P; Pirson, Y; Toussaint, C; Van Geertruyden, H; van Ypersele de Strihou, C; Vereerstraeten, P; Wauthier, M, 1983
)
0.51
" Reduction of the oral prednisone dosage provoked a severe exacerbation, with erythroderma associated with massive pustule formation."( Subcorneal pustular dermatosis with vesiculo-bullous eruption. Demonstration of subcorneal IgA deposits and a leukocyte chemotactic factor.
Iwase, Y; Iwatsuki, K; Tagami, H; Yamada, M, 1983
)
0.27
" We conclude from these results (1) that previously the dosage of CyA administered at this centre was probably too high, and (2) early adjustment of dose levels on the basis of blood concentrations and with low-dose prednisone cover appears to be safe and effective, but requires further verification."( Cyclosporin A used alone or in combination with low-dose steroids in cadaveric renal transplantation.
Brünisholz, M; Brunner, F; Follath, F; Harder, F; Landmann, J; Lörtscher, R; Mihatsch, M; Thiel, G; Wenk, M, 1983
)
0.27
" The dosage of CyA was related to body surface area, starting with 500 mg/m2 daily and was reduced weekly by 50 mg/m2 until the maintenance dose of 300 mg/m2 was reached at the end of the fifth week."( Dosage of Cyclosporin A in children with renal transplants.
Brodehl, J; Hoyer, PF; Offner, G; Pichlmayr, R; Wonigeit, K, 1984
)
0.27
" Nevertheless, the best initial dosage is still unknown."( [Treatment of bullous pemphigoid with prednisolone only: 0.75 mg/kg/day versus 1.25 mg/kg/day. A multicenter randomized study].
Guillaume, JC; Morel, P, 1984
)
0.54
"8 mg) participated in a double-blind cross-over study to determine the effect of timing (morning or night) of prednisolone dosage on morning stiffness."( The timing of prednisolone dosage and its effect on morning stiffness in rheumatoid arthritis.
Binder, A; De Silva, M; Hazleman, BL, 1984
)
0.84
" The mean silybin dosage was 33 mg/kg body weight/day; the mean duration of silybin therapy was 81."( [Pharmacotherapy of Amanita phalloides poisoning using silybin].
Csomos, G; Fuhrmann, M; Hruby, K; Thaler, H, 1983
)
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,
)
0.43
" The IV injection of prednisolone sodium succinate, 10 mg/kg at 25 minutes before dosing the pigs with endotoxin resulted in a significant increase in survival time."( Endotoxin shock in the pig: beneficial effects of pretreatment with prednisolone sodium succinate.
Houvenaghel, AM; Schrauwen, EM, 1984
)
0.82
" The dosage level of treatment was low enough to avoid major hematologic changes."( Effect of ophthalmic prednisolone acetate on the canine adrenal gland and hepatic function.
Lavach, JD; Macy, DW; Roberts, SM; Severin, GA, 1984
)
0.59
"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
)
1.71
" Treatment with steroid enemas resulted in symptomatic and sigmoidoscopic evidence of improvement more frequently than treatment with a dosage of oral steroid calculated to achieve similar plasma prednisolone levels."( A comparison of prednisolone enemas with low-dose oral prednisolone in the treatment of acute distal ulcerative colitis.
Axon, AT; Dickinson, RJ; Dixon, MF; Hamilton, I; Pinder, IF; Ruddell, WS, 1984
)
0.8
" 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,
)
0.13
" Although a dosage of 400 mg/kg/day was suitable for most patients, the wide range of individual responses suggested the desirability of determining an optimal dose for each patients."( A cooperative clinical trial of high-dose immunoglobulin therapy in 177 cases of idiopathic thrombocytopenic purpura.
Akatsuka, J; Uchino, H; Yasunaga, K, 1984
)
0.27
" Less neurotoxic and sufficiently effective dosage of VDS is considered to be 2 mg/m2, once weekly."( [A randomized controlled study on vindesine and vincristine in combination with prednisolone in the treatment of adult acute lymphocytic leukemia and blastic crisis of chronic myeloid leukemia].
, 1983
)
0.49
" No difference in nucleoid sedimentation was seen at a dosage of 5 mg of prednisolone, but after administration of 10, 25 and 40 mg a decrease in sedimentation velocity was observed and this effect might be explained by the DNA destabilizing effect of a steroid receptor complex followed by DNA strand breaks which had migrated into the nucleus."( [Molecular biology studies of synovial fluid cells of patients with chronic polyarthritis after intra-articular prednisolone medication].
Bröll, H, 1984
)
0.71
" Initial symptomatic response followed high dosage corticosteroid and immunosuppressant treatment, but reduction in the dosage of corticosteroids was achieved only by successive plasma exchange with concomitant reduction in plasma concentrations of both amiodarone and immune complexes."( Amiodarone associated alveolitis and polyarthropathy. Treatment by plasma exchange.
Douglas, AC; Paton, L; Russell, DC, 1983
)
0.27
" It is recommended that for maximum efficacy and minimum toxicity prednisolone therapy be confined to once-daily dosing in the morning."( Diurnal variation in prednisolone kinetics.
Dunne, M; English, J; Marks, V, 1983
)
0.82
" Oral prednisolone in the dosage described is as effective as about 10 times that dose of intravenous methylprednisolone; it is much cheaper and is viewed as less unpleasant by patients."( Comparison of high-dose intravenous methylprednisolone with low-dose oral prednisolone in acute renal allograft rejection in children.
Bewick, M; Chantler, C; Haycock, G; Orta-Sibu, N, 1982
)
1.01
"A series of 29 children with dermatomyositis has been reviewed and the outcome compared between cases treated by us initially with a low dosage short duration course of corticosteroids, and those referred late and having had various different therapeutic regimens and usually more active and higher dosage drug schedules."( Drug treatment of juvenile dermatomyositis.
Dubowitz, V; Heckmatt, JZ; Miller, G, 1983
)
0.27
" Because of the marked reduction in the extent of bioavailability of total, and especially free, prednisolone, dosage adjustments should be made accordingly if prednisolone and rifampicin are prescribed concomitantly."( Changes in prednisolone pharmacokinetics and protein binding during treatment with rifampicin.
Bergrem, H; Refvem, OK, 1983
)
0.87
" Because of the marked reduction in total and especially free prednisolone, the dosage should be adjusted accordingly if prednisolone and rifampicin are prescribed concomitantly."( Altered prednisolone pharmacokinetics in patients treated with rifampicin.
Bergrem, H; Refvem, OK, 1983
)
0.94
" All manifestations of the disease responded to the administration of prednisolone with rapid reduction of dosage to less than 10 mg daily."( Hyaline-vascular variant of angiofollicular lymph node hyperplasia with systemic manifestations and response to corticosteroids.
Bellingham, AJ; Goldsmith, HJ; Summerfield, GP; Taylor, W, 1983
)
0.5
" The planned dosage intensity had to be significantly reduced in over half of the patients because of marrow toxicity."( Measurement of drug dosage intensity in MVPP therapy in Hodgkin's disease.
Dawson, AA; Fell, LF; Green, JA; Murray, S, 1980
)
0.26
" After initial remission, the maintenance dosage of prednisolone was 10 mg per day, and the patients were prospectively followed for up to 3 1/2 years."( Deleterious effect of prednisolone in HBsAg-positive chronic active hepatitis.
Lai, CL; Lam, KC; Trepo, C; Wu, PC, 1981
)
0.83
" The daily dosage was such as to maintain the rosette-forming cell (RFC) level at 10% of baseline values."( Antithymocyte globulin in cadaver kidney transplantation: a randomized trial based on T-cell monitoring.
Bach, JF; Crosnier, J; Dandavino, R; Descamps, JM; Kreis, H; Mansouri, R; N'Guyen, AT, 1981
)
0.26
"We undertook two randomised studies in an effort to decrease the dosage of steroids in transplanted patients and to replace harmful steroid therapy by nonsteroid anti-inflammatory (NSAI) drugs."( Are there non-steroid-dependent rejection episodes?
Crosnier, J; Descamps, JM; Kreis, H; Mansouri, R, 1980
)
0.26
" It seems that a rather moderate dosage of methylprednisolone allows us to prolong and repeat the courses according to individual needs, and this may be the main reason for the significantly improved graft function at one year."( Steroids and rejection treatment in the Gothenburg transplant programme.
Brynger, H; Gelin, LE, 1980
)
0.52
" A relationship between mortality from a urological complication and steroid dosage was found."( The urological complications of 1000 renal transplants.
Bewick, M; Ellis, FG; Mundy, AR; Podesta, ML; Rudge, CJ, 1981
)
0.26
" It is suggested that the dosage of corticosteroid should be adjusted according to the severity of uveomeningitis."( Systemic corticosteroid treatment in Vogt-Koyanagi-Harada disease.
Hayasaka, S; Okabe, H; Takahashi, J, 1982
)
0.26
" The dose-response curve for prednisolone plateaued at high doses."( Influence of prednisolone on ethanol-induced gastric injury in the rat.
Derelanko, MJ; Long, JF, 1982
)
0.92
" Two oral corticosteroids, prednisolone (8 mg/day) and betamethasone (1 mg/day) have been compared in terms of efficacy and adrenal suppressive activity when used in chronic oral dosage in rheumatoid arthritis."( A pharmacological and clinical comparison of prednisolone and betamethasone in rheumatoid arthritis.
Al-Shakarchi, H; Bird, HA; Dixon, JS; Lowe, JR; Marwah, RJ; Pickup, ME; Wright, V, 1982
)
0.82
" dosage range."( Dose dependent pharmacokinetics of prednisone and prednisolone in man.
Jusko, WJ; Rose, JQ; Yurchak, AM, 1981
)
0.52
" Animals born of mothers given the highest dosage of the drug (400 microgram) weighed less than controls in adulthood."( Deleterious effects of prenatal prednisolone exposure upon morphological and behavioral development of mice.
Gandelman, R; Rosenthal, C, 1981
)
0.55
" Peak prednisolone levels were reached at between 2 and 4 hours after the intra-articular injection at both dosage levels, though the peak was higher with the larger dose."( Plasma steroid levels after intra-articular injection of prednisolone acetate in patients with rheumatoid arthritis.
Chakraborty, J; English, J; Gibson, T; Marks, V; Reeback, JS, 1980
)
0.99
"Changes in the level of neutrophil alkaline phosphatase (NAP) in a population of peripheral blood neutrophils were determined in healthy subjects dosed with either aetiocholanolone (Aetio, 4 mg/m2 im) or prednisolone sodium succinate (Pred, 30 mg/m2 iv)."( Alkaline phosphatase as a marker of maturity in human neutrophils. Studies in normals dosed with aetiocholanolone and prednisolone.
Mishler, JM; Williams, DM, 1980
)
0.66
" Saliva prednisolone levels were measurable for at least 3 h after dosing but showed no consistent relationship to either total or free plasma prednisolone concentrations."( Prednisolone concentrations in plasma, saliva and urine.
Baylis, M; Chakraborty, J; English, J; Hayes, M; Marks, V, 1981
)
2.14
" In the acute croton oil-induced ear edema dose-response bioassay, the topical anti-inflammatory potencies of these esters relative to prednisolone, 1, were: 8a:1."( Steroidal anti-inflammatory antedrugs: synthesis and pharmacological evaluation of 16 alpha-alkoxycarbonyl-17-deoxyprednisolone derivatives.
Choi, SJ; Khalil, MA; Kwon, T; Lee, HJ; Yoon, KJ, 1995
)
0.7
" Height SD score for age (HtSDS(ca)), HtSDS for bone age (HtSDS(ba)), BMI and steroid dosage in early childhood (3."( Adult height in women with early-treated congenital adrenal hyperplasia (21-hydroxylase type): relation to body mass index in earlier childhood.
Grant, DB; Yu, AC, 1995
)
0.29
" The initial heavy proteinuria promptly decreased after the prednisolone dosage was increased and disappeared 4 weeks later."( Minimal-change nephrotic syndrome associated with systemic lupus erythematosus.
Haramoto, T; Makino, H; Ogura, T; Ota, Z; Shikata, K, 1995
)
0.53
" Dose escalation was required in order to control carcinoid symptoms, and the final dosage was 5,950 micrograms/day."( Long-term survival in a patient with malignant carcinoid treated with high-dose octreotide.
Deguchi, H; Deguchi, K; Iwasaki, E; Kobayashi, T; Murashima, S; Shirakawa, S; Tsuda, M; Tsukada, T, 1994
)
0.29
" Over the next 6 months the prednisolone dosage was decreased to 10 mg daily."( [Collagenous sprue].
Fuhrmann, K; Hafkemeyer, P; Herbst, E; Köhler, G; Kreisel, W, 1995
)
0.59
" At a dosage of 20 mg/day, however, multiple nodular shadows were present on the X-ray film of the chest, but they disappeared after the dosage was increased."( [A case of idiopathic pulmonary arteritis with positive anti-myeloperoxidase antibodies].
Katou, K; Kimura, H; Kuriyama, T; Nagao, K; Okada, O; Shishihara, K; Tanabe, N; Tatsumi, K; Uchiyama, T, 1995
)
0.29
" During the last 6 months prior to the study the patients had a median Crohn's disease activity index (CDAI) of 193 (interquartile range: 122-230) (monthly controls) with a median prednisolone dosage of 14 mg per day (9-20)."( Budesonide in glucocorticoid dependent chronic active Crohn's disease; a pilot study.
Kleinberger, M; Lochs, H; Moser, G; Novacek, G; Vogelsang, H, 1995
)
0.48
" 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
" Corticosteroid dosage was then reduced according to clinical improvement."( Long-term corticosteroid and dipyridamole treatment of membranoproliferative glomerulonephritis type I in children.
Matsutani, H; Niimura, F; Takeda, A, 1995
)
0.29
"A dose of CBG to yield 95% binding with 1000 ng/ml of prednisolone in vitro in rat plasma or saline was administered before dosing 2 mg/kg of prednisolone hemisuccinate or methylprednisolone intravenously."( Effect of corticosteroid binding globulin on the pharmacokinetics of prednisolone in rats.
Almon, RR; Jusko, WJ; Ko, HC, 1995
)
0.77
" Dose-response profiles of the croton oil-induced ear edema bioassay in rats were used to calculate the following ID50 values (nmol/ear resulting in a 50% reduction of edema): prednisolone (P), 540 nmol; 2b, 135 nmol; and 3b, 101 nmol."( New steroidal antiinflammatory antedrugs: steroidal [16 alpha,17 alpha-d]-3'-carbethoxyisoxazolines.
Heiman, AS; Kwon, T; Lee, HJ; Oriaku, ET; Yoon, K, 1995
)
0.48
"In the dosage used, diclofenac was as effective an anti-inflammatory agent for uncomplicated post-cataract inflammation as prednisolone."( A comparison of topical diclofenac with prednisolone for postcataract inflammation.
Brennan, KM; Roberts, CW, 1995
)
0.77
" After an initial loading dose of 120 mg prednisolone per day for 6 weeks (11/1986), the steroid dosage was reduced to 40 mg (12/1986) and diminished to 15 mg/day in 1988 to 1989."( [Löffler endocarditis fibroplastica with simultaneous infectious endocarditis].
Bethge, C; Drude, L; Herzum, M; Maisch, B; Menz, V; Schönian, U, 1994
)
0.55
" Clinical response and outcome, as well as prednisone dosage and adverse effects, were recorded throughout the followup period."( Analysis of steroid related complications and mortality in temporal arteritis: a 15-year survey of 43 patients.
Friedlander, Y; Nesher, G; Sonnenblick, M, 1994
)
0.29
" The dosage of methylprednisolone (30 mg/kg/6 hours) which was successful in the National Acute Spinal Cord Injury Study 2 (NASCIS 2) evolved from the unique pharmacology of corticosteroids as antioxidants."( Traumatic optic neuropathy.
Goldberg, RA; Steinsapir, KD,
)
0.45
" On increasing the dosage of CCA to 320 mg/day because of unsatisfactory symptomatic responses elicited at the initial dose level, the patient became free from an asthmatic attack with a return to normal of his eosinophilic count."( [Successful treatment with lobenzarit disodium in case of Churg-Strauss syndrome].
Akiyama, Y; Dohi, Y; Imai, F; Katagiri, T; Ohno, S; Suzuki, T; Tanaka, M, 1993
)
0.29
" The patient has been in full remission for 25 months (prednisolone dosage reduced to 12."( [Angioimmunoblastic lymphadenopathy with dysproteinemia and sclerosing cholangitis].
Garbrecht, M; Nerl, C; Schmitt, W; Wegerle, W, 1994
)
0.54
" In this trial, the combination therapy was effective for the decrease of urinary protein in one case, and for the reduction of a dosage of oral PSL in one case."( [Effects of combined administration of prednisolone and mizoribine in the course of remission for SLE children with nephritis].
Aihara, Y; Ibe, M; Kuriyama, T; Mitsuda, T; Mori, M; Shimizu, C; Takahashi, Y; Yokota, S, 1994
)
0.56
" All three glucocorticoids were found to cause a modest induction of NAT activity towards procainamide after dosing for 10 days."( Glucocorticoid induction of hepatic acetyl CoA:arylamine N-acetyltransferase activity in the rat.
Svensson, CK; Zaher, H, 1994
)
0.29
" The three laboratory investigations were, therefore, of limited value in confirming relapses of PMR/GCA during prednisolone treatment, but alpha 1-ACT may be useful as an indicator of underlying disease activity and hence as a guide to the speed that the prednisolone dosage should be reduced."( Alpha 1-antichymotrypsin, C-reactive protein and erythrocyte sedimentation rate in polymyalgia rheumatica and giant cell arteritis.
Calvin, J; Hazleman, BL; Pountain, GD, 1994
)
0.5
" Slope differences in the dose-response curves suggest that prednisolone-induced muscle atrophy in the plantaris was more severe than that in the diaphragm."( Exercise and glucocorticoid-induced diaphragmatic myopathy.
Chen, CL; Criswell, D; Herb, RA; Lieu, FK; Martin, D; Powers, SK; Stainsby, W; Wood, C, 1993
)
0.53
"Twelve patients with chronic severe asthma, taking a mean daily dosage of 8 mg of prednisolone for a mean (SD) of 16."( Sternomastoid muscle fatigue and twitch maximum relaxation rate in patients with steroid dependent asthma.
Bugler, JR; Mak, VH; Spiro, SG, 1993
)
0.51
" For the dosage tested, we found no depression of adrenal function, neither in circadian cortisol secretion nor in hCRH-stimulation-test."( [Adrenal cortex function in children with bronchial asthma in fluticasone therapy].
Büttner, P; Hoffmann-Streb, A; L'Allemand, D; Niggemann, B; Wahn, U, 1993
)
0.29
" Prednisolone dosage at start of therapy depended on initial inflammatory activity (CDAI)."( [Alpha-interferon therapy in Crohn's disease: initial clinical results].
Ammann, R; Jost, R; Meyenberger, C; Münch, R; Wirth, HP; Zala, G, 1993
)
1.2
" A recurrence occurred after 5 months, while on a prednisolone dosage of 10 mg daily, together for the first time with arthralgias, suggesting systemic involvement."( [Glucocorticoid monotherapy for Cogan syndrome?].
Helmchen, C; Samtleben, W; Terjung, B, 1993
)
0.54
" The dosage was 20 mg qid via a special inhaler."( [Efficacy of disodium cromolyn in adult chronic asthma].
Ho, LI; Lien, TC; Wang, JH, 1993
)
0.29
" The complete absence of suppression of the corticoadrenal axis by fluticasone propionate was encouraging, however, and a higher dosage schedule should be assessed."( Double blind trial of oral fluticasone propionate v prednisolone in the treatment of active ulcerative colitis.
Burke, DA; Giaffer, MH; Hawkey, CJ; Hawthorne, AB; Holdsworth, CD; Keech, ML; Record, CO, 1993
)
0.54
" Attempts to further decrease the dosage of steroids or to discontinue their use were met with immediate recurrences of manifestations of the disease."( Usefulness of inhaled high-dose corticosteroids in allergic bronchopulmonary aspergillosis.
Cormier, Y; Imbeault, B, 1993
)
0.29
" The increasing dosage of steroid (60mg/day) improved general edema and decreased urinary protein, but abdominal pain and fullness occurred seven weeks after the admission."( [Pneumatosis cystoides intestinalis following steroid treatment in a nephrotic syndrome patient: report of a case].
Iitsuka, T; Izumi, Y; Kobayashi, M; Koyama, A, 1993
)
0.29
" The therapeutic protocol for ITP, proposed by the Japanese Idiopathic Disease of Hematopoietic Organ Research Committee, was modified for the elderly (group) as follows: the initial dosage of prednisolone was reduced by half and danazol therapy was selected in cases in which splenectomy was impossible."( [Treatment of elderly patients with chronic idiopathic thrombocytopenic purpura].
Abe, T; Hasegawa, Y; Kojima, H; Nagasawa, T; Ninomiya, H; Shibuya, A, 1993
)
0.48
" Increased TG levels were associated with increase in weight and higher daily prednisolone dosage at the time of evaluation."( Dyslipoproteinemia in renal transplantation.
Acharya, VN; Almeida, AF; Gunjotikar, RV; Taskar, SP,
)
0.36
"The purpose of this study was to examine the relationship of cumulative steroid dosage and duration of therapy with osteoporosis."( Osteoporosis in steroid-dependent asthma.
Gordon, EH; Hahn, TJ; Klaustermeyer, WB; Villareal, MS, 1996
)
0.29
" The dosage was reduced to 50 per cent after one week."( [Pharmacokinetics and tolerance of an orally administered combination preparation containing phenylbutazone and prednisolone in the dog].
Engelke, A; Kietzmann, M; Meyer-Lindenberg, A; Nolte, I, 1996
)
0.51
" This finding may serve to guide the selection of dexamethasone dosage in the treatment of ALL."( Comparative cytotoxicity of dexamethasone and prednisolone in childhood acute lymphoblastic leukemia.
Campana, D; Coustan-Smith, E; Evans, WE; Ito, C; Mahmoud, H; McNinch, L; Pui, CH, 1996
)
0.55
"To compare the long term effects of low dosage prednisolone or deflazacort treatments on bone mass in patients with polymyalgia rheumatica."( Changes in bone mass during low dose corticosteroid treatment in patients with polymyalgia rheumatica: a double blind, prospective comparison between prednisolone and deflazacort.
Krogsgaard, MR; Lund, B; Thamsborg, G, 1996
)
0.75
" We emphasise that the accuracy especially of the CRP for early prediction of silent infection in preterm labour does not seem to be impaired by this corticosteroid in a dosage usually administered for prevention of respiratory distress syndrome."( [Does lung maturation therapy with 16-methylene-prednisolone modify maternal infection parameters in threatened premature labor?].
Heyl, W; Rath, W; Reister, F; Winkler, M, 1996
)
0.55
"The smaller dosage of tacrolimus led to a higher trough concentration of 14."( Three-times-daily monotherapy with tacrolimus (FK 506) in kidney transplantation.
Fukunishi, T; Hanafusa, T; Ichikawa, Y; Kyo, M; Nagano, S, 1996
)
0.29
" The modal initial dosage of oral prednisolone was 40 mg for the adult and 30 mg for the child, and modal duration of oral steroid dosage was 5 days for both adult and child."( Management of acute asthma attacks associated with respiratory tract infection: a postal survey of general practitioners in the U.K.
Gruffydd-Jones, K; Jones, K, 1996
)
0.57
" Forty-eight patients with acute optic neuritis were treated orally either with methylprednisolone (100 mg per day initially, dosage reduction every 3 days; n = 15) or with thiamine (100 mg per day; n = 33) in the control group, 36 of them in a double-blind procedure."( The effect of oral prednisolone on visual evoked potential latencies in acute optic neuritis monitored in a prospective, randomized, controlled study.
Diener, HC; Dietz, K; Trauzettel-Klosinski, S; Zrenner, E,
)
0.68
" The aim of the present study was to evaluate if growth hormone administration would have an anabolic effect on rat bone when given to animals also receiving a high dosage of glucocorticoid."( Growth hormone is not able to counteract osteopenia of rat cortical bone induced by glucocorticoid with protracted effect.
Andreassen, TT; Brüel, A; Ortoft, G; Oxlund, H, 1995
)
0.29
" After initial chemotherapy, he received intravenous methotrexate (total dosage 1,035 mg), intrathecal methotrexate (total dosage 221 mg), and whole brain irradiation (2,400 cGy)."( Lenńox-Gastaut syndrome associated with leukoencephalopathy.
Ikuta, H; Mitsufuji, N; Sawada, T; Yoshioka, H, 1996
)
0.29
"Using standard lymphocyte culture techniques, the concentration of prednisolone (P) and methylprednisolone (MP) required to cause 50% inhibition (IC50) of the proliferative response to phytohemagglutinin (PHA) was determined from dose-response curves."( Differential glucocorticoid responsiveness of dialysis patients' lymphocytes.
Briggs, WA; Burdick, JF; Choi, MJ; Gao, ZH; Gimenez, LF; Scheel, PJ,
)
0.37
" The steroid dosage could be significantly reduced in group 1 (-3."( Association of methotrexate and corticosteroids in the treatment of patients with rheumatoid arthritis.
Bologna, C; Jorgensen, C; Sany, J,
)
0.13
" From the dose-response curves, the concentration of steroid required to cause 50% inhibition (IC50) of the PHA-induced proliferative response was determined."( Lymphocyte responsiveness to glucocorticoids, cyclosporine, or both.
Briggs, WA; Burdick, JF; Choi, MJ; Gao, ZH; Gimenez, LF; Scheel, PJ, 1996
)
0.29
" We found three predictors of flares: renal disease, persistence of dsDNA antibodies for at least 1 year after the beginning of treatment and reduction in azathioprine dosage to below 2 mg/kg/d."( Predictors of flares and long-term outcome of systemic lupus erythematosus during combined treatment with azathioprine and low-dose prednisolone.
Abendroth, K; Hein, G; Oelzner, P; Stein, G, 1996
)
0.5
" Follicular bronchiolitis was diagnosed from the results of an open-lung biopsy, and prednisolone therapy was started at a dosage of 40 mg/day."( [Follicular bronchiolitis associated with rheumatoid arthritis].
Chida, K; Hayakawa, H; Imokawa, S; Iwata, M; Morita, S; Sato, A; Sato, J; Todate, A; Toyoshima, M; Tsukamoto, K, 1996
)
0.52
" Dosage was reduced gradually to 10 mg daily over 4 weeks."( Therapeutic responses to corticosteroids in Graves' ophthalmopathy.
Chang, TC; Hsiao, YL; Huang, KM; Kao, SC; Lu, CP; Tzeng, SS, 1996
)
0.29
" The requirement that suspension eyedrops and similar dosage forms should be redispersable after sedimentation upon storage is stated in the monographs on eyedrops of the German Pharmacopoeia and can be found in similar contexts in other pharmacopoeias."( [Dosage problems in suspension eyedrops].
Diestelhorst, M; Kwon, KA; Süverkrüp, R,
)
0.13
" A variable dosing pattern with acceptable mean was observed for Chibro-Amuno 3, while the results for Inflanefran-forte were fully satisfactory."( [Dosage problems in suspension eyedrops].
Diestelhorst, M; Kwon, KA; Süverkrüp, R,
)
0.13
" Nine sirolimus dosage levels from 1 mg/m2/day to 13 mg/m2/day were studied and compared with placebo."( Pharmacokinetics of prednisolone during administration of sirolimus in patients with renal transplants.
Ferron, GM; Jusko, WJ; Kahan, BD; Mis, SM; Zimmerman, JJ, 1996
)
0.62
" Reduction of the prednisolone dosage was associated with multiple erosions in the esophagus."( Nonscarring inflammatory epidermolysis bullosa acquisita with esophageal involvement and linear IgG deposits.
Inaoki, M; Mori, T; Nishimura, Y; Takehara, K; Taniuchi, K, 1997
)
0.63
" As a consequence of improved delivery of enteral nutrition, in the year after the insertion of the gastrostomy there was a reduction in prednisolone dosage in all patients, with six patients being able to stop prednisolone completely."( Experience of percutaneous endoscopic gastrostomy in children with Crohn's disease.
Cosgrove, M; Jenkins, HR, 1997
)
0.5
" The dosage schedule was governed by the clinical and echocardiographic findings."( [Löffler's parietal fibroplastic endocarditis. Echocardiographic course over 5 years].
Braun, B; Günther, E; Hust, MH; Metzler, B; Perier, P, 1997
)
0.3
"Four children, 4 to 10 years old, with chronic uveitis were treated with cyclosporin A (CsA; starting dosage 2 mg/kg per day) and prednisolone."( [Cyclosporin A in therapy of chronic uveitis in childhood].
Dannecker, G; Schlote, T; Thiel, HJ; Zierhut, M, 1996
)
0.5
" We also investigated the effect of glucocorticoid in 10 DMD patients taking a dosage of prednisolone 1 mg/kg on alternate day."( [Glucocorticoid therapy in Duchenne muscular dystrophy].
Kang, J, 1996
)
0.52
" Plasma collected at intervals over the 48 h from dosing also suppressed monocyte TNF-alpha release in relation to the prednisolone concentration therein."( Suppression of human monocyte tumour necrosis factor-alpha release by glucocorticoid therapy: relationship to systemic monocytopaenia and cortisol suppression.
Joyce, DA; Steer, JH; Vuong, Q, 1997
)
0.51
" Both groups showed no statistical differences in number, kidney function, age, body weight, sex distribution, steroid dosage and follow-up time after transplantation."( Effects of cyclosporin A and FK 506 on lipid metabolism and fibrinogen in kidney transplant recipients.
Arlt, M; Brückner, D; Dietl, KH; Hohage, H; Spieker, C; Zidek, W, 1997
)
0.3
" However, in severely relapsed cases, corticosteroids are not always effective even when a high dosage is administered."( A pilot study of centrifugal leukocyte apheresis for corticosteroid-resistant active ulcerative colitis.
Ashida, T; Ayabe, T; Einami, K; Kohgo, Y; Nomura, M; Ono, M; Saitoh, Y; Santos, SB; Shibata, Y; Taniguchi, M; Taruishi, M, 1997
)
0.3
"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
)
0.3
" 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
"The aim of the study was to compare the long term effects of low dosage prednisolone or deflazacort treatment on bone mass in patients with polymyalgia rheumatica."( [Bone loss during low dose glucocorticoid treatment in patients with polymyalgia rheumatica. A double-blind, prospective comparison between prednisolone and deflazacort].
Krogsgaard, MR; Lund, B; Thamsborg, G, 1997
)
0.73
" His condition was dramatically improved within 1 week, and he is now well on an outpatient basis with the maintenance dosage of corticosteroid."( A case of a dialysis patient with sclerosing peritonitis successfully treated with corticosteroid therapy alone.
Hotta, N; Kawahara, H; Matsuo, S; Mori, Y; Sutoh, H; Toriyama, T, 1997
)
0.3
" The prednisolone dosage was then tapered to 5 mg/day."( Subglottic stenosis in Wegener's granulomatosis limited to the head and neck region.
Kadota, Y; Saeki, K; Yumoto, E, 1997
)
0.81
" The occurrence of steroid side effects depends on dosage and duration of steroid treatment."( [Steroid-induced myopathy in left-sided ulcerative colitis. Successful treatment and continued therapy with the topical steroid budesonide].
Andus, T; Caesar, I; Gross, V; Hohenberger, W; Roth, M; Schölmerich, J, 1997
)
0.3
"To compare the efficacy and safety of two dosage regimens of budesonide and prednisolone in patients with active Crohn's disease affecting the ileum and/or the ascending colon."( Oral budesonide is as effective as oral prednisolone in active Crohn's disease. The Global Budesonide Study Group.
Campieri, M; Doe, W; Ferguson, A; Nilsson, LG; Persson, T, 1997
)
0.79
"To probe into the pathogenesis of osteonecrosis of the femoral head, the authors obtained 37 asymptomatic human femoral heads at autopsy; of these, 13 were cases of high dosage corticosteroid therapy (steroid group) and 24 were cases without steroid therapy (nonsteroid group)."( Histopathologic alterations of retinacular vessels and osteonecrosis.
Hirano, K; Sueishi, K; Sugioka, Y; Tsutsui, H, 1997
)
0.3
"We evaluated a 1-year course of a newly developed immunosuppressant, mizoribine (at a dosage of 3 mg/kg body weight per day), in nine children with steroid-dependent nephrotic syndrome."( Mizoribine in steroid-dependent nephrotic syndrome of childhood.
Hamasaki, T; Kinoshita, Y; Mori, M; Saeki, T; Sakano, T, 1997
)
0.3
" As the steroid dosage was reduced, bone mass improved."( Effects of inflammation and treatment on bone turnover and bone mass in polymyalgia rheumatica.
Corrigall, V; Dasgupta, B; Dolan, AL; Li, F; Mackintosh, C; Moniz, C; Panayi, GS; Todd, P, 1997
)
0.3
" No proteinuria was observed after total dosage of immunosuppressants was increased."( [A case of recurrent IgA nephropathy following renal transplantation under tacrolimus (FK506)].
Hatori, M; Honda, M; Ichimaru, N; Imai, E; Kokado, Y; Kyo, M; Matsumiya, K; Miyamoto, M; Nonomura, N; Okuyama, A; Takahara, S; Takao, T; Yokoyama, K, 1997
)
0.3
" Potency estimates were made by comparing the dose-response of natural and synthetic glucocorticoids to that of corticosterone, the major glucocorticoid in rats."( Calcium-lowering action of glucocorticoids in adrenalectomized-parathyroidectomized rats. Specificity and relative potency of natural and synthetic glucocorticoids.
Hirsch, PF; Mahgoub, A; Munson, PL, 1997
)
0.3
"A 5-mg/kg dosage of ganciclovir was administered intravenously over a 60-min period under continuous venovenous hemodiafiltration."( Pharmacokinetics and clearance of ganciclovir during continuous hemodiafiltration.
Gando, S; Hayakawa, T; Kameue, T; Nakanishi, Y; Nanzaki, S, 1998
)
0.3
" To address possible differences in steady-state time-course, the aim of this study was to determine if repeated dosing with inhaled fluticasone would have facilitatory effects on lymphocyte beta2-AR."( Effects of oral and inhaled corticosteroid on lymphocyte beta2-adrenoceptor function in asthmatic patients.
Lipworth, BJ; McFarlane, LC; Tan, KS, 1997
)
0.3
"Repeated dosing with high-dose inhaled fluticasone did not up-regulate lymphocyte beta2-AR as compared with a single dose of oral prednisolone, despite having significantly suppressed early morning plasma cortisol."( Effects of oral and inhaled corticosteroid on lymphocyte beta2-adrenoceptor function in asthmatic patients.
Lipworth, BJ; McFarlane, LC; Tan, KS, 1997
)
0.5
" A dose-response curve (DRC) for systemic beta2-responses to inhaled salbutamol (800 to 3,200 microg) was constructed before and after each treatment period (ie, FM + PL or FM + PRED)."( Concomitant administration of low-dose prednisolone protects against in vivo beta2-adrenoceptor subsensitivity induced by regular formoterol.
Lipworth, BJ; McFarlane, LC; Tan, KS, 1998
)
0.57
" Its use as a second agent in combination with another immunosuppressant might enable reduction in the dosage or time of application."( A low dose immunorestorative effect of aporphinoid alkaloid oxoglaucine on experimentally immunosuppressed and infected mice.
Ivanovska, N; Philipov, S, 1997
)
0.3
" Prednisolone dosage was reduced and cyclosporin (350 mg/d) substituted for azathioprine."( [Late manifestation of a fatal Behçet's disease with cardiac involvement and lethal outcome].
Bocker, T; Görnig, M; Kaatz, M; Wollina, U; Zouboulis, CC, 1998
)
1.21
"The influence of prednisolone on monocyte chemotactic activity in vitro at prednisolone concentrations comparable with those achieved in man following oral dosage has been investigated."( Effect of long-term corticosteroid therapy on monocyte chemotaxis in man.
Halliday, JW; Powell, LW; Tanner, AR, 1980
)
0.6
"016) with the current glucocorticoid dosage (r=-0."( Testosterone levels in men with chronic obstructive pulmonary disease with or without glucocorticoid therapy.
Behre, HM; Castel, MA; Kamischke, A; Kemper, DE; Lüthke, M; Magnussen, H; Nieschlag, E; Rolf, C, 1998
)
0.3
" We retrospectively evaluated 35 children with idiopathic NS, 24 with steroid-dependent NS (SDNS), and 11 with steroid-resistant NS (SRNS), who received CsA therapy for more than 12 months (median, 23 months) at the dosage maintaining 50 to 120 ng/mL in trough level."( Follow-up study of children with nephrotic syndrome treated with a long-term moderate dose of cyclosporine.
Fukushima, K; Hino, S; Murakami, K; Okada, M; Takemura, T; Yagi, K; Yoshioka, K, 1998
)
0.3
" The dosage reductions are all significant but with no differences between the groups."( Comparison of three treatment regimens of inhaled sodium cromoglycate in the management of adult patients with severe, steroid-dependent asthma.
Asai, S; Edwards, A; Kohno, S; Matsuo, N; Matsuse, H; Obase, Y; Sakai, H; Shimoda, T, 1998
)
0.3
" Duration of treatment, dosage of drugs per kg body weight and serum cyclosporin levels were recorded."( Contribution of individual drugs to gingival overgrowth in adult and juvenile renal transplant patients treated with multiple therapy.
Ashley, FP; Koffman, CG; Morel, A; Ogg, CS; Rigden, SP; Smith, D; Wilson, RF, 1998
)
0.3
" The median total dosage of prednisolone at the time of diagnosis was 189 mg/kg (single manifestation 150 mg/kg; multiple manifestations 313 mg/kg) with a total range of 13-555 mg/kg."( Avascular necrosis of bone following allogeneic stem cell transplantation: MR screening and therapeutic options.
Böhm, P; Einsele, H; Faul, C; Kanz, L; Pereira, P; Wiesmann, A, 1998
)
0.59
" The same symptoms subsequently recurred, and ESR and CRP levels increased proportionately to a decreased dosage of prednisolone."( [Chronic thromboembolic pulmonary hypertension associated with initial pulmonary involvement in Takayasu arteritis].
Kashiwabara, K; Kiguchi, T; Kishi, K; Kobayashi, K; Kusama, H; Matsuoka, T; Nakamura, H; Sarashina, G; Yagyu, H, 1998
)
0.51
" After tapering of the corticosteroid dosage to a low level the retinal detachment resolved without laser treatment."( Fibrotic scar formation in central serous chorioretinopathy developed during systemic treatment with corticosteroids.
Hooymans, JM, 1998
)
0.3
"The colon-targeted delivery capsule (CTDC), a new capsule-type dosage form for colonic delivery of drugs, was investigated for the in vivo drug release behavior in dogs."( In vivo drug release behavior in dogs from a new colon-targeted delivery system.
Hatano, H; Ishibashi, T; Kobayashi, M; Mizobe, M; Yoshino, H, 1999
)
0.3
" Whole blood T-cell trafficking was determined indirectly by using the glucocorticoid receptor antagonist RU-40555 (250 ng/mL) added to ex vivo cultures of whole blood from animals dosed with prednisolone."( Influence of gender on prednisolone effects on whole blood T-cell deactivation and trafficking in rats.
Gobburu, JV; Jusko, WJ; Meno-Tetang, GM, 1999
)
0.8
" The interindividual variation was found to be mainly the time lag between dosage and maximum effect."( The effects of the glucocorticoids prednisolone, deflazacort and beclomethasone-dipropionate on the RM 3/1 macrophage in human peripheral blood.
Schmutzler, W; Zwadlo-Klarwasser, G, 1998
)
0.58
" These values were sustained throughout dosing but declined rapidly to baseline upon cessation of treatment."( Pharmacological validation of a feline model of steroid-induced ocular hypertension.
Bhattacherjee, P; Graff, G; Paterson, CA; Spellman, JM; Yanni, JM, 1999
)
0.3
" During pregnancy she was treated with a daily dosage of prednisolone 15 mg."( Successful pregnancy and delivery in a case of systemic lupus erythematosus treated with immunoadsorption therapy and cyclosporin A.
Kodama, N; Maeshima, E; Mune, M; Yamada, Y; Yukawa, S, 1999
)
0.55
" The administration of G-CSF at a dosage of 5 micrograms/kg/day for 11 doses following CHOP resulted in an overall net cost of $Can1257."( Cost-benefit analysis of prophylactic granulocyte colony-stimulating factor during CHOP antineoplastic therapy for non-Hodgkin's lymphoma.
Altmayer, C; Dranitsaris, G; Quirt, I, 1997
)
0.3
" Corticosteroid dosage was tapered according to a standard protocol."( Randomised trial of mycophenolate mofetil versus azathioprine for treatment of chronic active Crohn's disease.
Krummenauer, F; Meyer zum Büschenfelde, KH; Neurath, MF; Peters, M; Schlaak, JF; Wanitschke, R, 1999
)
0.3
" Except for the angiotensin-converting enzyme inhibitor, these medications were not effective in terms of allowing a reduction in the high dosage of steroid, which in turn threatened progressive osteoporosis and lumbar vertebrae fracture."( Effect of pituitary microsurgery on acromegaly complicated nephrotic syndrome with focal segmental glomerulosclerosis: report of a rare clinical case.
Akikusa, B; Hasegawa, S; Iesato, K; Murotani, N; Saeki, N; Shimada, T; Wakashin, M; Yamamoto, S; Yoshida, H, 1999
)
0.3
" MMF was administered at a dosage of 2 gm/day whereas Aza was initiated at 2 mg/kg/day and adapted by leukocyte count."( Comparison between mycophenolate mofetil- and azathioprine-based immunosuppressions in clinical lung transplantation.
Artemiou, O; Birsan, T; Dekan, G; Klepetko, W; Taghavi, S; Wisser, W; Wolner, E; Zuckermann, A, 1999
)
0.3
" After increased dosage of systemic prednisolone was prescribed, the retinal vascular changes resulting from CRVO (papillophlebitis) in the left eye gradually abated."( Central retinal vein occlusion during remission of ulcerative colitis.
Doi, M; Fujioka, C; Nakaseko, Y; Uji, Y,
)
0.41
"3 mg/kg body weight) initially for 2 months; the dosage was then reduced to half of the initial dose for the third month and was halved again for the fourth and final month."( The efficacy of low-dose oral corticosteroids in the treatment of vitiligo patients.
Hann, SK; Kim, SM; Lee, HS, 1999
)
0.3
" A moderate to high dosage of corticosteroids suppressed the development of new skin lesions, but relapses occurred when these systemic corticosteroids were tapered."( Epstein-Barr virus-associated lymphoproliferative skin lesion with recurrent necrotic papulovesicles of the face.
Jung, DY; Kim, JW; Lee, SK; Lee, WW, 1999
)
0.3
" In this group, a trial of prednisone withdrawal was initiated when patients were 6 months or more post-OLT, with normal liver function, and receiving an average prednisone dosage of 10 mg/d."( Successful withdrawal of prednisone after adult liver transplantation for autoimmune hepatitis.
Everson, GT; Kam, I; Shrestha, R; Trouillot, TE; Wachs, M, 1999
)
0.3
"The objective of the present study was to evaluate the dosing regimen of immunosuppressants necessary to avoid the formation of anti-hGH antibodies in a pig model."( Plasma concentration of hGH and anti-hGH antibodies after subcutaneous administration of hGH for 3 weeks to immunosuppressed pigs.
Agersø, H; Drustrup, J; Haahr, PM; Jørgensen, KD; Wilken, M, 1999
)
0.3
" All groups were dosed subcutaneously (s."( Plasma concentration of hGH and anti-hGH antibodies after subcutaneous administration of hGH for 3 weeks to immunosuppressed pigs.
Agersø, H; Drustrup, J; Haahr, PM; Jørgensen, KD; Wilken, M, 1999
)
0.3
"To determine the systemic dose-response relationships with oral prednisolone and inhaled fluticasone propionate administered in a putative 11:1 mg equivalent basis, in terms of effects on adrenal, bone and haematological markers."( Short-term dose-response relationships for the relative systemic effects of oral prednisolone and inhaled fluticasone in asthmatic adults.
Lipworth, BJ; Wilson, AM, 1999
)
0.77
"Systemic tissues exhibit different dose-response relationships for the effects of inhaled and oral corticosteroids with suppression of cortisol being greater than osteocalcin or eosinophils."( Short-term dose-response relationships for the relative systemic effects of oral prednisolone and inhaled fluticasone in asthmatic adults.
Lipworth, BJ; Wilson, AM, 1999
)
0.53
" No untoward effect from drugs sufficient to alter the dosage used was recorded."( Clinical features and treatment outcome of idiopathic membranous nephropathy in Chinese patients.
Chan, TM; Cheng, IK; Lai, KN; Tang, S, 1999
)
0.3
"Initial dosage of prednisolone was 15."( Efficacy of low-dose prednisolone maintenance for saliva production and serological abnormalities in patients with primary Sjögren's syndrome.
Matoba, K; Miyawaki, S; Nishiyama, S, 1999
)
0.96
"The prednisolone group received prednisolone at a dosage of 5 mg/kg, and the control group received sham saline injections for 5 days."( Detrimental effects of short-term glucocorticoid use on the rat diaphragm.
Dodd, SL; Eason, JM; Martin, AD; Powers, SK, 2000
)
0.87
" From these dose-response profiles, the following ID(50) values (nmol/ear resulting in a 50% reduction of edema) were calculated: 540, 618, 454, and 346 nmol for prednisolone (P), methyl 21-desoxy-21-chloro-11beta,17alpha-dihydroxy-3,20-dioxo-1, 4-pregnadien-16alpha-carboxylate (PClCM), methyl 21-desoxy-21-chloro-11beta,17alpha-dihydroxy-9alpha-fl uoro-3, 20-dioxo-1,4-pregnadien-16alpha-carboxylate (FPClCM), and methyl 21-desoxy-21-chloro-9alpha-fluoro-11beta-hydroxy-3,20-dioxo- 1, 4-pregnadien-16alpha-carboxylate (FDPClCM), respectively."( New steroidal anti-inflammatory antedrugs: methyl 21-desoxy-21-chloro-11beta,17alpha-dihydroxy-3,20-dioxo-1, 4-pregnadiene-16alpha-carboxylate, methyl 21-desoxy-21-chloro-11beta-hydroxy-3,20-dioxo-1, 4-pregnadiene-16alpha-carboxylate, and their 9alpha-flu
Chen, M; Heiman, AS; Ko, D; Lee, HJ, 2000
)
0.5
" He was hospitalized for severe exacerbation that worsen when steroid dosage was increase."( [A rare cause of asthma exacerbation: systemic anguilluliasis].
Didier, A; Leophonte, P; Linas, MD; Recco, P; Rivals, A; Rouquet, RM, 2000
)
0.31
" Information on the disease, initial DMARDs prescriptions and their side effects, prednisolone use, dosage and side effect(s) were focused and compared among three 5-year periods (1983-1987, 1988-1992 and 1993-1997)."( Initial disease modifying antirheumatic drugs and prednisolone prescriptions for patients with rheumatoid arthritis: a 15-year study.
Akkasilpa, S; Deesomchok, U; Osiri, M, 2000
)
0.79
" The initial prednisolone dosage was 50 mg and was tapered according to a standard protocol."( Mycophenolate mofetil versus azathioprine in patients with chronic active ulcerative colitis: a 12-month pilot study.
Galle, PR; Krummenauer, F; Mayet, WJ; Neurath, MF; Orth, T; Peters, M; Schlaak, JF; Wanitschke, R, 2000
)
0.68
"Treatment consisted uniformly of prednisolone in a starting dosage of 250 mg tapering over 18 days and accompanying infusion of dextran and pentoxifylline."( Bell's palsy: a 10-year experience with antiphlogistic-rheologic infusion therapy.
Eckel, HE; Guntinas-Lichius, O; Sittel, A; Sittel, C; Stennert, E, 2000
)
0.59
" Cyclophosphamide and anticoagulants along with increasing the dosage of corticosteroid were effective."( Dermatomyositis with splenic and renal infarctions during corticosteroid therapy.
Fukasawa, C; Hara, M; Harigai, M; Kamatani, N; Matsuda, Y; Nakajima, H; Takeuchi, M; Terajima, H; Yamada, T, 2000
)
0.31
" On Day 8, the nerve-evoked peak twitch tensions, tetanic tensions, and fatigability, and the dose-response curves of d-tubocurarine in the tibialis cranialis muscle were measured in vivo and related to muscle mass or expression of AChRs."( Prednisolone-induced muscle dysfunction is caused more by atrophy than by altered acetylcholine receptor expression.
Fink, H; Ibebunjo, C; Khiroya, R; Martyn, J; Shin, YS, 2000
)
1.75
" Mycophenolate mofetil was used in combination with cyclosporine and prednisone and allowed for significant reductions in dosage of these immunosuppressants."( Treatment of myasthenia gravis with mycophenolate mofetil: a case report.
Meriggioli, MN; Rowin, J, 2000
)
0.31
" The dosage of levamisole given was 2 to 3 mg/kg daily or every other day, depending on the patients' response."( Levamisole in steroid-sensitive nephrotic syndrome children with steroid-dependency and/or frequent relapses.
Chi, CS; Fu, LS,
)
0.13
" Although initiation of high-dose prednisolone therapy resulted in a gradual improvement in clinical symptoms, reducing the dosage of prednisolone caused a relapse."( Interstitial cystitis and ileus in pediatric-onset systemic lupus erythematosus.
Ito, T; Kakizaki, Y; Nakahata, T; Sugimoto, K; Tanaka, H; Tateyama, T; Tomimoto, K; Waga, S; Yokoyama, M, 2000
)
0.59
" There has been no study on prednisolone dosage for the effective treatment of nephrotic syndrome."( Older boys benefit from higher initial prednisolone therapy for nephrotic syndrome. The West Japan Cooperative Study of Kidney Disease in Children.
Haruki, S; Hayashi, S; Hiraoka, M; Mayumi, M; Miyagawa, K; Ohshima, Y; Okuhara, K; Suehiro, F; Takeda, N; Tsukahara, H, 2000
)
0.87
" After tapering the dosage of prednisolone in 5 mg increments per week, the pneumomediastinum disappeared without treatment."( [Mixed connective tissue disease-associated interstitial pneumonia complicated by pneumomediastinum during prednisolone therapy].
Kashiwabara, K; Kishi, K; Kobayashi, K; Matsuoka, T; Nakamura, H; Narushima, K; Sarashina, G; Yagyu, H, 2000
)
0.81
" These studies show that it is possible to detect the active ingredients in the intact dosage form, even where the substance comprises <1% of the total mass of the tablet."( Evaluation of solid-state forms present in tablets by Raman spectroscopy.
Langkilde, FW; Taylor, LS, 2000
)
0.31
" In the light of our data and of other publications, early treatment with corticosteroids in sufficient dosage seems appropriate, while therapeutic nihilism in AIFP does not seem justified."( [Antiphlogisitc-rheologic infusion therapy of acute idiopathic facial paralysis. Experiences and results of 344 cases].
Sittel, C; Stennert, E, 2000
)
0.31
" The mean oral prednisolone dosage was significantly greater in RG than NG during the first (P=0."( Randomized trial of blood eosinophil count monitoring as a guide to corticosteroid dosage adjustment after heart transplantation.
Akhlaghi, F; Cary, N; Large, S; Parameshwar, J; Sharples, LD; Steel, LA; Trull, AK; Wallwork, J, 2000
)
0.66
" Restriction of the EOS-guided steroid dosing protocol to periods of prolonged hospitalisation during the first 3 postoperative months should limit the requirement for higher prednisolone dosage without affecting immunosuppressive efficacy."( Randomized trial of blood eosinophil count monitoring as a guide to corticosteroid dosage adjustment after heart transplantation.
Akhlaghi, F; Cary, N; Large, S; Parameshwar, J; Sharples, LD; Steel, LA; Trull, AK; Wallwork, J, 2000
)
0.5
" Initial dosage was 60 mg/day, and 1 week later, the dosage was gradually dropped since the patient responded favourably."( Case of ulcerative colitis associated with oesophageal ulcer.
Akahane, Y; Asakawa, A; Fujii, E; Fujino, MA; Kojima, Y; Morozumi, A; Nakamura, T; Ohtaka, M; Sato, T; Shimazaki, R,
)
0.13
" However, it is important to monitor serum SRL levels to determine the optimal dosing regimen."( A calcineurin inhibitor-sparing regimen with sirolimus, mycophenolate mofetil, and anti-CD25 mAb provides effective immunosuppression in kidney transplant recipients with delayed or impaired graft function.
Ascher, NL; Chang, GJ; Freise, CE; Hirose, R; Mahanty, HD; Roberts, JP; Stock, PG; Vincenti, F, 2000
)
0.31
"A cross-sectional comparison of lumbar spine-bone mineral density (LS-BMD) was undertaken in 76 subjects after stratifying them according to dosage and administration route of corticosteroid."( Bone mineral density in prepubertal asthmatics receiving corticosteroid treatment.
Eisman, JA; Freezer, N; Harris, M; Hauser, S; Kelly, PJ; Morton, J; Nguyen, TV; Rodda, C; Strauss, BJ; Walker, JL, 2001
)
0.31
"We investigated whether there was a dose-response relationship for the use of corticosteroids in childhood acute lymphoblastic leukemia (ALL)."( Improved response with higher corticosteroid dose in children with acute lymphoblastic leukemia.
Chilton, D; Cohen, HJ; Gelber, RD; Sallan, SE; Schwartz, CL; Thompson, EB; Young, ML, 2001
)
0.31
" Increase in dosage of prednisolone resolved the skin lesion, leaving depressed atrophic scars."( Lupus erythematosus panniculitis in a patient with autoimmune hepatitis.
Fujiwara, K; Ishii, M; Kono, T; Saito, S; Taniguchi, S,
)
0.44
" In conclusion, the systemic corticosteroids are effective in 36% of patients, independent of dosage and pharmacological agents and duration of the therapy."( Management of cutaneous hemangiomas: a retrospective analysis of 1109 cases and comparison of conventional dose prednisolone with high-dose methylprednisolone therapy.
Akyüz, C; Büyükpamukçu, M; Kutluk, MT; Yariş, N,
)
0.34
" If an underlying problem requires long-term immunosuppressive medication, it is wiser to choose cimetidine rather than increasing the steroid dosage to resolve atypical PFAPA."( PFAPA syndrome (Periodic Fever, Aphthous stomatitis, Pharyngitis, Adenitis).
Chen, LC; Huang, JL; Lee, KF; Lee, WI; Lin, SJ; Yang, MH; Yeh, KW, 1999
)
0.3
" In the first group, only prednicarbat cream was applied to affected places twice a day for a maximum of 10 days, while in the other group also cetirizin was administered once a day in a dosage according to the patient's age."( [Prednicarbate and cetirizin dihydrochloride in the treatment of atopic eczema in the acute phase in children].
Bartosíková, L; Dzúrová, J; Frána, L; Frána, P; Kollár, P; Kotolová, H; Necas, J; Petrzelková, J, 2001
)
0.31
" Development of this complication was associated with elevated intravenous FK 506 dosing schedules, with the mean cumulative dose 43% higher than treated patients with unaffected kidney function."( Renal complications and development of hypertension in the European study of FK 506 and cyclosporin in primary liver transplant recipients.
Bismuth, H; Calne, R; Devlin, J; Groth, C; McMaster, P; Neuhaus, P; Otto, G; Pichlmayr, R; Williams, R, 1994
)
0.29
" 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
)
0.85
" Thereafter the dosage of prednisolone was gradually reduced."( [Repeated deterioration of tuberculous meningitis due to a reduction in the corticosteroid dosage during chemotherapy].
Itoh, H; Miyoshi, Y; Murai, H; Noda, S, 2000
)
0.61
" To further test this relationship between sodium transport and autoimmune hearing loss, dosage comparisons were made of prednisolone and aldosterone control of the auditory dysfunction in autoimmune MRL/MpJ-Fas(lpr) mice."( Aldosterone and prednisolone control of cochlear function in MRL/MpJ-Fas(lpr) autoimmune mice.
Kempton, JB; Trune, DR, 2001
)
0.86
" Three patients with chronic and active ASD unresponsive to corticosteroids and methotrexate were given intravenous Infliximab infusions at a dosage of 3 mg/kg at weeks 0, 2, 6 and then once every 8 weeks."( Infliximab in the treatment of adult Still's disease refractory to conventional therapy.
Bobbio-Pallavicini, F; Caporali, R; Cavagna, L; Epis, O; Montecucco, C,
)
0.13
" Five patients who treated with steroids at the onset of neurological symptoms showed clinical improvement, regardless of their age, sex, the pathology and stage of breast cancer, or the total dosage of chemotherapeutic agents."( 5-fluorouracil-induced leukoencephalopathy in patients with breast cancer.
Cho, KH; Choi, SM; Kim, BC; Kim, MK; Lee, SH; Yang, YS, 2001
)
0.31
"The extent and severity of hyperplasia was significantly correlated with the dosage and serum level of CsA at 3, 6 and 12 months post-transplantation; last recorded dosage, however (p<0."( Cyclosporin A-induced gingival overgrowth is unrelated to allograft function in renal transplant recipients.
Baboolal, K; Newcombe, RG; Subramanian, N; Thomas, DW, 2001
)
0.31
" The steroid therapy was continued for 4 months with decreasing dosing schedule."( [A case of retroperitoneal fibrosis responding to steroid therapy].
Habuchi, T; Horikawa, Y; Inoue, T; Kato, T; Satoh, S; Shimoda, N; Tachiki, Y, 2001
)
0.31
" The dosage of the steroid, life style factors, menopausal status, low bone mineral density at baseline and previous osteoporotic fractures predispose for the manifestation of steroid-induced osteoporosis."( [Risk of osteoporosis in steroid therapy. When and how to counter the risk].
Aschl, G; Hinterreiter, M; Kirchgatterer, A; Knoflach, P, 2001
)
0.31
" Relapse treatment consisted of cessation of inhaled corticosteroids and start of oral corticosteroids at a dosage of 2 mg/kg/d and then a tapered dose."( Inhaled corticosteroids for maintenance treatment in childhood pulmonary sarcoidosis.
Anadol, D; Göçmen, A; Kiper, N; Ozçelik, U, 2001
)
0.31
" Corticosteroid toxicity is a major problem, either because of inappropriate dosage or prolonged disease."( Polymyalgia rheumatica and giant cell arteritis. Avoiding management traps.
de Jager, JP, 2001
)
0.31
" Reduction in the dosage of topical corticosteroid and medical treatment of the raised IOP resulted in resolution of the microcystic edema and interface fluid accumulation."( Interface fluid after laser in situ keratomileusis.
Fogla, R; Padmanabhan, P; Rao, SK, 2001
)
0.31
" Gender, age at onset, duration of illness from onset, prednisolone dosage at the most-recent relapse, and regimens of initial steroid therapy at onset were not associated with risk."( Prediction of subsequent relapse in children with steroid-sensitive nephrotic syndrome.
Mizusawa, Y; Simoda, M; Takeda, A; Takimoto, H, 2001
)
0.56
" However, these differences do not suggest the need for dosage adjustments, and additional experiments with repeat dosing are needed to fully evaluate the clinical implication of these findings."( Prednisolone pharmacokinetics and pharmacodynamics in relation to sex and race.
Blum, RA; Jusko, WJ; Lates, CD; Magee, MH, 2001
)
1.75
"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
)
0.52
" During steroid pulse therapy, the patients who were treated with insulin needed a higher dosage of insulin; after steroid pulse therapy, the dosage returned to baseline."( Steroid pulse therapy combined with tonsillectomy in IgA nephropathy associated with diabetes mellitus.
Chiba, S; Furuta, T; Honda, S; Horigome, I; Hotta, O; Miyazaki, M; Noshiro, H; Satoh, M; Taguma, Y, 2001
)
0.31
" Plasmapheresis used in the treatment regimen substantially reduced the dosage of corticosteroids."( [Extracorporeal methods in treating sarcoidosis patients].
Romanov, VV, 2001
)
0.31
" CsA side effects can be eliminated by reducing the dosage of the drug."( Cyclosporine nephrotoxicity: associated allograft dysfunction at low trough concentration.
Druskis, V; Jankauskiene, A; Laurinavicius, A, 2001
)
0.31
" Dosing of rats with NCX-1015 (0."( Potent antiarthritic properties of a glucocorticoid derivative, NCX-1015, in an experimental model of arthritis.
Del Soldato, P; Flower, RJ; Mancini, L; Paul-Clark, MJ; Perretti, M, 2002
)
0.31
" From these dose-response profiles, the following ID(50) values (nmol/ear resulting in a 50% reduction of edema) were calculated: prednisolone (Pred); 454, FP16CM; 255, 21-acetate (FP16CM-acetyl); 402, 21-propionate (FP16CM-propionyl); 474, 21-valerate (FP16CM-valeryl); 446 and 21-pivalate (FP16CM-pivalyl); 219 nmol."( New steroidal antiinflammatory antedrugs: Methyl 3,20-dioxo-9 alpha-fluoro-11 beta,17 alpha,21-trihydroxy-1,4-pregnadiene-16 alpha-carboxylate and its 21-O-acyl derivatives.
Heiman, AS; Hudson, CE; Ko, DH; Lee, HJ, 2002
)
0.52
" Optimal sequencing of therapy and dosage still have to be examined."( [Treatment of keratitis superficialis chronica of the dog with strontium 90].
Allgoewer, I; Brunnberg, L; Grüning, G; Hinkelbein, W; Höcht, S; Nausner, M, 2002
)
0.31
" We propose that prednisolone at the 5-mg dosage (which gave partial HPA suppression), together with the assessment of salivary cortisol, can be used to investigate both impaired and enhanced glucocorticoid-mediated negative feedback in large samples of patients with psychiatric disorders."( A novel prednisolone suppression test for the hypothalamic-pituitary-adrenal axis.
Checkley, SA; English, J; Kerwin, RW; Lightman, S; Papadopoulos, AS; Pariante, CM; Poon, L, 2002
)
1.09
" Complications due to treatment included: duodenal ulcer in one patient that responded to medical treatment, and transient elevation in serum creatinine levels in three patients, which returned to normal after decrease in dosage or cessation of oral CSA."( Combined intravenous pulse methylprednisolone and oral cyclosporine A in the treatment of corneal graft rejection: 5-year experience.
Cheng, LL; Lam, DS; Leung, AT; Rao, SK; Wong, AK; Young, AL, 2002
)
0.6
" However, when the steroid dosage was reduced, signs of hyperthyroidism such as systolic hypertension and tachycardia were observed."( Development of hyperthyroidism in a patient with idiopathic nephrotic syndrome.
Harada, T; Hirai, H; Kondou, H; Kubota, T; Nakajima, S; Sawada, A; Shima, M; Shimizu, N, 2002
)
0.31
" Older patients who require a higher dosage of oral glucocorticosteroids at hospital discharge and who have low serum albumin levels are at greater risk of death within the first year after hospitalization."( Risk factors for lethal outcome in patients with bullous pemphigoid: low serum albumin level, high dosage of glucocorticosteroids, and old age.
Baima, B; Büchner, L; Büdinger, L; Hertl, M; Jung, M; Kaiser, HW; Kippes, W; Mecking, D; Messer, G; Messmer, EM; Meurer, M; Partscht, K; Pawelczyk, B; Pfeiffer, C; Prudlo, C; Rzany, B; Schuhmann, M; Sinkgraven, R; Sticherling, M; Zillikens, D, 2002
)
0.31
" The chest radiographic findings were spontaneously resolved after three years with no increase in the dosage of oral corticosteroids."( [Pulmonary sarcoidosis in a case of dermatomyositis under long-term steroid therapy].
Akiba, Y; Fujiuchi, S; Ide, H; Kikuchi, K; Nakano, H; Nishigaki, Y; Ohsaki, Y; Osanai, S; Yamamoto, Y, 2002
)
0.31
" The dosage of steroids was tapered in 3 out of 4 CyA-responsive cases without re-exacerbation."( Usefulness of cyclosporine A on rapidly progressive interstitial pneumonia in dermatomyositis.
Inase, N; Miyake, S; Miyasaka, N; Miyazaki, Y; Ohtani, Y; Sawada, M; Takano, S; Yoshizawa, Y, 2002
)
0.31
" albicans with fatal outcome was induced by a repeated dosing of prednisolone."( Protection of mice from lethal endogenous Candida albicans infection by immunization with Candida membrane antigen.
Ab, S; Mizutani, S; Ono, Y; Takesako, K; Tansho, S; Yamaguchi, H, 2002
)
0.55
" Information on uveitis diagnosis, associated risk factors, steroid dosage and treatment duration, prophylaxis and management, was collected."( Corticosteroid-induced osteoporosis in patients with uveitis.
Anderton, LC; Cheong, FM; Jones, NP; Lesnik-Oberstein, S; Murray, PI; Pavesio, C; Stanford, MR; Whallett, A, 2002
)
0.31
"The aim of this study was to evaluate the long-term effects in young children with Duchenne dystrophy of an intermittent low dosage regime of prednisolone (0."( An effective, low-dosage, intermittent schedule of prednisolone in the long-term treatment of early cases of Duchenne dystrophy.
Dubowitz, V; Kinali, M; Main, M; Mercuri, E; Muntoni, F, 2002
)
0.77
" Furthermore, the ability of MMF treatment to reduce the steroid dosage and/or substitute other immunosuppressive agents with unacceptable side-effects (cyclosporin A, tacrolimus, azathioprine) was evaluated."( [Efficiency of mycophenolate mofetil in the treatment of intermediate and posterior uveitis].
Forrester, JV; Greiner, K; Santiago, C; Varikkara, M, 2002
)
0.31
"Systemic corticosteroids and inhaled beta(2) agonists are accepted first line treatments for acute severe asthma, but there is no consensus on their optimum dosage and frequency of administration."( Randomised pragmatic comparison of UK and US treatment of acute asthma presenting to hospital.
Daynes, TJ; Harrison, BD; Innes, NJ; Stocking, JA, 2002
)
0.31
" Therefore, an alternative treatment is necessary in order to decrease steroid dosage and avoid the clinical problems associated with steroids."( Multicenter randomized controlled trial for the treatment of ulcerative colitis with a leukocytapheresis column.
Asakura, H; Hibi, T; Hiwatashi, N; Muto, T; Nagawa, H; Satomi, M; Sawada, K; Sawada, T; Shimoyama, T, 2003
)
0.32
" Due to the small inter- and intraindividual variations in the pharmacokinetic parameters, body surface area-based dosing is sufficient to obtain similar systemic exposure among patients."( Population pharmacokinetics of prednisolone in children with acute lymphoblastic leukemia.
Jusko, WJ; Petersen, KB; Rasmussen, M; Schmiegelow, K, 2003
)
0.6
" 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
" When prednisolone alone proved ineffective, supplementary treatment with suplatast tosilate, an antiallergic selective Th2 cytokine inhibitor, improved the patient's inflammation, reduced the level of cardiac enzymes, and allowed for a reduction in corticosteroid dosage without any adverse effects."( Effect of suplatast tosilate, an antiallergic selective Th2 cytokine inhibitor, on acute eosinophilic myocarditis: a case report.
Haraguchi, M; Itagaki, K; Itoh, S; Kimura, M; Matsuzaki, M; Tanaka, M; Umemoto, S, 2003
)
0.8
" However, the effects of a low maintenance dosage of corticosteroids on BW have not been studied longitudinally in RTx patients."( Weight changes after renal transplantation: a comparison between patients on 5-mg maintenance steroid therapy and those on steroid-free immunosuppressive therapy.
Christiaans, MH; Kooman, JP; Nieman, FH; van den Ham, EC; van Hooff, JP, 2003
)
0.32
" High dosage steroid should be started before there is biopsy confirmation of the disease."( [Excessive hyperferritinemia as an indication of a reactive hemophagocytosis syndrome].
Brunner, J; Dinser, R; Engel, A, 2003
)
0.32
" The correlation of proximal muscle strength, but not HG strength, with steroid dosage further supports a cause-effect relationship."( Corticosteroids and skeletal muscle function in cystic fibrosis.
Barry, SC; Gallagher, CG, 2003
)
0.32
"Both patients were treated with interferon-alpha in dosages of 3 million units of IFN-alpha 2b or an equivalent dosage of interferon-acon thrice weekly subcutaneously."( [Interferon-alpha treatment of the Churg-Strauss syndrome].
Förster, M; Kroegel, C; Mock, B; Reissig, A; Schilder, C, 2003
)
0.32
" No severe growth retardation was observed, but the duration and dosage of ALD prednisolone could be reduced further, since the patients with FSMPGN seemed to have an excellent prognosis."( Focal segmental membranoproliferative glomerulonephritis in children.
Iitaka, K; Moriya, S; Motoyama, O; Nakamura, S; Sakai, T, 2003
)
0.55
"We found that MMF permitted a reduction in prednisolone dosage without disease relapse."( An evaluation of the usefulness of mycophenolate mofetil in pemphigus.
Al Fares, S; Albert, S; Bhogal, B; Black, MM; Harman, KE; Powell, AM; Setterfield, J, 2003
)
0.58
" This case suggests that combining ECCT with steroid therapy can maintain such poorly controlled and high-risk UC patients safely for the scheduled colectomy while improving the prognosis by reducing the dosage of steroid efficiently prior to operation."( Poorly controlled ulcerative colitis treated by colectomy during remission induced by extracorporeal leukocyte removal therapy.
Fukuda, Y; Fukui, S; Fukunaga, K; Hori, K; Matoba, Y; Ohnishi, K; Sagayama, K; Sawada, K; Shimoyama, T, 2003
)
0.32
" In the dosage used, none of the compounds promoted discernible salt and water retention."( 16a-Methyl corticosteroids; a new series of anti-inflammatory compounds; clinical appraisal of their antirheumatic potencies.
BOLAND, EW, 1958
)
0.24
" 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
)
0.45
" In the first case, prednisolone in a dosage of 20 mg."( HEMATOLOGICAL COMPLICATIONS OF PHENYLBUTAZONE THERAPY: REVIEW OF THE LITERATURE AND REPORT OF TWO CASES.
CHALMERS, TM; MCCARTHY, DD, 1964
)
0.57
" However, when the dosage was tapered, the BOOP recurred."( [Successful treatment of bronchiolitis obliterans organizing pneumonia with cyclosporin and steroids].
Hamada, H; Higaki, J; Hiwada, K; Irita, J; Ito, R; Kadowaki, T; Katayama, H; Kukita, H; Mutsukado, Y; Onishi, H; Watanabe, A; Yokoyama, A, 2003
)
0.32
" The daily dosage of prednisolone and beclomethasone was progressively decreased while the gain in nasal comfort was being preserved."( [Sino-nasal polyposis. Evaluation of the efficacy of combined local and general corticotherapy in a series of 100 consecutive patients with a 3-year follow-up].
Avant, P; Bonfils, P; Norès, JM, 2002
)
0.63
"To determine whether a topical ophthalmic diclofenac sodium formulation containing a proprietary polymeric drug delivery system (ISV-205), when dosed concomitantly with 1% prednisolone acetate, is effective in blocking the intraocular pressure (IOP) response in humans."( Prevention of corticosteroid-induced intraocular pressure elevation using ISV-205.
Stewart, WC, 2003
)
0.51
" Initial dosage prednisolone was given for 1 month, and then tapered gradually in terms of dosage and interval."( [Quadritherapy with cyclosporine for membranous lupus nephropathy].
Iwasawa, H; Matsumoto, H; Nagaoka, Y; Nakao, T; Okada, T; Tomaru, R; Wada, T, 2003
)
0.66
" The daily oral steroid dosage (prednisolone 25."( Risk factors for nontraumatic osteonecrosis of the femoral head after renal transplantation.
Asano, T; Fujioka, M; Hirota, Y; Horii, M; Inoue, S; Kim, WC; Kubo, T; Nakagawa, M; Ogura, T; Shibatani, M; Tanaka, T, 2003
)
0.6
" For the treatment of pemphigus, a course of the lowest possible corticosteroid dosage in combination with immunosuppressive agents appears to be effective and less toxic than a high corticosteroid dosage."( Pemphigus in Korea: clinical manifestations and treatment protocol.
Choi, WW; Chung, JH; Seo, PG, 2003
)
0.32
" The average dosage of, respectively, procaine benzylpenicillin (I."( Pharmacological and toxicological aspects of combination of beta-lactam and aminoglycoside antibiotic, prednisolone and procaine hydrochloride on the example of Vetramycin.
Kania, BF; Kania, K, 2003
)
0.53
" The aim of our study was to review our data to determine if the steroid dosage is associated with the incidence of early complications after bowel resection in patients with prolonged steroid therapy for Crohńs disease (CD)."( Preoperative steroid administration: effect on morbidity among patients undergoing intestinal bowel resection for Crohńs disease.
Anthoni, C; Bruewer, M; Kersting, S; Krieglstein, CF; Laukoetter, MG; Rijcken, EJ; Senninger, N; Utech, M, 2003
)
0.32
" In children with a history of FSGS, caution is necessary when altering the dosing schedule of prednisone."( Nephrotic syndrome after conversion to alternate day steroids in two children with a history of recurrent FSGS.
Greenbaum, LA; Hanevold, CD, 2003
)
0.32
" The optimal dosage appears to be 3 mg/day in terms of efficacy and safety."( Efficacy and safety of tacrolimus (FK506) in treatment of rheumatoid arthritis: a randomized, double blind, placebo controlled dose-finding study.
Abe, T; Hara, M; Hashimoto, H; Irimajiri, S; Kondo, H; Sugawara, S; Uchida, S, 2004
)
0.32
"Concurrently with the changes in prednisolone dosage serum OC levels increased significantly at 28 weeks (p<0."( The effect of the steroid-sparing response to low-dose methotrexate on bone metabolism in glucocorticoid-dependent asthmatics.
Girgis, SI; Ind, PW; Nwokeji, A; Shakur, BH; Shiner, RJ, 2004
)
0.6
" There was a significant correlation between age at the onset of CSC and the daily dosage of corticosteroid."( Seventeen cases of central serous chorioretinopathy associated with systemic corticosteroid therapy.
Adachi-Usami, E; Igarashi, Y; Koyama, M; Mizota, A,
)
0.13
" Prednisone, begun perioperatively, was reduced gradually from a mean initial dosage of 38."( [Pneumocystis carinii pneumonia complicating brain tumor].
Gejyo, F; Nishibori, T; Takahashi, H; Tanaka, R; Tsukada, H; Uzuka, T, 2004
)
0.32
" The daily dosage of prednisolone and beclometasone was progressively decreased, while the gain in nasal comfort was being preserved."( Medical treatment of stage I nasal polyposis over a 3-year follow-up period.
Avan, P; Bonfils, P; Halimi, P; Norès, JM, 2004
)
0.64
"To evaluate the circadian variation in patients with renal transplant on twice daily dosing in order to evaluate if patients could need a dosage adjustment in diurnal or nocturnal dose."( Circadian variation of cyclosporine A in renal transplanted patients.
González López, EH; Jung Cook, H; Nava, A; Reyna Rodríguez, C,
)
0.13
" Oral steroid dosage had slowly been tapered over 1 month."( Pulmonary involvement in Crohn's disease report of a case and review of the literature.
Asahi, H; Inoue, Y; Irinoda, T; Omori, H; Saito, K, 2004
)
0.32
" Relapses did not occur with the tapering of PSL dosage when the ELISA values decreased to 40% of initial values, although they were still not within the normal range."( Monitoring of ELISA for anti-BP180 antibodies: clinical and therapeutic analysis of steroid-treated patients with bullous pemphigoid.
Esaki, C; Ichiki, Y; Izumi, T; Kitajima, Y, 2004
)
0.32
" Owners of the dogs recorded pruritus daily using a 10 cm visual analog scale and the dosage of prednisolone was established based on the pruritus score, according to written instructions."( A randomized, controlled study to evaluate the steroid sparing effect of essential fatty acid supplementation in the treatment of canine atopic dermatitis.
Bergvall, K; Hedhammar, A; Holm, BR; Kristensen, F; Larsen, S; Saevik, BK; Saijonmaa-Koulumies, LE, 2004
)
0.54
" Hence, a reduction in CsA dosage in kidney transplant recipients (KTR) may improve long-term outcomes."( Analysis of the cardiovascular risk profile in stable kidney transplant recipients after 50% cyclosporine reduction.
Cardarelli, F; Cosimi, AB; Delmonico, FL; Farrell, ML; Pascual, M; Saidman, SL; Shih, V; Tolkoff-Rubin, N; Winkelmayer, WC; Wong, W, 2004
)
0.32
" To fully benefit from this promising new drug, FK778 dosing will be optimized in subsequent studies."( The effects of FK778 in combination with tacrolimus and steroids: a phase II multicenter study in renal transplant patients.
Chang, R; Charpentier, B; Grinyó, JM; Jurewicz, A; Klinger, M; Kreis, H; Mourad, G; Neuhaus, P; Paczek, L; Paul, LC; Rostaing, L; Short, C; Squifflet, JP; van Hooff, JP; Vanrenterghem, Y; Wlodarczyk, Z, 2004
)
0.32
" Therapeutic studies were performed for up to 8 weeks of dosing with prednisolone, methotrexate, 3 nonsteroidal antiinflammatory drugs (celecoxib, diclofenac, and indomethacin), a p38 MAPK inhibitor, SB242235, and human soluble TNF receptor (sTNFR; etanercept) and murine sTNFR fusion proteins."( Characterization of pristane-induced arthritis, a murine model of chronic disease: response to antirheumatic agents, expression of joint cytokines, and immunopathology.
Bush, K; Life, P; Morgan, R; Patten, C; Rioja, I; Trill, J; Wooley, P, 2004
)
0.56
" The protocol calls for a 10-day pretransplantation conditioning period, starting with one dosage of rituximab and followed by full dose tacrolimus, mycophenolate mofetil and prednisolone."( ABO incompatible kidney transplantations without splenectomy, using antigen-specific immunoadsorption and rituximab.
Fehrman, I; Genberg, H; Kumlien, G; Lundgren, T; Sandberg, J; Tydén, G, 2005
)
0.52
" The intraperitoneal dosing of LPS produced large and transient elevations of plasma TNF-alpha, IFN-gamma, and NO concentrations."( Pharmacodynamic interactions between recombinant mouse interleukin-10 and prednisolone using a mouse endotoxemia model.
Chakraborty, A; Jusko, WJ; Pyszczynski, NA; Yeung, S, 2005
)
0.56
" Placebo-controlled studies with varying dosage schedules are required to standardize the dose of prednisolone used in pulse therapy, optimize the therapeutic efficacy, and minimize side effects."( Placebo-controlled oral pulse prednisolone therapy in alopecia areata.
Dogra, S; Handa, S; Kar, BR; Kumar, B, 2005
)
0.83
" As the prednisolone dosage could not be decreased to less than 2 mg/kg/48 h, the patient was re-challenged with Cs A 1 1/2 years later."( The use of cyclosporine in a boy with a prior episode of posterior encephalopathy.
Hasegawa, N; Iwasaki, N; Izumi, I; Kanemoto, K; Nakahara, C, 2005
)
0.76
"The aims of the current study were to determine whether therapeutic drug monitoring (TDM) might benefit kidney transplant recipients receiving everolimus, and to establish dosage recommendations when everolimus is used in combination with cyclosporine and corticosteroids."( Therapeutic drug monitoring for everolimus in kidney transplantation using 12-month exposure, efficacy, and safety data.
Kovarik, J; Li, Y; Lorber, MI; Mayer, HW; Ponticelli, C; Schmidli, H; Whelchel, J, 2005
)
0.33
"The aim of our study was to evaluate spontaneous fluctuations in serum PTH levels in six adult male patients (aged 31-64 years) receiving chronic (>6 months) therapy with glucocorticoids (daily dosage >7."( Chronic glucocorticoid treatment alters spontaneous pulsatile parathyroid hormone secretory dynamics in human subjects.
Bilezikian, JP; Bonadonna, S; Bugari, G; Burattin, A; Giustina, A; Iori, N; Nuzzo, M; Rosei, EA; Valle, D; Veldhuis, JD, 2005
)
0.33
"Univariate analysis identified the duration of transplant, papilla bleeding index, creatinine serum concentration, azathioprine and prednisolone dosage as risk factors for overgrowth severity."( Risk factors for gingival overgrowth in patients medicated with ciclosporin in the absence of calcium channel blockers.
Ellis, JS; Seymour, RA; Thomason, JM, 2005
)
0.53
" Dosage of each of the three immunosuppressants was identified as a risk factor for the severity of gingival change."( Risk factors for gingival overgrowth in patients medicated with ciclosporin in the absence of calcium channel blockers.
Ellis, JS; Seymour, RA; Thomason, JM, 2005
)
0.33
" The serum titer of anti-Ach-receptor antibodies decreased in parallel with clinical improvement due to tacrolimus, and we accordingly reduced the dosage of prednisolone."( Low-dose tacrolimus for two cases of myasthenia gravis with invasive thymoma that relapsed shortly after thymectomy.
Deguchi, K; Ikeda, K; Kuriyama, S; Sasaki, I; Shimamura, M; Takeuchi, H; Touge, T; Tsukaguchi, M; Urai, Y, 2005
)
0.53
" The antitumor effects of the free drugs have only been observed using treatment schedules based on high and frequent dosing for prolonged periods of time."( Liposome-encapsulated prednisolone phosphate inhibits growth of established tumors in mice.
Fens, MH; Janssen, AP; Metselaar, JM; Molema, G; Schiffelers, RM; Storm, G, 2005
)
0.64
" 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
)
0.55
" Prednisolone in standard dosage schedule as recommended by WHO is now being widely used in control programmes."( Reactions and their management.
Ganapati, R; Pai, VV, 2004
)
1.23
" Protocol biopsies may have therapeutic implications and may provide valuable information in the evaluation of start and dosing of ERT."( Focal and segmental glomerular sclerosis (FSGS) in a man and a woman with Fabry's disease.
Bostad, L; Houge, G; Iversen, BM; Kaarbøe, O; Lyngdal, PT; Svarstad, E; Tøndel, C, 2005
)
0.33
" There is increasing evidence that, even in equipotent dosage for glucocorticoid effect, dexamethasone has enhanced lymphoblast cytotoxicity and penetration of the central nervous system (CNS) compared with prednisolone."( Benefit of dexamethasone compared with prednisolone for childhood acute lymphoblastic leukaemia: results of the UK Medical Research Council ALL97 randomized trial.
Eden, TO; Kinsey, SE; Lilleyman, J; Mitchell, CD; Richards, SM; Vora, A, 2005
)
0.78
" Records were reviewed for the dosage of immunosuppression, rate of relapse, steroid side effects, current status of liver function tests and evidence for cirrhosis and its complications."( Autoimmune hepatitis type 1: safety and efficacy of prolonged medical therapy.
Boyer, JL; Seela, S; Sheela, H, 2005
)
0.33
" Median taking compliance was 100% (range 60-105%), median dosing compliance was 99% (range 58-100%); median timing compliance (TIC) was 94% (42-100%)."( Prevalence of prednisolone (non)compliance in adult liver transplant recipients.
Drent, G; Geest, SD; Haagsma, EB; Kleibeuker, JH; Slooff, MJ; Ten Vergert, EM; van den Berg, AP; van den Bosch, HJ, 2005
)
0.69
" Further trials are necessary to determine the optimal dosage and duration of therapy, and its efficacy in comparison to standard regimens."( Tacrolimus for induction therapy of diffuse proliferative lupus nephritis: an open-labeled pilot study.
Au, TC; Mok, CC; Siu, YP; To, CH; Tong, KH, 2005
)
0.33
" Both medications were dosed 4 times per day for 14 days and then BID until the container was empty."( A clinical comparison of two different prednisolone acetate formulations in patients undergoing cataract surgery.
Gayton, JL, 2005
)
0.6
" The dosage of oral corticosteroids and/or second-line immunosuppressive medication was reduced or stopped altogether in 18 of 33 eyes (54."( Outcome of intravitreal triamcinolone in uveitis.
Kok, H; Lau, C; Lightman, S; Maycock, N; McCluskey, P, 2005
)
0.33
" The PSL dosage was gradually tapered in accordance with improvement."( Leukocytapheresis therapy for steroid-naïve patients with active ulcerative colitis: its clinical efficacy and adverse effects compared with those of conventional steroid therapy.
Abe, T; Aoyama, N; Fukagawa, M; Kasuga, M; Maekawa, S; Nakahara, T; Nishioka, C; Shirasaka, D; Tamura, T; Umezu, M, 2005
)
0.33
" Type and dosage of immunosuppressive agents, pretransplant weight and human leukocyte antigen (HLA) phenotypes in PTDM patients were compared with 61 matched controls."( Is HLA-DR6 a protective factor against posttransplantation diabetes mellitus?
Amjadi, H; Amouzegar, A; Einollahi, B; Firouzan, A; Hemati, K; Nafar, M; Pour-Reza-Gholi, F, 2005
)
0.33
" Intravenous prednisolone dosage was started with 4 mg/kg per day and tapered by a half dose every 2 days."( Glucocorticoid receptor alpha expression in the intrahepatic biliary epithelium and adjuvant steroid therapy in infants with biliary atresia.
Muraji, T; Tatekawa, Y; Tsugawa, C, 2005
)
0.7
" During first 6 months of the trial, the patients also received prednisolone, which was started at a dosage of 15 mg daily and tapered to zero by the end of the sixth month."( A randomized unblinded trial of cyclophosphamide versus azathioprine in the treatment of systemic sclerosis.
Davis, P; Fritzler, M; Kovalenko, W; Nadashkevich, O, 2006
)
0.57
" In this context, we speculated that single-dose daily administration of low-dose CsA may be associated with a higher peak blood level without associated trough blood level elevation, and thereby yield better results and allow safer use of the drug than the conventional twice daily administration dosing used for the treatment of childhood idiopathic nephrotic syndrome (INS)."( C1-C2 point monitoring of low-dose cyclosporin a given as a single daily dose in children with steroid-dependent relapsing nephrotic syndrome.
Ito, E; Kudo, M; Nakahata, T; Suzuki, K; Tanaka, H; Tsugawa, K; Waga, S, 2005
)
0.33
" Upon successive dose reduction to a maintenance dosage of 10 mg prednisolone, the patient's clinical status and peripheral blood count remained stable."( Hypereosinophilic syndrome associated with acute necrotizing myocarditis and cardiomyopathy.
Fries, JW; Hoppe, UC; Huntgeburth, M; Lindner, M, 2005
)
0.57
" These results suggest a possible pharmacological action by PSL on the core circadian oscillation mechanism and indicate the possibility that the alteration of clock function induced by PSL can be avoided by optimizing the dosing schedule."( Chronic treatment with prednisolone represses the circadian oscillation of clock gene expression in mouse peripheral tissues.
Koyanagi, S; Kuramoto, Y; Ohdo, S; Okamura, H; Okazawa, S; Shimeno, H; Soeda, S; Ushijima, K, 2006
)
0.64
" The daily steroid dosage can be tapered rapidly, and the SLE-associated hyperlipidemia resolved parallel to the resolution of the acute lupus nephritis."( Sequential evaluation of clinical and laboratory changes amongst children suffering from lupus nephritis during intermittent intravenous cyclophosphamide therapy.
Chiu, SJ; Huang, JL; Hung, IJ; Ou, LS; Tsai, TL, 2006
)
0.33
" Patients received either two infusions of infliximab (5 mg/kg) alone (n=8) or in combination with long-term methotrexate at a dosage of 20 mg/week (n=11) over 48 weeks."( Combining infliximab with methotrexate for the induction and maintenance of remission in refractory Crohn's disease: a controlled pilot study.
Blumenstein, I; Schröder, O; Stein, J, 2006
)
0.33
" In this situation, administration of hydrofluoroalkane-beclomethasone dipropionate (HFA-BDP), 400 microg/day, was started instead of BUD, and then improvement of the clinical symptoms, PEF and pulmonary function were observed promptly, followed by reduction in the dosage of PSL and a short-acting beta-stimulant."( [A case of severe persistent bronchial asthma who showed significant improvement by switching to hfa-bdp, with reducing the dosage of oral steroids].
Ohbayashi, H, 2005
)
0.33
" However, imatinib mesylate was effective independently of the dosing regime."( Pharmacologic differentiation of inflammation and fibrosis in the rat bleomycin model.
Chaudhary, NI; Park, JE; Schnapp, A, 2006
)
0.33
" The treatment duration was 5 days at usual recommended dosage regimens."( [Efficacy of Derinox assessed with one PNIF (Peak Nasal Inspiratory Flow) in patients suffering from common cold].
Bruhwyler, J; Concas, V; Dessanges, JF; Peynegre, R, 2005
)
0.33
" For experiment 2, prednisolone administration at either dosage and duration did not alter plasma leptin concentrations in any dogs."( Effects of administration of glucocorticoids and feeding status on plasma leptin concentrations in dogs.
Honjo, T; Kitagawa, H; Kitoh, K; Maeda, S; Nishii, N; Ohba, Y; Ohtsuka, Y; Saito, M; Takasu, M, 2006
)
0.66
" Patients received a total steroid dosage between 100 and 500 mg of prednisolone."( Serum levels of cartilage oligomeric matrix protein (COMP): a rapid decrease in patients with active rheumatoid arthritis undergoing intravenous steroid treatment.
Bauer, K; Dunky, A; Feyertag, J; Haberhauer, G; Kittl, EM; Skoumal, M, 2006
)
0.57
" Intramuscular injections of dexamethasone 5 mg were given for 10 days, followed by oral administration of prednisolone at a dosage of 15 mg for two weeks and 10 mg for two weeks."( A case of complete ophthalmoplegia in herpes zoster ophthalmicus.
Lew, H; Shin, HM; Yun, YS, 2005
)
0.54
" These cases also had an increase in steroid dosage at the time of recurrence, but have been controlled medically so far."( Indications for surgery in intestinal Behçet's disease.
Katashi, F; Kurata, M; Murata, H; Nozue, M; Seino, K; Sumita, T,
)
0.13
" Prednisolone was replaced to a lower dosage dexamethasone (2 mg/day)."( Hepatocellular carcinoma with persistent hypoglycemia: successful treatment with corticosteroid and frequent high carbohydrate intake.
Bubpha, P; Thipaporn, T; Varaphon, V, 2005
)
1.24
" Later, pleural effusion waxed and waned depending on the dosage of PSL, but no other causative disorder was demonstrated by extensive examinations."( [Case of dermatomyositis complicated with massive pleural effusion that preceded the myopathy].
Hagiyama, H; Iwai, H; Kohsaka, H; Koike, R; Kubota, T; Miyasaka, N; Nagasaka, K; Nanki, T; Nishio, J; Nonomura, Y; Ogawa, J; Sugihara, T; Tsubata, R, 2002
)
0.31
" Takayasu arteritis had developed in a 24-year-old woman (March 2003) who had been treated with glucocorticoid including methylprednisolone pulse therapy and methotrexate; however, she relapsed during the tapering of the dosage of oral prednisolone."( Infliximab is effective for Takayasu arteritis refractory to glucocorticoid and methotrexate.
Aratake, K; Arima, K; Eguchi, K; Huang, M; Ida, H; Iwanaga, N; Izumi, Y; Kamachi, M; Kawakami, A; Nakamura, H; Origuchi, T; Tamai, M; Tanaka, F, 2006
)
0.54
" All six patients received prophylactic cranial irradiation with a dosage of 18 or 24 Gy."( Moyamoya syndrome following childhood acute lymphoblastic leukemia.
Hanada, R; Ikuta, K; Ishimoto, K; Kaneko, T; Kikuchi, A; Maeda, M; Okimoto, Y; Tsuchida, M, 2007
)
0.34
" She recovered completely by gradual dosage increase of short-acting corticosteroid after the discontinuation of prednisolone."( Acute onset of steroid psychosis with very low dose of prednisolone in Sheehan's syndrome.
Cho, DH; Chung, DJ; Chung, MY; Hong, SI; Kang, HC, 2006
)
0.79
" We evaluated total Quantitative MG (Q-MG) score, anti-acetylcholine receptor (AChR) antibody titer in the blood, interleukin 2 (IL-2) production in peripheral blood mononuclear cells (PBMCs), administration dosage of prednisolone (PSL), and adverse effects of FK506."( Long-term therapeutic efficacy and safety of low-dose tacrolimus (FK506) for myasthenia gravis.
Igarashi, S; Naruse, S; Nishizawa, M; Onodera, O; Oyake, M; Shimohata, T; Tada, M; Tanaka, K; Tsuji, S, 2006
)
0.52
"A reduction in steroid dosage of 50% without worsening of the symptoms was observed 1 year after FK506 administration in three out of six steroid-dependent MG patients (50."( Long-term therapeutic efficacy and safety of low-dose tacrolimus (FK506) for myasthenia gravis.
Igarashi, S; Naruse, S; Nishizawa, M; Onodera, O; Oyake, M; Shimohata, T; Tada, M; Tanaka, K; Tsuji, S, 2006
)
0.33
" Side-effects of corticosteroid therapy remain a major clinical problem after transplantation, justifying the use of prednisolone TDM to optimize dosing and minimize morbidity."( Therapeutic drug monitoring of prednisolone after lung transplantation.
Glanville, AR; Kear, LM; McWhinney, BC; Morton, JM; Potter, J; Williamson, S, 2006
)
0.83
" The introduction of infliximab has improved disease control, although a search for an optimum remittive dosing schedule is ongoing."( Treatment of vulval Crohn's disease with infliximab.
Hudson, N; Lewis, FM; Preston, PW, 2006
)
0.33
" Previous reports suggested that modification of MZR therapy with a total dosage and administration schedule may improve the therapeutic effect."( [Beneficial and adverse effects of high-dosage MZR therapy in the management of children with frequently relapsing nephrotic syndrome].
Goto, M; Hamasaki, Y; Hataya, H; Honda, M; Ikeda, M; Ishikura, K, 2006
)
0.33
" A reduction in MPA dosage at the time of conversion may be necessary to prevent over-immunosuppression."( Conversion to everolimus in maintenance patients--current clinical strategies.
Pohanka, E, 2006
)
0.33
" 36, 52, and 60 have anti-inflammatory activity in a mouse model of inflammation after topical dosing with 52 and 60, having an effect similar to that of dexamethasone."( Dissociated nonsteroidal glucocorticoid receptor modulators; discovery of the agonist trigger in a tetrahydronaphthalene-benzoxazine series.
Barker, M; Clackers, M; Copley, R; Demaine, DA; Haase, MV; House, D; Humphreys, D; Inglis, GG; Johnston, MJ; Jones, HT; Loiseau, R; Macdonald, SJ; McLay, IM; Nisbet, L; Pacquet, F; Shanahan, SE; Skone, PA; Tape, D; Uings, I; Upton, R; Vinader, VM; Washington, M, 2006
)
0.33
" dosage (10 AM & 10 PM) plus 6 placebo tablets in the morning (8 AM)."( Comparison of a short course of prednisolone with sustained-release theophylline in the control of nocturnal asthma.
Chhabra, SK,
)
0.41
" Tacrolimus was employed for the maintenance therapy, and the oral prednisolone dosage could successfully be tapered without recurrence, along with the decrement of the titer of MPO-ANCA."( Tacrolimus as a reinforcement therapy for a patient with MPO-ANCA-associated diffuse alveolar hemorrhage.
Eguchi, K; Honda, E; Honda, S; Ida, H; Iwanaga, N; Kawakami, A; Kawasaki, S; Nakamura, H; Origuchi, T; Tsuchihashi, Y; Yoshimine, H, 2007
)
0.58
" Although corticosteroid therapy has been reported to be effective in some CCE patients, the indications of steroid therapy, dosage of corticosteroids, duration of the treatment, or efficacy of prophylactic administration of antibiotics are not yet established."( [Pulmonary infection of Pneumocystis carinii and Cytomegalo virus in the treatment of cholesterol crystal embolism].
Fujii, M; Fujita, Y; Kitamura, H; Matsui, I; Okuno, A; Yamamoto, R, 2006
)
0.33
" Data about BNP dosage for cardiovascular monitoring of patients with ALA on renal replacement therapy are lacking."( Role of B-type natriuretic peptide in cardiovascular state monitoring in a hemodialysis patient with primary amyloidosis.
Cantelli, S; Catizone, L; Fabbian, F; Molino, C; Russo, G; Russo, M; Sartori, S; Stabellini, N, 2006
)
0.33
" Those receiving a higher CsA dosage (<2."( Bone mineral density in long-term Chinese heart transplant recipients: a cross-sectional study.
Chen, YH; Chou, NK; Kuo, HL; Su, IC; Wang, SS; Yang, RS, 2006
)
0.33
" The dosage of prednisolone was tapered, without a relapse, and then the corticosteroid therapy was stopped."( Nephrotic syndrome associated with interferon-beta-1b therapy for multiple sclerosis.
Fujita, T; Kumasaka, R; Murakami, R; Nakamura, M; Nakamura, N; Okumura, K; Osawa, H; Shimada, M; Shirato, K; Yamabe, H, 2006
)
0.69
"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 prednisolone are reviewed."( Biowaiver monographs for immediate release solid oral dosage forms: prednisolone.
Barends, DM; Derendorf, H; Dressman, JB; Junginger, HE; Krämer, J; Midha, KK; Shah, VP; Stavchansky, S; Vogt, M, 2007
)
0.77
" The potential salt form would ideally decrease the rate of (SBE)7M-beta-CD release from osmotic pump formulations and result in an increase in the rate and extent of drug release in osmotic pump tablet and pellet dosage forms."( Evaluation of various properties of alternative salt forms of sulfobutylether-beta-cyclodextrin, (SBE)7M-beta-CD.
Haslam, JL; Sotthivirat, S; Stella, VJ, 2007
)
0.34
" Information on dosage of prednisolone and immunosuppressive agents was also analyzed."( Follow-up of linear growth of body height in children with nephrotic syndrome.
Hung, YT; Yang, LY, 2006
)
0.63
" Infliximab was administered by intravenous infusion at a dosage of 3 mg/kg."( The effect of infliximab on chemokines in patients with rheumatoid arthritis.
Ichikawa, T; Kageyama, Y; Nagano, A; Suzuki, M; Torikai, E, 2007
)
0.34
" She subsequently received maintenance dosing in the outpatient clinic weekly for 4 weeks and bimonthly for 8 weeks, and she continues monthly maintenance VIT."( Ultrarush venom desensitization after systemic reactions during conventional venom immunotherapy.
Chegini, S; Hamilos, DL; Oren, E, 2006
)
0.33
" Accordingly, we made the diagnosis of cryptococcal meningitis and immediately started multiple anti fungal drugs with dosage modification according to her impaired renal function."( [A case of cryptococcal meningitis with nephrotic syndrome and renal insufficiency under immunosuppressive therapy].
Ichikawa, D; Kimura, K; Sato, T; Shima, Y; Tsuchida, H; Yasuda, T, 2007
)
0.34
"Although mizoribine (MZ), which inhibits inosine monophosphate dehydrogenase in the same way as mycophenolate mofetil, recently proved more effective when higher doses were administered than previously approved, neither the optimal dosage nor blood concentration has yet been clarified."( Prophylactic treatment of antibody-mediated rejection with high-dose mizoribine and pharmacokinetic study.
Kobayashi, T; Kuzuya, T; Liu, D; Ma, Y; Miwa, Y; Morozumi, K; Nagasaka, T; Nakao, A; Oikawa, T; Uchida, K; Yokoyama, I, 2007
)
0.34
" The aim of the present study was to compare the efficacy of two dosage regimens in this setting."( Short-term versus long-term induction therapy with antithymocyte globulin in orthotopic liver transplantation.
Berlakovich, GA; Burghuber, C; Györi, G; Hetz, H; Mühlbacher, F; Silberhumer, G; Soliman, T; Steininger, R, 2007
)
0.34
" We also evaluated the effectiveness and side effects of prednisolone using chitosan capsules compared with the conventional dosage form (gelatin capsules)."( [Study on the colon specific delivery of prednisolone using chitosan capsules].
Yamamoto, A, 2007
)
0.85
"5 mg/kg per day of CsA; the dosage was adjusted to reach a blood trough level of 80-150 ng/ml."( Prospective study of low-dose cyclosporine A in patients with refractory lupus nephritis.
Amano, K; Kameda, H; Nagasawa, H; Ogawa, H; Sekiguchi, N; Takei, H; Takeuchi, T; Tsuzaka, K, 2007
)
0.34
" By taking advantage of the heterogeneous methotrexate dosing that occurs among Japanese rheumatologists, we analyzed the efficacy and safety of different methotrexate doses."( Influence of methotrexate dose on its efficacy and safety in rheumatoid arthritis patients: evidence based on the variety of prescribing approaches among practicing Japanese rheumatologists in a single institute-based large observational cohort (IORRA).
Hara, M; Inoue, E; Kamatani, N; Nakajima, A; Tanaka, E; Taniguchi, A; Terai, C; Tomatsu, T; Yamanaka, H, 2007
)
0.34
" Dosage forms and the solid-state properties of drugs and excipients in a formulation may be influenced by the processing conditions used."( Characterization of prednisolone in controlled porosity osmotic pump pellets using solid-state NMR spectroscopy.
Haslam, JL; Lubach, JW; Munson, EJ; Sotthivirat, S; Stella, VJ, 2007
)
0.66
" 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
"5 mg/kg) (MP group); and a group given a reduced dosage of ketoprofen (0."( The interaction between orally administered non-steroidal anti-inflammatory drugs and prednisolone in healthy dogs.
Hara, S; Motoishi, K; Naito, Y; Narita, T; Sato, R; Tani, K, 2007
)
0.56
" Initial experiences with systemic administration of glucocorticoids after PCI failed to confirm the expected benefits of this treatment, probably as a result of inadequate dosage and pharmacokinetic calculations."( Glucocorticoids in the prevention of restenosis after coronary angioplasty: therapeutic potential.
Brunelleschi, S; Ferrero, V; Pesarini, G; Ribichini, F; Vassanelli, C, 2007
)
0.34
" Clinicians must remain alert to detect amiodarone-related pneumonitis even under low dosage and short duration of amiodarone usage."( Amiodarone-related pneumonitis.
Chang, SN; Chiang, FT; Hsu, KL; Hwang, JJ; Lai, LP; Lin, JL; Tsai, CT; Tseng, CD, 2007
)
0.34
" However, the symptoms were aggravated when the prednisolone dosage was reduced, and the titer of anti-MuSK antibody rose at the same time."( [Titer of anti-muscle-specific receptor tyrosine kinase (MuSK) antibody correlated with symptomatic improvement in response to corticosteroid therapy in a patient with anti-MuSK antibody-positive myasthenia gravis: a case report].
Kawajiri, M; Kohara, K; Miki, T; Nakahama, Y; Ochi, M; Ohta, K, 2007
)
0.6
" A young patient presenting with toxic maculopathy after 57 g of hydroxychloroquine and a daily dosage of 2 mg/kg body weight prompted us to retrospectively look at our patients examined in this respect over about 1 year."( [Chloroquine/hydroxychloroquine: variability of retinotoxic cumulative doses].
Berndt, S; Foerster, J; Rüther, K; Schroeter, J, 2007
)
0.34
"In the treatment of tuberculosis with rifampicin in patients treated with prednisolone and cyclosporine, we have to increase the dosage of these drugs."( [Examination of administrative dosage of cyclosporine during anti-tuberculosis chemotherapy including rifampicin].
Akagawa, S; Kawabe, Y; Kawashima, M; Kurashima, A; Machida, K; Masuda, K; Matsui, Y; Nagai, H; Nagayama, N; Suzuki, J; Tamura, A; Yotsumoto, H, 2007
)
0.57
" Prednisolone had been also administrated in all patients and the dosage was doubled from the beginning of the treatment."( [Examination of administrative dosage of cyclosporine during anti-tuberculosis chemotherapy including rifampicin].
Akagawa, S; Kawabe, Y; Kawashima, M; Kurashima, A; Machida, K; Masuda, K; Matsui, Y; Nagai, H; Nagayama, N; Suzuki, J; Tamura, A; Yotsumoto, H, 2007
)
1.25
"The appropriate dosage of cyclosporine was found to be approximately 3 times that of the initial dosage in all patients, but it required a long-term and frequent measurements of trough levels before reaching this goal."( [Examination of administrative dosage of cyclosporine during anti-tuberculosis chemotherapy including rifampicin].
Akagawa, S; Kawabe, Y; Kawashima, M; Kurashima, A; Machida, K; Masuda, K; Matsui, Y; Nagai, H; Nagayama, N; Suzuki, J; Tamura, A; Yotsumoto, H, 2007
)
0.34
"The utility of thermal inkjet (TIJ) technology for preparing solid dosage forms of drugs was examined."( Thermal inkjet application in the preparation of oral dosage forms: dispensing of prednisolone solutions and polymorphic characterization by solid-state spectroscopic techniques.
Albrecht, M; Ashvar, CS; Kane, KM; Meléndez, PA; Smith, PA, 2008
)
0.57
" Myocarditis should be screened systematically even when specific symptoms are missing; dosage of troponin serum is a simple and reliable mean for such screening."( [Troponin dosage in a patient with asymptomatic myocarditis due to trichinellosis].
Abboud, P; Caron, F; Dupouy-Camet, J; Etienne, M; Favennec, L; Gargala, G; Gauliard, E; Gueit, I; Lachkar, S; Tron, C, 2008
)
0.35
" More patients completed the first year without unplanned DMARD changes and without dosage adjustment and fewer had DMARD changes due to side effects or inefficacy in the step-down group compared with step-up, whereas the number of adverse events was comparable."( Daily practice effectiveness of a step-down treatment in comparison with a tight step-up for early rheumatoid arthritis.
Esselens, G; Verschueren, P; Westhovens, R, 2008
)
0.35
" Steroid therapy was stopped or tapered at 50-100% of the baseline dosage in all long-term responders."( Rituximab therapy for childhood Evans syndrome.
Aladjidi, N; Armari-Alla, C; Bader-Meunier, B; Bellmann, F; Bertrand, Y; Chaussé, A; Ledeist, F; Leverger, G; Monpoux, F; Munzer, M; Nelken, B; Pariente, A; Perel, Y; Picard, C; Robert, A; Yacouben, K, 2007
)
0.34
" In multivariate analysis, the effect of high dosage CYC on FVC persisted (OR 10."( Determinants of pulmonary function improvement in patients with scleroderma and interstitial lung disease.
Karadimitrakis, SP; Plastiras, SC; Tzelepis, GE; Vlachoyiannopoulos, PG,
)
0.13
" Thereafter, when tapering the dosage from 60 to 30 mg/day, the lupus nephritis flared up and he was re-hospitalized in February of 2001."( A case of lupus nephritis improved after appropriately adjusting the dosage of mizoribine.
Fukuda, W; Hamaguchi, M; Ishino, H; Kadoya, M; Kawahito, Y; Kohno, M; Niimi, M; Tsubouchi, Y; Wada, M; Yamamoto, A; Yoshikawa, T, 2008
)
0.35
" This makes it possible to decrease the dosage and duration of topical prednisolone acetate."( Intracameral triamcinolone acetonide to control postoperative inflammation following cataract surgery with phacoemulsification.
Akova, YA; Borazan, M; Karalezli, A, 2008
)
0.58
" Papillary bleeding index, time since transplant and azathioprine dosage were significant in the univariate and multivariate models (adjusted R=43."( Gingival overgrowth in renal transplant subjects medicated with tacrolimus in the absence of calcium channel blockers.
Cezário, ES; Costa, FO; Cota, LO; Ferreira, SD; Siqueira, FM; Soares, RV; Zenóbio, EG, 2008
)
0.35
" In severe to critical asthma, differences between sites were common and related to recommendations for: ipratropium use; metered-dose inhaler versus nebulised delivery of salbutamol in severe asthma; use of intravenous aminophylline, intravenous magnesium and dosing of intravenous salbutamol in critical asthma."( Paediatric acute asthma management in Australia and New Zealand: practice patterns in the context of clinical practice guidelines.
Acworth, J; Babl, FE; Borland, M; Cotterell, E; Francis, P; Jamison, S; Krieser, D; Neutze, J; Ngo, P; Schutz, J; Sheriff, N; Thomson, F, 2008
)
0.35
" Cox-regression analysis showed that the duration of oral corticosteroid treatment for less than 6 months was the only significant risk factor for recurrence of VKH after adjustment for age, gender, and the initial dosage of oral corticosteroid treatment (adjusted odds ratio=8."( Effects of the duration of initial oral corticosteroid treatment on the recurrence of inflammation in Vogt-Koyanagi-Harada disease.
Chan, CK; Chan, RP; Lai, TY; Lam, DS, 2009
)
0.35
" The therapeutic benefits of MZB pulse therapy were assessed based on a comparison of the incidence of relapse (times/year) and the required daily dosage of prednisolone (PSL) before and after therapy."( Effect of oral mizoribine pulse therapy for frequently relapsing steroid-dependent nephrotic syndrome.
Fujieda, M; Hayashi, A; Ishihara, M; Morita, T; Ohta, T; Sakano, T; Utsunomiya, Y; Wakiguchi, H, 2008
)
0.54
"05), and the required daily dosage of PSL after therapy was lower than that before therapy (0."( Effect of oral mizoribine pulse therapy for frequently relapsing steroid-dependent nephrotic syndrome.
Fujieda, M; Hayashi, A; Ishihara, M; Morita, T; Ohta, T; Sakano, T; Utsunomiya, Y; Wakiguchi, H, 2008
)
0.35
"Our results show that MZB pulse therapy is effective in decreasing the frequency of relapse and reducing the required PSL dosage in older pediatric patients with FR-SDNS."( Effect of oral mizoribine pulse therapy for frequently relapsing steroid-dependent nephrotic syndrome.
Fujieda, M; Hayashi, A; Ishihara, M; Morita, T; Ohta, T; Sakano, T; Utsunomiya, Y; Wakiguchi, H, 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
)
0.8
" On admission, he was administered intravenous immunoglobulins at a dosage of 400 mg/kg/day for 5 days yet continued to worsen."( Corticosteroids can help distinguish between Guillain-Barré syndrome and first attack of chronic inflammatory demyelinating neuropathy: an illustrative case report.
Alexander, KJ; Alshubaili, AF; Santhamoorthy, P; Sharafuddin, KM, 2008
)
0.35
" No correlation was observed between the daily prednisolone dosage (mg/d or mg kg d) and glucose AUC."( Role of prednisolone pharmacokinetics in postchallenge glycemia after renal transplantation.
Bergrem, H; Bergrem, HA; Hartmann, A; Hjelmesaeth, J; Jenssen, T, 2008
)
1.04
" We treated MCNS with PSL and cyclosporin (CyA) as an initial therapy to reduce PSL dosage and its side effects, and compared various clinical parameters in MCNS treated with the conventional PSL therapy."( [Combined effect of cyclosporin and prednisolone for minimal change nephrotic syndrome: comparison with prednisolone therapy].
Fukatsu, A; Hayashi, M; Kimura, N, 2008
)
0.62
" Total PSL dosage in Group A in hospital (386+/-173 mg) was smaller than in Group B (1,884+/-1,573 mg) (p=0."( [Combined effect of cyclosporin and prednisolone for minimal change nephrotic syndrome: comparison with prednisolone therapy].
Fukatsu, A; Hayashi, M; Kimura, N, 2008
)
0.62
" After exclusion of the unfulfilled criteria cases, 201 cases of Bell's palsy completed the study protocol and were followed for six months after a seven-day course of 60 mg/day followed by a five-day taper-off dosage of oral prednisolone."( Clinical prognostic factors for treatment outcome in Bell's palsy: a prospective study.
Sathirapanya, C; Sathirapanya, P, 2008
)
0.53
" Conclusion Larger prospective studies are needed to determine the clinical relevance of TPMT activity and to determine accurate azathioprine dosing guidelines based on TPMT activity."( Role of thiopurine methyltransferase activity in the safety and efficacy of azathioprine in the treatment of pemphigus vulgaris.
Chams-Davatchi, C; Firooz, A; Ghandi, N; Hallaji, Z; Karbakhsh Davari, M; Valikhani, M, 2008
)
0.35
" The mean maximum daily dosage of prednisolone was 32."( Changes in body composition after glucocorticoid therapy in patients with systemic lupus erythematosus.
Ma, KM; Mok, CC; To, CH, 2008
)
0.63
" UC patients whose neutrophils were isolated were divided into two subgroups according to their total preoperative dosage of prednisolone: group H, > or =10,000 mg; group L, <10,000 mg."( Neutrophil-related immunoinflammatory disturbance in steroid-overdosed ulcerative colitis patients.
Araki, T; Kusunoki, M; Miki, C; Okita, Y; Uchida, K; Yoshiyama, S, 2008
)
0.55
" In the present case, re-epithelization and healthy granulation were induced by the CDS without increasing the dosage of systemic prednisolone."( Case report: a case of pyoderma gangrenosum with intractable leg ulcers treated by allogeneic cultured dermal substitutes.
Furukawa, F; Kanazawa, N; Kishioka, A; Kuroyanagi, Y; Matsumoto, Y; Nishide, T; Toyozawa, S; Yamamoto, Y, 2008
)
0.55
" Consensus may end there, as there is no clear-cut "best" route of administration or dosing schedule."( Relapse management in multiple sclerosis.
Thrower, BW, 2009
)
0.35
" The immune-specific amplification of prednisolone anti-inflammatory activity by dipyridamole did not extend to glucocorticoid-mediated adverse effects, including corticosterone suppression or increased expression of tyrosine aminotransferase, in vivo after repeat dosing in rats."( Selective amplification of glucocorticoid anti-inflammatory activity through synergistic multi-target action of a combination drug.
Avery, W; Borisy, AA; Farwell, M; Finelli, AL; Fraser, CC; Zimmermann, GR, 2009
)
0.62
" Our findings suggested that the initial dosage of theophylline should be adjusted according to the gender of pediatric patients and particularly in the case of infants."( Effect of gender on theophylline clearance in the asthmatic acute phase in Japanese pediatric patients.
Igarashi, T; Iwakawa, S, 2009
)
0.35
" Whereas systemic exposure to budesonide was markedly lower in healthy subjects after the mouthwash compared to oral dosing (mean relative bioavailability 18%-36%), the systemic concentrations thereafter in patients were as high as those after the identical dose of oral budesonide."( Pharmacokinetics and pharmacodynamic action of budesonide after buccal administration in healthy subjects and patients with oral chronic graft-versus-host disease.
Bertz, H; Dilger, K; Finke, J; Gratwohl, A; Halter, J; Lopez-Lazaro, L, 2009
)
0.35
" Because patients are typically dosed per kilogram body weight, this might result in underexposure and overexposure in patients, with a low and high body weight, respectively."( Explaining variability in tacrolimus pharmacokinetics to optimize early exposure in adult kidney transplant recipients.
Danhof, M; de Fijter, JW; den Hartigh, J; Guchelaar, HJ; Ploeger, BA; Press, RR; van der Straaten, T; van Pelt, J, 2009
)
0.35
" Pharmacodynamic (PD) assay for evaluating the inhibition of interleukin-2 (IL-2) production for each patient could provide a more appropriate dosing regimen."( Evaluation of interleukin-2 mRNA in whole blood as a parameter for monitoring cyclosporine pharmacodynamics.
Katayama, A; Kobayashi, T; Kuzuya, T; Miwa, Y; Nagasaka, T; Nakao, A; Uchida, K; Yamada, K, 2009
)
0.35
" To determine if administration of an immunosuppressive dosage of prednisolone to adult dogs latently infected with CHV-1 results in recurrent ocular disease, adult beagles with and without experimentally induced CHV-1 latent infection were divided into groups: group 1 latently infected and administered prednisolone, group 2 latently infected and administered placebo, and group 3 not latently infected and administered prednisolone."( Experimental reactivation of latent canine herpesvirus-1 and induction of recurrent ocular disease in adult dogs.
Bicalho, RC; Dubovi, EJ; Kim, SG; Ledbetter, EC, 2009
)
0.59
" To perform the immediate effect analysis (GPi or zero time), of each mixture either at room or refrigerator temperature, the preparation procedure was similar, although GPR, iodoform, Rifocort and camphorated paramonochlorophenol were stored in the refrigerator and then taken out, dosed and manipulated, and had their immediate effect tested after a 1-week period at storage of 4 degrees C average temperature."( Antimicrobial action of a filling paste used in pulp therapy in primary teeth under different storage conditions.
Ferreira, FV; Friedrich, RS; Guedes-Pinto, AC; Praetzel, JR; Weiss, RN, 2008
)
0.35
" It has been reported that treatment of the steroid-induced psychiatric symptoms involves dosage reduction or discontinuation of steroid, and concomitant administration of psychotropics."( Can "steroid switching" improve steroid-induced psychosis in a patient with advanced cancer?
Ito, N; Okishiro, N; Tanimukai, H; Tsuneto, S, 2009
)
0.35
"Treatment with cyclophosphamide and steroids for idiopathic membranous nephropathy (IMN) is effective in Caucasian patients, but the cumulative cyclophosphamide dosage exceeds 10 g and includes steroid pulse therapy."( Long-term outcomes of idiopathic membranous nephropathy in Japanese patients treated with low-dose cyclophosphamide and prednisolone.
Eriguchi, M; Harada, A; Kamimura, T; Mizobuchi, T; Oka, H; Sugawara, K, 2009
)
0.56
" Patients were treated with cyclophosphamide (50 mg/day for the first 3 months and 25 mg/day for the next 3 months) and prednisolone (30 mg/day for the first week and the dosage was gradually tapered to withdraw by 2 years)."( Long-term outcomes of idiopathic membranous nephropathy in Japanese patients treated with low-dose cyclophosphamide and prednisolone.
Eriguchi, M; Harada, A; Kamimura, T; Mizobuchi, T; Oka, H; Sugawara, K, 2009
)
0.77
"5 mg/day), and appears to be as efficient but less diabetogenic compared to the standard once daily dosing (4."( Twice daily fractionated dose administration of prednisolone compared to standard once daily administration to patients with glomerulonephritis or with kidney transplants.
Decker, SO; Keller, F; Mayer, J; Stracke, S, 2009
)
0.61
" In contrast to the postdose reductions of IMPDH activity observed early posttransplant, IMPDH activity within both treatment groups was elevated throughout the dosing interval at week 13."( Mycophenolate pharmacokinetics and pharmacodynamics in belatacept treated renal allograft recipients - a pilot study.
Bergan, S; Bremer, S; Holdaas, H; Jørgensen, PF; Midtvedt, K; Rootwelt, H; Stenstrøm, J; Vethe, NT, 2009
)
0.35
"The significant influence of MPA on IMPDH1 expression, possibly mediated through reduced guanine nucleotide levels, could explain the elevations of IMPDH activity within dosing intervals at week 13."( Mycophenolate pharmacokinetics and pharmacodynamics in belatacept treated renal allograft recipients - a pilot study.
Bergan, S; Bremer, S; Holdaas, H; Jørgensen, PF; Midtvedt, K; Rootwelt, H; Stenstrøm, J; Vethe, NT, 2009
)
0.35
" Retreatment with an augmented dosage of prednisolone, +/- another immunosuppressive agent, resulted in CR and PR in 15 (79%) and 4 (21%) of these flare episodes, respectively."( Very long-term outcome of pure lupus membranous nephropathy treated with glucocorticoid and azathioprine.
Mok, CC; Ng, WL; Wong, WS; Yim, CW; Ying, KY, 2009
)
0.62
" No relationship was observed between osteoporosis and age, sex, body mass index, duration of hemodialysis therapy, cumulative dosage of any drugs, or use of pulsed methylprednisolone therapy."( Osteoporosis and related risk factors in renal transplant recipients.
Ahmadpoor, P; Ghafari, A; Makhdoomi, K; Rahimi, E; Reisi, S; Sepehrvand, N, 2009
)
0.55
" Maximum tacrolimus dosage administrated for patients over a 6-month period appeared not to be predictive for the DAS28-CRP remission at 6 months."( Prediction of DAS28-CRP remission in patients with rheumatoid arthritis treated with tacrolimus at 6 months by baseline variables.
Aoyagi, K; Aramaki, T; Arima, K; Eguchi, K; Fujikawa, K; Furuyama, M; Ida, H; Iwamoto, N; Kamachi, M; Kawakami, A; Kawashiri, SY; Matsuoka, N; Mizokami, A; Nakamura, H; Nakashima, M; Origuchi, T; Tamai, M; Ueki, Y; Yamasaki, S, 2009
)
0.35
" 2 patients reduced the MMF dosage because of anemia or herpes labialis."( Mycophenolate mofetil therapy for childhood-onset steroid dependent nephrotic syndrome after long-term cyclosporine: extended experience in a single center.
Fujinaga, S; Hirano, D; Kaneko, K; Nishizaki, N; Ohtomo, Y; Ohtsuka, Y; Shimizu, T; Someya, T, 2009
)
0.35
" While tapering the dosage of prednisolone, we carefully observed the appearance of skin lesions and erythema nodosum appearing on her right lower leg."( [Case of neuro-Behçet disease with HLA-B54, Cw1, which is difficult in clinical diagnosis from neuro-Sweet disease].
Kumakiri, M; Kuriyama, M; Sato, M; Yoneda, M, 2009
)
0.64
"4), while the risk factor for OFH was a recent maximum GC dosage (>1."( Notable difference between the development of vertebral fracture and osteonecrosis of the femoral head in patients treated with high-dose glucocorticoids for systemic rheumatic diseases.
Amano, K; Kameda, H; Nagasawa, H; Ogawa, H; Sekiguchi, N; Suzuki, K; Takei, H; Takeuchi, T, 2009
)
0.35
" He was effectively managed with methylprednisolone pulse therapy (500 mg/day x 3 days) followed by progressive dosage tapering."( [Case of microscopic polyangiitis presenting initially as prostatic vasculitis].
Akizawa, T; Ashikaga, E; Iyoda, M; Nagai, H; Shibata, T; Suzuki, H, 2009
)
0.62
" In the main dosing study, the mean RBC 6-TGN level in patients who remained in remission during the 1-year observation time (n = 151) was 322."( Thiopurine maintenance therapy for ulcerative colitis: the clinical significance of monitoring 6-thioguanine nucleotide.
Abe, J; Arai, O; Hanai, H; Hosoda, Y; Iida, T; Ikeya, K; Kageoka, M; Kubota, T; Maruyama, Y; Miwa, I; Oohata, A; Takeuchi, K; Watanabe, F; Yoshirou, S, 2010
)
0.36
" Due to lack of evidence, inclusion criteria was revised during the process of the review to include studies comparing different dosage of corticosteroids."( Corticosteroid regimens for treatment of acute and chronic graft versus host disease (GvHD) after allogenic stem cell transplantation.
Banihosseini, S; Ferrara, JL; Rabbani-Anari, M; Rahimi Darabad, R; Rohanizadegan, M; Salmasian, H; Shakiba, A, 2010
)
0.36
" Prednisolone dosage was increased from 10 to 60 mg/day."( Type B insulin resistance syndrome with systemic lupus erythematosus.
Gohda, T; Horikoshi, S; Ohsawa, I; Sato, N; Shirato, I; Takagi, M; Tomino, Y; Yamaguchi, Y, 2010
)
1.27
" This study was designed to deduce a dosage of prednisolone compatible with normal growth."( Long-term steroid treatment and growth: a study in steroid-dependent nephrotic syndrome.
Grundy, N; Simmonds, J; Trompeter, R; Tullus, K, 2010
)
0.62
" Primary ocular CHV-1 infection was experimentally induced in mature specific pathogen-free beagles by topical ocular inoculation and the presence of reactivatable latency was later confirmed by administration of an immunosuppressive dosage of systemic corticosteroid to the dogs."( The effect of topical ocular corticosteroid administration in dogs with experimentally induced latent canine herpesvirus-1 infection.
Dubovi, EJ; Kice, NC; Kim, SG; Ledbetter, EC; Matusow, RB, 2010
)
0.36
" After two years, the choice and dosing of DMARDs and prednisolone were not restricted, but the treatment was still targeted to achieve or maintain remission."( Renal safety of initial combination versus single DMARD therapy in patients with early rheumatoid arthritis: an 11-year experience from the FIN-RACo Trial.
Hannonen, PJ; Kaipiainen-Seppänen, OA; Karjalainen, AH; Karstila, KL; Korpela, MM; Leirisalo-Repo, M; Möttönen, TT; Mustonen, JT; Rantalaiho, VM,
)
0.38
" Moreover, concurrent prednisolone use at a dosage of 20 mg/day or higher was associated with a 22% higher clearance of CsA, hence lower CsA exposure."( Explaining variability in ciclosporin exposure in adult kidney transplant recipients.
Danhof, M; de Fijter, H; den Hartigh, J; Guchelaar, HJ; Ploeger, BA; Press, RR; van der Straaten, T; van Pelt, H, 2010
)
0.68
" However, chronic use of topical corticosteroids dosed at < or = 3 drops daily seemed to be associated with a lower risk of cataract development relative to eyes receiving higher doses over follow-up in the setting of suppressed uveitis."( Risk of cataract development among children with juvenile idiopathic arthritis-related uveitis treated with topical corticosteroids.
Dunn, JP; Jabs, DA; Thorne, JE; Woreta, FA, 2010
)
0.36
"In 53 patients, acute inflammation was suppressed with effective prednisolone dosage (1-2 mg/kg/day, tapered to 10 mg within 4-6 weeks)."( Safety and effectiveness of interferon alpha-2a in treatment of patients with Behçet's uveitis refractory to conventional treatments.
Bayer, A; Bayraktar, MZ; Durukan, AH; Erdem, U; Erdurman, C; Karagul, S; Köksal, S; Sobaci, G, 2010
)
0.6
" Withdrawal of the ciclosporin and reduction of the prednisolone dosage resulted in spontaneous resolution of the skin lesions within 40 days."( Cutaneous Alternaria infectoria infection in a dog in association with therapeutic immunosuppression for the management of immune-mediated haemolytic anaemia.
Choi, JS; de Hoog, GS; Dedola, C; Else, RW; Ridyard, AE; Stuart, AP; Thoday, KL; van den Broek, AH, 2010
)
0.61
" Compared to those who didn't, there were significantly more LL/BL patients with positive BI among SID whose cumulative prednisolone dosage was nearly 9000 mg as compared to half the amount among others."( A study of steroid-induced diabetes mellitus in leprosy.
Abraham, S; John, AS; Papang, R; Rao, PS,
)
0.34
" There was an increased risk of IFI in the lupus patients receiving high daily dosage of prednisolone therapy."( A retrospective study of catastrophic invasive fungal infections in patients with systemic lupus erythematosus from southern Taiwan.
Chang, HY; Chang, TW; Lee, NY; Lin, TS; Liu, MF; Wang, CR; Wang, JY; Weng, CT; Weng, MY; Wu, AB, 2010
)
0.58
"Taken together, the MTG-containing ZnO can be a more effective and convenient delivery system for the treatment of hemorrhoid with a reduced dosage interval."( Effect of zinc oxide on the rheological and mucoadhesive properties of poloxamer 407-based mucoadhesive thermosensitive gel.
Choi, HG; Kim, CK; Kim, HT; Kim, ST; Park, JS; Park, TH, 2010
)
0.36
"001), and a significant decrease in the mean oral prednisone dosage (55."( Azathioprine in severe uveitis of Behçet's disease.
Amoura, Z; Bodaghi, B; Cacoub, P; Cassoux, N; Hajage, D; Le Hoang, P; Le Thi Huong, D; Resche-Rigon, M; Saadoun, D; Terrada, C; Wechsler, B, 2010
)
0.36
" Difluprednate provides effective treatment for anterior uveitis and requires less frequent dosing than prednisolone acetate."( Durezol (Difluprednate Ophthalmic Emulsion 0.05%) compared with Pred Forte 1% ophthalmic suspension in the treatment of endogenous anterior uveitis.
Crockett, RS; Davanzo, R; Flynn, TE; Foster, CS; McLeod, K; Vogel, R, 2010
)
0.58
"Randomized controlled trials comparing any corticosteroid with placebo, no treatment, or other drug; or comparing one corticosteroid with another corticosteroid or dosage in women with HELLP syndrome."( Corticosteroids for HELLP (hemolysis, elevated liver enzymes, low platelets) syndrome in pregnancy.
Chandra, S; Dowswell, T; Hofmeyr, GJ; Woudstra, DM, 2010
)
0.36
"Dissolution testing is an important test for judging the effectiveness of a pharmaceutical dosage form."( Solid dispersion of prednisolone: solid state characterization and improvement of dissolution profile.
Khanam, J; Palanisamy, M, 2011
)
0.69
"5 mg prednisolone/kg)and Group 1B (1 mg prednisolone/kg) according to the dosage of prednisolone."( Influence of systemic steroids on subretinal fluid after scleral buckle surgery for macula-off retinal detachment.
Chen, SN; Hwang, JF; Lin, CJ; Wu, JS, 2011
)
0.88
" Treatment continued without obvious side effects, and PDL dosage was tapered to 10 mg/day."( [Complete response achieved in a case of gastric gastrointestinal stromal tumor by administration of imatinib mesilate with concurrent relatively high-dose steroid therapy to control side effects].
Kishimoto, H; Nakamura, M; Otagiri, N; Sasahara, K; Tauchi, K; Tsukada, Y; Yoshifuku, S, 2010
)
0.36
" Four (10%) containers did not include any additional type of warnings related to the medication, beyond the dosage amount and administration frequency."( Characteristics of container labeling in a sample of commonly prescribed children's oral medications.
DeVoe, JE; Keenum, AJ; Wallace, LS, 2010
)
0.36
" The two treatment groups were compared for blood concentrations of CsA, the extent of acceptable dosage reduction for the maintenance of immunotherapy, potential effects of kidney protection, and promotion of graft function."( Combination therapy with diltiazem plus CsA/MMF/Pred or CsA/Aza/Pred triple immunosuppressive regimens for use in clinical kidney transplantation in Northwestern China.
Ding, X; Fan, X; Feng, X; Hou, J; Pan, X; Qin, G; Song, Y; Tian, P; Tian, X; Xiang, H; Xue, W; Yan, H, 2011
)
0.37
"In our cohort of renal transplantation patients, co-administration of CsA and diltiazem increased CsA blood concentration, thereby resulting in a reduction in its required dosage treatment, which lightened the patients' economic burden while improving primary and long-term kidney function by promoting the recovery of graft function and decreasing hepatic and renal toxicity."( Combination therapy with diltiazem plus CsA/MMF/Pred or CsA/Aza/Pred triple immunosuppressive regimens for use in clinical kidney transplantation in Northwestern China.
Ding, X; Fan, X; Feng, X; Hou, J; Pan, X; Qin, G; Song, Y; Tian, P; Tian, X; Xiang, H; Xue, W; Yan, H, 2011
)
0.37
" In groups 1 and 3, mean lomustine dosage was 60."( Comparison of oral administration of lomustine and prednisolone or prednisolone alone as treatment for granulomatous meningoencephalomyelitis or necrotizing encephalitis in dogs.
Boettcher, IC; Doherr, MG; Flegel, T; Henke, D; Matiasek, K; Oechtering, G; Oevermann, A, 2011
)
0.62
" The aim of this work is to investigate the effect of a low dosage and long term dexamethasone treatment on the levels of endogenous corticosteroids in cattle and to evaluate the possible presence of prednisolone residues in bovines bred under strictly controlled conditions."( Studies on the presence of natural and synthetic corticosteroids in bovine urine.
Bozzetta, E; Caramelli, M; Draisci, R; Ferranti, C; Marchiafava, C; Palleschi, L; Pezzolato, M; Quadri, FD, 2011
)
0.56
" In a subsequent dose-response study, we found that a single dose of 1mg/kg liposomal prednisolone phosphate (PLP) was still equally effective in suppressing joint inflammation as 4 repeated once-daily injections of 10mg/kg free PLP."( Safety of glucocorticoids can be improved by lower yet still effective dosages of liposomal steroid formulations in murine antigen-induced arthritis: comparison of prednisolone with budesonide.
Hofkens, W; Nabbe, KC; Pesman, GJ; Storm, G; Sweep, FC; van den Berg, WB; van den Hoven, JM; van Lent, PL, 2011
)
0.79
" Our results suggest that CMV reactivation occurs more frequently in DM patients than previously recognized; CMV reactivation occurs regardless of the dosage and duration of corticosteroid administration or the presence of underlying disease."( Relationship between cytomegalovirus reactivation and dermatomyositis.
Hirahara, K; Kanetaka, Y; Kano, Y; Kurata, M; Shiohara, T,
)
0.13
" When treating rapidly progressive glomerulonephritis, immunosuppressive status should be carefully monitored regarding not only the dosage of therapeutic regimen but also the mental health status and nutrition of the patient."( A case of Goodpasture syndrome positive for anti-GBM antibody and MPO-ANCA complicated by a variety of serious infections.
Adachi, T; Hatta, T; Kimura, T; Kishimoto, N; Kusaba, T; Matsubara, H; Mori, Y; Nakagawa, H; Nakayama, M; Okigaki, M; Sakoda, C; Sonomura, K, 2011
)
0.37
" The purpose of this investigation was to evaluate the ocular pharmacokinetics of mapracorat after topical dosing over a range of dose levels in rabbits and monkeys."( Ocular pharmacokinetics of mapracorat, a novel, selective glucocorticoid receptor agonist, in rabbits and monkeys.
Lowe, ER; Proksch, JW; Ward, KW, 2011
)
0.37
" Given that repeat dosing of cells may be necessary to achieve a lasting therapeutic benefit, in this study, we examined approaches to avoid an immune response to multiple SC injections of UTC."( Approaches to avoid immune responses induced by repeated subcutaneous injections of allogeneic umbilical cord tissue-derived cells.
Chi, N; Cho, PS; Ferguson, KK; Goldman, SN; Hanekamp, JS; Hirsh, EL; Houser, S; Huang, CA; Lutton, BV; Messina, DJ; Popma, SH; Sachs, DH; Teague, AG; Yeap, BY, 2010
)
0.36
" The prednisolone dosage was tapered over 3 - 8 weeks."( [Juvenile sterile granulomatous dermatitis and lymphadenitis in the dog].
Eule, C; Kohn, B; Weingart, C; Welle, M, 2011
)
0.88
" Correlation between daily corticosteroid dosage and remission time and factors relating to final visual acuity of <20/40 were studied."( Central serous chorioretinopathy after renal transplantation.
Byeon, SH; Kang, EC; Koh, HJ; Lee, CS; Lee, KS; Lee, SC, 2011
)
0.37
"Thirty-one patients with SLE receiving a fixed dosage regimen of MMF (median and interquartile range, 1500 and 1000-2000mg/day) for at least 1month and who had not experienced any adverse drug reactions for more than 3months were enrolled."( Effective plasma concentrations of mycophenolic acid and its glucuronide in systemic lupus erythematosus patients in the remission-maintenance phase.
Kawakami, J; Mino, Y; Naito, T; Ogawa, N; Shimoyama, K, 2012
)
0.38
"MMF improved clinical laboratory markers and reduced prednisolone dosage in SLE patients with predose plasma concentration of MPA and MPAG in the interquartile ranges of 0·94-2·96 and 18·6-53·7μg/mL, respectively."( Effective plasma concentrations of mycophenolic acid and its glucuronide in systemic lupus erythematosus patients in the remission-maintenance phase.
Kawakami, J; Mino, Y; Naito, T; Ogawa, N; Shimoyama, K, 2012
)
0.63
"In a randomised placebo-controlled double-blind (participants and the investigators who performed the studies and assessed the outcomes were blinded) dose-response intervention study, 32 healthy men (age 22 ± 3 years; BMI 22."( Low-dose glucocorticoid treatment affects multiple aspects of intermediary metabolism in healthy humans: a randomised controlled trial.
Ackermans, MT; Brands, M; Diamant, M; Muskiet, MH; Pouwels, PJ; Sauerwein, HP; Serlie, MJ; van der Zijl, NJ; van Raalte, DH, 2011
)
0.37
" Therapy is safe because it is limited to several months and the dosage is continually weaned as the infant gains weight."( Oral prednisolone for infantile hemangioma: efficacy and safety using a standardized treatment protocol.
Couto, RA; Greene, AK, 2011
)
0.88
" We proposed a systematic classification scheme using FDA-approved drug labeling to assess the DILI potential of drugs, which yielded a benchmark dataset with 287 drugs representing a wide range of therapeutic categories and daily dosage amounts."( FDA-approved drug labeling for the study of drug-induced liver injury.
Chen, M; Fang, H; Liu, Z; Shi, Q; Tong, W; Vijay, V, 2011
)
0.37
" Methylprednisolone pulse therapy was performed in patients resistant to the high dosage of PSL."( The short-term role of corticosteroid therapy for pulmonary arterial hypertension associated with connective tissue diseases: report of five cases and a literature review.
Atsumi, T; Fujieda, Y; Horita, T; Kataoka, H; Kato, M; Koike, T; Nishimura, M; Odani, T; Ohira, H; Oku, K; Otomo, K; Tsujino, I; Yasuda, S, 2011
)
0.82
"An analytical, pharmacokinetic and histopathologic investigation was conducted by two experimental trials on beef cattle in order to determine fate and effects of dexamethasone and prednisolone, administered to distinct cattle groups at low dosage for long periods of time."( Effects of low-dose dexamethasone and prednisolone long term administration in beef calf: chemical and morphological investigation.
Biolatti, B; Cannizzo, FT; Capra, P; Ciccotelli, V; Divari, S; Vincenti, M, 2011
)
0.83
" Because of the variability in dose and dosing schedule, quantification of this risk is not possible."( Official Positions for FRAX(®) clinical regarding glucocorticoids: the impact of the use of glucocorticoids on the estimate by FRAX(®) of the 10 year risk of fracture from Joint Official Positions Development Conference of the International Society for Cl
Adachi, JD; Binkley, N; Geusens, PP; Hans, DB; Leib, ES; McCloskey, EV; Saag, KG,
)
0.13
" Although these agents are dosed to directly target airway inflammation, adrenocortical suppression and other systematic effects are still seen."( Synthesis, transport and mechanism of a type I prodrug: L-carnitine ester of prednisolone.
Gong, T; Mo, JX; Shi, SJ; Sun, X; Zhang, Q; Zhang, ZR, 2011
)
0.6
" Dose was raised until a final dosage of 30 mg/week."( [Autoimmune pancreatitis associated with rheumatoid arthritis: successful combination therapy with steroids and methotrexate].
Boltuch-Sherif, J; Erlacher, L; Horvath-Mechtler, B; Kowalski-Bodzenta, J; Mustak, M, 2011
)
0.37
" An ARB was given to all patients and the same dosage was used throughout the study."( Triple therapy with single daily dose of cyclosporine in Japanese patients with idiopathic membranous nephropathy.
Esaki, S; Gondo, A; Hayashi, A; Matsumoto, H; Miyaoka, Y; Nagaoka, Y; Nakao, T; Okada, T; Wada, T, 2011
)
0.37
"There was a significant positive correlation between the levels of MIF and the total preoperative dosage of prednisolone."( Neutrophil dysfunction in steroid-overdosed patients with ulcerative colitis: potential relevance of macrophage migration inhibitory factor to increased postoperative morbidity.
Araki, T; Kusunoki, M; Miki, C; Okita, Y; Otake, K; Uchida, K; Yoshiyama, S, 2011
)
0.58
"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
)
0.69
" Despite this very long experience, there remains considerable debate concerning the adequate dosing and timing of these medications, primarily because of frequent and sometimes serious side effects, particularly in high doses."( A dose of only 5 mg prednisolone daily retards radiographic progression in early rheumatoid arthritis - the Low-Dose Prednisolone Trial.
Rau, R; Wassenberg, S; Zeidler, H,
)
0.45
" In both groups, the average UC clinical disease activity index, the endoscopic index, and the concomitant prednisolone dosage were significantly and equally reduced during the course of 10 LCAP."( Optimal apheresis treatment volume for the efficacy and safety of leukocytapheresis with Cellsorba in patients with active ulcerative colitis.
Fukunaga, K; Hida, N; Iimuro, M; Kamikozuru, K; Kato, K; Kikuyama, R; Matsumoto, T; Miwa, H; Nagase, K; Nakamura, S; Ohda, Y; Takeda, N; Yokoyama, Y; Yoshida, K, 2011
)
0.58
" Quetiapine treatment was initiated at an initial dosage of 300 mg/day."( Report of a case of steroid-induced psychosis and inappropriate sexual behaviour in an adolescent.
Demir, T; Dogangun, B; Karacetin, G; Kocabasoglu, N, 2012
)
0.38
" Dose-response data and pharmacokinetic data were used to calculate effective and safe clinical doses of paquinimod."( Pharmacokinetics, tolerability, and preliminary efficacy of paquinimod (ABR-215757), a new quinoline-3-carboxamide derivative: studies in lupus-prone mice and a multicenter, randomized, double-blind, placebo-controlled, repeat-dose, dose-ranging study in
Axelsson, B; Bengtsson, AA; Leanderson, T; Lood, C; Ohman, MW; Rönnblom, L; Sparre, B; Sturfelt, G; Tuvesson, H; van Vollenhoven, RF, 2012
)
0.38
"Serum 25-hydroxyvitamin D [25(OH)D] concentrations were measured in 20 dogs with atopic dermatitis prior to treatment with a standard therapeutic dosage of prednisolone (0."( Prednisolone therapy for atopic dermatitis is less effective in dogs with lower pretreatment serum 25-hydroxyvitamin D concentrations.
Berry, J; Kovalik, M; Mellanby, RJ; Thoday, KL; van den Broek, AH, 2012
)
2.02
"5 mg/kg/day (maximum 60 mg) tapered to 0 by 17 weeks (arm 1), or MTX (same dosage as arm 1), etanercept placebo, and prednisolone placebo (arm 2)."( Trial of early aggressive therapy in polyarticular juvenile idiopathic arthritis.
Brunner, HI; Chira, P; Giannini, EH; Gottlieb, BS; Hamilton, S; Hashkes, PJ; Higgins, GC; Huang, B; Ilowite, NT; Johnson, A; Kimura, Y; Lovell, DJ; Milojevic, D; O'Neil, KM; Punaro, MG; Ringold, S; Schanberg, LE; Spalding, SJ; Sundel, RP; Szer, IS; Wallace, CA; Zeft, AS, 2012
)
0.59
" However, the most appropriate dosage regimen has not been determined and remains controversial."( COPD exacerbations in general practice: variability in oral prednisolone courses.
Berendsen, AJ; Bosveld, HE; de Vries, M; Kerstjens, HA; van der Molen, T, 2012
)
0.62
" Serum ACE level was reduced in all cases, and daily steroid dosage was reduced."( Refractory multisystem sarcoidosis responding to infliximab therapy.
Carruthers, D; Croft, AP; Giovanni, G; Gordon, C; Khair, O; Situnayake, D; Sivaguru, A, 2012
)
0.38
" Serum concentrations of calcium, phosphate, vitamin D metabolites and plasma concentrations of parathyroid hormone and ionised calcium together with urinary fractional excretion of calcium and phosphate, were measured in 16 dogs with atopic dermatitis before and 6 weeks after standard dosage prednisolone treatment (0."( Short-term prednisolone therapy has minimal impact on calcium metabolism in dogs with atopic dermatitis.
Berry, J; Evans, H; Kovalik, M; Mellanby, RJ; Thoday, KL; van den Broek, AH, 2012
)
0.94
" Data was obtained relevant to demographic characteristics, anatomic classification, and laterality of uveitis, associated systemic disorder, dosage of cyclosporine and prednisolone, usage of other immunosuppressive drugs, visual acuity (VA), control of uveitic activity, and adverse effects during the cyclosporine use."( Clinical outcomes of cyclosporine treatment for noninfectious uveitis.
Chung, H; Lee, SH; Yu, HG, 2012
)
0.57
" Prednisolone was administered in 10-, 20-, and 40-mg dosage to healthy volunteers to study detection of various metabolites."( Simultaneous identification of prednisolone and its ten metabolites in human urine by high performance liquid chromatography-tandem mass spectrometry.
Ahi, S; Beotra, A; Dubey, S; Jain, S; Upadhyay, A, 2012
)
1.58
"Prednisolone in customary dosage does not seem to influence recovery of idiopathic sudden sensorineural hearing loss."( Corticosteroid treatment of idiopathic sudden sensorineural hearing loss: randomized triple-blind placebo-controlled trial.
Hultcrantz, E; Nosrati-Zarenoe, R, 2012
)
1.82
" In the case example presented here the disease was due to an excessive dosage of prednisolone medication over a period of many years."( [Esophagitis during immunosuppression].
Gross, WL; Moosig, F, 2012
)
0.6
" Seven patients received a single topical dose of 30 mg and one special case subject received three doses with 4 weeks between dosing occasions."( Topical treatment with the Toll-like receptor agonist DIMS0150 has potential for lasting relief of symptoms in patients with chronic active ulcerative colitis by restoring glucocorticoid sensitivity.
Admyre, C; Löfberg, R; Lutfi, T; Malek, M; Musch, E; von Stein, OD; von Stein, P; Zargari, A, 2013
)
0.39
"Randomization within 72 hours in a factorial fashion to placebo plus placebo (n = 206); prednisolone, 60 mg/d for 5 days, with the dosage then tapered for 5 days, plus placebo (n = 210); valacyclovir hydrochloride, 1000 mg 3 times daily for 7 days, plus placebo (n = 207); or prednisolone plus valacyclovir (n = 206)."( The effect of prednisolone on sequelae in Bell's palsy.
Berg, T; Bylund, N; Engström, M; Hultcrantz, M; Jonsson, L; Kanerva, M; Marsk, E, 2012
)
0.96
" The therapeutic benefits of MZB pulse therapy were assessed based on a comparison of the incidence of relapse and the required daily dosage of prednisolone (PSL) in the 12 months prior to and following therapy."( Effect of single-dose oral mizoribine pulse therapy twice per week for frequently relapsing steroid-dependent nephrotic syndrome.
Fujieda, M; Hayashi, A; Ishihara, M; Morita, T; Ohta, T; Okada, S; Sakano, T; Wakiguchi, H, 2012
)
0.58
"01) and the required daily dosage of prednisolone (PSL) after therapy was lower than that before therapy (0."( Effect of single-dose oral mizoribine pulse therapy twice per week for frequently relapsing steroid-dependent nephrotic syndrome.
Fujieda, M; Hayashi, A; Ishihara, M; Morita, T; Ohta, T; Okada, S; Sakano, T; Wakiguchi, H, 2012
)
0.65
" 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
)
0.69
" 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
)
0.96
"Although dosing and treatment protocol is still debatable, steroids and interferon are good options for hemangioma treatment."( Infantile hemangiomas, complications and follow-up.
Agaoglu, L; Akcay, A; Anak, S; Baykal, C; Devecioglu, O; Garipardic, M; Karakas, Z; Ozturk, G; Saribeyoglu, ET; Unuvar, A, 2012
)
0.38
" He then was administered prednisolone at a dosage of 45 mg/d (0."( De novo postallogeneic hematopoietic stem cell transplant membranous nephropathy.
Ando, Y; Kusano, E; Mori, M; Morishita, Y; Muto, S; Numata, A; Saito, O; Takemoto, F; Yumura, W, 2013
)
0.69
" BMI, weight, and height Z score trajectories were described according to GC starting dosage in prednisone equivalents: high (≥1."( Glucocorticoid-related changes in body mass index among children and adolescents with rheumatic diseases.
Alos, N; Atkinson, SA; Brant, R; Cabral, DA; Collet, JP; Couch, R; Cummings, EA; Dent, PB; Ellsworth, J; Guzman, J; Hay, J; Houghton, K; Huber, AM; Jurencak, R; Lang, B; Larche, M; Leblanc, C; Miettunen, P; Rauch, F; Rodd, C; Roth, J; Saint-Cyr, C; Scuccimarri, R; Shiff, NJ; Stein, R; Stephure, D; Taback, S; Ward, LM, 2013
)
0.39
" This study highlights the importance of achieving early target exposure and suggests a potential role for individualized initial dosing or early therapeutic monitoring of all three immunosuppressive agents."( Kidney transplant outcomes are related to tacrolimus, mycophenolic acid and prednisolone exposure in the first week.
Barraclough, KA; Campbell, SB; Hawley, CM; Isbel, NM; Johnson, DW; Leary, DR; Lee, KJ; McWhinney, BC; Staatz, CE; Ungerer, JP, 2012
)
0.61
" The SLEDAI, BILAG, and urine protein levels and the prednisolone dosage were decreased after rituximab treatment, and the decreases in the BILAG, urine protein levels, and the prednisolone dose were found to be significant (P<0."( Efficacy and safety of rituximab therapy for systemic lupus erythematosus: a systematic review and meta-analysis.
Chen, JH; Han, F; Lan, L, 2012
)
0.63
"In a randomized, placebo-controlled, double-blind, dose-response intervention study, 32 healthy males (age: 22 ± 3 years; BMI 22."( Angiopoietin-like protein 4 is differentially regulated by glucocorticoids and insulin in vitro and in vivo in healthy humans.
Brands, M; Diamant, M; Kersten, S; Mudde, K; Sauerwein, HP; Serlie, MJ; Stienstra, R; van Raalte, DH, 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
)
0.89
"To compare, for the first time, the in vitro antileukemic activity of prednisolone alone to that of a combination of prednisolone and dexamethasone using dexamethasone at a very low and presumably safe dosage (1/50 w/w)."( Combination of prednisolone and low dosed dexamethasone exhibits greater in vitro antileukemic activity than equiactive dose of prednisolone and overcomes prednisolone drug resistance in acute childhood lymphoblastic leukemia.
Blazek, B; Bubanska, E; Burianova, R; Dzubak, P; Hajduch, M; Hak, J; Kaiserova, E; Konecny, P; Mihal, V; Novak, Z; Pospisilova, D; Radova, L; Salkova, S; Spenerova, M; Srovnal, J; Stary, J; Timr, P; Votava, T, 2014
)
0.99
" Gene expression profiling of muscle tissue derived from arthritic mice showed a partial activity of Org 214007-0 at an equi-efficacious dosage of prednisolone, with an increased ratio in repression versus induction of genes."( Org 214007-0: a novel non-steroidal selective glucocorticoid receptor modulator with full anti-inflammatory properties and improved therapeutic index.
Alkema, W; Boots, AM; Conti, PG; de Vlieg, J; Dijkema, R; Dokter, WH; Grefhorst, A; Hofstra, CL; Ingelse, BA; Jans, CG; Kuipers, F; Laskewitz, AJ; Lusher, SJ; McGuire, R; Plate, R; Schoonen, WG; Smeets, RL; Smit, MJ; Timmers, CM; van Boeckel, CA; van der Maaden, HM; van Dijk, TH; van Duin, M; van Lierop, MJ; van Schaik, RC, 2012
)
0.58
"A randomized, placebo-controlled, double-blind, dose-response intervention study was conducted in 32 healthy males (age: 21±2years; BMI: 21."( Islet-cell dysfunction induced by glucocorticoid treatment: potential role for altered sympathovagal balance?
Deacon, CF; Diamant, M; Heine, RJ; Holst, JJ; Karemaker, JM; Kwa, KA; Mari, A; Tushuizen, ME; van Genugten, RE; van Raalte, DH, 2013
)
0.39
" The daily dosage of PSL could be significantly reduced in both PM and DM after starting TAC compared with before."( Coadministration of tacrolimus with corticosteroid accelerates recovery in refractory patients with polymyositis/ dermatomyositis: a retrospective study.
Ikeda, S; Ishii, W; Matsuda, M; Shimojima, Y; Tazawa, K, 2012
)
0.38
" In this study, we used 15 mg/day of PSL as the initial dosage and tapered it by 5 mg every 2 weeks."( Initial treatment with 15 mg of prednisolone daily is sufficient for most patients with subacute thyroiditis in Japan.
Amino, N; Ito, M; Kubota, S; Kudo, T; Miyauchi, A; Nishihara, E, 2013
)
0.67
"2%) needed increases in the dosage of PSL."( Initial treatment with 15 mg of prednisolone daily is sufficient for most patients with subacute thyroiditis in Japan.
Amino, N; Ito, M; Kubota, S; Kudo, T; Miyauchi, A; Nishihara, E, 2013
)
0.67
"The treatment protocol that we employed had 15 mg/day of PSL as the initial dosage for the treatment of SAT, with tapering by 5 mg every 2 weeks, and was effective and safe for Japanese patients."( Initial treatment with 15 mg of prednisolone daily is sufficient for most patients with subacute thyroiditis in Japan.
Amino, N; Ito, M; Kubota, S; Kudo, T; Miyauchi, A; Nishihara, E, 2013
)
0.67
" Combination therapy with prednisolone and low-dose cyclosporin A not only improved the clinical symptoms of the very elderly myasthenia gravis patients but also resulted in a rapid reduction in prednisolone dosage and prednisolone-related side effects."( Prednisolone-sparing effect of cyclosporin A therapy for very elderly patients with myasthenia gravis.
Fujita, K; Kaneko, S; Kusaka, H; Morita, J; Nakamura, S; Nakano, S; Shinde, A, 2013
)
2.13
" There was a significant difference in the dosage of steroid per month just before colectomy between the two groups (P = 0."( Characteristics of extremely early-onset pouchitis after proctocolectomy with ileal pouch-anal anastomosis.
Araki, T; Fujikawa, H; Inoue, M; Inoue, Y; Kawamura, M; Kusunoki, M; Mohri, Y; Okita, Y; Shimura, T; Tanaka, K; Uchida, K, 2013
)
0.39
" High-dose CEP was well tolerated, and in some patients single-agent CEP therapy resulted in a significant elevation of platelets, allowing a reduced dosage of PSL."( [Clinical efficacy of high-dose cepharanthine for idiopathic thrombocytopenic purpura: retrospective multicenter analysis].
Endo, T; Fujimoto, K; Hashino, S; Imamura, M; Iwasaki, H; Kobayashi, N; Kohda, K; Kurosawa, M; Maekawa, I; Miyagishima, T; Miyake, T; Sasagawa, H; Takahata, M; Tanaka, J; Teshima, T; Tsustumi, Y, 2012
)
0.38
"In a randomized, placebo-controlled, double-blind, dose-response intervention study, 32 healthy males (aged 22 ± 3 years; body mass index 22."( No difference in glycosphingolipid metabolism and mitochondrial function in glucocorticoid-induced insulin resistance in healthy men.
Aerts, JM; Brands, M; Diamant, M; João Ferraz, M; Sauerwein, HP; Serlie, MJ; van Raalte, DH; Verhoeven, AJ, 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
)
0.89
" Consequently, sorafenib dosage was reduced to 200 mg daily, and the oral mucositis was attenuated."( Pharmacokinetic interaction between sorafenib and prednisolone in a patient with hepatocellular carcinoma.
Fujiyama, Y; Hira, D; Morita, SY; Noda, S; Shioya, M; Terada, T, 2013
)
0.64
" If prednisolone or vigabatrin is used, high dosage is recommended."( Treatment of infantile spasms.
Edwards, SW; Hancock, EC; Osborne, JP, 2013
)
0.95
" The patient initially received oral prednisolone at 30 mg/per day, followed by irradiation with a total dosage of 30 Gy to both eyes."( IgG4-related inflammation of the orbit simulating malignant lymphoma.
Hatanaka, K; Ishida, S; Ishijima, K; Kase, S; Noda, M; Yamamoto, T, 2013
)
0.66
"The study enrolled 46 patients with PV who had absence of any lesion, and had a daily prednisolone dosage of ≤ 10 mg without adjuvant drug treatment in the preceding 6 months."( Comparison of desmoglein 1 and 3 enzyme-linked immunosorbent assay and direct immunofluorescence for evaluation of immunological remission in pemphigus vulgaris.
Balighi, K; Chams-Davatchi, C; Daneshpazhooh, M; Kalantari, MS; Kamyab, K; Mortazavizadeh, SM; Naraghi, ZS; Ramezani, A; Shamohammadi, S, 2014
)
0.63
" However, there is still no consensus about its dosing regimens, efficacy, and side effects due to insufficient clinical trials."( Adjuvant rituximab in the treatment of pemphigus vulgaris: a phase II clinical trial.
Balighi, K; Chams-Davatchi, C; Cheyda, CD; Daneshpazhooh, M; Hajiseyed-javadi, M; Kamran, B; Khezri, S; Mahdavi-nia, M; Mahsa, HJ; Maryam, D; Mostafa, MN; Somayeh, K, 2013
)
0.39
"In a randomised, placebo-controlled, dose-response intervention study, 32 healthy normoglycaemic men (age: 21 ± 2 years; BMI: 21."( Glucocorticoid treatment impairs microvascular function in healthy men in association with its adverse effects on glucose metabolism and blood pressure: a randomised controlled trial.
Diamant, M; Eringa, EC; Guigas, B; Ijzerman, RG; Linssen, MM; Ouwens, DM; Serné, EH; van Raalte, DH, 2013
)
0.39
"A randomized, unmasked, multicenter study was conducted to evaluate the rate of pruritus reduction and improvement in clinical scoring by cyclosporine A (5 mg/kg orally, once daily for 28 days) either alone (n = 25 dogs) or with concurrent prednisolone (1 mg/kg once daily for 7 days, followed by alternate dosing for 14 days; n = 23 dogs) for the treatment of atopic dermatitis in dogs."( Concurrent short-term use of prednisolone with cyclosporine A accelerates pruritus reduction and improvement in clinical scoring in dogs with atopic dermatitis.
Bensignor, E; Carmichael, J; Dip, R; Letellier, I; Roberts, E; Rosenkrantz, W; Strehlau, G, 2013
)
0.86
" Uncontrolled observational data suggest that divided dosing may reduce requirements for hypoglycaemic agents."( Divided dosing reduces prednisolone-induced hyperglycaemia and glycaemic variability: a randomized trial after kidney transplantation.
Cohney, SJ; Colman, PG; Fourlanos, S; Yates, CJ, 2014
)
0.71
"Split prednisolone dosing reduces glycaemic variability and hyperglycaemia early post-kidney transplant."( Divided dosing reduces prednisolone-induced hyperglycaemia and glycaemic variability: a randomized trial after kidney transplantation.
Cohney, SJ; Colman, PG; Fourlanos, S; Yates, CJ, 2014
)
1.19
" All patients were treated with 30mg/day of prednisone after device implantation, which was tapered to a maintenance dosage of 5-10mg/day."( Recovery of atrioventricular block following steroid therapy in patients with cardiac sarcoidosis.
Hayashi, H; Hayashi, M; Horie, T; Iwasaki, YK; Miyauchi, Y; Seino, Y; Shimizu, W; Shiomura, R; Takahashi, K; Tsuboi, I; Uetake, S; Yodogawa, K, 2013
)
0.39
" Studies included were trials in which: (1) the participants were classified as having GCA by the 1990 ACR criteria or biopsy proven disease; (2) parallel-group randomised control of at least 16 weeks duration had been conducted with at least 20 participants; (3) the design included either alternative adjunct immunosuppressant regimens, alternative GCs dosing or routes of administration; and (4) outcome data was included on either relapse rates or rates of infection."( Prednisolone combined with adjunctive immunosuppression is not superior to prednisolone alone in terms of efficacy and safety in giant cell arteritis: meta-analysis.
Loke, YK; MacGregor, AJ; Watts, RA; Yates, M, 2014
)
1.85
"Differing study populations, lack of statistical power, method of data presentation (per couple or per cycle), the use of additional medications and differing dosage regimes contribute to data heterogeneity and suggest a cautious approach to data interpretation."( Interventions to improve reproductive outcomes in women with elevated natural killer cells undergoing assisted reproduction techniques: a systematic review of literature.
Barbosa, MA; Baumgarten, MN; Brosens, J; Campbell, B; Martins, WP; Polanski, LT; Quenby, S; Raine-Fenning, N, 2014
)
0.4
"The aim of this study was to delineate the status of oral corticosteroid therapy in myasthenia gravis (MG), and to elucidate the effectiveness of oral corticosteroids according to dosing regimen."( [Correlation between oral corticosteroid therapy and present disease status in myasthenia gravis].
Imai, T, 2013
)
0.39
" However, we should adjust the dosage of CyA by therapeutic drug monitoring to avoid complications."( Significance of combined cyclosporine-prednisolone therapy and cyclosporine blood concentration monitoring for idiopathic membranous nephropathy with steroid-resistant nephrotic syndrome: a randomized controlled multicenter trial.
Imai, E; Iwano, M; Kataoka, Y; Koyama, A; Maruyama, S; Matsumoto, K; Matsuo, S; Mitarai, T; Nangaku, M; Nishi, S; Ogahara, S; Saito, T; Sato, H; Shuto, H; Tomino, Y; Ueda, S; Yokoyama, H; Yorioka, N; Yoshimura, A, 2014
)
0.67
" After adding MZR, we successfully tapered the orally dosed prednisolone without recurrent fever or complications."( A case of microscopic polyangiitis in an elderly patient presenting predominantly with cholecystitis successfully treated with mizoribine.
Ichinose, K; Iwanaga, N; Kawakami, A; Nakamura, H; Okada, A; Origuchi, T; Tamai, M; Yamasaki, S, 2014
)
0.64
" Pemphigus activity scores, the time that new bulla formation stopped, the time corticosteroid was tapered, cumulative steroid dosage and medication side effects were analyzed."( Assessment of the adjuvant effect of tacrolimus in the management of pemphigus vulgaris: A randomized controlled trial.
Baghernejhad, M; Dastgheib, L; Sadati, MS, 2015
)
0.42
"To estimate the burden of ocular complications like posterior subcapsular cataract (PSCC) and raised intra ocular pressure (IOP) in children with nephrotic syndrome on long term steroid therapy and to assess the correlation of cumulative dosage and duration of consumption of steroids with these ocular complications."( Ocular complications in children with nephrotic syndrome on long term oral steroids.
Gaur, S; Iyengar, A; Joseph, M; Koshy, AS; Nityanandam, S; Phadke, KD; Subramanian, S; Vasudevan, A, 2014
)
0.4
"Rituximab is effective in inducing remission in ANCA-associated vasculitis (AAV), with randomized evidence to support its use as four infusions of 375 mg/m(2) (the conventional lymphoma dosing schedule)."( Induction treatment of ANCA-associated vasculitis with a single dose of rituximab.
Ashley, C; Burns, A; Dinneen, D; Howie, AJ; Little, MA; Pepper, RJ; Salama, AD; Sandhu, E; Stolagiewicz, NE; Turner-Stokes, T, 2014
)
0.4
" Use of this single-dose protocol saved an estimated £4533/patient (US$7103; €5276) compared with a 4 × 375 mg/m(2) dosing schedule."( Induction treatment of ANCA-associated vasculitis with a single dose of rituximab.
Ashley, C; Burns, A; Dinneen, D; Howie, AJ; Little, MA; Pepper, RJ; Salama, AD; Sandhu, E; Stolagiewicz, NE; Turner-Stokes, T, 2014
)
0.4
" The median initial dosage of corticosteroid (Prednisolone) was 30 mg/day (range: 15-60 mg/day), and the dosages were tapered according to improvement."( Therapeutic strategy for granulomatous lobular mastitis: a clinicopathological study of 12 patients.
Akahane, K; Ishigakis, S; Kato, M; Nagino, M; Nakamura, S; Noda, S; Satake, H; Shimoyama, Y; Tsunoda, N, 2013
)
0.65
"To investigate the clinical efficacy of dietary fat restriction in dogs with IL that were unresponsive to prednisolone treatment or showed relapse of clinical signs and hypoalbuminemia when the prednisolone dosage was decreased."( The clinical efficacy of dietary fat restriction in treatment of dogs with intestinal lymphangiectasia.
Kagawa, Y; Okanishi, H; Watari, T; Yoshioka, R,
)
0.34
"Nineteen of 24 (79%) dogs responded satisfactorily to dietary fat restriction, and the prednisolone dosage could be decreased."( The clinical efficacy of dietary fat restriction in treatment of dogs with intestinal lymphangiectasia.
Kagawa, Y; Okanishi, H; Watari, T; Yoshioka, R,
)
0.35
"Dietary fat restriction appears to be an effective treatment in dogs with IL that are unresponsive to prednisolone treatment or that have recurrent clinical signs and hypoalbuminemia when the dosage of prednisolone is decreased."( The clinical efficacy of dietary fat restriction in treatment of dogs with intestinal lymphangiectasia.
Kagawa, Y; Okanishi, H; Watari, T; Yoshioka, R,
)
0.35
"6 bicarbonate buffer system offers significant advantages during the development of dosage forms designed to release the drug in the upper small intestine."( Accelerating the dissolution of enteric coatings in the upper small intestine: evolution of a novel pH 5.6 bicarbonate buffer system to assess drug release.
Assi, P; Basit, AW; Goyanes, A; Merchant, HA; Varum, FJ; Zboranová, V, 2014
)
0.4
" The risk of joint-related AVN as a side effect of adjunctive steroid therapy should be taken into consideration when evaluating the dosage and treatment duration in tuberculous encephalitis."( Joint failure after steroid therapy in tuberculous encephalitis.
Kircher, J; Krauspe, R; Patzer, T; Richter, J; Ziskoven, C, 2014
)
0.4
" The dosage of MMF was initially 2,000 mg/day, but was reduced to 500 mg/day due to diarrhea 10 days before the operation."( [Perioperative agranulocytosis induced by immunosuppressants in a renal graft recipient : a case report].
Inoue, T; Kamba, T; Kobayashi, T; Matsui, Y; Matsumoto, K; Murakami, K; Negoro, H; Ogawa, O; Okubo, K; Sugino, Y; Terada, N; Yamasaki, T; Yoshimura, K, 2014
)
0.4
" Dosing was 4 times daily in months 1 to 3, thrice daily in month 4, twice daily in month 5, and once daily in months 6 to 12."( Randomized comparison of topical prednisolone acetate 1% versus fluorometholone 0.1% in the first year after descemet membrane endothelial keratoplasty.
Bachmann, BO; Kruse, FE; Price, FW; Price, MO; Tourtas, T, 2014
)
0.68
"The aim of this study was to elucidate the effectiveness of oral prednisolone (PSL) according to dosing regimen in 472 patients with myasthenia gravis (MG)."( Oral corticosteroid therapy and present disease status in myasthenia gravis.
Fujihara, K; Imai, T; Konno, S; Masuda, M; Murai, H; Nagane, Y; Nakane, S; Suzuki, N; Suzuki, S; Suzuki, Y; Tsuda, E; Utsugisawa, K, 2015
)
0.65
"Although glucocorticoids are widely used in the treatment of patients with early rheumatoid arthritis, the best dosage of glucocorticoids with regards to efficacy and safety is not known."( Comparison of the efficacy and safety of two starting dosages of prednisolone in early active rheumatoid arthritis (CORRA): study protocol for a randomized controlled trial.
Baraliakos, X; Braun, J; Klaassen-Mielke, R; Krause, D; Trampisch, HJ; Trampisch, US, 2014
)
0.64
" In parallel, all patients will be treated with methotrexate (usual dosage 15 mg/week)."( Comparison of the efficacy and safety of two starting dosages of prednisolone in early active rheumatoid arthritis (CORRA): study protocol for a randomized controlled trial.
Baraliakos, X; Braun, J; Klaassen-Mielke, R; Krause, D; Trampisch, HJ; Trampisch, US, 2014
)
0.64
"The CORRA trial will yield information concerning the optimal glucocorticoid dosage schedule in the treatment of patients with early rheumatoid arthritis."( Comparison of the efficacy and safety of two starting dosages of prednisolone in early active rheumatoid arthritis (CORRA): study protocol for a randomized controlled trial.
Baraliakos, X; Braun, J; Klaassen-Mielke, R; Krause, D; Trampisch, HJ; Trampisch, US, 2014
)
0.64
"A randomized placebo-controlled study has demonstrated no effect of prednisolone in customary dosage on idiopathic sudden sensorineural hearing loss (ISSNHL)."( Corticosteroid treatment of idiopathic sudden sensorineural hearing loss: analysis of an RCT and material drawn from the Swedish national database.
Hultcrantz, E; Nosrati-Zarenoe, R, 2015
)
0.65
" For initial remission induction, RTX was dosed at 1 g every 2 weeks or 375 mg/m(2) weekly for 4 consecutive weeks and for remission maintenance at 1 g every 6 months for 24 months."( Long-term follow-up of patients who received repeat-dose rituximab as maintenance therapy for ANCA-associated vasculitis.
Alberici, F; Chaudhry, A; Jayne, DR; Jones, RB; Roberts, DM; Smith, KG; Smith, RM; Willcocks, LC, 2015
)
0.42
" These results have suggested that a low dosage of prednisolone can be used with little concern for development of osteopenia in dogs."( Quantitative computed tomographic assessment of bone mineral density changes associated with administration of prednisolone or prednisolone and alendronate sodium in dogs.
Cho, KO; Choi, J; Oh, J; Park, S; Son, KY, 2015
)
0.88
" However, the dosing and the duration of immunosuppressive therapy have not been systematically studied in the setting of treating ipilimumab-induced irAEs."( Ipilimumab-induced toxicities and the gastroenterologist.
Bye, W; Cheng, R; Cooper, A; Kench, J; McNeil, C; Shackel, N; Watson, G, 2015
)
0.42
" The MG foundation of America (MGFA) classification, MGFA post-intervention status, dosage of prednisolone and pyridostigmine, and anti-acetylcholine receptor antibody titers were evaluated."( Two-year outcome of thymectomy in non-thymomatous late-onset myasthenia gravis.
Himuro, K; Kanai, T; Kawaguchi, N; Kuwabara, S; Oda, F; Uzawa, A; Yoshida, S; Yoshino, I, 2015
)
0.64
" We believe close follow-up should be taken when CCS patients are making medicine dosage alteration and tumor marker such as CEA may be included in the surveillance examination."( A case of recurrent Cronkhite-Canada syndrome containing colon cancer.
Shi, H; Tian, Y; Wang, J; Xiao, J; Zhang, Y; Zhou, X; Zhu, X; Zong, Y, 2015
)
0.42
"Orodispersible tablets (ODTs) and orodispersible films (ODFs) are solid oral dosage forms disintegrating or dissolving rapidly when placed in the mouth."( Orodispersible films and tablets with prednisolone microparticles.
Brniak, W; Jachowicz, R; Maślak, E, 2015
)
0.69
" Dosing was 4 times daily for 2 months, thrice daily for 1 month, twice daily for 1 month, and once daily for 7 months."( Loteprednol Etabonate 0.5% Gel Vs. Prednisolone Acetate 1% Solution After Descemet Membrane Endothelial Keratoplasty: Prospective Randomized Trial.
Feng, MT; Price, FW; Price, MO; Scanameo, A, 2015
)
0.69
" Decreasing glucocorticoid dosage appears important for improving bone metabolism."( Reducing glucocorticoid dosage improves serum osteocalcin in patients with rheumatoid arthritis-results from the TOMORROW study.
Inui, K; Koike, T; Mamoto, K; Nakamura, H; Okano, T; Sugioka, Y; Tada, M, 2016
)
0.43
" Changes in prednisolone dosage correlated negatively with ΔOC (β = -0."( Reducing glucocorticoid dosage improves serum osteocalcin in patients with rheumatoid arthritis-results from the TOMORROW study.
Inui, K; Koike, T; Mamoto, K; Nakamura, H; Okano, T; Sugioka, Y; Tada, M, 2016
)
0.81
"Decreased glucocorticoid dosage improved bone metabolic markers in RA, but disease activity, bisphosphonate therapy, and period of biologics therapy did not influence levels of bone metabolic markers."( Reducing glucocorticoid dosage improves serum osteocalcin in patients with rheumatoid arthritis-results from the TOMORROW study.
Inui, K; Koike, T; Mamoto, K; Nakamura, H; Okano, T; Sugioka, Y; Tada, M, 2016
)
0.43
" 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
)
0.81
" The aim of this study was to establish the optimal dosage and administration of immunosuppressants and antifungal agents."( [Optimization of Immunosuppression and the Prevention of Fungal Infection in Autoimmune Diseases].
Mino, Y, 2015
)
0.42
" Tacrolimus dosage was 2 mg/day (median)."( Long-term follow-up of patients with difficult to treat type 1 autoimmune hepatitis on Tacrolimus therapy.
Adams, DH; Füssel, K; Hirschfield, GM; Hodson, J; Lohse, AW; Mann, J; Oo, YH; Schramm, C; Than, NN; Weiler-Normann, C; Wiegard, C, 2016
)
0.43
" The patient interview revealed consumption to supra-therapeutic dosage of an association of naphazoline and prednisolone nasal sprays."( [Malignant hypertension and cardiac decompensation after overuse of nasal decongestant: A case report and literature review].
Bontemps, H; Bourdelin, M; Le Vavasseur, O; Novais, T, 2016
)
0.65
" Heterogeneity was related in part to the dosing strategy."( Corticosteroids for treating sepsis.
Annane, D; Bellissant, E; Bollaert, PE; Briegel, J; Keh, D; Kupfer, Y, 2015
)
0.42
" Information on the dosage and timing of GC use was extracted."( Risk of Incident Diabetes Mellitus Associated With the Dosage and Duration of Oral Glucocorticoid Therapy in Patients With Rheumatoid Arthritis.
Abrahamowicz, M; Beauchamp, ME; Dixon, WG; Michaud, K; Movahedi, M; Pedro, S; Ray, DW, 2016
)
0.43
" A range of conventional statistical models consistently confirmed increases in risk with the GC dosage and duration."( Risk of Incident Diabetes Mellitus Associated With the Dosage and Duration of Oral Glucocorticoid Therapy in Patients With Rheumatoid Arthritis.
Abrahamowicz, M; Beauchamp, ME; Dixon, WG; Michaud, K; Movahedi, M; Pedro, S; Ray, DW, 2016
)
0.43
" Risk is influenced by the dosage and treatment duration, although only for GC use within the last 6 months."( Risk of Incident Diabetes Mellitus Associated With the Dosage and Duration of Oral Glucocorticoid Therapy in Patients With Rheumatoid Arthritis.
Abrahamowicz, M; Beauchamp, ME; Dixon, WG; Michaud, K; Movahedi, M; Pedro, S; Ray, DW, 2016
)
0.43
" have published an open-labeled randomized clinical trial of 100 children with idiopathic nephrotic syndrome who were allocated either a body weight- or body surface area-based prednisolone dosing for a duration of 12 weeks."( Should we stop dosing steroids per body surface area for nephrotics?
Filler, G; Robinson, LA, 2016
)
0.63
"Body surface area (BSA)-based prednisolone dosing for childhood nephrotic syndrome (NS) leads to higher cumulative prednisolone doses than body weight (BW)-based dosing."( Body weight-based prednisolone versus body surface area-based prednisolone regimen for induction of remission in children with nephrotic syndrome: a randomized, open-label, equivalence clinical trial.
Harichandrakumar, KT; Krishnamurthy, S; Raman, V, 2016
)
1.06
"This parallel-group open-label randomized clinical trial enrolled 100 children with idiopathic NS, to receive BW-based (n = 50) or BSA-based (n = 50) prednisolone dosing by block randomization in a 1:1 ratio."( Body weight-based prednisolone versus body surface area-based prednisolone regimen for induction of remission in children with nephrotic syndrome: a randomized, open-label, equivalence clinical trial.
Harichandrakumar, KT; Krishnamurthy, S; Raman, V, 2016
)
0.97
" The cumulative prednisolone dosage during the enrolment episode was higher in the BSA group."( Body weight-based prednisolone versus body surface area-based prednisolone regimen for induction of remission in children with nephrotic syndrome: a randomized, open-label, equivalence clinical trial.
Harichandrakumar, KT; Krishnamurthy, S; Raman, V, 2016
)
1.11
"Clinical outcomes with BW-based dosing are equivalent to BSA dosing-related outcomes, although cumulative prednisolone doses are lower in the former."( Body weight-based prednisolone versus body surface area-based prednisolone regimen for induction of remission in children with nephrotic syndrome: a randomized, open-label, equivalence clinical trial.
Harichandrakumar, KT; Krishnamurthy, S; Raman, V, 2016
)
0.98
" The dosage of imepitoin was increased from 20 mg/kg twice daily to 30 mg/kg twice daily, 3 days before the onset of skin lesions, due to uncontrolled seizures."( Cutaneous adverse drug reaction in a dog associated with imepitoin.
Bhatti, S; De Cock, H; Kitshoff, A; Royaux, E; Van Ham, L; Vandenabeele, S, 2016
)
0.43
" Breed, age at diagnosis, weight, systemic disease status, eye affected, ophthalmic examination findings, systemic and topical therapy instituted, dosage and duration of therapy, visual outcome and histopathological analyses were recorded in cases meeting the inclusion criteria."( An association between systemic cyclosporine administration and development of acute bullous keratopathy in cats.
Bartoe, JT; Curran, PG; Gemensky-Metzler, AJ; Petersen-Jones, SM; Pierce, KE; Townsend, WM; Wilkie, DA, 2016
)
0.43
" JLSG-02 has been revised from JLSG-96 in the following respects: prednisolone dosage during Induction A increased; duration of maintenance therapy extended from 24 to 48 weeks; cyclosporine introduced to Induction B for progressive disease."( Intensified and prolonged therapy comprising cytarabine, vincristine and prednisolone improves outcome in patients with multisystem Langerhans cell histiocytosis: results of the Japan Langerhans Cell Histiocytosis Study Group-02 Protocol Study.
Bessho, F; Fujimoto, J; Horibe, K; Imamura, T; Imashuku, S; Ishii, E; Kawaguchi, H; Kobayashi, R; Koga, Y; Kudo, K; Morimoto, A; Sakashita, K; Shioda, Y; Tsunematsu, Y; Yasui, M, 2016
)
0.9
" The majority of surveyed prescribers follow the British National Formulary for Children recommendations on dosage rather than those included in the British Thoracic Society and the Scottish Intercollegiate Guidelines Network."( A review of prednisolone prescribing for children with acute asthma in the UK.
Ahmad, AN; Batchelor, HK; Gilchrist, FJ; Lenney, W; Marriott, JF, 2016
)
0.81
"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
" The most often prescribed oral steroids are prednisolone and dexamethasone, but current guidelines on dosing vary between countries, and often among different guideline producers within the same country."( Different oral corticosteroid regimens for acute asthma.
Kew, KM; Mansour, G; Normansell, R, 2016
)
0.69
" Clinically feasible models that combine important factors may help guide individual tacrolimus dosage adjustment in kidney transplant patients."( Population pharmacokinetics of tacrolimus in Thai kidney transplant patients: comparison with similar data from other populations.
Avihingsanon, Y; Praisuwan, S; Techawathanawanna, N; Treyaprasert, W; Vadcharavivad, S, 2016
)
0.43
" Current GC dose of below 5 mg per day (prednisolone equivalent dose) was not associated with an increased risk of death, but a dose-response association was seen for higher dose categories."( Oral glucocorticoid therapy and all-cause and cause-specific mortality in patients with rheumatoid arthritis: a retrospective cohort study.
Costello, R; Dixon, WG; Lunt, M; Movahedi, M; Pye, SR; Sergeant, JC, 2016
)
0.7
"The objective of this retrospective study was to examine factors that may have affected the stabilisation times of 50 dogs with spontaneous hypoadrenocorticism that were being treated with fludrocortisone acetate, with particular emphasis on dosing frequency and the concurrent use of prednisolone."( Factors that affect stabilisation times of canine spontaneous hypoadrenocorticism.
Boden, LA; Ramsey, IK; Roberts, E, 2016
)
0.61
" This study evaluated the effectiveness and the proper dosage of omalizumab for Asian CSU patients in a real-life setting."( Omalizumab therapy for treatment of recalcitrant chronic spontaneous urticaria in an Asian population.
Chularojanamontri, L; Kulthanan, K; Likitwattananurak, C; Tuchinda, P; Ungaksornpairote, C, 2017
)
0.46
"Omalizumab at an initial dosage of 150 mg was effective in the treatment of recalcitrant CSU among Asians."( Omalizumab therapy for treatment of recalcitrant chronic spontaneous urticaria in an Asian population.
Chularojanamontri, L; Kulthanan, K; Likitwattananurak, C; Tuchinda, P; Ungaksornpairote, C, 2017
)
0.46
"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
" Finally, this efficacious formulation was used as core material for the development of a final dosage form: F6/Cps allowed to significantly reduce prednisolone release in simulated gastric fluid (12."( Prednisolone Delivery Platforms: Capsules and Beads Combination for a Right Timing Therapy.
Aquino, RP; Auriemma, G; Cerciello, A; Del Gaudio, P; Morello, S; Russo, P, 2016
)
2.08
" Dosing regimens of oral steroids in EFT produced no differences in the time course."( Early fast-acting treatment strategy against generalized myasthenia gravis.
Akaishi, T; Aoki, M; Imai, T; Kawaguchi, N; Konno, S; Masuda, M; Minami, N; Murai, H; Nagane, Y; Suzuki, H; Suzuki, Y; Tsuda, E; Utsugisawa, K; Uzawa, A, 2017
)
0.46
" By combining the advantages of thermally stable pharmaceutically approved polymers and fillers, this unique approach provides a low cost production method for on demand manufacturing of individualised dosage forms."( Adaptation of pharmaceutical excipients to FDM 3D printing for the fabrication of patient-tailored immediate release tablets.
Ahmed, W; Alhnan, MA; Arafat, B; Isreb, A; Kelarakis, A; Sadia, M; Sośnicka, A, 2016
)
0.43
" If systemic corticosteroids are planned to be administrated in the prednisolone equivalent dosage of 5 mg/day or more for three months or longer, risk of bone fracture have to be assessed regardless of the primary pulmonary disease."( [Steroids-induced osteoporosis due to the treatment for Pulmonary diseases.]
Horita, N; Kaneko, T,
)
0.37
" Compared to the dexchlorpheniramine plus betamethasone combination, it showed similar clinical action, but with a lower incidence of adverse events and higher dosing convenience."( Association between desloratadine and prednisolone in the treatment of children with acute symptoms of allergic rhinitis: a double-blind, randomized and controlled clinical trial.
Amazonas, RB; Ensina, LF; Miranda, C; Sano, F; Silva, JMD; Solé, D; Wandalsen, GF,
)
0.4
" The reintroduced imatinib dosage was stepped up every week starting from 10 mg/d and increasing to 25, 50, 75, 100, 150, 200, and 300 mg/d until the target dose of 400 mg/d was achieved."( Slow desensitization of imatinib-induced nonimmediate reactions and dynamic changes of drug-specific CD4
Buranapraditkun, S; Klaewsongkram, J; Mongkolpathumrat, P; Sodsai, P; Thantiworasit, P, 2016
)
0.43
" In spite of the temporary remission after re-initiation of oral steroid therapy, reduction of oral steroid dosage resulted in new lesion formation apart from the initial locations."( An adult-onset multiphasic disseminated encephalomyelitis (MDEM) presenting favorable response to steroid therapy.
Fujimura, H; Fukada, K; Hazama, T; Inoue, K; Kinoshita, M; Sugimura, Y, 2016
)
0.43
" The current dosage of prednisolone correlated inversely with the levels of bioactive testosterone (r = -0."( Effect of Corticosteroids and Cyclophosphamide on Sex Hormone Profiles in Male Patients With Systemic Lupus Erythematosus or Systemic Sclerosis.
Arnaud, L; Gunnarsson, I; Hellbacher, E; Lundholm, H; Nordin, A; Svenungsson, E; Wikner, J; Zickert, A, 2017
)
0.77
" Rituximab has proven effective for the treatment of steroid-refractory pemphigus, although there is controversy over the optimum dosing protocol."( Low-dose rituximab and concurrent adjuvant therapy for pemphigus: Protocol and single-centre long-term review of nine patients.
Robinson, AJ; Scardamaglia, L; Unglik, GA; Varigos, GA; Vu, M, 2018
)
0.48
" This was likely the result of low-frequency dosing and short duration of steroid use."( Comparison of prednisolone acetate 1.0% and difluprednate ophthalmic emulsion 0.05% after cataract surgery: Incidence of postoperative steroid-induced ocular hypertension.
Ernest, P; McBain, M; Mian, SI; Musch, DC; Niziol, LM; Person, E; Tijunelis, MA, 2017
)
0.82
" Four different orodispersible dosage forms containing two poorly soluble drugs, levothyroxine and prednisolone, were produced on two different edible substrates by piezoelectric inkjet printing."( Application of a handheld NIR spectrometer in prediction of drug content in inkjet printed orodispersible formulations containing prednisolone and levothyroxine.
Desai, D; Preis, M; Sandler, N; Vakili, H; Wickström, H, 2017
)
0.88
" Primary endpoints were remission induction, occurrence of relapses, prednisolone (PSL) dosage at time of remission, and adverse events."( Interferon-α for Induction and Maintenance of Remission in Eosinophilic Granulomatosis with Polyangiitis: A Single-center Retrospective Observational Cohort Study.
Forberg, T; Förster, M; Happe, J; Kroegel, C; Moeser, A; Neumann, T; Seeliger, B, 2017
)
0.69
" In the treatment of CDS, it is recommended that a low dosage (15-30mg) of corticosteroids be used as first-line drugs rather than conventional NSAID therapy."( Clinical and quantitative analysis of patients with crowned dens syndrome.
Kamei, S; Takahashi, T; Takasu, T; Tamura, M, 2017
)
0.46
" However, orally administered colchicine along with prednisolone effectively ameliorated her symptoms, and prednisolone dosage was reduced again."( Serum cytokine profile in pediatric Sweet's syndrome: a case report.
Fujino, H; Sumimoto, SI; Takano, Y; Yachie, A, 2017
)
0.71
" However, after ME-CyA dosage reduction and discontinuation, the relapse rate increased."( Combined cyclosporine and prednisolone therapy using cyclosporine blood concentration monitoring for adult patients with new-onset minimal change nephrotic syndrome: a single-center pilot randomized trial.
Imai, N; Kimura, K; Matsui, K; Sakurada, T; Shibagaki, Y; Shirai, S; Sueki, S; Tominaga, N; Yasuda, T, 2018
)
0.78
" They showed that the mean prednisolone dosage significantly decreased (6."( A multicenter prospective observational study on the safety and efficacy of tacrolimus in patients with myasthenia gravis.
Ahn, SW; Cho, EB; Hong, YH; Joo, IS; Kang, SY; Kim, BJ; Min, JH; Minn, YK; Nam, TS; Oh, J; Oh, SY; Park, JS; Park, YE; Seok, HY; Seok, JI; Seok, JM; Shin, HY; Shin, JY; Suh, BC; Sung, JJ, 2017
)
0.75
"Five simple, sensitive, and eco-friendly LC and UV spectrophotometric methods have been developed for the simultaneous determination of phenylephrine hydrochloride (PHE) and prednisolone acetate (PRD) in their combined dosage form."( Development and Validation of Eco-Friendly Liquid Chromatographic and Spectrophotometric Methods for Simultaneous Determination of Coformulated Drugs: Phenylephrine Hydrochloride and Prednisolone Acetate.
El Mously, DA; Elsayed, GM; Hassan, NY; Mostafa, NM, 2017
)
0.84
" Because muscle pain disappeared, the CAM dosage was halved."( Successful treatment with clarithromycin and/or tacrolimus for two patients with polymyalgia rheumatica.
Horita, T; Ohe, M; Oku, K; Shida, H,
)
0.13
" Conclusion We confirmed that LI-CAP has therapeutic effects on reducing the dosage and discontinuing steroids in patients with steroid-dependent UC."( Long-interval Cytapheresis as a Novel Therapeutic Strategy Leading to Dosage Reduction and Discontinuation of Steroids in Steroid-dependent Ulcerative Colitis.
Etou, T; Iizuka, M; Kumagai, M; Matsuoka, A; Numata, Y; Sagara, S, 2017
)
0.46
"The number of intramuscularly applied dosage forms has been continuously increasing during the last decades."( In vitro dissolution testing of parenteral aqueous solutions and oily suspensions of paracetamol and prednisolone.
Klein, S; Probst, M; Schmidt, M; Seidlitz, A; Tietz, K; Weitschies, W, 2017
)
0.67
" The secondary outcomes are the number or relapses, progression to frequent relapsing or steroid dependent nephrotic syndrome and the cumulative dosage of prednisolone during the study period."( REducing STEroids in Relapsing Nephrotic syndrome: the RESTERN study- protocol of a national, double-blind, randomised, placebo-controlled, non-inferiority intervention study.
Bouts, AHM; Dorresteijn, EM; Keijzer-Veen, MG; Roeleveld, N; Schijvens, AM; Schreuder, MF; Ter Heine, R; van de Kar, NCAJ; van den Heuvel, LPWJ; van Wijk, JAE, 2017
)
0.65
" The suggested methods were validated in compliance with the ICH guidelines and were successfully applied to determine both drugs in their pure forms, laboratory prepared mixtures and dosage form."( Validated Chromatographic Methods for the Simultaneous Determination of Sulfacetamide Sodium and Prednisolone Acetate in their Ophthalmic Suspension.
AbdElHamid, G; El-Ragehy, NA; Hegazy, MA; Tawfik, SA, 2017
)
0.67
" The eye and ear pain showed exacerbations and remissions on reducing the dosage of steroid drugs."( Unique circumferential peripheral keratitis in relapsing polychondritis: A case report.
Fujihara, M; Hirami, Y; Ishida, K; Kurimoto, Y; Motozawa, N; Nakamura, T; Sotozono, C; Takagi, S, 2017
)
0.46
" The findings of this study indicate that cryptococcosis should be considered during the differential diagnosis of infection in patients receiving tocilizumab, especially in the presence of other risk factors for infections or a short tocilizumab dosing interval."( Disseminated cryptococcosis in a patient taking tocilizumab for Castleman's disease.
Kamei, H; Nishioka, H; Takegawa, H, 2018
)
0.48
"This study compared the pharmacokinetics of Prednisolone (PDS) in small- and large breed dogs with a dosing format based on body surface area (BSA) or body weight (BW)."( Comparison of body surface area-based and weight-based dosing format for oral prednisolone administration in small and large-breed dogs.
Jeong, JW; Kim, SM; Koo, TS; Nam, A; Seo, KW; Song, KH, 2017
)
0.94
"We examined the correlation between the dosing regimen of oral prednisolone (PSL) and the achievement of minimal manifestation status or better on PSL ≤5 mg/day lasting >6 months (the treatment target) in patients with generalised myasthenia gravis (MG)."( Oral corticosteroid dosing regimen and long-term prognosis in generalised myasthenia gravis: a multicentre cross-sectional study in Japan.
Akaishi, T; Aoki, M; Imai, T; Kawaguchi, N; Konno, S; Masuda, M; Minami, N; Murai, H; Nagane, Y; Suzuki, H; Suzuki, Y; Tsuda, E; Utsugisawa, K; Uzawa, A, 2018
)
0.72
"We classified 590 patients with generalised MG into high-dose (n=237), intermediate-dose (n=187) and low-dose (n=166) groups based on the oral PSL dosing regimen, and compared the clinical characteristics, previous treatments other than PSL and prognosis between three groups."( Oral corticosteroid dosing regimen and long-term prognosis in generalised myasthenia gravis: a multicentre cross-sectional study in Japan.
Akaishi, T; Aoki, M; Imai, T; Kawaguchi, N; Konno, S; Masuda, M; Minami, N; Murai, H; Nagane, Y; Suzuki, H; Suzuki, Y; Tsuda, E; Utsugisawa, K; Uzawa, A, 2018
)
0.48
" Hence maximum amount of drug could be released in the colon that may result in reduction in dose and dose frequency as well as side effects of drug as observed with the conventional dosage form of prednisolone."( Eudragit S100 coated microsponges for Colon targeting of prednisolone.
Hurkat, P; Jain, A; Jain, SK; Kumari, A; Tiwari, A, 2018
)
0.91
"5 mg/d and standard immunosuppressant dosage tolerance) was assessed."( Lupus Low Disease Activity State (LLDAS) attainment discriminates responders in a systemic lupus erythematosus trial:
Berglind, A; Illei, GG; Morand, EF; Trasieva, T; Tummala, R, 2018
)
0.48
" This led to the discovery of AZD9567 (15) with excellent in vivo efficacy when dosed orally in a rat model of joint inflammation."( Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
Berger, M; Bird, J; Chang, HF; Chapman, D; Dearman, M; Drmota, T; Edenro, G; Edman, K; Geschwindner, S; Harrison, R; Hegelund-Myrbäck, T; Hendrickx, R; Köhler, C; Lawitz, K; Lepistö, M; Llinas, A; Malmberg, J; Nikitidis, A; Olsson, RI; Ripa, L; Svanberg, P; Thorne, P; Ullah, V; Wissler, L, 2018
)
0.48
" We postulate that there is room for improvement of dosing, as the optimal immunosuppressive dose in calcineurin-free regimens is unknown and since the once daily dosing regimen for oncological indications is often associated with treatment-limiting toxicity."( A pharmacological rationale for improved everolimus dosing in oncology and transplant patients.
Burger, DM; de Fijter, JW; Guchelaar, HJ; Moes, DJAR; Reinders, MEJ; Ter Heine, R; van Erp, NP; van Herpen, CM, 2018
)
0.48
"We developed a mechanistic population pharmacokinetic model for everolimus in cancer and transplant patients and explored alternative dosing regimens."( A pharmacological rationale for improved everolimus dosing in oncology and transplant patients.
Burger, DM; de Fijter, JW; Guchelaar, HJ; Moes, DJAR; Reinders, MEJ; Ter Heine, R; van Erp, NP; van Herpen, CM, 2018
)
0.48
" JLSG-02 was modified from JLSG-96 as follows: increased prednisolone dosage at the induction phase and extension of maintenance therapy duration from 24 to 48 weeks."( Intensification of induction therapy and prolongation of maintenance therapy did not improve the outcome of pediatric Langerhans cell histiocytosis with single-system multifocal bone lesions: results of the Japan Langerhans Cell Histiocytosis Study Group-
Goto, H; Imamura, T; Imashuku, S; Kawaguchi, H; Kitoh, T; Kosaka, Y; Kudo, K; Morimoto, A; Shioda, Y; Tsunematsu, Y, 2018
)
0.73
" Dogs were considered stable if they showed no signs of glucocorticoid deficiency or excess, sodium and potassium were within the laboratory reference limits and no change of prednisolone and/or fludrocortisone dosage was recommended by the clinician."( Prednisolone dosages in Addisonian dogs after integration of ACTH measurement into treatment surveillance.
Haninger, T; Zeugswetter, FK, 2018
)
2.12
"We performed a post-hoc analysis of a randomised, placebo-controlled, double blind, dose-response intervention study involving 32 healthy males (age: 22 ± 3 years; BMI 22."( The osteoblast: Linking glucocorticoid-induced osteoporosis and hyperglycaemia? A post-hoc analysis of a randomised clinical trial.
Brands, M; de Jongh, RT; den Heijer, M; Heijboer, AC; Serlie, MJ; van Bommel, EJM; van Raalte, DH, 2018
)
0.48
" 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
)
0.48
" To assess the association between steroid dose used for relapse and subsequent outcomes, data of patients with tapered prednisolone (PSL) dosage to <10 mg/day before the first relapse in whom the dose was subsequently increased to ≥10 mg/day were extracted and assigned to the High-PSL or Low-PSL groups, based on the median dose of 20 mg/day."( Treatment patterns and steroid dose for adult minimal change disease relapses: A retrospective cohort study.
Ando, M; Kato, S; Katsuno, T; Maruyama, S; Ozeki, T; Tsuboi, N; Yamaguchi, M; Yasuda, Y, 2018
)
0.69
"Although therapeutic drug monitoring of plasma mycophenolic acid (MPA) concentrations has been recommended to individualize dosage in transplant recipients, little is known regarding lymphocyte concentrations of MPA, where MPA inhibits inosine monophosphate dehydrogenase (IMPDH)."( Mycophenolic acid concentrations in peripheral blood mononuclear cells are associated with the incidence of rejection in renal transplant recipients.
Carroll, RP; Coller, JK; McWhinney, BC; Md Dom, ZI; Sallustio, BC; Somogyi, AA; Tuke, J, 2018
)
0.48
"This study first revealed that using higher dose steroids was an independent risk factor for rebleeding after endoscopic hemostasis for peptic ulcer bleeding, with a dose-response relation."( The Use of Higher Dose Steroids Increases the Risk of Rebleeding After Endoscopic Hemostasis for Peptic Ulcer Bleeding.
Asano, N; Asanuma, K; Hatta, W; Imatani, A; Kanno, T; Koike, T; Kondo, Y; Masamune, A; Saito, M; Takahashi, Y, 2018
)
0.48
" Preventative measures are not usually required in patients who receive a short high-dosed treatment (30 mg PED in 7 days) or prednisolone at a dosage of < 15 mg/day."( [Infections during glucocorticoid use].
den Hoed, CM; Minderhoud, TC; Schurink, CAM; van Daele, PLA; van Meer, MPA; van Thiel, RJ, 2018
)
0.69
" We recommend combined therapy with albendazole and prednisolone, with consideration for increased steroid dosing in severe cases."( Severe CNS angiostrongyliasis in a young marine: a case report and literature review.
Bavaro, M; Cathey, M; Fortin Ensign, S; Larson, D; McAuliffe, L; Mukaigawara, M; Narita, M; Ohkusu, K; Quast, T; Volk, C; Yetto, J, 2019
)
0.76
" Clinical benefit was assessed in all patients and among subgroups with a baseline blood eosinophil count of less than 150 cells/μL, baseline OGC dosage of greater than 20 mg/d, or weight of greater than 85 kg."( Evaluation of clinical benefit from treatment with mepolizumab for patients with eosinophilic granulomatosis with polyangiitis.
Akuthota, P; Bradford, ES; Brown, J; Cid, MC; Gleich, GJ; Jayne, D; Khoury, P; Langford, CA; Mallett, S; Merkel, PA; Moosig, F; Specks, U; Steinfeld, J; Wechsler, ME; Weller, PF; Yancey, SW, 2019
)
0.51
" The dosage of prednisolone was gradually decreased as liver function improved."( Acute onset of autoimmune hepatitis with sinusoidal and central vein endotheliitis, and marked involvement of activated dendritic cells: A case report.
Obu, M; Oda, M; Okada, T; Uematsu, T; Yamazaki, H; Yokomori, H, 2018
)
0.83
" Within three years, all polyps had disappeared and the steroid therapy was finished while the dosage of mesalazine was reduced in a stepwise fashion."( Case report of patient with a Cronkhite-Canada syndrome: sustained remission after treatment with corticosteroids and mesalazine.
Drebber, U; Kaufmann, T; Kütting, F; Mertens, J; Nierhoff, D; Schulte, S; Steffen, HM; Töx, U, 2019
)
0.51
" A 74-year-old man without a history of autoimmune diseases received nivolumab at a dosage of 3 mg/kg once every 2 weeks for the treatment of stage IIIB squamous cell carcinoma."( [Effectiveness of a Low-dose Corticosteroid in a Patient with Polymyalgia Rheumatica Associated with Nivolumab Treatment].
Fujii, R; Imai, Y; Okazaki, K; Tanaka, M; Uchitani, K, 2019
)
0.51
"The range of CsA dosage was 50-200 mg/day, and mean CsA dose was 102."( Low-dose cyclosporine for active lupus nephritis: a dose titration approach.
Angthararak, S; Kitumnuaypong, T; Pichaiwong, W; Sumethkul, K, 2019
)
0.51
" While on maintenance dosing of oral valacyclovir, he experienced reactivation in the form of bilateral vasculitis, which was successfully managed once restarting therapeutic oral dosing."( Case Report: Varicella-zoster Encephalitis with Acute Retinal Necrosis and Oculomotor Nerve Palsy.
Quan, SC; Skondra, D, 2019
)
0.51
" AI patients need to adjust GC dosage in response to stressful events and illness in order to prevent life-threatening adrenal crisis (AC)."( Daily adjustment of glucocorticoids by patients with adrenal insufficiency.
Badenhoop, K; Beuschlein, F; Kienitz, T; Maison, N; Mayr, B; Meyer, G; Quinkler, M; Schöfl, C, 2019
)
0.51
" Twenty four patients, which contained 18 PMR and 6 RS3PE syndrome, were treated with initial dosages of 10-20 mg per day oral prednisolone, and the dosage of prednisolone was then tapered."( Predictive factors associated with the therapeutic response in patients with polymyalgia rheumatica and remitting seronegative symmetrical synovitis with pitting edema syndrome.
Inaba, K; Kawahito, K; Kawaminami, S; Kondo, K; Miyatake, A; Nakanishi, Y; Okura, Y; Suzuki, Y; Tabata, R; Tani, K; Umetani, K; Yamaguchi, H; Yuasa, S, 2019
)
0.72
" His clinical condition did not improve, therefore, we increased the dosage of prednisolone to 40 mg/day; however, his rash gradually expanded with papules and plaques."( A case of neutrophilic dermatosis with
Daisuke, N; Endo, Y; Furukawa, K; Ichinose, K; Igawa, T; Iwamoto, N; Kawakami, A; Kawashiri, SY; Koga, T; Koike, Y; Nakamura, H; Okamoto, M; Origuchi, T; Otsuka, M; Shimizu, T; Sumiyoshi, R; Takatani, A; Tamai, M; Tsuji, S, 2019
)
0.74
" We estimated dose-response risks of infection for this population in England."( Incidence of infections associated with oral glucocorticoid dose in people diagnosed with polymyalgia rheumatica or giant cell arteritis: a cohort study in England.
Keeley, A; Mallen, C; Morgan, AW; Pujades-Rodriguez, M; Wu, J, 2019
)
0.51
" Statistically significant, albeit clinically irrelevant, increases in blood glucose and N-terminal pro-B-type natriuretic peptide concentrations were observed between baseline and the prednisolone pharmacokinetic steady state (7 days after initiation) only when the 2-mg/kg dosage was administered."( Clinicopathologic, hemodynamic, and echocardiographic effects of short-term oral administration of anti-inflammatory doses of prednisolone to systemically normal cats.
Berger, DJ; Khelik, IA; Mochel, JP; Palerme, JS; Seo, YJ; Ward, JL; Ware, WA, 2019
)
0.91
" Demographic and clinical features including age, gender, House-Brackmann Facial Nerve Grading System House-Brackmann Grading Scale (HBGS) grade at admission and follow-up, and the dosage and onset of steroid treatment were reviewed."( Prognostic Factors Associated With Recovery in Children With Bell's Palsy.
Karatoprak, E; Yilmaz, S, 2019
)
0.51
" Eculizumab was administered at a dosage of 900 mg/wk for the first month and 1200 mg every 2 weeks thereafter."( Renal Transplantation in Patients With Atypical Hemolytic Uremic Syndrome: A Single Center Experience.
Alpay, N; Ozçelik, U, 2019
)
0.51
"Total and free plasma prednisolone measurements correlated poorly with saliva measurements; however, correlation improved when concentrations early in the dosing interval were excluded."( Prednisolone Concentrations in Plasma (Total and Unbound) and Saliva of Adult Kidney Transplant Recipients.
Brooks, E; Isbel, NM; McWhinney, B; Staatz, CE; Tett, SE, 2019
)
2.27
" The patient groups later developing hypothyroidism did not differ in age, BMI, pre-treatment TSH levels or initial dosage of prednisolone treatment."( Long-term Outcome of Subacute Thyroiditis.
Diederich, S; Görges, J; Janssen, OE; Keck, C; Müller-Wieland, D; Ulrich, J, 2020
)
0.76
" Prednisolone dosage was increased to 1 mg/kg/day, and the subsequent taper was performed slowly over the course of 10 weeks."( Drug reaction with eosinophilia and systemic symptoms syndrome in a patient taking lamotrigine.
Dória, MDC; Lameiras, C; Mendes Lopes, M; Ornelas, É, 2019
)
1.42
"Randomised-controlled trials (RCTs) comparing difluprednate and prednisolone acetate regardless of the dosing regimen used."( Difluprednate versus Prednisolone Acetate after Cataract Surgery: a Systematic Review and Meta-Analysis.
Basiony, A; KhalafAllah, MT; Salama, A, 2019
)
1.07
" The lower dosage of oral prednisolone was a significant risk factor compared with higher dosage when used."( Oral steroid decreases the progression of joint destruction of large joints in the lower extremities in rheumatoid arthritis.
Azukizawa, M; Doi, K; Hashimoto, M; Ito, H; Matsuda, S; Mimori, T; Murakami, K; Murata, K; Nishitani, K; Okahata, A; Saito, M; Tanaka, M; Tomizawa, T, 2019
)
0.81
" DWIBS makes it possible to adjust the medicine dosage while confirming the therapeutic effects and will likely be a useful method for monitoring IgG4-related disease."( Clinical Utility of Diffusion-weighted Whole-body Magnetic Resonance Imaging with Background Body Signal Suppression for Assessing and Monitoring IgG4-related Disease.
Kawakami, H; Kazatani, T; Kono, Y; Matsuoka, H; Miyoshi, T; Oshita, A; Suzuki, M, 2020
)
0.56
" 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
" Using linear regression and a negative binomial model, genetic variant association with three endpoints (accrued duration of remission, average oral glucocorticoid dose, and frequency of relapse) was tested in 61 EGPA subjects dosed with mepolizumab from MIRRA, a phase 3 trial."( Pharmacogenetic investigation of efficacy response to mepolizumab in eosinophilic granulomatosis with polyangiitis.
Condreay, LD; Ghosh, S; Parham, LR; Qu, XA; Raby, BA; Steinfeld, J; Wechsler, ME; Yancey, SW, 2020
)
0.56
" One trial (27 participants) found that HC and DXA treatment suppressed 17 OHP and androstenedione more than PD treatment after six weeks and a further trial (eight participants) reported no difference in 17 OHP between the five different dosing schedules of HC at between four and six weeks."( Glucocorticoid replacement regimens for treating congenital adrenal hyperplasia.
Krishan, A; Ng, SM; Stepien, KM, 2020
)
0.56
" However, chronic use of topical corticosteroids dosed at <3 drops daily seemed to be associated with a lower risk of cataract development relative to eyes receiving higher doses over follow-up in the setting of suppressed uveitis."( Risk of Cataract Development among Children with Juvenile Idiopathic Arthritis-Related Uveitis Treated with Topical Corticosteroids.
Dunn, JP; Jabs, DA; Thorne, JE; Woreta, FA, 2020
)
0.56
" Forty-five days after prednisolone therapy, partial remission of nephrotic syndrome and decrease of serum creatinine were achieved while peritoneal dialysis dosage had decreased."( Eosinophilic peritonitis and nephrotic syndrome in Kimura's disease: a case report and literature review : Eosinophilic peritonitis in Kimura's disease.
Dong, J; Nong, L; Song, D; Wang, S; Wang, Z; Xu, D; Yang, Z; Yu, B; Zhou, F, 2020
)
0.87
" We also comment on suggested dosing for patients who usually take modified release hydrocortisone or prednisolone."( ENDOCRINOLOGY IN THE TIME OF COVID-19: Management of adrenal insufficiency.
Arlt, W; Baldeweg, SE; Pearce, SHS; Simpson, HL, 2020
)
0.77
" Cumulative effects were seen for the 6 diseases studied, but dose-response effects were not found for daily dose."( Oral glucocorticoids and incidence of hypertension in people with chronic inflammatory diseases: a population-based cohort study.
Mebrahtu, TF; Morgan, AW; Pujades-Rodriguez, M; Stewart, PM; West, RM, 2020
)
0.56
" However, albeit strong recommendations, the treatment protocol is based on low-quality evidence and high-quality clinical trials are lacking with respect to the optimal initiation dosage and usage of corticosteroid."( Comparison of the therapeutic effects of 15 mg and 30 mg initial dosage of prednisolone daily in patients with subacute thyroiditis: protocol for a multicenter, randomized, open, parallel control study.
Chen, R; Gao, B; Gao, L; Jia, A; Jiang, Y; Jiao, Y; Jing, X; Shang, L; Wei, J; Xu, J; Xu, S; Xu, W; Zhang, J, 2020
)
0.79
" A total of 90 adult patients diagnosed with SAT who present moderate to severe pain or fail to respond to full doses of NSAIDs will be randomly assigned with a 1:1 ratio to the low initial PSL dosage group (15 mg daily) and standard initial PSL dosage group (30 mg daily)."( Comparison of the therapeutic effects of 15 mg and 30 mg initial dosage of prednisolone daily in patients with subacute thyroiditis: protocol for a multicenter, randomized, open, parallel control study.
Chen, R; Gao, B; Gao, L; Jia, A; Jiang, Y; Jiao, Y; Jing, X; Shang, L; Wei, J; Xu, J; Xu, S; Xu, W; Zhang, J, 2020
)
0.79
" Based on pharmacokinetic-pharmacodynamic models, TNFα dose-response relationships for AZD9567 and prednisolone were established."( Estimation of Equipotent Doses for Anti-Inflammatory Effects of Prednisolone and AZD9567, an Oral Selective Nonsteroidal Glucocorticoid Receptor Modulator.
Almquist, J; Eriksson, UG; Hegelund Myrbäck, T; Leander, J; Prothon, S; Sadiq, MW, 2020
)
1.01
"In immune-mediated inflammatory diseases, there is a lack of -estimates of glucocorticoid dose-response diabetes risk that consider changes in prescribed dose over time and disease activity."( Glucocorticoid dose-dependent risk of type 2 diabetes in six immune-mediated inflammatory diseases: a population-based cohort analysis.
Mackie, SL; Pujades-Rodriguez, M; Wu, J, 2020
)
0.56
" For the treatment of COVID-19 pneumonia, systemic and in-depth investigation is needed to determine the timing and dosage of glucocorticoids needed to inhibit overwhelming inflammatory response and not the protective immune response to COVID-19 pneumonia."( Clinical efficacy of glucocorticoid on the treatment of patients with COVID-19 pneumonia: A single-center experience.
Hu, Y; Hu, Z; Li, L; Peng, P; Wang, T; Wang, X; Zhang, Z, 2020
)
0.56
" Mesalazine at 4,000 mg/day and prednisolone at 60 mg/day were started, and the prednisolone dosage was thereafter gradually reduced and switched to golimumab."( Multiple Cerebral Infarction Associated with Cerebral Vasculitis in a Patient with Ulcerative Colitis.
Dohi, O; Hasegawa, D; Hirose, R; Inoue, K; Ishikawa, T; Itoh, Y; Kamada, K; Konishi, H; Naito, Y; Takagi, T; Uchiyama, K; Yasuda, T; Yoshida, N, 2021
)
0.9
"The median period of subject observation following the first RTX dosing was 34 months (cumulative RTX dose: 400 - 1,400 mg)."( Retrospective single-arm cohort study of steroid-dependent minimal change nephrotic syndrome treated with very low-dose rituximab.
Adachi, H; Fujii, A; Fujimoto, K; Furuichi, K; Kagaya, Y; Kumano, S; Matsuura, T; Nomura, K; Okada, K; Okino, K; Tsuruyama, Y; Yamazaki, K; Yokoyama, H, 2021
)
0.62
" Higher prednisolone dosage and PDAI-score were positively correlated with CTLA4 and FCGR3A expressions after 3 months, respectively (P-value = ."( Investigating expression pattern of eight immune-related genes in pemphigus patients compared with the healthy controls and after rituximab therapy: Potential roles of CTLA4 and FCGR3A genes expression in outcomes of rituximab therapy.
Abbasi, M; Balali, M; Balighi, K; Daneshpazhooh, M; Elikaei Behjati, S; Karami, F; Mahmoudi, H; Masoudi, J; Modarressi, MH; Salehi Farid, A; Tavakolpour, S, 2020
)
0.99
" 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
)
2.06
" However, a fall in FeNO following supervised inhaled corticosteroid dosing could indicate previous poor adherence."( Assessment of adherence to corticosteroids in asthma by drug monitoring or fractional exhaled nitric oxide: A literature review.
Alahmadi, F; Fowler, SJ; Keevil, B; Niven, R; Peel, A, 2021
)
0.62
" In order to improve immunosuppression and decrease dosage and duration of glucocorticoid treatment, a second immunosuppressive drug is commonly used in most of the immune-mediated diseases."( Combination of Prednisolone and Azathioprine for Steroid-Responsive Meningitis-Arteritis Treatment in Dogs.
Cauzinille, L; Giraud, L; Girod, M, 2021
)
0.97
" The freeze-drying method was used to convert the SLP suspension into a solid dosage form for buccal delivery by using mucoadhesive polymers."( Effects of Mucoadhesive Polymers on Released Particles and Drug Release in Solid Lipid Particle-Based Buccal Tablets.
Phan, TTH; Tran, PHL; Tran, TTD, 2021
)
0.62
" Les chats ont initialement été évalués au moment du recrutement et puis à huit semaines avec des radiographies thoraciques, lavage bronchoalvéolaire, tests de fonction pulmonaire et dosage de la fructosamine."( Treatment of naturally occurring asthma with inhaled fluticasone or oral prednisolone: A randomized pilot trial.
Bain, P; Egan, A; Knoll, J; Oura, TJ; Rozanski, EA; Sharp, CR; Verschoor-Kirss, M, 2021
)
0.85
" Corticosteroids are inexpensive and promising drugs for relapse prevention in NMOSD, but few studies have analysed the efficacy of corticosteroids in NMOSD, especially regarding the appropriate dosing and tapering regimens."( Optimal management of neuromyelitis optica spectrum disorder with aquaporin-4 antibody by oral prednisolone maintenance therapy.
Akaishi, T; Aoki, M; Fujihara, K; Kuroda, H; Misu, T; Nakashima, I; Nishiyama, S; Takahashi, T; Takai, Y, 2021
)
0.84
" Recently, corticosteroid dosing to treat relapses has been questioned, with data suggesting lower doses may be as effective."( Optimizing the corticosteroid dose in steroid-sensitive nephrotic syndrome.
Christian, MT; Maxted, AP, 2022
)
0.72
"001), and average oral dosage of >7."( Pneumocystis Jirovecii Pneumonia in Systemic Lupus Erythematosus: A Nationwide Cohort Study in Taiwan.
Chang, YS; Chen, WS; Huang, YF; Lai, CC; Li, TH; Tsao, YP; Wang, WH, 2022
)
0.72
" The side-effects of oral steroids require careful consideration and further studies are needed to ascertain appropriate dosage and treatment duration."( Short-term Oral Steroids Significantly Improves Chronic Rhinosinusitis Without Nasal Polyps.
Chao, J; Cildir, G; De Silva, AP; Lopez, A; Pant, H; Sarah, AH; Schembri, MA; Tumes, DJ; Yip, KH, 2021
)
0.62
" In this dosage range they promote osteoporosis, diabetes and hyperglycemia as well as cardiovascular events and infections, thereby contributing to an excess mortality."( [Safety aspects of the treatment with glucocorticoids for rheumatoid arthritis].
Keyßer, G, 2021
)
0.62
" 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
" Our investigations excluded other possible causes for deranged LFTs and there was no improvement of same despite reduced dosing of potentially hepatotoxic medications."( Prednisolone: role in amoxicillin-clavulanate-induced cholestatic liver injury.
Chigozie, R; Khan, I; Lee, MQ; O'Mara, G, 2021
)
2.06
" The corticosteroid dosage that is effective against inflammatory disorders depends on the pathological background of autoimmune diseases; however, owing to limited clinical evidence, the dosage has been empirically determined in routine medical practice."( [Corticosteroid Therapy in Patients with Autoimmune Diseases of the Central Nervous System].
Matsushita, T, 2021
)
0.62
" Patients aged 18 years or older with previously untreated asymptomatic or mildly symptomatic mCRPC who had progressive disease and Eastern Collaborative Oncology Group performance status of 0 or 1 were randomly assigned (1:1; permuted block method) to receive ipatasertib (400 mg once daily orally) plus abiraterone (1000 mg once daily orally) and prednisolone (5 mg twice a day orally) or placebo plus abiraterone and prednisolone (with the same dosing schedule)."( Ipatasertib plus abiraterone and prednisolone in metastatic castration-resistant prostate cancer (IPATential150): a multicentre, randomised, double-blind, phase 3 trial.
Alekseev, B; Alves, GV; Atduev, V; Borre, M; Bournakis, E; Bracarda, S; Buchschacher, GL; Chen, G; Chi, KN; Corrales, L; de Bono, JS; Gafanov, R; Gallo, J; Garcia, J; Hanover, J; Harle-Yge, ML; Massard, C; Matsubara, N; Olmos, D; Parnis, F; Puente, J; Sandhu, S; Sternberg, CN; Stroyakovskiy, D; Sweeney, C; Wongchenko, MJ, 2021
)
1.07
" Therefore, the dosage of PSL was increased to 65 mg once daily."( [A Case of Penile Pyoderma Gangrenosum Treated by Urethrocutaneostomy without Penectomy].
Hatano, S; Ishitoya, S; Kanematsu, A; Mizuno, K; Nishikawa, N; Ogura, K; Takada, H; Takao, N; Tsuchihashi, K, 2021
)
0.62
"To investigate the relationship between real life glucocorticoid (GC) dosing and relapse rates in patients with new onset GCA in a single centre."( Glucocorticoid dosing and relapses in giant cell arteritis-a single centre cohort study.
Aringer, M; Felten, L; Leuchten, N, 2022
)
0.72
" This study aimed to use meta-analysis methods to identify the appropriate dosage of prednisolone with the lowest recurrence rate in the treatment of patients with SAGT."( Identifying the Lowest Effective Initial Dose of Prednisolone for the Treatment of Subacute Granulomatous Thyroiditis: A Systematic Review and Meta-Analysis.
Aletaha, A; Fathi, M; Hadavi, M; Haghighat, S; Jouybari, L; Nourani, F; Roudsari, SB; Soltani, A, 2022
)
1.2
"According to the results of this meta-analysis, 15 to 20 mg/day of prednisolone is the most effective dosage with the lowest recurrence rate in the treatment of subacute Granulomatous thyroiditis."( Identifying the Lowest Effective Initial Dose of Prednisolone for the Treatment of Subacute Granulomatous Thyroiditis: A Systematic Review and Meta-Analysis.
Aletaha, A; Fathi, M; Hadavi, M; Haghighat, S; Jouybari, L; Nourani, F; Roudsari, SB; Soltani, A, 2022
)
1.21
" First, clinical symptoms improved as the dosage of prednisolone increased."( A suspected case of a multiple autoimmune syndrome in a poodle dog.
Bae, S; Jin, Y; Lim, D; Oh, T; Son, Y, 2022
)
0.97
"OCS users (n=30 352) had, compared with nonusers (n=121 408), an increased risk of all outcomes with evident dose-response relationships starting at cumulative doses of ≤500 mg (prednisolone-equivalent)."( Low-dose oral corticosteroids in asthma associates with increased morbidity and mortality.
Andersen, JH; Davidsen, JR; Henriksen, DP; Madsen, H; Pottegård, A; Skov, IR, 2022
)
0.91
" During the course of the study, patients were given standard treatment and an oral dose of 500 mg of RECOVEREEZ FORTE™ thrice daily, or standard of care and oral Prednisolone in tapered dosage (control group)."( Anti-inflammatory response of cardamom extract and prediction of therapeutic window in COVID-19 patients by assessing inflammatory markers using RT-PCR.
Hynse, A; Mandlecha, A; Shakeeb, N; Varkey, P, 2022
)
0.92
" The purpose of this study is to investigate whether the combination of Lactobacillus rhamnosus GG (LGG) with prednisolone could reduce the dosage of glucocorticoid in controlling airway inflammation in a murine model for allergic asthma."( Effect of combination treatment with Lactobacillus rhamnosus and corticosteroid in reducing airway inflammation in a mouse asthma model.
Ko, JL; Lue, KH; Sun, HL; Voo, PY; Wu, CT, 2022
)
0.93
"LGG may reduce the dosage of prednisolone and thus may be beneficial in the treatment of asthma."( Effect of combination treatment with Lactobacillus rhamnosus and corticosteroid in reducing airway inflammation in a mouse asthma model.
Ko, JL; Lue, KH; Sun, HL; Voo, PY; Wu, CT, 2022
)
1.01
"The presentation of 3D printing in drug innovation especially focuses on the advancement of patient-centered dosage forms based on the structural design."( A Recent Review On 3D-Printing: Scope and Challenges with Special Focus on Pharmaceutical Field.
Doolaanea, AA; Kumar, M; Mandal, UK; Singh, S, 2022
)
0.72
" Relative dosage was estimated as a weight-based, prednisolone-equivalent dose."( The absolute risk of incident type 2 diabetes following exposure to systemic corticosteroids in selected steroid-related and phenotypic groups.
Adamsson Eryd, S; Ambery, P; Astbury, C; Berni, E; Brown, MN; Currie, CJ; Heywood, B; Hunt, P; Jenkins-Jones, S, 2022
)
0.97
"Corticosteroid exposure increased the risk of incident type 2 diabetes, and there was evidence of both a dose-response and a duration response."( The absolute risk of incident type 2 diabetes following exposure to systemic corticosteroids in selected steroid-related and phenotypic groups.
Adamsson Eryd, S; Ambery, P; Astbury, C; Berni, E; Brown, MN; Currie, CJ; Heywood, B; Hunt, P; Jenkins-Jones, S, 2022
)
0.72
"Mepolizumab inhibits IL-5 activity and reduces exacerbation frequency and maintenance oral corticosteroid (OCS) dosage in patients with severe eosinophilic asthma (SEA)."( Corticosteroid Responsiveness Following Mepolizumab in Severe Eosinophilic Asthma-A Randomized, Placebo-Controlled Crossover Trial (MAPLE).
Borg, K; Bradding, P; Brightling, CE; Busby, J; Chaudhuri, R; Diver, SE; Heaney, LG; McDowell, JP; Pavord, ID; Shepherd, M; Shrimanker, R; Yang, F, 2022
)
0.72
" The first 125 mg of methylprednisolone (mPSL) for 3 days was intravenous, after which it was switched to oral prednisolone (PSL) therapy and the dosage was gradually reduced."( Posterior scleritis with choroidal detachments and periaortitis associated with IgG4-related disease: A case report.
Kadoya, M; Koizumi, K; Kondo, M; Kubo, A; Mase, Y; Masuda, K; Matsumoto, A; Sotozono, C, 2022
)
1.02
" These patients were divided into four treatment groups based on corticosteroid dosage and use of an antiviral agent."( Benefits of High-Dose Corticosteroid and Antiviral Agent Combination Therapy in the Treatment of House-Brackman Grade VI Ramsay Hunt Syndrome.
Abe, Y; Furukawa, T; Goto, T; Hull, M; Ito, T; Kakehata, S; Kubota, T; Sugiyama, M, 2022
)
0.72
" No dose-response relationship between ICS use and SES could be identified."( Socioeconomic status is associated with healthcare seeking behaviour and disease burden in young adults with asthma - A nationwide cohort study.
Backer, V; Håkansson, KEJ; Ulrik, CS,
)
0.13
" At the time points that prednisolone dosage was higher, higher levels of ALT, but no difference in AST levels was noted."( Prevalence and management of chronic hepatitis B in pemphigus and pemphigoid patients: New evidence for the safety of rituximab.
Aryanian, Z; Balighi, K; Daneshpazhooh, M; Hatami, P; Mahmoudi, H; Mohseniafshar, Z; Soori, T; Tahooneban, A; Tavakolpour, S, 2022
)
1.02
"Reduction of the hydroxychloroquine (HCQ) dosage is recommended in systemic lupus erythematosus (SLE) patients with renal impairment, but a pharmacokinetics (PK) study of patients with renal impairment has not yet been performed."( Pharmacokinetics of hydroxychloroquine in Japanese systemic lupus erythematosus patients with renal impairment.
Furudate, S; Hashiguchi, M; Nagai, Y; Ohshima, M; Setoguchi, K; Shimada, K; Shimizu, M; Yokogawa, N, 2023
)
0.91
"From the PK perspective, a dosage reduction is unnecessary in SLE patients with impaired renal function."( Pharmacokinetics of hydroxychloroquine in Japanese systemic lupus erythematosus patients with renal impairment.
Furudate, S; Hashiguchi, M; Nagai, Y; Ohshima, M; Setoguchi, K; Shimada, K; Shimizu, M; Yokogawa, N, 2023
)
0.91
" The lack of a robust evidence base to guide the use of plasma exchange and glucocorticoid dosing contributes to variation in practice and suboptimal outcomes."( Plasma exchange and glucocorticoids to delay death or end-stage renal disease in anti-neutrophil cytoplasm antibody-associated vasculitis: PEXIVAS non-inferiority factorial RCT.
Brettell, EA; Brezina, B; Broadhurst, E; Casian, A; Clark, W; de Zoysa, J; Flossmann, O; Fujimoto, S; Girard, L; Gregorini, G; Harper, L; Hawley, C; Ito-Ihara, T; Ives, N; Jarrett, H; Jayne, D; Jones, R; Khalidi, N; Levin, A; Mazzetti, A; McAlear, CA; Mehta, S; Merkel, PA; Pagnoux, C; Peh, CA; Puéchal, X; Pusey, CD; Reidlinger, D; Smyth, L; Specks, U; Szpirt, W; Wald, R; Walsh, M; Wheatley, K, 2022
)
0.72
" Patients were randomised in a two-by-two factorial design to receive either adjunctive plasma exchange or no plasma exchange, and either a reduced or a standard glucocorticoid dosing regimen."( Plasma exchange and glucocorticoids to delay death or end-stage renal disease in anti-neutrophil cytoplasm antibody-associated vasculitis: PEXIVAS non-inferiority factorial RCT.
Brettell, EA; Brezina, B; Broadhurst, E; Casian, A; Clark, W; de Zoysa, J; Flossmann, O; Fujimoto, S; Girard, L; Gregorini, G; Harper, L; Hawley, C; Ito-Ihara, T; Ives, N; Jarrett, H; Jayne, D; Jones, R; Khalidi, N; Levin, A; Mazzetti, A; McAlear, CA; Mehta, S; Merkel, PA; Pagnoux, C; Peh, CA; Puéchal, X; Pusey, CD; Reidlinger, D; Smyth, L; Specks, U; Szpirt, W; Wald, R; Walsh, M; Wheatley, K, 2022
)
0.72
" All patients received the same glucocorticoid dosing from 6 to 12 months."( Plasma exchange and glucocorticoids to delay death or end-stage renal disease in anti-neutrophil cytoplasm antibody-associated vasculitis: PEXIVAS non-inferiority factorial RCT.
Brettell, EA; Brezina, B; Broadhurst, E; Casian, A; Clark, W; de Zoysa, J; Flossmann, O; Fujimoto, S; Girard, L; Gregorini, G; Harper, L; Hawley, C; Ito-Ihara, T; Ives, N; Jarrett, H; Jayne, D; Jones, R; Khalidi, N; Levin, A; Mazzetti, A; McAlear, CA; Mehta, S; Merkel, PA; Pagnoux, C; Peh, CA; Puéchal, X; Pusey, CD; Reidlinger, D; Smyth, L; Specks, U; Szpirt, W; Wald, R; Walsh, M; Wheatley, K, 2022
)
0.72
" A health-economic analysis of data collected in this study to examine the impact of both plasma exchange and reduced glucocorticoid dosing is planned to address the utility of plasma exchange for reducing early end-stage renal disease rates."( Plasma exchange and glucocorticoids to delay death or end-stage renal disease in anti-neutrophil cytoplasm antibody-associated vasculitis: PEXIVAS non-inferiority factorial RCT.
Brettell, EA; Brezina, B; Broadhurst, E; Casian, A; Clark, W; de Zoysa, J; Flossmann, O; Fujimoto, S; Girard, L; Gregorini, G; Harper, L; Hawley, C; Ito-Ihara, T; Ives, N; Jarrett, H; Jayne, D; Jones, R; Khalidi, N; Levin, A; Mazzetti, A; McAlear, CA; Mehta, S; Merkel, PA; Pagnoux, C; Peh, CA; Puéchal, X; Pusey, CD; Reidlinger, D; Smyth, L; Specks, U; Szpirt, W; Wald, R; Walsh, M; Wheatley, K, 2022
)
0.72
" In particular, no biomarkers have been identified to help determine dosing in a particular patient, although this is one of the goals of the biomarker plan of this study."( Plasma exchange and glucocorticoids to delay death or end-stage renal disease in anti-neutrophil cytoplasm antibody-associated vasculitis: PEXIVAS non-inferiority factorial RCT.
Brettell, EA; Brezina, B; Broadhurst, E; Casian, A; Clark, W; de Zoysa, J; Flossmann, O; Fujimoto, S; Girard, L; Gregorini, G; Harper, L; Hawley, C; Ito-Ihara, T; Ives, N; Jarrett, H; Jayne, D; Jones, R; Khalidi, N; Levin, A; Mazzetti, A; McAlear, CA; Mehta, S; Merkel, PA; Pagnoux, C; Peh, CA; Puéchal, X; Pusey, CD; Reidlinger, D; Smyth, L; Specks, U; Szpirt, W; Wald, R; Walsh, M; Wheatley, K, 2022
)
0.72
" Treatment was started with 30 mg of prednisolone, and the dosage was gradually decreased."( [A Case of Unilateral Interstitial Lung Disease in a Patient Treated with Oxaliplatin, 5-Fluorouracil, and Leucovorin].
Aisaki, K; Aoki, K; Doumoto, Y; Funatsu, K; Hosaka, M; Kimura, T; Kobori, S; Minoshima, K; Ushiku, H; Wakabayashi, M; Yoshida, H, 2022
)
0.99
" A phase II selection design will be used to determine hdroxychloroquine's efficacy, using prednisolone dosage and Birmingham Vasculitis Activity Score as a measure of disease activity."( The HAVEN study-hydroxychloroquine in ANCA vasculitis evaluation-a multicentre, randomised, double-blind, placebo-controlled trial: study protocol and statistical analysis plan.
Arnold, L; Beckley-Hoelscher, N; Cape, A; Casian, A; D'Cruz, D; Douiri, A; Galloway, J; Jayne, D; John, S; Kim, S; Learoyd, AE; Luqmani, R; Morton, N; Nel, L; Reid, F; Sangle, S; Shivapatham, D, 2023
)
1.13
" Six patients (35%) experienced a prolonged reduction of intraretinal fluid when the dosage was reduced to once daily."( POTENTIAL TREATMENT FOR PERIPAPILLARY PACHYCHOROID SYNDROME.
Behar-Cohen, F; Fernández-Avellaneda, P; Martinez Ciriano, JP; Pothof, AB; Yzer, S, 2023
)
0.91
" We also followed the clinical indicators (absolute eosinophil counts, CRP and IgE levels, BVAS, Vascular Damage Index (VDI)) and daily prednisolone dosage at the EGPA diagnosis, at the mepolizumab induction and at the survey."( Mepolizumab exerts crucial effects on glucocorticoid discontinuation in patients with eosinophilic granulomatosis with polyangiitis: a retrospective study of 27 cases at a single center in Japan.
Hashiramoto, A; Yamane, T, 2023
)
1.11
" 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
)
1.16
" The mean dosage of oral prednisolone and mizoribine showed no differences among the three age groups."( Demographics and treatment of patients with primary membranoproliferative glomerulonephritis in Japan using a national registry of clinical personal records.
Isaka, Y; Kimura, T; Nakagawa, N; Narita, I; Sakate, R, 2023
)
1.21
" 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
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (7)

RoleDescription
adrenergic agentAny agent that acts on an adrenergic receptor or affects the life cycle of an adrenergic transmitter.
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.
drug metabolitenull
environmental contaminantAny minor or unwanted substance introduced into the environment that can have undesired effects.
xenobioticA xenobiotic (Greek, xenos "foreign"; bios "life") is a compound that is foreign to a living organism. Principal xenobiotics include: drugs, carcinogens and various compounds that have been introduced into the environment by artificial means.
[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
glucocorticoidGlucocorticoids are a class of steroid hormones that regulate a variety of physiological processes, in particular control of the concentration of glucose in blood.
11beta-hydroxy steroidAny 11-hydroxy steroid in which the hydroxy group at position 11 has beta- configuration.
21-hydroxy steroid
17alpha-hydroxy steroidThe alpha-stereoisomer of 17-hydroxy steroid.
20-oxo steroidAn oxo steroid carrying an oxo group at position 20.
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 (4)

PathwayProteinsCompounds
Prednisone Action Pathway13
Prednisolone Action Pathway21
Prednisone Metabolism Pathway13
Prednisolone Metabolism Pathway21

Protein Targets (49)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
hypoxia-inducible factor 1 alpha subunitHomo sapiens (human)Potency7.76163.189029.884159.4836AID1224846
RAR-related orphan receptor gammaMus musculus (house mouse)Potency0.09350.006038.004119,952.5996AID1159521; AID1159523
TDP1 proteinHomo sapiens (human)Potency16.83300.000811.382244.6684AID686978; AID686979
GLI family zinc finger 3Homo sapiens (human)Potency3.58320.000714.592883.7951AID1259369; AID1259392
AR proteinHomo sapiens (human)Potency0.09130.000221.22318,912.5098AID1259243; AID1259247; AID1259381; AID743036; AID743040; AID743042; AID743053; AID743054
progesterone receptorHomo sapiens (human)Potency32.94270.000417.946075.1148AID1346784; AID1346795; AID1347036
cytochrome P450 family 3 subfamily A polypeptide 4Homo sapiens (human)Potency0.17780.01237.983543.2770AID1346984
glucocorticoid receptor [Homo sapiens]Homo sapiens (human)Potency0.03700.000214.376460.0339AID720691; AID720692; AID720719
retinoic acid nuclear receptor alpha variant 1Homo sapiens (human)Potency15.99940.003041.611522,387.1992AID1159552; AID1159553; AID1159555
estrogen-related nuclear receptor alphaHomo sapiens (human)Potency17.58570.001530.607315,848.9004AID1224841; AID1224848; AID1224849; AID1259403
pregnane X nuclear receptorHomo sapiens (human)Potency53.70790.005428.02631,258.9301AID1346982
estrogen nuclear receptor alphaHomo sapiens (human)Potency6.50380.000229.305416,493.5996AID1259244; AID743075; AID743080; AID743091
aryl hydrocarbon receptorHomo sapiens (human)Potency0.00610.000723.06741,258.9301AID743122
cytochrome P450, family 19, subfamily A, polypeptide 1, isoform CRA_aHomo sapiens (human)Potency0.03920.001723.839378.1014AID743083
v-jun sarcoma virus 17 oncogene homolog (avian)Homo sapiens (human)Potency54.94770.057821.109761.2679AID1159528
nuclear receptor subfamily 1, group I, member 2Rattus norvegicus (Norway rat)Potency15.84890.10009.191631.6228AID1346983
nuclear factor erythroid 2-related factor 2 isoform 2Homo sapiens (human)Potency0.06550.00419.984825.9290AID504444; AID720524
Voltage-dependent calcium channel gamma-2 subunitMus musculus (house mouse)Potency0.30200.001557.789015,848.9004AID1259244
Interferon betaHomo sapiens (human)Potency0.03740.00339.158239.8107AID1347407
Cellular tumor antigen p53Homo sapiens (human)Potency21.38150.002319.595674.0614AID651631
Glutamate receptor 2Rattus norvegicus (Norway rat)Potency0.30200.001551.739315,848.9004AID1259244
ATPase family AAA domain-containing protein 5Homo sapiens (human)Potency0.01500.011917.942071.5630AID651632
Ataxin-2Homo sapiens (human)Potency0.01500.011912.222168.7989AID651632
[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)
ATP-binding cassette sub-family C member 3Homo sapiens (human)IC50 (µMol)133.00000.63154.45319.3000AID1473740
Multidrug resistance-associated protein 4Homo sapiens (human)IC50 (µMol)133.00000.20005.677410.0000AID1473741
Bile salt export pumpHomo sapiens (human)IC50 (µMol)119.82330.11007.190310.0000AID1443980; AID1449628; AID1473738
Fatty acid-binding protein, liverRattus norvegicus (Norway rat)Ki51.83000.01501.24876.9200AID407366; AID407369
Estrogen receptorHomo sapiens (human)IC50 (µMol)55.00000.00000.723732.7000AID1328549; AID1380153
Estrogen receptorHomo sapiens (human)Ki3.66670.00000.42297.9070AID604792; AID626802; AID70976
Glucocorticoid receptorHomo sapiens (human)IC50 (µMol)0.05080.00000.495310.0000AID1125607; AID1125610; AID1328537; AID1380129; AID1380136; AID1380145; AID1530700; AID1797832; AID1797836; AID202433; AID242155; AID267772; AID274990; AID299614; AID299615; AID304380; AID331519; AID331521; AID410446; AID47368; AID47369; AID480395; AID515514; AID515517; AID53571; AID552806; AID552808; AID578377; AID578481; AID579571; AID579573; AID589653; AID589655; AID625263; AID626140; AID626146; AID640508; AID640512; AID74078; AID74083; AID91902
Glucocorticoid receptorHomo sapiens (human)Ki0.00360.00010.38637.0010AID1071638; AID299616; AID331514; AID351941; AID473409; AID552717; AID578373; AID579568; AID589652; AID604795; AID625263; AID626799; AID74225; AID74226; AID74232
Progesterone receptorHomo sapiens (human)IC50 (µMol)6.01330.00000.580710.0000AID1125608; AID1328546; AID1380150; AID1530702; AID515515; AID626141
Progesterone receptorHomo sapiens (human)Ki5.42860.00030.03160.3997AID1071636; AID156392; AID162468; AID226107; AID331515; AID604793; AID626800
Glucocorticoid receptorRattus norvegicus (Norway rat)IC50 (µMol)0.05650.00010.39756.0000AID1380175; AID1380176; AID640510
Glycine receptor subunit alpha-1Rattus norvegicus (Norway rat)IC50 (µMol)0.01600.00150.76005.0740AID625263
Glycine receptor subunit alpha-1Rattus norvegicus (Norway rat)Ki0.00740.00070.76537.0010AID625263
Corticosteroid-binding globulinHomo sapiens (human)Ki0.03090.01323.248110.0000AID51055
Mineralocorticoid receptor Homo sapiens (human)IC50 (µMol)0.03220.00030.748410.0000AID1125609; AID1328548; AID1380152; AID515516; AID626142
Mineralocorticoid receptor Homo sapiens (human)Ki0.01860.00030.17380.8510AID1071639; AID225319
Androgen receptorHomo sapiens (human)IC50 (µMol)18.00000.00000.875310.0000AID1328547; AID1380151
Androgen receptorHomo sapiens (human)Ki2.68070.00020.42407.2000AID1071637; AID212921; AID39148
Cytochrome P450 2C9 Homo sapiens (human)IC50 (µMol)50.00000.00002.800510.0000AID1210069
Androgen receptorRattus norvegicus (Norway rat)IC50 (µMol)42.65790.00101.979414.1600AID255211
Glycine receptor subunit betaRattus norvegicus (Norway rat)IC50 (µMol)0.01600.00150.76005.0740AID625263
Glycine receptor subunit betaRattus norvegicus (Norway rat)Ki0.00740.00070.78467.0010AID625263
Glycine receptor subunit alpha-2Rattus norvegicus (Norway rat)IC50 (µMol)0.01600.00150.80445.0740AID625263
Glycine receptor subunit alpha-2Rattus norvegicus (Norway rat)Ki0.00740.00070.78467.0010AID625263
Glycine receptor subunit alpha-3Rattus norvegicus (Norway rat)IC50 (µMol)0.01600.00150.76005.0740AID625263
Glycine receptor subunit alpha-3Rattus norvegicus (Norway rat)Ki0.00740.00070.78467.0010AID625263
Prostaglandin G/H synthase 2Homo sapiens (human)Ki5.00000.00050.41861.5000AID162468
Cytochrome P450 2J2Homo sapiens (human)IC50 (µMol)50.00000.01202.53129.4700AID1210069
Estrogen receptor betaHomo sapiens (human)IC50 (µMol)55.00000.00010.529432.7000AID1328550; AID1380154
Estrogen receptor betaHomo sapiens (human)Ki1.00000.00000.12512.8760AID70976
Canalicular multispecific organic anion transporter 1Homo sapiens (human)IC50 (µMol)133.00002.41006.343310.0000AID1473739
[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)EC50 (µMol)0.02910.00040.05401.0000AID1380130; AID155103; AID213397; AID240069; AID240130; AID267775; AID296301; AID296303; AID296305; AID296307; AID299612; AID304381; AID331517; AID351942; AID351943; AID351946; AID410449; AID47188; AID47372; AID480396; AID480398; AID552720; AID578374; AID578376; AID579569; AID589660; AID589745; AID604797; AID604799; AID604800; AID604854; AID626200; AID626202; AID626804; AID626806; AID626808; AID626810; AID626812; AID81558; AID8455; AID86563
Glucocorticoid receptorRattus norvegicus (Norway rat)EC50 (µMol)0.01960.00080.00760.0196AID204332
Glucocorticoid receptorMus musculus (house mouse)EC50 (µMol)0.00460.00340.00460.0057AID240099; AID240161
Mineralocorticoid receptor Homo sapiens (human)EC50 (µMol)0.00100.00000.01260.1000AID604856; AID626803
Glutamine synthetaseHomo sapiens (human)EC50 (µMol)0.03200.03200.03200.0320AID74963
Histamine H1 receptorCavia porcellus (domestic guinea pig)EC50 (µMol)0.00260.00260.53341.2020AID86563
Nociceptin receptorRattus norvegicus (Norway rat)EC50 (µMol)0.00340.00090.01470.0631AID296307
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Other Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
luciferasePhoturis pensylvanica (Pennsylania firefly)AC5052.000015.210015.210015.2100AID588847
Glucocorticoid receptorHomo sapiens (human)Activity0.00240.00240.00240.0024AID73768
Glucocorticoid receptorHomo sapiens (human)ED500.00400.00400.00400.0040AID330359
Glucocorticoid receptorHomo sapiens (human)fEC500.02400.02400.02400.0240AID1380128
Glucocorticoid receptorHomo sapiens (human)fIC200.00090.00090.00100.0012AID1380148
Glucocorticoid receptorHomo sapiens (human)fIC300.02000.02000.05050.0810AID1380145
Progesterone receptorHomo sapiens (human)Activity5.00000.00130.00130.0013AID162463
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (396)

Processvia Protein(s)Taxonomy
xenobiotic metabolic processATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
bile acid and bile salt transportATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transportATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
leukotriene transportATP-binding cassette sub-family C member 3Homo sapiens (human)
monoatomic anion transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transport across blood-brain barrierATP-binding cassette sub-family C member 3Homo sapiens (human)
prostaglandin secretionMultidrug resistance-associated protein 4Homo sapiens (human)
cilium assemblyMultidrug resistance-associated protein 4Homo sapiens (human)
platelet degranulationMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic metabolic processMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
bile acid and bile salt transportMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transportMultidrug resistance-associated protein 4Homo sapiens (human)
urate transportMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
cAMP transportMultidrug resistance-associated protein 4Homo sapiens (human)
leukotriene transportMultidrug resistance-associated protein 4Homo sapiens (human)
monoatomic anion transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
export across plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
transport across blood-brain barrierMultidrug resistance-associated protein 4Homo sapiens (human)
guanine nucleotide transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell activation involved in immune responseInterferon betaHomo sapiens (human)
cell surface receptor signaling pathwayInterferon betaHomo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to virusInterferon betaHomo sapiens (human)
positive regulation of autophagyInterferon betaHomo sapiens (human)
cytokine-mediated signaling pathwayInterferon betaHomo sapiens (human)
natural killer cell activationInterferon betaHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylation of STAT proteinInterferon betaHomo sapiens (human)
cellular response to interferon-betaInterferon betaHomo sapiens (human)
B cell proliferationInterferon betaHomo sapiens (human)
negative regulation of viral genome replicationInterferon betaHomo sapiens (human)
innate immune responseInterferon betaHomo sapiens (human)
positive regulation of innate immune responseInterferon betaHomo sapiens (human)
regulation of MHC class I biosynthetic processInterferon betaHomo sapiens (human)
negative regulation of T cell differentiationInterferon betaHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIInterferon betaHomo sapiens (human)
defense response to virusInterferon betaHomo sapiens (human)
type I interferon-mediated signaling pathwayInterferon betaHomo sapiens (human)
neuron cellular homeostasisInterferon betaHomo sapiens (human)
cellular response to exogenous dsRNAInterferon betaHomo sapiens (human)
cellular response to virusInterferon betaHomo sapiens (human)
negative regulation of Lewy body formationInterferon betaHomo sapiens (human)
negative regulation of T-helper 2 cell cytokine productionInterferon betaHomo sapiens (human)
positive regulation of apoptotic signaling pathwayInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell differentiationInterferon betaHomo sapiens (human)
natural killer cell activation involved in immune responseInterferon betaHomo sapiens (human)
adaptive immune responseInterferon betaHomo sapiens (human)
T cell activation involved in immune responseInterferon betaHomo sapiens (human)
humoral immune responseInterferon betaHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIEstrogen receptorHomo sapiens (human)
negative regulation of transcription by RNA polymerase IIEstrogen receptorHomo sapiens (human)
antral ovarian follicle growthEstrogen receptorHomo sapiens (human)
epithelial cell developmentEstrogen receptorHomo sapiens (human)
chromatin remodelingEstrogen receptorHomo sapiens (human)
regulation of DNA-templated transcriptionEstrogen receptorHomo sapiens (human)
signal transductionEstrogen receptorHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayEstrogen receptorHomo sapiens (human)
positive regulation of cytosolic calcium ion concentrationEstrogen receptorHomo sapiens (human)
androgen metabolic processEstrogen receptorHomo sapiens (human)
male gonad developmentEstrogen receptorHomo sapiens (human)
negative regulation of gene expressionEstrogen receptorHomo sapiens (human)
positive regulation of phospholipase C activityEstrogen receptorHomo sapiens (human)
intracellular steroid hormone receptor signaling pathwayEstrogen receptorHomo sapiens (human)
intracellular estrogen receptor signaling pathwayEstrogen receptorHomo sapiens (human)
response to estradiolEstrogen receptorHomo sapiens (human)
regulation of toll-like receptor signaling pathwayEstrogen receptorHomo sapiens (human)
negative regulation of smooth muscle cell apoptotic processEstrogen receptorHomo sapiens (human)
negative regulation of canonical NF-kappaB signal transductionEstrogen receptorHomo sapiens (human)
negative regulation of DNA-binding transcription factor activityEstrogen receptorHomo sapiens (human)
response to estrogenEstrogen receptorHomo sapiens (human)
positive regulation of DNA-templated transcriptionEstrogen receptorHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIEstrogen receptorHomo sapiens (human)
fibroblast proliferationEstrogen receptorHomo sapiens (human)
positive regulation of fibroblast proliferationEstrogen receptorHomo sapiens (human)
stem cell differentiationEstrogen receptorHomo sapiens (human)
regulation of inflammatory responseEstrogen receptorHomo sapiens (human)
positive regulation of DNA-binding transcription factor activityEstrogen receptorHomo sapiens (human)
RNA polymerase II preinitiation complex assemblyEstrogen receptorHomo sapiens (human)
uterus developmentEstrogen receptorHomo sapiens (human)
vagina developmentEstrogen receptorHomo sapiens (human)
prostate epithelial cord elongationEstrogen receptorHomo sapiens (human)
prostate epithelial cord arborization involved in prostate glandular acinus morphogenesisEstrogen receptorHomo sapiens (human)
regulation of branching involved in prostate gland morphogenesisEstrogen receptorHomo sapiens (human)
mammary gland branching involved in pregnancyEstrogen receptorHomo sapiens (human)
mammary gland alveolus developmentEstrogen receptorHomo sapiens (human)
epithelial cell proliferation involved in mammary gland duct elongationEstrogen receptorHomo sapiens (human)
protein localization to chromatinEstrogen receptorHomo sapiens (human)
cellular response to estradiol stimulusEstrogen receptorHomo sapiens (human)
negative regulation of miRNA transcriptionEstrogen receptorHomo sapiens (human)
regulation of epithelial cell apoptotic processEstrogen receptorHomo sapiens (human)
regulation of transcription by RNA polymerase IIEstrogen receptorHomo sapiens (human)
cellular response to estrogen stimulusEstrogen receptorHomo sapiens (human)
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)
ovulation from ovarian follicleProgesterone receptorHomo sapiens (human)
glandular epithelial cell maturationProgesterone receptorHomo sapiens (human)
regulation of DNA-templated transcriptionProgesterone receptorHomo sapiens (human)
signal transductionProgesterone receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayProgesterone receptorHomo sapiens (human)
cell-cell signalingProgesterone receptorHomo sapiens (human)
positive regulation of gene expressionProgesterone receptorHomo sapiens (human)
negative regulation of gene expressionProgesterone receptorHomo sapiens (human)
paracrine signalingProgesterone receptorHomo sapiens (human)
negative regulation of phosphorylationProgesterone receptorHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIProgesterone receptorHomo sapiens (human)
lung alveolus developmentProgesterone receptorHomo sapiens (human)
regulation of epithelial cell proliferationProgesterone receptorHomo sapiens (human)
progesterone receptor signaling pathwayProgesterone receptorHomo sapiens (human)
maintenance of protein location in nucleusProgesterone receptorHomo sapiens (human)
tertiary branching involved in mammary gland duct morphogenesisProgesterone receptorHomo sapiens (human)
regulation of transcription by RNA polymerase IIProgesterone receptorHomo sapiens (human)
intracellular steroid hormone receptor signaling pathwayProgesterone receptorHomo sapiens (human)
glucocorticoid metabolic processCorticosteroid-binding globulinHomo sapiens (human)
negative regulation of endopeptidase activityCorticosteroid-binding globulinHomo sapiens (human)
signal transductionMineralocorticoid receptor Homo sapiens (human)
positive regulation of non-canonical NF-kappaB signal transductionMineralocorticoid receptor Homo sapiens (human)
regulation of transcription by RNA polymerase IIMineralocorticoid receptor Homo sapiens (human)
intracellular steroid hormone receptor signaling pathwayMineralocorticoid receptor Homo sapiens (human)
negative regulation of transcription by RNA polymerase IIAndrogen receptorHomo sapiens (human)
MAPK cascadeAndrogen receptorHomo sapiens (human)
in utero embryonic developmentAndrogen receptorHomo sapiens (human)
regulation of systemic arterial blood pressureAndrogen receptorHomo sapiens (human)
epithelial cell morphogenesisAndrogen receptorHomo sapiens (human)
transcription by RNA polymerase IIAndrogen receptorHomo sapiens (human)
signal transductionAndrogen receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayAndrogen receptorHomo sapiens (human)
cell-cell signalingAndrogen receptorHomo sapiens (human)
spermatogenesisAndrogen receptorHomo sapiens (human)
single fertilizationAndrogen receptorHomo sapiens (human)
positive regulation of cell population proliferationAndrogen receptorHomo sapiens (human)
negative regulation of cell population proliferationAndrogen receptorHomo sapiens (human)
positive regulation of gene expressionAndrogen receptorHomo sapiens (human)
male somatic sex determinationAndrogen receptorHomo sapiens (human)
intracellular estrogen receptor signaling pathwayAndrogen receptorHomo sapiens (human)
androgen receptor signaling pathwayAndrogen receptorHomo sapiens (human)
intracellular receptor signaling pathwayAndrogen receptorHomo sapiens (human)
positive regulation of intracellular estrogen receptor signaling pathwayAndrogen receptorHomo sapiens (human)
Leydig cell differentiationAndrogen receptorHomo sapiens (human)
multicellular organism growthAndrogen receptorHomo sapiens (human)
positive regulation of phosphorylationAndrogen receptorHomo sapiens (human)
positive regulation of MAPK cascadeAndrogen receptorHomo sapiens (human)
positive regulation of insulin-like growth factor receptor signaling pathwayAndrogen receptorHomo sapiens (human)
positive regulation of cell differentiationAndrogen receptorHomo sapiens (human)
negative regulation of integrin biosynthetic processAndrogen receptorHomo sapiens (human)
positive regulation of integrin biosynthetic processAndrogen receptorHomo sapiens (human)
positive regulation of DNA-templated transcriptionAndrogen receptorHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIAndrogen receptorHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIIAndrogen receptorHomo sapiens (human)
insulin-like growth factor receptor signaling pathwayAndrogen receptorHomo sapiens (human)
regulation of developmental growthAndrogen receptorHomo sapiens (human)
animal organ formationAndrogen receptorHomo sapiens (human)
male genitalia morphogenesisAndrogen receptorHomo sapiens (human)
epithelial cell proliferationAndrogen receptorHomo sapiens (human)
negative regulation of epithelial cell proliferationAndrogen receptorHomo sapiens (human)
positive regulation of NF-kappaB transcription factor activityAndrogen receptorHomo sapiens (human)
activation of prostate induction by androgen receptor signaling pathwayAndrogen receptorHomo sapiens (human)
morphogenesis of an epithelial foldAndrogen receptorHomo sapiens (human)
lateral sprouting involved in mammary gland duct morphogenesisAndrogen receptorHomo sapiens (human)
prostate gland growthAndrogen receptorHomo sapiens (human)
prostate gland epithelium morphogenesisAndrogen receptorHomo sapiens (human)
epithelial cell differentiation involved in prostate gland developmentAndrogen receptorHomo sapiens (human)
tertiary branching involved in mammary gland duct morphogenesisAndrogen receptorHomo sapiens (human)
mammary gland alveolus developmentAndrogen receptorHomo sapiens (human)
positive regulation of epithelial cell proliferation involved in prostate gland developmentAndrogen receptorHomo sapiens (human)
cellular response to steroid hormone stimulusAndrogen receptorHomo sapiens (human)
cellular response to estrogen stimulusAndrogen receptorHomo sapiens (human)
cellular response to testosterone stimulusAndrogen receptorHomo sapiens (human)
seminiferous tubule developmentAndrogen receptorHomo sapiens (human)
non-membrane-bounded organelle assemblyAndrogen receptorHomo sapiens (human)
positive regulation of miRNA transcriptionAndrogen receptorHomo sapiens (human)
regulation of protein localization to plasma membraneAndrogen receptorHomo sapiens (human)
negative regulation of extrinsic apoptotic signaling pathwayAndrogen receptorHomo sapiens (human)
male gonad developmentAndrogen receptorHomo sapiens (human)
intracellular steroid hormone receptor signaling pathwayAndrogen receptorHomo sapiens (human)
xenobiotic metabolic processCytochrome P450 2C9 Homo sapiens (human)
steroid metabolic processCytochrome P450 2C9 Homo sapiens (human)
cholesterol metabolic processCytochrome P450 2C9 Homo sapiens (human)
estrogen metabolic processCytochrome P450 2C9 Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 2C9 Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 2C9 Homo sapiens (human)
urea metabolic processCytochrome P450 2C9 Homo sapiens (human)
monocarboxylic acid metabolic processCytochrome P450 2C9 Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 2C9 Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 2C9 Homo sapiens (human)
amide metabolic processCytochrome P450 2C9 Homo sapiens (human)
icosanoid biosynthetic processCytochrome P450 2C9 Homo sapiens (human)
oxidative demethylationCytochrome P450 2C9 Homo sapiens (human)
omega-hydroxylase P450 pathwayCytochrome P450 2C9 Homo sapiens (human)
angiogenesisGlutamine synthetaseHomo sapiens (human)
glutamate catabolic processGlutamine synthetaseHomo sapiens (human)
glutamine biosynthetic processGlutamine synthetaseHomo sapiens (human)
cell population proliferationGlutamine synthetaseHomo sapiens (human)
cellular response to starvationGlutamine synthetaseHomo sapiens (human)
response to glucoseGlutamine synthetaseHomo sapiens (human)
regulation of endothelial cell migrationGlutamine synthetaseHomo sapiens (human)
protein palmitoylationGlutamine synthetaseHomo sapiens (human)
ribosome biogenesisGlutamine synthetaseHomo sapiens (human)
regulation of sprouting angiogenesisGlutamine synthetaseHomo sapiens (human)
regulation of protein localization to nucleolusGlutamine synthetaseHomo sapiens (human)
prostaglandin biosynthetic processProstaglandin G/H synthase 2Homo sapiens (human)
angiogenesisProstaglandin G/H synthase 2Homo sapiens (human)
response to oxidative stressProstaglandin G/H synthase 2Homo sapiens (human)
embryo implantationProstaglandin G/H synthase 2Homo sapiens (human)
learningProstaglandin G/H synthase 2Homo sapiens (human)
memoryProstaglandin G/H synthase 2Homo sapiens (human)
regulation of blood pressureProstaglandin G/H synthase 2Homo sapiens (human)
negative regulation of cell population proliferationProstaglandin G/H synthase 2Homo sapiens (human)
response to xenobiotic stimulusProstaglandin G/H synthase 2Homo sapiens (human)
response to nematodeProstaglandin G/H synthase 2Homo sapiens (human)
response to fructoseProstaglandin G/H synthase 2Homo sapiens (human)
response to manganese ionProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of vascular endothelial growth factor productionProstaglandin G/H synthase 2Homo sapiens (human)
cyclooxygenase pathwayProstaglandin G/H synthase 2Homo sapiens (human)
bone mineralizationProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of prostaglandin biosynthetic processProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of fever generationProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of synaptic plasticityProstaglandin G/H synthase 2Homo sapiens (human)
negative regulation of synaptic transmission, dopaminergicProstaglandin G/H synthase 2Homo sapiens (human)
prostaglandin secretionProstaglandin G/H synthase 2Homo sapiens (human)
response to estradiolProstaglandin G/H synthase 2Homo sapiens (human)
response to lipopolysaccharideProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of peptidyl-serine phosphorylationProstaglandin G/H synthase 2Homo sapiens (human)
response to vitamin DProstaglandin G/H synthase 2Homo sapiens (human)
cellular response to heatProstaglandin G/H synthase 2Homo sapiens (human)
response to tumor necrosis factorProstaglandin G/H synthase 2Homo sapiens (human)
maintenance of blood-brain barrierProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of protein import into nucleusProstaglandin G/H synthase 2Homo sapiens (human)
hair cycleProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of apoptotic processProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of nitric oxide biosynthetic processProstaglandin G/H synthase 2Homo sapiens (human)
negative regulation of cell cycleProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of vasoconstrictionProstaglandin G/H synthase 2Homo sapiens (human)
negative regulation of smooth muscle contractionProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of smooth muscle contractionProstaglandin G/H synthase 2Homo sapiens (human)
decidualizationProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of smooth muscle cell proliferationProstaglandin G/H synthase 2Homo sapiens (human)
regulation of inflammatory responseProstaglandin G/H synthase 2Homo sapiens (human)
brown fat cell differentiationProstaglandin G/H synthase 2Homo sapiens (human)
response to glucocorticoidProstaglandin G/H synthase 2Homo sapiens (human)
negative regulation of calcium ion transportProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of synaptic transmission, glutamatergicProstaglandin G/H synthase 2Homo sapiens (human)
response to fatty acidProstaglandin G/H synthase 2Homo sapiens (human)
cellular response to mechanical stimulusProstaglandin G/H synthase 2Homo sapiens (human)
cellular response to lead ionProstaglandin G/H synthase 2Homo sapiens (human)
cellular response to ATPProstaglandin G/H synthase 2Homo sapiens (human)
cellular response to hypoxiaProstaglandin G/H synthase 2Homo sapiens (human)
cellular response to non-ionic osmotic stressProstaglandin G/H synthase 2Homo sapiens (human)
cellular response to fluid shear stressProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of transforming growth factor beta productionProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of cell migration involved in sprouting angiogenesisProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of fibroblast growth factor productionProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of brown fat cell differentiationProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of platelet-derived growth factor productionProstaglandin G/H synthase 2Homo sapiens (human)
cellular oxidant detoxificationProstaglandin G/H synthase 2Homo sapiens (human)
regulation of neuroinflammatory responseProstaglandin G/H synthase 2Homo sapiens (human)
negative regulation of intrinsic apoptotic signaling pathway in response to osmotic stressProstaglandin G/H synthase 2Homo sapiens (human)
cellular response to homocysteineProstaglandin G/H synthase 2Homo sapiens (human)
response to angiotensinProstaglandin G/H synthase 2Homo sapiens (human)
fatty acid metabolic processCytochrome P450 2J2Homo sapiens (human)
icosanoid metabolic processCytochrome P450 2J2Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 2J2Homo sapiens (human)
regulation of heart contractionCytochrome P450 2J2Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 2J2Homo sapiens (human)
linoleic acid metabolic processCytochrome P450 2J2Homo sapiens (human)
organic acid metabolic processCytochrome P450 2J2Homo sapiens (human)
negative regulation of transcription by RNA polymerase IIEstrogen receptor betaHomo sapiens (human)
regulation of DNA-templated transcriptionEstrogen receptor betaHomo sapiens (human)
signal transductionEstrogen receptor betaHomo sapiens (human)
cell-cell signalingEstrogen receptor betaHomo sapiens (human)
negative regulation of cell growthEstrogen receptor betaHomo sapiens (human)
intracellular estrogen receptor signaling pathwayEstrogen receptor betaHomo sapiens (human)
positive regulation of DNA-templated transcriptionEstrogen receptor betaHomo sapiens (human)
positive regulation of DNA-binding transcription factor activityEstrogen receptor betaHomo sapiens (human)
cellular response to estradiol stimulusEstrogen receptor betaHomo sapiens (human)
regulation of transcription by RNA polymerase IIEstrogen receptor betaHomo sapiens (human)
cellular response to estrogen stimulusEstrogen receptor betaHomo sapiens (human)
xenobiotic metabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
negative regulation of gene expressionCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bile acid and bile salt transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
heme catabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic export from cellCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transepithelial transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
leukotriene transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
monoatomic anion transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell population proliferationATPase family AAA domain-containing protein 5Homo sapiens (human)
positive regulation of B cell proliferationATPase family AAA domain-containing protein 5Homo sapiens (human)
nuclear DNA replicationATPase family AAA domain-containing protein 5Homo sapiens (human)
signal transduction in response to DNA damageATPase family AAA domain-containing protein 5Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorATPase family AAA domain-containing protein 5Homo sapiens (human)
isotype switchingATPase family AAA domain-containing protein 5Homo sapiens (human)
positive regulation of DNA replicationATPase family AAA domain-containing protein 5Homo sapiens (human)
positive regulation of isotype switching to IgG isotypesATPase family AAA domain-containing protein 5Homo sapiens (human)
DNA clamp unloadingATPase family AAA domain-containing protein 5Homo sapiens (human)
regulation of mitotic cell cycle phase transitionATPase family AAA domain-containing protein 5Homo sapiens (human)
negative regulation of intrinsic apoptotic signaling pathway in response to DNA damage by p53 class mediatorATPase family AAA domain-containing protein 5Homo sapiens (human)
positive regulation of cell cycle G2/M phase transitionATPase family AAA domain-containing protein 5Homo sapiens (human)
negative regulation of receptor internalizationAtaxin-2Homo sapiens (human)
regulation of translationAtaxin-2Homo sapiens (human)
RNA metabolic processAtaxin-2Homo sapiens (human)
P-body assemblyAtaxin-2Homo sapiens (human)
stress granule assemblyAtaxin-2Homo sapiens (human)
RNA transportAtaxin-2Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (120)

Processvia Protein(s)Taxonomy
ATP bindingATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type bile acid transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATP hydrolysis activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
icosanoid transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
guanine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ATP bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type xenobiotic transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
urate transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
purine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type bile acid transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
efflux transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
15-hydroxyprostaglandin dehydrogenase (NAD+) activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATP hydrolysis activityMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
cytokine activityInterferon betaHomo sapiens (human)
cytokine receptor bindingInterferon betaHomo sapiens (human)
type I interferon receptor bindingInterferon betaHomo sapiens (human)
protein bindingInterferon betaHomo sapiens (human)
chloramphenicol O-acetyltransferase activityInterferon betaHomo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingEstrogen receptorHomo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificEstrogen receptorHomo sapiens (human)
TFIIB-class transcription factor bindingEstrogen receptorHomo sapiens (human)
transcription coregulator bindingEstrogen receptorHomo sapiens (human)
transcription corepressor bindingEstrogen receptorHomo sapiens (human)
transcription coactivator bindingEstrogen receptorHomo sapiens (human)
DNA-binding transcription activator activity, RNA polymerase II-specificEstrogen receptorHomo sapiens (human)
chromatin bindingEstrogen receptorHomo sapiens (human)
DNA-binding transcription factor activityEstrogen receptorHomo sapiens (human)
nuclear receptor activityEstrogen receptorHomo sapiens (human)
steroid bindingEstrogen receptorHomo sapiens (human)
protein bindingEstrogen receptorHomo sapiens (human)
calmodulin bindingEstrogen receptorHomo sapiens (human)
beta-catenin bindingEstrogen receptorHomo sapiens (human)
zinc ion bindingEstrogen receptorHomo sapiens (human)
TBP-class protein bindingEstrogen receptorHomo sapiens (human)
enzyme bindingEstrogen receptorHomo sapiens (human)
protein kinase bindingEstrogen receptorHomo sapiens (human)
nitric-oxide synthase regulator activityEstrogen receptorHomo sapiens (human)
nuclear estrogen receptor activityEstrogen receptorHomo sapiens (human)
nuclear estrogen receptor bindingEstrogen receptorHomo sapiens (human)
estrogen response element bindingEstrogen receptorHomo sapiens (human)
identical protein bindingEstrogen receptorHomo sapiens (human)
ATPase bindingEstrogen receptorHomo sapiens (human)
14-3-3 protein bindingEstrogen receptorHomo sapiens (human)
sequence-specific double-stranded DNA bindingEstrogen receptorHomo sapiens (human)
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 bindingProgesterone receptorHomo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificProgesterone receptorHomo sapiens (human)
transcription coactivator bindingProgesterone receptorHomo sapiens (human)
DNA-binding transcription activator activity, RNA polymerase II-specificProgesterone receptorHomo sapiens (human)
DNA bindingProgesterone receptorHomo sapiens (human)
nuclear steroid receptor activityProgesterone receptorHomo sapiens (human)
G protein-coupled receptor activityProgesterone receptorHomo sapiens (human)
steroid bindingProgesterone receptorHomo sapiens (human)
protein bindingProgesterone receptorHomo sapiens (human)
zinc ion bindingProgesterone receptorHomo sapiens (human)
enzyme bindingProgesterone receptorHomo sapiens (human)
identical protein bindingProgesterone receptorHomo sapiens (human)
ATPase bindingProgesterone receptorHomo sapiens (human)
estrogen response element bindingProgesterone receptorHomo sapiens (human)
nuclear receptor activityProgesterone receptorHomo sapiens (human)
steroid bindingCorticosteroid-binding globulinHomo sapiens (human)
serine-type endopeptidase inhibitor activityCorticosteroid-binding globulinHomo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificMineralocorticoid receptor Homo sapiens (human)
DNA-binding transcription factor activityMineralocorticoid receptor Homo sapiens (human)
nuclear steroid receptor activityMineralocorticoid receptor Homo sapiens (human)
steroid bindingMineralocorticoid receptor Homo sapiens (human)
protein bindingMineralocorticoid receptor Homo sapiens (human)
zinc ion bindingMineralocorticoid receptor Homo sapiens (human)
TBP-class protein bindingMineralocorticoid receptor Homo sapiens (human)
sequence-specific double-stranded DNA bindingMineralocorticoid receptor Homo sapiens (human)
nuclear receptor activityMineralocorticoid receptor Homo sapiens (human)
estrogen response element bindingMineralocorticoid receptor Homo sapiens (human)
transcription cis-regulatory region bindingAndrogen receptorHomo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingAndrogen receptorHomo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificAndrogen receptorHomo sapiens (human)
RNA polymerase II general transcription initiation factor bindingAndrogen receptorHomo sapiens (human)
transcription coactivator bindingAndrogen receptorHomo sapiens (human)
DNA-binding transcription activator activity, RNA polymerase II-specificAndrogen receptorHomo sapiens (human)
chromatin bindingAndrogen receptorHomo sapiens (human)
DNA-binding transcription factor activityAndrogen receptorHomo sapiens (human)
nuclear receptor activityAndrogen receptorHomo sapiens (human)
G protein-coupled receptor activityAndrogen receptorHomo sapiens (human)
signaling receptor bindingAndrogen receptorHomo sapiens (human)
steroid bindingAndrogen receptorHomo sapiens (human)
androgen bindingAndrogen receptorHomo sapiens (human)
protein bindingAndrogen receptorHomo sapiens (human)
beta-catenin bindingAndrogen receptorHomo sapiens (human)
zinc ion bindingAndrogen receptorHomo sapiens (human)
enzyme bindingAndrogen receptorHomo sapiens (human)
ATPase bindingAndrogen receptorHomo sapiens (human)
molecular adaptor activityAndrogen receptorHomo sapiens (human)
RNA polymerase II-specific DNA-binding transcription factor bindingAndrogen receptorHomo sapiens (human)
POU domain bindingAndrogen receptorHomo sapiens (human)
molecular condensate scaffold activityAndrogen receptorHomo sapiens (human)
estrogen response element bindingAndrogen receptorHomo sapiens (human)
monooxygenase activityCytochrome P450 2C9 Homo sapiens (human)
iron ion bindingCytochrome P450 2C9 Homo sapiens (human)
arachidonic acid epoxygenase activityCytochrome P450 2C9 Homo sapiens (human)
steroid hydroxylase activityCytochrome P450 2C9 Homo sapiens (human)
arachidonic acid 14,15-epoxygenase activityCytochrome P450 2C9 Homo sapiens (human)
arachidonic acid 11,12-epoxygenase activityCytochrome P450 2C9 Homo sapiens (human)
oxidoreductase activityCytochrome P450 2C9 Homo sapiens (human)
(S)-limonene 6-monooxygenase activityCytochrome P450 2C9 Homo sapiens (human)
(S)-limonene 7-monooxygenase activityCytochrome P450 2C9 Homo sapiens (human)
caffeine oxidase activityCytochrome P450 2C9 Homo sapiens (human)
(R)-limonene 6-monooxygenase activityCytochrome P450 2C9 Homo sapiens (human)
aromatase activityCytochrome P450 2C9 Homo sapiens (human)
heme bindingCytochrome P450 2C9 Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2C9 Homo sapiens (human)
glutamine synthetase activityGlutamine synthetaseHomo sapiens (human)
protein bindingGlutamine synthetaseHomo sapiens (human)
ATP bindingGlutamine synthetaseHomo sapiens (human)
protein-cysteine S-palmitoyltransferase activityGlutamine synthetaseHomo sapiens (human)
identical protein bindingGlutamine synthetaseHomo sapiens (human)
metal ion bindingGlutamine synthetaseHomo sapiens (human)
peroxidase activityProstaglandin G/H synthase 2Homo sapiens (human)
prostaglandin-endoperoxide synthase activityProstaglandin G/H synthase 2Homo sapiens (human)
protein bindingProstaglandin G/H synthase 2Homo sapiens (human)
enzyme bindingProstaglandin G/H synthase 2Homo sapiens (human)
heme bindingProstaglandin G/H synthase 2Homo sapiens (human)
protein homodimerization activityProstaglandin G/H synthase 2Homo sapiens (human)
metal ion bindingProstaglandin G/H synthase 2Homo sapiens (human)
oxidoreductase activity, acting on single donors with incorporation of molecular oxygen, incorporation of two atoms of oxygenProstaglandin G/H synthase 2Homo sapiens (human)
monooxygenase activityCytochrome P450 2J2Homo sapiens (human)
iron ion bindingCytochrome P450 2J2Homo sapiens (human)
arachidonic acid epoxygenase activityCytochrome P450 2J2Homo sapiens (human)
arachidonic acid 14,15-epoxygenase activityCytochrome P450 2J2Homo sapiens (human)
arachidonic acid 11,12-epoxygenase activityCytochrome P450 2J2Homo sapiens (human)
isomerase activityCytochrome P450 2J2Homo sapiens (human)
linoleic acid epoxygenase activityCytochrome P450 2J2Homo sapiens (human)
hydroperoxy icosatetraenoate isomerase activityCytochrome P450 2J2Homo sapiens (human)
arachidonic acid 5,6-epoxygenase activityCytochrome P450 2J2Homo sapiens (human)
heme bindingCytochrome P450 2J2Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2J2Homo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingEstrogen receptor betaHomo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificEstrogen receptor betaHomo sapiens (human)
DNA bindingEstrogen receptor betaHomo sapiens (human)
nuclear steroid receptor activityEstrogen receptor betaHomo sapiens (human)
nuclear receptor activityEstrogen receptor betaHomo sapiens (human)
steroid bindingEstrogen receptor betaHomo sapiens (human)
protein bindingEstrogen receptor betaHomo sapiens (human)
zinc ion bindingEstrogen receptor betaHomo sapiens (human)
enzyme bindingEstrogen receptor betaHomo sapiens (human)
nuclear estrogen receptor activityEstrogen receptor betaHomo sapiens (human)
estrogen response element bindingEstrogen receptor betaHomo sapiens (human)
receptor antagonist activityEstrogen receptor betaHomo sapiens (human)
protein bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
organic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type xenobiotic transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP hydrolysis activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
protein bindingATPase family AAA domain-containing protein 5Homo sapiens (human)
ATP bindingATPase family AAA domain-containing protein 5Homo sapiens (human)
ATP hydrolysis activityATPase family AAA domain-containing protein 5Homo sapiens (human)
DNA clamp unloader activityATPase family AAA domain-containing protein 5Homo sapiens (human)
DNA bindingATPase family AAA domain-containing protein 5Homo sapiens (human)
RNA bindingAtaxin-2Homo sapiens (human)
epidermal growth factor receptor bindingAtaxin-2Homo sapiens (human)
protein bindingAtaxin-2Homo sapiens (human)
mRNA bindingAtaxin-2Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (57)

Processvia Protein(s)Taxonomy
plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basal plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basolateral plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
nucleolusMultidrug resistance-associated protein 4Homo sapiens (human)
Golgi apparatusMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
platelet dense granule membraneMultidrug resistance-associated protein 4Homo sapiens (human)
external side of apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
extracellular spaceInterferon betaHomo sapiens (human)
extracellular regionInterferon betaHomo sapiens (human)
nucleusEstrogen receptorHomo sapiens (human)
nucleoplasmEstrogen receptorHomo sapiens (human)
transcription regulator complexEstrogen receptorHomo sapiens (human)
cytoplasmEstrogen receptorHomo sapiens (human)
Golgi apparatusEstrogen receptorHomo sapiens (human)
cytosolEstrogen receptorHomo sapiens (human)
plasma membraneEstrogen receptorHomo sapiens (human)
membraneEstrogen receptorHomo sapiens (human)
chromatinEstrogen receptorHomo sapiens (human)
euchromatinEstrogen receptorHomo sapiens (human)
protein-containing complexEstrogen receptorHomo sapiens (human)
nucleusEstrogen receptorHomo sapiens (human)
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 membraneProgesterone receptorHomo sapiens (human)
nucleoplasmProgesterone receptorHomo sapiens (human)
mitochondrial outer membraneProgesterone receptorHomo sapiens (human)
cytosolProgesterone receptorHomo sapiens (human)
chromatinProgesterone receptorHomo sapiens (human)
nucleusProgesterone receptorHomo sapiens (human)
nucleoplasmGlucocorticoid receptorMus musculus (house mouse)
extracellular regionCorticosteroid-binding globulinHomo sapiens (human)
extracellular spaceCorticosteroid-binding globulinHomo sapiens (human)
extracellular exosomeCorticosteroid-binding globulinHomo sapiens (human)
extracellular spaceCorticosteroid-binding globulinHomo sapiens (human)
nucleoplasmMineralocorticoid receptor Homo sapiens (human)
endoplasmic reticulum membraneMineralocorticoid receptor Homo sapiens (human)
cytosolMineralocorticoid receptor Homo sapiens (human)
chromatinMineralocorticoid receptor Homo sapiens (human)
receptor complexMineralocorticoid receptor Homo sapiens (human)
nucleusMineralocorticoid receptor Homo sapiens (human)
plasma membraneAndrogen receptorHomo sapiens (human)
nucleusAndrogen receptorHomo sapiens (human)
nucleoplasmAndrogen receptorHomo sapiens (human)
cytoplasmAndrogen receptorHomo sapiens (human)
cytosolAndrogen receptorHomo sapiens (human)
nuclear speckAndrogen receptorHomo sapiens (human)
chromatinAndrogen receptorHomo sapiens (human)
protein-containing complexAndrogen receptorHomo sapiens (human)
nucleusAndrogen receptorHomo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 2C9 Homo sapiens (human)
plasma membraneCytochrome P450 2C9 Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2C9 Homo sapiens (human)
cytoplasmCytochrome P450 2C9 Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2C9 Homo sapiens (human)
nucleusGlutamine synthetaseHomo sapiens (human)
mitochondrionGlutamine synthetaseHomo sapiens (human)
endoplasmic reticulumGlutamine synthetaseHomo sapiens (human)
cytosolGlutamine synthetaseHomo sapiens (human)
plasma membraneGlutamine synthetaseHomo sapiens (human)
cell bodyGlutamine synthetaseHomo sapiens (human)
extracellular exosomeGlutamine synthetaseHomo sapiens (human)
glial cell projectionGlutamine synthetaseHomo sapiens (human)
cytoplasmGlutamine synthetaseHomo sapiens (human)
plasma membraneGlutamate receptor 2Rattus norvegicus (Norway rat)
plasma membraneGlycine receptor subunit betaRattus norvegicus (Norway rat)
nuclear inner membraneProstaglandin G/H synthase 2Homo sapiens (human)
nuclear outer membraneProstaglandin G/H synthase 2Homo sapiens (human)
cytoplasmProstaglandin G/H synthase 2Homo sapiens (human)
endoplasmic reticulumProstaglandin G/H synthase 2Homo sapiens (human)
endoplasmic reticulum lumenProstaglandin G/H synthase 2Homo sapiens (human)
endoplasmic reticulum membraneProstaglandin G/H synthase 2Homo sapiens (human)
caveolaProstaglandin G/H synthase 2Homo sapiens (human)
neuron projectionProstaglandin G/H synthase 2Homo sapiens (human)
protein-containing complexProstaglandin G/H synthase 2Homo sapiens (human)
neuron projectionProstaglandin G/H synthase 2Homo sapiens (human)
cytoplasmProstaglandin G/H synthase 2Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 2J2Homo sapiens (human)
extracellular exosomeCytochrome P450 2J2Homo sapiens (human)
cytoplasmCytochrome P450 2J2Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2J2Homo sapiens (human)
nucleusEstrogen receptor betaHomo sapiens (human)
nucleoplasmEstrogen receptor betaHomo sapiens (human)
mitochondrionEstrogen receptor betaHomo sapiens (human)
intracellular membrane-bounded organelleEstrogen receptor betaHomo sapiens (human)
chromatinEstrogen receptor betaHomo sapiens (human)
nucleusEstrogen receptor betaHomo sapiens (human)
plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell surfaceCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
intercellular canaliculusCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
Elg1 RFC-like complexATPase family AAA domain-containing protein 5Homo sapiens (human)
nucleusATPase family AAA domain-containing protein 5Homo sapiens (human)
cytoplasmAtaxin-2Homo sapiens (human)
Golgi apparatusAtaxin-2Homo sapiens (human)
trans-Golgi networkAtaxin-2Homo sapiens (human)
cytosolAtaxin-2Homo sapiens (human)
cytoplasmic stress granuleAtaxin-2Homo sapiens (human)
membraneAtaxin-2Homo sapiens (human)
perinuclear region of cytoplasmAtaxin-2Homo sapiens (human)
ribonucleoprotein complexAtaxin-2Homo sapiens (human)
cytoplasmic stress granuleAtaxin-2Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (794)

Assay IDTitleYearJournalArticle
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.
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.
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.
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.
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.
AID171191The body weight change of rats after administration of the compound1995Journal of medicinal chemistry, Mar-17, Volume: 38, Issue:6
New steroidal antiinflammatory antedrugs: steroidal [16 alpha,17 alpha-d]-3'-carbethoxyisoxazolines.
AID1880335Anti-inflammatory activity against MRL/Ipr Systemic lupus erythematosus mouse model assessed as inhibition of urinary NGAL at 10 mg/kg, po administered for 8 weeks and measured 24 hrs post final dose relative to control2022ACS medicinal chemistry letters, May-12, Volume: 13, Issue:5
Identification of 2-Pyridinylindole-Based Dual Antagonists of Toll-like Receptors 7 and 8 (TLR7/8).
AID162463In vitro binding affinity against progesterone receptor2004Bioorganic & medicinal chemistry letters, Apr-05, Volume: 14, Issue:7
Differentiation of in vitro transcriptional repression and activation profiles of selective glucocorticoid modulators.
AID425652Total body clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID515514Binding affinity to glucocorticoid receptor expressed in baculovirus-infected insect cells using tetramethylrhodamine labeled Dexamethasone by fluorescence polarization microplate assay2010Journal of medicinal chemistry, Sep-23, Volume: 53, Issue:18
Nonsteroidal dissociated glucocorticoid agonists containing azaindoles as steroid A-ring mimetics.
AID1328555AUC (0 to infinity) in Wistar rat at 10 umol/kg administered through oral gavage by LC/MS/MS analysis2016Bioorganic & medicinal chemistry letters, 12-01, Volume: 26, Issue:23
Discovery of indazole ethers as novel, potent, non-steroidal glucocorticoid receptor modulators.
AID626802Displacement of fluorescently labeled ligand from ERalpha receptor by fluorescence polarization assay2011Journal of medicinal chemistry, Oct-27, Volume: 54, Issue:20
Azaxanthene based selective glucocorticoid receptor modulators: design, synthesis, and pharmacological evaluation of (S)-4-(5-(1-((1,3,4-thiadiazol-2-yl)amino)-2-methyl-1-oxopropan-2-yl)-5H-chromeno[2,3-b]pyridin-2-yl)-2-fluoro-N,N-dimethylbenzamide (BMS-
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]
AID604945Agonist activity at mineralocorticoid receptor in human A549 cells relative to control2010Journal of medicinal chemistry, Dec-09, Volume: 53, Issue:23
Dimethyl-diphenyl-propanamide derivatives as nonsteroidal dissociated glucocorticoid receptor agonists.
AID1075799Toxicity in collagen-induced B10.RIII mouse arthritis model assessed as change in femur cortical thickness at 3 mg/kg, po qd for 35 days relative to 30% cremophor-treated control2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Identification of highly efficacious glucocorticoid receptor agonists with a potential for reduced clinical bone side effects.
AID362611Effect on thymus weight in Lewis rat with implanted cotton pellets at 1.0 mg/kg, po bid2008Bioorganic & medicinal chemistry, Aug-15, Volume: 16, Issue:16
Discovery of betamethasone 17alpha-carbamates as dissociated glucocorticoid receptor modulators in the rat.
AID362618Effect on adrenal weight in Lewis rat with implanted cotton pellets at 2.5 mg/kg, po bid2008Bioorganic & medicinal chemistry, Aug-15, Volume: 16, Issue:16
Discovery of betamethasone 17alpha-carbamates as dissociated glucocorticoid receptor modulators in the rat.
AID274993Inhibition of IL1-stimulated IL6 production in HFF cells2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Quinol-4-ones as steroid A-ring mimetics in nonsteroidal dissociated glucocorticoid agonists.
AID187530The plasma corticosterone (ng/ml) concentration was measured in rats after compound administration1995Journal of medicinal chemistry, Mar-17, Volume: 38, Issue:6
New steroidal antiinflammatory antedrugs: steroidal [16 alpha,17 alpha-d]-3'-carbethoxyisoxazolines.
AID578482Transrepression activity at GR expressed in NHDF cells assessed as IL-1beta-mediated IL-6 transcription by ELISA relative to Dexamethasone2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Tetrahydroquinolin-3-yl carbamate glucocorticoid receptor agonists with reduced PEPCK activation.
AID187586Recovery of steroid from cecum at 4 hr after administration of 7.5 mg of the compound1984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
A colon-specific drug-delivery system based on drug glycosides and the glycosidases of colonic bacteria.
AID1125608Displacement of TAMRA-labeled mifepristone from progesterone receptor (unknown origin) by fluorescence polarization assay2014Bioorganic & medicinal chemistry letters, Apr-15, Volume: 24, Issue:8
Discovery of a potent and dissociated non-steroidal glucocorticoid receptor agonist containing an alkyl carbinol pharmacophore.
AID1328556Oral bioavailability in Wistar rat at 10 umol/kg administered through gavage by LC/MS/MS analysis2016Bioorganic & medicinal chemistry letters, 12-01, Volume: 26, Issue:23
Discovery of indazole ethers as novel, potent, non-steroidal glucocorticoid receptor modulators.
AID1880330Anti-inflammatory activity against MRL/Ipr Systemic lupus erythematosus mouse model assessed as inhibition of proteinuria at 10 mg/kg, po administered for 8 weeks and measured 24 hrs post final dose relative to control2022ACS medicinal chemistry letters, May-12, Volume: 13, Issue:5
Identification of 2-Pyridinylindole-Based Dual Antagonists of Toll-like Receptors 7 and 8 (TLR7/8).
AID274994Inhibition of IL1-stimulated IL6 production in HFF cells relative to Dexamethasone2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Quinol-4-ones as steroid A-ring mimetics in nonsteroidal dissociated glucocorticoid agonists.
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.
AID376395Immunosuppressive activity against human PBMC assessed as inhibition of LPS-induced IFN-gamma production at 0.3 ug/ml after 24 hrs by ELISA1999Journal of natural products, Nov, Volume: 62, Issue:11
Immunosuppressive diterpenoids from Tripterygium wilfordii.
AID626272Toxicity in B10.R3 mouse collagen-induced arthritis model assessed as change in body fat level at 3 mg/kg, po qd for 5 weeks relative to control2011Bioorganic & medicinal chemistry letters, Nov-15, Volume: 21, Issue:22
Non-steroidal dissociated glucocorticoid agonists: indoles as A-ring mimetics and function-regulating pharmacophores.
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.
AID626277Toxicity in B10.R3 mouse collagen-induced arthritis model assessed as change in serum free fatty acids level at 30 mg/kg, po qd for 5 weeks relative to control2011Bioorganic & medicinal chemistry letters, Nov-15, Volume: 21, Issue:22
Non-steroidal dissociated glucocorticoid agonists: indoles as A-ring mimetics and function-regulating pharmacophores.
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID51062In silico steroid binding affinity to transport protein corticosteroid binding globulin1994Journal of medicinal chemistry, Jul-22, Volume: 37, Issue:15
Compass: predicting biological activities from molecular surface properties. Performance comparisons on a steroid benchmark.
AID1125634Antiarthritic activity in B10.RIII mouse collagen/complete Freund's adjuvant-induced arthritis model assessed as reduction of disease score at 3 mg/kg, po qd for 5 weeks relative to control2014Bioorganic & medicinal chemistry letters, Apr-15, Volume: 24, Issue:8
Discovery of a potent and dissociated non-steroidal glucocorticoid receptor agonist containing an alkyl carbinol pharmacophore.
AID161463Bronchoalveolar lavages was collected after 48 hr (for eosinophil influx, eos) at 1 mg/kg dose2000Journal of medicinal chemistry, Aug-10, Volume: 43, Issue:16
3,5-Bis(trifluoromethyl)pyrazoles: a novel class of NFAT transcription factor regulator.
AID74232Binding affinity for glucocorticoid receptor2001Journal of medicinal chemistry, Aug-30, Volume: 44, Issue:18
Synthesis and characterization of non-steroidal ligands for the glucocorticoid receptor: selective quinoline derivatives with prednisolone-equivalent functional activity.
AID394967Inhibition of IL4 and LPS-induced IgE production in BALB/c mouse spleen B cell after 6 days by ELISA2009Bioorganic & medicinal chemistry letters, Mar-01, Volume: 19, Issue:5
Pseurotin A and its analogues as inhibitors of immunoglobulin E [correction of immunoglobuline E] production.
AID394971Cytotoxicity against BALB/c mouse B cells assessed as cell viability2009Bioorganic & medicinal chemistry letters, Mar-01, Volume: 19, Issue:5
Pseurotin A and its analogues as inhibitors of immunoglobulin E [correction of immunoglobuline E] production.
AID1380166Dose normalized AUC (0 to infinity) in Han-Wistar rat at 3.5 mg/kg, po2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID186886Tested for topical antiinflammatory activity in the croton oil ear edema assay and was expressed as mean change in ear thickness of rats1987Journal of medicinal chemistry, Dec, Volume: 30, Issue:12
Synthesis of new antiinflammatory steroidal 20-carboxamides: (20R)- and (20S)-21-(N-substituted amino)-11 beta,17,20-trihydroxy-3,21-dioxo-1,4- pregnadiene.
AID90430Efficacy for transcriptional activation of collagenase in Human cell native protein assay expressed as percentage of the maximal response of Dexamethasone2004Bioorganic & medicinal chemistry letters, Apr-05, Volume: 14, Issue:7
Differentiation of in vitro transcriptional repression and activation profiles of selective glucocorticoid modulators.
AID1569535Antiinflammatory activity in crohn's disease patient derived inflamed intestinal mucosa assessed as reduction in IL6 production at 1 uM measured after overnight incubation by immunoassay2019Journal of medicinal chemistry, 07-25, Volume: 62, Issue:14
Discovery of a First-in-Class Receptor Interacting Protein 2 (RIP2) Kinase Specific Clinical Candidate, 2-((4-(Benzo[
AID659509Transactivation activity in Brown Norway rat lung inflammation model assessed as thymolysis measuring decrease in thymus weight at 10 mg/kg, po for 3 days2012Bioorganic & medicinal chemistry letters, May-01, Volume: 22, Issue:9
Steroidal C-21 heteroaryl thioethers. Part 3: pregn-4-eno-[3,2-c]pyrazole fused A ring modified steroids as selective glucocorticoid receptor modulators (dissociated steroids).
AID515544Toxicity in B10.RIII mouse assessed as increase of serum insulin level at 30 mg/kg, po qd for 5 weeks2010Journal of medicinal chemistry, Sep-23, Volume: 53, Issue:18
Nonsteroidal dissociated glucocorticoid agonists containing azaindoles as steroid A-ring mimetics.
AID626821Antiinflammatory activity in human whole blood assessed as inhibition of IL-1beta-induced IL-8 production after overnight incubation by ELISA2011Journal of medicinal chemistry, Oct-27, Volume: 54, Issue:20
Azaxanthene based selective glucocorticoid receptor modulators: design, synthesis, and pharmacological evaluation of (S)-4-(5-(1-((1,3,4-thiadiazol-2-yl)amino)-2-methyl-1-oxopropan-2-yl)-5H-chromeno[2,3-b]pyridin-2-yl)-2-fluoro-N,N-dimethylbenzamide (BMS-
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.
AID223722Activity against arthritis on adjuvant-untreated paw in rats at 5 mg/kg by oral administration1992Journal of medicinal chemistry, Dec-11, Volume: 35, Issue:25
A novel orally active inhibitor of IL-1 generation: synthesis and structure-activity relationships of 3-(4-hydroxy-1-naphthalenyl)-2-propenoic acid derivatives.
AID604792Binding affinity to ERalpha by fluorescence polarization assay2010Journal of medicinal chemistry, Dec-09, Volume: 53, Issue:23
Dimethyl-diphenyl-propanamide derivatives as nonsteroidal dissociated glucocorticoid receptor agonists.
AID780045Toxicity in mouse assessed as change in body weight at 3 mg/kg, po qd after 20 days relative to untreated control2013Bioorganic & medicinal chemistry letters, Nov-01, Volume: 23, Issue:21
Discovery and structure-activity relationships of 6-(benzoylamino)benzoxaboroles as orally active anti-inflammatory agents.
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID224061% inhibition against arthritis on adjuvant-untreated paw in rats at 5 mg/kg by oral administration1992Journal of medicinal chemistry, Dec-11, Volume: 35, Issue:25
A novel orally active inhibitor of IL-1 generation: synthesis and structure-activity relationships of 3-(4-hydroxy-1-naphthalenyl)-2-propenoic acid derivatives.
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.
AID161624Resistance evaluated in an ascaris-induced nonhuman primate model of asthma after 6 hour at 1 mg/kg dose2000Journal of medicinal chemistry, Aug-10, Volume: 43, Issue:16
3,5-Bis(trifluoromethyl)pyrazoles: a novel class of NFAT transcription factor regulator.
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.
AID626276Toxicity in B10.R3 mouse collagen-induced arthritis model assessed as change in serum free fatty acids level at 3 mg/kg, po qd for 5 weeks relative to control2011Bioorganic & medicinal chemistry letters, Nov-15, Volume: 21, Issue:22
Non-steroidal dissociated glucocorticoid agonists: indoles as A-ring mimetics and function-regulating pharmacophores.
AID224210Inhibitory activity against IL-1 on CMC-LPS air-pouch model at 10 mg/kg by oral administration1992Journal of medicinal chemistry, Dec-11, Volume: 35, Issue:25
A novel orally active inhibitor of IL-1 generation: synthesis and structure-activity relationships of 3-(4-hydroxy-1-naphthalenyl)-2-propenoic acid derivatives.
AID47188Transcriptional activation in CV-1 cells expressing human glucocorticoid receptor2003Journal of medicinal chemistry, Mar-13, Volume: 46, Issue:6
Nonsteroidal selective glucocorticoid modulators: the effect of C-10 substitution on receptor selectivity and functional potency of 5-allyl-2,5-dihydro-2,2,4-trimethyl-1H-[1]benzopyrano[3,4-f]quinolines.
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.
AID538370Cytotoxicity against human LNCAP cells at 100 pM to 1 uM2010Journal of medicinal chemistry, Nov-11, Volume: 53, Issue:21
Synthesis and biological analysis of prostate-specific membrane antigen-targeted anticancer prodrugs.
AID189704Evaluated for antiinflammatory activity in granuloma bioassay and expressed as relative adrenal weight1987Journal of medicinal chemistry, Dec, Volume: 30, Issue:12
Synthesis of new antiinflammatory steroidal 20-carboxamides: (20R)- and (20S)-21-(N-substituted amino)-11 beta,17,20-trihydroxy-3,21-dioxo-1,4- pregnadiene.
AID187592Recovery of steroid from small intestine at 6 hr after administration of 7.5 mg of the compound1984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
A colon-specific drug-delivery system based on drug glycosides and the glycosidases of colonic bacteria.
AID299613Agonist activity at GR by GRE activation assay relative to Dexamethasone2007Bioorganic & medicinal chemistry letters, Aug-01, Volume: 17, Issue:15
5(Z)-benzylidene-1,2-dihydro-9-hydroxy-10-methoxy-2,2,4-trimethyl-5H-1-aza-6-oxa-chrysenes as non-steroidal glucocorticoid receptor modulators.
AID330373Activity at human glucocorticoid receptor expressed in CV1 cells assessed as repression of TNF and IL-1-beta-induced E-selectin gene expression by luciferase reporter gene assay relative to control2007Proceedings of the National Academy of Sciences of the United States of America, Dec-04, Volume: 104, Issue:49
Antiinflammatory glucocorticoid receptor ligand with reduced side effects exhibits an altered protein-protein interaction profile.
AID626141Displacement of tetramethylrhodamine-labeled RU-486 from human recombinant progesterone receptor expressed in baculovirus infected insect cells by fluorescence polarization assay2011Bioorganic & medicinal chemistry letters, Nov-15, Volume: 21, Issue:22
Non-steroidal dissociated glucocorticoid agonists: indoles as A-ring mimetics and function-regulating pharmacophores.
AID394975Selectivity for IgE production in BALB/c mouse spleen B cells over IgG2a production in BALB/c mouse spleen B cells2009Bioorganic & medicinal chemistry letters, Mar-01, Volume: 19, Issue:5
Pseurotin A and its analogues as inhibitors of immunoglobulin E [correction of immunoglobuline E] production.
AID90305Effective concentration of compound for transcriptional activation of PGE-2 in Human cell native protein assay2004Bioorganic & medicinal chemistry letters, Apr-05, Volume: 14, Issue:7
Differentiation of in vitro transcriptional repression and activation profiles of selective glucocorticoid modulators.
AID351941Displacement of FITC-dexamethasone from human recombinant glucocorticoid receptor alpha by fluorescence polarization assay2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Discovery of novel dihydro-9,10-ethano-anthracene carboxamides as glucocorticoid receptor modulators.
AID202433Transcriptional repression activity in HEP G2 cells expressing glucocorticoid receptor compared to Dexamethasone2001Journal of medicinal chemistry, Aug-30, Volume: 44, Issue:18
Synthesis and characterization of non-steroidal ligands for the glucocorticoid receptor: selective quinoline derivatives with prednisolone-equivalent functional activity.
AID304384Antagonist activity at glucocorticoid receptor in human A549 cells transfected with MMTV luciferase reporter gene assessed as inhibition of dexamethasone-induced activation2007Journal of medicinal chemistry, Dec-27, Volume: 50, Issue:26
Nonsteroidal glucocorticoid agonists: tetrahydronaphthalenes with alternative steroidal A-ring mimetics possessing dissociated (transrepression/transactivation) efficacy selectivity.
AID410448Inhibition of TNF-induced NFkappaB activation in human A549 cells after 15 hrs relative to Dexamethasone2009Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1
Aryl aminopyrazole benzamides as oral non-steroidal selective glucocorticoid receptor agonists.
AID1091958Hydrophobicity, log P of the compound in octanol-water by shaking-flask method2011Journal of agricultural and food chemistry, Apr-13, Volume: 59, Issue:7
Importance of physicochemical properties for the design of new pesticides.
AID362624Inhibition of granuloma formation in cotton pellet implanted Lewis rat at 2.5 mg/kg, po bid2008Bioorganic & medicinal chemistry, Aug-15, Volume: 16, Issue:16
Discovery of betamethasone 17alpha-carbamates as dissociated glucocorticoid receptor modulators in the rat.
AID1449628Inhibition of human BSEP expressed in baculovirus transfected fall armyworm Sf21 cell membranes vesicles assessed as reduction in ATP-dependent [3H]-taurocholate transport into vesicles incubated for 5 mins by Topcount based rapid filtration method2012Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 40, Issue:12
Mitigating the inhibition of human bile salt export pump by drugs: opportunities provided by physicochemical property modulation, in silico modeling, and structural modification.
AID626813Transactivation activity at GR-alpha in human NP1 Hela cells assessed as inhibition of GAL4-DBD after 20 hrs by luciferase reporter gene assay in presence of 100 nM Dexamethasone2011Journal of medicinal chemistry, Oct-27, Volume: 54, Issue:20
Azaxanthene based selective glucocorticoid receptor modulators: design, synthesis, and pharmacological evaluation of (S)-4-(5-(1-((1,3,4-thiadiazol-2-yl)amino)-2-methyl-1-oxopropan-2-yl)-5H-chromeno[2,3-b]pyridin-2-yl)-2-fluoro-N,N-dimethylbenzamide (BMS-
AID171195Compound was evaluated for antiinflammatory activity in granuloma bioassay and measured as body weight gain1987Journal of medicinal chemistry, Dec, Volume: 30, Issue:12
Synthesis of new antiinflammatory steroidal 20-carboxamides: (20R)- and (20S)-21-(N-substituted amino)-11 beta,17,20-trihydroxy-3,21-dioxo-1,4- pregnadiene.
AID579572Agonist activity at GR expressed in IL-1beta- and TNFalpha-stimulated HepG2 cells assessed as inhibition of NFKB- or AP-1 mediated E-selectin transcription by luciferase reporter gene assay2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Discovery of orally available tetrahydroquinoline-based glucocorticoid receptor agonists.
AID659507Antiinflammatory activity in Brown Norway rat lung inflammation model assessed as total cell inhibition at 10 mg/kg, po for 3 days2012Bioorganic & medicinal chemistry letters, May-01, Volume: 22, Issue:9
Steroidal C-21 heteroaryl thioethers. Part 3: pregn-4-eno-[3,2-c]pyrazole fused A ring modified steroids as selective glucocorticoid receptor modulators (dissociated steroids).
AID190480The thymus weight change of rats after administration of the compound1995Journal of medicinal chemistry, Mar-17, Volume: 38, Issue:6
New steroidal antiinflammatory antedrugs: steroidal [16 alpha,17 alpha-d]-3'-carbethoxyisoxazolines.
AID53796Binding affinity to the corticosteroid-binding globulin (CBG) receptor.2000Journal of medicinal chemistry, Aug-24, Volume: 43, Issue:17
GRid-INdependent descriptors (GRIND): a novel class of alignment-independent three-dimensional molecular descriptors.
AID161621Resistance evaluated in an ascaris-induced nonhuman primate model of asthma after 10 min at 1 mg/kg dose2000Journal of medicinal chemistry, Aug-10, Volume: 43, Issue:16
3,5-Bis(trifluoromethyl)pyrazoles: a novel class of NFAT transcription factor regulator.
AID640609Antiinflammatory activity in ovalbumin-induced allergic Brown Norway rat lung inflammation model assessed as inhibition of forced vital capacity at 30 mg/kg, po qd administered 3 days before ovalbumin-challenge measured 24 hrs of post ovalbumin challenge2012Bioorganic & medicinal chemistry letters, Jan-15, Volume: 22, Issue:2
Steroidal C-21 heteroaryl thioethers (Part 2): discovery of orally bioavailable selective glucocorticoid receptor modulators (dissociated steroids).
AID1880351Toxicity in MRL/Ipr Systemic lupus erythematosus mouse model assessed as change in body weight at 10 mg/kg, po administered for 8 weeks and measured 24 hrs post final dose2022ACS medicinal chemistry letters, May-12, Volume: 13, Issue:5
Identification of 2-Pyridinylindole-Based Dual Antagonists of Toll-like Receptors 7 and 8 (TLR7/8).
AID1880340Anti-inflammatory activity against MRL/Ipr Systemic lupus erythematosus mouse model assessed as inhibition of anti-Sm/RNP Ab titer at 10 mg/kg, po administered for 8 weeks and measured 24 hrs post final dose relative to control2022ACS medicinal chemistry letters, May-12, Volume: 13, Issue:5
Identification of 2-Pyridinylindole-Based Dual Antagonists of Toll-like Receptors 7 and 8 (TLR7/8).
AID1075819Toxicity in collagen-induced B10.RIII mouse arthritis model assessed as change in body fat at 30 mg/kg, po qd for 35 days relative to 30% cremophor-treated control2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Identification of highly efficacious glucocorticoid receptor agonists with a potential for reduced clinical bone side effects.
AID330366Inhibition of collagen-induced arthritis in DBA/1 mouse at less than 3 mg/kg, po after 15 days2007Proceedings of the National Academy of Sciences of the United States of America, Dec-04, Volume: 104, Issue:49
Antiinflammatory glucocorticoid receptor ligand with reduced side effects exhibits an altered protein-protein interaction profile.
AID288185Permeability coefficient through artificial membrane in presence of stirred water layer2007Bioorganic & medicinal chemistry, Jun-01, Volume: 15, Issue:11
QSAR study on permeability of hydrophobic compounds with artificial membranes.
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.
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID267773Agonist activity at GR assessed as NF-kappaB-mediated transrepression of secreted placental alkaline phosphatase gene in human A549 cells relative to Dexamethasone2006Journal of medicinal chemistry, Jul-13, Volume: 49, Issue:14
Dissociated nonsteroidal glucocorticoid receptor modulators; discovery of the agonist trigger in a tetrahydronaphthalene-benzoxazine series.
AID1880349Toxicity in MRL/Ipr Systemic lupus erythematosus mouse model assessed as relative spleen weight at 10 mg/kg, po administered for 8 weeks and measured 24 hrs post final dose relative to control2022ACS medicinal chemistry letters, May-12, Volume: 13, Issue:5
Identification of 2-Pyridinylindole-Based Dual Antagonists of Toll-like Receptors 7 and 8 (TLR7/8).
AID1125643Toxicity in B10.RIII mouse assessed as free fatty acid level in serum at 3 mg/kg, po qd for 5 weeks relative to control2014Bioorganic & medicinal chemistry letters, Apr-15, Volume: 24, Issue:8
Discovery of a potent and dissociated non-steroidal glucocorticoid receptor agonist containing an alkyl carbinol pharmacophore.
AID626200Transactivation activity of glucocorticoid receptor in HFF assessed as induction of aromatase activity by measuring beta-estradiol activity after 18 to 24 hrs by ELISA2011Bioorganic & medicinal chemistry letters, Nov-15, Volume: 21, Issue:22
Non-steroidal dissociated glucocorticoid agonists: indoles as A-ring mimetics and function-regulating pharmacophores.
AID1075804Toxicity in collagen-induced B10.RIII mouse arthritis model assessed as change in insulin level at 30 mg/kg, po qd for 35 days relative to 30% cremophor-treated control2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Identification of highly efficacious glucocorticoid receptor agonists with a potential for reduced clinical bone side effects.
AID1328568Thermodynamic solubility of compound in 0.1 M phosphate buffer at pH 7.42016Bioorganic & medicinal chemistry letters, 12-01, Volume: 26, Issue:23
Discovery of indazole ethers as novel, potent, non-steroidal glucocorticoid receptor modulators.
AID331519Antagonist activity at glucocorticoid receptor assessed as inhibition of dexamethasone-induced glucose response element transcriptional transactivation by luciferase assay2008Bioorganic & medicinal chemistry letters, Jun-15, Volume: 18, Issue:12
Discovery of nonsteroidal glucocorticoid receptor ligands based on 6-indole-1,2,3,4-tetrahydroquinolines.
AID1473738Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID331515Binding affinity at progesterone receptor2008Bioorganic & medicinal chemistry letters, Jun-15, Volume: 18, Issue:12
Discovery of nonsteroidal glucocorticoid receptor ligands based on 6-indole-1,2,3,4-tetrahydroquinolines.
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).
AID1125641Toxicity in B10.RIII mouse assessed as free fatty acid level in serum at 30 mg/kg, po qd for 5 weeks relative to control2014Bioorganic & medicinal chemistry letters, Apr-15, Volume: 24, Issue:8
Discovery of a potent and dissociated non-steroidal glucocorticoid receptor agonist containing an alkyl carbinol pharmacophore.
AID74963Ability to induce human glutamine synthetase in skeletal muscle cells2004Journal of medicinal chemistry, May-06, Volume: 47, Issue:10
Novel N-arylpyrazolo[3,2-c]-based ligands for the glucocorticoid receptor: receptor binding and in vivo activity.
AID1380128Transactivation of GR in cryopreserved human primary hepatocytes assessed as upregulation of TAT mRNA expression level after 18 hrs by RT-qPCR analysis2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID362605Effect on spleen weight in Lewis rat with implanted cotton pellets at 1.0 mg/kg, po bid2008Bioorganic & medicinal chemistry, Aug-15, Volume: 16, Issue:16
Discovery of betamethasone 17alpha-carbamates as dissociated glucocorticoid receptor modulators in the rat.
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).
AID661542Antiinflammatory activity in human RBC assessed as membrane stabilization at 50 ug/mL after 30 mins by UV-Visible spectrophotometry2012Bioorganic & medicinal chemistry letters, Jun-01, Volume: 22, Issue:11
Synthesis, study on anti-arthritic, anti-inflammatory activity and toxicity of some novel bis-oxy cyclophane diamides.
AID27580Partition coefficient (logP)2000Journal of medicinal chemistry, Jul-27, Volume: 43, Issue:15
ElogPoct: a tool for lipophilicity determination in drug discovery.
AID304383Agonist activity at glucocorticoid receptor in human A549 cells at 10 mM by MMTV transactivation assay relative to Dexamethasone2007Journal of medicinal chemistry, Dec-27, Volume: 50, Issue:26
Nonsteroidal glucocorticoid agonists: tetrahydronaphthalenes with alternative steroidal A-ring mimetics possessing dissociated (transrepression/transactivation) efficacy selectivity.
AID552720Agonist activity at glucocorticoid receptor in human HepG2 cells co-transfected with GRE assessed as transactivation activity by luciferase reporter gene assay2011Bioorganic & medicinal chemistry letters, Jan-01, Volume: 21, Issue:1
Tetrahydroquinoline glucocorticoid receptor agonists: discovery of a 3-hydroxyl for improving receptor selectivity.
AID274998Activation of MMTV in HeLa cells measured by luciferase activity relative to Dexamethasone2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Quinol-4-ones as steroid A-ring mimetics in nonsteroidal dissociated glucocorticoid agonists.
AID1328542Antiinflammatory activity in human primary PBMC assessed as inhibition of LPS-induced TNFalpha release preincubated for 45 mins followed by LPS addition after 18 hrs by ELISA relative to dexamethasone2016Bioorganic & medicinal chemistry letters, 12-01, Volume: 26, Issue:23
Discovery of indazole ethers as novel, potent, non-steroidal glucocorticoid receptor modulators.
AID127633Ability to induce mouse macrophage IL-6 assay in peritoneal exudate cells harvested by gavage from C57BI/6 mice.2004Journal of medicinal chemistry, May-06, Volume: 47, Issue:10
Novel N-arylpyrazolo[3,2-c]-based ligands for the glucocorticoid receptor: receptor binding and in vivo activity.
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).
AID1380187Induction of PRGC2 recruitment in N-terminal thrombin cleavable 6-His-tagged glucocorticoid receptor (unknown origin) at 50 uM by SPR method2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID357248Inhibition of lipopolysaccharide IL4 production in human PMNC at 0.3 ug/mL by ELISA2002Journal of natural products, Dec, Volume: 65, Issue:12
Sesquiterpenes from Ferula penninervis.
AID91224Antiinflammatory activity measured by using McKenzie-Stoughton human vasoconstrictor assay1986Journal of medicinal chemistry, Nov, Volume: 29, Issue:11
Computer-aided studies of the structure-activity relationships between the structure of some steroids and their antiinflammatory activity.
AID155103Inhibition of concanavalin A stimulated T-cell proliferation in human PBMCs2003Journal of medicinal chemistry, Mar-13, Volume: 46, Issue:6
Nonsteroidal selective glucocorticoid modulators: the effect of C-10 substitution on receptor selectivity and functional potency of 5-allyl-2,5-dihydro-2,2,4-trimethyl-1H-[1]benzopyrano[3,4-f]quinolines.
AID700171Antiinflammatory activity against DSS-induced colitis BALB/c mouse model assessed as decrease in myeloperoxidative activity at 5 mg/kg, po qd for 7 days measured on day 7 relative to vehicle-treated control2012Journal of medicinal chemistry, Jun-14, Volume: 55, Issue:11
6-(methylamino)hexane-1,2,3,4,5-pentanol 4-(((1S,2S)-1-hydroxy-2,3-dihydro-1H,1'H-[2,2-biinden]-2-yl)methyl)benzoate (PH46A): a novel small molecule with efficacy in murine models of colitis.
AID1071633Antiinflammatory activity in PMA-differentiated human U937 cells assessed as inhibition of LPS-induced TNFalpha production incubated for 60 mins prior to LPS challenge measured after 24 hrs2014Journal of medicinal chemistry, Feb-13, Volume: 57, Issue:3
Glucocorticoid receptor modulators informed by crystallography lead to a new rationale for receptor selectivity, function, and implications for structure-based design.
AID1328554Terminal half life in Wistar rat at 1 umol/kg, iv through bolus administration by LC/MS/MS analysis2016Bioorganic & medicinal chemistry letters, 12-01, Volume: 26, Issue:23
Discovery of indazole ethers as novel, potent, non-steroidal glucocorticoid receptor modulators.
AID362593Effect on body weight change in Lewis rat with implanted cotton pellets at 1.0 mg/kg, po bid for 4 days2008Bioorganic & medicinal chemistry, Aug-15, Volume: 16, Issue:16
Discovery of betamethasone 17alpha-carbamates as dissociated glucocorticoid receptor modulators in the rat.
AID480397Agonist activity at glucocorticoid receptor in human fibroblast assessed as inhibition of IL-1-beta-induced IL6 production treated 1 hr before IL1-beta challenge measured after 24 hrs by transrepression assay relative to Dexamethasone2010Bioorganic & medicinal chemistry letters, May-15, Volume: 20, Issue:10
5-Functionalized indazoles as glucocorticoid receptor agonists.
AID81482Inhibitory concentration against interleukin-1 beta production in HL-60 cells stimulated with lipopolysaccharide (LPS).2001Bioorganic & medicinal chemistry letters, Sep-03, Volume: 11, Issue:17
Synthesis and bioactivities of novel pyridazine derivatives: inhibitors of interleukin-1 beta (IL-1beta) production.
AID1380168Oral bioavailability in Han-Wistar rat at 3.5 mg/kg2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID376391Immunosuppressive activity against human PBMC assessed as inhibition of LPS-induced IL8 production at 0.3 ug/ml after 24 hrs by ELISA1999Journal of natural products, Nov, Volume: 62, Issue:11
Immunosuppressive diterpenoids from Tripterygium wilfordii.
AID1569529Antiinflammatory activity TNBS-induced mouse model of colitis assessed as decrease in colitis score at 1.5 mg/kg, po administered twice daily via gavage pretreated for 2 days followed by TNBS stimulation on day 3 and subsequent compound dosing from day 3 2019Journal of medicinal chemistry, 07-25, Volume: 62, Issue:14
Discovery of a First-in-Class Receptor Interacting Protein 2 (RIP2) Kinase Specific Clinical Candidate, 2-((4-(Benzo[
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).
AID626270Toxicity in B10.R3 mouse collagen-induced arthritis model assessed as change in body weight at 3 mg/kg, po qd for 5 weeks relative to control2011Bioorganic & medicinal chemistry letters, Nov-15, Volume: 21, Issue:22
Non-steroidal dissociated glucocorticoid agonists: indoles as A-ring mimetics and function-regulating pharmacophores.
AID626803Agonist activity at human mineralocorticoid receptor expressed in human A549 cells by fluorescence polarization assay2011Journal of medicinal chemistry, Oct-27, Volume: 54, Issue:20
Azaxanthene based selective glucocorticoid receptor modulators: design, synthesis, and pharmacological evaluation of (S)-4-(5-(1-((1,3,4-thiadiazol-2-yl)amino)-2-methyl-1-oxopropan-2-yl)-5H-chromeno[2,3-b]pyridin-2-yl)-2-fluoro-N,N-dimethylbenzamide (BMS-
AID296311Antiinflammatory activity in mouse assessed as inhibition of LPS-induced TNFalpha at 3 mg/kg relative to prednisolone2007Bioorganic & medicinal chemistry letters, Jun-15, Volume: 17, Issue:12
Novel glucocorticoids containing a 6,5-bicyclic core fused to a pyrazole ring: synthesis, in vitro profile, molecular modeling studies, and in vivo experiments.
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).
AID589745Agonist activity at glucocorticoid receptor in human HepG2 cells co-transfected with PEPCK assessed as GRE activation by luciferase reporter gene assay2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Nonsteroidal 2,3-dihydroquinoline glucocorticoid receptor agonists with reduced PEPCK activation.
AID1328544Antiinflammatory activity in human whole blood assessed as inhibition of LPS-induced THNFalpha release preincubated for 45 mins followed by LPS addition after 18 hrs by ELISA relative to dexamethasone2016Bioorganic & medicinal chemistry letters, 12-01, Volume: 26, Issue:23
Discovery of indazole ethers as novel, potent, non-steroidal glucocorticoid receptor modulators.
AID362613Effect on thymus weight in Lewis rat with implanted cotton pellets at 6.0 mg/kg, po bid2008Bioorganic & medicinal chemistry, Aug-15, Volume: 16, Issue:16
Discovery of betamethasone 17alpha-carbamates as dissociated glucocorticoid receptor modulators in the rat.
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.
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.
AID267775Agonist activity at GR assessed as MMTV-mediated transactivation of renilla luciferase gene in human A549 cells relative to Dexamethasone2006Journal of medicinal chemistry, Jul-13, Volume: 49, Issue:14
Dissociated nonsteroidal glucocorticoid receptor modulators; discovery of the agonist trigger in a tetrahydronaphthalene-benzoxazine series.
AID115547Percent inhibition of proteinuria by compound dose of 10 mg/kg given perorally to murine in chronic graft-versus-host-disease test2002Bioorganic & medicinal chemistry letters, Jan-07, Volume: 12, Issue:1
Synthesis and antinephritic activities of quinoline-3-carboxamides and related compounds.
AID407369Displacement of 1-anilinonaphthalene-8-sulphonic acid from rat recombinant L-FABP low binding affinity site expressed in Escherichia coli BL21 by competitive fluorescence displacement assay2008Journal of medicinal chemistry, Jul-10, Volume: 51, Issue:13
Characterization of the drug binding specificity of rat liver fatty acid binding protein.
AID351946Agonist activity at GR ligand binding domain expressed in human NP1 cells assessed as glucocorticoid response element transactivation by GAL4 luciferase reporter gene assay2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Discovery of novel dihydro-9,10-ethano-anthracene carboxamides as glucocorticoid receptor modulators.
AID133427Acute lethal toxicity (peroral administration), determined by observing the mortality for 7 days after the administration in mouse1992Journal of medicinal chemistry, Jul-24, Volume: 35, Issue:15
New antiinflammatory agents. 2. 5-Phenyl-3H-imidazo[4,5-c][1,8]naphthyridin-4(5H)-ones: a new class of nonsteroidal antiinflammatory agents with potent activity like glucocorticoids.
AID362606Effect on spleen weight in Lewis rat with implanted cotton pellets at 2.5 mg/kg, po bid2008Bioorganic & medicinal chemistry, Aug-15, Volume: 16, Issue:16
Discovery of betamethasone 17alpha-carbamates as dissociated glucocorticoid receptor modulators in the rat.
AID224992Dose of the compound (oral administration) showing antiinflammatory effect on rat paw edema model (reversed passive Arthus reaction-induced paw edema, RPAR)1992Journal of medicinal chemistry, Jul-24, Volume: 35, Issue:15
New antiinflammatory agents. 2. 5-Phenyl-3H-imidazo[4,5-c][1,8]naphthyridin-4(5H)-ones: a new class of nonsteroidal antiinflammatory agents with potent activity like glucocorticoids.
AID640607Antiinflammatory activity in ovalbumin-induced allergic Brown Norway rat lung inflammation model assessed as inhibition of forced vital capacity at 3 mg/kg, po qd administered 3 days before ovalbumin-challenge measured 24 hrs of post ovalbumin challenge2012Bioorganic & medicinal chemistry letters, Jan-15, Volume: 22, Issue:2
Steroidal C-21 heteroaryl thioethers (Part 2): discovery of orally bioavailable selective glucocorticoid receptor modulators (dissociated steroids).
AID640513Transactivation of glucocorticoid receptor in human HepG2 cells assessed as induction of TAT measuring degradation of tyrosine to p-hydroxy phenyl pyruvate at 1 uM relative to untreated control2012Bioorganic & medicinal chemistry letters, Jan-15, Volume: 22, Issue:2
Steroidal C-21 heteroaryl thioethers (Part 2): discovery of orally bioavailable selective glucocorticoid receptor modulators (dissociated steroids).
AID81559Transcriptional repression in HepG2 cells expressing human glucocorticoid receptor compared to Dexamethasone2003Journal of medicinal chemistry, Mar-13, Volume: 46, Issue:6
Nonsteroidal selective glucocorticoid modulators: the effect of C-10 substitution on receptor selectivity and functional potency of 5-allyl-2,5-dihydro-2,2,4-trimethyl-1H-[1]benzopyrano[3,4-f]quinolines.
AID626221Antiinflammatory activity in mouse plasma assessed as inhibition of LPS-induced TNFalpha production at 10 mg/kg, po administered 1 hr before LPS challenge measured after 1 hr2011Bioorganic & medicinal chemistry letters, Nov-15, Volume: 21, Issue:22
Non-steroidal dissociated glucocorticoid agonists: indoles as A-ring mimetics and function-regulating pharmacophores.
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
AID579573Agonist activity at human GR expressed in NHDF cells assessed as inhibition of IL-6 production by ELISA relative to Dexamethasone2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Discovery of orally available tetrahydroquinoline-based glucocorticoid receptor agonists.
AID29360Ionization constant (pKa)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID578378Transrepression activity at GR expressed in IL-1beta- and TNFalpha-stimulated HepG2 cells assessed as inhibition of NFKB- or AP-1 mediated E-selectin transcription by luciferase reporter gene assay relative to Dexamethasone2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Tetrahydroquinolin-3-yl carbamate glucocorticoid receptor agonists with reduced PEPCK activation.
AID185118The antiinflammatory activity was evaluated as %inhibition of croton oil induced ear edema in the right ear of rat1995Journal of medicinal chemistry, Mar-17, Volume: 38, Issue:6
New steroidal antiinflammatory antedrugs: steroidal [16 alpha,17 alpha-d]-3'-carbethoxyisoxazolines.
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).
AID1075829Toxicity in collagen-induced B10.RIII mouse arthritis model assessed as change in AUC at 3 mg/kg, po qd for 35 days relative to 1% methylcellulose-treated control2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Identification of highly efficacious glucocorticoid receptor agonists with a potential for reduced clinical bone side effects.
AID626819Antiinflammatory activity in human whole blood assessed as inhibition of TNF-alpha-induced IL-8 production after overnight incubation by ELISA2011Journal of medicinal chemistry, Oct-27, Volume: 54, Issue:20
Azaxanthene based selective glucocorticoid receptor modulators: design, synthesis, and pharmacological evaluation of (S)-4-(5-(1-((1,3,4-thiadiazol-2-yl)amino)-2-methyl-1-oxopropan-2-yl)-5H-chromeno[2,3-b]pyridin-2-yl)-2-fluoro-N,N-dimethylbenzamide (BMS-
AID1075811Toxicity in collagen-induced B10.RIII mouse arthritis model assessed as change in free fatty acid level at 3 mg/kg, po qd for 35 days relative to 30% cremophor-treated control2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Identification of highly efficacious glucocorticoid receptor agonists with a potential for reduced clinical bone side effects.
AID589746Agonist activity at glucocorticoid receptor in human HepG2 cells co-transfected with PEPCK assessed as GRE activation by luciferase reporter gene assay relative to Dexamethasone2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Nonsteroidal 2,3-dihydroquinoline glucocorticoid receptor agonists with reduced PEPCK activation.
AID1328557Antiinflammatory activity in Wistar rat PBMC assessed as inhibition of LPS-induced TNFalpha release preincubated for 45 mins followed by LPS addition after 18 hrs by ELISA2016Bioorganic & medicinal chemistry letters, 12-01, Volume: 26, Issue:23
Discovery of indazole ethers as novel, potent, non-steroidal glucocorticoid receptor modulators.
AID311367Permeability coefficient in human skin2007Bioorganic & medicinal chemistry, Nov-15, Volume: 15, Issue:22
Transdermal penetration behaviour of drugs: CART-clustering, QSPR and selection of model compounds.
AID626223Antiarthritic activity in B10.R3 mouse collagen-induced arthritis model assessed as AUC of disease progression inhibition at 30 mg/kg, po qd for 5 weeks2011Bioorganic & medicinal chemistry letters, Nov-15, Volume: 21, Issue:22
Non-steroidal dissociated glucocorticoid agonists: indoles as A-ring mimetics and function-regulating pharmacophores.
AID394968Immunosuppressive activity in rat lymphocytes assessed as inhibition of mixed-lymphocyte reaction2009Bioorganic & medicinal chemistry letters, Mar-01, Volume: 19, Issue:5
Pseurotin A and its analogues as inhibitors of immunoglobulin E [correction of immunoglobuline E] production.
AID351943Transrepression activity at GR in IL-1-beta-stimulated human A549 cells assessed as inhibition of NF-kappaB-dependent E-selectin transcription by luciferase reporter gene assay2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Discovery of novel dihydro-9,10-ethano-anthracene carboxamides as glucocorticoid receptor modulators.
AID74225Binding affinity towards glucocorticoid receptor (GR) by displacing [3H]dexamethasone2001Journal of medicinal chemistry, Dec-06, Volume: 44, Issue:25
Nonsteroidal selective glucocorticoid modulators: the effect of C-5 alkyl substitution on the transcriptional activation/repression profile of 2,5-dihydro-10-methoxy-2,2,4-trimethyl-1H-[1]benzopyrano[3,4-f]quinolines.
AID626199Agonist activity at glucocorticoid receptor in HFF assessed as inhibition of IL1-induced IL-6 production after 18 to 24 hrs relative to Dexamethasone2011Bioorganic & medicinal chemistry letters, Nov-15, Volume: 21, Issue:22
Non-steroidal dissociated glucocorticoid agonists: indoles as A-ring mimetics and function-regulating pharmacophores.
AID1460368Anti-inflammatory activity in po dosed Wistar rat assessed as inhibition of croton oil-induced ear edema2017Bioorganic & medicinal chemistry letters, 02-01, Volume: 27, Issue:3
Discovery of new selective glucocorticoid receptor agonist leads.
AID589660Agonist activity at glucocorticoid receptor in human HepG2 cells co-transfected with GRE assessed as GRE activation by luciferase reporter gene assay2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Nonsteroidal 2,3-dihydroquinoline glucocorticoid receptor agonists with reduced PEPCK activation.
AID515542Toxicity in B10.RIII mouse assessed as increase of body fat content at 30 mg/kg, po qd for 5 weeks2010Journal of medicinal chemistry, Sep-23, Volume: 53, Issue:18
Nonsteroidal dissociated glucocorticoid agonists containing azaindoles as steroid A-ring mimetics.
AID360030Immunosuppressive activity in human PBMC assessed as inhibition of LPS-stimulated IL4 production at 0.3 ug/mL after 18 to 24 hrs by ELISA2001Journal of natural products, May, Volume: 64, Issue:5
Immunosuppressive sesquiterpene alkaloids from Tripterygium wilfordii.
AID1413895Antiinflammatory activity against TPA-induced ear edema in BALB/c mouse assessed as weight of ear punches at 5 mM administered topically for 15 mins prior to TPA challenge and measured after 12 hrs (Rvb = 12.4 +/- 0.1 mg)2018MedChemComm, Sep-01, Volume: 9, Issue:9
Glycyrrhizic acid from licorice down-regulates inflammatory responses
AID1413893Antiinflammatory activity against TPA-induced ear edema in BALB/c mouse assessed as weight of ear punches at 5 mM administered topically for 15 mins prior to TPA challenge and measured after 3 hrs (Rvb = 8.3 +/- 0.1 mg)2018MedChemComm, Sep-01, Volume: 9, Issue:9
Glycyrrhizic acid from licorice down-regulates inflammatory responses
AID1688016Inhibition of LPS-induced TNF-alpha expression in human U-937 cells preincubated for 1 hr followed by LPS addition and measured after 24 hrs by ELISA2020European journal of medicinal chemistry, Feb-15, Volume: 188Synthesis and biological evaluation of some novel 1,2,3-triazole hybrids of myrrhanone B isolated from Commiphora mukul gum resin: Identification of potent antiproliferative leads active against prostate cancer cells (PC-3).
AID1328550Binding affinity to ERbeta (unknown origin) by FP assay2016Bioorganic & medicinal chemistry letters, 12-01, Volume: 26, Issue:23
Discovery of indazole ethers as novel, potent, non-steroidal glucocorticoid receptor modulators.
AID1211794Fraction unbound in blood (not specified)2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
Comparison of cryopreserved HepaRG cells with cryopreserved human hepatocytes for prediction of clearance for 26 drugs.
AID515538Toxicity in collagen and Freund's complete adjuvant-induced B10.RIII mouse arthritis model assessed as increase of body fat content at 30 mg/kg, po qd for 5 weeks2010Journal of medicinal chemistry, Sep-23, Volume: 53, Issue:18
Nonsteroidal dissociated glucocorticoid agonists containing azaindoles as steroid A-ring mimetics.
AID296301Activity at human glucocorticoid receptor in human A549 cells assessed as repression of human IL62007Bioorganic & medicinal chemistry letters, Jun-15, Volume: 17, Issue:12
Novel glucocorticoids containing a 6,5-bicyclic core fused to a pyrazole ring: synthesis, in vitro profile, molecular modeling studies, and in vivo experiments.
AID626804Transrepression activity at glucocorticoid receptor alpha in phorbol myristate acetate-stimulated human A549 cells assessed as inhibition of AP1 response element by luciferase reporter gene assay2011Journal of medicinal chemistry, Oct-27, Volume: 54, Issue:20
Azaxanthene based selective glucocorticoid receptor modulators: design, synthesis, and pharmacological evaluation of (S)-4-(5-(1-((1,3,4-thiadiazol-2-yl)amino)-2-methyl-1-oxopropan-2-yl)-5H-chromeno[2,3-b]pyridin-2-yl)-2-fluoro-N,N-dimethylbenzamide (BMS-
AID604797Transrepression activity of glucocorticoid receptor in human A549 cells expressing AP-1 assessed as inhibition of PMA-induced AP-1 activity by luciferase reporter gene assay2010Journal of medicinal chemistry, Dec-09, Volume: 53, Issue:23
Dimethyl-diphenyl-propanamide derivatives as nonsteroidal dissociated glucocorticoid receptor agonists.
AID330362Activity at endogenous glucocorticoid receptor in rat H42E liver cells assessed as increase in transcriptional activation of pyruvate dehydrogenase kinase at 0.1 uM after 24 hrs by RT-PCR2007Proceedings of the National Academy of Sciences of the United States of America, Dec-04, Volume: 104, Issue:49
Antiinflammatory glucocorticoid receptor ligand with reduced side effects exhibits an altered protein-protein interaction profile.
AID240069GR-mediated transrepression of IL-6 in human A549 lung carcinoma cells2005Bioorganic & medicinal chemistry letters, Apr-15, Volume: 15, Issue:8
Novel heterocyclic glucocorticoids: in vitro profile and in vivo efficacy.
AID1380176Modulation of glucocorticoid receptor in rat plasma2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID640515Toxicity in Brown Norway rat allergic lung inflammation model assessed as decrease in thymus weight at 10 mg/kg, po for 3 days2012Bioorganic & medicinal chemistry letters, Jan-15, Volume: 22, Issue:2
Steroidal C-21 heteroaryl thioethers (Part 2): discovery of orally bioavailable selective glucocorticoid receptor modulators (dissociated steroids).
AID155128Inhibition of concanavalin A stimulated T-cell proliferation in human PBMCs compared to Dexamethasone2003Journal of medicinal chemistry, Mar-13, Volume: 46, Issue:6
Nonsteroidal selective glucocorticoid modulators: the effect of C-10 substitution on receptor selectivity and functional potency of 5-allyl-2,5-dihydro-2,2,4-trimethyl-1H-[1]benzopyrano[3,4-f]quinolines.
AID47370Efficacy expressed relative to maximal response produced by Dex for GRE activation.2001Journal of medicinal chemistry, Dec-06, Volume: 44, Issue:25
Nonsteroidal selective glucocorticoid modulators: the effect of C-5 alkyl substitution on the transcriptional activation/repression profile of 2,5-dihydro-10-methoxy-2,2,4-trimethyl-1H-[1]benzopyrano[3,4-f]quinolines.
AID1075843Agonist activity at glucocorticoid receptor in human HMG-63 cells assessed as suppression of vitamin D-induced osteocalcin production at 2 uM after 48 hrs by Gla-type osteocalcin ELISA relative to dexomethasone2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Identification of highly efficacious glucocorticoid receptor agonists with a potential for reduced clinical bone side effects.
AID296300Displacement of [3H]dexamethasone from human glucocorticoid receptor alpha2007Bioorganic & medicinal chemistry letters, Jun-15, Volume: 17, Issue:12
Novel glucocorticoids containing a 6,5-bicyclic core fused to a pyrazole ring: synthesis, in vitro profile, molecular modeling studies, and in vivo experiments.
AID589654Transrepression activity at glucocorticoid receptor in human HepG2 cells assessed as inhibition of TNFalpha/IL1beta-stimulated NFkappaB-dependent E-selectin repression by luciferase reporter gene assay relative to Dexamethasone2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Nonsteroidal 2,3-dihydroquinoline glucocorticoid receptor agonists with reduced PEPCK activation.
AID552719Agonist activity at glucocorticoid receptor in human HepG2 cells co-transfected with GRE assessed as transactivation activity by luciferase reporter gene assay relative to Dexamethasone2011Bioorganic & medicinal chemistry letters, Jan-01, Volume: 21, Issue:1
Tetrahydroquinoline glucocorticoid receptor agonists: discovery of a 3-hydroxyl for improving receptor selectivity.
AID1328547Binding affinity to AR (unknown origin) by FP assay2016Bioorganic & medicinal chemistry letters, 12-01, Volume: 26, Issue:23
Discovery of indazole ethers as novel, potent, non-steroidal glucocorticoid receptor modulators.
AID1440084Antiarthritic activity in rat model of collagen-induced arthritis assessed as inhibition of paw swelling at 3 mg/kg, bid for 8 days relative to control2016Bioorganic & medicinal chemistry letters, 11-15, Volume: 26, Issue:22
Synthesis and optimization of furano[3,2-d]pyrimidines as selective spleen tyrosine kinase (Syk) inhibitors.
AID626140Displacement of tetramethylrhodamine-labeled Dexamethasone from human recombinant glucocorticoid receptor expressed in baculovirus infected insect cells by fluorescence polarization assay2011Bioorganic & medicinal chemistry letters, Nov-15, Volume: 21, Issue:22
Non-steroidal dissociated glucocorticoid agonists: indoles as A-ring mimetics and function-regulating pharmacophores.
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]
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.
AID626146Agonist activity at glucocorticoid receptor in HFF assessed as inhibition of IL1-induced IL-6 production after 18 to 24 hrs2011Bioorganic & medicinal chemistry letters, Nov-15, Volume: 21, Issue:22
Non-steroidal dissociated glucocorticoid agonists: indoles as A-ring mimetics and function-regulating pharmacophores.
AID90431Efficacy for transcriptional activation of osteocalcin in Human cell native protein assay expressed as percentage of the maximal response of Dexamethasone2004Bioorganic & medicinal chemistry letters, Apr-05, Volume: 14, Issue:7
Differentiation of in vitro transcriptional repression and activation profiles of selective glucocorticoid modulators.
AID626816Induction of glutamine synthase expression in human MG63 cells after overnight incubation by spectrophotometry relative to prednisolone2011Journal of medicinal chemistry, Oct-27, Volume: 54, Issue:20
Azaxanthene based selective glucocorticoid receptor modulators: design, synthesis, and pharmacological evaluation of (S)-4-(5-(1-((1,3,4-thiadiazol-2-yl)amino)-2-methyl-1-oxopropan-2-yl)-5H-chromeno[2,3-b]pyridin-2-yl)-2-fluoro-N,N-dimethylbenzamide (BMS-
AID224211Inhibitory activity against IL-1 on CMC-LPS air-pouch model at 2.5 mg/kg by oral administration1992Journal of medicinal chemistry, Dec-11, Volume: 35, Issue:25
A novel orally active inhibitor of IL-1 generation: synthesis and structure-activity relationships of 3-(4-hydroxy-1-naphthalenyl)-2-propenoic acid derivatives.
AID1125631Antiinflammatory activity in mouse assessed as inhibition of LPS-induced TNFalpha production at 3 mg/kg, po2014Bioorganic & medicinal chemistry letters, Apr-15, Volume: 24, Issue:8
Discovery of a potent and dissociated non-steroidal glucocorticoid receptor agonist containing an alkyl carbinol pharmacophore.
AID1075807Toxicity in collagen-induced B10.RIII mouse arthritis model assessed as change in insulin level at 30 mg/kg, po qd for 35 days relative to 1% methylcellulose-treated control2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Identification of highly efficacious glucocorticoid receptor agonists with a potential for reduced clinical bone side effects.
AID515540Toxicity in collagen and Freund's complete adjuvant-induced B10.RIII mouse arthritis model assessed as increase of triglyceride level at 30 mg/kg, po qd for 5 weeks2010Journal of medicinal chemistry, Sep-23, Volume: 53, Issue:18
Nonsteroidal dissociated glucocorticoid agonists containing azaindoles as steroid A-ring mimetics.
AID187591Recovery of steroid from small intestine at 5 hr after administration of 7.5 mg of the compound1984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
A colon-specific drug-delivery system based on drug glycosides and the glycosidases of colonic bacteria.
AID1075828Toxicity in collagen-induced B10.RIII mouse arthritis model assessed as change in AUC at 30 mg/kg, po qd for 35 days relative to 1% methylcellulose-treated control2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Identification of highly efficacious glucocorticoid receptor agonists with a potential for reduced clinical bone side effects.
AID357244Inhibition of lipopolysaccharide IL1-beta production in human PMNC at 0.3 ug/mL by ELISA2002Journal of natural products, Dec, Volume: 65, Issue:12
Sesquiterpenes from Ferula penninervis.
AID288184Permeability coefficient through artificial membrane in presence of unstirred water layer by PAMPA2007Bioorganic & medicinal chemistry, Jun-01, Volume: 15, Issue:11
QSAR study on permeability of hydrophobic compounds with artificial membranes.
AID1530700Displacement of [3H]dexamethasone from GR in human IM9 cells after 6 hrs by scintillation counting method2019European journal of medicinal chemistry, Jan-01, Volume: 161Discovery of a subnanomolar and selective spirocyclic agonist of the glucocorticoid receptor.
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.
AID552808Transrepression activity at glucocorticoid receptor in IL-1beta-stimulated human HepG2 cells assessed as inhibition of AP1 response element-induced IL-6 production by ELISA2011Bioorganic & medicinal chemistry letters, Jan-01, Volume: 21, Issue:1
Tetrahydroquinoline glucocorticoid receptor agonists: discovery of a 3-hydroxyl for improving receptor selectivity.
AID240099Inhibition of mouse glutamine synthetase by GR-mediated transactivation in C2C12 cells2005Bioorganic & medicinal chemistry letters, Apr-15, Volume: 15, Issue:8
Novel heterocyclic glucocorticoids: in vitro profile and in vivo efficacy.
AID90303Effective concentration for transcriptional activation of aromatase in Human cell native protein assay2004Bioorganic & medicinal chemistry letters, Apr-05, Volume: 14, Issue:7
Differentiation of in vitro transcriptional repression and activation profiles of selective glucocorticoid modulators.
AID184570Tested for inhibition of formation of granulation tissue around the cotton pellet untreated with steroid1987Journal of medicinal chemistry, Dec, Volume: 30, Issue:12
Synthesis of new antiinflammatory steroidal 20-carboxamides: (20R)- and (20S)-21-(N-substituted amino)-11 beta,17,20-trihydroxy-3,21-dioxo-1,4- pregnadiene.
AID515537Antiinflammatory effect in collagen and Freund's complete adjuvant-induced B10.RIII mouse arthritis model assessed as inhibition of disease progression administered as po qd for 5 weeks2010Journal of medicinal chemistry, Sep-23, Volume: 53, Issue:18
Nonsteroidal dissociated glucocorticoid agonists containing azaindoles as steroid A-ring mimetics.
AID578481Transrepression activity at GR expressed in NHDF cells assessed as IL-1beta-mediated IL-6 transcription by ELISA2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Tetrahydroquinolin-3-yl carbamate glucocorticoid receptor agonists with reduced PEPCK activation.
AID1328567AUC in Lewis rat model of SCW-induced joint inflammation at anti-inflammatory ED50 administered via oral gavage once daily for 8 days measured 24 hrs post last dose on day 8 by LC/MS/MS analysis2016Bioorganic & medicinal chemistry letters, 12-01, Volume: 26, Issue:23
Discovery of indazole ethers as novel, potent, non-steroidal glucocorticoid receptor modulators.
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.
AID1380184Induction of NROB1 recruitment in N-terminal thrombin cleavable 6-His-tagged glucocorticoid receptor (unknown origin) at 50 uM by SPR method2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID102827Compound (0.10 ug/mL) was tested for their immunomodulatory activity in vitro using mixed lymphocyte reaction2000Bioorganic & medicinal chemistry letters, Jun-05, Volume: 10, Issue:11
Immunomodulatory activity of hexapeptides related to proline rich peptide from colostrum.
AID1380177Ratio of drug level in rat blood to plasma2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID296305Activity at human glucocorticoid receptor in C57BI/6 mouse peritoneal exudate cells assessed as repression of mouse IL62007Bioorganic & medicinal chemistry letters, Jun-15, Volume: 17, Issue:12
Novel glucocorticoids containing a 6,5-bicyclic core fused to a pyrazole ring: synthesis, in vitro profile, molecular modeling studies, and in vivo experiments.
AID360029Immunosuppressive activity in human PBMC assessed as inhibition of LPS-stimulated IL2 production at 0.3 ug/mL after 18 to 24 hrs by ELISA2001Journal of natural products, May, Volume: 64, Issue:5
Immunosuppressive sesquiterpene alkaloids from Tripterygium wilfordii.
AID1679118Binding affinity to enhanced YFP tagged rat glucocorticoid receptor (497-795)-LBD expressed in Saccharomyces cerevisiae FY250 cells by measuring increase in fluorescence intensity incubated at 100 uM for 15 hrs by fluorescence microscopy2021RSC medicinal chemistry, Mar-04, Volume: 12, Issue:2
Microwave-assisted green synthesis of bile acid derivatives and evaluation of glucocorticoid receptor binding.
AID227270The compound was tested for PGE-2 generation on CMC-LPS air-pouch model at 10 mg/kg by oral administration1992Journal of medicinal chemistry, Dec-11, Volume: 35, Issue:25
A novel orally active inhibitor of IL-1 generation: synthesis and structure-activity relationships of 3-(4-hydroxy-1-naphthalenyl)-2-propenoic acid derivatives.
AID1075801Toxicity in collagen-induced B10.RIII mouse arthritis model assessed as change in femur cortical thickness at 30 mg/kg, po qd for 35 days relative to 1% methylcellulose-treated control2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Identification of highly efficacious glucocorticoid receptor agonists with a potential for reduced clinical bone side effects.
AID204333Inhibition of concanavalin A stimulated rat splenocyte proliferation compared to Dexamethasone2003Journal of medicinal chemistry, Mar-13, Volume: 46, Issue:6
Nonsteroidal selective glucocorticoid modulators: the effect of C-10 substitution on receptor selectivity and functional potency of 5-allyl-2,5-dihydro-2,2,4-trimethyl-1H-[1]benzopyrano[3,4-f]quinolines.
AID1328545Fraction unbound in human plasma at 10 uM2016Bioorganic & medicinal chemistry letters, 12-01, Volume: 26, Issue:23
Discovery of indazole ethers as novel, potent, non-steroidal glucocorticoid receptor modulators.
AID515536Antiinflammatory effect in collagen and Freund's complete adjuvant-induced B10.RIII mouse arthritis model assessed as inhibition of disease progression at 30 mg/kg, po qd for 5 weeks2010Journal of medicinal chemistry, Sep-23, Volume: 53, Issue:18
Nonsteroidal dissociated glucocorticoid agonists containing azaindoles as steroid A-ring mimetics.
AID1075814Toxicity in collagen-induced B10.RIII mouse arthritis model assessed as change in free fatty acid level at 3 mg/kg, po qd for 35 days relative to 1% methylcellulose-treated control2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Identification of highly efficacious glucocorticoid receptor agonists with a potential for reduced clinical bone side effects.
AID1328559Fraction unbound in rat plasma at 10 uM2016Bioorganic & medicinal chemistry letters, 12-01, Volume: 26, Issue:23
Discovery of indazole ethers as novel, potent, non-steroidal glucocorticoid receptor modulators.
AID604866Toxicity in Sprague-Dawley rat assessed as induction of TAT activity in liver homogenates at 30 mg/kg, po after 6 hrs2010Journal of medicinal chemistry, Dec-09, Volume: 53, Issue:23
Dimethyl-diphenyl-propanamide derivatives as nonsteroidal dissociated glucocorticoid receptor agonists.
AID26304Partition coefficient (logD6.5)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID1293466Agonist activity at TGR5 in human whole blood assessed as inhibition of LPS-induced TNF-alpha release2016ACS medicinal chemistry letters, Jan-14, Volume: 7, Issue:1
Discovery of a Potent and Orally Efficacious TGR5 Receptor Agonist.
AID1075820Toxicity in collagen-induced B10.RIII mouse arthritis model assessed as change in body fat at 3 mg/kg, po qd for 35 days relative to 30% cremophor-treated control2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Identification of highly efficacious glucocorticoid receptor agonists with a potential for reduced clinical bone side effects.
AID699976Antiinflammatory activity against DSS-induced colitis BALB/c mouse model assessed as reduction in IL1b level at 5 mg/kg, po qd for 7 days measured on day 7 relative to vehicle-treated control2012Journal of medicinal chemistry, Jun-14, Volume: 55, Issue:11
6-(methylamino)hexane-1,2,3,4,5-pentanol 4-(((1S,2S)-1-hydroxy-2,3-dihydro-1H,1'H-[2,2-biinden]-2-yl)methyl)benzoate (PH46A): a novel small molecule with efficacy in murine models of colitis.
AID304381Agonist activity at glucocorticoid receptor in human A549 cells by MMTV transactivation assay2007Journal of medicinal chemistry, Dec-27, Volume: 50, Issue:26
Nonsteroidal glucocorticoid agonists: tetrahydronaphthalenes with alternative steroidal A-ring mimetics possessing dissociated (transrepression/transactivation) efficacy selectivity.
AID481239Ratio of ED50 for BALB/c mouse collagen antibody induced arthritis model to tolerated dose for BALB/c mouse collagen antibody induced arthritis model2010Bioorganic & medicinal chemistry letters, May-15, Volume: 20, Issue:10
Discovery of anti-inflammatory clinical candidate E6201, inspired from resorcylic lactone LL-Z1640-2, III.
AID589656Transrepression activity at glucocorticoid receptor in human NHDF cells assessed as inhibition of IL-1beta-stimulated AP1 dependent IL-6 repression by ELISA relative to Dexamethasone2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Nonsteroidal 2,3-dihydroquinoline glucocorticoid receptor agonists with reduced PEPCK activation.
AID255211Inhibitory concentration against recombinant rat androgen receptor expressed in Escherichia coli using [3H]methyltrienolone (R 1881)2005Journal of medicinal chemistry, Sep-08, Volume: 48, Issue:18
Impact of induced fit on ligand binding to the androgen receptor: a multidimensional QSAR study to predict endocrine-disrupting effects of environmental chemicals.
AID351945Transrepression activity at GR in IL-1-beta-stimulated human A549 cells assessed as inhibition of NF-kappaB-dependent E-selectin transcription by luciferase reporter gene assay relative to Dexamethasone2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Discovery of novel dihydro-9,10-ethano-anthracene carboxamides as glucocorticoid receptor modulators.
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).
AID1413896Antiinflammatory activity against TPA-induced ear edema in BALB/c mouse assessed as weight of ear punches at 5 mM administered topically for 15 mins prior to TPA challenge and measured after 24 hrs (Rvb = 12.1 +/- 0.2 mg)2018MedChemComm, Sep-01, Volume: 9, Issue:9
Glycyrrhizic acid from licorice down-regulates inflammatory responses
AID74239Transcriptional activation in CV-1 cells expressing glucocorticoid receptor compared to Dexamethasone2001Journal of medicinal chemistry, Aug-30, Volume: 44, Issue:18
Synthesis and characterization of non-steroidal ligands for the glucocorticoid receptor: selective quinoline derivatives with prednisolone-equivalent functional activity.
AID1319836Anti-autoimmune activity in lupus prone NZB/WF1 mouse model assessed as protection against tubulo-interstitial nephritis at 10 mg/kg, po administered qd for 16 weeks2016Journal of medicinal chemistry, 10-13, Volume: 59, Issue:19
Discovery of 6-Fluoro-5-(R)-(3-(S)-(8-fluoro-1-methyl-2,4-dioxo-1,2-dihydroquinazolin-3(4H)-yl)-2-methylphenyl)-2-(S)-(2-hydroxypropan-2-yl)-2,3,4,9-tetrahydro-1H-carbazole-8-carboxamide (BMS-986142): A Reversible Inhibitor of Bruton's Tyrosine Kinase (BT
AID1211791Fraction unbound in human hepatocytes2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
Comparison of cryopreserved HepaRG cells with cryopreserved human hepatocytes for prediction of clearance for 26 drugs.
AID440586Acute toxicity in rat2009European journal of medicinal chemistry, Dec, Volume: 44, Issue:12
Analgesic, anticonvulsant and anti-inflammatory activities of some synthesized benzodiazipine, triazolopyrimidine and bis-imide derivatives.
AID589744Agonist activity at glucocorticoid receptor in human HepG2 cells co-transfected with GRE assessed as GRE activation by luciferase reporter gene assay relative to Dexamethasone2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Nonsteroidal 2,3-dihydroquinoline glucocorticoid receptor agonists with reduced PEPCK activation.
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.
AID1380164Terminal half life in Han-Wistar rat at 3.5 mg/kg, po2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID47372The effective concentration in CV-1 cells for glucocorticoid response element activation (GRE).2001Journal of medicinal chemistry, Dec-06, Volume: 44, Issue:25
Nonsteroidal selective glucocorticoid modulators: the effect of C-5 alkyl substitution on the transcriptional activation/repression profile of 2,5-dihydro-10-methoxy-2,2,4-trimethyl-1H-[1]benzopyrano[3,4-f]quinolines.
AID178273Anti-asthmatic effect as eosinophil influx in rat lung model2001Journal of medicinal chemistry, Aug-30, Volume: 44, Issue:18
Synthesis and characterization of non-steroidal ligands for the glucocorticoid receptor: selective quinoline derivatives with prednisolone-equivalent functional activity.
AID379619Immunosuppressive activity against human peripheral mononuclear cells assessed as inhibition of LPS-stimulated IL2 production at 0.3 ug/mL2000Journal of natural products, Mar, Volume: 63, Issue:3
Prenylated benzoic acid derivatives from Ferula kuhistanica.
AID481238Toxicity in po dosed BALB/c mouse collagen antibody induced arthritis model assessed as tolerated dose2010Bioorganic & medicinal chemistry letters, May-15, Volume: 20, Issue:10
Discovery of anti-inflammatory clinical candidate E6201, inspired from resorcylic lactone LL-Z1640-2, III.
AID1125611Agonist activity at glucocorticoid receptor in human foreskin fibroblasts assessed as inhibition of IL-1-induced IL-6 production at 2 uM by trans-repression assay relative to dexamethasone2014Bioorganic & medicinal chemistry letters, Apr-15, Volume: 24, Issue:8
Discovery of a potent and dissociated non-steroidal glucocorticoid receptor agonist containing an alkyl carbinol pharmacophore.
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).
AID376392Immunosuppressive activity against human PBMC assessed as inhibition of LPS-induced IL1-beta production at 0.3 ug/ml after 24 hrs by ELISA1999Journal of natural products, Nov, Volume: 62, Issue:11
Immunosuppressive diterpenoids from Tripterygium wilfordii.
AID188437Tested for inhibition of formation of granulation tissue around the cotton pellet untreated with steroid and expressed as net dry weight1987Journal of medicinal chemistry, Dec, Volume: 30, Issue:12
Synthesis of new antiinflammatory steroidal 20-carboxamides: (20R)- and (20S)-21-(N-substituted amino)-11 beta,17,20-trihydroxy-3,21-dioxo-1,4- pregnadiene.
AID73771Displacement of [3H]dexamethasone from glucocorticoid receptor of human blood mononuclear cells at 1 uM2004Journal of medicinal chemistry, Jan-29, Volume: 47, Issue:3
Synthesis of nitro esters of prednisolone, new compounds combining pharmacological properties of both glucocorticoids and nitric oxide.
AID187644Evaluated for antiinflammatory activity in granuloma bioassay and expressed as relative thymus weight1987Journal of medicinal chemistry, Dec, Volume: 30, Issue:12
Synthesis of new antiinflammatory steroidal 20-carboxamides: (20R)- and (20S)-21-(N-substituted amino)-11 beta,17,20-trihydroxy-3,21-dioxo-1,4- pregnadiene.
AID579574Agonist activity at human GR expressed in NHDF cells assessed as inhibition of IL-6 production by ELISA2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Discovery of orally available tetrahydroquinoline-based glucocorticoid receptor agonists.
AID626822Antiinflammatory activity in human whole blood assessed as inhibition of IL-1beta-induced IL-8 production after overnight incubation by ELISA relative to Dexamethasone2011Journal of medicinal chemistry, Oct-27, Volume: 54, Issue:20
Azaxanthene based selective glucocorticoid receptor modulators: design, synthesis, and pharmacological evaluation of (S)-4-(5-(1-((1,3,4-thiadiazol-2-yl)amino)-2-methyl-1-oxopropan-2-yl)-5H-chromeno[2,3-b]pyridin-2-yl)-2-fluoro-N,N-dimethylbenzamide (BMS-
AID54050Glucocorticoid-induced aromatase activity in human skin fibroblasts compared to Dexamethasone2001Journal of medicinal chemistry, Aug-30, Volume: 44, Issue:18
Synthesis and characterization of non-steroidal ligands for the glucocorticoid receptor: selective quinoline derivatives with prednisolone-equivalent functional activity.
AID394970Cytotoxicity against human K562 cells2009Bioorganic & medicinal chemistry letters, Mar-01, Volume: 19, Issue:5
Pseurotin A and its analogues as inhibitors of immunoglobulin E [correction of immunoglobuline E] production.
AID640610Antiinflammatory activity in po dosed ovalbumin-induced allergic Brown Norway rat lung inflammation model assessed as inhibition of forced vital capacity administered 3 days before ovalbumin-challenge measured 24 hrs of post ovalbumin challenge2012Bioorganic & medicinal chemistry letters, Jan-15, Volume: 22, Issue:2
Steroidal C-21 heteroaryl thioethers (Part 2): discovery of orally bioavailable selective glucocorticoid receptor modulators (dissociated steroids).
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.
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]
AID296302Activity at human glucocorticoid receptor in human A549 cells assessed as repression of human IL6 relative to Dexamethasone2007Bioorganic & medicinal chemistry letters, Jun-15, Volume: 17, Issue:12
Novel glucocorticoids containing a 6,5-bicyclic core fused to a pyrazole ring: synthesis, in vitro profile, molecular modeling studies, and in vivo experiments.
AID184943Tested for topical antiinflammatory activity in the croton oil ear edema assay1987Journal of medicinal chemistry, Dec, Volume: 30, Issue:12
Synthesis of new antiinflammatory steroidal 20-carboxamides: (20R)- and (20S)-21-(N-substituted amino)-11 beta,17,20-trihydroxy-3,21-dioxo-1,4- pregnadiene.
AID552806Transrepression activity at glucocorticoid receptor in TNFalpha/IL1beta-stimulated human HepG2 cells assessed as inhibition of NFkappaB-dependent E-selectin transcription by luciferase reporter gene assay2011Bioorganic & medicinal chemistry letters, Jan-01, Volume: 21, Issue:1
Tetrahydroquinoline glucocorticoid receptor agonists: discovery of a 3-hydroxyl for improving receptor selectivity.
AID330360Activity at endogenous glucocorticoid receptor in rat H42E liver cells assessed as increase in transcriptional activation of phosphoenol pyruvate carboxykinase at 0.01 uM after 24 hrs by RT-PCR2007Proceedings of the National Academy of Sciences of the United States of America, Dec-04, Volume: 104, Issue:49
Antiinflammatory glucocorticoid receptor ligand with reduced side effects exhibits an altered protein-protein interaction profile.
AID425653Renal clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID86563Effective concentration in HepG2 cells transfected with LUC gene (E-sel-Luc).2001Journal of medicinal chemistry, Dec-06, Volume: 44, Issue:25
Nonsteroidal selective glucocorticoid modulators: the effect of C-5 alkyl substitution on the transcriptional activation/repression profile of 2,5-dihydro-10-methoxy-2,2,4-trimethyl-1H-[1]benzopyrano[3,4-f]quinolines.
AID362619Effect on adrenal weight in Lewis rat with implanted cotton pellets at 6.0 mg/kg, po bid2008Bioorganic & medicinal chemistry, Aug-15, Volume: 16, Issue:16
Discovery of betamethasone 17alpha-carbamates as dissociated glucocorticoid receptor modulators in the rat.
AID90421Effective concentration of compound for transcriptional activation of collagenase in Human cell native protein assay2004Bioorganic & medicinal chemistry letters, Apr-05, Volume: 14, Issue:7
Differentiation of in vitro transcriptional repression and activation profiles of selective glucocorticoid modulators.
AID377220Antiinflammatory activity against mouse RAW264.7 cells assessed as inhibition of LPS-induced TNFalpha production after 4 hrs by ELISA2000Journal of natural products, Sep, Volume: 63, Issue:9
In vitro antiinflammatory effects of neolignan woorenosides from the rhizomes of Coptis japonica.
AID700174Antiinflammatory activity against DSS-induced colitis BALB/c mouse model assessed as decrease in disease activity index at 5 mg/kg, po qd for 7 days measured on day 7 relative to vehicle-treated control2012Journal of medicinal chemistry, Jun-14, Volume: 55, Issue:11
6-(methylamino)hexane-1,2,3,4,5-pentanol 4-(((1S,2S)-1-hydroxy-2,3-dihydro-1H,1'H-[2,2-biinden]-2-yl)methyl)benzoate (PH46A): a novel small molecule with efficacy in murine models of colitis.
AID426622Antiinflammatory activity in BALB/c mouse model assessed as inhibition of ovalbumin-induced ear swelling at 10 mg/kg, po administered 60 mins before ovalbumin challenge measured 1 hr after elicitation by immediate type reaction assay2009Bioorganic & medicinal chemistry letters, May-15, Volume: 19, Issue:10
Synthesis and structure-activity relationships of phenothiazine carboxylic acids having pyrimidine-dione as novel histamine H(1) antagonists.
AID1380130Transactivation activity at glucocorticoid receptor (unknown origin) expressed in human ChaGoK1 cells incubated for 24 hrs by beta-galactosidase reporter gene assay2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID350313Inhibition of dextran sodium sulfate-induced ulcerative colitis in po dosed BALB/c mouse assessed as decrease in colon shortening administered twice daily for 6 days relative to control2009Journal of medicinal chemistry, May-28, Volume: 52, Issue:10
Design, synthesis, and pharmacological effects of a cyclization-activated steroid prodrug for colon targeting in inflammatory bowel disease.
AID1380189Antiinflammatory activity in streptococcal cell wall reactivation Lewis rat model assessed as reduction of joint swelling at 20 mg/kg administered once daily for 8 days by oral gavage starting 1 day prior to streptococcal cell wall challenge measured duri2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID440597Antiinflammatory activity in albino rat assessed as protection against carrageenan-induced paw edema at 25 mg/kg, po administered 1 hr before carrageenan challenge measured after 4 hrs2009European journal of medicinal chemistry, Dec, Volume: 44, Issue:12
Analgesic, anticonvulsant and anti-inflammatory activities of some synthesized benzodiazipine, triazolopyrimidine and bis-imide derivatives.
AID410446Displacement of fluorescent labelled Dexamethasone from glucocorticoid receptor2009Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1
Aryl aminopyrazole benzamides as oral non-steroidal selective glucocorticoid receptor agonists.
AID242155Inhibition of human glucocorticoid receptor alpha by displacement of [3H]dexamethasone2005Bioorganic & medicinal chemistry letters, Apr-15, Volume: 15, Issue:8
Novel heterocyclic glucocorticoids: in vitro profile and in vivo efficacy.
AID267772Agonist activity at GR assessed as NF-kappaB-mediated transrepression of secreted placental alkaline phosphatase gene in human A549 cells2006Journal of medicinal chemistry, Jul-13, Volume: 49, Issue:14
Dissociated nonsteroidal glucocorticoid receptor modulators; discovery of the agonist trigger in a tetrahydronaphthalene-benzoxazine series.
AID589653Transrepression activity at glucocorticoid receptor in human HepG2 cells assessed as inhibition of TNFalpha/IL1beta-stimulated NFkappaB-dependent E-selectin repression by luciferase reporter gene assay2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Nonsteroidal 2,3-dihydroquinoline glucocorticoid receptor agonists with reduced PEPCK activation.
AID296307Activity at human glucocorticoid receptor in C2C12 cells assessed as mouse glutamine synthetase activity2007Bioorganic & medicinal chemistry letters, Jun-15, Volume: 17, Issue:12
Novel glucocorticoids containing a 6,5-bicyclic core fused to a pyrazole ring: synthesis, in vitro profile, molecular modeling studies, and in vivo experiments.
AID1473739Inhibition of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
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.
AID187403Compound was evaluated for antiinflammatory activity in granuloma bioassay and measured as plasma corticosterone weight1987Journal of medicinal chemistry, Dec, Volume: 30, Issue:12
Synthesis of new antiinflammatory steroidal 20-carboxamides: (20R)- and (20S)-21-(N-substituted amino)-11 beta,17,20-trihydroxy-3,21-dioxo-1,4- pregnadiene.
AID1071638Displacement of [3H]-dexamethasone from human glucocorticoid receptor expressed in HEK293 cells2014Journal of medicinal chemistry, Feb-13, Volume: 57, Issue:3
Glucocorticoid receptor modulators informed by crystallography lead to a new rationale for receptor selectivity, function, and implications for structure-based design.
AID626800Displacement of fluorescently labeled ligand from progesterone receptor by fluorescence polarization assay2011Journal of medicinal chemistry, Oct-27, Volume: 54, Issue:20
Azaxanthene based selective glucocorticoid receptor modulators: design, synthesis, and pharmacological evaluation of (S)-4-(5-(1-((1,3,4-thiadiazol-2-yl)amino)-2-methyl-1-oxopropan-2-yl)-5H-chromeno[2,3-b]pyridin-2-yl)-2-fluoro-N,N-dimethylbenzamide (BMS-
AID376394Immunosuppressive activity against human PBMC assessed as inhibition of LPS-induced IL2 production at 0.3 ug/ml after 24 hrs by ELISA1999Journal of natural products, Nov, Volume: 62, Issue:11
Immunosuppressive diterpenoids from Tripterygium wilfordii.
AID480395Binding affinity to human glucocorticoid receptor by fluorescence polarization competitive binding assay2010Bioorganic & medicinal chemistry letters, May-15, Volume: 20, Issue:10
5-Functionalized indazoles as glucocorticoid receptor agonists.
AID625277FDA Liver Toxicity Knowledge Base Benchmark Dataset (LTKB-BD) drugs of less concern for DILI2011Drug discovery today, Aug, Volume: 16, Issue:15-16
FDA-approved drug labeling for the study of drug-induced liver injury.
AID656153Antiinflammatory activity in LPS-stimulated acute inflammation BALB/c mouse model assessed as inhibition of plasma TNF-alpha level at 10 mg/kg, po administered 2 hrs before LPS challenge2012Bioorganic & medicinal chemistry letters, Apr-15, Volume: 22, Issue:8
From ApoA1 upregulation to BET family bromodomain inhibition: discovery of I-BET151.
AID1075810Toxicity in collagen-induced B10.RIII mouse arthritis model assessed as change in free fatty acid level at 30 mg/kg, po qd for 35 days relative to 30% cremophor-treated control2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Identification of highly efficacious glucocorticoid receptor agonists with a potential for reduced clinical bone side effects.
AID1328558Antiinflammatory activity in rat whole blood assessed as inhibition of LPS-induced TNFalpha release preincubated for 45 mins followed by LPS addition after 18 hrs by ELISA2016Bioorganic & medicinal chemistry letters, 12-01, Volume: 26, Issue:23
Discovery of indazole ethers as novel, potent, non-steroidal glucocorticoid receptor modulators.
AID1530699Antiinflammatory activity in Sprague-Dawley rat whole blood assessed as inhibition of LPS-induced TNFalpha production measured after 18 hrs by AlphaLisa assay2019European journal of medicinal chemistry, Jan-01, Volume: 161Discovery of a subnanomolar and selective spirocyclic agonist of the glucocorticoid receptor.
AID187588Recovery of steroid from cecum at 6 hr after administration of 7.5 mg of the compound1984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
A colon-specific drug-delivery system based on drug glycosides and the glycosidases of colonic bacteria.
AID1380155Induction of nuclear translocation of glucocorticoid receptor in human EA.hy926 cells after 1 hr by Hoechst staining-based method2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID331521Activity at glucocorticoid receptor assessed as repression of TNFalpha and IL1 beta-induced E-selectin expression2008Bioorganic & medicinal chemistry letters, Jun-15, Volume: 18, Issue:12
Discovery of nonsteroidal glucocorticoid receptor ligands based on 6-indole-1,2,3,4-tetrahydroquinolines.
AID376393Immunosuppressive activity against human PBMC assessed as inhibition of LPS-induced IL4 production at 0.3 ug/ml after 24 hrs by ELISA1999Journal of natural products, Nov, Volume: 62, Issue:11
Immunosuppressive diterpenoids from Tripterygium wilfordii.
AID1380186Induction of PRGC1 recruitment in N-terminal thrombin cleavable 6-His-tagged glucocorticoid receptor (unknown origin) at 50 uM by SPR method2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID480398Agonist activity at glucocorticoid receptor in human MDA-kb2 cells transfected with MMTV-LUC assessed as induction of MMTV-LTR/promoter linked LUC gene by luciferase transactivation assay2010Bioorganic & medicinal chemistry letters, May-15, Volume: 20, Issue:10
5-Functionalized indazoles as glucocorticoid receptor agonists.
AID373867Hepatic clearance in human hepatocytes in absence of fetal calf serum2009European journal of medicinal chemistry, Apr, Volume: 44, Issue:4
First-principle, structure-based prediction of hepatic metabolic clearance values in human.
AID626843Antiinflammatory activity in Freund's complete adjuvant-induced Lewis rat arthritis model assessed as reduction in paw swelling at 5 mg/kg/day, po qd for 21 days2011Journal of medicinal chemistry, Oct-27, Volume: 54, Issue:20
Azaxanthene based selective glucocorticoid receptor modulators: design, synthesis, and pharmacological evaluation of (S)-4-(5-(1-((1,3,4-thiadiazol-2-yl)amino)-2-methyl-1-oxopropan-2-yl)-5H-chromeno[2,3-b]pyridin-2-yl)-2-fluoro-N,N-dimethylbenzamide (BMS-
AID410447Inhibition of TNF-induced NF-kappaB activation in human A549 cells after 15 hrs2009Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1
Aryl aminopyrazole benzamides as oral non-steroidal selective glucocorticoid receptor agonists.
AID604793Binding affinity to progesterone receptor by fluorescence polarization assay2010Journal of medicinal chemistry, Dec-09, Volume: 53, Issue:23
Dimethyl-diphenyl-propanamide derivatives as nonsteroidal dissociated glucocorticoid receptor agonists.
AID1125644Toxicity in B10.RIII mouse assessed as insulin level in serum at 30 mg/kg, po qd for 5 weeks relative to control2014Bioorganic & medicinal chemistry letters, Apr-15, Volume: 24, Issue:8
Discovery of a potent and dissociated non-steroidal glucocorticoid receptor agonist containing an alkyl carbinol pharmacophore.
AID1328551Intrinsic clearance in rat hepatocytes assessed per million cells2016Bioorganic & medicinal chemistry letters, 12-01, Volume: 26, Issue:23
Discovery of indazole ethers as novel, potent, non-steroidal glucocorticoid receptor modulators.
AID1380154Binding affinity to human ERbeta expressed in Sf9 cells by fluoligand binding-based fluorescence polarization method2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID552718Binding affinity to progesterone receptor2011Bioorganic & medicinal chemistry letters, Jan-01, Volume: 21, Issue:1
Tetrahydroquinoline glucocorticoid receptor agonists: discovery of a 3-hydroxyl for improving receptor selectivity.
AID1075808Toxicity in collagen-induced B10.RIII mouse arthritis model assessed as change in insulin level at 3 mg/kg, po qd for 35 days relative to 1% methylcellulose-treated control2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Identification of highly efficacious glucocorticoid receptor agonists with a potential for reduced clinical bone side effects.
AID362617Effect on adrenal weight in Lewis rat with implanted cotton pellets at 1.0 mg/kg, po bid2008Bioorganic & medicinal chemistry, Aug-15, Volume: 16, Issue:16
Discovery of betamethasone 17alpha-carbamates as dissociated glucocorticoid receptor modulators in the rat.
AID656151Antiinflammatory activity in LPS-stimulated acute inflammation BALB/c mouse model assessed as inhibition of plasma IL-6 level at 10 mg/kg, po administered 2 hrs before LPS challenge2012Bioorganic & medicinal chemistry letters, Apr-15, Volume: 22, Issue:8
From ApoA1 upregulation to BET family bromodomain inhibition: discovery of I-BET151.
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.
AID1091957Apparent permeability of the compound by PAMPA2011Journal of agricultural and food chemistry, Apr-13, Volume: 59, Issue:7
Importance of physicochemical properties for the design of new pesticides.
AID626143Displacement of [3H]-testosterone from human recombinant androgen receptor expressed in baculovirus infected insect cells at 2000 nM2011Bioorganic & medicinal chemistry letters, Nov-15, Volume: 21, Issue:22
Non-steroidal dissociated glucocorticoid agonists: indoles as A-ring mimetics and function-regulating pharmacophores.
AID699541Inhibition of human liver OATP2B1 expressed in HEK293 Flp-In cells assessed as reduction in [3H]E3S uptake at 20 uM incubated for 5 mins by scintillation counting2012Journal of medicinal chemistry, May-24, Volume: 55, Issue:10
Classification of inhibitors of hepatic organic anion transporting polypeptides (OATPs): influence of protein expression on drug-drug interactions.
AID1319854Anti-autoimmune activity in lupus prone NZB/WF1 mouse model assessed as reduction in immune complex deposits at 10 mg/kg, po administered qd for 16 weeks2016Journal of medicinal chemistry, 10-13, Volume: 59, Issue:19
Discovery of 6-Fluoro-5-(R)-(3-(S)-(8-fluoro-1-methyl-2,4-dioxo-1,2-dihydroquinazolin-3(4H)-yl)-2-methylphenyl)-2-(S)-(2-hydroxypropan-2-yl)-2,3,4,9-tetrahydro-1H-carbazole-8-carboxamide (BMS-986142): A Reversible Inhibitor of Bruton's Tyrosine Kinase (BT
AID1071635Transactivation of human glucocorticoid receptor expressed in HEK293 cells at 10 uM after 24 hrs by luciferase reporter gene assay relative to control2014Journal of medicinal chemistry, Feb-13, Volume: 57, Issue:3
Glucocorticoid receptor modulators informed by crystallography lead to a new rationale for receptor selectivity, function, and implications for structure-based design.
AID29811Oral bioavailability in human2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID350306Apparent permeability from basolateral to apical side in human Caco-2 cells by HPLC2009Journal of medicinal chemistry, May-28, Volume: 52, Issue:10
Design, synthesis, and pharmacological effects of a cyclization-activated steroid prodrug for colon targeting in inflammatory bowel disease.
AID90429Efficacy for transcriptional activation of aromatase in Human cell native protein assay expressed as percentage of the maximal response of Dexamethasone2004Bioorganic & medicinal chemistry letters, Apr-05, Volume: 14, Issue:7
Differentiation of in vitro transcriptional repression and activation profiles of selective glucocorticoid modulators.
AID299614Antagonist activity at GR assessed as inhibition of dexamethasone-induced GRE activation2007Bioorganic & medicinal chemistry letters, Aug-01, Volume: 17, Issue:15
5(Z)-benzylidene-1,2-dihydro-9-hydroxy-10-methoxy-2,2,4-trimethyl-5H-1-aza-6-oxa-chrysenes as non-steroidal glucocorticoid receptor modulators.
AID426624Antiinflammatory activity in BALB/c mouse model assessed as inhibition of ovalbumin-induced ear swelling at 10 mg/kg, po administered 60 mins before ovalbumin challenge measured 24 hrs after elicitation by late type reaction assay2009Bioorganic & medicinal chemistry letters, May-15, Volume: 19, Issue:10
Synthesis and structure-activity relationships of phenothiazine carboxylic acids having pyrimidine-dione as novel histamine H(1) antagonists.
AID626812Transactivation activity at GR-alpha in human NP1 Hela cells assessed as inhibition of GAL4-DBD after 20 hrs by luciferase reporter gene assay2011Journal of medicinal chemistry, Oct-27, Volume: 54, Issue:20
Azaxanthene based selective glucocorticoid receptor modulators: design, synthesis, and pharmacological evaluation of (S)-4-(5-(1-((1,3,4-thiadiazol-2-yl)amino)-2-methyl-1-oxopropan-2-yl)-5H-chromeno[2,3-b]pyridin-2-yl)-2-fluoro-N,N-dimethylbenzamide (BMS-
AID626274Toxicity in B10.R3 mouse collagen-induced arthritis model assessed as change in serum triglyceride level at 3 mg/kg, po qd for 5 weeks relative to control2011Bioorganic & medicinal chemistry letters, Nov-15, Volume: 21, Issue:22
Non-steroidal dissociated glucocorticoid agonists: indoles as A-ring mimetics and function-regulating pharmacophores.
AID440599Antiinflammatory activity in albino rat assessed as inhibition of increase in plasma PGE2 level at 25 mg/kg, po by EIA2009European journal of medicinal chemistry, Dec, Volume: 44, Issue:12
Analgesic, anticonvulsant and anti-inflammatory activities of some synthesized benzodiazipine, triazolopyrimidine and bis-imide derivatives.
AID578375Agonist activity at GR expressed in african green monkey CV1 cells transfected with luciferase gene linked to MMTV promoter assessed as induction of luciferase transactivation activity relative to Dexamethasone2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Tetrahydroquinolin-3-yl carbamate glucocorticoid receptor agonists with reduced PEPCK activation.
AID362581Inhibition of granuloma formation in cotton pellet implanted Lewis rat at 1.0 mg/kg, po bid2008Bioorganic & medicinal chemistry, Aug-15, Volume: 16, Issue:16
Discovery of betamethasone 17alpha-carbamates as dissociated glucocorticoid receptor modulators in the rat.
AID350315Toxicity in dextran sodium sulfate treated po dosed BALB/c mouse ulcerative colitis model assessed as reduction in thymus weight to body weight ratio administered twice daily for 6 days relative to control2009Journal of medicinal chemistry, May-28, Volume: 52, Issue:10
Design, synthesis, and pharmacological effects of a cyclization-activated steroid prodrug for colon targeting in inflammatory bowel disease.
AID626810Transactivation activity at glucocorticoid receptor alpha human 13D3/Huh7 cells assessed as induction of TAT activity after 4 hrs by spectrophotometry2011Journal of medicinal chemistry, Oct-27, Volume: 54, Issue:20
Azaxanthene based selective glucocorticoid receptor modulators: design, synthesis, and pharmacological evaluation of (S)-4-(5-(1-((1,3,4-thiadiazol-2-yl)amino)-2-methyl-1-oxopropan-2-yl)-5H-chromeno[2,3-b]pyridin-2-yl)-2-fluoro-N,N-dimethylbenzamide (BMS-
AID515516Binding affinity to mineralocorticoid receptor expressed in baculovirus-infected insect cells using tetramethylrhodamine labeled Dexamethasone by fluorescence polarization microplate assay2010Journal of medicinal chemistry, Sep-23, Volume: 53, Issue:18
Nonsteroidal dissociated glucocorticoid agonists containing azaindoles as steroid A-ring mimetics.
AID51049Binding affinity against corticosteroid-binding globulin1993Journal of medicinal chemistry, Feb-19, Volume: 36, Issue:4
Structure-activity relationships from molecular similarity matrices.
AID604799Transactivation activity of glucocorticoid receptor ligand binding domain expressed in human NP-1 Hela cells co-expressing GAL4 DNA binding domain by luciferase reporter gene assay2010Journal of medicinal chemistry, Dec-09, Volume: 53, Issue:23
Dimethyl-diphenyl-propanamide derivatives as nonsteroidal dissociated glucocorticoid receptor agonists.
AID699974Antiinflammatory activity against DSS-induced colitis BALB/c mouse model assessed as reduction in TNFalpha level at 5 mg/kg, po qd for 7 days measured on day 7 relative to vehicle-treated control2012Journal of medicinal chemistry, Jun-14, Volume: 55, Issue:11
6-(methylamino)hexane-1,2,3,4,5-pentanol 4-(((1S,2S)-1-hydroxy-2,3-dihydro-1H,1'H-[2,2-biinden]-2-yl)methyl)benzoate (PH46A): a novel small molecule with efficacy in murine models of colitis.
AID1075822Toxicity in collagen-induced B10.RIII mouse arthritis model assessed as change in body fat at 30 mg/kg, po qd for 35 days relative to 1% methylcellulose-treated control2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Identification of highly efficacious glucocorticoid receptor agonists with a potential for reduced clinical bone side effects.
AID187589Recovery of steroid from small intestine at 3h after administration of 7.5 mg of the compound1984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
A colon-specific drug-delivery system based on drug glycosides and the glycosidases of colonic bacteria.
AID51048In silico binding affinity to human corticosteriod binding globulin1997Journal of medicinal chemistry, Sep-26, Volume: 40, Issue:20
Validation of EGSITE2, a mixed integer program for deducing objective site models for experimental binding data.
AID81481Inhibitory concentration against interleukin-1 beta production in HL-60 cells stimulated with lipopolysaccharide (LPS).2001Bioorganic & medicinal chemistry letters, Sep-03, Volume: 11, Issue:17
Synthesis and bioactivities of novel 5,6-bis(4-methoxyphenyl)-2H-pyridazin-3-one derivatives: inhibitors of interleukin-1 beta (IL-1beta) production.
AID24428Partition coefficient (logP)1985Journal of medicinal chemistry, Jan, Volume: 28, Issue:1
Drug glycosides: potential prodrugs for colon-specific drug delivery.
AID330359Activity at human glucocorticoid receptor expressed in CV1 cells assessed as repression of TNF and IL-1-beta-induced E-selectin gene expression by luciferase reporter gene assay2007Proceedings of the National Academy of Sciences of the United States of America, Dec-04, Volume: 104, Issue:49
Antiinflammatory glucocorticoid receptor ligand with reduced side effects exhibits an altered protein-protein interaction profile.
AID1380156Induction of nuclear translocation of mineralocorticoid receptor in human EA.hy926 cells after 1 hr by Hoechst staining-based method2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID604855Transactivation activity at glucocorticoid receptor in human 13D3/Huh7 cells assessed as induction of tyrosine aminotransferase activity after 24 hrs relative to Dexamethasone2010Journal of medicinal chemistry, Dec-09, Volume: 53, Issue:23
Dimethyl-diphenyl-propanamide derivatives as nonsteroidal dissociated glucocorticoid receptor agonists.
AID1210069Inhibition of human recombinant CYP2J2 assessed as reduction in astemizole O-demethylation by LC-MS/MS method2013Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1
Discovery and characterization of novel, potent, and selective cytochrome P450 2J2 inhibitors.
AID515515Binding affinity to progesterone receptor expressed in baculovirus-infected insect cells using tetramethylrhodamine labeled RU-486 by fluorescence polarization microplate assay2010Journal of medicinal chemistry, Sep-23, Volume: 53, Issue:18
Nonsteroidal dissociated glucocorticoid agonists containing azaindoles as steroid A-ring mimetics.
AID227700Anticonvulsant activity2003Bioorganic & medicinal chemistry letters, Aug-18, Volume: 13, Issue:16
Topological virtual screening: a way to find new anticonvulsant drugs from chemical diversity.
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
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]
AID331514Displacement of radiolabeled Dexamethasone from glucocorticoid receptor2008Bioorganic & medicinal chemistry letters, Jun-15, Volume: 18, Issue:12
Discovery of nonsteroidal glucocorticoid receptor ligands based on 6-indole-1,2,3,4-tetrahydroquinolines.
AID81558Transcriptional repression in HepG2 cells expressing human glucocorticoid receptor2003Journal of medicinal chemistry, Mar-13, Volume: 46, Issue:6
Nonsteroidal selective glucocorticoid modulators: the effect of C-10 substitution on receptor selectivity and functional potency of 5-allyl-2,5-dihydro-2,2,4-trimethyl-1H-[1]benzopyrano[3,4-f]quinolines.
AID74083Transcriptional activation in CV-1 cells expressing glucocorticoid receptor2001Journal of medicinal chemistry, Aug-30, Volume: 44, Issue:18
Synthesis and characterization of non-steroidal ligands for the glucocorticoid receptor: selective quinoline derivatives with prednisolone-equivalent functional activity.
AID1125637Toxicity in B10.RIII mouse assessed as body fate level in serum at 3 mg/kg, po qd for 5 weeks relative to control2014Bioorganic & medicinal chemistry letters, Apr-15, Volume: 24, Issue:8
Discovery of a potent and dissociated non-steroidal glucocorticoid receptor agonist containing an alkyl carbinol pharmacophore.
AID626808Transactivation activity at GR-alpha in human NP1 Hela cells assessed as induction of GAL4-DBD after 20 hrs by luciferase reporter gene assay2011Journal of medicinal chemistry, Oct-27, Volume: 54, Issue:20
Azaxanthene based selective glucocorticoid receptor modulators: design, synthesis, and pharmacological evaluation of (S)-4-(5-(1-((1,3,4-thiadiazol-2-yl)amino)-2-methyl-1-oxopropan-2-yl)-5H-chromeno[2,3-b]pyridin-2-yl)-2-fluoro-N,N-dimethylbenzamide (BMS-
AID267774Activity at GR assessed as ability to antagonize dexamethasone-induced MMTV luciferase reporter gene transactivation in human A549 cells2006Journal of medicinal chemistry, Jul-13, Volume: 49, Issue:14
Dissociated nonsteroidal glucocorticoid receptor modulators; discovery of the agonist trigger in a tetrahydronaphthalene-benzoxazine series.
AID39148Binding affinity for androgen receptor2001Journal of medicinal chemistry, Aug-30, Volume: 44, Issue:18
Synthesis and characterization of non-steroidal ligands for the glucocorticoid receptor: selective quinoline derivatives with prednisolone-equivalent functional activity.
AID1319838Anti-autoimmune activity in lupus prone NZB/WF1 mouse model assessed as protection against inflammatory infiltration at 10 mg/kg, po administered qd for 16 weeks2016Journal of medicinal chemistry, 10-13, Volume: 59, Issue:19
Discovery of 6-Fluoro-5-(R)-(3-(S)-(8-fluoro-1-methyl-2,4-dioxo-1,2-dihydroquinazolin-3(4H)-yl)-2-methylphenyl)-2-(S)-(2-hydroxypropan-2-yl)-2,3,4,9-tetrahydro-1H-carbazole-8-carboxamide (BMS-986142): A Reversible Inhibitor of Bruton's Tyrosine Kinase (BT
AID1380159Dose normalized Cmax in Han-Wistar rat at 3.5 mg/kg, po2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID1380147Therapeutic index, ratio of fEC50 for transactivation of GR in cryopreserved human primary hepatocytes assessed as upregulation of TAT mRNA expression level to fIC30 for transrepression of GR in human whole blood assessed as inhibition of LPS-induced TNF-2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID626807Transrepression activity at glucocorticoid receptor alpha in IL-1beta-stimulated human A549 cells assessed as inhibition of NFkappaB-dependent E-selectin transcription by luciferase reporter gene assay relative to Dexamethasone2011Journal of medicinal chemistry, Oct-27, Volume: 54, Issue:20
Azaxanthene based selective glucocorticoid receptor modulators: design, synthesis, and pharmacological evaluation of (S)-4-(5-(1-((1,3,4-thiadiazol-2-yl)amino)-2-methyl-1-oxopropan-2-yl)-5H-chromeno[2,3-b]pyridin-2-yl)-2-fluoro-N,N-dimethylbenzamide (BMS-
AID1265331Inhibition of LPS-induced TNF-alpha production in mouse RAW264.7 cells pretreated with compound at 10 uM for 1 hr followed by addition of 1 ug/ml LPS for 6 hrs by ELISA2015Bioorganic & medicinal chemistry letters, Dec-15, Volume: 25, Issue:24
Attenuation of TNF-α secretion by L-proline-based cyclic dipeptides produced by culture broth of Pseudomonas aeruginosa.
AID330367Toxicity in Swiss-Webster mouse assessed as increase in body fat at 10 mg/kg after 28 days2007Proceedings of the National Academy of Sciences of the United States of America, Dec-04, Volume: 104, Issue:49
Antiinflammatory glucocorticoid receptor ligand with reduced side effects exhibits an altered protein-protein interaction profile.
AID699959Antiinflammatory activity against DSS-induced colitis BALB/c mouse model assessed as prevention of body weigth loss at 5 mg/kg, po qd for 7 days measured on day 7 relative to vehicle-treated control2012Journal of medicinal chemistry, Jun-14, Volume: 55, Issue:11
6-(methylamino)hexane-1,2,3,4,5-pentanol 4-(((1S,2S)-1-hydroxy-2,3-dihydro-1H,1'H-[2,2-biinden]-2-yl)methyl)benzoate (PH46A): a novel small molecule with efficacy in murine models of colitis.
AID1380138Transrepression activity at glucocorticoid receptor (unknown origin) expressed in human ChaGoK1 cells assessed as inhibition of PMA-stimulated gene expression incubated for 24 hrs by beta-galactosidase reporter gene assay relative to dexamethasone2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID1071625Antiinflammatory activity in po dosed Sprague-Dawley rat assessed as inhibition of carrageenan-induced IL-1beta secretion incubated for 2 hrs prior to carrageenan challenge measured after 5 hrs by ELISA2014Journal of medicinal chemistry, Feb-13, Volume: 57, Issue:3
Glucocorticoid receptor modulators informed by crystallography lead to a new rationale for receptor selectivity, function, and implications for structure-based design.
AID360026Immunosuppressive activity in human PBMC assessed as inhibition of LPS-stimulated TNFalpha production at 0.3 ug/mL after 18 to 24 hrs by ELISA2001Journal of natural products, May, Volume: 64, Issue:5
Immunosuppressive sesquiterpene alkaloids from Tripterygium wilfordii.
AID1380170Clearance in Han-Wistar rat at 0.9 mg/kg, iv2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID126442Binding affinity towards aldosterone receptor (Mineralocorticoid receptor)2003Journal of medicinal chemistry, Mar-13, Volume: 46, Issue:6
Nonsteroidal selective glucocorticoid modulators: the effect of C-10 substitution on receptor selectivity and functional potency of 5-allyl-2,5-dihydro-2,2,4-trimethyl-1H-[1]benzopyrano[3,4-f]quinolines.
AID604852Transrepression activity of glucocorticoid receptor in human A549 cells assessed as inhibition of IL1beta-stimulated NFkappaB-dependent E-selectin transcription by luciferase reporter gene assay relative to Dexamethasone2010Journal of medicinal chemistry, Dec-09, Volume: 53, Issue:23
Dimethyl-diphenyl-propanamide derivatives as nonsteroidal dissociated glucocorticoid receptor agonists.
AID1328546Binding affinity to PR (unknown origin) by FP assay2016Bioorganic & medicinal chemistry letters, 12-01, Volume: 26, Issue:23
Discovery of indazole ethers as novel, potent, non-steroidal glucocorticoid receptor modulators.
AID604860Antiinflammatory activity against carrageenan-induced paw edema Sprague-Dawley rat model assessed as inhibition of hind paw swelling at 30 mg/kg, po measured after 5 hrs post carrageenan challenge2010Journal of medicinal chemistry, Dec-09, Volume: 53, Issue:23
Dimethyl-diphenyl-propanamide derivatives as nonsteroidal dissociated glucocorticoid receptor agonists.
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID330372Toxicity in Swiss-Webster mouse assessed as decrease in bone formation at 30 mg/kg after 28 days2007Proceedings of the National Academy of Sciences of the United States of America, Dec-04, Volume: 104, Issue:49
Antiinflammatory glucocorticoid receptor ligand with reduced side effects exhibits an altered protein-protein interaction profile.
AID161614Bronchoalveolar lavages was collected after 6 hr in an ascaris-induced nonhuman primate model of asthma at 1 mg/kg dose (for eotaxin)2000Journal of medicinal chemistry, Aug-10, Volume: 43, Issue:16
3,5-Bis(trifluoromethyl)pyrazoles: a novel class of NFAT transcription factor regulator.
AID156392Binding affinity towards progesterone receptor (PR) by displacing [3H]progesterone.2001Journal of medicinal chemistry, Dec-06, Volume: 44, Issue:25
Nonsteroidal selective glucocorticoid modulators: the effect of C-5 alkyl substitution on the transcriptional activation/repression profile of 2,5-dihydro-10-methoxy-2,2,4-trimethyl-1H-[1]benzopyrano[3,4-f]quinolines.
AID407366Displacement of 1-anilinonaphthalene-8-sulphonic acid from rat recombinant L-FABP high binding affinity site expressed in Escherichia coli BL21 by competitive fluorescence displacement assay2008Journal of medicinal chemistry, Jul-10, Volume: 51, Issue:13
Characterization of the drug binding specificity of rat liver fatty acid binding protein.
AID362594Effect on body weight change in Lewis rat with implanted cotton pellets at 2.5 mg/kg, po bid for 4 days2008Bioorganic & medicinal chemistry, Aug-15, Volume: 16, Issue:16
Discovery of betamethasone 17alpha-carbamates as dissociated glucocorticoid receptor modulators in the rat.
AID1309957Inhibition of TNFalpha production in intestinal mucosa derived from Crohn's disease patient at 1 uM measured after 24 hrs by sandwich ELISA2016Journal of medicinal chemistry, 05-26, Volume: 59, Issue:10
The Identification and Pharmacological Characterization of 6-(tert-Butylsulfonyl)-N-(5-fluoro-1H-indazol-3-yl)quinolin-4-amine (GSK583), a Highly Potent and Selective Inhibitor of RIP2 Kinase.
AID552717Displacement of radiolabeled Dexamethasone from glucocorticoid receptor expressed in baculovirus2011Bioorganic & medicinal chemistry letters, Jan-01, Volume: 21, Issue:1
Tetrahydroquinoline glucocorticoid receptor agonists: discovery of a 3-hydroxyl for improving receptor selectivity.
AID223738The compound was tested for IL-1 generation on CMC-LPS air-pouch model at 2.5 mg/kg by oral administration1992Journal of medicinal chemistry, Dec-11, Volume: 35, Issue:25
A novel orally active inhibitor of IL-1 generation: synthesis and structure-activity relationships of 3-(4-hydroxy-1-naphthalenyl)-2-propenoic acid derivatives.
AID360028Immunosuppressive activity in human PBMC assessed as inhibition of LPS-stimulated IL8 production at 0.3 ug/mL after 18 to 24 hrs by ELISA2001Journal of natural products, May, Volume: 64, Issue:5
Immunosuppressive sesquiterpene alkaloids from Tripterygium wilfordii.
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]
AID1125607Displacement of TAMRA-labeled dexamethasone from glucocorticoid receptor (unknown origin) by fluorescence polarization assay2014Bioorganic & medicinal chemistry letters, Apr-15, Volume: 24, Issue:8
Discovery of a potent and dissociated non-steroidal glucocorticoid receptor agonist containing an alkyl carbinol pharmacophore.
AID136368Observation of behavior in mice following 30 mg/kg i.p. administration; No significant change.2001Bioorganic & medicinal chemistry letters, Sep-03, Volume: 11, Issue:17
Synthesis and bioactivities of novel pyridazine derivatives: inhibitors of interleukin-1 beta (IL-1beta) production.
AID440598Antiinflammatory activity in albino rat assessed as protection against carrageenan-induced paw edema at 50 mg/kg, po administered 1 hr before carrageenan challenge measured after 4 hrs2009European journal of medicinal chemistry, Dec, Volume: 44, Issue:12
Analgesic, anticonvulsant and anti-inflammatory activities of some synthesized benzodiazipine, triazolopyrimidine and bis-imide derivatives.
AID307449Inhibition of DNFB-induced ear edema in mouse chronic dermatitis model at 10 mg/kg, ip after 24 hrs relative to control2007Bioorganic & medicinal chemistry letters, Jun-15, Volume: 17, Issue:12
Development of 6-benzyl substituted 4-aminocarbonyl-1,4-diazepane-2,5-diones as orally active human chymase inhibitors.
AID1380149Therapeutic index, ratio of fIC20 for transrepression of GR in cryopreserved human fetal osteoblasts assessed as inhibition of OPG mRNA expression to fIC30 for transrepression of GR in human whole blood assessed as inhibition of LPS-induced TNF-alpha rele2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID360031Immunosuppressive activity in human PBMC assessed as inhibition of LPS-stimulated IFN-gamma production at 0.3 ug/mL after 18 to 24 hrs by ELISA2001Journal of natural products, May, Volume: 64, Issue:5
Immunosuppressive sesquiterpene alkaloids from Tripterygium wilfordii.
AID362612Effect on thymus weight in Lewis rat with implanted cotton pellets at 2.5 mg/kg, po bid2008Bioorganic & medicinal chemistry, Aug-15, Volume: 16, Issue:16
Discovery of betamethasone 17alpha-carbamates as dissociated glucocorticoid receptor modulators in the rat.
AID604862Toxicity in carrageenan-induced paw edema Sprague-Dawley rat model assessed as increase in blood glucose level at 30 mg/kg, po measured after 5 hrs post carrageenan challenge by glucometer2010Journal of medicinal chemistry, Dec-09, Volume: 53, Issue:23
Dimethyl-diphenyl-propanamide derivatives as nonsteroidal dissociated glucocorticoid receptor agonists.
AID299616Displacement of radiolabeled Dexamethasone from glucocorticoid receptor2007Bioorganic & medicinal chemistry letters, Aug-01, Volume: 17, Issue:15
5(Z)-benzylidene-1,2-dihydro-9-hydroxy-10-methoxy-2,2,4-trimethyl-5H-1-aza-6-oxa-chrysenes as non-steroidal glucocorticoid receptor modulators.
AID1380150Displacement of [3H]progesterone from progesterone receptor in human T47D cells after 1200 mins by scintillation counting method2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID394976Selectivity for IgE production in BALB/c mouse spleen B cells over IgG1 production in BALB/c mouse spleen B cells2009Bioorganic & medicinal chemistry letters, Mar-01, Volume: 19, Issue:5
Pseurotin A and its analogues as inhibitors of immunoglobulin E [correction of immunoglobuline E] production.
AID91481Binding constant against human serum albumin (HSA)2001Journal of medicinal chemistry, Dec-06, Volume: 44, Issue:25
Cheminformatic models to predict binding affinities to human serum albumin.
AID70976Binding affinity for estrogen receptor2001Journal of medicinal chemistry, Aug-30, Volume: 44, Issue:18
Synthesis and characterization of non-steroidal ligands for the glucocorticoid receptor: selective quinoline derivatives with prednisolone-equivalent functional activity.
AID699957Antiinflammatory activity against DSS-induced colitis BALB/c mouse model assessed as reduction in shortening of colon at 5 mg/kg, po qd for 7 days measured on day 7 relative to vehicle-treated control2012Journal of medicinal chemistry, Jun-14, Volume: 55, Issue:11
6-(methylamino)hexane-1,2,3,4,5-pentanol 4-(((1S,2S)-1-hydroxy-2,3-dihydro-1H,1'H-[2,2-biinden]-2-yl)methyl)benzoate (PH46A): a novel small molecule with efficacy in murine models of colitis.
AID661543Antiinflammatory activity in human RBC assessed as membrane stabilization at 100 ug/mL after 30 mins by UV-Visible spectrophotometry2012Bioorganic & medicinal chemistry letters, Jun-01, Volume: 22, Issue:11
Synthesis, study on anti-arthritic, anti-inflammatory activity and toxicity of some novel bis-oxy cyclophane diamides.
AID1309958Inhibition of IL6 production in intestinal mucosa derived from Crohn's disease patient at 1 uM measured after 24 hrs by sandwich ELISA2016Journal of medicinal chemistry, 05-26, Volume: 59, Issue:10
The Identification and Pharmacological Characterization of 6-(tert-Butylsulfonyl)-N-(5-fluoro-1H-indazol-3-yl)quinolin-4-amine (GSK583), a Highly Potent and Selective Inhibitor of RIP2 Kinase.
AID1460370Anti-inflammatory activity in Wistar rat assessed as inhibition of croton oil-induced ear edema at 30 mg/kg, po relative to control2017Bioorganic & medicinal chemistry letters, 02-01, Volume: 27, Issue:3
Discovery of new selective glucocorticoid receptor agonist leads.
AID640510Transactivation of glucocorticoid receptor in rat H42E cells assessed as induction of TAT measuring degradation of tyrosine to p-hydroxy phenyl pyruvate2012Bioorganic & medicinal chemistry letters, Jan-15, Volume: 22, Issue:2
Steroidal C-21 heteroaryl thioethers (Part 2): discovery of orally bioavailable selective glucocorticoid receptor modulators (dissociated steroids).
AID1530702Displacement of [3H]progesterone from progesterone receptor in human T47D cells after 20 hrs by scintillation counting method2019European journal of medicinal chemistry, Jan-01, Volume: 161Discovery of a subnanomolar and selective spirocyclic agonist of the glucocorticoid receptor.
AID1071639Displacement of [3H]-aldosterone from human mineralocorticoid receptor expressed in HEK293 cells2014Journal of medicinal chemistry, Feb-13, Volume: 57, Issue:3
Glucocorticoid receptor modulators informed by crystallography lead to a new rationale for receptor selectivity, function, and implications for structure-based design.
AID331520Activity at glucocorticoid receptor assessed as repression of TNFalpha and IL1 beta-induced E-selectin expression relative to prednislone2008Bioorganic & medicinal chemistry letters, Jun-15, Volume: 18, Issue:12
Discovery of nonsteroidal glucocorticoid receptor ligands based on 6-indole-1,2,3,4-tetrahydroquinolines.
AID699540Inhibition of human liver OATP1B3 expressed in HEK293 Flp-In cells assessed as reduction in [3H]E17-betaG uptake at 20 uM incubated for 5 mins by scintillation counting2012Journal of medicinal chemistry, May-24, Volume: 55, Issue:10
Classification of inhibitors of hepatic organic anion transporting polypeptides (OATPs): influence of protein expression on drug-drug interactions.
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.
AID626820Antiinflammatory activity in human whole blood assessed as inhibition of TNF-alpha-induced IL-8 production after overnight incubation by ELISA relative to dexamethasone2011Journal of medicinal chemistry, Oct-27, Volume: 54, Issue:20
Azaxanthene based selective glucocorticoid receptor modulators: design, synthesis, and pharmacological evaluation of (S)-4-(5-(1-((1,3,4-thiadiazol-2-yl)amino)-2-methyl-1-oxopropan-2-yl)-5H-chromeno[2,3-b]pyridin-2-yl)-2-fluoro-N,N-dimethylbenzamide (BMS-
AID626811Transactivation activity at glucocorticoid receptor alpha human 13D3/Huh7 cells assessed as induction of TAT activity after 4 hrs by spectrophotometry relative to Dexamethasone2011Journal of medicinal chemistry, Oct-27, Volume: 54, Issue:20
Azaxanthene based selective glucocorticoid receptor modulators: design, synthesis, and pharmacological evaluation of (S)-4-(5-(1-((1,3,4-thiadiazol-2-yl)amino)-2-methyl-1-oxopropan-2-yl)-5H-chromeno[2,3-b]pyridin-2-yl)-2-fluoro-N,N-dimethylbenzamide (BMS-
AID578373Displacement of radiolabeled Dexamethasone from GR2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Tetrahydroquinolin-3-yl carbamate glucocorticoid receptor agonists with reduced PEPCK activation.
AID350312Inhibition of dextran sodium sulfate-induced ulcerative colitis in po dosed BALB/c mouse assessed as decrease in disease activity index administered twice daily for 6 days relative to control2009Journal of medicinal chemistry, May-28, Volume: 52, Issue:10
Design, synthesis, and pharmacological effects of a cyclization-activated steroid prodrug for colon targeting in inflammatory bowel disease.
AID1211796Intrinsic clearance in cryopreserved human HepaRG cells assessed per 10'6 cells by LC-MS/MS method2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
Comparison of cryopreserved HepaRG cells with cryopreserved human hepatocytes for prediction of clearance for 26 drugs.
AID29421Partition coefficient (logP) (HPLC)2000Journal of medicinal chemistry, Jul-27, Volume: 43, Issue:15
ElogPoct: a tool for lipophilicity determination in drug discovery.
AID1380145Transrepression of GR in human whole blood assessed as inhibition of LPS-induced TNF-alpha release preincubated for 45 mins followed by LPS addition after 18 hrs by AlphaLISA method2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID659506Cmax in po dosed rat2012Bioorganic & medicinal chemistry letters, May-01, Volume: 22, Issue:9
Steroidal C-21 heteroaryl thioethers. Part 3: pregn-4-eno-[3,2-c]pyrazole fused A ring modified steroids as selective glucocorticoid receptor modulators (dissociated steroids).
AID578376Agonist activity at GR expressed in rat H4IIEC3 cells assessed as induction of PEPCK transactivation by luciferase reporter gene assay2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Tetrahydroquinolin-3-yl carbamate glucocorticoid receptor agonists with reduced PEPCK activation.
AID90422Effective concentration of compound for transcriptional activation of osteocalcin in Human cell native protein assay2004Bioorganic & medicinal chemistry letters, Apr-05, Volume: 14, Issue:7
Differentiation of in vitro transcriptional repression and activation profiles of selective glucocorticoid modulators.
AID1309959Inhibition of TNFalpha production in intestinal mucosa derived from ulcerative colitis patient at 1 uM measured after 24 hrs by sandwich ELISA2016Journal of medicinal chemistry, 05-26, Volume: 59, Issue:10
The Identification and Pharmacological Characterization of 6-(tert-Butylsulfonyl)-N-(5-fluoro-1H-indazol-3-yl)quinolin-4-amine (GSK583), a Highly Potent and Selective Inhibitor of RIP2 Kinase.
AID1075826Toxicity in collagen-induced B10.RIII mouse arthritis model assessed as change in AUC at 3 mg/kg, po qd for 35 days relative to 30% cremophor-treated control2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Identification of highly efficacious glucocorticoid receptor agonists with a potential for reduced clinical bone side effects.
AID90426Efficacy for transcriptional activation of PGE-2 in Human cell native protein assay expressed as percentage of the maximal response of Dexamethasone2004Bioorganic & medicinal chemistry letters, Apr-05, Volume: 14, Issue:7
Differentiation of in vitro transcriptional repression and activation profiles of selective glucocorticoid modulators.
AID1460371Anti-inflammatory activity in Brown Norway rat assessed as inhibition of TMA-induced ear edema at 30 mg/kg, po relative to control2017Bioorganic & medicinal chemistry letters, 02-01, Volume: 27, Issue:3
Discovery of new selective glucocorticoid receptor agonist leads.
AID626275Toxicity in B10.R3 mouse collagen-induced arthritis model assessed as change in serum triglyceride level at 30 mg/kg, po qd for 5 weeks relative to control2011Bioorganic & medicinal chemistry letters, Nov-15, Volume: 21, Issue:22
Non-steroidal dissociated glucocorticoid agonists: indoles as A-ring mimetics and function-regulating pharmacophores.
AID377780Inhibition of LPS-induced IL10 production in human PBMC at 0.3 mg/mL after 48 hrs by ELISA2005Journal of natural products, Apr, Volume: 68, Issue:4
Cyclobutane dimers from the Colombian medicinal plant Achyrocline bogotensis.
AID86562Efficacy relative to maximal response produced by Dex for E-selectin repression.2001Journal of medicinal chemistry, Dec-06, Volume: 44, Issue:25
Nonsteroidal selective glucocorticoid modulators: the effect of C-5 alkyl substitution on the transcriptional activation/repression profile of 2,5-dihydro-10-methoxy-2,2,4-trimethyl-1H-[1]benzopyrano[3,4-f]quinolines.
AID296304Activity at human glucocorticoid receptor in human HepG2 cells assessed as tyrosine amino transferase activity relative to Dexamethasone2007Bioorganic & medicinal chemistry letters, Jun-15, Volume: 17, Issue:12
Novel glucocorticoids containing a 6,5-bicyclic core fused to a pyrazole ring: synthesis, in vitro profile, molecular modeling studies, and in vivo experiments.
AID362623Inhibition of granuloma formation in cotton pellet implanted Lewis rat at 6.0 mg/kg, po bid2008Bioorganic & medicinal chemistry, Aug-15, Volume: 16, Issue:16
Discovery of betamethasone 17alpha-carbamates as dissociated glucocorticoid receptor modulators in the rat.
AID604854Transactivation activity at glucocorticoid receptor in human 13D3/Huh7 cells assessed as induction of tyrosine aminotransferase activity after 24 hrs2010Journal of medicinal chemistry, Dec-09, Volume: 53, Issue:23
Dimethyl-diphenyl-propanamide derivatives as nonsteroidal dissociated glucocorticoid receptor agonists.
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).
AID47369Inhibition of transcriptional repression in CV-1 cells expressing glucocorticoid receptor2004Bioorganic & medicinal chemistry letters, Apr-05, Volume: 14, Issue:7
Differentiation of in vitro transcriptional repression and activation profiles of selective glucocorticoid modulators.
AID350307Apparent permeability from apical to basolateral side in human Caco-2 cells by HPLC2009Journal of medicinal chemistry, May-28, Volume: 52, Issue:10
Design, synthesis, and pharmacological effects of a cyclization-activated steroid prodrug for colon targeting in inflammatory bowel disease.
AID515518Transrepression activity at glucocorticoid receptor in HFF assessed as inhibition of IL-1-induced IL-6 production after 18 to 24 hrs by ELISA relative to Dexamethasone2010Journal of medicinal chemistry, Sep-23, Volume: 53, Issue:18
Nonsteroidal dissociated glucocorticoid agonists containing azaindoles as steroid A-ring mimetics.
AID480396Agonist activity at glucocorticoid receptor in human fibroblast assessed as inhibition of IL-1-beta-induced IL6 production treated 1 hr before IL1-beta challenge measured after 24 hrs by transrepression assay2010Bioorganic & medicinal chemistry letters, May-15, Volume: 20, Issue:10
5-Functionalized indazoles as glucocorticoid receptor agonists.
AID276835Antiinflammatory activity assessed as prevention of hypotonicity-induced lysis of human RBC at 100 ug/ml2006Bioorganic & medicinal chemistry letters, Dec-01, Volume: 16, Issue:23
Synthesis and study of anti-inflammatory activity of some novel cyclophane amides.
AID224991Dose of the compound (oral administration) showing antiinflammatory effect on rat paw edema model (carrageenan-induced paw edema, CPE)1992Journal of medicinal chemistry, Jul-24, Volume: 35, Issue:15
New antiinflammatory agents. 2. 5-Phenyl-3H-imidazo[4,5-c][1,8]naphthyridin-4(5H)-ones: a new class of nonsteroidal antiinflammatory agents with potent activity like glucocorticoids.
AID240130Inhibition of GR-mediated tyrosine amino transferase activity in human HepG2 cells2005Bioorganic & medicinal chemistry letters, Apr-15, Volume: 15, Issue:8
Novel heterocyclic glucocorticoids: in vitro profile and in vivo efficacy.
AID187585Recovery of steroid from cecum at 3h after administration of 7.5 mg of the compound1984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
A colon-specific drug-delivery system based on drug glycosides and the glycosidases of colonic bacteria.
AID1380148Transrepression of GR in cryopreserved human fetal osteoblasts assessed as inhibition of OPG mRNA expression after 4 hrs by RT-qPCR analysis2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID656150Antiinflammatory activity in LPS-stimulated acute inflammation BALB/c mouse model assessed as inhibition of plasma PAI-1 level at 10 mg/kg, po administered 2 hrs before LPS challenge2012Bioorganic & medicinal chemistry letters, Apr-15, Volume: 22, Issue:8
From ApoA1 upregulation to BET family bromodomain inhibition: discovery of I-BET151.
AID626271Toxicity in B10.R3 mouse collagen-induced arthritis model assessed as change in body weight at 30 mg/kg, po qd for 5 weeks relative to control2011Bioorganic & medicinal chemistry letters, Nov-15, Volume: 21, Issue:22
Non-steroidal dissociated glucocorticoid agonists: indoles as A-ring mimetics and function-regulating pharmacophores.
AID1319837Anti-autoimmune activity in lupus prone NZB/WF1 mouse model assessed as protection against glomerular nephritis at 10 mg/kg, po administered qd for 16 weeks2016Journal of medicinal chemistry, 10-13, Volume: 59, Issue:19
Discovery of 6-Fluoro-5-(R)-(3-(S)-(8-fluoro-1-methyl-2,4-dioxo-1,2-dihydroquinazolin-3(4H)-yl)-2-methylphenyl)-2-(S)-(2-hydroxypropan-2-yl)-2,3,4,9-tetrahydro-1H-carbazole-8-carboxamide (BMS-986142): A Reversible Inhibitor of Bruton's Tyrosine Kinase (BT
AID1071623Antiinflammatory activity in Lewis rat collagen-induced arthritis model assessed as reduction in ankle diameter at 10 mg/kg, po administered for 15 days measured during compound dosing2014Journal of medicinal chemistry, Feb-13, Volume: 57, Issue:3
Glucocorticoid receptor modulators informed by crystallography lead to a new rationale for receptor selectivity, function, and implications for structure-based design.
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID589652Displacement of radiolabeled Dexamethasone from glucocorticoid receptor expressed in baculovirus2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Nonsteroidal 2,3-dihydroquinoline glucocorticoid receptor agonists with reduced PEPCK activation.
AID1380153Binding affinity to human ERalpha expressed in Sf9 cells by fluoligand binding-based fluorescence polarization method2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID362601Effect on body weight change in Lewis rat with implanted cotton pellets at 6.0 mg/kg, po bid for 7 days2008Bioorganic & medicinal chemistry, Aug-15, Volume: 16, Issue:16
Discovery of betamethasone 17alpha-carbamates as dissociated glucocorticoid receptor modulators in the rat.
AID626142Displacement of tetramethylrhodamine-labeled Dexamethasone from human recombinant mineralocorticoid receptor expressed in baculovirus infected insect cells by fluorescence polarization assay2011Bioorganic & medicinal chemistry letters, Nov-15, Volume: 21, Issue:22
Non-steroidal dissociated glucocorticoid agonists: indoles as A-ring mimetics and function-regulating pharmacophores.
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.
AID51054Binding affinity for corticosteroid binding globulin is expressed as log(1/k)1996Journal of medicinal chemistry, May-24, Volume: 39, Issue:11
Comparative molecular moment analysis (CoMMA): 3D-QSAR without molecular superposition.
AID224213Inhibitory activity against PGE-2 on CMC-LPS air-pouch model at 10 mg/kg by oral administration1992Journal of medicinal chemistry, Dec-11, Volume: 35, Issue:25
A novel orally active inhibitor of IL-1 generation: synthesis and structure-activity relationships of 3-(4-hydroxy-1-naphthalenyl)-2-propenoic acid derivatives.
AID115391Percent inhibition of anti-DNA antibody was evaluated by ELISA technique as a measure of auto-immune disease after injection of compound dose of 0.1 mg/kg in murine2002Bioorganic & medicinal chemistry letters, Jan-07, Volume: 12, Issue:1
Synthesis and antinephritic activities of quinoline-3-carboxamides and related compounds.
AID1768730Relative lipophilicity of the compound in methanol assessed as retardation factor by reversed-phase TLC analysis2021Bioorganic & medicinal chemistry letters, 10-01, Volume: 49Estimation of the lipophilicity of purine-2,6-dione-based TRPA1 antagonists and PDE4/7 inhibitors with analgesic activity.
AID626847Agonist activity at human mineralocorticoid receptor expressed in human A549 cells by fluorescence polarization assay relative to aldosterone2011Journal of medicinal chemistry, Oct-27, Volume: 54, Issue:20
Azaxanthene based selective glucocorticoid receptor modulators: design, synthesis, and pharmacological evaluation of (S)-4-(5-(1-((1,3,4-thiadiazol-2-yl)amino)-2-methyl-1-oxopropan-2-yl)-5H-chromeno[2,3-b]pyridin-2-yl)-2-fluoro-N,N-dimethylbenzamide (BMS-
AID377782Inhibition of LPS-induced TNFalpha production in human PBMC at 0.3 mg/mL after 48 hrs by ELISA2005Journal of natural products, Apr, Volume: 68, Issue:4
Cyclobutane dimers from the Colombian medicinal plant Achyrocline bogotensis.
AID1071637Displacement of [3H]-methyltrienolone from human androgen receptor expressed in HEK293 cells2014Journal of medicinal chemistry, Feb-13, Volume: 57, Issue:3
Glucocorticoid receptor modulators informed by crystallography lead to a new rationale for receptor selectivity, function, and implications for structure-based design.
AID362600Effect on body weight change in Lewis rat with implanted cotton pellets at 2.5 mg/kg, po bid for 7 days2008Bioorganic & medicinal chemistry, Aug-15, Volume: 16, Issue:16
Discovery of betamethasone 17alpha-carbamates as dissociated glucocorticoid receptor modulators in the rat.
AID579568Displacement of radiolabeled Dexamethasone from GR2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Discovery of orally available tetrahydroquinoline-based glucocorticoid receptor agonists.
AID55274Concentration of compound required to inhibit the binding of 28 nM [3H]dexamethasone by 50% to rat hepatic cytosolic receptors1987Journal of medicinal chemistry, Dec, Volume: 30, Issue:12
Synthesis of new antiinflammatory steroidal 20-carboxamides: (20R)- and (20S)-21-(N-substituted amino)-11 beta,17,20-trihydroxy-3,21-dioxo-1,4- pregnadiene.
AID185115The antiinflammatory activity was evaluated as %inhibition of croton oil induced ear edema in the left ear of rat1995Journal of medicinal chemistry, Mar-17, Volume: 38, Issue:6
New steroidal antiinflammatory antedrugs: steroidal [16 alpha,17 alpha-d]-3'-carbethoxyisoxazolines.
AID1569537Antiinflammatory activity in ulcerative colitis patient derived inflamed intestinal mucosa assessed as reduction in IL6 production at 1 uM measured after overnight incubation by immunoassay2019Journal of medicinal chemistry, 07-25, Volume: 62, Issue:14
Discovery of a First-in-Class Receptor Interacting Protein 2 (RIP2) Kinase Specific Clinical Candidate, 2-((4-(Benzo[
AID473409Displacement of [3H]DEX from human glucocorticoid receptor2010Journal of medicinal chemistry, Apr-22, Volume: 53, Issue:8
Virtual screening for the identification of novel nonsteroidal glucocorticoid modulators.
AID1380183Induction of NCOA2 recruitment in N-terminal thrombin cleavable 6-His-tagged glucocorticoid receptor (unknown origin) at 50 uM by SPR method2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID740301Transactivation of glucocorticoid receptor in HEK293 cells co-transfected with GRE assessed as induction of GRE-dependent gene expression after 6 hrs by luciferase reporter gene assay2013Bioorganic & medicinal chemistry, Apr-15, Volume: 21, Issue:8
VBP15: preclinical characterization of a novel anti-inflammatory delta 9,11 steroid.
AID240161GR-mediated transrepression of IL-6 in peritoneal exudate cells harvested from C57BI/6 mice2005Bioorganic & medicinal chemistry letters, Apr-15, Volume: 15, Issue:8
Novel heterocyclic glucocorticoids: in vitro profile and in vivo efficacy.
AID330371Toxicity in Swiss-Webster mouse assessed as decrease in bone formation at 10 mg/kg after 28 days2007Proceedings of the National Academy of Sciences of the United States of America, Dec-04, Volume: 104, Issue:49
Antiinflammatory glucocorticoid receptor ligand with reduced side effects exhibits an altered protein-protein interaction profile.
AID640508Transrepression activity at glucocorticoid receptor in human H292 cells assessed as inhibition of TNF-stimulated IL-8 production2012Bioorganic & medicinal chemistry letters, Jan-15, Volume: 22, Issue:2
Steroidal C-21 heteroaryl thioethers (Part 2): discovery of orally bioavailable selective glucocorticoid receptor modulators (dissociated steroids).
AID275000Inhibition of LPS-stimulated TNFalpha production in BALB/c mouse at 3 mg/kg, po2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Quinol-4-ones as steroid A-ring mimetics in nonsteroidal dissociated glucocorticoid agonists.
AID626278Toxicity in B10.R3 mouse collagen-induced arthritis model assessed as change in serum insulin level at 3 mg/kg, po qd for 5 weeks by ELISA relative to control2011Bioorganic & medicinal chemistry letters, Nov-15, Volume: 21, Issue:22
Non-steroidal dissociated glucocorticoid agonists: indoles as A-ring mimetics and function-regulating pharmacophores.
AID274990Inhibition of tetramethylrhodamine labeled dexamethasone binding to GR by FP assay2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Quinol-4-ones as steroid A-ring mimetics in nonsteroidal dissociated glucocorticoid agonists.
AID184569Tested for inhibition of formation of granulation tissue around the cotton pellet treated with steroid1987Journal of medicinal chemistry, Dec, Volume: 30, Issue:12
Synthesis of new antiinflammatory steroidal 20-carboxamides: (20R)- and (20S)-21-(N-substituted amino)-11 beta,17,20-trihydroxy-3,21-dioxo-1,4- pregnadiene.
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).
AID313952Inhibition of pleural eosinophils infiltration into BAL fluid in rat at 10 mg/kg, po tid after 24 hrs2008Bioorganic & medicinal chemistry letters, Feb-01, Volume: 18, Issue:3
Synthetic study of VLA-4/VCAM-1 inhibitors: synthesis and structure-activity relationship of piperazinylphenylalanine derivatives.
AID330368Toxicity in Swiss-Webster mouse assessed as increase in body fat at 30 mg/kg after 28 days2007Proceedings of the National Academy of Sciences of the United States of America, Dec-04, Volume: 104, Issue:49
Antiinflammatory glucocorticoid receptor ligand with reduced side effects exhibits an altered protein-protein interaction profile.
AID188016Anti-inflammatory effect in rat granuloma assay, activity relative to hydrocortisone and hydrocortisone 21-acetate1983Journal of medicinal chemistry, Mar, Volume: 26, Issue:3
Structure-activity relationships in the antiinflammatory steroids: a pattern-recognition approach.
AID1075825Toxicity in collagen-induced B10.RIII mouse arthritis model assessed as change in AUC at 30 mg/kg, po qd for 35 days relative to 30% cremophor-treated control2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Identification of highly efficacious glucocorticoid receptor agonists with a potential for reduced clinical bone side effects.
AID47367Transcriptional activation in CV-1 cells expressing glucocorticoid receptor compared to Dexamethasone2004Bioorganic & medicinal chemistry letters, Apr-05, Volume: 14, Issue:7
Differentiation of in vitro transcriptional repression and activation profiles of selective glucocorticoid modulators.
AID626809Transactivation activity at GR-alpha in human NP1 Hela cells assessed as induction of GAL4-DBD after 20 hrs by luciferase reporter gene assay relative to Dexamethasone2011Journal of medicinal chemistry, Oct-27, Volume: 54, Issue:20
Azaxanthene based selective glucocorticoid receptor modulators: design, synthesis, and pharmacological evaluation of (S)-4-(5-(1-((1,3,4-thiadiazol-2-yl)amino)-2-methyl-1-oxopropan-2-yl)-5H-chromeno[2,3-b]pyridin-2-yl)-2-fluoro-N,N-dimethylbenzamide (BMS-
AID515541Toxicity in collagen and Freund's complete adjuvant-induced B10.RIII mouse arthritis model assessed as increase of free fatty acids level at 30 mg/kg, po qd for 5 weeks2010Journal of medicinal chemistry, Sep-23, Volume: 53, Issue:18
Nonsteroidal dissociated glucocorticoid agonists containing azaindoles as steroid A-ring mimetics.
AID1075823Toxicity in collagen-induced B10.RIII mouse arthritis model assessed as change in body fat at 3 mg/kg, po qd for 35 days relative to 1% methylcellulose-treated control2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Identification of highly efficacious glucocorticoid receptor agonists with a potential for reduced clinical bone side effects.
AID1328541Antiinflammatory activity in human primary PBMC assessed as inhibition of LPS-induced TNFalpha release preincubated for 45 mins followed by LPS addition after 18 hrs by ELISA2016Bioorganic & medicinal chemistry letters, 12-01, Volume: 26, Issue:23
Discovery of indazole ethers as novel, potent, non-steroidal glucocorticoid receptor modulators.
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID74078Inhibition of human Glucocorticoid receptor2004Journal of medicinal chemistry, May-06, Volume: 47, Issue:10
Novel N-arylpyrazolo[3,2-c]-based ligands for the glucocorticoid receptor: receptor binding and in vivo activity.
AID1413894Antiinflammatory activity against TPA-induced ear edema in BALB/c mouse assessed as weight of ear punches at 5 mM administered topically for 15 mins prior to TPA challenge and measured after 6 hrs (Rvb = 12.5 +/- 0.3 mg)2018MedChemComm, Sep-01, Volume: 9, Issue:9
Glycyrrhizic acid from licorice down-regulates inflammatory responses
AID188436Tested for inhibition of formation of granulation tissue around the cotton pellet treated with steroid and expressed as net dry weight1987Journal of medicinal chemistry, Dec, Volume: 30, Issue:12
Synthesis of new antiinflammatory steroidal 20-carboxamides: (20R)- and (20S)-21-(N-substituted amino)-11 beta,17,20-trihydroxy-3,21-dioxo-1,4- pregnadiene.
AID1380136Transrepression activity at glucocorticoid receptor (unknown origin) expressed in human ChaGoK1 cells assessed as inhibition of PMA-stimulated gene expression incubated for 24 hrs by beta-galactosidase reporter gene assay2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID90425Efficacy for transcriptional activation of IL-6 in Human cell native protein assay expressed as percentage of the maximal response of Dexamethasone2004Bioorganic & medicinal chemistry letters, Apr-05, Volume: 14, Issue:7
Differentiation of in vitro transcriptional repression and activation profiles of selective glucocorticoid modulators.
AID640612Antiinflammatory activity in rat assessed as inhibition of LPS-induced TNF-alpha secretion at 3 mg/kg, po2012Bioorganic & medicinal chemistry letters, Jan-15, Volume: 22, Issue:2
Steroidal C-21 heteroaryl thioethers (Part 2): discovery of orally bioavailable selective glucocorticoid receptor modulators (dissociated steroids).
AID515543Toxicity in B10.RIII mouse assessed as increase of triglyceride level at 30 mg/kg, po qd for 5 weeks2010Journal of medicinal chemistry, Sep-23, Volume: 53, Issue:18
Nonsteroidal dissociated glucocorticoid agonists containing azaindoles as steroid A-ring mimetics.
AID1697881Induction of beta cells proliferation in 5 days post fertilize Tg(-1.2ins:H2BmCherry) zebra fish larvae assessed as beta cell number at 10 uM after 24 hrs by confocal microscopic method (Rvb = 35 +/- 1 No_unit)2020Journal of natural products, 10-23, Volume: 83, Issue:10
Staprexanthones, Xanthone-Type Stimulators of Pancreatic β-Cell Proliferation from a Mangrove Endophytic Fungus.
AID578377Transrepression activity at GR expressed in IL-1beta- and TNFalpha-stimulated HepG2 cells assessed as inhibition of NFKB- or AP-1 mediated E-selectin transcription by luciferase reporter gene assay2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Tetrahydroquinolin-3-yl carbamate glucocorticoid receptor agonists with reduced PEPCK activation.
AID640608Antiinflammatory activity in ovalbumin-induced allergic Brown Norway rat lung inflammation model assessed as inhibition of forced vital capacity at 10 mg/kg, po qd administered 3 days before ovalbumin-challenge measured 24 hrs of post ovalbumin challenge2012Bioorganic & medicinal chemistry letters, Jan-15, Volume: 22, Issue:2
Steroidal C-21 heteroaryl thioethers (Part 2): discovery of orally bioavailable selective glucocorticoid receptor modulators (dissociated steroids).
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.
AID1328543Antiinflammatory activity in human whole blood assessed as inhibition of LPS-induced TNFalpha release preincubated for 45 mins followed by LPS addition after 18 hrs by ELISA2016Bioorganic & medicinal chemistry letters, 12-01, Volume: 26, Issue:23
Discovery of indazole ethers as novel, potent, non-steroidal glucocorticoid receptor modulators.
AID21087Octanol- water partition coefficient was determined.1987Journal of medicinal chemistry, Dec, Volume: 30, Issue:12
Synthesis of new antiinflammatory steroidal 20-carboxamides: (20R)- and (20S)-21-(N-substituted amino)-11 beta,17,20-trihydroxy-3,21-dioxo-1,4- pregnadiene.
AID304382Agonist activity at glucocorticoid receptor in human A549 cells at 10 mM by NF-kappaB transrepression assay relative to Dexamethasone2007Journal of medicinal chemistry, Dec-27, Volume: 50, Issue:26
Nonsteroidal glucocorticoid agonists: tetrahydronaphthalenes with alternative steroidal A-ring mimetics possessing dissociated (transrepression/transactivation) efficacy selectivity.
AID1380175Modulation of glucocorticoid receptor in rat whole blood2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID274995Induction of aromatase activity in HFF cells assessed as production of beta estradiol by aromatase assay2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Quinol-4-ones as steroid A-ring mimetics in nonsteroidal dissociated glucocorticoid agonists.
AID223904The compound was tested for Granuloma generation on CMC-LPS air-pouch model at 10 mg/kg by oral administration1992Journal of medicinal chemistry, Dec-11, Volume: 35, Issue:25
A novel orally active inhibitor of IL-1 generation: synthesis and structure-activity relationships of 3-(4-hydroxy-1-naphthalenyl)-2-propenoic acid derivatives.
AID552721Transrepression activity at glucocorticoid receptor in TNFalpha/IL1beta-stimulated human HepG2 cells assessed as inhibition of NFkappaB-dependent E-selectin transcription by luciferase reporter gene assay relative to Dexamethasone2011Bioorganic & medicinal chemistry letters, Jan-01, Volume: 21, Issue:1
Tetrahydroquinoline glucocorticoid receptor agonists: discovery of a 3-hydroxyl for improving receptor selectivity.
AID1075817Toxicity in collagen-induced B10.RIII mouse arthritis model assessed as change in triglyceride level at 3 mg/kg, po qd for 35 days relative to 1% methylcellulose-treated control2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Identification of highly efficacious glucocorticoid receptor agonists with a potential for reduced clinical bone side effects.
AID1328553Volume of distribution at steady state in Wistar rat at 1 umol/kg, iv through bolus administration by LC/MS/MS analysis2016Bioorganic & medicinal chemistry letters, 12-01, Volume: 26, Issue:23
Discovery of indazole ethers as novel, potent, non-steroidal glucocorticoid receptor modulators.
AID1075816Toxicity in collagen-induced B10.RIII mouse arthritis model assessed as change in triglyceride level at 30 mg/kg, po qd for 35 days relative to 1% methylcellulose-treated control2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Identification of highly efficacious glucocorticoid receptor agonists with a potential for reduced clinical bone side effects.
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.
AID680437TP_TRANSPORTER: inhibition of Ouabain uptake (Ouabain: 100 uM, Prednisolone: 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.
AID1380185Induction of NRIP1 recruitment in N-terminal thrombin cleavable 6-His-tagged glucocorticoid receptor (unknown origin) at 50 uM by SPR method2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID1328552Clearance in Wistar rat at 1 umol/kg, iv through bolus administration by LC/MS/MS analysis2016Bioorganic & medicinal chemistry letters, 12-01, Volume: 26, Issue:23
Discovery of indazole ethers as novel, potent, non-steroidal glucocorticoid receptor modulators.
AID604800Transrepression activity of glucocorticoid receptor in human A549 cells assessed as inhibition of IL1beta-stimulated NFkappaB-dependent E-selectin transcription by luciferase reporter gene assay2010Journal of medicinal chemistry, Dec-09, Volume: 53, Issue:23
Dimethyl-diphenyl-propanamide derivatives as nonsteroidal dissociated glucocorticoid receptor agonists.
AID161613Bronchoalveolar lavages was collected after 6 hr in an ascaris-induced nonhuman primate model of asthma at 1 mg/kg dose (for IL-8)2000Journal of medicinal chemistry, Aug-10, Volume: 43, Issue:16
3,5-Bis(trifluoromethyl)pyrazoles: a novel class of NFAT transcription factor regulator.
AID362599Effect on body weight change in Lewis rat with implanted cotton pellets at 1.0 mg/kg, po bid for 7 days2008Bioorganic & medicinal chemistry, Aug-15, Volume: 16, Issue:16
Discovery of betamethasone 17alpha-carbamates as dissociated glucocorticoid receptor modulators in the rat.
AID204332Inhibition of concanavalin A stimulated rat splenocyte proliferation2003Journal of medicinal chemistry, Mar-13, Volume: 46, Issue:6
Nonsteroidal selective glucocorticoid modulators: the effect of C-10 substitution on receptor selectivity and functional potency of 5-allyl-2,5-dihydro-2,2,4-trimethyl-1H-[1]benzopyrano[3,4-f]quinolines.
AID51052In silico binding affinity to corticosteroid binding globulin (CBG)1997Journal of medicinal chemistry, Dec-19, Volume: 40, Issue:26
Three-dimensional quantitative structure-activity relationships from molecular similarity matrices and genetic neural networks. 1. Method and validations.
AID626203Agonist activity at glucocorticoid receptor in human HeLa cells transfected with luciferase gene linked to MMTV promoter assessed as luciferase transactivation activity relative to Dexamethasone2011Bioorganic & medicinal chemistry letters, Nov-15, Volume: 21, Issue:22
Non-steroidal dissociated glucocorticoid agonists: indoles as A-ring mimetics and function-regulating pharmacophores.
AID699968Antiinflammatory activity against DSS-induced colitis BALB/c mouse model assessed as reduction in histological colon damage score at 5 mg/kg, po qd for 7 days measured on day 7 relative to vehicle-treated control2012Journal of medicinal chemistry, Jun-14, Volume: 55, Issue:11
6-(methylamino)hexane-1,2,3,4,5-pentanol 4-(((1S,2S)-1-hydroxy-2,3-dihydro-1H,1'H-[2,2-biinden]-2-yl)methyl)benzoate (PH46A): a novel small molecule with efficacy in murine models of colitis.
AID1181711Antiinflammatory activity in Lewis rat assessed as inhibition of LPS-induced TNF-alpha production at 30 mg/kg, po administered 90 mins prior to LPS challenge measured after 90 mins relative to vehicle-treated control2014Bioorganic & medicinal chemistry letters, Aug-01, Volume: 24, Issue:15
Discovery of acylurea isosteres of 2-acylaminothiadiazole in the azaxanthene series of glucocorticoid receptor agonists.
AID579569Agonist activity at GR expressed in african green monkey CV1 cells transfected with luciferase gene linked to MMTV promoter assessed as induction of luciferase transactivation activity relative to Dexamethasone2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Discovery of orally available tetrahydroquinoline-based glucocorticoid receptor agonists.
AID579570Agonist activity at GR expressed in african green monkey CV1 cells transfected with luciferase gene linked to MMTV promoter assessed as induction of luciferase transactivation activity2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Discovery of orally available tetrahydroquinoline-based glucocorticoid receptor agonists.
AID1460369Anti-inflammatory activity in po dosed Brown Norway rat assessed as inhibition of TMA-induced ear edema2017Bioorganic & medicinal chemistry letters, 02-01, Volume: 27, Issue:3
Discovery of new selective glucocorticoid receptor agonist leads.
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).
AID626818Antiinflammatory activity in human whole blood assessed as inhibition of LPS-induced TNFalpha production after overnight incubation by ELISA relative to Dexamethasone2011Journal of medicinal chemistry, Oct-27, Volume: 54, Issue:20
Azaxanthene based selective glucocorticoid receptor modulators: design, synthesis, and pharmacological evaluation of (S)-4-(5-(1-((1,3,4-thiadiazol-2-yl)amino)-2-methyl-1-oxopropan-2-yl)-5H-chromeno[2,3-b]pyridin-2-yl)-2-fluoro-N,N-dimethylbenzamide (BMS-
AID22293Delta logD (logD6.5 - logD7.4)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID267771Inhibition of fluorescent-labeled Dexamethasone binding to GR2006Journal of medicinal chemistry, Jul-13, Volume: 49, Issue:14
Dissociated nonsteroidal glucocorticoid receptor modulators; discovery of the agonist trigger in a tetrahydronaphthalene-benzoxazine series.
AID140313Compound was tested for the immunomodulatory activity in vitro expressed as stimulation index by lymphocyte transformation test at 0.1 ug/mL1998Bioorganic & medicinal chemistry letters, Feb-17, Volume: 8, Issue:4
Immunosuppressant activity in human beta-casein fragment analogs.
AID659505AUC in po dosed rat2012Bioorganic & medicinal chemistry letters, May-01, Volume: 22, Issue:9
Steroidal C-21 heteroaryl thioethers. Part 3: pregn-4-eno-[3,2-c]pyrazole fused A ring modified steroids as selective glucocorticoid receptor modulators (dissociated steroids).
AID1328537Binding affinity to GR (unknown origin) by FP assay2016Bioorganic & medicinal chemistry letters, 12-01, Volume: 26, Issue:23
Discovery of indazole ethers as novel, potent, non-steroidal glucocorticoid receptor modulators.
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.
AID626279Toxicity in B10.R3 mouse collagen-induced arthritis model assessed as change in serum insulin level at 30 mg/kg, po qd for 5 weeks by ELISA relative to control2011Bioorganic & medicinal chemistry letters, Nov-15, Volume: 21, Issue:22
Non-steroidal dissociated glucocorticoid agonists: indoles as A-ring mimetics and function-regulating pharmacophores.
AID1530703Antiinflammatory activity in human A549 cells assessed as inhibition of IL1beta-induced IL6 production preincubated for 30 mins followed by IL1beta-stimulation and measured after 20 hrs by AlphaLisa assay2019European journal of medicinal chemistry, Jan-01, Volume: 161Discovery of a subnanomolar and selective spirocyclic agonist of the glucocorticoid receptor.
AID356333Antiedemic activity against DMSO-induced paw edema in sc dosed Albino rat2003Journal of natural products, Aug, Volume: 66, Issue:8
Acinospesigenin-A, -B, and -C: three new triterpenoids from Phytolacca acinosa.
AID342145Antiinflammatory activity against peptidoglycan polysaccharide-induced arthritis in rat reactivation model after 14 days2008Bioorganic & medicinal chemistry letters, Aug-01, Volume: 18, Issue:15
Biphenyl amide p38 kinase inhibitors 3: Improvement of cellular and in vivo activity.
AID74226Binding affinity towards human glucocorticoid receptor (GR) was determined using [3H]dexamethasone as radioligand in SF-1 cells2003Journal of medicinal chemistry, Mar-13, Volume: 46, Issue:6
Nonsteroidal selective glucocorticoid modulators: the effect of C-10 substitution on receptor selectivity and functional potency of 5-allyl-2,5-dihydro-2,2,4-trimethyl-1H-[1]benzopyrano[3,4-f]quinolines.
AID296306Activity at human glucocorticoid receptor in C57BI/6 mouse peritoneal exudate cells assessed as repression of mouse IL6 relative to Dexamethasone2007Bioorganic & medicinal chemistry letters, Jun-15, Volume: 17, Issue:12
Novel glucocorticoids containing a 6,5-bicyclic core fused to a pyrazole ring: synthesis, in vitro profile, molecular modeling studies, and in vivo experiments.
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.
AID224207Inhibitory activity against Granuloma on CMC-LPS air-pouch model at 10 mg/kg by oral administration1992Journal of medicinal chemistry, Dec-11, Volume: 35, Issue:25
A novel orally active inhibitor of IL-1 generation: synthesis and structure-activity relationships of 3-(4-hydroxy-1-naphthalenyl)-2-propenoic acid derivatives.
AID362607Effect on spleen weight in Lewis rat with implanted cotton pellets at 6.0 mg/kg, po bid2008Bioorganic & medicinal chemistry, Aug-15, Volume: 16, Issue:16
Discovery of betamethasone 17alpha-carbamates as dissociated glucocorticoid receptor modulators in the rat.
AID1664530Antiinflammatory activity in human U937 cells assessed as inhibition of PMA/LPS-stimulated TNFalpha production at 1 uM after 24 hrs by ELISA relative to control2020Bioorganic & medicinal chemistry letters, 08-15, Volume: 30, Issue:16
Synthesis and anti-inflammatory activity of 2-oxo-2H-chromenyl and 2H-chromenyl-5-oxo-2,5-dihydrofuran-3-carboxylates.
AID299615Activity at GR assessed as repression of TNFalpha and IL 1-beta induced E-selectin response2007Bioorganic & medicinal chemistry letters, Aug-01, Volume: 17, Issue:15
5(Z)-benzylidene-1,2-dihydro-9-hydroxy-10-methoxy-2,2,4-trimethyl-5H-1-aza-6-oxa-chrysenes as non-steroidal glucocorticoid receptor modulators.
AID8455Ability to induce human IL-6 assay in A549 lung carcinoma cell line.2004Journal of medicinal chemistry, May-06, Volume: 47, Issue:10
Novel N-arylpyrazolo[3,2-c]-based ligands for the glucocorticoid receptor: receptor binding and in vivo activity.
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.
AID357246Inhibition of lipopolysaccharide IL2 production in human PMNC at 0.3 ug/mL by ELISA2002Journal of natural products, Dec, Volume: 65, Issue:12
Sesquiterpenes from Ferula penninervis.
AID202557Transcriptional repression activity in HEP G2 cells expressing glucocorticoid receptor compared to Dexamethasone2001Journal of medicinal chemistry, Aug-30, Volume: 44, Issue:18
Synthesis and characterization of non-steroidal ligands for the glucocorticoid receptor: selective quinoline derivatives with prednisolone-equivalent functional activity.
AID330370Toxicity in Swiss-Webster mouse assessed as decrease in bone formation at 3 mg/kg after 28 days2007Proceedings of the National Academy of Sciences of the United States of America, Dec-04, Volume: 104, Issue:49
Antiinflammatory glucocorticoid receptor ligand with reduced side effects exhibits an altered protein-protein interaction profile.
AID626838Antiinflammatory activity in Sprague-Dawley rat assessed as inhibition of carrageenan-induced paw edema at 30 mg/kg, po administered as a single dose 2 hrs before carrageenan challenge measured 4 hrs post carrageenan challenge by plethysmometry relative t2011Journal of medicinal chemistry, Oct-27, Volume: 54, Issue:20
Azaxanthene based selective glucocorticoid receptor modulators: design, synthesis, and pharmacological evaluation of (S)-4-(5-(1-((1,3,4-thiadiazol-2-yl)amino)-2-methyl-1-oxopropan-2-yl)-5H-chromeno[2,3-b]pyridin-2-yl)-2-fluoro-N,N-dimethylbenzamide (BMS-
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.
AID224993Oral dose required for antiinflammatory effect on zymosan induced rat paw edema.1992Journal of medicinal chemistry, Jul-24, Volume: 35, Issue:15
New antiinflammatory agents. 2. 5-Phenyl-3H-imidazo[4,5-c][1,8]naphthyridin-4(5H)-ones: a new class of nonsteroidal antiinflammatory agents with potent activity like glucocorticoids.
AID90428Efficacy for transcriptional activation of TAT in Human cell native protein assay expressed as percentage of the maximal response of Dexamethasone2004Bioorganic & medicinal chemistry letters, Apr-05, Volume: 14, Issue:7
Differentiation of in vitro transcriptional repression and activation profiles of selective glucocorticoid modulators.
AID1125629Antiarthritic activity in B10.RIII mouse collagen/complete Freund's adjuvant-induced arthritis model assessed as reduction of disease score at 30 mg/kg, po qd for 5 weeks relative to control2014Bioorganic & medicinal chemistry letters, Apr-15, Volume: 24, Issue:8
Discovery of a potent and dissociated non-steroidal glucocorticoid receptor agonist containing an alkyl carbinol pharmacophore.
AID515517Transrepression activity at glucocorticoid receptor in HFF assessed as inhibition of IL-1-induced IL-6 production after 18 to 24 hrs by ELISA2010Journal of medicinal chemistry, Sep-23, Volume: 53, Issue:18
Nonsteroidal dissociated glucocorticoid agonists containing azaindoles as steroid A-ring mimetics.
AID604861Antiinflammatory activity in po dosed carrageenan-induced paw edema Sprague-Dawley rat model assessed as inhibition of hind paw swelling after 5 hrs post carrageenan challenge2010Journal of medicinal chemistry, Dec-09, Volume: 53, Issue:23
Dimethyl-diphenyl-propanamide derivatives as nonsteroidal dissociated glucocorticoid receptor agonists.
AID515539Toxicity in collagen and Freund's complete adjuvant-induced B10.RIII mouse arthritis model assessed as increase of serum insulin level at 30 mg/kg, po qd for 5 weeks2010Journal of medicinal chemistry, Sep-23, Volume: 53, Issue:18
Nonsteroidal dissociated glucocorticoid agonists containing azaindoles as steroid A-ring mimetics.
AID640511Transactivation of glucocorticoid receptor in rat H42E cells assessed as induction of TAT measuring degradation of tyrosine to p-hydroxy phenyl pyruvate at 1 uM relative to prednisolone2012Bioorganic & medicinal chemistry letters, Jan-15, Volume: 22, Issue:2
Steroidal C-21 heteroaryl thioethers (Part 2): discovery of orally bioavailable selective glucocorticoid receptor modulators (dissociated steroids).
AID1473740Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID182857Adjuvant arthritic activity in rat injected leg on day 16 tested at 20 mg/kg perorally.1984Journal of medicinal chemistry, Jan, Volume: 27, Issue:1
Antiinflammatory activity of 5,6-diaryl-2,3-dihydroimidazo[2,1-b]thiazoles. Isomeric 4-pyridyl and 4-substituted phenyl derivatives.
AID1328549Binding affinity to ERalpha (unknown origin) by FP assay2016Bioorganic & medicinal chemistry letters, 12-01, Volume: 26, Issue:23
Discovery of indazole ethers as novel, potent, non-steroidal glucocorticoid receptor modulators.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
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.
AID296308Activity at human glucocorticoid receptor in C2C12 cells assessed as mouse glutamine synthetase activity relative to Dexamethasone2007Bioorganic & medicinal chemistry letters, Jun-15, Volume: 17, Issue:12
Novel glucocorticoids containing a 6,5-bicyclic core fused to a pyrazole ring: synthesis, in vitro profile, molecular modeling studies, and in vivo experiments.
AID377781Inhibition of LPS-induced IL12 production in human PBMC at 0.3 mg/mL after 48 hrs by ELISA2005Journal of natural products, Apr, Volume: 68, Issue:4
Cyclobutane dimers from the Colombian medicinal plant Achyrocline bogotensis.
AID1688017Inhibition of LPS-induced IL-1beta expression in human U-937 cells preincubated for 1 hr followed by LPS addition and measured after 24 hrs by ELISA2020European journal of medicinal chemistry, Feb-15, Volume: 188Synthesis and biological evaluation of some novel 1,2,3-triazole hybrids of myrrhanone B isolated from Commiphora mukul gum resin: Identification of potent antiproliferative leads active against prostate cancer cells (PC-3).
AID243854Percent inhibition of LPS-induced tumor necrosis factor alpha release in mice relative to prednisolone at 3 mg/kg dose2005Bioorganic & medicinal chemistry letters, Apr-15, Volume: 15, Issue:8
Novel heterocyclic glucocorticoids: in vitro profile and in vivo efficacy.
AID1125610Agonist activity at glucocorticoid receptor in human foreskin fibroblasts assessed as inhibition of IL-1-induced IL-6 production by trans-repression assay2014Bioorganic & medicinal chemistry letters, Apr-15, Volume: 24, Issue:8
Discovery of a potent and dissociated non-steroidal glucocorticoid receptor agonist containing an alkyl carbinol pharmacophore.
AID212921Binding affinity towards testosterone receptor2003Journal of medicinal chemistry, Mar-13, Volume: 46, Issue:6
Nonsteroidal selective glucocorticoid modulators: the effect of C-10 substitution on receptor selectivity and functional potency of 5-allyl-2,5-dihydro-2,2,4-trimethyl-1H-[1]benzopyrano[3,4-f]quinolines.
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).
AID47366Repression of transcriptional activity in CV-1 cells expressing glucocorticoid receptor compared to Dexamethasone2004Bioorganic & medicinal chemistry letters, Apr-05, Volume: 14, Issue:7
Differentiation of in vitro transcriptional repression and activation profiles of selective glucocorticoid modulators.
AID73767Inhibition of [3H]dexamethasone binding to glucocorticoid receptor of human blood mononuclear cells2004Journal of medicinal chemistry, Jan-29, Volume: 47, Issue:3
Synthesis of nitro esters of prednisolone, new compounds combining pharmacological properties of both glucocorticoids and nitric oxide.
AID51058Binding affinity towards corticosteroid-binding globulin (CBG)2003Journal of medicinal chemistry, Apr-10, Volume: 46, Issue:8
Mapping property distributions of molecular surfaces: algorithm and evaluation of a novel 3D quantitative structure-activity relationship technique.
AID1380179Antiinflammatory activity in streptococcal cell wall reactivation Lewis rat model assessed as reduction of joint swelling at 5 mg/kg administered once daily for 8 days by oral gavage starting 1 day prior to streptococcal cell wall challenge measured durin2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID394974Selectivity for IgE production in BALB/c mouse spleen B cells over IgM production in BALB/c mouse spleen B cells2009Bioorganic & medicinal chemistry letters, Mar-01, Volume: 19, Issue:5
Pseurotin A and its analogues as inhibitors of immunoglobulin E [correction of immunoglobuline E] production.
AID182980Adjuvant arthritic activity in rat uninjected leg on day 16 tested at 20 mg/kg perorally.1984Journal of medicinal chemistry, Jan, Volume: 27, Issue:1
Antiinflammatory activity of 5,6-diaryl-2,3-dihydroimidazo[2,1-b]thiazoles. Isomeric 4-pyridyl and 4-substituted phenyl derivatives.
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.
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID299612Agonist activity at GR by GRE activation assay2007Bioorganic & medicinal chemistry letters, Aug-01, Volume: 17, Issue:15
5(Z)-benzylidene-1,2-dihydro-9-hydroxy-10-methoxy-2,2,4-trimethyl-5H-1-aza-6-oxa-chrysenes as non-steroidal glucocorticoid receptor modulators.
AID51059Binding affinity to corticosteroid binding globulin1998Journal of medicinal chemistry, Jul-02, Volume: 41, Issue:14
Three-dimensional quantitative similarity-activity relationships (3D QSiAR) from SEAL similarity matrices.
AID1664533Antiinflammatory activity in human U937 cells assessed as inhibition of PMA/LPS-stimulated TNFalpha production after 24 hrs by ELISA2020Bioorganic & medicinal chemistry letters, 08-15, Volume: 30, Issue:16
Synthesis and anti-inflammatory activity of 2-oxo-2H-chromenyl and 2H-chromenyl-5-oxo-2,5-dihydrofuran-3-carboxylates.
AID274997Activation of MMTV in HeLa cells measured by luciferase activity2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Quinol-4-ones as steroid A-ring mimetics in nonsteroidal dissociated glucocorticoid agonists.
AID1569534Antiinflammatory activity in crohn's disease patient derived inflamed intestinal mucosa assessed as reduction in IL1beta production at 1 uM measured after overnight incubation by immunoassay2019Journal of medicinal chemistry, 07-25, Volume: 62, Issue:14
Discovery of a First-in-Class Receptor Interacting Protein 2 (RIP2) Kinase Specific Clinical Candidate, 2-((4-(Benzo[
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.
AID679082TP_TRANSPORTER: transepithelial transport of Prednisolone at a concentration of 20 uM in MDR1-expressing MDCK cells2003Pharmaceutical research, Aug, Volume: 20, Issue:8
Novel experimental parameters to quantify the modulation of absorptive and secretory transport of compounds by P-glycoprotein in cell culture models of intestinal epithelium.
AID90104Potency relative to fluocinolone 16,17-acetonide in the human vasoconstictor test1983Journal of medicinal chemistry, Mar, Volume: 26, Issue:3
Structure-activity relationships in the antiinflammatory steroids: a pattern-recognition approach.
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.
AID1413897Antiinflammatory activity against TPA-induced ear edema in BALB/c mouse assessed as weight of ear punches at 5 mM administered topically for 15 mins prior to TPA challenge and measured after 48 hrs (Rvb = 11.4 +/- 0.3 mg)2018MedChemComm, Sep-01, Volume: 9, Issue:9
Glycyrrhizic acid from licorice down-regulates inflammatory responses
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.
AID604795Displacement of GS-red from GRapha by fluorescence polarization assay2010Journal of medicinal chemistry, Dec-09, Volume: 53, Issue:23
Dimethyl-diphenyl-propanamide derivatives as nonsteroidal dissociated glucocorticoid receptor agonists.
AID115394Percent inhibition of anti-DNA antibody was evaluated by ELISA technique as a measure of auto-immune disease after injection of compound dose of 1 mg/kg in murine2002Bioorganic & medicinal chemistry letters, Jan-07, Volume: 12, Issue:1
Synthesis and antinephritic activities of quinoline-3-carboxamides and related compounds.
AID626799Displacement of GS-red from glucocorticoid receptor by fluorescence polarization assay2011Journal of medicinal chemistry, Oct-27, Volume: 54, Issue:20
Azaxanthene based selective glucocorticoid receptor modulators: design, synthesis, and pharmacological evaluation of (S)-4-(5-(1-((1,3,4-thiadiazol-2-yl)amino)-2-methyl-1-oxopropan-2-yl)-5H-chromeno[2,3-b]pyridin-2-yl)-2-fluoro-N,N-dimethylbenzamide (BMS-
AID552807Transrepression activity at glucocorticoid receptor in IL-1beta-stimulated human HepG2 cells assessed as inhibition of AP1 response element-induced IL-6 production by ELISA relative to Dexamethasone2011Bioorganic & medicinal chemistry letters, Jan-01, Volume: 21, Issue:1
Tetrahydroquinoline glucocorticoid receptor agonists: discovery of a 3-hydroxyl for improving receptor selectivity.
AID73768In vitro binding affinity against human glucocorticoid receptor (GR)2004Bioorganic & medicinal chemistry letters, Apr-05, Volume: 14, Issue:7
Differentiation of in vitro transcriptional repression and activation profiles of selective glucocorticoid modulators.
AID1380162Terminal half life in Han-Wistar rat at 0.9 mg/kg, iv2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID362595Effect on body weight change in Lewis rat with implanted cotton pellets at 6.0 mg/kg, po bid for 4 days2008Bioorganic & medicinal chemistry, Aug-15, Volume: 16, Issue:16
Discovery of betamethasone 17alpha-carbamates as dissociated glucocorticoid receptor modulators in the rat.
AID626201Transactivation activity of glucocorticoid receptor in HFF assessed as induction of aromatase activity by measuring beta-estradiol activity after 18 to 24 hrs by ELISA relative to Dexamethasone2011Bioorganic & medicinal chemistry letters, Nov-15, Volume: 21, Issue:22
Non-steroidal dissociated glucocorticoid agonists: indoles as A-ring mimetics and function-regulating pharmacophores.
AID1071634Antiinflammatory activity in human CCD-39SK cells assessed as inhibition of IL-1beta-induced IL-6 production incubated for 60 mins prior to IL-1beta induction measured after 24 hrs2014Journal of medicinal chemistry, Feb-13, Volume: 57, Issue:3
Glucocorticoid receptor modulators informed by crystallography lead to a new rationale for receptor selectivity, function, and implications for structure-based design.
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.
AID115541Percent inhibition of proteinuria by compound dose of 0.1 mg/kg given perorally to murine in chronic graft-versus-host-disease test2002Bioorganic & medicinal chemistry letters, Jan-07, Volume: 12, Issue:1
Synthesis and antinephritic activities of quinoline-3-carboxamides and related compounds.
AID243716Percent absolute inhibition of LPS-induced tumor necrosis factor alpha release in mice at 3 mg/kg dose2005Bioorganic & medicinal chemistry letters, Apr-15, Volume: 15, Issue:8
Novel heterocyclic glucocorticoids: in vitro profile and in vivo efficacy.
AID589655Transrepression activity at glucocorticoid receptor in human NHDF cells assessed as inhibition of IL-1beta-stimulated AP1 dependent IL-6 repression by ELISA2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Nonsteroidal 2,3-dihydroquinoline glucocorticoid receptor agonists with reduced PEPCK activation.
AID1091955Dissociation constant, pKa of the compound at pH 7.32011Journal of agricultural and food chemistry, Apr-13, Volume: 59, Issue:7
Importance of physicochemical properties for the design of new pesticides.
AID480399Agonist activity at glucocorticoid receptor in human MDA-kb2 cells transfected with MMTV-LUC assessed as induction of MMTV-LTR/promoter linked LUC gene at 3.3 uM by luciferase transactivation assay relative to Dexamethasone2010Bioorganic & medicinal chemistry letters, May-15, Volume: 20, Issue:10
5-Functionalized indazoles as glucocorticoid receptor agonists.
AID626280Antiarthritic activity in B10.R3 mouse collagen-induced arthritis model assessed as AUC of disease progression inhibition at 3 mg/kg, po qd for 5 weeks2011Bioorganic & medicinal chemistry letters, Nov-15, Volume: 21, Issue:22
Non-steroidal dissociated glucocorticoid agonists: indoles as A-ring mimetics and function-regulating pharmacophores.
AID182860Adjuvant arthritic activity in rat injected leg on day 3 tested at 50 mg/kg perorally1984Journal of medicinal chemistry, Jan, Volume: 27, Issue:1
Antiinflammatory activity of 5,6-diaryl-2,3-dihydroimidazo[2,1-b]thiazoles. Isomeric 4-pyridyl and 4-substituted phenyl derivatives.
AID681136TP_TRANSPORTER: inhibition of Taurocholate uptake in OAT-K2-expressing MDCK cells1999Molecular pharmacology, Apr, Volume: 55, Issue:4
Cloning and functional characterization of a new multispecific organic anion transporter, OAT-K2, in rat kidney.
AID678781TP_TRANSPORTER: increase in brain concentration in mdr1a(-/-) mouse2002The Journal of endocrinology, Oct, Volume: 175, Issue:1
The role of the efflux transporter P-glycoprotein in brain penetration of prednisolone.
AID640512Transactivation of glucocorticoid receptor in human HepG2 cells assessed as induction of TAT measuring degradation of tyrosine to p-hydroxy phenyl pyruvate2012Bioorganic & medicinal chemistry letters, Jan-15, Volume: 22, Issue:2
Steroidal C-21 heteroaryl thioethers (Part 2): discovery of orally bioavailable selective glucocorticoid receptor modulators (dissociated steroids).
AID640516AUC in Brown Norway rat at at 10 mg/kg, po2012Bioorganic & medicinal chemistry letters, Jan-15, Volume: 22, Issue:2
Steroidal C-21 heteroaryl thioethers (Part 2): discovery of orally bioavailable selective glucocorticoid receptor modulators (dissociated steroids).
AID410449Agonist activity at human glucocorticoid receptor in human A549 cells assessed as transcriptional activity by MMTV luciferase reporter gene assay2009Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1
Aryl aminopyrazole benzamides as oral non-steroidal selective glucocorticoid receptor agonists.
AID599697Analgesic effect in po dosed Lewis rat peptidoglycan-polysaccharide-induced reactivation arthritis model assessed as increase in weight bearing on injected paw at 2 mg/kg, po bid for 3 days2009Journal of medicinal chemistry, Oct-22, Volume: 52, Issue:20
p38alpha mitogen-activated protein kinase inhibitors: optimization of a series of biphenylamides to give a molecule suitable for clinical progression.
AID1125609Displacement of TAMRA-labeled dexamethasone from mineralocorticoid receptor (unknown origin) by fluorescence polarization assay2014Bioorganic & medicinal chemistry letters, Apr-15, Volume: 24, Issue:8
Discovery of a potent and dissociated non-steroidal glucocorticoid receptor agonist containing an alkyl carbinol pharmacophore.
AID304379Displacement of fluorescent labeled Dexamethasone from glucocorticoid receptor2007Journal of medicinal chemistry, Dec-27, Volume: 50, Issue:26
Nonsteroidal glucocorticoid agonists: tetrahydronaphthalenes with alternative steroidal A-ring mimetics possessing dissociated (transrepression/transactivation) efficacy selectivity.
AID379618Immunosuppressive activity against human peripheral mononuclear cells assessed as inhibition of LPS-stimulated IL4 production at 0.3 ug/mL2000Journal of natural products, Mar, Volume: 63, Issue:3
Prenylated benzoic acid derivatives from Ferula kuhistanica.
AID296309Antiinflammatory activity in mouse assessed as inhibition of LPS-induced TNFalpha at 3 mg/kg2007Bioorganic & medicinal chemistry letters, Jun-15, Volume: 17, Issue:12
Novel glucocorticoids containing a 6,5-bicyclic core fused to a pyrazole ring: synthesis, in vitro profile, molecular modeling studies, and in vivo experiments.
AID1075798Toxicity in collagen-induced B10.RIII mouse arthritis model assessed as change in femur cortical thickness at 30 mg/kg, po qd for 35 days relative to 30% cremophor-treated control2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Identification of highly efficacious glucocorticoid receptor agonists with a potential for reduced clinical bone side effects.
AID115396Percent inhibition of anti-DNA antibody was evaluated by ELISA technique as a measure of auto-immune disease after injection of compound dose of 10 mg/kg in murine2002Bioorganic & medicinal chemistry letters, Jan-07, Volume: 12, Issue:1
Synthesis and antinephritic activities of quinoline-3-carboxamides and related compounds.
AID351947Agonist activity at GR ligand binding domain expressed in human NP1 cells assessed as glucocorticoid response element transactivation by GAL4 luciferase reporter gene assay relative to Dexamethasone2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Discovery of novel dihydro-9,10-ethano-anthracene carboxamides as glucocorticoid receptor modulators.
AID288192Partition coefficient, log P of the compound2007Bioorganic & medicinal chemistry, Jun-01, Volume: 15, Issue:11
QSAR study on permeability of hydrophobic compounds with artificial membranes.
AID350311Inhibition of dextran sodium sulfate-induced ulcerative colitis in po dosed BALB/c mouse assessed as decrease in body weight loss administered twice daily for 6 days relative to control2009Journal of medicinal chemistry, May-28, Volume: 52, Issue:10
Design, synthesis, and pharmacological effects of a cyclization-activated steroid prodrug for colon targeting in inflammatory bowel disease.
AID1071626Antiinflammatory activity in po dosed Sprague-Dawley rat assessed as inhibition of carrageenan-induced paw edema incubated for 2 hrs prior to carrageenan challenge measured after 5 hrs by ELISA2014Journal of medicinal chemistry, Feb-13, Volume: 57, Issue:3
Glucocorticoid receptor modulators informed by crystallography lead to a new rationale for receptor selectivity, function, and implications for structure-based design.
AID223905The compound was tested for Granuloma generation on CMC-LPS air-pouch model at 2.5 mg/kg by oral administration1992Journal of medicinal chemistry, Dec-11, Volume: 35, Issue:25
A novel orally active inhibitor of IL-1 generation: synthesis and structure-activity relationships of 3-(4-hydroxy-1-naphthalenyl)-2-propenoic acid derivatives.
AID187590Recovery of steroid from small intestine at 4 hr after administration of 7.5 mg of the compound1984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
A colon-specific drug-delivery system based on drug glycosides and the glycosidases of colonic bacteria.
AID1679120Binding affinity to enhanced YFP tagged rat glucocorticoid receptor (497-795)-LBD expressed in Saccharomyces cerevisiae FY250 cells by measuring fluorescence changes incubated for 15 hrs by fluorescence spectroscopy2021RSC medicinal chemistry, Mar-04, Volume: 12, Issue:2
Microwave-assisted green synthesis of bile acid derivatives and evaluation of glucocorticoid receptor binding.
AID21993Water solubility was determined2004Journal of medicinal chemistry, Jan-29, Volume: 47, Issue:3
Synthesis of nitro esters of prednisolone, new compounds combining pharmacological properties of both glucocorticoids and nitric oxide.
AID699975Antiinflammatory activity against DSS-induced colitis BALB/c mouse model assessed as reduction in IL6 level at 5 mg/kg, po qd for 7 days measured on day 7 relative to vehicle-treated control2012Journal of medicinal chemistry, Jun-14, Volume: 55, Issue:11
6-(methylamino)hexane-1,2,3,4,5-pentanol 4-(((1S,2S)-1-hydroxy-2,3-dihydro-1H,1'H-[2,2-biinden]-2-yl)methyl)benzoate (PH46A): a novel small molecule with efficacy in murine models of colitis.
AID661544Antiinflammatory activity in human RBC assessed as membrane stabilization at 200 ug/mL after 30 mins by UV-Visible spectrophotometry2012Bioorganic & medicinal chemistry letters, Jun-01, Volume: 22, Issue:11
Synthesis, study on anti-arthritic, anti-inflammatory activity and toxicity of some novel bis-oxy cyclophane diamides.
AID90304Effective concentration of compound for transcriptional activation of IL-6 in Human cell native protein assay2004Bioorganic & medicinal chemistry letters, Apr-05, Volume: 14, Issue:7
Differentiation of in vitro transcriptional repression and activation profiles of selective glucocorticoid modulators.
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID604871Toxicity in Sprague-Dawley rat assessed as increase in serum glucose level at 30 mg/kg, po after 6 hrs2010Journal of medicinal chemistry, Dec-09, Volume: 53, Issue:23
Dimethyl-diphenyl-propanamide derivatives as nonsteroidal dissociated glucocorticoid receptor agonists.
AID224214Inhibitory activity against PGE-2 on CMC-LPS air-pouch model at 2.5 mg/kg by oral administration1992Journal of medicinal chemistry, Dec-11, Volume: 35, Issue:25
A novel orally active inhibitor of IL-1 generation: synthesis and structure-activity relationships of 3-(4-hydroxy-1-naphthalenyl)-2-propenoic acid derivatives.
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID331516Agonist activity at glucocorticoid receptor assessed as glucose response element transcriptional transactivation by luciferase assay relative to Dexamethasone2008Bioorganic & medicinal chemistry letters, Jun-15, Volume: 18, Issue:12
Discovery of nonsteroidal glucocorticoid receptor ligands based on 6-indole-1,2,3,4-tetrahydroquinolines.
AID223737The compound was tested for IL-1 generation on CMC-LPS air-pouch model at 10 mg/kg by oral administration1992Journal of medicinal chemistry, Dec-11, Volume: 35, Issue:25
A novel orally active inhibitor of IL-1 generation: synthesis and structure-activity relationships of 3-(4-hydroxy-1-naphthalenyl)-2-propenoic acid derivatives.
AID1380129Displacement of fluormone RED from human full length glucocorticoid receptor after 4 hrs by fluorescence polarization assay2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID1075813Toxicity in collagen-induced B10.RIII mouse arthritis model assessed as change in free fatty acid level at 30 mg/kg, po qd for 35 days relative to 1% methylcellulose-treated control2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Identification of highly efficacious glucocorticoid receptor agonists with a potential for reduced clinical bone side effects.
AID604856Agonist activity at mineralocorticoid receptor in human A549 cells2010Journal of medicinal chemistry, Dec-09, Volume: 53, Issue:23
Dimethyl-diphenyl-propanamide derivatives as nonsteroidal dissociated glucocorticoid receptor agonists.
AID1125646Toxicity in B10.RIII mouse assessed as insulin level in serum at 3 mg/kg, po qd for 5 weeks relative to control2014Bioorganic & medicinal chemistry letters, Apr-15, Volume: 24, Issue:8
Discovery of a potent and dissociated non-steroidal glucocorticoid receptor agonist containing an alkyl carbinol pharmacophore.
AID162468Displacement of [3H]progesterone from human Progesterone receptor A2003Journal of medicinal chemistry, Mar-13, Volume: 46, Issue:6
Nonsteroidal selective glucocorticoid modulators: the effect of C-10 substitution on receptor selectivity and functional potency of 5-allyl-2,5-dihydro-2,2,4-trimethyl-1H-[1]benzopyrano[3,4-f]quinolines.
AID225319Binding affinity for mineralocorticoid receptor2001Journal of medicinal chemistry, Aug-30, Volume: 44, Issue:18
Synthesis and characterization of non-steroidal ligands for the glucocorticoid receptor: selective quinoline derivatives with prednisolone-equivalent functional activity.
AID476929Human intestinal absorption in po dosed human2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Neural computational prediction of oral drug absorption based on CODES 2D descriptors.
AID640514Antiinflammatory activity against Brown Norway rat allergic lung inflammation model assessed as total cell inhibition at 10 mg/kg, po for 3 days2012Bioorganic & medicinal chemistry letters, Jan-15, Volume: 22, Issue:2
Steroidal C-21 heteroaryl thioethers (Part 2): discovery of orally bioavailable selective glucocorticoid receptor modulators (dissociated steroids).
AID51053Compound was evaluated for its binding affinity towards the human corticosteroid binding globulin1999Journal of medicinal chemistry, Feb-25, Volume: 42, Issue:4
Self-organizing molecular field analysis: a tool for structure-activity studies.
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID626815Induction of glutamine synthase expression in human MG63 cells after overnight incubation by spectrophotometry2011Journal of medicinal chemistry, Oct-27, Volume: 54, Issue:20
Azaxanthene based selective glucocorticoid receptor modulators: design, synthesis, and pharmacological evaluation of (S)-4-(5-(1-((1,3,4-thiadiazol-2-yl)amino)-2-methyl-1-oxopropan-2-yl)-5H-chromeno[2,3-b]pyridin-2-yl)-2-fluoro-N,N-dimethylbenzamide (BMS-
AID1125640Toxicity in B10.RIII mouse assessed as triglyceride level in serum at 3 mg/kg, po qd for 5 weeks relative to control2014Bioorganic & medicinal chemistry letters, Apr-15, Volume: 24, Issue:8
Discovery of a potent and dissociated non-steroidal glucocorticoid receptor agonist containing an alkyl carbinol pharmacophore.
AID394969Inhibition of PHA-induced BALB/c mouse T cell proliferation at 10 uM2009Bioorganic & medicinal chemistry letters, Mar-01, Volume: 19, Issue:5
Pseurotin A and its analogues as inhibitors of immunoglobulin E [correction of immunoglobuline E] production.
AID1075802Toxicity in collagen-induced B10.RIII mouse arthritis model assessed as change in femur cortical thickness at 3 mg/kg, po qd for 35 days relative to 1% methylcellulose-treated control2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Identification of highly efficacious glucocorticoid receptor agonists with a potential for reduced clinical bone side effects.
AID1380134Transactivation activity at glucocorticoid receptor (unknown origin) expressed in human ChaGoK1 cells incubated for 24 hrs by beta-galactosidase reporter gene assay relative to dexamethasone2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID1768729Lipophilicity, logP of compound by shake flask method2021Bioorganic & medicinal chemistry letters, 10-01, Volume: 49Estimation of the lipophilicity of purine-2,6-dione-based TRPA1 antagonists and PDE4/7 inhibitors with analgesic activity.
AID91903Repression activity of GR ligand with interleukin-6 receptor in native cell assay using Dexamethasone was determined as percentage efficacy2001Journal of medicinal chemistry, Aug-30, Volume: 44, Issue:18
Synthesis and characterization of non-steroidal ligands for the glucocorticoid receptor: selective quinoline derivatives with prednisolone-equivalent functional activity.
AID357250Inhibition of lipopolysaccharide TNFalpha production in human PMNC at 0.3 ug/mL by ELISA2002Journal of natural products, Dec, Volume: 65, Issue:12
Sesquiterpenes from Ferula penninervis.
AID360027Immunosuppressive activity in human PBMC assessed as inhibition of LPS-stimulated IL1-beta production at 0.3 ug/mL after 18 to 24 hrs by ELISA2001Journal of natural products, May, Volume: 64, Issue:5
Immunosuppressive sesquiterpene alkaloids from Tripterygium wilfordii.
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.
AID1328566Antiinflammatory activity against SCW-induced joint inflammation Lewis rat model assessed as inhibition of ankle AUC administered qd through oral gavage for 8 days2016Bioorganic & medicinal chemistry letters, 12-01, Volume: 26, Issue:23
Discovery of indazole ethers as novel, potent, non-steroidal glucocorticoid receptor modulators.
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.
AID1380172Volume of distribution at steady state in Han-Wistar rat at 0.9 mg/kg, iv2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID626805Transrepression activity at glucocorticoid receptor alpha in phorbol myristate acetate-stimulated human A549 cells assessed as inhibition of AP1 response element by luciferase reporter gene assay relative to Dexamethasone2011Journal of medicinal chemistry, Oct-27, Volume: 54, Issue:20
Azaxanthene based selective glucocorticoid receptor modulators: design, synthesis, and pharmacological evaluation of (S)-4-(5-(1-((1,3,4-thiadiazol-2-yl)amino)-2-methyl-1-oxopropan-2-yl)-5H-chromeno[2,3-b]pyridin-2-yl)-2-fluoro-N,N-dimethylbenzamide (BMS-
AID47368Inhibition of transcriptional activation in CV-1 cells expressing glucocorticoid receptor2004Bioorganic & medicinal chemistry letters, Apr-05, Volume: 14, Issue:7
Differentiation of in vitro transcriptional repression and activation profiles of selective glucocorticoid modulators.
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.
AID51055Binding affinity to human CBG receptor (corticosteroid-binding globulins)2004Journal of medicinal chemistry, May-20, Volume: 47, Issue:11
Comparative molecular active site analysis (CoMASA). 1. An approach to rapid evaluation of 3D QSAR.
AID656152Antiinflammatory activity in LPS-stimulated acute inflammation BALB/c mouse model assessed as inhibition of plasma MCP-1 level at 10 mg/kg, po administered 2 hrs before LPS challenge2012Bioorganic & medicinal chemistry letters, Apr-15, Volume: 22, Issue:8
From ApoA1 upregulation to BET family bromodomain inhibition: discovery of I-BET151.
AID626281Antiarthritic activity in B10.R3 mouse collagen-induced arthritis model assessed as AUC of disease progression inhibition at 10 mg/kg, po qd for 5 weeks2011Bioorganic & medicinal chemistry letters, Nov-15, Volume: 21, Issue:22
Non-steroidal dissociated glucocorticoid agonists: indoles as A-ring mimetics and function-regulating pharmacophores.
AID1380151Displacement of [3H]methyltrienolone from androgen receptor in human LNCaP cells after 1440 mins by scintillation counting method2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID1443980Inhibition of human BSEP expressed in fall armyworm sf9 cell plasma membrane vesicles assessed as reduction in vesicle-associated [3H]-taurocholate transport preincubated for 10 mins prior to ATP addition measured after 15 mins in presence of [3H]-tauroch2010Toxicological sciences : an official journal of the Society of Toxicology, Dec, Volume: 118, Issue:2
Interference with bile salt export pump function is a susceptibility factor for human liver injury in drug development.
AID1380152Displacement of [3H]-aldosterone from human mineralocorticoid receptor LBD (729 to 984 residues) after 1 hr by scintillation proximity assay2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID296303Activity at human glucocorticoid receptor in human HepG2 cells assessed as tyrosine amino transferase activity2007Bioorganic & medicinal chemistry letters, Jun-15, Volume: 17, Issue:12
Novel glucocorticoids containing a 6,5-bicyclic core fused to a pyrazole ring: synthesis, in vitro profile, molecular modeling studies, and in vivo experiments.
AID376390Immunosuppressive activity against human PBMC assessed as inhibition of LPS-induced TNFalpha production at 0.3 ug/ml after 24 hrs by ELISA1999Journal of natural products, Nov, Volume: 62, Issue:11
Immunosuppressive diterpenoids from Tripterygium wilfordii.
AID1125638Toxicity in B10.RIII mouse assessed as triglyceride level in serum at 30 mg/kg, po qd for 5 weeks relative to control2014Bioorganic & medicinal chemistry letters, Apr-15, Volume: 24, Issue:8
Discovery of a potent and dissociated non-steroidal glucocorticoid receptor agonist containing an alkyl carbinol pharmacophore.
AID346025Binding affinity to beta cyclodextrin2009Bioorganic & medicinal chemistry, Jan-15, Volume: 17, Issue:2
Convenient QSAR model for predicting the complexation of structurally diverse compounds with beta-cyclodextrins.
AID379620Immunosuppressive activity against human peripheral mononuclear cells assessed as inhibition of LPS-stimulated IFN-gamma production at 0.3 ug/mL2000Journal of natural products, Mar, Volume: 63, Issue:3
Prenylated benzoic acid derivatives from Ferula kuhistanica.
AID187587Recovery of steroid from cecum at 5 hr after administration of 7.5 mg of the compound1984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
A colon-specific drug-delivery system based on drug glycosides and the glycosidases of colonic bacteria.
AID1211797Intrinsic clearance in cryopreserved human hepatocytes cells assessed per 10'6 cells by LC-MS/MS method2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
Comparison of cryopreserved HepaRG cells with cryopreserved human hepatocytes for prediction of clearance for 26 drugs.
AID351942Transrepression activity at GR in PMA-stimulated human A549 cells assessed as inhibition of AP1 response element-induced luciferase reporter gene activity2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Discovery of novel dihydro-9,10-ethano-anthracene carboxamides as glucocorticoid receptor modulators.
AID362592Inhibition of LPS-induced TNFalpha production in mouse2008Bioorganic & medicinal chemistry, Aug-15, Volume: 16, Issue:16
Discovery of betamethasone 17alpha-carbamates as dissociated glucocorticoid receptor modulators in the rat.
AID661541Antiinflammatory activity in human RBC assessed as membrane stabilization at 10 ug/mL after 30 mins by UV-Visible spectrophotometry2012Bioorganic & medicinal chemistry letters, Jun-01, Volume: 22, Issue:11
Synthesis, study on anti-arthritic, anti-inflammatory activity and toxicity of some novel bis-oxy cyclophane diamides.
AID1211793Lipophilicity, log P of the compound2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
Comparison of cryopreserved HepaRG cells with cryopreserved human hepatocytes for prediction of clearance for 26 drugs.
AID604853Transactivation activity of glucocorticoid receptor ligand binding domain expressed in human NP-1 Hela cells co-expressing GAL4 DNA binding domain by luciferase reporter gene assay relative to Dexamethasone2010Journal of medicinal chemistry, Dec-09, Volume: 53, Issue:23
Dimethyl-diphenyl-propanamide derivatives as nonsteroidal dissociated glucocorticoid receptor agonists.
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).
AID304380Agonist activity at glucocorticoid receptor in human A549 cells by NF-kappaB transrepression assay2007Journal of medicinal chemistry, Dec-27, Volume: 50, Issue:26
Nonsteroidal glucocorticoid agonists: tetrahydronaphthalenes with alternative steroidal A-ring mimetics possessing dissociated (transrepression/transactivation) efficacy selectivity.
AID481237Antiarthritic activity in po dosed BALB/c mouse collagen antibody induced arthritis model assessed as increase of arthritis score administered qd for 2 days after collagen antibody challenge measured after 2 days2010Bioorganic & medicinal chemistry letters, May-15, Volume: 20, Issue:10
Discovery of anti-inflammatory clinical candidate E6201, inspired from resorcylic lactone LL-Z1640-2, III.
AID1473741Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID226107Binding affinity for progesterone receptor2001Journal of medicinal chemistry, Aug-30, Volume: 44, Issue:18
Synthesis and characterization of non-steroidal ligands for the glucocorticoid receptor: selective quinoline derivatives with prednisolone-equivalent functional activity.
AID1880344Anti-inflammatory activity against MRL/Ipr Systemic lupus erythematosus mouse model assessed as inhibition of anti-dsDNA Ab titer at 10 mg/kg, po administered for 8 weeks and measured 24 hrs post final dose relative to control2022ACS medicinal chemistry letters, May-12, Volume: 13, Issue:5
Identification of 2-Pyridinylindole-Based Dual Antagonists of Toll-like Receptors 7 and 8 (TLR7/8).
AID1380158Tmax in Han-Wistar rat at 3.5 mg/kg, po2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID213397Glucocorticoid induced transactivation of human tyrosine amino transferase in HepG2 cells2004Journal of medicinal chemistry, May-06, Volume: 47, Issue:10
Novel N-arylpyrazolo[3,2-c]-based ligands for the glucocorticoid receptor: receptor binding and in vivo activity.
AID699539Inhibition of human liver OATP1B1 expressed in HEK293 Flp-In cells assessed as reduction in E17-betaG uptake at 20 uM by scintillation counting2012Journal of medicinal chemistry, May-24, Volume: 55, Issue:10
Classification of inhibitors of hepatic organic anion transporting polypeptides (OATPs): influence of protein expression on drug-drug interactions.
AID626202Agonist activity at glucocorticoid receptor in human HeLa cells transfected with luciferase gene linked to MMTV promoter assessed as luciferase transactivation activity2011Bioorganic & medicinal chemistry letters, Nov-15, Volume: 21, Issue:22
Non-steroidal dissociated glucocorticoid agonists: indoles as A-ring mimetics and function-regulating pharmacophores.
AID224208Inhibitory activity against Granuloma on CMC-LPS air-pouch model at 2.5 mg/kg by oral administration1992Journal of medicinal chemistry, Dec-11, Volume: 35, Issue:25
A novel orally active inhibitor of IL-1 generation: synthesis and structure-activity relationships of 3-(4-hydroxy-1-naphthalenyl)-2-propenoic acid derivatives.
AID47197Transcriptional activation in CV-1 cells expressing human glucocorticoid receptor compared to Dexamethasone2003Journal of medicinal chemistry, Mar-13, Volume: 46, Issue:6
Nonsteroidal selective glucocorticoid modulators: the effect of C-10 substitution on receptor selectivity and functional potency of 5-allyl-2,5-dihydro-2,2,4-trimethyl-1H-[1]benzopyrano[3,4-f]quinolines.
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).
AID1328569Ratio of AUC for Lewis rat model of SCW-induced joint inflammation to EC50 for antiinflammatory activity in rat whole blood2016Bioorganic & medicinal chemistry letters, 12-01, Volume: 26, Issue:23
Discovery of indazole ethers as novel, potent, non-steroidal glucocorticoid receptor modulators.
AID274996Induction of aromatase activity in HFF cells assessed as production of beta estradiol by aromatase assay relative to Dexamethasone2006Journal of medicinal chemistry, Dec-28, Volume: 49, Issue:26
Quinol-4-ones as steroid A-ring mimetics in nonsteroidal dissociated glucocorticoid agonists.
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.
AID1569536Antiinflammatory activity in ulcerative colitis patient derived inflamed intestinal mucosa assessed as reduction in IL1beta production at 1 uM measured after overnight incubation by immunoassay2019Journal of medicinal chemistry, 07-25, Volume: 62, Issue:14
Discovery of a First-in-Class Receptor Interacting Protein 2 (RIP2) Kinase Specific Clinical Candidate, 2-((4-(Benzo[
AID780047Antiinflammatory activity in collagen-induced arthritis mouse model at 3 mg/kg, po qd after 20 days2013Bioorganic & medicinal chemistry letters, Nov-01, Volume: 23, Issue:21
Discovery and structure-activity relationships of 6-(benzoylamino)benzoxaboroles as orally active anti-inflammatory agents.
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.
AID579571Agonist activity at GR expressed in IL-1beta- and TNFalpha-stimulated HepG2 cells assessed as inhibition of NFKB- or AP-1 mediated E-selectin transcription by luciferase reporter gene assay relative to Dexamethasone2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Discovery of orally available tetrahydroquinoline-based glucocorticoid receptor agonists.
AID69856Binding affinity towards estradiol receptor (Estrogen receptor)2003Journal of medicinal chemistry, Mar-13, Volume: 46, Issue:6
Nonsteroidal selective glucocorticoid modulators: the effect of C-10 substitution on receptor selectivity and functional potency of 5-allyl-2,5-dihydro-2,2,4-trimethyl-1H-[1]benzopyrano[3,4-f]quinolines.
AID1071636Displacement of [3H]-methyltrienolone from human progesterone receptor expressed in HEK293 cells2014Journal of medicinal chemistry, Feb-13, Volume: 57, Issue:3
Glucocorticoid receptor modulators informed by crystallography lead to a new rationale for receptor selectivity, function, and implications for structure-based design.
AID679083TP_TRANSPORTER: transepithelial transport of Prednisolone at a concentration of 20 uM in Caco-2 cells2003Pharmaceutical research, Aug, Volume: 20, Issue:8
Novel experimental parameters to quantify the modulation of absorptive and secretory transport of compounds by P-glycoprotein in cell culture models of intestinal epithelium.
AID91902Repression activity of GR ligand with interleukin-6 receptor in native cell assay using Dexamethasone was determined as maximal potency2001Journal of medicinal chemistry, Aug-30, Volume: 44, Issue:18
Synthesis and characterization of non-steroidal ligands for the glucocorticoid receptor: selective quinoline derivatives with prednisolone-equivalent functional activity.
AID351944Transrepression activity at GR in PMA-stimulated human A549 cells assessed as inhibition of AP1 response element-induced luciferase reporter gene activity relative to Dexamethasone2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Discovery of novel dihydro-9,10-ethano-anthracene carboxamides as glucocorticoid receptor modulators.
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID410450Agonist activity at human glucocorticoid receptor in human A549 cells assessed as transcriptional activity by MMTV luciferase reporter gene assay relative to Dexamethasone2009Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1
Aryl aminopyrazole benzamides as oral non-steroidal selective glucocorticoid receptor agonists.
AID53571Glucocorticoid-induced aromatase activity in human skin fibroblasts2001Journal of medicinal chemistry, Aug-30, Volume: 44, Issue:18
Synthesis and characterization of non-steroidal ligands for the glucocorticoid receptor: selective quinoline derivatives with prednisolone-equivalent functional activity.
AID1075805Toxicity in collagen-induced B10.RIII mouse arthritis model assessed as change in insulin level at 3 mg/kg, po qd for 35 days relative to 30% cremophor-treated control2014Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4
Identification of highly efficacious glucocorticoid receptor agonists with a potential for reduced clinical bone side effects.
AID578374Agonist activity at GR expressed in african green monkey CV1 cells transfected with luciferase gene linked to MMTV promoter assessed as induction of luciferase transactivation activity2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Tetrahydroquinolin-3-yl carbamate glucocorticoid receptor agonists with reduced PEPCK activation.
AID1125635Toxicity in B10.RIII mouse assessed as body fate level in serum at 30 mg/kg, po qd for 5 weeks relative to control2014Bioorganic & medicinal chemistry letters, Apr-15, Volume: 24, Issue:8
Discovery of a potent and dissociated non-steroidal glucocorticoid receptor agonist containing an alkyl carbinol pharmacophore.
AID1309960Inhibition of IL6 production in intestinal mucosa derived from ulcerative colitis patient at 1 uM measured after 24 hrs by sandwich ELISA2016Journal of medicinal chemistry, 05-26, Volume: 59, Issue:10
The Identification and Pharmacological Characterization of 6-(tert-Butylsulfonyl)-N-(5-fluoro-1H-indazol-3-yl)quinolin-4-amine (GSK583), a Highly Potent and Selective Inhibitor of RIP2 Kinase.
AID1211798Intrinsic clearance in human using well stirred liver model by LC-MS/MS method2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
Comparison of cryopreserved HepaRG cells with cryopreserved human hepatocytes for prediction of clearance for 26 drugs.
AID626273Toxicity in B10.R3 mouse collagen-induced arthritis model assessed as change in body fat level at 30 mg/kg, po qd for 5 weeks relative to control2011Bioorganic & medicinal chemistry letters, Nov-15, Volume: 21, Issue:22
Non-steroidal dissociated glucocorticoid agonists: indoles as A-ring mimetics and function-regulating pharmacophores.
AID604798Transrepression activity of glucocorticoid receptor in human A549 cells expressing AP-1 assessed as inhibition of PMA-induced AP-1 activity by luciferase reporter gene assay relative to Dexamethasone2010Journal of medicinal chemistry, Dec-09, Volume: 53, Issue:23
Dimethyl-diphenyl-propanamide derivatives as nonsteroidal dissociated glucocorticoid receptor agonists.
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).
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.
AID1277567Antiinflammatory activity in mouse assessed as inhibition of picryl chloride-induced contact hypersensitivity reaction at 10 mg/kg, po administered 30 mins prior to picryl chloride challenge2016Bioorganic & medicinal chemistry letters, Feb-15, Volume: 26, Issue:4
Synthesis and biological evaluation of novel orally available 1-phenyl-6-aminouracils containing dimethyldihydrobenzofuranol structure for the treatment of allergic skin diseases.
AID578372Agonist activity at GR expressed in rat H4IIEC3 cells assessed as induction of PEPCK transactivation by luciferase reporter gene assay relative to Dexamethasone2011Bioorganic & medicinal chemistry letters, Mar-15, Volume: 21, Issue:6
Tetrahydroquinolin-3-yl carbamate glucocorticoid receptor agonists with reduced PEPCK activation.
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.
AID1091956Apparent hydrophobicity, log D of the compound in Octanol-buffer2011Journal of agricultural and food chemistry, Apr-13, Volume: 59, Issue:7
Importance of physicochemical properties for the design of new pesticides.
AID1328548Displacement of 3H-aldosterone from MR (unknown origin) ligand binding domain by SPA assay2016Bioorganic & medicinal chemistry letters, 12-01, Volume: 26, Issue:23
Discovery of indazole ethers as novel, potent, non-steroidal glucocorticoid receptor modulators.
AID227271The compound was tested for PGE-2 generation on CMC-LPS air-pouch model at 2.5 mg/kg by oral administration1992Journal of medicinal chemistry, Dec-11, Volume: 35, Issue:25
A novel orally active inhibitor of IL-1 generation: synthesis and structure-activity relationships of 3-(4-hydroxy-1-naphthalenyl)-2-propenoic acid derivatives.
AID161466Bronchoalveolar lavages was collected after 6 hr in an ascaris-induced nonhuman primate model of asthma at 1 mg/kg dose (for IL-5)2000Journal of medicinal chemistry, Aug-10, Volume: 43, Issue:16
3,5-Bis(trifluoromethyl)pyrazoles: a novel class of NFAT transcription factor regulator.
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.
AID626817Antiinflammatory activity in human whole blood assessed as inhibition of LPS-induced TNFalpha production after overnight incubation by ELISA2011Journal of medicinal chemistry, Oct-27, Volume: 54, Issue:20
Azaxanthene based selective glucocorticoid receptor modulators: design, synthesis, and pharmacological evaluation of (S)-4-(5-(1-((1,3,4-thiadiazol-2-yl)amino)-2-methyl-1-oxopropan-2-yl)-5H-chromeno[2,3-b]pyridin-2-yl)-2-fluoro-N,N-dimethylbenzamide (BMS-
AID331517Agonist activity at glucocorticoid receptor assessed as glucose response element transcriptional transactivation by luciferase assay2008Bioorganic & medicinal chemistry letters, Jun-15, Volume: 18, Issue:12
Discovery of nonsteroidal glucocorticoid receptor ligands based on 6-indole-1,2,3,4-tetrahydroquinolines.
AID191933Cutaneous oxazolone induced contact sensitivity in mouse and percent stimulation in right hind paw was determined at a dose 20 mg/kg perorally1984Journal of medicinal chemistry, Jan, Volume: 27, Issue:1
Antiinflammatory activity of 5,6-diaryl-2,3-dihydroimidazo[2,1-b]thiazoles. Isomeric 4-pyridyl and 4-substituted phenyl derivatives.
AID440600Antiinflammatory activity in albino rat assessed as inhibition of increase in plasma PGE2 level at 50 mg/kg, po by EIA2009European journal of medicinal chemistry, Dec, Volume: 44, Issue:12
Analgesic, anticonvulsant and anti-inflammatory activities of some synthesized benzodiazipine, triazolopyrimidine and bis-imide derivatives.
AID19427HPLC capacity factor (k)2000Journal of medicinal chemistry, Jul-27, Volume: 43, Issue:15
ElogPoct: a tool for lipophilicity determination in drug discovery.
AID1380139Aqueous solubility of the compound2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID626806Transrepression activity at glucocorticoid receptor alpha in IL-1beta-stimulated human A549 cells assessed as inhibition of NFkappaB-dependent E-selectin transcription by luciferase reporter gene assay2011Journal of medicinal chemistry, Oct-27, Volume: 54, Issue:20
Azaxanthene based selective glucocorticoid receptor modulators: design, synthesis, and pharmacological evaluation of (S)-4-(5-(1-((1,3,4-thiadiazol-2-yl)amino)-2-methyl-1-oxopropan-2-yl)-5H-chromeno[2,3-b]pyridin-2-yl)-2-fluoro-N,N-dimethylbenzamide (BMS-
AID276834Antiinflammatory activity assessed as prevention of hypotonicity-induced lysis of human RBC at 50 ug/ml2006Bioorganic & medicinal chemistry letters, Dec-01, Volume: 16, Issue:23
Synthesis and study of anti-inflammatory activity of some novel cyclophane amides.
AID626814Induction of alkaline phosphatase expression in human Saos2 cells after 3 days by spectrophotometry2011Journal of medicinal chemistry, Oct-27, Volume: 54, Issue:20
Azaxanthene based selective glucocorticoid receptor modulators: design, synthesis, and pharmacological evaluation of (S)-4-(5-(1-((1,3,4-thiadiazol-2-yl)amino)-2-methyl-1-oxopropan-2-yl)-5H-chromeno[2,3-b]pyridin-2-yl)-2-fluoro-N,N-dimethylbenzamide (BMS-
AID90307Effective concentration of compound for transcriptional activation of TAT in Human cell native protein assay2004Bioorganic & medicinal chemistry letters, Apr-05, Volume: 14, Issue:7
Differentiation of in vitro transcriptional repression and activation profiles of selective glucocorticoid modulators.
AID115545Percent inhibition of proteinuria by compound dose of 1 mg/kg given perorally to murine in chronic graft-versus-host-disease test2002Bioorganic & medicinal chemistry letters, Jan-07, Volume: 12, Issue:1
Synthesis and antinephritic activities of quinoline-3-carboxamides and related compounds.
AID1211792Hepatic clearance in human2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
Comparison of cryopreserved HepaRG cells with cryopreserved human hepatocytes for prediction of clearance for 26 drugs.
AID331518Antagonist activity at glucocorticoid receptor assessed as inhibition of dexamethasone-induced glucose response element transcriptional transactivation by luciferase assay relative to control2008Bioorganic & medicinal chemistry letters, Jun-15, Volume: 18, Issue:12
Discovery of nonsteroidal glucocorticoid receptor ligands based on 6-indole-1,2,3,4-tetrahydroquinolines.
AID640509Transrepression activity at glucocorticoid receptor in human H292 cells assessed as inhibition of TNF-stimulated IL-8 production at 1 uM relative to prednisolone2012Bioorganic & medicinal chemistry letters, Jan-15, Volume: 22, Issue:2
Steroidal C-21 heteroaryl thioethers (Part 2): discovery of orally bioavailable selective glucocorticoid receptor modulators (dissociated steroids).
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.
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.
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.
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.
AID1347110qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for A673 cells)2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
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.
AID1347116qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
AID1347412qHTS assay to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: Counter screen cell viability and HiBit confirmation2020ACS 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.
AID1347121qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
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.
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.
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.
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.
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.
AID1347117qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
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.
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.
AID1347112qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
AID1347126qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
AID1347114qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
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.
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.
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.
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.
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.
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.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1347128qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
AID1347129qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
AID1347127qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
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.
AID1347115qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
AID1347111qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
AID1347415qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: tertiary screen by RT-qPCR2020ACS 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.
AID1347413qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: tertiary screen by RT-qPCR, retest select compounds2020ACS 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.
AID1347123qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
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.
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.
AID1347113qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
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.
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.
AID1347122qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
AID1347124qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
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.
AID1347119qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
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.
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.
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.
AID1347125qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
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.
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.
AID1347118qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
AID1347109qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory 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.
AID1745845Primary qHTS for Inhibitors of ATXN expression
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.
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.
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.
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.
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.
AID1797832GR Binding Assay and Human IL-6 Assay from Article 10.1021/jm030585i: \\Novel N-arylpyrazolo[3,2-c]-based ligands for the glucocorticoid receptor: receptor binding and in vivo activity.\\2004Journal of medicinal chemistry, May-06, Volume: 47, Issue:10
Novel N-arylpyrazolo[3,2-c]-based ligands for the glucocorticoid receptor: receptor binding and in vivo activity.
AID1797836GR Binding Assay and Human IL-6 Assay from Article 10.1016/j.bmcl.2007.03.103: \\Novel glucocorticoids containing a 6,5-bicyclic core fused to a pyrazole ring: synthesis, in vitro profile, molecular modeling studies, and in vivo experiments.\\2007Bioorganic & medicinal chemistry letters, Jun-15, Volume: 17, Issue:12
Novel glucocorticoids containing a 6,5-bicyclic core fused to a pyrazole ring: synthesis, in vitro profile, molecular modeling studies, and in vivo experiments.
AID1346902Human Mineralocorticoid receptor (3C. 3-Ketosteroid receptors)2001Journal of medicinal chemistry, Aug-30, Volume: 44, Issue:18
Synthesis and characterization of non-steroidal ligands for the glucocorticoid receptor: selective quinoline derivatives with prednisolone-equivalent functional activity.
AID1346902Human Mineralocorticoid receptor (3C. 3-Ketosteroid receptors)2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID1346849Human Glucocorticoid receptor (3C. 3-Ketosteroid receptors)2018Journal of medicinal chemistry, 03-08, Volume: 61, Issue:5
Discovery of a Novel Oral Glucocorticoid Receptor Modulator (AZD9567) with Improved Side Effect Profile.
AID1346849Human Glucocorticoid receptor (3C. 3-Ketosteroid receptors)2000The Journal of biological chemistry, Jun-23, Volume: 275, Issue:25
Functional probing of the human glucocorticoid receptor steroid-interacting surface by site-directed mutagenesis. Gln-642 plays an important role in steroid recognition and binding.
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.
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.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (32,159)

TimeframeStudies, This Drug (%)All Drugs %
pre-199012236 (38.05)18.7374
1990's5434 (16.90)18.2507
2000's6628 (20.61)29.6817
2010's6313 (19.63)24.3611
2020's1548 (4.81)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 127.35

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 Index127.35 (24.57)
Research Supply Index10.54 (2.92)
Research Growth Index4.47 (4.65)
Search Engine Demand Index254.92 (26.88)
Search Engine Supply Index2.07 (0.95)

This Compound (127.35)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials3,302 (9.59%)5.53%
Reviews2,175 (6.32%)6.00%
Case Studies11,909 (34.61%)4.05%
Observational106 (0.31%)0.25%
Other16,922 (49.17%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (1146)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Efficacy of Helicobacter Pylori Eradication, Anti-D and Danazol Combination in Steroid Dependant or Refractory Immune Thrombocytopenia (ITP) [NCT01162941]Phase 238 participants (Anticipated)Interventional2010-02-28Recruiting
Effects of Intraoperative Local Steroid Utilization in a Single-Level Minimally Invasive Transforaminal Lumbar Interbody Fusion [NCT03308084]Phase 3105 participants (Actual)Interventional2015-11-13Completed
A Phase II Randomised Study of Oral Prednisolone in Early Diffuse Cutaneous Systemic Sclerosis (Initially Double-blind, Then Switched to Open-label Because of Covid-19) [NCT03708718]Phase 235 participants (Actual)Interventional2017-12-21Completed
Electroretinographic Changes in Healthy Young Men Before and After Induction of Glucose Intolerance by Glucocorticoids Treatment, Hyperphagia and Lack of Exercise [NCT01140932]10 participants (Actual)Interventional2010-02-28Completed
Effectiveness of Hydrolyzed Collagen Peptide Injection for the Treatment of Collateral Ligament Pain: A Randomized Controlled Trial [NCT05971004]62 participants (Actual)Interventional2022-04-13Completed
A Phase 1, Active and Placebo-Controlled, Multiple-Dose Escalation Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04171327 (Part 1), and a Single Dose Pharmacokinetic Assessment of a Tablet Formulation (Part 2) in H [NCT00812825]Phase 178 participants (Actual)Interventional2009-01-31Completed
EuroPainClinics® Study II (Prospective Randomized Double Blinded Trial) [NCT02459392]300 participants (Actual)Interventional2021-12-31Completed
Randomized, Masked Comparison of Bromfenac and Besifloxacin BID With Either Prednisolone BID or Loteprednol 0.5% BID for Prevention of Retinal Thickening and CME Following Phacoemulsification [NCT01193504]Phase 4100 participants (Anticipated)Interventional2010-09-30Recruiting
Efficacy and Tolerability of Systemic Methylprednisolone in Children and Adolescents With Chronic Rhinosinusitis [NCT01205984]Phase 448 participants (Actual)Interventional2007-07-31Completed
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
Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome: Open-label, Multi-center, Single Arm, Phase 4 Trial (DoSAKOM) [NCT03794492]Phase 4169 participants (Actual)Interventional2018-03-31Active, not recruiting
Investigating Anti-inflammatory Effects of Topical Antibiotics in an LPS Skin Challenge Model [NCT03779360]32 participants (Actual)Interventional2018-10-12Completed
CIRcadian Rhythms and CortisoL. Effects on Substrate Metabolism and Clock Gene Expression and Functioning [NCT06035081]10 participants (Anticipated)Interventional2023-09-15Recruiting
Effect of Preoperative Administration of Dexamethasone Versus Methylprednisolone in Surgical Extraction of Retained Lower Third Molars [NCT05752305]Phase 2/Phase 384 participants (Actual)Interventional2022-01-15Completed
An Early Combined Microbiota and Metabolic Signature in Ulcerative Colitis Patients Predict the Clinical Success of Anti-inflammatory Therapy [NCT05702879]240 participants (Anticipated)Observational2023-09-06Recruiting
A Phase 1/2a Open-Label Ascending Dose Study to Evaluate the Safety and Effects of LY3884961 in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL) [NCT04127578]Phase 1/Phase 220 participants (Anticipated)Interventional2020-01-03Recruiting
The Registry to Observe Clinical Outcomes of Patients With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan [NCT04034095]979 participants (Actual)Observational [Patient Registry]2019-07-08Active, not recruiting
Registry of IgA Nephropathy in Chinese Children [NCT03015974]1,200 participants (Anticipated)Observational [Patient Registry]2016-01-31Recruiting
Anti-CD20 Antibody Rituximab in Addition to Prednisolone in Treatment of Warm Antibody Related Autoimmune Hemolytic Anemia. A Randomised Danish Multicenter Trial. [NCT01134432]Phase 365 participants (Actual)Interventional2005-03-31Completed
[NCT01137084]300 participants (Anticipated)Interventional2005-01-31Completed
Steroid Treatment as Anti-inflammatory and Neuroprotective Agent Following Out-of-Hospital Cardiac Arrest. A Randomized Trial [NCT04624776]Phase 2158 participants (Actual)Interventional2020-10-10Completed
An Investigator Initiated Open Study to Evaluate the Efficacy and Safety of Intra Arterial Infusion for Treatment of Steroid Resistant Acute Hepatic Graft Versus Host Disease (AGVHD) [NCT01140984]2 participants (Actual)Interventional2010-09-30Terminated(stopped due to technical issues)
Role of Add-on Azithromycin in the Management of Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis [NCT05842681]30 participants (Anticipated)Interventional2023-06-01Not yet recruiting
Intravenous Methylprednisolone Versus High Dose Oral Prednisolone for the Treatment of Infantile Spasms: a Randomized Open-labelled Trial [NCT03876444]Phase 2/Phase 3128 participants (Anticipated)Interventional2019-04-01Recruiting
A Phase II Clinical Trial to Assess Risk and Benefit of Oral Low Dose Prednisolone for HIV Infected People Prior to the Commencement of Antiretroviral Treatment [NCT01299948]Phase 2326 participants (Actual)Interventional2007-06-30Completed
First-line Treatment of P53 Mutation With PD-L1 Expression in DLBCL With Anti-PD-1 Mab and R-CHOP: a Randomized, Open, Multicenter Clinical Study [NCT05280626]Phase 2100 participants (Anticipated)Interventional2022-03-25Not yet recruiting
Effect of Corticosteroids On MyocardiaL Injury Among Patients Hospitalized for Community-AcquirEd PneUMonia - COLOSSEUM TRIAL [NCT03745664]Phase 3122 participants (Anticipated)Interventional2021-01-10Recruiting
A Single-Center, Randomized, Double-Masked, Vehicle and Active-Controlled, Dose-Ranging Phase 2 Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis Using the Conjunctival Allergen Challenge M [NCT03320434]Phase 2120 participants (Actual)Interventional2017-10-13Completed
Ruxolitinib and Methylprednisolone as First Line Therapy for Acute Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation [NCT03701698]Phase 230 participants (Anticipated)Interventional2018-11-01Not yet recruiting
A Phase II Study of R-CHOP With Intensive CNS Prophylaxis and Scrotal Irradiation in Patients With Primary Testicular Diffuse Large B-cell Lymphoma [NCT00945724]Phase 254 participants (Actual)Interventional2009-04-30Active, not recruiting
Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology: a Randomized, Double Blind, Placebo-controlled Trial [NCT03875690]Phase 31,200 participants (Anticipated)Interventional2019-07-02Recruiting
Efficacy and Safety of Subacromial Corticosteroid Injection in Type-2 Diabetic [NCT03652480]20 participants (Actual)Observational2013-03-31Completed
The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy: A Prospective, Double Blinded, Placebo Controlled Study [NCT01106547]Phase 455 participants (Anticipated)Interventional2009-08-31Completed
Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol. [NCT03942861]50 participants (Anticipated)Observational2019-02-21Recruiting
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 Clinical Trial Comparing Hyaluronic Acid (Hylan G-F 20) and Corticosteroid (Methylprednisolone Acetate) for Knee Osteoarthritis [NCT01132677]78 participants (Anticipated)Interventional2010-05-31Enrolling by invitation
Evaluation of Miracle Mouthwash (MMW) Plus Hydrocortisone and Prednisolone Mouth Rinse as Prophylaxis for Everolimus-Associated Stomatitis [NCT02229136]Phase 2104 participants (Actual)Interventional2014-09-04Completed
Preemptive Therapy Study of Cetuximab(Erbitux®)Induced Skin Rash Using Doxycycline, Sunscreen, Hydrocortisone and Moisturizer in Colorectal and Head and Neck Cancer Patients [NCT01874860]Phase 224 participants (Actual)Interventional2013-08-31Completed
Molecular Imaging in Cardiovascular Disease Using Hybrid Positron Emission Tomography/Magnetic Resonance Imaging (PET/MR): Cardiac Sarcoidosis [NCT03705884]40 participants (Anticipated)Interventional2018-01-01Recruiting
Comparison Between Intra-articular Pulsed Radiofrequency With Steroids Injection Versus Intra-articular Steroids Injection in Chronic Sacroiliac Joint Arthritis [NCT03564106]Phase 2/Phase 340 participants (Actual)Interventional2019-03-01Completed
A Phase II, Randomised Study of CHOP-R in Combination With Acalabrutinib Compared to CHOP-R in Patients With Newly Diagnosed Richter's Syndrome and a Platform for Initial Investigations Into Activity of Novel Treatments in Relapsed/Refractory and Newly Di [NCT03899337]Phase 2105 participants (Anticipated)Interventional2019-07-23Recruiting
Ultrasound Guided Platelet Rich Plasma Injections for Post Traumatic Greater Occipital Neuralgia: A Randomized Controlled Pilot Study [NCT04051203]Phase 135 participants (Anticipated)Interventional2019-02-01Active, not recruiting
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
High-dose Busulfan, High-dose Cyclophosphamide, and Allogeneic Bone Marrow Transplantation for Leukemia, Myelodysplastic Syndromes, Multiple Myeloma and Lymphoma [NCT01177371]Phase 213 participants (Actual)Interventional1988-03-31Completed
A Multicentre Trial of Frontline R-CHOP/Pola-RCHP and Glofitamab in Younger, Higher Risk Patients With Diffuse Large B Cell Lymphoma (DLBCL) [NCT04914741]Phase 1/Phase 280 participants (Actual)Interventional2021-06-29Active, not recruiting
A Phase I/II Study of RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas [NCT01198665]Phase 1/Phase 246 participants (Actual)Interventional2010-07-31Completed
Steroids In The Management Of Acute Asthma Exacerbations In Children, Which Form Is More Suitable? [NCT03204760]Phase 250 participants (Actual)Interventional2017-01-01Active, not recruiting
Effect of Preoperative Intravenous High Dose Methylprednisolone on Orthostatic Intolerance and Heart Rate Variability in Patients Scheduled for Total Hip-arthroplasty [NCT02445898]Phase 2/Phase 364 participants (Actual)Interventional2015-09-30Completed
Randomized Clinical Trial Comparing Conventional Conservative Treatment for Plantar Fasciopathia With Endoscopic Surgery With Fascial Release. [NCT02448316]Phase 430 participants (Actual)Interventional2015-04-01Completed
Prospective Evaluation of Perioperative Steroid Dosing on Postsurgical Edema in Orthognathic Surgery [NCT03190642]Phase 4180 participants (Actual)Interventional2018-01-01Completed
Single Dose Oral Dexamethasone Versus Multi-dose Prednisolone in the Treatment of Acute Exacerbations of Asthma in Children Who Attend the Emergency Department [NCT03698630]Phase 4250 participants (Actual)Interventional2011-07-06Completed
Comparison of Sulfasalazine Versus Leflunomide Based Combination Disease Modifying Anti-rheumatic Drug Therapy (DMARD) in Patients With Rheumatoid Arthritis Failing Methotrexate Monotherapy : A Randomized Control Trial [NCT02930343]Phase 3136 participants (Actual)Interventional2016-09-30Terminated(stopped due to Due to time constraints, the study was halted prematurely)
Efficacy and Tolerance of Ultrasound-guided Needling and Lavage of Calcific Tendinitis of the Rotator Cuff Performed With or Without Subacromial Corticosteroid Injection: A Double Blind Controlled Study [NCT02403856]Phase 4136 participants (Actual)Interventional2015-04-04Completed
Cannabidiol for the Treatment of Severe (Grades III/IV) Acute Graft-versus-host Disease [NCT02392780]Phase 210 participants (Anticipated)Interventional2015-04-30Not yet recruiting
DEXTENZA Compared to Topical Steroid Therapy Prior to Cataract Surgery in Patients Who Receive Premium Intraocular Lenses [NCT04479748]Phase 413 participants (Actual)Interventional2020-10-01Completed
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
Can Injection of Methylprednisoloneacetate 80 mg, in the Cavity After Mastectomy for Primary Breast Cancer, at the Time of Removal of the Drain, Prevent Seroma Formation? [NCT01380912]160 participants (Anticipated)Observational2010-08-31Recruiting
Prednisolone Administration in Patients With Unexplained REcurrent MIscarriages, PREMI Trial [NCT05725512]Phase 2490 participants (Anticipated)Interventional2024-01-01Not yet recruiting
Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease: A Multicentre Randomised Controlled Trial [NCT04078568]Phase 33,200 participants (Anticipated)Interventional2020-01-15Recruiting
Evaluating Clinical and Immunological Effects of Rituximab With Cyclophosphamide Compared to Rituximab Alone in AAV Patients [NCT03942887]Phase 3100 participants (Anticipated)Interventional2019-05-03Recruiting
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
Adding Prednisolone During Ovulation Induction With Clomiphene Citrate in Lean Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome [NCT02344888]Phase 4300 participants (Anticipated)Interventional2015-02-28Recruiting
To Study the Effect of Adjunctive Oral Methylprednisolone Therapy in Pediatric Urinary Tract Infection [NCT02331862]Phase 3160 participants (Anticipated)Interventional2015-01-31Not yet recruiting
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
Prospective rAndomized Controlled tRial of Crohn's diseAse Exclusion Diet vs corticosteroIds in patientS With activE Crohn's Disease - PARADISE [NCT05284136]Phase 2/Phase 380 participants (Anticipated)Interventional2022-04-01Not yet recruiting
A Single-center, Prospective, Non-comparative Clinical Trial of Ruxolitinib and Methylprednisolone as a First-line Treatment for Macrophage Activation Syndrome [NCT05137496]Phase 340 participants (Anticipated)Interventional2022-06-01Not yet recruiting
Use of a Combined Regimen of Fluoxetine, Prednisolone and Ivermectin in the Treatment of Mild COVID-19 to Prevent Disease Progression in Papua New Guinea: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial [NCT05283954]Phase 2/Phase 30 participants (Actual)Interventional2022-05-01Withdrawn(stopped due to Lack of funding)
Safety and Efficacy of Thymus Transplantation in Complete DiGeorge Anomaly, IND#9836 [NCT01220531]0 participants Expanded AccessApproved for marketing
MP3-pulses-COVID-19. Methylprednisolone Pulses Versus Dexamethasone According RECOVERY Protocol in Patients With Pneumonia Due to SARS-COV-2 Coronavirus Infection [NCT04780581]Phase 4127 participants (Actual)Interventional2021-02-01Terminated(stopped due to Impossibility of reaching the sample size established by protocol)
A Phase III, Randomized, Two-armed, Double-blind, Parallel, Active Controlled Clinical Trial to Determine the Non-inferior Efficacy and Safety of CinnoRA® (Adalimumab, CinnaGen Co.) Versus Humira® for Treatment of Active RA [NCT03172325]Phase 3136 participants (Actual)Interventional2015-11-18Completed
A Multicenter Randomized Placebo Controlled Treatment Study of Leflunomide in Polymyalgia Rheumatica [NCT03576794]Phase 394 participants (Anticipated)Interventional2019-03-01Recruiting
An Open-Label, Single-Arm, Multiple Center Extension Study to Evaluate One Year of Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer With YONSA™ 500 mg (4 x 125 mg qd) With Methylprednisolone (4 mg Bid) [NCT02962284]Phase 220 participants (Actual)Interventional2016-11-30Completed
Corticosteroids for Acute Migraine. An ED-based, Randomized, Comparative Effectiveness Trial [NCT02847494]Phase 4220 participants (Actual)Interventional2016-09-01Completed
Purine-Alkylator Combination In Follicular Lymphoma Immuno-Chemotherapy for Older Patients: a Phase III Comparison of First-line R-CVP Versus R-FC [NCT01303887]Phase 3680 participants (Anticipated)Interventional2009-10-31Recruiting
Health Related Quality of Life and Pain Managment Using Infiltration or Suprascapular Nerve Block Ultrasound Guided in Patients With Glenohumeral Arthirtis [NCT03794505]Phase 340 participants (Actual)Interventional2018-04-01Completed
Cyclic Oral Methylprednisolone Trial in Multiple Sclerosis [NCT01305837]Phase 230 participants (Actual)Interventional2011-04-30Completed
[NCT01321827]Phase 2/Phase 3100 participants (Actual)Interventional2011-04-30Completed
Clinical Study of Pirfenidone Combined With Methylprednisolone Versus Methylprednisolone in the Treatment of Checkpoint Inhibitor-related Pneumonitis [NCT05280873]Phase 148 participants (Anticipated)Interventional2021-10-10Recruiting
Efficacy and Cost-effectiveness of Intra-Articular Ketorolac Injection for Knee Osteoarthritis: A Randomized, Controlled, Double-Blinded Study [NCT03694821]Phase 418 participants (Actual)Interventional2018-07-05Terminated(stopped due to Low enrollment)
The Efficacy of Steroid Therapy in Vestibular Neuritis Confirmed by Head Impulse Test: Prospective Randomized Controlled Study [NCT02098330]Phase 340 participants (Actual)Interventional2014-03-31Completed
Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis: Two-arm, Open, Single-center Study [NCT06119490]Early Phase 130 participants (Anticipated)Interventional2023-07-05Recruiting
Corticosteroid(CS) Injections for the Treatment of Common Upper Extremity Pathologies, With or Without Lidocaine [NCT03704584]Phase 462 participants (Actual)Interventional2019-05-14Terminated(stopped due to Enrollment and study activities were initially suspended due to COVID-19. The investigator has also left Emory and the study will not resume.)
Phase II Study of Simvastatin, Zoledronic Acid, Bortezomib, Bendamustine and Methylprednisolone for Relapsed/Refractory Myeloma [NCT01332617]Phase 20 participants (Actual)Interventional2011-04-30Withdrawn(stopped due to Investigators no longer interested in activating study)
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
A Prospective Randomized Trial of Systemic Corticosteroids (Oral Prednisolone) in Severe Exacerbation of COPD Requiring Ventilatory Assistance [NCT01353235]Phase 3317 participants (Actual)Interventional2010-04-30Completed
Feasibility and Safety of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord: an Open-Labeled, Dose-Escalating Clinical Trial [NCT01354483]Phase 1/Phase 220 participants (Actual)Interventional2011-09-30Completed
The Effect of Everolimus on the Pharmacokinetics of Tacrolimus in Renal Transplant Patients, and the Effect of ABCB1、CYP3A4、CYP3A5、PORGenetic Polymorphism on the Two Drugs [NCT02077556]Phase 414 participants (Actual)Interventional2014-04-30Completed
Combination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis. [NCT01941589]Phase 4149 participants (Actual)Interventional2013-09-30Completed
Subcutaneous Injection of TNFα Monoclonal Antibody for Treating Traumatic Acute Spinal Cord Injury [NCT04988425]Phase 1/Phase 290 participants (Anticipated)Interventional2022-09-01Not yet recruiting
A Comparative Study of Strategies for Management of Duchenne Myopathy in Assiut University Children Hospital [NCT03633565]Phase 445 participants (Anticipated)Interventional2018-09-30Not yet recruiting
Phase II Trial of Cisplatin Plus Etoposide Plus Gemcitabine Plus Solumedrol (PEGS) in Peripheral T-Cell Non-Hodgkin's Lymphoma [NCT00109928]Phase 234 participants (Actual)Interventional2005-09-30Completed
A Phase II, Open-labeled, Ophthalmological External Investigator-blinded, Single-center, Randomized, Superiority, Non Profit, Pilot Clinical Trial to Evaluate the Effects of Atorvastatin on Graves' Orbitopathy (GO) in Hypercholesterolemic Patients With Mo [NCT03110848]Phase 288 participants (Actual)Interventional2020-06-01Completed
Manipulation Versus Steroid Injection in the Treatment of Morton's Neuroma [NCT05707572]62 participants (Actual)Interventional2014-09-30Completed
Randomized, Double-blind, Placebo- and Active Comparator- Controlled Crossover Study in Healthy Male Subjects and an Open Label Study in Healthy Subjects and MS Patients to Assess the Safety, Pharmacokinetics and Pharmacodynamics of 2B3-201 [NCT02048358]Phase 147 participants (Actual)Interventional2013-11-30Terminated
Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial [NCT03593759]Phase 3194 participants (Anticipated)Interventional2019-01-15Recruiting
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
Does Injection Site Matter? A Randomized Controlled Trial to Evaluate Efficacy of Knee Intraarticular Injections on Improval of Patient Reported Outcomes. [NCT02176304]Phase 460 participants (Actual)Interventional2014-06-30Completed
[NCT01281748]Phase 483 participants (Actual)Interventional2005-07-31Terminated(stopped due to Low rate of enrollment)
Safety and Efficacy of Oral Mega Pulse Methylprednisolone in Severe Therapy Resistant Alopecia Areata [NCT01167946]Phase 442 participants (Actual)Interventional2003-01-31Completed
Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas [NCT01189864]3,493 participants (Actual)Observational2010-02-01Terminated(stopped due to Terminated to initiate FDA IND-cleared study protocol)
Prednisone Acetate and Acupuncture for the Treatment of Facial Neuritis: a Multiple Center, Comparative Effectiveness Research in China [NCT01201642]1,800 participants (Anticipated)Interventional2010-09-30Recruiting
Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study Low Dose Study [NCT01560052]503 participants (Actual)Interventional2012-05-05Completed
Investigating New Onset Diabetes Mellitus in Kidney Transplant Recipients Receiving an Advagraf-Based Immunosuppressive Regimen With or Without Corticosteroids - A Multicenter, Two Arm, Randomized, Open Label Clinical Study [NCT01304836]Phase 41,166 participants (Actual)Interventional2011-01-22Completed
Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in Sjogren's Syndrome [NCT05694130]Phase 2/Phase 3110 participants (Anticipated)Interventional2023-02-28Not yet recruiting
Oral Megadose Corticosteroid Therapy of Acute Exacerbations of Multiple Sclerosis (OMEGA) [NCT00418145]Phase 316 participants (Actual)Interventional2003-09-30Terminated(stopped due to low enrollment - data was not analyzed for this study)
A Randomized, International, Multi Centre Study to Assess the Efficacy and Safety of Intravenous PEG-liposomal Prednisolone Sodium Phosphate (Nanocort®) vs Intravenous Methylprednisolone (Solu-Medrol®) Treatment in Patients With Acute Exacerbation of Rela [NCT01039103]Phase 215 participants (Actual)Interventional2009-12-31Terminated
Corticosteroid Treatment in the Acute Phase of Caustic Ingestion Management for the Prevention of Refractory Stenosis of the Esophagus and Pharynx- The CORTICAU Study [NCT03760354]Phase 230 participants (Anticipated)Interventional2019-02-15Not yet recruiting
An Open Label, Dose Escalation, Safety and Pharmacokinetics Phase I Study With Cabazitaxel Administered as a 1-hour Intravenous Infusion Every 3 Weeks in Combination With Daily Prednisolone in Patients With Hormone Refractory Prostate Cancer [NCT01324583]Phase 148 participants (Actual)Interventional2011-01-31Completed
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
Ultrasound-guided Medial Lumbar Bundle Branch Block by Caudal-cranial Approach: Radiographic Comparison of a New Ultrasound-guided Method [NCT05930236]40 participants (Anticipated)Interventional2023-04-21Recruiting
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
Evaluation of clINical reCovery After a Relapse: a Pilot Study assEssing the Neuronal Effects of D-Aspartate in RR-MS Subjects Treated With IntErferon Beta 1a 44 mcg TIW (INCREASE) [NCT03387046]Phase 27 participants (Actual)Interventional2018-03-26Terminated(stopped due to Study was terminated early due to slow recruitment rate.)
A Prospective, Randomized, Controlled, Open Label, Assessor-blinded, Parallel-group Phase III Clinical Trial to Evaluate the Impact of Tapering Systemic Immunosuppressive Therapy in a Treat-to-target Approach on Maintaining Minimal Disease Activity in Adu [NCT04610476]Phase 3270 participants (Anticipated)Interventional2020-10-19Recruiting
Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion [NCT03327272]Phase 30 participants (Actual)Interventional2018-05-22Withdrawn(stopped due to Did not enroll, PI decided not to proceed.)
Low Dose Versus High Dose Steroids in Treatment of Viral Encephalitis [NCT04103684]Phase 4100 participants (Anticipated)Interventional2020-03-30Not yet recruiting
Single Arm Study To Assess Comprehensive Infusion Guidance For The Management Of The Infusion- Associated Reactions (IARs) In Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Treated With LEMTRADA [NCT02205489]Phase 458 participants (Actual)Interventional2014-10-31Completed
Effects of Glucocortioids in Human Skeletal Muscle, Adipose Tissue and Skin [NCT06145126]12 participants (Anticipated)Interventional2023-12-31Not yet recruiting
A Trial of Prednisolone in Combination With SPI-62 or Placebo in Subjects With Polymyalgia Rheumatica (PMR) [NCT05436652]Phase 248 participants (Anticipated)Interventional2022-07-22Recruiting
Evaluation of Intraoperative Use of Dexycu on the Signs and Symptoms of Dry Eye [NCT04184999]Phase 440 participants (Actual)Interventional2019-08-10Completed
A Prospective, Randomized, Double-Blind Study to Compare the Effects of Dexamethasone Versus Depo-Medrol When Used in Lumbar Epidural Injections [NCT01397552]8 participants (Actual)Interventional2009-09-30Terminated(stopped due to Low enrollment, too many subjects getting second injection)
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
MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE [NCT03355482]Phase 240 participants (Anticipated)Interventional2017-04-10Suspended(stopped due to recruitment, funding)
Delivering Personalised Care in the Management of Exacerbations of Chronic Obstructive Pulmonary Disease: A Multi-centre Randomised Clinical Trial [NCT04458636]Phase 4203 participants (Actual)Interventional2017-11-02Completed
A Phase 3/4, Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract [NCT05191706]Phase 460 participants (Anticipated)Interventional2022-01-04Recruiting
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
Evaluation of the Efficacy of an Antibiotic Combined With Standard Treatment in Severe Alcoholic Hepatitis [NCT02281929]Phase 3297 participants (Actual)Interventional2015-06-13Completed
Local Steroid Injection in the Treatment of Idiopathic Carpal Tunnel Syndrome: A Randomized Double-blind Placebo-controlled Trial Among Patients Planned for Surgical Treatment [NCT00806871]Phase 2/Phase 3112 participants (Actual)Interventional2008-11-30Completed
Glucocorticoid Inflammation Paradox in Human Skeletal Muscle [NCT03529929]Phase 30 participants (Actual)Interventional2019-06-01Withdrawn(stopped due to withdrawn)
The Effect of High Dose Steroid and Normobaric Oxygen Therapy on Recent Onset Non-arteritic Anterior Ischemic Optic Neuropathy(NAION); a Randomized Clinical Trial [NCT02439866]Phase 390 participants (Anticipated)Interventional2014-02-28Recruiting
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
Cabazitaxel in Combination With Prednisolone With Primary Prophylaxis With PEG-G-CSF for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer [NCT02441894]Phase 421 participants (Actual)Interventional2015-04-30Completed
A Phase 4 Study of Zytiga in Poor-risk mCRPC (Metastatic Castration-Resistant Prostate Cancer) Patients Who Was Failed the First-line CAB (Combined Androgen Blockade) Therapy [NCT02405858]Phase 451 participants (Actual)Interventional2015-04-10Completed
A Randomized, Parallel Group, Double-masked, Active-controlled Phase 1/2 Clinical Trial to Evaluate the Efficacy and Safety of Dexamethasone Sodium Phosphate Visulex System for the Treatment of Non-infectious Anterior Uveitis [NCT02309385]Phase 1/Phase 244 participants (Actual)Interventional2014-10-31Completed
Targeting Steroid Resistance During Acute Exacerbations of Chronic Obstructive Pulmonary Disease With Respiratory Failure - The AECOPD Resistance Study [NCT03680495]46 participants (Anticipated)Observational [Patient Registry]2017-07-21Recruiting
Evaluation of Ultrasound Guided Platelet Rich Plasma Injection Versus Steroids Injection for Pain Relief in Cases of Partial Rotator Cuff Tears [NCT05317624]Early Phase 160 participants (Actual)Interventional2021-08-10Completed
Imatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised Study [NCT03674099]Phase 2200 participants (Anticipated)Interventional2018-10-01Recruiting
Calcific Tendinitis: Comparing Minimally Invasive Modalities [NCT02367560]60 participants (Anticipated)Interventional2015-07-31Recruiting
Effect of Preoperative Intravenous High Dose Methylprednisolone on Complement Activation in Patients Scheduled for Total Knee-arthroplasty [NCT02332616]Phase 370 participants (Actual)Interventional2015-01-31Completed
Persistence of Inflammation and Study of T2 Pathways Following Inhibition of InterLeukin-5 With Mepolizumab in Severe Eosinophilic Asthma [NCT03610685]Phase 433 participants (Actual)Interventional2018-10-19Completed
A Phase 2, Double-Blind, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 in Combination With Prednisolone Versus Prednisolone Alone in Subjects With Severe Alcoholic Hepatitis (AH) [NCT02854631]Phase 2104 participants (Actual)Interventional2016-09-01Completed
Phase-2 Trial of 5mg/kg/Week Prednisolone in Young Boys With DMD [NCT05412394]Phase 426 participants (Anticipated)Interventional2021-04-30Recruiting
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
EFFECTIVENESS OF SINGLE DOSE ORAL DEXAMETHASONE VERSUS MULTIDOSE PREDNISOLONE FOR TREATMENT OF ACUTE EXACERBATIONS OF ASTHMA AMONG CHILDREN ATTENDING THE EMERGENCY DEPARTMENT OF CHILDREN HOSPITAL, ISLAMABAD [NCT05850143]192 participants (Anticipated)Interventional2019-01-26Enrolling by invitation
Efficacy and Safety of Infliximab for Immune Checkpoint Inhibitor Induced Colitis: a Multinational, Randomised, Open Label, Phase III Trial - The iCaD Study [NCT05947669]Phase 3195 participants (Anticipated)Interventional2023-08-22Recruiting
An Open-Label, Single Arm Study of MK-8808 in Patients With Advanced CD20-Positive Follicular Lymphoma [NCT01370694]Phase 17 participants (Actual)Interventional2011-08-19Terminated(stopped due to The study was terminated for business reasons.)
[NCT02591953]22 participants (Actual)Interventional2015-11-30Terminated(stopped due to Unable to meet enrollment and follow up criteria)
Pulse Glucocorticoid Therapy in Patients With ST-Segment Elevation Myocardial Infarction [NCT05462730]Phase 2530 participants (Actual)Interventional2022-11-14Active, not recruiting
Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Less Than 2 Years of Age: a Point-of-care Testing Guided Randomized, Double-blind, Placebo-controlled Trial [NCT05444699]Phase 4210 participants (Anticipated)Interventional2022-10-11Recruiting
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
Transforaminal Epidural Injection in Acute Sciatica [NCT03924791]142 participants (Anticipated)Interventional2019-06-01Recruiting
Phase II Study of Ofatumumab in Combination With High Dose Methylprednisolone Followed by Ofatumumab and Lenalidomide Consolidative Therapy for the Treatment of Untreated CLL/SLL The HiLOG Trial [NCT01496976]Phase 245 participants (Actual)Interventional2012-03-30Active, not recruiting
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of COLAL-PRED in the Treatment of Patients With Moderate to Severe Ulcerative Colitis [NCT00676832]Phase 2190 participants (Actual)Interventional2008-05-31Completed
Ultrasound Guided Continuous Suprascapular Nerve Block With Oral Gabapentin For Pain Management In Patients With Frozen Shoulder [NCT05037994]40 participants (Actual)Interventional2021-04-01Completed
A Phase 3, Multicenter, Randomized, Evaluator-blinded Clinical Trial to Assess the Safety and Efficacy of Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% Compared to Prednisolone Acetate, 1% in the Treatment of Inflammation After Cataract Surgery in [NCT05724446]Phase 360 participants (Anticipated)Interventional2022-12-12Recruiting
Chidamide Combines With Etoposide and Methylprednisolone in the Treatment of Hemophagocytic Lymphohistiocytosis [NCT05137522]20 participants (Anticipated)Interventional2021-07-01Recruiting
Local Steroid Injection vs Wrist Splinting for Carpal Tunnel Syndrome: A Randomized Clinical Trial [NCT02140632]Phase 450 participants (Actual)Interventional2013-12-31Completed
[NCT02253966]Phase 248 participants (Actual)Interventional2014-10-31Completed
Steroid Loaded Intranasal Films as a Local Treatment of Anosmia [NCT05328414]Phase 1/Phase 2200 participants (Actual)Interventional2022-03-01Completed
Effect and Security of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial. [NCT02160132]Phase 2180 participants (Anticipated)Interventional2014-06-30Recruiting
Efficacy of Steroids on Functional Outcomes After Musculoskeletal Injuries of the Hand [NCT05003596]Phase 2/Phase 360 participants (Anticipated)Interventional2021-09-01Not yet recruiting
Outcome of Myocardial Inflammation After Steroid Therapy in Thai Systemic Sclerosis Patients: an Open Label Study [NCT03607071]Phase 220 participants (Actual)Interventional2018-05-15Completed
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 Parallel-arm, Single Blind Randomised Controlled Trial Comparing 'AIRWAY PRESSURE RELEASE VENTILATION' and 'LOW-TIDAL VOLUME VENTILATION' in Children With Acute Respiratory Distress Syndrome [NCT02167698]52 participants (Actual)Interventional2014-02-28Terminated(stopped due to Increased mortality in the intervention arm at 50% enrolment)
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
Checkpoint Inhibitor Induced Colitis and Arthritis -Immunomodulation With IL-6 Blockade and Exploration of Disease Mechanisms [NCT03601611]20 participants (Actual)Interventional2019-01-01Completed
Efficacy and Safety of Methylprednisolone Versus Dexamethasone in Caudal Block for Children Undergoing Hypospadias Surgical Repair: A Bi-center Randomized Controlled Study [NCT05717374]80 participants (Anticipated)Interventional2023-02-13Recruiting
The Efficacy and Safety of 36 Weeks Short-Term Optimization Treatment of Glucocorticosteroid in the Patients With Chronic Recurrent Drug-Induced Liver Injury [NCT03266146]Phase 1/Phase 290 participants (Actual)Interventional2017-09-02Completed
The Prospective Evaluation of Peri-Operative Glucocorticoid Use in the Management of Cervicofacial Infections of Odontogenic Origin [NCT05951504]Phase 2/Phase 329 participants (Actual)Interventional2022-06-22Completed
Corticosteroid Pulse Therapy Effects on MRI Asymptomatic Gadolinium-enhancing Lesions Conversion to a Non-enhancing Black Hole With or Without Treatment in MS Clinic of Booalisina Hospital Sari 2021-2023 [NCT04979650]Phase 2104 participants (Anticipated)Interventional2021-05-22Enrolling by invitation
Prospective Randomized, Placebo-controlled Clinical Study to Study the Effect of Postoperative Additive Systemic Steroids in Chronic Rhinosinusitis With Nasal Polyps [NCT04915456]Phase 4106 participants (Actual)Interventional2005-01-18Completed
The Impact of Dexamethasone Versus Methylprednisolone Upon Neutrophil/Lymphocyte Ratio (NLR) in COVID-19 Diseased Patients Admitted in ICU [NCT04909918]Phase 360 participants (Actual)Interventional2021-05-28Completed
Prevention of Development of Transcutaneous Sensitization in Children With Atopic Dermatitis During Their First Year of Life: an Observational Study [NCT04900948]Phase 4108 participants (Actual)Interventional2017-12-10Completed
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.)
Evaluation Of Vision Recovery And Comfort Index In Patients With Borderline/Mild Dry Eyes Undergoing Femtosecond Laser-Assisted Cataract Surgery With Premium Intraocular Lens - The ENHANCE Study [NCT04863742]Phase 430 participants (Anticipated)Interventional2021-04-26Recruiting
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
Single-blind, Investigator-initiated, Randomized, Controlled Trial to Assess the Safety and Efficacy of Intravenous Corticosteroid Therapy to Treat Patients With Acute Myocarditis With Mildly Reduced Left Ventricular Ejection Fraction [NCT05974462]Phase 3174 participants (Anticipated)Interventional2024-01-01Not yet recruiting
Evaluation of the Feasibility of Depomedrol Added to Bupivacaine in Ultrasound-guided Genicular Nerve Block in the Combination With Adductor Canal Block for Postoperative Analgesia and Rehabilitation After Reconstructive Knee Surgery. [NCT05893771]48 participants (Actual)Interventional2023-06-07Completed
Mechanisms of Neurodynamic Treatments (MONET) [NCT05859412]108 participants (Anticipated)Interventional2023-04-13Recruiting
Methylprednisolone Taper After Total Knee Replacement: A Prospective Randomized Trial [NCT05859269]Phase 4200 participants (Anticipated)Interventional2023-10-16Recruiting
Phase II, Multi-Center, Randomized, Blinded Study Evaluating the Efficacy, Safety and Tolerability of a Single Intratympanic Dose of AC102 Compared to Oral Steroids for the Treatment of Idiopathic Sudden Sensorineural Hearing Loss [NCT05776459]Phase 2210 participants (Anticipated)Interventional2022-10-13Recruiting
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
Insulinotropic Effect of GIP and GLP-1 Before and After Reduced Glucose Induced by Steroid Treatment, Relative Physical Inactivity and High Calorie Diet [NCT01173978]10 participants (Actual)Interventional2010-04-30Completed
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
Ultrasound Guided Sacroiliac Joint Injections With Ketorolac Versus Corticosteroid: A Prospective Non-inferiority Study [NCT06081101]Early Phase 180 participants (Anticipated)Interventional2024-01-31Not yet recruiting
Hypertonic Dextrose Versus Corticosteroid Intra-Articular Injections for the Treatment of Trapeziometacarpal Arthritis: A Prospective Double-blind Randomized Controlled Clinical Trial [NCT04791202]Phase 3130 participants (Anticipated)Interventional2021-04-01Not yet recruiting
Lateral Elbow Tendinopathy: A Randomized Controlled Trial Examining The Treatment Effect Of Strength Training Combined With Cortico-Steroid Injection, Dry-Needling Or Placebo [NCT02521298]60 participants (Actual)Interventional2015-10-31Completed
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
uPAR in Blood From Zytiga® (Abiraterone) Treated Patients With Castration Resistant Prostate Cancer - a Predictive Marker of Response? [NCT02125617]3 participants (Actual)Observational2014-01-31Terminated(stopped due to Poor recruition)
Procollagen-3 Driven Corticosteroids for Persistent Acute Respiratory Distress Syndrome [NCT03371498]Phase 3356 participants (Anticipated)Interventional2018-12-27Recruiting
High-dose Intravenous Methylprednisolone Therapy in Patients With Graves' Orbitopathy is Associated With the Increased Activity of Factor VIII [NCT03535090]26 participants (Actual)Observational2011-01-01Completed
Low-dose Glucocorticoids Plus Rituximab Versus High-dose Glucocorticoids Plus Rituximab for Remission Induction in ANCA-associated Vasculitis; a Multicentre, Open Label, Randomised Control Trial [NCT02198248]Phase 4140 participants (Actual)Interventional2014-10-31Active, not recruiting
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
Efficacy of Combination Therapy of Glucocorticoids, and Bovine Colostrum in Treatment of Severe Alcoholic Hepatitis: A Pilot Study. [NCT02265328]Phase 225 participants (Actual)Interventional2014-09-30Completed
A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Effect on Synovial Thickness and Vascularity of 28 Days Repeat Dosing of GW274150 or 7.5mg Prednisolone in RA Subjects. [NCT00379990]Phase 248 participants (Actual)Interventional2006-01-31Completed
Methylprednisolone Taper to Treat Delayed Post-Operative Recovery After Total Knee Arthroplasty: a Double-Blind Randomized Controlled Trial [NCT05113901]Phase 44 participants (Actual)Interventional2022-03-03Terminated(stopped due to Extremely low participation, decided to focus on similar study instead)
ACP Max™ PRP System for Knee Osteoarthritis: A Feasibility Trial [NCT05765266]45 participants (Anticipated)Interventional2023-08-12Not yet recruiting
Open-label, Single -Center, Prospective Study on the Efficacy and Safety of Intracanalicular Dexamethasone Insert 0.4mg (Dextenza) in the Treatment of Postoperative Pain and Inflammation Following Vitreo-retinal Surgery - The ADHERE Study [NCT04462523]Phase 440 participants (Actual)Interventional2020-01-03Completed
Comparative Study Between the Uses of High Dose Corticosteroid Therapy for Short Duration Versus Low Dose Corticosteroid for Long Duration in Severe Lung Contusion With ARDS [NCT04467892]Phase 2240 participants (Actual)Interventional2018-01-02Completed
International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones [NCT03007147]Phase 3475 participants (Anticipated)Interventional2017-08-08Recruiting
Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura [NCT03647852]150 participants (Anticipated)Interventional2019-09-01Recruiting
A Randomised Controlled Trial to Compare the Clinical Effectiveness of Lower Extremity Manipulation to That of Steroid Injection in the Treatment of Morton's Neuroma [NCT02304094]64 participants (Anticipated)Interventional2015-10-31Recruiting
A 12 Month, Single-center, Open-label, Randomized-controlled Trial to Investigate Efficacy, Safety and Tolerability of Everolimus in Combination With Cyclosporine A and Corticosteroid in de Novo Transplant Recipients of Expanded Criteria Donor Kidneys or [NCT02314312]Phase 348 participants (Anticipated)Interventional2012-01-31Active, not recruiting
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
The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study [NCT03491098]Early Phase 160 participants (Anticipated)Interventional2018-05-15Not yet recruiting
Mycophenolate Mofetil and Prednisolone Versus Prednisolone Alone in Fibrotic Hypersensitivity Pneumonitis: a Randomized Controlled Trial [NCT05626387]Phase 4144 participants (Anticipated)Interventional2022-11-23Recruiting
A Prospective, Randomized, Controlled Phase Ⅱ Study of Preventively Use of Methylprednisolone After Split-course Chemoradiotherapy to Reduce the Risk of Radiation-induced Pulmonary Injury For Bulky Local Advanced None-small Cell Lung Cancer [NCT03661567]Phase 252 participants (Actual)Interventional2018-08-09Terminated(stopped due to slow enrollment)
Efficacy of Intra-operative Subacromial Corticosteroid Injections on Surgical Outcomes After Arthroscopic Shoulder Surgery [NCT02867904]Phase 412 participants (Actual)Interventional2016-03-31Terminated(stopped due to It was difficult to recruit patients to get the appropriate sample size.)
A Double-masked, Methylprednisolone-control, Efficacy and Safety Study of 99Tc-MDP for Thyroid Associated Ophthalmopathy. [NCT03948191]Phase 450 participants (Actual)Interventional2017-10-16Completed
Scientific Title: Efficacy of Oral Prednisolone and Erythropoietin Injection in Treatment of Acute Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) [NCT03715881]Phase 299 participants (Anticipated)Interventional2018-12-01Recruiting
Phase II Study Evaluating the Toxicity and Efficacy of a Modified German Paediatric Hodgkin's Lymphoma Protocol (HD95) in Young Adults (Aged 18-30 Years) With Hodgkin's Lymphoma [NCT00666484]Phase 247 participants (Actual)Interventional2008-03-31Completed
A Prospective, Open-label Trial of Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children [NCT01217099]47 participants (Actual)Interventional2007-05-31Terminated(stopped due to terminated)
Double-Masked, Randomized, Parallel Group Study for Evaluation of Non-Inferiority of 0.3%Gatifloxacin/1.0% Prednisolone Association Compared With Their Isolated Administration in the Prevention of Ocular Infection/Inflammation After LASIK Surgery [NCT01218737]Phase 3101 participants (Actual)Interventional2009-01-31Completed
Multicenter Registry of Pediatric Lupus Nephritis in China [NCT03791827]1,200 participants (Anticipated)Observational2018-12-01Recruiting
Impact of Intermittent Hypoxia and Prednisolone on Motor Performance in Persons With SCI [NCT03752749]14 participants (Actual)Interventional2014-12-01Completed
Steroid Free Immunosuppression or Calcineurin Inhibitor Minimization After Basiliximab Induction Therapy in Kidney Transplantation: Comparison With a Standard Quadruple Immunosuppressive Regimen [NCT01560572]Phase 4305 participants (Actual)Interventional2011-04-30Completed
In Vivo Prednisolone/Prednisone Pharmacokinetic Pilot Study in Children With Asthma Exacerbations [NCT01260623]20 participants (Actual)Observational2009-09-09Completed
Myfortic® Combined With Low-dose Steroid in Minimal Change Nephrotic Syndrome [NCT01185197]Phase 420 participants (Actual)Interventional2010-09-30Completed
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
A Randomized, Parallel-Arm, Active Control, Multi-Center Study Assessing the Safety And Efficacy Of Dextenza® for the Treatment Of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract [NCT04539548]Phase 360 participants (Anticipated)Interventional2020-09-04Recruiting
The LIPMAT Study: Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation [NCT02495662]Phase 230 participants (Actual)Interventional2015-11-30Terminated(stopped due to Slow inclusion)
Clinical Trial of Belimumab Combined With Multi-target Induction Therapy in Adult Patients With Severe Lupus Nephritis [NCT05863936]Phase 315 participants (Anticipated)Interventional2023-04-01Recruiting
Steroid Metabolism in Obese and Non-Obese Pediatric Patients Hospitalized for Status Asthmaticus [NCT04874610]15 participants (Actual)Observational2021-08-16Completed
A Phase II Study of Ofatumumab-High Dose Methylprednisolone Followed by Ofatumumab-Alemtuzumab in 17p Deletion CLL [NCT01465334]Phase 230 participants (Actual)Interventional2011-12-31Terminated(stopped due to Terminated early due to change in practice.)
The Effect of a New Antioxidant Combination (ASTED) on Moderate to Severe Thyroid Eye Disease, a Double Blind Placebo Controlled Randomized Clinical Trial [NCT02422368]Phase 2/Phase 30 participants (Actual)Interventional2022-09-01Withdrawn(stopped due to Do not access to the drug)
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
A Phase Ⅱ Study of Erythropoietin for Management of Anemia Caused by Chemotherapy in Patients With Diffuse Large B-cell Lymphoma [NCT02890602]Phase 253 participants (Actual)Interventional2012-09-01Completed
An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate [NCT01000610]Phase 418 participants (Actual)Interventional2008-03-17Completed
A Protocol Based Treatment for Early and Severe Systemic Sclerosis With (Anti-CD20), Rituximab [NCT00379431]Phase 29 participants (Actual)Interventional2006-11-27Completed
Phase 4, Randomized Study of Oral Glucocorticosteroid Administration in the Treatment of Acute Severe Asthma Exacerbation in Hospitalized Patients [NCT00627731]Phase 450 participants (Actual)Interventional2007-06-30Completed
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
Impact of the Administration of Systemic Glucocorticoids on Inflammatory Response and Clinical Evolution of Patients Diagnosed With Moderate- Severe Bronchiolitis [NCT02571517]Phase 494 participants (Actual)Interventional2011-11-30Completed
Viral Inception of Asthma: Prospective Study From Infancy to School-age. [NCT00731575]200 participants (Anticipated)Interventional2007-06-30Active, not recruiting
Immunomodulatory Effect of Extracorporeal Cytokine Adsorption in Cardiac Surgery [NCT02666703]Phase 360 participants (Actual)Interventional2016-02-01Completed
Comparison of Intravenous Low Dose Versus High Dose Cyclophosphamide as Induction Therapy in the Treatment of Proliferative Lupus Nephritis [NCT02645565]Phase 475 participants (Actual)Interventional2015-12-31Completed
Propranolol vs Prednisolone for Infant Hemangiomas-A Clinical and Molecular Study [NCT00967226]Phase 219 participants (Actual)Interventional2009-07-31Terminated(stopped due to Serious adverse events with prednisolone, primarily temporary growth retardation, <5th percentile.)
Phase II Pilot Cohort Study to Investigate the Safety and Efficacy of Infliximab as Additional Therapy in the Treatment if Anti-Neutrophil Cytoplasm Antibody Associated Vasculitis [NCT00753103]Phase 237 participants (Actual)Interventional2003-01-31Completed
Treatment With Methylprednisolone in Acute Exacerbations of Multiple Sclerosis: Enhanced Effect With Nighttime Treatment? [NCT00764413]57 participants (Actual)Interventional2009-04-30Terminated(stopped due to Low inclusion frequency and not enough human resources for completing study)
Efficacy of Nebulized Magnesium Sulfate as an Adjunct to Standard Therapy in Asthma Exacerbation. A Randomized Controlled Trial [NCT02584738]Phase 4152 participants (Anticipated)Interventional2015-09-30Recruiting
Subacromial Injection of Methylprednisolone Versus Ketorolac to Treat Shoulder Impingement: a Double-blind Randomized Controlled Trial [NCT03913702]Phase 21 participants (Actual)Interventional2019-09-09Terminated(stopped due to Inadequate patient enrollment)
Stop Exogenous Allergic Alveolitis (EAA) in Childhood: Healthy Into Adulthood - A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate Prednisolone Treatment and Course of Disease [NCT02631603]Phase 245 participants (Anticipated)Interventional2015-04-30Suspended(stopped due to funding pending)
Phase 2/3 Study of Rituximab for Graves' Ophthalmopathy [NCT00595335]Phase 2/Phase 325 participants (Actual)Interventional2008-04-30Completed
A Proof Of Concept Study to Investigate the Clinical, Histological And Molecular Predictors of Response to Oral and Intranasal Corticosteroid in Nasal Polyposis [NCT00788749]Phase 460 participants (Actual)Interventional2004-05-31Completed
Adverse Effects of Glucocorticoid Therapy on Bone in Childhood Crohn's Disease [NCT00609752]Phase 480 participants (Anticipated)Interventional2008-02-29Recruiting
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 Phase IV Trial of Neuroprotection With ACTH in Acute Optic Neuritis [NCT01838174]Phase 437 participants (Actual)Interventional2013-05-31Terminated(stopped due to Sponsor requested)
Efficacy and Safety of Prednisolone and Chloroquine Add on Therapy in Osteoarthritis of the Knee Treated With Fixed Dose Combination of Glucosamine and Chondroitin Sulfate. [NCT00805519]Phase 4230 participants (Actual)Interventional2009-02-28Completed
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
Umbilical Cord Blood (UCB) Allogeneic Stem Cell Transplant for Hematologic Malignancies [NCT01093586]Phase 214 participants (Actual)Interventional2007-09-30Completed
An Open-Label, Multicenter, Phase 1/2 Study of Tazemetostat as a Single Agent in Subjects With Advanced Solid Tumors or With B-cell Lymphomas and Tazemetostat in Combination With Prednisolone in Subjects With Diffuse Large B Cell Lymphoma [NCT01897571]Phase 1/Phase 2400 participants (Actual)Interventional2013-06-13Completed
Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of a BI 653048 BS H3PO4 Capsule Formulation Administered as Multiple Doses of 25 mg to 200 mg Once Daily (qd) for 3 Days Assessing Pharmacodynamics as Endotoxin-induced Inflammatory Response of a [NCT02224105]Phase 156 participants (Actual)Interventional2010-03-31Completed
A Multicenter, Randomized, Double-blind, Placebo-controlled TRial Evaluating Immunosuppressive Treatment in Patients With Chronic Virus-Negative Inflammatory cardiomyopaThY (TRINITY Trial) [NCT05570409]Phase 2/Phase 3130 participants (Anticipated)Interventional2023-03-28Recruiting
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)
Assessment of the Efficacy of Medrol Dose Pack for Post-Concussive Headaches [NCT04685772]25 participants (Anticipated)Observational [Patient Registry]2021-04-01Recruiting
Methylprednisolone Pulse Therapy for Coronary Artery Dilatation or Aneurysm Formation in Kawasaki Disease [NCT04509219]Phase 110 participants (Anticipated)Interventional2020-04-15Recruiting
The Effect on Wrist Range of Motion With Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures: A Randomized Controlled Trial [NCT03898154]Phase 4200 participants (Anticipated)Interventional2019-07-10Recruiting
The Outcome of Dexamethasone and Methylprednisolone Treatment for Patients With ARDS Caused by COVID-19 [NCT04499313]Phase 360 participants (Anticipated)Interventional2020-08-02Recruiting
A Feasibility Study to Undertake a Definitive Randomised Multi-centre, Double-blind, Double-dummy Controlled Study of a Novel Agent Anakinra vs. Depo-Medrone for Acute Gout Attacks in Patients With Moderate Chronic Kidney Disease [NCT02578394]Phase 2/Phase 321 participants (Actual)Interventional2016-04-30Completed
Effects of Methylprednisolone Plus Ropivacaine Infiltration Before Wound Closure on Laminoplasty or Laminectomy [NCT04493463]Phase 4132 participants (Actual)Interventional2020-07-31Completed
Syndrome du Tunnel Carpien - Essai Clinique randomisé évaluant l'efficacité de l'Utilisation de l'échographie Lors de l'Infiltration de corticostéroïdes [NCT02036125]50 participants (Anticipated)Interventional2013-10-31Recruiting
Prevention of Glucocorticoid Induced Impairment of Bone Metabolism - A Randomized, Placebo-Controlled, Single Centre Clinical Trial [NCT04767711]50 participants (Actual)Interventional2022-05-16Completed
Zonisamide and Methylprednisolone to Prevent Noise-induced Temporary Hearing Loss [NCT02049073]Phase 1/Phase 20 participants (Actual)Interventional2017-10-31Withdrawn(stopped due to new data makes this trial unethical)
Randomised Trial of Intra-articular Injection of Lidocaine Versus Placebo in Inflammatory Arthritis [NCT05302232]80 participants (Anticipated)Interventional2022-04-18Not yet 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
Comparison of High-dose, Short-term Steroid and Low-dose Long-term Steroid Use in ARDS Caused by COVID-19 - Retrospective Cross-sectional Study [NCT05047874]200 participants (Anticipated)Observational2021-09-20Recruiting
In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery [NCT05023304]Phase 430 participants (Anticipated)Interventional2021-08-23Not yet recruiting
An Open-Label, Parallel Group, Controlled Study in Healthy Subjects to Characterize Biological Responses to Immunological Challenges and to Measure the Effect of Marketed Anti-Inflammatory Agents on Those Responses [NCT02252809]Early Phase 151 participants (Actual)Interventional2008-11-30Completed
Comparative Evaluation of Preoperative Methylprednisolone or Ibuprofen on Anesthetic Efficacy of Inferior Alveolar Nerve Blocks in Patients With Symptomatic Irreversible Pulpitis [NCT04157036]Phase 33 participants (Actual)Interventional2020-02-01Terminated(stopped due to COVID halted recruitment for 2 years. A majority of patients eligible for the study had already taken preoperative analgesics, which disqualified them for the study.)
Dose Reduction and Discontinuation of Prednisolone Using Structured Treat-to-target Taper in Patients With Polymyalgia Rheumatica [NCT05636501]120 participants (Anticipated)Interventional2023-01-12Recruiting
A Controlled Randomized, Open-label, Multi-centre Study Evaluating if a Steroid-free Immunosuppressive Protocol, Based ATG-induction, Low Tacrolimus-dose and Therapeutic Drug Monitoring of Mycophenolate Mofetil, Reduces the Incidence of New Onset Diabetes [NCT02083991]Phase 4224 participants (Actual)Interventional2013-01-31Completed
A Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Primary Biliary Cholangitis-Autoimmune Hepatitis Overlap Syndrome [NCT04933292]Phase 478 participants (Anticipated)Interventional2021-06-16Recruiting
Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia: A Randomized, Controlled, 2x2 Factorial Study [NCT04485429]Phase 30 participants (Actual)Interventional2020-07-20Withdrawn(stopped due to It was not possible to perform the study due to the availability and logistics of porcine heparin)
Phase 2a, Double-blind, Randomized, Placebo-controlled Trial of Methylprednisolone Versus Placebo in Patients With Cognitive Deficits in Post-COVID-19 Syndrome (PCS) [NCT05986422]Phase 2418 participants (Anticipated)Interventional2023-10-01Recruiting
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
Open-label Pilot Study of Methylprednisolone for the Treatment of Patients With Friedreich Ataxia (FRDA) [NCT02424435]Early Phase 111 participants (Actual)Interventional2015-06-30Completed
Comparison Of Efficacy Of Hydrocortisone And Methyl Prednisolone In Acute Severe Asthma [NCT06171932]60 participants (Anticipated)Observational [Patient Registry]2023-11-26Enrolling by invitation
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
The Role of Budesonide Intrapolyp Injection in Chronic Rhinosinusitis With Nasal Polyps. A Randomized Clinical Trial. [NCT05474924]Phase 490 participants (Anticipated)Interventional2022-08-01Recruiting
Comparative Study Between Prednisolone, Cerebrolysin in the Treatment of Bell's Palsy [NCT05821075]Phase 1/Phase 290 participants (Anticipated)Interventional2023-04-24Recruiting
A Pilot Study Examining Selinexor's Ability to Overcome Resistance in Multiple Myeloma Patients Who Are Refractory to Lenalidomide-containing Therapy. [NCT04519476]Phase 122 participants (Anticipated)Interventional2020-11-01Recruiting
The Facial Nerve Palsy And Cortisone Evaluation (FACE) Study in Children: A Randomized Double-blind, Placebo-controlled, Multicenter Trial [NCT03781700]Phase 4500 participants (Anticipated)Interventional2019-05-03Recruiting
Evaluation of the Efficacy of 2% Cyclosporine in Preventing Graft Rejection [NCT02206789]200 participants (Anticipated)Interventional2012-02-29Recruiting
Using SMART Design to Develop Dynamic Treatment Regimens for Glucocorticoid Tapering [NCT06072768]Phase 2200 participants (Anticipated)Interventional2023-03-09Recruiting
Top-down Infliximab Study in Kids With Crohn's Disease [NCT02517684]Phase 4100 participants (Anticipated)Interventional2015-04-30Active, not recruiting
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 the Urinary Elimination Kinetics of Prednisolone After Intra-articular Injection in the Knee [NCT05300490]45 participants (Anticipated)Observational2022-03-31Not yet recruiting
Impact of Cyclosporine or Steroid Withdrawal at 3 Months Post Transplantation on Graft Function, Patient Survival and Cardiovascular Surrogate Markers the First 5 Years After Renal Transplantation. [NCT00903188]Phase 4152 participants (Anticipated)Interventional2008-10-31Recruiting
Comparative Evaluation of the Efficacy and Tolerability of Prednisolone Acetate 0.5% Cream Versus Betamethasone Valerate 0.1% Cream in the Treatment of Pediatric and Adult Dermatosis [NCT01011621]Phase 3170 participants (Anticipated)Interventional2010-02-28Not yet recruiting
Double Blind, Placebo Controlled, Parallel Group Study With an Open Label Reference Arm to Assess the Effects of Intravenously Administered AIN457 on Ozone Induced Neutrophilia Compared to Placebo & Oral Corticosteroid in Healthy Volunteers [NCT00920933]Phase 1/Phase 224 participants (Actual)Interventional2009-01-31Completed
Phase III Trial Comparing Treatment With Melphalan+Prednisolon (MP) With Melphalan+Prednisolon+Thalidomide (MPT) for Previously Untreated Elderly Patients With Multiple Myeloma [NCT00934154]Phase 3122 participants (Actual)Interventional2006-03-31Completed
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
A Randomized, Placebo-controlled, Double-blind, Single-center Study Using Multiple Doses of Prednisolone to Quantify Effects on Selected Biomarkers and Assess Pharmacokinetics in Healthy Males [NCT00971724]72 participants (Actual)Interventional2006-05-31Completed
Randomised Double-blinded Trial Comparing Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis Relapses [NCT00984984]Phase 3200 participants (Anticipated)Interventional2008-03-31Recruiting
To Assess the Role of Sphingosine-1-phosphate in the Pathobiology of Pneumonia: Generate a New Strategy for Treatment of Severe Community-acquired Pneumonia [NCT04007328]Phase 2/Phase 3400 participants (Anticipated)Interventional2019-06-15Recruiting
(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
Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment [NCT00977444]Phase 2/Phase 3114 participants (Actual)Interventional2007-11-30Active, not recruiting
Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass [NCT00934843]77 participants (Actual)Interventional2007-03-31Completed
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
A Phase II Study of Panobinostat (LBH589) as Second-Line Therapy in Patients With Chronic Graft-Versus-Host Disease [NCT01028313]Phase 20 participants (Actual)InterventionalWithdrawn(stopped due to A decision was made to not move forward with the study. No participants were enrolled or treated.)
Two-arm, Randomized, Open-label, Phase IIIb Study Investigating the Safety of a 3 Hour i.p. Infusion of Catumaxomab With and Without Prednisolone Premedication in Patients With Malignant Ascites Due to Epithelial Cancer [NCT00822809]Phase 3230 participants (Actual)Interventional2008-12-31Completed
Assessment of Platelet Function in Patients With Chronic Autoimmune Thrombocytopenic Purpura (cAITP) Treated With the Thrombopoietin Receptor (MPL) Agonist Eltrombopag. [NCT00888901]Phase 430 participants (Actual)Interventional2009-05-31Completed
Prospective Donor-specific Cellular Alloresponse Assessment for Immunosuppression Minimization in de Novo Renal Transplantation [NCT02540395]184 participants (Actual)Interventional2015-03-31Completed
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
Immune Suppression of Infants Treated With Oral Corticosteroids for Infantile Hemangiomas: A Pilot Study [NCT00433940]16 participants (Actual)Observational2006-10-31Completed
Use of TNF-blocking Therapy in Combination With DMARDs in Patients With Early Rheumatoid Arthritis [NCT00908089]Phase 4100 participants (Actual)Interventional2003-03-31Active, not recruiting
Corticoids in Severe Community-acquired Pneumonia [NCT00908713]Phase 4120 participants (Actual)Interventional2004-01-31Completed
The Effect of Preoperative Oral Administration of Prednisolone on Postoperative Pain in Patients With Symptomatic Irreversible Pulpitis: A Single Center Randomized Controlled Trial [NCT02819648]Phase 4400 participants (Actual)Interventional2012-06-30Completed
Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease [NCT00931957]80 participants (Anticipated)Interventional2010-10-31Recruiting
The Impact of Early Protocol Biopsy in Kidney Transplant Recipients Receiving TAC and MMF; a Prospective Observational Study [NCT02733510]200 participants (Anticipated)Observational2016-04-30Recruiting
Clinical Treatment of Traumatic Optic Neuropathy: Optic Nerve Decompression Randomized Controlled Study [NCT02711982]2 participants (Anticipated)Interventional2010-01-31Recruiting
Greater Occipital Nerve Block for Migraine Prophylaxis [NCT00915473]Phase 470 participants (Actual)Interventional2009-06-30Completed
A Study of Safety and Efficacy of Leflunomide for Maintenance of Remission in IgG4 Related Disease [NCT02703194]Phase 468 participants (Actual)Interventional2016-03-31Completed
The Effect of Curcumin on the Development of Prednisolone-induced Hepatic Insulin Resistance in Overweight and Obese Participants [NCT04315350]24 participants (Actual)Interventional2019-12-01Terminated(stopped due to We stopped recruiting having 8 in each intervention group instead of 9 due to recruitment problems due to COVID19 pandemic)
A Pilot Randomized Controlled Trial of Efficacy of Perineural Local Anesthetics and Steroids for Chronic Post-traumatic Neuropathic Pain in the Ankle and the Foot: The PREPLAN Study [NCT02680548]Early Phase 18 participants (Actual)Interventional2015-11-30Completed
An Bioequivalence Study of Prednisolone and Dexamethasone; Corticosteroids Revised - The CORE Study [NCT04733144]Phase 124 participants (Anticipated)Interventional2021-03-04Recruiting
A Randomized Open Label Trial of Spironolactone Versus Prednisolone in Corticosteroid-naïve Boys With DMD [NCT03777319]Phase 12 participants (Actual)Interventional2018-12-05Terminated(stopped due to Inability to recruit participants.)
Glucocorticoid Therapy for Critically Ill Patients With Severe Acute Respiratory Infections Caused by COVID-19: a Prospective, Randomized Controlled Trial [NCT04244591]Phase 2/Phase 380 participants (Actual)Interventional2020-01-26Completed
Phenol Neurolysis of Genicular Nerves for Chronic Knee Pain Following Total Knee Arthroplasty: a Pilot Prospective, Randomized, Crossover Trial [NCT03973177]Phase 40 participants (Actual)Interventional2019-05-24Withdrawn(stopped due to Covid restrictions on recruitment)
A Prospective Study to Assess the Safety and Effectiveness of Medrol® in Acute Asthma in Indian Patients [NCT00971893]0 participants (Actual)Observational2009-10-31Withdrawn
A Phase Ib Feasibility Study of Personalized Kinase Inhibitor Therapy Combined With Induction in Acute Leukemias Who Exhibit In Vitro Kinase Inhibitor Sensitivity [NCT02779283]Phase 17 participants (Actual)Interventional2016-01-13Completed
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)
A Phase 1 Study of Abemaciclib in Combination With Other Anti-Cancer Therapy in Japanese Patients With Advanced Cancer [NCT04071262]Phase 16 participants (Actual)Interventional2019-12-20Completed
Sitagliptin Prophylaxis for Glucocorticoid-Induced Impairment of Glucose Metabolism and Beta-Cell Dysfunction in Males With the Metabolic Syndrome X: A Randomized, Placebo-controlled, Double-blind Intervention Study With a 2x2 Factorial Design [NCT00721552]82 participants (Actual)Interventional2008-10-31Completed
DFCI ALL Adult Consortium Protocol: Adult ALL Trial [NCT01005758]Phase 2180 participants (Anticipated)Interventional2009-01-31Not yet recruiting
A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus Infliximab to Corticosteroids Plus Azathioprine for Acute Severe Colitis [NCT02425852]Phase 465 participants (Actual)Interventional2016-12-31Completed
Effects of Volume and Dose of Local Anaesthetic Solution in Epidural Steroidal Injections for Patients With Chronic Lower Back Pain [NCT00887003]252 participants (Actual)Interventional2005-05-31Completed
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
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 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
Effect of Steroids on Post-Operative Complications Following Proximal Hypospadias Repair [NCT02162810]28 participants (Actual)Interventional2014-05-31Terminated(stopped due to We were unable to meet our enrollment goal necessary to analyze the outcome measures.)
Transplantation of Umbilical Cord Blood for Myeloid Leukemia Patients Not in CR With Cyclophosphamide/Fludarabine/Total Body Irradiation Myeloablative Preparative Regimen and UCB NK Cells [NCT00354172]Phase 216 participants (Actual)Interventional2006-02-28Terminated(stopped due to Competing study was started.)
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
Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome in In-vitro Fertilization Cycles: A Randomized Controlled Trial [NCT01014104]Phase 1/Phase 2218 participants (Actual)Interventional2009-10-31Completed
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
Trial of Early Aggressive Therapy in Juvenile Idiopathic Arthritis (TREAT in JIA) [NCT00443430]Phase 485 participants (Actual)Interventional2007-05-31Completed
Effects of Pre-operative Methylprednisolone (125mg iv) After Total Hip Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail [NCT00968903]Phase 448 participants (Actual)Interventional2010-04-30Completed
Comparison of Monthly Pulse ACTH (Acthar Gel) Therapy With Methylprednisolone (MP, Solumedrol) for Long-Term Treatment of Multiple Sclerosis (MS) as an Add on Therapy to Beta-interferons (Avonex, Betaseron or Rebif) [NCT01049451]Phase 123 participants (Actual)Interventional2009-11-30Completed
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
Methylprednisolone Combined Electric-acupuncture Treatment Effects on Cognitive Function After Surgery for Elderly Patients With General Anesthesia [NCT02535039]Phase 1/Phase 280 participants (Anticipated)Interventional2015-10-31Recruiting
Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma [NCT00481832]Phase 250 participants (Actual)Interventional2007-01-31Terminated(stopped due to Accrual Factor)
Comparison of the Efficacy and Safety of Tocilizumab Versus Methylprednisolone in the Cytokine Release Syndrome of Patients With COVID-19. A Prospective Randomized Controlled Phase II Trial [NCT04377503]Phase 230 participants (Actual)Interventional2020-05-01Terminated(stopped due to The number of critically ill patients wirh COVID-19 decrease abruptly)
Preoperative Methylprednisolone in Endovascular Aortic Repair - a Randomized Double Blind Placebo Controlled Clinical Trial [NCT00989729]150 participants (Actual)Interventional2009-10-31Completed
A Multicenter, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Combination With MMF and Steroids in Patients Undergoing Kidney Transplantation and a Pharmacokinetics Study. [NCT00481819]Phase 3240 participants (Actual)Interventional2007-07-31Completed
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 Prospective, Randomized Single-Masked Clinical Trial Comparing OCT and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone [NCT00698724]Phase 4200 participants (Anticipated)Interventional2008-06-30Completed
The MAGIC Algorithm Probability Guided Preemption of Steroid-refractory Graft-versus-host Disease With Methylprednisolone [NCT05368181]Phase 256 participants (Anticipated)Interventional2022-05-01Recruiting
Multicentre, Prospective, Randomized, Open-label Study Comparing the Efficacy and Safety of CellCept With Delayed Introduction of Sirolimus and Discontinuation of Cyclosporine, With Those of Standard Immunosuppression Comprising CellCept and Long-term Con [NCT02686619]Phase 3237 participants (Actual)Interventional2004-11-30Completed
Efficacy of N-acetylcysteine With or Without Steroids in Drug Induced Liver Injury: A Prospective Randomized Controlled Trial [NCT02686385]4 participants (Actual)Interventional2016-03-01Terminated(stopped due to Steroids were given for 2 patients who had biopsy proven Drug induced Liver Injury and both have them developed sepsis.)
High-Dose Methotrexate Plus Steroid Followed by Concurrent Whole Brain Chemoradiation With Temozolomide for Immunocompetent Patients With Primary Central Nervous System Lymphoma - a Phase II Study [NCT00455286]Phase 225 participants Interventional2006-11-30Recruiting
A Phase II, Prospective, Multi-center Study of Sintilimab in Combination With R-CHOP in Patients With Treatment-naive EBV-positive DLBCL, NOS [NCT04181489]Phase 255 participants (Anticipated)Interventional2019-01-01Recruiting
Comparing Subacromial Injection of Platelet-rich Plasma Versus Methylprednisolone in the Treatment of Shoulder Subacromial Impingement Syndrome [NCT02669303]19 participants (Actual)Interventional2015-09-30Terminated(stopped due to low recruitment rate and high rate of loss-to-followup)
Validity and Security of Reh-acteoside Therapy for Patients of IgA Nephropathy -- A Prospective, Randomized, Controlled, Multi-Center Clinical Trial [NCT02662283]Phase 2/Phase 375 participants (Anticipated)Interventional2016-05-31Not yet recruiting
Comparison of Combination Disease Modifying Antirheumatic Drugs (DMARDs) With Single Drug (Methotrexate) Therapy in Early Rheumatoid Arthritis [NCT02644499]Phase 4186 participants (Actual)Interventional2015-12-31Completed
PreOperative Steroid in Abdominal Wall Reconstruction: A Double-blinded Randomized Clinical Trial [NCT02594241]42 participants (Actual)Interventional2016-03-31Completed
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt in Conjunction With Topical Drop Regimen Treating Pain and inflamMation Following Cataract Surgery Compared to SOC Topical Drop Regimen [NCT05626478]Phase 4100 participants (Anticipated)Interventional2023-06-01Recruiting
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt in Conjunction With Topical Prednisolone Acetate 1% Treating Pain, and inflamMation Following Corneal Transplant Surgery Compared to Topical Prednisolone Acetate 1%. [NCT04521140]Phase 436 participants (Actual)Interventional2020-10-16Completed
Phase II Trial Of Yttrium-90-Ibritumomab Tiuxetan (Zevalin®) Radioimmunotherapy After Cytoreduction With ESHAP Chemotherapy In Patients With Relapsed Follicular Non-Hodgkin's Lymphoma [NCT00732498]Phase 228 participants (Actual)Interventional2006-05-15Completed
A Randomised Double Blind Controlled Trial Comparing Ciclosporin and Prednisolone in the Treatment of New Leprosy Type 1 Reactions [NCT00919815]Phase 2/Phase 373 participants (Actual)Interventional2010-08-31Completed
Effectiveness of Transtympanic Steroids in Unilateral Ménière's Disease: a Randomised Controlled Double-Blind Trial [NCT00802529]Phase 2/Phase 360 participants (Actual)Interventional2009-04-30Completed
"Are Steroids Efficacious in Hospitalized Patients With Bronchiolitis Who Show an Objective Clinical Improvement After Albuterol (Albuterol Responders)?" [NCT00798616]0 participants (Actual)InterventionalWithdrawn(stopped due to We were unable to enroll a sufficient number of patients due to manpower.)
Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia With Lobar Consolidation or Pleural Effusion in Children [NCT02618057]Phase 480 participants (Anticipated)Interventional2016-06-30Recruiting
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 Pilot (Double Blind Controlled) Study Randomizing Patients With New Acute ENL to Treatment Either With Ciclosporin or Prednisolone. [NCT00919542]Phase 212 participants (Actual)Interventional2010-07-31Completed
Assessment of Clinical Efficacy of 1% Prednisolone Acetate (Ster ®), Produced by união química, Compared to 1% Prednisolone Acetate (Pred ® Fort), Produced by Allergan, in the Control of Postoperative Inflammation in Cataract Surgery. [NCT01227876]Phase 3106 participants (Actual)Interventional2011-01-31Completed
Prospective Comparison of Sirolimus Against Corticosteroids in Treatment of Patients With Active Thyroid Eye Disease [NCT04936854]Phase 260 participants (Anticipated)Interventional2023-01-01Recruiting
Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients -A Randomized Controlled Trial. [NCT04066179]126 participants (Anticipated)Interventional2019-09-07Recruiting
Tacrolimus After rATG and Infliximab Induction Immunosuppression (RIMINI) [NCT04114188]Phase 268 participants (Actual)Interventional2016-12-15Completed
Corticosteroids and Azathioprine Versus Corticosteroids Alone in IgA Nephropathy: a Randomized Controlled Trial. [NCT00755859]Phase 4206 participants (Actual)Interventional1998-05-31Completed
Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery [NCT00758199]Phase 449 participants (Actual)Interventional2008-07-31Completed
[NCT00469781]Phase 495 participants (Actual)Interventional2007-05-31Completed
An Observational, Retrospective, Single-center, Clinical Study to Evaluate the Efficacy of Sirolimus (Rapamycin) in Patients With Graves' Disease and Moderate-to-severe and Active Graves' Orbitopathy (GO) [NCT05345119]30 participants (Actual)Observational2020-01-15Completed
A Randomised, Double-blind, Placebo-controlled, Multi-way Crossover Study to Assess the Effects of Single Oral Doses of SRT2104 and Prednisolone on Biomarkers in Blood in Healthy Volunteers [NCT00920660]Phase 120 participants (Actual)Interventional2009-04-06Completed
A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years; Vinblastine, Cyclophosphamide, Procarbazine, Prednisolone, Etoposide, Mitoxantrone, and Bleomycin in Treating Older Patients With Hodgkin's Lymphoma [NCT00079105]Phase 2175 participants (Actual)Interventional2004-01-31Completed
"Real Life Proof-of-Concept Study to Assess the Effect of Methylcellulose as add-on Seal to the In-season Pharmacologic Rescue Treatment in Subjects With Allergic Rhinitis" [NCT02557269]Phase 460 participants (Actual)Interventional2015-05-31Active, not recruiting
Phase I/II Study of Hyper-CVAD Plus RAD001 (Everolimus) for Patients With Relapsed or Refractory Acute Lymphocytic Leukemia (ALL) [NCT00968253]Phase 1/Phase 224 participants (Actual)Interventional2009-11-30Completed
An Open-label Extension (OLE), Expanded Access Study, to Assess Long-term Safety of SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) With Methylprednisolone (4mg Bid) in Patients Who Completed Study Number CHL-AA-201 [NCT02887976]Phase 32 participants (Actual)Interventional2016-09-30Completed
The Effect of Steroid Pulse Therapy for the Reduction of Acute Rejection Episode in Subclinical Borderline Changes: An Open-Label, Randomized Clinical Trial [NCT02664493]154 participants (Anticipated)Interventional2016-02-29Recruiting
Treatment of Chronic Subdural Hematoma by Corticosteroids [NCT02650609]Phase 3202 participants (Actual)Interventional2016-06-24Completed
Randomized Trial of Plasma Exchange as Adjunctive Therapy for Severe Crescentic GlomerUlonephritis of IgA NEphropathy (RESCUE Study) [NCT02647255]Phase 2/Phase 310 participants (Actual)Interventional2016-03-31Terminated(stopped due to Due to the rarity and rapid progressive course of the disease, patients were less likely to participate in randomization.)
Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men [NCT00957801]Phase 429 participants (Actual)Interventional2009-03-31Completed
A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients [NCT00782717]Phase 2263 participants (Actual)Interventional2008-11-30Completed
Hematopoietic Stem Cell Therapy for Patients With Refractory Myasthenia Gravis [NCT00424489]Phase 19 participants (Actual)Interventional2002-02-28Terminated(stopped due to No participants enrolled for more than two years. No plan to continue study.)
[NCT00494624]Phase 4300 participants (Anticipated)Interventional2000-09-30Recruiting
Phase 4, Randomized Study of Three Months-prednisolone Therapy in the Treatment of Chronic Eosinophilic Pneumonia [NCT00632554]Phase 450 participants (Anticipated)Interventional2008-06-30Completed
Triple Arm, Prospectively Randomized Multi Centre Study Phase IV to Evaluate Calcineurin Inhibitor Reduced, Steroid Free Immunosuppression After Renal Transplantation in Non-risk Patients [NCT00724022]Phase 4600 participants (Anticipated)Interventional2008-06-30Completed
Effect of Anti-inflammatory Topical Prednisolone Acetate 1%, Nepafenac of 0.1% and Ketorolac Tromethamine 0.4% in Intra-operative Mydriasis in Facetectomies [NCT00865540]Phase 430 participants (Actual)Interventional2009-03-31Active, not recruiting
Intra-discal Steroid Injection for MODIC I Discopathy: A Randomized Control Trial [NCT00804531]Phase 4137 participants (Actual)Interventional2009-04-30Completed
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
Multicenter, Randomized, Parallel, Double-blind, Comparative Study of the Superiority of the FDC of Desloratadine 0.5 mg/mL and Prednisolone 4 mg/mL Versus Desloratadine 0.5 mg/mL in the Treat. of Persistent Allergic Rhinitis in Children [NCT05214911]Phase 3248 participants (Anticipated)Interventional2024-03-30Not yet recruiting
A Randomized Controlled Trial of Deflazacort vs. Prednisolone in Acute-stage Allergic Bronchopulmonary Aspergillosis [NCT04227483]Phase 2/Phase 3150 participants (Actual)Interventional2020-01-15Active, not recruiting
A Randomized, Double Blind, Placebo-Controlled, Phase IIIb Study of the Efficacy and Safety of Continuing Enzalutamide in Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer Patients Treated With Docetaxel Plus Prednisolone Who Have Progres [NCT02288247]Phase 3688 participants (Actual)Interventional2014-12-01Active, not recruiting
Role of Doxycycline in the Management of Patients With Chronic Rhinosinusitis With Nasal Polyps [NCT05157412]Phase 360 participants (Anticipated)Interventional2022-03-01Not yet recruiting
The Role of Anterior Segment Optical Coherence Tomography in Management of Acquired Punctal Stenosis [NCT04318652]Phase 480 participants (Actual)Interventional2018-09-02Completed
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)
A Trial of Adjunctive Prednisolone and Mycobacterium w Immunotherapy in Tuberculous Pericarditis [NCT00810849]Phase 31,400 participants (Actual)Interventional2008-12-31Completed
Evaluation of High-dose Corticosteroids on Microcirculation Alterations in Cardiac Surgery, by FMD (Flow Mediated vasoDilation), Near Infrared Spectrophotometry (NIRS) and Biological Analysis (Syndecan-1) [NCT02798068]Phase 460 participants (Anticipated)Interventional2016-05-31Recruiting
Evaluation of Efficacy in the Resolution of Post-Operative Inflammation and Pain in Patients Receiving Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery [NCT04316936]Phase 415 participants (Actual)Interventional2019-12-10Completed
GON-injection for a Sooner and Better Treatment of Cluster Headache: a Double-blind Randomized Controlled Trial [NCT04014634]Phase 480 participants (Anticipated)Interventional2019-08-01Recruiting
Effect of Addition of Short Course of Prednisolone to Gluten Free Diet and Gluten Free Diet Alone in the Recovery of Clinical, Histological and Immunological Features in Naive Adult Patients With Celiac Disease [NCT01045837]Phase 2/Phase 333 participants (Actual)Interventional2009-04-30Completed
A Phase I, Randomised, Single-blind Study to Asses the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of AZD9567 in Healthy Volunteers Using Prednisolone as Positive Control [NCT02760316]Phase 164 participants (Anticipated)Interventional2016-05-02Completed
Rituximab Plus Short-term Methylprednisolone Versus Standard Dose Methylprednisolone in Newly Diagnosed Participants With Immune Thrombocytopenia (ITP): A Multicenter, Randomized Phase II Study in China [NCT02757196]Phase 2112 participants (Anticipated)Interventional2016-05-31Not yet recruiting
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)
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
Oral Prednisolone in the Treatment of Esophageal Stricture After Esophageal Surgery [NCT02703376]Phase 18 participants (Anticipated)Interventional2016-01-31Recruiting
IntraVitreal Triamcinolone Acetonide: Preventing Raised Eye-pressure by Tracking Elevations After Topical Steroids [NCT00744666]Phase 470 participants (Anticipated)Interventional2008-09-30Recruiting
Intrathecal Rituximab in Progressive Multiple Sclerosis [NCT02545959]Phase 210 participants (Actual)Interventional2015-11-30Completed
Randomized, Placebo-Controlled Trial of Bilateral 3rd/4th Common Digital Foot Nerve Injections to Treat Restless Legs Syndrome [NCT00656110]60 participants (Anticipated)Interventional2008-04-30Recruiting
Topical Epidural Steroid Usage in Patients Undergoing Posterior Lumbar Decompression: A Randomized Control Trial [NCT05058287]Phase 3150 participants (Anticipated)Interventional2021-11-05Recruiting
CHOP-Campath, A Pilot Study of CHOP Plus Campath for the Primary Treatment of ALK-ve Peripheral T Cell Lymphoma [CHOP-CAMPATH] [NCT00562068]Phase 130 participants (Anticipated)Interventional2007-05-31Recruiting
Multicenter, Randomized, Double Blind, Clinical Trial to Compare the Clinical and Radiological Efficacy of Equivalent Doses of Methylprednisolone Administered Orally or Intravenously in Patients With Multiple Sclerosis During Relapse [NCT00753792]Phase 449 participants (Actual)Interventional2008-11-30Completed
Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II:A Randomized Controlled Open-label Clinical Trial [NCT04617561]Phase 490 participants (Anticipated)Interventional2020-11-01Recruiting
A Randomised Phase II Feasibility Study of Docetaxel (Taxotere®) Plus Prednisolone vs. Docetaxel (Taxotere®) Plus Prednisolone Plus Zoledronic Acid (Zometa®) vs. Docetaxel (Taxotere®) Plus Prednisolone Plus Strontium-89 vs. Docetaxel (Taxotere®) Plus Pred [NCT00554918]Phase 2300 participants (Anticipated)Interventional2005-02-28Completed
Steroid Injection for the Treatment of Greater Trochanteric Pain Syndrome: A Randomized Controlled Trial [NCT00863889]Phase 40 participants (Actual)Interventional2009-03-31Withdrawn
Effect of Diclofenac Potassium Versus Prednisolone as a Premedication on Post-endodontic Pain and Pulpal Interleukin (IL)-8 Expression in Symptomatic Irreversible Pulpitis Cases: A Randomized Clinical Trial [NCT04608981]Phase 436 participants (Anticipated)Interventional2021-03-31Not yet recruiting
An Unusual Association Between Pancreatic Cancer and Purtscher-like Retinopathy: Presentation of a Unique Case [NCT05350384]1 participants (Actual)Observational2021-06-18Completed
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
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 II/III Study of Oral Prednisolone Test in Patients With Rheumatoid Arthritis [NCT01395251]Phase 2/Phase 3130 participants (Actual)Interventional2012-02-29Completed
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
Phase I Study of Escalating Doses of Carfilzomib With Hyper-CVAD in Patients With Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma [NCT02293109]Phase 110 participants (Actual)Interventional2015-12-17Completed
Phase II Study of Irofulven in AR-targeted and Docetaxel-Pretreated Metastatic Castration-Resistant Prostate Cancer Patients, Who Have a Drug Response Predictor (DRP®) Indicating a High Likelihood of Response to Irofulven. [NCT03643107]Phase 227 participants (Anticipated)Interventional2018-10-17Active, not recruiting
Phase 1, Open-label, Randomized, Single-dose, 2-treatment, Crossover Be Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 16 Mg Tablet Under Fasting Conditions [NCT01405157]Phase 10 participants (Actual)Interventional2012-01-01Withdrawn
Phase 1, Open-label, Randomized, Single-dose, 2-treatment, Crossover Be Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 32 Mg Tablet Under Fed Conditions [NCT01405170]Phase 10 participants (Actual)Interventional2011-10-14Withdrawn
A Phase IV Single Blind Placebo-controlled Cross Over Study to Investigate the Efficacy of Greater Occipital Nerve Block With Local Anesthetic and Steroid in Patients With Chronic Migraine [NCT04017741]Phase 48 participants (Actual)Interventional2018-02-14Completed
Randomised Trial of Plasma Exchange or High Dose Methyl Prednisolone as Adjunctive Therapy for Severe Renal Vasculitis [NCT01408836]Phase 2/Phase 3150 participants (Actual)Interventional1995-03-31Terminated(stopped due to Completed)
Comparison Between Standard Dose Methyl Prednisolone and Megadose Methyl Prednisolone as Regards Outcome in SARS.COV.2 Patients in Intensive Care Unit : Retrospective Study [NCT05279482]104 participants (Actual)Observational2022-01-19Completed
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 Randomized Phase II Study for the Evaluation of Extracorporeal Photopheresis (ECP) in Combination With Corticosteroids for the Initial Treatment of Acute Graft-Versus-Host Disease (GVHD) [NCT00609609]Phase 281 participants (Actual)Interventional2008-01-31Completed
Effects of Pre-operative Methylprednisolone (125mg iv) After Total Knee Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail [NCT00968578]Phase 448 participants (Actual)Interventional2009-08-31Completed
Phase II Study of The Modified Hyper-CVAD Program for Acute Lymphoblastic Leukemia [NCT00671658]Phase 2220 participants (Actual)Interventional2002-11-30Completed
Effect of Preoperative Intravenous High Dose Methylprednisolone on Immune Signaling in Patients Scheduled for Total Hip-arthroplasty [NCT02542592]Phase 2/Phase 364 participants (Actual)Interventional2015-09-30Completed
Efficacy of Oral Prednisolone Versus Partial Endodontic Treatment on Pain Reduction in Emergency Care of Acute Irreversible Pulpitis of Mandibular Molars: Non Inferiority Randomized Clinical Trial [NCT02629042]Phase 35 participants (Actual)Interventional2017-05-15Completed
An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Different Hormone Doses in the Treatment of 2019-nCoV Severe Pneumonia [NCT04263402]Phase 4100 participants (Anticipated)Interventional2020-02-01Recruiting
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
Prednisolone-induced Impairment of Glucose Metabolism and Beta-cell Dysfunction and the Protective Effects of Exenatide: a Single-center, Randomized, Double-blind, Placebo-controlled Crossover Study in Healthy Volunteers [NCT00744224]8 participants (Anticipated)Interventional2009-02-28Completed
A Randomized, Double Blind Controlled Trial to Evaluate the Therapeutic Effect of Telbivudine With or Without Prednisolone Priming in Patients With Chronic Hepatitis B [NCT00778596]Phase 4160 participants (Anticipated)Interventional2009-02-28Recruiting
Phase III Randomised Study on Liposomal Cytarabine (DepoCyte®) vs. Intrathecal Triple for CNS-Treatment During Maintenance Therapy in High-Risk Acute Lymphoblastic Leukemia Patients in NOPHO ALL 2008 Treatment Protocol [NCT00991744]Phase 3100 participants (Anticipated)Interventional2009-01-31Suspended(stopped due to Sterility problems in DepoCyte production)
Efficacy of Vigabatrin With High Dose Prednisolone Combination Therapy Versus Vigabatrin Alone for Infantile Spasm: a Randomized Trial [NCT04302116]250 participants (Anticipated)Interventional2020-05-18Recruiting
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.)
Budesonide MMX Versus Prednisolone in Management of Mild to Moderate Ulcerative Colitis [NCT05341401]Phase 2/Phase 3100 participants (Anticipated)Interventional2022-06-30Not yet recruiting
A Phase II, Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of Pegfilgrastim (Neulasta®) in Patients With Alcoholic Hepatitis [NCT02776059]Phase 234 participants (Actual)Interventional2017-01-21Completed
Pilot Randomized, Placebo-Controlled Trial to Evaluate The Effect of Oral Pulsed Methylprednisolone on Seizure Frequency in Pediatric Patients With Idiopathic Intractable Convulsive Epilepsy [NCT04219995]Phase 1/Phase 210 participants (Anticipated)Interventional2020-02-03Recruiting
Soluble Tumor Necrosis Factor Receptor: Enbrel® (Etanercept) for the Treatment of Acute Non-Infectious Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation [NCT00309907]Phase 239 participants (Actual)Interventional2006-04-30Completed
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
Swiss PACK-CXL (Photoactivated Chromophore for Infectious Keratitis Cross-linking) Multicenter Trial for the Treatment of Infectious Keratitis [NCT02717871]Phase 335 participants (Actual)Interventional2016-03-31Completed
A Phase Ib-II Study of Tazemetostat (EPZ-6438) in Newly Diagnosed Diffuse Large B Cell Lymphoma (DLBCL) or High Risk Follicular Lymphoma (FL) Patients Treated by R-CHOP [NCT02889523]Phase 1/Phase 2214 participants (Actual)Interventional2016-10-31Active, not recruiting
Multicenter Trial for Treatment of Acute Lymphoblastic Leukemia in Adults (05/93) [NCT00199069]Phase 4720 participants Interventional1993-04-30Completed
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 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
The Use of Benralizumab, an Interleukin-5 Receptor-α Monoclonal Antibody as Treatment of Acute Exacerbations of Airways Disease [NCT04098718]Phase 2158 participants (Anticipated)Interventional2021-03-29Recruiting
Relative Efficacy of Repeat Course of Intravenous methyLprednisolone and Intramuscular ACTH in the Treatment of Acute Relapse of Multiple Sclerosis After Sub Response to Initial Course of Intravenous Methylprednisolone (RECLAIM): a Single Center Pilot Stu [NCT00947895]Phase 2/Phase 330 participants (Actual)Interventional2009-10-31Terminated(stopped due to Study reached halfway point in approximately one year time period and was halted to analyze data.)
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
Lessdrops™ Prophylactic Treatment After Routine Phacoemulsification Compared to Standard Drops Regimen [NCT03578276]Phase 435 participants (Actual)Interventional2018-06-22Completed
A Phase II Multicentre Trial of Gemcitabine, CVP, and Rituximab (R-GCVP) for the Treatment of Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma, Considered Unsuitable for R-CHOP Chemotherapy [NCT00971763]Phase 262 participants (Actual)Interventional2006-03-31Completed
"Nutritional Ergogenic Aids: The Effects of Carbohydrate-Protein Supplementation During Endurance Exercise" [NCT00972387]12 participants (Actual)Interventional2009-08-31Completed
Novel Treatment of Adrenal Crisis: an Early Clinical Trial With Nebulized Prednisolone [NCT05639127]Early Phase 112 participants (Anticipated)Interventional2022-11-03Recruiting
Acute Respiratory Distress Syndrome Clinical Network (ARDSNet) [NCT00000579]Phase 30 participants Interventional1994-09-30Completed
Prednisolone Addition for Patients With Recent-onset Psychotic Disorder: the Role of Immune-modulating Strategies in the Treatment of Psychosis [NCT02949232]Phase 442 participants (Actual)Interventional2014-07-31Terminated(stopped due to Difficulties with recruitment)
Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis [NCT02949349]Phase 232 participants (Actual)Interventional2015-07-31Completed
A Multicentre Randomised Trial of First Line Treatment Pathways for Newly Diagnosed Immune Thrombocytopenia: Standard Steroid Treatment Versus Combined Steroid and Mycophenolate [NCT03156452]Phase 3123 participants (Actual)Interventional2017-10-25Completed
Intérêt de la corticothérapie Dans la Pneumocystose Grave du Patient immunodéprimé Non VIH. Essai Prospectif Multicentrique Randomisé Contrôlé : PIC [NCT02944045]Phase 3222 participants (Anticipated)Interventional2017-02-15Recruiting
Efficacy of Methylprednisolone in Severe Community-acquired Pneumonia,A Multi-center Randomized Controlled Trial [NCT02552342]Phase 4610 participants (Anticipated)Interventional2015-05-31Recruiting
A Prospective, Randomized Controlled Study to Compare the Efficacy and Safety of Baricitinib Combined With Glucocorticoid and Glucocorticoid Monotherapy in Proliferative IgG4-RD Patients With Eosinophilia [NCT05781516]74 participants (Anticipated)Interventional2023-01-20Recruiting
A Phase 2 Randomized, Investigator-Masked, Comparator-controlled Trial to Evaluate the Safety and Efficacy of NS2 Eye Drops in Patients With Anterior Uveitis [NCT02406209]Phase 245 participants (Actual)Interventional2015-03-31Completed
Acute Unilateral Vestibulopathy and Corticosteroid Treatment [NCT02912182]Phase 478 participants (Actual)Interventional2015-12-31Terminated(stopped due to Placebo medication expired)
Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas [NCT01024322]1,189 participants (Actual)Observational2009-10-01Terminated(stopped due to Terminated to initiate FDA IND-cleared study protocol)
A Randomized, Open-label Study to Compare the Effect of CellCept Plus Corticosteroids, and Cyclophosphamide Plus Corticosteroids Followed by Azathioprine, on Remission Rate in Patients With Lupus Nephritis [NCT00425438]Phase 352 participants (Actual)Interventional2007-03-31Terminated(stopped due to Study was terminated early for administrative reasons.)
Utility of Intramuscular Corticosteroids for Radicular Low Back Pain [NCT00290589]Phase 382 participants (Actual)Interventional2003-06-30Completed
Local Injection of Ozone Versus Methylprednisolone Acetate in Carpal Tunnel Syndrome of Scleroderma Patients. A Single-blind Randomized Clinical Trial [NCT03742466]50 participants (Actual)Interventional2018-11-10Completed
A Randomised Evaluation of Molecular Guided Therapy for Diffuse Large B-cell Lymphoma With Bortezomib [NCT01324596]Phase 31,132 participants (Actual)Interventional2011-04-30Completed
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
An Open-label, Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of Chronic Graft Versus Host Disease After TLI/ARG Nonmyeloablative Allogeneic Stem Cell Transplantation [NCT00186628]Phase 236 participants (Actual)Interventional2005-06-30Completed
Safety and Feasibility of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord: an Open-Labeled, Dose-Escalating Clinical Tiral [NCT01046786]Phase 1/Phase 28 participants (Actual)Interventional2010-01-31Completed
Efficacy and Safety of add-on Dapsone Versus add-on Methotrexate in Patients With Bullous Pemphigoid: A Randomized Controlled Trial [NCT05984381]Phase 462 participants (Anticipated)Interventional2023-08-01Recruiting
An Oral Methylprednisolone Taper Within a Multimodal Analgesic Regimen After Total Knee Arthroplasty: a Double-Blind Randomized Placebo-Controlled Trial [NCT05097976]Phase 4420 participants (Anticipated)Interventional2022-03-01Recruiting
First International Inter-Group Study for Nodular Lymphocyte-Predominant Hodgkin's Lymphoma in Children and Adolescents [NCT01088750]Phase 4225 participants (Actual)Interventional2009-11-01Completed
Acupuncture in Patients With Carpal Tunnel Syndrome ~ A Randomized Controlled Trial [NCT01014221]77 participants (Actual)Interventional2007-07-31Completed
Evaluation of the Effect of Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis [NCT00332696]Phase 264 participants (Actual)Interventional2005-09-30Completed
A Phase II, Double-blind, Placebo-controlled, Randomised Study to Assess the Efficacy and Safety of Docetaxel (Taxotere)/Prednisolone/ZD6474 vs Docetaxel/Prednisolone/Placebo in Patients With Hormone Refractory Prostrate Cancer (HRPC) [NCT00498797]Phase 286 participants (Actual)Interventional2005-12-31Completed
A Randomized, Double-Blinded, Placebo-Controlled Trial of Corticosteroid Therapy Following Portoenterostomy in Infants With Biliary Atresia [NCT00294684]141 participants (Actual)Interventional2005-11-30Completed
A Phase IIIB, Multicenter, Randomized, Double-Masked, Parallel-Group, Active-Controlled Study of the Safety and Efficacy of Difluprednate Ophthalmic Emulsion, 0.05% (Durezol™) 4 Times Daily (QID) and Prednisolone Acetate Ophthalmic Suspension, 1.0% (Pred [NCT01124045]Phase 380 participants (Actual)Interventional2010-08-31Completed
A Phase II Study of Oxaliplatin and Prednisolone (Ox-P) for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma [NCT01068392]Phase 242 participants (Actual)Interventional2009-10-31Completed
A Randomized Trial of Rituximab in Induction Therapy for Living Donor Renal Transplantation [NCT01095172]Phase 4100 participants (Actual)Interventional2010-11-30Active, not recruiting
High Dose Cyclophosphamide & ATG With Hematopoietic Stem Cell Transplantation in Patients With Refractory Idiopathic Inflammatory Myopathy Diseases: A Phase I Trial [NCT00278564]Phase 17 participants (Actual)Interventional2005-09-30Terminated(stopped due to high relapse rate)
Infliximab Top-down Study in Kids With Crohn's Disease [NCT01880307]Phase 413 participants (Actual)Interventional2013-01-31Terminated(stopped due to Not enough study subjects)
A Prospective Randomised, Open-labeled, Trial Comparing Sirolimus-Containing Versus mTOR-Inhibitor-Free Immunosuppression in Patients Undergoing Liver Transplantation for Hepatocellular Carcinoma [NCT00355862]Phase 3525 participants (Actual)Interventional2006-01-31Completed
Phase I, Prospective, Open-label, Multi-centric, Dose Finding Trial of Combination of IGEV and Panobinostat Before Autologous Stem Cell Transplant in Patients With Hodgkin's Lymphoma [NCT01884428]Phase 124 participants (Anticipated)Interventional2011-07-31Recruiting
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
Evaluation of Inhaled Corticosteroid Treatment in Sinusitis [NCT01907204]Phase 2/Phase 350 participants (Actual)Interventional2013-07-31Completed
A Randomized Study To Compare The Safety And Efficacy Of Two Immunosuppressive Regimens In De Novo Renal Allograft Recipients:Sirolimus Plus Mycophenolate Mofetil Plus Corticosteroids Following A Rabbit Anti-Human Thymocyte Globulin Induction (RATG) Vs Ta [NCT00261820]Phase 4160 participants InterventionalCompleted
A Comparative Study for Non-Hodgkin's Lymphoma in Hepatitis B Virus Carriers [NCT00262210]Phase 250 participants Interventional1995-06-30Completed
Assessing the Efficacy of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Comparison to Topical Prednisolone Acetate Following Bilateral Small Incision Lenticule Extraction (SMILE) [NCT04380857]Phase 420 participants (Actual)Interventional2020-06-18Completed
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
Macular Edema Nepafenac vs. Difluprednate Uveitis Trial [NCT01939691]Phase 49 participants (Actual)Interventional2018-09-12Terminated(stopped due to Difficulty enrolling)
German Multicenter Trial for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years With Rituximab for Improvement of Prognosis in CD20 Positive Standard Risk ALL (Amend 2) [NCT00199004]Phase 460 participants (Anticipated)Interventional2004-04-30Completed
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (SELECT-Takayasu) [NCT04161898]Phase 356 participants (Anticipated)Interventional2020-02-04Active, not recruiting
A STUDY TO MEASURE SERUM PERIOSTIN, ASTHMA-RELATED BIOMARKERS AND RESPONSE TO PREDNISOLONE IN ADULT AND ADOLESCENT PATIENTS WITH SEVERE ORAL CORTICOSTEROID-DEPENDENT ASTHMA [NCT01948401]Phase 254 participants (Actual)Interventional2013-07-31Completed
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 Double-blind, Two-arm, Multicenter, Randomized Trial to Evaluate Efficacy of Cyclophosphamide Versus Methylprednisolone in Patients With Recent Secondary Progressive Multiple Sclerosis: P.R.OM.E.S.S Study [NCT00241254]Phase 3138 participants (Actual)Interventional2005-12-31Completed
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Itolizumab in Subjects With Newly Diagnosed Acute Graft Versus Host Disease [NCT05823675]Phase 144 participants (Anticipated)Interventional2023-05-19Recruiting
Phase II Study of High-dose Methylprednisolone and Rituximab in Previously Treated Patients With High Risk Chronic B Lymphocytic Leukemia [NCT00558181]Phase 229 participants (Actual)Interventional2007-09-30Completed
European Multicenter and Open-Label Controlled Randomized Trial to Evaluate the Efficacy of Sequential Treatment With Tacrolimus-Rituximab Versus Steroids Plus Cyclophosphamide in Patients With Primary Membranous Nephropathy (The STARMEN Study) [NCT01955187]Phase 386 participants (Actual)Interventional2014-01-31Completed
Steroid Injections vs. Platelet Rich Plasma Injections in Patients With Plantar Fasciitis: A Comparison of Clinical and Ultrasound Findings [NCT01957631]Phase 2/Phase 30 participants (Actual)Interventional2013-06-30Withdrawn(stopped due to Lack of funding)
A Randomized Trial of Intravenous Pulse Versus Sequential Steroid Therapy for Patients With Graves' Orbitopathy [NCT01969019]Phase 470 participants (Anticipated)Interventional2010-01-31Recruiting
Antiemetic Corticosteroid Rotation From Dexamethasone to Methylprednisolone to Prevent Dexamethasone-Induced Hiccup in Cancer Patients Treated With Chemotherapy: A Randomized, Single-Blind, Crossover Phase III Trial [NCT01974024]Phase 365 participants (Actual)Interventional2013-10-01Completed
Single Blind Randomized Controlled Trial to Assess the Safety and Efficacy of High Dose Pulse Intravenous Corticosteroid Therapy to Treat Patients With Complicated/Fulminant Acute Myocarditis [NCT05150704]Phase 3288 participants (Anticipated)Interventional2021-10-07Recruiting
A Prospective Randomized 3-arm Trial Comparing Intra-articular Corticosteroid Injection vs Arthrographic Distention vs Arthrographic Distention Plus Intra-articular Corticosteroid Injection in the Treatment of Adhesive Capsulitis [NCT01983527]132 participants (Anticipated)Interventional2013-12-31Not yet recruiting
Comparing the Effectiveness of Steroid Injection Versus Placebo and Immobilization Versus no Immobilization in Treating Patients With Lateral Epicondylitis [NCT01986465]Phase 2/Phase 378 participants (Actual)Interventional2013-05-31Completed
Multicenter, Randomized, Double-blind Clinical Trial to Compare the Clinical and Radiological Efficacy of 625 mg Versus 1250 mg of Oral Methylprednisolone in Patients With Multiple Sclerosis in Relapse. [NCT01986998]Phase 449 participants (Actual)Interventional2013-10-31Completed
Comparison of Efficacy of Dexamethasone and Methylprednisolone in Moderate to Severe Covid 19 Disease [NCT04603729]Phase 3100 participants (Actual)Interventional2020-05-30Completed
PhaseIV Study of Intra-articular Methylprednisolone in TMJ Arthralgia [NCT01995019]Phase 456 participants (Actual)Interventional2013-12-10Completed
Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars) [NCT04593706]40 participants (Anticipated)Interventional2020-11-01Not yet recruiting
Preoperative Glucocorticoid Use in Major Hepatectomy - A Randomized Controlled Trial [NCT01997658]Phase 2/Phase 3200 participants (Actual)Interventional2014-10-31Completed
Comparison of the Efficacy and Safety of Two Different Starting Dosages of Prednisolone in Early Active Rheumatoid Arthritis: a Randomized, Placebo Controlled Trial [NCT02000336]Phase 3395 participants (Actual)Interventional2014-01-31Completed
High Doses of Methylprednisolone in the Management of Caustic Esophageal Burns in Children [NCT02002078]Phase 483 participants (Actual)Interventional2007-02-28Completed
Efficacy of the Intralesional Infusion of Local Anesthetic and Steroids After Major Abdominal Surgery: a Randomized Double Blind Phase III Trial [NCT02002663]Phase 3120 participants (Actual)Interventional2013-08-31Completed
A Randomized, Controlled, Masked (Reading Center) Prospective Study of the Effectiveness and Safety of the Ocular Therapeutix Dextenza (Dexamethasone Ophthalmic Insert) 0.4 mg for the Treatment of Post-operative Inflammation and Pain in Patients Who Have [NCT04396990]20 participants (Actual)Observational2020-06-08Completed
Randomised, Multicentre, Open Label, Parallel Group Pragmatic Clinical Trial of Local Steroid Injection Versus Night Splinting in Mild to Moderate Carpal Tunnel Syndrome (CTS) [NCT02038452]Phase 4234 participants (Actual)Interventional2014-04-30Completed
Influence of Corticoids on Renal Function in Cardiac Surgery [NCT00879931]Phase 280 participants (Actual)Interventional2013-01-31Completed
Efficacy and Safety of Two Glucocorticoid Regimens in the Treatment of Sarcoidosis: a Randomized Controlled Trial [NCT03265405]Phase 486 participants (Actual)Interventional2017-04-01Completed
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
Do Intraoperative Topical Corticosteroids Aid in the Prevention of Postoperative Dysphagia Following Elective Anterior Cervical Discectomy and Fusion? A Randomized, Controlled, Double Blinded Clinical Trial [NCT02539394]128 participants (Actual)Interventional2015-08-31Completed
The PREDMETH Trial: Effectiveness of Methotrexate Versus Prednisolone as First-line Therapy for Pulmonary Sarcoidosis - A Randomized Controlled Trial [NCT04314193]Phase 4138 participants (Anticipated)Interventional2020-06-01Recruiting
Efficacy and Safety of Difluprednate Ophthalmic Emulsion vs. a Fixed-Combination of Prednisolone Acetate - Phenylephrine Ophthalmic Suspension on Post-operative Inflammation Following Cataract Surgery. [NCT04631315]Phase 4255 participants (Actual)Interventional2019-03-24Completed
Study on the Association Between the Effect of Glucocorticoid Pulse Therapy on Neuromyelitis Optica and Gene Polymorphism: a Cohort Study [NCT04601142]350 participants (Anticipated)Observational2020-10-31Recruiting
Peking University Third Hospital Medical Science Research Ethics Committee [NCT04590183]30 participants (Anticipated)Interventional2020-10-01Recruiting
Multicentre Study to Determine the Cardiotoxicity of R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristin and Prednisolone) Compared to R-COMP (Rituximab, Cyclophosphamide, Liposomal Doxorubicin, Vincristin and Prednisolone) in Patients With Diffu [NCT00575406]Phase 294 participants (Actual)Interventional2007-12-31Completed
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 Phase 2a Randomised, Double Blind, Multi-centre Study to Assess the Effect on Glucose Homeostasis of Two Dose Levels of AZD9567, Compared to Prednisolone, in Adults With Type 2 Diabetes [NCT04556760]Phase 246 participants (Actual)Interventional2020-11-26Completed
Study HZA106851: A Study of the Effects of Inhaled Fluticasone Furoate/GW642444 Versus Placebo on the HPA Axis of Adolescent and Adult Asthmatics [NCT01086410]Phase 3185 participants (Actual)Interventional2010-03-31Completed
A Randomized, Controlled, PRospective Study of the Effectiveness and Safety of the Ocular Therapeutix Dextenza (Dexamethasone Ophthalmic Insert) 0.4 mg for the treatMEnt of Post-operative Inflammation in Patients Who Plan to Undergo Refractive Lens Exchan [NCT04549935]Phase 420 participants (Anticipated)Interventional2020-09-14Recruiting
The Efficacy Of Magnesium In Radicular Lower Limb Pain When It Is Added To Local Anesthetics And Steroids In The Transforaminal Epidural Injections. A Comparative Study [NCT04532775]Phase 1100 participants (Anticipated)Interventional2020-08-30Not yet recruiting
Cadaveric Organ Donor Management: Thyroid and Adrenocortical Hormone Replacement [NCT04528797]199 participants (Actual)Interventional2010-09-02Completed
A Phase 3 Multicenter, Randomized, Double-Masked Study of the Safety and Efficacy of Difluprednate 0.05% Ophthalmic Emulsion Compared to Prednisolone Acetate 1% Ophthalmic Suspension in the Treatment of Endogenous Anterior Uveitis [NCT01201798]Phase 3111 participants (Actual)Interventional2010-10-31Completed
Comparison of the Efficacy Between Ultrasound-guided Dextrose Injection Versus Dextrose With Methylprednisolone Injection in Patients With Carpal Tunnel Syndrome: a Prospective, Randomized Double-blind Clinical Trial. [NCT06045013]Phase 370 participants (Anticipated)Interventional2023-09-13Recruiting
Randomised Placebo Controlled Clinical Trial of Efficacy of MYOcardial Protection in Patients With Postacute inFLAMmatory Cardiac involvEment Due to COVID-19 [NCT05619653]Phase 3280 participants (Anticipated)Interventional2022-12-12Recruiting
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
A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Paediatric Patients With Relapsing Remitting Multiple Sclerosis (RRMS) With Disease Activity on Prior Disease Modifyi [NCT03368664]Phase 316 participants (Actual)Interventional2017-10-24Active, not recruiting
A Phase I/II, Single-Center, Randomized, Placebo-Controlled Study Evaluating the Therapeutic Efficacy of Intravenously Injected PEG-liposomal Prednisolone Sodium Phosphate (Nanocort®) in Subjects With Severe Inflamed Carotid or Aortic Atherosclerosis Plaq [NCT01601106]Phase 1/Phase 230 participants (Anticipated)Interventional2011-09-30Recruiting
Risk Stratification-directed Low-dose Glucocorticoid Prophylaxis for Acute GVHD After Unmanipulated Haploidentical Blood and Marrow Transplantation--a Randomized, Controlled, Clinical Trial [NCT01607580]145 participants (Actual)Interventional2012-06-30Completed
Evaluation of the Bioavailability of Methylprednisolone Succinate Administered Intranasally [NCT05649878]8 participants (Actual)Interventional2021-11-05Completed
Non-Invasive Mechanical Ventilation in Elderly Patients Affected by Acute Hypercapnic Respiratory Failure:A Randomized Control Study vs Standard Medical Therapy A Multicentric Randomized Controlled Trial [NCT00600639]Phase 482 participants (Actual)Interventional2004-01-31Terminated
A Pilot Double Blind Controlled Study Randomizing Patients Whose ENL is Not Controlled With Standard Prednisolone, and Comparing a Group Treated With Ciclosporin to a Group Treated With Additional Steroid Only. [NCT00919776]Phase 220 participants (Actual)Interventional2010-08-31Completed
Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study [NCT04168112]Phase 420 participants (Actual)Interventional2020-02-12Completed
A Randomized, Prospective, Open-Label Study of Rituximab in the Treatment of Recurrent IgA Nephropathy With Active Endocapillary Proliferation Pathology [NCT02571842]Phase 430 participants (Anticipated)Interventional2012-01-31Recruiting
Assessment of the Efficacy of Glucocorticoids in Improving Post-operative Organ Dysfunction in Patients With Acute Type A Aortic Dissection(GLAD): a Randomized Controlled Trial [NCT05329740]Phase 4212 participants (Actual)Interventional2022-02-07Completed
"Efficacy of Infliximab as Bridging Therapy in the Treatment of Patients Affected by Corticodependent Crohn's Disease Under Standard Treatment With Azathioprine" [NCT00796250]Phase 39 participants (Actual)Interventional2003-11-01Terminated(stopped due to Due to poor patient recruitment, a decision was made to terminate this trial.)
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
Evaluation of Therapeutic Effect of 0.5 mg Colchicine and 5 mg Prednisolone on Oral Aphthae [NCT00723268]Phase 230 participants (Anticipated)Interventional2007-05-31Active, not recruiting
Randomised Phase II Study of Metronomic Chemotherapy Plus the Same Aromatase Inhibitor Compared to Metronomic Chemotherapy Alone in Women With Hormone Receptor Positive, Her-2 Non-Overexpressing Advanced Breast Cancer Whose Disease Has Progressed While Re [NCT00687648]Phase 270 participants (Anticipated)Interventional2008-05-31Recruiting
Incretin Physiology and Beta-Cell Function Before and After Treatment With Steroid Hormone in Healthy Individuals [NCT00713440]10 participants (Actual)Interventional2008-07-31Completed
A Phase II Evaluation of High Dose Chemotherapy and Autologous Stem Cell Transplantation for Intestinal T-cell Lymphomas [NCT00669812]Phase 260 participants (Anticipated)Interventional2008-02-29Recruiting
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
Preoperative Methylprednisolone to Patients Suspected of Appendicitis Undergoing Laparoscopy [NCT02711449]Phase 278 participants (Actual)Interventional2016-04-30Completed
An Open-label Multicenter Trial to Study the Efficacy and Safety of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic Purpura [NCT04074187]Phase 2/Phase 321 participants (Actual)Interventional2019-10-21Completed
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 Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma (IELSG 26) [NCT00689845]120 participants (Anticipated)Interventional2007-06-30Recruiting
Sirolimus Versus Sirolimus Plus Prednisolone for Kaposiform Hemangioendothelioma With Kasabach-Merritt Syndrome [NCT03188068]Phase 230 participants (Actual)Interventional2017-06-01Completed
Phase II Study of Ibrutinib in Combination With Rituximab-CHOP in Epstein-Barr Virus-positive Diffuse Large B-cell Lymphoma 54179060LYM2003 (Nick Name: IVORY Study) [NCT02670616]Phase 224 participants (Actual)Interventional2016-05-01Completed
A Controlled Randomized Trial to Study the Efficacy of Adjunctive Methylprednisolone for the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Pediatric AIDS Patients [NCT00000741]Phase 30 participants (Actual)InterventionalWithdrawn
A Randomized Controlled Clinical Trial on the Efficacy and Safety of Glucocorticosteroid in the Patients With Chronic Recurrent Drug-induced Liver Injury [NCT02651350]Phase 1/Phase 280 participants (Actual)Interventional2015-12-31Completed
Comparison of Corticosteroids Versus Placebo on Duration of Ventilatory Support During Severe Acute Exacerbations of COPD Patients in the Intensive Care Unit: a Multicentre Randomized Controlled Trial [NCT04163536]Phase 3440 participants (Anticipated)Interventional2021-10-25Recruiting
A Randomised Phase II Trial of Inotuzumab Ozogamicin Plus Rituximab & CVP (IO-R-CVP) vs Gemcitabine Plus Rituximab & CVP (Gem-R-CVP) for the First Line Treatment of Patients With DLBCL Who Are Not Suitable for Anthracycline Containing Chemotherapy [NCT01679119]Phase 2129 participants (Actual)Interventional2013-10-31Completed
Desensitization for Preformed Anti-HLA Antibodies in Kidney Transplantation [NCT00908583]Phase 444 participants (Actual)Interventional2009-05-31Completed
Corticosteroids for Cancer Pain [NCT00676936]Phase 350 participants (Actual)Interventional2008-04-30Completed
The Effect of Reduced Corticosteroid Therapy in Patients With Acute Exacerbation of COPD [NCT02857842]Phase 4318 participants (Actual)Interventional2016-08-31Completed
DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK [NCT04281862]Phase 420 participants (Anticipated)Interventional2020-01-23Recruiting
[NCT02855502]Phase 4100 participants (Actual)Interventional2014-11-30Completed
Efficacy of Lower Dose Prednisolone in the Induction of Remission of Lupus Nephritis [NCT04146220]Phase 432 participants (Actual)Interventional2018-07-16Completed
Evaluation of Lycopene in the Treatment of Erosive Oral Lichen Planus (A Randomized Clinical Trial) [NCT04652739]Phase 2/Phase 320 participants (Actual)Interventional2018-10-01Completed
Phase 1, Open-label, Randomized, Single-dose, 2-treatment, 2 Period Crossover Bioequivalence Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 32 Mg Tablet Under Fasted Conditions [NCT01405131]Phase 10 participants (Actual)Interventional2012-01-01Withdrawn
Assessment of Corticosteroid Effect in the Prevention of Facial Palsy After Cerebella-pontine Angle Surgery [NCT00438087]Phase 3313 participants (Actual)Interventional2007-03-31Completed
Retrospective Study of Intrapleural Methylprednisolone Injection for Multiple Organ Failure With Acute Respiratory Distress Syndrome [NCT01423864]Phase 229 participants (Actual)Interventional2005-06-30Completed
Comparison Between Prednisolone and Dexamethasone on D28 Mortality in Patients on Oxygen Therapy, With CoViD-19: Multicenter, Randomized, Open-label Non-inferiority Study [NCT04765371]Phase 389 participants (Actual)Interventional2021-03-03Completed
A Randomized, Multicentre, Double-blind Study to Evaluate the Efficacy of High-dose Administration of Methylprednisolone in Addition to Standard Treatment, in SARS-CoV2 (COVID-19) Pneumonia Patients [NCT04673162]Phase 3260 participants (Actual)Interventional2020-12-17Completed
Open-labeled, Multicenter Phase II Study of Rituximab, Cyclophosphamide, Vincristine, and Prednisolone (R-CVP) Chemotherapy in Patients With Non-conjunctival Ocular Adnexal MALT Lymphoma [NCT01427114]Phase 233 participants (Actual)Interventional2011-07-01Completed
Unicentric Comparing Effectiveness of Polymyxin B Sulphate + Prednisolone + Benzocaine + Clioquinol to Betamethasone + Gentamicin + Tolnaftate + Clioquinol in Acute and Sub-acute Dermatitis Eczematous [NCT01429701]Phase 376 participants (Actual)Interventional2012-05-31Completed
Treatment Protocol of the Third International Study For Langerhans Cell Histiocytosis [NCT00276757]376 participants (Anticipated)Interventional2001-04-30Completed
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 Open Label, Multi-centre Trial of Alipogene Tiparvovec for the Treatment of LPLD Patients [NCT02904772]Phase 20 participants (Actual)Interventional2016-10-31Withdrawn(stopped due to uniQure, has decided not to renew the Marketing Authorization of Glybera in the EU. This decision is not related to any safety, efficacy or quality issue)
Assessing the Efficacy and Safety of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment [NCT04464629]Phase 47 participants (Actual)Interventional2020-07-14Terminated(stopped due to Poor enrollment)
Multi-center, Randomized, Double Masked, Vehicle Controlled Phase IV Study to Compare the Efficacy, Ocular Safety and Tolerability of a Two Day Treatment With Eye Drops (0.5% Prednisolone Acetate, One Drop Four Times Per Day) in Patients With Intraocular [NCT00170729]Phase 462 participants (Actual)Interventional2004-08-17Completed
Multicenter Trial for Treatment Optimization in T-lymphoblastic Lymphoma in Adults and Adolescents Older Than 15 Years (GMALL T-LBL 1/2004) (Amend 1) [NCT00199017]Phase 475 participants (Anticipated)Interventional2004-04-30Completed
A Randomized Pilot Trial of a Steroid-free Immunosuppressant Regimen in Pediatric Liver Transplantation [NCT00694408]Phase 315 participants (Actual)Interventional2008-06-30Terminated(stopped due to Study terminated due to withdrawal from market of Daclizumab)
Immunotherapy in Intractable Cryptogenic Epilepsy Patients With Autoimmune Antibody [NCT02695797]Phase 440 participants (Anticipated)Interventional2015-09-30Recruiting
Longitudinal Assessment of Clinical Course and BIOmarkers in Severe Chronic AIRway Disease [NCT00555607]233 participants (Actual)Interventional2002-03-31Active, not recruiting
Gleevec (Imatinib) Plus Multi-Agent Chemotherapy For Newly-Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia [NCT00618501]Phase 250 participants (Anticipated)Interventional2005-10-31Completed
Evaluation of the Tolerability and Efficacy of Erythropoietin (EPO) Treatment in Spinal Shock: Comparative Study VS Methylprednisolone (MP) [NCT00561067]Phase 310 participants (Actual)Interventional2008-04-30Terminated(stopped due to Italian Medicines Agency decision)
Effect of Different Therapeutic Strategies on Regulatory T Cells in Kidney Transplantation: a Randomized Study [NCT01640743]58 participants (Actual)Interventional2010-03-31Completed
A Parallel Randomised Phase II Trial of CHOP Chemotherapy With or Without Bortezomib in Relapsed Mantle Cell Lymphoma [NCT00513955]Phase 250 participants (Actual)Interventional2006-06-30Completed
Double-Blind, Placebo Controlled, Randomized, Multicenter, Parallel-Group Study to Compare the Efficacy and Safety of Advantan Cream Twice Weekly With Advabase Cream During a Maintenance Phase of 16 Weeks After Successful Treatment of Atopic Dermatitis Wi [NCT00185510]Phase 4250 participants (Actual)Interventional2005-03-31Completed
The Outcomes and Safety of Immunomodulators and Thrombopoietin Receptor Agonists in Primary Immune Thrombocytopenia Egyptian Patients With Hemorrhage Comorbidity [NCT05861297]Phase 4467 participants (Anticipated)Interventional2020-05-05Recruiting
Can Montelukast Shorten Corticosteroid Therapy In Children With Mild To Moderate Acute Asthma? [NCT00213252]Phase 2130 participants (Actual)Interventional2005-09-30Completed
Multisystem Inflammatory Syndrome Therapies in Children (MISTIC) Comparative Effectiveness Study [NCT04898231]Phase 2/Phase 3180 participants (Anticipated)Interventional2020-12-22Active, not recruiting
A Phase 2b, Double-Blind, Three Arm, Randomized, Placebo Controlled Trial With Restricted Response Adaptive Randomization Testing the Efficacy and Safety of High Dose Methylprednisolone or Equine Anti-Thymocyte Globulin as Treatment for Acute Liver Failur [NCT04862221]Phase 2163 participants (Anticipated)Interventional2022-02-09Recruiting
Treatment of Acute Lymphoblastic Leukemia in Children [NCT00400946]Phase 3800 participants (Actual)Interventional2005-04-30Completed
[NCT01865500]Phase 4100 participants (Actual)Interventional2013-01-31Completed
LAL-AR-N-2005: Study Treatment for Children High Risk Acute Lymphoblastic Leukemia [NCT00526409]Phase 440 participants (Anticipated)Interventional2005-06-30Completed
A Randomized, Controlled, Partial-blind, Parallel-group Study Evaluating the Effect of Oral Administration of BAY 1834845 and BAY 1830839 Twice Daily for 7 Consecutive Days on Local and Systemic IRAK4 Pathway-related Challenges in Healthy Male Participant [NCT05003089]Phase 151 participants (Actual)Interventional2021-06-28Completed
A Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, Crossover Bioavailability Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/Ml to Methylprednisolone 32 Mg Tablet Under Fasted Conditions [NCT01267201]Phase 124 participants (Actual)Interventional2010-11-30Completed
International Collaborative Treatment Protocol for Infants Under One Year With Acute Lymphoblastic or Biphenotypic Leukemia [NCT00550992]445 participants (Anticipated)Interventional2006-01-31Recruiting
Comparison of the Efficacy and Safety of Two Corticosteroid Regimens in the Treatment of Diffuse Lung Disease After Coronavirus Disease 2019 (COVID-19) Pneumonia [NCT04657484]130 participants (Actual)Interventional2020-12-01Completed
The Norwegian Prednisolone in Early Psychosis Study - NorPEPS. The Role of Immune-modulating Strategies in the Treatment of Psychosis [NCT03340909]Phase 212 participants (Actual)Interventional2018-02-02Terminated(stopped due to Stopped because of COVID 19 pandemic)
Comparison of the Effectiveness of the Ultrasound Guided Subacromial, Acromioclavicular With Subacromial Injection and Suprascapular Nerve Block in Patients With Shoulder Impingement Syndrome ; A Randomized Controlled, Single Blind, Clinical Trial [NCT05015322]Phase 488 participants (Actual)Interventional2017-01-01Completed
Steroids And Laser Trabeculoplasty (SALT) Trial: Effect of Anti-Inflammatory Treatment on the Efficacy of SLT [NCT00981435]Phase 497 participants (Actual)Interventional2009-09-30Completed
Use of Topical Euphrasia, a Homeopathic Remedy in Ophthalmology [NCT02416128]0 participants (Actual)Interventional2015-04-30Withdrawn(stopped due to No participants enrolled)
A Two-Part, Multi-Center, Prospective, Phase 2/3 Clinical Study to Evaluate the Safety and Efficacy of GLASSIA as an Add-On Biopharmacotherapy to Conventional Steroid Treatment in Subjects With Acute Graft-Versus-Host Disease With Lower Gastrointestinal I [NCT02956122]Phase 2/Phase 31 participants (Actual)Interventional2017-04-26Terminated(stopped due to The decision to discontinue the study was based on business reasons.)
[NCT00000138]Phase 30 participants Interventional1989-05-31Active, not recruiting
Research on the Treatment of Severe Community-acquired Pneumonia in Children [NCT05768204]Phase 4160 participants (Anticipated)Interventional2023-03-10Recruiting
A Phase 1/2 Trial Evaluating Treatment of Emergent Graft Versus Host Disease (GvHD) With AP1903 After Planned Donor Infusions (DLIs) of T-cells Genetically Modified With the iCasp9 Suicide Gene in Patients With Hematologic Malignancies [NCT01875237]Phase 1/Phase 23 participants (Actual)Interventional2013-12-27Terminated
The Effect of a Combination of Systemic Steroids and Antibiotics on Obstructive Sleep Apnea Syndrome in Children [NCT00456339]Phase 44 participants (Actual)Interventional2006-07-31Terminated(stopped due to Problems recruiting; patient relapse following treatment)
Phase IV Study of Perioperative Steroid's Effects on Death or MI in High-Risk Patients Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass [NCT00427388]Phase 47,507 participants (Actual)Interventional2007-06-30Active, not recruiting
[NCT00480675]65 participants (Actual)Interventional2007-03-31Completed
A Multicenter, Open-Label, Phase 2 Study of SyB L-0501 (Bendamustine Hydrochloride) for Patients With Multiple Myeloma [NCT01179490]Phase 25 participants (Actual)Interventional2010-09-30Terminated
[NCT00501579]Phase 30 participants InterventionalCompleted
A Randomized, Masked Multi-center Safety & Efficacy Study of the Effects of Preoperative & Postoperative Cataract Surgery Use of Difluprednate Ophthalmic Emulsion, 0.05% Compared to Prednisolone Acetate Ophthalmic Suspension 1% on Visual Acuity & Corneal [NCT01244334]Phase 452 participants (Actual)Interventional2009-03-31Completed
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
A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and Corticosteroid With Tacrolimus and Corticosteroid as Immunosuppressive Treatment for Lupus Membra [NCT00404794]Phase 320 participants (Anticipated)Interventional2005-11-30Completed
A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5% [NCT01437982]Phase 4140 participants (Anticipated)Interventional2010-08-05Completed
Role of Extended Low Dose Prednisolone in Achieving Clinical and Biochemical Remission in Steroid Responsive Severe Alcoholic Hepatitis. [NCT06155760]150 participants (Anticipated)Interventional2023-11-25Not yet recruiting
A Multicenter, Double-blinded, Randomized, Placebo-controlled Trial to Compare the Effectiveness of Intratympanic Injections methylPREDnisolon Versus Placebo in the Treatment of Vertigo Attacks in MENière's Disease (PREDMEN Trial). [NCT05851508]Phase 3148 participants (Anticipated)Interventional2023-10-01Recruiting
Prednisolone and Vitamin B1, B6, and B12 in Patients With Post-COVID-19-Syndrome (PC19S) - a Randomized Controlled Trial in Primary Care [NCT05638633]Phase 3340 participants (Anticipated)Interventional2022-11-11Recruiting
A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine (NSC# 102816) to Chemotherapy in Infants With Acute Lymphoblastic Leukemia (ALL) and KMT2A (MLL) Gene Rearrangement [NCT02828358]Phase 278 participants (Actual)Interventional2017-04-01Active, not recruiting
Mesenchymal Stem Cells Under Basiliximab/Low Dose RATG to Induce Renal Transplant Tolerance [NCT00752479]Phase 1/Phase 24 participants (Actual)Interventional2008-05-31Terminated(stopped due to Necessity of major revision of the protocol)
Remission Induction in Very Early Rheumatoid Arthritis: a Comparison of Etanercept Plus Methotrexate Plus Steroid With Standard Therapy [NCT00523692]Phase 420 participants (Anticipated)Interventional2007-09-30Not yet recruiting
A Multicentre Placebo-Controlled Evaluation of Prednisolone and/or Valaciclovir for the Treatment of Bell's Palsy [NCT00510263]Phase 4839 participants (Actual)Interventional2001-05-31Completed
The Evaluation of the Safety and Efficacy of Sustained Release Dexamethasone Intracanalicular Insert (DEXTENZA) in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia (TENDER) [NCT05620901]Early Phase 130 participants (Anticipated)Interventional2023-02-01Recruiting
Nivolumab With Standard of Care Chemotherapy for the First Line Treatment of Peripheral T Cell Lymphoma [NCT03586999]Phase 1/Phase 218 participants (Actual)Interventional2018-11-07Active, 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
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
Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants [NCT02935101]Phase 24 participants (Actual)Interventional2016-10-31Terminated(stopped due to difficulties in recruiting study participants)
Pilot Study Investigating the Utility of Epidural AlloGen-LI Injection for Treatment of Spinal Stenosis Symptoms [NCT02932020]0 participants (Actual)Interventional2016-10-31Withdrawn
A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab (AIN457) in Patients With Giant Cell Arteritis (TitAIN) [NCT03765788]Phase 252 participants (Actual)Interventional2019-01-30Completed
Phase IIIb Study of Corticosteroids as Post-Operative Adjuvant Therapy in Biliary Atresia [NCT00539565]Phase 3100 participants (Anticipated)Interventional2000-01-31Enrolling by invitation
Corticosteroids in the Maintenance Therapy of Proliferative Lupus Nephritis: a Randomized Pilot Study [NCT00539799]Phase 315 participants (Anticipated)InterventionalWithdrawn(stopped due to Local pharmacy unwilling to comply with study protocol)
Clinical and Radiological Comparison of the Efficacy of Hyaluronic Acid, PRP and Steroid Injections in Partial Rotator Cuff Tears: A Prospective Randomized Study [NCT04681937]80 participants (Anticipated)Interventional2021-06-01Not yet recruiting
LBL 2018 - International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma [NCT04043494]Phase 3683 participants (Anticipated)Interventional2019-08-23Recruiting
Ma-Spore ALL 2010 Study [NCT02894645]Phase 4500 participants (Anticipated)Interventional2008-10-31Recruiting
High-Dose Corticosteroids for Immune Reconstitution Inflammatory Syndrome in Patients Who Develop Progressive Multifocal Leukoencephalopathy on Natalizumab [NCT01211665]Phase 43 participants (Actual)Interventional2010-09-30Terminated(stopped due to This study was stopped prematurely due to lack of enrollment within a 1-5-year period.)
DEXTENZA for the Treatment of Post-Surgical Pain and Inflammation ComparEd to StandaRd of Care Topical Cortico-Steroid Treatment In PatientS Who Undergo BilaTeral Pterygium Surgery PERSIST Study [NCT04351737]Phase 420 participants (Anticipated)Interventional2020-07-15Active, not recruiting
A PedAL/EuPAL Phase 1/2 Trial of IMGN632 in Pediatric Patients With Relapsed or Refractory Leukemia [NCT05320380]Phase 1/Phase 20 participants (Actual)Interventional2023-08-01Withdrawn(stopped due to Withdrawn per CS0150757)
Safety and Efficacy of Prednisolone in Adrenal Insufficiency Disease (PRED-AID Study) [NCT03936517]Phase 344 participants (Anticipated)Interventional2019-07-31Active, not recruiting
Effects of Peri-Operative Glucosteroid Administration on Outcomes Following Distal Radius Fracture [NCT05655130]Phase 160 participants (Anticipated)Interventional2018-11-06Active, not recruiting
An Open-label, Single-arm Study to Describe Glucocorticoid Use in Rheumatoid Arthritis Patients Treated With Tocilizumab in Daily Clinical Practice and to Evaluate Systematic Glucocorticoid Dose Reduction Once Low Disease Activity is Reached (ACT-ALONE) [NCT01219933]Phase 468 participants (Actual)Interventional2011-01-31Completed
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)
[NCT00854061]Phase 3172 participants (Actual)Interventional2009-02-28Completed
Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma [NCT00882895]Phase 218 participants (Actual)Interventional2009-05-05Active, not recruiting
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
A Double-blind,Double Dummy, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Adults With Moderate - Severe Persistent Allergic Rhinitis [NCT01720485]Phase 3234 participants (Anticipated)Interventional2013-10-31Not yet recruiting
Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm [NCT04355247]Phase 220 participants (Anticipated)Interventional2020-04-14Recruiting
TREATMENT OF ADULT PATIENTS WITH RELAPSING ACUTE LYMPHOCYTIC LEUKEMIA, A MULTICENTER TRIAL [NCT00002532]Phase 20 participants Interventional1993-01-31Active, not recruiting
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
Matched Unrelated and Haploidentical Bone Marrow Transplantation for Hematologic Malignancies [NCT00003960]Phase 236 participants (Anticipated)Interventional1998-04-30Completed
Chronic Lymphocytic Leukemia Trial 4: A Randomized Comparison of Chlorambucil, Fludarabine and Fludarabine Plus Cyclophosphamide [NCT00004218]Phase 30 participants Interventional1999-10-31Completed
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
Conversion Study to Optimize Immunosuppressive Regimen by Withdrawal of Steroids, Cyclosporine A Dose Reduction and a Switch to Mycophenolatmofetile for Patients After Heart Transplantation in the Long-Term. [NCT00359658]40 participants (Actual)Interventional2004-11-30Completed
[NCT00372294]Phase 30 participants Interventional2005-07-31Active, not recruiting
Investigation of the Side Effects of Orally Administered Glucocorticoids. An Open Label Study to Investigate the Effects of Orally Administered Prednisolone on Bone Metabolism in Patients With COPD. [NCT00384306]Phase 19 participants (Actual)Interventional2004-06-30Completed
Randomized Controlled Clinical Trial of Low Dose Corticosteroids vs Anti TNF Treatment in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient- a Pilot Study [NCT01724268]Phase 380 participants (Anticipated)Interventional2012-05-31Recruiting
Open Randomized Study on the Efficacy of corticoïd Infiltration Versus Physiological Solution Infiltration Versus Feigning of Infiltration Via Sacro-coccygien Hiatus Versus Natural Evolution in Discal Sciatica [NCT01482897]Phase 313 participants (Actual)Interventional2011-12-31Terminated(stopped due to Enrolment stopped on December 01, 2014 since after 3 years, only 13 patients were included (instead of 274) (Date of last visit last patient : October 3, 2013).)
Effects of High Dose Inhaled Budesonide+ Formoterol Versus Placebo and Oral Prednisolone on Biomarkers of Airway Inflammation in the Treatment of Exacerbations in Non-hospitalised Patients With Mild to Moderate COPD. [NCT00239278]Phase 2120 participants Interventional2001-01-31Completed
Congenital Adrenal Hyperplasia: Innovative Once Daily Dual Release Hydrocortisone Treatment [NCT03760835]Phase 4150 participants (Anticipated)Interventional2016-08-11Recruiting
Hodgkin's Disease Study [NCT00416377]353 participants (Anticipated)InterventionalActive, not recruiting
Urinary Aquaporin 2 Excretion After Methylprednisolone in Fasting Healthy Humans [NCT00281710]Phase 420 participants Interventional2005-10-31Completed
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
Prospective Phase II Study of Early Low Dose Steroid Therapy of Acute Respiratory Distress Syndrome (ARDS) After Thoracic Surgery (E-START) [NCT00290602]Phase 240 participants Interventional2004-02-29Completed
Phase 2 Study of Imatinib-Combined Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia [NCT00130195]Phase 2100 participants (Actual)Interventional2002-09-30Completed
Does a Single Steroid Injection Reduce the Formation of Postmastectomy Seroma [NCT00307606]Phase 440 participants (Anticipated)Interventional2005-12-31Recruiting
Effect of High-Dose Prednisolone (Solu Dacortin®) Treatment on Choroidal and Optic Nerve Head Blood Flow in Humans [NCT00312325]Phase 424 participants Interventional2005-07-31Completed
The Efficacy and Safety of Intravenous Pulse Steroids Compared to Standard Oral Steroids in the Treatment of Problematic Hemangiomas in Infants: A Randomized Controlled Trial [NCT00312520]Phase 320 participants Interventional2002-07-31Completed
A Clinical Study Was Conducted to Evaluate the Efficacy and Safety of the RCMOP Regimen Sequential Therapy as a First-line Treatment for Patients With Intermediate-to-high Risk Diffuse Large B-cell Lymphoma Who Had Incomplete Remission. [NCT05990985]20 participants (Anticipated)Interventional2023-09-01Not yet recruiting
Dropless Pars Plana Vitrectomy Study [NCT05331664]Phase 4168 participants (Anticipated)Interventional2022-07-25Recruiting
Genomic Effects of Glucocorticoids in Patients With Systemic Lupus Erythematosus [NCT04233164]Early Phase 147 participants (Actual)Interventional2020-03-04Active, not recruiting
A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment [NCT05665270]Phase 440 participants (Anticipated)Interventional2023-01-30Enrolling by invitation
Multicentric Study for the Treatment of Children With Acute Lymphoblastic Leukemia [NCT00343369]550 participants (Anticipated)Interventional2003-01-31Recruiting
[NCT00433225]Phase 40 participants InterventionalCompleted
First International Inter-Group Study for Classical Hodgkin's Lymphoma in Children and Adolescents [NCT00433459]Phase 32,134 participants (Actual)Interventional2007-01-31Completed
Treatment of Patients With Idiopathic Membranous Nephropathy at Risk for Renal Insufficiency: Comparison of Early Versus Late Start of Immunosuppressive Therapy [NCT00135954]Phase 329 participants (Actual)Interventional1997-07-31Completed
CHEMO-T: Cyclophosphamide, Doxorubicin, Vincristine and Prednisolone (CHOP) Versus Gemcitabine, Cisplatin and Methyl Prednisolone (GEM-P) in the First Line Treatment Of T-cell Lymphoma,a Multicentre Randomised Phase II Study [NCT01719835]Phase 287 participants (Actual)Interventional2012-03-31Active, not recruiting
A Randomized Controlled Multicentre Trial of High Dose Dexamethasone Versus Conventional Dose Prednisolone for Adults With Untreated Idiopathic Thrombocytopenic Purpura [NCT00451594]Phase 3157 participants (Actual)Interventional2005-09-30Completed
A Masked Comparison of Acular LS Plus Steroid Versus Steroid Alone for the Prevention of Macular Leakage in Cataract Patients [NCT00348244]Phase 40 participants InterventionalCompleted
A Multi-Center, Randomized, Blinded, Parallel-Group Study of AVONEX Compared With AVONEX in Combination With Oral Methotrexate, Intravenous Methylprednisolone, or Both in Subjects With Relapsing Remitting MS Who Have Breakthrough Disease on AVONEX Monothe [NCT00112034]Phase 4350 participants Interventional2003-06-30Completed
Prednisolone vs. Ciclosporine in Severe Atopic Eczema [NCT00445081]Phase 466 participants (Anticipated)Interventional2007-03-31Completed
Double-Blind Randomized Placebo-Controlled Trial on Clinical and Biological Effects of Oral Corticosteroids or Doxycyclin in Patients With Nasal Polyposis [NCT00480298]Phase 248 participants Interventional2002-11-30Completed
The Effect of 6-Methyl-Prednisolone on Organ Dysfunction and Mortality of Patients With Unresolving Multiple Organ Dysfunction Syndrome [NCT00127985]Phase 4240 participants (Anticipated)Interventional2005-08-31Recruiting
Randomized Controlled Trial to Test Efficacy of High-Dose Methotrexate Consolidation Therapy for BCR-ABL-Negative Acute Lymphoblastic Leukemia in Adults [NCT00131027]Phase 3240 participants (Anticipated)Interventional2002-09-30Recruiting
A Prospective Non-randomised Trial of Chemotherapy and Radiotherapy for Osteolymphoma [NCT00141648]70 participants (Actual)Interventional2000-09-30Completed
A Randomised, Placebo-controlled, Parallel Group Single Dose Study of SB681323 in Patients With Active RA to Investigate the CRP Dose Response Relationship [NCT00134693]Phase 277 participants (Actual)Interventional2005-06-21Completed
Medication Overuse Headache: A Randomised Double Blind Study of Prednisolone or Placebo in Withdrawal Therapy (Phase 3), and a Randomised 1 Year Follow up by Neurologist or General Physician After Successful Withdrawal Therapy [NCT00135122]Phase 3100 participants (Actual)Interventional2003-09-30Completed
Role of Topical Immuonosuppressant in the Management of Spring Catarrh: a Comparative Study Between Cyclosporine A 2% and Tacrolimus 0.3% [NCT04705584]180 participants (Anticipated)Interventional2021-01-31Not yet recruiting
Standardized Time- and Score-oriented Treatment of Moderate and Severe Atopic Dermatitis [NCT00148746]0 participants Interventional2004-05-31Completed
Repeated Corticosteroid Injections Around the Greater Occipital Nerve (GON) as Prophylactic Treatment in Chronic Cluster Headache [NCT05324748]Phase 350 participants (Anticipated)Interventional2022-11-07Recruiting
A Phase I Randomized, Double-blind, Placebo-controlled, Dose-increasing Single Dose Study Evaluating the Safety, Tolerability,Pharmacokinetics and Pharmacodynamics Analysis of Pegloticase in Subjects With Asymptomatic Hyperuricemia [NCT05302388]Phase 145 participants (Actual)Interventional2022-04-11Completed
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
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
A Randomized, Multicenter, Open-Label Study of Single Dose Filgrastim-SD/01 Versus Daily Filgrastim Following ESHAP Chemotherapy for Non-Hodgkin's Lymphoma [NCT00004192]Phase 260 participants (Anticipated)Interventional2000-05-01Completed
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
Health Sciences University Bursa Yüksek Ihtisas Training and Research Hospital [NCT04847687]300 participants (Actual)Observational2021-03-01Completed
Methotrexate and Prednisolone Study in Erythema Nodosum Leprosum (MaPS in ENL [NCT03775460]550 participants (Anticipated)Interventional2023-01-15Recruiting
Topical Endorectal Vietamin E Ovules for the Treatment of Grade 2 and 3 Hemorrhoids [NCT04362384]Phase 3120 participants (Anticipated)Interventional2020-05-01Not yet recruiting
The Pharmacokinetics and Anti-inflammatory Effects of Prednisolone in Severe Asthma [NCT00662298]Phase 45 participants (Actual)Interventional2011-06-30Completed
Trial of High Dose Immunosuppressive Therapy With Hematopoietic Stem Cell Support in Devic's Disease [NCT00787722]Phase 1/Phase 213 participants (Actual)Interventional2009-10-10Completed
Phase II Study of Combination of Thymoglobulin, Cyclosporine, Methylprednisone, and Granulocyte Colony-stimulating Factor (GCSF) in Patients With Newly Diagnosed Aplastic Anemia or With Hypoplastic or Low/Intermediate-1 Risk Myelodysplastic Syndrome [NCT00806598]Phase 253 participants (Actual)Interventional2005-05-31Completed
A Prospective Randomized Controlled Trial of Early Non-Invasive Positive Pressure Ventilation in Patients With Hypoxemic Respiratory Failure and Malignancies [NCT02464696]256 participants (Anticipated)Interventional2015-10-06Recruiting
Lymphodepleting Chemotherapy and T-Cell Suppression Followed By Allogeneic Natural Killer Cells and IL-2 in Patients With Recurrent Ovarian, Fallopian Tube, Primary Peritoneal Cancer and Advanced Metastatic Breast Cancer (MT2009-30) [NCT01105650]Phase 213 participants (Actual)Interventional2010-07-31Completed
Evaluation of TNF-α Blockade Effect in Patients With Severe Cutaneous Adverse Drug Reactions (SCAR) [NCT01276314]135 participants (Actual)Interventional2009-01-31Completed
Phase III Trial Comparing CHOP ot PMitCEBO in Good Risk Patients With Histologically Aggresive Non Hodgkin's Lymphoma [NCT00005867]Phase 3310 participants (Anticipated)Interventional1998-01-31Completed
Injection of Dorsal Scapular n at Different Levels, Dose it Make Difference? [NCT04693312]Phase 2/Phase 360 participants (Actual)Interventional2020-01-01Completed
The Impact of Pre-emptive Large Doses of Methylprednisolone Combined With Gabapentin on Pain Treatment and Convalescence After Total Knee Arthroplasty in Elderly: A Double-blind Randomized Study [NCT04653415]Phase 4160 participants (Actual)Interventional2019-06-01Completed
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
Reduction in Symptomatic Oesophageal Stricture Formation Post-two Stage Complete Barrett's Excision for High Grade Dysplasia or Early Adenocarcinoma With Short-term Steroid Therapy: A Randomized, Doubleblind, Placebo-controlled, Multicentre Trial. [NCT02004782]Phase 40 participants (Actual)Interventional2022-03-31Withdrawn(stopped due to study abandoned)
Platelet-rich Plasma Infiltration Versus Corticosteroid Infiltration (Prednisolone) in Treatment of Lumbar Facet Joint Syndrome [NCT05105256]72 participants (Anticipated)Interventional2021-12-21Recruiting
Gene Transfer for Patients With Fanconi Anemia Complementation Group A (FANCA) [NCT01331018]Phase 13 participants (Actual)Interventional2012-02-22Active, not recruiting
CSP #574 - Evaluate the Safety and Efficacy of Methylprednisolone in Hospitalized Veterans With Severe Community-Acquired Pneumonia [NCT01283009]Phase 3584 participants (Actual)Interventional2012-01-09Completed
[NCT00000147]0 participants Interventional1988-07-31Active, not recruiting
A Study To Validate Key Therapeutic Targets and Characterise Their Response to Corticosteroids in Multiple Asthma Phenotypes [NCT00331058]Phase 158 participants (Actual)Interventional2006-02-18Terminated(stopped due to The study was truncated due to the long period of enrollment and the collection of a sufficient amount of data that allowed the scientific objectives to be met)
Comparison of Efficacy and Safety of Intravenous Pulsed Methylprednisolone and Oral Methotrexate Versus Intravenous Pulsed Methylprednisolone and Oral Placebo in the Treatment of Active Moderate and Severe Thyroid Eye Disease - a Prospective, Randomized, [NCT00348413]80 participants (Anticipated)Interventional2003-06-30Completed
Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty (SLT): A Randomized, Masked, Placebo Controlled Study [NCT00485108]120 participants (Actual)Interventional2007-01-31Completed
Intradiscal Gelified Ethanol Versus Intradiscal Steroid in Refractory Lumbar Discogenic Pain: a Randomized Single-blind Study [NCT03415828]83 participants (Actual)Interventional2018-05-29Active, not recruiting
A Double-blind, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Children (2-12 Years) With Moderate - Severe Persistent Allergic Rhinit [NCT01529229]Phase 3210 participants (Actual)Interventional2013-11-30Completed
Pilot, Phase I, Single Blind Trial to Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers. (PRURITUS- Nimpa Study). [NCT01529320]Phase 118 participants (Actual)Interventional2012-02-29Completed
A RANDOMIZED PROSPECTIVE TRIAL OF CHOP VERSUS MCOP IN ELDERLY PATIENTS WITH INTERMEDIATE AND HIGH GRADE NON-HODGKIN'S LYMPHOMA (AGED 65 YEARS AND OVER) [NCT00002576]Phase 3200 participants (Anticipated)Interventional1992-11-30Completed
Prospective Controlled Protocol for 3 Months Steroid Withdrawal With Tacrolimus, Basiliximab, and Mycophenolate Mofetil in Renal Transplant Recipients [NCT01550445]Phase 430 participants (Anticipated)Interventional2008-05-31Recruiting
Comparison of Relapse Rate After 12 Weeks Verses 20 Weeks Steroid Therapy for the Management of First Episode of Steroid Sensitive Nephrotic Syndrome: A Randomized Control Trial at Children Hospital, Pakistan Institute of Medical Sciences, Islamabad [NCT04713410]68 participants (Anticipated)Interventional2020-12-22Recruiting
Phase II Clinical Trial Incorporating Alemtuzumab (Campath-1H) in Combination With FK506 and Methylprednisolone for Treatment of Severe Acute Graft vs Host Disease [NCT00109993]Phase 234 participants (Actual)Interventional2005-01-31Completed
MULTICENTRE TRIAL OF INTENSIFIED THERAPY FOR ADULT ALL (O5/93) [NCT00002531]Phase 20 participants Interventional1993-01-31Active, not recruiting
Initiation of Chronic Asthma Care Regimens in the Pediatric Emergency Department [NCT00388739]0 participants (Actual)Interventional2006-11-01Withdrawn(stopped due to Different study was designed)
[NCT00000146]Phase 30 participants Interventional1988-07-31Active, not recruiting
Pilot Study Of PMitCEBO Plus G-CSF In Good-Prognosis HIV-Related Lymphoma [NCT00032149]Phase 1/Phase 230 participants (Anticipated)Interventional2001-10-31Active, not recruiting
International Collaborative Treatment Protocol for Infants Under One Year With Acute Lymphoblastic Leukemia [NCT00015873]Phase 3350 participants (Anticipated)Interventional1999-05-31Completed
A Double-blind, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Children (2-12 Years) With Acute Cutaneous Rash [NCT01529242]Phase 317 participants (Actual)Interventional2014-02-28Terminated(stopped due to By sponsor decision due to difficulty of recruitment)
[NCT00017628]Phase 120 participants 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
Impact of Tuberculosis on HIV Infection in Uganda [NCT00057421]Phase 2190 participants Interventional1998-11-30Completed
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
Randomised, Double-Arm, Controlled, Open-Label Study Comparing Calcineurin Inhibitor-Free Immunosuppression (Zenapax®, CellCept® and Prednisolone) and Cyclosporine A Based Immunosuppression (Sandimmun Neoral®, CellCept® and Prednisolone) on the Outcome of [NCT00138970]Phase 470 participants Interventional2002-01-31Completed
A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and Corticosteroid With Conventional Immunosuppressive Treatment on Proteinuria in Idiopathic Membranous Nephropathy (MN) and Focal Segmental Glomerulosclerosis (FSGS) [NCT00404833]Phase 316 participants (Anticipated)Interventional2003-01-31Completed
Treatment Protocol for T-Cell and B-Precursor Cell Lymphoblastic Lymphoma of the European Inter-group Co-operation on Childhood Non-Hodgkin-Lymphoma (EICNHL) [NCT00275106]Phase 3600 participants (Anticipated)Interventional2004-09-30Terminated(stopped due to Withdrawn due to an excess of toxic deaths)
Rituxumab Combined With Chemotherapy (PVB) For Poor Prognosis HIV-Related Non-Hodgkin's Lymphoma [NCT00031902]Phase 10 participants Interventional2001-10-31Active, not recruiting
Phase IV Study of Early RA: a Randomized Magnetic Resonance Imaging Study Comparing the Effects of Methotrexate Alone or in Combination With Infliximab or Intravenous Pulse Methylprednisolone [NCT00396747]Phase 445 participants (Actual)Interventional2003-06-30Completed
A Phase IV, Randomized, Multi-center Clinical Trial to Compare the Efficacy of Orbital Radiotherapy in Association With Intravenous Glucocorticoids vs Intravenous Glucocorticoids Alone for Moderately Severe and Active Graves' Orbitopathy [NCT03098225]Phase 4120 participants (Anticipated)Interventional2024-01-01Not yet recruiting
Administration of Oral Prednisolone to Prevent Esophageal Stricture After Balloon-type Radiofrequency Ablation for Long-segment Esophageal Neoplasia [NCT05768282]Phase 450 participants (Anticipated)Interventional2016-01-01Recruiting
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
Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis [NCT00682357]25 participants (Actual)Interventional2008-05-31Completed
Protocol For The Treatment Of Children And Adolescents With Hodgkin's Disease [NCT00025064]Phase 2260 participants (Anticipated)Interventional2000-01-31Active, not recruiting
Treatment of Acute Graft vs. Host Disease With Steroids Plus Daclizumab (Zenapax) or Placebo [NCT00053976]Phase 3105 participants (Actual)Interventional2001-01-31Completed
Phase 2 Study of Applying Pediatric Regimens to Younger Adult Patients With BCR-ABL-Negative Acute Lymphoblastic Leukemia [NCT00131053]Phase 2120 participants (Anticipated)Interventional2002-09-30Recruiting
Single-Center, Randomized, Double Masked, Two-Period Cross-Over, Three Days Per Period, Phase IV Study to Compare Ocular Safety and Tolerability of Prednisolone Acetate 0.5% Eye Drops Versus Vehicle in Healthy Volunteers [NCT00134992]Phase 430 participants Interventional2004-08-31Completed
The Role of Topical Prednisolone Acetate Following Selective Laser Trabeculoplasty [NCT00406042]25 participants Interventional2005-09-30Completed
Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease [NCT00152620]40 participants Interventional2004-06-30Terminated(stopped due to study completed)
A Phase I Trial of BBR 2778 in Combination With Cytarabine, Methylprednisolone and Cisplatin in the Treatment of Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma [NCT00053105]Phase 10 participants Interventional2002-02-28Active, not recruiting
A Multi-Center, Randomized, Double Masked, Bioequivalence Study of Tobramycin and Prednisolone Acetate (0.3/1.0%, ISTA) Ophthalmic Suspension Compared to PredForte (1.0% Prednisolone Acetate, Allergan) Ophthalmic Suspension [NCT00198523]Phase 3132 participants Interventional2005-07-31Completed
Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids: a Prospective, Double-Blind, Placebo-Controlled Trial. [NCT00199576]Phase 3670 participants Interventional2000-12-31Completed
The Effect of Different Intra-articular Injections on Pain and Function in Primary Gonarthrosis [NCT05291793]80 participants (Actual)Interventional2020-04-01Completed
the Effect of Single Dose of Etomidate Used During Emergency Intubation on Hemodynamics and Adrenal Cortex: a Randomized Clinical Trial [NCT01792037]Phase 490 participants (Actual)Interventional2012-12-31Completed
Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery [NCT04200651]Phase 425 participants (Actual)Interventional2020-01-13Completed
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
A Phase II Study of JNJ-212082 (Abiraterone Acetate) in Metastatic Castration-Resistant Prostate Cancer Patients Who Have Received Docetaxel-based Chemotherapy [NCT01795703]Phase 247 participants (Actual)Interventional2012-06-30Completed
Peri-articular Injections Containing a Corticosteroid During Total Knee Arthroplasty [NCT00492973]101 participants (Actual)Interventional2006-03-31Completed
Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion (OME) Compared to That of Combination of Antibiotic, Antihistaminic, and Nasal Decongestant [NCT03590912]Phase 4160 participants (Actual)Interventional2018-09-05Completed
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy of CRx-102 in Subjects With Symptomatic Knee Osteoarthritis and Optional One-Year Extension [NCT00521989]Phase 2279 participants (Actual)Interventional2007-08-31Terminated(stopped due to CRx-102-006 study results, negative)
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Superiority of CRx-102 Over Each of Its Components When Given to Subjects With Active Rheumatoid Arthritis (RA) [NCT00551707]Phase 251 participants (Actual)Interventional2007-10-31Completed
A California Cooperative Clinical Study Comparing Allogeneic Hematopoietic Cell Transplantation Using Nonmyeloablative Host Conditioning With Total Lymphoid Irradiation and Anti-thymocyte Globulin Versus Best Standard of Care in Acute Myeloid Leukemia (AM [NCT00568633]Phase 358 participants (Actual)Interventional2007-08-31Terminated(stopped due to Poor accrual)
Adrenal Cortical Function and Vitamin A Deficiency in Sepsis, Severe Sepsis and Septic Shock: Prospective Randomized, Double Blind Placebo Controlled Clinical Trials [NCT03152474]Phase 4300 participants (Actual)Interventional1993-02-28Completed
Multicentre Prospective Open Label Clinical Study to Evaluate the Effect of Personalized Therapy on Patients With Immunoglobulin A Nephropathy. [NCT04662723]Phase 4878 participants (Anticipated)Interventional2023-05-01Recruiting
Efficacy and Safety of MEthylprednisolone Administered Intravenously for the Treatment of Patients With Active AnkyLosing spondyLitis (METALL) - a 12-week, Prospective, Open-label, Pilot Study [NCT01790022]Phase 220 participants (Actual)Interventional2012-07-31Active, not recruiting
Genomic Response of Human Immune and Non-Immune Cells to Glucocorticoids [NCT02798523]Phase 133 participants (Actual)Interventional2017-01-24Completed
Evaluation of HepQuant SHUNT to Assess Liver Disease; Substudy Within GS-US-416-2124 [NCT03087968]Early Phase 10 participants (Actual)Interventional2016-07-31Withdrawn(stopped due to No longer a sub-study - Changing to an independent parallel study)
Pilot Study of Methylprednisolone Replacement for Dexamethasone-induced Hiuup Patients [NCT01277731]0 participants (Actual)Interventional2010-07-31Withdrawn
Steroid Versus Platelet Rich Plasma in Ultrasound Guided Sacroiliac Joint Injection for Chronic Low Back Pain [NCT02334475]40 participants (Actual)Interventional2013-07-31Completed
Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2 [NCT05736549]Phase 266 participants (Anticipated)Interventional2023-02-07Recruiting
Asia-wide, Multicenter Open-label, Phase II Non-randomised Study Involving Children With Down Syndrome Under 21 Year-old With Newly Diagnosed, Treatment naïve Acute Lymphoblastic Leukemia [NCT03286634]Phase 260 participants (Anticipated)Interventional2017-04-18Recruiting
[NCT00699803]Phase 264 participants (Actual)Interventional2008-05-31Completed
Short Chemo Radiotherapy in Follicular Lymphoma Trial of 90Y Ibritumomab Tiuxetan (ZevalinTM) as Therapy for First and Second Relapse in Follicular Lymphoma [NCT00637832]Phase 21 participants (Actual)Interventional2008-04-01Terminated(stopped due to no information)
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
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
Azithromycin for Preventing the Development of Upper Respiratory Tract Illness Into Lower Respiratory Tract Symptoms in Children and Oral Corticosteroids for Treating Episodes of Significant Lower Respiratory Tract Symptoms in Children [NCT01272635]Phase 3607 participants (Actual)Interventional2011-03-31Completed
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
A Phase I/II Study of Bortezomib Plus CHOP Every 2 Weeks in Patients With Advanced Stage Diffuse Large B-cell Lymphomas [NCT00379574]Phase 1/Phase 249 participants (Actual)Interventional2006-09-30Completed
An Open-label, Randomized, Cross-over Interventional Study to Evaluate the Efficacy and Safety of Tocilizumab Versus Corticosteroids in Hospitalised COVID-19 Patients With High Risk of Progression [NCT04345445]Phase 3310 participants (Anticipated)Interventional2020-04-15Not yet recruiting
Phase II Randomized Double Blind Trial of Methylprednisolone and N-acetylcysteine in Hepatic Resections. [NCT01726465]Phase 250 participants (Actual)Interventional2012-11-30Terminated(stopped due to The first phase was completed)
Efficacy and Safety Evaluation of Rapamycin Combined With Methylprednisolone in the Treatment of Hyperthyroidism Exophthalmos: A Randomized, Controlled, Multicenter Clinical Trial. [NCT05532072]Early Phase 1140 participants (Anticipated)Interventional2022-09-30Not yet recruiting
Preoperative Methylprednisolone on Thoracic Endovascular Repair for Reducing Post-implantation Syndrome [NCT05349071]158 participants (Anticipated)Interventional2022-05-01Not yet recruiting
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 Prospective, Randomized Study Comparing the Effects of Topical Aqueous Suppressants on Intraocular Gas Duration Following Scleral Buckling and Pneumatic Retinopexy. [NCT01843920]21 participants (Actual)Interventional2011-06-30Completed
The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric Hemangioma [NCT01908972]Phase 434 participants (Actual)Interventional2013-06-30Completed
Conventional Step-Up Versus Infliximab Monotherapy in Patients With Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study [NCT00984568]Phase 328 participants (Actual)Interventional2009-11-30Terminated(stopped due to Due to slow recruitment the study was stopped prematurely.)
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
Intraorbital Injection Versus Oral Steroid in Patients With Anterior Idiopathic Orbital Inflammation: A Randomized Clinical Trial [NCT03958344]Phase 3120 participants (Anticipated)Interventional2022-01-01Recruiting
Extended Follow-up of a Randomized Placebo-controlled Trial of Local Steroid Injection in Carpal Tunnel Syndrome [NCT02652390]Phase 4111 participants (Actual)Interventional2016-02-29Completed
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
Efficacy of Injectable Methylprednisolone Sodium Succinate in the Treatment of Patients With Signs of Severe Acute Respiratory Syndrome Under the New Coronavirus (SARS-CoV2): a Phase IIb, Randomized, Double-blind, Placebo-controlled, Clinical Trial. [NCT04343729]Phase 2416 participants (Actual)Interventional2020-04-18Completed
Perks of Methylprednisolone for Hospitalized COVID-19 Patients: A Clinical Trial [NCT04559113]200 participants (Anticipated)Interventional2020-05-01Recruiting
Maternal Epidural Steroids to Prevent Neonatal Exposure to Hyperthermia and Inflammation [NCT02212210]Early Phase 1135 participants (Actual)Interventional2012-02-29Terminated(stopped due to PI permanently closed accrual for the study based on FDA warning issued in April 2014. Study is closed)
A Randomised, Double Blind, Double Dummy, Multicentre Phase III Study Comparing the Efficacy of Budesonide/Formoterol (Symbicort® Forte Turbuhaler®) and Oral Prednisolone + Formoterol (Oxis® Turbuhaler) During Two Weeks, in COPD Patients With an Acute Exa [NCT00259779]Phase 3120 participants (Anticipated)Interventional2005-09-30Completed
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)
The Use of Intra-articular Corticosteroid Injection to Treat Osteoarthritis of the Carpometacarpal Joint: A Randomized Control Trial [NCT04177433]Phase 490 participants (Anticipated)Interventional2020-12-02Recruiting
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (Biomarkers) of BI 653048 BS H3PO4 Capsule Formulation Administered as Multiple Doses of 25 mg to 200 mg qd for 10 Days. A Randomised, Double-blind Within Dose Groups, Placebo-controlled, Multipl [NCT02217631]Phase 1140 participants (Actual)Interventional2009-10-31Completed
A Proof of Concept Study to Determine the Local Delivery and Efficacy of Intravenously Injected PEG-liposomal Prednisolone Sodium Phosphate (Nanocort) in Atherosclerotic Tissue in Subjects With Peripheral Artery Disease. [NCT01647685]Phase 1/Phase 221 participants (Anticipated)Interventional2012-05-31Recruiting
Long-Circulating Liposomal Prednisolone Versus Pulse Intramuscular Methylprednisolone in Patients With Active Rheumatoid Arthritis [NCT00241982]Phase 222 participants (Actual)Interventional2005-10-31Completed
Threecenter Placebo Controlled Three Arm Trial in Patients With Active Ankylosing Spondylitis With Prednisolone [NCT00244166]Phase 2/Phase 375 participants Interventional2002-05-31Recruiting
Efficacy of Moxifloxacin 0.5%/Prednisolone 1% Fixed Combination Compared With Individual Administration of Moxifloxacin 0.5% and Prednisolone 1% in the Prevention of Post Operative Inflammation in Patients Having Lasik Surgery [NCT01603030]Phase 366 participants (Anticipated)Interventional2012-06-30Not yet recruiting
Preemptive Effect of Dexamethasone and Methylprednisolone on Pain, Swelling and Trismus After Third Molar Surgery: a Split-mouth Randomized Triple-blind Clinical Trial [NCT01603498]18 participants (Actual)Interventional2011-04-30Completed
A Multicentre, Randomised, Double Blind, Double Dummy, Active Comparator Controlled, Parallel Group Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis [NCT00299013]Phase 3796 participants (Actual)Interventional2006-03-31Completed
Phase IV Study Comparing a Nutritional Anti-Inflammatory Treatment to Steroids for Pediatric Crohn's Disease - the Molecular Basis [NCT00265772]Phase 424 participants Interventional2005-11-30Recruiting
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
Hodgkins Disease Study [NCT00417014]358 participants (Anticipated)InterventionalActive, not recruiting
A Randomized, Controlled, Parallel-Group, Multicenter Study of Extracorporeal Photoimmune Therapy With THERAKOS* UVADEX* for the Treatment of Patients With Newly Diagnosed Acute Graft Versus-Host Disease [NCT00282503]Phase 319 participants (Actual)Interventional2006-01-31Terminated(stopped due to Lack of recruitment)
A Comparison of Intravenous Versus Oral Administration of Prednisolone in the Treatment of Exacerbations of Chronic Obstructive Pulmonary Disease [NCT00311961]Phase 4256 participants Interventional2001-06-30Completed
Corticosteroids and Cataracts : Prospective Study of the Impact of Systemic Corticosteroid Therapy on Lens Transparency Evaluated by Scheimpflug Photography and Quantification of Lens Autofluorescence. [NCT00337623]22 participants Interventional2000-06-30Completed
Long Term Tapering or Standard Steroids for Nephrotic Syndrome [NCT00308321]Phase 450 participants (Anticipated)Interventional2003-09-30Recruiting
Multicenter, Open-label, Randomized Study on Steroid-free Immunosuppression, in Comparison With Daily Steroid Therapy, in Children With Stable Renal Transplant Function Under Cyclosporine (CyA) and Mycophenolate Mofetil (MMF) [NCT00309218]Phase 342 participants (Actual)Interventional1999-03-31Completed
A Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Corticosteroids for Treatment of Patients With Tuberculous Pleurisy [NCT00338793]1,500 participants (Anticipated)Interventional2006-07-31Completed
Comparison of Efficacy of Intra-articular Morphine vs Methylprednisolone in Patients With Knee Osteoarthritis. A Single - Blind, Randomized-controlled Study [NCT06163755]Phase 20 participants (Actual)Interventional2018-01-01Withdrawn(stopped due to Lack of funding)
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
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Adeno-Associated Virus Serotype 8-Mediated Gene Transfer of Glucose-6-Phosphatase in Patients With Glycogen Storage Disease Type Ia [NCT05139316]Phase 346 participants (Actual)Interventional2021-11-08Active, not recruiting
Epidural Steroid Following Discectomy for Herniated Lumbar Disc Reduces Neurological Impairment and Enhances Recovery. A Randomized Study With Two-year Follow-up [NCT01499641]200 participants (Actual)Interventional2001-05-31Completed
A Prospective, Multi-Center, Randomized, Double-Masked, Positive-Controlled Phase 3 Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution Compared to Prednisolone Acetate Ophthalmic Suspen [NCT01505088]Phase 3193 participants (Actual)Interventional2011-12-31Completed
The Efficacy of Exercise Therapy Followed by Ultrasound Guided Injection in Patients With a Painful Shoulder - a Randomised Controlled Study With Blinded Observer [NCT01506804]99 participants (Actual)Interventional2010-11-30Completed
Phase 4 Study of Low Dose Prednisolone for Knee Osteoarthritis [NCT01619163]Phase 4125 participants (Actual)Interventional2011-11-30Completed
A Randomized Controlled Trial of Voriconazole in Allergic Bronchopulmonary Aspergillosis [NCT01621321]Phase 2/Phase 350 participants (Actual)Interventional2013-06-30Completed
[NCT01627236]120 participants (Anticipated)Interventional2012-12-31Recruiting
Targeting Iatrogenic Cushing's Syndrome With 11β-hydroxysteroid Dehydrogenase Type 1 Inhibition (TICSI) [NCT03111810]Phase 232 participants (Actual)Interventional2017-05-25Completed
Randomized, Multicentric Study Evaluating the Efficacy and the Safety of Methylprednisolone Bolus in the Treatment of Renal Sarcoidosis [NCT01652417]40 participants (Actual)Interventional2012-10-31Terminated(stopped due to insufficient recruitment)
A Randomised Study of High Dose Chemotherapy/Radiotherapy and Autologous Bone Marrow Transplantation in Patients With High Grade Malignant Non-Hodgkin's Lymphoma (Kiel Classification) According to Prognostic Groups [NCT00003815]Phase 30 participants Interventional1994-06-30Active, not recruiting
Blood Pressure Profile and NT-proBNP Dynamics in Response to Intravenous Methylprednisolone Pulse Therapy of Severe Graves' Orbitopathy [NCT03590080]32 participants (Actual)Observational2011-01-01Completed
Use of G-CSF Stimulated HLA-Identical Allogeneic Peripheral Blood Stem Cells for Patients With High Risk Acute Myelogenous Leukemia or CML in Blast Crisis [NCT00002833]Phase 253 participants (Actual)Interventional1994-10-31Completed
Phase II Single-arm Study Evaluating Neo-adjuvant (Pre-radical Radiotherapy) Abiraterone Acetate (Plus Prednisolone) and Gonadotropin-Releasing Hormone (GnRH) Agonist in High Risk Localised Prostate Carcinoma [NCT02160353]Phase 245 participants (Actual)Interventional2015-07-09Completed
The Effect of Moderate-Dose Steroid Therapy in Sepsis: A Placebo-Controlled, Randomized Study [NCT01275638]Phase 455 participants (Actual)Interventional2005-04-30Completed
Combined T Cell Depleted Haploidentical Peripheral Blood Stem Cell and Unrelated Umbilical Cord Blood Transplantation in Patients With Hematologic Malignancies Using a Total Lymphoid Irradiation Based Preparative Regimen [NCT02199041]Phase 224 participants (Actual)Interventional2014-07-11Terminated(stopped due to The study was halted early due to slow accrual.)
Phase I/II Trial of Thymus Transplantation With Immunosuppression, #950 [NCT00579527]Phase 1/Phase 214 participants (Actual)Interventional2005-12-19Completed
Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies. [NCT01694134]Phase 350 participants (Actual)Interventional2012-07-12Completed
Alternative Treatment Paradigm for Natalizumab Trial [NCT01710228]Phase 20 participants (Actual)Interventional2013-07-31Withdrawn(stopped due to sponsor stopped)
A Prospective Randomized Control Trial of Pilocarpine Use After Combined Cataract/Kahook Dual Blade Surgery [NCT03933631]Phase 3142 participants (Anticipated)Interventional2019-05-01Recruiting
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)
Phase III Study to Evaluate the Efficacy and Safety of NPB-01 in Patients With Autoimmune Encephalitis Refractory to Steroid Pulse Therapy [NCT05177939]Phase 340 participants (Anticipated)Interventional2022-03-03Recruiting
Effect of Steroids on Cerebrospinal Fluid Markers of Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement [NCT01755338]30 participants (Actual)Interventional2012-12-31Completed
A Phase II Study of JNJ-212082 (Abiraterone Acetate) in Metastatic Castration Resistant Prostate Cancer Patients Who Are Chemotherapy-Naïve [NCT01756638]Phase 248 participants (Actual)Interventional2012-06-06Completed
Phase II, Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Evaluate the Effects and Safety of Infusion of Low-Doses of Methylprednisolone in Early ALI and ARDS in Children [NCT01757899]Phase 20 participants (Actual)Interventional2014-01-31Withdrawn(stopped due to Technical problems)
Glucocorticoid Induced Inhibition of IGF-I Activity: Exploring Underlying Mechanisms. [NCT01762540]Phase 219 participants (Actual)Interventional2013-01-31Completed
A Randomised, Single Blind, Placebo-Controlled, Cross-over, Phase 1 Methodology Study to Validate the Cantharidin Blister Model in Healthy Male Volunteers [NCT01762787]Phase 140 participants (Actual)Interventional2010-08-17Completed
Evaluation of Oxidant Status in Patients With Immune Thrombocytopenia (ITP) and the Role of an Adjuvant Antioxidant Therapy [NCT01763658]Phase 2/Phase 3100 participants (Anticipated)Interventional2013-03-31Not yet recruiting
Phase 3 Open Label Randomised Multicentre Controlled Trial of Rituxmab and Mycophenolate Mofetil Without Oral Steroids for the Treatment of Lupus Nephritis [NCT01773616]Phase 324 participants (Actual)Interventional2015-04-30Terminated(stopped due to Study assessments for patients recruited continuing per protocol so patients receive a minimum of 6 months follow up. No safety concerns have been raised.)
FDG PET/CT: Reducing False Positive Mediastinal Uptake by Premedicating With Methylprednisolone [NCT01789892]0 participants (Actual)Interventional2011-06-30Withdrawn(stopped due to no patient accrual)
The Use of Intraocular Triamcinolone in the Perioperative Period of Congenital Cataract Surgery [NCT01800708]60 participants (Actual)Interventional2010-01-31Completed
Safety and Efficacy of Nonsteroidal Antiinflammatory Drug and Glucocorticoids in Acute Sciatica [NCT01816334]Phase 450 participants (Actual)Interventional2013-01-31Completed
Kidney Graft Function Under the Immunosuppression Strategies With Low Dose of Neoral®(Cyclosporine) and Standard Dose of Myfortic®(Enteric-Coated Mycophenolate Sodium) vs. With Conventional Dose of Neoral®(Cyclosporine) and Reduced Dose of Myfortic®(Enter [NCT01817322]Phase 4140 participants (Actual)Interventional2011-06-30Completed
Addition of Pyridoxine to Prednisolone in the Treatment of Infantile Spasms: A Randomized Controlled Trial [NCT01828437]Phase 362 participants (Actual)Interventional2012-11-30Completed
A Single Arm Study to Evaluate the Control of Chemotherapy Induced Nausea and Vomiting in Non-Hodgkin Lymphoma Patients Receiving R-CHOP. [NCT01843868]130 participants (Anticipated)Interventional2013-05-31Not yet recruiting
A Phase I, Randomized, Single-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Ascending Oral Doses Of AZD9567 In Healthy Subjects. [NCT02512575]Phase 172 participants (Actual)Interventional2015-11-18Completed
A Multi-center Randomized Controlled Trial of Efficacy and Safety of Perineural Local Anesthetics and Steroids for Chronic Peripheral Post-traumatic Neuropathic Pain: The Resperist Study [NCT03009500]Phase 33 participants (Actual)Interventional2017-01-31Completed
Study of Visual Recovery After Erythropoietin (EPO) Injection, in Patients With Traumatic Optic Neuropathy (TON) [NCT01783847]Phase 1/Phase 2117 participants (Actual)Interventional2015-02-28Completed
Open Label Randomized Controlled Clinical Trial of Vedolizumab Versus Conventional Treatment for Checkpoint Inhibitor Induced Colitis [NCT04797325]Phase 282 participants (Anticipated)Interventional2021-08-30Recruiting
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.)
Double-blind Randomized Controlled Trial of Anakinra, Pentoxifylline, and Zinc Compared to Methylprednisolone in Severe Acute Alcoholic Hepatitis [NCT01809132]Phase 2/Phase 3104 participants (Actual)Interventional2013-09-30Completed
Descemet Endothelial Thickness Comparison Trial [NCT02373137]Phase 438 participants (Actual)Interventional2015-01-22Active, not recruiting
A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 Compared to Prednisolone 20 mg in Patients With Active Rheumatoid Arthritis (RA) [NCT03368235]Phase 221 participants (Actual)Interventional2018-01-18Completed
SMART Trial: Steroid Dosing by bioMARker Guided Titration in Critically Ill Patients With Pneumonia [NCT03852537]Phase 244 participants (Actual)Interventional2019-12-02Completed
Killer Immunoglobulin-like Receptor (KIR) Incompatible Unrelated Donor Hematopoietic Cell Transplantation (SCT) for AML With Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory and Relapsed Acute Myelogenous Leukemia (AML) in Children: A Children's Oncolo [NCT00553202]Phase 2158 participants (Actual)Interventional2008-01-31Completed
Increased Heart Rhythm in Response to High-dose Intravenous Methylprednisolone Pulse Therapy of Moderate-to-severe Graves' Orbitopathy [NCT04391439]40 participants (Actual)Observational2011-01-01Completed
A Randomised, Double-blind, Double-dummy, Placebo-controlled, Five-way Crossover Study to Assess the Effects of Single Oral Doses of SB-681323 (7.5 mg and 25 mg) and Prednisolone (10 mg and 30 mg) on Biomarkers in Induced Sputum and Blood in COPD Patients [NCT00380133]Phase 120 participants (Actual)Interventional2005-06-30Completed
Towards a Self-Administered Hearing Protection Regimen [NCT04826237]Phase 4100 participants (Anticipated)Interventional2023-02-09Recruiting
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
Tacrolimus vs Prednisolone for the Treatment Minimal Change Disease [NCT00982072]Phase 452 participants (Actual)Interventional2009-12-31Completed
Randomised Evaluation of COVID-19 Therapy (RECOVERY) in Children With PIMS-TS in Switzerland (SWISSPED-RECOVERY) [NCT04826588]Phase 376 participants (Actual)Interventional2021-05-23Completed
A Randomized, Controlled, Open-Label Study to Evaluate the Efficacy of Extracorporeal Photopheresis (ECP) Versus Corticosteroids in the Treatment of Patients With Secondary Progressive Multiple Sclerosis (SPMS) [NCT02296346]13 participants (Actual)Interventional2014-10-31Terminated(stopped due to Low enrollment/PI relocated. New site couldn't reach agreement with manufacturer)
Safety and Efficacy of KPI-121 1% Ophthalmic Suspension Versus Prednisolone Acetate Ophthalmic Suspension 1% for the Treatment of Inflammation Following Cataract Surgery in Children 0 to 3 Years of Age [NCT03596723]Phase 32 participants (Actual)Interventional2018-07-03Terminated(stopped due to NDA #210565 did not trigger the need for a Pediatric Research Equity Act study.)
The Efficacy and Mechanism of Hydroxychloroquine in Patients With Inflammatory Cardiomyopathy After Myocarditis [NCT05961202]Phase 2/Phase 3200 participants (Anticipated)Interventional2022-01-01Recruiting
Efficacy of Peripheral Nerve Blocks for Episodic Migraine Treatment and Prophylaxis [NCT05734625]Phase 260 participants (Anticipated)Interventional2023-07-10Recruiting
Effect of Preoperative Intravenous High Dose Methylprednisolone on Glucose Homeostasis in Patients Scheduled for Total Hip- and Knee-arthroplasty [NCT02332603]Phase 3134 participants (Actual)Interventional2015-01-31Completed
Focal Cerebral Arteriopathy Steroid Trial [NCT06040255]Phase 480 participants (Anticipated)Interventional2023-10-01Not yet recruiting
Pre-Approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination) [NCT05401214]0 participants Expanded AccessApproved for marketing
Glucocorticoid Treatment in Patients Undergoing TAVR to Reduce the Incidence of Atrioventricular Block and Pacemaker Implantation [NCT06076824]Phase 4100 participants (Anticipated)Interventional2023-08-12Recruiting
Systemic Corticosteroids in Treatment of Post-COVID-19 Interstitial Lung Disease [NCT04988282]Phase 4262 participants (Actual)Interventional2021-05-24Completed
Medrol® In Contact Dermatitis: A Prospective Study To Assess The Safety And Effectiveness Of Medrol In Contact Dermatitis In Indian Subjects [NCT00929981]80 participants (Actual)Observational2009-09-30Completed
A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy [NCT03018535]Phase 376 participants (Actual)Interventional2012-01-31Active, not recruiting
The Effect of 4.5 Gram Methylprednisolone Administered Once Weekly for 12 Weeks on Bone Metabolism in Graves´ Ophthalmopathy [NCT03122847]30 participants (Anticipated)Observational2017-06-07Active, not recruiting
Phase 2/Phase 3 of the Randomized Control Trial to Evaluate the Efficacy of Autologous Blood Injection Versus Local Corticosteroid Injection for Treatment of Lateral Epicondylitis. [NCT00947765]Phase 2/Phase 360 participants (Actual)Interventional2007-01-31Completed
Autologous Hematopoietic Stem Cell Transplant for Patients With Systemic Sclerosis and Cardiac Dysfunction [NCT03593902]Phase 2/Phase 39 participants (Actual)Interventional2018-05-17Terminated(stopped due to PI Sabbatical)
Clinical Evaluation of New Treatment Strategy of Mucous Membrane Pemphigoid Using Large Dose of Prednisolone Plus Intra-lesional of Triamcinolone Acetonide Followed by Combination of Mycophenolate Mofetil, Dapsone and Low Dose Prednisolone [NCT04744623]Phase 2/Phase 310 participants (Actual)Interventional2020-09-30Active, not recruiting
Prolonged Low Doses of Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome [NCT04323592]173 participants (Actual)Observational [Patient Registry]2020-03-23Completed
Clinical Effectiveness of Symptomatic Therapy Compared to Standard Step up Care for the Treatment of Low Impact Psoriatic Oligoarthritis: a 2 Arm Parallel Group Feasibility Study [NCT03797872]Phase 41 participants (Actual)Interventional2019-04-17Completed
The Value of Addition of Prednisolone to Acetylsalicylic Acid Prior to Embryo Transfer in Patients With First ICSI Cycles: A Randomized Controlled Trial [NCT03503227]Phase 2/Phase 3250 participants (Actual)Interventional2018-04-23Completed
Effect of Preoperative Intravenous High Dose Methylprednisolone on Endothelial Function in Patients Scheduled for Total Knee-arthroplasty [NCT02332629]Phase 370 participants (Actual)Interventional2015-01-31Completed
Effectiveness of Single Dose Pre Medication of Piroxicam and Prednisolone on Post Endodontic Pain After a One Visit Root Canal Treatment. Randomized Trial . [NCT04124822]Phase 2/Phase 360 participants (Actual)Interventional2018-05-30Completed
International, Multi-centre Randomised Clinical Trial of Obinutuzumab Versus Corticosteroid and Cyclophosphamide in Primary Membranous Nephropathy (REMIT Trial). [NCT06120673]Phase 3224 participants (Anticipated)Interventional2024-07-31Not yet recruiting
Multicenter, Randomized, Observer-blind, Controlled Study of the Anti-IL-6 Receptor Antibody Tocilizumab (TCZ) or Methylprednisolone (MP) Treatment in Patients With Active Moderate-severe Graves' Orbitopathy [NCT04876534]Phase 264 participants (Anticipated)Interventional2019-12-18Recruiting
A Phase II, Prospective, Single-center Study of Lenalidomide in Combination With CHOP in Patients With Untreated PTCL [NCT04423926]Phase 1/Phase 291 participants (Anticipated)Interventional2020-06-10Recruiting
Phase 2 Historically Controlled Trial of Corticosteroids in Young Boys With Duchenne Muscular Dystrophy [NCT02167217]Phase 225 participants (Actual)Interventional2014-04-17Completed
Pilot Study in AIDS-Related Lymphomas [NCT00002524]Phase 246 participants (Actual)Interventional1993-06-30Completed
A Prospective Randomized Double-blinded Controlled Single Center Clinical Study of the Efficacy and Safety for Tofacitinib Compared With Glucocorticoid in the Remission-reduction Treatment of Active Takayasu's Arteritis [NCT05749666]Phase 350 participants (Anticipated)Interventional2023-01-20Recruiting
Multicenter Study to Optimise Therapy of B-ALL, Burkitt's NHL and High-Grade Non-Hodgkin's Lymphoma in Adults (Amend 7) [NCT00199082]Phase 4650 participants (Anticipated)Interventional2002-07-31Completed
Treatment of Metastatic Prostate Cancer That is Hormone-Independent: Evaluation of the Role of Chemotherapy on the Quality of Life of Patients. Phase II Study [NCT00003682]Phase 3160 participants (Anticipated)Interventional1998-10-31Terminated(stopped due to lack of inclusions)
Multicenter Trial for Treatment of Acute Lymphocytic Leukemia in Adults (Pilot Study 06/99) [NCT00199056]Phase 4225 participants Interventional1999-10-31Completed
Multicenter Study To Optimize Treatment in Elderly Patients (> 55 Years, No Upper Age Limit) With Acute Lymphoblastic Leukemia (GMALL Elderly 1/2003)(Amend 2) [NCT00198978]Phase 4377 participants (Actual)Interventional2003-01-31Completed
Sudden Hearing Loss Multicenter Treatment Trial [NCT00097448]Phase 3255 participants (Actual)Interventional2004-12-31Completed
Phase II Trial of Natalizumab (Tysabri®) Plus Prednisone for Initial Therapy of Acute Graft Versus Host Disease (aGVHD) of the Gastrointestinal Tract [NCT02176031]Phase 221 participants (Actual)Interventional2015-01-31Completed
STeroids to REduce Systemic Inflammation After Infant Heart Surgery (STRESS) [NCT03229538]Phase 31,263 participants (Actual)Interventional2017-10-18Completed
A Randomized Phase III Trial to Assess Response Adapted Therapy Using FDG-PET Imaging in Patients With Newly Diagnosed, Advanced Hodgkin Lymphoma [NCT00678327]Phase 31,202 participants (Actual)Interventional2008-08-29Active, not recruiting
A Randomised, Comparator Controlled, Two Part, Open-label Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Multiple Doses of Otelixizumab in Patients With Thyroid Orbitopathy [NCT01114503]Phase 22 participants (Actual)Interventional2010-07-07Terminated(stopped due to Clinical study in Graves' ophthalmopathy terminated until there is a better understanding of an efficacious dose with Otelixizumab from other clinical studies.)
Single Center, Randomized, Double-Blind, Placebo-Controlled Treatment Of Knee Osteoarthritis With Intra-Articular Infliximab [NCT01144143]Phase 416 participants (Actual)Interventional2007-07-31Completed
Improvement in Function and Pain Due to Subacromial Bursitis in Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone [NCT02242630]61 participants (Actual)Interventional2014-09-30Completed
Intratympanic Dexamethasone or Methylprednisolone for Sudden Hearing Loss as a Salvage Treatment: a Randomized, Double-blind, Multi-center Study [NCT04129697]30 participants (Anticipated)Interventional2020-01-01Not yet recruiting
Comparison of the Efficacy of Two Different Glucocorticoid Regimens for Treatment of Active Moderate-to-severe Graves' Orbitopathy [NCT05793359]62 participants (Actual)Observational [Patient Registry]2017-07-25Completed
Efficacy and Safety of Corticosteroids in COVID-19: A Prospective Randomized Controlled Trails [NCT04273321]86 participants (Actual)Interventional2020-02-14Completed
Principal Investigator [NCT01455337]Phase 3126 participants (Anticipated)Interventional2009-01-31Enrolling by invitation
Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis. Randomized Controlled Trial. [NCT04942002]Phase 2/Phase 350 participants (Anticipated)Interventional2021-06-15Recruiting
Early Administration of Steroids in the Ambulance Setting: An Observational Design Trial [NCT03962894]Phase 41,464 participants (Actual)Interventional2019-11-13Active, not recruiting
Safety and Efficacy of Topical Loteprednol Etabonate 0.5%, Versus Prednisolone Acetate 1%, for the Treatment of Intraocular Inflammation Following Surgery for Childhood Cataract [NCT01475643]Phase 3107 participants (Actual)Interventional2013-06-30Completed
German Multicenter Study for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years (Amend 3) (GMALL 07/2003) [NCT00198991]Phase 41,883 participants (Actual)Interventional2003-04-30Completed
Hyper-CVAD With Liposomal Vincristine (Hyper-CMAD) in Acute Lymphoblastic Leukemia [NCT01319981]Phase 231 participants (Actual)Interventional2013-03-05Completed
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
Evaluation of DEXTENZA on the Management of Pain and Inflammation in Patients With Anterior Uveitis Compared to Standard of Care Topical Corticosteroids [NCT04426734]Phase 430 participants (Anticipated)Interventional2020-07-01Not yet recruiting
Phase II Study of Infliximab for the Treatment of Ipilimumab Colitis [NCT04305145]Phase 242 participants (Anticipated)Interventional2020-08-31Recruiting
Corticosteriods vs. Saline vs. Air Placebo Intra-articular Injections for Knee Osteoarthritis: A Single Blinded Prospective Randomized Trial [NCT02995083]Early Phase 10 participants (Actual)Interventional2017-06-30Withdrawn(stopped due to Study deemed not feasible)
Oral Prednisolone Dosing in Children Hospitalized With Asthma [NCT00257933]Phase 4152 participants (Actual)Interventional2006-02-28Completed
Effect of Intravenous Methylprednisolone and Intravenous Erythropoietin in Toxic Optic Neuropathies: Randomized Clinical Trial. [NCT05748561]Phase 2/Phase 318 participants (Anticipated)Interventional2022-04-05Recruiting
Musculoskeletal Ultrasound Changes in the Plantar Fascia After a Single Injection of Platelet Rich Plasma Compared to Steroid [NCT05339542]98 participants (Actual)Interventional2022-03-10Completed
Randomized Controlled Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery [NCT01559675]121 participants (Actual)Interventional2010-09-30Completed
The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the Cost-effectiveness and Safety of Additional Low-dose Glucocorticoid in Treatment Strategies for Elderly Patients With Rheumatoid Arthritis [NCT02585258]Phase 4451 participants (Actual)Interventional2016-06-30Completed
Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes [NCT04977427]Phase 4200 participants (Anticipated)Interventional2021-07-31Not yet recruiting
A Pilot Study Investigating the Feasibility and Efficacy of Locoregional Intra-arterial Administration of Methylprednisolone as a Bridge Therapy to Treat Symptomatic Flares in Inflammatory Bowel Disease. [NCT05587673]Phase 130 participants (Anticipated)Interventional2022-10-06Recruiting
Comparison of Efficacy and Safety of Two Different Ultrasound-Guided Suprascapular Nerve Block Techniques in Chronic Shoulder Pain: A Prospective Double-Blinded Randomized Controlled Study [NCT04938037]80 participants (Anticipated)Interventional2021-06-01Recruiting
A Feasibility Randomised Placebo-controlled Trial With Objective Outcome Measures to Evaluate the Efficacy of Biosimilar Rituximab in Musculoskeletal and Mucocutaneous Systemic Lupus Erythematosus [NCT03054259]Phase 230 participants (Anticipated)Interventional2017-09-21Recruiting
Transverse Abdominis Plane Block Using Liposomal Bupivacaine for Post-operative Cesarean Delivery Analgesia- Walking Towards Recovery [NCT04393207]Phase 4300 participants (Anticipated)Interventional2022-02-01Recruiting
Intracanalicular Dexamethasone Insert for Management of Post-operative Pain and Inflammation in Patients Undergoing Vitreoretinal Surgery [NCT04371445]Phase 430 participants (Anticipated)Interventional2020-12-01Enrolling by invitation
Evaluation of Sleep EEG Changes in Paediatric Patients With Language Dysfunction: A Follow up Study. Evaluation of Sleep EEG Changes in Paediatric Patients With Language Dysfunction: A Follow up Study. Evaluation of Sleep EEG Changes in Pediatric Patients [NCT05487521]Phase 393 participants (Actual)Interventional2020-02-20Completed
Clinical Study of the Effect of Methylprednisolone Combined With Two Hydroxypropyl Theophylline on Respiratory Dynamics During Thoracoscopic Lobectomy [NCT04810819]110 participants (Anticipated)Interventional2021-07-01Not yet recruiting
A Randomized Controlled Trial to Evaluate the Efficacy and Safety of Docetaxel Combined With Platinum-based Drugs Compared With Docetaxel Alone for Metastatic Hormone-sensitive Prostate Cancer Patients Carrying DNA Repair Mutation [NCT05461261]Phase 250 participants (Anticipated)Interventional2022-07-01Recruiting
Application of Ultrasound Shear Wave Elastography on the Adjunct Corticosteroid Therapy on Tuberculous Lymphadenitis: a Randomized Control Trial [NCT05861440]50 participants (Anticipated)Interventional2023-05-31Recruiting
Efficacy and Safety of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 Chronic Kidney Disease [NCT05510323]Phase 3208 participants (Anticipated)Interventional2022-08-31Not yet recruiting
The Effectiveness of Pulsed Radiofrequency of the Suprascapular Nerve and Shoulder Joint Compared to Intra-articular Corticosteroid Injection for Hemiplegic Shoulder Pain Management and Functional Improvement. [NCT05563571]20 participants (Anticipated)Interventional2022-04-01Recruiting
Feasibility of Assessing Lymphoma Response to Precise Local Injection of Candidate Chemotherapy Agents Using the CIVO(tm) Microdosing System [NCT01831505]Phase 14 participants (Actual)Interventional2012-11-30Completed
DEXTENZA VS. PREDNISOLONE ACETATE 1% in the Incidence of Pseudophakic Macular Edema in Patients With Diabetic Retinopathy Undergoing Cataract Surgery [NCT04362241]Phase 430 participants (Anticipated)Interventional2020-08-07Recruiting
Improvement in Pregnancy Outcomes in Immunologically Infertile Male Patients Undergoing Prednisolone Treatment and Conventional IVF Preceded by Sperm Penetration Assay: A Randomized Controlled Trial [NCT02935738]241 participants (Actual)Interventional2014-10-31Completed
Efficacy and Safety of Steroid for Treatment of Acute/Subacute Severe Cerebral Venous Thrombosis. [NCT05990894]248 participants (Actual)Observational2018-01-01Completed
Early Short Course Corticosteroids in Hospitalized Patients With COVID-19 [NCT04374071]250 participants (Actual)Observational2020-03-12Completed
Randomized Trial of High Dose (4mg/kg) Versus Usual Dose (2mg/kg) Oral Prednisolone in the Treatment of Infantile Spasms. [NCT01575639]Phase 363 participants (Actual)Interventional2012-02-29Completed
The Effect of Intravenous Glucocorticoids on the Tearfilm in Eyes With Thyroid-associated Ophthalmopathy [NCT01579539]Phase 318 participants (Actual)Interventional2013-06-27Completed
Addition of Prednisolone and Heparin in Patients With Repeated Implantation Failures: a Prospective Clinical Study [NCT01590173]Phase 2/Phase 386 participants (Actual)Interventional2012-01-31Completed
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)
Observational Study of Visual Outcomes in Retinal Disease [NCT01613963]2,000 participants (Anticipated)Observational2012-05-31Enrolling by invitation
Pre-operative Intravenous Steroid in Unilateral Primary Total Knee Replacement for Pain Relief and Recovery: A Double-Blind Randomized Controlled Trial [NCT03082092]Phase 460 participants (Actual)Interventional2017-06-01Completed
A Controlled Randomized Open-label Multicenter Study Evaluating if Early Conversion to Everolimus (Certican) From Cyclosporine (Neoral) in de Novo Renal Transplant Recipients Can Improve Long-term Renal Function and Slow Down the Progression of Chronic Al [NCT00634920]Phase 4204 participants (Actual)Interventional2008-03-31Completed
Autologous Hematopoietic Stem Cell Transplant for Neuromyelitis Optica Spectrum Disorder (NMOSD) [NCT03829566]Phase 2/Phase 30 participants (Actual)Interventional2019-11-30Withdrawn(stopped due to Discontinued by Investigator)
Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment [NCT02283996]Phase 4260 participants (Anticipated)Interventional2014-11-30Recruiting
Efficacy and Safety of Granulocyte-colony Stimulating Factor in Patients With Severe Alcoholic Hepatitis With Null or Partial Response to Steroid: A Randomized, Double-blind, Placebo-controlled, Nationwide Multi-center Study [NCT02442180]Phase 364 participants (Actual)Interventional2015-07-31Terminated(stopped due to failure to recruit eligible patients)
Open-Label, Randomized, Comparative, Multi-Center Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf Cap.®) in Combination With Low-Dose Corticosteroid Compared With High-Dose Corticosteroid Alone in Patients With Minimal-Change Nephrotic Syn [NCT01763580]Phase 4144 participants (Actual)Interventional2012-07-16Completed
Cyclophosphamide Added to Corticosteroid in the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Placebo-controlled Randomized Trial [NCT02460588]Phase 3120 participants (Actual)Interventional2015-12-31Completed
Randomized, Double-Masked, Vehicle Controlled, Clinical Evaluation To Assess The Safety And Efficacy Of Nepafenac Ophthalmic Suspension, 0.3% For Improvement In Clinical Outcomes Among Diabetic Subjects Following Cataract Surgery [NCT01872611]Phase 3819 participants (Actual)Interventional2013-06-30Completed
B-NHL 2013 - Treatment Protocol of the NHL-BFM and the NOPHO Study Groups for Mature Aggressive B-cell Lymphoma and Leukemia in Children and Adolescents [NCT03206671]Phase 3650 participants (Anticipated)Interventional2017-08-03Recruiting
Treatment Protocol for Relapsed Anaplastic Large Cell Lymphoma of Childhood and Adolescence [NCT00317408]96 participants (Anticipated)Interventional2004-04-30Active, not recruiting
A Study to Assess Disease Pathology and Key Therapeutic Targets in Severe Asthma [NCT00327197]Phase 147 participants (Actual)Interventional2005-08-02Terminated(stopped due to The study was truncated due to the long period of enrollment and the collection of a sufficient amount of data that allowed the scientific objectives to be met)
Effect of Prednisolone Treatment on Uterine Natural Killer Cells and Endometrial Angiogenesis in Recurrent Miscarriage Around the Time of Embryo Implantation [NCT03902912]Phase 384 participants (Anticipated)Interventional2019-07-30Recruiting
A Phase I/II Clinical Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT) [NCT00985959]Phase 1101 participants (Actual)Interventional2008-07-31Completed
Phase II Study of Ofatumumab in Combination With High Dose Methylprednisolone Followed by Ofatumumab and Lenalidomide Consolidative Therapy for the Treatment of Relapsed or Refractory CLL/SLL The HiLOG Trial [NCT01497496]Phase 229 participants (Actual)Interventional2012-01-26Completed
Dextenza in Pterygium Surgery [NCT04403516]Phase 430 participants (Actual)Interventional2020-10-01Completed
Comparison of Dropless Prophylaxis After Routine Phacoemulsification to Standard Drops Regimen [NCT02515045]Phase 459 participants (Actual)Interventional2015-01-31Completed
Prospective, Randomized Clinical Trial of Meibomian Gland Probing Versus Sham Procedure for Refractory Meibomian Gland Dysfunction [NCT02256969]Phase 445 participants (Actual)Interventional2014-10-31Completed
The Value of Dexamethasone Versus Prednisolone During Induction and Maintenance Therapy of Prolonged Versus Conventional Duration of L-Asparaginase Therapy During Consolidation and Late Intensification, and of Corticosteroid + VCR Pulses During Maintenanc [NCT00003728]Phase 31,500 participants (Anticipated)Interventional1998-12-31Active, not recruiting
A UKLG Randomised Trial of Initial Chemotherapy for Advanced Stage Hodgkins Disease [NCT00003421]Phase 3800 participants (Anticipated)Interventional1998-06-30Completed
Safety and Effectiveness of Single-dose Subconjunctival Triamcinolone Compared to Topical Prednisolone Eye Drops in Manual Small Incision Cataract Surgery [NCT05248139]100 participants (Anticipated)Interventional2022-10-31Not yet recruiting
Phase II Study of Prednisolone/Methylprednisolone Absorption in Children With Juvenile Dermatomyositis [NCT00004357]Phase 26 participants (Actual)Interventional1997-09-30Completed
Phase III Randomized, Double-Blind Study of Methylprednisolone by 24- Versus 48-Hour Infusion Versus Tirilazad for Acute Spinal Cord Injury [NCT00004759]Phase 3497 participants Interventional1991-12-31Completed
An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Disease Activity in Patients With Active Rheumatoid Arthritis After DMARD Treatment Failure [NCT02006706]Phase 315 participants (Actual)Interventional2006-08-10Completed
Intra-articular and Intravenous Infliximab in the Treatment of Resistant Seronegative Oligoarthritis of the Knee [NCT01216631]Phase 21 participants (Actual)Interventional2010-09-30Terminated(stopped due to Unable to recruit)
A Phase II, Randomized, Double-Blind Comparison of Corticosteroid and Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH) [NCT01074437]Phase 29 participants (Actual)Interventional2010-02-28Terminated(stopped due to Insufficient enrollment)
Effect of Steroids on Post-tonsillectomy Morbidities [NCT02401529]Phase 2100 participants (Actual)Interventional2013-01-31Completed
"Minimal Initial Therapy (MIT) for Early Supradiaphragmatic Hodgkin's Disease: A Multicenter Randomized Trial of Short Neoadjuvant Chemotherapy (VAPEC-B) Plus Involved Field Radiotherapy (MIT) Versus Mantle Radiotherapy" [NCT00002987]Phase 3400 participants (Anticipated)Interventional1997-01-31Active, not recruiting
Effects of a Multiple Sclerosis Relapse Therapy With Methylprednisolone (MP) During Pregnancy on Offspring Cognitive Function, Stress Sensitivity, Behaviour and Functional and Structural Brain Development [NCT04832269]80 participants (Anticipated)Observational2020-10-19Recruiting
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Adeno-associated Virus (AAV) Serotype 8 (AAV8)-Mediated Gene Transfer of Human Ornithine Transcarbamylase (OTC) in Patients With Late-onset OTC Deficiency [NCT05345171]Phase 350 participants (Anticipated)Interventional2022-10-18Recruiting
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
A Prospective Randomized Control Trial of Pilocarpine Use After Combined Cataract/Trabectome Surgery [NCT04005079]Phase 30 participants (Actual)Interventional2019-06-05Withdrawn(stopped due to not performing Trabectomes)
[NCT02115997]Phase 430 participants (Actual)Interventional2015-07-06Completed
A Phase 3, Prospective, Randomized, Parallel-design, Multicenter Study to Evaluate the Safety of Icon Bioscience-10090 for the Treatment of Inflammation Associated With Cataract Surgery [NCT02547623]Phase 3194 participants (Actual)Interventional2015-11-06Completed
Does Anesthetic Contribute to Symptomatic Relief in Corticosteroid Injections for Knee Osteoarthritis? A Double-Blind Randomized Trial Comparing Corticosteroid/Ropivacaine Versus Corticosteroid/Saline Injections [NCT02576249]Phase 429 participants (Actual)Interventional2015-10-31Completed
A Multicenter, Randomized, Open-label, Blinded-assessor, Follow-up, Phase 4 Study in Patients With Rheumatoid Arthritis Who Have Completed the Initial Treatment Part in the NORD-STAR Study and Have Reached Stable Low Disease Activity [NCT02466581]Phase 425 participants (Actual)Interventional2015-02-03Active, not recruiting
Safety and Efficacy of Topical Tacrolimus 0.05% in the Treatment of Ocular Graft-Versus-Host Disease [NCT01977781]Phase 140 participants (Actual)Interventional2013-12-31Completed
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
High Dose Steroids for Liver Resection - Effect on Complications and Endothelial Function in the Immediate Postoperative Phase - a Randomized, Doubleblind, Controlled Trial [NCT03403517]Phase 4174 participants (Actual)Interventional2017-12-11Completed
Non-Hodgkin's Lymphoma T Cell Protocol [NCT00003423]Phase 3100 participants (Anticipated)Interventional1995-05-31Active, not recruiting
A Randomized Prospective Study of Early Intensification Versus Alternating Triple Therapy for Patients With Poor Prognosis Lymphoma [NCT00002835]Phase 3116 participants (Actual)Interventional1995-10-30Completed
A Randomised Study Comparing CIDEX (CCNU, Oral Idarubicin and Dexamethasone) With Melphalan and Prednisolone in Relapsed Multiple Myeloma [NCT00003603]Phase 3660 participants (Anticipated)Interventional1998-03-31Active, not recruiting
[NCT00004785]Phase 354 participants Interventional1995-11-30Completed
Phase I/II Study of Idarubicin, Cytarabine, and Nivolumab in Patients With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) [NCT02464657]Phase 1/Phase 244 participants (Actual)Interventional2015-07-31Completed
Open Randomized Single Centre Clinical Trial to Evaluate Methylprednisolone Pulses and Tacrolimus in Patients With Severe Lung Injury Secondary to COVID-19 [NCT04341038]Phase 384 participants (Anticipated)Interventional2020-04-01Recruiting
Comparative Study of the Efficacy of Lycopene Versus Prednisolone in the Management of Oral Lichen Planus: A Randomized, Double Blind Clinical Trial [NCT02587117]Phase 428 participants (Actual)Interventional2013-02-28Completed
Physiologic Effects of Stress Dose Corticosteroids in the Management of Inhospital Cardiac Arrest - CORTICA [NCT02790788]Phase 1/Phase 2100 participants (Actual)Interventional2016-11-04Completed
Efficacy and Safety of Loteprednol 0.5% Gel for Routine Prophylaxis After Photorefractive Keratectomy Compared to Prednisolone Acetate 1% Suspension and Fluorometholone 0.1% Suspension [NCT03123614]Phase 4131 participants (Actual)Interventional2014-09-19Completed
A Single-center, Phase II Neoadjuvant Study of Abiraterone Acetate in the Treatment of Intraductal Carcinoma of the Prostate [NCT04736108]Phase 250 participants (Anticipated)Interventional2021-05-31Not yet recruiting
A Randomized, Double-blind Study of Treatment With a Known Anti-inflammatory (Prednisolone) to Evaluate Novel Endpoints in Patients With Chronic Obstructive Pulmonary Disease (COPD) [NCT00379730]Phase 190 participants Interventional2006-03-21Completed
An Open-label, Randomised Trial of Bortezomib Consolidation (With Thalidomide and Prednisolone) Vs Thalidomide and Prednisolone Alone in Previously Untreated Subjects With Multiple Myeloma After Receiving Bortezomib, Cyclophosphamide, Dexamethasone (VCD) [NCT01539083]Phase 3256 participants (Actual)Interventional2012-01-13Completed
A Phase 4, Randomized, Double-Masked, Single Center, Placebo-Controlled Adaptive Clinical Trial, Using Prednisolone Sodium Phosphate Ophthalmic Solution, 1%, in Subjects With Allergic Conjunctivitis to Evaluate a Modified Conjunctival Allergen Challenge ( [NCT01534195]Phase 411 participants (Actual)Interventional2012-01-31Completed
Treatment Optimization in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment - a Phase IV-trial With a Phase III-part to Evaluate Safety and Efficacy of Ne [NCT02881086]Phase 31,000 participants (Actual)Interventional2016-08-31Active, not recruiting
Treatment of COVID-19 Pneumonia With Glucocorticoids. A Randomized Controlled Trial [NCT04438980]Phase 372 participants (Actual)Interventional2020-05-15Completed
Combined Radiotherapy and Intravenous Steroids for Early Progressive Thyroid Eye Disease [NCT02339142]Phase 4100 participants (Anticipated)Interventional2015-01-31Not yet recruiting
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
Placebo-Controlled, Double-Blind, Ascending Single and Multiple Oral Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-791826 and to Assess Its Marker Specific Pharmacodynamics in Relation to Prednisolone in Healthy Males [NCT03198013]Phase 1120 participants (Actual)Interventional2008-11-11Completed
A Multi-center, Open Label, Randomised Parallel- Group Study to Compare the Efficacy of Cholestyramine Plus Standard Treatment Versus Prednisolone Plus Standard Treatment Versus Standard Treatment Alone in Treatment of Overt Hyperthyroidism [NCT03303053]Phase 3135 participants (Anticipated)Interventional2017-05-11Recruiting
Intra-articular Injections of Platelet-rich Plasma, Hyaluronic Acid, or Corticosteroids for Knee Osteoarthritis, Which is Better? A Prospective Study of a Single-blind Randomized Control Trial RCT From the Iraqi Population [NCT04980105]Phase 3150 participants (Actual)Interventional2020-03-02Active, not recruiting
Effectiveness and Pharmacoeconomic Study of Using Different Corticosteroids in the Treatment of Interstitial Lung Diseases [NCT04982809]107 participants (Actual)Interventional2018-07-01Completed
Hit Hard and Early. The Effect of High Dose Methylprednisolone on Nailfold Capillary Changes and Biomarkers in Early SSc: a 12-week Randomised Explorative Double-blind Placebo-controlled Trial. [NCT03059979]Early Phase 130 participants (Anticipated)Interventional2017-01-31Recruiting
Second Affiliated Hospital, College of Medicine, Zhejiang University [NCT04918953]Phase 290 participants (Anticipated)Interventional2021-06-02Not yet recruiting
NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma [NCT01451515]Phase 223 participants (Actual)Interventional2012-05-25Completed
The Efficacy and Safety of R-EPOCH and R-CHOP Regimen for Patients With AIDS Associated CD20+ Diffuse Large B Lymphoma [NCT03045471]50 participants (Anticipated)Observational2017-03-01Not yet recruiting
A Randomized Open-label Trial to Evaluate the Efficacy of Immunoglobulin Plus Steroid for Prevention of Coronary Artery Abnormalities in Taiwanese Refractory Kawasaki Disease (RAST Study) [NCT03200561]Phase 3100 participants (Anticipated)Interventional2013-10-17Recruiting
Study of the Excretion of Orally Administered Corticosteroids for the Improval of the Detection of Said Substances in Anti-doping Controls [NCT04791345]Phase 150 participants (Anticipated)Interventional2021-02-26Recruiting
Pre-emptive Increase of Immunosuppressive Treatments in Lupus Nephritis Patients With Asymptomatic Serological Reactivation [NCT04870359]150 participants (Anticipated)Interventional2016-04-21Recruiting
Autologous Platelet Rich Fibrin Versus Steroid in Ultrasound-Guided Sacroiliac Joint Injection for Joint Dysfunction (Randomized Comparative Study) [NCT04757740]Phase 494 participants (Anticipated)Interventional2021-03-01Recruiting
The Role of Doxycycline in Management of Moderate to Severe Chronic Rhinosinusitis With Nasal Polyps [NCT02569437]Phase 249 participants (Actual)Interventional2014-09-30Terminated(stopped due to A high percentage of patients were dropping out of the study and were not able to complete the protocol.)
Topical Use of Corticosteroid to Prevent Epiretinal Membrane Formation in Eyes With Retinal Tear Undergoing Laser Retinopexy: a Pilot Prospective Clinical Study [NCT02412059]200 participants (Actual)Interventional2015-08-31Completed
Intravenous Immunoglobulin and Prednisolone to Women With Unexplained Recurrent Pregnancy Loss After Assisted Reproductive Technology Treatment: a Randomised, Double-blind, Placebo-controlled Trial [NCT04701034]Phase 274 participants (Anticipated)Interventional2021-02-06Recruiting
Triamcinolone Versus Methylprednisolone in Ultrasound Guided Transversus Abdominis Plane Block in Major Open Abdominal Surgery [NCT04480775]Phase 2/Phase 384 participants (Actual)Interventional2020-07-15Completed
[NCT00004430]150 participants (Anticipated)Interventional1994-09-30Completed
Safety and Efficacy of Steroids in the Management of Fulminant Hepatic Failure Due to Hepatitis A Virus in the Pediatric Age Group [NCT02375867]Phase 433 participants (Actual)Interventional2015-01-31Completed
Once a Month High-dose Methylprednisolone During Wash-out Period Between Natalizumab and Fingolimod Treatments in Patients With Multiple Sclerosis: a Randomised, Controlled, Double-blind Trial (NTZ2FTY) [NCT02769689]Phase 456 participants (Anticipated)Interventional2019-06-12Recruiting
Intra-Arterial Steroid Administration of De Novo Acute Graft-vs-Host Disease of the Gastrointestinal Tract: A Phase II Study [NCT02425813]Phase 20 participants (Actual)Interventional2015-10-31Withdrawn(stopped due to Slow Accrual)
Comparative Evaluation of the Effectiveness of Premedication With Two Different Single Doses of Prednisolone on Inter-appointment Pain in Symptomatic Patients With Irreversible Pulpitis: a Double-blind Randomized Controlled Clinical Trial [NCT04481971]Phase 272 participants (Anticipated)Interventional2020-08-09Not yet recruiting
Comparison of the Treatment Efficacy of High-Dose Corticosteroid and Tocilizumab During Clinical Worsening in Patients With COVID-19 Pneumonia [NCT05133635]Phase 40 participants (Actual)Interventional2021-02-01Withdrawn(stopped due to A recent study suggested a new corticosteroid regime for intensive care unit patients.)
Corticosteroids in Severe Alcoholic Hepatitis Patients With Early Spontaneous Improvement [NCT03160651]140 participants (Anticipated)Interventional2018-02-09Recruiting
Comparison Between Ultrasound Guided Ozone, Platelet-Rich Plasma or Steroid Injection in the Treatment of Sacroiliitis; a Randomized Double Blinded Controlled Study [NCT05914350]105 participants (Anticipated)Interventional2023-06-23Recruiting
Investigating Differences in Flare Reaction Incidence and Intensity Following Trigger Finger Injections Using Betamethasone and Methylprednisolone [NCT04900220]Phase 466 participants (Actual)Interventional2021-09-15Completed
Evaluation of High Dose Prednisolone Pharmacokinetics in the Acute and Chronic Setting [NCT05012033]120 participants (Anticipated)Observational2023-04-12Recruiting
Randomized, Unicentric, Open, Controlled Clinical Trial, in Phase Iii, to Demonstrate the Effectiveness of Tocilizumab Against Systemic Corticotherapy in Patients Admitted by Covid-19 With Bilateral Pneumonia and Poor Evolution [NCT05002517]Phase 360 participants (Anticipated)Interventional2020-09-03Active, not recruiting
Antiviral Treatment in Facial Palsy. Randomized Control Trial [NCT02328079]50 participants (Actual)Interventional2013-04-30Completed
Comparison Of Two Corticosteroid Dosing Regimens For Prevention Of Corneal Transplant Rejection Episodes After Descemet's Membrane Endothelial Keratoplasty [NCT01448213]Phase 2264 participants (Actual)Interventional2011-10-31Completed
A Phase II Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Methylprednisolone as a Treatment for Presumed Hantavirus Cardiopulmonary Syndrome [NCT00128180]Phase 266 participants (Actual)Interventional2003-01-31Completed
A Phase 2 Trial of Pre-phase Treatment Before R-CHOP Chemotherapy in Elderly Patients With Newly Diagnosed DLBCL [NCT03465527]Phase 237 participants (Actual)Interventional2017-04-13Completed
A Phase II Study of Rituximab and Temozolomide in Recurrent Primary CNS Lymphoma [NCT00248534]Phase 216 participants (Actual)Interventional2005-09-30Terminated(stopped due to slow accrual/lack of resources/low priority due to combining 2 consortia)
Prednisolon Behandling Ved Akut Interstitiel Nefritis - et Randomiseret, Prospektivt Studie [NCT04376216]Phase 4110 participants (Anticipated)Interventional2017-09-01Recruiting
Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to a Single Intrabursal Injection of Corticosteroids in Patients With Shoulder Calcific Tendinopathy [NCT01652495]Phase 444 participants (Actual)Interventional2012-03-31Completed
Intratympanic Steroid Injection for Treatment of Idiopathic Facial Nerve Paralysis [NCT03508440]Phase 2/Phase 311 participants (Actual)Interventional2018-01-31Completed
Prospective, Randomized Comparison of Corticosteroid Dosing Regimens Following Endothelial Keratoplasty [NCT01853696]Phase 4167 participants (Actual)Interventional2013-03-31Completed
Randomized, Double-Masked, Vehicle Controlled, Clinical Evaluation To Assess The Safety And Efficacy Of Nepafenac Ophthalmic Suspension, 0.3% For Improvement In Clinical Outcomes Among Diabetic Subjects Following Cataract Surgery [NCT01853072]Phase 3881 participants (Actual)Interventional2013-06-30Completed
A Phase 1 Proof of Concept Study Evaluating Intravitreal AAVCAGsCD59 for the Treatment of Wet Age-Related Macular Degeneration (AMD) [NCT03585556]Phase 125 participants (Actual)Interventional2018-09-13Completed
Impact of Preoperative Single Corticosteroid Flash on Morbidity After Colorectal Resection: Monocentric Prospective Pilot Study [NCT03437746]Phase 278 participants (Actual)Interventional2018-03-01Terminated(stopped due to insufficient rate of inclusion)
Effect of Depo-Medrol Application on the Psoas Muscle After Transpsoas LLIF on Post-operative Hip Flexor Weakness, Thigh Pain and Numbness [NCT05929755]Phase 480 participants (Anticipated)Interventional2023-05-12Recruiting
Effect of Methylprednisolone on Systemic Inflammatory Response and Clinical Parameters During Pediatric Congenital Open-Heart Surgery: A Randomized Controlled Trial [NCT05927233]Phase 460 participants (Anticipated)Interventional2023-04-01Recruiting
Comparison of the Efficiency of Intravenous Treatments Used in Bridge Treatment of Medication Overuse Headache [NCT05608642]45 participants (Anticipated)Interventional2022-10-22Active, not recruiting
The D3 Study: Drug Delivery vs Drops - A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1% in Controlling Post-operative Pain and Inflammation in Patients Undergoing Sequential Cataract Surgery [NCT04273282]Phase 431 participants (Actual)Interventional2019-12-16Completed
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)
The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy [NCT01451710]30 participants (Actual)Interventional2011-03-31Completed
Double-Blind, Randomized, Parallel Group, Multicenter Study of Durolane Compared to Methylprednisolone in Subjects With Osteoarthritis of the Knee [NCT01209364]Phase 3442 participants (Actual)Interventional2007-03-31Completed
High Dose Steroids in Children With Stroke and Unilateral Focal Arteriopathy: Paediatric Arteriopathy Steroid Aspirin (PASTA) Project. A Multicentre Randomized Trial. [NCT03249844]Phase 30 participants (Actual)Interventional2022-09-01Withdrawn(stopped due to discontinuation of the trial)
Allogeneic Hematopoietic Cell Transplantation of Positively Selected CD34+ Cells and Defined Inoculum of T Cells From Related Haploidentical Donors for Older Patients With Indolent Hematologic Malignancies [NCT00185692]Phase 216 participants (Actual)Interventional2000-08-31Completed
Evaluation of a Strategy Based on the 3-month Screening Biopsy to Optimize the Immunosuppression in Renal Transplantation: the I4BiS Study [NCT02444429]Phase 3346 participants (Anticipated)Interventional2015-09-30Recruiting
A Randomized Prospective Double Masked Controlled Trial Comparing Ketorolac Tromethamine 0.4% and Prednisolone Acetate 1% in Reducing Post-selective Laser Trabeculoplasty Anterior Chamber Flare and Cells. [NCT00478036]31 participants (Actual)Interventional2007-05-31Terminated(stopped due to insufficient enrollment)
Management of Recurrent Croup: Comparison Between Inhaled Fluticasone and Oral Prednisolone [NCT01748162]Phase 310 participants (Actual)Interventional2012-09-30Terminated
Effect of Azole/Echinocandin Use on Tacrolimus Pharmacokinetics in Kidney Transplant Recipients [NCT06044558]507 participants (Actual)Observational2022-09-01Completed
Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17 [NCT03755804]Phase 2250 participants (Anticipated)Interventional2018-12-12Recruiting
A Phase Ib/II Combination of Acalabrutinib With R-CHOP for Patient Diffuse Large B-cell Lymphoma (DLBCL) [NCT03571308]Phase 1/Phase 239 participants (Actual)Interventional2017-06-02Completed
Treatment Effects of Chinese Medicine (Yi-Qi-Qing-Jie Herbal Compound) Combined With Immunosuppression Therapies in IgA Nephropathy Patients With High-risk of End-stage Renal Disease (TCM-WINE) [NCT03418779]Phase 2/Phase 360 participants (Actual)Interventional2019-07-04Active, not recruiting
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 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
[NCT00733096]Phase 2/Phase 384 participants (Actual)Interventional2008-08-31Completed
Steroids in Pediatric Acute Lung Injury/ARDS Trial: A Blinded, Placebo-controlled, Randomized Clinical Trial [NCT01274260]Phase 2100 participants (Anticipated)Interventional2010-10-31Active, not recruiting
A Multicenter, Randomized, Blinded Study Comparing the Effect of CRx-102 Plus DMARD Therapy to That of Placebo Plus DMARD Therapy on Serum C Reactive Protein (CRP) and Cytokines in Subjects With RA [NCT00747214]Phase 259 participants (Actual)Interventional2004-11-30Completed
SAAB: Randomized, Double Blind STudy of Corticosteroid Pulse After Ablation [NCT00807586]Phase 4119 participants (Actual)Interventional2008-12-31Completed
A Phase 2 Open Label Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy. [NCT01685983]Phase 282 participants (Actual)Interventional2011-08-30Completed
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
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
The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis: A Pilot Study [NCT03511625]Phase 36 participants (Anticipated)Interventional2018-10-02Active, not recruiting
High Dose Methylprednisolone Verses Low Dose in Correction of Congenital Acynotic Heart Disease [NCT05103397]Phase 475 participants (Anticipated)Interventional2021-10-16Recruiting
A Prospective, Multi-arm, Multi-center Clinical Trial on Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer [NCT05406999]Phase 2900 participants (Anticipated)Interventional2020-02-01Recruiting
Patient PReference, Efficacy, and SaFety of an Intracanalicular DExamenthasone InseRt comparEd to Topical PrednisoloNe in PatienTs UndergoIng SequentiAl PhacoemuLsification With Intraocular Lens Surgery OR Combined Phacoemulsification With IOL and a Minim [NCT04563559]Phase 2/Phase 30 participants (Actual)Interventional2020-11-30Withdrawn(stopped due to PI decided not to open study)
Effectiveness of Remedesvir in SARS-CoV2 Patients Presenting at Mayo Hospital Lahore [NCT04871633]66 participants (Actual)Interventional2020-08-01Completed
Is the Effect of Systemic Steroids Treating Pollen Induced Allergic Rhinitis Mainly Due to a Placebo Effect [NCT04622917]Phase 444 participants (Actual)Interventional2019-04-10Active, not recruiting
Randomized Controlled Trial on the Efficacy of Dexamethasone Versus Methyl Prednisolone in Covid-19 Infected Patients With High Oxygen Flow [NCT05062681]Phase 460 participants (Anticipated)Interventional2021-09-15Recruiting
Methylprednisolone and Hyaluronic Acid Versus Each Agent Alone to Control Post-extraction Complications of Impacted Mandibular Third Molar [NCT04816253]72 participants (Actual)Interventional2021-02-10Completed
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
[NCT03067753]Phase 228 participants (Anticipated)Interventional2016-12-31Recruiting
Medical Research Council Working Party on Leukaemia in Children UK National Lymphoblastic Leukaemia (ALL) Trial [NCT00003437]Phase 31,800 participants (Anticipated)Interventional1997-01-31Active, not recruiting
A Phase I/II Study of High-Dose Deoxyazacytidine, Busulfan, and Cyclophosphamide With Allogeneic Stem Cell Transplantation for Hematologic Malignancies [NCT00002831]Phase 1/Phase 224 participants (Actual)Interventional1995-08-01Completed
Effect on Pain and Inflammation With DEXTENZA Treatment in Patients Undergoing Intravitreal Anti-VEGF Injections [NCT04563299]Phase 410 participants (Actual)Interventional2020-12-09Terminated(stopped due to Subject Enrollment)
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
Role of Montelukast in the Management of Chronic Rhinosinusitis With Nasal Polyps. [NCT05143502]Phase 1/Phase 260 participants (Anticipated)Interventional2022-01-01Active, not recruiting
Niacin (as a Vasodilator), and a Topical Steroid (for Macular Edema), Non-Ischemic CRVO,HRVO,BRVO [NCT00493064]Phase 2/Phase 363 participants (Actual)Interventional2006-10-31Completed
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 Randomised Multicentre Trial of Involved Field Radiotherapy Versus Involved Field Radiotherapy Plus Chemotherapy in Combination With Rituximab (Mabthera®) for Stage I - II Low Grade Follicular Lymphoma [NCT00115700]Phase 3150 participants (Actual)Interventional2000-02-29Completed
Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass [NCT01579513]190 participants (Actual)Interventional2012-06-30Completed
A Pilot Study: Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas [NCT00624416]Phase 1/Phase 210 participants (Actual)Interventional2007-10-31Completed
Single Center, Randomized, Double-Masked Evaluation of the Efficacy of PredAcetate 1% Ophthalmic Suspension Compared to Pred Acetate 0.12% Ophthalmic Suspension, Lot Etab 0.2% Ophthalmic Suspension, and Placebo in a Modified CAC Model [NCT00689078]Phase 436 participants (Actual)Interventional2008-05-31Completed
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
Multi-center, Randomized, Open Label, Comparative, Phase IV Study to Evaluate the Efficacy and Safety of a Combination of Mycophenolate Mofetil and Corticosteroid for 48 Weeks in Advanced IgA Nephropathy [NCT02981212]Phase 4100 participants (Anticipated)Interventional2016-06-30Recruiting
Effect of Drop-less Surgery Compared to Topical NSAID Alone and Combination of Steroid and NSAID on Central Macular Thickness After Cataract Surgery, a Randomized Controlled Trial [NCT03383328]Phase 4470 participants (Actual)Interventional2018-02-01Completed
Randomized Controlled Trial of Ultrasound-guided Steroid Injection Versus Wrist Splint in Patients With Carpal Tunnel Syndrome [NCT04515966]Phase 470 participants (Anticipated)Interventional2020-12-01Recruiting
Rituximab (RTX) Therapy in Steroid Resistant Patients or Patients Relapsing After Intravenous Steroids With Active TAO [NCT02378298]Phase 426 participants (Actual)Interventional2011-12-31Active, not recruiting
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
High Dose Steroids in Children With Stroke and Unilateral Focal Arteriopathy: A Multicentre Randomized Controlled Trial PASTA (Paediatric Arteriopathy Steroid Aspirin) Trial [NCT04873583]Phase 370 participants (Anticipated)Interventional2021-11-16Recruiting
A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy [NCT03959085]Phase 34,772 participants (Anticipated)Interventional2019-10-31Recruiting
A Single-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Compared to Placebo in a Modified Conjunctival Allergen Challenge (CAC) Model [NCT01730872]Phase 416 participants (Actual)Interventional2012-11-30Completed
The Utility of feNO in the Differential Diagnosis of Chronic Cough: The Response to Anti-inflammatory Therapy With Prednisolone and Montelukast [NCT02479074]Phase 449 participants (Actual)Interventional2016-01-31Completed
First Line Treatment of Familiar Lymphohistiocytosis by Alemtuzumab (CAMPATH®) [NCT02472054]Phase 1/Phase 229 participants (Actual)Interventional2015-06-29Completed
Pragmatic, Randomized, Multicenter, Double-blind, Controlled, Clinical Trial of Prednisolone Versus Colchicine for Acute Gout in Primary Care [NCT05698680]Phase 4314 participants (Anticipated)Interventional2023-01-18Recruiting
A Phase II, Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of Mycophenolate Mofetil and Rilonacept (Anti-interleukin-1) in Patients With Alcoholic Hepatitis [NCT01903798]Phase 24 participants (Actual)Interventional2014-12-31Completed
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
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
A Randomized, Double-blinded, Controlled Trial of Adding a Short Burst of Corticosteroid to the Conventional Treatment of H1 Antihistamines [NCT03296358]75 participants (Actual)Interventional2017-10-01Completed
Zoledronic Acid or Methylprednisolone in the Management of Active Charcot's Neuroarthropathy of Foot in Patients With Diabetes Mellitus: A Randomized, Double-blind, Placebo Controlled Trial [NCT03289338]Phase 2/Phase 336 participants (Actual)Interventional2016-06-01Completed
Comparative Study Between Analgesic Effect of Oral Prednisolone and Oral Pregabalin in Management of Post-dural Puncture Headache in Patients Undergoing Lower Limb Surgeries [NCT04662125]63 participants (Actual)Interventional2020-12-10Completed
A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/Refractory Multiple Myeloma (RRMM) Patients [NCT03110822]Phase 1134 participants (Anticipated)Interventional2017-02-01Recruiting
Effectiveness and Safety of Efgartigimod in the Acute Phase of Neuromyelitis Optica Spectrum Disorders-a Multicentric, Controlled, Retrospective, Real-Word Study [NCT06118398]24 participants (Anticipated)Observational2023-11-05Not yet recruiting
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
A Randomized Trial Comparing the Role of Prednisolone, Itraconazole, or Their Combination in Patients With Acute Stage of Allergic Bronchopulmonary Aspergillosis [NCT06174922]Phase 3300 participants (Anticipated)Interventional2023-12-31Recruiting
Comparison of the Risk of Complications and the Quality of Life During Ramadan Fasting in Patients With Corticotrope Deficiency Treated Either by Hydrocortisone or by Prednisolone [NCT03585829]Phase 453 participants (Actual)Interventional2018-05-17Completed
The Effect of Positive Airway Pressure on Idiopathic Sudden Sensorineural Hearing Loss Comorbided With Obstructive Sleep Apnea: A Clinical Randomized Controlled Study [NCT04192656]Phase 4102 participants (Anticipated)Interventional2019-11-01Recruiting
Low Dose Versus High Dose Methylprednisolone for Children With Severe Mycoplasma Pneumoniae Pneumonia : a Multicenter Randomized Blinded Trial [NCT02303587]424 participants (Actual)Interventional2014-12-31Completed
Effect of Preoperative Intravenous High Dose Methylprednisolone on Quadriceps Muscle Function in Patients Scheduled for Total Knee-arthroplasty [NCT02319343]Phase 370 participants (Actual)Interventional2015-01-31Completed
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
Mepolizumab Long-term Access Programme for Subjects Who Participated in Study MEA115921 (Placebo-controlled Study of Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis in Subjects Receiving Standard-of-care Therapy) [NCT03298061]Phase 3104 participants (Actual)Interventional2015-04-14Active, not recruiting
Parasitic Ulcer Treatment Trial Pilot [NCT03484507]Phase 249 participants (Actual)Interventional2018-01-01Active, not recruiting
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
Prednisolone vs. Vigabatrin in the First-line Treatment of Infantile Spasms [NCT02299115]Phase 30 participants (Actual)Interventional2017-09-05Withdrawn(stopped due to Most centres are now using oral steroids as 1st line treatment so question of efficacy is no longer of high interest.)
Pre-emptive Scalp Infiltration With Ropivacaine Plus Methylprednisolone vs Ropivacaine Alone for Relief of Postoperative Pain After Craniotomy in Children (RP/MP vs RP) [NCT03636165]Phase 490 participants (Anticipated)Interventional2022-09-01Not yet recruiting
Preoperative Single-high Dose Glucocorticoid for Patients Undergoing Hip Fracture Surgery and the Effect on Postoperative Delirium. [NCT02317601]Phase 4122 participants (Actual)Interventional2014-12-31Completed
Electroclinical Effect of Steroid in Patients With Benign Childhood Epilepsy With Centrotemporal Spikes [NCT03490487]Phase 4100 participants (Anticipated)Interventional2018-06-20Recruiting
Randomized Controlled Trial of Methylprednisolone Versus Dexamethasone in COVID-19 Pneumonia (MEDEAS Trial) [NCT04636671]Phase 3690 participants (Actual)Interventional2021-04-14Completed
Effect of Preoperative Low-dose of Methylprednisolone on Postoperative Pain and Immune Functions After Video-assisted Thoracoscopic Surgery: A Prospective Randomized Controlled Trial [NCT03393949]Phase 4112 participants (Actual)Interventional2015-07-01Completed
Exclusive Enteral Nutrition in Patients With Ileocaecal Crohn's Disease (XENIC): an Open-label, Multicenter, Prospective, Randomized Clinical Trial [NCT04921033]Phase 3256 participants (Anticipated)Interventional2021-03-01Recruiting
A Prospective, Multi-Center, Randomized, Double-Masked, Positive Controlled, Phase 3 Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution Compared to Prednisolone Acetate Ophthalmic Suspe [NCT02517619]Phase 3251 participants (Actual)Interventional2016-01-16Completed
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 II Study of Horse Anti-Thymocyte Globulin (hATG), Cyclosporine, Methylprednisolone, and GCSF (Filgrastim or Pegfilgrastim) in Patients With Aplastic Anemia (AA), or Low/Int-1 Risk Myelodysplastic Syndrome (MDS) [NCT01624805]Phase 2100 participants (Anticipated)Interventional2012-06-25Recruiting
CORTERAS STUDY: The Effect of Corticosteroids on Early Recovery After Major Surgery in Elderly Patients [NCT05220319]Phase 4672 participants (Anticipated)Interventional2022-02-03Recruiting
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 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
The Effects of Intraoperative Local and Systemic Corticosteroid Administration on Postoperative Dysphagia After Anterior Cervical Fusion [NCT03311425]Phase 3140 participants (Actual)Interventional2014-08-01Completed
Post-operative Oral Corticosteroids Following Tonsillectomy: A Randomized Controlled Trial [NCT03352115]200 participants (Anticipated)Interventional2018-01-31Not yet recruiting
[NCT02028754]Phase 4180 participants (Actual)Interventional2011-07-31Completed
Randomized, Double-blinded, Comparison Between Ultrasound-Guided Genicular Nerve Phenol Neurolysis and Intra-articular Steroid Injections [NCT06000709]Phase 440 participants (Anticipated)Interventional2023-10-20Not yet recruiting
A Phase 2a Single-arm, Prospective, Open-label Pilot Study to Evaluate the Safety and Efficacy of Dual Costimulation Blockade With VIB4920 and Belatacept for Prophylaxis of Allograft Rejection in Adults Receiving a Kidney Transplant [NCT04046549]Phase 225 participants (Actual)Interventional2019-10-30Completed
Yale Steroid Enhanced Versus Exparel Nerveblock TKA Randomized Controlled Trial (RCT) Study [NCT05279092]Phase 2250 participants (Anticipated)Interventional2022-09-08Recruiting
Comparison of Follow-up and Steroid Treatment Results in Intussusception in Children [NCT05640375]Phase 1/Phase 2120 participants (Anticipated)Interventional2019-12-24Recruiting
Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis (ITN055AI) [NCT02260934]Phase 243 participants (Actual)Interventional2015-07-09Completed
The Potential Therapeutic Effect of Roflumilust (a Selective Phosphodiesterase 4inhibitor) on Chronic Rhinosinusitis With Nasal Polyposis. [NCT05369039]Phase 260 participants (Anticipated)Interventional2022-06-30Not yet recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00057811 (4) [back to overview]Toxic Death
NCT00057811 (4) [back to overview]Grade ≥ 3 Stomatitis
NCT00057811 (4) [back to overview]Response Rate
NCT00057811 (4) [back to overview]Minimal Residual Disease
NCT00066469 (1) [back to overview]Event-free Survival
NCT00097448 (1) [back to overview]Hearing Improvement
NCT00109928 (4) [back to overview]Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
NCT00109928 (4) [back to overview]2-year Overall Survival Rate
NCT00109928 (4) [back to overview]2-year Progression-free Survival Rate
NCT00109928 (4) [back to overview]Response Rate
NCT00128180 (10) [back to overview]Duration of Hospital Stay in Days
NCT00128180 (10) [back to overview]Development of Serum Creatinine Greater Than or Equal to 3.0 mg/dL After Study Entry
NCT00128180 (10) [back to overview]Duration of ICU Stays
NCT00128180 (10) [back to overview]Length of Time on a Ventilator
NCT00128180 (10) [back to overview]Duration of Shock and/or Pressor/Inotropic Support
NCT00128180 (10) [back to overview]Number of Participants Intubated and Placed on a Ventilator After Study Entry.
NCT00128180 (10) [back to overview]Number of Participants on Extracorporeal Membrane Oxygenation (ECMO)
NCT00128180 (10) [back to overview]Number of Participants Who Developed Refractory Shock Despite Fluid Resuscitation After Study Entry
NCT00128180 (10) [back to overview]Number of Participants With SAEs
NCT00128180 (10) [back to overview]The Proportion of Subjects Who Develop Death, PaO2/FiO2 Ratio Less Than or Equal to 55, Cardiac Index Less Than or Equal to 2.2, Pulseless Electrical Activity, Ventricular Tachycardia or Fibrillation
NCT00185692 (2) [back to overview]Engraftment of Haploidentical CD34+ Selected Blood Stem Cells in Older Patients or Those With Medical Co-morbidities Following Total Lymphoid Irradiation and Antithymocyte Globulin Transplant Conditioning
NCT00185692 (2) [back to overview]Acute Graft-versus-Host Disease (GVHD) Grade 2-4 Risk From Time of Transplant Until Day 90 Post-transplant
NCT00186628 (4) [back to overview]Chronic Graft-vs-Host Disease (cGvHD)
NCT00186628 (4) [back to overview]Incidence of Relapse
NCT00186628 (4) [back to overview]Overall Survival
NCT00186628 (4) [back to overview]Mortality
NCT00248534 (4) [back to overview]6-month Progression-free Survival
NCT00248534 (4) [back to overview]1 Year Overall Survival Rate
NCT00248534 (4) [back to overview]Number of Participants Alive at 3 Years
NCT00248534 (4) [back to overview]Percentage of Participants With Objective Response
NCT00257933 (1) [back to overview]Time Measured From the Administration of the Loading Dose of Prednisolone (2mg/kg up to Max 60mg) in the Emergency Department (ED) Until the Home Dose of Albuterol is Administered
NCT00278564 (1) [back to overview]Survival
NCT00290589 (3) [back to overview]Numerical Rating Scale (0-10), an Interval Pain Scale, on Which 0 Indicates no Pain and 10 Indicates the Worst Pain Imaginable
NCT00290589 (3) [back to overview]Functional Disability Scales
NCT00290589 (3) [back to overview]Number of Patients Using Analgesics
NCT00294658 (29) [back to overview]Time-weighted Average Alternate-day Prednisone Dose (mg) Measured Over 3 Years
NCT00294658 (29) [back to overview]Plasma Exchange Use
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]Treatment Associated Complications (TAC)
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]Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Sex
NCT00294658 (29) [back to overview]Intravenous Immunoglobulin Use
NCT00294658 (29) [back to overview]Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Prednisone Use at Enrollment
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]Number of Patients With at Least One Serious Adverse Events
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]Classification of Serious Adverse Events
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)
NCT00294658 (29) [back to overview]Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Sex
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]Short Form-36 Standardized Physical Component
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]Cumulative Days in Hospital for Myasthenia Gravis Exacerbation
NCT00294658 (29) [back to overview]Azathioprine Use
NCT00294658 (29) [back to overview]Treatment Associated Symptoms (TAS)
NCT00294658 (29) [back to overview]Cumulative Days in Hospital for Myasthenia Gravis Exacerbation
NCT00294658 (29) [back to overview]Cumulative Number of Hospital Days
NCT00294658 (29) [back to overview]Hospitalization for Exacerbation of Myasthenia Gravis
NCT00294684 (9) [back to overview]Weight Z-Score
NCT00294684 (9) [back to overview]Total Bilirubin Concentration at 24 Months of Age
NCT00294684 (9) [back to overview]The Percentage of Patients With Serum Total Bilirubin <1.5 mg/dL and With Native Liver at 6 Months After Portoenterostomy
NCT00294684 (9) [back to overview]Total Bilirubin Concentration at 12 Months
NCT00294684 (9) [back to overview]Survival With Native Liver at 24 Months of Age
NCT00294684 (9) [back to overview]Serum Total Bilirubin Concentration
NCT00294684 (9) [back to overview]Presence of Ascites at 24 Months
NCT00294684 (9) [back to overview]Presence of Ascites at 12 Months
NCT00294684 (9) [back to overview]Height Z-Score
NCT00309907 (6) [back to overview]Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28.
NCT00309907 (6) [back to overview]Plasma Cytokine IL6 Level
NCT00309907 (6) [back to overview]C-reactive Protein Levels
NCT00309907 (6) [back to overview]Toxicity of Etanercept Plus Corticosteroid Therapy Using the Common Terminology Criteria Version 4.0
NCT00309907 (6) [back to overview]Survival Rate
NCT00309907 (6) [back to overview]Estimate Percentage Pulmonary Response in Patients With IPS Treated With Etanercept + Corticosteroid Therapy
NCT00332696 (11) [back to overview]Participant's Quality of Life Using the Edmonton Scale
NCT00332696 (11) [back to overview]Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14
NCT00332696 (11) [back to overview]Number of Participants With Treatment Success From Day 10 to Day 13
NCT00332696 (11) [back to overview]Number of Participants With Relief From Obstruction at Day 7 and Day 14
NCT00332696 (11) [back to overview]Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3
NCT00332696 (11) [back to overview]Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2
NCT00332696 (11) [back to overview]Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1
NCT00332696 (11) [back to overview]Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7
NCT00332696 (11) [back to overview]Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14
NCT00332696 (11) [back to overview]Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1
NCT00332696 (11) [back to overview]Number of Participants With Treatment Success From Day 5 to Day 7
NCT00345046 (1) [back to overview]Percent Change in Flare at Resolution
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Were Disease-free and Alive at 6 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Experienced Relapse by 24 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Experienced Relapse by 12 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Died Due to Transplant.
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Died by 24 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Died by 12 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Attained Platelet Engraftment
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Attained Neutrophil Engraftment
NCT00354172 (15) [back to overview]Chimerism After Double Umbilical Cord Blood Transplant (UCBT)
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Were Disease-free and Alive at 12 Months
NCT00354172 (15) [back to overview]Number of Patients Who Were Disease-free and Alive at 24 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) With Successful Natural Killer Cell Expansion
NCT00354172 (15) [back to overview]Number of Participants (Patients) With Chronic Graft-Versus-Host Disease
NCT00354172 (15) [back to overview]Number of Participants (Patients) With Acute Graft-versus-Host Disease at Grade III-IV
NCT00354172 (15) [back to overview]Number of Participants (Patients) With Acute Graft-versus-host Disease (GVHD) Grade II-IV
NCT00379574 (2) [back to overview]Number of Patients Who Experienced Adverse Events
NCT00379574 (2) [back to overview]Number of Patients Who Achieved Complete Response
NCT00393367 (12) [back to overview]Number of Patients Hospitalized
NCT00393367 (12) [back to overview]Number of Subjects Moving From the Severe Asthma to Mild Asthma Category
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]Change in Mean Heart Rate
NCT00393367 (12) [back to overview]Mean Change in Asthma Score at 2 Hours
NCT00393367 (12) [back to overview]Mean Change in Respiratory Rate.
NCT00393367 (12) [back to overview]Median Change in Asthma Score 2 Hours After Intervention
NCT00400946 (10) [back to overview]5-Year Disease-Free Survival by MRD Day 32 Status
NCT00400946 (10) [back to overview]Asparaginase-Related Toxicity Rate
NCT00400946 (10) [back to overview]Induction Infection Toxicity Rate
NCT00400946 (10) [back to overview]Post-Induction Therapeutic Nadir Serum Asparaginase Activity Rate
NCT00400946 (10) [back to overview]Induction Serum Asparaginase Activity Level
NCT00400946 (10) [back to overview]Induction Therapeutic Nadir Serum Asparaginase Activity Rate
NCT00400946 (10) [back to overview]Post-Induction Nadir Serum Asparaginase Activity Level
NCT00400946 (10) [back to overview]5-year Disease-Free Survival by CNS Directed Treatment Group
NCT00400946 (10) [back to overview]5-Year Disease-Free Survival by Bone Marrow Day 18 Status
NCT00400946 (10) [back to overview]5-Year Disease-Free Survival
NCT00423098 (10) [back to overview]Number of Patients With Treatment Failure
NCT00423098 (10) [back to overview]Number of Patients With Moderate to Severe Flares
NCT00423098 (10) [back to overview]Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG)
NCT00423098 (10) [back to overview]Number of Patients With Complete Remission
NCT00423098 (10) [back to overview]Number of Patients With Partial 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]Duration of Exposure to Study Medication
NCT00424489 (1) [back to overview]Survival
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]Participants Achieving Renal Improvement (RI) or CRR at Month 12 During Short-term Period
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]Participants With Marked Hematology Abnormalities During the Short-term 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]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 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: Diastolic Blood Pressure (DBP)
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]Baseline Physical Component Summary of the Short Form (SF)-36 During 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 Fatigue as Measured by the Fatigue Visual Analog Scale 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 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]Number of Participants Achieving Renal Response (RR) at Month 12 During Short-term Period
NCT00430677 (42) [back to overview]Number of Months CRR Was Maintained 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]Baseline Mental Component Summary of the Short SF-36 During Short-term Period
NCT00430677 (42) [back to overview]Number of Participants Achieving Renal Response
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 Patient Response (PR) at Month 12 During the Short-term Period
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]Time to Achieve First Confirmed Renal Improvement (RI) During Short-term Period (as Determined by Kaplan-Meier Methodology)
NCT00430677 (42) [back to overview]Vital Signs Summary During the Short-term Period: Temperature
NCT00430677 (42) [back to overview]Baseline Quantitative Immunoglobulins During the 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]Number of Participants Achieving Complete Response by ACCESS Definition
NCT00430677 (42) [back to overview]Mean Change From Baseline in SLICC/ACR Damage Index
NCT00430677 (42) [back to overview]Change in Renal Function From Baseline Over Time 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 Fatigue From Baseline as Measured by the Fatigue Visual Analog Scale 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 From Baseline in Physical Component Summary of the SF-36 During Short-term 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]Baseline Renal Function Over Time During Short-term Period
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]Clinical Remission on Medication
NCT00443430 (3) [back to overview]Proportion of Participants Who Attain Inactive Disease by 6 Months
NCT00473746 (17) [back to overview]Phase 1: Total Body Clearance (Cl_F_obs) 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 Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score
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 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: Maximum Tolerated Dose (MTD) of Abiraterone Acetate
NCT00473746 (17) [back to overview]Phase 1: Maximum Plasma Concentration (Cmax) 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: Radiographic Progression Free Survival (RAD-PFS)
NCT00473746 (17) [back to overview]Phase 2: Time to PSA Progression
NCT00473746 (17) [back to overview]Phase 2: Radiographic Objective Response Rate (RAD-ORR)
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
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
NCT00478036 (1) [back to overview]Interocular Pressure
NCT00481832 (10) [back to overview]Achieving Full Donor Chimerism
NCT00481832 (10) [back to overview]Relapse Rate
NCT00481832 (10) [back to overview]Event-free Survival (EFS)
NCT00481832 (10) [back to overview]Incidence of Acute Graft Versus Host Disease (GvHD)
NCT00481832 (10) [back to overview]Incidence of Chemotherapy-associated Pneumonitis
NCT00481832 (10) [back to overview]Incidence of Chronic Graft Versus Host Disease (GvHD)
NCT00481832 (10) [back to overview]Median Time to Neutrophile Engraftment
NCT00481832 (10) [back to overview]Median Time to Platelet Engraftment
NCT00481832 (10) [back to overview]Overall Mortality Rate
NCT00481832 (10) [back to overview]Overall Survival (OS)
NCT00492973 (5) [back to overview]Amount of Pain Medication Taken Per Day
NCT00492973 (5) [back to overview]Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc.
NCT00492973 (5) [back to overview]Knee Range of Motion
NCT00492973 (5) [back to overview]Knee Society Scores
NCT00492973 (5) [back to overview]Length of Hospital Stay
NCT00493064 (1) [back to overview]Number of Participants With An Improvement in Vision, as Measured by an Increase of 15 Letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) Vision Chart.
NCT00494780 (15) [back to overview]CL After the Sixth Infusion (Week 15, Visit 22)
NCT00494780 (15) [back to overview]Duration of Response
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]AUC(0-inf) and AUC(0-504) After the Sixth Infusion (Week 15, Visit 22)
NCT00494780 (15) [back to overview]Cmax and Ctrough at the Sixth Infusion (Week 15, Visit 22)
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]Half Life (t1/2) of Ofatumumab at the Sixth Infusion (Week 15, Visit 22)
NCT00498797 (2) [back to overview]Prostate Specific Antigen (PSA) Response
NCT00498797 (2) [back to overview]Number of Patients With an Objective Disease Progression Event
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]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 Adverse Events as a Measure of Safety
NCT00519285 (11) [back to overview]Prostate Specific Antigen Response Rate
NCT00519285 (11) [back to overview]Number of Participants With Positive Anti-aflibercept Antibody Levels as a Measure of Immunogenicity of Aflibercept
NCT00521989 (1) [back to overview]Change From Baseline to Day 98 Using the WOMAC Pain Question #1
NCT00549848 (6) [back to overview]Probability of Event-free Survival
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%
NCT00549848 (6) [back to overview]Probability of Overall Survival
NCT00549848 (6) [back to overview]Probability of CNS Relapse
NCT00549848 (6) [back to overview]Percentage of Participants With Continuous Complete Remission of Patients Receiving High-dose and Conventional Dose PEG-asparaginase.
NCT00551707 (2) [back to overview]Absolute C-reactive Protein (CRP) Values at Day 98 - As Treated Population
NCT00551707 (2) [back to overview]Percent Change From Baseline to Day 98 in C-reactive Protein (CRP) Values - As Treated Population
NCT00553202 (2) [back to overview]Cumulative Incidence of NK Cell Reconstitution
NCT00553202 (2) [back to overview]Overall Survival (OS)
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]Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy
NCT00557193 (10) [back to overview]Percent Probability of Event Free Survival (EFS) by MRD Status and Treatment Arm
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 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) for Patients on Arm A
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]Describe in Vitro Sensitivity 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]Number of Patients Who Experienced Lestaurtinib-related Dose Limiting Toxicity (DLT)
NCT00562965 (7) [back to overview]Progression-Free Survival (PFS)
NCT00562965 (7) [back to overview]Number of Participants With Grade 3 or 4 Treatment Emergent Adverse Events (TEAEs)
NCT00562965 (7) [back to overview]Percentage of Participants With Objective Response (OR)
NCT00562965 (7) [back to overview]Overall Survival Probability at Months 6, 12 and 24
NCT00562965 (7) [back to overview]Number of Participants With Clinically Significant Change From Baseline in Vital Signs
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 Laboratory Findings
NCT00568633 (8) [back to overview]Relapse Rate
NCT00568633 (8) [back to overview]Overall Survival (OS)
NCT00568633 (8) [back to overview]Transplant-related Mortality
NCT00568633 (8) [back to overview]Early Graft Loss
NCT00568633 (8) [back to overview]Patients Completing the Intended Therapy in Both Arms
NCT00568633 (8) [back to overview]Non-relapse Mortality
NCT00568633 (8) [back to overview]Complete Donor Hematopoietic Cell Chimerism
NCT00568633 (8) [back to overview]Disease-free Survival (DFS)
NCT00577993 (2) [back to overview]Number of Participants With Overall Survival (10 Years) by Treatment
NCT00577993 (2) [back to overview]Number of Participants With Progression Free Survival (10 Years) by Treatment
NCT00579527 (8) [back to overview]Survival at 1 Year Post-CTTI
NCT00579527 (8) [back to overview]Survival at 2 Years Post-CTTI
NCT00579527 (8) [back to overview]Immune Reconstitution Efficacy - Total CD8 T Cells
NCT00579527 (8) [back to overview]Immune Reconstitution Efficacy - Naive CD4 T Cells
NCT00579527 (8) [back to overview]Immune Reconstitution Efficacy - Naive CD8 T Cells
NCT00579527 (8) [back to overview]Immune Reconstitution Efficacy - Response to Mitogens
NCT00579527 (8) [back to overview]Immune Reconstitution Efficacy - Total CD3 T Cells
NCT00579527 (8) [back to overview]Immune Reconstitution Efficacy - Total CD4 T Cells
NCT00595335 (8) [back to overview]Failure Rate at One Year
NCT00595335 (8) [back to overview]Change in Clinical Activity Score (CAS)
NCT00595335 (8) [back to overview]Graves' Ophthalmopathy Quality of Life Score Using the Short Form-12 (SF-12) Health Survey
NCT00595335 (8) [back to overview]Change in Lid Fissure
NCT00595335 (8) [back to overview]Failure Rate
NCT00595335 (8) [back to overview]Change in Proptosis
NCT00595335 (8) [back to overview]Change in Extraocular Motility
NCT00595335 (8) [back to overview]Change in Disease Severity
NCT00609609 (3) [back to overview]Percentage of Participants Alive, In Remission & Without GVHD Progression Day 28 & Day 56
NCT00609609 (3) [back to overview]Day 56 Treatment Success
NCT00609609 (3) [back to overview]Non-relapse Mortality (NRM) at 6 Months
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)
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)
NCT00624416 (3) [back to overview]The Number of Lipoma Increased in Volume.
NCT00624416 (3) [back to overview]The Average Percent Volume Reduction in the Lipoma.
NCT00624416 (3) [back to overview]The Number of Subjects Elected to Have the Lipoma Removed.
NCT00634920 (19) [back to overview]Progression of Measured Glomerular Filtration Rate
NCT00634920 (19) [back to overview]Percentage of Participants With Treatment Failures
NCT00634920 (19) [back to overview]Percentage of Participants With Graft Loss or Death
NCT00634920 (19) [back to overview]Percentage of Participants With Biopsy Proven Acute Rejection (BPAR)
NCT00634920 (19) [back to overview]Measured Glomerular Filtration Rate
NCT00634920 (19) [back to overview]Proteinuria (Measured as Urine Albumin/Creatinine Ratio (mg/mmol))
NCT00634920 (19) [back to overview]Lipid Profile for HDL-C, LDL-C,Total Cholesterol, and Triglycerides
NCT00634920 (19) [back to overview]Measured Glomerular Filtration Rate
NCT00634920 (19) [back to overview]Time to First Malignancy
NCT00634920 (19) [back to overview]Time to Treatment Failure
NCT00634920 (19) [back to overview]Calculated Glomerular Filtration Rate
NCT00634920 (19) [back to overview]Health-related Quality of Life (QoL) as Measured by EuroQoL EQ-5D
NCT00634920 (19) [back to overview]Lipid Profile for Apolipoprotein
NCT00634920 (19) [back to overview]Number of Antihypertensive Drugs Taken
NCT00634920 (19) [back to overview]Number of Lipid-lowering Drugs Taken
NCT00634920 (19) [back to overview]Percentage of Participants on Antihypertensive Drugs
NCT00634920 (19) [back to overview]Percentage of Participants on Lipid-lowering Drugs
NCT00634920 (19) [back to overview]Percentage of Participants Who Developed CAN (Chronic Allograft Nephropathy)
NCT00634920 (19) [back to overview]Percentage of Participants Who Had Donor Specific Antibodies (DSA)
NCT00634933 (12) [back to overview]Number of Tender Joints
NCT00634933 (12) [back to overview]Number of Swollen Joints
NCT00634933 (12) [back to overview]Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24
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% (ACR50) Response
NCT00634933 (12) [back to overview]Health Assessment Questionnaire Disability Index (HAQ-DI)
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 70% (ACR70) Response
NCT00634933 (12) [back to overview]Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
NCT00634933 (12) [back to overview]Patient Global Assessment (PtGA) of Disease Activity
NCT00638690 (4) [back to overview]Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria
NCT00638690 (4) [back to overview]Radiographic Progression-free Survival
NCT00638690 (4) [back to overview]Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%
NCT00638690 (4) [back to overview]Overall Survival
NCT00651040 (1) [back to overview]The Primary Endpoint is the Total Dose of Glucocorticoids Administered Between Baseline and the End of Treatment.
NCT00662298 (2) [back to overview]Serum Prednisolone Levels Over 24 Hours
NCT00662298 (2) [back to overview]Difference Between Baseline and Day 14 in Serum Prednisolone Levels
NCT00671658 (1) [back to overview]Number of Participants With a Response
NCT00682357 (4) [back to overview]Change in Serum Cortisol
NCT00682357 (4) [back to overview]Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b)
NCT00682357 (4) [back to overview]Change in Testosterone
NCT00682357 (4) [back to overview]Change in Serum Osteocalcin
NCT00689078 (10) [back to overview]Ocular Redness at Day 7
NCT00689078 (10) [back to overview]Ocular Itching at Baseline (Day 0)
NCT00689078 (10) [back to overview]Ocular Itching at Day 27
NCT00689078 (10) [back to overview]Ocular Itching at Day 28
NCT00689078 (10) [back to overview]Ocular Itching at Day 6
NCT00689078 (10) [back to overview]Ocular Itching at Day 7
NCT00689078 (10) [back to overview]Ocular Redness at Baseline (Day 0)
NCT00689078 (10) [back to overview]Ocular Redness at Day 27
NCT00689078 (10) [back to overview]Ocular Redness at Day 28
NCT00689078 (10) [back to overview]Ocular Redness at Day 6
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)
NCT00720109 (5) [back to overview]Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy
NCT00720109 (5) [back to overview]Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy
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]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]Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation
NCT00732498 (4) [back to overview]Complete Response Rate
NCT00732498 (4) [back to overview]Median Time to Progression
NCT00732498 (4) [back to overview]Overall Response Rate
NCT00732498 (4) [back to overview]Progression-free Survival at 1 Year
NCT00733096 (4) [back to overview]Global Perceived Effect
NCT00733096 (4) [back to overview]Medication Reduction
NCT00733096 (4) [back to overview]Oswestry Disability Score
NCT00733096 (4) [back to overview]Numerical Rating Leg Pain Score
NCT00747214 (4) [back to overview]Improvement of ACR 20 Scores at End of Study (Day 42/Visit 5)
NCT00747214 (4) [back to overview]Change in Fatigue (MAF Scale) Score From Baseline to Day 42
NCT00747214 (4) [back to overview]Change in DAS28 Score From Baseline to Day 42
NCT00747214 (4) [back to overview]Change in CRP From Baseline to Day 42
NCT00782717 (2) [back to overview]Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).
NCT00782717 (2) [back to overview]Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery
NCT00787722 (6) [back to overview]Disability Score: Expanded Disability Status Scale (EDSS)
NCT00787722 (6) [back to overview]NMO-IgG Aquaporin- 4 Autoantibody Titer
NCT00787722 (6) [back to overview]Number of Patients Who Require No Device Assistance for Ambulation
NCT00787722 (6) [back to overview]Post HSCT Immune -Modulating Medication and Relapse
NCT00787722 (6) [back to overview]Quality of Life (QOL) Short Form - 36 (SF-36)
NCT00787722 (6) [back to overview]Survival
NCT00792948 (3) [back to overview]Continuous Complete Remission (CCR) Rate
NCT00792948 (3) [back to overview]Overall Survival (OS)
NCT00792948 (3) [back to overview]Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation
NCT00802529 (3) [back to overview]Change in Hearing
NCT00802529 (3) [back to overview]Vertigo Attacks
NCT00802529 (3) [back to overview]Change in Speech Discrimination
NCT00806598 (1) [back to overview]Overall Response
NCT00807586 (3) [back to overview]Repeat Intervention
NCT00807586 (3) [back to overview]Cardiac Pain Assessment
NCT00807586 (3) [back to overview]Number of Participants With Clinically Significant Atrial Arrhythmias at 6 Weeks
NCT00836810 (6) [back to overview]Change in Area Under the Curve (AUC) of Plasma IL-6
NCT00836810 (6) [back to overview]Clinician's Opinion of Disease Activity.
NCT00836810 (6) [back to overview]Pain (Severity)
NCT00836810 (6) [back to overview]Patient's Opinion of Condition
NCT00836810 (6) [back to overview]Percentage Change in Morning Stiffness
NCT00836810 (6) [back to overview]Change in Peak Serum IL-6 Concentration
NCT00854061 (1) [back to overview]Means Aqueous Humor Prednisolone Acetate Concentration
NCT00908583 (4) [back to overview]Overall Safety of Bortezomib
NCT00908583 (4) [back to overview]Acute Rejection Rate
NCT00908583 (4) [back to overview]Number of Patients Whose Cytotoxic Panel Reactive Antibody (PRA) is Decreased by 50%
NCT00908583 (4) [back to overview]Number of Living Donor Transplant Candidates That Are Transplanted
NCT00915473 (4) [back to overview]Mean Frequency of Days With a Migraine
NCT00915473 (4) [back to overview]Number of Subjects With at Least 50% Reduction in the Frequency of Days With Moderate or Severe Migraine in the 4 Week Post Injection Compared to the 4 Week Pre-injection Baseline Period
NCT00915473 (4) [back to overview]Mean Number of Hours With Moderate or Severe Migraine
NCT00915473 (4) [back to overview]Mean Number of Days With Acute Medication Use
NCT00929695 (12) [back to overview]Prednisone-associated Toxicity as Assessed by Hyperglycemia
NCT00929695 (12) [back to overview]Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral)
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]Chronic Extensive GVHD
NCT00929695 (12) [back to overview]Overall Survival
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]Non-relapse Mortality
NCT00929695 (12) [back to overview]Prednisone-associated Toxicity as Assessed by Hypertension
NCT00929981 (7) [back to overview]Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit
NCT00929981 (7) [back to overview]Treatment Status (Success/Failure) of CD at the Third Follow-up Visit
NCT00929981 (7) [back to overview]Treatment Status (Success/Failure) of CD at the First Follow-up Visit
NCT00929981 (7) [back to overview]Treatment Status (Success/Failure) of CD at the Final Follow-up Visit
NCT00929981 (7) [back to overview]Change From Baseline in Participant-rated Pruritus Score at First, Second, Third and Final Follow-up Visits
NCT00929981 (7) [back to overview]Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits
NCT00929981 (7) [back to overview]Change From Baseline in Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits
NCT00934843 (5) [back to overview]Total Intake/Output of Fluid
NCT00934843 (5) [back to overview]Urine Output
NCT00934843 (5) [back to overview]Inotropic Score
NCT00934843 (5) [back to overview]Number of Participants Who Died Between 36 Hours and 30 Days Following Cardiac Surgery
NCT00934843 (5) [back to overview]Primary Endpoint: Number of Participants With Low Cardiac Output Syndrome (LCOS) or Death at 36 Hours From Admission to the Intensive Care Unit (ICU) After Surgery.
NCT00947765 (8) [back to overview]Pain(at 1 Week): Nirschl Staging (0 to 7)
NCT00947765 (8) [back to overview]Pain(at 12 Weeks): Nirschl Staging
NCT00947765 (8) [back to overview]Pain(at 12 Weeks): Visual Analogue Scale
NCT00947765 (8) [back to overview]Pain(at 4 Weeks): Nirschl Staging
NCT00947765 (8) [back to overview]Pain(at 4 Weeks): Visual Analogue Scale
NCT00947765 (8) [back to overview]Pain(at 6 Months): Nirschl Staging
NCT00947765 (8) [back to overview]Pain(at 6 Months): Visual Analogue Scale
NCT00947765 (8) [back to overview]Pain (at 1 Week): Visual Analogue Scale(0 to 10)
NCT00957801 (40) [back to overview]Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 7
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 6
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 5
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 4
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 3
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured on Treatment Day 2
NCT00957801 (40) [back to overview]Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Serum Estradiol Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Serum Estradiol Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Prostate Specific Antigen (PSA) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Prostate Specific Antigen (PSA) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Low-Density Lipoproteins (LDL) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Low-Density Lipoproteins (LDL) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Insulin Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Insulin Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]High-Density Lipoproteins (HDL) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]High-Density Lipoproteins (HDL) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Hematocrit Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Hematocrit Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) in the Pre-treatment Week
NCT00957801 (40) [back to overview]Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) During the Treatment Week
NCT00957801 (40) [back to overview]Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Triglycerides Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Triglycerides Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Total Cholesterol Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Total Cholesterol Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 1 (Baseline Study)
NCT00957801 (40) [back to overview]Cortisol Measured on Treatment Day 8 (Post Study) BEFORE Exercise Protocol
NCT00957801 (40) [back to overview]Cortisol Measured on Treatment Day 8 (Post Study) AFTER Exercise Protocol
NCT00957801 (40) [back to overview]Cortisol Measured on Treatment Day 1 (Baseline Study) BEFORE Exercise Protocol
NCT00957801 (40) [back to overview]Cortisol Measured on Treatment Day 1 (Baseline Study) AFTER Exercise Protocol
NCT00957801 (40) [back to overview]C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post Study)
NCT00957801 (40) [back to overview]C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline Study)
NCT00967226 (13) [back to overview]Pulmonary/Respiratory Adverse Events
NCT00967226 (13) [back to overview]Vascular Adverse Events
NCT00967226 (13) [back to overview]Allergy/Immunology Adverse Events
NCT00967226 (13) [back to overview]Infectious Adverse Events
NCT00967226 (13) [back to overview]Growth and Development Adverse Events
NCT00967226 (13) [back to overview]Tolerability of Medication
NCT00967226 (13) [back to overview]Gastrointestinal Adverse Events
NCT00967226 (13) [back to overview]Endocrinologic Adverse Events
NCT00967226 (13) [back to overview]Dermatologic Adverse Events
NCT00967226 (13) [back to overview]Decrease in Size of Hemangioma (Length x Width) in Square mm
NCT00967226 (13) [back to overview]Constitutional Adverse Events
NCT00967226 (13) [back to overview]Number of Serious Adverse Events (SAEs)
NCT00967226 (13) [back to overview]Metabolic or Laboratory AEs
NCT00968253 (3) [back to overview]Maximum Tolerated Dose [MTD] Determination by Number of Participants With Dose Limiting Toxicity (DLT)
NCT00968253 (3) [back to overview]Overall Response Rate (OR) Where OR = CR + CRp + CRi
NCT00968253 (3) [back to overview]Participant Responses by Daily Dose Level Assignment (RAD001 5 mg, 10 mg and MTD 5 mg)
NCT00981435 (2) [back to overview]Intraocular Pressure (IOP) Change
NCT00981435 (2) [back to overview]Intraocular Inflammation
NCT00982072 (4) [back to overview]Percentage of Patients Achieving Complete Remission From Nephrotic Syndrome at 16 and 26 Weeks
NCT00982072 (4) [back to overview]Percentage of Patients Achieving Remission Who Then Relapse
NCT00982072 (4) [back to overview]Percentage of Participants Achieving Complete Remission From Nephrotic Syndrome at 8 Weeks
NCT00982072 (4) [back to overview]Number of Serious Adverse Events
NCT00984568 (2) [back to overview]Number of Participants Achieving Treatment Response
NCT00984568 (2) [back to overview]Number of Participants With Response at Week 4 and Steroid-Free Remission at Week 50
NCT00985959 (7) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Prednisolone - Phase I
NCT00985959 (7) [back to overview]Median Time to First Response - Phase II
NCT00985959 (7) [back to overview]Number of Participants With Dose Limiting Toxicity During the Phase I (Cycle 1)
NCT00985959 (7) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 in Combination With Melphalan and Prednisolone) - Phase I
NCT00985959 (7) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 Alone) - Phase I
NCT00985959 (7) [back to overview]Number of Participants With Overall Response (Complete Response [CR] + Partial Response [PR]) - Phase I and II
NCT00985959 (7) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Melphalan - Phase I
NCT01000610 (4) [back to overview]Change in Bone Density (in Participants Untreated With Bisphosphonates)
NCT01000610 (4) [back to overview]Percentage Change in Disease Activity Score 28 (DAS28) From Baseline to Week 24
NCT01000610 (4) [back to overview]Percentage of Participants Whose DAS28 Improved by >1.2 at Week 24
NCT01000610 (4) [back to overview]Number of Participants Reporting Adverse Events (AEs)
NCT01085097 (2) [back to overview]Percent Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24
NCT01085097 (2) [back to overview]Number of Participants With Adverse Events (AEs)
NCT01086410 (22) [back to overview]Change From Baseline in Hemoglobin Values at Day 42/EW
NCT01086410 (22) [back to overview]Change From Baseline in Hematocrit Values at Day 42/EW
NCT01086410 (22) [back to overview]AUC(0-t) for VI on Day 42
NCT01086410 (22) [back to overview]Cmax for VI on Day 42
NCT01086410 (22) [back to overview]Ratio From Baseline of Serum Cortisol Trough (0-24 Hours) at Day -1/1 (Baseline) and Day 42
NCT01086410 (22) [back to overview]Ratio From Baseline of the Serum Cortisol Area Under the Concentration-time Curve (AUC) (0-24 Hour) on Day -1/1 (Baseline) and Day 42
NCT01086410 (22) [back to overview]Ratio From Baseline of the Serum Cortisol Weighted Mean (0-24 Hours) on Day -1/1 (Baseline) and Day 42
NCT01086410 (22) [back to overview]AUC(0-t) and AUC(0-24) for FF on Day 42
NCT01086410 (22) [back to overview]Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW
NCT01086410 (22) [back to overview]Change From Baseline in Albumin and Total Protein Values at Day 42/EW
NCT01086410 (22) [back to overview]Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW)
NCT01086410 (22) [back to overview]Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW
NCT01086410 (22) [back to overview]Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW
NCT01086410 (22) [back to overview]Cmax for FF on Day 42
NCT01086410 (22) [back to overview]Tmax and Tlast of VI at Day 42
NCT01086410 (22) [back to overview]Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline
NCT01086410 (22) [back to overview]Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW
NCT01086410 (22) [back to overview]Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period
NCT01086410 (22) [back to overview]Plasma FF and VI Pharmacokinetic (PK) Concentration
NCT01086410 (22) [back to overview]Tmax and Tlast of FF at Day 42
NCT01086410 (22) [back to overview]Ratio From Baseline of 0-24 Hour Urinary Free Cortisol Excretion on Day -1/1 (Baseline) and Day 42
NCT01086410 (22) [back to overview]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline
NCT01093586 (14) [back to overview]Transplant Related Mortality
NCT01093586 (14) [back to overview]Overall Survival
NCT01093586 (14) [back to overview]Disease Free
NCT01093586 (14) [back to overview]Disease Free
NCT01093586 (14) [back to overview]Hematologic Engraftment
NCT01093586 (14) [back to overview]Incidence of Acute Graft-versus-host Disease (GVHD)
NCT01093586 (14) [back to overview]Incidence of Chronic GVHD
NCT01093586 (14) [back to overview]Occurrence of Serious Infections
NCT01093586 (14) [back to overview]Overall Survival
NCT01093586 (14) [back to overview]Overall Survival
NCT01093586 (14) [back to overview]Recurrence or Relapse
NCT01093586 (14) [back to overview]Recurrence or Relapse
NCT01093586 (14) [back to overview]Toxicity Related to UCB Transplantation and Cytoreduction as Assessed by CTC v3.0
NCT01093586 (14) [back to overview]Transplant Related Mortality
NCT01105650 (4) [back to overview]Overall Survival
NCT01105650 (4) [back to overview]Number of Participants With Progressive Disease at One Year
NCT01105650 (4) [back to overview]Response Rate
NCT01105650 (4) [back to overview]Time to Disease Progression
NCT01114503 (8) [back to overview]Number of Participants With Thyroid Function Assessment, Hormone and Glucose Assay Abnormalities Meeting the Criteria for PCC
NCT01114503 (8) [back to overview]Number of Participants With Vital Signs Abnormalities Meeting the Criteria for PCC
NCT01114503 (8) [back to overview]Number of Participants With at Least One Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event
NCT01114503 (8) [back to overview]Number of Participants With Laboratory Urinalysis Abnormalities Meeting the Criteria for PCC
NCT01114503 (8) [back to overview]Number of Participants With an Epstein Barr Virus (EBV) Viral Load Abnormalities Meeting the Criteria for PCC
NCT01114503 (8) [back to overview]Number of Participants With Electrocardiogram (ECG) Abnormalities Meeting the Criteria for PCC
NCT01114503 (8) [back to overview]Number of Participants With Laboratory Clinical Chemistry Abnormalities Meeting the Criteria for Potential Clinical Concern (PCC)
NCT01114503 (8) [back to overview]Number of Participants With Laboratory Hematology Abnormalities Meeting the Criteria for PCC
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity
NCT01124045 (13) [back to overview]Global Assessment Score of Postoperative Inflammation by Visit
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia
NCT01124045 (13) [back to overview]Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation
NCT01124045 (13) [back to overview]Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade
NCT01144143 (5) [back to overview]Change in Serum CRP Day 0 to Day 56
NCT01144143 (5) [back to overview]Change in Levels of Serum IL-6
NCT01144143 (5) [back to overview]Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score Target Knee
NCT01144143 (5) [back to overview]Change in Joint Effusions From Day 0 to Day 56 Target Knee
NCT01144143 (5) [back to overview]Change in Serum SAA Levels Day 0 to Day 56
NCT01179490 (18) [back to overview]Response Rate (Based on the IMWG Criteria)
NCT01179490 (18) [back to overview]Response Rate (Based on the Modified SWOG Criteria)
NCT01179490 (18) [back to overview]Time to Treatment Failure (TTF)
NCT01179490 (18) [back to overview]Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Related Serious Adverse Event
NCT01179490 (18) [back to overview]Pharmacokinetic Parameters (Cmax)
NCT01179490 (18) [back to overview]Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values
NCT01179490 (18) [back to overview]Number of Adverse Events, Related Adverse Events, Serious Adverse Events, and Related Serious Adverse Events
NCT01179490 (18) [back to overview]Overall Survival (OS)
NCT01179490 (18) [back to overview]Duration of Response (DOR)
NCT01179490 (18) [back to overview]CR Rate Based on the (Bladé) Criteria
NCT01179490 (18) [back to overview]CR Rate [Based on the International Myeloma Working Group (IMWG) Criteria]
NCT01179490 (18) [back to overview]Complete Response (CR) Rate [Based on the Modified Southwest Oncology Group (SWOG) Criteria]
NCT01179490 (18) [back to overview]Number of Abnormalities (Grade ≥3) in Laboratory Test Values
NCT01179490 (18) [back to overview]Response Rate (Based on the Bladé Criteria)
NCT01179490 (18) [back to overview]Pharmacokinetic Parameters (t1/2)
NCT01179490 (18) [back to overview]Pharmacokinetic Parameters (Tmax)
NCT01179490 (18) [back to overview]Progression-Free Survival (PFS)
NCT01179490 (18) [back to overview]Pharmacokinetic Parameters (AUC)
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 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]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 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]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 Complete 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): 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]Overall Survival (OS)
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: 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 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 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 I and II (Pooled): Ctrough of Rituximab at Each Maintenance Treatment Cycle
NCT01200758 (26) [back to overview]Percentage of Participants With B-Cell Depletion by Cycle for Induction Phase
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): Percentage of Participants Positive for Human Anti-Human Antibodies (HAHAs) to Rituximab
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): Rituximab Levels 12 Weeks, 24 Weeks, and 36 Weeks After the Last Rituximab Administration
NCT01200758 (26) [back to overview]Percentage of Participants With B-Cell Depletion by Cycle for Maintenance Phase
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]Stage I and II (Pooled): Ctrough of Rituximab at Each Induction Treatment Cycle
NCT01200758 (26) [back to overview]Stage I: Observed Area Under the Serum Concentration-Time Curve (AUC) of Rituximab
NCT01201798 (10) [back to overview]Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits
NCT01201798 (10) [back to overview]Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points
NCT01201798 (10) [back to overview]Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points
NCT01201798 (10) [back to overview]Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14
NCT01201798 (10) [back to overview]Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14
NCT01201798 (10) [back to overview]Proportion of Subjects Who Discontinued Due to Lack of Efficacy
NCT01201798 (10) [back to overview]Proportion of Subjects With Anterior Chamber Cell Grade of 0
NCT01201798 (10) [back to overview]Proportion of Subjects With Anterior Chamber Cell Grade ≤1
NCT01201798 (10) [back to overview]Proportion of Subjects With Anterior Chamber Cell Count of 0
NCT01201798 (10) [back to overview]Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0
NCT01211665 (3) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01211665 (3) [back to overview]Severity of AEs and SAEs
NCT01211665 (3) [back to overview]Number of Participants Who Survived at 6 Months Following Completion of Plasma Exchange (PLEX)
NCT01219933 (33) [back to overview]Percentage of Participants Able to Acheive LDA Assessed Using DAS28 While Receiving Oral GC on Background Tocilizumab Treatment During the Noninterventional Phase
NCT01219933 (33) [back to overview]Number of Participants With Changes in Tocilizumab Dose During the Noninterventional Phase
NCT01219933 (33) [back to overview]Median Time Interval Between V1 and V2
NCT01219933 (33) [back to overview]Median Dose of Tocilizumab During the Noninterventional Phase
NCT01219933 (33) [back to overview]VAS-Physician's Global Assessment of Disease Activity (GDA) During the Interventional Phase
NCT01219933 (33) [back to overview]VAS for Pain (VAS-Pain) During the Interventional Phase
NCT01219933 (33) [back to overview]Type of GC Taken at the End of the Noninterventional Phase
NCT01219933 (33) [back to overview]SJC and TJC During the Interventional Phase
NCT01219933 (33) [back to overview]Short-Form 36 (SF-36) Mental Component Score (MCS) and Physical Component Score (PCS) During the Interventional Phase
NCT01219933 (33) [back to overview]DAS28-CRP During the Interventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using DAS28-CRP
NCT01219933 (33) [back to overview]Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using CDAI
NCT01219933 (33) [back to overview]Percentage of Participants With Erosions During the NonInterventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants Positive for Rheumatoid Factor (RF) During the Noninterventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants Positive for Anti-cyclic Citrullinated Peptide (Anti-CCP) Antibody During the Noninterventional Phase
NCT01219933 (33) [back to overview]Number of Erosions During the NonInterventional Phase
NCT01219933 (33) [back to overview]Median GC Dose Taken During the Noninterventional Phase
NCT01219933 (33) [back to overview]Health Assessment Questionnaire Disability Index (HAQ-DI) During the Noninterventional Phase
NCT01219933 (33) [back to overview]HAQ-DI During the Interventional Phase
NCT01219933 (33) [back to overview]Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score During the Interventional Phase
NCT01219933 (33) [back to overview]DAS28-ESR During the Noninterventional Phase
NCT01219933 (33) [back to overview]DAS28-CRP During the Noninterventional Phase
NCT01219933 (33) [back to overview]Clinical Disease Activity Index (CDAI) During the Noninterventional Phase
NCT01219933 (33) [back to overview]CDAI Score During the Interventional Phase
NCT01219933 (33) [back to overview]Time-Averaged GC Dose Changes During the Interventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants With Changes in RA Treatment During the Noninterventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants in the Interventional Phase Who Achieved LDA and Discontinued Oral GC Within 20 Weeks
NCT01219933 (33) [back to overview]Percentage of Participants Able to Start the GC Reduction Phase at V3
NCT01219933 (33) [back to overview]Number of Participants With GC Switches During the Noninterventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants Acheiving Remission Assessed Using DAS28 While Receiving Oral GC on Background TocilizumabTreatment During the Noninterventional Phase
NCT01219933 (33) [back to overview]Percentage of Participants Able to Reduce Oral GCs by ≥50 Percent (%) During the Interventional Phase by V9
NCT01219933 (33) [back to overview]Percentage of Participants Able to Discontinue GCs During the Interventional Phase by V9
NCT01219933 (33) [back to overview]SF-36 Subscale Scores During the Interventional Phase
NCT01267201 (4) [back to overview]Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
NCT01267201 (4) [back to overview]Maximum Observed Plasma Concentration (Cmax)
NCT01267201 (4) [back to overview]Time to Reach Maximum Observed Plasma Concentration (Tmax)
NCT01267201 (4) [back to overview]Plasma Decay Half-life (t1/2)
NCT01272635 (5) [back to overview]Drug Related Side Effects
NCT01272635 (5) [back to overview]Urgent Care Visits, ED Visits and Hospitalizations
NCT01272635 (5) [back to overview]Progression to Clinically Significant Lower Respiratory Tract Symptoms
NCT01272635 (5) [back to overview]OCELOT: Pediatric Respiratory Assessment Measure
NCT01272635 (5) [back to overview]Asthma Related Symptoms Among RTI Progressing to Severe LRTI
NCT01276314 (1) [back to overview]Skin Healing Time
NCT01283009 (1) [back to overview]60-day Mortality
NCT01308580 (18) [back to overview]Time to Tumor Progression
NCT01308580 (18) [back to overview]Time to PSA Progression
NCT01308580 (18) [back to overview]Time to Pain Progression
NCT01308580 (18) [back to overview]Time to First Definitive Consumption of Narcotic Medication
NCT01308580 (18) [back to overview]Time to Definitive Deterioration of ECOG PS Score From Baseline
NCT01308580 (18) [back to overview]Progression Free Survival (PFS)
NCT01308580 (18) [back to overview]Plasma Clearance (CL) for Cabazitaxel
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 Pain Response
NCT01308580 (18) [back to overview]Percentage of Participants With Overall Objective Tumor Response
NCT01308580 (18) [back to overview]Percentage of Participants With FACT-P Total Score Response
NCT01308580 (18) [back to overview]Overall Survival (OS)
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]Plasma Steady State Volume of Distribution (Vss) for Cabazitaxel
NCT01308580 (18) [back to overview]Time to Definitive Weight Loss by 5% and 10% From Baseline
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]Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
NCT01319981 (3) [back to overview]Overall Survival
NCT01319981 (3) [back to overview]Number of Patients With Complete Remission at One Year
NCT01319981 (3) [back to overview]Complete Response Duration
NCT01369745 (1) [back to overview]Change From Baseline in DAS28-CRP at 12 Weeks
NCT01370694 (2) [back to overview]Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) During MK-8808/CVP Combination Therapy
NCT01370694 (2) [back to overview]Clinical Response of Tumor to MK-8808/CVP Combination Therapy
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
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)
NCT01448213 (2) [back to overview]Number of Eyes With Immunologic Graft Rejection Episodes
NCT01448213 (2) [back to overview]Number of Eyes With Intraocular Pressure (IOP) Elevation
NCT01451515 (4) [back to overview]Minimal Residual Disease (MRD)
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 Disseminated Disease (MDD)
NCT01465334 (11) [back to overview]Number of Participants With Treatment-Related Grades 1-3 Hyperglycemia During Part A Induction
NCT01465334 (11) [back to overview]Overall MRD Negative Rate
NCT01465334 (11) [back to overview]Overall Objective Response Rate (ORR)
NCT01465334 (11) [back to overview]Transplant Rate
NCT01465334 (11) [back to overview]3-year Overall Survival (OS) Probability
NCT01465334 (11) [back to overview]3-Year Progression-Free Survival (PFS) Probability
NCT01465334 (11) [back to overview]Induction Overall Response Rate (ORR)
NCT01465334 (11) [back to overview]Number of Participants Completing Only 2 Cycles of Part A Treatment
NCT01465334 (11) [back to overview]Number of Participants Completing Part A Treatment
NCT01465334 (11) [back to overview]Number of Participants With Overall CR
NCT01465334 (11) [back to overview]Number of Participants Achieving Induction Complete Response (CR)
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
NCT01475643 (2) [back to overview]Anterior Chamber Cells & Flare
NCT01475643 (2) [back to overview]Anterior Chamber Inflammation
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: Ipatasertib Plasma Concentrations When Co-Administered With Abiraterone
NCT01485861 (46) [back to overview]Phase II: G-037720 (Metabolite of Ipatasertib) Plasma Concentrations
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)
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 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
NCT01496976 (4) [back to overview]Rate of Progression/Relapse Free Survival (PFS)
NCT01496976 (4) [back to overview]Number of Participants With Partial Response (PR)
NCT01496976 (4) [back to overview]Number of Participants With Overall Survival (OS)
NCT01496976 (4) [back to overview]Number of Participants With Complete Response (CR)
NCT01497496 (1) [back to overview]Objective Response Rate (ORR)
NCT01534195 (4) [back to overview]Episcleral Redness Change From Baseline to Day 6
NCT01534195 (4) [back to overview]Ciliary Redness Change From Baseline to Day 6
NCT01534195 (4) [back to overview]Conjunctival Redness Change From Baseline to Day 11
NCT01534195 (4) [back to overview]Ocular Itching Change From Baseline to Day 11
NCT01539083 (8) [back to overview]Disease-free Survival (DFS)
NCT01539083 (8) [back to overview]Consolidation Phase: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) at Month 12
NCT01539083 (8) [back to overview]Consolidation Phase: Change From Baseline in FACT/GOG-NTX Total Score at the End of the Consolidation Phase
NCT01539083 (8) [back to overview]Consolidation Phase: Change From Baseline in AQOL-6D Scores at the End of the Consolidation Phase
NCT01539083 (8) [back to overview]Progression Free Survival (PFS)
NCT01539083 (8) [back to overview]Overall Survival (OS)
NCT01539083 (8) [back to overview]Consolidation Phase: Percentage of Participants With Stringent Complete Response (sCR) at Months 3, 6, 9 and 12
NCT01539083 (8) [back to overview]Consolidation Phase: Percentage of Participants With Complete Response (CR) at Months 3, 6, 9 and 12
NCT01559675 (1) [back to overview]Orthostatic Hypotension
NCT01579513 (5) [back to overview]Neurodevelopmental Outcome
NCT01579513 (5) [back to overview]Number of Participants With a Clinically Derived Composite Morbidity-mortality Outcome
NCT01579513 (5) [back to overview]Intensive Care Unit Stay
NCT01579513 (5) [back to overview]Hospital Stay
NCT01579513 (5) [back to overview]Duration of Mechanical Ventilation Post Cardiac Surgery.
NCT01652495 (3) [back to overview]Functional Improvement Measured According to Percentage Change in Constant Score
NCT01652495 (3) [back to overview]Reduction of Pain Severity Expressed as Percentage Change in VAS Score
NCT01652495 (3) [back to overview]Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis
NCT01685983 (7) [back to overview]Percentage of Participants With Objective Radiographic Response
NCT01685983 (7) [back to overview]Overall Survival
NCT01685983 (7) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT01685983 (7) [back to overview]Dehydroepiandrosterone Sulfate (DHEA-S)
NCT01685983 (7) [back to overview]Time to PSA Progression
NCT01685983 (7) [back to overview]Percentage of Participants With Prostate-specific Antigen (PSA) Response
NCT01685983 (7) [back to overview]Serum Testosterone
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]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 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]Number of Participants Who Achieved a Total Reduction of OCS Dose During Weeks 20 to 24 While Maintaining Asthma Control
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)
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]Complete Response (CR) Rate
NCT01724021 (14) [back to overview]Disease-free Survival (DFS)
NCT01724021 (14) [back to overview]Event-free Survival (EFS)
NCT01724021 (14) [back to overview]Number of Participants With Treatment Emergent Adverse Events (AEs)
NCT01724021 (14) [back to overview]Overall Survival (OS)
NCT01730872 (3) [back to overview]Ocular Redness Change From Baseline to Day 6
NCT01730872 (3) [back to overview]Ocular Itching Change From Baseline to Day 6
NCT01730872 (3) [back to overview]Inflammation Change From Baseline to Day 6
NCT01783847 (2) [back to overview]Number of Participants With Change/Improvement Visual Acuity From the Beseline
NCT01783847 (2) [back to overview]Number of Participants With Relative Afferent Papillary Defect (RAPD) Grade +4
NCT01809132 (4) [back to overview]MELD Score at 28 Days
NCT01809132 (4) [back to overview]180 Days Mortality
NCT01809132 (4) [back to overview]MELD Score at 180 Days
NCT01809132 (4) [back to overview]MELD Score at 90 Days
NCT01843920 (1) [back to overview]Complete Resolution of Intraocular Gas Bubble
NCT01853072 (6) [back to overview]Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit [Time Frame: Day 7 up to Any Visit]
NCT01853072 (6) [back to overview]Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60
NCT01853072 (6) [back to overview]Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit
NCT01853072 (6) [back to overview]Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90
NCT01853072 (6) [back to overview]Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)
NCT01853072 (6) [back to overview]Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90
NCT01853696 (2) [back to overview]Intraocular Pressure
NCT01853696 (2) [back to overview]Immunologic Graft Rejection Episode
NCT01872611 (6) [back to overview]Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit
NCT01872611 (6) [back to overview]Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90
NCT01872611 (6) [back to overview]Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60
NCT01872611 (6) [back to overview]Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit
NCT01872611 (6) [back to overview]Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90
NCT01872611 (6) [back to overview]Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)
NCT01875237 (8) [back to overview]To Assess the Incidence of Acute GvHD Flare After CR/PR Requiring Additional Agent for Systemic Therapy Before Day 56 Post-administration of AP1903.
NCT01875237 (8) [back to overview]To Assess Post Donor Lymphocyte Infusion (DLI) Chimerism
NCT01875237 (8) [back to overview]Number of Participants Assessed Post Donor Lymphocyte Infusion (DLI): Disease-free Survival & Non-relapse Mortality, Chimerism and GVHD.
NCT01875237 (8) [back to overview]To Evaluate the Safety of Donor Lymphocyte Infusion Followed by Dimerizer Drug, AP1903 by Number of Participants With Adverse Events.
NCT01875237 (8) [back to overview]To Assess the Incidence of Epstein-Barr Virus -PTLD or EBV Reactivation Requiring Therapy Post DLI.
NCT01875237 (8) [back to overview]To Assess the Proportion of Patients Developing Grade I-IV Acute GvHD
NCT01875237 (8) [back to overview]To Assess the Proportions of GvHD Response Post-administration of AP1903.
NCT01875237 (8) [back to overview]To Assess the Incidence of GvHD Treatment Failure Post-administration of AP1903.
NCT01897571 (4) [back to overview]Duration of Response for Tazemetostat as a Single Agent or in Combination With Prednisolone (Phase 2 Only)
NCT01897571 (4) [back to overview]Objective Response Rate (ORR; Complete Response + Partial Response [CR + PR]) (Phase 2)
NCT01897571 (4) [back to overview]Recommended Phase 2 Dose (RP2D) of Tazemetostat as a Single-Agent and in Combination With Prednisolone (Phase 1 Only)
NCT01897571 (4) [back to overview]Progression Free Survival for Tazemetostat as a Single Agent or in Combination With Prednisolone (Phase 2 Only)
NCT01903798 (2) [back to overview]Survival at Day 29 of the Assigned Treatment
NCT01903798 (2) [back to overview]Number of Patients Reported Ascites
NCT01908972 (15) [back to overview]Percent Reduction in Hemangioma Volume From Baseline
NCT01908972 (15) [back to overview]Number of Participants With Change in Color as Compared to Baseline
NCT01908972 (15) [back to overview]Number of Participants With Clinical Response From Baseline in Hemangioma Volume Measured by MRI or SONO
NCT01908972 (15) [back to overview]Number of Participants With Drug Compliance Within 16 Weeks
NCT01908972 (15) [back to overview]Number of Participants With Gastroesophageal Reflux Within 16 Weeks
NCT01908972 (15) [back to overview]Number of Participants With Growth Retardation Within 16 Weeks
NCT01908972 (15) [back to overview]Number of Participants With Reepithelialzation in 16weeks
NCT01908972 (15) [back to overview]Number of Participants With Regression
NCT01908972 (15) [back to overview]Number of Participants With Size Reduction of Ulceration
NCT01908972 (15) [back to overview]Number of Participants With Stop of Proliferation
NCT01908972 (15) [back to overview]Number of Participants With Adverse Drug Reaction
NCT01908972 (15) [back to overview]Number of Participants in Which, the Systolic Blood Pressure Fall of >25% of Baseline Postdose With Child Awake, Anytime During the 16 Weeks
NCT01908972 (15) [back to overview]Number of Participants in Which, Facial Edema Occurs, Anytime During the 16 Weeks
NCT01908972 (15) [back to overview]Number of Participants in Which, Glucose Levels Fall (to <50mg/dl), Anytime During the 16 Weeks
NCT01908972 (15) [back to overview]Number of Participants in Which, the Heart Rate Fell to <70% of Acceptable Age Related Minimum Post-dose With Child Awake, Anytime During the 16 Weeks
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]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]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 Infectious 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]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]Descriptive of Hematological Adverse Events
NCT01920932 (11) [back to overview]Complete Response Rate Estimate for All Evaluable Participants
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
NCT01972217 (28) [back to overview]Part B: Percentage of Patients Experiencing AEs
NCT01972217 (28) [back to overview]Part B: Percentage of Patients With PSA Responses
NCT01972217 (28) [back to overview]Part B: Median Overall Survival (OS)
NCT01972217 (28) [back to overview]Part A: Percentage of Patients Experiencing Adverse Events (AEs)
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 B: Median Time to Second Progression or Death (PFS2)
NCT01972217 (28) [back to overview]Part A PK: Abiraterone Cmin,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 B: Median Radiological Progression-Free Survival (rPFS) Time
NCT01972217 (28) [back to overview]Part A PK: Abiraterone AUCss
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: Percentage of Patients With Progression Events or Death (rPFS)
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]Median Time to First Subsequent Therapy (TFST) and Median Time to Second Subsequent Therapy (TSST)
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 A PK Analysis: Olaparib Area Under the Plasma Concentration-Time Curve at Steady State (AUCss)
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 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: Number of Patients With Dose Limiting Toxicities (DLTs)
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 B: Median Best Percentage Change From Baseline in Prostate Specific Antigen (PSA) Levels
NCT01977781 (7) [back to overview]Corneal Epitheliopathy (Corneal Fluorescein Staining Using the NEI Grading Scheme)
NCT01977781 (7) [back to overview]Schirmer Tear Test (mm)
NCT01977781 (7) [back to overview]Intraocular Pressure
NCT01977781 (7) [back to overview]Ocular Surface Disease Index (OSDI) Questionnaire
NCT01977781 (7) [back to overview]Visual Acuity
NCT01977781 (7) [back to overview]Tear Film Break-Up Time
NCT01977781 (7) [back to overview]Ocular Burning Sensation, Ocular Discharge, Ocular Redness, Ocular Itching, Foreign Body Sensation
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 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]Duration of Response, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population
NCT01992653 (29) [back to overview]Plasma Levels of Doxorubicin
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]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
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) 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) Global Score
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]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]Time to Prostate Specific Antigen (PSA) Progression
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) 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) Functional Well-Being 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]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) Social/Family 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]Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation
NCT01995513 (27) [back to overview]Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation
NCT01995513 (27) [back to overview]Percentage of Participants With Treatment-Emergent 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 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]Prostate Specific Antigen (PSA) Response Rate
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
NCT02006706 (2) [back to overview]Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24
NCT02006706 (2) [back to overview]Health Assessment Questionnaire-Disability Index (HAQ-DI)
NCT02028754 (7) [back to overview]Tear Break-Up Time (TBUT) in the Study Eye
NCT02028754 (7) [back to overview]Fluorescein Staining Score in the Study Eye
NCT02028754 (7) [back to overview]Lissamine Green Staining Score in the Study Eye
NCT02028754 (7) [back to overview]Ocular Surface Disease Index (OSDI) Questionnaire Score in the Study Eye
NCT02028754 (7) [back to overview]Results of Schirmer I Test With Anesthetics in the Study Eye
NCT02028754 (7) [back to overview]Subjective Symptom Total Score in the Study Eye
NCT02028754 (7) [back to overview]Tear Break-Up Time (TBUT) in the Study Eye
NCT02038452 (44) [back to overview]QALYS at 12 Months (Cross-walk Tariff)
NCT02038452 (44) [back to overview]NHS Cost Differences at 6 Months (CC)
NCT02038452 (44) [back to overview]NHS Cost Differences at 6 Months
NCT02038452 (44) [back to overview]NHS Cost Differences at 24 Months
NCT02038452 (44) [back to overview]NHS Cost Differences at 12 Months
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity Over 24 Months: 6 Weeks
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity Over 24 Months: 6 Months
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity Over 24 Months: 24 Months
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity Over 24 Months: 12 Months
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity 6 Weeks (PP)
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity 6 Weeks
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (Subgroup Analysis (SG), Intervention of Their Preference)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Months
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Weeks
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations Over 24 Months: 12 Months
NCT02038452 (44) [back to overview]BCTQ Symptom Severity Subscale 6 Months
NCT02038452 (44) [back to overview]BCTQ Symptom Severity Subscale 6 Months (CC)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity Subscale 6 Months (PP)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity Subscale 6 Weeks
NCT02038452 (44) [back to overview]BCTQ Symptom Severity Subscale 6 Weeks (CC)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity Subscale 6 Weeks (PP)
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity 6 Months
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity 6 Months (CC)
NCT02038452 (44) [back to overview]BCTQ Functional Limitations Subscale 6 Months
NCT02038452 (44) [back to overview]BCTQ Functional Limitations Subscale 6 Months (CC)
NCT02038452 (44) [back to overview]BCTQ Functional Limitations Subscale 6 Months (PP)
NCT02038452 (44) [back to overview]BCTQ Functional Limitations Subscale 6 Weeks
NCT02038452 (44) [back to overview]BCTQ Functional Limitations Subscale 6 Weeks (CC)
NCT02038452 (44) [back to overview]BCTQ Functional Limitations Subscale 6 Weeks (PP)
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity 6 Months (PP)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Injection)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Months (CC)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Months (PP)
NCT02038452 (44) [back to overview]Hand-wrist Pain Intensity 6 Weeks (CC)
NCT02038452 (44) [back to overview]Symptom Severity and Limitations in Hand Function as Assessed by the BCTQ 6 Weeks
NCT02038452 (44) [back to overview]Secondary: BCTQ Symptom Severity and Functional Limitations Over 24 Months: 24 Months
NCT02038452 (44) [back to overview]QALYS at 6 Months (Cross-walk Tariff)
NCT02038452 (44) [back to overview]QALYS at 24 Months (Cross-walk Tariff)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not State a Preference of Intervention)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Months
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not Receive the Intervention of Their Preference)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Splint)
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (Per-Protocol Analysis (PP))
NCT02038452 (44) [back to overview]BCTQ Symptom Severity and Functional Limitations 6 Weeks (Complete Case Analysis (CC))
NCT02043678 (14) [back to overview]Number of Participants With Treatment-emergent Bone Fractures
NCT02043678 (14) [back to overview]Symptomatic Skeletal Event Free Survival (SSE-FS)
NCT02043678 (14) [back to overview]Time to Cytotoxic Chemotherapy
NCT02043678 (14) [back to overview]Number of Subjects With Radium-223/Placebo-related Treatment-emergent Adverse Events Per Maximum Intensity
NCT02043678 (14) [back to overview]Time to Opiate Use for Cancer Pain
NCT02043678 (14) [back to overview]Time to Pain Progression
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]Overall Survival (OS)
NCT02043678 (14) [back to overview]Radiological Progression Free Survival (rPFS)
NCT02043678 (14) [back to overview]Number of Participants With Post-treatment Adverse Events
NCT02043678 (14) [back to overview]Number of Participants With Post-treatment Bone Fractures
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 Treatment-emergent Adverse Events
NCT02043678 (14) [back to overview]Number of Participants With Any Treatment-emergent Additional Primary Malignancies
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)
NCT02162771 (4) [back to overview]B-cell Kinetics (B-cell Depletion and Recovery)
NCT02162810 (7) [back to overview]Meatus Location After Hypospadias Repair
NCT02162810 (7) [back to overview]Meatus Location After Hypospadias Repair
NCT02162810 (7) [back to overview]Meatus Location After Hypospadias Repair
NCT02162810 (7) [back to overview]Complications After Hypospadias Repair
NCT02162810 (7) [back to overview]Complication Rate After Hypospadias Repair
NCT02162810 (7) [back to overview]Improvement of Chordee After Hypospadias Repair
NCT02162810 (7) [back to overview]Complication Rate After Hypospadias Repair
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
NCT02167217 (1) [back to overview]Bayley III Gross Motor Scaled Score (Change From Baseline to 12 Month)
NCT02176031 (6) [back to overview]Overall Survival (OS) Rate
NCT02176031 (6) [back to overview]Rate of GVHD Flares
NCT02176031 (6) [back to overview]GI aGVHD Response Rate
NCT02176031 (6) [back to overview]Graft-verus-host Disease (GVHD) Response Rate
NCT02176031 (6) [back to overview]Percentage Steroid Dose Was Reduced at Day 28, 56, and 100 in Comparison to Steroid Dose at First Administration of Natalizumab.
NCT02176031 (6) [back to overview]GVHD-free Survival Rate
NCT02199041 (9) [back to overview]Number of Participants by Severity With Acute Graft Versus Host Disease (GVHD) in the First 100 Days After HCT
NCT02199041 (9) [back to overview]Number of Participants With Transplant-related Mortality (TRM)
NCT02199041 (9) [back to overview]Number of Participants With Transplant-related Morbidity
NCT02199041 (9) [back to overview]Number of Participants With Secondary Graft Failure
NCT02199041 (9) [back to overview]Number of Participants With Overall Survival (OS)
NCT02199041 (9) [back to overview]Number of Participants by Severity With Chronic Graft Versus Host Disease (GVHD) in the First 100 Days After HCT
NCT02199041 (9) [back to overview]Number of Participants With Event-free Survival (EFS)
NCT02199041 (9) [back to overview]Number of Participants With Neutrophil Engraftment
NCT02199041 (9) [back to overview]Number of Participants With Malignant Relapse
NCT02242630 (2) [back to overview]Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale
NCT02242630 (2) [back to overview]Change in Shoulder Function, as Measured by the QuickDASH ®
NCT02256969 (4) [back to overview]Tear Break Up Time (TBUT)
NCT02256969 (4) [back to overview]Symptom Assessment in Dry Eye (SANDE)
NCT02256969 (4) [back to overview]Ocular Surface Disease Index (OSDI)
NCT02256969 (4) [back to overview]Corneal Fluorescein Staining (CFS)
NCT02260934 (15) [back to overview]Percentage of Participants With Treatment Failure by Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With a Sustained Complete Response
NCT02260934 (15) [back to overview]Count of Participants: Frequency of Non-renal Flares by Week 24
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 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 Hypocomplementemic for Complement Component C3 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 With a Complete Response at Week 24, Week 48, and Week 96
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 an Overall Response 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
NCT02288247 (9) [back to overview]Progression Free Survival (PFS)
NCT02288247 (9) [back to overview]Time to Prostate-specific Antigen (PSA) Progression
NCT02288247 (9) [back to overview]Change From Baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS)
NCT02288247 (9) [back to overview]Objective Response Rate (ORR)
NCT02288247 (9) [back to overview]Prostate-specific Antigen (PSA) Response
NCT02288247 (9) [back to overview]Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P)
NCT02288247 (9) [back to overview]Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P)
NCT02288247 (9) [back to overview]Change From Baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS)
NCT02288247 (9) [back to overview]Time to First Skeletal-related Event (SRE)
NCT02296346 (1) [back to overview]Multiple Sclerosis Functional Composite (MSFC) Z-score and Expanded Disability Status Scale (EDSS)
NCT02373137 (13) [back to overview]Best Spectacle-Corrected Visual Acuity
NCT02373137 (13) [back to overview]Best Spectacle-Corrected Visual Acuity
NCT02373137 (13) [back to overview]Endothelial Cell Count
NCT02373137 (13) [back to overview]Adverse Events/Complication Rates
NCT02373137 (13) [back to overview]Best Spectacle-Corrected Visual Acuity
NCT02373137 (13) [back to overview]Corneal Higher-Order Aberrations
NCT02373137 (13) [back to overview]Corneal Higher-Order Aberrations
NCT02373137 (13) [back to overview]National Eye Institute - Visual Functioning Questionnaire (NEI-VFQ)
NCT02373137 (13) [back to overview]Interface Haze
NCT02373137 (13) [back to overview]Graft Thickness
NCT02373137 (13) [back to overview]Graft Failure/Graft Rejection
NCT02373137 (13) [back to overview]Endothelial Cell Count
NCT02373137 (13) [back to overview]Interface Haze
NCT02401529 (10) [back to overview]Occurence of Postoperative Vomiting
NCT02401529 (10) [back to overview]Occurence of Post-operative Nausea
NCT02401529 (10) [back to overview]Maximum Severity of Post-operative Pain
NCT02401529 (10) [back to overview]Duration of Post-operative Pain
NCT02401529 (10) [back to overview]Duration of Post-operative Nausea
NCT02401529 (10) [back to overview]Average Frequency of Meals Per Day
NCT02401529 (10) [back to overview]Average Amount of Meal Per Day
NCT02401529 (10) [back to overview]Total Number of Post-operative Vomiting Episodes
NCT02401529 (10) [back to overview]Onset of Post-operative Nausea
NCT02401529 (10) [back to overview]Onset of 1st Post-operative Oral Intake
NCT02406209 (1) [back to overview]Anterior Chamber Cell Grade at Week 8
NCT02464657 (4) [back to overview]Relapse Free Survival
NCT02464657 (4) [back to overview]Event-Free Survival (EFS)
NCT02464657 (4) [back to overview]Maximum Tolerated Dose (MTD) of Nivolumab
NCT02464657 (4) [back to overview]Overall Survival
NCT02512575 (9) [back to overview]Safety and Tolerability of AZD9567 by Assessing the Number of Participants With Adverse Events
NCT02512575 (9) [back to overview]Secondary Outcome: Relative Change From Baseline of AUC0-4h for Plasma Glucose to Assess the Effects on Glucose Homeostasis (Oral Glucose Tolerance Test [OGTT])
NCT02512575 (9) [back to overview]Relative Change From Baseline of AUC0-4h for Serum Insulin to Assess the Effects on Glucose Homeostasis (Oral Glucose Tolerance Test [OGTT])
NCT02512575 (9) [back to overview]Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Area Under the Plasma Concentration-curve From Time Zero Extrapolated to Infinity (AUC)
NCT02512575 (9) [back to overview]Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Area Under the Plasma Concentration-curve From Time Zero to the Time of Last Quantifiable Analyte Concentration (AUC(0-last))
NCT02512575 (9) [back to overview]Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Observed Maximum Plasma Concentration (Cmax)
NCT02512575 (9) [back to overview]Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Terminal Half-life (t½λz)
NCT02512575 (9) [back to overview]Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Time to Reach Maximum Plasma Concentration(Tmax)
NCT02512575 (9) [back to overview]Relative Change From Baseline of AUC0-4h for Serum C-peptide to Assess the Effects on Glucose Homeostasis (Oral Glucose Tolerance Test [OGTT])
NCT02515045 (3) [back to overview]Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)
NCT02515045 (3) [back to overview]Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)
NCT02515045 (3) [back to overview]Change From Baseline (Preoperative Exam) in Macular Thickness
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]Percentage of Participants Achieving >= 50% Reduction in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control
NCT02528214 (14) [back to overview]Annualized Rate of Severe Exacerbation Events During The 24-Week Treatment Period
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 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]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 Asthma Control Questionnaire 5-Question Version (ACQ-5) Score at Weeks 2, 4, 8, 12, 16, 20, and 24
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]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]Change From Baseline in Sino Nasal Outcome Test-22 (SNOT-22) Global Score at Week 12 and Week 24
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]Percentage of Participants Who No Longer Required Oral Corticosteroids Dose 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 Achieving a Reduction in Oral Corticosteroids Dose to <5 mg/Day at Week 24 While Maintaining Asthma Control
NCT02539394 (19) [back to overview]Adverse Event
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Burden)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Communication)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Eating Desire)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Eating Duration)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Fatigue)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Food Selection)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Mental)
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Social)
NCT02539394 (19) [back to overview]Patient Reported Swallowing Difficulty Over 1 Year
NCT02539394 (19) [back to overview]Patients' Neck Disability
NCT02539394 (19) [back to overview]Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain
NCT02539394 (19) [back to overview]Fusion Rate
NCT02539394 (19) [back to overview]Patients' Bazaz Dysphagia Score - Solid
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Fear Swallow)
NCT02539394 (19) [back to overview]Patients' Pain Scores on the Visual Analog Scale - Neck Pain
NCT02539394 (19) [back to overview]Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain
NCT02539394 (19) [back to overview]Degree of Dysphagia Patients Experience (Sleep)
NCT02539394 (19) [back to overview]Patients' Bazaz Dysphagia Score - Liquid
NCT02547623 (13) [back to overview]Dilated Opthalmoscopy Findings - Choroid (Study Eye)
NCT02547623 (13) [back to overview]Visual Acuity in Study Eye
NCT02547623 (13) [back to overview]Summary of Concomitant Medications Used in the Study Eye or Both Eyes
NCT02547623 (13) [back to overview]Intraocular Pressure Measurement
NCT02547623 (13) [back to overview]Changes in the Corneal Endothelial Cell Count
NCT02547623 (13) [back to overview]Slit Lamp Biomicroscopy - Cornea Edema Grade
NCT02547623 (13) [back to overview]Optic Disc Cup-disc Ratio for the Study Eye
NCT02547623 (13) [back to overview]Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
NCT02547623 (13) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
NCT02547623 (13) [back to overview]Dilated Opthalmoscopy Findings - Vitreous (Study Eye)
NCT02547623 (13) [back to overview]Dilated Opthalmoscopy Findings - Retina (Study Eye)
NCT02547623 (13) [back to overview]Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)
NCT02547623 (13) [back to overview]Dilated Opthalmoscopy Findings - Macula (Study Eye)
NCT02569437 (5) [back to overview]Visual Analog Scale
NCT02569437 (5) [back to overview]Middle Meatus Culture
NCT02569437 (5) [back to overview]Sino-nasal Outcome Test (SNOT 22)
NCT02569437 (5) [back to overview]Endoscopic Nasal Polyp Score
NCT02569437 (5) [back to overview]Subjective Symptom Composite Scoring
NCT02576249 (3) [back to overview]Tegner Activity Level Scale
NCT02576249 (3) [back to overview]The Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale
NCT02576249 (3) [back to overview]Pain Scale Score
NCT02585258 (3) [back to overview]Joint Damage Progression
NCT02585258 (3) [back to overview]Signs and Symptoms: Mean DAS28 Post Baseline
NCT02585258 (3) [back to overview]The Total Number of Patients Experiencing at Least One Adverse Event (AE) of Special Interest (AESI)
NCT02587117 (2) [back to overview]Burning Sensation or Pain by Using NRS (Numerical Rating Scale)
NCT02587117 (2) [back to overview]Change in Severity of Lesions(Degree of Reticular, Erythematous and Ulceration) by Using Piboonniyom REU Severity Score
NCT02613910 (11) [back to overview]Number of Participants With Post-injection Systemic Reactions
NCT02613910 (11) [back to overview]Number of Participants With Severe Adverse Events
NCT02613910 (11) [back to overview]Number of Participants With Vital Signs of Clinical Concern
NCT02613910 (11) [back to overview]Number of Participants Withdrawn Due to Treatment-related AEs
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 Injection Site Reactions
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 Related to Ofatumumab SC
NCT02613910 (11) [back to overview]Number of Participants With Clinically-significant Electrocardiogram (ECG) Abnormalities
NCT02613910 (11) [back to overview]Number of Participants With Infections
NCT02613910 (11) [back to overview]Number of Participants With Laboratory Results of Potential Clinical Concern
NCT02652390 (6) [back to overview]11-item Disabilities of the Arm, Shoulder and Hand (DASH) Score
NCT02652390 (6) [back to overview]Bodily Pain Score
NCT02652390 (6) [back to overview]Palmar Pain Score
NCT02652390 (6) [back to overview]Satisfaction Score
NCT02652390 (6) [back to overview]Symptom Severity Score
NCT02652390 (6) [back to overview]Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand
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 17-OHP
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
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]Changes Relative to Standard Glucocorticoid Therapy in Body Composition (DEXA - Fat Mass and Lean Mass)
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
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]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]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 % Predicted FEV1 AUC 0-4 Hours on Day 1 and Week 12 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]Area Under the Plasma Concentration-Time Curve of Mometasone Furoate From Time 0 to 12 Hours (AUC0-12)
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]Maximum Plasma Concentration (Cmax) of Mometsone Furoate
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]Time to Maximum Plasma Concentration (Tmax) of Mometsone Furoate
NCT02741271 (13) [back to overview]Participants Using SABA Rescue Medication Across Weeks 1-12 of the Treatment Period
NCT02790788 (22) [back to overview]Steroid-associated Complications.
NCT02790788 (22) [back to overview]Left and Right Ventricular Ejection Fraction (%) by Echocardiography.
NCT02790788 (22) [back to overview]Left and Right Ventricular Diastolic Area (cm^2) by Echocardiography.
NCT02790788 (22) [back to overview]Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.
NCT02790788 (22) [back to overview]Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring (as Feasible).
NCT02790788 (22) [back to overview]Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring (as Feasible).
NCT02790788 (22) [back to overview]Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.
NCT02790788 (22) [back to overview]Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL).
NCT02790788 (22) [back to overview]Core Body Temperature in Degrees Celcius.
NCT02790788 (22) [back to overview]Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.
NCT02790788 (22) [back to overview]Survival to Hospital Discharge With Favorable Functional Outcome.
NCT02790788 (22) [back to overview]Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.
NCT02790788 (22) [back to overview]Cerebral Blood Flow Index by Near Infrared Spectroscopy With Indocyanine Green.
NCT02790788 (22) [back to overview]Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.
NCT02790788 (22) [back to overview]Organ Failure-free Days.
NCT02790788 (22) [back to overview]Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.
NCT02790788 (22) [back to overview]Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.
NCT02790788 (22) [back to overview]Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port (as Feasible).
NCT02790788 (22) [back to overview]Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.
NCT02790788 (22) [back to overview]Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.
NCT02790788 (22) [back to overview]Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.
NCT02790788 (22) [back to overview]Eccentricity Index by Echocardiography.
NCT02798523 (1) [back to overview]Number of Participants Sampled for RNA-seq Differential Expression Analysis (Biological Replicates)
NCT02828358 (5) [back to overview]Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of First Course of Azacitidine
NCT02828358 (5) [back to overview]Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to Second Course of Azacitidine
NCT02828358 (5) [back to overview]Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to First Course of Azacitidine
NCT02828358 (5) [back to overview]Tolerability of Azacitidine in Combination With Interfant-06 Standard Chemotherapy in Evaluable Infant Patients With Newly Diagnosed ALL With KMT2A Gene Rearrangement (KMT2A-R). KMT2A Gene Rearrangement (KMT2A-R)
NCT02828358 (5) [back to overview]Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of Second Course of Azacitidine
NCT02836496 (5) [back to overview]Time to First HES Flare
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]Number of HES Flares Per Participant Per Year
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
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
NCT02847494 (3) [back to overview]Headache Days as Self-reported by Participants
NCT02847494 (3) [back to overview]Number of Participants With Sustained Headache Freedom
NCT02847494 (3) [back to overview]Medication Preference as Assessed by Self-report
NCT02854631 (27) [back to overview]Change From Baseline in Prognostic Index: Model for End-Stage Liver Disease (MELD) Score
NCT02854631 (27) [back to overview]Change From Baseline in Prognostic Index: Maddrey Discriminant Function (DF) Score
NCT02854631 (27) [back to overview]Lille Score at Day 7 as a Continuous Variable
NCT02854631 (27) [back to overview]Percentage of Participants Who Died by Week 24
NCT02854631 (27) [back to overview]Change From Baseline in Prognostic Index: Child-Pugh-Turcotte (CPT) Score
NCT02854631 (27) [back to overview]Change From Baseline in Liver Biochemistry Tests: Gamma Glutamyl Transferase (GGT)
NCT02854631 (27) [back to overview]Percentage of Participants With Lille Response (Score < 0.45) at Day 7
NCT02854631 (27) [back to overview]Percentage of Participants With Infection
NCT02854631 (27) [back to overview]Percentage of Participants With Hepatorenal Syndrome (HRS)
NCT02854631 (27) [back to overview]Percentage of Participants With a Lille Null Response (Score ≥ 0.56) at Day 7
NCT02854631 (27) [back to overview]Change From Baseline in Liver Biochemistry Tests: Aspartate Aminotransferase (AST)
NCT02854631 (27) [back to overview]Percentage of Participants Who Died by Week 8
NCT02854631 (27) [back to overview]Percentage of Participants With Survival at Week 12 Using Kaplan-Meier
NCT02854631 (27) [back to overview]Percentage of Participants With Survival at Week 24 Using Kaplan-Meier
NCT02854631 (27) [back to overview]Percentage of Participants With Survival at Week 8 Using Kaplan-Meier
NCT02854631 (27) [back to overview]Change From Baseline in Liver Biochemistry Tests: Alanine Aminotransferase (ALT)
NCT02854631 (27) [back to overview]Change From Baseline in Liver Biochemistry Tests: Albumin
NCT02854631 (27) [back to overview]Change From Baseline in Liver Biochemistry Tests: Alkaline Phosphatase
NCT02854631 (27) [back to overview]Change From Baseline in Liver Biochemistry Tests: International Normalized Ratio (INR)
NCT02854631 (27) [back to overview]Change From Baseline in Liver Biochemistry Tests: Bilirubin
NCT02854631 (27) [back to overview]Percentage of Participants Who Died by Week 12
NCT02854631 (27) [back to overview]Percentage of Participants Who Died by Day 28
NCT02854631 (27) [back to overview]Percentage of Participants With Survival at Day 28 Using Kaplan-Meier
NCT02854631 (27) [back to overview]Percentage of Participants With Treatment-Emergent (TE) Adverse Events (AE), Serious AEs (SAE), AEs Leading to Premature Study Drug Discontinuation, and Grade 3 or 4 Laboratory Abnormalities
NCT02854631 (27) [back to overview]Percentage of Participants With Estimated Mortality at Month 2 and Month 6: Combined Scoring Including Lille Score at Day 7 and Baseline Model for End-Stage Liver Disease (MELD) Score
NCT02854631 (27) [back to overview]Percentage of Participants Who Received a Liver Transplant
NCT02854631 (27) [back to overview]Length of Hospital Stay
NCT02930343 (4) [back to overview]Disease Activity as Per Ultrasound-7 (US-7) Score
NCT02930343 (4) [back to overview]Number of Participants With Adverse Drug Reactions
NCT02930343 (4) [back to overview]Number of Patients Achieving Good EULAR Response at the End of 12 Weeks
NCT02930343 (4) [back to overview]Indian Health Assessment Questionnaire (iHAQ)
NCT02935738 (1) [back to overview]Number of Control and Treated Participants With Successful Live Births Following Conventional IVF or ICSI Cycles
NCT02953678 (10) [back to overview]Failure-free Survival (FFS)
NCT02953678 (10) [back to overview]Number of Participants With Treatment-emergent Adverse Events (TEAES), Serious TEAEs, And Grade 3 or Higher TEAEs
NCT02953678 (10) [back to overview]Overall Survival (OS)
NCT02953678 (10) [back to overview]Overall Response Rate (ORR)
NCT02953678 (10) [back to overview]Overall Response Rate (ORR) at Day 28
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]Relapse Rate
NCT02953678 (10) [back to overview]Relapse-related Mortality Rate
NCT02953678 (10) [back to overview]Nonrelapse Mortality (NRM)
NCT02956122 (22) [back to overview]Transplant-related Mortality
NCT02956122 (22) [back to overview]Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180
NCT02956122 (22) [back to overview]Graft-versus-host Disease (GvHD)-Free Survival - Percentage of Participants With an Event
NCT02956122 (22) [back to overview]"Area Under the Plasma Concentration Curve From Time Zero to Time t AUC(0-t) of GLASSIA"
NCT02956122 (22) [back to overview]Apparent Terminal Half-life (t1/2) of GLASSIA
NCT02956122 (22) [back to overview]Apparent Volume of Distribution at Steady State (Vss) of GLASSIA
NCT02956122 (22) [back to overview]Area Under the Plasma Concentration Curve (AUC0-inf) From Time Zero to Infinity
NCT02956122 (22) [back to overview]Maximum Observed Plasma Concentration (Cmax) of GLASSIA
NCT02956122 (22) [back to overview]Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
NCT02956122 (22) [back to overview]Number of Participants With Clinically Significant Changes in Vital Signs
NCT02956122 (22) [back to overview]Number of Participants With Recurrence of Primary Malignancies
NCT02956122 (22) [back to overview]Percentage of Participants Achieving Gastrointestinal (GI) Response at Day 28
NCT02956122 (22) [back to overview]Percentage of Participants Achieving Overall Response (OR) At Day 28
NCT02956122 (22) [back to overview]Percentage of Participants Achieving Overall Response at Day 56
NCT02956122 (22) [back to overview]Systemic Clearance at Steady State (CLss) of GLASSIA
NCT02956122 (22) [back to overview]All-cause Mortality - Percentage of Participants With an Event
NCT02956122 (22) [back to overview]Failure-free Survival - Percentage of Participants With an Event
NCT02956122 (22) [back to overview]Graft-versus-host Disease (GvHD)-Related Mortality - Percentage of Participants With an Event
NCT02956122 (22) [back to overview]Incidence of Chronic Graft-versus-host Disease (GvHD)
NCT02956122 (22) [back to overview]Infection-related Mortality - Percentage of Participants With an Event
NCT02956122 (22) [back to overview]Number of Participants With Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs and Temporally-associated AEs
NCT02956122 (22) [back to overview]Overall Survival (OS) - Percentage of Participants With an Event
NCT02962284 (6) [back to overview]Testosterone Levels
NCT02962284 (6) [back to overview]Percentage of Subjects With Prostate Specific Antigen - 50 Response
NCT02962284 (6) [back to overview]Proportion of Subjects With Disease Progression
NCT02962284 (6) [back to overview]Prostate Specific Antigen Levels
NCT02962284 (6) [back to overview]Number of Subjects With Adverse Events
NCT02962284 (6) [back to overview]Testosterone Complete Suppression
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]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 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 Clinical Response in the Biomarker Subpopulation for Immunohistochemistry (IHC) CD8 T-Cell Density
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 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]Participants With Treatment Emergent Adverse Events (TEAE)
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
NCT03072238 (4) [back to overview]Investigator-Assessed Radiographic Progression-Free Survival (rPFS) Per PCWG3 Criteria (Intent-To-Treat (ITT) Population)
NCT03123614 (4) [back to overview]Number of Eyes With Corneal Haze
NCT03123614 (4) [back to overview]Best Corrected Visual Acuity at 3 Months
NCT03123614 (4) [back to overview]Change in Intraocular Pressure (IOP) From Baseline Through Month 3
NCT03123614 (4) [back to overview]Uncorrected Visual Acuity
NCT03139604 (20) [back to overview]CL/F of Itacitinib When Administered in Combination With Corticosteroids
NCT03139604 (20) [back to overview]Nonrelapse Mortality
NCT03139604 (20) [back to overview]AUC of Itacitinib When Administered in Combination With Corticosteroids
NCT03139604 (20) [back to overview]Objective Response Rate
NCT03139604 (20) [back to overview]Cmax of Itacitinib When Administered in Combination With Corticosteroids
NCT03139604 (20) [back to overview]Cmin of Itacitinib When Administered in Combination With Corticosteroids
NCT03139604 (20) [back to overview]Duration of Response
NCT03139604 (20) [back to overview]Failure-free Survival
NCT03139604 (20) [back to overview]Proportion of Subjects Who Discontinue Corticosteroids
NCT03139604 (20) [back to overview]Incidence Rate of Secondary Graft Failure
NCT03139604 (20) [back to overview]Time to Response
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]Incidence Rate of aGVHD Flares
NCT03139604 (20) [back to overview]Malignancy Relapse-related Mortality Rate
NCT03139604 (20) [back to overview]Incidence Rate of cGVHD
NCT03139604 (20) [back to overview]Proportion of Subjects Who Discontinue Immunosuppressive Medications
NCT03139604 (20) [back to overview]Tmax of Itacitinib When Administered in Combination With Corticosteroids
NCT03139604 (20) [back to overview]Number of Treatment-emergent Adverse Events With INCB39110
NCT03172325 (5) [back to overview]Health Assessment Questionnaire (HAQ) Disability Index at Week 24.
NCT03172325 (5) [back to overview]The Incidence of Adverse Events
NCT03172325 (5) [back to overview]Percentage of Patients Achieving ACR20, ACR50 and ACR70 Response Rates at Week 24
NCT03172325 (5) [back to overview]Percentage of Patients With DAS28-EULAR Good and Moderate Responses at Week 24
NCT03172325 (5) [back to overview]Immunogenicity: Number of Participants With Anti-Drug Antibodies (ADA)
NCT03229538 (7) [back to overview]Number of Participants With Any Other Post-operative Complications From the Start of Study Drug Administration Until Hospital Discharge.
NCT03229538 (7) [back to overview]Number of Participants With Death or Major Complication as Defined by an Outcome in One of the 7 Highest Global Ranking Categories
NCT03229538 (7) [back to overview]Number of Participants With Mortality, Including In-hospital Mortality or Mortality After Hospital Discharge But Within 30 Days of the Last Dose of Study Drug
NCT03229538 (7) [back to overview]Number of Participants With Occurrence of Any One or More of the Following STS-CHSD-defined Major Post-operative Infectious Complications: Postprocedural Infective Endocarditis, Pneumonia, Sepsis, Deep Wound Infection, Mediastinitis.
NCT03229538 (7) [back to overview]Number of Participants With Post-operative Low Cardiac Output Syndrome
NCT03229538 (7) [back to overview]Number of Participants With a Post-operative Length of Stay Greater Than 90 Days
NCT03229538 (7) [back to overview]Number of Participants With Prolonged Mechanical Ventilation (Greater Than 7 Days)
NCT03320434 (4) [back to overview]Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15
NCT03320434 (4) [back to overview]Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1
NCT03320434 (4) [back to overview]Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15
NCT03320434 (4) [back to overview]Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1
NCT03368235 (16) [back to overview]Last Plasma Concentration Measured Before the Last Dose (Ctrough) of AZD9567
NCT03368235 (16) [back to overview]LS Mean Change From Baseline in CRP at Day 15
NCT03368235 (16) [back to overview]Area Under the Plasma Concentration-Time Curve Until the Last Quantifiable Concentration (AUClast) of AZD9567
NCT03368235 (16) [back to overview]Area Under the Concentration-Time Curve From Time Zero to 6 Hours After Dose (AUC0-6) of AZD9567
NCT03368235 (16) [back to overview]Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Responses
NCT03368235 (16) [back to overview]LS Mean Change From Baseline in GH Score at Day 15
NCT03368235 (16) [back to overview]Time to Reach Maximum Plasma Concentration (Tmax) of AZD9567
NCT03368235 (16) [back to overview]LS Mean Change From Baseline in Participant's Assessment of Pain Score at Day 15
NCT03368235 (16) [back to overview]LS Mean Change From Baseline in Participant's Assessment of Physical Function Score at Day 15
NCT03368235 (16) [back to overview]LS Mean Change From Baseline in SJC28 Score at Day 15
NCT03368235 (16) [back to overview]LS Mean Change From Baseline in SJC66 Score at Day 15
NCT03368235 (16) [back to overview]LS Mean Change From Baseline in TJC28 Score at Day 15
NCT03368235 (16) [back to overview]LS Mean Change From Baseline in TJC68 Score at Day 15
NCT03368235 (16) [back to overview]Maximum Observed Plasma Concentration (Cmax) of AZD9567
NCT03368235 (16) [back to overview]Least Square (LS) Mean Change From Baseline in 28 Joint Disease Activity Score Using C-Reactive Protein (DAS28-CRP) at Day 15
NCT03368235 (16) [back to overview]LS Mean Change From Baseline in Physician's Global Assessment of Disease Activity Score at Day 15
NCT03368664 (3) [back to overview]Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan
NCT03368664 (3) [back to overview]Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Participants With New or Enlarged T2 Lesions Per MRI Scan
NCT03368664 (3) [back to overview]Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Months 4 and 8
NCT03387046 (16) [back to overview]Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
NCT03387046 (16) [back to overview]Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
NCT03387046 (16) [back to overview]Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
NCT03387046 (16) [back to overview]Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
NCT03387046 (16) [back to overview]9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 8
NCT03387046 (16) [back to overview]Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
NCT03387046 (16) [back to overview]Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03387046 (16) [back to overview]Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 12 and 24
NCT03387046 (16) [back to overview]Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
NCT03387046 (16) [back to overview]Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
NCT03403517 (5) [back to overview]PACU Stay
NCT03403517 (5) [back to overview]Mortality
NCT03403517 (5) [back to overview]Hospital Stay
NCT03403517 (5) [back to overview]Complications, Post-anesthesia Care Unit (PACU)
NCT03403517 (5) [back to overview]Total Complication Rate
NCT03578276 (3) [back to overview]Change From Baseline (Preoperative Exam) in Macular Thickness
NCT03578276 (3) [back to overview]Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)
NCT03578276 (3) [back to overview]Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)
NCT03593902 (2) [back to overview]Survival of Treatment
NCT03593902 (2) [back to overview]Change in Skin Score by mRSS
NCT03704584 (3) [back to overview]Number of Patients With Subsequent Reinjection and Surgical Operation
NCT03704584 (3) [back to overview]10 Point Likert Scale of Pain Scores Before the Injection and After the Injection and During Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
NCT03704584 (3) [back to overview]Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7
NCT03765788 (13) [back to overview]Change From Baseline in FACIT-Fatigue Scale
NCT03765788 (13) [back to overview]Percentage of Participants in Remission at Week 12
NCT03765788 (13) [back to overview]Percentage of Participants in Sustained Remission Until Week 28
NCT03765788 (13) [back to overview]Percentage of Participants With GCA Who Had Sustained Remission Until Week 52
NCT03765788 (13) [back to overview]Time to First GCA Flare After Clinical Remission
NCT03765788 (13) [back to overview]Change From Baseline in C-Reactive Protein (CRP) Level
NCT03765788 (13) [back to overview]Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire
NCT03765788 (13) [back to overview]Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
NCT03765788 (13) [back to overview]Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS)
NCT03765788 (13) [back to overview]Change From Baseline in Short-Form (SF)-36 Questionnaire
NCT03765788 (13) [back to overview]Total Cumulative Prednisolone Dose Over 28 Weeks and 52 Weeks
NCT03765788 (13) [back to overview]Number of Participants on Prednisolone Dose ≤ 5mg/Day
NCT03765788 (13) [back to overview]Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS)
NCT03777319 (3) [back to overview]Safety Will be Monitored Through Regular Review of Electrolytes.
NCT03777319 (3) [back to overview]Efficacy: Change in Time to Complete a 100 Meter Timed Test.
NCT03777319 (3) [back to overview]Efficacy: Dynamometry Score
NCT03797872 (1) [back to overview]Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study
NCT03817853 (8) [back to overview]Time to IRR From Infusion to Onset of the IRR During Cycle 2
NCT03817853 (8) [back to overview]Type of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle
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]Objective Response Rate (ORR) at the End of Induction (EOI) Therapy
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]Percentage of Participants With Adverse Events (AEs)
NCT03817853 (8) [back to overview]Duration (In Minutes) of Obinutuzumab Administration by Cycle
NCT03834519 (2) [back to overview]Radiographic Progression-Free Survival (rPFS)
NCT03834519 (2) [back to overview]Overall Survival (OS)
NCT03852537 (14) [back to overview]ICU Admission
NCT03852537 (14) [back to overview]Cardiovascular Dysfunction
NCT03852537 (14) [back to overview]Need for Noninvasive Mechanical Ventilation
NCT03852537 (14) [back to overview]Organ Failure
NCT03852537 (14) [back to overview]Timely Initiation of Corticosteroids and Implementation of Biomarker-titrated Corticosteroid Dosing
NCT03852537 (14) [back to overview]Oxygen-free Days
NCT03852537 (14) [back to overview]Occurrence of Secondary Infection
NCT03852537 (14) [back to overview]Occurrence of Hyperglycemia
NCT03852537 (14) [back to overview]Occurrence of Delirium
NCT03852537 (14) [back to overview]New Onset Cardiac Arrhythmias
NCT03852537 (14) [back to overview]Need for Invasive Mechanical Ventilation
NCT03852537 (14) [back to overview]Need for High Flow Nasal Cannula Oxygen
NCT03852537 (14) [back to overview]Myocardial Injury
NCT03852537 (14) [back to overview]Mortality
NCT04046549 (7) [back to overview]Percentage of Participants With Biopsy Proven Acute Rejection (BPAR)
NCT04046549 (7) [back to overview]Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR)
NCT04046549 (7) [back to overview]Percentage of Participants With Treated Acute Rejections
NCT04046549 (7) [back to overview]Percentage of Participants With Antibody-Mediated Rejection
NCT04046549 (7) [back to overview]Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Week 24
NCT04046549 (7) [back to overview]Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Weeks 12 and 48
NCT04046549 (7) [back to overview]Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR), Graft Loss, Death or Loss to Follow-up (LTFU)
NCT04054375 (15) [back to overview]Fasting Lipid Profile
NCT04054375 (15) [back to overview]Functional Assessments - NSAD Change
NCT04054375 (15) [back to overview]6 Minute Walk Test
NCT04054375 (15) [back to overview]HbgA1c
NCT04054375 (15) [back to overview]Lean Mass %
NCT04054375 (15) [back to overview]Muscle Strength Test
NCT04054375 (15) [back to overview]Respiratory Changes
NCT04054375 (15) [back to overview]Vignos Scale Score
NCT04054375 (15) [back to overview]Bone Density
NCT04054375 (15) [back to overview]10 Meter Run Timed
NCT04054375 (15) [back to overview]Muscle Imaging
NCT04054375 (15) [back to overview]Functional Assessments - Upper Limb Strength
NCT04054375 (15) [back to overview]Brooke Scale Score
NCT04054375 (15) [back to overview]Creatine Kinase
NCT04054375 (15) [back to overview]Fasting Glucose
NCT04184999 (1) [back to overview]Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively
NCT04233164 (1) [back to overview]Number of SLE Patients That Were Sampled for RNA-seq Differential Expression Analysis (Biological Replicates)
NCT04323592 (6) [back to overview]Admission to Intensive Care Unit (ICU)
NCT04323592 (6) [back to overview]In-hospital Death Within 28 Days
NCT04323592 (6) [back to overview]Endotracheal Intubation (Invasive Mechanical Ventilation)
NCT04323592 (6) [back to overview]Change in C-reactive Protein (CRP)
NCT04323592 (6) [back to overview]Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation (MV), or All-cause Death by Day 28
NCT04323592 (6) [back to overview]Number of Days Free From Mechanical Ventilation
NCT04380857 (5) [back to overview]Patient Preference Between Groups
NCT04380857 (5) [back to overview]Mean Change in Pain
NCT04380857 (5) [back to overview]Loss of Lines in Uncorrected Visual Acuity
NCT04380857 (5) [back to overview]Post op Pain Management Per Eye
NCT04380857 (5) [back to overview]Number of Lines Lost From Best Corrected Visual Acuity
NCT04396990 (4) [back to overview]Spectacle Corrected Distance Visual Acuity at Months 1 and 3 Post-operative
NCT04396990 (4) [back to overview]Mean Pain Score Per Eye (Group A: Dextenza vs. Group B: Topical Steroid)
NCT04396990 (4) [back to overview]Uncorrected Distance Visual Acuity
NCT04396990 (4) [back to overview]SPEED Questionnaire Results at Baseline and Postoperative Day 28
NCT04900220 (2) [back to overview]Incidence of Pain
NCT04900220 (2) [back to overview]Intensity of Pain
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Post Treatment Pain Scores
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Post Treatment Pain Scores (6 Weeks)
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Post Treatment Pain Scores
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures:(Immediate) Post Treatment Pain Scores
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee Prior to Treatment
NCT05113901 (18) [back to overview]Number of Participants With Complications Following Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee Prior to Treatment
NCT05113901 (18) [back to overview]Range of Motion in Degrees at Pre and Post Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Pre Treatment Pain Scores Using Knee Society Scores
NCT05113901 (18) [back to overview]Adverse Events or Outcomes Outside of Manipulations Under Anesthesia
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee 6 Wks After Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee After Surgery and Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee After Surgery and Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee Before Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee Before Treatment
NCT05113901 (18) [back to overview]Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment

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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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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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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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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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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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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2-year Overall Survival Rate

The overall survival rate is the percentage of patients who are alive 2 years after registration to the study. Overall survival is defined as the time between study registration and death due to any cause. (NCT00109928)
Timeframe: 0-2 years

Interventionpercentage of participants (Number)
PEGS31

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2-year Progression-free Survival Rate

Progression-free survival rate is the percentage of patients who do not show signs of progression at 2 years after registration to the study, including those whose disease has either completely or partially responded to treatment, or those whose disease is stable. Progression-free survival is defined as the time between study registration and documented progression, or death if no progression was observed. (NCT00109928)
Timeframe: 0-2 years

Interventionpercentage of participants (Number)
PEGS12

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Response Rate

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. (NCT00109928)
Timeframe: up to 3 years or time of disease progression

Interventionparticipants (Number)
Complete ResponseUnconfirmed Complete ResponsePartial ResponseNo Response
PEGS62520

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Duration of Hospital Stay in Days

Days (NCT00128180)
Timeframe: 6 months

Interventiondays (Mean)
Active8.90
Placebo10.67

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Development of Serum Creatinine Greater Than or Equal to 3.0 mg/dL After Study Entry

(NCT00128180)
Timeframe: 6 months

Interventionparticipants (Number)
Active1
Placebo6

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Duration of ICU Stays

(NCT00128180)
Timeframe: 6 months

Interventiondays (Mean)
Active4.48
Placebo5.83

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Length of Time on a Ventilator

(NCT00128180)
Timeframe: 6 months

Interventiondays (Mean)
Active2.64
Placebo4.95

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Duration of Shock and/or Pressor/Inotropic Support

Pressor/inotropic support refers to the use of adrenaline-like medications to maintain blood pressure and cardiac output. (NCT00128180)
Timeframe: 6 months

Interventiondays (Mean)
Active2.67
Placebo3.75

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Number of Participants Intubated and Placed on a Ventilator After Study Entry.

Participants (NCT00128180)
Timeframe: 6 months

Interventionparticipants (Number)
Active6
Placebo10

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Number of Participants on Extracorporeal Membrane Oxygenation (ECMO)

number of participants (NCT00128180)
Timeframe: 6 months

Interventionparticipants (Number)
Active0
Placebo0

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Number of Participants Who Developed Refractory Shock Despite Fluid Resuscitation After Study Entry

Refractory shock refers to shock that persists despite fluid resucitation. Fluid resusitation refers to administration of intravenous fluids to maintain blood pressure and cardiac output. (NCT00128180)
Timeframe: 6 months

Interventionparticipants (Number)
Active4
Placebo6

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Number of Participants With SAEs

The Number of participants with SAEs (NCT00128180)
Timeframe: 6 months

Interventionparticipants (Number)
Active14
Placebo25

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The Proportion of Subjects Who Develop Death, PaO2/FiO2 Ratio Less Than or Equal to 55, Cardiac Index Less Than or Equal to 2.2, Pulseless Electrical Activity, Ventricular Tachycardia or Fibrillation

(NCT00128180)
Timeframe: 28 days

Interventionproportion of paticipants (Number)
Active0.27
Placebo0.47

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Engraftment of Haploidentical CD34+ Selected Blood Stem Cells in Older Patients or Those With Medical Co-morbidities Following Total Lymphoid Irradiation and Antithymocyte Globulin Transplant Conditioning

number achieving donor cell engraftment (>95%) by day 90 after transplant. (NCT00185692)
Timeframe: 100 days

InterventionParticipants (Count of Participants)
Transplantation of CD34+ Cells4

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Acute Graft-versus-Host Disease (GVHD) Grade 2-4 Risk From Time of Transplant Until Day 90 Post-transplant

GVHD grading system goes from 0-4 where grade 4 is the most severe. Grade 0 and 1 do not require systemic treatment, Grade 2-4 require treatment. This trial evaluated the risk of developing acute GVHD grades 2-4 within 90 days of transplant. (NCT00185692)
Timeframe: 90 days

InterventionParticipants (Count of Participants)
Transplantation of CD34+ Cells1

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Chronic Graft-vs-Host Disease (cGvHD)

The cumulative percentage of participants who develop chronic graft-vs-host disease (cGvHD). Chronic cGvHD was defined as at least one instance of a clinically-accepted marker for cGvHD (see Filipovich, et al. Biology of Blood and Marrow Transplantation. 2005;11:945-955) (NCT00186628)
Timeframe: 4 years

Interventionpercentage of participants (Number)
Prophylactic Rituximab20

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Incidence of Relapse

Subjects who Relapsed following after Allogeneic HSCT (NCT00186628)
Timeframe: 4 years

InterventionParticipants (Count of Participants)
Prophylactic Rituximab18

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Overall Survival

(NCT00186628)
Timeframe: 4 years

InterventionPercentage of participants by disease (Number)
Prophylactic Rituximab (CLL Patients)73
Prophylactic Rituximab (MCL Patients)69

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Mortality

Number of participants who died within 100 days and within 1 year, non-relapse and associated with relapse. (NCT00186628)
Timeframe: Day 100 and 1 year

InterventionParticipants (Number)
Mortality within 100 days, all causesNonrelapse mortality within 1 yearRelapse + mortality within 1 year
Prophylactic Rituximab012

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6-month Progression-free Survival

"Scan at 6 months~Complete response: Complete disappearance of all tumor on MRI scan, off all glucocorticoids with stable or improving neurological exam minimum of 4 wks~Partial response: Greater than or equal 50% reduction in tumor size on MRI, on sable or decreasing glucocorticoids with stable or improving neurological exam for a minimum of 4 wks.~Progressive disease: Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion.~Stable disease: Clinical status and MRI does not qualify for complete response, partial response or progression" (NCT00248534)
Timeframe: 6 months

Interventionpercentage of participants (Number)
IV Rituximab13

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1 Year Overall Survival Rate

(NCT00248534)
Timeframe: 1 year

Interventionpercentage of participants (Number)
IV Rituximab71

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Number of Participants Alive at 3 Years

The intent was to measure Median Overall Survival at 3 years, however only one participant was analyzable at this time point. Therefore, the number of participants who survived is reported instead. (NCT00248534)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
IV Rituximab1

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Percentage of Participants With Objective Response

Objective response rate of the combination of Rituximab and TMZ (NCT00248534)
Timeframe: 2 months

Interventionpercent of participants (Number)
IV Rituximab14

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Time Measured From the Administration of the Loading Dose of Prednisolone (2mg/kg up to Max 60mg) in the Emergency Department (ED) Until the Home Dose of Albuterol is Administered

(NCT00257933)
Timeframe: Median time from loading dose to home dose of albuterol

InterventionHours (Median)
High Dose Prednisolone35
Lower Dose Prednisolone33

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Survival

Survival (NCT00278564)
Timeframe: up to 5 years

InterventionParticipants (Count of Participants)
Hematopoietic Stem Cell Transplantation7

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Numerical Rating Scale (0-10), an Interval Pain Scale, on Which 0 Indicates no Pain and 10 Indicates the Worst Pain Imaginable

Improvement in Numerical Rating Scale between the time of the emergency department visit and the one month telephone call is rated on an 11-point scale ranging from 0-10 with 0 indicating no pain and 10 indicating worse pain imaginable. (NCT00290589)
Timeframe: 1 month

Interventionunits on a scale (Mean)
Intramuscular Methylprednisolone Acetate7.1
Placebo5.8

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Functional Disability Scales

The low back pain functional disability scale is the Roland Morris Disability questionnaire score (RMDQ). The RMDQ is a 24-item low back pain functional scale recommended for use in low back pain research.Higher scores signify greater low back-related functional impairment.0= no functional impairment, 24= severe functional impairment. (NCT00290589)
Timeframe: 1 month

Interventionunits on a scale (Median)
Intramuscular Methylprednisolone Acetate0
Placebo0

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Number of Patients Using Analgesics

Use of analgesics for low back pain (within the previous 24 hours) (NCT00290589)
Timeframe: Assessed at 1 month

InterventionParticipants (Count of Participants)
Intramuscular Methylprednisolone Acetate8
Placebo17

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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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Plasma Exchange Use

(NCT00294658)
Timeframe: baseline to 3 years

Interventionparticipants (Number)
Thymectomy Plus Prednisone10
Prednisone Alone9

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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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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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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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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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Intravenous Immunoglobulin Use

(NCT00294658)
Timeframe: baseline to 3 years

Interventionparticipants (Number)
Thymectomy Plus Prednisone11
Prednisone Alone23

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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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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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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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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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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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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)

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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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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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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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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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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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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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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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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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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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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Weight Z-Score

weight for age Z-score (in subjects without ascites) over the course of the study (NCT00294684)
Timeframe: HPE until 24 months of age

InterventionZ-score (Mean)
Corticosteroids-0.8
Placebo-0.8

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Total Bilirubin Concentration at 24 Months of Age

(NCT00294684)
Timeframe: At 24 Months of Age

Interventionmg/dL (Mean)
Corticosteroids1.3
Placebo1.6

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The Percentage of Patients With Serum Total Bilirubin <1.5 mg/dL and With Native Liver at 6 Months After Portoenterostomy

(NCT00294684)
Timeframe: Measurements will be made at 6 months after portoenterostomy

Interventionpercentage of participants (Number)
Corticosteroids58.6
Placebo48.6

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Total Bilirubin Concentration at 12 Months

(NCT00294684)
Timeframe: 12 Months post HPE

Interventionmg/dL (Mean)
Corticosteroids1.7
Placebo3.7

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Survival With Native Liver at 24 Months of Age

(NCT00294684)
Timeframe: Measurements will be made at 24 months of age

Interventionpercentage of participants (Number)
Corticosteroids58.7
Placebo59.4

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Serum Total Bilirubin Concentration

(NCT00294684)
Timeframe: Measurements will be made at 3 months after portoenterostomy

Interventionmg/dL (Mean)
Corticosteroids3.5
Placebo5.1

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Presence of Ascites at 24 Months

(NCT00294684)
Timeframe: 24 Months

Interventionparticipants (Number)
Corticosteroids1
Placebo3

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Presence of Ascites at 12 Months

(NCT00294684)
Timeframe: 12 Months

Interventionparticipants (Number)
Corticosteroids5
Placebo3

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Height Z-Score

Height by Age Z-score over the course of the study (NCT00294684)
Timeframe: HPE to age 24 Months

InterventionZ-score (Mean)
Corticosteroids-0.7
Placebo-0.6

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Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28.

Response to therapy is defined as survival to Day 28 of study, PLUS complete discontinuation all supplemental oxygen support by Day 28 of study. Subjects must be able to remain off all supplemental oxygen support for > 72 consecutive hours. Subjects who discontinue supplemental oxygen within the last 72 hours of the observation period will be followed until they have completed 72 consecutive hours off oxygen or failed prior to assessing response. (NCT00309907)
Timeframe: At day 28

Interventionparticipants (Number)
With ResponseWithout Response
Etanercept and Corticosteroid Therapy208

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Plasma Cytokine IL6 Level

Estimated mean and standard error of IL6 level (NCT00309907)
Timeframe: From baseline to days 7 and 28

Interventionpg/ml (Mean)
BaselineDay 7Day 28
Etanercept and Corticosteroid Therapy205.228.823.1

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C-reactive Protein Levels

Estimated mean and standard deviation (NCT00309907)
Timeframe: From baseline to days 7, 14, 21, and 28

Interventionmg/dL (Mean)
BaselineDay 7 Non RespondersDay 7 RespondersDay 14 Non RespondersDay 14 RespondersDay 21 Non RespondersDay 21 RespondersDay 28 Non RespondersDay 28 Responders
Etanercept and Corticosteroid Therapy28.15.41.84.9110.71.619.65.3

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Toxicity of Etanercept Plus Corticosteroid Therapy Using the Common Terminology Criteria Version 4.0

Grade 3-5 organ toxicities attributable to etanercept. (NCT00309907)
Timeframe: Up to 56 days

InterventionPatients (Number)
Etanercept and Corticosteroid Therapy0

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Survival Rate

Estimated Day 56 survival rate following initiation of etanercept + corticosteroid therapy for patients with IPS. (NCT00309907)
Timeframe: Up to day 56

Interventionpercentage of participants (Number)
Etanercept and Corticosteroid Therapy75

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Estimate Percentage Pulmonary Response in Patients With IPS Treated With Etanercept + Corticosteroid Therapy

Pulmonary response is defined as alive & come off of oxygen . (NCT00309907)
Timeframe: up to day 56

Interventionpercentage of participants (Number)
Etanercept and Corticosteroid Therapy74

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Participant's Quality of Life Using the Edmonton Scale

The Edmonton Scale consisted of 9 items: pain, activity, nausea, depression, anxiety, fatigue, appetite, sensation of well-being and dyspnea (difficult or labored breathing). Participants rated these items on a scale of 0 to 10, with 10 being the worse. (NCT00332696)
Timeframe: Day 1, Day 7, Day 14, Month 1, Month 2 and Month 3

,
InterventionScores on a scale (Mean)
Day 1 (n=30,29)Day 7 (n=24,26)Day 14 (n=20,14)Month 1 (n=11,13)Month 2 (n=7,4)Month 3 (n=2,2)
Octreotide4.124.234.304.183.460.05
Placebo4.123.373.854.493.231.60

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Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14

The mean number of vomiting episodes per a 24 hour period is presented for Day 1, Day 7 and Day 14. (NCT00332696)
Timeframe: Day 1, Day 7 and Day 14

,
InterventionVomiting episodes (Mean)
Day 1Day 7 (n=31,31)Day 14 (n=28,27)
Octreotide1.20.30.3
Placebo0.60.40.5

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Number of Participants With Treatment Success From Day 10 to Day 13

"Treatment Success was defined as: less than 2 episodes of vomiting on average per day for the 4 days prior to Day 14 [from Day 10 to Day 13] and no use of an Nasogastric Tube (NGT) since at least Day 10 and no use of an anticholinergic agent until Day 14.~Treatment Failure is defined as: 2 or more episodes of vomiting per day on average for the 4 days prior to Day 14 or use of an NGT after Day 9 or use of an anticholinergic agent before Day 14 or withdrawal from the trial between Day 1 and Day 14 (included), whatever the cause." (NCT00332696)
Timeframe: Day 10 to Day 13

,
InterventionParticipants (Number)
TREATMENT SUCCESSVomiting episodes <2 (per day)Vomiting episodes ≥2 (per day)No Nasogastric Tube since Day 10Nasogastric Tube used since Day 10No Anticholinergic agentsAnticholinergic agents takenPremature discontinuation/missing data, failure
Octreotide1219214718311
Placebo913213211417

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Number of Participants With Relief From Obstruction at Day 7 and Day 14

Relief from obstruction is defined by combining restart of stools for at least the previous 3 days, less than 2 episodes of vomiting on average for the previous 4 days and the restarting of flatus (gas generated in the stomach or bowels) for at least the previous 12 hours. (NCT00332696)
Timeframe: Day 7 and Day 14

,
InterventionParticipants (Number)
Relief from Obstruction: Day 7No Relief from Obstruction: Day 7Relief from Obstruction: Day 14No Relief from Obstruction: Day 14
Octreotide9201110
Placebo1512105

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Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3

Recurrence of bowel obstruction was confirmed by abdominal X-ray. (NCT00332696)
Timeframe: Month 3

,
InterventionParticipants (Number)
Recurrence at Month 3No Recurrence at Month 3
Octreotide03
Placebo02

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Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2

Recurrence of bowel obstruction was confirmed by abdominal X-ray. (NCT00332696)
Timeframe: Month 2

,
InterventionParticipants (Number)
Recurrence at Month 2No Recurrence at Month 2
Octreotide26
Placebo25

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Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1

Recurrence of bowel obstruction was confirmed by abdominal X-ray. (NCT00332696)
Timeframe: 1 Month

,
InterventionParticipants (Number)
Recurrence at Month 1No Recurrence at Month 1
Octreotide113
Placebo213

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Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7

Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 7. (NCT00332696)
Timeframe: Day 7

,
InterventionParticipants (Number)
Score=0Score=1Score=2Score=3
Octreotide21253
Placebo15961

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Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14

Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 14. (NCT00332696)
Timeframe: Day 14

,
InterventionParticipants (Number)
Score=0Score=1Score=2Score=3
Octreotide22222
Placebo22311

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Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1

Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 1. (NCT00332696)
Timeframe: Day 1

,
InterventionParticipants (Number)
Score=0Score=1Score=2Score=3
Octreotide16178
Placebo13298

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Number of Participants With Treatment Success From Day 5 to Day 7

Day 7 treatment success was defined as improvement of symptoms in the previous 2 days (average number of vomiting episodes less than 2 from Day 5, no Nasogastric Tube (NGT) since Day 5 and no anticholinergic agent or withdrawal from trial). (NCT00332696)
Timeframe: Day 5 to Day 7

,
InterventionParticipants (Number)
TREATMENT SUCCESSVomiting episodes <2 (per day) since Day 5Vomiting episodes ≥2 (per day) since Day 5No Nasogastric Tube since Day 5Nasogastric Tube used since Day 5No Anticholinergic agentsAnticholinergic agents takenPremature discontinuation/missing data
Octreotide222812272633
Placebo202522432525

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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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Number of Participants (Patients) Who Were Disease-free and Alive at 6 Months

Number of patients who were alive and free of disease (malignancy) at 6 months after transplant. (NCT00354172)
Timeframe: 6 Months Post Transplant

InterventionParticipants (Number)
Evaluable Patients2

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Number of Participants (Patients) Who Experienced Relapse by 24 Months

Number of patients who experienced recurrence or progression of disease from the time of transplant. (NCT00354172)
Timeframe: 2 Years Post transplant

InterventionParticipants (Number)
Evaluable Patients11

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Number of Participants (Patients) Who Experienced Relapse by 12 Months

Number of patients who experienced recurrence or progression of disease from the time of transplant. (NCT00354172)
Timeframe: 1 Year Post Transplant

InterventionParticipants (Number)
Evaluable Patients10

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Number of Participants (Patients) Who Died Due to Transplant.

Patients who had transplant-related mortality (TRM). TRM = adverse event(s) that occur(s) after the patient has received a transplant, the principal investigator decides it is related to the procedure and the patient dies within 6 months. (NCT00354172)
Timeframe: 6 Months Post Transplant

InterventionParticipants (Number)
Evaluable Patients4

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Number of Participants (Patients) Who Died by 24 Months

Number of patients who died after receiving treatment within 24 months post transplant. (NCT00354172)
Timeframe: 2 years post-transplant

InterventionParticipants (Number)
Evaluable Patients15

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Number of Participants (Patients) Who Died by 12 Months

Number of patients who died after receiving treatment within 12 months post transplant. (NCT00354172)
Timeframe: 1 year Post Transplant

InterventionParticipants (Number)
Evaluable Patients14

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Number of Participants (Patients) Who Attained Platelet Engraftment

Platelet engraftment is defined as platelet counts > 50 x 10^9/Liter for 3 consecutive days. (NCT00354172)
Timeframe: 1 Year Post Transplant

InterventionParticipants (Number)
Evaluable Patients5

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Number of Participants (Patients) Who Attained Neutrophil Engraftment

"Defined as absolute neutrophils (ANC) > 5 x 10^8/Liter for 3 consecutive days.~ANC is the real number of white blood cells (WBCs) that are neutrophils. The absolute neutrophil count is commonly called the ANC. The ANC is not measured directly. It is derived by multiplying the WBC count times the percent of neutrophils in the differential WBC count. The percent of neutrophils consists of the segmented (fully mature) neutrophils) + the bands (almost mature neutrophils). The normal range for the ANC = 1.5 to 8.0 (1,500 to 8,000/mm3)." (NCT00354172)
Timeframe: Day 42 Post Transplant

InterventionParticipants (Number)
Evaluable Patients13

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Chimerism After Double Umbilical Cord Blood Transplant (UCBT)

Calculation of Median (range) of percentage of donor cells engrafted (present) in the recipient (patient). (NCT00354172)
Timeframe: Day 21, Day 100, 6 Months

InterventionPercentage of Engrafted Cells (Median)
Day 21Day 1006 Months
Evaluable Patients9210096.5

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Number of Participants (Patients) Who Were Disease-free and Alive at 12 Months

Number of patients who were alive and free of disease (malignancy) at 12 months after transplant. (NCT00354172)
Timeframe: 12 Months Post transplant

InterventionParticipants (Number)
Evaluable Patients1

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Number of Patients Who Were Disease-free and Alive at 24 Months

Number of patients who were alive and free of disease (malignancy) at 24 months after transplant. (NCT00354172)
Timeframe: 24 Months Post transplant

InterventionParticipants (Number)
Evaluable Patients0

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Number of Participants (Patients) With Successful Natural Killer Cell Expansion

Defined by an absolute circulating donor-derived natural killer cell count of >100 cells/microliter 10-13 days after infusion with <5% donor T and B cells in the mononuclear population (NCT00354172)
Timeframe: 10-13 Days Post Infusion

InterventionParticipants (Number)
Evaluable Patients3

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Number of Participants (Patients) With Chronic Graft-Versus-Host Disease

The chronic form of graft-versus-host-disease (cGVHD) normally occurs after 100 days. The appearance of moderate to severe cases of cGVHD adversely influences long-term survival. (NCT00354172)
Timeframe: Day 100 through 1 Year Post Transplant

InterventionParticipants (Number)
Evaluable Patients1

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Number of Participants (Patients) With Acute Graft-versus-Host Disease at Grade III-IV

Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis. (NCT00354172)
Timeframe: Day 100 post transplant

InterventionParticipants (Number)
Evaluable Patients1

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Number of Participants (Patients) With Acute Graft-versus-host Disease (GVHD) Grade II-IV

Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis. (NCT00354172)
Timeframe: Day 100 Post Transplant

InterventionParticipants (Number)
Evaluable Patients6

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Number of Patients Who Experienced Adverse Events

(NCT00379574)
Timeframe: 6 months

Interventionparticipants (Number)
Bortezomib + CHOP Every 2 Weeks49

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Number of Patients Who Achieved Complete Response

All patients,9 patients of phase I study and 40 patietns in phase II stuay, were assessed with International Working Group response criteria assessed by CT; Complete Response (CR), Disappearance of all detectable clinical and radiographic evidence of disease and diappearance of all disease-related symptoms. (NCT00379574)
Timeframe: 14 weeks

Interventionparticipants (Number)
Bortezomib + CHOP Every 2 Weeks32

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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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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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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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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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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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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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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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5-Year Disease-Free Survival by MRD Day 32 Status

Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI. (NCT00400946)
Timeframe: Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.

Interventionprobability (Number)
Low Day 32 MRD Level.79
High Day 32 MRD Level.90

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Induction Infection Toxicity Rate

Infection toxicity rate is defined as the percentage of patients who experience bacterial or fungal infection of grade 3 or higher with treatment attribution of possibly, probably or definite based on CTCAEv3 during remission induction phase of combination chemotherapy. (NCT00400946)
Timeframe: Assessed daily during remission induction days 4-32.

Interventionpercentage of participants (Number)
Overall26

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Post-Induction Therapeutic Nadir Serum Asparaginase Activity Rate

Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods. Post-Induction therapeutic NSAA rate is defined as the percentage of patients achieving a NSAA level above 0.1 IU/mL ever during post-induction therapy. (NCT00400946)
Timeframe: Samples for nadir serum asparaginase activity analyses were obtained before doses administered at weeks 5, 11, 17, 23 and 29 of post-induction asparaginase treatment.

Interventionpercentage of participants (Number)
Intramuscular Native E Coli L-asparaginase (IM-EC)71
Intravenous PEG-asparaginase (IV-PEG)99

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Induction Serum Asparaginase Activity Level

Serum asparaginase activity (NSAA) levels were estimated based on established methods. (NCT00400946)
Timeframe: Samples for serum asparaginase activity analyses were obtained days 4, 11, 18 and 25 post one-dose of IV-PEG on day 7 of the induction phase.

InterventionIU/mL (Median)
Day 4 NSAA LevelDay 11 NSAA LevelDay 18 NSAA LevelDay 25 NSAA Level
Overall.694.505.211.048

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Induction Therapeutic Nadir Serum Asparaginase Activity Rate

Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods. Induction therapeutic NSAA rate is defined as the percentage of patients achieving a NSAA level above 0.1 IU/mL at a given timepoint. (NCT00400946)
Timeframe: Samples for serum asparaginase activity analyses were obtained days 4, 11, 18 and 25 post one-dose of IV-PEG on day 7 of the induction phase.

Interventionpercentage of participants (Number)
Day 4 NSAA RateDay 11 NSAA RateDay 18 NSAA RateDay 25 NSAA Rate
Overall97968712

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Post-Induction Nadir Serum Asparaginase Activity Level

Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods. (NCT00400946)
Timeframe: Samples for nadir serum asparaginase activity analyses were obtained before doses administered at weeks 5, 11, 17, 23 and 29 of post-induction asparaginase treatment.

,
InterventionIU/mL (Mean)
Week 5 NSAA LevelWeek 11 NSAA LevelWeek 17 NSAA LevelWeek 23 NSAA LevelWeek 29 NSAA Level
Intramuscular Native E Coli L-asparaginase (IM-EC)0.1290.1430.1590.1800.123
Intravenous PEG-asparaginase (IV-PEG)0.7260.7730.7870.7570.806

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5-year Disease-Free Survival by CNS Directed Treatment Group

Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI. (NCT00400946)
Timeframe: Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.

Interventionprobability (Number)
CNS-1.89
CNS-2.89
CNS-31.00
Traumatic Tap With Blasts.84
Traumatic Tap Without Blasts.87

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5-Year Disease-Free Survival by Bone Marrow Day 18 Status

Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI. (NCT00400946)
Timeframe: Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.

Interventionprobability (Number)
M1 Day 18 Bone Marrow Status.89
M2/M3 Day 18 Bone Marrow Status.78
Hypocellular Day 18 Bone Marrow Status.88

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5-Year Disease-Free Survival

Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI. (NCT00400946)
Timeframe: Disease evaluations occurred continuously on treatment. Suggested long-term follow-up was monthly for 6m, bi-monthly for 6m, every 4 months for 1y, semi-annually for 1y, then annually. Median follow-up in this study cohort is 6 yrs, up to 10y.

Interventionprobability (Number)
Intramuscular Native E Coli L-asparaginase (IM-EC).89
Intravenous PEG-asparaginase (IV-PEG).90

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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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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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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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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 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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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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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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Survival

Survival (NCT00424489)
Timeframe: Up to 5 years

InterventionParticipants (Count of Participants)
Hematopoietic Stem Cell Transplantation6

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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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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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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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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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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 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: 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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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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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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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 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 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 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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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 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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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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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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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 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 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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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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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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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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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 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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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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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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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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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 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 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 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 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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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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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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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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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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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 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 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 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 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: 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 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 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: 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: 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 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: 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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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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Interocular Pressure

IOP, measured by Goldmann applanation tonometry (NCT00478036)
Timeframe: 8 weeks

,,
InterventionmmHg (Mean)
BaselineDay 1Week 1Week 4week 8
Acular LS16.111.615.214.314.0
Pred Forte17.012.415.714.015.0
Refresh Tears17.813.415.614.615.8

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Achieving Full Donor Chimerism

Achieving full donor chimerism (donor T cells >95%): Blood was sent for donor cell percentage measured by short tandem repeat (STR) at post-transplant Day 30; Day 60; Day 90; Day 120; Day 180; Day 270; and Day 360. Full donor chimerism is defined as donor CD3+ cells > 95%. (NCT00481832)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
T & B Cell Mobilization Auto & Allo HCT10

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Relapse Rate

Relapse rate (disease recurrence) 3 years after transplant, for participants who received both transplants, as determined by Kaplan-Meier estimation. (NCT00481832)
Timeframe: 3 years

Interventionpercentage of participants (Number)
T & B Cell Mobilization Auto & Allo HCT27

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Event-free Survival (EFS)

"Event-free survival (EFS) as determined for participants who receive both planned transplants, for a minimum of 3 years.~Events are defined as disease progression/relapse and death of all causes." (NCT00481832)
Timeframe: 3 years

Interventionpercentage of participants (Number)
T & B Cell Mobilization Auto & Allo HCT35

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Incidence of Acute Graft Versus Host Disease (GvHD)

The development of GvHD in vaccinated patients of any grade and at 6 months. (NCT00481832)
Timeframe: 6 Months

InterventionParticipants (Count of Participants)
T & B Cell Mobilization Auto & Allo HCT3

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Incidence of Chemotherapy-associated Pneumonitis

Interstitial pneumonitis (IP) is a risk associated with high-dose carmustine (BCNU) or other chemotherapy drugs used for transplantation. IP is diagnosed by 1) a decrease of >25% in DLCO compared with pre-transplant PFT DLCO values or 2) a drop of 7% or more in oxygen saturation after exertion. (NCT00481832)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
T & B Cell Mobilization Auto & Allo HCT16

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Incidence of Chronic Graft Versus Host Disease (GvHD)

The development of GvHD in vaccinated patients of any grade at 6 months. (NCT00481832)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
T & B Cell Mobilization Auto & Allo HCT3

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Median Time to Neutrophile Engraftment

Complete blood counts were measured daily after allogeneic transplant. Time to neutrophil engraftment is defined as the number of days it takes to reach an absolute neutrophils count (ANC) >500, counting from the day of transplant. (NCT00481832)
Timeframe: up to 45 days

InterventionDays (Median)
T & B Cell Mobilization Auto & Allo HCT17

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Median Time to Platelet Engraftment

Complete blood counts were measured daily after allogeneic transplant. Time to platelet engraftment is defined as the number of days it takes to reach platelet count >20,000, counting from the day of transplant. (NCT00481832)
Timeframe: Up to 45 days

InterventionDays (Median)
T & B Cell Mobilization Auto & Allo HCT11

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Overall Mortality Rate

Overall mortality is determined by Kaplan-Meier estimation. The overall morality rate is expressed as the percentage of patients who died for any reason, including disease-related death. (NCT00481832)
Timeframe: 3 years

Interventionpercentage of participants (Number)
T & B Cell Mobilization Auto & Allo HCT56

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Overall Survival (OS)

Overall Survival (OS) 3 years after transplant, for participants who received both transplants, as determined by Kaplan-Meier estimation. (NCT00481832)
Timeframe: 3 years

Interventionpercentage of participants (Number)
T & B Cell Mobilization Auto & Allo HCT57

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Amount of Pain Medication Taken Per Day

(NCT00492973)
Timeframe: Average of 3 days after surgery

Interventionmg/day morphine equivalant (Mean)
Control Group47.8
Corticosteroid46.0

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Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc.

(NCT00492973)
Timeframe: any point during the first postoperative year

InterventionNumber of participants with complication (Number)
Control Group0
Corticosteroid3

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Knee Range of Motion

(NCT00492973)
Timeframe: 3 months

Interventiondegrees (Mean)
Control Group112.5
Corticosteroid112.4

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Knee Society Scores

The Knee Society Score is on a scale of 0 to 100, with 0 being the worst possible score, and 100 being the best possible score. The Knee Society Score takes into account subjective patient reports of pain and functional ability as well as clinical measures of passive knee range of motion. (NCT00492973)
Timeframe: 3 months postoperative

Interventionunits on a scale (Mean)
Control Group87.1
Corticosteroid83.3

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Length of Hospital Stay

(NCT00492973)
Timeframe: days after surgery

Interventiondays (Mean)
Control Group3.5
Corticosteroid2.6

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Number of Participants With An Improvement in Vision, as Measured by an Increase of 15 Letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) Vision Chart.

improvement with combination of niacin and topical prednisolone acetate (NCT00493064)
Timeframe: one year

InterventionParticipants (Count of Participants)
Prospective Active Treatment63

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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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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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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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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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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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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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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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Prostate Specific Antigen (PSA) Response

Prostate Specific Antigen (PSA) response was defined as a reduction of at least 50% from baseline at any assessment, confirmed by a second assessment 2-4 weeks after the initial response (NCT00498797)
Timeframe: PSA measurements were to be performed at screening, at baseline (>2 weeks after screening) and every 3 weeks during the study. Any response was to be confirmed 2-4 weeks after the initial assessment of a 50% fall in PSA from baseline

InterventionParticipants (Number)
Vandetanib17
Placebo29

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Number of Patients With an Objective Disease Progression Event

Number of patients with objective disease progression or death (by any cause in the absence of objective progression) (NCT00498797)
Timeframe: RECIST tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (21 July 2007 or up to 7 days in advance of DCO)

InterventionParticipants (Number)
Vandetanib28
Placebo26

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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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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 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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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 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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Change From Baseline to Day 98 Using the WOMAC Pain Question #1

"The WOMAC Index is a validated, 24-question self-administered assessment of three dimensions of pain, stiffness, and physical function for subjects with knee or hip OA. The WOMAC pain question #1 asks subjects to think about the pain you felt in your (study joint) caused by your arthritis during the last 48 hours when walking on a flat surface. This is a visual analog scale (VAS) where the subject indicates pain severity by making a mark through a 100 mm horizontal line with No Pain on the left (0 mm) and Extreme Pain on the right (100 mm). The distance between the left end of the scale and the subject's mark is measured in millimeters. Lower values represent a better outcome." (NCT00521989)
Timeframe: Baseline to Day 98

Interventionmillimeters (Mean)
CRx-102 (2.7/90 mg)-32.4
CRx-102 (2.7/180 mg)-33.2
CRx-102 (2.7/360 mg)-37.3
Prednisolone-40.4
Placebo-34.6

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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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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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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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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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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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Absolute C-reactive Protein (CRP) Values at Day 98 - As Treated Population

Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated. (NCT00551707)
Timeframe: Day 98

Interventionmg/L (Median)
CRx-102 (2.7/180)12.85
CRx-102 (2.7/360)14.25
Prednisolone21.85
Dipyridamole16.60
Placebo2.68

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Percent Change From Baseline to Day 98 in C-reactive Protein (CRP) Values - As Treated Population

Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated. (NCT00551707)
Timeframe: baseline to day 98

Interventionpercentage of change from baseline (Median)
CRx-102 (2.7/180)-29.90
CRx-102 (2.7/360)-40.84
Prednisolone15.92
Dipyridamole-33.67
Placebo-27.64

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Cumulative Incidence of NK Cell Reconstitution

Cumulative incidence of successful reconstitution to donor level is calculated. (NCT00553202)
Timeframe: At 5 years from HSCT date

InterventionPercentage of participants (Number)
Treatment (Chemotherapy and Allogeneic SCT)48.1

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Overall Survival (OS)

OS - Time from HSCT until death (NCT00553202)
Timeframe: At 5 years from HSCT date

InterventionPercentage of participants (Number)
Treatment (Chemotherapy and Allogeneic SCT)45.9

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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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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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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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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 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) 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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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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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 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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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 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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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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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 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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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 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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Relapse Rate

Relapse will be determined as ≥ 5% blast cells in the bone marrow, not secondary to regeneration after myelosuppressive therapy; OR emergence of extramedullary leukemia; OR the re-emergence of blasts in the peripheral blood. The outcome will be reported as the number and percentage of participants that meet these criteria (a number without dispersion). (NCT00568633)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Allo-HSCT + TLI + ATG20
Best Standard Care24

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Overall Survival (OS)

Overall survival defined as the time interval between the date of attaining a first complete remission (CR) and the date of death from any cause. The outcome is reported as the number of participants alive (without dispersion). (NCT00568633)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Allo-HSCT + TLI + ATG9
Best Standard Care13

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Early Graft Loss

Early graft loss means a failure to achieve donor T-cell chimerism of > 5% at any time after transplant. The outcome is reported as the percentage of participants that experience early graft loss, a number without dispersion. (NCT00568633)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Allo-HSCT + TLI + ATG4

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Patients Completing the Intended Therapy in Both Arms

The assessment for completion of the intended therapy (in both arms) will be reported as the percentage of participants, a number without dispersion (NCT00568633)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Allo-HSCT + TLI + ATG100
Best Standard Care81.8

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Non-relapse Mortality

Non-relapse mortality is defined as death that occurs after therapy, from any cause except a cause associated with relapse. This will be reported as the number of participants experiencing non-relapse mortality (a number without dispersion). (NCT00568633)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Allo-HSCT + TLI + ATG1
Best Standard Care2

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Complete Donor Hematopoietic Cell Chimerism

Complete donor hematopoietic cell chimerism was evaluated in transplant recipients. Complete donor chimerism will be assessed as the presence of > 95% donor T-cells (CD3+) in the blood. The outcome is reported as the percentage of participants that achieve complete donor chimerism, a number without dispersion. (NCT00568633)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Allo-HSCT + TLI + ATG56

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Disease-free Survival (DFS)

Disease-free survival is defined as the time interval between the date of attaining a first complete remission (CR) and the date of relapse. Disease free survival (DFS) will compared to conventional therapy vs Non-myeloablative Host Conditioning (NMA HCT). The outcome is reported as the number of participants which never experienced disease relapse (without dispersion). (NCT00568633)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Allo-HSCT + TLI + ATG5
Best Standard Care9

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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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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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Survival at 1 Year Post-CTTI

Survival at 1 year post cultured thymus tissue implantation was assessed using the Kaplan Meier Estimated Survival. This mathematical function estimates the survival for a certain length of time. (NCT00579527)
Timeframe: 1 year post-CTTI

Intervention% of participants who survive to 1 year (Number)
Cultured Thymus Tissue With Immunosuppression71

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Survival at 2 Years Post-CTTI

Survival at 2 years post cultured thymus tissue implantation was assessed using the Kaplan Meier Estimated Survival. This mathematical function estimates the survival for a certain length of time. (NCT00579527)
Timeframe: 2 years post-CTTI

Intervention% of participants who survive to 2 years (Number)
Cultured Thymus Tissue Implantation With Immunosuppression71

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Immune Reconstitution Efficacy - Total CD8 T Cells

The development of total CD8 T cells at one year as measured using flow cytometry (NCT00579527)
Timeframe: 1 year post-CTTI

Interventioncells/mm3 (Median)
Cultured Thymus Tissue Implantation With Immunosuppression145

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Immune Reconstitution Efficacy - Naive CD4 T Cells

The development of total naive CD4 T cells at one year as measured using flow cytometry (NCT00579527)
Timeframe: 1 year post-CTTI

Interventioncells/mm3 (Median)
Cultured Thymus Tissue Implantation With Immunosuppression156

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Immune Reconstitution Efficacy - Naive CD8 T Cells

The development of total naive CD8 T cells at one year as measured using flow cytometry (NCT00579527)
Timeframe: 1 year post-CTTI

Interventioncells/mm3 (Median)
Cultured Thymus Tissue Implantation With Immunosuppression37

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Immune Reconstitution Efficacy - Response to Mitogens

Measurement of the T cell proliferative response to the mitogen phytohemagglutin (PHA). (NCT00579527)
Timeframe: 1 year post-CTTI

Interventioncounts per minute (cpm) (Median)
Cultured Thymus Tissue Implantation With Immunosuppression139189

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Immune Reconstitution Efficacy - Total CD3 T Cells

The development of total CD3 T cells at one year as measured using flow cytometry (NCT00579527)
Timeframe: 1 year post-CTTI

Interventioncells/mm3 (Median)
Cultured Thymus Tissue Implantation With Immunosuppression726

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Immune Reconstitution Efficacy - Total CD4 T Cells

The development of total CD4 T cells at one year as measured using flow cytometry (NCT00579527)
Timeframe: 1 year post-CTTI

Interventioncells/mm3 (Median)
Cultured Thymus Tissue Implantation With Immunosuppression593

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Failure Rate at One Year

The failure rate was defined as a composite variable of CAS decrease of < 2 points or need for additional therapy (excluding cosmetic surgery) for the eye disease. (NCT00595335)
Timeframe: one year

Interventionpercentage of participants (Number)
Rituximab46
Placebo50

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Change in Clinical Activity Score (CAS)

The clinical activity score (CAS), for Grave's ophthalmopathy has become a widely accepted tool to assess disease activity and help decide the management of the condition. The CAS, which is based on classical signs of inflammation (pain, redness, and swelling), consists of 7 equally weighted items. The total CAS (as used in this study) may range from 0 to 7. The higher the CAS, the greater degree of inflammation is present. A drop in CAS of 2 or more points suggests an improvement in the inflammatory components of the disease. A CAS ≥3 implies active disease. (NCT00595335)
Timeframe: baseline, 6 months after the first infusion

Interventionunits on a scale (Mean)
Rituximab-1.2
Placebo-1.5

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Graves' Ophthalmopathy Quality of Life Score Using the Short Form-12 (SF-12) Health Survey

Quality of life (QoL) was measured by the SF-12 questionnaire. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Physical and Mental Health Composite Scores are computed (combined, scored, and weighted) using the scores of the 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Improvement was defined as a change of ≥ 6 points. (NCT00595335)
Timeframe: baseline, 6 months after first infusion, 12 months after first infusion

,
Interventionunits on a scale (Median)
Baseline QoL physicalBaseline QoL mental6 months QoL physical6 months QoL mental12 months QoL physical12 months QoL mental
Placebo39.946.140.346.146.749.4
Rituximab53.244.345.952.851.856.1

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Change in Lid Fissure

"The palpebral fissure is the elliptic space between the medial and lateral canthi of the two open eye lids. In adults, this measures about 10mm vertically and 30mm horizontally. The fissure may be increased in vertical height in Graves' disease.~Improvement was defined as a decrease in lid aperture width by ≥3 mm." (NCT00595335)
Timeframe: baseline, 6 months after first infusion

,
Interventionmm (Median)
Lid fissure right eyeLid fissure left eye
Placebo00.5
Rituximab00

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Failure Rate

The failure rate was defined as a composite variable of CAS decrease of < 2 points or need for additional therapy (excluding cosmetic surgery) for the eye disease. (NCT00595335)
Timeframe: 6 months after first infusion, 12 months after first infusion

,
Interventionpercentage of participants (Number)
Failure rate at 6 monthsFailure rate at 12 months
Placebo7550
Rituximab6946

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Change in Proptosis

Eye proptosis is a condition resulting in forward displacement of the globe from its normal position within the orbit. It is measured by computed tomography. Improvement in proptosis was defined as a decrease in proptosis by ≥2 mm. (NCT00595335)
Timeframe: baseline, 12 months after first infusion

,
Interventionmm (Mean)
Proptosis right eyeProptosis left eye
Placebo0.800.0
Rituximab0.820.1

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Change in Extraocular Motility

"Change extraocular motility was assessed using the Gorman diplopia score. Diplopia, commonly known as double vision, is the simultaneous perception of two images of a single object that may be displaced horizontally, vertically, or diagonally (i.e., both vertically and horizontally) in relation to each other. It is usually the result of impaired function of the extraocular muscles, where both eyes are still functional but they cannot converge to target the desired object.~The Gorman diplopia score includes four categories: 1) no diplopia (absent), 2) diplopia when the patient is tired or awakening (intermittent), 3) diplopia at extremes of gaze (inconstant), and 4) continuous diplopia in the primary or reading position (constant)." (NCT00595335)
Timeframe: baseline, 6 months after first infusion, 12 months after first infusion

,
Interventionunits on a scale (Median)
Change baseline-6 monthsChange baseline-12 months
Placebo2.51.5
Rituximab32

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Change in Disease Severity

Disease severity was measured by the NOSPECS Score. This classification scheme of the eye changes in thyroid eye disease was introduced by the American Thyroid Association. It separates patients into seven classes of disease (class 0-6), with 0 being no signs or symptoms and 6 being sight loss. (The acronym is based on the first letter of the defining characteristic of each class, the classification is known as: 'no signs or symptoms; only signs; soft tissue; proptosis; extraocular muscle; cornea; sight loss' (NOSPECS) ). (NCT00595335)
Timeframe: baseline, 6 months after first infusion

,
Interventionparticipants (Number)
Improvement by 1 classImprovement by 2 classesDeteriorationNo change
Placebo8202
Rituximab6223

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Percentage of Participants Alive, In Remission & Without GVHD Progression Day 28 & Day 56

Percentage meeting steroid milestone who were alive, in remission and did not have GVHD progression before Day 28 or Day 56. (NCT00609609)
Timeframe: Up to day 56

,
Interventionpercentage of participants (Number)
Day 28 Steroid dose Day 56 steroid dose < 0.1mg/kg
Corticosteroids1030
ECP + Corticosteroids23.543

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Day 56 Treatment Success

Definition of Treatment Failure: No Response according to the following: A) Skin: 1) No change in GVHD stage by day 14; 2) Gut: No change in GVHD stage by Day 7; 3) Liver: No change in GVHD stage by Day 21. B) Progressive Disease (PD): 1) Skin/Gut: Increase in Stage by 72 hours from the start of therapy; 2) Liver: Increase in Stage by Day 14; 3) Initiation of 2nd line treatment at any time for acute GVHD: 4) Any new organ involvement by acute GVHD. C) Inability to Taper: 1) Patient still on >1 mg/kg/d of methylprednisolone equivalent at 1 month. 2) Patient still on > 0.5 mg/kg/d of methylprednisolone equivalent at 2 months; 3) Death from GVHD. Definition of Treatment Success: Participants not defined above in Treatment Failure definition. Baseline biopsy with Acute GVHD assessed weekly until last ECP procedure (anticipated Day 63). At 6 months follow up with a phone call for survival and GVHD status. (NCT00609609)
Timeframe: Day 1 to Day 63 (approximately 9 weeks), Acute GVHD scored weekly.

,
Interventionpercentage of participants (Number)
Skin-onlyVisceral InvolvementTotal
Corticosteroids574353
ECP + Corticosteroids724765

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Non-relapse Mortality (NRM) at 6 Months

Percentage of participants at 6 months whose deaths were without relapse/recurrence. (NCT00609609)
Timeframe: 6 months

Interventionpercentage of participants (Number)
Corticosteroids19.6
ECP + Corticosteroids20.0

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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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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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The Number of Lipoma Increased in Volume.

(NCT00624416)
Timeframe: After four weeks of treatment up to one year.

InterventionLipomas (Number)
Prednisolone and Isoproteronol9

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The Average Percent Volume Reduction in the Lipoma.

(NCT00624416)
Timeframe: Baseline and 4 weeks

InterventionPercent Volume reduction (cc^3) (Mean)
Prednisolone and Isoproteronol50

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The Number of Subjects Elected to Have the Lipoma Removed.

(NCT00624416)
Timeframe: After four weeks up to one year.

Interventionparticipants (Number)
Prednisolone and Isoproteronol8

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Progression of Measured Glomerular Filtration Rate

Change in renal progression measured by mean mGFR from week 7 to Month 36 (NCT00634920)
Timeframe: Week 7, Week 52, Month 36

,
InterventionmL/min/1.73m^2 (Mean)
Week 7Week 52Change from week 7 to Week 52Month 36Change from week 7 to Month 36
Control (CsA)47.847.80.046.1-1.7
Everolimus (CNI-free)46.351.55.648.21.3

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Percentage of Participants With Treatment Failures

Treatment failure was defined as graft loss or death. (NCT00634920)
Timeframe: Months 12, 24, 36

,
InterventionPercentage of participants (Number)
Month 12: No FailureMonth 12: FailureMonth 24: No FailureMonth 24: FailureMonth 36: No FailureMonth 36: Failure
Control (CsA)100.00.098.81.296.73.3
Everolimus (CNI-free)100.00.098.81.298.81.2

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Percentage of Participants With Graft Loss or Death

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, the day of nephrectomy was the day of graft loss. Graft loss was considered an SAE (serious adverse event). (NCT00634920)
Timeframe: Months 12, 24, 36

,
InterventionPercentage of participants (Number)
Month 12: Event First YearMonth 12: No Event First YearMonth 24: Event Second YearMonth 24: No Event Second YearMonth 36: Event Third YearMonth 36: No Event Third Year
Control (CsA)0.0100.01.198.92.297.8
Everolimus (CNI-free)0.0100.01.198.90.0100.0

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Percentage of Participants With Biopsy Proven Acute Rejection (BPAR)

A BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III (Banff 97 classification). Biopsy graded IA: Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells). Biopsy grade IB: Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells). Biopsy grade IIA: Mild to moderate intimal arteritis. Biopsy graded IIB: Severe intimal arteritis comprising > 25% of the lumenal area. (NCT00634920)
Timeframe: Months 12, 24, 36

,
InterventionPercentage of participants (Number)
Month 12: lAMonth 12: lBMonth 12: llAMonth 12: llBMonth 24: lAMonth 24: lBMonth 36: lAMonth 36: lB
Control (CsA)4.40.02.21.14.43.31.10.0
Everolimus (CNI-free)19.610.92.22.25.41.12.21.1

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Measured Glomerular Filtration Rate

Progression of renal function measured by mean mGFR at 36 months after renal TX. The mGFR was measured using Iohexol or Cr-EDTA clearance according to local practice. (NCT00634920)
Timeframe: Month 36

InterventionmL/min/1.73m^2 (Mean)
Everolimus (CNI-free)48.2
Control (CsA)46.1

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Proteinuria (Measured as Urine Albumin/Creatinine Ratio (mg/mmol))

"Proteinuria is when a large amount of protein, that should remain circulating in a person's blood, is spilled into their urine and eliminated from the body." (NCT00634920)
Timeframe: Months 12, 24, 36

,
Interventionmg/mmol (Mean)
Month 12Month 24Month 36
Control (CsA)11.2724.5580.73
Everolimus (CNI-free)17.3162.8378.78

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Lipid Profile for HDL-C, LDL-C,Total Cholesterol, and Triglycerides

Blood lipid levels of patients in both groups: HDL-C, LDL-C,Total cholesterol, and triglycerides. (NCT00634920)
Timeframe: Months 12, 24, 36

,
Interventionmmol/L (Mean)
Month 12: HDL CholesterolMonth 24: HDL CholesterolMonth 36: HDL CholesterolMonth 12: LDL CholesterolMonth 24: LDL CholesterolMonth 36: LDL CholesterolMonth 12: Total CholesterolMonth 24: Total CholesterolMonth 36: Total CholesterolMonth 12: TriglyceridesMonth 24: TriglyceridesMonth 36: Triglycerides
Control (CsA)1.4191.4091.5293.1302.9252.8225.3185.1124.8301.8681.7571.580
Everolimus (CNI-free)1.4861.4771.4953.5693.3813.2066.0915.8235.5952.4612.2882.164

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Measured Glomerular Filtration Rate

To compare the efficacy between treatment regimens by assessing the difference in renal function evaluated by mean measured glomerular filtration rate (mGFR) 12 months after renal transplantation (TX). The mGFR was measured using Iohexol or Cr-EDTA clearance according to local practice. (NCT00634920)
Timeframe: Month 12

InterventionmL/min/1.73m^2 (Mean)
Everolimus (CNI-free)51.5
Control (CsA)47.8

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Time to First Malignancy

This is the time to first diagnosed malignancy. Malignancies (skin- or solid cancer) were listed whether they reoccurred in situ, were metastatic or de novo. This is shown as mean time. (NCT00634920)
Timeframe: Months 12, 24, 36

InterventionMonths (Mean)
Everolimus (CNI-free)35.5
Control (CsA)35.1

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Time to Treatment Failure

Treatment failure was defined as graft loss or death.Time to treatment failure is shown as mean time to treatment failure. (NCT00634920)
Timeframe: Months 12, 24, 36

InterventionDays (Mean)
Everolimus (CNI-free)972.7
Control (CsA)959.5

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Calculated Glomerular Filtration Rate

The GFR was calculated according to the Modification of Diet in Renal Disease Study Group (MDRD) method, the Cockcroft-Gault method, and the Nankivell formula. cGFR was calculated from blood samples collected at predefined time points. (NCT00634920)
Timeframe: Months 12, 36

,
InterventionmL/min/1.73m^2 (Mean)
MDRD M12MDRD M36Cockcroft-Gault M12Cockcroft-Gault M36Nankivel M12Nankivel M36
Control (CsA)60.157.445.642.161.858.9
Everolimus (CNI-free)65.059.445.443.166.361.8

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Lipid Profile for Apolipoprotein

Blood lipid levels of patients in both groups for Apolipoprotein (Apo) A1 and B. (NCT00634920)
Timeframe: Months 12, 24, 36

,
Interventiong/L (Mean)
Month 12: Apolipoprotein A1Month 24: Apolipoprotein A1Month 36: Apolipoprotein A1Month 12: Apolipoprotein BMonth 24: Apolipoprotein B (Month 36: Apolipoprotein B
Control (CsA)1.461.361.560.9231.0580.934
Everolimus (CNI-free)1.591.551.700.9351.1780.984

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Number of Antihypertensive Drugs Taken

(NCT00634920)
Timeframe: Months 12, 24, 36

,
InterventionNumber of antihypertensive dugs (Mean)
Month 12Month 24Month 36
Control (CsA)2.52.42.2
Everolimus (CNI-free)2.52.52.0

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Number of Lipid-lowering Drugs Taken

(NCT00634920)
Timeframe: Months 12, 24, 36

,
InterventionNumber of lipid-lowering drugs (Mean)
Month 12Month 24Month 36
Control (CsA)0.80.90.8
Everolimus (CNI-free)0.91.00.9

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Percentage of Participants on Antihypertensive Drugs

(NCT00634920)
Timeframe: Months 12, 24, 36

,
InterventionPercentage of participants (Number)
Month 12: No antihypertensive drugsMonth 12: Has antihypertensive drugsMonth 24: No antihypertensive drugsMonth 24: Has antihypertensive drugsMonth 36: No antihypertensive drugsMonth 36: Has antihypertensive drugs
Control (CsA)3.396.75.394.712.887.2
Everolimus (CNI-free)9.290.84.295.815.684.4

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Percentage of Participants on Lipid-lowering Drugs

(NCT00634920)
Timeframe: Months 12, 24, 36

,
InterventionPercentage of participants (Number)
Month 12Month 24Month 36
Control (CsA)60.065.063.0
Everolimus (CNI-free)75.078.073.0

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Percentage of Participants Who Developed CAN (Chronic Allograft Nephropathy)

Assessed by protocol biopsies findings (Banff 1997 lesion scores and morphometry of the interstitial space) (NCT00634920)
Timeframe: Month 12, Month 36

,
InterventionPercentage of participants (Number)
Month 12Month 36
Control (CsA)1.064.0
Everolimus (CNI-free)1.059.0

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Percentage of Participants Who Had Donor Specific Antibodies (DSA)

Venous blood was drawn for donor specific (DSA) measurements prior to transplantation and at the final visit (36 months). The blood sample was first screened for the presence of PRA i.e. donor specific Immunoglobulin-G antibodies against specific HLA antigens. If PRA antibodies were detected, the blood sample was tested for specific DSAs on single antigen Luminex beads (coated with single HLA class I or II molecules). In this way, the specificity of these antibodies could be determined. (NCT00634920)
Timeframe: Month 36

,
InterventionPercentage of participants (Number)
ND (not done)NegativePositive
Control (CsA)9.070.021.0
Everolimus (CNI-free)7.078.015.0

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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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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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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% (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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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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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 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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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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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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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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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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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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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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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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Serum Prednisolone Levels Over 24 Hours

(NCT00662298)
Timeframe: 2h, 6h, 24h

Interventionnmol/l (Mean)
2h6h24h
Severe Asthma800700NA

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Difference Between Baseline and Day 14 in Serum Prednisolone Levels

(NCT00662298)
Timeframe: Baseline, 14 days

Interventionnmol/litres (Mean)
baseline14days
Severe Asthma2.02.11

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Number of Participants With a Response

Response - Complete remission (CR): Normalization peripheral blood & bone marrow 5% or & platelet count >100x10^9/L; CR with incomplete platelet recovery (CRp): CR but platelet count <100x10^9/L. CR with incomplete recovery (CRi): CR but platelet count <100x10^9/L or absolute neutrophil count < 1x10^9/L. Partial response (PR): As above except for presence of 6-25% marrow blasts. Lymphoblastic lymphoma (& ALL subtypes with extramedullary disease): CR - disappearance all known disease. PR - >50% decrease in tumor size using sum of product, includes 50% volume decrease in lesions measurable in 3 dimensions. No Response (NR) - No significant change (includes stable disease). Lesions decreased size but <50% or lesions with slight enlargement <25% increase in size. Progressive Disease (PD): Appearance new lesions, 25% or > increase in size existing lesions (>50% if 1 lesion & <2). (NCT00671658)
Timeframe: Response assessed following first 21 day course up to end of treatment with 8 cycles, up to 210 days

InterventionParticipants (Number)
Complete Response (CR)Complete Response without Platelet RecoveryPartial Response (PR)
HYPER-CVAD19834

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Change in Serum Cortisol

Cortisol levels were measured over 28 days. Outcome represents mean change in cortisol level between baseline visit and day 28. (NCT00682357)
Timeframe: Change from Baseline Visit to Day 28

Interventionmcg/dL (Mean)
Group 1 - Standard Dose-1.16
Group 2 - Low Dose0.65
Group 3 - Placebo1.30

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Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b)

Outcome represents the mean change in serum biomarkers of bone breakdown (TRACP-5b) from baseline visit to day 28. (NCT00682357)
Timeframe: Change from Baseline Visit to Day 28

InterventionU/L (Mean)
Group 1 - Standard Dose-0.153
Group 2 - Low Dose-0.295
Group 3 - Placebo-0.148

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Change in Testosterone

Outcome represents the mean change in testosterone level from baseline visit to day 28. (NCT00682357)
Timeframe: Change from Baseline Visit to Day 28

Interventionng/dL (Mean)
Group 1 - Standard Dose0.08

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Change in Serum Osteocalcin

Change in serum markers of bone formation (osteocalcin) from Day 0 to Day 28. (NCT00682357)
Timeframe: Change from Baseline Visit to Day 28

Interventionng/mL (Mean)
Group 1 - Standard Dose-2.18
Group 2 - Low Dose-0.45
Group 3 - Placebo-1.10

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Ocular Redness at Day 7

Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 7. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. (NCT00689078)
Timeframe: 7, 15, 20 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Alrex1.591.591.47
Pred Forte2.081.831.72
Pred Mild1.531.691.78
Tears Naturale1.591.661.5

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Ocular Itching at Baseline (Day 0)

A baseline CAC was performed on Day 0. Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. (NCT00689078)
Timeframe: 3, 5, 7 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
Alrex2.613.063.08
Pred Forte2.532.923.03
Pred Mild3.083.473.44
Tears Naturale2.52.752.83

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Ocular Itching at Day 27

Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 27. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. (NCT00689078)
Timeframe: 3, 5, 7 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
Alrex1.752.092
Pred Forte2.142.172.03
Pred Mild2.432.642.64
Tears Naturale2.031.841.72

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Ocular Itching at Day 28

Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. (NCT00689078)
Timeframe: 3, 5, 7 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
Alrex2.0321.78
Pred Forte1.831.971.89
Pred Mild2.252.642.71
Tears Naturale1.751.781.56

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Ocular Itching at Day 6

Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. (NCT00689078)
Timeframe: 3, 5, 7 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
Alrex2.062.412.31
Pred Forte2.172.442.17
Pred Mild2.192.592.72
Tears Naturale2.332.532.14

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Ocular Itching at Day 7

Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 7. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed. (NCT00689078)
Timeframe: 3, 5, 7 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
3 minutes post-CAC5 minutes post-CAC7 minutes post-CAC
Alrex2.092.031.88
Pred Forte2.112.111.97
Pred Mild2.282.692.75
Tears Naturale2.031.941.72

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Ocular Redness at Baseline (Day 0)

A baseline CAC was performed on Day 0. Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. (NCT00689078)
Timeframe: 7, 15, 20 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Alrex1.862.112
Pred Forte2.112.332.22
Pred Mild2.112.312.28
Tears Naturale2.082.252.06

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Ocular Redness at Day 27

Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 27. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. (NCT00689078)
Timeframe: 7, 15, 20 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Alrex1.441.631.53
Pred Forte1.721.721.53
Pred Mild2.142.111.89
Tears Naturale1.561.721.72

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Ocular Redness at Day 28

Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. (NCT00689078)
Timeframe: 7, 15, 20 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Alrex1.691.691.69
Pred Forte1.581.811.5
Pred Mild1.962.111.86
Tears Naturale1.811.941.72

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Ocular Redness at Day 6

Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed. (NCT00689078)
Timeframe: 7, 15, 20 minutes post-CAC

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Alrex1.842.132.03
Pred Forte21.972
Pred Mild2.222.412.31
Tears Naturale2.112.282.17

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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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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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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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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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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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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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Complete Response Rate

To evaluate the complete (CR) response rate with relapsed follicular NHL treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy (NCT00732498)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
ESHAP Followed by Zevalin and Rituximab10

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Median Time to Progression

To evaluate the median TTP of patients with relapsed follicular NHL treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy. (NCT00732498)
Timeframe: 5 years

Interventionmonths (Median)
ESHAP Followed by Zevalin and Rituximab10

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Overall Response Rate

To evaluate the overall (ORR) response rate with relapsed follicular NHL treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy. Descriptive and summary statistics for demographic and clinical variables obtained. The incidences of reported adverse events (AEs) tabulated. Kaplan-Meier survival analysis for PFS and OS performed on TPP. All the analyses were performed using Stata [12]. (NCT00732498)
Timeframe: 5 years

Interventionpercentage of participants (Number)
ESHAP Followed by Zevalin and Rituximab77.3

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Progression-free Survival at 1 Year

To evaluate the 1-year progression-free survival (PFS) of patients with relapsed follicular non-Hodgkin's lymphoma (NHL) treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy. (NCT00732498)
Timeframe: 1 year

Interventionpercentage of participants (Number)
ESHAP Followed by Zevalin and Rituximab38

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Global Perceived Effect

Satisfaction. Number of participants with positive perceived global satisfaction. (NCT00733096)
Timeframe: 1 month

Interventionparticipants (Number)
Steroid23
Etanercept15
Saline17

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Medication Reduction

Number of people who reduced medications (NCT00733096)
Timeframe: 1 month

Interventionparticipants (Number)
Steroid17
Etanercept9
Saline14

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Oswestry Disability Score

0-100%. 0= no disability, 100% is complete disability (NCT00733096)
Timeframe: 1 month

Interventionpercentage of disability out of 100% (Mean)
Steroid22.4
Etanercept40.26
Saline30.00

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Numerical Rating Leg Pain Score

0-10 pain score. 0= no pain, 10= worst imaginable pain. (NCT00733096)
Timeframe: 1 month

Interventionunits on a scale (Mean)
Steroid2.54
Etanercept3.56
Saline3.78

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Improvement of ACR 20 Scores at End of Study (Day 42/Visit 5)

The percentage of subjects in each group that achieved an ACR 20 response on Day 42 (NCT00747214)
Timeframe: Day 42

Interventionpercentage of participants (Number)
CRx-102 Plus DMARD Therapy63
Placebo Plus DMARD Therapy30

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Change in Fatigue (MAF Scale) Score From Baseline to Day 42

"The Multidimensional Assessment of Fatigue (MAF) scale is a self-administered, 16 item questionnaire to measure self-reported fatigue (http://www.son.washington.edu/research/maf/). The following steps were used to calculate a single score ranging from 1 (no fatigue) to 50 (severe fatigue).~Convert item #15 to a 0 to 10 scale by multiplying each score by 2.5~Sum items #1, 2, and 3~Average items #4 through 14~Add results from above Steps 1 through 3 to obtain a single score~A score was not be assigned to items #4 through 14 if a respondent indicated they did not engage any activity for reasons other than fatigue. If respondent selected no fatigue on item #1, a 0 was to be assigned to items #2 through 16; item #16 was not included in the global fatigue index." (NCT00747214)
Timeframe: Baseline and Day 42

Interventionunits on a scale (Mean)
CRx-102 Plus DMARD Therapy-7.840
Placebo Plus DMARD Therapy-2.965

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Change in DAS28 Score From Baseline to Day 42

To calculate the DAS28, the number of swollen joints and tender joints should be assessed using 28-joint counts, the ESR should have been measured in mm/hour, and the patient's general health (GH) or global disease activity measured on a Visual Analog Scale (VAS) of 100 mm must be obtained. Using these data, the DAS28 could be calculated using the following formula: DAS28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.70 * ln(ESR) + 0.014 * GH. The DAS28 provides a number between 0 and 10 that indicates the current activity of RA in the subject. A DAS28 above 5.1 means high disease activity and below 3.2 indicates low activity. Remission is achieved when a DAS28 score is lower than 2.6. The DAS28 measurements were to be taken at each visit. (NCT00747214)
Timeframe: Baseline and Day 42

Interventionunits on a scale (Mean)
CRx-102 Plus DMARD Therapy-1.521
Placebo Plus DMARD Therapy-0.697

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Change in CRP From Baseline to Day 42

The primary efficacy variable in this study was the change in CRP from Baseline (Day 1/Visit 2) to End of Study (Day 42/Visit 5). Blood samples for the analysis of serum CRP were taken at each visit. (NCT00747214)
Timeframe: Baseline and Day 42

Interventionpercentage change from baseline (Mean)
CRx-102 Plus DMARD Therapy-16.12
Placebo Plus DMARD Therapy9.60

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Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).

BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study. (NCT00782717)
Timeframe: From Day 7 to Day 90 (or Early Exit)

InterventionPercentage of patients (Number)
NEVANAC6
Nepafenac Vehicle12

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Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery

Macular edema (thickening of the center of the back of the eye) was defined as 30% or greater increase from pre-operative baseline measurement in central subfield macular thickness as measured using Optical Coherence Tomography(OCT). (NCT00782717)
Timeframe: 3 Months

InterventionPercentage of patients (Number)
NEVANAC3
Nepafenac Vehicle17

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Disability Score: Expanded Disability Status Scale (EDSS)

"Disability scores (disease improvement defined by at least a 1 point increase in the Expanded Disability Status Scale (EDSS) on consecutive evaluations at least three months apart.~The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability." (NCT00787722)
Timeframe: pretransplant 6 month, 5 year

Interventionscore on a scale (Mean)
Pretransplant Disability Score (EDSS)1 Year Post Transplant Disability Score (EDSS)5 Year Post Transplant Disability Score (EDSS)
Hematopoietic Stem Cell Transplantation4.42.83.3

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NMO-IgG Aquaporin- 4 Autoantibody Titer

NMO-IgG aquaporin- 4 autoantibody titer will be tested pretransplant and post transplant. (NCT00787722)
Timeframe: Pretransplant and 5 year Post Transplant

InterventionParticipants (Count of Participants)
Pretransplant NMO ASSAY positive5 year post transplant NMO Assay positive
Hematopoietic Stem Cell Transplantation112

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Number of Patients Who Require No Device Assistance for Ambulation

No Device Assistance Needed for Ambulation evaluated at 6 months, 1 year, 2 year, 3 year, 4 year, 5 year - after the transplant (NCT00787722)
Timeframe: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year - after the transplant

InterventionParticipants (Count of Participants)
Pre HSCT- No Assistive Required6 Mos Post HSCT- No Assistive Device Required1 Year Post HSCT- No Assistive Device Required2 Year Post HSCT- No Assistive Device Required3 Year Post HSCT- No Assistive Device Required4 Year Post HSCT- No Assistive Device Required5 Year Post HSCT- No Assistive Device Required
Hematopoietic Stem Cell Transplantation69109889

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Post HSCT Immune -Modulating Medication and Relapse

Number of immune - modulating medication and relapse evaluated 5 year - after the transplant (NCT00787722)
Timeframe: Pre transplant and 6 months, 1 year, 2 year, 3 year, 4 year and 5 year after transplant

InterventionParticipants (Count of Participants)
Pre HSCT - Immunosuppression/Relapse Rate6 Mos Post HSCT Immunosuppression/ Relapse Rate1 Year Post HSCT Immunosuppression/Relapse Rate2 Year Post HSCT Immunosuppression/Relapse Rate3 Year Post HSCT Immunosuppression/Relapse Rate4 Year Post HSCT Immunosuppression/Relapse Rate5 Year Post HSCT Immunosuppression Relapse Rate
Hematopoietic Stem Cell Transplantation (HSCT)12113011

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Quality of Life (QOL) Short Form - 36 (SF-36)

SF- 36 is a self-administered quality of life exam. The evaluation of the results was done by attributing scores to each question, which were then transformed into a scale ranging from 0 to 100, where 0 corresponds to the worst quality of life and 100 to the best. (NCT00787722)
Timeframe: pre-transplant 12mo and 5 years

Interventionscore on a scale (Median)
Pretransplant1 Year Post Transplant5 Year Post Transplant
Hematopoietic Stem Cell Transplantation30.8352.6961.63

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Survival

survival rate will be evaluated at 6 months,1 year, 2 year, 3 year, 4 year, 5 year after the transplant (NCT00787722)
Timeframe: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year - after the transplant

InterventionParticipants (Count of Participants)
6 months survival1 year survival2 year survival3 year survival4 year survival5 year survival
Hematopoietic Stem Cell Transplantation131212111111

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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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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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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 Hearing

Hearing was measured as ipsilesional pure-tone threshold at Baseline, 1month, 2months, 6months, 12month, 18months and 24 months follow-up. Hearing level was taken as the average threshold across 0.5, 1, 2 and 3KHz. (NCT00802529)
Timeframe: Baseline, 1,2,6,12,18 and 24months after initial treatment

,
InterventiondB (Mean)
Baseline1month2months6months12months18months24months
Gentamicin51.552.1848.9945.4847.3444.8249.1
Steroid (Methylprednisolone)53.2549.2949.8346.6747.0248.4446.9

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Vertigo Attacks

The number of vertigo attacks between 18-24months follow-up were taken retrospectively during a face-to-face appointment at 24 months follow-up and compared to 6 month pre-enrollment baseline (as per Committee on Hearing and Equilibrium guidelines). (NCT00802529)
Timeframe: 6month pre-enrollment baseline, 18-24 months after initial treatment

,
InterventionVertigo Attacks (Mean)
Baseline18-24months
Gentamicin19.932.5
Steroid (Methylprednisolone)16.41.6

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Change in Speech Discrimination

"Speech discrimination was measured at Baseline, 1month, 2months, 6months, 12month and 24 months follow-up.~Speech discrimination was assessed by means of ipsilesional suprathreshold word recognition (%). Arthur Boothroyd's isophonemic word lists (AB wordlists, Guymark, Southampton) comprising sets of 10 words were played to the ipsilesional ear at the low-frequency pure-tone threshold of 0·5, 1 and 2 kHz +30dB with masking sound in the contralesional ear if necessary. The formula for masking level was: low-frequency pure-tone threshold in ipsilesional ear - bone conduction mean threshold (0·5, 1 and 2KHz) in contralesional ear - 40dB. Speech loudness and masking were rounded to the nearest 5dB. Step increments and decrements of 10dB for speech loudness and masking were used to attain the maximum speech discrimination score." (NCT00802529)
Timeframe: Baseline, 1,2,6,12 and 24months after initial treatment

,
InterventionPercentage correct (Mean)
Baseline1month2months6months12months24months
Gentamicin72.1069.4374.3176.3571.5864.99
Steroid (Methylprednisolone)64.9771.7876.1075.6373.4376.32

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Overall Response

Complete response (CR) was defined as normalization of peripheral blood and bone marrow with <5% blasts, a peripheral absolute neutrophil count (ANC) >/= 1 * 10^9/l, hemoglobin >/= 100g/l, and a platelet count >/= * 10^9/l, Partial Response (PR) was defined as transfusion independence with a peripheral blood ANC >=/ 0.05 * 10^9/l, a platelet count >/= 20 * 10^9/l, and a hemoglobin >/= 40 g/l. Hematologic improvement was defined as a clinically relevant increase in hemoglobin, platelets or absolute neutrophil count. (NCT00806598)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Assessed first at 3 months on study, continuing monthly up to 3 years.

Interventionparticipants (Number)
Complete ResponsePartial ResponseHematological Improvement
Thymoglobulin + Cyclosporin884

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Repeat Intervention

Need for repeat ablation (NCT00807586)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
Steroid2
Placebo8

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Cardiac Pain Assessment

Perception of cardiac pain assessed by a numerical pain scale (0= no pain; 10=worst pain imaginable) (NCT00807586)
Timeframe: one day and one week

,
Interventionunits on a scale (Mean)
Pain Scale Day 1Pain Scale Week 1
Placebo1.50.6
Steroid0.90.8

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Number of Participants With Clinically Significant Atrial Arrhythmias at 6 Weeks

Clinically significant atrial arrhythmias include ER, urgent care, or hospitalization for atrial fibrillation, cardioversion for atrial fibrillation, or atrial fibrillation requiring an increase in anti-arrhythmia medication (NCT00807586)
Timeframe: 6 weeks

InterventionParticipants (Count of Participants)
Steroid4
Placebo12

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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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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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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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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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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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Means Aqueous Humor Prednisolone Acetate Concentration

(NCT00854061)
Timeframe: 35 days

Interventionng/mL (Mean)
T-Pred100.02
Pred Forte131.65

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Overall Safety of Bortezomib

Incidence of grade 3 and above non-hematologic toxicities. Incidence of grade 4 hematologic toxicities. Incidence of all grades of peripheral neuropathy. Incidence of Cytomegalovirus (CMV), Polyomavirus Allograft Nephropathy (PVN), and Posttransplant Lymphoproliferative Disorder (PTLD). (NCT00908583)
Timeframe: Study Day 62

,,,,,,,
Interventionparticipants (Number)
Incidence of CTCAE Grade 3 Anemia (<8.0-6.5 g/dL)Incidence of CTCAE Grade 4 Anemia (<6.5g/dL)Incidence of CTCAE Grade 3 ThrombocytopeniaIncidence of CTCAE Grade 4 ThrombocytopeniaIncidence of CTCAE Grade 3 NeutropeniaIncidence of CTCAE Grade 4 NeutropeniaIncidence of new onset level 1 PNIncidence of new onset level 2 PNIncidence of new onset level 3 PNIncidence of new onset level 4 PNIncidence of new onset level 5 PNCMV D+/R- StatusCMV Viremia or Invasive DiseasePolyomavirus Allograft Nephropathy (PVN)Malignancy
Phase 1 Cycle 2202010033100000
Phase 1, Cycle 1101000151010000
Phase 2 Cycle 2000000230000000
Phase 2, Cycle 1100000320100000
Phase 3, Cycle 1001000021000000
Phase 3, Cycle 2001000110010000
Phase 4, Single Stage000000000000000
Phase 5, Single Stage100000100000000

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Acute Rejection Rate

Acute rejection rate at 6 months of all desensitized and transplanted patients (NCT00908583)
Timeframe: 6 months post transplant

Interventionparticipants (Number)
All Transplanted Participants3

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Number of Patients Whose Cytotoxic Panel Reactive Antibody (PRA) is Decreased by 50%

Number of patients on the waiting list whose cytotoxic PRA is decreased by 50%. (NCT00908583)
Timeframe: 46 days

Interventionparticipants (Number)
All Study Participants6

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Number of Living Donor Transplant Candidates That Are Transplanted

Number of living donor transplant candidates who convert to a negative flow T- and B-cell crossmatch via desensitization and are subsequently transplanted (NCT00908583)
Timeframe: 1 year post baseline

Interventionparticipants (Number)
All Study Participants19

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Mean Frequency of Days With a Migraine

(NCT00915473)
Timeframe: 4 weeks post-injection

,
Interventiondays per 4 weeks (Mean)
SevereAt Least ModerateAt Least Mild
Active Injection3.47.09.3
Placebo Injection2.97.810.4

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Number of Subjects With at Least 50% Reduction in the Frequency of Days With Moderate or Severe Migraine in the 4 Week Post Injection Compared to the 4 Week Pre-injection Baseline Period

The baseline frequency will be the number of calendar days with moderate or severe migraine during the 4 week period prior to injection, and the follow-up frequency will be the number of calendar days with migraine during the 4 week period following injection. (NCT00915473)
Timeframe: 4 weeks pre-injection baseline, 4 weeks post-injection

Interventionparticipants (Number)
Active Injection10
Placebo Injection9

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Mean Number of Hours With Moderate or Severe Migraine

(NCT00915473)
Timeframe: 4 weeks post-injection

Interventionhours per 4 weeks (Mean)
Active Injection60
Placebo Injection58

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Mean Number of Days With Acute Medication Use

"Acute medication use meant the consumption of a drug to abort or terminate a headache." (NCT00915473)
Timeframe: 4 weeks post-injection

Interventiondays per 4 weeks (Mean)
Active Injection6.7
Placebo Injection7.7

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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 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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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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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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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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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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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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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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Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit

"The signs and symptoms of CD were rated on Physician's Global Assessment (PGA) 5-point scale (range, 0 - 4 scale): 0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. Success was defined as a score of 0 or 1 and failure was defined as a score of 2, 3, or 4." (NCT00929981)
Timeframe: Second follow-up visit (Day 5-28)

InterventionPercentage of Participants (Number)
SuccessFailure
Medrol93.86.30

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Treatment Status (Success/Failure) of CD at the Third Follow-up Visit

"The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 - 4 scale): 0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. Success was defined as a score of 0 or 1 and failure was defined as a score of 2, 3, or 4." (NCT00929981)
Timeframe: Third follow-up visit (between Day 6 to 10 after EOT)

InterventionPercentage of Participants (Number)
SuccessFailure
Medrol100.000

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Treatment Status (Success/Failure) of CD at the First Follow-up Visit

"The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 - 4 scale): 0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. Success was defined as a score of 0 or 1 and failure was defined as a score of 2, 3, or 4." (NCT00929981)
Timeframe: First follow-up visit (between Day 6 to 10 after start of treatment)

InterventionPercentage of Participants (Number)
SuccessFailure
Medrol52.5047.50

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Treatment Status (Success/Failure) of CD at the Final Follow-up Visit

"The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 - 4 scale): 0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. Success was defined as a score of 0 or 1 and failure was defined as a score of 2, 3, or 4." (NCT00929981)
Timeframe: Final follow-up visit (between Day 25 to 35 after EOT)

InterventionPercentage of Participants (Number)
SuccessFailure
Medrol100.000

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Change From Baseline in Participant-rated Pruritus Score at First, Second, Third and Final Follow-up Visits

Participant-rated pruritus score of lesions rated the severity of pruritus suffered in the past 24 hours on an 11-point NRS where 0 = no pruritus and 10 = most severe possible pruritus. (NCT00929981)
Timeframe: Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)

InterventionUnits on a scale (Mean)
BaselineChange at first follow-upChange at second follow-upChange at third follow-upChange at final follow-up
Medrol7.3-4.2-6.3-7.1-7.2

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Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits

Participant-rated clinical severity score of lesions rated the severity of all symptoms in the past 24 hours on an 11-point Numerical Rating Scale (NRS) where 0 = No lesions and 10 = Most severe possible lesions. (NCT00929981)
Timeframe: Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)

InterventionUnits on a scale (Mean)
BaselineChange at first follow-upChange at second follow-upChange at third follow-upChange at final follow-up
Medrol6.8-4.1-6.2-6.7-6.8

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Change From Baseline in Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits

Investigator-rated total signs and symptoms score of CD included pruritus, erythema, induration, vesiculation, edema or other specific sign or symptom rated on a 5 point scale of 0 - 4 (0=none, 1=mild, 2=moderate, 3=severe, 4=extreme) with a total score of 0 - 20 (lower score was preferred). (NCT00929981)
Timeframe: Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)

InterventionUnits on a scale (Mean)
BaselineChange at first follow-upChange at second follow-upChange at third follow-upChange at final follow-up
Medrol9.2-5.6-8.3-9.0-9.1

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Total Intake/Output of Fluid

Total amount of all fluids in and out during the first 36 hours postoperatively in mL. (NCT00934843)
Timeframe: over 36 hours

,
InterventionmL (Mean)
Total Fluid in at 36 hrTotal Fluid out at 36 hr
MP Single Dose575600
MP Two Dose586558

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Urine Output

Total urine output in mL over the first 36 hours after cardiac surgery (NCT00934843)
Timeframe: over 36 hours

InterventionmL (Mean)
MP Single Dose498
MP Two Dose453

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Inotropic Score

The inotropic score was calculated by the equation using drug dosages in micrograms/kg/min, (dopamine+dobutamine) + (milrinonex10) + (epinephrinex100) and recorded hourly upon arrival to the ICUthrough 36 hours postoperatively. The highest score during this timeframe was recorded. This score converts dosages of commonly used inotropic medications into a score. The higher the score the more inotropic medications required. The minimum score would be zero indicating no inotropic medications were used. There is no maximum score. (NCT00934843)
Timeframe: over the first 36 hours after surgery

InterventionScores on a scale (Mean)
MP Single Dose14.4
MP Two Dose15.0

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Number of Participants Who Died Between 36 Hours and 30 Days Following Cardiac Surgery

Number of participants who died of any cause between 36 hours and 30 days following cardiac surgery (NCT00934843)
Timeframe: at 36 hours and 30 days

Interventionparticipants (Number)
MP Single Dose1
MP Two Dose0

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Primary Endpoint: Number of Participants With Low Cardiac Output Syndrome (LCOS) or Death at 36 Hours From Admission to the Intensive Care Unit (ICU) After Surgery.

The presence of low cardiac output syndrome (LCOS) was defined by the same definition used in the PRIMACORP study (Hoffman TM.et.al. Circulation 2003 107:996-1002). Specifically, if there were clinical signs and symptoms of low cardiac output (e.g., tachycardia, oliguria, cold extremities, cardiac arrest, etc.) which required one or more of the following interventions: mechanical circulatory support, the escalation of existing pharmacological circulatory support to >100% over baseline, or the initiation of new pharmacological circulatory support. (NCT00934843)
Timeframe: 36 hours

Interventionparticipants (Number)
MP Single Dose17
MP Two Dose15

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Pain(at 1 Week): Nirschl Staging (0 to 7)

"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain" (NCT00947765)
Timeframe: 1 week

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group5.1
Local Corticosteroid Injection Group3.06

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Pain(at 12 Weeks): Nirschl Staging

"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain" (NCT00947765)
Timeframe: 12 weeks

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group0.433
Local Corticosteroid Injection Group1.03

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Pain(at 12 Weeks): Visual Analogue Scale

"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted visual analogue scale. It consists of a 10 centimeter line marked at one end with no pain and at other end with worst pain ever. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between no pain to patients mark.~No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever." (NCT00947765)
Timeframe: 12 weeks

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group0.6
Local Corticosteroid Injection Group1.5

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Pain(at 4 Weeks): Nirschl Staging

"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain" (NCT00947765)
Timeframe: 4 weeks

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group2.2
Local Corticosteroid Injection Group1.03

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Pain(at 4 Weeks): Visual Analogue Scale

"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted visual analogue scale. It consists of a 10 centimeter line marked at one end with no pain and at other end with worst pain ever. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between no pain to patients mark.~No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever." (NCT00947765)
Timeframe: 4 weeks

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group3.2
Local Corticosteroid Injection Group1.533

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Pain(at 6 Months): Nirschl Staging

"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain" (NCT00947765)
Timeframe: 6 months

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group0.366
Local Corticosteroid Injection Group1.233

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Pain(at 6 Months): Visual Analogue Scale

"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted visual analogue scale. It consists of a 10 centimeter line marked at one end with no pain and at other end with worst pain ever. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between no pain to patients mark.~No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever." (NCT00947765)
Timeframe: 6 months

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group0.533
Local Corticosteroid Injection Group1.833

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Pain (at 1 Week): Visual Analogue Scale(0 to 10)

"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted visual analogue scale. It consists of a 10 centimeter line marked at one end with no pain and at other end with worst pain ever. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between no pain to patients mark.~No pain____1___2___3___4___5___6___7___8___9___10 worst pain ever." (NCT00947765)
Timeframe: 1 week

InterventionUnits on a scale (Mean)
Autologous Blood Injection Group7.166
Local Corticosteroid Injection Group4.5

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Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 8 (Post Study)

Dehydroepiandrosterone sulfate (DHEA-S) was measured before and after the treatment week on study treatment days 1 and 8. DHEA-S was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 28-290 ug/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionug/dL (Mean)
Testosterone Injection37.96
Testosterone Gel35.54
Medrol 6 Day Dose Pack34.74
Testosterone Injection and Medrol 6 Day Dose Pack36.07

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Serum Total Testosterone Measured on Treatment Day 8 (Post Study)

"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 8

Interventionng/dL (Mean)
Testosterone Injection454.29
Testosterone Gel435.14
Medrol 6 Day Dose Pack340.17
Testosterone Injection and Medrol 6 Day Dose Pack481.14

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Serum Total Testosterone Measured on Treatment Day 7

"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 7

Interventionng/dL (Mean)
Testosterone Injection578.29
Testosterone Gel485.86
Medrol 6 Day Dose Pack320.0
Testosterone Injection and Medrol 6 Day Dose Pack579.57

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Serum Total Testosterone Measured on Treatment Day 6

"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 6

Interventionng/dL (Mean)
Testosterone Injection629.0
Testosterone Gel536.43
Medrol 6 Day Dose Pack284.5
Testosterone Injection and Medrol 6 Day Dose Pack645.14

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Serum Total Testosterone Measured on Treatment Day 5

"TesTestosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 5

Interventionng/dL (Mean)
Testosterone Injection722.0
Testosterone Gel460.14
Medrol 6 Day Dose Pack246.33
Testosterone Injection and Medrol 6 Day Dose Pack669.71

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Serum Total Testosterone Measured on Treatment Day 4

"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 4

Interventionng/dL (Mean)
Testosterone Injection779.57
Testosterone Gel441.71
Medrol 6 Day Dose Pack271.6
Testosterone Injection and Medrol 6 Day Dose Pack734.57

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Serum Total Testosterone Measured on Treatment Day 3

"TTestosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 3

Interventionng/dL (Mean)
Testosterone Injection828.71
Testosterone Gel527.43
Medrol 6 Day Dose Pack206.0
Testosterone Injection and Medrol 6 Day Dose Pack673.29

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Serum Total Testosterone Measured on Treatment Day 2

"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 2

Interventionng/dL (Mean)
Testosterone Injection980.86
Testosterone Gel526.71
Medrol 6 Day Dose Pack191.87
Testosterone Injection and Medrol 6 Day Dose Pack675.86

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Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study)

"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration." (NCT00957801)
Timeframe: treatment day 1

Interventionng/dL (Mean)
Testosterone Injection307.57
Testosterone Gel363.43
Medrol 6 Day Dose Pack408.17
Testosterone Injection and Medrol 6 Day Dose Pack318.68

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Serum Estradiol Measured on Treatment Day 8 (Post Study)

Estradiol was measured during the treatment week (treatment days 1 and 8). Serum estradiol was analyzed by UTMB clinical laboratory. Normal ranges are 20-47 pg/mL. (NCT00957801)
Timeframe: treatment day 8

Interventionpg/mL (Mean)
Testosterone Injection48.29
Testosterone Gel33.43
Medrol 6 Day Dose Pack30.83
Testosterone Injection and Medrol 6 Day Dose Pack47.14

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Serum Estradiol Measured on Treatment Day 1 (Baseline Study)

Estradiol was measured during the treatment week (treatment days 1 and 8). Serum estradiol was analyzed by UTMB clinical laboratory. Normal ranges are 20-47 pg/mL. (NCT00957801)
Timeframe: treatment day 1

Interventionpg/mL (Mean)
Testosterone Injection22.86
Testosterone Gel33.69
Medrol 6 Day Dose Pack36.33
Testosterone Injection and Medrol 6 Day Dose Pack34.71

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Prostate Specific Antigen (PSA) Measured on Treatment Day 8 (Post Study)

Prostate Specific Antigen (PSA) was measured before and after treatment week (study treatment days 1 and 8). PSA was analyzed by UTMB clinical laboratory. Normal ranges are less than 4.0 ng/mL. (NCT00957801)
Timeframe: treatment day 8

Interventionng/mL (Mean)
Testosterone Injection1.98
Testosterone Gel2.32
Medrol 6 Day Dose Pack1.78
Testosterone Injection and Medrol 6 Day Dose Pack2.07

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Prostate Specific Antigen (PSA) Measured on Treatment Day 1 (Baseline Study)

Prostate Specific Antigen (PSA) was measured before and after treatment week (study treatment days 1 and 8). PSA was analyzed by UTMB clinical laboratory. Normal ranges are less than 4.0 ng/mL. (NCT00957801)
Timeframe: treatment day 1

Interventionng/mL (Mean)
Testosterone Injection1.92
Testosterone Gel2.33
Medrol 6 Day Dose Pack1.85
Testosterone Injection and Medrol 6 Day Dose Pack1.83

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Low-Density Lipoproteins (LDL) Measured on Treatment Day 8 (Post Study)

Low Density Lipoproteins (LDL) was measured before and after treatment week (study treatment days 1 and 8). LDL was analyzed by UTMB clinical laboratory. Normal ranges are less than 160 mg/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionmg/dL (Mean)
Testosterone Injection104.0
Testosterone Gel94.57
Medrol 6 Day Dose Pack87.5
Testosterone Injection and Medrol 6 Day Dose Pack75.14

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Low-Density Lipoproteins (LDL) Measured on Treatment Day 1 (Baseline Study)

Low Density Lipoproteins (LDL) was measured before and after treatment week (study treatment days 1 and 8). LDL was analyzed by UTMB clinical laboratory. Normal ranges are less than 160 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionmg/dL (Mean)
Testosterone Injection103.0
Testosterone Gel93.57
Medrol 6 Day Dose Pack96.83
Testosterone Injection and Medrol 6 Day Dose Pack90.71

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Insulin Measured on Treatment Day 8 (Post Study)

Insulin was measured before and after the treatment week on study treatment days 1 and 8. Insulin was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is less than 25 uIu/mL. (NCT00957801)
Timeframe: treatment day 8

InterventionuIu/mL (Mean)
Testosterone Injection7.47
Testosterone Gel10.58
Medrol 6 Day Dose Pack3.92
Testosterone Injection and Medrol 6 Day Dose Pack3.89

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Insulin Measured on Treatment Day 1 (Baseline Study)

Insulin was measured before and after the treatment week on study treatment days 1 and 8. Insulin was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is less than 25 uIu/mL. (NCT00957801)
Timeframe: treatment day 1

InterventionuIu/mL (Mean)
Testosterone Injection8.53
Testosterone Gel10.28
Medrol 6 Day Dose Pack4.09
Testosterone Injection and Medrol 6 Day Dose Pack9.89

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Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 8 (Post Study)

Insulin like growth factor 1 (IGF-1) was measured before and after the treatment week on study treatment days 1 and 8. IGF-1 was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 33-220 ng/mL. (NCT00957801)
Timeframe: treatment day 8

Interventionng/mL (Mean)
Testosterone Injection80.16
Testosterone Gel72.11
Medrol 6 Day Dose Pack69.17
Testosterone Injection and Medrol 6 Day Dose Pack54.86

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Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 1 (Baseline Study)

Insulin like growth factor 1 (IGF-1) was measured before and after the treatment week on study treatment days 1 and 8. IGF-1 was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 33-220 ng/mL. (NCT00957801)
Timeframe: treatment day 1

Interventionng/mL (Mean)
Testosterone Injection71.77
Testosterone Gel69.2
Medrol 6 Day Dose Pack61.42
Testosterone Injection and Medrol 6 Day Dose Pack90.74

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High-Density Lipoproteins (HDL) Measured on Treatment Day 8 (Post Study)

High Density Lipoproteins (HDL) was measured before and after treatment week (study treatment days 1 and 8). HDL was analyzed by UTMB clinical laboratory. Normal ranges are higher than 35 mg/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionmg/dL (Mean)
Testosterone Injection41.29
Testosterone Gel36.71
Medrol 6 Day Dose Pack47.67
Testosterone Injection and Medrol 6 Day Dose Pack43.43

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High-Density Lipoproteins (HDL) Measured on Treatment Day 1 (Baseline Study)

High Density Lipoproteins (HDL) was measured before and after treatment week (study treatment days 1 and 8). HDL was analyzed by UTMB clinical laboratory. Normal ranges are higher than 35 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionmg/dL (Mean)
Testosterone Injection40.29
Testosterone Gel38.86
Medrol 6 Day Dose Pack46.50
Testosterone Injection and Medrol 6 Day Dose Pack42.14

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Hematocrit Measured on Treatment Day 8 (Post Study)

Hematocrit was measured before and after treatment week (study treatment days 1 and 8). Hematocrit was analyzed by UTMB clinical laboratory. Normal ranges are 38.4% - 49.3%. (NCT00957801)
Timeframe: treatment day 8

Interventionpercent (Mean)
Testosterone Injection38.74
Testosterone Gel37.23
Medrol 6 Day Dose Pack40.53
Testosterone Injection and Medrol 6 Day Dose Pack39.24

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Hematocrit Measured on Treatment Day 1 (Baseline Study)

Hematocrit was measured before and after treatment week (study treatment days 1 and 8). Hematocrit was analyzed by UTMB clinical laboratory. Normal ranges are 38.4% - 49.3%. (NCT00957801)
Timeframe: treatment day 1

Interventionpercent (Mean)
Testosterone Injection39.17
Testosterone Gel38.4
Medrol 6 Day Dose Pack40.45
Testosterone Injection and Medrol 6 Day Dose Pack39.86

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Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) in the Pre-treatment Week

"The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with 0 being no fatigue and 10 being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions.~This data is presented as the pre-treatment week average of study days -7 to -1." (NCT00957801)
Timeframe: Study days -7 to -1 (Pre - treatment)

Interventionunits on a scale (Mean)
Testosterone Injection2.25
Testosterone Gel1.47
Medrol 6 Day Dose Pack2.26
Testosterone Injection and Medrol 6 Day Dose Pack1.86

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Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) During the Treatment Week

"The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with 0 being no fatigue and 10 being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions.~This data is presented as the treatment week average of study days 1-8." (NCT00957801)
Timeframe: Study days 1-7 (treatment week)

Interventionunits on a scale (Mean)
Testosterone Injection1.84
Testosterone Gel1.79
Medrol 6 Day Dose Pack2.19
Testosterone Injection and Medrol 6 Day Dose Pack1.57

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Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 1 (Baseline Study)

Dehydroepiandrosterone sulfate (DHEA-S) was measured before and after the treatment week on study treatment days 1 and 8. DHEA-S was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 28-290 ug/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionug/dL (Mean)
Testosterone Injection46.34
Testosterone Gel34.16
Medrol 6 Day Dose Pack62.55
Testosterone Injection and Medrol 6 Day Dose Pack46.07

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Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 8 (Post Study)

Very Low Density Lipoproteins (VLDL) was measured before and after treatment week (study treatment days 1 and 8). VLDL was analyzed by UTMB clinical laboratory. Normal ranges are 5-60 mg/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionmg/dL (Mean)
Testosterone Injection26.71
Testosterone Gel29.29
Medrol 6 Day Dose Pack31.0
Testosterone Injection and Medrol 6 Day Dose Pack24.71

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Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 1 (Baseline Study)

Very Low Density Lipoproteins (VLDL) was measured before and after treatment week (study treatment days 1 and 8). VLDL was analyzed by UTMB clinical laboratory. Normal ranges are 5-60 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionmg/dL (Mean)
Testosterone Injection28
Testosterone Gel33.14
Medrol 6 Day Dose Pack24.67
Testosterone Injection and Medrol 6 Day Dose Pack23.86

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Triglycerides Measured on Treatment Day 8 (Post Study)

Triglycerides were measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 30-170 mg/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionmg/dL (Mean)
Testosterone Injection112.57
Testosterone Gel160.0
Medrol 6 Day Dose Pack155.17
Testosterone Injection and Medrol 6 Day Dose Pack116.28

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Triglycerides Measured on Treatment Day 1 (Baseline Study)

Triglycerides were measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 30-170 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionmg/dL (Mean)
Testosterone Injection140.42
Testosterone Gel164.0
Medrol 6 Day Dose Pack122.5
Testosterone Injection and Medrol 6 Day Dose Pack119.71

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Total Cholesterol Measured on Treatment Day 8 (Post Study)

Total Cholesterol was measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 120-200 mg/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionmg/dL (Mean)
Testosterone Injection172
Testosterone Gel162.86
Medrol 6 Day Dose Pack166.17
Testosterone Injection and Medrol 6 Day Dose Pack141.86

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Total Cholesterol Measured on Treatment Day 1 (Baseline Study)

Total Cholesterol was measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 120-200 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionmg/dL (Mean)
Testosterone Injection171.29
Testosterone Gel165.57
Medrol 6 Day Dose Pack168.00
Testosterone Injection and Medrol 6 Day Dose Pack156.71

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Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 8 (Post Study)

Sex Hormone Binding Globulin (SHBG) was measured before and after the treatment week on study treatment days 1 and 8. SHBG was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 10-57 nmol/L. (NCT00957801)
Timeframe: treatment day 8

Interventionnmol/L (Mean)
Testosterone Injection17.62
Testosterone Gel20.13
Medrol 6 Day Dose Pack19.22
Testosterone Injection and Medrol 6 Day Dose Pack14.57

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Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 1 (Baseline Study)

Sex Hormone Binding Globulin (SHBG) was measured before and after the treatment week on study treatment days 1 and 8. SHBG was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 10-57 nmol/L. (NCT00957801)
Timeframe: treatment day 1

Interventionnmol/L (Mean)
Testosterone Injection21.78
Testosterone Gel19.86
Medrol 6 Day Dose Pack25.66
Testosterone Injection and Medrol 6 Day Dose Pack24.70

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Cortisol Measured on Treatment Day 8 (Post Study) BEFORE Exercise Protocol

Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL. (NCT00957801)
Timeframe: treatment day 8 - before exercise

Interventionug/dL (Mean)
Testosterone Injection7.84
Testosterone Gel5.97
Medrol 6 Day Dose Pack6.28
Testosterone Injection and Medrol 6 Day Dose Pack5.19

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Cortisol Measured on Treatment Day 8 (Post Study) AFTER Exercise Protocol

Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL. (NCT00957801)
Timeframe: treatment day 8 - after exercise

Interventionug/dL (Mean)
Testosterone Injection7.05
Testosterone Gel6.28
Medrol 6 Day Dose Pack4.40
Testosterone Injection and Medrol 6 Day Dose Pack5.78

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Cortisol Measured on Treatment Day 1 (Baseline Study) BEFORE Exercise Protocol

Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL. (NCT00957801)
Timeframe: treatment day 1 - before exercise

Interventionug/dL (Mean)
Testosterone Injection7.25
Testosterone Gel6.00
Medrol 6 Day Dose Pack6.64
Testosterone Injection and Medrol 6 Day Dose Pack6.28

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Cortisol Measured on Treatment Day 1 (Baseline Study) AFTER Exercise Protocol

Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL. (NCT00957801)
Timeframe: treatment day 1 - after exercise

Interventionug/dL (Mean)
Testosterone Injection7.71
Testosterone Gel7.20
Medrol 6 Day Dose Pack4.76
Testosterone Injection and Medrol 6 Day Dose Pack4.15

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C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post Study)

C-Reactive Protein (CRP) was measured during the treatment week (study treatment days 1 and 8). CRP was analyzed by UTMB clinical laboratory. Normal ranges are 0.0 - 0.8 mg/dL. (NCT00957801)
Timeframe: treatment day 8

Interventionmg/dL (Mean)
Testosterone Injection0.47
Testosterone Gel0.31
Medrol 6 Day Dose Pack0.32
Testosterone Injection and Medrol 6 Day Dose Pack0.3

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C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline Study)

C-Reactive Protein (CRP) was measured during the treatment week (study treatment days 1 and 8). CRP was analyzed by UTMB clinical laboratory. Normal ranges are 0.0 - 0.8 mg/dL. (NCT00957801)
Timeframe: treatment day 1

Interventionmg/dL (Mean)
Testosterone Injection0.47
Testosterone Gel0.33
Medrol 6 Day Dose Pack0.32
Testosterone Injection and Medrol 6 Day Dose Pack0.4

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Pulmonary/Respiratory Adverse Events

Number of pulmonary/respiratory adverse events (CTCAE 22) in each study arm (NCT00967226)
Timeframe: enrollment through study close out or withdrawal, up to 9 months

InterventionAdverse Events (Number)
Pulmonary/Respiratory AEs Propranolol14
Pulmonary/Respiratory AEs Prednisolone4

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Vascular Adverse Events

Number of Vascular AEs in each study arm. (NCT00967226)
Timeframe: enrollment to study withdrawal or close out up to 9 months

InterventionAdverse Events (Number)
Vascular AEs Propranolol3
Vascular AEs Prednisolone4

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Allergy/Immunology Adverse Events

Number of allergy/immunology AE per study arm (NCT00967226)
Timeframe: enrollment through study closeout or study withdrawal up to 9 months

InterventionAdverse Events (Number)
Allergy/Immunology Events Propranolol1
Allergy/Immunology Events Prednisolone1

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Infectious Adverse Events

Number of infectious AEs in each study arm (i.e. conjunctivitis, thrush, fever) (NCT00967226)
Timeframe: enrollment to study withdrawal or close out up to 9 months

InterventionAdverse Events (Number)
Infectious AEs Propranolol5
Infectious AEs Prednisolone3

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Growth and Development Adverse Events

Number of Growth and Development AEs in each study arm (NCT00967226)
Timeframe: enrollment to study withdrawal or close out up to 9 months

InterventionAdverse Events (Number)
Growth/Developoment AEs Propranolol0
Growth/Development AEs Prednisolone1

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Tolerability of Medication

All adverse events relating to medication tolerability including: adrenal crisis, growth/development, constitutional (dehydration), allergy/immunology, dermatologic, endocrine, GI, infection, metabolism/labs, pulmonary, vascular. (NCT00967226)
Timeframe: enrollment until study close out or withdrawal up to 9 months

,
InterventionEvents (Number)
Adverse EventsSerious Adverse Events
Overall Number of Adverse Events in Prednisolone3011
Overall Number of Adverse Events in Propranolol341

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Gastrointestinal Adverse Events

Number of Gastrointestinal AEs in each arm (NCT00967226)
Timeframe: enrollment to study withdrawal or study close out up to 9 months

InterventionAdverse Events (Number)
Gastrointestinal AEs Propranolol6
Gastrointestinal AEs Prednisolone6

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Endocrinologic Adverse Events

Number of Endocrinologic AEs (of which adrenal crisis does not overlap). (NCT00967226)
Timeframe: enrollment to close out or study withdrawal up to 9 months

InterventionAdverse Events (Number)
Endocrine AEs Propranolol0
Endocrinologic AEs Prednisolone7

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Dermatologic Adverse Events

Number of Dermatologic Adverse Events in each study arm. (NCT00967226)
Timeframe: enrollment to study close out or withdrawal up to 9 months

InterventionAdverse Events (Number)
Dermatologic AEs Propranolol2
Dermatologic AEs Prednisolone1

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Decrease in Size of Hemangioma (Length x Width) in Square mm

A priori primary outcome was proportional change in the total surface area as measured by lesion's outer margin length x width at baseline minus the same measure at 4 months with surrogate data used at 5 months if 4 months not available. (NCT00967226)
Timeframe: 4-5 months after initiating therapy

Interventionmm squared (Mean)
Propranolol0.57
Prednisolone0.63

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Constitutional Adverse Events

Number of constitutional AEs in each study arm. (NCT00967226)
Timeframe: enrollment to study close out or withdrawal up to 9 months

InterventionAdverse Events (Number)
Constitutional AEs Propranolol2
Constitutional AEs Prednisolone3

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Number of Serious Adverse Events (SAEs)

Number of serious adverse events experienced by the participants in each treatment arm within the categories adrenal crisis, growth/development, constitutional. Serious adverse events are defined as events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity, or result in a congenital anomaly/birth defect. Other important medical events, based upon appropriate medical judgment, may also be considered Serious Adverse Events if a trial participant's health is at risk and intervention is required to prevent an outcome mentioned. (NCT00967226)
Timeframe: enrollment until study close out or withdrawal up to 9 months

InterventionSerious Adverse Events (Number)
Number of Serious Adverse Events in Propranolol1
Number of Serious Adverse Events in Prednisolone11

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Metabolic or Laboratory AEs

Number of Metabolic or Laboratory AEs in each study arm. (NCT00967226)
Timeframe: enrollment to study withdrawal or close out up to 9 months

InterventionAdverse Events (Number)
Metabolic/Laboratory AEs Propranolol1
Metabolic/Laboratory AEs Prednisolone0

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Maximum Tolerated Dose [MTD] Determination by Number of Participants With Dose Limiting Toxicity (DLT)

"The Maximum tolerated dose (MTD) was the highest dose level at which fewer than 2 of 6 patients developed a dose limiting toxicity (DLT) in the first two cycles of therapy. A 3 by 3 design was used for dose escalation in the phase I portion of the study.~A dose-limiting toxic effect (DLT) was defined as a clinically significant adverse event or abnormal laboratory value directly attributable to everolimus and assessed as unrelated to disease progression, intercurrent illness, or concomitant medications, occurring during the first or second cycle of therapy, that met any of the following criteria: CTCAE version 3.0 grade 3 increased AST or ALT for 7 days, CTCAE grade 4 increased AST or ALT of any duration, or any other clinically significant CTCAE grade 3 or 4 toxic effect. Electrolyte abnormalities (changes in glucose, chemistries, liver enzymes, pancreatic enzymes) correctable by optimal therapy and without clinical impact were not considered DLTs." (NCT00968253)
Timeframe: Following first two dose cycles (21 days/each), up to 42 days

InterventionParticipants (Count of Participants)
Phase I: RAD001 5 mg + Combination Chemo0
Phase I: RAD001 10 mg + Combination Chemo1

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Overall Response Rate (OR) Where OR = CR + CRp + CRi

Number of participants out of total treated who experienced a complete response response according to RECIST criteria either (CR + CRp) CR Without Platelet Recovery. Response (CR + CRp) defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x10^9/L, platelet count > 100 x10^9/L, and blasts < 5% in a normocellular or hypercellular marrow. Complete remission without platelet recovery (CRp): Peripheral blood and marrow parameters as for CR, but with platelet count > 20 x 10^9/L and < 100 x 10^9/L in the absence of platelet transfusions. CR with incomplete blood count recovery (CRi): Same as CR but platelets ≤ 100,000/mcl and/or neutrophils ≤ 1,000/mcl. (NCT00968253)
Timeframe: 8 courses of treatment, up to 24 weeks

Interventionpercentage of participants (Number)
Phase I: RAD001 5 mg + Combination Chemo33
Phase I: RAD001 10 mg + Combination Chemo33
Phase II: MTD RAD001 + Combination Chemo33

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Participant Responses by Daily Dose Level Assignment (RAD001 5 mg, 10 mg and MTD 5 mg)

Response defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x10^9/L, platelet count > 100 x10^9/L, and blasts < 5% in a normocellular or hypercellular marrow. Complete remission without platelet recovery (CRp): Peripheral blood and marrow parameters as for CR, but with platelet count > 20 x 10^9/L and < 100 x 10^9/L in the absence of platelet transfusions. CR with incomplete blood count recovery (CRi): Same as CR but platelets ≤ 100,000/mcl and/or neutrophils ≤ 1,000/mcl. Partial remission (PR): Peripheral blood count recovery as for CR, with decrease in marrow blasts by > 50% from pretreatment values with no more than 25% leukemia/lymphoma cells in the marrow. Nonresponder, Other: All other responses will be considered failures. (NCT00968253)
Timeframe: Up to 20 cycles of study drugs (21 day cycles) or till disease progression

,,
Interventionparticipants (Number)
Complete RemissionComplete Remission without platelet recoveryCR with incomplete blood count recoveryPartial RemissionNonresponder
Phase I: RAD001 10 mg + Combination Chemo20115
Phase I: RAD001 5 mg + Combination Chemo10011
Phase II: MTD RAD001 + Combination Chemo31008

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Intraocular Pressure (IOP) Change

IOP will be measured before and at 6 and 12 weeks after intervention using Goldman tonometry. (NCT00981435)
Timeframe: Baseline to Week 12

InterventionmmHg (Mean)
Artificial Tears-3.0
Non-steroidal Anti-inflammatory-6.2
Steroid-5.2

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Intraocular Inflammation

The count of patients with inflammation defined as anterior chamber cells was measured in each study arm. (NCT00981435)
Timeframe: Up to week 12

InterventionParticipants (Count of Participants)
Artificial Tears0
Non-steroidal Anti-inflammatory0
Steroid0

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Percentage of Patients Achieving Complete Remission From Nephrotic Syndrome at 16 and 26 Weeks

(NCT00982072)
Timeframe: 16 and 26 weeks

,
InterventionParticipants (Count of Participants)
16 weeks26 weeks
Prednisolone2323
Tacrolimus1922

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Percentage of Patients Achieving Remission Who Then Relapse

(NCT00982072)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Prednisolone17
Tacrolimus16

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Percentage of Participants Achieving Complete Remission From Nephrotic Syndrome at 8 Weeks

normalisation of serum albumin and urine PCR <50 units (NCT00982072)
Timeframe: 8 weeks

InterventionParticipants (Count of Participants)
Prednisolone21
Tacrolimus17

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Number of Serious Adverse Events

(NCT00982072)
Timeframe: 3 years

Interventionserious adverse events (Number)
Prednisolone4
Tacrolimus3

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Number of Participants Achieving Treatment Response

"Response was defined as a minimum decrease from baseline in total Mayo score of 3 points and 30% up to and including 4 weeks after the start of treatment. The Mayo score consists of the following 4 subscores: stool frequency; rectal bleeding; endoscopy results; physician's global assessment. Each subscore~is rated on a scale from 0 (best) to 3 (worst). The total Mayo score is calculated as the sum of the 4 subscores and ranges from 0 (best) to 12 (worst)." (NCT00984568)
Timeframe: Up to Week 4

InterventionParticipants (Number)
Top-Hold10
Step-Up10

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Number of Participants With Response at Week 4 and Steroid-Free Remission at Week 50

Response at Week 4 was defined as a minimum decrease from baseline in Mayo score of 3 points and 30%. Steroid-free remission at Week 50 was defined as a total Mayo score (including endoscopic assessment) of 2 points or lower and no individual subscore exceeding 1. The Mayo score consists of the following 4 subscores: stool frequency; rectal bleeding; endoscopy results; physician's global assessment. Each subscore is rated on a scale from 0 (best) to 3 (worst). The total Mayo score is calculated as the sum of the 4 subscores and ranges from 0 (best) to 12 (worst). (NCT00984568)
Timeframe: Week 50

InterventionParticipants (Number)
Top-Hold5
Step-Up5

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Maximum Observed Plasma Concentration (Cmax) of Prednisolone - Phase I

Cmax of Prednisolone at dose of 60 mg/m2 on Cycle 2/Day 4 (NCT00985959)
Timeframe: Day 4 of Cycle 2

Interventionng/mL (Mean)
Prednisolone1131

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Median Time to First Response - Phase II

Time to first response is the duartion of time required to achieve first response to treatment (NCT00985959)
Timeframe: up to 54 weeks

InterventionDays (Median)
Phase II - JNJ-26866138 1.3 mg/m2 Group51

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Number of Participants With Dose Limiting Toxicity During the Phase I (Cycle 1)

Dose limiting toxicity defined as an adverse event or adverse drug reaction experienced by the participants during 6 weeks of treatment Cycle 1 (NCT00985959)
Timeframe: 6 weeks

InterventionParticipants (Number)
Phase I - JNJ-26866138 0.7 mg/m2 Group0
Phase I - JNJ-26866138 1.0 mg/m2 Group0
Phase I - JNJ-26866138 1.3 mg/m2 Group1

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Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 in Combination With Melphalan and Prednisolone) - Phase I

Cmax of bortezomib following intravenous administration of JNJ-26866138 at dose of 0.7, 1.0, and 1.3 mg/m2 on Cycle 2/Day 4 (combination with melphalan and prednisolone) (NCT00985959)
Timeframe: Day 4 of Cycle 2

Interventionng/mL (Mean)
Phase I - JNJ-26866138 0.7 mg/m2 Group34.40
Phase I - JNJ-26866138 1.0 mg/m2 Group69.50
Phase I - JNJ-26866138 1.3 mg/m2 Group88.87

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Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 Alone) - Phase I

Cmax of bortezomib following intravenous administration of JNJ-26866138 at dose of 0.7, 1.0, and 1.3 mg/m2 on Cycle 1/Day 25 (JNJ-26866138 alone) (NCT00985959)
Timeframe: Day 25 of Cycle 1

Interventionng/mL (Mean)
Phase I - JNJ-26866138 0.7 mg/m2 Group45.43
Phase I - JNJ-26866138 1.0 mg/m2 Group59.42
Phase I - JNJ-26866138 1.3 mg/m2 Group120.3

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Number of Participants With Overall Response (Complete Response [CR] + Partial Response [PR]) - Phase I and II

Response is evaluated as per the criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation (Blade et al. 1998). CR: disappearance of the original monoclonal protein from the blood and urine and <5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks; no increase in the size or number of lytic bone lesions; disappearance of soft tissue plasmacytomas for at least 6 weeks. PR: ≥50% reduction in the level of serum monoclonal protein 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 for at least 6 weeks; no increase in size or number of lytic bone lesions (NCT00985959)
Timeframe: 54 weeks

InterventionParticipants (Number)
Phase I - JNJ-26866138 0.7 mg/m2 Group6
Phase I - JNJ-26866138 1.0 mg/m2 Group5
Phase I - JNJ-26866138 1.3 mg/m2 Group4
Phase II - JNJ-26866138 1.3 mg/m2 Group60
Total71

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Maximum Observed Plasma Concentration (Cmax) of Melphalan - Phase I

Cmax of melphalan at dose of 9 mg/m2 on Cycle 2/Day 4 (NCT00985959)
Timeframe: Day 4 of Cycle 2

Interventionng/mL (Mean)
Melphalan100.2

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Change in Bone Density (in Participants Untreated With Bisphosphonates)

Bone mineral density test was performed using x-ray radiation and the values of bone density were provided directly by the apparatus as grams per square centimeter (g/cm^2) . T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. (NCT01000610)
Timeframe: Screening and Week 84

Interventiont-score (Number)
ScreeningWeek 84
Rituximab-1.82-1.6

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Percentage Change in Disease Activity Score 28 (DAS28) From Baseline to Week 24

The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity [visual analog scale: [VAS] 0 equals (=) no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to 10. Scores less than (<) 2.6 indicate best disease control and scores greater than or equal to (≥) 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. The average improvement at each visit to the group score is equal to the formula (Previous DAS28 minus [-] current DAS 28)/ Previous DAS 28 x 100. Negative percentages indicate that the participant has worsened in comparison to last evaluation, and positive percentages indicate improvement of its DAS28 score and correlated with a bettering of clinical situation. (NCT01000610)
Timeframe: Baseline and Week 24

Interventionpercentage change from baseline (Mean)
Rituximab-1.7

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Percentage of Participants Whose DAS28 Improved by >1.2 at Week 24

The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [VAS: 0 = no disease activity to 100 = maximum disease activity] and the ESR for a total possible score of 0 to 10. Scores < 2.6 indicate best disease control and scores ≥ 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. An improvement of >1.2 was considered to be clinically significant improvement. (NCT01000610)
Timeframe: Baseline and Week 24

Interventionpercentage of participants (Number)
Rituximab75.0

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Number of Participants Reporting Adverse Events (AEs)

(NCT01000610)
Timeframe: Days 1 and 15, every 8 weeks up to Week 24 and and then every 3 months up to 18 months for a total of 104 weeks

Interventionnumber of participants (Number)
Participants who experienced an AEParticipants who experienced more than 1 AE
Rituximab117

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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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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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Change From Baseline in Hemoglobin Values at Day 42/EW

Blood samples were collected for the measurement of hemoglobin at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. (NCT01086410)
Timeframe: Baseline and Day 42/EW

,,,
InterventionGrams per liter (g/L) (Mean)
Day 42, n=50, 48, 53, 11EW, n=2, 2, 0, 0
FF/VI 100/25 µg PM-6.2-3.0
FF/VI 200/25 µg PM-5.7NA
Placebo-5.8-10.5
Prednisolone 10 mg AM-3.5NA

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Change From Baseline in Hematocrit Values at Day 42/EW

Blood samples were collected for the measurement of hematocrit at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. (NCT01086410)
Timeframe: Baseline and Day 42/EW

,,,
InterventionProportion of 1 (Mean)
Day 42, n=50, 48, 53, 11EW, n=2, 2, 0, 0
FF/VI 100/25 µg PM-0.0120-0.0050
FF/VI 200/25 µg PM-0.0114NA
Placebo-0.0123-0.0175
Prednisolone 10 mg AM-0.0072NA

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AUC(0-t) for VI on Day 42

Area under the concentration-time (AUC[0-t]) curve from time zero (pre-dose) to the last time of quantifiable VI concentration on Day 42 was measured. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42. (NCT01086410)
Timeframe: Day 42

Interventionpicograms*hour per milliliter (pg*hr/mL) (Mean)
FF/VI 100/25 µg PM41.177
FF/VI 200/25 µg PM66.937

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Cmax for VI on Day 42

Cmax is defined as the maximum observed concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42. (NCT01086410)
Timeframe: Day 42

Interventionpicograms per milliliter (pg/mL) (Mean)
FF/VI 100/25 µg PM101.227
FF/VI 200/25 µg PM118.531

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Ratio From Baseline of Serum Cortisol Trough (0-24 Hours) at Day -1/1 (Baseline) and Day 42

Serum cortisol trough is defined as the minimum value of serum cortisol measured over the 24-hour period. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr. Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline. (NCT01086410)
Timeframe: Day -1/1 (Baseline) and Day 42

Interventionratio from Baseline (Geometric Mean)
Placebo1.04
FF/VI 100/25 µg PM0.84
FF/VI 200/25 µg PM0.73
Prednisolone 10 mg AM0.28

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Ratio From Baseline of the Serum Cortisol Area Under the Concentration-time Curve (AUC) (0-24 Hour) on Day -1/1 (Baseline) and Day 42

Area under the plasma drug concentration-time (AUC[0-24 hour]) curve from time zero (pre-dose) to the last time of quantifiable serum cortisol concentration at 24 hours post-dose on Day -1/1 (Baseline) and Day 42 was measured. AUC reflects the actual body exposure to drug over a specified period of time after administration of a dose. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr. Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline. (NCT01086410)
Timeframe: Day -1/1 (Baseline) and Day 42

Interventionratio from Baseline (Geometric Mean)
Placebo0.99
FF/VI 100/25 µg PM0.99
FF/VI 200/25 µg PM0.97
Prednisolone 10 mg AM0.32

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Ratio From Baseline of the Serum Cortisol Weighted Mean (0-24 Hours) on Day -1/1 (Baseline) and Day 42

"Serum cortisol weighted mean was determined for each participant over the time period 0-12 hours on Day -1/1 (Baseline) and Day 42. Serum cortisol weighted mean was derived by dividing the area under the concentration-time curve (AUC; defined as thearea under the concentration-time curve from time zero up to 24 hours) by the sample collection time interval. The sample collection time interval is defined as the difference between the time of the last cortisol sample and the time of the first cortisol sample. Samples were collected at the following time points: 0 (first blood draw/pre-dose); 2, 4, 9, 12, 14, 16, 20, 22, and 24 hours (relative to the 0 time point). Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline." (NCT01086410)
Timeframe: Day -1/1 (Baseline) and Day 42

Interventionratio from Baseline (Geometric Mean)
Placebo0.99
FF/VI 100/25 µg PM0.99
FF/VI 200/25 µg PM0.96
Prednisolone 10 mg AM0.32

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AUC(0-t) and AUC(0-24) for FF on Day 42

Area under the plasma drug concentration-time (AUC[0-t]) curve from time zero (pre-dose) to the last time of quantifiable FF concentration and AUC(0-24) is the concentration time curve from zero (pre-dose) to 24 hours of quantifiable FF concentration on Day 42 was measured. AUC reflects the actual body exposure to drug over a specified period of time after administration of a dose. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42. (NCT01086410)
Timeframe: Day 42

,
Interventionpicograms*hour per milliliter (pg*hr/mL) (Geometric Mean)
AUC(0-t), n=54, 55AUC(0-24), n=49, 53
FF/VI 100/25 µg PM58.842NA
FF/VI 200/25 µg PM221.694324.015

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Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW

Blood samples were collected for the measurement of ALT, ALP, AST, CK, and GGT at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. (NCT01086410)
Timeframe: Baseline and Day 42/EW

,,,
InterventionInternational units per liter (IU/L) (Mean)
ALT, Day 42, n=55, 51, 55, 12ALT, EW, n=2, 2, 0, 0ALP, Day 42, n=55, 51, 55, 12ALP, EW, n=2, 2, 0, 0AST, Day 42, n=54, 50, 51, 12AST, EW, n=2, 2, 0, 0CK, Day 42, n=55, 51, 55, 12CK, EW, n=2, 2, 0, 0GGT, Day 42, n=55, 51, 55, 12GGT, EW, n=2, 2, 0, 0
FF/VI 100/25 µg PM-2.00.5-2.1-1.0-1.40.0-18.533.0-2.5-0.5
FF/VI 200/25 µg PM-2.2NA-2.6NA-0.6NA5.5NA2.2NA
Placebo-1.3-5.0-6.81.5-0.10.5-42.315.0-3.3-2.5
Prednisolone 10 mg AM0.8NA-4.9NA-1.8NA-17.3NA3.1NA

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Change From Baseline in Albumin and Total Protein Values at Day 42/EW

Blood samples were collected for the measurement of albumin and total protein at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. (NCT01086410)
Timeframe: Baseline and Day 42/EW

,,,
InterventionGrams per liter (Mean)
Albumin, Day 42, n=55, 51, 55, 12Albumin, EW, n=2, 2, 0, 0Total Protein, Day 42, n=55, 51, 55, 12Total Protein, EW, n=2, 2, 0, 0
FF/VI 100/25 µg PM-1.50.5-1.90.0
FF/VI 200/25 µg PM-1.3NA-1.8NA
Placebo-2.7-1.5-4.1-0.5
Prednisolone 10 mg AM-0.3NA-0.8NA

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Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW)

Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and segmented neutrophils at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. (NCT01086410)
Timeframe: Baseline and Day 42/Early Withdrawal (EW)

,,,
InterventionPercentage (Mean)
Basophils, Day 42, n=50, 47, 53, 11Basophils, EW, n=2, 2, 0, 0Eosinophils, Day 42, n=50, 47, 53, 11Eosinophils, EW, n=2, 2, 0, 0Lymphocytes, Day 42, n=50, 47, 53, 11Lymphocytes, EW, n=2, 2, 0, 0Monocytes, Day 42, n=50, 47, 53, 11Monocytes, EW, n=2, 2, 0, 0Segmented Neutrophils, Day 42, n=50, 47, 53, 11Segmented Neutrophils, EW, n=2, 2, 0, 0
FF/VI 100/25 µg PM0.040.100.27-0.551.542.00-0.03-0.70-1.85-0.85
FF/VI 200/25 µg PM-0.05NA-0.99NA-1.32NA0.07NA2.30NA
Placebo0.05-0.100.570.501.092.90-0.51-1.00-1.16-2.30
Prednisolone 10 mg AM-0.08NA-1.11NA-2.48NA-0.70NA4.37NA

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Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW

Blood samples were collected for the measurement of direct bilirubin, indirect bilirubin, total bilirubin, and creatinine at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. (NCT01086410)
Timeframe: Baseline and Day 42/EW

,,,
InterventionMicromoles per liter (µmol/L) (Mean)
Direct Bilirubin, Day 42, n=55, 51, 55, 12Direct Bilirubin, EW, n=2, 2, 0, 0Indirect Bilirubin, Day 42, n=55, 51, 55, 12Indirect Bilirubin, EW, n=2, 2, 0, 0Total Bilirubin, Day 42, n=55, 51, 55, 12Total Bilirubin, EW, n=2, 2, 0, 0Creatinine, Day 42, n=55, 51, 55, 12Creatinine, EW, n=2, 2, 0, 0
FF/VI 100/25 µg PM-0.60.0-2.5-2.0-3.2-2.00.350.95
FF/VI 200/25 µg PM-0.5NA-1.4NA-1.8NA0.04NA
Placebo-0.6-1.0-2.0-1.5-2.5-2.5-0.410.00
Prednisolone 10 mg AM0.3NA-1.0NA-0.8NA4.61NA

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Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW

Blood samples were collected for the measurement of eosinophils, total neutrophils, platelets, and WBC count at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. (NCT01086410)
Timeframe: Baseline and Day 42/EW

,,,
Intervention10^9 cells per liter (GI/L) (Mean)
Eosinophils, Day 42, n=50, 47, 53, 11Eosinophils, EW, n=2, 2, 0, 0Total Neutrophils, Day 42, n=50, 47, 53, 11Total Neutrophils, EW, n=2, 2, 0, 0Platelets, Day 42, n=50, 48, 51, 11Platelets, EW, n=1, 2, 0, 0WBC Day 42, n=50, 47, 53, 11WBC EW, n=2, 2
FF/VI 100/25 µg PM0.044-0.0600.289-1.165-8.2-39.50.71-1.65
FF/VI 200/25 µg PM-0.022NA0.704NA-3.9NA0.96NA
Placebo0.0660.0150.017-0.420-11.1-2.00.22-0.25
Prednisolone 10 mg AM-0.036NA1.435NA16.1NA1.69NA

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Cmax for FF on Day 42

Cmax is defined as the maximum observed concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42. (NCT01086410)
Timeframe: Day 42

Interventionpicograms per milliliter (pg/mL) (Geometric Mean)
FF/VI 100/25 µg PM19.388
FF/VI 200/25 µg PM33.017

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Tmax and Tlast of VI at Day 42

tmax is defined as the time to reach the observed maximum concentration, and tlast is defined as the time of the last observed quantifiable VI concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42. (NCT01086410)
Timeframe: Day 42

,
Interventionhours (Median)
tmaxtlast
FF/VI 100/25 µg PM0.0830.500
FF/VI 200/25 µg PM0.0830.950

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Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline

Heart rate was measured at Baseline and at Days 14, 28, 42, and EW. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. Scheduled, unscheduled, and early withdrawal visits were used for the maximum post-Baseline assessment. (NCT01086410)
Timeframe: Days 14, 28, 42, and EW

,,,
InterventionBeats per minute (Mean)
Day 14, n=58, 55, 56, 14Day 28, n=57, 55, 56, 14Day 42, n=55, 54, 56, 13Maximum post-Baseline, n=58, 56, 56, 15
FF/VI 100/25 µg PM1.7-0.9-0.96.0
FF/VI 200/25 µg PM0.0-1.90.95.5
Placebo1.52.9-0.18.0
Prednisolone 10 mg AM-1.8-2.7-2.32.9

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Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW

Blood samples were collected for the measurement of chloride, carbon dioxide (CO2) content/bicarbonate, glucose, potassium, sodium, and urea/blood urea nitrogen (BUN) at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. (NCT01086410)
Timeframe: Baseline and Day 42/EW

,,,
InterventionMillimoles per liter (mmol/L) (Mean)
Chloride, Day 42, n=55, 51, 55, 12Chloride, EW, n=2, 2, 0, 0CO2 content/bicarbonate, Day 42, n=54, 50, 51, 12CO2 content/bicarbonate, EW, n=2, 2, 0, 0Glucose, Day 42, n=55, 51, 55, 12Glucose, EW, n=2, 2, 0, 0Potassium, Day 42, n=54, 50, 51, 12Potassium, EW, n=2, 2, 0, 0Sodium, Day 42, n=55, 51, 55, 12Sodium, EW, n=2, 2, 0, 0Urea/BUN, Day 42, n=55, 51, 55, 12Urea/BUN, EW, n=2, 2, 0, 0
FF/VI 100/25 µg PM0.9-0.5-2.00.00.230.40-0.11-0.65-0.1-3.50.48-0.85
FF/VI 200/25 µg PM0.7NA-1.5NA-0.03NA-0.16NA-0.1NA-0.00NA
Placebo1.22.0-1.0-3.50.111.00-0.10-0.200.01.5-0.141.30
Prednisolone 10 mg AM-1.0NA-0.1NA0.40NA0.03NA-0.2NA0.94NA

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Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period

An AE is defined as 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. A serious adverse event (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, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs. (NCT01086410)
Timeframe: From the start of study medication until Day 42 (Visit 5)/Early Withdrawal

,,,
InterventionParticipants (Number)
Any AEAny SAE
FF/VI 100/25 µg PM230
FF/VI 200/25 µg PM210
Placebo160
Prednisolone 10 mg AM50

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Plasma FF and VI Pharmacokinetic (PK) Concentration

Plasma FF and VI Pharmacokinetic (PK) Concentration were estimates at the following time points:0 (immediately pre-dose inhaled study drug), and post-dose at 5 min, 15 min, 30 min, and 1 hr, 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, 24 hr on Day 42. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Pharmacokinetic Population. (NCT01086410)
Timeframe: Day 42

,
Interventionpicograms per milliliter (pg/mL) (Mean)
FF, 0 hour, n=53, 54FF, 5 minutes post-dose, n=51, 54FF, 15 minutes post-dose, n=50, 54FF, 30 minutes post-dose, n=52, 52FF, 1 hour post-dose, n=54, 54FF, 2 hours post-dose, n=51, 53FF, 4 hours post-dose, n=54, 53FF, 9 hours post-dose, n=48, 52FF, 12 hours post-dose, n=51, 55FF, 16 hours post-dose, n=49, 52FF, 20 hours post-dose, n=51, 51FF, 24 hours post-dose, n=48, 53VI, 0 hours, n=52, 54VI, 5 minutes post-dose, n=50, 54VI, 15 minutes post-dose, n=48, 55VI, 30 minutes post-dose, n=51, 55VI, 1 hour post-dose, n=52, 53VI, 2 hours post-dose, n=52, 55VI, 4 hours post-dose, n=52, 54VI, 9 hours post-dose, n=52, 55VI, 12 hours post-dose, n=52, 55VI, 16 hours post-dose, n=51, 52VI, 20 hours post-dose, n=50, 54VI, 24 hours post-dose, n=52, 55
FF/VI 100/25 µg PM3.5716.6516.3517.1216.9115.009.786.204.622.551.741.552.5785.2262.9433.3814.637.090.000.000.000.000.001.19
FF/VI 200/25 µg PM10.0225.5528.8430.6830.0730.2021.7915.9913.3711.739.287.587.9590.5472.5336.8820.076.060.450.471.214.760.000.00

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Tmax and Tlast of FF at Day 42

tmax is defined as the time to reach the observed maximum concentration, and tlast is defined as the time of the last observed quantifiable concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42. (NCT01086410)
Timeframe: Day 42

,
Interventionhours (Median)
tmaxtlast
FF/VI 100/25 µg PM0.5009.000
FF/VI 200/25 µg PM0.50020.042

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Ratio From Baseline of 0-24 Hour Urinary Free Cortisol Excretion on Day -1/1 (Baseline) and Day 42

A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion at Day -1/1 (Baseline) and Day 42. Only those participants available at the specified time points were analyzed. Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline. (NCT01086410)
Timeframe: Day -1/1 (Baseline) and Day 42

Interventionratio from Baseline (Geometric Mean)
Placebo0.87
FF/VI 100/25 µg PM1.03
FF/VI 200/25 µg PM0.92
Prednisolone 10 mg AM0.40

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Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline

SBP and DBP were measured at Baseline and at Days 14, 28, 42, and EW. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. Scheduled, unscheduled, and early withdrawal visits were used for the maximum post-Baseline assessment. (NCT01086410)
Timeframe: Days 14, 28, 42, and EW

,,,
InterventionMillimeters of mercury (mmHg) (Mean)
SBP, Day 14, n=58, 55, 56, 14SBP, Day 28, n=57, 55, 56, 14SBP, Day 42, n=55, 54, 56, 13SBP, maximum post-Baseline, n=58, 56, 56, 15DBP, Day 14, n=58, 55, 56, 14DBP, Day 28, n=57, 55, 56, 14DBP, Day 42, n=55, 54, 56, 13DBP, maximum post-Baseline, n=58, 56, 56, 15
FF/VI 100/25 µg PM-1.9-0.7-0.45.0-1.1-0.6-1.2-5.2
FF/VI 200/25 µg PM-1.3-2.3-1.83.9-0.60.10.3-5.4
Placebo-0.5-0.92.36.20.01.81.2-3.3
Prednisolone 10 mg AM-1.0-3.91.54.90.1-0.41.2-4.9

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Overall Survival

Number of participants that were alive. (NCT01093586)
Timeframe: At 1 year

InterventionParticipants (Count of Participants)
Arm I6

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Disease Free

Number of participants that were disease free (NCT01093586)
Timeframe: At 1 year

InterventionParticipants (Count of Participants)
Arm I4

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Disease Free

Number of participants that were disease free (NCT01093586)
Timeframe: At 2 years

InterventionParticipants (Count of Participants)
Arm I4

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Hematologic Engraftment

Number of participants that were able to complete engraftment by day 42. (NCT01093586)
Timeframe: On day +42

InterventionParticipants (Count of Participants)
Arm I10

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Incidence of Acute Graft-versus-host Disease (GVHD)

Number of participants that had acute GVHD (NCT01093586)
Timeframe: At 100 days

InterventionParticipants (Count of Participants)
Arm I11

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Incidence of Chronic GVHD

Number of participants that have chronic GVHD. Chronic GVHD will be diagnosed and graded on clinical and histological criteria from the Center for International Blood and Marrow Transplant Research (CIBMTR) (NCT01093586)
Timeframe: At 1 year

InterventionParticipants (Count of Participants)
Arm I1

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Occurrence of Serious Infections

Number of participants that had infections (NCT01093586)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Arm I13

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Overall Survival

Number of participants alive at 180 days post engraftment. (NCT01093586)
Timeframe: On day +180

InterventionParticipants (Count of Participants)
Arm I8

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Overall Survival

Number of participants that were alive. (NCT01093586)
Timeframe: At 2 years

InterventionParticipants (Count of Participants)
Arm I4

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Recurrence or Relapse

Number of subjects that had disease recurrence (NCT01093586)
Timeframe: one year in patients post UCBT

InterventionParticipants (Count of Participants)
Arm I2

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Recurrence or Relapse

Number of subjects that had disease recurrence (NCT01093586)
Timeframe: two years post transplant

InterventionParticipants (Count of Participants)
Arm I2

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Overall Survival

Number of participants alive at 1 year. (NCT01105650)
Timeframe: 1 Year

Interventionparticipants (Number)
Arm 1: CsA0
Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-21
Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-23

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Number of Participants With Progressive Disease at One Year

(NCT01105650)
Timeframe: 1 Year

InterventionParticipants (Count of Participants)
Arm 1: CsA2
Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-21
Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-25

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Response Rate

Response includes Complete Response (CR), Partial Response (PR), and Stable Disease (SD) as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v.1.1) 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; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease. (NCT01105650)
Timeframe: Month 3

Interventionparticipants (Number)
Arm 1: CsA1
Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-22
Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-24

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Time to Disease Progression

Time from study entry until progressive disease or data collection cutoff. (NCT01105650)
Timeframe: 1 Year

Interventiondays (Median)
Arm 1: CsA52
Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-298
Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2100

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Number of Participants With Thyroid Function Assessment, Hormone and Glucose Assay Abnormalities Meeting the Criteria for PCC

The following laboratory parameters were analyzed: thyroid function assessment (thyroid stimulating hormone [TSH], thyroid peroxidase antibody, thyrotropin receptor antibodies (TSH-R-Abs) or TSH-binding inhibiting immunoglobulin (TBII), free thyroxine [fT4], free triiodothyronine [fT3]; hormone and glucose assays (cortisol, adrenocorticotrophic hormone [ACTH], insulin-like growth factor [IgF-1] and plasma glucose. Thyroid function tests were done at Day 1 (pre-dose) and Week 4-24. Hormone and glucose assays were done at Day 1 (pre-dose) and Week 2-24. (NCT01114503)
Timeframe: Up to Week 24

InterventionParticipants (Number)
Otelixizumab Cohort A10

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Number of Participants With Vital Signs Abnormalities Meeting the Criteria for PCC

Vital signs assessment included pulse rate, blood pressure, temperature and respiratory rate. Criteria for vital sign values meeting potential clinical concern included: supine pulse rate <40 or >110 beats per minute (bpm), >= 15 increase from baseline and >= 30 decrease from baseline; systolic blood pressure (SBP) < 85 and > 160 millimeters of mercury (mm Hg), >= 20 mmHg increase from baseline and >= 40 mmHg decrease from baseline; diastolic blood pressure (DBP) < 45 and > 100 mm Hg, >= 10 mmHg increase from baseline and >= 20 mmHg decrease from baseline. (NCT01114503)
Timeframe: Up to Month 24 (Long term follow-up)

InterventionParticipants (Number)
Otelixizumab Cohort A10

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Number of Participants With Laboratory Urinalysis Abnormalities Meeting the Criteria for PCC

The urinalysis parameters included pH, glucose, protein, blood and ketones by dipstic and microscopy (if urine dipstick was positive for blood or protein). The assessments were done at Day 1 (pre dose), Day 8, Week 2-24, Month 12 and 24. (NCT01114503)
Timeframe: Up to Month 24 (Long term follow-up)

InterventionParticipants (Number)
Otelixizumab Cohort A10

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Number of Participants With an Epstein Barr Virus (EBV) Viral Load Abnormalities Meeting the Criteria for PCC

The PCC range for EBV viral load was > 10,000 copies of deoxyribonucleic acid (DNA) per million lymphocytes. The assessments were done at Week 2, Week 4, Week 8 and Week 12. (NCT01114503)
Timeframe: Week 2 to Week 12

InterventionParticipants (Number)
Otelixizumab Cohort A10

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Number of Participants With Electrocardiogram (ECG) Abnormalities Meeting the Criteria for PCC

ECG parameters included pulse rate (PR) interval, QRS interval, QT interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval <110 and >220 milliseconds (msec); QRS interval <75 and >110 msec; QTc interval >480 to <= 500 msec, increase from baseline QTc >30 to <= 60 msec. (NCT01114503)
Timeframe: Screening (Day -35 to Day -1)

InterventionParticipants (Number)
Otelixizumab Cohort A10

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Number of Participants With Laboratory Clinical Chemistry Abnormalities Meeting the Criteria for Potential Clinical Concern (PCC)

The PCC range for clinical chemistry parameters included albumin, <30 gram per liter (g/L); calcium, low- < 2.0 millimole (mmol)/L: high->2.75 mmol/L; creatinine, high- > 1.3x ULN mmol/L or > 159 micromole (μmol)/L or > 44 μmol/L change from Baseline; glucose, low- < 3.0 mmol/L, high- > 9.0 0 mmol/L; magnesium, low- < 0.5 mmol/L, high- > 1.23 mmol/L, phosphorus, low- < 0.8 mmol/L, high- > 1.6 mmol/L; potassium, Low- < 3.0 mmol/L, high- > 5.5 mmol/L; sodium, low- < 130 mmol/L, high- > 150 mmol/L; bicarbonate, low- < 18 mmol/L, high- > 32 mmol/L; alanine aminotransferase, high->= 2x ULN, where the normal range was (NR) 0 - 39 international units (IU)/L; aspartate aminotransferase, high- >= 2x ULN, where NR was 0 - 39 IU/L; alkaline phosphatase, high- >= 1.5x ULN, where NR was 35 - 120 IU/L; total bilirubin- >= 1.5x ULN, where NR was 0 - 18 μmol/L.The assessments were done at Day 1 (pre dose), Day 8, Week 2-24 and Month 12 and 24. (NCT01114503)
Timeframe: Up to Month 24 (Long term follow-up)

InterventionParticipants (Number)
Otelixizumab Cohort A10

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Number of Participants With Laboratory Hematology Abnormalities Meeting the Criteria for PCC

The PCC range for hematology parameters included white blood cell count, low- < 3 giga cells (GI)/L, high- > 20 GI/L; neutrophil count, low- < 1.5 GI/L; hemoglobin, low- > 25 g/L change from baseline, high- 180 g/L; hematocrit, low- > 0.075 L change from baseline, high- 0.54 L; platelet count, low- < 100 GI/L, high- >550 GI/L and lymphocytes, low < 0.8 GI/L. The assessments were done at Day 1 (pre dose), Day 8, Week 2-24, Month 12 and 24. (NCT01114503)
Timeframe: Upto Month 24 (Long term follow-up)

InterventionParticipants (Number)
Otelixizumab Cohort A10

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity

Wound integrity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of wound integrity (healing, 1-3) is a sign of inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 1: Grade 0Month 1: Grade 1Month 1: Grade 2Month 1: Grade 3
DUREZOL100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0

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Global Assessment Score of Postoperative Inflammation by Visit

A Global Assessment Score (GAS) was assigned by the Investigator based on the clinical evidence of postoperative inflammation: 0=clear, 1=improving satisfactorily; 2=not improving or worsening, withdrawal from study indicated to allow appropriate alternative therapy to be instituted. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 29: Grade 0Day 29: Grade 1Day 29: Grade 21 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 2Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2
DUREZOL30.869.20.048.748.72.656.443.60.079.520.50.089.77.72.692.35.12.6
PRED FORTE17.582.50.025.070.05.050.050.00.072.525.02.590.07.52.592.57.50.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia

Photophobia was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Photophobia (abnormal intolerance to visual perception of light) is a symptom of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL71.820.57.70.089.710.30.00.097.42.60.00.097.42.60.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE60.035.05.00.087.510.02.50.095.05.00.00.092.55.00.02.597.52.50.00.0100.00.00.00.0

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Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days

Anterior cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. (NCT01124045)
Timeframe: Day 15 ± 2 days

InterventionPercentage of patients (Number)
DUREZOL78.9
PRED FORTE77.5

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade

Anterior chamber flare was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. The presence of flare (increased protein levels) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL41.051.37.70.061.535.92.60.074.417.97.70.087.212.80.00.094.92.62.60.092.35.12.60.0
PRED FORTE45.037.512.55.052.540.05.02.570.027.52.50.092.57.50.00.092.57.50.00.095.05.00.00.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis

Vitritis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Vitritis (accumulation of inflammatory cells or exudates in the vitreous humor, the fluid that fills the middle chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE97.52.50.00.097.50.02.50.097.50.02.50.097.50.02.50.097.50.02.50.097.50.02.50.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis

Chemosis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Chemosis (swelling of the conjunctiva) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL82.115.40.02.697.42.60.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE85.015.00.00.0100.00.00.00.097.52.50.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection

Ciliary/limbal injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Ciliary/limbal injection (redness of the white sclera of the eye near the limbal ring) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL69.228.20.02.689.710.30.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE57.540.02.50.090.010.00.00.0100.00.00.00.097.52.50.00.0100.00.00.00.0100.00.00.00.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection

Conjunctival injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Conjunctival injection (redness of the white sclera of the eye) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL46.248.72.62.679.520.50.00.089.710.30.00.097.42.60.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE25.065.010.00.077.522.50.00.092.57.50.00.095.05.00.00.0100.00.00.00.0100.00.00.00.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity

Corneal clarity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of corneal clarity (1-3) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL92.37.70.00.094.95.10.00.094.95.10.00.097.42.60.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE87.512.50.00.090.07.52.50.090.010.00.00.097.52.50.00.097.52.50.00.097.52.50.00.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon

Hypopyon was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Hypopyon (pus in the anterior chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation

Lacrimation was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Excessive lacrimation (tear production and secretion, 1-3) is a symptom of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 31 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 3Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3
DUREZOL64.130.85.10.094.95.10.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0
PRED FORTE72.522.55.00.097.52.50.00.095.05.00.00.0100.00.00.00.0100.00.00.00.0100.00.00.00.0

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Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade

Anterior chamber cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported. (NCT01124045)
Timeframe: Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week

,
InterventionPercentage of patients (Number)
Day 1: Grade 0Day 1: Grade 1Day 1: Grade 2Day 1: Grade 3Day 1: Grade 4Day 8: Grade 0Day 8: Grade 1Day 8: Grade 2Day 8: Grade 3Day 8: Grade 4Day 15: Grade 0Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 15: Grade 4Day 29: Grade 0Day 29: Grade 1Day 29: Grade 2Day 29: Grade 3Day 29: Grade 41 Week after Last Dose: Grade 01 Week after Last Dose: Grade 11 Week after Last Dose: Grade 21 Week after Last Dose: Grade 31 Week After Last Dose: Grade 4Month 3: Grade 0Month 3: Grade 1Month 3: Grade 2Month 3: Grade 3Month 3: Grade 4
DUREZOL23.757.915.82.60.055.336.85.32.60.078.918.40.02.60.089.510.50.00.00.097.42.60.00.00.094.75.30.00.00.0
PRED FORTE40.030.027.50.02.557.532.510.00.00.077.517.55.00.00.095.02.52.50.00.095.02.52.50.00.097.50.02.50.00.0

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Change in Serum CRP Day 0 to Day 56

Serum measure of systemic inflammation (NCT01144143)
Timeframe: Day 0 to Day 56

Interventionmg/dl (Mean)
Infliximab-0.18
Salt Water-0.15
Methylprednisolone Acetate0.08

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Change in Levels of Serum IL-6

(NCT01144143)
Timeframe: Change from Day 0 to Day 56

Interventionpg/ml (Mean)
Infliximab-0.4
Salt Water8.1
Methylprednisolone Acetate5.5

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Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score Target Knee

The WOMAC questionnaire is used to evaluate the condition of patients with osteoarthritis. Patients answer questions based on how they are feeling. The questionnaire has a total of 24 questions which deal with pain, stiffness and physical function. Participants are asked to respond to how difficult it is for them to do/complete an activity. There is a total possible score of 96. A score of 0 equals no difficulty completing any of the 24 activities. A score of 96 would indicate extreme difficulty with all activities. (NCT01144143)
Timeframe: Change from Day 0 to Day 56

Interventionunits on a scale (Mean)
Infliximab-25.9
Normal Saline-9.3
Methylprednisolone Acetate2.0

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Change in Joint Effusions From Day 0 to Day 56 Target Knee

"Outcome calculated based on Physician observation of joint swelling from 0-3. A score of 0 = no effusion,1 = positive bulge, 2 = moderate effusion, 3 = tense effusion. The outcome represents the change in means between the two time points." (NCT01144143)
Timeframe: Change from Day 0 to Day 56

Interventionunits on a scale (Mean)
Infliximab0.3
Salt Water0.0
Methylprednisolone Acetate0.0

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Change in Serum SAA Levels Day 0 to Day 56

Serum Amyloid A (NCT01144143)
Timeframe: Day 0 to Day 56

Interventionug/ml (Mean)
Infliximab-1.0
Salt Water-715.6
Methylprednisolone Acetate-1580.2

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Response Rate (Based on the IMWG Criteria)

"The proportion of subjects evaluated as response [sCR + CR + very good partial response (VGPR) + Partial Response (PR)] was calculated.~VGPR (IMWG): 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 <100mg per 24 h~PR (IMWG): ≥50% reduction of serum M-protein and reduction in 24 h urinary M-protein by ≥90% or to <200mg per 24 h" (NCT01179490)
Timeframe: Up to 36 weeks

InterventionPercentage of participants (Number)
SyB L-0501 + Prednisolone60.0

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Response Rate (Based on the Modified SWOG Criteria)

"The proportion of subjects evaluated as response (CR + PR) was calculated.~PR (SWOG) requires the followings:~Decline in myeloma protein of ≥25%-<74% in serum myeloma protein~Reduction in 24h urinary myeloma protein of ≥25%-<89%~No increase in skeletal destruction~Serum calcium within normal range" (NCT01179490)
Timeframe: Up to 36 weeks

InterventionPercentage of participants (Number)
SyB L-0501 + Prednisolone60.0

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Time to Treatment Failure (TTF)

TTF is the period from patient registration to either the date of recurrence, exacerbation, progression, death or discontinuation of treatment. (NCT01179490)
Timeframe: Up to 2 years

InterventionDays (Median)
SyB L-0501 + Prednisolone205.0

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Pharmacokinetic Parameters (Cmax)

Plasma pharmacokinetics (Cmax) of unchanged bendamustine (NCT01179490)
Timeframe: On Day 1 only

Interventionng/mL (Mean)
SyB L-0501 + Prednisolone8795.769

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Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values

"Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE.~grade 1 : mild~grade 2 : moderate~grade 3 : severe or medically significant but not immediately life-threatening~grade 4 : life threatening or disabling~grade 5 : death related to AE" (NCT01179490)
Timeframe: Up to 2 years

InterventionParticipants (Number)
Subjects with Grade 3 abnormalitySubjects with Grade 4 abnormalitySubjects with Grade 5 abnormality
SyB L-0501 + Prednisolone550

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Overall Survival (OS)

OS is the period from the date of patient registration to the date of death. (NCT01179490)
Timeframe: Up to 2 years

InterventionDays (Median)
SyB L-0501 + Prednisolone205.0

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Duration of Response (DOR)

DOR is the period from the date of achieving CR or PR to either the date of recurrence, exacerbation, progression or death. (NCT01179490)
Timeframe: Up to 2 years

InterventionDays (Median)
SyB L-0501 + Prednisolone162.0

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CR Rate Based on the (Bladé) Criteria

"The proportion of subjects evaluated as CR was calculated.~CR (Bladé) requires all of the followings:~Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR.~<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy is performed. If absence of monoclonal protein is sustained for 6 weeks it is not necessary to repeat the bone marrow, except in patients with non-secretory myeloma where the marrow examination must be repeated after an interval of at least 6 weeks to confirm CR.~No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response)~Disappearance of soft tissue plasmacytomas" (NCT01179490)
Timeframe: Up to 36 weeks

InterventionPercentage of participants (Number)
SyB L-0501 + Prednisolone0.0

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CR Rate [Based on the International Myeloma Working Group (IMWG) Criteria]

"The proportion of subjects evaluated as CR [strict CR (sCR) + CR] was calculated.~sCR (IMWG): CR as defined below plus Normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence~CR (IMWG): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow" (NCT01179490)
Timeframe: Up to 36 weeks

InterventionPercentage of participants (Number)
SyB L-0501 + Prednisolone0.0

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Complete Response (CR) Rate [Based on the Modified Southwest Oncology Group (SWOG) Criteria]

"The proportion of subjects evaluated as CR was calculated.~CR (modified SWOG) requires all of the followings:~Decline in serum myeloma protein by ≥75% to ≤25 g/L~Reduction in 24 h urinary protein by ≥90% to ≤200 mg/24 h~No increase in skeletal destruction~Serum calcium within normal range~No blood transfusion required in the previous 3 months" (NCT01179490)
Timeframe: Up to 36 weeks

InterventionPercentage of Participants (Number)
SyB L-0501 + Prednisolone40.0

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Number of Abnormalities (Grade ≥3) in Laboratory Test Values

Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE. (NCT01179490)
Timeframe: Up to 2 years

InterventionEvents (Number)
Grade 3 abnormalitiesGrade 4 abnormalitiesGrade 5 abnormalities
SyB L-0501 + Prednisolone33390

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Response Rate (Based on the Bladé Criteria)

"The proportion of subjects evaluated as response (CR + PR) was calculated.~PR (Bladé) requires 1. or all of the others:~Some, but not all, of the criteria for CR are fulfilled~≥50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks.~Reduction in 24 h urinary light chain excretion either by ≥90% or to <200 mg, maintained for a minimum of 6 weeks.~For patients with non-secretory myeloma only, ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy, if biopsy is performed, maintained for a minimum of 6 weeks.~≥50% reduction in the size of soft tissue plasmacytomas (by radiography or clinical examination).~No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response)." (NCT01179490)
Timeframe: Up to 36 weeks

InterventionPercentage of participants (Number)
SyB L-0501 + Prednisolone60.0

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Pharmacokinetic Parameters (t1/2)

Plasma pharmacokinetics (t1/2) of unchanged bendamustine (NCT01179490)
Timeframe: On Day 1 only

Interventionh (Mean)
SyB L-0501 + Prednisolone0.44

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Pharmacokinetic Parameters (Tmax)

Plasma pharmacokinetics (tmax) of unchanged bendamustine (NCT01179490)
Timeframe: On Day 1 only

Interventionh (Mean)
SyB L-0501 + Prednisolone1.00

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Progression-Free Survival (PFS)

"PFS is the period from patient registration to either the date of recurrence, exacerbation, progression or death.~Recurrence, exacerbation, progression were assessed from serum M-protein, urine M-protein, serum free light chain (FLC), the percentage of marrow plasma cells, disappearance of clonal plasma cells, plasma cell tumor in soft tissue, and bone lesion." (NCT01179490)
Timeframe: Up to 2 years

InterventionDays (Median)
SyB L-0501 + Prednisolone205.0

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Pharmacokinetic Parameters (AUC)

Plasma pharmacokinetics (AUC) of unchanged bendamustine (NCT01179490)
Timeframe: On Day 1 only

Interventionng・h/mL (Mean)
SyB L-0501 + Prednisolone12315.992

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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 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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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 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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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 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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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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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: 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: 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: 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 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 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 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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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 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): 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): 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): 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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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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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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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: 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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Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits

The following signs were each graded on a 0 - 3 scale (0 = absent; 1 = mild; 2 = moderate; 3 = severe): posterior synechia, hypopyon, limbal injection, and keratic precipitates. Peripheral synechia was graded by the combined number of clock hours affected (0 = absent; 1 = < 3 hrs; 2 = 3-6 hours; 3 = > 6 hours). The total sign score was calculated as the sum of the 5 individual sign scores, the anterior chamber cell grade and the anterior chamber flare grade. The minimum/best total sign score was 0, and the maximum/worst total sign score was 23. (NCT01201798)
Timeframe: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionUnits on a scale (Mean)
Baseline (Day 0)Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol7.1-3.5-5.2-6.1-6.5-6.4-6.3-6.2
Pred Forte7.3-3.6-5.0-5.8-6.2-6.2-6.2-6.3

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Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points

The following symptoms were each graded by the subject according to a 0-100 visual analog scale (VAS) using a mark on a 100 mm line (0 = absent, 100 = maximal): eye pain, photophobia, blurred vision, and lacrimation. The total symptom score was calculated as the sum of the 4 individual symptom scores. (NCT01201798)
Timeframe: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionUnits on a scale (Mean)
Baseline (Day 0)Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol186.7-88.4-108.2-133.3-138.8-140.1-143.9-146.2
Pred Forte203.2-88.4-123.8-137.4-149.5-152.4-147.3-155.5

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Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points

Anterior chamber flare (protein escaping from dialated vessels) was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe. (NCT01201798)
Timeframe: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionUnits on a scale (Mean)
Baseline (Day 0)Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol2.2-1.1-1.6-2.0-2.0-2.0-2.0-2.0
Pred Forte2.3-1.2-1.6-1.9-2.0-2.0-2.0-2.0

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Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14

Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count. (NCT01201798)
Timeframe: Baseline (Day 0), Day 14

,
InterventionUnits on a scale (Mean)
Baseline (Day 0)Day 14
Durezol2.6-2.2
Pred Forte2.6-2.0

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Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14

Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count. (NCT01201798)
Timeframe: Baseline (Day 0), Day 3, Day 7, Day 21, Day 28, Day 35, Day 42

,
InterventionUnits on a scale (Mean)
Baseline (Day 0)Day 3Day 7Day 21Day 28Day 35Day 42
Durezol2.6-1.1-1.8-2.4-2.3-2.3-2.3
Pred Forte2.6-1.0-1.6-2.1-2.1-2.1-2.1

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Proportion of Subjects Who Discontinued Due to Lack of Efficacy

Lack of efficacy was defined as those subjects who discontinued study participation either due to treatment failure or an adverse event with a preferred term of iridocyclitis, iritis, uveitis, or vitritis. Proportion is reported as percentage of subjects. (NCT01201798)
Timeframe: Time to Event

InterventionPercentage of subjects (Number)
Durezol0
Pred Forte14.9

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Proportion of Subjects With Anterior Chamber Cell Grade of 0

Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count. Proportion is reported as percentage of subjects. (NCT01201798)
Timeframe: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionPercentage of subjects (Number)
Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol15.234.865.284.880.478.376.1
Pred Forte6.425.555.363.870.270.274.5

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Proportion of Subjects With Anterior Chamber Cell Grade ≤1

As assessed by the investigator during slit lamp examination. Anterior chamber cell grade was graded on a 5-point scale, with 0 = no cells; 1 = 1 to 10 cells; 2 = 11 to 20 cells; 3 = 21 to 50 cells; and 4 = more than 50 cells. Proportion is reported as percentage of subjects. (NCT01201798)
Timeframe: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionPercentage of subjects (Number)
Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol50.087.093.593.593.593.591.3
Pred Forte57.480.985.189.487.285.185.1

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Proportion of Subjects With Anterior Chamber Cell Count of 0

Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and recorded based on actual cell count. Proportion is reported as a percentage of subjects. (NCT01201798)
Timeframe: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionPercentage of subjects (Number)
Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol13.021.752.273.973.969.669.6
Pred Forte2.121.338.348.963.863.868.1

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Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0

Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and recorded based on actual cell count. Anterior chamber flare (protein escaping from dialated vessels) was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe. Proportion is reported as percentage of subjects. (NCT01201798)
Timeframe: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42

,
InterventionPercentage of subjects (Number)
Day 3Day 7Day 14Day 21Day 28Day 35Day 42
Durezol13.041.378.382.680.482.680.4
Pred Forte14.940.461.776.676.676.678.7

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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

AE=any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. (NCT01211665)
Timeframe: from the first dose of study treatment through the end of the treatment period (6 months) + a 4-week post-treatment period

,
Interventionparticipants (Number)
AEsSAEs
IVMP With Oral Prednisolone Taper11
Pulsed IVMP22

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Severity of AEs and SAEs

AEs and SAEs were categorized as mild, moderate or severe according to the following criteria: Mild=barely noticeable to participant or does not make participant uncomfortable; does not influence performance or functioning; prescription drug not ordinarily needed for relief of symptom(s) but may be given because of personality of participant. Moderate=of a sufficient severity to make participant uncomfortable; performance of daily activity is influenced; participant is able to continue in study; treatment for symptom(s) may be needed. Severe=symptoms cause severe discomfort; symptoms cause incapacity or significant impact on participant's daily life; severity may cause cessation of treatment with study treatment; treatment for symptom(s) may be given and/or participant hospitalized. Please see Outcome Measure 3 for AE and SAE definitions. (NCT01211665)
Timeframe: from the first dose of study treatment through the end of the treatment period (6 months) + a 4-week post-treatment period

,
Interventionevents (Number)
Mild SAEModerate SAESevere SAEMild AEModerate AESevere AE
IVMP With Oral Prednisolone Taper110510
Pulsed IVMP112330

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Number of Participants Who Survived at 6 Months Following Completion of Plasma Exchange (PLEX)

Following the completion of rapid removal of natalizumab using PLEX or equivalent. (NCT01211665)
Timeframe: 6 months

Interventionparticipants (Number)
Pulsed IVMP1
IVMP With Oral Prednisolone Taper1

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Percentage of Participants Able to Acheive LDA Assessed Using DAS28 While Receiving Oral GC on Background Tocilizumab Treatment During the Noninterventional Phase

DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the CRP and Patient's Global Assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 and oral GC intake with MP equivalent dose of ≥1 mg and ≤20 mg/day= LDA. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
Tocilizumab72.1

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Number of Participants With Changes in Tocilizumab Dose During the Noninterventional Phase

The dose of tocilizumab could have been reduced from the recommended 8 mg/kg to 4 mg/kg in participants in the case of adverse events. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionparticipants (Number)
Tocilizumab1

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Median Time Interval Between V1 and V2

The noninterventional phase was planned to last for a maximum of 6 months per participant. The time between V1 and V2 was measured in months. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionmonths (Median)
Tocilizumab2.3

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Median Dose of Tocilizumab During the Noninterventional Phase

(NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionmg/kg (Median)
Tocilizumab8.0

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VAS-Physician's Global Assessment of Disease Activity (GDA) During the Interventional Phase

Physician's were asked to determine the overall GDA for each participant using a 100-mm VAS, where 0=no disease activity and 100=maximum disease activity. The physician marked the line corresponding to their assessment and the distance from the left edge was measured. V3, CV, and the change from V3 to CV was determined. (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionmm (Mean)
V3 (n=40)CV (n=28)Change from V3 to CV (n=26)
Tocilizumab16.616.73.1

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VAS for Pain (VAS-Pain) During the Interventional Phase

Participants were asked to mark the line corresponding to the intensity of their pain on a 100-mm VAS, where 0=no pain and 100=worst possible pain. The distance from the left edge was measured. Change = V3 mean minus CV mean. (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionmm (Mean)
V3 (n=43)CV (n=28)Change from V3 to CV (n=28)
Tocilizumab19.924.96.9

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Type of GC Taken at the End of the Noninterventional Phase

During the noninterventional phase of the study participants received GC as prescribed by the physician. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
MPPrednisolonePrednisone
Tocilizumab70.028.02.0

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SJC and TJC During the Interventional Phase

TJC and SJC were assessed for 28 joints. An assessment of 28 joints for swelling and tenderness was made. Joints were assessed and classified as swollen (1)/not swollen (0) and tender (1)/not tender (0) by pressure and joint manipulation on physical examination for a total score range of 0-28. Higher scores indicated greater disease activity (tenderness/swelling). V3, CV, and the change from V3 to CV was determined. (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionjoints (Mean)
SJC V3 (n=43)SJC CV (n=29)SJC Change from V3 to CV (n=29)TJC V3 (n=43)TJC CV (n=29)TJC Change from V3 to CV (n=29)
Tocilizumab0.90.4-0.30.91.81.0

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Short-Form 36 (SF-36) Mental Component Score (MCS) and Physical Component Score (PCS) During the Interventional Phase

"36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores reflect higher quality of life. V3, CV, and the change from V3 to CV was determined." (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionunits on a scale (Mean)
MCS V3 (n=37)MCS CV (n=26)MCS: Change from V3 to CV (n=22)PCS V3 (n=36)PCS CV (n=26)PCS: Change from V3 to CV (n=22)
Tocilizumab47.046.2-4.442.541.8-2.1

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DAS28-CRP During the Interventional Phase

DAS28-CRP was calculated from the SJC and TJC using the 28-joint count and CRP (mg/L). Total score range: 0 to 10, higher score indicated more disease activity. DAS28-CRP) ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-CRP <2.6=remission. DAS28-CRP values indicated in the CRF were recalculated by the data manager. The cumulative DAS28 (CRP) value (AUC method) was performed using the calculated DAS28. The recalculated values were used in the statistical analyses. (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionunits on a scale (Mean)
V3 (n=42)CV (n=27)Change from V3 to CV (n=27)
Tocilizumab2.22.30.2

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Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using DAS28-CRP

DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joint count, the CRP and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28-CRP ≤3.2 and oral GC intake with MP equivalent dose of ≥1 mg and ≤20 mg/day=LDA; DAS28 <2.6 = remission. (NCT01219933)
Timeframe: Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), 8 (12 months), 9 (24 weeks after V3) or CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionpercentage of participants (Number)
V3 LDA (n=42)V3 Remission (n=42)V4 LDA (n=41)V4 Remission (n=41)V5 LDA (n=35)V5 Remission (n=35)V6 LDA (n=35)V6 Remission (n=35)V7 LDA (n=33)V7 Remission (n=33)V8 LDA (n=32)V8 Remission (n=32)V9 LDA (n=30)V9 Remission (n=30)CV LDA (n=27)CV Remission (n=27)
Tocilizumab90.573.885.473.288.671.482.962.990.957.687.562.573.356.788.959.3

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Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using CDAI

The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-100 mm VAS; higher scores=greater affection due to disease activity. CDAI total score=0-76. CDAI ≤2.8=disease remission and >2.8 to 10=LDA. (NCT01219933)
Timeframe: Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), 8 (12 months), and 9 (24 weeks after V3) or CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionpercentage of participants (Number)
V3 LDA (n=40)V3 Remission (n=40)V4 LDA (n=41)V4 Remission (n=41)V5 LDA (n=38)V5 Remission (n=38)V6 LDA (n=35)V6 Remission (n=35)V7 LDA (n=33)V7 Remission (n=33)V8 LDA (n=31)V8 Remission (n=31)V9 LDA (n=29)V9 Remission (n=29)CV LDA (n=27)CV Remission (n=27)
Tocilizumab85.027.582.939.081.647.471.437.175.833.380.638.769.031.077.833.3

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Percentage of Participants With Erosions During the NonInterventional Phase

In RA, the presence, number and size of bone erosions and the number of joints with erosions on conventional radiographs (CRs) are hallmarks for diagnosis, staging and prediction of damage progression and are used for treatment monitoring in randomized controlled studies. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
V1 (n=57)Between V1 and V2 (n=36)
Tocilizumab47.441.7

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Percentage of Participants Positive for Rheumatoid Factor (RF) During the Noninterventional Phase

RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
V1 (n=39)Between V1 and V2 (n=21)
Tocilizumab56.452.4

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Percentage of Participants Positive for Anti-cyclic Citrullinated Peptide (Anti-CCP) Antibody During the Noninterventional Phase

Anti-CCP antibodies are important markers of bone erosion in RA. Anti-CCP antibodies were classified as positive if >7 U/mL. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
V1 (n=20)Between V1 and V2 (n=6)
Tocilizumab75.083.3

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Number of Erosions During the NonInterventional Phase

In RA, the presence, number, and size of bone erosions and the number of joints with erosions on CRs are hallmarks for diagnosis, staging and prediction of damage progression and are used for treatment monitoring in randomized controlled studies. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionerosions (Mean)
V1 (n=11)Between V1 and V2 (n=6)
Tocilizumab5.13.2

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Median GC Dose Taken During the Noninterventional Phase

During the noninterventional phase of the study participants received GC as prescribed by the physician. Doses of all GC administered are expressed as MP equivalents. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionmg (Median)
Start dose V1 (n=68)Start dose (V1) for Interventional phase (n=50)Stop dose (V2; n=50)Change from start to stop (n=50)Cumulative dose from V1 to V2 (n=45)
Tocilizumab6640320

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Health Assessment Questionnaire Disability Index (HAQ-DI) During the Noninterventional Phase

HAQ-DI is a self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. Timepoint was V2, or before V2 for participants withdrawn before V2. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionunits on a scale (Mean)
V1 (n=66)V2 (n=61)Change from V1 to V2 (n=60)
Tocilizumab1.71.2-0.5

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HAQ-DI During the Interventional Phase

HAQ-DI is a self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. V3, CV, and the change from V3 to CV was determined. (NCT01219933)
Timeframe: Visit 3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionunits on a scale (Mean)
V3 (n=41)CV (n=28)Change from V3 to CV (n=26)
Tocilizumab1.00.80.0

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Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score During the Interventional Phase

FACIT-F is a 13-item questionnaire. Participants 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 participant's 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-F score for a total possible score of 0 (worse score) to 52 (better score). V3, CV, and the change from V3 to CV was determined. (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionunits on a scale (Mean)
V3 (n=37)CV (n=26)Change from V3 to CV (n=22)
Tocilizumab37.535.68.8

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DAS28-ESR During the Noninterventional Phase

DAS28-ESR was calculated from the SJC and TJC using the 28 joints count and ESR (millimeters per hour [mm/hr]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-ESR ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-ESR <2.6=remission. Timepoint was V2, or before V2 for participants withdrawn before V2; DAS28-ESR values indicated in the CRF were recalculated by the data manager. The recalculated values were used in the statistical analyses. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionunits on a scale (Mean)
V1 (n=62)V2 (n=52)Change from V1 to V2 (n=50)
Tocilizumab5.83.3-2.7

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DAS28-CRP During the Noninterventional Phase

DAS28-CRP was calculated from the swollen joint count (SJC) and tender joint count (TJC) using the 28-joint count and CRP (mg/L). Total score range: 0 to 10, higher score indicated more disease activity. DAS28-CRP ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-CRP <2.6=remission. Timepoint was V2, or before V2 for participants withdrawn before V2; DAS28-CRP values indicated in the Case Report Form (CRF) were recalculated by the data manager. The recalculated values were used in the statistical analyses. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionunits on a scale (Mean)
V1 (n=67)V2 (n=66)Change from V1 to V2 (n=65)
Tocilizumab5.42.9-2.5

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Clinical Disease Activity Index (CDAI) During the Noninterventional Phase

The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and Physician Global Assessment (PGA) of disease assessed on 0-100 mm Visual analog scale (VAS); higher scores=greater affection due to disease activity. CDAI total score=0-76. CDAI ≤2.8=disease remission, >2.8 to 10=LDA, >10 to 22=moderate disease activity, and >22=high disease activity. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionunits on a scale (Mean)
V1 (n=62)V2 (n=52)Change from V1 to V2 (n=50)
Tocilizumab33.814.6-20.4

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CDAI Score During the Interventional Phase

The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-100 mm VAS; higher scores=greater affection due to disease activity. CDAI total score=0-76. CDAI ≤2.8=disease remission, >2.8 to 10=LDA, >10 to 22=moderate disease activity, and >22=high disease activity. V3, CV, and the change from V3 to CV was determined. (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionunits on a scale (Mean)
V3 (n=40)CV (n=27)Change from V3 to CV (n=25)
Tocilizumab5.66.51.4

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Time-Averaged GC Dose Changes During the Interventional Phase

"Area Under the Curve (AUC) of GC dose during the interventional phase was determined using the trapezoidal method and was calculated as:~AUC = sigma(Ti+1 - Ti) x [(Di+1+Di)/2]~With Di=dosage at time Ti~It corresponds to the total GC dose received between Baseline (visit 3) and visit 9 and has been calculated only for the 30 patients achieving visit 9." (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionmg (Mean)
Tocilizumab341.8

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Percentage of Participants With Changes in RA Treatment During the Noninterventional Phase

(NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
Tocilizumab15.2

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Percentage of Participants in the Interventional Phase Who Achieved LDA and Discontinued Oral GC Within 20 Weeks

The percentage of participants with rheumatoid arthritis (RA) with LDA was defined as DAS28 ≤3.2, able to discontinue oral GC within 20 weeks and at the latest at V8, confirmed at the Consolidation Visit without loss of clinical response defined as DAS28 (CRP) >3.2. (NCT01219933)
Timeframe: Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), and 8 (12 months)

Interventionpercentage of participants (Number)
Tocilizumab58.1

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Percentage of Participants Able to Start the GC Reduction Phase at V3

All participants who maintained LDA (defined as DAS28-CRP ≤3.2) from V2 to V3 were included in the interventional phase for reduction of GC. (NCT01219933)
Timeframe: V3 (7 months)

Interventionpercentage of participants (Number)
Tocilizumab87.8

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Number of Participants With GC Switches During the Noninterventional Phase

During the noninterventional phase of the study, once LDA was achieved, GC was switched to MP tablets. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionparticipants (Number)
Tocilizumab0

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Percentage of Participants Acheiving Remission Assessed Using DAS28 While Receiving Oral GC on Background TocilizumabTreatment During the Noninterventional Phase

DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the CRP and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <2.6 = remission. (NCT01219933)
Timeframe: V1 and V2 (up to 6 months after V1)

Interventionpercentage of participants (Number)
Tocilizumab41.2

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Percentage of Participants Able to Reduce Oral GCs by ≥50 Percent (%) During the Interventional Phase by V9

(NCT01219933)
Timeframe: V9 (24 weeks after V3)

Interventionpercentage of participants (Number)
Tocilizumab93.3

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Percentage of Participants Able to Discontinue GCs During the Interventional Phase by V9

(NCT01219933)
Timeframe: V9 (24 weeks after V3)

Interventionpercentage of participants (Number)
Tocilizumab3.3

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SF-36 Subscale Scores During the Interventional Phase

"SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores reflect higher quality of life. V3, CV, and the change from V3 to CV was determined." (NCT01219933)
Timeframe: V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)

Interventionunits on a scale (Mean)
Physical functioning V3 (n=36)Physical functioning CV (n=26)Change in physical functioning V3 to CV (n=22)Physical sub-score V3 (n=37)Physical sub-score CV (n=26)Change in physical sub-score V3 to CV (n=22)Bodily pain V3 (n=37)Bodily pain CV (n=26)Change in bodily pain V3 to CV (n=22)General health V3 (n=37)General health CV (n=26)Change in general health V3 to CV (n=22)Vitality V3 (n=37)Vitality CV (n=26)Change in vitality V3 to CV (n=22)Social functioning V3 (n=37)Social functioning CV (n=26)Change in social functioning V3 to CV (n=22)Emotional sub-score V3 (n=37)Emotional sub-score CV (n=26)Change in emotional sub-score V3 to CV (n=22)Mental health V3 (n=37)Mental health CV (n=26)Change in Mental health V3 to CV (n=22)
Tocilizumab41.5241.92-1.8040.6139.85-2.7945.8844.65-3.2143.1140.82-3.7850.5148.91-4.3745.4245.58-2.7340.5940.37-2.4547.1445.94-5.47

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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). (NCT01267201)
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hours (hrs) post-dose

Interventionng*hr/mL (Geometric Mean)
Methylprednisolone 32 mg Tablet1286.00
Methylprednisolone 32 mg Micronized API1204.00
Methylprednisolone 32 mg Sieve Cut API1180.00

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Maximum Observed Plasma Concentration (Cmax)

(NCT01267201)
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose

Interventionng/mL (Geometric Mean)
Methylprednisolone 32 mg Tablet289.00
Methylprednisolone 32 mg Micronized API279.10
Methylprednisolone 32 mg Sieve Cut API246.20

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Time to Reach Maximum Observed Plasma Concentration (Tmax)

(NCT01267201)
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose

Interventionhr (Median)
Methylprednisolone 32 mg Tablet2.00
Methylprednisolone 32 mg Micronized API1.00
Methylprednisolone 32 mg Sieve Cut API2.00

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Plasma Decay Half-life (t1/2)

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. (NCT01267201)
Timeframe: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose

Interventionhr (Mean)
Methylprednisolone 32 mg Tablet2.43
Methylprednisolone 32 mg Micronized API2.42
Methylprednisolone 32 mg Sieve Cut API2.45

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Urgent Care Visits, ED Visits and Hospitalizations

Number of participants who had urgent care visits, ED visits, and/or hospitalizations for respiratory symptoms. (NCT01272635)
Timeframe: 14 days after initiation of therapy

Interventionparticipants (Number)
Azythromycin20
Placebo38

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Progression to Clinically Significant Lower Respiratory Tract Symptoms

Progression to clinically significant lower respiratory tract symptoms defined by: (1) having symptoms that were more than mild after 3 albuterol administrations over 1 hour, or (2) requiring albuterol administrations more often than once every 4 hours, or (3) requiring more than 6 albuterol treatments over a 24-hour period, or (4) having moderate to severe cough or wheeze for 5 or more days since study medication was initiated. (NCT01272635)
Timeframe: 14 days after initiation of APRIL therapy

Interventionparticipants (Number)
Azythromycin35
Placebo57

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OCELOT: Pediatric Respiratory Assessment Measure

The Pediatric Respiratory Assessment Measure (PRAM) is a composite outcome with scores ranging from 0-12 with higher numbers representing worse symptoms. The score is calculated as the sum total of the follow five elements: (1) scalene retractions, (2) suprasternal retractions, (3) wheezing, (4) air entry, (5) oxygen saturation. A complete description can be found in: Ducharme FM, Chalut D, Plotnick L, et al. The Pediatric Respiratory Assessment Measure: a valid clinical score for assessing acute asthma severity from toddlers to teenagers. J Pediatr 2008;152:476-80. (NCT01272635)
Timeframe: 36-72 hours after initiation of OCELOT therapy

InterventionPRAM score (Mean)
Prednisone0.82
Placebo1.00

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Skin Healing Time

Healing was defined as complete re-epithelialization (i.e., the complete absence of erosions). We recorded the time taken by the skin to heal. (NCT01276314)
Timeframe: One to two months for SJS/TEN cases, and one to six months for DRESS cases.

Interventiondays (Median)
Anti- TNF-a Treatment (SJS/TEN)13.75
Control Group (SJS/TEN)19
Anti- TNF-a Treatment (DRESS)40.5
Control Group (DRESS)34

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60-day Mortality

The primary outcome is all-cause mortality at 60 days, defined by whether the patient has died by the end of study day 60. (NCT01283009)
Timeframe: 60-day

InterventionParticipants (Count of Participants)
Died on or prior to study day 6072325123Died on or prior to study day 6072325124On Mechanical Ventilation at Study Entry72325123On Mechanical Ventilation at Study Entry72325124Not on Mechanical Ventilation72325123Not on Mechanical Ventilation72325124
YesNoUnknown
Arm 1: Inactive Substance50
Arm 2: Methylprednisolone47
Arm 1: Inactive Substance227
Arm 2: Methylprednisolone239
Arm 1: Inactive Substance10
Arm 2: Methylprednisolone11
Arm 1: Inactive Substance24
Arm 2: Methylprednisolone22
Arm 1: Inactive Substance70
Arm 2: Methylprednisolone72
Arm 1: Inactive Substance2
Arm 2: Methylprednisolone3
Arm 1: Inactive Substance26
Arm 2: Methylprednisolone25
Arm 1: Inactive Substance157
Arm 2: Methylprednisolone167
Arm 1: Inactive Substance8
Arm 2: Methylprednisolone8

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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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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 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 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 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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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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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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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 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 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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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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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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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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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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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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Overall Survival

Time from date of treatment start until date of death due to any cause or last Follow-up. Survival will be measured by the estimated median survival computed by Kaplan-Meier (K-M) analysis, which is the time point at which the cumulative survival drops below 50%, if present. If not present then the median Overall Survival is not reached and not available (NA) as there are an insufficient number of participants with events. In either case ranges are provided for observed survival intervals used in the K-M analysis. (NCT01319981)
Timeframe: Up to 7 years, 8 months

InterventionMonths (Median)
Hyper-CMAD + RituximabNA
Hyper-CMADNA

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Number of Patients With Complete Remission at One Year

The complete remission (CR) is the total number of patients who are in CR at one year divided by the total number of patients who received at least one dose of HCVAD with liposomal vincristine. CR was defined as the presence of 1x10^9/L neutrophils, >100x10^9/L platelets in the perpherial blood, and no extramedullary disease. (NCT01319981)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Hyper-CMAD + Rituximab12
Hyper-CMAD13

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Complete Response Duration

The complete remission (CR) is the total number of patients who are in CR at one year divided by the total number of patients who received at least one dose of HCVAD with liposomal vincristine. CR was defined as the presence of 1x10^9/L neutrophils, >100x10^9/L platelets in the perpherial blood, and no extramedullary disease. Response date to loss of response or last follow up. Remission duration will be measured by the estimated median remission duration computed by Kaplan-Meier (K-M) analysis, which is the time point at which the cumulative remission duration drops below 50%, if present. If not present then median remission duration is not reached and not available (NA) as there are an insufficient number of participants with events. In either case ranges are provided for observed survival intervals used in the K-M analysis.. (NCT01319981)
Timeframe: Up to 7 years, 8 months

InterventionMonths (Median)
Hyper-CMAD + RituximabNA
Hyper-CMADNA

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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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Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) During MK-8808/CVP Combination Therapy

An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. (NCT01370694)
Timeframe: From first dose of combination therapy up to 24 weeks

InterventionParticipants (Number)
MK-8808 Combination Therapy6

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Clinical Response of Tumor to MK-8808/CVP Combination Therapy

The response of the tumor to MK-8808/CVP combination therapy was radiographically assessed using Response Criteria Evaluation in Solid Tumors (RECIST). Response categories of partial response (PR), complete resonse (CR), and uncomfirmed (CRu) central review. (NCT01370694)
Timeframe: Up to 2 years

InterventionParticipants (Number)
PRCRCRu
MK-8808 Combination Therapy600

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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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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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Number of Eyes With Immunologic Graft Rejection Episodes

(NCT01448213)
Timeframe: Within 1 year

Interventioneyes (Number)
Fluorometholone 0.1% Solution2
Prednisolone Acetate 1% Solution0

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Number of Eyes With Intraocular Pressure (IOP) Elevation

Absolute IOP greater than or equal to 24 mm Hg or a relative increase of 10 mm Hg over the baseline preoperative reading. (NCT01448213)
Timeframe: one day, two days, one week, one month, 3 months, 6 months and 12 months after DMEK

Interventioneyes (Number)
Fluorometholone 0.1% Solution9
Prednisolone Acetate 1% Solution32

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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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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 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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Overall MRD Negative Rate

Overall MRD negative rate is the percentage of participants classified as MRD negative by four color flow cytometry. The assay has a sensitivity of 1 in 10,000 leukocytes. (NCT01465334)
Timeframe: MRD was assessed after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C.

Interventionpercentage of participants (Number)
Treatment Naive80
Relapsed/Refractory53

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Overall Objective Response Rate (ORR)

Overall ORR is the percentage of participants achieving a minimum of partial response (PR) over induction and maintenance treatment based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. PR is a 50% or greater decrease of measured size of lymphadenopathy, hepatomegaly, splenomegaly as well as blood lymphocytes (over baseline), marrow infiltrate or B-lymphoid nodules and a 50% or greater increase from baseline in platelet count (or level >100,000/micro liter), hemoglobin (or level >11 grams/deciliter), neutrophils (or level >1500/microliter). (NCT01465334)
Timeframe: Disease was evaluated after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C.

Interventionpercentage of participants (Number)
Treatment Naive80
Relapsed/Refractory67

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Transplant Rate

Percentage of participants eligible for allogeneic hematopoietic stem cell transplantation (alloHSCT) that are able and willing to proceed to alloHSCT. (NCT01465334)
Timeframe: Evaluated up to 36 cycles (approximately 2.75 years) of treatment (Parts A, B and C)

Interventionpercentage of participants (Number)
Treatment Naive43
Relapsed/Refractory43

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3-year Overall Survival (OS) Probability

3-year OS is the probability of participants remaining alive at 3 years from study entry estimated using Kaplan-Meier methods. (NCT01465334)
Timeframe: Median survival follow-up was 45 months (range 31-58 months) in this study cohort.

Interventionpercentage probability (Number)
Treatment Naive66
Relapsed/Refractory53

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3-Year Progression-Free Survival (PFS) Probability

3-year PFS is the probability of participants remaining alive and progression-free at 3 years from study entry estimated using Kaplan-Meier methods. Disease progression (PD) per International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008) is: the appearance of any new lesion (enlarged lymph node minimum >1.5 centimeters); an increase by 50% in greatest determined diameter of any previous site; an increase in the previously noted enlargement of the liver or spleen by 50% or more or the de novo appearance of hepatomegaly, splenomegaly; a 50% increase of blood lymphocytes (over baseline with level at least 5,000/microliter); occurrence of cytopenia secondary to CLL at least 3 months post treatment including a 50% or greater decrease from baseline in platelet count (or level <100,000/microliter) or a hemoglobin decrease of >2 grams/deciliter (or level <10 grams/deciliter); and transformation to a more aggressive histology. (NCT01465334)
Timeframe: Disease was evaluated on treatment after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C as well as off-treatment every 3 months up to 5 years.

Interventionpercentage probability (Number)
Treatment Naive53
Relapsed/Refractory25

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Induction Overall Response Rate (ORR)

Induction ORR is the percentage of participants achieving a minimum of partial response (PR) over induction treatment based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. PR is a 50% or greater decrease of measured size of lymphadenopathy, hepatomegaly, splenomegaly as well as blood lymphocytes (over baseline), marrow infiltrate or B-lymphoid nodules and a 50% or greater increase from baseline in platelet count (or level >100,000/micro liter), hemoglobin (or level >11 grams/deciliter), neutrophils (or level >1500/microliter). (NCT01465334)
Timeframe: Disease was evaluated after weeks 8 and 16 of Part A and at 12, 18 and 24 weeks during part B.

Interventionpercentage of participants (Number)
Treatment Naive73
Relapsed/Refractory60

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Number of Participants Completing Only 2 Cycles of Part A Treatment

Participants counted if only completed 2 cycles of Part A treatment per protocol. (NCT01465334)
Timeframe: Evaluated after 2 cycles/8 weeks of Part A therapy.

Interventionparticipants (Number)
Treatment Naive0
Relapsed/Refractory0

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Number of Participants Completing Part A Treatment

Participants counted as completing Part A with either 2 or 4 cycles of treatment per protocol. (NCT01465334)
Timeframe: Evaluated up to 4 cycles/16 weeks.

Interventionparticipants (Number)
Treatment Naive12
Relapsed/Refractory15

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Number of Participants With Overall CR

CR overall (induction and maintenance treatment) was based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. CR is absence of significant lymphadenopathy (nodes<1.5 centimeters in long axis diameter), hepatomegaly, splenomegaly as well as blood lymphocytes<4000/microliter, normocellular for age marrow with <30% lymphocytes, no B-lymphoid nodules and platelet>100,000/micro liter, hemoglobin>11 grams/deciliter, neutrophils>1500/microliter. (NCT01465334)
Timeframe: Disease was evaluated after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C.

Interventionparticipants (Number)
Treatment Naive2
Relapsed/Refractory0

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Number of Participants Achieving Induction Complete Response (CR)

CR over induction treatment was based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. CR is absence of significant lymphadenopathy (nodes<1.5 centimeters in long axis diameter), hepatomegaly, splenomegaly as well as blood lymphocytes<4000/microliter, normocellular for age marrow with <30% lymphocytes, no B-lymphoid nodules and platelet>100,000/micro liter, hemoglobin>11 grams/deciliter, neutrophils>1500/microliter. (NCT01465334)
Timeframe: Disease was evaluated after weeks 8 and 16 of Part A and at 12, 18 and 24 weeks during part B.

Interventionparticipants (Number)
Treatment Naive0
Relapsed/Refractory0

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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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Anterior Chamber Cells & Flare

"Anterior Chamber Flare (for those subjects that could be examined with a slit lamp):~Assessed scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0 = None No Tyndall effect~= Mild Tyndall effect barely discernible~= Moderate Tyndall effect in anterior chamber is moderately intense. Iris pattern is seen clearly~= Severe Tyndall effect in anterior chamber is severely intense. Iris pattern cannot be seen clearly~= Very severe Tyndall effect is very severely intense. The aqueous has a white and milky appearance" (NCT01475643)
Timeframe: Over all visits 42 days

InterventionGrade of anterior chamber flare (Mean)
Loteprednol Etabonate.192
Prednisolones Acetate.341

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Anterior Chamber Inflammation

"Anterior Chamber Inflammation (for subjects that could only be examined with a pen light and a 20D [g20 Diopter] magnifying lens): 0 = None Clear anterior chamber with no visible clouding (Tyndall effect and cells combined). Red reflex normal~= Mild Mild anterior chamber clouding. Clear iris pattern on visualization. Red reflex normal~= Moderate Moderate anterior chamber clouding~= Severe Severe anterior chamber clouding. Iris pattern not clearly visualized. Red reflex diminished~= Very severe Severe anterior chamber clouding with a white and/or milky appearance of the anterior chamber. Red reflex absent or severely diminished" (NCT01475643)
Timeframe: Postoperative Day 29

Interventiongrade of anterior chamber cells (Mean)
Loteprednol Etabonate.913
Prednisolones Acetate.783

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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: 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 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 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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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 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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Rate of Progression/Relapse Free Survival (PFS)

Progression-free survival (PFS), defined as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier. (NCT01496976)
Timeframe: Up to 56 months

Interventionmonths (Median)
Immunotherapy54.4

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Number of Participants With Partial Response (PR)

The primary endpoint for this trial is the combined complete and partial response rate to the protocol therapy at 3 months, which is also the end of Cycle 3. The objective response (CR+PR) rate will be summarized using both a point estimate and its exact confidence interval based on the binomial distribution. (NCT01496976)
Timeframe: 3 Months

Interventionparticipants (Number)
Immunotherapy33

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Number of Participants With Overall Survival (OS)

Overall survival will be summarized with the Kaplan-Meier curve. (NCT01496976)
Timeframe: 36 Months

Interventionparticipants (Number)
Immunotherapy24

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Number of Participants With Complete Response (CR)

Number of participants with complete response, the disappearance of all signs of cancer in response to treatment. (NCT01496976)
Timeframe: 3 Months

InterventionParticipants (Count of Participants)
Immunotherapy1

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Objective Response Rate (ORR)

ORR at 3 months. Assessment for response will be made following the National Cancer Institute Working Group (NCIWG) 2008 Chronic Lymphocytic Leukemia (CLL) criteria for response. Objective response = Complete Response (disappearance of all target lesions) + Partial Response (>=30% decrease in the sum of the longest diameter of target lesions) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) (NCT01497496)
Timeframe: 3 Months

Interventionpercentage of participants (Number)
Immunotherapy48.3

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Episcleral Redness Change From Baseline to Day 6

Episcleral redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC.0 was best (least redness), and 4 was worst (most redness). (NCT01534195)
Timeframe: 7 minutes post-CAC

Interventionscore on a scale (Mean)
Prednisolone-1.0
Placebo0.45

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Ciliary Redness Change From Baseline to Day 6

Ciliary redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (least redness), and 4 was worst (most redness). (NCT01534195)
Timeframe: 7 minutes post-CAC

Interventionscore on a scale (Mean)
Prednisolone-0.94
Placebo0.30

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Conjunctival Redness Change From Baseline to Day 11

Conjunctival Redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (no redness), and 4 was worst (most redness) (NCT01534195)
Timeframe: 7 Minutes post-CAC

Interventionscore on a scale (Mean)
Prednisolone-0.69
Placebo0.40

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Ocular Itching Change From Baseline to Day 11

Ocular itching, as assessed by the participant, was measured on a 4-point scale 5 minutes after the conjunctival allergen challenge (CAC). 0 was best (no itching), and 4 was worst (worst itching). (NCT01534195)
Timeframe: 5 minutes post-CAC

Interventionunits on a scale (Mean)
Prednisolone-1.1
Placebo-0.45

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Disease-free Survival (DFS)

DFS, defined as the duration from the start of CR to the time of relapse from CR. DFS applied only to participants in CR. CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow. Relapse from CR: reappearance of serum or urine M-protein by immunofixation or electrophoresis; development of >= 5 percent plasma cells in the bone marrow; appearance of any other sign of progression (ie, new plasmacytoma, lytic bone lesion, or hypercalcaemia). (NCT01539083)
Timeframe: Up to 5 years

Interventionmonths (Median)
Thalidomide + Prednisolone [TP Consolidation]18.53
Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]13.37

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Consolidation Phase: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) at Month 12

CR as per IMWG criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (<) 5 percent plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90 percent or greater reduction in serum M-protein plus urine M-protein level <100 milligram (mg) per 24 hours. (NCT01539083)
Timeframe: Month 12

Interventionpercentage of participants (Number)
Thalidomide + Prednisolone [TP Consolidation]81.3
Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]92.9

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Consolidation Phase: Change From Baseline in FACT/GOG-NTX Total Score at the End of the Consolidation Phase

Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) consists of 10 items and evaluates symptoms and concerns associated specifically with chemotherapy-induced neuropathy. 1 FACT/GOG-NTX total score has a range of 0 to 108 with a higher score indicating better quality of life. (NCT01539083)
Timeframe: Baseline, Month 12

Interventionunits on a scale (Mean)
Thalidomide + Prednisolone [TP Consolidation]2.9
Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]1.0

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Consolidation Phase: Change From Baseline in AQOL-6D Scores at the End of the Consolidation Phase

The assessment of quality of life-6D (AQoL-6D) is a multi-attribute health-related quality of life instrument (QoL). It comprises dimension scores for independent living, relationships, mental health, coping, pain, senses, and utility score for AQol-6D. Each scale ranges between 1 (best QoL) and -0.04 (worst possible QoL). (NCT01539083)
Timeframe: Baseline, Month 12

,
Interventionunits on a scale (Mean)
Independent LivingRelationshipsMental HealthCopingPainSensesAQoL-6D Utility score
Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]0.140.050.180.050.200.000.11
Thalidomide + Prednisolone [TP Consolidation]0.150.060.180.080.200.030.11

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Progression Free Survival (PFS)

PFS, calculated as the time between randomization to disease progression or death (regardless of cause), whichever occurred first. Progressive disease as per IMWG criteria: increase of >= 25 percent from lowest response level in Serum M-component and/or (the absolute increase must be >=0.5 gram per deciliter [g/dL]) Urine M-component and/or (the absolute increase must be >=200 mg/24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be >10 mg/dL. Bone marrow plasma cell percentage: the absolute percent must be >=10 percent. 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 or 2.65 millimole per liter (mmol/L) that can be attributed solely to the plasma cell proliferative disorder. (NCT01539083)
Timeframe: Baseline until progressive disease (up to 5 years)

Interventionmonths (Median)
Thalidomide + Prednisolone [TP Consolidation]22.05
Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]22.51

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Overall Survival (OS)

OS was defined as the time between randomization and death. Death of a participant regardless of the cause was considered as an event. (NCT01539083)
Timeframe: Up to 5 years

Interventionmonths (Median)
Thalidomide + Prednisolone [TP Consolidation]NA
Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]NA

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Consolidation Phase: Percentage of Participants With Stringent Complete Response (sCR) at Months 3, 6, 9 and 12

sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow. CR is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow. (NCT01539083)
Timeframe: Months 3, 6, 9 and 12

,
Interventionpercentage of participants (Number)
Month 3Month 6Month 9Month 12
Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]23.528.630.628.6
Thalidomide + Prednisolone [TP Consolidation]20.827.126.026.0

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Consolidation Phase: Percentage of Participants With Complete Response (CR) at Months 3, 6, 9 and 12

CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow. (NCT01539083)
Timeframe: Months 3, 6, 9 and 12

,
Interventionpercentage of participants (Number)
Month 3Month 6Month 9Month 12
Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]36.744.952.053.1
Thalidomide + Prednisolone [TP Consolidation]36.544.849.051.0

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Orthostatic Hypotension

(NCT01559675)
Timeframe: Postoperative Day 1

Interventionparticipants (Number)
High Dose Steroid2
Low Dose Steroid2

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Neurodevelopmental Outcome

Bayley Scales of Infant and Toddler Development version 3 at 1 year. Cognitive, language, and motor composite scores will be used. The general population has a mean of 100 with a standard deviation of 15 for each composite score. Higher scores are better. The minimum composite score is 46 and maximum 154. (NCT01579513)
Timeframe: 1 year

,
Interventionscore on a scale (Mean)
Cognitive DomainLanguage DomainMotor Domain
Intraoperative Methylprednisone10510190
Placebo10410091

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Number of Participants With a Clinically Derived Composite Morbidity-mortality Outcome

The composite morbidity-mortality outcome will be met if any of the following occur after surgery but before hospital discharge: death, cardiac arrest, extracorporeal membrane oxygenation, renal insufficiency (creatinine more than two times normal), hepatic insufficiency (aspartate aminotransferase or alanine aminotransferase more than two times normal), or rising lactic acidosis (>5mmol/L). This outcome was choosen because death rarely occurs in this population. We have found this endpoint to be highly associated with other important clinical outcomes in this population. (NCT01579513)
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

InterventionParticipants (Count of Participants)
Intraoperative Methylprednisone27
Placebo40

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Intensive Care Unit Stay

Amount of time in the intensive care unit following cardiac surgery (NCT01579513)
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

InterventionDays (Mean)
Intraoperative Methylprednisone11
Placebo11

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Hospital Stay

Total duration of hospital stay following cardiac surgery (NCT01579513)
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

InterventionDays (Mean)
Intraoperative Methylprednisone20
Placebo22

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Duration of Mechanical Ventilation Post Cardiac Surgery.

Amount of time on mechanical ventilation following cardiac surgery (NCT01579513)
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

InterventionDays (Median)
Intraoperative Methylprednisone4
Placebo5

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Functional Improvement Measured According to Percentage Change in Constant Score

"Patients will be evaluated clinically by Constant Score~Constant score: range 0 (total shoulder impairment) to 100 (non impaired shoulder). The score is obtained from two subjective (pain and relation between pain and daily-life activities) - and two objective physician-assessed (strength and range of motion) measurements~Reference: Constant CR and Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4." (NCT01652495)
Timeframe: 180 days after treatment

Interventionpercentage of improvement Constant score (Mean)
Methylprednisolone Acetate Group99
Triamcinolone Acetonide Group95

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Reduction of Pain Severity Expressed as Percentage Change in VAS Score

"VAS score~VAS score is a 10 -cm graduated scale with scores ranging from 0 (no pain) to 10 (unbearable pain) self- reported by patients~Reference: Langley GB and Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int 1985;5(4):145-148." (NCT01652495)
Timeframe: 180 days after treatment

Interventionpercentage of pain reduction (Mean)
Methylprednisolone Acetate Group82
Triamcinolone Acetonide Group96

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Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis

"Evaluation of blood cortisol and ACTH, free urinary cortisol, urinary levels of methylprednisolone or triamcinolone (depending on the administered drug) by RIA immunoassay and tandem mass assays~Persistent suppression of the HPA axis at the end of the follow up is based on the evidence of ACTH, plasmatic and urinary cortisol levels under reference values" (NCT01652495)
Timeframe: 45 days after treatment

Intervention% of patients with HPA suppression (Number)
Methylprednisolone Acetate Group0
Triamcinolone Acetonide Group15

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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. (NCT01685983)
Timeframe: Up to 3 Years

InterventionPercentage of participants (Number)
Abiraterone Acetate and Prednisolone6.1

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Overall Survival

Overall survival is defined as the time interval from the date of the first dose to the date of death due to any reason. (NCT01685983)
Timeframe: Up to 3 Years

InterventionDays (Median)
Abiraterone Acetate and Prednisolone538

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Number of Participants With 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. (NCT01685983)
Timeframe: Up to 3 Years

InterventionParticipants (Number)
AEsSAEs
Abiraterone Acetate and Prednisolone8140

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Dehydroepiandrosterone Sulfate (DHEA-S)

Median DHEA-S concentration was reported at baseline and End-of-Treatment visit. (NCT01685983)
Timeframe: Baseline and End-of-Treatment Visit (up to approximately 3 years)

Interventionmicromole per liter (Median)
BaselineEnd-of-Treatment Visit
Abiraterone Acetate and Prednisolone0.7250.080

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Time to PSA Progression

Time to PSA progression was measured as the time interval from the date of the first dose to the date of PSA progression as defined in the protocol-specific PSAWG criteria. For participants who have achieved a greater than or equal to (>=) 50% decrease from the baseline PSA, assessment of time to disease progression is when the PSA has increased 50% above the nadir and at a minimum of 5 nanogram/mililiter (ng/mL). For participants without a PSA decrease of this magnitude or without a decrease, the time for progression is calculated at the time a 25% increase from baseline PSA has been achieved. (NCT01685983)
Timeframe: Up to 28 Months

InterventionDays (Median)
Abiraterone Acetate and Prednisolone141

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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. (NCT01685983)
Timeframe: Baseline, Month 4

InterventionPercentage of participants (Number)
Abiraterone Acetate and Prednisolone42.7

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Serum Testosterone

Median serum testosterone concentration was reported at baseline and End-of-Treatment visit. (NCT01685983)
Timeframe: Baseline and End-of-Treatment Visit (up to approximately 3 years)

Interventionnanomole per liter (Median)
BaselineEnd-of-Treatment Visit
Abiraterone Acetate and Prednisolone1.2101.210

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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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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 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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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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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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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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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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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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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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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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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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Ocular Redness Change From Baseline to Day 6

Ocular redness was measured by the investigator on a 4-point scale 7 minutes post-CAC. 0 = best (no redness), 4 = worst (most redness). (NCT01730872)
Timeframe: 7 minutes post-CAC

Interventionscore on a scale (Mean)
Prednisolone-1.1
Placebo0.31

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Ocular Itching Change From Baseline to Day 6

Ocular itching was measured by subject on a scale of 0 to 4 where 0 = no itching and 4 = worst itching. This measurement was taken 7 minutes post CAC (NCT01730872)
Timeframe: 7 minutes post-CAC

Interventionscore on a scale (Mean)
Prednisolone-1.1
Placebo-1.0

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Inflammation Change From Baseline to Day 6

Ocular inflammation was measured by a masked clinician on a 4-point scale 90 minutes after the conjunctival allergen challenge (CAC) . 0 = best (little to no inflammation), 4 = worst (most inflammation). (NCT01730872)
Timeframe: 90 minutes post CAC

Interventionscore on a scale (Mean)
Prednisolone-1.2
Placebo-0.19

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Number of Participants With Change/Improvement Visual Acuity From the Beseline

Best corrected visual acuity will measure at 1,2,3 days, 1 week, 2 weeks and 1 month and at least 3 months after treatment. Improvement is defined based on 1) mean logMAR[12], 2) 0.3 change in logMAR (improvement, deterioration, and no change) [12,16] , 3) mean improvement percentage which is calculated as: improvement%= (logMar ( of VA after treatment)-logMar ( of initial VA))/(logMar(20/13)˟-logMar ( of initial VA) 4) percentage of patients at different ordinal categorization of the BCVA as no light perception (NLP), light perception (LP)and hand motion (HM), count fingers (CF), and ≥ 20/200. (NCT01783847)
Timeframe: Change from baseline at least 3 months after treatment

InterventionParticipants (Count of Participants)
Recombinant Human Erythropoietin (EPO)28
Methylprednisolone3
Observation5

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Number of Participants With Relative Afferent Papillary Defect (RAPD) Grade +4

A positive RAPD means there are differences between the two eyes in the afferent pathway due to retinal or optic nerve disease. Graded from +1 to +4. The higher one is a better grade (NCT01783847)
Timeframe: Change from baseline at least 3 months after treatment

InterventionParticipants (Count of Participants)
Recombinant Human Erythropoietin (EPO)26
Methylprednisolone7
Observation8

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MELD Score at 28 Days

"Model of End Stage Liver Disease Score calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR). MELD score ranges from 6-40. A higher score indicates a lesser outcome.~The Model for End Stage Liver Disease scoring system is based on the INR, total serum bilirubin and serum creatinine. The measure reflects 90 day prognosis of alcohol associated liver disease from the time of measurement and therefore can only be assessed on subjects who are alive at the specified time point since lab values from that time point are required for the measure." (NCT01809132)
Timeframe: 28 days

Interventionscore on a scale (Mean)
Anakinra & Pentoxifylline & Zinc Sulfate22.57
Methylprednisolone20.95

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180 Days Mortality

Death at 180 days (NCT01809132)
Timeframe: Time to event up to 6 months

InterventionParticipants (Count of Participants)
Anakinra & Pentoxifylline & Zinc Sulfate17
Methylprednisolone22
Observational0

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MELD Score at 180 Days

"Model of End Stage Liver Disease Score calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR). MELD score ranges from 6-40. A higher score indicates a lesser outcome.~The Model for End Stage Liver Disease scoring system is based on the INR, total serum bilirubin and serum creatinine. The measure reflects 90 day prognosis of alcohol associated liver disease from the time of measurement and therefore can only be assessed on subjects who are alive at the specified time point since lab values from that time point are required for the measure." (NCT01809132)
Timeframe: 180 Days

Interventionscore on a scale (Mean)
Anakinra & Pentoxifylline & Zinc Sulfate15.81
Methylprednisolone11.85

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MELD Score at 90 Days

"Model of End Stage Liver Disease Score calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR). MELD score ranges from 6-40. A higher score indicates a lesser outcome.~The Model for End Stage Liver Disease scoring system is based on the INR, total serum bilirubin and serum creatinine. The measure reflects 90 day prognosis of alcohol associated liver disease from the time of measurement and therefore can only be assessed on subjects who are alive at the specified time point since lab values from that time point are required for the measure." (NCT01809132)
Timeframe: 90 Days

Interventionscore on a scale (Mean)
Anakinra & Pentoxifylline & Zinc Sulfate15.50
Methylprednisolone16.38

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Complete Resolution of Intraocular Gas Bubble

This will be reported by the patient when they see/feel the gas bubble disappear. (NCT01843920)
Timeframe: Following surgery, until gas bubble is gone. Up to 2 months.

InterventionDuration in days, gas bubble (Mean)
Post Surgery Without Glaucoma Drops40.4
Post Surgery With Glaucoma Drops37.8

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Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit [Time Frame: Day 7 up to Any Visit]

(NCT01853072)
Timeframe: Day 7 up to any visit through Day 90

Interventionpercentage of participants (Number)
Nepafenac15.4
Vehicle27.3

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Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60

(NCT01853072)
Timeframe: Baseline to Day 60

InterventionPercentage of participants (Number)
Nepafenac76.2
Vehicle64.7

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Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit

(NCT01853072)
Timeframe: Day 7 up to any visit through Day 90

Interventionpercentage of participants (Number)
Nepafenac9.1
Vehicle15.3

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Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90

(NCT01853072)
Timeframe: Baseline to Day 90

InterventionPercentage of participants (Number)
Nepafenac77.2
Vehicle67.7

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Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)

Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis. (NCT01853072)
Timeframe: Day 0 to Day 90

InterventionPercentage of participants (Number)
Nepafenac2.3
Vehicle17.3

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Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90

BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis. (NCT01853072)
Timeframe: Baseline to Day 14, and maintained through Day 90

InterventionPercentage of participants (Number)
Nepafenac61.7
Vehicle43.0

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Intraocular Pressure

Number of eyes in which the absolute intraocular pressure equaled or exceeded 24 mm Hg OR in which there was a relative increase of at least 10 mm Hg over the baseline preoperative reading. (NCT01853696)
Timeframe: from 1 to 12 months after transplant

Interventioneyes (Number)
Loteprednol11
Prednisolone Acetate27

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Immunologic Graft Rejection Episode

Rejection episodes were assessed by slit lamp examination and categorized as definite when an endothelial rejection line was detected in a previously clear graft, probable when inflammation (stromal infiltrate, keratic precipitates, cells in the anterior chamber, or ciliary injection) was detected in a previously clear graft without an endothelial rejection line, and possible if central corneal pachymetry increased by 30 microns or more, even if the cornea was clear and no inflammation was detected by slit lamp examination. (NCT01853696)
Timeframe: within first year after cornea transplantation

Interventioneyes (Number)
Loteprednol0
Prednisolone Acetate0

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Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit

(NCT01872611)
Timeframe: Day 7 up to any visit through Day 90

Interventionpercentage of participants (Number)
Nepafenac10.7
Vehicle8.9

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Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90

(NCT01872611)
Timeframe: Baseline to Day 90

InterventionPercentage of participants (Number)
Nepafenac65.4
Vehicle65.9

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Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60

(NCT01872611)
Timeframe: Baseline to Day 60

InterventionPercentage of participants (Number)
Nepafenac68.9
Vehicle62.1

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Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit

(NCT01872611)
Timeframe: Day 7 up to any visit through Day 90

Interventionpercentage of participants (Number)
Nepafenac18.7
Vehicle16.7

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Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90

BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis. (NCT01872611)
Timeframe: Baseline to Day 14, and maintained through Day 90

InterventionPercentage of participants (Number)
Nepafenac48.8
Vehicle50.5

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Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)

Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis. (NCT01872611)
Timeframe: Day 0 to Day 90

InterventionPercentage of participants (Number)
Nepafenac5.9
Vehicle14.3

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To Assess the Incidence of Acute GvHD Flare After CR/PR Requiring Additional Agent for Systemic Therapy Before Day 56 Post-administration of AP1903.

"To assess participants with incidence of acute GvHD flare after CR/PR requiring additional agent (including 2.5 mg/kg/day of prednisone [or methylprednisolone equivalent of 2 mg/kg/day]) for systemic therapy before Day 56 post-administration of AP1903." (NCT01875237)
Timeframe: before Day 56 post AP1903

InterventionParticipants (Count of Participants)
Transplant Only0
Transplat Plus DLI1

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To Assess Post Donor Lymphocyte Infusion (DLI) Chimerism

To assess the number of Participants with 100% donor chimerism at 6 months post donor lymphocyte infusion (DLI) (NCT01875237)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Transplant Only0
Transplat Plus DLI1

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Number of Participants Assessed Post Donor Lymphocyte Infusion (DLI): Disease-free Survival & Non-relapse Mortality, Chimerism and GVHD.

Participants to assess at 6 months post donor lymphocyte infusion (DLI): disease-free survival & non-relapse mortality, chimerism and GVHD (NCT01875237)
Timeframe: 6 months

,
InterventionParticipants (Count of Participants)
disease-free survivaIchimerism post DLIGVHD post DLInon-relapse mortality
Transplant Only0000
Transplat Plus DLI1110

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To Evaluate the Safety of Donor Lymphocyte Infusion Followed by Dimerizer Drug, AP1903 by Number of Participants With Adverse Events.

To evaluate the safety of the infusion of inducible caspase 9 (BPZ-1001) modified T-cells followed by dimerizer drug, AP1903. Safety evaluated by number of participants with Adverse events. (NCT01875237)
Timeframe: up to 3.5 years

InterventionParticipants (Count of Participants)
Transplant Only0
Transplat Plus DLI1

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To Assess the Incidence of Epstein-Barr Virus -PTLD or EBV Reactivation Requiring Therapy Post DLI.

To assess the incidence of Epstein-Barr virus (EBV)-associated lymphoproliferative disorder or EBV reactivation requiring therapy post DLI. (NCT01875237)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Transplant Only0
Transplat Plus DLI1

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To Assess the Proportion of Patients Developing Grade I-IV Acute GvHD

To assess the proportion of patients developing grade I-IV acute GvHD by Day 28, 56, and 180 post DLI. (NCT01875237)
Timeframe: Day 28, 56, and 180 post DLI.

,
InterventionParticipants (Count of Participants)
Day 28Day 56Day 180
Transplant Only000
Transplat Plus DLI110

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To Assess the Proportions of GvHD Response Post-administration of AP1903.

To assess the proportions of GvHD complete response (CR), partial response (PR), mixed response, no response, and progression among surviving patients at Day 3, 7, 14, 28, and 56 post-administration of AP1903. (NCT01875237)
Timeframe: Day 3, 7, 14, 28, and 56 post-administration of AP1903

InterventionParticipants (Count of Participants)
Day 3 post-administration of AP190371985950Day 3 post-administration of AP190371985951Day 7 post-administration of AP190371985951Day 7 post-administration of AP190371985950Day 14 post-administration of AP190371985951Day 14 post-administration of AP190371985950Day 28 post-administration of AP190371985951Day 28 post-administration of AP190371985950Day 56 post-administration of AP190371985951Day 56 post-administration of AP190371985950
no responsecomplete responseprogressionpartial response
Transplat Plus DLI1
Transplat Plus DLI0
Transplant Only0

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To Assess the Incidence of GvHD Treatment Failure Post-administration of AP1903.

To assess the incidence of GvHD treatment failure, defined as no response, progression, administration of additional therapy for GvHD, or mortality post-administration of AP1903. (NCT01875237)
Timeframe: Day 3, 7, 14, 28, and 56 post-administration of AP1903.

,
InterventionParticipants (Count of Participants)
Day 3 post-administration of AP1903.Day 7 post-administration of AP1903.Day 14 post-administration of AP1903.Day 28 post-administration of AP1903.Day 56 post-administration of AP1903.
Transplant Only00000
Transplat Plus DLI11111

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Duration of Response for Tazemetostat as a Single Agent or in Combination With Prednisolone (Phase 2 Only)

The time (in months) from the date of the initial response (CR or PR, whichever was first) until the date of the first documented disease progression per an Independent Review Committee (for Groups 1 and 2), per Investigator (Group 3), or death due to any cause. Patients who were alive and progression free at the time of the analysis were censored at the last date where the patient was known to be in response. Note: the DOR was censored, meaning data collection was stopped early for analysis, making the top limit of the 95% confidence interval not estimable (NE). Per RECIST v.1.0, CR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 mm in the short axis. The PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. (NCT01897571)
Timeframe: Radiologic tumor assessments performed at baseline (within 28 days before start of study treatment) and every 8 weeks during Cycles 2 to 6, and then every 12 weeks thereafter until confirmed PD/death, a maximum of approximately 82 months

Interventionmonths (Median)
Phase 2 Group 1: Tazemetostat in R/R FL With Mutant EZH211.3
Phase 2 Group 2: Tazemetostat in R/R FL With Wild-Type EZH213.0
Phase 2 Group 3: Tazemetostat in R/R DLBCL Monotherapy5.8
Phase 2 Group 4: Tazemetostat + Prednisone in R/R DLBCL Combination Therapy5.7

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Objective Response Rate (ORR; Complete Response + Partial Response [CR + PR]) (Phase 2)

Number of patients achieving an objective response (CR or PR)/number of patients treated x 100%. ORR was calculated as the percentage of patients with a confirmed complete response (CR) or partial response (PR) relative to the total number of patients in the analysis population per response evaluation criteria in solid tumors (RECIST) version (v)1.1. Complete Response (CR) was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. (NCT01897571)
Timeframe: Radiologic tumor assessments performed at baseline(within 28 days before start of study treatment)and every 8 weeks during Cycles 2 to 6,and then every 12 weeks thereafter until confirmed disease progression (PD)/death,a maximum of approximately 82 months

InterventionParticipants (Count of Participants)
Phase 2 Group 1: Tazemetostat in R/R FL With Mutant EZH234
Phase 2 Group 2: Tazemetostat in R/R FL With Wild-Type EZH219
Phase 2 Group 3: Tazemetostat in R/R DLBCL Monotherapy30
Phase 2 Group 4: Tazemetostat + Prednisolone in R/R DLBCL Combination Therapy8

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Progression Free Survival for Tazemetostat as a Single Agent or in Combination With Prednisolone (Phase 2 Only)

The time (in months) from the date of first dose of tazemetostat until the earliest date of disease progression or death from any cause. Per RECIST v1.0, CR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 mm in the short axis. The PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. (NCT01897571)
Timeframe: Radiologic tumor assessments performed at baseline (within 28 days before start of study treatment) and every 8 weeks during Cycles 2 to 6, and then every 12 weeks thereafter until confirmed PD/death, a maximum of approximately 82 months

Interventionmonths (Median)
Phase 2 Group 1: Tazemetostat in R/R FL With Mutant EZH213.8
Phase 2 Group 2: Tazemetostat in R/R FL With Wild-Type EZH211.1
Phase 2 Group 3: Tazemetostat in R/R DLBCL Monotherapy1.9
Phase 2 Group 4: Tazemetostat + Prednisolone in R/R DLBCL Combination Therapy1.8

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Survival at Day 29 of the Assigned Treatment

"To determine whether treatment with prednisolone + mycophenolate mofetil is better than standard of care treatment among patients with alcoholic hepatitis who fail to respond to 1 week of prednisolone (i.e., Lille score of ≥0.45). Primary outcome is survival at Day 29.~All study participants received the Standard of care (prednisolone) with or without experimental drug at Day 1 (based on randomization). Response to the treatment was determined at Day 8. Data was collected for both responders and non-responders." (NCT01903798)
Timeframe: Day 8 to Day 29

InterventionParticipants (Count of Participants)
Continue Prednisolone (Lille <0.45)2
Rilonacept + Prednisolone (Lille <0.45)0
Standard of Care (Lille ≥ 0.45)1
Mycophenolate + Prednisolone (Lille ≥ 0.45)1

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Number of Patients Reported Ascites

(NCT01903798)
Timeframe: Week 24

InterventionParticipants (Count of Participants)
Continue Prednisolone (Lille <0.45)0
Rilonacept + Prednisolone (Lille <0.45)0
Standard of Care (Lille ≥ 0.45)1
Mycophenolate + Prednisolone (Lille ≥ 0.45)0

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Percent Reduction in Hemangioma Volume From Baseline

Percent Reduction in Hemangioma Volume from Baseline (measured by MRI or Sono (from basline to 16 weeks)) (NCT01908972)
Timeframe: After 16 weeks

Intervention% from baseline (Mean)
Prednisolone46.52
Propranolol55.87

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Number of Participants With Change in Color as Compared to Baseline

Participants were observed for any change in color. The possible change in colors included change to Red/Purple/Blue/Gray/Apricot. Reported are the number of participants who experienced a change in color by the type of color (NCT01908972)
Timeframe: After 16 weeks

,
InterventionParticipants (Count of Participants)
RedPurple
Prednisolone130
Propranolol140

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Number of Participants With Clinical Response From Baseline in Hemangioma Volume Measured by MRI or SONO

The primary efficacy variable was the clinical response at 16 weeks, classified as follows: when the volume did not increase or decreased by less than 25% after treatment began, we defined it as stop of progression; when the volume decreased by 25% or more compared with the original size, we defined it as regression. Both stop of progression and regressionwere defined as reaction. If the volume at the primary efficacy evaluation point was greater than the size measured when treatment started,we called it an increase. Increase was defined as a nonreaction. (NCT01908972)
Timeframe: After 16weeks

InterventionParticipants (Count of Participants)
Prednisolone14
Propranolol16

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Number of Participants With Drug Compliance Within 16 Weeks

We checked Number of participants with Drug compliance within 16 weeks (NCT01908972)
Timeframe: After 16 weeks

InterventionParticipants (Count of Participants)
Prednisolone15
Propranolol17

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Number of Participants With Gastroesophageal Reflux Within 16 Weeks

Number of Participants With Gastroesophageal reflux within 16 weeks.. (NCT01908972)
Timeframe: up to 16weeks

InterventionParticipants (Count of Participants)
Prednisolone0
Propranolol0

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Number of Participants With Growth Retardation Within 16 Weeks

Number of Participants with Growth Retardation within 16 weeks.. (NCT01908972)
Timeframe: up to 16weeks

InterventionParticipants (Count of Participants)
Prednisolone2
Propranolol0

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Number of Participants With Reepithelialzation in 16weeks

Number of participants with Reepithelialzation in 16weeks.. (NCT01908972)
Timeframe: After 16 weeks

InterventionParticipants (Count of Participants)
Prednisolone4
Propranolol8

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Number of Participants With Regression

Number of participants whose hemangioma showed regression in 16 weeks. (NCT01908972)
Timeframe: Within 16 weeks

InterventionParticipants (Count of Participants)
Prednisolone9
Propranolol13

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Number of Participants With Size Reduction of Ulceration

size was measure the horizontal and vertical size (2-dimension) of ulceration (from baseline to 16 weeks after medication) (NCT01908972)
Timeframe: After 16 weeks

InterventionParticipants (Count of Participants)
Prednisolone2
Propranolol1

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Number of Participants With Stop of Proliferation

Number of participants whose hemangioma stop proliferating in 16weeks (NCT01908972)
Timeframe: After 16 weeks

InterventionParticipants (Count of Participants)
Prednisolone15
Propranolol17

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Number of Participants With Adverse Drug Reaction

All symptoms associated adverse drug reaction will be checked (NCT01908972)
Timeframe: up to 16weeks

InterventionParticipants (Count of Participants)
Prednisolone15
Propranolol16

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Number of Participants in Which, the Systolic Blood Pressure Fall of >25% of Baseline Postdose With Child Awake, Anytime During the 16 Weeks

Number of Participants in Which, the Systolic blood pressure fall of >25% of baseline postdose with child awake, Anytime During the 16 Weeks.. (NCT01908972)
Timeframe: up to 16weeks

InterventionParticipants (Count of Participants)
Prednisolone1
Propranolol5

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Number of Participants in Which, Facial Edema Occurs, Anytime During the 16 Weeks

Number of Participants in Which, facial edema occurs, Anytime During the 16 Weeks.. (NCT01908972)
Timeframe: up to 16weeks

InterventionParticipants (Count of Participants)
Prednisolone5
Propranolol0

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Number of Participants in Which, Glucose Levels Fall (to <50mg/dl), Anytime During the 16 Weeks

Number of Participants in Which, Glucose levels fall (to <50mg/dl), Anytime During the 16 Weeks.. (NCT01908972)
Timeframe: up to 16weeks

InterventionParticipants (Count of Participants)
Prednisolone0
Propranolol0

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Number of Participants in Which, the Heart Rate Fell to <70% of Acceptable Age Related Minimum Post-dose With Child Awake, Anytime During the 16 Weeks

Number of Participants in which, the Heart rate fell to <70% of acceptable age related minimum post-dose with child awake, anytime during the 16 weeks Count of patients whose Heart rate fall to <70% of acceptable age related minimum post-dose with child awake (NCT01908972)
Timeframe: up to 16weeks

InterventionParticipants (Count of Participants)
Prednisolone1
Propranolol5

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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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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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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 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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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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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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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: 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: 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 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 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 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 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 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 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 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 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: 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 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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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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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 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 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 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)
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: 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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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 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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Corneal Epitheliopathy (Corneal Fluorescein Staining Using the NEI Grading Scheme)

Corneal fluorescein staining is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The corneal fluorescein staining scale ranges from 0 to 15, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy. (NCT01977781)
Timeframe: 10 weeks

Interventionunits on a scale (Mean)
Tacrolimus3.7
Methylprednisolone Sodium Succinate6.6

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Schirmer Tear Test (mm)

Schirmer tear test measures the amount of tear secretion produced by a patient in millimeters (mm). Generally, the greater amounts of tear secretion is better than smaller amounts of tear secretion. The minimum value of this scale is 0 mm of tear secretion and there is no maximum value to this scale. (NCT01977781)
Timeframe: 10 weeks

Interventionmillimeter (mm) (Mean)
Tacrolimus3.5
Methylprednisolone Sodium Succinate3.5

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Intraocular Pressure

Intraocular pressure is the measure of the fluid pressure within the eye as measured by tonometry. Intraocular pressure is normally measured in millimeters of mercury (mmHg). The normal range for intraocular pressure is 12-20 mmHg, there is no better or worse measurement. (NCT01977781)
Timeframe: 10 weeks

Interventionmillimeters of mercury (mmHg) (Mean)
Tacrolimus16.5
Methylprednisolone Sodium Succinate17.1

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Ocular Surface Disease Index (OSDI) Questionnaire

The OSDI questionnaire is a 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate each of the dry eye symptoms on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms. (NCT01977781)
Timeframe: 10 weeks

Interventionunits on a scale (Mean)
Tacrolimus42
Methylprednisolone Sodium Succinate28

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Visual Acuity

Visual acuity is measured by asking subjects to read letters on a chart that consists of different rows of letters. Each row of letters corresponds to different levels of visual acuity. The Logarithm of the Minimum Angle of Resolution (LogMAR) scale generally ranges from 0 to 1, with 0 corresponding to 20/20 vision and 1 corresponding to 20/200 vision. The range from 0-1 is not absolute, however, as patients who have vision better than 20/20 or vision worse than 20/200 will score out side of the 0 to 1 range. (NCT01977781)
Timeframe: 10 weeks

InterventionLogMAR Scale (Mean)
Tacrolimus0.13
Methylprednisolone Sodium Succinate0.13

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Tear Film Break-Up Time

Tear Film Break-Up Time measures the amount of time, in seconds, that the tear film completely coats the ocular surface after each blink. The longer the amount of time the tear film completely coats the ocular surface is considered to be better than a shorter amount of time. (NCT01977781)
Timeframe: 10 weeks

InterventionSeconds (Mean)
Tacrolimus2.6
Methylprednisolone Sodium Succinate1.0

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Ocular Burning Sensation, Ocular Discharge, Ocular Redness, Ocular Itching, Foreign Body Sensation

Ocular burning sensation, ocular discharge, ocular redness, ocular Itching, and foreign body sensation were measured to evaluate the safety and tolerability of topical tacrolimus 0.05% twice a day in the treatment of patients with ocular GVHD. Safety and tolerability of topical tacrolimus 0.05% twice a day will be monitored by the occurrence of systemic and ocular adverse events in addition to symptoms directly related to the instillation or use of the investigational medication. Subjects will be monitored at each study visit for the occurrence of any adverse events found through examination or patient reports. Tolerability will be evaluated at every visit with a self-response questionnaire that assessed burning sensation, discharge, redness, itchiness, and foreign body sensation on a scale from 0 to 4 (none = 0, trace = 1, mild = 2, moderate = 3, and severe = 4). Where a higher value represents more symptoms (less tolerability). (NCT01977781)
Timeframe: 10 weeks

,
Interventionunits on a scale (Mean)
Ocular Burning SensationOcular DischargeOcular RednessOcular ItchingForeign Body Sensation
Methylprednisolone Sodium Succinate2.230.260.430.600.57
Tacrolimus3.500.161.250.500.70

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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 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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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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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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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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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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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 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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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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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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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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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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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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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) 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) 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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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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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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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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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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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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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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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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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 Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24

DAS28 was calculated from the number of swollen joints and painful joints 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 using visual analog scale [VAS]) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity. (NCT02006706)
Timeframe: Baseline, Week 24

Interventionscore on a scale (Mean)
Rituximab/Methylprednisolone/MTX2.98

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Health Assessment Questionnaire-Disability Index (HAQ-DI)

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. (NCT02006706)
Timeframe: Baseline, Week 24

Interventionscore on a scale (Mean)
BaselineWeek 24
Rituximab/Methylprednisolone/MTX1.911.05

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Tear Break-Up Time (TBUT) in the Study Eye

TBUT is the time required for dry spots to appear on the surface of the study eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. (NCT02028754)
Timeframe: Day 7

InterventionSeconds (Mean)
Sodium Carboxymethylcellulose and Conventional Therapy8.5
Conventional Therapy6.6

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Fluorescein Staining Score in the Study Eye

The cornea is evaluated following ocular administration of fluorescein stain in the study eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The cornea is divided into 3 regions. Each region is scored according to the extent of staining, with scores ranging from 0 to 3 points: 0=non-staining, 1=staining range < 1/2 of the cornea, 2=staining range ≥ 1/2 of the cornea, and 3=regional whole staining of the cornea. The total score ranges from 0 to 9 points. The higher the staining score, the worse the dry eye condition. (NCT02028754)
Timeframe: Day 7, Day 30

,
InterventionScores on a Scale (Mean)
Day 7Day 30 (N=83, 82)
Conventional Therapy1.81.2
Sodium Carboxymethylcellulose and Conventional Therapy2.01.1

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Lissamine Green Staining Score in the Study Eye

Conjunctival and corneal staining are evaluated following ocular administration of lissamine green dye in the study eye. The conjunctiva is the clear membrane covering the white surface of the eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The conjunctiva and cornea are divided into 5 regions that are scored based on the extent of staining. Scores range from 0 to 3 points: 0=non-staining, 1=staining range < 1/2 of the conjunctiva and cornea, 2=staining range ≥ 1/2 of the conjunctiva and cornea, and 3=regional whole staining of the conjunctiva and cornea. The total score ranges from 0 to 15 points. The higher the grade score, the worse the dry eye condition. (NCT02028754)
Timeframe: Day 7, Day 30

,
InterventionScores on a Scale (Mean)
Day 7Day 30 (N=83,82)
Conventional Therapy2.62.3
Sodium Carboxymethylcellulose and Conventional Therapy2.92.1

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Ocular Surface Disease Index (OSDI) Questionnaire Score in the Study Eye

The OSDI is a 12-question survey for patients to document their dry eye disease symptoms in the study eye. The OSDI consists of a 5-point scale (0=none of the time and 4 = all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). (NCT02028754)
Timeframe: Day 7, Day 30

,
InterventionScores on a Scale (Mean)
Day 7Day 30 (N=83, 82)
Conventional Therapy18.114.2
Sodium Carboxymethylcellulose and Conventional Therapy15.612.7

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Results of Schirmer I Test With Anesthetics in the Study Eye

The Schirmer I test consists of anesthetic drops being placed into the lower eyelid of the study eye. Patients then close their eyes. Test paper is placed on the lower eyelid of the patient's closed eyes. The paper is then removed and the moisture length on the paper recorded. Shorter distances indicate worse dry eye symptoms. (NCT02028754)
Timeframe: Day 7, Day 30

,
InterventionMillimeters (Mean)
Day 7Day 30 (N=83, 82)
Conventional Therapy12.512.6
Sodium Carboxymethylcellulose and Conventional Therapy11.812.7

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Subjective Symptom Total Score in the Study Eye

The following 11 subjective symptoms are evaluated in the study eye: foreign body sensation, photophobia, itching, pain in the eye, dry eye, eye heaviness, blurred vision, eye fatigue, eye discomfort, eye secretions and tears. Each of these symptoms is divided into 4 classes: no symptom=0; occasional symptoms=1; intermittent mild symptoms=2; and persistent obvious symptoms=3. The total score ranged from 0 (best) to 33 (worst). (NCT02028754)
Timeframe: Day 7, Day 30

,
InterventionScores on a Scale (Mean)
Day 7Day 30 (N=83, 82)
Conventional Therapy6.45.6
Sodium Carboxymethylcellulose and Conventional Therapy6.15.1

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Tear Break-Up Time (TBUT) in the Study Eye

TBUT is the time required for dry spots to appear on the surface of the study eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. (NCT02028754)
Timeframe: Day 30

InterventionSeconds (Mean)
Sodium Carboxymethylcellulose and Conventional Therapy9.0
Conventional Therapy6.7

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QALYS at 12 Months (Cross-walk Tariff)

"The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score.~Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values." (NCT02038452)
Timeframe: 12 months

Interventionscore on a scale (Mean)
Steroid Injection0.723
Wrist Splint0.736

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NHS Cost Differences at 6 Months (CC)

Complete case analysis on the cost of interventions at 6 months (NCT02038452)
Timeframe: 6 months

InterventionUK Pounds (Mean)
Steroid Injection353.48
Wrist Splint306.42

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NHS Cost Differences at 6 Months

Cost of interventions at 6 months (NCT02038452)
Timeframe: 6 months

InterventionUK Pounds (Mean)
Steroid Injection346.78
Wrist Splint313.24

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NHS Cost Differences at 24 Months

Cost of interventions at 24 months (NCT02038452)
Timeframe: 24 months

InterventionUK Pounds (Mean)
Steroid Injection657.87
Wrist Splint586.77

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NHS Cost Differences at 12 Months

Cost of interventions at 12 months (NCT02038452)
Timeframe: 12 months

InterventionUK Pounds (Mean)
Steroid Injection508.69
Wrist Splint395.54

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Hand-wrist Pain Intensity Over 24 Months: 6 Weeks

Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 6 weeks. (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection3.33
Wrist Splint4.28

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Hand-wrist Pain Intensity Over 24 Months: 6 Months

Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 6 months. (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection4.11
Wrist Splint3.29

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Hand-wrist Pain Intensity Over 24 Months: 24 Months

Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 24 months. (NCT02038452)
Timeframe: 24 months

Interventionscore on a scale (Mean)
Steroid Injection2.81
Wrist Splint2.40

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Hand-wrist Pain Intensity Over 24 Months: 12 Months

Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 12 months. (NCT02038452)
Timeframe: 12 months

Interventionscore on a scale (Mean)
Steroid Injection3.17
Wrist Splint3.14

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Hand-wrist Pain Intensity 6 Weeks (PP)

Per protocol analysis for comparison of pain scores between treatment groups at 6 weeks follow-up (higher score indicates more pain) on participants with complete data. (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection3.33
Wrist Splint4.44

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Hand-wrist Pain Intensity 6 Weeks

Comparison of pain scores between treatment groups at 6 weeks follow-up (0-10 scale, higher score indicates more pain). (NCT02038452)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Steroid Injection3.42
Wrist Splint4.28

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BCTQ Symptom Severity and Functional Limitations 6 Weeks (Subgroup Analysis (SG), Intervention of Their Preference)

Subgroup analysis was performed in patients who were allocated the intervention of their preference. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.88
Wrist Splint2.19

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BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Months

Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up. Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 6 months. BCTQ: Boston Carpal Tunnel Questionnaire. (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.08
Wrist Splint2.04

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BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Weeks

Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 6 weeks. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.95
Wrist Splint2.30

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BCTQ Symptom Severity and Functional Limitations Over 24 Months: 12 Months

Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment). Results are presented at 12 months. BCTQ: Boston Carpal Tunnel Questionnaire. (NCT02038452)
Timeframe: 12 months

Interventionscore on a scale (Mean)
Steroid Injection1.98
Wrist Splint2.05

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BCTQ Symptom Severity Subscale 6 Months

Comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more severe symptoms). BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.33
Wrist Splint2.18

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BCTQ Symptom Severity Subscale 6 Months (CC)

"Sensitivity analysis for comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ:~Boston Carpal Tunnel Questionnaire" (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.29
Wrist Splint2.16

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BCTQ Symptom Severity Subscale 6 Months (PP)

"Per protocol analysis for comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ:~Boston Carpal Tunnel Questionnaire" (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.28
Wrist Splint2.15

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BCTQ Symptom Severity Subscale 6 Weeks

Comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms). BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.12
Wrist Splint2.43

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BCTQ Symptom Severity Subscale 6 Weeks (CC)

"Sensitivity analysis for comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ:~Boston Carpal Tunnel Questionnaire" (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.07
Wrist Splint2.44

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BCTQ Symptom Severity Subscale 6 Weeks (PP)

"Per protocol analysis for comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ:~Boston Carpal Tunnel Questionnaire" (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.07
Wrist Splint2.44

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Hand-wrist Pain Intensity 6 Months

Comparison of pain scores between treatment groups at 6 months follow-up. 0-10 scale, higher score indicates more pain. (NCT02038452)
Timeframe: 6 months

Interventionunits on a scale (Mean)
Steroid Injection4.32
Wrist Splint3.46

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Hand-wrist Pain Intensity 6 Months (CC)

Sensitivity analysis for comparison of pain scores between treatment groups at 6 months follow-up (scale 0-10, higher score indicates more pain) on participants with complete data. (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection4.11
Wrist Splint3.29

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BCTQ Functional Limitations Subscale 6 Months

Comparison of BCTQ functional limitations between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection1.91
Wrist Splint1.89

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BCTQ Functional Limitations Subscale 6 Months (CC)

Sensitivity analysis for comparison of BCTQ function limitations between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection1.85
Wrist Splint1.88

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BCTQ Functional Limitations Subscale 6 Months (PP)

Per protocol analysis for comparison of BCTQ functional limitations between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection1.89
Wrist Splint1.84

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BCTQ Functional Limitations Subscale 6 Weeks

Comparison of BCTQ functional limitations between treatment groups at 6 weeks follow-up (1-5 scale, higher score indicates more severe functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.88
Wrist Splint2.09

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BCTQ Functional Limitations Subscale 6 Weeks (CC)

Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.86
Wrist Splint2.10

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BCTQ Functional Limitations Subscale 6 Weeks (PP)

"Per protocol analysis for comparison of BCTQ functional limitations between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data.~BCTQ: Boston Carpal Tunnel Questionnaire" (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.88
Wrist Splint2.06

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Hand-wrist Pain Intensity 6 Months (PP)

Per protocol analysis for comparison of pain scores between treatment groups at 6 months follow-up (scale 0-10, higher score indicates more pain) on participants with complete data. (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection4.11
Wrist Splint3.38

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BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Injection)

Subgroup analysis was performed in patients who preferred injection. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.88
Wrist Splint2.40

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BCTQ Symptom Severity and Functional Limitations 6 Months (CC)

Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.08
Wrist Splint2.04

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BCTQ Symptom Severity and Functional Limitations 6 Months (PP)

Per protocol analysis for comparison of overall BCTQ between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.09
Wrist Splint2.02

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Hand-wrist Pain Intensity 6 Weeks (CC)

Sensitivity analysis for comparison of pain scores between treatment groups at 6 weeks follow-up (scale 0-10, higher score indicates more pain) on participants with complete data. (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection3.33
Wrist Splint4.28

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Symptom Severity and Limitations in Hand Function as Assessed by the BCTQ 6 Weeks

Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.02
Wrist Splint2.29

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Secondary: BCTQ Symptom Severity and Functional Limitations Over 24 Months: 24 Months

Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 24 months. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 24 months

Interventionscore on a scale (Mean)
Steroid Injection1.79
Wrist Splint1.73

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QALYS at 6 Months (Cross-walk Tariff)

"The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score.~Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values." (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection0.354
Wrist Splint0.356

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QALYS at 24 Months (Cross-walk Tariff)

"The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score.~Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values." (NCT02038452)
Timeframe: 24 months

Interventionscore on a scale (Mean)
Steroid Injection1.461
Wrist Splint1.497

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BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not State a Preference of Intervention)

Subgroup analysis was performed in patients who did not state a preference of intervention. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.03
Wrist Splint2.26

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BCTQ Symptom Severity and Functional Limitations 6 Months

Comparison of overall BCTQ between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more severe symptoms and functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Steroid Injection2.15
Wrist Splint2.06

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BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not Receive the Intervention of Their Preference)

Subgroup analysis was performed in patients who did not receive the intervention of their preference. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.15
Wrist Splint2.40

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BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Splint)

Subgroup analysis was performed in patients who preferred splint. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection2.15
Wrist Splint2.40

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BCTQ Symptom Severity and Functional Limitations 6 Weeks (Per-Protocol Analysis (PP))

Per protocol analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.96
Wrist Splint2.28

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BCTQ Symptom Severity and Functional Limitations 6 Weeks (Complete Case Analysis (CC))

Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire (NCT02038452)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Steroid Injection1.95
Wrist Splint2.29

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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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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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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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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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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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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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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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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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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 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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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 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 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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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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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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Meatus Location After Hypospadias Repair

Post operative follow-up after stent removal at 4-12 weeks of the overall cosmetic appearance of the phallus (i.e. location of the urethral meatus). (NCT02162810)
Timeframe: after stent removal at 4-12 weeks

,
InterventionParticipants (Count of Participants)
glanularcoronalsubcoronaldistal shaftproximal shaftpenoscrotalother
Oral Steroids9100030
Placebo-controlled8100020

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Meatus Location After Hypospadias Repair

The overall cosmetic appearance of the phallus (i.e. location of the urethral meatus) post-operatively. (NCT02162810)
Timeframe: postoperative follow up 7-12 days after the surgery following completion of the 5-day course of prednisolone vs. placebo.

,
InterventionParticipants (Count of Participants)
glanularcoronalsubcoronaldistal shaftproximal shaftpenoscrotalother
Oral Steroids13000040
Placebo-controlled8000021

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Meatus Location After Hypospadias Repair

The overall cosmetic appearance of the phallus (i.e. location of the urethral meatus) 6 months post-operatively. (NCT02162810)
Timeframe: 6-months after surgery

,
InterventionParticipants (Count of Participants)
glanularcoronalsubcoronaldistal shaftproximal shaftpenoscrotalother
Oral Steroids4000030
Placebo-controlled1100010

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Complications After Hypospadias Repair

6-month follow-up incidence of wound breakdown, fistula formation, stenosis or stricture formation, and the need for subsequent redo-hypospadias surgeries and/or fistula repairs, after Hypospadias repair. (NCT02162810)
Timeframe: 6 months after surgery

,
InterventionParticipants (Count of Participants)
meatal retractionmeatal stenosisglans dehiscenceskin breakdown along suture lines, urethra intacturethra breakdown proximal to glansurethrocutaneous fistulasuspected stricturesuspected urethral diverticulum
Oral Steroids00000201
Placebo-controlled00000100

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Complication Rate After Hypospadias Repair

Post-operative incidence of wound breakdown, fistula formation, stenosis or stricture formation, and the need for subsequent redo-hypospadias surgeries and/or fistula repairs, after Hypospadias repair. (NCT02162810)
Timeframe: postoperative follow up 7-12 days after the surgery following completion of the 5-day course of prednisolone vs. placebo.

,
InterventionParticipants (Count of Participants)
meatal retractionmeatal stenosisglans dehiscenceskin breakdown along suture lines, urethra intacturethra breakdown proximal to glansurethrocutaneous fistulasuspected stricturesuspected urethral diverticulum
Oral Steroids10000201
Placebo-controlled00100000

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Improvement of Chordee After Hypospadias Repair

Improvement of Chordee post-operatively after Hypospadias repair. (NCT02162810)
Timeframe: postoperative follow up 7-12 days after the surgery following completion of the 5-day course of prednisolone vs. placebo.

InterventionParticipants (Count of Participants)
improvement of chordee with degloving72438393improvement of chordee with degloving72438394improvement in ventral chordee72438393improvement in ventral chordee72438394improvement of chordee with plication72438393improvement of chordee with plication72438394
resolvedimprovedimprovement described but not documentedno improvementnot described
Oral Steroids2
Oral Steroids3
Oral Steroids1
Placebo-controlled0
Placebo-controlled2
Oral Steroids0
Oral Steroids5
Oral Steroids8
Placebo-controlled7
Oral Steroids7
Placebo-controlled6
Placebo-controlled1
Oral Steroids9
Placebo-controlled4

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Complication Rate After Hypospadias Repair

Post-operative incidence of wound breakdown, fistula formation, stenosis or stricture formation, and the need for subsequent redo-hypospadias surgeries and/or fistula repairs, after Hypospadias repair. (NCT02162810)
Timeframe: after stent removal at 4-12 weeks

,
InterventionParticipants (Count of Participants)
meatal retractionmeatal stenosisglans dehiscenceskin breakdown along suture lines, urethra intacturethra breakdown proximal to glansurethrocutaneous fistulasuspected stricturesuspected urethral diverticulum
Oral Steroids10000200
Placebo-controlled00100000

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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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Bayley III Gross Motor Scaled Score (Change From Baseline to 12 Month)

Bayley III Gross Motor Scaled Score measures motor development. This is normed for typically developing children and follow a bell shaped curve. The scale has mean of 10 +/-3 for children at all ages and is bell shaped. Therefore the two standard deviation range is 16 to 4 with higher values indicated better performance. Lower values have been shown to be common in boys with DMD and it this study the baseline average score was 4.2. (NCT02167217)
Timeframe: One year

Interventionunits on a scale (Mean)
Oral Prednisolone4.8

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Overall Survival (OS) Rate

Overall survival (OS) is defined from the date of natalizumab infusion to death or censored at last clinical evaluation. OS was estimated using the Kaplan-Meier method. (NCT02176031)
Timeframe: 2 years

Interventionpercentage of patients (Number)
Natalizumab43

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Rate of GVHD Flares

Number of subjects who experienced graft-versus-host disease (GVHD) flares requiring therapy after initial complete response (CR) or partial response (PR) by day 28 after the first dose of Natalizumab. (NCT02176031)
Timeframe: by Day 28

InterventionParticipants (Count of Participants)
Natalizumab0

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GI aGVHD Response Rate

Gastrointestinal (GI) acute graft-versus-host disease (GVHD) Response is defined by complete response, very good partial response, or partial response in signs and symptoms of GI aGVHD. (NCT02176031)
Timeframe: Day 28, Day 56

Interventionpercentage of patients (Number)
Overall response rate for GI GVHD at Day 28Overall response rate for GI GVHD at Day 56
Natalizumab5752

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Graft-verus-host Disease (GVHD) Response Rate

"Complete Response (CR) is defined as resolution of all signs and symptoms of acute GVHD.~Very Good Partial Response (VGPR) is defined by no rash or residual erythematous rash involving less than 25% of the body surface, and total serum bilirubin concentration less than 2 mg/dL or less than 25% of baseline at enrollment and tolerating food or enteral feeding, predominantly formed stools, no overt gastrointestinal bleeding or abdominal cramping, and no more than occasional nausea and vomiting.~Partial Response (PR) is defined as an improvement of one stage in one or more organs without progression in any other organ.~Non-response (NR) is defined as no reduction in any GVHD organ staging.~Progression is defined as either new organ involvement on day +8 or thereafter, or increased organ specific symptoms sufficient to increase the organ stage by one or more or the initiation of an additional GVHD agent.~Overall Response Rate (ORR) is the sum of CR, VGPR, and PR." (NCT02176031)
Timeframe: 28 Days, 56 Days

InterventionParticipants (Count of Participants)
Overall Response at Day 28Complete Response at Day 28Very Good Partial Response at Day 28Partial Response at Day 28Non-response/Progression of GVHD at Day 28Overall Response at Day 56Complete Response at Day 56Very Good Partial Response at Day 56Partial Response at Day 56Non-response/Progression of GVHD at Day 56
Natalizumab127237117226

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Percentage Steroid Dose Was Reduced at Day 28, 56, and 100 in Comparison to Steroid Dose at First Administration of Natalizumab.

Median percentage steroid dose was reduced at Day 28, Day 56, and Day 100 in comparison to steroid dose at first administration of Natalizumab. (NCT02176031)
Timeframe: Day 28, 56, and 100

Interventionpercentage of steroid dose (Median)
Median reduction in steroid dose at day 28Median reduction in steroid dose at day 56Median reduction in steroid dose at day 100
Natalizumab427185

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GVHD-free Survival Rate

Graft-versus-host disease (GVHD) free survival is defined as achieving complete response without death or relapse or requiring secondary immunosuppressive therapy . Proportions are reported descriptively. GVHD-free survival was assessed using the Kaplan-Meier method. (NCT02176031)
Timeframe: Day 56

Interventionpercentage of patients (Number)
Natalizumab33.3

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Number of Participants by Severity With Acute Graft Versus Host Disease (GVHD) in the First 100 Days After HCT

"Cumulative incidence of acute GVHD was estimated using Kalbfleisch-Prentice method. Death is the competing risk event. SAS macro (bmacro252-Excel2007cin) available at St. Jude was used for analysis. Severity of GVHD and stage were determined using the Clinical Oncology Group (COG) Stem Cell Committee Consensus Guidelines for establishing organ stage and overall grade of acute GVHD. Participants are graded on a scale from I to IV, with I being mild and IV being severe.~Overall Clinical Grade (based on the highest stage obtained):~Grade 0: No stage 1-4 of any organ. Grade I: Stage 1-2 skin and no liver or gut involvement. Grade II: Stage 3 skin, or Stage I liver involvement, or Stage 1 gastrointestinal (GI).~Grade III: Stage 0-3 skin, with Stage 2-3 liver, or Stage 2-3 GI. Grade IV: Stage 4 skin, liver or GI involvement.~Due to early close of study, a small number of patients were enrolled. The number of patients who experienced acute GVHD is provided." (NCT02199041)
Timeframe: 100 days after transplantation

InterventionParticipants (Count of Participants)
No Acute GVHDGrade IGrade IIGrade IIIGrade IV
Treatment80121

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Number of Participants With Secondary Graft Failure

"The cumulative incidence of secondary graft failure will be estimated using the Kalbfleisch-Prentice method. Deaths due to toxicity and relapse before day 100 are the competing events.~Secondary graft failure or graft rejection will be defined as no evidence of donor chimerism by umbilical cord blood (UCB) and/or haploidentical donor (<10%), or too few cells to perform adequate chimerism analysis, in research participants with prior neutrophil engraftment.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced secondary graft failure is provided." (NCT02199041)
Timeframe: 100 days after transplantation

InterventionParticipants (Count of Participants)
Treatment0

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Number of Participants With Overall Survival (OS)

"The Kaplan-Meier estimate of OS with relapse, death due to any cause and graft failure as events along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007kme) available in the Department of Biostatistics at St. Jude, where OS = min (date of last follow-up, date of death) - date of hematopoietic cell transplantation (HCT) and all participants surviving after 1 year post-transplant will be considered as censored.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who did not die at 1 year post-transplant is provided." (NCT02199041)
Timeframe: One year after transplantation

InterventionParticipants (Count of Participants)
Treatment6

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Number of Participants by Severity With Chronic Graft Versus Host Disease (GVHD) in the First 100 Days After HCT

"Cumulative incidence of acute and chronic GVHD was estimated using Kalbfleisch-Prentice method. Death is competing risk event. SAS macro (bmacro252-Excel2007cin) available St. Jude was used for such analysis. Severity of chronic GVHD was evaluated using National Institutes of Health (NIH) Consensus Global Severity Scoring. Mild is considered a better outcome with severe being the worst.~Criteria for grading chronic GVHD:~Mild: 1-2 organs/sites, maximum organ score of 1, and lung score of 1. Moderate: 3 or more organs/sites and maximum organ score of 1 and lung score of 1, OR at least 1 organ/site and maximum organ score of 2 and lung score of 1. Severe: At least 1 organ/site and maximum organ score of 3 and lung score of 2-3.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced chronic GVHD is provided." (NCT02199041)
Timeframe: 100 days after transplantation

InterventionParticipants (Count of Participants)
No Chronic GVHDMildModerateSevere
Treatment11001

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Number of Participants With Event-free Survival (EFS)

"The Kaplan-Meier estimate of EFS with relapse, death due to any cause and graft failure as events along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007kme) available in the Department of Biostatistics at St. Jude, where EFS = min (date of last follow-up, date of relapse, date of graft failure, date of death due to any cause) - date of transplant, and all participants surviving at the time of analysis without events will be censored. The number of participants who did not experience any of these events through one year post-transplant is given.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who did not experience any events defined above is provided." (NCT02199041)
Timeframe: One year after transplantation

InterventionParticipants (Count of Participants)
Treatment4

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Number of Participants With Neutrophil Engraftment

Neutrophil engraftment is defined as absolute neutrophil count (ANC) recovery of ≥ 0.5 x 10^9/L (500/mm^3) for three consecutive laboratory values obtained on different days (derived from either donor). Date of engraftment is the date of the first of the three consecutive laboratory values. The number of patients engrafted by day +42 post-transplant is provided. (NCT02199041)
Timeframe: Until day 42 post-transplant

InterventionParticipants (Count of Participants)
Treatment11

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Number of Participants With Malignant Relapse

"Relapse was evaluated using standard World Health Organization (WHO) criteria for each disease. The estimate of cumulative incidence of relapse will be estimated using Kalbfleisch-Prentice method. Relapse defined as the recurrence of original disease. Death is the competing risk event. The analysis will be implemented using Statistical Analysis System (SAS) macro (bmacro252-Excel2007cin).~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced malignant relapse is provided" (NCT02199041)
Timeframe: One year after transplantation

InterventionParticipants (Count of Participants)
Treatment7

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Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale

Change in shoulder pain reported by the subject after injection at 6 weeks. The subject will report shoulder pain on a scale from 0 (no pain) to 10 (maximal pain) after injection. A 2 point change is expected. (NCT02242630)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Methylprednisolone, 20 mg1.0
Methylprednisolone, 40 mg1.8
Triamcinolone, 20 mg1.9
Triamcinolone, 40 mg1.8

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Change in Shoulder Function, as Measured by the QuickDASH ®

The primary outcome of this study will be to compare the dose and type of intrabursal corticosteroid received to improvements in a functional measure of the shoulder, the QuickDASH. The QuickDASH is a validated questionnaire of shoulder function consisting of 11 questions with a score from 100 (maximal dysfunction) to 0 (no dysfunction). It is expected that improvements will lead to at least a 10 point improvement (minimal clinically important difference) (NCT02242630)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Methylprednisolone, 20 mg19.2
Methylprednisolone, 40 mg21.3
Triamcinolone, 20 mg19.1
Triamcinolone, 40 mg24.7

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Tear Break Up Time (TBUT)

TBUT measures the amount of time, in seconds, a dry spot appears in the tear film after each blink. Values less than 10 seconds are considered abnormal. (NCT02256969)
Timeframe: 4 week Time Point

InterventionSeconds (Mean)
Meibomian Gland Probing Plus Lubricant3.5
Sham Meibomian Gland Probing Plus Lubricant4.2
Meibomian Gland Probing Plus Blephamide3.2

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Symptom Assessment in Dry Eye (SANDE)

A two-item survey used to assess the frequency and severity of dry eye disease. The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms. (NCT02256969)
Timeframe: 4 week Time Point

Interventionunits on a scale (Mean)
Meibomian Gland Probing Plus Lubricant49.1
Sham Meibomian Gland Probing Plus Lubricant50.2
Meibomian Gland Probing Plus Blephamide47.6

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Ocular Surface Disease Index (OSDI)

A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms. (NCT02256969)
Timeframe: 4 week Time Point

Interventionunits on a scale (Mean)
Meibomian Gland Probing Plus Lubricant38.7
Sham Meibomian Gland Probing Plus Lubricant36.9
Meibomian Gland Probing Plus Blephamide37.3

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Corneal Fluorescein Staining (CFS)

Is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy. (NCT02256969)
Timeframe: 4 week Time Point

Interventionunits on a scale (Mean)
Meibomian Gland Probing Plus Lubricant2.4
Sham Meibomian Gland Probing Plus Lubricant2.0
Meibomian Gland Probing Plus Blephamide1.4

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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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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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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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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 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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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 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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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 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 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 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 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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Progression Free Survival (PFS)

PFS: time from randomization (Period 2 Week 1) to earliest progression event. Progression is defined as radiographic progression, unequivocal clinical progression, or death on study. Radiographic progression is defined for bone disease by appearance of ≥ 2 new lesions on whole-body radionuclide bone scan per Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria (i.e., unconfirmed progressive disease) that needs to be confirmed in the next assessment (i.e., progressive disease in the next assessment) or for soft tissue disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Unequivocal clinical progression is defined as new onset cancer pain requiring chronic administration of opiate analgesia or deterioration from prostate cancer of Eastern Cooperative Oncology Group (ECOG) performance status score to ≥ 3, or initiation of subsequent lines of cytotoxic chemotherapy or radiation therapy or surgical intervention due to complications of tumor progression. (NCT02288247)
Timeframe: From date of randomization to the earliest of either documented disease progression (median duration: 35 weeks)

Interventionmonths (Median)
Enzalutamide9.53
Placebo8.28

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Time to Prostate-specific Antigen (PSA) Progression

Time to PSA progression, defined as the time from randomization (Period 2 Week 1) to the date of the first PSA value in Period 2 demonstrating progression (Period 2). The PSA progression date is defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir recorded in Period 2 is documented, which must be confirmed by a second consecutive value obtained at least 3 weeks later. (NCT02288247)
Timeframe: From date of randomization to the first PSA value (median duration: 35 weeks)

Interventionmonths (Median)
Enzalutamide8.44
Placebo6.24

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Change From Baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS)

The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale, where the endpoints are labelled from 0 (worst health imaginable) to 100 (best health imaginable). (NCT02288247)
Timeframe: Period 2: Baseline, weeks 1, 13, 25, 37, 49, 61, 73, 85, 97, 109, 121, 133, 145, 157, 169, 181

Interventionscore on a scale (Mean)
BaselineChange at Week 1Change at Week 13Change at Week 25Change at Week 37Change at Week 49Change at Week 61Change at Week 73Change at Week 85Change at Week 97Change at Week 109Change at Week 121Change at Week 133Change at Week 145Change at Week 157Change at Week 169Change at Week 181
Enzalutamide0.00.02.3-3.0-1.3-2.51.3-3.57.217.817.7-7.00.51.0-4.02.0-4.0

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Objective Response Rate (ORR)

ORR, defined as the best overall radiographic response after randomization (Period 2 Week 1) as per Investigator assessments of response for soft tissue disease per RECIST 1.1, in participants who had a measurable tumor. ORR was reported as the percentage of participants with complete response (CR) or partial response (PR). CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. (NCT02288247)
Timeframe: From date of randomization up to median duration of 35 weeks

Interventionpercentage of participants (Number)
Enzalutamide31.6
Placebo25.9

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Prostate-specific Antigen (PSA) Response

PSA response, defined as a decrease in percentage change from randomization (Period 2 Week 1) of 50% or more. PSA response was derived at Week 13 and at any time after randomization in Period 2. PSA response at any time is defined as a decrease in percentage change from randomization (Period 2 Week 1) at any time after randomization of 50% or more. Percentage of participants with PSA response was reported. (NCT02288247)
Timeframe: Randomization, Week 13, any time after randomization in Period 2 (median of 35 weeks)

,
Interventionpercentage of participants (Number)
Week 13Any time after randomization (median of 35 weeks)
Enzalutamide44.955.9
Placebo25.237.0

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Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P)

FACT-P quality of life questionnaire is a multi-dimensional, self-reported quality of life instrument specifically designed for use with prostate cancer participants. It consists of 27 core items which assess participant function in four domains rated on 0 to 4 Likert-type scale: physical well-being (PWB) (7 items; 0 [worst] to 4 [better], score range 0-28), social/family well-being (SWB) (7 items; 0 [worst] to 4 [better], score range 0-28), emotional well-being (EWB) (6 items; 0 [worst] to 4 [better], score range 0-24), and functional well-being (FWB) (7 items; 0 [worst] to 4 [better], score range 0-28), which is further supplemented by 12 site-specific items to assess for prostate-related symptoms (Prostate Cancer Subscale [PCS] 12 items rated on Likert-type scale 0 [worst] to 4 [better], score range 0-48). The total domain scores and PCS subscale score are then combined to a global quality of life score ranging between 0 to 156; higher scores representing better quality of life. (NCT02288247)
Timeframe: Period 2: Baseline, weeks 1, 13, 25, 37, 49, 61, 73, 85, 97, 109, 121, 133, 145, 157, 169, 181

Interventionscore on a scale (Mean)
EWB: BaselineEWB: Change at Week 1EWB: Change at Week 13EWB: Change at Week 25EWB: Change at Week 37EWB: Change at Week 49EWB: Change at Week 61EWB: Change at Week 73EWB: Change at Week 85FWB: BaselineFWB: Change at Week 1FWB: Change at Week 13FWB: Change at Week 25FWB: Change at Week 37FWB: Change at Week 49FWB: Change at Week 61FWB: Change at Week 73FWB: Change at Week 85Global Score: BaselineGlobal Score: Change at Week 1Global Score: Change at Week 13Global Score: Change at Week 25Global Score: Change at Week 37Global Score: Change at Week 49Global Score: Change at Week 61PWB: BaselinePWB: Change at Week 1PWB: Change at Week 13PWB: Change at Week 25PWB: Change at Week 37PWB: Change at Week 49PWB: Change at Week 61PWB: Change at Week 73PWB: Change at Week 85PCS: BaselinePCS: Change at Week 1PCS: Change at Week 13PCS: Change at Week 25PCS: Change at Week 37PCS: Change at Week 49PCS: Change at Week 61SWB: BaselineSWB: Change at Week 1SWB: Change at Week 13SWB: Change at Week 25SWB: Change at Week 37SWB: Change at Week 49SWB: Change at Week 61SWB: Change at Week 73SWB: Change at Week 85
Placebo0.000.001.361.031.430.732.00-1.00-5.000.00000.0000-0.3121-0.8229-0.1459-1.3818-2.3333-2.00000.00000.00000.00001.79861.07620.1649-4.62026.09390.00000.0000-0.6347-0.4590-0.9556-1.39131.33333.00003.00000.00000.00001.60111.86320.6988-0.72234.26060.00000.0000-0.2953-0.0462-0.3963-0.75360.8333-24.0000-24.0000

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Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P)

FACT-P quality of life questionnaire is a multi-dimensional, self-reported quality of life instrument specifically designed for use with prostate cancer participants. It consists of 27 core items which assess participant function in four domains rated on 0 to 4 Likert-type scale: physical well-being (PWB) (7 items; 0 [worst] to 4 [better], score range 0-28), social/family well-being (SWB) (7 items; 0 [worst] to 4 [better], score range 0-28), emotional well-being (EWB) (6 items; 0 [worst] to 4 [better], score range 0-24), and functional well-being (FWB) (7 items; 0 [worst] to 4 [better], score range 0-28), which is further supplemented by 12 site-specific items to assess for prostate-related symptoms (Prostate Cancer Subscale [PCS] 12 items rated on Likert-type scale 0 [worst] to 4 [better], score range 0-48). The total domain scores and PCS subscale score are then combined to a global quality of life score ranging between 0 to 156; higher scores representing better quality of life. (NCT02288247)
Timeframe: Period 2: Baseline, weeks 1, 13, 25, 37, 49, 61, 73, 85, 97, 109, 121, 133, 145, 157, 169, 181

Interventionscore on a scale (Mean)
EWB: BaselineEWB: Change at Week 1EWB: Change at Week 13EWB: Change at Week 25EWB: Change at Week 37EWB: Change at Week 49EWB: Change at Week 61EWB: Change at Week 73EWB: Change at Week 85EWB: Change at Week 97EWB: Change at Week 109EWB: Change at Week 121EWB: Change at Week 133EWB: Change at Week 145EWB: Change at Week 157EWB: Change at Week 169EWB: Change at Week 181FWB: BaselineFWB: Change at Week 1FWB: Change at Week 13FWB: Change at Week 25FWB: Change at Week 37FWB: Change at Week 49FWB: Change at Week 61FWB: Change at Week 73FWB: Change at Week 85FWB: Change at Week 97FWB: Change at Week 109FWB: Change at Week 121FWB: Change at Week 133FWB: Change at Week 145FWB: Change at Week 157FWB: Change at Week 169FWB: Change at Week 181Global Score: BaselineGlobal Score: Change at Week 1Global Score: Change at Week 13Global Score: Change at Week 25Global Score: Change at Week 37Global Score: Change at Week 49Global Score: Change at Week 61Global Score: Change at Week 73Global Score: Change at Week 85Global Score: Change at Week 97Global Score: Change at Week 109Global Score: Change at Week 121Global Score: Change at Week 133Global Score: Change at Week 145Global Score: Change at Week 157Global Score: Change at Week 169Global Score: Change at Week 181PWB: BaselinePWB: Change at Week 1PWB: Change at Week 13PWB: Change at Week 25PWB: Change at Week 37PWB: Change at Week 49PWB: Change at Week 61PWB: Change at Week 73PWB: Change at Week 85PWB: Change at Week 97PWB: Change at Week 109PWB: Change at Week 121PWB: Change at Week 133PWB: Change at Week 145PWB: Change at Week 157PWB: Change at Week 169PWB: Change at Week 181PCS: BaselinePCS: Change at Week 1PCS: Change at Week 13PCS: Change at Week 25PCS: Change at Week 37PCS: Change at Week 49PCS: Change at Week 61PCS: Change at Week 73PCS: Change at Week 85PCS: Change at Week 97PCS: Change at Week 109PCS: Change at Week 121PCS: Change at Week 133PCS: Change at Week 145PCS: Change at Week 157PCS: Change at Week 169PCS: Change at Week 181SWB: BaselineSWB: Change at Week 1SWB: Change at Week 13SWB: Change at Week 25SWB: Change at Week 37SWB: Change at Week 49SWB: Change at Week 61SWB: Change at Week 73SWB: Change at Week 85SWB: Change at Week 97SWB: Change at Week 109SWB: Change at Week 121SWB: Change at Week 133SWB: Change at Week 145SWB: Change at Week 157SWB: Change at Week 169SWB: Change at Week 181
Enzalutamide0.000.001.150.691.911.220.591.691.003.902.934.002.002.002.001.002.000.00000.0000-1.8144-2.4472-1.5697-1.15790.0000-1.81821.2000-0.5000-1.3333-1.5000-0.5000-2.00000.0000-1.00000.00000.00000.0000-0.7836-5.9204-1.5351-4.4880-0.2957-0.39171.76366.2864-2.73334.0000-7.0000-11.0000-1.0000-10.0000-4.00000.00000.0000-1.3322-3.1317-2.1786-2.5316-1.3889-0.36361.00001.7500-0.6667-4.0000-4.5000-4.00000.0000-4.0000-2.00000.00000.00001.1842-0.4775-1.1433-1.84650.36900.91742.16363.8864-1.66672.0000-3.0000-5.00000.0000-3.0000-2.00000.00000.0000-0.1581-0.36340.8798-0.0719-0.8167-0.8182-3.6000-2.7500-2.00000.5000-1.0000-2.0000-3.0000-3.0000-2.0000

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Change From Baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS)

The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale, where the endpoints are labelled from 0 (worst health imaginable) to 100 (best health imaginable). (NCT02288247)
Timeframe: Period 2: Baseline, weeks 1, 13, 25, 37, 49, 61, 73, 85, 97, 109, 121, 133, 145, 157, 169, 181

Interventionscore on a scale (Mean)
BaselineChange at Week 1Change at Week 13Change at Week 25Change at Week 37Change at Week 49Change at Week 61Change at Week 73Change at Week 85
Placebo0.00.0-0.8-0.20.4-8.32.5-20.0-10.0

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Multiple Sclerosis Functional Composite (MSFC) Z-score and Expanded Disability Status Scale (EDSS)

"MSFC score is a composite score calculated from 3 tests: 1) Timed 25-Foot walk (leg function); 2) 9-Hole Peg Test (arm function); and 3) Paced Auditory Serial Addition Test (cognitive function). The results are combined to create a single score (the MSFC Z-Score) to measure performance and change over time in subjects with MS. MSFC Z-score = {Z arm + Z leg + Z cognitive} / 3.0. A positive score indicates that, on average, an individual performed better than the reference population and a negative score indicates that, on average, an individual performed worse than the reference population.~The Expanded Disability Status Scale (EDSS) is used to quantify disability due to symptoms of MS and to track changes in disability status over time. Scores range from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). Scores are determined by performing a neurological exam and given in increments of 0.5." (NCT02296346)
Timeframe: 1 year

,
Interventionscore on a scale (Mean)
EDSS ScoreMSFC Z-Score
Corticosteroid Arm6.250.6751
ECP Arm61.1031

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Best Spectacle-Corrected Visual Acuity

The BSCVA was recorded at 4 meters by a masked refractionist certified for the study using a protocol adapted from the Age-Related Eye Disease Study using Early Treatment Diabetic Retinopathy Study charts: chart R(2110), chart 1(2111), and chart 2(2112) (Precision Vision, Woodstock, IL). (NCT02373137)
Timeframe: 24 Months

InterventionLogMar (Mean)
UT-DSAEK0.15
DMEK0.09

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Best Spectacle-Corrected Visual Acuity

The BSCVA was recorded at 4 meters by a masked refractionist certified for the study using a protocol adapted from the Age-Related Eye Disease Study using Early Treatment Diabetic Retinopathy Study charts: chart R(2110), chart 1(2111), and chart 2(2112) (Precision Vision, Woodstock, IL). (NCT02373137)
Timeframe: 6 months

InterventionlogMAR (Mean)
UT-DSAEK0.22
DMEK0.05

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Endothelial Cell Count

(NCT02373137)
Timeframe: 24 months

Interventioncells/mm^2 (Mean)
UT-DSAEK1626
DMEK1400

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Adverse Events/Complication Rates

composite measure (NCT02373137)
Timeframe: 3, 6, 12, 24 months

,
Interventionnew adverse events reported (Number)
Adverse Events at 3 monthsAdverse Events at 6 monthsAdverse Events at 12 monthsAdverse Events at 24 months
DMEK6540
UT-DSAEK4410

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Best Spectacle-Corrected Visual Acuity

The BSCVA was recorded at 4 meters by a masked refractionist certified for the study using a protocol adapted from the Age-Related Eye Disease Study using Early Treatment Diabetic Retinopathy Study charts: chart R(2110), chart 1(2111), and chart 2(2112) (Precision Vision, Woodstock, IL). (NCT02373137)
Timeframe: 3 and 12 months

,
InterventionlogMAR (Mean)
3 Months12 Months
DMEK0.110.04
UT-DSAEK0.240.16

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Corneal Higher-Order Aberrations

As measured by Pentacam (NCT02373137)
Timeframe: 24 months

,
Interventionroot mean square in micrometers (Mean)
24 Months Anterior Cornea 4.0-mm24 Months Posterior Cornea 4.0-mm24 Months Anterior Cornea 6.0-mm24 Months Posterior Cornea 6.0-mm
DMEK0.2110.0860.6790.260
DSAEK0.2150.1550.7070.450

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Corneal Higher-Order Aberrations

Corneal anterior and posterior surface higher-order aberrations (HOA) were measured with Scheimpflug imaging (Pentacam) before surgery and at 3, 6, and 12 months post-operatively. Zernike orders 3-8 were calculated at 4.0- and 6.0-mm-diameter optical zones. The results reported here represent total HOA (Sum of Zernike orders 3-8). Note a single observation was not available for one eye in the DMEK group at 6 months, this was analyzed with last observation carried forward. (NCT02373137)
Timeframe: 3, 6, 12 months

,
Interventionroot mean square in micrometers (Mean)
3 Months Anterior Cornea 4.0-mm3 Months Posterior Cornea 4.0-mm3 Months Anterior Cornea 6.0-mm3 Months Posterior Cornea 6.0-mm6 Months Anterior Cornea 4.0-mm6 Months Posterior Cornea 4.0-mm6 Months Anterior Cornea 6.0-mm6 Months Posterior Cornea 6.0-mm12 Months Anterior Cornea 4.0-mm12 Months Posterior Cornea 4.0-mm12 Months Anterior Cornea 6.0-mm12 Months Posterior Cornea 6.0-mm
DMEK0.2880.1160.8290.3460.2430.0950.7240.2880.2410.0980.7230.284
UT-DSAEK0.2740.2170.8970.6210.2300.1790.7390.5050.2280.1590.7250.459

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National Eye Institute - Visual Functioning Questionnaire (NEI-VFQ)

"The National Eye Institute has developed the validated Visual Functioning Questionnaire (NEI-VFQ) to assess the effect of ocular conditions and vision on patient quality of life. The answers to the questionnaire are transformed into sub-scales, including: general health, general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision. Participants are assigned a numerical value for each sub-scale based on their answers between 0-100, where higher numbers indicate better visual function. These sub-scales are then combined according to National Eye Institute guidelines into an overall composite score for each participant. This overall composite score is also on a scale of 0-100, where higher numbers indicate better visual function.~Composite score based on National Eye Institute guidelines." (NCT02373137)
Timeframe: Baseline, 12 months

,
InterventionComposite scores on a scale (Mean)
Baseline12 Months
DMEK72.387.3
UT-DSAEK72.585.9

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Interface Haze

As measured by Pentacam densitometry (NCT02373137)
Timeframe: 24 months

,
Interventioneyes (Number)
Mild Interface Haze at 24 monthsModerate Interface Haze at 24 monthsSevere Interface Haze at 24 months
DMEK000
UT-DSAEK010

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Graft Thickness

As measured by Optical coherence tomography (OCT) and Pachymetry (NCT02373137)
Timeframe: 3, 6, 12, 24 months

,
Interventionroot mean square in micrometers (Mean)
3 months6 months12 months24 months
DMEK516.5519.67521.36526.88
UT-DSAEK589.36592.24585.96593.67

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Graft Failure/Graft Rejection

(NCT02373137)
Timeframe: Baseline 12 months

,
Interventioneyes (Count of Units)
Graft RejectionGraft Failure
DMEK01
UT-DSAEK01

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Endothelial Cell Count

(NCT02373137)
Timeframe: 3, 6, 12 months

,
Interventioncells/mm^2 (Mean)
3 Months6 Months12 Months
DMEK203719631855
UT-DSAEK211421132070

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Interface Haze

As measured by Pentacam densitometry (NCT02373137)
Timeframe: 3, 6, 12 months

,
Interventioneyes (Number)
Mild Interface Haze at 3 monthsModerate Interface Haze at 3 monthsSevere Interface Haze at 3 monthsMild Interface Haze at 6 monthsoderate Interface Haze at 6 monthsSevere Interface Haze at 6 monthsMild Interface Haze at 12 monthsoderate Interface Haze at 12 monthsSevere Interface Haze at 12 months
DMEK100100000
UT-DSAEK200210000

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Occurence of Postoperative Vomiting

Postoperative vomiting occurrence (yes, no) (NCT02401529)
Timeframe: 7 days

,
Interventionparticipants (Number)
yesno
IV Dexamethasone and Oral Prednisolone2525
Placebo3614

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Occurence of Post-operative Nausea

Postoperative nausea occurence (yes, no) (NCT02401529)
Timeframe: 7 days

,
Interventionparticipants (Number)
yesno
IV Dexamethasone and Oral Prednisolone1733
Placebo2921

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Maximum Severity of Post-operative Pain

5 grades (pain free, low disability and low intensity, low disability and high intensity, high disability and moderate intensity, high disability and severly limiting) (NCT02401529)
Timeframe: The severest pain grade felt within a week

,
Interventionparticipants (Number)
Low disability and low intensityhigh disability and moderate intensityhigh disability and high intensity
IV Dexamethasone and Oral Prednisolone37130
Placebo26213

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Duration of Post-operative Pain

4 selections (1 day, 2 days, 3 days, if more specify) (NCT02401529)
Timeframe: number of days at which pain was experienced within the the 1st sevn days post -surgery

,
Interventionparticipants (Number)
one daytwo daysthree days
IV Dexamethasone and Oral Prednisolone36113
Placebo23198

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Duration of Post-operative Nausea

Postoperative nausea duration (no nausea,1 day, 2 days, 3 days, 4 days, if more specify) (NCT02401529)
Timeframe: 7 days

,
Interventionparticipants (Number)
no nauseaone daytwo daysthree days
IV Dexamethasone and Oral Prednisolone333140
Placebo218156

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Average Frequency of Meals Per Day

average frequency of meals (1 meal, 2 meals, if more specify) (NCT02401529)
Timeframe: average number of meals consumed per day for the 1st three days post-surgery

,
Interventionparticipants (Number)
1 meal2 meals3 meals
IV Dexamethasone and Oral Prednisolone22028
Placebo13415

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Average Amount of Meal Per Day

adequacy of meals (inadequate, adequate) (NCT02401529)
Timeframe: 3 days

,
Interventionparticipants (Number)
inadequateadequate
IV Dexamethasone and Oral Prednisolone1634
Placebo2723

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Total Number of Post-operative Vomiting Episodes

Postoperative vomiting number of attacks (no vomiting,1, 2, 3, if more specify) (NCT02401529)
Timeframe: total number of post-operative vomiting episodes which were experienced within the 1st week post-surgery

,
Interventionparticipants (Number)
no vomitingoncetwicethree timesmore than 3 times
IV Dexamethasone and Oral Prednisolone2513741
Placebo1491980

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Onset of Post-operative Nausea

Postoperative nausea onset (no nausea, immediate, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day, 7th day) (NCT02401529)
Timeframe: onset of 1st ocurence of nausea attack within the 1st week post-surgery

,
Interventionparticipants (Number)
no nauseaimmediately1st dayimmediately and 1st day
IV Dexamethasone and Oral Prednisolone331043
Placebo2181110

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Onset of 1st Post-operative Oral Intake

feeding onset (1st day i. surgery day, 2nd day, 3rd day) (NCT02401529)
Timeframe: Onset of 1st post-operative oral intake recorded within the 1st 3days post-surgery

,
Interventionparticipants (Number)
surgery day1st day after surgery
IV Dexamethasone and Oral Prednisolone464
Placebo3713

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Anterior Chamber Cell Grade at Week 8

Change from baseline comparison of NS2 ophthalmic drops (0.5%), NS2 (0.5%) and Pred Forte® (0.1%) ophthalmic drops, and Pred Forte® (1%) ophthalmic drops on an anterior chamber cell grade scale of 0 to 4 (0 = absent, 4 = severe). The least squares mean (standard error) was derived from analysis of covariance (ANCOVA) with baseline as a covariate and treatment group as a factor. (NCT02406209)
Timeframe: The efficacy assessment period was assessed at Week 8; baseline was Day 1.

Interventionunits on a scale (Least Squares Mean)
NS2 Ophthalmic Drops (0.5%)-0.7
NS2 (0.5%) and Pred Forte® (0.1%) Ophthalmic Drops-0.9
Pred Forte® (1%) Ophthalmic Drops-0.5

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Relapse Free Survival

Relapse-free survival was defined as the time from treatment response to date of relapse or death, whichever occurred first. (NCT02464657)
Timeframe: Up to 2 years and10 Months

InterventionMonths (Median)
Ph 2 - Nivolumab (3mg) + Idarubicin + Cytarabine18.54

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Event-Free Survival (EFS)

EFS defined as time from the treatment start till treatment failure, relapse, or death whichever comes first. Event Free Survival will be presented by median EFS, which is the time point at which the cumulative survival drops below 50%. If there is no median survival (not reached), it means the cumulative survival was more than 50%. (NCT02464657)
Timeframe: 56 days

InterventionMonths (Median)
Ph 2 Nivolumab (3mg) + Idarubicin + CytarabineNA

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Maximum Tolerated Dose (MTD) of Nivolumab

MTD is highest dose level in which <2 patients of 6 develop first cycle dose-limiting toxicity (DLT). (NCT02464657)
Timeframe: 28 days

Interventionmg/kg (Number)
Ph 1 - Nivolumab (1mg) + Idarubicin + CytarabineNA
Ph 1 - Nivolumab (3mg) + Idarubicin + Cytarabine3

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Overall Survival

Overall survival was defined as the time from the start of treatment to death or date of last follow-up. (NCT02464657)
Timeframe: Up to 2 years and 10 Months

InterventionMonths (Median)
Ph 2 Nivolumab (3mg) + Idarubicin + Cytarabine18.54

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Safety and Tolerability of AZD9567 by Assessing the Number of Participants With Adverse Events

"Safety and tolerability variables included AEs, vital signs (blood pressure and pulse), ECGs (12-lead ECGs, safety ECGs and telemetry), clinical laboratory safety evaluations (haematology, clinical chemistry [including osteocalcin], coagulation, urinalysis [including 24 hour urine cortisol per day {tU-cortisol}]) and physical examinations.~Note: No clinically relevant findings were noted in clinical laboratory results and vial signs assessments. Hence, none of the laboratory or vital signs findings were reported as AEs." (NCT02512575)
Timeframe: At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days post-dose)

,,,,,,,,,
InterventionParticipants (Number)
Any AEAny AE (including events with outcome =death)Any serious adverse event (SAE) (including death)Any AE leading to discontinuation of AZD9567
AZD9567 - 10 mg0000
AZD9567 - 100 mg2000
AZD9567 - 125 mg1000
AZD9567 - 155 mg0000
AZD9567 - 2 mg0000
AZD9567 - 20 mg1000
AZD9567 - 40 mg0000
AZD9567 - 80 mg0000
Pooled Placebo3000
Prednisolone - 60 mg0000

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Secondary Outcome: Relative Change From Baseline of AUC0-4h for Plasma Glucose to Assess the Effects on Glucose Homeostasis (Oral Glucose Tolerance Test [OGTT])

"To assess the effect of AZD9567 and prednisolone on OGTT after administration of 75 g glucose solution, blood samples were collected pre glucose intake and at post glucose intake for the analyses of plasma glucose. AUC0-4h relative change between Day 1 and Day -1 was calculated for each subject in a specific treatment group.~Note: Total AUC0-4h was calculated using the linear trapezoidal method. Statistical analysis for the change in OGTT plasma glucose total AUC0-4h values were assessed via an analysis of variance (ANCOVA), with treatment as fixed effect." (NCT02512575)
Timeframe: At Day -1 (baseline) and Day 1 (pre glucose intake and at 30, 60, 90, 120, 150, 180 and 240 minutes post glucose intake)

Interventionmin*mmol/L (Geometric Mean)
AZD9567 - 2 mg1.04
AZD9567 - 10 mg1.01
AZD9567 - 20 mg1.07
AZD9567 - 40 mg1.06
AZD9567 - 80 mg1.08
AZD9567 - 100 mg1.17
AZD9567 - 125 mg1.16
AZD9567 - 155 mg1.20
Prednisolone - 60 mg1.19
Pooled Placebo1.01

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Relative Change From Baseline of AUC0-4h for Serum Insulin to Assess the Effects on Glucose Homeostasis (Oral Glucose Tolerance Test [OGTT])

"To assess the effect of AZD9567 and prednisolone on OGTT after administration of 75 g glucose solution, blood samples were collected pre glucose intake and at post glucose intake for the analyses of serum insulin. AUC0-4h relative change between Day 1 and Day -1 was calculated for each subject in a specific treatment group.~Note: Total AUC0-4h was calculated using the linear trapezoidal method. Statistical analysis for the change in OGTT serum insulin total AUC0-4h values were assessed via an analysis of variance (ANCOVA), with treatment as fixed effect." (NCT02512575)
Timeframe: At Day -1 (baseline) and Day 1 (pre glucose intake and at 30, 60, 90, 120, 150, 180 and 240 minutes post glucose intake)

Interventionmin*pmol/L (Geometric Mean)
AZD9567 - 2 mg1.19
AZD9567 - 10 mg1.20
AZD9567 - 20 mg1.03
AZD9567 - 40 mg1.04
AZD9567 - 80 mg0.999
AZD9567 - 100 mg0.980
AZD9567 - 125 mg1.15
AZD9567 - 155 mg1.16
Prednisolone - 60 mg0.784
Pooled Placebo1.14

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Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Area Under the Plasma Concentration-curve From Time Zero Extrapolated to Infinity (AUC)

To assess AUC of AZD9567 oral suspension following 8 single ascending doses (2, 10, 20, 40, 80, 100, 125 and 155 mg) in Cohorts 1 to 8 in the fasted state. AUC was estimated by AUC(0-last) + Clast/λz. Clast - the last observed quantifiable concentration. (NCT02512575)
Timeframe: On Day 1 (at pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours post-dose), Day 2 (24 hours post-dose) and Day 3 (48 hours post-dose)

Interventionh*nmol/L (Geometric Mean)
AZD9567 - 2 mg1007
AZD9567 - 10 mg5266
AZD9567 - 20 mg7670
AZD9567 - 40 mg14000
AZD9567 - 80 mg31840
AZD9567 - 100 mg42080
AZD9567 - 125 mg41290
AZD9567 - 155 mg57500

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Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Area Under the Plasma Concentration-curve From Time Zero to the Time of Last Quantifiable Analyte Concentration (AUC(0-last))

To assess AUC(0-last) of AZD9567 oral suspension following 8 single ascending doses (2, 10, 20, 40, 80, 100, 125 and 155 mg) in Cohorts 1 to 8 in the fasted state. (NCT02512575)
Timeframe: On Day 1 (at pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours post-dose), Day 2 (24 hours post-dose) and Day 3 (48 hours post-dose)

Interventionh*nmol/L (Geometric Mean)
AZD9567 - 2 mg940.6
AZD9567 - 10 mg5069
AZD9567 - 20 mg7598
AZD9567 - 40 mg13860
AZD9567 - 80 mg31600
AZD9567 - 100 mg41850
AZD9567 - 125 mg40930
AZD9567 - 155 mg56940

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Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Observed Maximum Plasma Concentration (Cmax)

To assess the Cmax of AZD9567 oral suspension following 8 single ascending doses (2, 10, 20, 40, 80, 100, 125 and 155 mg) in Cohorts 1 to 8 in the fasted state. Cmax was taken directly from the individual concentration-time curve. (NCT02512575)
Timeframe: On Day 1 (at pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours post-dose), Day 2 (24 hours post-dose) and Day 3 (48 hours post-dose)

Interventionnmol/L (Geometric Mean)
AZD9567 - 2 mg184.9
AZD9567 - 10 mg751.6
AZD9567 - 20 mg1327
AZD9567 - 40 mg2536
AZD9567 - 80 mg4261
AZD9567 - 100 mg5835
AZD9567 - 125 mg6080
AZD9567 - 155 mg6900

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Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Terminal Half-life (t½λz)

To assess t½λz of AZD9567 oral suspension following 8 single ascending doses (2, 10, 20, 40, 80, 100, 125 and 155 mg) in Cohorts 1 to 8 in the fasted state. t½λz was estimated as (ln2)/λz. (NCT02512575)
Timeframe: On Day 1 (at pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours post-dose), Day 2 (24 hours post-dose) and Day 3 (48 hours post-dose)

InterventionHours (Mean)
AZD9567 - 2 mg4.716
AZD9567 - 10 mg5.444
AZD9567 - 20 mg3.929
AZD9567 - 40 mg4.199
AZD9567 - 80 mg5.286
AZD9567 - 100 mg5.297
AZD9567 - 125 mg4.664
AZD9567 - 155 mg6.449

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Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Time to Reach Maximum Plasma Concentration(Tmax)

To assess the tmax of AZD9567 oral suspension following 8 single ascending doses (2, 10, 20, 40, 80, 100, 125 and 155 mg) in Cohorts 1 to 8 in the fasted state. tmax was taken directly from the individual concentration-time curve. (NCT02512575)
Timeframe: On Day 1 (at pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours post-dose), Day 2 (24 hours post-dose) and Day 3 (48 hours post-dose)

InterventionHours (Median)
AZD9567 - 2 mg0.50
AZD9567 - 10 mg0.75
AZD9567 - 20 mg0.51
AZD9567 - 40 mg0.75
AZD9567 - 80 mg1.00
AZD9567 - 100 mg1.00
AZD9567 - 125 mg1.00
AZD9567 - 155 mg1.25

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Relative Change From Baseline of AUC0-4h for Serum C-peptide to Assess the Effects on Glucose Homeostasis (Oral Glucose Tolerance Test [OGTT])

"To assess the effect of AZD9567 and prednisolone on OGTT after administration of 75 g glucose solution, blood samples were collected pre glucose intake and at post glucose intake for the analyses of serum C-peptide. AUC0-4h relative change between Day 1 and Day -1 was calculated for each subject in a specific treatment group.~Note: Total AUC0-4h was calculated using the linear trapezoidal method. Statistical analysis for the change in OGTT serum C-peptide total AUC0-4h values were assessed via an analysis of variance (ANCOVA), with treatment as fixed effect." (NCT02512575)
Timeframe: At Day -1 (baseline) and Day 1 (pre glucose intake and at 30, 60, 90, 120, 150, 180 and 240 minutes post glucose intake)

Interventionmin*nmol/L (Geometric Mean)
AZD9567 - 2 mg1.06
AZD9567 - 10 mg1.04
AZD9567 - 20 mg1.02
AZD9567 - 40 mg0.933
AZD9567 - 80 mg0.919
AZD9567 - 100 mg1.00
AZD9567 - 125 mg0.983
AZD9567 - 155 mg0.968
Prednisolone - 60 mg0.749
Pooled Placebo1.08

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Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)

Intraocular pressure refers to the pressure inside the eye. It is measured in mmHg using a device called a tonometer. The mean IOP is 15.5 mmHg. Raised IOP after cataract surgery is common and in most cases it is transient and benign. (NCT02515045)
Timeframe: Month 1.

InterventionmmHg (Mean)
TriMoxiVanc-0.5
TriMoxiVanc + Ilevro-1.03
Control-1.1

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Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)

"Cornea is the clear part of the front of the eye. Normal corneal thickness is in average 0.540 mm. The corneal thickness is measured with a handheld device called pachymeter.~An increase in corneal thickness may indicate corneal edema (swelling of the cornea) that could be seen after ocular surgery." (NCT02515045)
Timeframe: Month 1

InterventionMicrons (Mean)
TriMoxiVanc14.44
TriMoxiVanc + Ilevro5.94
Control4.47

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Change From Baseline (Preoperative Exam) in Macular Thickness

Macula is the area in the retina that is responsible for the best central vision. Changes in its thickness may occur after cataract surgery due to the normal inflammatory process that occurs postoperatively but it returns to preoperative values unless there is an underlying disease. (NCT02515045)
Timeframe: Month 1.

InterventionMicrons (Mean)
TriMoxiVanc12.34
TriMoxiVanc + Ilevro10.96
Control9.84

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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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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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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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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 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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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 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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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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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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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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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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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 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 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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Adverse Event

"Adverse Event (AE) following surgical treatment.~Adverse event were classified by severity based on the AO-ISSG criteria and treatment required:~Mild: Observed, medication, consult, X-ray. Essentially any management that was quick and easy and could be done at bedside Moderate: ICU admission, re-intubation, complication that had a documented prolonged hospital stay, medical procedure (such as flexible endoscopy), re-presentation to ED Severe: Inpatient re-admission, return to OR for any reason, mortality, failed OR.~AE were also categorize as Surgery-site related or unrelated adverse event. Finally, AE were also categorize as potentially related to steroid use (example: leukocytosis, pseudoarthrosis, or wound complications)" (NCT02539394)
Timeframe: 12 month

,
InterventionParticipants (Count of Participants)
Any Adverse Event?Mild/Moderate Adverse Event?Severe Adverse Event?Adverse Event Related to Operated Site?Adverse Event Unrelated to Operated Site?Mild/Moderate Adverse Event Related to Operated Site?Mild/Moderate Adverse Event Unrelated to Operated Site?Severe Adverse Event Related to Operated Site?Severe Adverse Event Unrelated to Operated Site?Adverse Event Potentially Related to Steroid Use?Adverse Event Unrelated to Steroid use?Mild/Moderate Adverse Event Potentially Related to Steroid Use?Mild/Moderate Adverse Event Unrelated to Steroid use?Severe Adverse Event Potentially Related to Steroid Use?Severe Adverse Event Unrelated to Steroid use?
Control444233826362630114394221
Treatment4746338303730301642154112

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Degree of Dysphagia Patients Experience (Burden)

SWAL-QOL survey - Burden domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control1005062.5100100100100
Treatment1007575100100100100

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Degree of Dysphagia Patients Experience (Communication)

SWAL-QOL survey - Communication domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control100100100100100100100
Treatment100100100100100100100

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Degree of Dysphagia Patients Experience (Eating Desire)

SWAL-QOL survey - Eating desire domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control10083.383.3100100100100
Treatment10087.591.7100100100100

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Degree of Dysphagia Patients Experience (Eating Duration)

SWAL-QOL survey - Eating duration domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control100755087.5100100100
Treatment1007575100100100100

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Degree of Dysphagia Patients Experience (Fatigue)

SWAL-QOL survey - Fatigue domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control83.3358.3358.3358.33757575
Treatment83.3358.3366.677583.3383.3391.67

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Degree of Dysphagia Patients Experience (Food Selection)

SWAL-QOL survey - Food Selection domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control1007562.5100100100100
Treatment10093.7575100100100100

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Degree of Dysphagia Patients Experience (Mental)

SWAL-QOL survey - Mental domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control100808595100100100
Treatment10010097.5100100100100

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Degree of Dysphagia Patients Experience (Social)

SWAL-QOL survey - Social domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control1009585100100100100
Treatment100100100100100100100

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Patient Reported Swallowing Difficulty Over 1 Year

"The Eating Assessment Tool (EAT-10) is used to screen for self-perceived oropharyngeal dysphagia (OD) in community-dwelling elders. A summated EAT-10 total score ranges from 0 to 40, with a score ≥ 3 indicative of OD.~Modified Eat-10 : Eat-10 questionnaire without questions 1 (My swallowing problem has caused me to lose weight) and 2 (My swallowing problem interferes with my ability to go out for meals) to be applicable during hospitalization.~Eat-10 interpretation: Score ranging from 0 to 40 (best-worst)~each question response is 0-4, 0=no problem and 4=severe problem; score is a summation of each question's response Modified EAT-10 interpretation: Score ranging from 0 to 32 (best-worst)~each question response is 0-4, 0=no problem and 4=severe problem; score is a summation of each question's response" (NCT02539394)
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operative Eat-10Pre-operative Eat-10 modifiedPOD1 Eat-10POD1 Eat-10 modifiedPOD2 Eat-10POD2 Eat-10 modified4-6 weeks Eat-104-6 weeks Eat-10 modified3 months Eat-103 months Eat-10 modified6 months Eat-106 months Eat-10 modified1 year Eat-101 year Eat-10 modified
Control001614161454221100
Treatment0098.58722000000

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Patients' Neck Disability

Neck Disability Index (NDI) Range from 0 to 100 (best-worst) (NCT02539394)
Timeframe: Pre-Op, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionindex (Mean)
Pre-operative4-6 weeks3 months6 months1 year
Control35.535.327.323.920.6
Treatment29.930.817.715.413.2

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Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain

Visual Analog Scale (VAS) - Left arm pain Range from 0 to 100 (best-worst) (NCT02539394)
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionunits on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control17.51056.455.824
Treatment195.356.452.752.51.1751

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Fusion Rate

"Flex-Ex X-rays~Bony bridging on a CT scan~Obvious bony remodeling on lateral X-ray" (NCT02539394)
Timeframe: 12 Months

InterventionParticipants (Count of Participants)
Treatment25
Control23

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Patients' Bazaz Dysphagia Score - Solid

Bazaz dysphagia scale defines dysphagia as none, mild, moderate and severe, depending on patients' symptoms with solid and liquid foods. (NCT02539394)
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

InterventionParticipants (Count of Participants)
Pre-operative72323488Pre-operative72323489POD172323488POD172323489POD272323488POD2723234896-4 weeks723234896-4 weeks723234883 months723234883 months723234896 months723234886 months723234891 year723234891 year72323488
RareOccasionally (only with specific food)NoneFrequent (majority of solids)
Control44
Treatment52
Treatment17
Control8
Control21
Treatment18
Control6
Treatment15
Treatment13
Control19
Control17
Treatment27
Control18
Treatment16
Control11
Treatment11
Treatment2
Control25
Treatment34
Treatment8
Control12
Control2
Treatment0
Control30
Treatment37
Control15
Treatment10
Control5
Treatment3
Control1
Treatment1
Control29
Treatment35
Control7
Treatment6
Control9
Treatment4
Control0

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Degree of Dysphagia Patients Experience (Fear Swallow)

SWAL-QOL survey - Fear swallow domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control10093.7587.593.75100100100
Treatment100100100100100100100

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Patients' Pain Scores on the Visual Analog Scale - Neck Pain

Visual Analog Scale (VAS) - Neck pain Range from 0 to 100 (best-worst) (NCT02539394)
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionunits on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control54.551.55120221412.25
Treatment2648.2526.514.59.566.5

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Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain

Visual Analog Scale (VAS) - Right arm pain Range from 0 to 100 (best-worst) (NCT02539394)
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionunits on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control20237463.5
Treatment15.52.2542222.4

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Degree of Dysphagia Patients Experience (Sleep)

SWAL-QOL survey - Sleep domain Score ranges between 0 and 100 (worst-best) (NCT02539394)
Timeframe: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

,
Interventionscore on a scale (Median)
Pre-operativePOD1POD24-6 weeks3 months6 months1 year
Control7562.5505062.562.575
Treatment81.2556.2562.575757587.5

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Patients' Bazaz Dysphagia Score - Liquid

Bazaz dysphagia scale defines dysphagia as none, mild, moderate and severe, depending on patients' symptoms with solid and liquid foods. (NCT02539394)
Timeframe: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

InterventionParticipants (Count of Participants)
Pre-operative72323489Pre-operative72323488POD172323488POD172323489POD272323488POD2723234896-4 weeks723234886-4 weeks723234893 months723234883 months723234896 months723234896 months723234881 year723234881 year72323489
NoneRare
Control47
Treatment54
Control6
Treatment2
Control20
Treatment36
Control33
Treatment20
Control17
Treatment23
Control34
Treatment31
Treatment39
Control18
Treatment17
Control39
Control11
Treatment13
Control42
Treatment41
Control9
Treatment10
Control35
Treatment40
Control10
Treatment7

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Dilated Opthalmoscopy Findings - Choroid (Study Eye)

The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's choroid (NCT02547623)
Timeframe: Baseline, POD 90/Early termination

InterventionParticipants (Count of Participants)
Screening (Baseline)72176611Screening (Baseline)72176612Postoperative day 90/End of treatment72176611Postoperative day 90/End of treatment72176612
NormalAbnormalNot analyzed
Dexamethasone Depot124
Prednisolone Drops 1% (Standard of Care)54
Dexamethasone Depot0
Prednisolone Drops 1% (Standard of Care)0
Dexamethasone Depot2
Prednisolone Drops 1% (Standard of Care)1
Dexamethasone Depot122
Prednisolone Drops 1% (Standard of Care)50
Dexamethasone Depot1
Dexamethasone Depot3
Prednisolone Drops 1% (Standard of Care)5

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Visual Acuity in Study Eye

Visual Acuity assessed by the Snellen chart, was expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1 (NCT02547623)
Timeframe: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination

,
InterventionLogMar (Mean)
Screening (Baseline)Post Operative Day 1Post Operative Day 8Post Operative Day 30Post Operative Day 90/End of Treatment
Dexamethasone Depot.292.249.073.039.040
Prednisolone Drops 1% (Standard of Care).355.327.073.040.047

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Summary of Concomitant Medications Used in the Study Eye or Both Eyes

(NCT02547623)
Timeframe: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination

,
InterventionParticipants (Count of Participants)
Patients reporting at least one concomitant medicaAntiseptics and disinfectantsAnestheticsPsycholepticsOphthalmologicalsThyroid therapy
Dexamethasone Depot1241421240
Prednisolone Drops 1% (Standard of Care)55111551

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Intraocular Pressure Measurement

Intraocular Pressure was measured by Goldmann applanation tonometry. (NCT02547623)
Timeframe: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination

,
InterventionmmHG (Mean)
Screening (Baseline)Post Operative Day 1Post Operative Day 8Post Operative Day 30Post Operative Day 90/End of Treatment
Dexamethasone Depot15.119.115.013.813.0
Prednisolone Drops 1% (Standard of Care)14.417.515.114.112.7

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Changes in the Corneal Endothelial Cell Count

Corneal Endothelial Cell Density was measured by specular microscopy. (NCT02547623)
Timeframe: Baseline, Postoperative day 90/Early termination

,
Interventioncells/mm^2 (Mean)
BaselinePostoperative day 90/End of treatmentChange from Baseline
Dexamethasone Depot2483.662141.77-334.60
Prednisolone Drops 1% (Standard of Care)2398.332106.39-288.83

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Slit Lamp Biomicroscopy - Cornea Edema Grade

"Slit lamp biomicroscopy of the anterior chamber was performed using a slit beam of 1-mm height and 1-mm width with maximum luminance through the highest-powered lens using the Investigator's standard slit lamp equipment and procedure.~Cornea edema slit lamp results in the study eye were summarized by treatment group and time point." (NCT02547623)
Timeframe: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination

InterventionParticipants (Count of Participants)
Baseline72176611Baseline72176612Postoperative day 172176611Postoperative day 172176612Postoperative day 872176612Postoperative day 872176611Postoperative day 3072176612Postoperative day 3072176611Postoperative day 90/End of Treatment72176611Postoperative day 90/End of Treatment72176612
No value0 (Absent)1 (Mild)2 (Moderate)3 (Severe)
Dexamethasone Depot126
Prednisolone Drops 1% (Standard of Care)54
Dexamethasone Depot74
Prednisolone Drops 1% (Standard of Care)37
Dexamethasone Depot43
Prednisolone Drops 1% (Standard of Care)15
Dexamethasone Depot9
Dexamethasone Depot109
Prednisolone Drops 1% (Standard of Care)48
Dexamethasone Depot16
Prednisolone Drops 1% (Standard of Care)6
Dexamethasone Depot1
Prednisolone Drops 1% (Standard of Care)1
Dexamethasone Depot121
Dexamethasone Depot2
Dexamethasone Depot3
Dexamethasone Depot123
Prednisolone Drops 1% (Standard of Care)52
Dexamethasone Depot0
Prednisolone Drops 1% (Standard of Care)0
Prednisolone Drops 1% (Standard of Care)3

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Optic Disc Cup-disc Ratio for the Study Eye

Calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). (NCT02547623)
Timeframe: Baseline, POD 90/Early termination

,
Interventionratio (Mean)
Screening (Baseline)Postoperative day 90/End of treatment
Dexamethasone Depot.31.31
Prednisolone Drops 1% (Standard of Care).32.33

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Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade

"Slit lamp biomicroscopy of the anterior chamber was performed using a slit beam of 1-mm height and 1-mm width with maximum luminance through the highest-powered lens using the Investigator's standard slit lamp equipment and procedure.~Conjunctiva hyperemia slit lamp results were summarized by treatment group and time point." (NCT02547623)
Timeframe: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination

InterventionParticipants (Count of Participants)
Baseline72176611Baseline72176612Postoperative day 172176612Postoperative day 172176611Postoperative day 872176612Postoperative day 872176611Postoperative day 3072176612Postoperative day 3072176611Postoperative day 90/End of Treatment72176612Postoperative day 90/End of Treatment72176611
0 (Absent)1 (Mild)2 (Moderate)3 (Severe)No value
Dexamethasone Depot124
Prednisolone Drops 1% (Standard of Care)55
Dexamethasone Depot1
Dexamethasone Depot103
Dexamethasone Depot21
Prednisolone Drops 1% (Standard of Care)10
Dexamethasone Depot115
Prednisolone Drops 1% (Standard of Care)45
Dexamethasone Depot11
Prednisolone Drops 1% (Standard of Care)2
Dexamethasone Depot107
Prednisolone Drops 1% (Standard of Care)44
Dexamethasone Depot14
Prednisolone Drops 1% (Standard of Care)8
Dexamethasone Depot2
Prednisolone Drops 1% (Standard of Care)0
Prednisolone Drops 1% (Standard of Care)3
Dexamethasone Depot119
Prednisolone Drops 1% (Standard of Care)50
Dexamethasone Depot4
Dexamethasone Depot0
Dexamethasone Depot3

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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Treatment-emergent Adverse Events were defined as events that started after the study drug administration, and occurred before termination of the study, or were present before study drug administration and worsened after dose administration. (NCT02547623)
Timeframe: Baseline to postoperative day 90/ early termination

InterventionParticipants (Count of Participants)
Ocular events: study eye72176611Ocular events: study eye72176612Ocular events: fellow eye72176612Ocular events: fellow eye72176611Systemic events72176611Systemic events72176612
Any TEAESerious TEAENo TEAE
Dexamethasone Depot53
Prednisolone Drops 1% (Standard of Care)13
Dexamethasone Depot1
Dexamethasone Depot72
Prednisolone Drops 1% (Standard of Care)42
Dexamethasone Depot12
Prednisolone Drops 1% (Standard of Care)4
Dexamethasone Depot0
Prednisolone Drops 1% (Standard of Care)0
Dexamethasone Depot114
Prednisolone Drops 1% (Standard of Care)51
Dexamethasone Depot10
Prednisolone Drops 1% (Standard of Care)6
Dexamethasone Depot2
Prednisolone Drops 1% (Standard of Care)49

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Dilated Opthalmoscopy Findings - Vitreous (Study Eye)

The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's vitreous (NCT02547623)
Timeframe: Baseline, POD 90/Early termination

InterventionParticipants (Count of Participants)
Screening (Baseline)72176612Screening (Baseline)72176611Postoperative day 90/End of treatment72176611Postoperative day 90/End of treatment72176612
NormalAbnormalNot analyzed
Dexamethasone Depot104
Prednisolone Drops 1% (Standard of Care)49
Dexamethasone Depot21
Prednisolone Drops 1% (Standard of Care)5
Dexamethasone Depot1
Prednisolone Drops 1% (Standard of Care)1
Dexamethasone Depot107
Prednisolone Drops 1% (Standard of Care)44
Dexamethasone Depot16
Prednisolone Drops 1% (Standard of Care)7
Dexamethasone Depot3
Prednisolone Drops 1% (Standard of Care)4

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Dilated Opthalmoscopy Findings - Retina (Study Eye)

The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's retina (NCT02547623)
Timeframe: Baseline, POD 90/Early termination

InterventionParticipants (Count of Participants)
Screening (Baseline)72176611Screening (Baseline)72176612Postoperative day 90/End of treatment72176611Postoperative day 90/End of treatment72176612
NormalAbnormalNot analyzed
Dexamethasone Depot120
Prednisolone Drops 1% (Standard of Care)51
Dexamethasone Depot5
Dexamethasone Depot1
Prednisolone Drops 1% (Standard of Care)0
Dexamethasone Depot118
Prednisolone Drops 1% (Standard of Care)50
Prednisolone Drops 1% (Standard of Care)1
Dexamethasone Depot3
Prednisolone Drops 1% (Standard of Care)4

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Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)

The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's optic disc (NCT02547623)
Timeframe: Baseline, POD 90/Early termination

InterventionParticipants (Count of Participants)
Screening (Baseline)72176611Screening (Baseline)72176612Postoperative day 90/End of treatment72176611Postoperative day 90/End of treatment72176612
NormalAbnormalNot analyzed
Dexamethasone Depot115
Prednisolone Drops 1% (Standard of Care)52
Dexamethasone Depot9
Prednisolone Drops 1% (Standard of Care)2
Dexamethasone Depot119
Prednisolone Drops 1% (Standard of Care)50
Dexamethasone Depot2
Prednisolone Drops 1% (Standard of Care)1
Dexamethasone Depot5
Prednisolone Drops 1% (Standard of Care)4

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Dilated Opthalmoscopy Findings - Macula (Study Eye)

The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's macula. (NCT02547623)
Timeframe: Baseline, POD 90/Early termination

InterventionParticipants (Count of Participants)
Screening (Baseline)72176611Screening (Baseline)72176612Postoperative day 90/End of treatment72176611Postoperative day 90/End of treatment72176612
NormalAbnormalNot analyzed
Dexamethasone Depot109
Prednisolone Drops 1% (Standard of Care)44
Dexamethasone Depot15
Prednisolone Drops 1% (Standard of Care)11
Dexamethasone Depot2
Prednisolone Drops 1% (Standard of Care)0
Dexamethasone Depot107
Prednisolone Drops 1% (Standard of Care)39
Dexamethasone Depot16
Prednisolone Drops 1% (Standard of Care)12
Dexamethasone Depot3
Prednisolone Drops 1% (Standard of Care)4

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Visual Analog Scale

The visual analog scale for overall symptoms will be used to define disease severity. Range of 0 to 10. As per the European Position Paper 2012, mild, moderate, and severe disease will be defined as 0 to and including 3, > 3 to and including 7, and > 7 to and including 10, respectively. (NCT02569437)
Timeframe: Baseline and 12 weeks

,
Interventionunits on a scale (Mean)
Baseline12 weeks
Doxycycline8.45.2
Sugar Pill8.14.5

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Middle Meatus Culture

Culture swab for the presence or absence of microbial growth (NCT02569437)
Timeframe: Baseline and 12 weeks

,
InterventionParticipants (Count of Participants)
Culture growth at initial visit and 12 week visitCulture growth initial visit, none at 12 weeksNo growth initial visit, but growth at 12 weeks
Doxycycline512
Sugar Pill221

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Sino-nasal Outcome Test (SNOT 22)

a validated 22 item quality of life questionnaire for patients with chronic rhinosinusitis. Range of 0 to 110, higher scores indicate worse outcome (NCT02569437)
Timeframe: Baseline and 12 weeks

,
Interventionunits on a scale (Mean)
Baseline12 weeks
Doxycycline55.243.7
Sugar Pill54.449.8

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Endoscopic Nasal Polyp Score

"0- Absence of nasal polyps~Polyps confined to the middle meatus and not beyond the inferior border of the middle turbinate~Polyps reaching below the lower border of the middle turbinate~Large polyps extending to the lower border of the inferior turbinate or medial to the middle turbinate~Large polyps extending to the lower border of the inferior turbinate or medial to the middle turbinate Nasal polyp scores. The score is determined for each nostril, and the two scores added for a total nasal polyp score. Range of 0 to 8, graded on a size system from 0 to 4 and summed from the right and left nostrils." (NCT02569437)
Timeframe: Baseline and 12 weeks

,
Interventionunits on a scale (Mean)
Baseline12 weeks
Doxycycline6.04.3
Sugar Pill6.54.9

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Subjective Symptom Composite Scoring

"A subjective symptom score will be extracted from the patient's score (on a scale of 0-5, where 0 defines no problems with the given symptom and 5 defines maximal problems ) on the SNOT-22 for each fo the following symptoms: blockage/congestion, runny nose, post-nasal discharge, facial pain/pressure, and sense of taste/smell. Range of 0 to 25, with higher score reflecting worse symptoms." (NCT02569437)
Timeframe: Baseline and 12 weeks

,
Interventionunits on a scale (Mean)
Baseline12 weeks
Doxycycline16.311.9
Sugar Pill17.113.6

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Tegner Activity Level Scale

"The Tegner activity level scale is a scale that aims to provide a standardized method of grading work and sporting activities. The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury.~A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports. A score >6 can only be achieved if the person participates in recreational or competitive sport." (NCT02576249)
Timeframe: baseline (pre-injection), 2 weeks, 3 months

,
Interventionunits on a scale (Mean)
baseline (pre-injection)2 weeks3 months
Ropivacaine and Methylprednisolone3.54.33.5
Saline and Methylprednisolone3.03.23

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The Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale

The KOOS holds 42 items in five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. (NCT02576249)
Timeframe: 3 months after the injection

Interventionunits on a scale (Mean)
Ropivacaine and Methylprednisolone63.1
Saline and Methylprednisolone67.2

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Pain Scale Score

Pain was measured by a Visual Analog Scale (VAS) marked from 0 (no pain) to 10 (unbearable pain) at rest and with activity. It was collected at baseline (pre-injection), immediately post-injection on the day of surgery, and at 2 weeks and 3 months. (NCT02576249)
Timeframe: Pre-injection, immediately post-injection, 2 weeks, 3 months

,
Interventionunits on a scale (Mean)
Pre-injection ActivityPre-injection RestImmediately Post-injection ActivityImmediately Post-injection Rest2 Weeks Activity2 Weeks Rest3 Months Activity3 Months Rest
Ropivacaine and Methylprednisolone6.42.41.91.23.61.73.92.6
Saline and Methylprednisolone5.842.41.43.62.74.62.8

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Joint Damage Progression

"2-year change in total Sharp/van der Heijde damage score of hands and forefeet radiographs. Range of damage score: 0-448.~score at 24 months minus score at baseline: positive result means increasing/worsening of damage." (NCT02585258)
Timeframe: 0, 24 months

Interventionscore on a scale (Mean)
Prednisolone0.3
Placebo1.9

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Signs and Symptoms: Mean DAS28 Post Baseline

mean of the DAS28 (disease activity score-28 joints) post baseline. Range 0-8, higher scores mean more disease activity. See link in reference list. (NCT02585258)
Timeframe: 0,3,6,12,18,24 months

,
Interventionscore on a scale (Mean)
3 months6 months12 months18 months24 months
Placebo3.623.423.253.893.33
Prednisolone3.263.062.893.022.97

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The Total Number of Patients Experiencing at Least One Adverse Event (AE) of Special Interest (AESI)

AESI: (a serious adverse event [SAE], or an AE on a prespecified list of clinically relevant AEs commonly associated with the disease and glucocorticoid use (NCT02585258)
Timeframe: 24 months

InterventionParticipants (Count of Participants)
Prednisolone134
Placebo111

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Burning Sensation or Pain by Using NRS (Numerical Rating Scale)

Standard self-response Numerical Rating Scale (NRS) of 0 (no oral discomfort) to 10 (worst imaginable oral discomfort) to represent the intensity of burning sensation or pain or discomfort. The mean of NRS burning sensation score was calculated after eight weeks of treatment and considered as 8th week NRS burning sensation score. (NCT02587117)
Timeframe: 8 weeks minus baseline

InterventionScores on a scale (Mean)
Lycopene Group0.23
Prednisolone Group0.07

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Change in Severity of Lesions(Degree of Reticular, Erythematous and Ulceration) by Using Piboonniyom REU Severity Score

Reticular: score 0= no white striations; score 1= white striations. Erythematous: score 0= no lesion; score 1= lesion <1 cm2; score 2: lesion 1-3 cm2; score 3= lesion >3 cm2. Ulceration: score 0= no lesion; score 1= lesion <1 cm2; score 2= lesion 1-3 cm2; score 3= lesion >3 cm2. Total weighted score was derived by sum total scores of each lesion and multiplication with weighted score 1.5 & 2.0 in total erythematous and total ulceration scores as ΣR + ΣE × 1.5 + ΣU × 2.0.Total weighted score was dependent on the number of lesions of each participant which was not the same across participants. Higher value of the total score represent worse outcome & zero value represent no lesion. (NCT02587117)
Timeframe: 8 weeks minus baseline

InterventionScores on a scale (Mean)
Lycopene Group2.15
Prednisolone Group0.73

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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 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 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 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 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 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 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 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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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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11-item Disabilities of the Arm, Shoulder and Hand (DASH) Score

Score for the 11-item DASH scale, a measure of activity limitations related to the upper extremity. Score range 0 (best) to 100 (worst) (NCT02652390)
Timeframe: 5-7 years

Interventionscore on a scale (Mean)
Methylprednisolone 80 mg13.1
Methylprednisolone 40 mg16.9
Placebo19.3

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Bodily Pain Score

Score for the 2-item bodily pain scale, range 0 (worst) to 100 (best). (NCT02652390)
Timeframe: 5-7 years

Interventionscore on a scale (Mean)
Methylprednisolone 80 mg81.4
Methylprednisolone 40 mg79.9
Placebo78.2

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Palmar Pain Score

Score for pain in the proximal palm and related activity limitations, range 0 (worst) to 100 (best). (NCT02652390)
Timeframe: 5-7 years

Interventionscore on a scale (Mean)
Methylprednisolone 80 mg86.4
Methylprednisolone 40 mg84.6
Placebo83.0

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Satisfaction Score

Visual analog scale about treatment satisfaction, score 0 (worst) to 100 (best). (NCT02652390)
Timeframe: 5-7 years

Interventionscore on a scale (Mean)
Methylprednisolone 80 mg77.5
Methylprednisolone 40 mg71.4
Placebo68.4

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Symptom Severity Score

Change in symptom severity score from baseline to 5 to 7 years. Score range 1 (no symptoms) to 5 (most severe symptoms). (NCT02652390)
Timeframe: 5-7 years

Interventionscore on a scale (Mean)
80-mg Mrthylprednisolone and no Surgery1.34
Surgery After Methylprednisolone or Placebo1.53

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Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand

Number of patients who have had carpal tunnel release surgery on the study hand. (NCT02652390)
Timeframe: 5 to 7 years

InterventionParticipants (Count of Participants)
Methylprednisolone 80 mg31
Methylprednisolone 40 mg34
Placebo36

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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 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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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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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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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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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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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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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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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 % 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 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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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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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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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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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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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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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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Steroid-associated Complications.

Episodes of 1) Hyperglycemia (defined as Blood Glucose >200 mg/dL), 2) Hypernatremia (defined as blood gas analysis-derived sodium ion concentration >150 mEq/L), and 3) Infections (defined as any microbiologically documented, intensive care unit-acquired, or hospital-acquired infection). (NCT02790788)
Timeframe: Up to 180 days postrandomization.

,
InterventionNumber of Episodes per Patient (Median)
No. of Episodes of HyperglycemiaNo. of Episodes of HypernatremiaNo. of Episodes of Infections
Control Group000
Steroids Group000

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Left and Right Ventricular Ejection Fraction (%) by Echocardiography.

Results are provided on left ventricular ejection fraction (LVEF) and right ventricular ejection fraction (RVEF) within 12 hours and 72 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: Within the first 12 hours and at 72 hours postresuscitation.

,
InterventionPercentage (Mean)
LVEF within 12 hours after ROSCRVEF within 12 hours after ROSCLVEF at 72 hours after ROSCRVEF at 72 hours after ROSC
Control Group45.942.75044.7
Steroids Group42.341.74542.8

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Left and Right Ventricular Diastolic Area (cm^2) by Echocardiography.

Results are provided on left ventricular end-diastolic area (LVEDA) and right ventricular diastolic area (RVEDA) by echocardiography within 12 hours and 72 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: Within the first 12 hours and at 72 hours postresuscitation.

,
Interventioncm^2 (Mean)
LVEDA within 12 hours after ROSCRVEDA within 12 hours after ROSCLVEDA at 72 hours after ROSCRVEDA at 72 hours after ROSC
Control Group22.813.018.512.6
Steroids Group23.112.123.114.5

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Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.

Results on postresuscitation, mean arterial blood pressure (mmHg) are provided for the fifth, pre-specified time point of measurement, i.e. at 72 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 72 hours after ROSC.

InterventionmmHg (Mean)
Steroids Group85.2
Control Group84.7

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Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring (as Feasible).

Results on early postresuscitation, mean arterial blood pressure (mmHg) are provided for the second, pre-specified time point of measurement, i.e. at 4 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 4 hours after ROSC.

InterventionmmHg (Mean)
Steroids Group83.9
Control Group78.9

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Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring (as Feasible).

Results on early postresuscitation, mean arterial blood pressure (mmHg) are provided for the first, pre-specified time point of measurement, i.e. at 20 min after the return of spontaneous circulation (ROSC). (NCT02790788)
Timeframe: Time point of measurement: 20 min after the return of spontaneous circulation (ROSC).

InterventionmmHg (Mean)
Steroids Group78.4
Control Group75.1

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Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.

RESULTS ARE PROVIDED FOR CARDIAC OUTPUT (CO) AT 4 HOURS AFTER ROSC. (NCT02790788)
Timeframe: Time points of measurement: 4 hours after ROSC.

InterventionL/min (Mean)
Steroids Group4.9
Control Group5.0

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Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL).

Logarithm (base 10)-transformed serum levels of tumor necrosis factor alpha (TNFa), interleukin (IL)-1 beta, IL-6, IL-8, and IL-10; blood samples were obtained by venipuncture. (NCT02790788)
Timeframe: Time points of measurement: 4, 24, 48, and 72 hours postresuscitation.

,
InterventionLog(10) transformed values of pg/mL (Mean)
IL-6 at 4 hours after ROSCTNFα at 4 hours after ROSCIL-1β at 4 hours after ROSCIL-8 at 4 hours after ROSCIL-10 at 4 hours after ROSCIL-6 at 24 hours after ROSCTNFα at 24 hours after ROSCIL-1β at 24 hours after ROSCIL-8 at 24 hours after ROSCIL-10 at 24 hours after ROSCIL-6 at 48 hours after ROSCTNFα at 48 hours after ROSCIL-1β at 48 hours after ROSCIL-8 at 48 hours after ROSCIL-10 at 48 hours after ROSCIL-6 at 72 hours after ROSCTNFα at 72 hours after ROSCIL-1β at 72 hours after ROSCIL-8 at 72 hours after ROSCIL-10 at 72 hours after ROSC
Control Group2.222.032.032.431.761.992.002.092.291.541.911.962.032.171.531.901.962.042.191.45
Steroids Group2.191.972.072.391.762.062.022.062.271.691.871.992.092.151.561.932.002.052.151.66

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Core Body Temperature in Degrees Celcius.

Results are provided for core body temperature averaged over the following time intervals after ROSC: 1) 0-6 hours; 2) 6-12 hours; 3) 12-18 hours; 4) 18-24 hours; 5) 24-30 hours; 6) 30-36 hours; 7) 36-42 hours; and 42-48 hours. (NCT02790788)
Timeframe: Time points of measurement: Hourly from intensive care admission to 48 hours postresuscitation.

,
InterventionDegrees Celcius (Mean)
Temperature averaged over 0-6 hours after ROSCTemperature averaged over 6-12 hours after ROSCTemperature averaged over 12-18 hours after ROSCTemperature averaged over 18-24 hours after ROSCTemperature averaged over 24-30 hours after ROSCTemperature averaged over 30-36 hours after ROSCTemperature averaged over 36-42 hours after ROSCTemperature averaged over 42-48 hours after ROSC
Control Group35.636.636.536.336.236.236.236.3
Steroids Group36.536.336.036.136.136.036.136.2

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Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.

Results are provided for CO at 24 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 24 hours after ROSC.

InterventionL/min (Mean)
Steroids Group5.6
Control Group5.4

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Survival to Hospital Discharge With Favorable Functional Outcome.

Survival to hospital discharge with a Cerebral Performance Category (CPC) Score of 1 or 2. The CPC Score ranges can have the following values: 1, 2, 3, 4, and 5; lower Scores correspond to better outcomes, whereas higher Scores reflect worsening outcomes, e.g. a Score of 4 means Coma or Vegetative state, and a Score of 5 means Brain Death. (NCT02790788)
Timeframe: Up to 180 days postrandomization.

InterventionParticipants (Count of Participants)
Steroids Group2
Control Group5

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Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.

Results on postresuscitation central venous oxygen saturation (%) are provided for the third, pre-specified time point of measurement, i.e., at 24 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 24 hours after ROSC.

InterventionPercent Hemoglobin Concentration (Mean)
Steroids Group71.1
Control Group70.1

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Cerebral Blood Flow Index by Near Infrared Spectroscopy With Indocyanine Green.

Results are reported for 2 pairs of cerebral blood flow index (CBFI) measurements performed each time at a lower and a higher level of mean arterial pressure (MAP) at the following time points: 1) at 4 hours after ROSC and 2) at 72 hours after ROSC (NCT02790788)
Timeframe: Time points of measurement: 4 and 72 hours postresuscitation.

,
InterventionnM/s (Mean)
CBFI 4 HOURS POST-ROSC MEAN MAP=75.5 MMHGCBFI 4 HOURS POST-ROSC MEAN MAP=96.0 MMHGCBFI 72 HOURS POST-ROSC MEAN MAP=75.5 MMHGCBFI 72 HOURS POST-ROSC MEAN MAP= 97.0 MMHG
Control Group3.33.53.43.8
Steroids Group4.04.24.34.9

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Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.

Results on postresuscitation central venous oxygen saturation (%) are provided for the fourth, pre-specified time point of measurement, i.e., at 48 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 48 hours after ROSC.

InterventionPercent Hemoglobin Concentration (Mean)
Steroids Group73.3
Control Group70.5

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Organ Failure-free Days.

Number of organ failure-free days during days 1 through 60 postrandomization. Organ failure free=corresponding Sequential Organ Failure Assessment Subscore <3; each subscore can have the following values: 0, 1, 2, 3, and 4; increasing values indicate worsening organ failure. (NCT02790788)
Timeframe: Days 1 to 60 postrandomization.

InterventionNumber of Days without Organ Failure (Median)
Steroids Group0
Control Group0

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Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.

Results are provided for CO at 48 hours after ROSC (NCT02790788)
Timeframe: Time points of measurement: 48 hours after ROSC.

InterventionL/min (Mean)
Steroids Group5.8
Control Group5.7

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Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.

Results are provided for CO at 72 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 72 hours after ROSC.

InterventionL/min (Mean)
Steroids Group5.8
Control Group5.6

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Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port (as Feasible).

Results on postresuscitation central venous oxygen saturation (%) are provided for the second, pre-specified time point of measurement, i.e., at 4 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 4 hours after ROSC.

InterventionPercent Hemoglobin Concentration (Mean)
Steroids Group67.4
Control Group56.8

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Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.

Results on postresuscitation central venous oxygen saturation (%) are provided for the fifth, pre-specified time point of measurement, i.e., at 72 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 72 hours after ROSC.

InterventionPercent Hemoglobin Saturation (Mean)
Steroids Group72.5
Control Group70.4

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Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.

Results on postresuscitation, mean arterial blood pressure (mmHg) are provided for the third, pre-specified time point of measurement, i.e. at 24 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 24 hours after ROSC.

InterventionmmHg (Mean)
Steroids Group79.9
Control Group81.9

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Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.

Results on postresuscitation, mean arterial blood pressure (mmHg) are provided for the fourth, pre-specified time point of measurement, i.e. at 48 hours after ROSC. (NCT02790788)
Timeframe: Time points of measurement: 48 hours after ROSC.

InterventionmmHg (Mean)
Steroids Group80.2
Control Group84.2

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Eccentricity Index by Echocardiography.

"Eccentricity index (ECCI) is defined as the ratio of the left ventricular (LV) longitudinal (or anteroposterior) diameter to the LV transverse (or septo-lateral) diameter, measured at end diastole and end systole in a short-axis view. Pertinent results are provided for a first determination within 12 hours after ROSC and a second determination at 72 hours after ROSC." (NCT02790788)
Timeframe: Time points of measurement: Within the first 12 hours and at 72 hours postresuscitation.

,
InterventionECCENTRICITY INDEX (Mean)
End-diastolic ECCI within 12 hours after ROSCEnd-systolic ECCI within 12 hours after ROSCEnd-diastolic ECCI at 72 hours after ROSCEnd-systolic ECCI at 72 hours after ROSC
Control Group1.31.31.31.3
Steroids Group1.21.31.21.2

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Number of Participants Sampled for RNA-seq Differential Expression Analysis (Biological Replicates)

Number of participants (biological replicates) that were successfully sampled for RNA-seq differential gene expression analysis in glucocorticoid-treated immune cells. The analysis employed a cutoff value of < 5% false-discovery rate (FDR) to select the transcripts that were considered differentially expressed at each time point. The resulting gene lists were contrasted to determine which genes were uniquely differentially expressed in different cell types. (NCT02798523)
Timeframe: Up to 2 or 4 hours post infusion depending on group

InterventionParticipants (Count of Participants)
Up to 2 Hours Post Infusion5
Up to 4 Hours Post Infusion20

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Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of First Course of Azacitidine

Will calculate the percentage of CpG site methylation for all patients after the first course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 6, Day 5 (Following the induction phase (35 days), the first course of Azacitidine began around Week 6 of therapy)

InterventionPercentage of CpG methylation (Mean)
KMT2A-Rearranged75.54

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Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to Second Course of Azacitidine

Will calculate the percentage of CpG site methylation for all patients before the second course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 13, Day 1 (Following induction phase (5 weeks), the first course of Azacitidine (1 week), and consolidation (6 weeks), the second course of Azacitidine began around Week 13 of therapy)

InterventionPercentage of CpG methylation (Mean)
KMT2A-Rearranged76.5

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Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to First Course of Azacitidine

Will calculate the percentage of CpG site methylation for all patients before the first course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 6, Day 1 (Following the induction phase (35 days), the first course of Azacitidine began around Week 6 of therapy)

InterventionPercentage of CpG methylation (Mean)
KMT2A-Rearranged78.17

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Tolerability of Azacitidine in Combination With Interfant-06 Standard Chemotherapy in Evaluable Infant Patients With Newly Diagnosed ALL With KMT2A Gene Rearrangement (KMT2A-R). KMT2A Gene Rearrangement (KMT2A-R)

Proportion of KMT2A-Rearranged patients treated with azacitidine with Dose Limiting Toxicities (DLTs) from the first course of azacitidine administration up to fourth course of azacitidine administration. (NCT02828358)
Timeframe: 6 months

Interventionpercentage of participants (Number)
KMT2A-Rearranged6.45

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Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of Second Course of Azacitidine

Will calculate the percentage of CpG site methylation for all patients after the second course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 13, Day 5 (Following induction phase (5 weeks), the first course of Azacitidine (1 week), and consolidation (6 weeks), the second course of Azacitidine began around Week 13 of therapy)

InterventionPercentage of CpG methylation (Mean)
KMT2A-Rearranged74.52

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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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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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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 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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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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Headache Days as Self-reported by Participants

At the seven day follow-up, participants will be asked by phone how many days they experienced headaches since being discharged. (NCT02847494)
Timeframe: 7 days after discharge from emergency department

Interventiondays (Mean)
Control3.0
Experimental3.3

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Number of Participants With Sustained Headache Freedom

Sustained headache freedom is defined as achieving a headache intensity = none within two hours of treatment and maintaining this level, without requiring additional headache medication, for 7 days following discharge from the Emergency Department. Participants will be asked by phone how number of days they experienced headaches during the week after discharge from the emergency department. Reported values are participants who experienced no headaches at all during the 7 days immediately following discharge. (NCT02847494)
Timeframe: 7 days after discharge from emergency department

InterventionParticipants (Count of Participants)
Control10
Experimental6

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Medication Preference as Assessed by Self-report

"Participants will be asked, by phone, if they would want the same medication during a subsequent visit to the emergency department. Reported values indicate participants who responded yes." (NCT02847494)
Timeframe: 7 days after discharge from emergency department

InterventionParticipants (Count of Participants)
Control76
Experimental75

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Change From Baseline in Prognostic Index: Model for End-Stage Liver Disease (MELD) Score

MELD scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40, with higher scores indicating greater disease severity. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. (NCT02854631)
Timeframe: Baseline (Day 1) and up to 24 weeks

,
InterventionUnits on a scale (Mean)
Change at Week 1Change at Week 2Change at Week 3Change at Week 4Change at Week 6Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24
Placebo + Prednisolone-3-5-5-6-7-8-10-9-10-10
Selonsertib + Prednisolone-2-3-4-5-6-7-7-7-8-9

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Change From Baseline in Prognostic Index: Maddrey Discriminant Function (DF) Score

Baseline Maddrey DF score is a prognostic tool used to determine the next step of treatment based on the severity of AH. Maddrey DF score of < 32 indicates mild to moderate AH and a lower chance of death in the next few months. Maddrey DF score of ≥ 32 indicates severe AH and a higher chance of death in the next few months. The score has no bounds. (NCT02854631)
Timeframe: Baseline (Day 1) and up to 24 weeks

,
InterventionUnits on a scale (Mean)
Change at Week 1Change at Week 2Change at Week 3Change at Week 4Change at Week 6Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24
Placebo + Prednisolone-10-15-17-19-19-21-23-23-23-22
Selonsertib + Prednisolone-8-13-17-19-20-19-23-23-25-27

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Lille Score at Day 7 as a Continuous Variable

The Lille score is a tool used to predict which participants with severe AH were not responding to corticosteroid therapy. It ranges between 0 and 1, with low scores (< 0.16) indicating complete response or positive response to steroids (continue therapy) and high scores (≥ 0.56) indicating no response or poor response to steroids (stop therapy). The Lille score was calculated using baseline factors: age, albumin, total bilirubin, serum creatinine, prothrombin time; and the change in total bilirubin between baseline (Day 1) and Day 7. (NCT02854631)
Timeframe: Day 7

InterventionLille score (Mean)
Selonsertib + Prednisolone0.254
Placebo + Prednisolone0.178

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Percentage of Participants Who Died by Week 24

The percentage of participants who died by Week 24 was calculated. (NCT02854631)
Timeframe: Week 24

InterventionPercentage of participants (Number)
Selonsertib + Prednisolone31.7
Placebo + Prednisolone18.8

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Change From Baseline in Prognostic Index: Child-Pugh-Turcotte (CPT) Score

CPT scores are used to assess the severity of cirrhosis. Scores can range from 5 to 15, with higher scores indicating a greater severity of disease (NCT02854631)
Timeframe: Baseline (Day 1) and up to 24 weeks

,
InterventionUnits on a scale (Mean)
Change at Week 1Change at Week 2Change at Week 3Change at Week 4Change at Week 6Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24
Placebo + Prednisolone-1-1-1-2-2-2-3-3-3-3
Selonsertib + Prednisolone0-1-1-1-1-2-2-2-3-3

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Change From Baseline in Liver Biochemistry Tests: Gamma Glutamyl Transferase (GGT)

Change from Baseline was calculated as the value at endpoint minus the value at Baseline. (NCT02854631)
Timeframe: Baseline (Day 1) and up to 24 weeks

,
InterventionU/L (Mean)
Change at Week 1Change at Week 2Change at Week 3Change at Week 4Change at Week 6Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24
Placebo + Prednisolone-199-5-72-121-100-114-85-54
Selonsertib + Prednisolone39-12-7-61-96-105-87-134-131

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Percentage of Participants With Lille Response (Score < 0.45) at Day 7

The Lille score is a tool used to predict which participants with severe alcoholic hepatitis (AH) were not responding to corticosteroid therapy. It ranges between 0 and 1, with low scores (< 0.16) indicating complete response or positive response to steroids (continue therapy) and high scores (≥ 0.56) indicating no response or poor response to steroids (stop therapy). The Lille score was calculated using baseline factors: age, albumin, total bilirubin, serum creatinine, prothrombin time; and the change in total bilirubin between baseline (Day 1) and Day 7. Lille response was defined as having a Lille score < 0.45. (NCT02854631)
Timeframe: Day 7

InterventionPercentage of participants (Number)
Selonsertib + Prednisolone77.1
Placebo + Prednisolone86.3

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Percentage of Participants With Infection

The occurrence of bacterial, fungal, or viral infections was recorded. An infection was considered definite in participants with clinical evidence of infection and a positive culture from a normally sterile source (with the exception of spontaneous bacterial peritonitis). (NCT02854631)
Timeframe: Up to 24 weeks

InterventionPercentage of participants (Number)
Selonsertib + Prednisolone37.5
Placebo + Prednisolone29.4

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Percentage of Participants With Hepatorenal Syndrome (HRS)

The occurrence of HRS was confirmed based on the following diagnostic criteria from the International Ascites Club (IAC): 1) Cirrhosis with ascites, 2) Diagnosis of acute kidney injury (AKI) according to the ICA-AKI criteria, 3) Absence of shock, 4) No current or recent treatment with nephrotoxic drugs, and 5) Absence of parenchymal renal disease as indicated by proteinuria >500 mg/day, microhematuria (> 50 red blood cells per high power field) and/or abnormal renal ultrasonography. (NCT02854631)
Timeframe: Up to 24 weeks

InterventionPercentage of participants (Number)
Selonsertib + Prednisolone4.2
Placebo + Prednisolone2.0

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Percentage of Participants With a Lille Null Response (Score ≥ 0.56) at Day 7

The Lille score is a tool used to predict which participants with severe AH were not responding to corticosteroid therapy. It ranges between 0 and 1, with low scores (< 0.16) indicating complete response or positive response to steroids (continue therapy) and high scores (≥ 0.56) indicating no response or poor response to steroids (stop therapy). The Lille score was calculated using baseline factors: age, albumin, total bilirubin, serum creatinine, prothrombin time; and the change in total bilirubin between baseline (Day 1) and Day 7. Lille null response was defined as having a Lille score ≥ 0.56. (NCT02854631)
Timeframe: Day 7

InterventionPercentage of participants (Number)
Selonsertib + Prednisolone14.6
Placebo + Prednisolone7.8

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Change From Baseline in Liver Biochemistry Tests: Aspartate Aminotransferase (AST)

Change from Baseline was calculated as the value at endpoint minus the value at Baseline. (NCT02854631)
Timeframe: Baseline (Day 1) and up to 24 weeks

,
InterventionU/L (Mean)
Change at Week 1Change at Week 2Change at Week 3Change at Week 4Change at Week 6Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24
Placebo + Prednisolone4-11-39-55-74-61-63-70-64-68
Selonsertib + Prednisolone-2-17-34-45-54-48-59-59-57-59

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Percentage of Participants Who Died by Week 8

The percentage of participants who died by Week 8 was calculated. (NCT02854631)
Timeframe: Week 8

InterventionPercentage of participants (Number)
Selonsertib + Prednisolone20.5
Placebo + Prednisolone6.1

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Percentage of Participants With Survival at Week 12 Using Kaplan-Meier

The percentage of participants with survival at Week 12 using Kaplan-Meier was calculated. (NCT02854631)
Timeframe: Week 12

InterventionPercentage of participants (Number)
Selonsertib + Prednisolone75.3
Placebo + Prednisolone89.9

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Percentage of Participants With Survival at Week 24 Using Kaplan-Meier

The percentage of participants with survival at Week 24 using Kaplan-Meier was calculated. (NCT02854631)
Timeframe: Week 24

InterventionPercentage of participants (Number)
Selonsertib + Prednisolone70.3
Placebo + Prednisolone81.7

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Percentage of Participants With Survival at Week 8 Using Kaplan-Meier

The percentage of participants with survival at Week 8 using Kaplan-Meier was calculated. (NCT02854631)
Timeframe: Week 8

InterventionPercentage of participants (Number)
Selonsertib + Prednisolone80.0
Placebo + Prednisolone94.0

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Change From Baseline in Liver Biochemistry Tests: Alanine Aminotransferase (ALT)

Change from Baseline was calculated as the value at endpoint minus the value at Baseline. (NCT02854631)
Timeframe: Baseline (Day 1) and up to 24 weeks

,
InterventionU/L (Mean)
Change at Week 1Change at Week 2Change at Week 3Change at Week 4Change at Week 6Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24
Placebo + Prednisolone29362412-18-20-17-21-24-22
Selonsertib + Prednisolone26312415-10-13-15-14-12-12

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Change From Baseline in Liver Biochemistry Tests: Albumin

Change from Baseline was calculated as the value at endpoint minus the value at Baseline. (NCT02854631)
Timeframe: Baseline (Day 1) and up to 24 weeks

,
Interventiong/dL (Mean)
Change at Week 1Change at Week 2Change at Week 3Change at Week 4Change at Week 6Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24
Placebo + Prednisolone0.20.40.40.50.40.60.60.70.80.8
Selonsertib + Prednisolone0.20.30.30.40.20.30.50.50.80.8

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Change From Baseline in Liver Biochemistry Tests: Alkaline Phosphatase

Change from Baseline was calculated as the value at endpoint minus the value at Baseline. (NCT02854631)
Timeframe: Baseline (Day 1) and up to 24 weeks

,
InterventionU/L (Mean)
Change at Week 1Change at Week 2Change at Week 3Change at Week 4Change at Week 6Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24
Placebo + Prednisolone-3-5-4-16-21-47-52-50-45-43
Selonsertib + Prednisolone11231081-14-35-26-29-25

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Change From Baseline in Liver Biochemistry Tests: International Normalized Ratio (INR)

Change from Baseline was calculated as the value at endpoint minus the value at Baseline. (NCT02854631)
Timeframe: Baseline (Day 1) and up to 24 weeks

,
InterventionRatio (Mean)
Change at Week 1Change at Week 2Change at Week 3Change at Week 4Change at Week 6Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24
Placebo + Prednisolone-0.1-0.2-0.2-0.2-0.2-0.3-0.3-0.3-0.3-0.3
Selonsertib + Prednisolone-0.1-0.2-0.3-0.3-0.2-0.3-0.3-0.3-0.3-0.4

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Change From Baseline in Liver Biochemistry Tests: Bilirubin

Change from Baseline was calculated as the value at endpoint minus the value at Baseline. (NCT02854631)
Timeframe: Baseline (Day 1) and up to 24 weeks

,
Interventionmg/dL (Mean)
Change at Week 1Change at Week 2Change at Week 3Change at Week 4Change at Week 6Change at Week 8Change at Week 12Change at Week 16Change at Week 20Change at Week 24
Placebo + Prednisolone-4.3-6.3-7.2-8.6-9.3-10.3-11.2-11.3-11.3-10.7
Selonsertib + Prednisolone-2.1-2.9-4.8-6.3-8.7-8.4-9.5-9.4-8.1-9.4

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Percentage of Participants Who Died by Week 12

The percentage of participants who died by Week 12 was calculated. (NCT02854631)
Timeframe: Week 12

InterventionPercentage of participants (Number)
Selonsertib + Prednisolone25.6
Placebo + Prednisolone10.2

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Percentage of Participants Who Died by Day 28

The percentage of participants who died by Day 28 was calculated. (NCT02854631)
Timeframe: Day 28

InterventionPercentage of participants (Number)
Selonsertib + Prednisolone4.3
Placebo + Prednisolone4.0

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Percentage of Participants With Survival at Day 28 Using Kaplan-Meier

The percentage of participants with survival at Day 28 using Kaplan-Meier was calculated. (NCT02854631)
Timeframe: Day 28

InterventionPercentage of participants (Number)
Selonsertib + Prednisolone95.7
Placebo + Prednisolone96.1

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Percentage of Participants With Treatment-Emergent (TE) Adverse Events (AE), Serious AEs (SAE), AEs Leading to Premature Study Drug Discontinuation, and Grade 3 or 4 Laboratory Abnormalities

An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. (NCT02854631)
Timeframe: Up to Day 28 plus 30 days

,
InterventionPercentage of participants (Number)
TEAEsTE SAEsTEAEs (discontinuation of Selonsertib/Placebo)TEAEs (discontinuation of Prednisolone)TEAEs (discontinuation of both drugs in regimen)Laboratory abnormalities (Grade 3 or 4)Laboratory abnormalities (Grade 3)Laboratory abnormalities (Grade 4)
Placebo + Prednisolone94.240.47.711.57.772.052.020.0
Selonsertib + Prednisolone94.050.018.014.014.072.042.030.0

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Percentage of Participants With Estimated Mortality at Month 2 and Month 6: Combined Scoring Including Lille Score at Day 7 and Baseline Model for End-Stage Liver Disease (MELD) Score

The Lille score is a tool used to predict which participants with severe AH were not responding to corticosteroid therapy. It ranges between 0 and 1, with low scores (< 0.16) indicating complete response or positive response to steroids (continue therapy) and high scores (≥ 0.56) indicating no response or poor response to steroids (stop therapy). MELD scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40, with higher scores indicating greater disease severity. A scoring system combining the Lille score at Day 7 and the baseline MELD score was used to calculate the percentage of participants expected to die by Month 2 and by Month 6. (NCT02854631)
Timeframe: Baseline and Day 7 Time Points used to calculate Overall Mortality Risk at Months 2 and 6

,
InterventionPercentage of participants (Mean)
Mortality Risk at Month 2Mortality Risk at Month 6
Placebo + Prednisolone9.715.2
Selonsertib + Prednisolone13.019.8

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Percentage of Participants Who Received a Liver Transplant

The percentage of participants who received a liver transplant by week 24 was calculated. (NCT02854631)
Timeframe: Day 28, Week 8, Week 12, and Week 24

,
InterventionPercentage of participants (Number)
Day 28Week 8Week 12Week 24
Placebo + Prednisolone0002.6
Selonsertib + Prednisolone2.22.83.06.9

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Length of Hospital Stay

Length of initial hospital stay from first dose date of study drug was calculated for participants who were released from initial hospitalization separately from those who died during their initial hospitalization. (NCT02854631)
Timeframe: Up to 24 weeks

,
InterventionDays (Mean)
Released from initial hospitalizationDied during initial hospitalization
Placebo + Prednisolone11.06.0
Selonsertib + Prednisolone11.036.0

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Disease Activity as Per Ultrasound-7 (US-7) Score

Ultrasound 7 score (US-7) Calculates ultrasound score in 7 joints using greyscale and power doppler to evaluate for disease activity (synovitis, tenosynovitis) and damage (erosions) Score minimum value= 0 Maximum value = 108 Higher score indicates worse disease (NCT02930343)
Timeframe: 12 weeks

Interventionunits on a scale (Median)
Group 1- MTX+LEF+HCQ3.5
Group 2- MTX+SSZ+HCQ4

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Number of Participants With Adverse Drug Reactions

Infections, transaminitis, nausea, vomiting, derranged renal function tests etc (NCT02930343)
Timeframe: 24 weeks

,
InterventionParticipants (Count of Participants)
Total number of any adverse eventsSerious adverse eventsAny gastrointestinal adverse reactionNauseaDiarrheaSwitch to parenteral MethotrexateRaised liver enzymes > 2 times upper limit normalHerpes labialisupper respiratory tract infectionurinary tract infectionHypertensionhairfallCytopenia
Group 1- MTX+LEF+HCQ150114151051120
Group 2- MTX+SSZ+HCQ2101661141250020

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Number of Patients Achieving Good EULAR Response at the End of 12 Weeks

"EULAR response criteria for Rheumatoid arthritis includes- estimation of DAS 28 ESR, that includes-~Tender joint count 28~Swollen joint count 28~ESR~Patient global assessment of health" (NCT02930343)
Timeframe: 12 weeks

Interventionparticipants (Number)
Group 1- MTX+LEF+HCQ40
Group 2- MTX+SSZ+HCQ37

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Indian Health Assessment Questionnaire (iHAQ)

Indian version of Health assessment Questionnaire (iHAQ) Comprises of 12 questions relating to functional activity iHAQ score ranges from 0 to 3 (minimum 0, maximum 3) Higher scores indicate more disability (NCT02930343)
Timeframe: 12 weeks

Interventionscore on a scale (Median)
Group 1- MTX+LEF+HCQ0.7
Group 2- MTX+SSZ+HCQ0.5

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Number of Control and Treated Participants With Successful Live Births Following Conventional IVF or ICSI Cycles

Live birth rates in treated and control patients undergoing conventional IVF or ICSI cycles as determined by the sperm penetration assay (SPA) of hamster zone free ova (NCT02935738)
Timeframe: Nine months (pregnancy term) after the in vitro fertilization.

Interventionparticipants (Number)
Prednisolone Treated Men / Positive SPA / IVF18
Prednisolone Treated Men / Negative SPA / ICSI13
Control Men / Positive SPA / IVF8
Control Men / Negative SPA / ICSI9

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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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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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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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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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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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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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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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Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180

Grading of GvHD was performed by the investigator according to the modified International Bone Marrow Transplant Registry (IBMTR) grading system which classifies the degree of involvement of each organ system by stage on a scale of 0 to 4. The degree of skin involvement was staged depending upon degree and severity of the lesions: Stage 1: Maculopapular rash over less than (<) 25% of body area, Stage 2: Maculopapular rash over 25 to 50% of body area, Stage 3: Generalized erythroderma, Stage 4: Generalized erythroderma with bullous formation. Degree of GI involvement was staged based on severity of diarrhoea: Stage 1: 500 to 1000 mL/day,Stage 2: 1000 to 1500 mL/day, Stage 3: 1500 to 2000 mL/day, Stage 4: greater than (>) 2000 mL/day OR pain OR ileus. Degree of liver involvement was staged based upon serum total bilirubin level as follows: Stage 1: 2 to 3 mg/dL, Stage 2: 3 to 6 mg/dL, Stage 3: 6 to 15 mg/dL, Stage 4: >15 mg/dL. (NCT02956122)
Timeframe: Days 28, 56 and 180

InterventionParticipants (Count of Participants)
Day 28: Degree of skin Involvement72260019Day 28: Degree of GI Involvement72260019Day 28: Degree of liver Involvement72260019Day 56: Degree of skin Involvement72260019Day 56: Degree of GI Involvement72260019Day 56: Degree of liver Involvement72260019Day 180: Degree of skin Involvement72260019Day 180: Degree of GI Involvement72260019Day 180: Degree of liver Involvement72260019
Stage 1Stage 3Stage 4Stage 0Stage 2
GLASSIA1
GLASSIA0

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Graft-versus-host Disease (GvHD)-Free Survival - Percentage of Participants With an Event

GVHD-free survival was defined as being alive without previous onset of acute GVHD or chronic GVHD requiring immunosuppressive therapy. (NCT02956122)
Timeframe: Days 28, 56, 100, 180 and 365

InterventionPercentage of participants (Number)
Day 28Day 56Day 100Day 180Day 365
GLASSIA100100100100100

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"Area Under the Plasma Concentration Curve From Time Zero to Time t AUC(0-t) of GLASSIA"

AUC(0-t) of GLASSIA was reported. (NCT02956122)
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours

Interventionh*mg/dL (Number)
GLASSIA: Day 1: 90 mg/kg16300
GLASSIA: Day 13: 30 mg/kg11000
GLASSIA: Day 22: 120 mg/kg40400
GLASSIA: Day 50: 120 mg/kg33400

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Apparent Terminal Half-life (t1/2) of GLASSIA

Apparent terminal half-life (hour), determined as ln2/lambda-z. lambda-z is the apparent terminal rate constant (one per hour), determined by linear regression of the terminal points of the log-linear concentration-time curve. Visual assessment will be used to identify the terminal linear phase of the concentration-time profile. A minimum of 3 data points will be used for determination. t1/2 of GLASSIA was reported. (NCT02956122)
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours

InterventionHour (h) (Number)
GLASSIA: Day 1: 90 mg/kg152
GLASSIA: Day 13: 30 mg/kg117
GLASSIA: Day 22: 120 mg/kg317
GLASSIA: Day 50: 120 mg/kg247

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Apparent Volume of Distribution at Steady State (Vss) of GLASSIA

Vss of GLASSIA was reported. (NCT02956122)
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours

InterventionDeciliter (dL) (Number)
GLASSIA: Day 13: 30 mg/kg50.9
GLASSIA: Day 22: 120 mg/kg123
GLASSIA: Day 50: 120 mg/kg91.1

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Area Under the Plasma Concentration Curve (AUC0-inf) From Time Zero to Infinity

AUC of GLASSIA was reported. (NCT02956122)
Timeframe: Day 1: through 48 hours; Day 13: through 48 hours; Day 22 and Day 50: through approximately 168 hours

InterventionHour*milligrams per deciliter (h*mg/dL) (Number)
GLASSIA: Day 1: 90 mg/kg61500
GLASSIA: Day 13: 30 mg/kg43500
GLASSIA: Day 22: 120 mg/kg126000
GLASSIA: Day 50: 120 mg/kg117000

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Maximum Observed Plasma Concentration (Cmax) of GLASSIA

Cmax of GLASSIA was reported. (NCT02956122)
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours

InterventionMilligrams per deciliter (mg/dl) (Number)
GLASSIA: Day 1: 90 mg/kg339
GLASSIA: Day 13: 30 mg/kg262
GLASSIA: Day 22: 120 mg/kg390
GLASSIA: Day 50: 120 mg/kg409

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Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments

Clinical laboratory assessments such as hematology, clinical chemistry, lipid and coagulation panels and urinalysis were performed. (NCT02956122)
Timeframe: Baseline up to Day 56

InterventionParticipants (Count of Participants)
GLASSIA0

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Number of Participants With Clinically Significant Changes in Vital Signs

Vital signs included body temperature, respiratory rate, pulse rate and systolic and diastolic blood pressure. (NCT02956122)
Timeframe: Baseline up to Day 56

InterventionParticipants (Count of Participants)
GLASSIA0

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Number of Participants With Recurrence of Primary Malignancies

Incidence of recurrence of primary malignancies was reported. (NCT02956122)
Timeframe: Baseline up to Day 365

InterventionParticipants (Count of Participants)
GLASSIA0

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Percentage of Participants Achieving Gastrointestinal (GI) Response at Day 28

GI response was defined as complete response (CR) + partial response (PR), defined as: - GI CR was able to eat; not requiring parenteral nutrition, and passing primarily formed stools - GI PR was decrease in need for parenteral nutrition to less than or equal to (<=) 50% of required calories; and reduction of stool volume by greater than or equal to (>=) 50%, without ileus. (NCT02956122)
Timeframe: Day 28

InterventionPercentage of participants (Number)
GLASSIA100

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Percentage of Participants Achieving Overall Response (OR) At Day 28

OR was defined as graft-versus-host disease (GvHD) complete response (CR) + partial response (PR), defined as: - GvHD CR was complete resolution of all signs and symptoms of acute GvHD in all organs without intervening salvage and GvHD PR was improvement of 1 stage in 1 or more organs involved in GvHD without progression in other organs. (NCT02956122)
Timeframe: Day 28

InterventionPercentage of participants (Number)
GLASSIA100

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Percentage of Participants Achieving Overall Response at Day 56

Overall response was defined as graft-versus-host disease (GvHD) complete response (CR) + partial response (PR), defined as: - GvHD CR was complete resolution of all signs and symptoms of acute GvHD in all organs without intervening salvage - GvHD PR was improvement of 1 stage in 1 or more organs involved in GvHD without progression in other organs. (NCT02956122)
Timeframe: Day 56

InterventionPercentage of participants (Number)
GLASSIA100

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Systemic Clearance at Steady State (CLss) of GLASSIA

CLss of GLASSIA was reported. (NCT02956122)
Timeframe: Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours

InterventionDeciliters per hour (dL/h) (Number)
GLASSIA: Day 13: 30 mg/kg0.297
GLASSIA: Day 22: 120 mg/kg0.286
GLASSIA: Day 50: 120 mg/kg0.260

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All-cause Mortality - Percentage of Participants With an Event

All-cause mortality was defined as the time from HSCT to death due to any cause. (NCT02956122)
Timeframe: Days 28, 56, 100 and 180

InterventionPercentage of participants (Number)
Day 28Day 56Day 100Day180
GLASSIA0000

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Failure-free Survival - Percentage of Participants With an Event

Failure-free survival was defined as the absence of all of the following criteria: Need for second-line treatment for acute GvHD, Non-relapse mortality (death during continuous complete remission) and recurrent malignancy. (NCT02956122)
Timeframe: Days 100 and 180

InterventionPercentage of participants (Number)
Day 100Day 180
GLASSIA100100

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Incidence of Chronic Graft-versus-host Disease (GvHD)

Incidence of chronic GvHD at Days 180 and 365 was reported. (NCT02956122)
Timeframe: Days 180 and 365

InterventionParticipants (Number)
Day 180Day 365
GLASSIA00

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Overall Survival (OS) - Percentage of Participants With an Event

OS was defined as the time from the date of randomization to the date of death due to any cause. (NCT02956122)
Timeframe: Days 100, 180 and 365

InterventionPercentage of participants (Number)
Day 100Day 180Day 365
GLASSIANANANA

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Testosterone Levels

Change in serum testosterone levels from baseline (NCT02962284)
Timeframe: Baseline and 360 days

Interventionng/dL (Mean)
Preceding Treatment - Yonsa-6.24
Preceding Treatment - Zytiga-5.87

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Percentage of Subjects With Prostate Specific Antigen - 50 Response

A decrease of ≥50% reduction from baseline of the study CHL-AA-201 (NCT02962284)
Timeframe: 360 days

Interventionpercentage of number of subjects (Number)
Preceding Treatment - Yonsa60.0
Preceding Treatment - Zytiga55.6

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Proportion of Subjects With Disease Progression

Number of participants who had disease progression (NCT02962284)
Timeframe: one year

InterventionParticipants (Count of Participants)
Preceding Treatment - Yonsa1
Preceding Treatment - Zytiga3

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Prostate Specific Antigen Levels

Change in serum testosterone levels after one year of treatment against baseline (NCT02962284)
Timeframe: One year

Interventionng/dL (Mean)
Preceding Treatment - Yonsa-60.12
Preceding Treatment - Zytiga-112.76

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Number of Subjects With Adverse Events

Adverse events (NCT02962284)
Timeframe: one year

InterventionParticipants (Number)
Preceding Treatment - Yonsa8
Preceding Treatment - Zytiga9

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Testosterone Complete Suppression

Proportion of subjects with complete suppression of testosterone levels (NCT02962284)
Timeframe: 360 days

Interventionpercentage of subjects (Number)
Preceding Treatment - Yonsa100
Preceding Treatment - Zytiga87.5

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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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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 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 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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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 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 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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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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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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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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Number of Eyes With Corneal Haze

As determined by slit lamp examination (NCT03123614)
Timeframe: 12 months

InterventionEyes (Count of Units)
Loteprednol Etabonate 0.5% Oph Gel3
Prednisolone Acetate 1% Oph Susp7

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Best Corrected Visual Acuity at 3 Months

Best uncorrected visual acuity will be measured at 3 months (NCT03123614)
Timeframe: 3 months

InterventionlogMAR (Mean)
Loteprednol Etabonate 0.5% Oph Gel-0.120
Prednisolone Acetate 1% Oph Susp-0.114

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Change in Intraocular Pressure (IOP) From Baseline Through Month 3

Intraocular pressure will be measured by applanation tonometry (NCT03123614)
Timeframe: Baseline, 1 week post-op, 1 month post-op, 2 months post-op, 3 months post-op

,
InterventionmmHg (Mean)
Baseline intraocular pressure (IOP)IOP 1 week postopIOP 1 month postopIOP 2 months postopIOP 3 months postop
Loteprednol Etabonate 0.5% Oph Gel14.3813.6714.1513.3613.15
Prednisolone Acetate 1% Oph Susp14.3013.2814.6013.1612.22

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Uncorrected Visual Acuity

Best uncorrected visual acuity will be measured at 3 months (NCT03123614)
Timeframe: 3 months

InterventionlogMAR (Mean)
Loteprednol Etabonate 0.5% Oph Gel-0.078
Prednisolone Acetate 1% Oph Susp-0.075

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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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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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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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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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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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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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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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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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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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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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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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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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Incidence Rate of aGVHD Flares

(NCT03139604)
Timeframe: up to day 100

Interventionparticipants (Number)
Itacitinib Plus Corticosteroids42
Placebo Plus Corticosteroids48

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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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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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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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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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Health Assessment Questionnaire (HAQ) Disability Index at Week 24.

Quality of life is assessed using the Health Assessment Questionnaire (HAQ). The HAQ is a self-reported scale used in studies of rheumatoid arthritis to assess areas such as dressing/grooming, arising, eating, walking, reach, grip, maintaining hygiene, and daily activities. There are 20 questions in the mentioned 8 sections. In each section, the highest score is considered as the main answer. Scores should be between 0 and 3 and the final answer is the average of scores relating to all sections. An increased score indicates a worsening of the disability. The disability index of Health Assessment Questionnaire (HAQ) at week 24 is reported. (NCT03172325)
Timeframe: Week 24

Interventionscore on a scale (Median)
CinnaGen Adalimumab0.25
AbbVie Adalimumab0.19

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The Incidence of Adverse Events

The incidence of adverse events at each visit is recorded based on patients' reports, vital signs, physical examinations, and laboratory tests for systemic safety, including liver function, renal function, complete blood count and clinical chemistries, urinalysis, and hematologic testing. (NCT03172325)
Timeframe: From the time of first treatment up to the last dose of study treatment; 24 weeks.

InterventionParticipants (Count of Participants)
CinnaGen Adalimumab23
AbbVie Adalimumab30

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Percentage of Patients Achieving ACR20, ACR50 and ACR70 Response Rates at Week 24

ACR20, ACR50, and ACR70 Response Rates are considered as respectively an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score from Baseline at Week 24. (NCT03172325)
Timeframe: Week 24

,
Interventionpercentage of participants (Number)
Percentage of Patients achieving ACR20Percentage of Patients achieving ACR50Percentage of Patients achieving ACR70
AbbVie Adalimumab897553
CinnaGen Adalimumab927747

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Percentage of Patients With DAS28-EULAR Good and Moderate Responses at Week 24

"The primary variables are the percentage of patients with DAS28-EULAR Good and Moderate Responses at week 24 compared with Humira. Moderate response is defined as decrement of more than 1.2 in patient's DAS score while patient's DAS score is equal to or more than 3.2 or decrement of 0.6-1.2 while patient's DAS score is equal to or below 5.1. Good response is defined as decrement of more than 1.2 in patient's DAS score while patient's DAS score is below 3.2. We used the Disease Activity Score-28 for rheumatoid arthritis with erythrocyte sedimentation rate (DAS28-ESR) to assess disease activity in patients with rheumatoid arthritis. This score ranges from 2 to 10, and higher values indicate higher disease activity. DAS28-ESR is calculated with the following formula:~DAS28-ESR= (0.56*√(Tender Joint Count)+0.28*√(Swollen Joint Count)+0.7*ln(ESR)+0.014*(global health))" (NCT03172325)
Timeframe: Week 24

Interventionpercentage of participants (Number)
CinnaGen Adalimumab63
AbbVie Adalimumab63

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Immunogenicity: Number of Participants With Anti-Drug Antibodies (ADA)

Number of Participants with Anti-Drug Antibodies (ADA) at Week 24. The ELISA method was used for immunogenicity assessments of adalimumab. (NCT03172325)
Timeframe: Week 24

InterventionParticipants (Count of Participants)
CinnaGen Adalimumab5
AbbVie Adalimumab2

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Number of Participants With Any Other Post-operative Complications From the Start of Study Drug Administration Until Hospital Discharge.

(NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

InterventionParticipants (Count of Participants)
Methylprednisolone Arm237
Placebo Arm264

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Number of Participants With Death or Major Complication as Defined by an Outcome in One of the 7 Highest Global Ranking Categories

The 7 highest global ranking categories range from 91 (postoperative length of hospital stay > 90 days) to 97 (operative mortality). (NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

InterventionParticipants (Count of Participants)
Methylprednisolone Arm103
Placebo Arm122

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Number of Participants With Mortality, Including In-hospital Mortality or Mortality After Hospital Discharge But Within 30 Days of the Last Dose of Study Drug

(NCT03229538)
Timeframe: up to 30 days

InterventionParticipants (Count of Participants)
Methylprednisolone Arm12
Placebo Arm17

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Number of Participants With Occurrence of Any One or More of the Following STS-CHSD-defined Major Post-operative Infectious Complications: Postprocedural Infective Endocarditis, Pneumonia, Sepsis, Deep Wound Infection, Mediastinitis.

(NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

InterventionParticipants (Count of Participants)
Methylprednisolone Arm31
Placebo Arm24

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Number of Participants With Post-operative Low Cardiac Output Syndrome

"Based upon the STS-CHSD registry defined cardiac dysfunction resulting in low cardiac output complication variable." (NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

InterventionParticipants (Count of Participants)
Methylprednisolone Arm31
Placebo Arm37

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Number of Participants With a Post-operative Length of Stay Greater Than 90 Days

Calculated as discharge date minus surgery date. (NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

InterventionParticipants (Count of Participants)
Methylprednisolone Arm18
Placebo Arm29

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Number of Participants With Prolonged Mechanical Ventilation (Greater Than 7 Days)

(NCT03229538)
Timeframe: Until hospital discharge, up to 4 months

InterventionParticipants (Count of Participants)
Methylprednisolone Arm41
Placebo Arm51

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Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15

Ocular Itching was assessed by the subjects using a 0 to 4 point scale(0=none (best/no itching) to 4=severe (worst/most itching)). The ocular itching was averaged across all subjects at each time point. (NCT03320434)
Timeframe: post CAC exposure at 5, 7, and 10 minutes post CAC on Day 15

,,,
Interventionunits on a scale (Mean)
5 minutes post-CAC7 minutes post-CAC10 minutes post-CAC
Patanol0.7750.8080.833
PRT-2761 0.5%2.4312.3621.922
PRT-2761 0%2.5272.3661.929
PRT-2761 1%2.6112.6022.204

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Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1

"Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)).~The conjunctival redness was averaged across all subjects at each time point." (NCT03320434)
Timeframe: post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 1.

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Patanol1.5921.8331.917
PRT-2761 0.5%1.2821.4111.371
PRT-2761 0%1.9572.1812.164
PRT-2761 1%1.4911.5261.603

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Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15

"Conjunctival Redness was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no redness) to 4=severe (worst/most redness)).~The conjunctival redness was averaged across all subjects at each time point." (NCT03320434)
Timeframe: post CAC exposure at 7, 15, and 20 minutes post-CAC on Day 15.

,,,
Interventionunits on a scale (Mean)
7 minutes post-CAC15 minutes post-CAC20 minutes post-CAC
Patanol1.2421.6171.592
PRT-2761 0.5%1.7231.9201.857
PRT-2761 0%1.9731.9912.036
PRT-2761 1%2.0562.1762.222

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Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1

Ocular Itching was assessed by a trained investigator post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0=none (best/no itching) to 4=severe (worst/most itching). The ocular itching was averaged across all subjects at each time point. (NCT03320434)
Timeframe: post CAC exposure at 5, 7, and 10 minutes post CAC on Day 1

,,,
Interventionunits on a scale (Mean)
5 minutes post-CAC7 minutes post-CAC10 minutes post-CAC
Patanol1.2171.3581.258
PRT-2761 0.5%2.5732.6772.250
PRT-2761 0%2.6472.6292.190
PRT-2761 1%2.5002.5092.293

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Last Plasma Concentration Measured Before the Last Dose (Ctrough) of AZD9567

The Ctrough of AZD9567 was determined using non-compartmental method before the last dose on Day 15. (NCT03368235)
Timeframe: Predose on Day 15

Interventionnmol/L (Geometric Mean)
AZD9567NA

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LS Mean Change From Baseline in CRP at Day 15

CRP was evaluated as one of the components that comprised the DAS28-score. The CRP was collected at the local laboratory during screening and central laboratory on Days 1, 8, 15 and 28. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. (NCT03368235)
Timeframe: Baseline and Day 15

Interventionmg per liter (L) (Least Squares Mean)
AZD9567-10.830
Prednisolone-15.586

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Area Under the Plasma Concentration-Time Curve Until the Last Quantifiable Concentration (AUClast) of AZD9567

The AUClast was determined using non-compartmental method and calculated using the linear trapezoidal rule when concentrations were increased and the logarithmic trapezoidal rule when concentrations were decreased. (NCT03368235)
Timeframe: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4 and 6 hour postdose on Day 15.

Interventionhour*nanomole per L (h*nmol/L) (Geometric Mean)
AZD956717800

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Area Under the Concentration-Time Curve From Time Zero to 6 Hours After Dose (AUC0-6) of AZD9567

The AUC0-6 was determined using non-compartmental method and calculated using the linear trapezoidal rule when concentrations were increased and the logarithmic trapezoidal rule when concentrations were decreased. (NCT03368235)
Timeframe: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4 and 6 hour postdose on Day 15.

Interventionh*nmol/L (Geometric Mean)
AZD956717740

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Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Responses

The ACR20, ACR50 or ACR70 was achieved if there was at least a 20%, 50% or 70% improvement from baseline in swollen joint count 66 (SJC66) and tender joint count 68 (TJC68) and 3 or more of the 5 following assessments: participant's assessment of pain, GH, physician's global assessment of disease activity, participant's assessment of physical function and CRP. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. (NCT03368235)
Timeframe: Day 15

,
Interventionpercentage of participants (Number)
ACR20ACR50ACR70
AZD956763.636.418.2
Prednisolone70.070.050.0

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LS Mean Change From Baseline in GH Score at Day 15

GH was evaluated as one of the components that comprised the DAS28-score. Participant's GH was measured using PGA of disease activity by means of the visual analogue scale (VAS). The PGA VAS consists of a 100 millimeter (mm) long scale ranging from 0 (very well) to 100 (very poor). Higher score indicated greater disease severity. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. (NCT03368235)
Timeframe: Baseline and Day 15

Interventionscore on a scale (Least Squares Mean)
AZD9567-27.7
Prednisolone-37.4

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Time to Reach Maximum Plasma Concentration (Tmax) of AZD9567

The tmax of AZD9567 was determined using non-compartmental method. (NCT03368235)
Timeframe: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4 and 6 hour postdose on Day 15.

Interventionhour (Median)
AZD95670.67

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LS Mean Change From Baseline in Participant's Assessment of Pain Score at Day 15

Participant's assessment of pain score was evaluated as one of the components that comprised the ACR. Participant's assessment of pain score was assessed from the amount of pain due to RA on a VAS ranging from 0 (no pain) to 100 (extreme pain). Higher score indicated greater disease severity. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. (NCT03368235)
Timeframe: Baseline and Day 15

Interventionscore on a scale (Least Squares Mean)
AZD9567-27.3
Prednisolone-43.4

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LS Mean Change From Baseline in Participant's Assessment of Physical Function Score at Day 15

Participant's assessment of physical function score was evaluated as one of the components that comprised the ACR. The participant's assessment of physical function across 8 functional areas was measured by health assessment questionnaire. The total score ranging from 0 (no difficulty) to 24 (inability to perform tasks). Higher score indicated greater disease severity. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. (NCT03368235)
Timeframe: Baseline and Day 15

Interventionscore on a scale (Least Squares Mean)
AZD9567-0.441
Prednisolone-0.571

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LS Mean Change From Baseline in SJC28 Score at Day 15

SJC28 was evaluated as one of the components that comprised the DAS28-score. A total of 28 joints (14 left, 14 right) were evaluated for swelling as obtained from the joint count right or left eCRF. The swollen joint count represents the number of joints in which there was synovial fluid and or soft tissue swelling, but not if bony overgrowth was found. A swollen joint was scored as 0 (absent) and 1 (present) for each joint. The SJC28 was calculated as sum of swollen joints with present status on eCRF. The swollen joint count ranged from 0-28 with higher score indicating disease severity. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. (NCT03368235)
Timeframe: Baseline and Day 15

Interventionscore on a scale (Least Squares Mean)
AZD9567-5.14
Prednisolone-5.40

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LS Mean Change From Baseline in SJC66 Score at Day 15

A total of 66 joints (33 left, 33 right) were evaluated for swelling. The swollen joint count represents the number of joints in which there was synovial fluid and or soft tissue swelling, but not if bony overgrowth was found. A swollen joint was scored as 0 (absent) and 1 (present) for each joint. The SJC66 was calculated as sum of swollen joints with present status on electronic case report form (eCRF). The swollen joint count ranged from 0-66 with higher score indicating disease severity. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. (NCT03368235)
Timeframe: Baseline and Day 15

Interventionscore on a scale (Least Squares Mean)
AZD9567-6.24
Prednisolone-6.66

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LS Mean Change From Baseline in TJC28 Score at Day 15

TJC28 was evaluated as one of the components that comprised the DAS28-score. A total of 28 joints (14 left, 14 right) were evaluated for tenderness as obtained from the joint count right or left eCRF. The tender joint count represents the number of joints in which pain was reported. A tender joint was scored as 0 (absent) and 1 (present) for each joint. The TJC28 was calculated as sum of tender joints with present status on eCRF. The tender joint count ranged from 0-28 with higher score indicating disease severity. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. (NCT03368235)
Timeframe: Baseline and Day 15

Interventionscore on a scale (Least Squares Mean)
AZD9567-6.12
Prednisolone-6.07

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LS Mean Change From Baseline in TJC68 Score at Day 15

A total of 68 joints (34 left, 34 right) were evaluated for tenderness. The tender joint count represents the number of joints in which pain was reported. A tender joint was scored as 0 (absent) and 1 (present) for each joint. The TJC68 was calculated as sum of tender joints with present status on eCRF. The tender joint count ranged from 0-68 with higher score indicating disease severity. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. (NCT03368235)
Timeframe: Baseline and Day 15

Interventionscore on a scale (Least Squares Mean)
AZD9567-9.02
Prednisolone-7.90

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Maximum Observed Plasma Concentration (Cmax) of AZD9567

The Cmax of AZD9567 was determined using non-compartmental method. (NCT03368235)
Timeframe: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4 and 6 hour postdose on Day 15.

Interventionnmol/L (Geometric Mean)
AZD95674468

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Least Square (LS) Mean Change From Baseline in 28 Joint Disease Activity Score Using C-Reactive Protein (DAS28-CRP) at Day 15

The DAS28-CRP is a measure of disease activity in RA. The score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment (PGA) of health (ranging from very well to very poor). The DAS28-CRP was derived as follows: 0.56 x √[tender joint count 28 (TJC28)] + 0.28 x √[swollen joint count 28 (SJC28)] + 0.014 x global health (GH) + 0.36 x Ln(CRP+1) + 0.96 to produce the overall DAS28-CRP score on a scale ranged from 0-10 with higher score indicating worse RA symptoms. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. (NCT03368235)
Timeframe: Baseline (Day 1) and Day 15

Interventionscore on a scale (Least Squares Mean)
AZD9567-1.931
Prednisolone-2.403

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LS Mean Change From Baseline in Physician's Global Assessment of Disease Activity Score at Day 15

Physician's global assessment of disease activity score was evaluated as one of the components that comprised the ACR. The physician's global assessment of disease activity was measured on a VAS ranging from 0 (very well) to 100 (very poor). Higher score indicated greater disease severity. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. (NCT03368235)
Timeframe: Baseline and Day 15

Interventionscore on a scale (Least Squares Mean)
AZD9567-37.0
Prednisolone-40.9

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Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan

Number of new or enlarged T2 lesions per scan was defined as the total number of new or enlarged T2 lesion that occurred during a specified period divided by the total number of scans performed during that specified period. (NCT03368664)
Timeframe: Period 1: Month -4 up to Month 0, Period 2: Month 4 to Month 8

Interventionlesions per scan (Number)
Period 13.53
Period 20.13

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Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Participants With New or Enlarged T2 Lesions Per MRI Scan

Number of participants with at least one new or enlarged T2 lesions per MRI scan was reported in this outcome measure. Number of new or enlarged T2 lesions per scan was defined as the total number of new or enlarged T2 lesion that occurred during treatment period divided by the total number of scans performed during treatment period. (NCT03368664)
Timeframe: Period 1: Month -4 up to Month 0, Period 2: Month 4 to Month 8

InterventionParticipants (Count of Participants)
Period 110
Period 23

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Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Months 4 and 8

EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other). EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicated worst outcomes. (NCT03368664)
Timeframe: Baseline, Months 4 and 8

Interventionscores on scale (Mean)
Month 4Month 8
Alemtuzumab0.050.00

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Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)

TMS is an electrophysiological technique that was used to measure neurologic changes associated with recovery from stroke via alterations in the excitability of the motor system. Motor threshold measures reflect global excitability of the corticospinal pathway, including large pyramidal cells, excitatory/inhibitory interneurons, and spinal motor neurons. Long term potentiation can be measured non invasively and painlessly, in awake humans through transcranial magnetic stimulation (TMS). TMS uses high intensity, brief duration, magnetic fields that, when applied on the scalp, can activate neurons within a small focal region of the cerebral cortex, through electromagnetic induction. Motor Evoked Potentials (MEP) amplitudes elicited by single TMS pulses of increasing intensity (110, 120 and 130% of the Resting Motor Threshold [RMT]) will be measured to calculate recruitment curves of the motor cortex. Participant wise data was reported for this outcome. (NCT03387046)
Timeframe: Baseline (0 minute) and Post-Baseline (15 minutes) at Week 8

Interventionmillivolts (Number)
Participants 6: Week 8 (Baseline): 110% RMTParticipants 6: Week 8 (Baseline): 120% RMTParticipants 6: Week 8 (Baseline): 130% RMTParticipants 6: Week 8 (Post-baseline): 110% RMTParticipants 6: Week 8 (Post-baseline): 120% RMTParticipants 6: Week 8 (Post-baseline): 130% RMTParticipants 7: Week 8 (Baseline): 110% RMTParticipants 7: Week 8 (Baseline): 120% RMTParticipants 7: Week 8 (Baseline): 130% RMTParticipants 7: Week 8 (Post-baseline): 110% RMTParticipants 7: Week 8 (Post-baseline): 120% RMTParticipants 7: Week 8 (Post-baseline): 130% RMT
Placebo + IFN Beta-1a + Methylprednisolone288311826911253314014930135138

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Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)

TMS is an electrophysiological technique that was used to measure neurologic changes associated with recovery from stroke via alterations in the excitability of the motor system. Motor threshold measures reflect global excitability of the corticospinal pathway, including large pyramidal cells, excitatory/inhibitory interneurons, and spinal motor neurons. Long term potentiation can be measured non invasively and painlessly, in awake humans through transcranial magnetic stimulation (TMS). TMS uses high intensity, brief duration, magnetic fields that, when applied on the scalp, can activate neurons within a small focal region of the cerebral cortex, through electromagnetic induction. Motor Evoked Potentials (MEP) amplitudes elicited by single TMS pulses of increasing intensity (110, 120 and 130% of the Resting Motor Threshold [RMT]) will be measured to calculate recruitment curves of the motor cortex. Participant wise data was reported for this outcome. (NCT03387046)
Timeframe: Baseline (0 minute) and Post-Baseline (15 minutes) at Week 8

Interventionmillivolts (Number)
Participants 1: Week 8 (Baseline): 110% RMTParticipants 1: Week 8 (Baseline): 120% RMTParticipants 1: Week 8 (Baseline): 130% RMTParticipants 1: Week 8 (Post-baseline): 110% RMTParticipants 1: Week 8 (Post-baseline): 120% RMTParticipants 1: Week 8 (Post-baseline): 130% RMTParticipants 3: Week 8 (Baseline): 110% RMTParticipants 3: Week 8 (Baseline): 120% RMTParticipants 3: Week 8 (Baseline): 130% RMTParticipants 3: Week 8 (Post-baseline): 110% RMTParticipants 3: Week 8 (Post-baseline): 120% RMTParticipants 3: Week 8 (Post-baseline): 130% RMT
D-aspartate + IFN Beta-1a + Methylprednisolone3010514239128154239511531103118

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Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24

Fatigue Severity Scale (FSS) is a method of evaluating fatigue in multiple sclerosis and is designed to differentiate fatigue from clinical depression, since both share some of the same symptoms. The Fatigue Severity Scale is a 9-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 1-7 scale (1= no fatigue and 7= severe fatigue). The total score was calculated as the average of individual 9-items and ranged from 1 to 7 with a higher value indicating greater impairment due to fatigue. Participant wise data was reported for this outcome. (NCT03387046)
Timeframe: Week 8, 12 and 24

Interventionunits on a scale (Number)
Participant 6: Week 8Participant 7: Week 8Participant 6: Week 12Participant 7: Week 12Participant 7: Week 24
Placebo + IFN Beta-1a + Methylprednisolone4.32.24.14.13.3

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Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24

Fatigue Severity Scale (FSS) is a method of evaluating fatigue in multiple sclerosis and is designed to differentiate fatigue from clinical depression, since both share some of the same symptoms. The Fatigue Severity Scale is a 9-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 1-7 scale (1= no fatigue and 7= severe fatigue). The total score was calculated as the average of individual 9-items and ranged from 1 to 7 with a higher value indicating greater impairment due to fatigue. Participant wise data was reported for this outcome. (NCT03387046)
Timeframe: Week 8, 12 and 24

Interventionunits on a scale (Number)
Participant 1: Week 8Participant 2: Week 8Participant 3: Week 8Participant 4: Week 8Participant 5: Week 8Participant 1: Week 12Participant 3: Week 12Participant 4: Week 12Participant 5: Week 12Participant 1: Week 24Participant 3: Week 24Participant 4: Week 24Participant 5: Week 24
D-aspartate + IFN Beta-1a + Methylprednisolone1.22.61.71.111.32.6211.32.821.1

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Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24

MFIS is a structured, self-report questionnaire consisting of 21 items assessing the effects of fatigue. All 21 items are scaled 0 to 4, with higher scores indicating a greater impact of fatigue on participant's activities. The Total MFIS score ranges from 0 to 84. A score of 0 indicates fatigue has no impact on activities and the high-end score indicates fatigue has extreme impact on activities. Participant wise data was reported for this outcome. (NCT03387046)
Timeframe: Week 8, 12 and 24

Interventionunits on a scale (Number)
Participant 1: Week 8Participant 2: Week 8Participant 3: Week 8Participant 4: Week 8Participant 5: Week 8Participant 1: Week 12Participant 3: Week 12Participant 4: Week 12Participant 5: Week 12Participant 1: Week 24Participant 3: Week 24Participant 4: Week 24Participant 5: Week 24
D-aspartate + IFN Beta-1a + Methylprednisolone82715218612121510481215

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Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24

MFIS is a structured, self-report questionnaire consisting of 21 items assessing the effects of fatigue. All 21 items are scaled 0 to 4, with higher scores indicating a greater impact of fatigue on participant's activities. The Total MFIS score ranges from 0 to 84. A score of 0 indicates fatigue has no impact on activities and the high-end score indicates fatigue has extreme impact on activities. Participant wise data was reported for this outcome. (NCT03387046)
Timeframe: Week 8, 12 and 24

Interventionunits on a scale (Number)
Participant 6: Week 8Participant 7: Week 8Participant 6: Week 12Participant 7: Week 12Participant 7: Week 24
Placebo + IFN Beta-1a + Methylprednisolone2729273043

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PACU Stay

from operation to discharge from PACU (NCT03403517)
Timeframe: up to 24 hours

Interventionminutes (Median)
Methylprednisolone203
Dexamethasone186

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Mortality

any cause mortality (NCT03403517)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Methylprednisolone0
Dexamethasone0

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Hospital Stay

from operation to discharge (NCT03403517)
Timeframe: 3 months

Interventionhours (Median)
Methylprednisolone98
Dexamethasone102

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Complications, Post-anesthesia Care Unit (PACU)

Number of patients with any complication at any time, during stay in the PACU. Complications according to DASAIMS discharge criteria (modified Aldrete criteria) (NCT03403517)
Timeframe: up to 24 hours

InterventionParticipants (Count of Participants)
Methylprednisolone51
Dexamethasone58

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Total Complication Rate

any complications, 30 day morbidity (NCT03403517)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Methylprednisolone19
Dexamethasone19

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Change From Baseline (Preoperative Exam) in Macular Thickness

Thickness of the macula measured in microns, recorded as the change from baseline. (NCT03578276)
Timeframe: Month 1

Interventionmicrons (Mean)
LessDrops4.91
Standard of Care1.30

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Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)

Thickness of the cornea measured in microns, measured as the change from baseline (NCT03578276)
Timeframe: Month 1

Interventionmicrons (Mean)
LessDrops3.18
Standard of Care0.63

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Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)

Measurement of the pressure inside the eye in mmHg, recorded as the change from baseline (NCT03578276)
Timeframe: Month 1

InterventionmmHg (Mean)
LessDrops-0.33
Standard of Care-0.21

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Survival of Treatment

Survival of Hematopoietic Stem Cell Transplant during treatment and post treatment up to 1 year. (NCT03593902)
Timeframe: During Treatment and Post Treatment up to 1 year

InterventionParticipants (Count of Participants)
Hematopoietic Stem Cell Transplantation9

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Change in Skin Score by mRSS

Defined by at least a 25% improvement (decline) in skin score by modified Rodnan skin score (mRSS) if skin score is greater than 14 on enrollment. If skin score is less than 14 on enrollment, improvement is defined by at least a 5% improvement on mRSS. The modified Rodnan skin score (MRSS) is a measure for skin disease in scleroderma and is calculated by summation of skin thickness in 17 different body sites. The scale ranges from at total score of normal skin thickness (0) to severe thickness (51). (NCT03593902)
Timeframe: Pre Treatment and Post Treatment

Interventionunits on a scale (Mean)
Pre TreatmentPost Treatment
Hematopoietic Stem Cell Transplantation2516

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Number of Patients With Subsequent Reinjection and Surgical Operation

The number of patients with subsequent reinjection and surgical operation was collected during follow up. (NCT03704584)
Timeframe: End of follow up (6 weeks post intervention)

InterventionParticipants (Count of Participants)
Treatment Group (Corticosteroid Injection Plus Lidocaine)0
Control Group (Corticosteroid Alone)0

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10 Point Likert Scale of Pain Scores Before the Injection and After the Injection and During Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group

Pain will be assessed with a 10-point scale (0: no pain, 10: highest amount of pain) of anticipated pain and anxiety before injection and a 10-point pain scale of the pain of the needle, medication, overall pain and anxiety after the injection was administered to the participants. (NCT03704584)
Timeframe: Pre injection, Post injection day, 2 weeks and at 6 weeks

,
Interventionscore on a scale (Mean)
Pre-Injection: How painful do you think the injection will be?Pre-Injection: How painful do you think it will be 1-minute after the injection?Pre-Injection: How nervous are you about the injection?Post-Injection: Actual pain of the needlePost-Injection: Actual pain of the medicationPost-Injection: Actual pain 1-minute after the injection
Control Group (Corticosteroid Alone)5.43.23.54.24.31.7
Treatment Group (Corticosteroid Injection Plus Lidocaine)5.94.44.04.34.71.7

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Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7

Participants were instructed to log their pain twice daily (morning and night) using a VAS pain scale of 0-10 (0: no pain, 10: highest amount of pain) for the first 7 days after injection. Participants were instructed to bring that pain journal to their 2-week visit. Average daily scores are presented. (NCT03704584)
Timeframe: Post injection day (1-7), 2 weeks and at 6 weeks post intervention

,
Interventionscore on a scale (Mean)
Post injection day 1Post injection day 2Post injection day 3Post injection day 4Post injection day 5Post injection day 6Post injection day 7
Control Group (Corticosteroid Alone)3.73.02.62.22.01.51.6
Treatment Group (Corticosteroid Injection Plus Lidocaine)3.72.21.71.11.00.690.58

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Change From Baseline in FACIT-Fatigue Scale

Patient Reported Outcome: Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue is a 13-item questionnaire with a full scale of 0 -52 that assesses self-reported fatigue and its impact upon daily activities and function. The higher the score the better functioning (less fatigue). (NCT03765788)
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52

,
Interventionscores on a scale (Mean)
Week 4 (n = 27, 23)Week 8 (n = 26, 21)Week 12 (n = 25, 20)Week 16 (n = 25, 20)Week 20 (n =24, 20)Week 24 (n = 23, 20)Week 28 (n = 23, 19)Week 36 (n = 21, 19)Week 44 (n = 21, 16)Week 52 (n = 21, 16)
Placebo-0.960.81-0.25-0.360.05-3.100.421.840.310.19
Secukinumab2.112.190.962.123.422.913.613.902.673.19

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Percentage of Participants in Remission at Week 12

"Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper Regimen.~Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (>/=) 30 millimeters per hour (mm/hr) and/or CRP (>/=10.0 mg/L) attributable to GCA.~Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the escape arm (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28." (NCT03765788)
Timeframe: Week 12

InterventionParticipants (Count of Participants)
Secukinumab22
Placebo12

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Percentage of Participants in Sustained Remission Until Week 28

"Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper regimen.~Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of Giant Cell Arteritis (GCA) and/or erythrocyte sedimentation rate (ESR) greater than or equal to (>/=) 30 millimeters per hour (mm/hr) and/or C-reactive Protein (CRP) (>/=10.0 mg/L) attributable to GCA.~Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the escape arm (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28." (NCT03765788)
Timeframe: Until week 28

InterventionParticipants (Count of Participants)
Secukinumab19
Placebo6

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Percentage of Participants With GCA Who Had Sustained Remission Until Week 52

"Remission was defined as the absence of flare. Sustained remission was defined as patients without flare until Week 52 and in adherence to the protocol prednisolone taper regimen plus prednisolone-free phase from Week 27 onwards. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (>/=) 30 millimeters per hour (mm/hr) and/or CRP (>/=10.0 mg/L) attributable to GCA.~Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the escape arm (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28." (NCT03765788)
Timeframe: Until Week 52

InterventionParticipants (Count of Participants)
Secukinumab16
Placebo2

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Time to First GCA Flare After Clinical Remission

"Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (>/=) 30 millimeters per hour (mm/hr) and/or CRP (>/=10.0 mg/L) attributable to GCA. Time to first flare after remission referred to time from first day of study treatment until first post-Baseline flare.~For time to first GCA flare after remission (up to and including Week 52), patients who prematurely discontinued study treatment prior to Week 52 were censored at the time of premature discontinuation and patients who completed treatment and did not have a flare were censored at their last visit in the treatment phase.~Time to first GCA flare after remission was calculated using Kaplan-Meier plot of time." (NCT03765788)
Timeframe: Up to Week 52 (included)

Interventiondays (Median)
SecukinumabNA
Placebo197.0

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Change From Baseline in 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. This was assessed in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. (NCT03765788)
Timeframe: Baseline, Week 28, Week 52

,
Interventionmg/L (Mean)
Week 28 (n = 23, 19)Week 52 (n = 21, 16)
Placebo5.2164.650
Secukinumab4.426-1.433

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Change From Baseline in EQ-5D-5L (EuroQol 5D) Questionnaire

"EQ-5D-5L, a self-administered questionnaire assessing health status in adults, is divided into 2 sections. The 1st section addresses 5 dimensions (mobility, self-care, usual activity, pain/discomfort, & anxiety/depression). Items are rated either no problem, slight problems, moderate problems, severe problems, or extreme problems/unable. A composite health index is defined by combining the levels for each dimension. The 2nd section measures self-rated (global) health status via vertically oriented VAS where 100 represents the best possible health state & 0 represents the worst possible health state. The EQ-5D-5L contains 6 items assessing health status via a single index value or health utility score and allows weighting by the patient of health states & generation of patient utilities. Published weights are available allowing for creation of a single summary health utility score. Scores range from 0 to 1, with lower scores representing a higher level of dysfunction." (NCT03765788)
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52

,
Interventionscores on a scale (Mean)
EQ-5D-5L VAS: Week 4 (n = 27, 23)EQ-5D-5L VAS: Week 8 (n = 26, 21)EQ-5D-5L VAS: Week 12 (n = 25, 20)EQ-5D-5L VAS: Week 16 (n = 25, 20)EQ-5D-5L VAS: Week 20 (n = 24, 20)EQ-5D-5L VAS: Week 24 (n = 23, 20)EQ-5D-5L VAS: Week 28 (n = 23, 19)WEQ-5D-5L VAS: Week 36 (n = 21, 19)EQ-5D-5L VAS: Week 44 (n = 21, 16)EQ-5D-5L VAS: Week 52 (n = 21, 16)EQ-5D-5L utility index: Week 4 (n = 27, 23)EQ-5D-5L utility index: Week 8 (n = 26, 21)EQ-5D-5L utility index: Week 12 (n = 25, 20)EQ-5D-5L utility index: Week 16 (n = 25, 20)EQ-5D-5L utility index: Week 20 (n = 24, 20)EQ-5D-5L utility index: Week 24 (n = 23, 20)EQ-5D-5L utility index: Week 28 (n = 23, 19)EQ-5D-5L utility index: Week 36 (n = 21, 19)EQ-5D-5L utility index: Week 44 (n = 21, 16)EQ-5D-5L utility index: Week 52 (n = 21, 16)
Placebo1.875.523.304.406.30-1.0010.375.3212.6910.81-0.07020.0087-0.0122-0.01960.0221-0.04440.0240-0.01550.00900.0205
Secukinumab11.265.584.647.0007.885.394.436.906.3811.620.0166-0.00340.00160.01860.02100.0402-0.00020.0063-0.0119-0.0076

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Change From Baseline in Erythrocyte Sedimentation Rate (ESR)

ESR is a laboratory test that provides a non-specific measure of inflammation. This was assessed in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. 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. (NCT03765788)
Timeframe: Baseline, Week 28, Week 52

,
Interventionmm/hr (Mean)
Week 28 (n = 23, 18)Week 52 (n = 21, 16)
Placebo14.66710.000
Secukinumab4.043-3.286

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Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS)

Clinician Reported Outcome: Physicians global assessment (PhGA) using a visual analogue scale (VAS) scale. VAS is a range of scores from 0-100, with lower change from baseline scores indicating a more favorable outcome and higher change from baseline scores indicating a greater disease activity. (NCT03765788)
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52

,
Interventionscores on a scale (Mean)
Week 4 (n = 27, 23)Week 8 (n = 26, 21)Week 12 (n = 25, 20)Week 16 (n = 25, 20)Week 20 (n = 24, 20)Week 24 (n = 23, 20)Week 28 (23, 19)Week 36 (21, 19)Week 44 (n = 21, 16)Week 52 (n = 21, 16)
Placebo-3.22.1-3.10.7-1.52.23.90.71.14.0
Secukinumab-4.8-5.8-3.4-4.1-6.9-4.3-5.4-8.7-5.5-9.5

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Change From Baseline in Short-Form (SF)-36 Questionnaire

Patient Reported Outcome: The SF-36 is a standardized questionnaire used to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consists of 8 subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. The higher the score (change from baseline) the more favorable the outcome. The values were reported by change from baseline in SF-36 domain scores. (NCT03765788)
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52

,
Interventionscores on a scale (Mean)
Week 4: Physical Functioning (PF) (n = 27, 23)Week 8: PF (n = 26 ,21)Week 12: PF (n = 25, 20)Week 16: PF (n = 25, 20)Week 20: PF (n = 24, 20)Week 24: PF (n = 22, 20)Week 28: PF (n = 23, 19)Week 36: PF (n = 21, 19)Week 44: PF (n = 21, 16)Week 52: PF (n = 21, 16)Week 4: Role-Physical (R-P) (n =27, 23)Week 8: R-P (n =26, 21)Week 12: R-P (n = 25, 20)Week 16: R-P (n = 25, 20)Week 20: R-P (n = 24, 20)Week 24: R-P (n = 22, 20)Week 28: R-P (n = 23, 19)Week 36: R-P (n = 21, 19)Week 44: R-P (n = 21, 16)Week 52: R-P (n = 21, 16)Week 4: Bodily Pain (BP) (n = 27, 23)Week 8: BP (n = 26, 21Week 12: BP (n = 25, 20)Week 16: BP (n = 25, 20)Week 20: BP (n = 24, 20)Week 24: BP (n = 22, 20)Week 28: BP (n = 23, 19)Week 36: BP (n = 21, 19)Week 44: BP (n = 21, 16)Week 52: BP (n = 21, 16)Week 4: General Health (GH) ( n = 27, 23)Week 8: GH (n = 26, 21)Week 12: GH (n = 25, 20Week 16: GH (n = 25, 20)Week 20: GH (n = 24, 20)Week 24: GH (n = 22, 20)Week 28: GH (n = 23, 19)Week 36:GH (n = 21, 19)Week 44: GH (n = 21, 16)Week 52: GH (n = 21, 16)Week 4: Vitality (n = 27, 23)Week 8: Vitality (n = 26, 21)Week 12: Vitality (n = 25, 20)Week 16: Vitality (n = 25, 20)Week 20: Vitality (n = 24, 20)Week 24: Vitality (n = 22, 20)Week 28: Vitality (n = 23, 19)Week 36: Vitality (n = 21, 19)Week 44: Vitality (n = 21, 16)Week 52: Vitality (n = 21, 16)Week 4: Social Functioning (SF) (n = 27, 23)Week 8: SF (n = 26, 21)Week 12: SF (n = 25, 20)Week 16: SF (n = 25, 20)Week 20: SF (n = 24, 20)Week 24: SF (n = 22, 20)Week 28: SF (n = 23, 19)Week 36: SF (n = 21, 19)Week 44: SF (n = 21, 16)Week 52: SF (n = 21, 16)Week 4: Role-Emotional (RE) (n = 27, 23)Week 8: RE (n = 26, 21)Week 12: RE (n = 25, 20)Week 16: RE (n = 25, 20)Week 20: RE (n = 24, 20)Week 24: RE (n = 22, 20)Week 28: RE (n = 23, 19)Week 36: RE (n = 21, 19)Week 44: RE (n = 21, 16)Week 52: RE (n = 21, 16)Week 4: Mental Health (MH) (n = 27, 23)Week 8: MH (n = 26, 21)Week 12: MH (n = 25, 20)Week 16: MH (n = 25, 20)Week 20: MH (n = 24, 20)Week 24: MH (n = 22, 20)Week 28: MH (n = 23, 19)Week 36: MH (n = 21, 19)Week 44: MH (n = 21, 16)Week 52: MH (n = 21, 16)
Placebo-1.250.18-0.38-0.86-0.10-2.11-0.40-1.31-0.360.120.49-0.751.01-1.12-0.45-0.001.770.240.701.407.689.686.844.508.633.936.327.819.008.390.230.180.62-0.74-0.38-0.191.18-0.47-0.300.15-1.420.71-0.30-0.450.45-1.930.161.41-0.930.371.742.631.760.753.510.003.175.010.632.823.481.990.52-0.000.35-1.221.100.733.260.430.571.494.455.366.412.616.065.641.144.25
Secukinumab0.14-0.440.38-0.000.800.521.251.371.002.463.493.803.324.584.403.375.965.995.136.208.035.806.927.696.105.976.477.208.015.493.492.742.222.284.502.853.533.421.023.034.072.173.574.284.703.786.207.076.087.213.714.824.015.214.814.563.497.166.457.16-0.773.08-0.423.763.482.853.635.474.156.143.02.823.144.293.492.622.845.984.115.73

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Total Cumulative Prednisolone Dose Over 28 Weeks and 52 Weeks

Total cumulative co-administered prednisolone treatment was summarized over time by treatment arm. Patients received a daily dose of prednisolone, which was decreased (i.e. tapered down) from Baseline to Week 26. No additional prednisolone or equivalent was permitted. (NCT03765788)
Timeframe: from Baseline to week 28, from baseline to week 52 weeks

,
Interventionmilligrams (Mean)
Baseline to Week 28Baseline to Week 52
Placebo2693.743375.58
Secukinumab2689.702841.26

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Number of Participants on Prednisolone Dose ≤ 5mg/Day

"Number of participants on co-administered prednisolone treatment ≤ 5mg/day who responded at Week 19, Week 26 and Week 52.~Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper Regimen. There were 2 taper regimens: for patients on 40 to 60 mg/day prednisolone at Baseline and for patients on 25 to 40 mg/day prednisolone at Baseline depending on patients' prednisolone levels at Baseline. Prednisolone was tapered from a dose of 25 mg to 60 mg at Baseline to 1 mg at Week 26 [last dose]." (NCT03765788)
Timeframe: Week 19, Week 28, Week 52

,
InterventionParticipants (Count of Participants)
Week 19 (n = 25, 20)Week 28 (n = 23, 20)Week 52 (n = 21, 17)
Placebo10913
Secukinumab221919

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Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS)

Patient Reported Outcome: Patients global assessment (PGA) score using a VAS scale. VAS is a range of scores from 0-100, with lower change from baseline scores indicating a more favorable outcome and higher change from baseline scores indicating a greater disease activity. (NCT03765788)
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52

,
Interventionscores on a scale (Mean)
Week 4 (n = 27, 23)Week 8 (n = 26, 21)Week 12 (n = 25, 20)Week 16 (n = 25, 20)Week 20 (n = 24, 20)Week 24 (n = 23, 20)Week 28 (n = 23, 19)Week 36 (n = 21, 19)Week 44 (n = 21, 16)Week 52 (n = 21, 16)
Placebo-0.5-10.8-11.9-8.8-6.9-7.0-8.0-8.6-9.4-15.9
Secukinumab-15.8-15.8-8.0-18.6-19.18-14.9-14.4-20.9-21.7-19.2

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Safety Will be Monitored Through Regular Review of Electrolytes.

Electrolytes (Sodium, Potassium, Cloride and Carbon dioxide, mmol/L) will be measured on a monthly basis following initiation of either spironolactone or prednisolone. (NCT03777319)
Timeframe: 6 months

,
Interventionmmol/L (Number)
Sodium-BaselineSodium-Month 1Sodium-Month 2Sodium-Month 3Sodium-Month 4Sodium-Month 5Sodium-Month 6Potassium-BaselinePotassium-Month 1Potassium-Month 2Potassium-Month 3Potassium-Month 4Potassium-Month 5Potassium-Month 6Chloride-BaselineChloride-Month 1Chloride-Month 2Chloride-Month 3Chloride-Month 4Chloride-Month 5Chloride-Month 6CO2-BaselineCO2-Month 1CO2-Month 2CO2-Month 3CO2-Month 4CO2-Month 5CO2-Month 6
Prednisolone1401401391411391391433.844.53.94.64.23.910510510410510510610522242424252626
Spironolactone1421421411421391391404.54.74.24.14.54.54.310310910710310310310129222527282826

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Efficacy: Change in Time to Complete a 100 Meter Timed Test.

The determination of whether spironolactone has similar efficacy to glucocorticoids in improving muscle strength in steroid naïve DMD patients. This will be determined by measuring the time to complete a 100 meter timed test (100M). (NCT03777319)
Timeframe: 6 months

Interventionsec (Number)
Spironolactone-0.6
Prednisolone-5.3

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Efficacy: Dynamometry Score

Secondary outcome measures will be Dynamometry score, which is a summation of maximum voluntary isometric contraction test values for knee flexion, knee extension, elbow flexion, and elbow extension (NCT03777319)
Timeframe: 6 months

,
Interventionkg (Number)
Elbow Flexion (Right)-BaselineElbow Flexion (Left)-BaselineElbow Extension (Right)-BaselineElbow Extension (Left)-BaselineKnee Flexion (Right)-BaselineKnee Flexion (Left)-BaselineKnee Extension (Right)-BaselineKnee Extension (Left)-BaselineElbow Flexion (Right)-Month 6Elbow Flexion (Left)-Month 6Elbow Extension (Right)-Month 6Elbow Extension (Left)-Month 6Knee Flexion (Right)-Month 6Knee Flexion (Left)-Month 6Knee Extension (Right)-Month 6Knee Extension (Left)-Month 6
Prednisolone3.64.15.34.13.33.44.85.22.93.44.33.84.13.965.1
Spironolactone00004.12.83.85.93.13.52.42.54.34.17.28.3

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Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study

To establish acceptability of this treatment approach assessing proportion of patients who are eligible, consent and complete the 48 week study. We will examine how many patients in the MONITOR cohort are eligible per year. All eligible patients in the MONITOR cohort will be approached and invited to join the study. We will then review how many patients complete the 48 week study period attending all visits from baseline to 48 weeks (0, 12, 24, 36 and 48). (NCT03797872)
Timeframe: 48 weeks

InterventionParticipants (Count of Participants)
Standard Care0

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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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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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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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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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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 (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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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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ICU Admission

Number of subjects admitted to the ICU (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

InterventionParticipants (Count of Participants)
Usual Care10
Biomarker-adjusted Steroid Dosing5

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Cardiovascular Dysfunction

Number of subjects with new and/or worsening right ventricle (RV)/left ventricle (LV) dysfunction (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

InterventionParticipants (Count of Participants)
Usual Care1
Biomarker-adjusted Steroid Dosing1

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Need for Noninvasive Mechanical Ventilation

Assessed by the number of participants that required noninvasive mechanical ventilation. (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

InterventionParticipants (Count of Participants)
Usual Care4
Biomarker-adjusted Steroid Dosing2

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Organ Failure

Organ failures measured by Sequential Organ Failure Assessment (SOFA). The overall score is based on 6 sub-scores respiratory system, neurologic system, cardiovascular system, hepatic system, coagulation, and renal system using an overall scale of 0-24, which 0=no organ failure, 24=complete organ failure. (NCT03852537)
Timeframe: Measured daily for approximately 5 days

,
Interventionscore on a scale (Median)
Day 1Day 2Day 3Day 4Day 5
Biomarker-adjusted Steroid Dosing7.03.03.03.05.5
Usual Care3.03.03.03.03.0

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Timely Initiation of Corticosteroids and Implementation of Biomarker-titrated Corticosteroid Dosing

Number of eligible subjects to adhered to the timely initiation and daily corticosteroid treatment according to ESICM/Society of Critical Care Medicine SCCM clinical practice guideline (control group) or biomarker concordance (intervention group) (NCT03852537)
Timeframe: Within 30 days of enrollment in study.

InterventionParticipants (Count of Participants)
Usual Care20
Biomarker-adjusted Steroid Dosing19

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Oxygen-free Days

Number of days subjects did not require oxygen assistance. (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

Interventiondays (Median)
Usual Care21.0
Biomarker-adjusted Steroid Dosing24.0

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Occurrence of Secondary Infection

Number of participants who develop secondary infections during and after steroid therapy. A secondary infection is defined as a new infection that develops after initiation of corticosteroid therapy, until 5 days after steroids are discontinued. (NCT03852537)
Timeframe: Up to day +14 following study enrollment.

InterventionParticipants (Count of Participants)
Usual Care0
Biomarker-adjusted Steroid Dosing0

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Occurrence of Hyperglycemia

Number of participants who have hyperglycemia while receiving corticosteroids. Hyperglycemia is defined as a consistently elevated blood sugar level requiring insulin administration. (NCT03852537)
Timeframe: Up to day +5 following study enrollment.

InterventionParticipants (Count of Participants)
Usual Care11
Biomarker-adjusted Steroid Dosing18

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Occurrence of Delirium

Number of participants who develop delirium while receiving corticosteroids. Delirium will be assessed by Confusion Assessment Method for the ICU (CAM-ICU) measurement tool. The CAM-ICU is a binary (yes/no) scale for assessing the presence of delirium. (NCT03852537)
Timeframe: Up to day +5 following study enrollment.

InterventionParticipants (Count of Participants)
Usual Care5
Biomarker-adjusted Steroid Dosing5

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New Onset Cardiac Arrhythmias

Number of participants who develop arrhythmias identified by electrocardiogram or echocardiogram. (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

InterventionParticipants (Count of Participants)
Usual Care0
Biomarker-adjusted Steroid Dosing1

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Need for Invasive Mechanical Ventilation

Assessed by the number of participants that required invasive mechanical ventilation. (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

InterventionParticipants (Count of Participants)
Usual Care3
Biomarker-adjusted Steroid Dosing2

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Need for High Flow Nasal Cannula Oxygen

Number of subjects to need high flow nasal cannula oxygen (NCT03852537)
Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

InterventionParticipants (Count of Participants)
Usual Care7
Biomarker-adjusted Steroid Dosing4

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Myocardial Injury

Number of participants with evidence of myocardial injury determined by daily troponin peak and /or new diagnosis of Left Ventricular (LV) dysfunction (LVEF <40%) or new diagnosis of cor pulmonale (NCT03852537)
Timeframe: Up to day +14 following study enrollment.

InterventionParticipants (Count of Participants)
Usual Care8
Biomarker-adjusted Steroid Dosing10

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Mortality

Number of subject deaths (NCT03852537)
Timeframe: 90 days

InterventionParticipants (Count of Participants)
Usual Care1
Biomarker-adjusted Steroid Dosing1

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Percentage of Participants With Biopsy Proven Acute Rejection (BPAR)

Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. (NCT04046549)
Timeframe: Week 12, 24, 48

Interventionpercentage of participants (Number)
Week 12Week 24Week 48
Belatacept+VIB492025.025.025.0

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Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR)

Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. tBPAR was defined as a BPAR which was treated with anti-rejection therapy. (NCT04046549)
Timeframe: Week 12, 24, 48

Interventionpercentage of participants (Number)
Week 12Week 24Week 48
Belatacept+VIB492025.025.025.0

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Percentage of Participants With Treated Acute Rejections

Acute rejections, per clinical judgement of the investigator followed by confirmatory biopsy, were treated with bolus methylprednisolone (other corticosteroids were acceptable at an equivalent dose) according to local practice. (NCT04046549)
Timeframe: Week 12, 24, 48

Interventionpercentage of participants (Number)
Week 12Week 24Week 48
Belatacept+VIB492025.025.030.0

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Percentage of Participants With Antibody-Mediated Rejection

The diagnosis of antibody-mediated rejection was based on Banff criteria 2017 - a set of standardized guidelines used by pathologists and clinicians to diagnose and classify rejection based on specific features observed in biopsy samples from the transplanted organ, such as the presence of certain types of immune cells, inflammation, and injury patterns. (NCT04046549)
Timeframe: Week 12, 24, 48

Interventionpercentage of participants (Number)
Week 12Week 24Week 48
Belatacept+VIB492010.010.015.0

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Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Week 24

Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. (NCT04046549)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Belatacept+VIB492025.0

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Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Weeks 12 and 48

Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. (NCT04046549)
Timeframe: Weeks 12 and 48

Interventionpercentage of participants (Number)
Week 12Week 48
Belatacept+VIB492025.025.0

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Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR), Graft Loss, Death or Loss to Follow-up (LTFU)

Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima. (NCT04046549)
Timeframe: Week 12, 24, 48

Interventionpercentage of participants (Number)
Week 12Week 24Week 48
Belatacept+VIB492025.025.025.0

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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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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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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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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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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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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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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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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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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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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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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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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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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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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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Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively

Tear Film Osmolarity as measured on Tear Lab system; validated measure of Tear Film Osmolarity Osmolarity was reported in milliosmoles per liter (mOsmol/L) (NCT04184999)
Timeframe: 3 weeks

InterventionmOsmol/L (Mean)
Intracameral Dexamethasone311.15
Postoperative Prednisolone Acetate316.3

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Number of SLE Patients That Were Sampled for RNA-seq Differential Expression Analysis (Biological Replicates)

Number of of SLE patients that were sampled for RNA-seq differential gene expression analysis in glucocorticoid-treated immune cells. The analysis employed a cutoff value of < 5% false-discovery rate (FDR) to select the transcripts that were considered differentially expressed at each time point. The resulting gene lists were contrasted to determine which genes were uniquely differentially expressed in different cell types. (NCT04233164)
Timeframe: 2 hours and 4 hours post infusion

,
InterventionParticipants (Count of Participants)
2 hours post infusion4 hours post infusion
Group A: Glucocorticoids 1 mg/kg Dose2020
Group B: Glucocorticoids 250 mg Dose2020

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Admission to Intensive Care Unit (ICU)

We reported below the number of participants admitted to ICU within 28 days. (NCT04323592)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Exposed to Methylprednisolone15
Non-exposed to Methylprednisolone27

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In-hospital Death Within 28 Days

We reported below the number of participants who died within 28 days, during the hospital stay. (NCT04323592)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Exposed to Methylprednisolone6
Non-exposed to Methylprednisolone21

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Endotracheal Intubation (Invasive Mechanical Ventilation)

We reported below the number of participants who needed endotracheal intubation during ICU admission (NCT04323592)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Exposed to Methylprednisolone15
Non-exposed to Methylprednisolone26

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Change in C-reactive Protein (CRP)

Change in C-reactive protein after 7 days from baseline. A reduction of CRP reveals a laboratory improvement. (NCT04323592)
Timeframe: 7 days

Interventionmg/L (Mean)
Exposed to Methylprednisolone-82.08
Non-exposed to Methylprednisolone-34.34

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Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation (MV), or All-cause Death by Day 28

We reported below the number of participants meeting at least one of three among death or ICU admission or Invasive mechanical ventilation. (NCT04323592)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Exposed to Methylprednisolone19
Non-exposed to Methylprednisolone40

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Number of Days Free From Mechanical Ventilation

number of days free from mechanical ventilation (both invasive and non-invasive) by day 28 (NCT04323592)
Timeframe: 28 days

Interventiondays (Mean)
Exposed to Methylprednisolone19.11
Non-exposed to Methylprednisolone14.34

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Patient Preference Between Groups

As reported by patients choosing one of five options; Strongly preferred insert, preferred insert, no preference, preferred standard drop regimen, strongly preferred standard drop regimen. (NCT04380857)
Timeframe: Day 7, Day 30 and Day 90

,,
InterventionParticipants (Count of Participants)
Day 7Day 30Day 90
Dexamethasone Ophthalmic Insert 0.4 mg14119
No Preference435
Topical Prednisolone Acetate Ophthalmic Drops233

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Mean Change in Pain

"post-op pain as measured as scores on an Ocular Pain Assessment Scale from 0-10 (0 being no pain and 10 being the worst pain you could imagine)" (NCT04380857)
Timeframe: Change is being assessed at Baseline, Day 1, Day 7, Day 30 and Day 90

,
InterventionScore on a scale from 0-10 (Mean)
Pre-operativeDay 1Day 7Day 30Day 90
Dexamethasone Ophthalmic Insert 0.4 mg0.150.950.470.410
Topical Prednisolone Acetate Ophthalmic Drops0.200.900.370.060

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Loss of Lines in Uncorrected Visual Acuity

All units assessed for uncorrected visual acuity using ETDRS. Number of lines seen was then converted to LogMar to measure changes in uncorrected visual acuity between Baseline and Day 90. (NCT04380857)
Timeframe: Baseline to Day 7, Day 30 and Day 90

,
InterventionlogMAR (Mean)
1 week1 month3 months
Dexamethasone Ophthalmic Insert 0.4 mg-0.010-0.014-0.071
Topical Prednisolone Acetate Ophthalmic Drops0.013-0.026-0.068

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Post op Pain Management Per Eye

Count of participants requiring pain management from Day 0 to Day 90. (NCT04380857)
Timeframe: Day 0 to Day 90

InterventionEyes (Count of Units)
Dexamethasone Ophthalmic Insert 0.4 mg0
Topical Prednisolone Acetate Ophthalmic Drops0

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Number of Lines Lost From Best Corrected Visual Acuity

After manifest refraction all units assessed for best corrected distance visual acuity using ETDRS. Number of lines seen was then converted to LogMar score (on a scale of -0.30 to 1.00 where smaller numbers indicate better vision and larger numbers indicate worse vision) to measure changes in Best Corrected Distance Visual Acuity between Baseline and Day 90 (NCT04380857)
Timeframe: Baseline through Day 90

InterventionScore on a scale (Mean)
Dexamethasone Ophthalmic Insert 0.4 mg0
Topical Prednisolone Acetate Ophthalmic Drops0

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Spectacle Corrected Distance Visual Acuity at Months 1 and 3 Post-operative

Best-corrected distance visual acuity measured using ETDRS acuity chart at 4 meters, recorded in logMAR notation (NCT04396990)
Timeframe: Month 1 and Month 3

,
InterventionlogMAR (Mean)
Month 1Month 3
Dexamethasone Insert Arm-0.051-0.146
Topical Steroid Arm-0.093-0.167

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Mean Pain Score Per Eye (Group A: Dextenza vs. Group B: Topical Steroid)

Pain score as measured by the Numerical Rating Scale (NRS) at day 3 post-operative. The rating scale is from 0-10 with 0 being no pain and 10 being severe pain. (NCT04396990)
Timeframe: Day 3

Interventionscore on a scale (Mean)
Dextenza Group Pain Score0.9
Topical Steroid Group Pain Score0.850

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Uncorrected Distance Visual Acuity

measured using the ETDRS acuity chart at 4 meters recorded in logMAR. (NCT04396990)
Timeframe: Month 1 and Month 3.

,
InterventionlogMAR (Mean)
Uncorrected distance visual acuity at month 1Uncorrected distance visual acuity at month 3
Dexamethasone Insert Group0.0005-1.117
Topical Steroid Group-0.073-0.153

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SPEED Questionnaire Results at Baseline and Postoperative Day 28

Patient evaluation of eye dryness measured by a modified SPEED questionnaire with a results recorded 0-28 with 28 being the most severe. (NCT04396990)
Timeframe: Pre-op Visit and Month 1 (Day 28)

,
Interventionscore on a scale (Mean)
BaselineDay 28
Dexamethasone Insert Group3.754.00
Topical Steroid Group3.704.22

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Incidence of Pain

Recorded when subject reports pain. Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever (NCT04900220)
Timeframe: Up to 7 days

InterventionParticipants (Count of Participants)
Betamethasone6
Methylprednisolone11

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Intensity of Pain

Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever (NCT04900220)
Timeframe: Up to 7 days

,
Interventionscore on a scale (Mean)
BaselineFive MinutesDay 1Day 2Day 3Day 4Day 5Day 6Day 7
Betamethasone2.80.31.41.31.00.70.60.60.5
Methylprednisolone2.10.82.92.11.51.00.80.70.6

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Patient Reported Outcome Measures: Post Treatment Pain Scores

"Knee society score (KSS); done standard of care on a scale of 0-100, where 100 means a more functional knee.~**Please note, the study was terminated early, only 4 subjects were enrolled and none were randomized to the placebo group. At 3 weeks post treatment, only 3 of the 4 subjects enrolled were still part of the study." (NCT05113901)
Timeframe: 3 weeks post treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper68.33

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Patient Reported Outcome Measures: Post Treatment Pain Scores (6 Weeks)

"Using daily defense and veterans pain rating scale (DVPRS) on a scale of 1 to 10, 10 being the worst.~Please note, only one patient made it to the 6 week post treatment mark of the 4 enrolled. The study was terminated and none of the patients were randomized to the placebo group. All other patients followed up but were not interested in continuing. No range could be provided given only one subject answered and completed this visit" (NCT05113901)
Timeframe: 6 weeks post treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper1.93

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Patient Reported Outcome Measures: Post Treatment Pain Scores

"Knee society score (KSS); done standard of care on a scale of 0-100, where 100 means a more functional knee.~**Please note, the study was terminated early, only 4 subjects were enrolled and none were randomized to the placebo group. This is a standard of care survey available on all subjects." (NCT05113901)
Timeframe: 6 weeks post treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper78.75

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Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment

Single Assessment Numeric Evaluation (SANE), a single-question patient rating of 0-100, scoring their function to the area being treated. Zero represents a poor functional knee and 100 is the best functioning. (NCT05113901)
Timeframe: 6 weeks after treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper89.5

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Patient Reported Outcome Measures:(Immediate) Post Treatment Pain Scores

"Using Daily Visual Analogue Scale (VAS) pain score, which measures intensity of pain on a scale of 0 (no pain) to 10 (worst pain possible).~**Please note, this study was terminated early, only enrolling 4 patients, none were randomized to the placebo group." (NCT05113901)
Timeframe: Days 1 through 6 following treatment

Interventionscore on a scale (Mean)
Day 1Day 2Day 3Day 4Day 5Day 6
Methylprednisolone Taper2.3331.331.331.672.3

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Patient Reported Outcome Measures: Overall Assessment of Knee Prior to Treatment

UCLA activity score, on a scale of 1 to 10 where 10 is the most active patient with examples of activities (NCT05113901)
Timeframe: pre treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper4.25

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Number of Participants With Complications Following Treatment

Manipulations under anesthesia (MUAs) following total knee arthroplasty surgery and treatment (NCT05113901)
Timeframe: within 90 days after initial total knee arthroplasty

InterventionParticipants (Count of Participants)
Methylprednisolone Taper0
Placebo Taper0

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Patient Reported Outcome Measures: Overall Assessment of Knee Prior to Treatment

Forgotten Joint Score (FJS) is a survey scored ranging from 0 to 100, where a high score indicates a high degree of a forgetting they have an artificial joint, which is an ideal outcome. (NCT05113901)
Timeframe: pre treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper91.67

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Range of Motion in Degrees at Pre and Post Treatment

"Range of motion (ROM) from pre-treatment to six weeks following treatment. Patients started treatment after total knee replacement surgery and presented to clinic with at least one inclusion criteria to be enrolled. Range of motion in degrees is taken at each visit by a clinician (standard of care), starting at zero degrees (straight leg) to about 135 degrees. The ROM was documented as part of consenting and enrollment into study. Subjects returned to the office at 6 weeks post treatment where ROM was performed in a clinic setting once again and documented. ROM is done using a goniometer by a clinician in each clinic.~This study was terminated early, therefore of the 4 enrolled, zero were randomized to the placebo group. Only 1 of the four subjects completed the 6 weeks, however, ROM was captured on all as standard of care." (NCT05113901)
Timeframe: Baseline, Week 6 Following Treatment

InterventionRange of Motion in Degrees (Mean)
Pre treatmentPost treatment
Methylprednisolone Taper82.5112

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Patient Reported Outcome Measures: Pre Treatment Pain Scores Using Knee Society Scores

"Knee society score (KSS); done standard of care on a scale of 0-100, where 100 means a more functional knee~**Please note, the study was terminated early, only 4 subjects were enrolled and none were randomized to the placebo group." (NCT05113901)
Timeframe: pre treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper66.25

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Adverse Events or Outcomes Outside of Manipulations Under Anesthesia

Adverse outcomes including infection, avascular necrosis, and 90-day readmission rates (NCT05113901)
Timeframe: within 90 days after initial total knee arthroplasty

InterventionParticipants (Count of Participants)
Methylprednisolone Taper0
Placebo Taper0

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Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment

VR-12: Assesses physical functioning, physical/ mental limitations. Scored as summary of mental and physical, measure in standard deviations. The scale range is 0 to 100, where a score of 100 represents the best physical and mental health and zero is the worst outcome. (NCT05113901)
Timeframe: 6 weeks after treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper50.28

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Patient Reported Outcome Measures: Overall Assessment of Knee 6 Wks After Treatment

Forgotten Joint Score (FJS) is a survey scored ranging from 0 to 100, where a high score indicates a high degree of a forgetting they have an artificial joint, which is an ideal outcome. (NCT05113901)
Timeframe: 6 weeks after treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper57.82

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Patient Reported Outcome Measures: Overall Assessment of Knee After Surgery and Treatment

Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR), a survey given to patients standard of care containing 7 questions. The score ranges from 0 to 100 where zero represents total disability and 100 represents a perfect knee health. (NCT05113901)
Timeframe: 6 weeks after treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper72.12

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Patient Reported Outcome Measures: Overall Assessment of Knee After Surgery and Treatment

Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR), a survey given to patients standard of care containing 7 questions. The score ranges from 0 to 100 where zero represents total disability and 100 represents a perfect knee health. (NCT05113901)
Timeframe: pre treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper50.04

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Patient Reported Outcome Measures: Overall Assessment of Knee Before Treatment

Single Assessment Numeric Evaluation (SANE), a single-question patient rating of 0-100, scoring their function to the area being treated. Zero represents a poor functional knee and 100 is the best functioning. (NCT05113901)
Timeframe: pre treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper29.5

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Patient Reported Outcome Measures: Overall Assessment of Knee Before Treatment

Veterans Rand 12-Item Health Survey (VR-12), a survey of 12 questions to measure health relating to patient's quality of life. Scored as summary of mental and physical, measure in standard deviations. The scale range is 0 to 100, where a score of 100 represents the best physical and mental health and zero is the worst outcome. (NCT05113901)
Timeframe: pre treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper38.73

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Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment

UCLA activity score, on a scale of 1 to 10 where 10 is the most active patient with examples of activities (NCT05113901)
Timeframe: 6 weeks after treatment

Interventionscore on a scale (Mean)
Methylprednisolone Taper5.25

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